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Clinical NLP Lab 23

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Seven studies met the inclusion criteria. No studies had investigated selective inclusion of results in systematic reviews, or discrepancies in outcomes and analyses between systematic review registry entries and published systematic reviews. Based on a meta-analysis of four studies (including 485 Cochrane Reviews), 38% (95% confidence interval (CI) 23% to 54%) of systematic reviews added, omitted, upgraded or downgraded at least one outcome between the protocol and published systematic review. The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain. The meta-analytic estimate suggested an increased risk of adding or upgrading (i.e. changing a secondary outcome to primary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.43, 95% CI 0.71 to 2.85; two studies, n = 552 meta-analyses). Also, the meta-analytic estimate suggested an increased risk of downgrading (i.e. changing a primary outcome to secondary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.26, 95% CI 0.60 to 2.62; two studies, n = 484 meta-analyses). None of the included studies had investigated whether the association between statistical significance and adding, upgrading or downgrading of outcomes was modified by the type of comparison, direction of effect or type of outcome; or whether there is an association between direction of the effect estimate and discrepant outcome reporting. Several secondary outcomes were reported in the included studies. Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic reviews (6% in one study and 22% in the other). One study (including 62 Cochrane Reviews) found that 32% (95% CI 21% to 45%) of systematic reviews did not report all primary outcomes in the abstract. Another study (including 64 Cochrane and 118 non-Cochrane reviews) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes (RR 2.66, 95% CI 1.81 to 3.90). None of the studies included systematic reviews published after 2009 when reporting standards for systematic reviews (Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, and Methodological Expectations of Cochrane Intervention Reviews (MECIR)) were disseminated, so the results might not be generalisable to more recent systematic reviews. Discrepant outcome reporting between the protocol and published systematic review is fairly common, although the association between statistical significance and discrepant outcome reporting is uncertain. Complete reporting of outcomes in systematic review abstracts is associated with statistical significance of the results for those outcomes. Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results. Modifications that occur once the review has commenced, along with their justification, should be clearly reported. Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results. The lack of research on selective inclusion of results in systematic reviews needs to be addressed and studies that avoid the methodological weaknesses of existing research are also needed.\nOutput:\n" }, { "from": "agent", "value": "A systematic review summarises evidence from multiple studies to answer a specific research question (e.g. what are the benefits and harms of a particular intervention for a particular health condition?). Often, there are many outcomes that systematic review authors could report to address their research question (e.g. pain, disability and quality of life for patients with musculoskeletal conditions) and many different results available for a particular outcome (e.g. a study might measure pain using three different scales at four time points). If the decision about which outcomes to investigate in a systematic review is made based on the results for those outcomes in the eligible studies, this may lead to bias. While, if the decision about which outcomes to report in a systematic review and the ways to report them is based on the results, this may mislead users of the systematic review. This methodology review summarises the findings of studies examining the inclusion of results and reporting of outcomes in systematic reviews. We searched for studies indexed in electronic bibliographic databases up to May 2013. We included seven studies and found that outcomes investigated and reported in systematic reviews were often changed between the protocol and published systematic review. We also found that it was unclear whether the decision to make these changes was related to how statistically convincing the treatment effect for that outcome was. More studies are needed to confirm if this relationship exists. Also, one study found that some systematic reviews did not report all of the most important outcomes in the abstract of the review. Another study found that outcomes with a more statistically convincing result were more likely to be completely reported in the abstract than other outcomes. The studies that we included were limited to systematic reviews published before 2009. New studies are needed to examine the inclusion of results and reporting of outcomes in more recent systematic reviews." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 14 studies investigating the use of cholinergic drugs compared with placebo published between 1976 and 2014. All studies involved small numbers of participants (five to 60 people). Three studies that investigated the new cholinergic Alzheimer drugs for the treatment of TD are new to this update. Overall, the risk of bias in the included studies was unclear, mainly due to poor reporting; allocation concealment was not described, generation of the sequence was not explicit, studies were not clearly blinded, we are unsure if data are incomplete, and data were often poorly or selectively reported. We are uncertain about the effect of new or old cholinergic drugs on no clinically important improvement in TD symptoms when compared with placebo; the quality of evidence was very low (RR 0.89, 95% CI 0.65 to 1.23; 27 people, 4 RCTs). Eight trials found that cholinergic drugs may make little or no difference to deterioration of TD symptoms (low-quality evidence, RR 1.11, 95% CI 0.55 to 2.24; 147 people). Again, due to very low-quality evidence, we are uncertain about the effects on mental state (RR 0.50, 95% CI 0.10 to 2.61; 77 people, 5 RCTs), adverse events (RR 0.56, 95% CI 0.15 to 2.14; 106 people, 4 RCTs), and leaving the study early (RR 1.09,95% CI 0.56 to 2.10; 288 people 12 RCTs). No study reported on social confidence, social inclusion, social networks, or personalised quality of life. TD remains a major public health problem. The clinical effects of both older cholinergic drugs and new cholinergic agents, now used for treating Alzheimer's disease, are unclear, as too few, too small studies leave many questions unanswered. Cholinergic drugs should remain of interest to researchers and currently have little place in routine clinical work. However, with the advent of new cholinergic agents now used for treating Alzheimer's disease, scope exists for more informative trials. If these new cholinergic agents are to be investigated for treating people with TD, their effects should be demonstrated in large well-designed, conducted and reported randomised trials.\nOutput:\n" }, { "from": "agent", "value": ". We searched for trials in July 2015 and April 2017, using the Cochrane Schizophrenia Group's register of trials. The review includes 14 studies investigating the use of cholinergic drugs compared with placebo. All studies randomised small numbers of participants (five to 60 people) with schizophrenia or other chronic mental illnesses who had also developed antipsychotic-induced tardive dyskinesia. . We found the effects of both older and newer cholinergic drugs to be unclear as too few and too small studies are available and do not yield great evidence and leave many questions unanswered. . The available evidence is weak, limited, and small scale. It is not possible to recommend these drugs as a treatment for tardive dyskinesia based on our findings. To fully investigate whether the use of cholinergic drugs have any positive effects for people with tardive dyskinesia, there would have to be well-designed, larger, longer-term studies, particularly on new cholinergic drugs currently being used for treating Alzheimer’s disease. Ben Gray, Senior Peer Researcher, McPin Foundation. http://mcpin.org/" } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Twenty-two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy-two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy-one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly-seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo-controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co-morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co-morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest.\nOutput:\n" }, { "from": "agent", "value": "We searched the medical literature up to 26 January 2017. All randomised trials that compare two different antibiotics, or variations in dosing of a single antibiotic for treatment of CDI were included. Trials comparing antibiotic to placebo (e.g. a sugar pill) or no treatment were sought but, save for one poor quality placebo-controlled trial, none were found. Trials that compared antibiotics to a non-antibiotic treatment were not included. Results Twenty-two studies (total 3215 participants) were included. The majority of studies enrolled participants with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded participants with severe CDI and few participants with severe CDI were included in the other studies. Twelve different antibiotics were assessed. Most of the studies compared vancomycin or metronidazole with other antibiotics. One small study compared vancomycin to placebo (e.g. sugar pill). There were no other studies that compared antibiotic treatment to a placebo or a no treatment control group. Seventeen of the 22 included studies had quality issues. In four studies, vancomycin was found to be superior to metronidazole for achieving sustained symptomatic cure (defined as resolution of diarrhoea and no recurrence of CDI). We rated the quality of the evidence supporting this finding as moderate. A new antibiotic, fidaxomicin, was, in two large studies, found to be superior to vancomycin. The quality of the evidence supporting this finding was moderate. It should be noted that the differences in effectiveness between these antibiotics were not too great and that metronidazole is far less expensive than either vancomycin and fidaxomicin. A pooled analysis of two small studies suggests that teicoplanin may be more effective than vancomycin for achieving symptomatic cure. The quality of the evidence supporting this finding was very low. The quality of the evidence for the other seven antibiotics in this review was very poor because the studies were very small, and many patients dropped out of these studies before completion. One hundred and forty deaths were reported in the studies, all of which were attributed to participants preexisting health problems. The only side effects attributed to antibiotics were rare nausea and temporary elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13. Vancomycin 125 mg costs USD 1779 compared to fidaxomicin 200 mg at USD 3453.83 or more and teicoplanin at approximately USD 83.67. Conclusion No firm conclusions can be drawn regarding the effectiveness of antibiotic treatment in severe CDI as most studies excluded these patients. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the antibiotic that caused CDI. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other antibiotics. The quality of evidence for teicoplanin is very low. Larger studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin would be of interest." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included in the review seven studies with a total of 852 participants. The methodological quality of the included studies was generally ranked as showing low risk of bias in most domains, with the exception of one study, which did not mask participants. We were able to include data from 838 participants in the meta-analysis. We found no statistically significant differences between participants receiving air and those given saline in any of the outcomes evaluated: inability to locate the epidural space (three trials, 619 participants) (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.33 to 2.31, low-quality evidence); accidental intravascular catheter placement (two trials, 223 participants) (RR 0.90, 95% CI 0.33 to 2.45, low-quality evidence); accidental subarachnoid catheter placement (four trials, 682 participants) (RR 2.95, 95% CI 0.12 to 71.90, low-quality evidence); combined spinal epidural failure (two trials, 400 participants) (RR 0.98, 95% CI 0.44 to 2.18, low-quality evidence); unblocked segments (five studies, 423 participants) (RR 1.66, 95% CI 0.72 to 3.85); and pain measured by VAS (two studies, 395 participants) (mean difference (MD) -0.09, 95% CI -0.37 to 0.18). With regard to adverse effects, we found no statistically significant differences between participants receiving air and those given saline in the occurrence of paraesthesias (three trials, 572 participants) (RR 0.89, 95% CI 0.69 to 1.15); difficulty in advancing the catheter (two trials, 227 participants) (RR 0.91, 95% CI 0.32 to 2.56); catheter replacement (two trials, 501 participants) (RR 0.69, 95% CI 0.26 to 1.83); and postdural puncture headache (one trial, 110 participants) (RR 0.83, 95% CI 0.12 to 5.71). Low-quality evidence shows that results do not differ between air and saline in terms of the loss of resistance technique for identification of the epidural space and reduction of complications. Applicability might be compromised, as most of the results described in this review were obtained from parturient patients. This review underlines the need to conduct well-designed trials in this field.\nOutput:\n" }, { "from": "agent", "value": "Adults (18 years of age and older) undergoing surgical procedures, pregnant women in obstetrical labour and patients receiving postoperative pain relief. The evidence is current to September 2013. We found seven studies with a total of 852 participants. The maximum time that a participant was followed by the doctor was 24 hours after giving birth. The quality of the included studies was considered reasonable. The following results were examined: inability to locate the epidural space; accidental catheter placement (mis-insertion of the catheter); combined spinal epidural failure (cases of failed regional anaesthetic technique, which combines the benefits of spinal and epidural anaesthesia); unblocked segments (patchy block); and pain. We found no convincing evidence that results differed when air or saline was used. Because conducted studies were only reasonably well conducted (results very similar across studies; minor issues with study design; and not enough data), we ranked the overall quality of the evidence as low. The applicability of findings might be compromised, as most of the results described in this review were obtained from parturient patients. Low-quality evidence shows that results do not differ between air and saline in using loss of resistance technique for identification of the epidural space and in reducing complications." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: The search identified 13 studies in addition to the two studies in the previous version of our systematic review. Overall, we included data from 15 trials with 33,970 people. We completed a 'Risk of bias' assessment for all studies. The risk of bias was low in four trials because they were at low risk of bias for all key domains (random sequence generation, allocation concealment, blinding, selective outcome reporting and incomplete outcome data), even if some of them were funded by the pharmaceutical industry. Analysis showed no difference in the effectiveness of aspirin plus clopidogrel in preventing cardiovascular mortality (RR 0.98, 95% CI 0.88 to 1.10; participants = 31,903; studies = 7; moderate quality evidence), and no evidence of a difference in all-cause mortality (RR 1.05, 95% CI 0.87 to 1.25; participants = 32,908; studies = 9; low quality evidence). There was a lower risk of fatal and non-fatal myocardial infarction with clopidogrel plus aspirin compared with aspirin plus placebo or aspirin alone (RR 0.78, 95% CI 0.69 to 0.90; participants = 16,175; studies = 6; moderate quality evidence). There was a reduction in the risk of fatal and non-fatal ischaemic stroke (RR 0.73, 95% CI 0.59 to 0.91; participants = 4006; studies = 5; moderate quality evidence). However, there was a higher risk of major bleeding with clopidogrel plus aspirin compared with aspirin plus placebo or aspirin alone (RR 1.44, 95% CI 1.25 to 1.64; participants = 33,300; studies = 10; moderate quality evidence) and of minor bleeding (RR 2.03, 95% CI 1.75 to 2.36; participants = 14,731; studies = 8; moderate quality evidence). Overall, we would expect 13 myocardial infarctions and 23 ischaemic strokes be prevented for every 1000 patients treated with the combination in a median follow-up period of 12 months, but 9 major bleeds and 33 minor bleeds would be caused during a median follow-up period of 10.5 and 6 months, respectively. The available evidence demonstrates that the use of clopidogrel plus aspirin in people at high risk of cardiovascular disease and people with established cardiovascular disease without a coronary stent is associated with a reduction in the risk of myocardial infarction and ischaemic stroke, and an increased risk of major and minor bleeding compared with aspirin alone. According to GRADE criteria, the quality of evidence was moderate for all outcomes except all-cause mortality (low quality evidence) and adverse events (very low quality evidence).\nOutput:\n" }, { "from": "agent", "value": "This review contains evidence up to July 2017. We found 15 studies which together included more than 30,000 people at high risk of heart disease who are taking aspirin. All studies randomly assigned participants to the intervention group (taking aspirin and clopidogrel) or the control group (taking aspirin and placebo (a pretend treatment that has no effect). Participants took clopidogrel between six weeks and 3.4 years, depending on the study they took part in. The results do not apply to people with recent placement of coronary stents (tubes inserted in the blood vessel to keep it open), who were excluded from this review. The results showed that there is a benefit of adding clopidogrel to aspirin in terms of reducing the risk of heart attack or stroke. However, there is a higher risk of major and minor bleeding associated with this. There was no effect on death due to heart problems or death from any cause. Using Cochrane criteria, four trials were at low risk of bias. Using GRADE standards, the quality of published evidence was moderate for most results, but low for death from any cause and very low for side effects." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Fourteen trials were identified, of which 10 trials (792 patients) were included. Four trials are awaiting assessment. In the 10 included trials follow up was performed at 14 to 35 days after stroke. In all studies neurological outcome was assessed but none of them reported on disability (activities of daily living function) or quality of life. Only three trials reported adverse events. In nine trials, all of them assessed to be of inferior quality, significant improvement in neurological deficit at the end of the treatment was used as the outcome measure. When analysing these trials together, Ginkgo biloba extract was associated with a significant increase in the number of improved patients (Peto odds ratio (OR) 2.66; 95% confidence interval (CI) 1.79 to 3.94). One placebo-controlled trial, assessed to be of good quality, reported neurological outcome as a continuous variable. It failed to show an improvement of neurological deficit at the end of treatment (weighted mean difference (fixed) 0.81; 95% CI -8.9 to 10.52). No deaths or major adverse events were reported during the follow-up period. There was no convincing evidence from trials of sufficient methodological quality to support the routine use of Ginkgo biloba extract to promote recovery after stroke. High-quality and large-scale randomised controlled trials are needed to test its efficacy.\nOutput:\n" }, { "from": "agent", "value": "This review identified all randomised or quasi-randomised trials of Ginkgo biloba extract in patients with acute ischaemic stroke. There was no convincing evidence, from trials of sufficient methodological quality, to support the routine use of Ginkgo biloba extract to promote recovery after stroke. High-quality and large-scale randomised controlled trials are needed to test its efficacy." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included in this updated review five RCTs with a total of 403 participants, and we added two new trials identified during the 2015 search. One of the included studies was found to have a high risk of bias; no trial featured all pre-specified outcomes. We found two trials for which data are awaited for classification and one ongoing trial. Three studies compared advanced haemodynamic monitoring with a protocol using standard measures; three compared advanced haemodynamic monitoring with usual care; and one compared a protocol using standard measures with usual care. Meta-analyses for the two advanced haemodynamic monitoring comparisons are consistent with both increased and decreased risk of mortality (RR Mantel-Haenszel (M-H) random-effects 0.41, 95% confidence interval (CI) 0.14 to 1.20; 280 participants; RR M-H random-effects 0.45, 95% CI 0.07 to 2.95; 213 participants, respectively). The study comparing a protocol with usual care found no difference between groups for this outcome. Three studies comparing advanced haemodynamic monitoring with usual care reported data for length of stay and time to medical fitness. There was no statistically significant difference between groups for these outcomes in the two studies that we were able to combine (MD IV fixed 0.63, 95% CI -1.70 to 2.96); MD IV fixed 0.01, 95% CI -1.74 to 1.71, respectively) and no statistically significant difference in the third study. One study reported reduced time to medical fitness when comparing advanced haemodynamic monitoring with a protocol, and when comparing protocol monitoring with usual care. The number of participants with one or more complications showed no statistically significant differences in each of the two advanced haemodynamic monitoring comparisons (RR M-H random-effects 0.83, 95% CI 0.59 to 1.17; 280 participants; RR M-H random-effects 0.72, 95% CI 0.40 to 1.31; 173 participants, respectively), nor any differences in the protocol and usual care comparison. Only one study reported the number of participants able to return to normal accommodation after discharge with no statistically significant difference between groups. There were few studies with a small number of participants, and by using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) approach, we judged the quality of the outcome evidence as low. We had included one study with a high risk of bias, but upon applying GRADE, we downgraded the quality of this outcome evidence to very low. Five studies including a total of 403 participants provided no evidence that fluid optimization strategies improve outcomes for participants undergoing surgery for PFF. Further research powered to test some of these outcomes is ongoing.\nOutput:\n" }, { "from": "agent", "value": "Evidence is current to September 2015. We found five studies with 403 participants, each of which compared two or three methods of guiding fluid therapy. These methods include 'usual care' (whereby staff use changes in basic measurements, such as heart rate, to decide for themselves how much fluid to give), 'protocols using standard measures' (whereby staff use changes in basic measurements when giving fluid according to a formal set of rules) and 'advanced haemodynamic monitoring' (whereby staff use invasive equipment, such as specialized blood pressure monitoring devices placed into arteries, to determine how much fluid to give). These trials found no evidence to suggest that using one method instead of another reduces harm, including death, or decreases the number of complications. We found no evidence, when study results were combined, indicating that any method reduced length of hospital stay or time that participants were assessed as medically fit for discharge. Results also showed no difference in the number of participants able to return to normal accommodation after discharge. We found few relevant studies with only a small number of participants. The time difference between the earliest study, published in 1985, and the latest study, published in 2014, suggests that standard practice for managing hip fracture may differ between these studies. We judged one study as having a high risk of bias, and we used the GRADE approach to assess evidence quality as low or very low. Results of the review are applicable only to countries in which the relevant studies were conducted, as 'usual care' may differ in other countries. Current evidence is insufficient to show which method of finding maximum effective fluid levels in people undergoing hip fracture surgery is preferable." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Nine Cochrane reviews were selected for this overview. Their scores on the Overview Quality Assessment Questionnaire varied from four to six of a maximal possible score of seven. Compared with general anaesthesia, neuraxial blockade reduced the zero to 30-day mortality (risk ratio [RR] 0.71, 95% confidence interval [CI] 0.53 to 0.94; I2 = 0%) based on 20 studies that included 3006 participants. Neuraxial blockade also decreased the risk of pneumonia (RR 0.45, 95% CI 0.26 to 0.79; I2 = 0%) based on five studies that included 400 participants. No difference was detected in the risk of myocardial infarction between the two techniques (RR 1.17, 95% CI 0.57 to 2.37; I2 = 0%) based on six studies with 849 participants. Compared with general anaesthesia alone, the addition of a neuraxial block to general anaesthesia did not affect the zero to 30-day mortality (RR 1.07, 95% CI 0.76 to 1.51; I2 = 0%) based on 18 studies with 3228 participants. No difference was detected in the risk of myocardial infarction between combined neuraxial blockade-general anaesthesia and general anaesthesia alone (RR 0.69, 95% CI 0.44 to 1.09; I2 = 0%) based on eight studies that included 1580 participants. The addition of a neuraxial block to general anaesthesia reduced the risk of pneumonia (RR 0.69, 95% CI 0.49 to 0.98; I2 = 9%) after adjustment for publication bias and based on nine studies that included 2433 participants. The quality of the evidence was judged as moderate for all six comparisons. No serious adverse events (seizure or cardiac arrest related to local anaesthetic toxicity, prolonged central or peripheral neurological injury lasting longer than one month or infection secondary to neuraxial blockade) were reported. The quality of the reporting score of complications related to neuraxial blocks was nine (four to 12 (median range)) of a possible maximum score of 14. Compared with general anaesthesia, a central neuraxial block may reduce the zero to 30-day mortality for patients undergoing surgery with intermediate to high cardiac risk (level of evidence, moderate). Further research is required.\nOutput:\n" }, { "from": "agent", "value": "When epidurals or spinals were used to replace general anaesthesia, the risk of dying during the surgery or within the following 30 days was reduced by approximately 29% (from 20 studies with 3006 participants). Also, the risk of developing pneumonia (chest infection) was reduced by 55% (from five studies with 400 participants). However, the risk of developing a myocardial infarction (heart attack) was the same for both anaesthetic techniques (from six studies with 849 participants). When epidurals (and less frequently spinals) were used to reduce the quantity of other drugs required while general anaesthesia was used, the risk of dying during the surgery or within 30 days was the same for both anaesthetic techniques (from 18 studies with 3228 participants). Also, a difference was not detected for the risk of developing myocardial infarction (from eight studies with 1580 participants). The risk of developing pneumonia was reduced by approximately 30% when a correction was made for possible missing studies (from nine studies with 2433 participants). No serious side effects (seizures, cardiac arrest, nerve damage lasting longer than one month or infection) were reported from the use of epidurals or spinals in these studies. The quality of the evidence for all six comparisons was rated as moderate because of some imperfections in how the studies were carried out. Therefore further research is likely to have an important impact on our confidence in these results and may even change the results. ." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Five studies met the criteria for inclusion in the review. Two of these were multi-intervention studies where the dietary intervention was one component of a wider programme of prevention, but where data on dietary behaviour change were reported. One of the single intervention studies was concerned with dental caries prevention. The other two concerned general health outcomes. There were no studies concerned with dietary change aimed at preventing tooth erosion. In four out of the five included studies a significant change in dietary behaviour was found for at least one of the primary outcome variables. There is some evidence that one-to-one dietary interventions in the dental setting can change behaviour, although the evidence is greater for interventions aiming to change fruit/vegetable and alcohol consumption than for those aiming to change dietary sugar consumption. There is a need for more studies, particularly in the dental practice setting, as well as greater methodological rigour in the design, statistical analysis and reporting of such studies.\nOutput:\n" }, { "from": "agent", "value": "We identified five studies. Two of these were concerned with diet advice given concerning general health (one was about alcohol and one was about fruit and vegetable consumption). In both these studies there was a change to healthier behaviour following the advice. We also identified three studies which attempted to change sugar consumption habits in order to reduce dental decay. However, in two out of these three studies there were also other types and forms of advice given at the same time, for example about toothbrushing. It was therefore impossible to say whether changes in diet came about because of the diet advice given or because they were subtly influenced by the other messages. For example: advice on toothbrushing might make patients more aware of their oral health resulting in changes to their diet. Most of the studies concerning sugar consumption are of relatively weak quality. The evidence for dietary advice aiming to change sugar consumption is poor. Further studies in this area should be considered." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: For this update, we added 11 studies and included a total of 20 studies (1477 participants). Rehabilitation programmes showed great diversity in terms of exercise training (number of completed exercise sessions; type, intensity and supervision), patient education (from none to extensive self-management programmes) and how they were organised (within one setting, e.g. pulmonary rehabilitation, to across several settings, e.g. hospital, outpatient centre and home). In eight studies, participants completed extensive pulmonary rehabilitation, and in 12 studies, participants completed pulmonary rehabilitation ranging from not extensive to moderately extensive. Eight studies involving 810 participants contributed data on hospital readmissions. Moderate-quality evidence indicates that pulmonary rehabilitation reduced hospital readmissions (pooled odds ratio (OR) 0.44, 95% confidence interval (CI) 0.21 to 0.91), but results were heterogenous (I2 = 77%). Extensiveness of rehabilitation programmes and risk of bias may offer an explanation for the heterogeneity, but subgroup analyses were not statistically significant (P values for subgroup effects were between 0.07 and 0.11). Six studies including 670 participants contributed data on mortality. The quality of evidence was low, and the meta-analysis did not show a statistically significant effect of rehabilitation on mortality (pooled OR 0.68, 95% CI 0.28 to 1.67). Again, results were heterogenous (I2 = 59%). Subgroup analyses showed statistically significant differences in subgroup effects between trials with more and less extensive rehabilitation programmes and between trials at low and high risk for bias, indicating possible explanations for the heterogeneity. Hospital readmissions and mortality studies newly included in this update showed, on average, significantly smaller effects of rehabilitation than were seen in earlier studies. High-quality evidence suggests that pulmonary rehabilitation after an exacerbation improves health-related quality of life. The eight studies that used St George's Respiratory Questionnaire (SGRQ) reported a statistically significant effect on SGRQ total score, which was above the minimal important difference (MID) of four points (mean difference (MD) -7.80, 95% CI -12.12 to -3.47; I2 = 64%). Investigators also noted statistically significant and important effects (greater than MID) for the impact and activities domains of the SGRQ. Effects were not statistically significant for the SGRQ symptoms domain. Again, all of these analyses showed heterogeneity, but most studies showed positive effects of pulmonary rehabilitation, some studies showed large effects and others smaller but statistically significant effects. Trials at high risk of bias because of lack of concealment of random allocation showed statistically significantly larger effects on the SGRQ than trials at low risk of bias. High-quality evidence shows that six-minute walk distance (6MWD) improved, on average, by 62 meters (95% CI 38 to 86; I2 = 87%). Heterogeneity was driven particularly by differences between studies showing very large effects and studies showing smaller but statistically significant effects. For both health-related quality of life and exercise capacity, studies newly included in this update showed, on average, smaller effects of rehabilitation than were seen in earlier studies, but the overall results of this review have not changed to an important extent compared with results reported in the earlier version of this review. Five studies involving 278 participants explicitly recorded adverse events, four studies reported no adverse events during rehabilitation programmes and one study reported one serious event. Overall, evidence of high quality shows moderate to large effects of rehabilitation on health-related quality of life and exercise capacity in patients with COPD after an exacerbation. Some recent studies showed no benefit of rehabilitation on hospital readmissions and mortality and introduced heterogeneity as compared with the last update of this review. Such heterogeneity of effects on hospital readmissions and mortality may be explained to some extent by the extensiveness of rehabilitation programmes and by the methodological quality of the included studies. Future researchers must investigate how the extent of rehabilitation programmes in terms of exercise sessions, self-management education and other components affects the outcomes, and how the organisation of such programmes within specific healthcare systems determines their effects after COPD exacerbations on hospital readmissions and mortality.\nOutput:\n" }, { "from": "agent", "value": "We included 20 studies involving 1477 participants with COPD. Rehabilitation programmes started in hospital in some trials and after discharge in others. These programmes showed great diversity in terms of exercise training (e.g. number of completed exercise sessions, type and intensity of exercise training), patient education (none to extensive self-management programmes) and how programmes were organised (within one setting, e.g. pulmonary rehabilitation, to across several settings, e.g. hospital, outpatient centre and home). Quality of life and exercise capacity were improved by rehabilitation, and the effect was substantially larger than the minimal important difference. Results for hospital readmissions and mortality were diverse, with some studies showing that pulmonary rehabilitation reduced hospital admissions and mortality compared with usual community care (no rehabilitation), and other studies not showing such effects. Uncertainty about reasons for differences across trials in terms of hospital readmissions and mortality led to downgrading of the quality of evidence (moderate-quality evidence for reduction in hospital readmissions and low-quality evidence for reduction in mortality). The quality of evidence was high for quality of life and exercise capacity. Pulmonary rehabilitation improves quality of life and exercise capacity and is a safe intervention for patients with COPD after they have experienced an exacerbation. The reasons for diverse effects on hospital readmissions and mortality, however, are not fully clear. Future studies should explore whether the extent of the rehabilitation programme and the organisation of such programmes within specific healthcare systems (e.g. within the rehabilitation setting vs embedded in the continuum of care from hospital to home to outpatient care) determines the effects of rehabilitation after COPD exacerbations." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three RCTs in this review. It was unclear if the RCTs were three separate studies involving 1199 participants in total, or if they were reports from the same study involving fewer participants. We decided to treat the studies separately, as we were unable to make contact with the study authors to clarify. All three RCTs are of very low study quality because of issues with unclear randomization methods, allocation concealment and uncertainty of effect size. Some of the studies were reported as abstracts only and contained limited data, which prevented meaningful analysis and assessment of potential biases. The studies included participants who all received automated electronic monitoring during their hospital stay. Participants were randomized to an intervention group (automated alerts sent from the system) or to usual care (no automated alerts sent from the system). Evidence from all three studies reported 'Time to initiation of antimicrobial therapy'. We were unable to pool the data, but the largest study involving 680 participants reported median time to initiation of antimicrobial therapy in the intervention group of 5.6 hours (interquartile range (IQR) 2.3 to 19.7) in the intervention group (n = not stated) and 7.8 hours (IQR 2.5 to 33.1) in the control group (n = not stated). No studies reported 'Time to initiation of fluid resuscitation' or the adverse event 'Mortality at 30 days'. However very low-quality evidence was available where mortality was reported at other time points. One study involving 77 participants reported 14-day mortality of 20% in the intervention group and 21% in the control group (numerator and denominator not stated). One study involving 442 participants reported mortality at 28 days, or discharge was 14% in the intervention group and 10% in the control group (numerator and denominator not reported). Sample sizes were not reported adequately for these outcomes and so we could not estimate confidence intervals. Very low-quality evidence from one study involving 442 participants reported 'Length of stay in ICU'. Median length of stay was 3.0 days in the intervention group (IQR = 2.0 to 5.0), and 3.0 days (IQR 2.0 to 4.0 in the control). Very low-quality evidence from one study involving at least 442 participants reported the adverse effect 'Failed detection of sepsis'. Data were only reported for failed detection of sepsis in two participants and it wasn't clear which group(s) this outcome occurred in. No studies reported 'Quality of life'. It is unclear what effect automated systems for monitoring sepsis have on any of the outcomes included in this review. Very low-quality evidence is only available on automated alerts, which is only one component of automated monitoring systems. It is uncertain whether such systems can replace regular, careful review of the patient's condition by experienced healthcare staff.\nOutput:\n" }, { "from": "agent", "value": "We conducted a search to identify evidence published before September 2017. Studies were eligible for inclusion if they compared automated sepsis monitoring to standard care (such as paper-based systems) in people admitted to intensive or critical care units for critical illness. We did not include non-randomized studies (studies where participants were not allocated to treatment groups by chance), quasi-randomized studies (studies where participants were allocated to treatment groups by a method that is not truly down to chance, such as date of birth or medical number), and cross-over studies (where participants first receive one treatment and then cross over to receive the other treatment). Studies including people already diagnosed with sepsis were also excluded. We included three randomized controlled trials (studies where participants were allocated to treatment groups by chance), involving 1199 participants in this review. Overall there were no significant differences in time to start of antimicrobial therapy (such as antimicrobial and antifungal treatments, very low-quality evidence), length of stay in the intensive care setting (very low-quality evidence), or in mortality at 14 days, 28 days or discharge (very low-quality evidence) when automated monitoring systems were compared to standard care. Very low-quality evidence was available on failed detection of sepsis but data reporting was too unclear to enable us to analyse this in a meaningful way. Other outcomes that we wished to assess like time to initiation of fluid resuscitation (the process of increasing the amount of fluids in the body), mortality at 30 days, and quality of life were not reported in any of the studies. Results of this review show limited, very low-quality evidence, which has prevented us from drawing meaningful conclusions. It is unclear what effect automated systems for monitoring sepsis have on any outcomes included in this review, and therefore we are uncertain if automated sepsis monitoring is beneficial or not. Additional, high-quality evidence is needed to help address our review question." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Five randomised trials met our inclusion criteria (n = 302). Three studies objectively measured infant breastfeeding using standardised assessment tools. Pooled analysis of two studies (n = 155) showed no change on a 10-point feeding scale following frenotomy (mean difference (MD) -0.1, 95% confidence interval (CI) -0.6 to 0.5 units on a 10-point feeding scale). A third study (n = 58) showed objective improvement on a 12-point feeding scale (MD 3.5, 95% CI 3.1 to 4.0 units of a 12-point feeding scale). Four studies objectively assessed maternal pain. Pooled analysis of three studies (n = 212) based on a 10-point pain scale showed a reduction in maternal pain scores following frenotomy (MD -0.7, 95% CI -1.4 to -0.1 units on a 10-point pain scale). A fourth study (n = 58) also showed a reduction in pain scores on a 50-point pain scale (MD -8.6, 95% CI -9.4 to -7.8 units on a 50-point pain scale). All studies reported no adverse effects following frenotomy. These studies had serious methodological shortcomings. They included small sample sizes, and only two studies blinded both mothers and assessors; one did not attempt blinding for mothers nor for assessors. All studies offered frenotomy to controls, and most controls underwent the procedure, suggesting lack of equipoise. No study was able to report whether frenotomy led to long-term successful breastfeeding. Frenotomy reduced breastfeeding mothers’ nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.\nOutput:\n" }, { "from": "agent", "value": "Five randomised controlled trials enrolling 302 infants met the inclusion criteria. In an infant with tongue-tie and feeding difficulties, surgical release of the tongue-tie does not consistently improve infant feeding but is likely to improve maternal nipple pain. Further research is needed to clarify and confirm this effect. The quality of the evidence is very low to moderate because overall only a small number of studies have looked at this condition, the total number of babies included in these studies was low and some studies could have been better designed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Six studies met the inclusion criteria (198 participants with 250 ulcers). Each trial investigated a different intervention and within this review we have grouped these as systemic pharmaceutical interventions (L-cartinine, arginine butyrate, isoxsuprine) and topical pharmaceutical interventions (Solcoseryl® cream, RGD peptide dressing, topical antibiotics). Three interventions reported on the change in ulcer size (arginine butyrate, RGD peptide, L-cartinine). Of these, RGD peptide matrix significantly reduced ulcer size compared with a control group, mean reduction 6.60cm2 (95% CI 5.51 to 7.69; very low quality of evidence). Three trials reported on the incidence of complete closure (isoxsuprine, arginine butyrate, RGD peptide matrix; ranging between low and very low quality of evidence). None reported a significant effect. No trial reported on: the time to complete ulcer healing; ulcer-free survival following treatment for sickle cell leg ulcers; quality of life measures; or incidence of amputation. There was no reported information on the safety of these interventions. There is evidence that a topical intervention (RGD peptide matrix) reduced ulcer size in treated participants compared to controls. This evidence of efficacy is limited by the generally high risk of bias associated with these reports. We planned to analyse results according to general groups: pharmaceutical interventions (systemic and topical); and non-pharmaceutical interventions (surgical and non-surgical). However, we were unable to pool findings due to the heterogeneity in outcome definitions, and inconsistency between the unit of randomisation and the unit of analysis. This heterogeneity, along with a paucity of identified trials, prevented us performing any meta-analyses. This Cochrane review provides some evidence for the effectiveness of one topical intervention - RGD peptide matrix. However, this intervention was assessed as having a high risk of bias due to inadequacies in the single trial report. Other included studies were also assessed as having a high risk of bias. We recommend that readers interpret the trial results with caution. The safety profile of the all interventions was inconclusive.\nOutput:\n" }, { "from": "agent", "value": "In this Cochrane review we found six randomised controlled trials including 198 participants with 250 ulcers. Four of the randomised controlled trials were conducted in Jamaica and two in the USA. These trials included medications or dressings applied directly to the ulcer (topical medications) and medications given orally or intravenously (systemic medications). Given the very different modes of action of these two groups, we treated them separately throughout the review. The topical agents included Solcoseryl® cream, RGD peptide matrix dressing and topical antibiotics. Socoseryl aims to improve the use of oxygen by the skin tissue and so promote wound healing. Topical antibiotics are also used to prevent infection. The RGD peptide matrix is a gel that promotes cell growth. The systemic interventions included arginine butyrate, L-cartinine, and isoxsuprine. Aginine butyrate, given intravenously, is thought to accelerate wound healing, L-carnitine, given orally, is thought to improve tissue hypoxia, and isoxsuprine, given orally as isoxsuprine hydrochloride, is thought to widen blood vessels, so increasing blood flow to an affected wound. One medication, a topical intervention (RGD peptide matrix) reduced ulcer size in treated participants compared to controls. However, this effect should be interpreted with caution given the high risk of bias due to the inadequacies associated with this trial report. The evidence for the use of interventions to treat people with sickle cell disease and chronic leg ulceration is not strong. All randomised clinical trials that we included in this review were associated with a high risk of bias. This systematic review has shown the need for well-designed, high-quality randomised trials to assess the benefits and harms of interventions to improve the healing of leg ulcers in people with sickle cell disease." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included five trials with a total of 1920 women. Two placebo-controlled trials of women with PMDD showed less severe premenstrual symptoms after three months with drospirenone 3 mg plus ethinyl estradiol 20 μg than with placebo (MD -7.92; 95% CI -11.16 to -4.67). The drospirenone group had greater mean decreases in impairment of productivity (MD -0.31; 95% CI -0.55 to -0.08), social activities (MD -0.29; 95% CI -0.54 to -0.04), and relationships (MD -0.30; 95% CI -0.54 to -0.06). Side effects more common with the use of the drospirenone COC contraceptive were nausea, intermenstrual bleeding, and breast pain. The respective odds ratios were 3.15 (95% CI 1.90 to 5.22), 4.92 (95% CI 3.03 to 7.96), and 2.67 (95% CI 1.50 to 4.78). Total adverse events related to the study drug were more likely for the drospirenone COC group (OR 2.36; 95% CI 1.62 to 3.44). Three trials studied the effect of drospirenone 3 mg plus ethinyl estradiol 30 μg on less severe symptoms. A placebo-controlled six-month trial had insufficient data for primary outcome analysis. Another six-month study used levonorgestrel 150 µg plus ethinyl estradiol 30 µg for the comparison group but did not provide enough data on premenstrual symptoms. In a two-year trial, the drospirenone COC group had similar premenstrual symptoms to the comparison group given desogestrel 150 µg plus ethinyl estradiol 30 µg (OR 0.87; 95% CI 0.63 to 1.22). The groups were also similar for adverse events related to treatment (OR 1.02; 95% CI 0.78 to 1.33). Drospirenone 3 mg plus ethinyl estradiol 20 μg may help treat premenstrual symptoms in women with severe symptoms, that is, premenstrual dysphoric disorder. The placebo also had a large effect. We do not know whether the combined oral contraceptive works after three cycles, helps women with less severe symptoms, or is better than other oral contraceptives. Larger and longer trials of higher quality are needed to address these issues. Trials should follow CONSORT guidelines.\nOutput:\n" }, { "from": "agent", "value": "We did a computer search for trials that compared a birth control pill containing drospirenone and estrogen to a placebo ('dummy') or another birth control pill in treating premenstrual symptoms. We wrote to researchers to find other trials. We looked at whether the pills reduced symptoms and if side effects were reported. Women recorded their symptoms over time. We found five trials with 1920 women. Two trials compared a dummy pill to a drospirenone pill with low estrogen. All the women had PMDD, the severe form of PMS, before the trial. After three months, women on the drospirenone pill with low estrogen had less severe premenstrual symptoms than the group taking the dummy pill. Women in the drospirenone group said they could do more and had more social activities and friends. Women on the drospirenone pill had more nausea, bleeding between periods, and breast pain. These side effects are common with birth control pills. Three trials studied a drospirenone pill with more estrogen for treating less severe symptoms. These women did not all have PMDD. One compared the drospirenone pill to a dummy pill but did not have enough data for our review. Two compared the study pill to another birth control pill. The two-year study showed the groups were similar for premenstrual symptoms and side effects. The six-month study did not give enough data on the symptoms. A drospirenone pill with low estrogen seems to help premenstrual symptoms in women with severe symptoms (PMDD). The drospirenone pill worked a little better than the dummy pill, which also affected symptoms. We do not know if the birth control pill works longer than three cycles, helps women with less severe symptoms, or is better than other birth control pills. Longer and better studies with more women are needed to address these issues. Trials reports should be clearer about how the study was done." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Eighteen studies (7446 participants) compared cinacalcet in addition to standard therapy with no treatment or placebo plus standard therapy. In adults with GFR category G5 (GFR below 15 mL/min/1.73 m²) treated with dialysis, routine cinacalcet treatment had little or no effect on all-cause mortality (RR 0.97, 95% CI 0.89 to 1.05), imprecise effects on cardiovascular mortality (RR 0.67, 95% CI 0.16 to 2.87), and prevented surgical parathyroidectomy (RR 0.49, 95% CI 0.40 to 0.59) and hypercalcaemia (RR 0.23, 95% CI 0.05 to 0.97), but increased hypocalcaemia (RR 6.98, 95% CI 5.10 to 9.53), nausea (RR 2.02, 95% CI 1.45 to 2.81) and vomiting (RR 1.97, 95% CI 95% CI 1.73 to 2.24). Cinacalcet decreased serum PTH (MD -281.39 pg/mL, 95% CI -325.84 to -234.94) and calcium (MD -0.87 mg/dL, 95% CI -0.96 to -0.77) levels, but had little or no effect on serum phosphorous levels (MD -0.23 mg/dL, 95% CI -0.58 to 0.12). Data were sparse for adults with GFR categories G3a to G4 (GFR 15 to 60 mL/min/1.73 m²) and kidney transplant recipients. Overall, based on GRADE criteria, evidence for cinacalcet in adults with GFR category G5 treated with dialysis (mortality, parathyroidectomy, hypocalcaemia, and nausea) is of high or moderate quality. High quality evidence suggests \"further research is very unlikely to change our confidence in the estimate of treatment effect\" and moderate quality evidence is \"further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate\". Information for adults with less severe CKD GFR category G3a to G4 is of low or very low quality. This means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Routine cinacalcet therapy reduced the need for parathyroidectomy in adults treated with dialysis and elevated PTH levels but does not improve all-cause or cardiovascular mortality. Cinacalcet increases risks of nausea, vomiting and hypocalcaemia, suggesting harms may outweigh benefits in this population.\nOutput:\n" }, { "from": "agent", "value": "A newer treatment called cinacalcet showed promise for improving abnormal mineral levels but the effects of this drug on patient outcomes (the way patients feel function and survive) were unclear from early studies. We have updated an earlier review dated 2006 to include studies that assessed the effects of cinacalcet in about 7500 people with chronic kidney disease. While cinacalcet improves some blood abnormalities, it does not improve risk of death or heart disease in people treated with dialysis. In addition, people who take cinacalcet may experience increased nausea, vomiting and the need for blood tests to check blood calcium levels. The current research is high-quality and means that additional new studies are unlikely to change our confidence in these results. Information for the use of cinacalcet in people with milder forms of kidney disease and those with a kidney transplant is insufficient to guide decision making." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: This update included 49 trials containing 12,045 participants. Risk of treatment failure was higher with short courses of antibiotics (OR 1.34, 95% CI 1.15 to 1.55) at one month after initiation of therapy (21% failure with short-course treatment and 18% with long-course; absolute difference of 3% between groups). There were no differences found when examining treatment with ceftriaxone for less than seven days (30% failure in those receiving ceftriaxone and 27% in short-acting antibiotics administered for seven days or more) or azithromycin for less than seven days (18% failure in both those receiving azithromycin and short-acting antibiotics administered for seven days or more) with respect to risk of treatment failure at one month or less. Significant reductions in gastrointestinal adverse events were observed for treatment with short-acting antibiotics and azithromycin. Clinicians need to evaluate whether the minimal short-term benefit from longer treatment of antibiotics is worth exposing children to a longer course of antibiotics.\nOutput:\n" }, { "from": "agent", "value": "This review of 49 trials found that treating children with a short course (less than seven days) of antibiotics, compared to treatment with a long course (seven days or greater) of antibiotics, increases the likelihood of treatment failure in the short term. No differences are seen one month later. The amount of gastrointestinal adverse events decreased with a shorter course of antibiotics." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 15 trials, with a total of 755 participants for analysis in the review. Fourteen trials compared prophylactic use of FFP against no FFP. One study compared therapeutic use of two types of plasma. The timing of intervention varied, including FFP transfusion at the time of heparin neutralisation and stopping cardiopulmonary bypass (CPB) (seven trials), with CPB priming (four trials), after anaesthesia induction (one trial) and postoperatively (two trials). Twelve trials excluded patients having emergency surgery and nine excluded patients with coagulopathies. Overall the trials were small, with only four reporting an a priori sample size calculation. No trial was powered to determine changes in mortality as a primary outcome. There was either high risk of bias, or unclear risk, in the majority of trials included in this review. There was no difference in the number of deaths between the intervention arms in the six trials (with 287 patients) reporting mortality (very low quality evidence). There was also no difference in blood loss in the first 24 hours for neonatal/paediatric patients (four trials with 138 patients; low quality evidence): mean difference (MD) -1.46 ml/kg (95% confidence interval (CI) -4.7 to 1.78 ml/kg); or adult patients (one trial with 120 patients): MD -12.00 ml (95% CI -101.16 to 77.16 ml). Transfusion with FFP was inferior to control for preventing patients receiving any red cell transfusion: Peto odds ratio (OR) 2.57 (95% CI 1.30 to 5.08; moderate quality evidence). There was a difference in prothrombin time within two hours of FFP transfusion in eight trials (with 210 patients; moderate quality evidence) favouring the FFP arm: MD -0.71 seconds (95% CI -1.28 to -0.13 seconds). There was no difference in the risk of returning to theatre for reoperation (eight trials with 398 patients; moderate quality evidence): Peto OR 0.81 (95% CI 0.26 to 2.57). Only one included study reported adverse events as an outcome and reported no significant adverse events following FFP transfusion. This review has found no evidence to support the prophylactic administration of FFP to patients without coagulopathy undergoing elective cardiac surgery. There was insufficient evidence about treatment of patients with coagulopathies or those who are undergoing emergency surgery. There were no reported adverse events attributable to FFP transfusion, although there was a significant increase in the number of patients requiring red cell transfusion who were randomised to FFP. Variability in outcome reporting between trials precluded meta-analysis for many outcomes across all trials, and there was evidence of a high risk of bias in most of the studies. Further adequately powered studies of FFP, or comparable pro-haemostatic agents, are required to assess whether larger reductions in prothrombin time translate into clinical benefits. Overall the evidence from randomised controlled trials for the safety and efficacy of prophylactic transfusion of FFP for cardiac surgery is insufficient.\nOutput:\n" }, { "from": "agent", "value": "We searched scientific sources to identify eligible trials and found 15 studies with 755 patients. The evidence is up to date to April 2015. Fourteen studies compared prophylactic FFP against no FFP and one study compared two types of FFP, both used therapeutically. No studies reported on all outcomes. There was either high risk of bias, or unclear risk, in the majority of trials included in this review. Our primary outcome was death within 30 days after surgery. Six trials (with 287 patients) looked at this outcome and found no clear difference in mortality between the treatment arms but the quality of the evidence was very low. There was also no difference in the amount of blood lost in the first 24 hours following surgery (measured in five trials; low quality evidence), or the risk of returning to theatre for a reoperation (measured in eight trials; moderate quality evidence). Patients who had FFP received significantly more red blood cells, suggesting that FFP may not be effective in this setting (moderate quality evidence). Measurement of a blood test used to assess blood clotting (prothrombin time) was reported in eight trials and showed that clotting was improved by the use of prophylactic FFP (moderate quality evidence). However, the difference was too small to make a difference in clinical practice. Only one included study reported adverse events as an outcome and reported no adverse events due to FFP transfusion. The review found no evidence for the efficacy of FFP for the prevention of bleeding in heart surgery and it found some evidence of an increased overall need for red cell transfusion in those treated with FFP. There were no reported adverse events due to FFP transfusion. Overall the evidence for the safety and efficacy of prophylactic FFP for cardiac surgery is insufficient. The trials focused on prevention of bleeding and did not address prevention of bleeding for patients with abnormal blood clotting or for the treatment of bleeding patients." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified 14 trials evaluating surgery versus surgery plus radiotherapy. Individual participant data were available for 11 of these trials, and our analyses are based on 2343 participants (1511 deaths). Results show a significant adverse effect of PORT on survival, with a hazard ratio of 1.18, or an 18% relative increase in risk of death. This is equivalent to an absolute detriment of 5% at two years (95% confidence interval (CI) 2% to 9%), reducing overall survival from 58% to 53%. Subgroup analyses showed no differences in effects of PORT by any participant subgroup covariate. We did not undertake analysis of the effects of PORT on quality of life and adverse events. Investigators did not routinely collect quality of life information during these trials, and it was unlikely that any benefit of PORT would offset the observed survival disadvantage. We considered risk of bias in the included trials to be low. Results from 11 trials and 2343 participants show that PORT is detrimental to those with completely resected non-small cell lung cancer and should not be used in the routine treatment of such patients. Results of ongoing RCTs will clarify the effects of modern radiotherapy in patients with N2 tumours.\nOutput:\n" }, { "from": "agent", "value": "We searched for relevant trials up to 8 July 2016. These studies brought together available trial data from all over the world, with 11 trials and 2343 patients. Trials were carried out between 1966 and 1998. Results showed that fewer people given PORT treatment lived for two years after the operation (53 out of every 100 patients) than those not given PORT after the operation (58 out of every 100 patients). Researchers reported no difference in effects of PORT by types of patients included in trials. Researchers did not routinely collect quality of life information during the trials, and it was unlikely that any benefit of PORT would offset the observed survival disadvantage. Radiotherapy given after successful removal of tumour at operation is not beneficial for patients with non-small cell lung cancer and should not be used as routine treatment; however, further research into new types of radiotherapy for patients at higher risk of recurrence is ongoing. These systematic reviews and meta-analyses use individual participant data, which are considered the gold standard for this type of review. We included all eligible trials, if possible, no matter what language they were published in, or whether or not they were published. This meta-analysis included 88% of all participants in eligible trials. Studies were well designed and conducted and addressed the review question, with consistent effects noted across trials. The impact of any data not included in our analyses is small." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: This updated review includes a total of 25 studies, with outcome data for 11,246 mothers and babies enrolled in 21 studies. We assessed the overall risk of bias of included studies to be low or unclear, mainly because of limited reporting or uncertainty in how randomisation was generated or concealed (which led us to downgrade the quality of most outcomes to moderate), and the impracticability of blinding participants. When compared with routine care, programmes offering additional social support for at-risk pregnant women may slightly reduce the number of babies born with a birthweight less than 2500 g from 127 per 1000 to 120 per 1000 (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.86 to 1.04; 16 studies, n = 11,770; moderate-quality evidence), and the number of babies born with a gestational age less than 37 weeks at birth from 128 per 1000 to 117 per 1000 (RR 0.92, 95% CI 0.84 to 1.01, 14 studies, n = 12,282; moderate-quality evidence), though the confidence intervals for the pooled effect for both of these outcomes just crossed the line of no effect, suggesting any effect is not large. There may be little or no difference between interventions for stillbirth/neonatal death (RR 1.11, 95% CI 0.88 to 1.41; 15 studies, n = 12,091; low-quality evidence). Secondary outcomes of moderate quality suggested that there is probably a reduction in caesarean section (from 215 per 1000 to 194 per 1000; RR 0.90, 95% CI 0.83 to 0.97; 15 studies, n = 9550), a reduction in the number of antenatal hospital admissions per participant (RR 0.78, 95% CI 0.68 to 0.91; 4 studies; n = 787), and a reduction in the mean number of hospitalisation episodes (mean difference −0.05, 95% CI −0.06 to −0.04; 1 study, n = 1525) in the social support group, compared to the controls. Postnatal depression and women's satisfaction were reported in different ways in the studies that considered these outcomes and so we could not include data in a meta-analysis. In one study postnatal depression appeared to be slightly lower in the support group in women who screened positively on the Edinbugh Postnatal Depression Scale at eight to 12 weeks postnatally (RR 0.74, 95% CI 0.55 to 1.01; 1 study, n = 1008; moderate-quality evidence). In another study, again postnatal depression appeared to be slightly lower in the support group and this was a self-report measure assessed at six weeks postnatally (RR 0.85, 95% CI 0.69 to 1.05; 1 study, n = 458; low-quality evidence). A higher proportion of women in one study reported that their prenatal care was very helpful in the supported group (RR 1.17, 95% CI 1.05 to 1.30; 1 study, n = 223; moderate-quality evidence), although in another study results were similar. Another study assessed satisfaction with prenatal care as being \"not good\" in 51 of 945 in the additional support group, compared with 45 of 942 in the usual care group. No studies considered long-term morbidity for the infant. No single outcome was reported in all studies. Subgroup analysis demonstrated consistency of effect when the support was provided by a healthcare professional or a trained lay worker. The descriptions of the additional social support were generally consistent across all studies and included emotional support, tangible support such as home visits, and informational support. Pregnant women need the support of caring family members, friends, and health professionals. While programmes that offer additional social support during pregnancy are unlikely to have a large impact on the proportion of low birthweight babies or birth before 37 weeks' gestation and no impact on stillbirth or neonatal death, they may be helpful in reducing the likelihood of caesarean birth and antenatal hospital admission.\nOutput:\n" }, { "from": "agent", "value": "We searched for evidence on 5 February 2018. We identified 21 randomised controlled trials from which 11,246 mother-baby pairs contributed results for this review. Examples of the additional social support include information, home visits, telephone calls and stress management. The overall quality of evidence for most outcomes was moderate. It was not possible to blind women to which group they were in. We found that women who received additional social support during pregnancy may be slightly less likely to have a baby with low birthweight (16 studies, 11,770 babies), or give birth too early (14 studies, 12,282 babies). The number of babies that died around the time of birth was similar for both groups of women (15 studies, 12,091 babies). Women who received the additional social support were, however, probably less likely to be admitted to hospital during their pregnancy (4 studies, 787 women), or to have a caesarean birth (15 studies, 9550 women). Women with additional social support may be less likely to be depressed (1 study, 1008 women). Findings around satisfaction with care were mixed, with one study reporting the support group being more satisfied, whilst another study suggested women in the usual care group were more satisfied. The findings did not appear to be different if the social support was provided by trained lay people or health professionals. Although programmes that offer additional social support during pregnancy are unlikely to prevent the pregnancy from resulting in a low birthweight or early birth, before 37 weeks of pregnancy, they may be helpful in reducing the likelihood of antenatal hospital admissions and the need for caesarean births. Additional social support is not powerful enough to improve the outcomes of the pregnancy during which it is provided, as measured by the outcomes considered in this review. The factors contributing to deprivation require social change in order to bring about improvements in health for mothers and their newborn babies." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified six randomised controlled trials including a total of 262 participants. Four studies were conducted with primary school or kindergarten teachers, one with student teachers and one with telemarketers. Three studies found similar self-reported vocal symptoms between those who attended direct voice training and those who were in a no intervention control group (standardised mean difference (SMD) 0.27; 95% CI -0.12 to 0.66). Two studies found similar self-reported vocal symptoms between those who attended indirect voice training and those who were in a no intervention control group (SMD 0.44; 95% CI -0.03 to 0.92). One study found similar scores on the Voice Handicap Index for those who had direct and indirect voice training combined and for those who had no intervention. Two studies compared a combination of direct and indirect voice training with indirect voice training only. Both studies found similar scores for self-reported phonation difficulty (mean difference -5.55; 95% CI -23.75 to 12.66) in both groups. The evidence for all comparisons was rated as low quality. No work-directed studies were found. No studies evaluated the effectiveness of prevention in terms of sick leave or number of diagnosed voice disorders. We found no evidence that either direct or indirect voice training or the two combined are effective in improving self-reported vocal functioning when compared to no intervention. The current practice of giving training to at-risk populations for preventing the development of voice disorders is therefore not supported by definitive evidence of effectiveness. Larger and methodologically better trials are needed with outcome measures that better reflect the aims of interventions.\nOutput:\n" }, { "from": "agent", "value": "We conducted a systematic search of the literature on preventing voice disorders in adults. We then appraised the quality of the studies found and combined their results. We found six studies which met our inclusion criteria. Four were conducted with teachers, one with student teachers and one with telemarketers. We found no evidence that either direct or indirect voice training nor the two combined are effective in improving vocal functioning when measured using self-reported outcomes and when compared to no intervention. All the included studies were small and of low methodological quality. Given the extent of the problem and the widespread use of voice training, further research is warranted." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three trials (283 participants in the analyses) that ran for two to three years. All participants were ex- or never-smokers and had genetic variants that carried a high risk of developing COPD. Only one trial reported mortality data (one person of 93 died in the treatment group and three of 87 died in the placebo group). There was no information on harms in the oldest trial. Another trial reported serious adverse events in 10 participants in the treatment group and 18 participants in the placebo group. In the most recent trial, serious adverse events occurred in 28 participants in each group. None of the trials reported mean number of lung infections or hospital admissions. In the two trials that reported exacerbations, there were more exacerbations in the treatment group than in the placebo group, but the results of both trials included the possibility of no difference. Quality of life was similar in the two groups. Forced expiratory volume in one second (FEV1) deteriorated more in participants in the treatment group than in the placebo group but the confidence interval (CI) included no difference (standardised mean difference -0.19, 95% CI -0.42 to 0.05; P = 0.12). For carbon monoxide diffusion, the difference was -0.11 mmol/minute/kPa (95% CI -0.35 to 0.12; P = 0.34). Lung density measured by computer tomography (CT) scan deteriorated significantly less in the treatment group than in the placebo group (mean difference (MD) 0.86 g/L, 95% CI 0.31 to 1.42; P = 0.002). Several secondary outcomes were unreported in the largest and most recent trial whose authors had numerous financial conflicts of interest. This review update added one new study and 143 new participants, but the conclusions remain unchanged. Due to sparse data, we could not arrive at a conclusion about the impact of augmentation therapy on mortality, exacerbations, lung infections, hospital admission and quality of life, and there was uncertainty about possible harms. Therefore, it is our opinion that augmentation therapy with alpha-1 antitrypsin cannot be recommended.\nOutput:\n" }, { "from": "agent", "value": "We reviewed the benefits and harms of treating patients who have the form of the disease that affects the lungs with alpha-1 antitrypsin extracted from blood donations. We found three randomised clinical trials (283 participants in the analyses) comparing treatment with alpha-1 antitrypsin with placebo (a pretend treatment) for two to three years. All participants were ex-smokers or had never smoked but had the genetic problem that carried a high risk of developing lung problems. The evidence is current to March 2016. Only one trial reported deaths (one of 93 participants died taking the medicine and three of 87 died taking placebo). There was no information on harms in the oldest trial. In another trial, serious adverse events occurred in 10 participants in the medicine group and 18 participants in the placebo group. In the most recent trial, serious adverse events occurred in 28 participants in each group. None of the trials reported on the number of lung infections or hospital admissions. There were more exacerbations (acute worsening in lung function) in the medicine group than in the placebo group, whereas quality of life was similar in the two groups. All trials measured lung function using forced expiratory volume in one second (how much air a person can breathe out during a forced breath) and carbon monoxide diffusion (a medical test that measures how much gas travels from the lungs to the blood). Lung function was slightly worse in participants taking the medicine but the differences were not significant. Lung function deteriorated significantly less when measured by a special type of X-ray called a computer tomography (CT) scan. Several secondary outcomes were unreported in the largest and most recent trial whose authors had numerous financial conflicts of interest. Due to a lack of information, we cannot be sure whether this treatment works or not. Therefore, it is our opinion that treatment with alpha-1 antitrypsin augmentation cannot be recommended." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: One trial involving 76 women who planned to have their babies delivered by caesarean section met the inclusion criteria, but data were available for only 64 women. This trial was of low quality with unclear allocation concealment and only a few main clinical outcomes reported for the women. The trial did not report any infant outcomes. It appears that music added to standard care during caesarean section under regional anaesthesia had some impact on pulse rate at the end of maternal contact with the neonate in the intra-operative period (MD -7.50 fewer beats per minute, 95% CI -14.08 to -0.92) and after completion of skin suture for the caesarean section (MD -7.37 fewer beats per minute, 95% CI -13.37 to -1.37). There was also an improvement in the birth satisfaction score (maximum possible score of 35) (MD of 3.38, 95%CI 1.59 to 5.17). Effects on other outcomes were either not significant or not reported in the one included trial. The findings indicate that music during planned caesarean section under regional anaesthesia may improve pulse rate and birth satisfaction score. However, the magnitude of these benefits is small and the methodological quality of the one included trial is questionable. Therefore, the clinical significance of music is unclear. More research is needed to investigate the effects of music during caesarean section under regional anaesthesia on both maternal and infant outcomes, in various ethnic pregnant women, and with adequate sample sizes.\nOutput:\n" }, { "from": "agent", "value": "The review findings indicate that listening to music during planned caesarean section under regional anaesthesia may improve pulse rates and birth satisfaction scores, although the effect sizes were not large enough to indicate a clinically beneficial effect. The review authors identified one controlled trial that randomly assigned 76 women who listened to their preferred music through earphones, or to standard care, but data were available for only 64 women. The music was provided from the beginning of anaesthesia to the end of surgery. The women's heart rates were reduced by some seven beats/minute when measured at the end of contact with the newborn during the intra-operative period and after the surgeon had completed skin suture. Birth satisfaction scores were increased by a mean of 3.4 points on a 35-point scale when women listened to music. Respiration rates were no different for the two groups and neither were levels of anxiety, which decreased at the end of contact with the newborn and again after closing the skin, with no clear difference with or without music. The trial was from Taiwan and reporting of trial methodology was poor." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified seven RCTs that enrolled 372 women. We could not pool results of trials as the treatment comparisons differed. Six RCTs (n = 340) conducted over 15 years ago, evaluated adjuvant therapy (chemotherapy, pelvic external irradiation or intra-peritoneal radioactive isotope therapy) after radical surgery; over 87% of participants had Stage I tumours. Most participants were followed up for over 10 years. Overall and recurrence-free survival were similar between both arms of these trials, except that one trial (n = 66) showed a significantly lower survival (P = 0.03) in women who received chemotherapy (thio-TEPA). Adverse effects of treatment were incompletely reported and all six trials were at high risk of bias. One further trial (n = 32) that recruited participants with bilateral serous tumours who were wishing fertility preservation, revealed a significantly increased chance of pregnancy (hazard ratio (HR) = 3.3, 95% CI 1.4 to 8.0) but non-significantly earlier disease recurrence (HR = 1.5, 95% CI 0.6 to 3.8) in the women who had ultra-conservative surgery (bilateral cystectomy) than in those who had conservative surgery (cystectomy and contralateral oophorectomy). This trial was at low risk of bias. Quality of life (QoL) was not documented in any included trial. We did not find any trials that compared radical with conservative surgery or laparoscopy with laparotomy. We did not find evidence to support the use of any specific type of adjuvant therapy for borderline ovarian tumours. RCTs evaluating the benefit of adjuvant therapy with optimally dosed chemotherapy and newer targeted drugs are necessary, particularly for advanced borderline ovarian tumours. The low mortality from borderline ovarian tumours should make recurrence-free survival, time to recurrence and morbidity important end points in such trials. Bilateral cystectomy may be offered to women with bilateral borderline ovarian tumours diagnosed intra-operatively who are wishing to preserve their fertility. Similarly, women who had RCTs comparing radical with conservative surgery and comparing laparoscopy with laparotomy are needed.\nOutput:\n" }, { "from": "agent", "value": "In this review, we found six trials which enrolled 340 patients who had undergone surgery for borderline ovarian tumours. These trials compared the number of deaths among women who had various forms of treatment or no additional treatment after surgery. In five of the trials, the women had tumours confined to the ovaries and most were followed up for over 10 years. Only one trial enrolled women with tumours that had spread beyond the ovary, and this trial followed patients up for less than three years, which is not long enough to detect any difference between groups receiving different treatments. None of the trials found any demonstrable benefit from any of the additional forms of treatment. However, all six trials were conducted over 15 years ago and since then platinum-based chemotherapy has become widely used to treat advanced ovarian cancer. However, only one of the trials in our review assessed this more modern type of chemotherapy. Further trials of platinum-based chemotherapy and of less toxic treatments are needed, looking at the benefit of reducing the anxiety and distress of further surgery and treatment for relapse. One further trial, which recruited 32 women who had borderline ovarian tumours in both ovaries, compared conservative surgery (taking away the most diseased ovary and removing the tumour from the other ovary) with ultra-conservative surgery (removing the tumours without taking away either ovary). Nearly all the women who had ultra-conservative surgery became pregnant compared with half of those who had conservative surgery. Although about two thirds of the women in the trial developed similar tumours again, most women got pregnant before the disease recurred, all had their recurrences treated by further surgery, none developed invasive ovarian cancer nor died of their tumour. This small study suggests that ultra-conservative surgery by an experienced surgeon with careful follow up for recurrence may be recommended for women with bilateral borderline ovarian tumours who still intend to have children but, ideally, this approach should be evaluated in other independent trials. Despite rigorous searches, we did not find any trial directly comparing conservative surgery with radical surgery (surgery to remove all of the female reproductive organs) or comparing keyhole surgery (laparoscopy) with open surgery (laparotomy) for women with borderline ovarian tumours. None of these trials looked at how the various treatments affected the quality of life (QoL) of the women." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: This update located nine new studies, which were added to the six studies from our last update in 2008. This review now includes 15 studies (eight RCTs, five CBA and two ITS studies). All of these studies measured the effectiveness of IPE interventions compared to no educational intervention. Seven studies indicated that IPE produced positive outcomes in the following areas: diabetes care, emergency department culture and patient satisfaction; collaborative team behaviour and reduction of clinical error rates for emergency department teams; collaborative team behaviour in operating rooms; management of care delivered in cases of domestic violence; and mental health practitioner competencies related to the delivery of patient care. In addition, four of the studies reported mixed outcomes (positive and neutral) and four studies reported that the IPE interventions had no impact on either professional practice or patient care. This updated review reports on 15 studies that met the inclusion criteria (nine studies from this update and six studies from the 2008 update). Although these studies reported some positive outcomes, due to the small number of studies and the heterogeneity of interventions and outcome measures, it is not possible to draw generalisable inferences about the key elements of IPE and its effectiveness. To improve the quality of evidence relating to IPE and patient outcomes or healthcare process outcomes, the following three gaps will need to be filled: first, studies that assess the effectiveness of IPE interventions compared to separate, profession-specific interventions; second, RCT, CBA or ITS studies with qualitative strands examining processes relating to the IPE and practice changes; third, cost-benefit analyses.\nOutput:\n" }, { "from": "agent", "value": "Nine studies met the inclusion criteria for the review. These studies were added to the six that we found the last time we updated the review, bringing the total to 15 studies. Seven of these studies reported positive outcomes for healthcare processes or patient outcomes, or both, four studies reported mixed outcomes (positive and neutral) and four reported no effects of IPE. The studies differed in many respects. They were conducted in different areas of clinical practice and included different IPE interventions. The study designs and outcome measures were also different. All 15 studies compared outcomes following an IPE intervention to outcomes, either in similar clinical settings that did not receive the IPE intervention, or in the same clinical setting before the intervention was made. Because no studies compared an interprofessional intervention to a profession-specific intervention, our understanding of interprofessional interventions is limited. The small number of studies included in this review, and their varied nature, limit our understanding of the key components of IPE and its effectiveness. More studies are needed to allow sound conclusions to be reached about the effectiveness of IPE, as well as to inform IPE policy development. In particular, these should include: first, studies that assess the effectiveness of IPE interventions compared to separate, profession-specific interventions; second, RCT, CBA or ITS studies with qualitative strands examining processes relating to the IPE and practice changes; third, cost-benefit analyses." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We found only one trial, which randomized 11 infants to intravenous doxapram and 10 infants to placebo. There were fewer treatment failures after 48 hours in the group of preterm infants treated with doxapram (4/11) compared with the group treated with placebo (8/10). The wide confidence intervals made this result non-significant [summary relative risk 0.45 (0.20 to 1.05)]. Only one infant, who was from the placebo group, was given IPPV. Of the seven responders by 48 hours in the group of 11 who received doxapram, five failed to respond between 48 hours and seven days after commencement of therapy. This gives a late failure rate of 9/11, similar to the short-term failure rate in the placebo group of 8/10. It is not possible to evaluate the late responses of all those in the placebo group since they crossed over to a treatment arm. Although intravenous doxapram might reduce apnea within the first 48 hours of treatment, there are insufficient data to evaluate the precision of this result or to assess potential adverse effects. No long-term outcomes have been measured. Further studies are needed to determine the role of this treatment in clinical practice.\nOutput:\n" }, { "from": "agent", "value": "The review of one small trial found that apnea might be reduced in the first few days after treatment, but there were not enough infants studied to know if this was a significant effect. There is no evidence from this trial on longer term effects or less common adverse effects. More research is needed on the effectiveness, potential harm and long-term benefits or adverse effects of these drugs." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Nine trials, including 4654 participants, met our inclusion criteria. Five trials evaluated appointment reminders for people on treatment for active TB, two for people on prophylaxis for latent TB, and four for people undergoing TB screening using skin tests. We classified the interventions into 'pre-appointment' reminders (telephone calls or letters prior to a scheduled appointment) or 'default' reminders (telephone calls, letters, or home visits to people who had missed an appointment). For people being treated for active TB, clinic attendance and TB treatment completion were higher in people receiving pre-appointment reminder phone-calls (clinic attendance: 66% versus 50%; RR 1.32, 95% CI 1.10 to 1.59, one trial (USA), 615 participants, low quality evidence; TB treatment completion: 100% versus 88%; RR 1.14, 95% CI 1.02 to 1.27, one trial (Thailand), 92 participants, low quality evidence). Clinic attendance and TB treatment completion were also higher with default reminders (letters or home visits) (clinic attendance: 52% versus 10%; RR 5.04, 95% CI 1.61 to 15.78, one trial (India), 52 participants, low quality evidence; treatment completion: RR 1.17, 95% CI 1.11 to 1.24, two trials (Iraq and India), 680 participants, moderate quality evidence). For people on TB prophylaxis, clinic attendance was higher with a policy of pre-appointment phone-calls (63% versus 48%; RR 1.30, 95% CI 1.07 to 1.59, one trial (USA), 536 participants); and attendance at the final clinic was higher with regular three-monthly phone-calls or nurse visits (93% versus 65%, one trial (Spain), 318 participants). For people undergoing screening for TB, three trials of pre-appointment phone-calls found little or no effect on the proportion of people returning to clinic for the result of their skin test (three trials, 1189 participants, low quality evidence), and two trials found little or no effect with take home reminder cards (two trials, 711 participants). All four trials were conducted among healthy volunteers in the USA. Policies of sending reminders to people pre-appointment, and contacting people who miss appointments, seem sensible additions to any TB programme, and the limited evidence available suggests they have small but potentially important benefits. Future studies of modern technologies such as short message service (SMS) reminders would be useful, particularly in low-resource settings.\nOutput:\n" }, { "from": "agent", "value": "This Cochrane Review summarizes trials evaluating the effects of reminder systems on attendance at tuberculosis (TB) clinics and completion of TB treatment. After searching for relevant trials up to 29 August 2014, we included nine trials, including 4654 people. What are reminder systems and how might they help? Effective treatment for TB requires people to take multiple drugs daily for at least six months. Consequently, once they start to feel well again, some patients stop attending clinics and stop taking their medication which can lead to the illness returning and the development of drug resistance. One strategy the World Health Organization recommends is that an appointed person (a health worker or volunteer) watches the person take their medication everyday (called direct observation). Other strategies include reminder systems to prompt patients to attend for appointments on time, or to re-engage people who have missed or defaulted on a scheduled appointment. These prompts may be in the form of telephone calls or letters before the next scheduled appointment (\"pre-appointment reminders\"), or phone calls, letters, or home visits after a missed appointment (\"default reminders\"). What the research says: For people being treated for active TB: - More people attended the clinic and completed TB treatment with pre-appointment reminder phone-calls (low quality evidence). - More people attended the clinic and completed TB treatment with a policy of default reminders (low and moderate quality evidence respectively). For people on TB prophylaxis: - More people attended the clinic with pre-appointment phone-calls, and the number attending the final clinic was higher with three-monthly phone-calls or nurse home visits. For people undergoing screening for TB: - Similar numbers of people attended clinic for skin test reading with and without pre-appointment phone-calls (low quality evidence). - Similar numbers of people attended clinic for skin test reading with and without take home reminder cards." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: From 85 papers describing IQCODE, we included three papers, representing data from 626 individuals. Of this total, 22% (N = 135/626) were excluded because of prevalent dementia. There was substantial attrition; 47% (N = 295) of the study population received reference standard assessment at first follow-up (three to six months) and 28% (N = 174) received reference standard assessment at final follow-up (one to three years). Prevalence of dementia ranged from 12% to 26% at first follow-up and 16% to 35% at final follow-up. The three studies were considered to be too heterogenous to combine, so we did not perform meta-analyses to describe summary estimates of interest. Included patients were poststroke (two papers) and hip fracture (one paper). The IQCODE was used at three thresholds of positivity (higher than 3.0, higher than 3.12 and higher than 3.3) to predict those at risk of a future diagnosis of dementia. Using a cut-off of 3.0, IQCODE had a sensitivity of 0.75 (95%CI 0.51 to 0.91) and a specificity of 0.46 (95%CI 0.34 to 0.59) at one year following stroke. Using a cut-off of 3.12, the IQCODE had a sensitivity of 0.80 (95%CI 0.44 to 0.97) and specificity of 0.53 (95C%CI 0.41 to 0.65) for the clinical diagnosis of dementia at six months after hip fracture. Using a cut-off of 3.3, the IQCODE had a sensitivity of 0.84 (95%CI 0.68 to 0.94) and a specificity of 0.87 (95%CI 0.76 to 0.94) for the clinical diagnosis of dementia at one year after stroke. In generaI, the IQCODE was sensitive for identification of those who would develop dementia, but lacked specificity. Methods for both excluding prevalent dementia at baseline and assessing for the development of dementia were varied, and had the potential to introduce bias. Included studies were heterogenous, recruited from specialist settings, and had potential biases. The studies identified did not allow us to make specific recommendations on the use of the IQCODE for the future diagnosis of dementia in clinical practice. The included studies highlighted the challenges of delayed verification dementia research, with issues around prevalent dementia assessment, loss to follow-up over time, and test non-completion potentially limiting the studies. Future research should recognise these issues and have explicit protocols for dealing with them.\nOutput:\n" }, { "from": "agent", "value": "We found three relevant studies, all of which were carried out in specific hospital settings. Two papers only included patients with acute stroke, and the other included those who had sustained a hip fracture. The papers differed in many other ways, so we we were unable to estimate a summary of their combined results. In general, a 'positive' IQCODE picked up patients who would go on to develop dementia (good sensitivity), but mislabelled a number who did not develop dementia (poor specificity). We cannot make recommendations for current practice, based on the studies we reviewed. The included studies demonstrated some of the challenges of research that follows people at risk of dementia over time. Not all the studies had a robust method of ensuring that none of the included participants had dementia at the start of the study, and that only new cases were identified. Similarly, many of the participants included at the start of the study were not available for re-assessment, due to death or other illness. The review was performed by a team based in research centres in the UK (Glasgow, Edinburgh, Oxford). We had no external funding specific to this study, and we have no conflicts of interest that may have influenced our assessment of the research data." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: This is an update of a 2001 review that identified no eligible trials. One trial including 40 infants met the inclusion criteria for this review. Using GRADE criteria, we judged the quality of the evidence as low owing to risk of bias (inadequate reporting of methods of randomisation, allocation concealment and/or blinding) and imprecision (wide confidence intervals and data from a single small trial). We found no evidence of a difference between calcium and phosphorus supplementation versus no supplementation for neonatal growth outcomes (weight, length, head circumference) at any time point reported (two, four or six weeks postnatal age). At six weeks postnatal age, supplementation with calcium/phosphorus was associated with a decrease in serum alkaline phosphatase concentration (MD -56.85 IU/L, 95% CI -101.27 to -12.43; one randomised controlled trial (RCT); n = 40 infants). Investigators provided no data on growth at 12 to 18 months, neonatal fractures, feed intolerance, breastfeeding or any of the prespecified childhood outcomes for this review (fractures, growth, neurodevelopmental outcomes). We identified one small trial including only 40 infants that compared supplementation of human milk with calcium and phosphorus versus no supplementation in hospitalised preterm infants. We judged the evidence to be of low quality and found no evidence of differences between groups for clinically important outcomes including growth and fractures. Although serum alkaline phosphatase concentration was reduced in the group receiving supplementation at six weeks postnatal age, this difference is unlikely to be of clinical significance. We conclude that evidence is insufficient to determine whether benefit or harm ensues when human milk is supplemented with calcium and/or phosphorus for the hospitalised preterm infant. We see no advantage of conducting further trials of this intervention because with the advent of multi-component human milk fortifier, supplementation of human milk with calcium and/or phosphorus alone is no longer common practice. Future trials should consider assessing effects of multi-component fortifiers with different mineral compositions on clinically important outcomes during the neonatal period and in later childhood.\nOutput:\n" }, { "from": "agent", "value": "We searched for evidence in April 2016 and identified one randomised controlled trial including 40 babies. Investigators reported a small decrease in the concentration of alkaline phosphatase (an enzyme involved in bone growth) among infants who had received calcium/phosphorus supplementation. We found no difference in growth between infants who had been given human milk supplemented with extra calcium and phosphorus and infants who had received no supplementation. One small trial provided the evidence, and we judged the evidence to be of low quality. Researchers reported no follow-up of these babies into childhood. Evidence is insufficient to allow a judgement as to whether extra calcium and/or phosphorus provided to preterm babies confers benefit for their bones and growth. It is no longer very common to give calcium and phosphorus supplements alone, as human milk fortifiers now available include many other components as well as minerals to support the growth and development of preterm babies. We therefore suggest that future trials conducted to examine effects of mineral supplements in preterm babies include them in multi-component human milk fortifiers and assess clinically important outcomes into childhood." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included seven trials with a total of 239 participants. Two trials were of cross-over design, and outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with 213 participants. Treatment effects were observed on the following primary endpoints of emotionalism: There is very low quality of evidence from one small RCT that antidepressants increased the number of people who had 50% reduction in emotionalism (RR 16.50, 95% CI 1.07 to 253.40; 19 participants) and low quality evidence from one RCT of improved scores on Center for Neurologic Study - Lability Scale (CNS-LS) and Clinician Interview-Based Impression of Change (CIBIC) with antidepressants (RR 1.44, 95% CI 0.95 to 2.19; 28 participants). There was moderate quality evidence from three RCTS that they increased the number of people who had a reduction in tearfulness (RR 2.18, 95% CI 1.29 to 3.71; 164 participants); and low quality evidence from one RCT of improved scores on the Pathological Laughter and Crying Scale (PLCS) (MD 8.40, 95% CI 11.56 to 5.24; 28 participants). Six trials reported adverse events (death) and found no difference between the groups in death (RR 0.59, 95% CI 0.08 to 4.50; 6 RCTs, 172 participants, moderate-quality evidence). Antidepressants may reduce the frequency and severity of crying or laughing episodes based on very low quality evidence. Our conclusions must be qualified by several methodological deficiencies in the studies and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance and include careful assessment and complete reporting of adverse events.\nOutput:\n" }, { "from": "agent", "value": "We included seven randomised controlled trials involving 239 participants in the review, which reported on the use of antidepressants for treating emotionalism. Trials ranged from small (10 participants) to large (92 participants). Mean/median age of participants ranged from 57.8 years to 73 years. Studies were from Europe (UK: 1, Denmark: 1, Scotland: 1, and Sweden: 1); Asia (South Korea: 1; and Japan: 1); and the USA: 1. We included seven trials involving 239 participants (we identified no new trials since the previous version of the review). Two trials were of cross-over design, and outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Data were only available for five trials with 213 participants. We observed treatment effects on the following: 50% reduction in emotionalism, improvements (reduction) in lability, Clinician Interview-Based Impression of Change (CIBIC), diminished tearfulness and scores on the Pathological Laughter and Crying Scale (PLCS). However, confidence intervals were wide indicating that treatment may have had only a small positive effect, or even a small negative effect (in one trial). Six trials reported death as an adverse event and found no differences between groups. We rated the evidence from very low to moderate quality due to these being small trials with some degree of bias. Antidepressant drugs appear to reduce outbursts of crying or laughing. More trials with systematic assessment and reporting of adverse events are needed to ensure that these benefits outweigh the risks." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included eight RCTs with 1157 patient participants and 943 carer participants. We found no quasi-RCTs. We identified seven studies that await classification, and three ongoing studies. Three studies designed an intervention targeted at patients, four at carers, and one at both patients and carers. Studies included varied information: standardised or tailored, presented once or several times, and that included verbal or written information, audio recordings, multimedia information, and interactive information packs. Five studies reported robust methods of randomisation and allocation concealment. We noted high attrition rates in five studies. It was not feasible to blind participants, and we rated all studies as at high risk of performance bias, and at unclear risk of detection bias because most outcomes required self reporting. We attempted to pool data statistically, however this was not always possible due to high levels of heterogeneity. We calculated mean differences (MDs) using data reported from individual study authors where possible, and narratively synthesised the results. We reported the following two comparisons. Information or education intervention versus no information or education intervention (4 studies) For patient anxiety, we did not pool data from three studies (332 participants) owing to unexplained substantial statistical heterogeneity and possible clinical or methodological differences between studies. One study reported less anxiety when an intervention was used (MD -3.20, 95% confidence interval (CI) -3.38 to -3.02), and two studies reported little or no difference between groups (MD -0.40, 95% CI -4.75 to 3.95; MD -1.00, 95% CI -2.94 to 0.94). Similarly, for patient depression, we did not pool data from two studies (160 patient participants). These studies reported less depression when an information or education intervention was used (MD -2.90, 95% CI -4.00 to -1.80; MD -1.27, 95% CI -1.47 to -1.07). However, it is uncertain whether information or education interventions reduce patient anxiety or depression due to very low-certainty evidence. It is uncertain whether information or education interventions improve health-related quality of life due to very low-certainty evidence from one study reporting little or no difference between intervention groups (MD -1.30, 95% CI -4.99 to 2.39; 143 patient participants). No study reported adverse effects, knowledge acquisition, PTSD severity, or patient or carer satisfaction. We used the GRADE approach and downgraded certainty of the evidence owing to study limitations, inconsistencies between results, and limited data from few small studies. Information or education intervention as part of a complex intervention versus a complex intervention without information or education (4 studies) One study (three comparison groups; 38 participants) reported little or no difference between groups in patient anxiety (tailored information pack versus control: MD 0.09, 95% CI -3.29 to 3.47; standardised general ICU information versus control: MD -0.25, 95% CI -4.34 to 3.84), and little or no difference in patient depression (tailored information pack versus control: MD -1.26, 95% CI -4.48 to 1.96; standardised general ICU information versus control: MD -1.47, 95% CI -6.37 to 3.43). It is uncertain whether information or education interventions as part of a complex intervention reduce patient anxiety and depression due to very low-certainty evidence. One study (175 carer participants) reported fewer carer participants with poor comprehension among those given information (risk ratio 0.28, 95% CI 0.15 to 0.53), but again this finding is uncertain due to very low-certainty evidence. Two studies (487 carer participants) reported little or no difference in carer satisfaction; it is uncertain whether information or education interventions as part of a complex intervention increase carer satisfaction due to very low-certainty evidence. Adverse effects were reported in only one study: one participant withdrew because of deterioration in mental health on completion of anxiety and depression questionnaires, but the study authors did not report whether this participant was from the intervention or comparison group. We downgraded certainty of the evidence owing to study limitations, and limited data from few small studies. No studies reported severity of PTSD, or health-related quality of life. We are uncertain of the effects of information or education interventions given to adult ICU patients and their carers, as the evidence in all cases was of very low certainty, and our confidence in the evidence was limited. Ongoing studies may contribute more data and introduce more certainty when incorporated into future updates of the review.\nOutput:\n" }, { "from": "agent", "value": "The evidence is current up to 10 April 2017. We included eight studies with 1157 ICU patients and 943 carers of ICU patients. Seven studies are awaiting classification because we could not assess their eligibility, and three studies are ongoing. We included studies that assessed information given to patients or their carers compared to no information, and studies that assessed information as part of a more complex intervention compared to a complex intervention that did not include information or education. Studies included varied information: standardised or tailored to the individual, given regularly or on a single occasion, and that included verbal or written information, audio recordings, multimedia information, and interactive information packs. Overall, it is uncertain whether information or education (given alone or as part of a more complex intervention) improves outcomes for patients and their carers following a stay in the ICU. For patients, it is uncertain whether or not information or education reduces anxiety or depression, or improves health-related quality of life. One patient asked to withdraw from the study because they believed that their mental health worsened when they completed a questionnaire to assess anxiety and depression, but it is not clear whether this person received the information intervention or not. No studies reported PTSD in patients. For carers, it is uncertain whether or not information or education reduces anxiety or depression or improves carers' knowledge acquisition or their satisfaction with information provided. It was not possible for researchers to mask patients and carers to the intervention they received, and it was unclear whether this would affect the results, which relied on self assessments. Study authors did not consistently report rigorous methods for carrying out randomised trials, and we noted some losses of patients and carers during the studies. We found few small studies for this review, reporting limited data for many outcomes of interest. It is uncertain whether information or education is effective due to very low-certainty evidence. We are uncertain about the effects of information or education interventions given to adult ICU patients and their carers. The evidence was of very low certainty, and our confidence in the evidence was limited. We are aware of three ongoing studies and seven studies that were recently completed but not yet published. These studies may provide additional evidence or improve the certainty in the findings in future updates of the review." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Nine studies were included representing 425 participants. All studies compared omega-3 fatty acid supplementation with placebo lasting from four weeks to two years. Three studies with long treatment periods administered additional substances, making any observed effects impossible to attribute to omega-3 fatty acids and were excluded from the statistical analyses. One study did not express any mean values and, therefore, could not be included in statistical analyses. No significant differences between intervention and control groups were observed in pain-free walking distance (mean difference (MD) 11.62 m, 95% confidence interval (CI) -67.74 to 90.98), maximal walking distance (MD 16.99 m, 95% CI -72.14 to 106.11), ankle brachial pressure index (MD -0.02, 95% CI -0.09 to 0.05), total cholesterol levels (MD 0.27 mmol/L, 95% CI -0.48 to 1.01), high-density lipoprotein cholesterol levels (MD 0.00 mmol/L, 95% CI -0.16 to 0.15), low-density lipoprotein cholesterol levels (MD 0.44 mmol/L, 95% CI -0.31 to 1.19), triglyceride levels (MD -0.39 mmol/L, 95% CI -1.10 to 0.33), systolic blood pressure (MD 5.00 mmHg, 95% CI -11.59 to 21.59) or plasma viscosity (MD 0.03 mPa/s, 95% CI -0.02 to 0.08). There was some limited evidence that blood but not plasma viscosity levels decreased with treatment and gastrointestinal side effects such as nausea, diarrhoea and flatulence were observed in two studies. Omega-3 fatty acids appear to have little haematological benefit in people with intermittent claudication and there is no evidence of consistently improved clinical outcomes (quality of life, walking distance, ankle brachial pressure index or angiographic findings). Supplementation may also cause adverse effects such as nausea, diarrhoea and flatulence. Further research is needed to evaluate fully short- and long-term effects of omega-3 fatty acids on the most clinically relevant outcomes in people with intermittent claudication before they can be recommended for routine use.\nOutput:\n" }, { "from": "agent", "value": "The review included nine randomised controlled trials with 425 participants, comparing omega-3 fatty acid supplementation with other fatty acids. On the basis of these studies, omega-3 fatty acid supplementation did not improve walking distance, blood pressure in the leg or any other measure of clinical benefit. There was some limited evidence to suggest that omega-3 fatty acid supplementation may reduce blood viscosity (the resistance of blood to flow), which when high could potentially contribute to intermittent claudication. There was no evidence to suggest that omega-3 fatty acid supplementation reduced plasma (the liquid component of blood) viscosity or improved the levels of different types of cholesterol or any other components of blood tested. Side effects such as nausea, diarrhoea and flatulence were observed in two studies." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified 81 studies that comprised 9072 participants for inclusion in our review. We categorised many studies at high or unclear risk of the bias' assessed. There was statistical evidence that use of CG reduced TFF [overall reduction of 10.4 hours (95% CI: -11.9, -8.9): 12.5 hours (95% CI: -17.2, -7.8) in CRS, 7.9 hours (95% CI: –10.0, -5.8) in CS, 10.6 hours (95% CI: -12.7, -8.5) in OS]. There was also statistical evidence that use of CG reduced TBM [overall reduction of 12.7 hours (95% CI: -14.5, -10.9): 18.1 hours (95% CI: -25.3, -10.9) in CRS, 9.1 hours (95% CI: -11.4, -6.7) in CS, 12.3 hours (95% CI: -14.9, -9.7) in OS]. There was statistical evidence that use of CG slightly reduced LOHS [overall reduction of 0.7 days (95% CI: -0.8, -0.5): 1.0 days in CRS (95% CI: -1.6, -0.4), 0.2 days (95% CI: -0.3, -0.1) in CS, 0.8 days (95% CI: -1.1, -0.5) in OS]. There was statistical evidence that use of CG slightly reduced TBS [overall reduction of 5.0 hours (95% CI: -6.4, -3.7): 3.21 hours (95% CI: -7.0, 0.6) in CRS, 4.4 hours (95% CI: -5.9, -2.8) in CS, 6.3 hours (95% CI: -8.7, -3.8) in OS]. Effect sizes were largest in CRS and smallest in CS. There was statistical evidence of heterogeneity in all analyses other than TBS in CRS. There was little difference in mortality, infection risk and readmission rate between the groups. Some studies reported reduced nausea and vomiting and other complications in the intervention group. CG was generally well-tolerated by participants. There was little difference in cost between the groups in the two studies reporting this outcome. Sensitivity analyses by quality of studies and robustness of review estimates revealed no clinically important differences in effect estimates. Sensitivity analysis of ERAS studies showed a smaller effect size on TFF, larger effect size on TBM, and no difference between groups for LOHS. Meta-regression analyses indicated that surgical site is associated with the extent of the effect size on LOHS (all surgical subgroups), and TFF and TBM (CS and CRS subgroups only). There was no evidence that ROB score predicted the extent of the effect size on any outcome. Neither variable explained the identified heterogeneity between studies. This review identified some evidence for the benefit of postoperative CG in improving recovery of GI function. However, the research to date has primarily focussed on CS and CRS, and largely consisted of small, poor quality trials. Many components of the ERAS programme also target ileus, therefore the benefit of CG alongside ERAS may be reduced, as we observed in this review. Therefore larger, better quality RCTS in an ERAS setting in wider surgical disciplines would be needed to improve the evidence base for use of CG after surgery.\nOutput:\n" }, { "from": "agent", "value": "This review found 81 relevant studies that recruited over 9000 participants in total. The studies mainly focussed on people having bowel surgery or caesarean section, but there were some studies of other surgery types. There were few studies of children. Most studies were of poor quality, which may mean their results are less reliable. We found some evidence that people who chewed gum after an operation were able to pass wind and have bowel movements sooner than people who did not chew gum. We also found some evidence that people who chewed gum after an operation had bowel sounds (gurgling sounds heard using a stethoscope held to the abdomen) slightly sooner than people who did not chew gum. There was a small difference in how long people stayed in hospital between people who did or did not chew gum. There were no differences in complications (such as infection or death) between people who did or did not chew gum. There was also no difference in the overall cost of treatment between people who did or did not chew gum. There is some evidence that chewing gum after surgery may help the digestive system to recover. However, the studies included in this review are generally of poor quality, which meant that their results may not be reliable. We also know that there are many factors affecting ileus, and that modern treatment plans attempt to reduce risk of ileus. Therefore to further explore using chewing gum after surgery, more studies would be needed which are larger, of better quality, include different types of surgery, and consider recent changes in health care systems." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Four controlled trials of 3,4-diaminopyridine compared with placebo in a total of 54 participants with Lambert-Eaton myasthenic syndrome were eligible: three cross-over trials and one parallel group. Two were added at this update. One of these trials also assessed pyridostigmine in conjunction with 3,4-diaminopyridine. A further cross-over trial compared intravenous immunoglobulin (IVIg) to placebo in nine participants. Four trials of 3,4-diaminopyridine reported significant improvement in the primary outcome, muscle strength score, or myometric limb measurement for between hours and a week following treatment, and significant improvement in resting compound muscle action potential (CMAP) amplitude following 3,4-diaminopyridine, compared with placebo. A meta-analysis of the primary endpoint showed Quantitative Myasthenia Gravis (QMG) muscle score assessed between three and eight days was likely to improve by a mean of 2.44 points (95% confidence interval 3.6 to 1.22). Meta-analysis of the secondary endpoint CMAP amplitude also showed a mean improvement of 1.36 mV (95% confidence interval 0.99 to 1.72) over the same period. The risk of bias was determined to be low, and quality of evidence moderate to high. A single cross-over trial reported significant improvement in myometric limb strength and non-significant improvement in mean resting CMAP amplitude with IVIg compared to placebo. Clinical improvement lasted for up to eight weeks. Limited but moderate to high quality evidence from randomised controlled trials showed that over days 3,4-diaminopyridine, or for up to 8 weeks IVIg, improved muscle strength scores and CMAP amplitudes in participants with Lambert-Eaton myasthenic syndrome. There are insufficient data at present to quantify this effect. Other possible treatments have not been tested in randomised controlled trials.\nOutput:\n" }, { "from": "agent", "value": "Four small randomised controlled trials involving 54 participants in total showed that 3,4-diaminopyridine improves muscle strength. This was determined by measuring the compound muscle action potential (CMAP) which is a test that records the amount of electrical activity generated in a muscle when it is stimulated by its nerve. Although the number of trials is relatively small, the quality of evidence from these trials is moderate to high, which supports the findings of this review. The changes are measured over days only. A single trial involving nine participants showed that intravenous immunoglobulin also improved muscle strength up to 8 weeks from treatment. Other possible treatments such as plasma exchange, steroids and immunosuppressive agents have not been tested in randomised controlled trials. Further trials of these treatments are needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included nine RCTs involving 725 women. However, five trials did not contribute data. Four trials involving 358 women contributed data. Trials were generally at mixed risk of bias. We only identified data for three comparisons: pharmaceutical treatment versus placebo or no treatment; acupuncture versus no treatment and pharmacological intervention versus advice on dietary and lifestyle changes. Pharmaceutical treatment compared with placebo or no treatment Two trials evaluated any pharmaceutical treatment compared with placebo or no treatment. One trial examined a treatment rarely used nowadays (intramuscular prostigmine 0.5 mg versus placebo). One trial evaluated the effect of magnesium and aluminium hydroxide plus simethicone liquid and tablet compared with placebo. For the primary outcome of this review (relief of heartburn), women who received pharmaceutical treatment reported complete heartburn relief more often than women receiving no treatment or placebo (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.36 to 2.50 in two RCTs of 256 women, I2 = 0%, moderate-quality evidence). Data on partial relief of heartburn were heterogenous and showed no clear difference (average RR 1.35, 95% CI 0.38 to 4.76 in two RCTs of 256 women, very low-quality evidence). In terms of secondary outcomes, there was no clear difference in the rate of side effects between the pharmaceutical treatment group and the placebo/no treatment group (RR 0.63, 95% CI 0.21 to 1.89 in two RCTs of 256 women, very low-quality evidence). Pharmacological intervention versus advice on dietary and lifestyle choices One study compared 1 g of sucralfate with advice on dietary and lifestyle choices in treating heartburn. More women in the sucralfate group experienced complete relief of heartburn compared to women who received advice on diet and lifestyle choices (RR 2.41, 95% CI 1.42 to 4.07; participants = 65; studies = one). The only secondary outcome of interest addressed by this trial was side effects. The evidence was not clear on intervention side effects rate between the two groups (RR 1.74, 95% CI 0.07 to 41.21; participants = 66; studies = one). There was only one instance of side effects in the pharmacological group. Acupuncture compared with no treatment One trial evaluated acupuncture compared with no treatment but did not report data relating to this review's primary outcome (relief of heartburn). In terms of secondary outcomes, there was no difference in the rate of side effects between women who had acupuncture and women who had no treatment (RR 2.43, 95% CI 0.11 to 55.89 in one RCT of 36 women). With regard to quality of life, women who had acupuncture reported improved ability to sleep (RR 2.80, 95% CI 1.14 to 6.86) and eat (RR 2.40, 95% CI 1.11 to 5.18 in one RCT of 36 women). The following secondary outcomes were not reported upon in any of the trials included in the review: miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight. There are no large-scale RCTs to assess heartburn relief in pregnancy. This review of nine small studies (which involved data from only four small studies) indicates that there are limited data suggesting that heartburn in pregnancy could be completely relieved by pharmaceutical treatment. Three outcomes were assessed and assigned a quality rating using the GRADE methods. Evidence from two trials for the outcome of complete relief of heartburn was assessed as of moderate quality. Evidence for the outcomes of partial heartburn relief and side effects was graded to be of very low quality. Downgrading decisions were based in part on the small size of the trials and on heterogenous and imprecise results. There are insufficient data to assess acupuncture versus no treatment and no data to assess other comparisons (miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight). Further RCTs are needed to fully evaluate the effectiveness of interventions for heartburn in pregnancy. Future research should also address other medications such as histamine 2-receptor antagonists, promotility drugs, proton pump inhibitors, and a raft-forming alginate reflux suppressant in treatment of heartburn in pregnancy. More research is needed on acupuncture and other complimentary therapies as treatments for heartburn in pregnancy. Future research should also evaluate any adverse outcomes, maternal satisfaction with treatment and measure pregnant women's quality of life in relation to the intervention.\nOutput:\n" }, { "from": "agent", "value": "We found four small trials that provided data on 358 women. We estimated that the risk of bias was low for women enrolled in the study and the researchers as far as knowing if they were in the treatment group or the control (or placebo) group. It was unclear if there was a risk of bias for how the decisions were made to for women to be in the treatment or control/placebo groups, for those looking at the results and if all the results were reported. Two trials looked at medication compared with placebo or no treatment. One study examined the effect of a medication(sucralfate) in comparison to advice on dietary and lifestyle choice. One trial evaluated acupuncture versus no treatment. Women who received medication reported complete relief from heartburn more often than women receiving no treatment or placebo, or women who received advice on diet and lifestyle choices (moderate quality of evidence). We found no difference in partial relief of heartburn nor in side effects between the treatment groups (very low quality of evidence). We also found women who received acupuncture reported improved quality of life in terms of improved ability to sleep and eat, and no difference in the rate of side effects compared to women who received no acupuncture, From the little evidence there is, medication seems to help relieve heartburn but there is not enough data to say which medication is best. Acupuncture seems to help women to eat and sleep better when troubled with heartburn. Further research is needed to fully evaluate the effectiveness of interventions for heartburn in pregnancy. Future research should also address other medications such as histamine 2-receptor antagonists, promotility drugs, proton pump inhibitors, and a raft-forming alginate reflux suppressant in treatment of heartburn in pregnancy. More research is needed on acupuncture and other complimentary therapies as treatments for heartburn in pregnancy. Future research should also consider any adverse outcomes, maternal satisfaction with treatment and measure pregnant women's quality of life in relation to the intervention." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 57 RCTs (74 randomised comparisons) involving 3002 participants in this review (some appearing in more than one comparison). Twenty-seven randomised comparisons (1620 participants) assessed SLT versus no SLT; SLT resulted in clinically and statistically significant benefits to patients' functional communication (standardised mean difference (SMD) 0.28, 95% confidence interval (CI) 0.06 to 0.49, P = 0.01), reading, writing, and expressive language, but (based on smaller numbers) benefits were not evident at follow-up. Nine randomised comparisons (447 participants) assessed SLT with social support and stimulation; meta-analyses found no evidence of a difference in functional communication, but more participants withdrew from social support interventions than SLT. Thirty-eight randomised comparisons (1242 participants) assessed two approaches to SLT. Functional communication was significantly better in people with aphasia that received therapy at a high intensity, high dose, or over a long duration compared to those that received therapy at a lower intensity, lower dose, or over a shorter period of time. The benefits of a high intensity or a high dose of SLT were confounded by a significantly higher dropout rate in these intervention groups. Generally, trials randomised small numbers of participants across a range of characteristics (age, time since stroke, and severity profiles), interventions, and outcomes. Our review provides evidence of the effectiveness of SLT for people with aphasia following stroke in terms of improved functional communication, reading, writing, and expressive language compared with no therapy. There is some indication that therapy at high intensity, high dose or over a longer period may be beneficial. HIgh-intensity and high dose interventions may not be acceptable to all.\nOutput:\n" }, { "from": "agent", "value": "The evidence is current to September 2015. We found and included 57 studies involving 3002 people with aphasia in our review. We reviewed all SLT types, regimens, and methods of delivery. Based on 27 studies (and 1620 people with aphasia), speech and language therapy benefits functional use of language, language comprehension (for example listening or reading), and language production (speaking or writing), when compared with no access to therapy, but it was unclear how long these benefits may last. There was little information available to compare SLT with social support. Information from nine trials (447 people with aphasia) suggests there may be little difference in measures of language ability. However, more people stopped taking part in social support compared with those that attended SLT. Thirty-eight studies compared two different types of SLT (involving 1242 people with aphasia). Studies compared SLT that differed in therapy regimen (intensity, dosage and duration), delivery models (group, one-to-one, volunteer, computer-facilitated), and approach. We need more information on these comparisons. Many hours of therapy over a short period of time (high intensity) appeared to help participants' language use in daily life and reduced the severity of their aphasia problems. However, more people stopped attending these highly intensive treatments (up to 15 hours a week) than those that had a less intensive therapy schedule. Generally, the quality of the studies conducted and reported could be improved. Key quality features were only reported by half of the latest trials. Thus, it is unclear whether this was the result of poorly conducted studies or poorly reported studies. Most comparisons we made would benefit from the availability of more studies involving more people with aphasia." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We found no additional RCTs for inclusion in this update. This review includes one RCT dating from the 1960s with an overall high risk of bias. The RCT included 2307 healthy participants, all of whom were included in analyses. This trial compared the effect of an adenovirus vaccine against placebo. No statistically significant difference in common cold incidence was found: there were 13 (1.14%) events in 1139 participants in the vaccines group and 14 (1.19%) events in 1168 participants in the placebo group (risk ratio 0.95, 95% confidence interval 0.45 to 2.02; P = 0.90). No adverse events related to the live vaccine were reported. The quality of the evidence was low due to limitations in methodological quality and a wide 95% confidence interval. This Cochrane Review was based on one study with low-quality evidence. We found no conclusive results to support the use of vaccines for preventing the common cold in healthy people compared with placebo. We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Any future trials on medical treatments for preventing the common cold should assess a variety of virus vaccines for this condition. Outcome measures should include common cold incidence, vaccine safety, and mortality related to the vaccine.\nOutput:\n" }, { "from": "agent", "value": "We found no new studies in this update. This review includes one previously identified randomised controlled trial performed in 1965. This study involved 2307 healthy people at a training facility for the United States Navy and evaluated the effect of a live weakened (attenuated) adenovirus vaccine compared to a fake vaccine (placebo). This study was funded by a government institution. There were no differences in the frequency of occurrence of the common cold between those who received the vaccine compared to those who received a fake vaccine. There were no adverse events related to the vaccine. However, due to the low numbers of people included in the study and numbers of colds, as well as flaws in the study design, our confidence in the results is low. Further research may be able to clarify if vaccines can prevent common cold, since the current evidence does not support the use of adenovirus vaccine to prevent common cold in healthy people. We assessed the quality of the evidence as low due to high risk of bias and low numbers of people included in the study and numbers of colds, which resulted in imprecision." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Ten studies, reporting data from 354 participants, were included in this review, the majority of which were carried out in a university dental hospital setting. The studies were published between 2005 and 2011 and were conducted in Europe and in Brazil. The age range of participants was from nine to 15 years, with an even distribution of males and females in seven of the studies, and a slight predominance of female patients in three of the studies. The quality of the studies was generally poor; seven studies were at an overall high risk of bias, three studies were at an unclear risk of bias, and we judged no study to be at low risk of bias. We carried out random-effects meta-analyses as appropriate for the primary clinical outcomes of movement of upper first molars (mm), and loss of anterior anchorage, where there were sufficient data reported in the primary studies. Four studies, involving 159 participants, compared a distalising appliance to an untreated control. Meta-analyses were not undertaken for all primary outcomes due to incomplete reporting of all summary statistics, expected outcomes, and differences between the types of appliances. The degree and direction of molar movement and loss of anterior anchorage varied with the type of appliance. Four studies, involving 150 participants, compared a distalising appliance versus headgear. The mean molar movement for intraoral distalising appliances was -2.20 mm and -1.04 mm for headgear. There was a statistically significant difference in mean distal molar movement (mean difference (MD) -1.45 mm; 95% confidence interval (CI) -2.74 to -0.15) favouring intraoral appliances compared to headgear (four studies, high or unclear risk of bias, 150 participants analysed). However, a statistically significant difference in mean mesial upper incisor movement (MD 1.82 mm; 95% CI 1.39 to 2.24) and overjet (fixed-effect: MD 1.64 mm; 95% CI 1.26 to 2.02; two studies, unclear risk of bias, 70 participants analysed) favoured headgear, i.e. there was less loss of anterior anchorage with headgear. We reported direct comparisons of intraoral appliances narratively due to the variation in interventions (three studies, high or unclear risk of bias, 93 participants randomised). All appliances were reported to provide some degree of distal movement, and loss of anterior anchorage varied with the type of appliance. No included studies reported on the incidence of adverse effects (harm, injury), number of attendances or rate of non-compliance. It is suggested that intraoral appliances are more effective than headgear in distalising upper first molars. However, this effect is counteracted by loss of anterior anchorage, which was not found to occur with headgear when compared with intraoral distalising appliance in a small number of studies. The number of trials assessing the effects of orthodontic treatment for distilisation is low, and the current evidence is of low or very low quality.\nOutput:\n" }, { "from": "agent", "value": "This review of existing studies was carried out by the Cochrane Oral Health Group, and the evidence is current as of December 2012. In this review there are 10 studies published between 2005 and 2011 in which a total of 354 children were randomised to receive treatment with a distalising orthodontic appliance and compared to either no treatment, headgear or another distalising appliance. The age range of children in nine of the studies was from 11 to 15 years, although the children recruited to one study were younger, from nine to 10 years old. Both girls and boys participated in the studies. Where it was mentioned, the funding was from a university or dental research foundation. The authors did not assess the impact of the funding sources. When intraoral appliances are compared to headgear they will probably move the upper molar teeth backwards more than headgear. However, the use of intraoral appliances was also associated with movement of the upper front teeth when compared to extraoral appliances in four studies. This is an unwanted effect that was not observed with the use of the headgear appliances. Harm, injury from the appliances and other characteristics of the appliances which may be important to patients were not reported in the studies. The evidence presented is generally of low quality. The main shortcomings were related to trial design." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 13 studies, involving 1622 women. All were comparisons of single-dose treatment with short-course (four- to seven-day) treatments. The risk of bias of trials included in this review was largely unclear, and most trials were at high risk of performance bias. The quality of the evidence was assessed using the GRADE approach. When the any antibiotic agent was used, the 'no cure' rate for asymptomatic bacteriuria in pregnant women was slightly lower for the short-course treatment over the single-dose treatment, although there was evidence of statistical heterogeneity (average risk ratio (RR) 1.28, 95% confidence interval (CI) 0.87 to 1.88; women = 1502, studies = 13; I² = 56%; very low quality evidence). Data from only good quality trials also showed better cure rates with short (four- to seven-day) regimens of the same microbial agent (average RR 1.72, 95% CI 1.27 to 2.33; women = 803, studies = two; I² = 0%; high quality evidence). There was no clear difference in the recurrence of asymptomatic bacteriuria rate between treatment and control groups, whether the same or different microbial agents were used (RR 1.13, 95% CI 0.77 to 1.66; 445 women studies = eight; I² = 0%; very low quality evidence). Differences were detected for low birthweight babies, favoring a short course (four- to seven-day treatment) of the same microbial agent, although the data come from a single trial (RR 1.65, 95% CI 1.06 to 2.57; 714 women; high quality evidence), but no differences were observed for preterm delivery (RR 1.17, 95% CI 0.77 to 1.78; women = 804; studies = three; I² = 23%; moderate quality) or pyelonephritis (RR 3.09, 95% CI 0.54 to 17.55; women = 102; studies = two; I² = 0%; very low quality evidence). Finally, single-dose treatment of any microbial agent was associated with a decrease in reports of 'any side effects' (RR 0.70, 95% CI 0.56 to 0.88; 1460 women, studies = 12; I² = 9%; low quality evidence). Evidence was downgraded for risk of bias concerns in trials contributing data and for imprecise effect estimates (wide confidence intervals crossing the line of no effect, and in some cases, small studies with few events). A single-dose regimen of antibiotics may be less effective than a short-course (four- to seven-day) regimen, but more evidence is needed from large trials measuring important outcomes, such as cure rate. Women with asymptomatic bacteriuria in pregnancy should be treated by the standard regimen of antibiotics until more data become available testing seven-day treatment compared with shorter courses of three- or five-day regimens.\nOutput:\n" }, { "from": "agent", "value": "This review aimed to identify whether single-dose antibiotic treatments are as effective as longer ones for maternal and newborn outcomes. In general, the risk of bias of trials included in this review was largely unclear. The overall quality of the evidence was assessed using the GRADE approach. The review of 13 studies, involving over 1622 women, found that a seven-day regimen is more effective than a one-day course, especially for the outcome of low birthweight (high quality evidence), but this result is based on just one study. There were no clear differences between a single dose and a four- to seven-day short course of antibiotics for other review outcomes, including kidney infection (very low quality evidence) and preterm birth (moderate quality evidence). Women with a single-dose regimen reported fewer side effects (low quality evidence). More trials are needed to confirm which length of treatment is best for women and babies." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: No additional studies were identified in this 2015 review update, in total leading to no studies meeting the criteria for inclusion in this review. The efficacy of ECP in the treatment of chronic GvHD in paediatric patients after haematopoietic stem cell transplantation based on RCTs cannot be evaluated since the original version of this review and the first review update found no RCTs. Current recommendations are based on retrospective or observational studies only. Thus, ideally, ECP should be applied in the context of controlled trials only. However, performing RCTs in this patient population will be challenging due to the limited number of patients, the variable disease presentation and the lack of well-defined response criteria. International collaboration, multicentre trials and appropriate funding for such trials will be needed. If treatment decisions based on clinical data are made in favour of ECP, patients should be carefully monitored for beneficial and harmful effects. In addition, efforts should be made to share this information with other clinicians, for example by setting up registries for paediatric patients that are treated with ECP.\nOutput:\n" }, { "from": "agent", "value": "We searched scientific databases for randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) that were designed to evaluate the effectiveness and safety of ECP for the management of chronic graft-versus-host disease in children and adolescents (under 18 years of age) after HSCT. The original version of this review and this 2015 review update found no RCTs that analysed the efficacy of ECP for paediatric patients with chronic graft-versus-host disease after HSCT. Current recommendations are based on retrospective (a study in which the outcomes have occurred to the participants before the study began) or observational (a study in which the investigators do not seek to intervene, and simply observed the course of events) studies only. Thus, ideally, ECP should be applied in paediatric patients in the context of RCTs only. ECP may be considered in people with steroid-refractory chronic GvHD, keeping in mind that such a treatment is not supported by high-level evidence. If treatment decisions based on clinical data in favour of ECP are made, patients should be carefully monitored for beneficial and harmful effects and efforts should be made to share this information with other clinicians, for example by setting up registries for paediatric patients that are treated with ECP." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included five trials with a total of 1115 women and their babies (922 women and their babies contributed outcome data). Four of the five included trials had small sample sizes with one large trial that recruited 855 women and babies. All five included trials had a moderate risk of bias. When comparing women receiving additional exercise interventions with those having routine antenatal care, there was no significant difference in GDM incidence (three trials, 826 women, risk ratio (RR) 1.10, 95% confidence interval (CI) 0.66 to 1.84), caesarean section (two trials, 934 women, RR 1.33, 95% CI 0.97 to 1.84) or operative vaginal birth (two trials, 934 women, RR 0.83, 95% CI 0.58 to 1.17). No trial reported the infant primary outcomes prespecified in the review. None of the five included trials found significant differences in insulin sensitivity. Evidence from one single large trial suggested no significant difference in the incidence of developing pregnancy hyperglycaemia not meeting GDM diagnostic criteria, pre-eclampsia or admission to neonatal ward between the two study groups. Babies born to women receiving exercise interventions had a non-significant trend to a lower ponderal index (mean difference (MD) -0.08 gram x 100 m3, 95% CI -0.18 to 0.02, one trial, 84 infants). No significant differences were seen between the two study groups for the outcomes of birthweight (two trials, 167 infants, MD -102.87 grams, 95% CI -235.34 to 29.60), macrosomia (two trials, 934 infants, RR 0.91, 95% CI 0.68 to 1.22), or small-for-gestational age (one trial, 84 infants, RR 1.05, 95% CI 0.25 to 4.40) or gestational age at birth (two trials, 167 infants, MD -0.04 weeks, 95% CI -0.37 to 0.29) or Apgar score less than seven at five minutes (two trials, 919 infants, RR 1.00, 95% CI 0.27 to 3.65). None of the trials reported long-term outcomes for women and their babies. No information was available on health services costs. There is limited randomised controlled trial evidence available on the effect of exercise during pregnancy for preventing pregnancy glucose intolerance or GDM. Results from three randomised trials with moderate risk of bias suggested no significant difference in GDM incidence between women receiving an additional exercise intervention and routine care. Based on the limited data currently available, conclusive evidence is not available to guide practice. Larger, well-designed randomised trials, with standardised behavioural interventions are needed to assess the effects of exercise on preventing GDM and other adverse pregnancy outcomes including large-for-gestational age and perinatal mortality. Longer-term health outcomes for both women and their babies and health service costs should be included. Several such trials are in progress. We identified another seven trials which are ongoing and we will consider these for inclusion in the next update of this review.\nOutput:\n" }, { "from": "agent", "value": "This review aimed to assess the effects of physical exercise for pregnant women in preventing glucose intolerance or GDM and was based on limited evidence from five randomised controlled trials. Two trials involved obese women. The trials provided data from 922 women and their babies and were of moderate risk of bias. The exercise programs including individualised exercise with regular advice, weekly supervised group exercise session or home-based stationary cycling, either supervised or unsupervised, had no clear effect on preventing GDM (three trials with 826 women screened at 18 to 36 weeks' gestation), or improving insulin sensitivity (five trials) compared with standard antenatal care with normal daily activities. Based on these limited data, conclusive evidence is not available to guide practice. Larger, well-designed randomised trials are needed. Several such trials are in progress. We identified another seven trials which are ongoing and we will consider these for inclusion in the next update." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Thirteen randomized double-blinded placebo-controlled trials that examined the blood pressure lowering efficacy of six partial agonists in 605 hypertensive patients were included in this review. Five of the included studies were parallel studies and the other eight were cross-over studies. The overall risk of bias is high in this review due to the small sample size and high risk of detection bias. Pindolol, celiprolol and alprenolol lowered SBP and DBP compared to placebo. Acebutolol lowered SBP but there was no clear evidence that it lowered DBP. There was no clear evidence that pindolol and oxprenolol lowered SBP or DBP. Other than for celiprolol, sample sizes were generally small increasing the uncertainty in findings for individual agents versus placebo. In patients with moderate to severe hypertension, partial agonists (considered as a subclass) lowered peak BP by an average of 8 mmHg systolic (95% CI, -10 to -6, very low quality evidence), 4 mmHg diastolic (95%CI, -5 to -3, very low quality evidence) and reduced heart rate by five beats per minute (95%CI, -6 to -4, very low quality evidence). Higher dose partial agonists did not appear to provide additional BP lowering effects compared to lower dose. The maximum BP lowering effect of the overall subclass occurred at the starting dose. Partial agonists reduced pulse pressure by 4 mmHg (95% CI, -5 to -2, very low evidence). Only one study reported withdrawal due to adverse effects, the risk ratio (95% confidence interval) was 0.72 (0.07, 7.67). There was very low quality evidence that in patients with moderate to severe hypertension, partial agonists lowered peak BP by an average of 8/4 mmHg and reduced heart rate by five beats per minute. There was no evidence of a greater effect at doses higher than the initial doses. This estimate was probably exaggerated as it was subject to a high risk of bias. Based on the indirect comparison of the results in this review and two Cochrane reviews on angiotensin-converting-enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which also used similar inclusion criteria as this review, the BP lowering effect appeared to be less than the effect in patients with mild to moderate elevated BP who were taking ACE inhibitors and ARBs based on an indirect comparison. Withdrawals due to adverse effects were only reported in one trial so it is impossible to assess the harm of these drugs.\nOutput:\n" }, { "from": "agent", "value": "We developed a comprehensive search strategy to search relevant scientific databases for clinical trials and found 13 trials that randomly assigned 605 high blood pressure patients to either fixed-dose partial agonist treatment or placebo for up to 12 weeks. On average, partial agonists lowered blood pressure by eight points in systolic and four points in diastolic pressure in patient with moderate to severe high blood pressure. We did not find any evidence showing that doses higher than the recommended starting doses would further lower blood pressure. On average, partial agonists lowered pulse pressure by 4 mmHg. The included studies generally did not report side effects serious enough that lead to termination of treatment. It was not clear whether partial agonists provide more side effects serious enough that lead to withdrawal compared to placebo. The quality of evidence is very low due to small sample size and high risk of bias." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: This review included 19 trials involving 2137 participants. Only five trials fulfilled the criteria of good methodological quality. One trial compared laser trabeculoplasty with topical beta-blocker to no intervention in early glaucoma. The risk of glaucoma progression was higher in the control group at six years of follow up (risk ratio (RR) 0.71 95% confidence interval (CI) 0.53 to 0.95). No difference in health-related quality of life was observed between the two groups. Three trials compared laser trabeculoplasty to medication (regimens used before the 1990s) in people with newly diagnosed OAG. The risk of uncontrolled intraocular pressure (IOP) was higher in the medication group compared to the trabeculoplasty group at six months and two years of follow up. Three trials compared laser trabeculoplasty with trabeculectomy. The risk of uncontrolled IOP was significantly higher in the trabeculoplasty group at six months but significant heterogeneity was observed at two years. Diode and selective laser are compared to argon laser trabeculoplasty in three trials and there is some evidence showing a comparable effect in controlling IOP at six months and one year of follow up. Evidence suggests that, in people with newly diagnosed OAG, the risk of uncontrolled IOP is higher in people treated with medication used before the 1990s when compared to laser trabeculoplasty at two years follow up. Trabeculoplasty is less effective than trabeculectomy in controlling IOP at six months and two years follow up. Different laser technology and protocol modalities were compared to the traditional laser trabeculoplasty and more evidence is necessary to determine if they are equivalent or not. There is no evidence to determine the effectiveness of laser trabeculoplasty compared to contemporary medication (prostaglandin analogues, topical anhydrase inhibitors and alpha2-agonists) and also with contemporary surgical techniques. Also there should be further investigation in to the effectiveness of laser trabeculoplasty in specific racial groups, specific diagnostic groups, such as pseudoexfoliation and pigmentary glaucoma and different stages of OAG. More research is also required determining cost-effectiveness of laser trabeculoplasty in the management of glaucoma.\nOutput:\n" }, { "from": "agent", "value": "This review included 19 trials (2137 participants). One trial compared laser trabeculoplasty associated with a hypotensive eyedrop with no intervention, and at six years of follow up the risk of visual field decay was greater in non treated participants. Three trials compared hypotensive eyedrops with trabeculoplasty, and the risk of uncontrolled IOP was greater at two years in the laser group. It is necessary to mention that the eyedrops used in these trials differ significantly from the ones used currently, since these trials were developed a decade ago. Three other trials compared trabeculoplasty with trabeculectomy and the risk of uncontrolled IOP was higher in the laser group at six months of follow up. There is some evidence showing that diode laser and selective trabeculoplasty have similar effect in controlling IOP when compared to argon laser trabeculoplasty. Comparisons of different lasers and different techniques of application were done in the remaining trials, but there is still not enough evidence to determine which is the best treatment protocol. Further research is necessary to compare trabeculoplasty with new hypotensive eyedrops and also the results of laser therapy in people of different ethnicities, since some studies suggest that they have a different response to this kind of laser therapy. More research is required to analyse cost-effectiveness of these interventions." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included eight studies (334 participants, 9 references) in this review. Twelve studies are ongoing and will be considered in future versions of this review as appropriate. We have been unable to obtain full-text versions of a further 12 studies and have designated them as 'awaiting classification'. Four studies were at a low risk of bias for randomization; two at a low risk of bias for allocation concealment. Four studies were at a low risk of bias for blinding of participants and personnel. We considered three studies at a low risk of bias for blinding of outcome assessors. We considered most studies at a high risk of selective reporting bias. We report results for the following four main comparisons. Sumatriptan versus placebo (1 parallel study; 102 participants) Data on sumatriptan showed a reduction of the risk of AMS when compared with a placebo (risk ratio (RR) = 0.43, CI 95% 0.21 to 0.84; 1 study, 102 participants; low quality of evidence). The one included study did not report events of HAPE, HACE or adverse events related to administrations of sumatriptan. Magnesium citrate versus placebo (1 parallel study; 70 participants) The estimated RR for AMS, comparing magnesium citrate tablets versus placebo, was 1.09 (95% CI 0.55 to 2.13; 1 study; 70 participants; low quality of evidence). In addition, the estimated RR for loose stools was 3.25 (95% CI 1.17 to 8.99; 1 study; 70 participants; low quality of evidence). The one included study did not report events of HAPE or HACE. Spironolactone versus placebo (2 parallel studies; 205 participants) Pooled estimation of RR for AMS was not performed due to considerable heterogeneity between the included studies (I² = 72%). RR from individual studies was 0.40 (95% CI 0.12 to 1.31) and 1.44 (95% CI 0.79 to 2.01; very low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated. Acetazolamide versus spironolactone (1 parallel study; 232 participants) Data on acetazolamide compared with spironolactone showed a reduction of the risk of AMS with the administration of acetazolamide (RR = 0.36, 95% CI 0.18 to 0.70; 232 participants; low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated. This Cochrane Review is the second in a series of three providing relevant information to clinicians and other interested parties on how to prevent high altitude illness. The assessment of five of the less commonly used classes of drugs suggests that there is a scarcity of evidence related to these interventions. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. Overall, the evidence is limited due to the low number of studies identified (for most of the comparison only one study was identified); limitations in the quality of the evidence (moderate to low); and the number of studies pending classification (24 studies awaiting classification or ongoing). We lack the large and methodologically sound studies required to establish or refute the efficacy and safety of most of the pharmacological agents evaluated in this review.\nOutput:\n" }, { "from": "agent", "value": "The evidence is current to May 2017. We included eight studies and 334 participants related to five different classes of medicines sometimes recommended for HAI prevention. These medicines included those that mimic the action of serotonin at selected sites (selective 5-hydroxytryptamine(1) receptor agonists), medicines that regulate the action of calcium (N-methyl-D-aspartate (NMDA) antagonist), medicines that promote dilation of the blood vessels (endothelin-1 antagonist), medicines that prevent a neuron (nerve cell) from 'firing' (initiating an action) and convulsions from developing (anticonvulsant medicines), as well as medicines that regulate the body´s sodium and water levels (spironolactone). All studies were undertaken in high altitude mountain areas. The participants ranged between 16 and 65 years of age. Only one study included people at a high risk of this condition due to their history of HAI. Four trials provided the intervention between one to three days prior to the ascent (50%), and three trials less than 24 hours prior (37.5%). The participants in all these studies reached a final altitude of between 3500 and 5895 metres above sea level. Only one of the eight included studies did not provide clear information about the source of funding (12.5%). Twenty-four additional studies were classified as ongoing (12), or awaiting classification (12; unable to obtain full texts). The assessment of the less commonly used pharmacological interventions suggest that there is a scarcity of evidence related to these interventions. For most of the assessed comparisons, we only found evidence from a single study. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. The quality of the evidence was rated from low to very low. Several studies had quality shortcomings such as only having small sample sizes and therefore generating uncertain results. For most of the medicines evaluated, additional research is required to clarify their effectiveness and safety." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified two RCTs involving 978 women with cervical cancer stage IIB to IVA. As the trials were significantly different clinically, we did not perform meta-analyses. One industry-funded trial involving 515 women compared CCRT (cisplatin) versus CCRT (cisplatin and gemcitabine) plus ACT (two additional cycles). This trial reported significant improvement in progression-free survival (PFS) and overall survival (OS) in women who were given CCRT plus ACT compared with those treated with CCRT alone: Three-year PFS was 74.4% versus 65.0% (hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.49 to 0.95, P value 0.027), and three-year OS was 80% versus 69% (HR 0.68, 95% CI 0.49 to 0.95, P value 0.022). However, as the CCRT chemotherapy differed between the two arms, we considered the findings to be at high risk of bias. The second trial was a four-arm study from which we extracted data on 463 women in two study arms receiving CCRT (intravenous mitomycin C and oral 5-fluorouracil (5-FU)) or CCRT plus ACT (oral 5-FU for three cycles). The HR for OS in women who received ACT after CCRT compared with the HR for OS in those who were given CCRT alone was 1.309 (95% CI 0.795 to 2.157), and the HR for disease-free survival (DFS) was 1.125 (95% CI 0.799 to 1.586). Haematological adverse events were more common in the ACT arms of both trials. Quality of life (QoL) was not reported in either trial. With limited data from only two trials, we found insufficient evidence to support the use of ACT after CCRT. Future large trials are required to demonstrate efficacy, toxicities and QoL.\nOutput:\n" }, { "from": "agent", "value": "The two studies were very different; therefore we could not pool their data. One trial conducted internationally between 2002 and 2004, involving 515 women, found that cancer took longer to return in women receiving ACT (cisplatin and gemcitabine), and more women in the ACT group were alive after three years than in the standard treatment group (80% versus 69%). We considered the findings to be at high risk of bias in this trial, as women were given different drugs during standard treatment, and so the overall effect of the study treatment could not be attributed to the ACT alone. The other trial, which was conducted in several hospitals in Thailand between 1988 and 1994, involved 463 women. ACT (5-fluorouracil) did not improve the length of survival or the time taken for cancer to return in women in this trial. A trend towards increased side effects was reported in the ACT arms of both studies. We found insufficient evidence to support giving additional anticancer drugs to women who have received standard treatment for locally advanced cervical cancer, as currently only limited data are available from two very different trials." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included two RCTs involving 2193 participants in the review. Both studies randomised participants to either beta-blocker (atenolol 5 mg) or placebo and were of a high methodological quality. We noted no statistical differences among the groups in risks of fatal and non-fatal stroke (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.76 to 1.18). For other outcomes analysed (major vascular events, death from all causes, death from cardiovascular causes) , we observed no significant differences between the groups. There were minor blood pressure reductions in the intervention group. Neither of the included studies reported the occurrence of diabetes among their outcomes or assessed quality of life. Adverse events were significantly more frequent in participants taking atenolol than in those given placebo, and were the most common reason given for discontinuing treatment (RR 1.85, 95% CI 1.45 to 2.35). To date, no available evidence supports the routine use of beta-blockers for secondary prevention after stroke or TIA. More studies with larger samples are needed.\nOutput:\n" }, { "from": "agent", "value": "Searching for studies up to May 2014, we found two high quality trials involving 2193 participants that tested beta-blockers after stroke in people with a recent stroke or TIA. No clear evidence indicated that beta-blockers reduced the risk of stroke, heart attack, or death from vascular disease. Participants who received beta blockers instead of placebo showed significantly more adverse effects. More studies with larger samples are needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three randomised controlled trials (351 participants) investigating immediate versus delayed chemotherapy in people diagnosed with asymptomatic, metastatic, incurable colorectal cancer. Giving immediate versus delayed chemotherapy may make little or no difference to overall survival (hazard ratio (HR) 1.17, 95% confidence interval (CI) 0.93 to 1.46; 3 studies, 351 persons; low-quality evidence). For toxicity, giving immediate versus delayed chemotherapy may make little or no difference to the risk of grade 3 or 4 nausea and vomiting (risk ratio (RR) 0.84, 95% CI 0.31 to 2.25; 2 studies, 140 persons; very low-quality evidence), stomatitis (RR 1.10, 95% CI 0.47 to 2.55; 2 studies, 140 persons; very low-quality evidence), or diarrhoea (RR 0.69, 95% CI 0.34 to 1.40; 2 studies, 140 persons, very low-quality evidence). We are uncertain whether delayed chemotherapy made a difference to quality of life (very low-quality evidence), progression-free survival (low-quality evidence), or compliance with chemotherapy (low-quality evidence), as we had insufficient data to pool for these outcomes. Based on a limited number of trials, very sparse data, and uncertainty of the evidence, this review was unable to establish whether there was a difference in overall survival or other clinically relevant outcomes, between immediate or delayed chemotherapy in persons with metastatic, incurable, colorectal cancer. The results should be interpreted with caution.\nOutput:\n" }, { "from": "agent", "value": "We included three randomised clinical trials. In these trials, people with metastatic and incurable colorectal cancer, without symptoms, received chemotherapy straight away (standard group) or their chemotherapy was delayed (intervention group). There were a total of 176 participants In the standard groups and 175 in the intervention groups. The available data allowed us to complete analyses for overall survival and toxicities. Participants with metastatic, incurable colorectal cancer without symptoms, who received chemotherapy straight away, did not live longer than those whose chemotherapy was delayed until symptoms appeared. For toxicities measures, our findings were inconclusive due to sparse data from only two trials and few participants. There were insufficient data to compare other outcomes of interest, such as quality of life, progression-free survival (the length of time during and after treatment that a person lives with the disease, but it does not get worse), and compliance with chemotherapy (whether a participant was able to complete the chemotherapy regimen). Based on very sparse data and uncertainty of the evidence, we were unable to establish whether there was a difference in overall survival and other important outcomes in people with metastatic, incurable, colorectal cancer, who received chemotherapy either straight away or waited until after symptoms had appeared." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Thirty-four trials were identified which included approximately 19,676 incontinent women of whom 9599 received oestrogen therapy (1464 involved in trials of local vaginal oestrogen administration). Sample sizes of the studies ranged from 16 to 16,117 women. The trials used varying combinations of type of oestrogen, dose, duration of treatment and length of follow up. Outcome data were not reported consistently and were available for only a minority of outcomes. The combined result of six trials of systemic administration (of oral systemic oestrogens) resulted in worse incontinence than on placebo (risk ratio (RR) 1.32, 95% CI 1.17 to 1.48). This result was heavily weighted by a subgroup of women from the Hendrix trial, which had large numbers of participants and a longer follow up of one year. All of the women had had a hysterectomy and the treatment used was conjugated equine oestrogen. The result for women with an intact uterus where oestrogen and progestogen were combined also showed a statistically significant worsening of incontinence (RR 1.11, 95% CI 1.04 to 1.18). There was some evidence that oestrogens used locally (for example vaginal creams or pessaries) may improve incontinence (RR 0.74, 95% CI 0.64 to 0.86). Overall, there were around one to two fewer voids in 24 hours amongst women treated with local oestrogen, and there was less frequency and urgency. No serious adverse events were reported although some women experienced vaginal spotting, breast tenderness or nausea. Women who were continent and received systemic oestrogen replacement, with or without progestogens, for reasons other than urinary incontinence were more likely to report the development of new urinary incontinence in one large study. One small trial showed that women were more likely to have an improvement in incontinence after pelvic floor muscle training (PFMT) than with local oestrogen therapy (RR 2.30, 95% CI 1.50 to 3.52). The data were too few to address questions about oestrogens compared with or in combination with other treatments, different types of oestrogen or different modes of delivery. Urinary incontinence may be improved with the use of local oestrogen treatment. However, there was little evidence from the trials on the period after oestrogen treatment had finished and no information about the long-term effects of this therapy was given. Conversely, systemic hormone replacement therapy using conjugated equine oestrogen may worsen incontinence. There were too few data to reliably address other aspects of oestrogen therapy, such as oestrogen type and dose, and no direct evidence comparing routes of administration. The risk of endometrial and breast cancer after long-term use of systemic oestrogen suggests that treatment should be for limited periods, especially in those women with an intact uterus.\nOutput:\n" }, { "from": "agent", "value": "The review found 34 trials including more than 19,000 women of whom over 9000 received oestrogen. The review found that significantly more women who received local (vaginal) oestrogen for incontinence reported that their symptoms improved compared to placebo. There was no evidence about whether the benefits of local oestrogen continue after stopping treatment but this seems unlikely as women would revert to having naturally low oestrogen levels. Trials investigating systemic (oral) administration, on the other hand, found that women reported worsening of their urinary symptoms. The evidence comes mainly from two very large trials including 17,642 incontinent women. These trials were investigating other effects of hormone replacement therapy as well as incontinence, such as prevention of heart attacks in women with coronary heart disease, bone fractures, breast and colorectal cancer. In addition, in one large trial women who did not have incontinence at first were more likely to develop incontinence. There may be risks from long-term use of systemic oestrogen, such as heart disease, stroke and cancer of the breast and uterus." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Three RCTs (1713 participants) fulfilled the selection criteria and we included them in the review. All three trials compared alemtuzumab versus subcutaneous interferon beta-1a for patients with relapsing–remitting MS. Patients were treatment-naive in the CARE-MS and CAMMS223 studies. The CARE-MS II study included patients with at least one relapse while being treated with interferon beta or glatiramer acetate. Alemtuzumab was given for 12 or 24 months; for some outcomes, the follow-up period reached 36 months. The regimens were (a) 12 mg or 24 mg per day administered intravenously, once a day for five consecutive days at month 0 and 12 or (b) 24 mg per day, intravenously, once a day for three consecutive days at month 12 and 24. The patients in the other arm of the trials received interferon beta-1a 44 μg subcutaneously three times weekly after dose titration. At 24 months, alemtuzumab 12 mg was associated with: (a) higher relapse-free survival (hazard ratio (HR) 0.50, 95% CI 0.41 to 0.60; 1248 participants, two studies, moderate quality evidence); (b) higher sustained disease progression-free survival (HR 0.62, 95% CI 0.44 to 0.87; 1191 participants; two studies; moderate quality evidence); (c) a slightly higher number of participants with at least one adverse event (RR 1.04, 95% CI 1.01 to 1.06; 1248 participants; two studies; moderate quality evidence); (d) a lower number of participants with new or enlarging T2-hyperintense lesions on magnetic resonance imaging (MRI) (RR 0.74, 95% CI 0.59 to 0.91; 1238 participants; two studies; I2 = 80%); and (e) a lower number of dropouts (RR 0.31, 95% CI 0.23 to 0.41; 1248 participants; two studies, I2 = 29%; low quality evidence). At 36 months, alemtuzumab 24 mg was associated with: (a) higher relapse-free survival (45 versus 17; HR 0.21, 95% CI 0.11 to 0.40; one study; 221 participants); (b) a higher sustained disease progression-free survival (HR 0.33, 95% CI 0.16 to 0.69; one study; 221 participants); and (c) no statistical difference in the rate of participants with at least one adverse event. We did not find any study that reported any of the following outcomes: rate of participants free of clinical disease activity, quality of life, fatigue or change in the numbers of MRI T2- and T1-weighted lesions after treatment. It was not possible to perform subgroup analyses according to disease type and disability at baseline due to lack of data. In patients with relapsing-remitting MS, alemtuzumab 12 mg was better than subcutaneous interferon beta-1a for the following outcomes assessed at 24 months: relapse-free survival, sustained disease progression-free survival, number of participants with at least one adverse event and number of participants with new or enlarging T2-hyperintense lesions on MRI. The quality of the evidence for these results was low to moderate. Alemtuzumab 24 mg seemed to be better than subcutaneous interferon beta-1a for relapse-free survival and sustained disease progression-free survival, at 36 months. More randomised clinical trials are needed to evaluate the effects of alemtuzumab on other forms of MS and compared with other therapeutic options. These new studies should assess additional relevant outcomes such as the rate of participants free of clinical disease activity, quality of life, fatigue and adverse events (individual rates, serious adverse events and long-term adverse events). Moreover, these new studies should evaluate other doses and durations of alemtuzumab course.\nOutput:\n" }, { "from": "agent", "value": "We found three studies (including 1713 participants) that fulfilled the review selection criteria. All studies compared alemtuzumab versus subcutaneous interferon beta-1a for people with relapsing–remitting MS. In two of the studies (CARE-MS and CAMMS223) the participants were being treated for the first time (treatment-naive). The third study (CARE-MS II) included participants with at least one relapse while being treated with interferon beta or glatiramer acetate for at least six months. The review of these comparative studies found that, compared to subcutaneous interferon beta-1a, alemtuzumab reduces the risk of relapse, improves function and seems not to increase the overall risk of adverse events. Additionally, alemtuzumab reduces the risk of new or enlarging lesions of MS detected using magnetic resonance imaging (MRI). However, there is a lack of information about the effects of alemtuzumab on several patient-related outcomes such as (a) quality of life, (b) the rate of each adverse events (separately) and (c) the frequency of long-term adverse events and serious adverse events. The overall methodological quality of the included studies was moderate to high. However, because of the small number of included studies and the low rate of events, we judged the overall quality of the evidence for the main outcomes as very low to moderate. This means that new studies are likely to have an important impact on our confidence in the estimate of effect and may change the estimate or that we are very uncertain about the estimate." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Three trials met the inclusion criteria. Two trials (n = 20,451) assessed the effect of TXA. The larger of these (CRASH-2, n = 20,211) was conducted in 40 countries and included patients with a variety of types of trauma; the other (n = 240) restricted itself to those with traumatic brain injury (TBI) only. One trial (n = 77) assessed aprotinin in participants with major bony trauma and shock. The pooled data show that antifibrinolytic drugs reduce the risk of death from any cause by 10% (RR 0.90, 95% CI 0.85 to 0.96; P = 0.002) (quality of evidence: high). This estimate is based primarily on data from the CRASH-2 trial of TXA, which contributed 99% of the data. There is no evidence that antifibrinolytics have an effect on the risk of vascular occlusive events (quality of evidence: moderate), need for surgical intervention or receipt of blood transfusion (quality of evidence: high). There is no evidence for a difference in the effect by type of antifibrinolytic (TXA versus aprotinin) however, as the pooled analyses were based predominantly on trial data concerning the effects of TXA, the results can only be confidently applied to the effects of TXA. The effects of aprotinin in this patient group remain uncertain. There is some evidence from pooling data from one study (n = 240) and a subset of data from CRASH-2 (n = 270) in patients with TBI which suggest that TXA may reduce mortality although the estimates are imprecise, the quality of evidence is low, and uncertainty remains. Stronger evidence exists for the possibility of TXA reducing intracranial bleeding in this population. TXA safely reduces mortality in trauma patients with bleeding without increasing the risk of adverse events.  TXA should be given as early as possible and within three hours of injury, as further analysis of the CRASH-2 trial showed that treatment later than this is unlikely to be effective and may be harmful. Although there is some promising evidence for the effect of TXA in patients with TBI, substantial uncertainty remains. Two ongoing trials being conducted in patients with isolated TBI should resolve these remaining uncertainties.\nOutput:\n" }, { "from": "agent", "value": "Two trials assessed the effect of TXA in patients aged 16 and over. The largest (n = 20,211) involved patients suffering from a variety of types of trauma, and the other (n = 240) only those who had suffered traumatic brain injury. Results The trial assessing the effect of aprotinin was too small to provide reliable data. Results for TXA suggest that, when given early, TXA reduces the risk of death compared to patients who do not receive TXA without increasing the risk of side effects. However, there is still some uncertainty about the effect of TXA in patients who have bleeding inside the brain from a head injury, but are not bleeding from injuries elsewhere. It is possible that the effects of TXA are different in this specific patient group. We have found two ongoing trials that are trying to answer this question. The authors of this review conclude that TXA can safely reduce death in trauma patients with bleeding and should be given as soon as possible after injury. However, they cannot conclude whether or not TXA is also effective in patients with traumatic brain injury with no other trauma, until the ongoing trials have been completed. Quality of the evidence Evidence for important outcomes including mortality, need for further surgery and blood transfusion, came from high-quality evidence, meaning we have confidence in the findings. There was moderate-quality evidence for important adverse events including vascular occlusive events (including heart attacks, deep vein thrombosis, stroke and pulmonary embolism)." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 28 studies, with a total of 2306 participants. We assessed most of the studies at high 'risk of bias', particularly in blinding of participants and personnel, and there was substantial inconsistency between studies, so any positive effect of CHM must be treated with caution. We did not include the four studies from the previous version in this review, because they investigated a CHM product that has been withdrawn from the market since 2004. Four studies (three oral and one topical) compared CHM to placebo. Pooled data from 2 studies showed the total effectiveness rate in the CHM group was higher (by risk ratio (RR) 2.09, 95% confidence interval (CI) 1.32 to 3.32; 2 studies; n = 85), and the itching visual analogue score (VAS) in the CHM group was 1.53 lower (by standardised mean difference (SMD), 95% CI 2.64 to 0.41; 2 Studies; n = 94) than the placebo group, where a lower VAS score indicates reduced itch. One study of 85 participants with moderate to severe eczema who received an oral CHM formula for 12 weeks reported a quality of life (QoL) score 2.5 lower in the CHM group (by difference in means (MD), 95% CI 4.77 to 0.23; 1 study; n = 85) than the placebo group, where a lower score indicates better QoL. Twenty-two studies and 1 arm from a study with a 4-arm parallel controlled design compared CHM (5 oral, 6 topical, and 12 mixed oral and topical) to conventional medicines. The total effectiveness rate in the CHM groups was superior (RR 1.43, 95% CI 1.27 to 1.61; 21 studies; n = 1868; very low quality evidence), and the itching VAS in the CHM groups was 0.83 lower (SMD, 95% CI 1.43 to 0.22; 7 studies; n = 465) than the comparators. Two studies compared combined oral and topical CHM to the same oral CHM formula alone. The total effectiveness rate in 1 study was not statistically significant (RR 1.13, 95% CI 0.78 to 1.63; 1 study; n = 20). In the other study, the itching VAS in the CHM group was 1.05 lower (MD, 95% CI 1.75 to 0.35; 1 study; n = 23) than the control group. With regard to side-effects, four studies did not give any report of adverse events. The other 24 studies reported minor adverse events, which were reversed soon after stopping CHM. One participant withdrew from one trial because of exacerbation of their condition after using the CHM intervention. Eight studies received government funding. We could not find conclusive evidence that CHM taken by mouth or applied topically to the skin could reduce the severity of eczema in children or adults. Well-designed, adequately powered RCTs are needed to evaluate the efficacy and safety of CHM for managing eczema.\nOutput:\n" }, { "from": "agent", "value": "A former Cochrane review published in 2004 found some evidence of a possible benefit of using oral Chinese herbal medicine (CHM) for eczema; however, the results from only 4 included studies were inconclusive and need to be updated (those four studies have not been included in this update as they investigated a product that has been withdrawn from the market since 2004). As well as updating that review, we have also widened the scope of the review to assess the effects of topical CHM for eczema. We wrote a new protocol to expand the scope of this review. This review included 28 randomised controlled trials (RCTs), with 2306 children and adults, of which 4 compared CHM to placebo, 22 to conventional medications, and 2 to CHM taken by mouth. Most of the included studies reported a higher number of participants who had recovered and significantly improved, with less itching in the CHM groups than the control groups. Where CHM was compared to conventional drugs, although the total effectiveness rate outcome was superior with CHM, it was based on very low quality evidence. One study reported that the quality of life (QoL) score in the CHM group was better than in the placebo group after using a CHM formula taken by mouth for 12 weeks. We assessed most of the studies as at high 'risk of bias' and therefore not of good quality, and there was substantial inconsistency between the studies, so any positive effect in CHM must be treated with caution. One study reported one severe adverse event. Minor adverse events were observed in 24 studies, including temporary elevation of enzymes in 3 cases, which was reversed soon after stopping CHM. Eight included studies received government funding. We could not find conclusive evidence that CHM taken by mouth or applied to the skin was of benefit to children or adults with eczema. Well-designed, adequately powered RCTs are needed to evaluate the efficacy and safety of CHM for eczema." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Administration of dexamethasone prior to extubation significantly reduced the need for reintubation of the trachea. This result applies to both the high-risk group and to the total population of infants enrolled. However, the incidence of extubation failure was zero in the trial that attempted to exclude infants at high risk of airway edema. The side effects of higher blood sugar levels and glycosuria were found in the two trials where these were sought. Implications for practice Dexamethasone reduces the need for endotracheal reintubation of neonates after a period of IPPV. In view of the lack of effect in low-risk infants and the documented and potential side effects, it appears reasonable to restrict its use to infants at increased risk for airway edema and obstruction, such as those who have received repeated or prolonged intubations. Implications for research Issues of dosage and applicability to the extremely low birthweight population could be addressed in future trials. Outcomes such as chronic lung disease, duration of assisted ventilation and length of hospital stay as well as long-term neurodevelopment should also be examined.\nOutput:\n" }, { "from": "agent", "value": "This review found that giving dexamethasone (a corticosteroid drug) around the time of extubation can help prevent swelling in the baby's throat that might require reinsertion of the tube. However, the review found that there are adverse effects of dexamethasone. The benefits only outweigh the risks for babies at high risk of complication (such as those who have received several, or prolonged, intubations)." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included two trials that involved 294 infants. No new studies were included for the 2017 update. The incidence of death or BPD at 36 weeks' postmenstrual age was not statistically significantly different between infants who received inhaled or systemic steroids (RR 1.09, 95% CI 0.88 to 1.35; RD 0.05, 95% CI -0.07 to 0.16; 1 trial, N = 278). The incidence of BPD at 36 weeks' postmenstrual age among survivors was not statistically significant between groups (RR 1.34, 95% CI 0.94 to 1.90; RD 0.11, 95% CI -0.02 to 0.24; 1 trial, N = 206). There was no statistically significant difference in the outcomes of BPD at 28 days, death at 28 days or 36 weeks' postmenstrual age and the combined outcome of death or BPD by 28 days between groups (2 trials, N = 294). The duration of mechanical ventilation was significantly longer in the inhaled steroid group compared with the systemic steroid group (typical MD 4 days, 95% CI 0.2 to 8; 2 trials, N = 294; I² = 0%) as was the duration of supplemental oxygen (typical MD 11 days, 95% CI 2 to 20; 2 trials, N = 294; I² = 33%). The incidence of hyperglycaemia was significantly lower with inhaled steroids (RR 0.52, 95% CI 0.39 to 0.71; RD -0.25, 95% CI -0.37 to -0.14; 1 trial, N = 278; NNTB 4, 95% CI 3 to 7 to avoid 1 infant experiencing hyperglycaemia). The rate of patent ductus arteriosus increased in the group receiving inhaled steroids (RR 1.64, 95% CI 1.23 to 2.17; RD 0.21, 95% CI 0.10 to 0.33; 1 trial, N = 278; NNTH 5, 95% CI 3 to 10). In a subset of surviving infants in the United Kingdom and Ireland there were no significant differences in developmental outcomes at 7 years of age. However, there was a reduced risk of having ever been diagnosed as asthmatic by 7 years of age in the inhaled steroid group compared with the systemic steroid group (N = 48) (RR 0.42, 95% CI 0.19 to 0.94; RD -0.31, 95% CI -0.58 to -0.05; NNTB 3, 95% CI 2 to 20). According to GRADE the quality of the evidence was moderate to low. Evidence was downgraded on the basis of design (risk of bias), consistency (heterogeneity) and precision of the estimates. Both studies received grant support and the industry provided aero chambers and metered dose inhalers of budesonide and placebo for the larger study. No conflict of interest was identified. We found no evidence that early inhaled steroids confer important advantages over systemic steroids in the management of ventilator-dependent preterm infants. Based on this review inhaled steroids cannot be recommended over systemic steroids as a part of standard practice for ventilated preterm infants. Because they might have fewer adverse effects than systemic steroids, further randomised controlled trials of inhaled steroids are needed that address risk/benefit ratio of different delivery techniques, dosing schedules and long-term effects, with particular attention to neurodevelopmental outcome.\nOutput:\n" }, { "from": "agent", "value": "The review looked at trials that compared preterm babies who received steroids by inhalation to those who received steroids systemically (through a vein or orally) while they were receiving mechanical ventilation. We included two trials that involved 294 infants. One study included 278 infants and the other study included 16 infants. No new studies were included for the 2017 update. Both studies received grant support and the industry provided aero chambers and metered dose inhalers of budesonide and placebo for the larger study. No conflict of interest was identified. There was no evidence that inhaling steroids compared to systemic steroids prevented the primary outcome of death or bronchopulmonary dysplasia. The number of days the baby needed mechanical ventilation support or additional oxygen were increased in infants who received inhaled steroids versus infants who received systemic steroids. These outcomes were reported in both the trials. The rate of patent ductus arteriosus (failure for the ductus arteriosus, an arterial shunt in fetal life, to close after birth) was increased in the group receiving inhaled steroids. There was a lower incidence of high blood sugars in the inhaled steroid group compared with the systemic steroid group. These secondary outcomes were reported in only one trial (the larger trial). In a sub-sample of 52 children at age 7 years there were no differences in long-term follow-up outcomes between the inhaled and the systemic steroid groups. in an even smaller sample of 48 infants the outcome of 'ever diagnosed as asthmatic by seven years of age' was significantly lower in the inhaled steroid group compared with the systemic steroid group. According to GRADE the quality of the evidence was moderate to low." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 10 studies (830 participants, 1387 eyes), published between 1998 and 2012. Prevalence of CSMO was 19% to 65% (median 50%) in nine studies with CSMO as the target condition. Study quality was often unclear or at high risk of bias for QUADAS 2 items, specifically regarding study population selection and the exclusion of participants with poor quality images. Applicablity was unclear in all studies since professionals referring patients and results of prior testing were not reported. There was a specific 'unit of analysis' issue because both eyes of the majority of participants were included in the analyses as if they were independent. In nine studies providing data on CSMO (759 participants, 1303 eyes), pooled sensitivity was 0.78 (95% confidence interval (CI) 0.72 to 0.83) and specificity was 0.86 (95% CI 0.76 to 0.93). The median central retinal thickness cut-off we selected for data extraction was 250 µm (range 230 µm to 300 µm). Central CSMO was the target condition in all but two studies and thus our results cannot be applied to non-central CSMO. Data from three studies reporting accuracy for detection of DMO (180 participants, 343 eyes) were not pooled. Sensitivities and specificities were about 0.80 in two studies and were both 1.00 in the third study. Since this review was conceived, the role of OCT has changed and has become a key ingredient of decision-making at all levels of ophthalmic care in this field. Moreover, disagreements between OCT and fundus examination are informative, especially false positives which are referred to as subclinical DMO and are at higher risk of developing clinical CSMO. Using retinal thickness thresholds lower than 300 µm and ophthalmologist's fundus assessment as reference standard, central retinal thickness measured with OCT was not sufficiently accurate to diagnose the central type of CSMO in patients with DR referred to retina clinics. However, at least OCT false positives are generally cases of subclinical DMO that cannot be detected clinically but still suffer from increased risk of disease progression. Therefore, the increasing availability of OCT devices, together with their precision and the ability to inform on retinal layer structure, now make OCT widely recognised as the new reference standard for assessment of DMO, even in some screening settings. Thus, this review will not be updated further.\nOutput:\n" }, { "from": "agent", "value": "Our review included 10 studies (830 participants, 1387 eyes) published between 1998 and 2012. Nine of these studies investigated the ability of OCT to diagnose CSMO. Study funding sources There were no overt declarations of potential conflicts of interest in terms of the manufacturer of the OCT device being involved in funding the research. Key results We found that OCT retinal thickness measurement is not sufficiently accurate to detect CSMO, involving the centre of the macula, using clinical fundus examination as the reference standard. Of 10 patients with diabetic retinopathy, 5 of whom have CSMO, 1 of 5 with no CSMO would be wrongly diagnosed as having CSMO, and about 1 of 5 with CSMO would be missed. However, researchers have found that disagreements between OCT and clinical examination occur because OCT can detect early, subclinical retinal thickening in people without CSMO and more advanced retinopathy. They suggested that such cases of subclinical macular oedema are followed more closely, since they are at increased risk of progression to CSMO. Furthermore, OCT is an essential tool to manage antiangiogenic therapy in patients with DMO and is believed by many to be a new reference standard for its diagnosis. Quality of the evidence Study quality was often unclear because of incomplete reporting or because it was at risk of bias. Specifically, this concerned how patients were selected in the study, who referred them and how, and exclusion of those for whom poor quality images were obtained. Furthermore, many studies included both patient's eyes, which is a problem in data analyses." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Thirty-one trials involving 17,771 women are included in this review. This review found that folic acid supplementation has no impact on pregnancy outcomes such as preterm birth (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.38; three studies, 2959 participants), and stillbirths/neonatal deaths (RR 1.33, 95% CI 0.96 to 1.85; three studies, 3110 participants). However, improvements were seen in the mean birthweight (mean difference (MD) 135.75, 95% CI 47.85 to 223.68). On the other hand, the review found no impact on improving pre-delivery anaemia (average RR 0.62, 95% CI 0.35 to 1.10; eight studies, 4149 participants; random-effects), mean pre-delivery haemoglobin level (MD -0.03, 95% CI -0.25 to 0.19; 12 studies, 1806 participants), mean pre-delivery serum folate levels (standardised mean difference (SMD) 2.03, 95% CI 0.80 to 3.27; eight studies, 1250 participants; random-effects), and mean pre-delivery red cell folate levels (SMD 1.59, 95% CI -0.07 to 3.26; four studies, 427 participants; random-effects). However, a significant reduction was seen in the incidence of megaloblastic anaemia (RR 0.21, 95% CI 0.11 to 0.38, four studies, 3839 participants). We found no conclusive evidence of benefit of folic acid supplementation during pregnancy on pregnancy outcomes.\nOutput:\n" }, { "from": "agent", "value": "The review authors found 31 trials (involving 17,771 women) that looked at the impact of providing folic acid supplementation during pregnancy. The data showed that taking folate during pregnancy was not associated with reducing the chance of preterm births, stillbirths, neonatal deaths, low birthweight babies, pre-delivery anaemia in the mother or low pre-delivery red cell folate, although pre-delivery serum levels were improved. The review also did not show any impact of folate supplementation on improving mean birthweight and the mother’s mean haemoglobin levels during pregnancy compared with taking a placebo. However, the review showed some benefit in indicators of folate status in the mother. The evidence provided so far from these trials did not find conclusive results for any overall benefit of folic acid supplementation during pregnancy. Most of the studies were conducted over 30 to 45 years ago." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included six randomised controlled trials involving 899 children; we added three studies (331 children) in this update. We assessed two studies as at high risk of performance and detection bias; three studies as at unclear risk of attrition bias; and three studies as at unclear risk of other bias. Studies compared honey with dextromethorphan, diphenhydramine, salbutamol, bromelin (an enzyme from the Bromeliaceae (pineapple) family), no treatment, and placebo. Five studies used 7-point Likert scales to measure symptomatic relief of cough; one used an unclear 5-point scale. In all studies, low score indicated better cough symptom relief. Using a 7-point Likert scale, honey probably reduces cough frequency better than no treatment or placebo (no treatment: mean difference (MD) -1.05, 95% confidence interval (CI) -1.48 to -0.62; I² = 0%; 2 studies; 154 children; moderate-certainty evidence; placebo: MD -1.62, 95% CI -3.02 to -0.22; I² = 0%; 2 studies; 402 children; moderate-certainty evidence). Honey may have a similar effect as dextromethorphan in reducing cough frequency (MD -0.07, 95% CI -1.07 to 0.94; I² = 87%; 2 studies; 149 children; low-certainty evidence). Honey may be better than diphenhydramine in reducing cough frequency (MD -0.57, 95% CI -0.90 to -0.24; 1 study; 80 children; low-certainty evidence). Giving honey for up to three days is probably more effective in relieving cough symptoms compared with placebo or salbutamol. Beyond three days honey probably had no advantage over salbutamol or placebo in reducing cough severity, bothersome cough, and impact of cough on sleep for parents and children (moderate-certainty evidence). With a 5-point cough scale, there was probably little or no difference between the effects of honey and bromelin mixed with honey in reducing cough frequency and severity. Adverse events included nervousness, insomnia, and hyperactivity, experienced by seven children (9.3%) treated with honey and two children (2.7%) treated with dextromethorphan (risk ratio (RR) 2.94, 95% Cl 0.74 to 11.71; I² = 0%; 2 studies; 149 children; low-certainty evidence). Three children (7.5%) in the diphenhydramine group experienced somnolence (RR 0.14, 95% Cl 0.01 to 2.68; 1 study; 80 children; low-certainty evidence). When honey was compared with placebo, 34 children (12%) in the honey group and 13 (11%) in the placebo group complained of gastrointestinal symptoms (RR 1.91, 95% CI 1.12 to 3.24; I² = 0%; 2 studies; 402 children; moderate-certainty evidence). Four children who received salbutamol had rashes compared to one child in the honey group (RR 0.19, 95% CI 0.02 to 1.63; 1 study; 100 children; moderate-certainty evidence). No adverse events were reported in the no-treatment group. Honey probably relieves cough symptoms to a greater extent than no treatment, diphenhydramine, and placebo, but may make little or no difference compared to dextromethorphan. Honey probably reduces cough duration better than placebo and salbutamol. There was no strong evidence for or against using honey. Most of the children received treatment for one night, which is a limitation to the results of this review. There was no difference in occurrence of adverse events between the honey and control arms.\nOutput:\n" }, { "from": "agent", "value": "We included six small trials involving 899 children aged 12 months to 18 years conducted in Iran, Israel, the USA, Brazil, and Kenya. This update included three new trials conducted between 2007 and 2016 that involved 331 children. Two studies were supported by pharmaceutical manufacturers; one by a university research centre; one by the Honey Board of Israel and non-government agencies; and one by USA National Honey Board. One study did not report funding sources. We compared honey to over-the-counter cough preparations, bromelin (a pineapple enzyme) mixed with honey, fake treatment (placebo), and no treatment. Honey probably reduces cough symptoms more than placebo and salbutamol (a drug that opens lung airways) when given for up to three days. Honey is probably more effective at providing cough relief and reducing the impact of cough on children's sleep at night than no treatment. There may be little or no difference between the effects of honey and dextromethorphan (an ingredient in over-the-counter cough remedies) or honey and bromelin with honey on all cough symptoms. Honey may be better than diphenhydramine (an antihistamine) at relieving and reducing children's cough. The parents of seven children given honey and two given dextromethorphan reported side effects in their children, such as not falling asleep easily, restlessness, and becoming overexcited. The parents of three children in the diphenhydramine group reported that their children were often sleepy. The parents of nine children given salbutamol, seven given honey, and six given placebo reported diarrhoea. The parents of four children who received salbutamol and one child given honey reported rash. We found no evidence for or against the use of honey to relieve cough in children. Using honey for infants aged up to 12 months is not advised because of poor immunity against bacteria that may be present, which can cause paralysis. Most of the children received honey for just one night, which is a limitation to the results of this review. Overall, evidence quality was low to moderate. Some studies did not blind participants." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included one study from the USA (re-analysed as an ITS) involving one hospital and an unknown number of nurses and patients. The study evaluated the effects of a standardised evidence-based nursing procedure on nursing care for patients at risk of developing healthcare-acquired pressure ulcers (HAPUs). If a patient's admission Braden score was below or equal to 18 (i.e. indicating a high risk of developing pressure ulcers), nurses were authorised to initiate a pressure ulcer prevention bundle (i.e. a set of evidence-based clinical interventions) without waiting for a physician order. Re-analysis of data as a time series showed that against a background trend of decreasing HAPU rates, if that trend was assumed to be real, there was no evidence of an intervention effect at three months (mean rate per quarter 0.7%; 95% confidence interval (CI) 1.7 to 3.3; P = 0.457). Given the small percentages post intervention it was not statistically possible to extrapolate effects beyond three months. Despite extensive searching of published and unpublished research we identified only one low-quality study; we excluded many studies due to non-eligible study design. If policy-makers and healthcare organisations wish to promote evidence-based nursing successfully at an organisational level, they must ensure the funding and conduct of well-designed studies to generate evidence to guide policy.\nOutput:\n" }, { "from": "agent", "value": "We searched the literature for robust evaluations of the effectiveness of organisational interventions in promoting EBP in nursing. We included one study from the USA which involved one hospital and for which the number of nurses was not reported. The study evaluated the effects of a standardised evidence-based nursing procedure on improved nursing care for patients at risk of developing healthcare-acquired pressure ulcers (HAPUs), as measured by the HAPU rate. If a patient's admission Braden score was lower than or equal to 18, nurses were authorised to initiate a prevention pressure ulcer care bundle, without a physician order. The Braden scale is a tool used to assess a patient's risk of developing pressure ulcers. An adult with a score below or equal to 18 is considered to have a high risk for developing a pressure ulcer. Re-analysis of the HAPU data, as an interrupted time series, was suggestive of a trend in rates prior to intervention and, if that trend was assumed to be real, there was no evidence of an intervention effect at three months (mean rate per quarter 0.7%; 95% confidence interval (CI) 1.7 to 3.3; P = 0.457). Given the small percentages post intervention it was not statistically possible to extrapolate effects beyond three months. Considering the importance placed on organisational change in promoting EBP in nursing, it is surprising that eight years after the previous empty Cochrane review was published, appropriately evaluated organisational infrastructure interventions are still lacking. If policy-makers and healthcare organisations wish to promote evidence-based nursing at an organisational level successfully, they must ensure the funding and conduct of well-designed studies to generate evidence to guide policy." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 14 trials (17 comparisons) in the review; three trials involved multiple comparisons. Six trials, two of which had three comparison arms, (972 participants) compared hair removal (shaving, clipping, or depilatory cream) with no hair removal and found no statistically significant difference in SSI rates however the comparison is underpowered. Three trials (1343 participants) that compared shaving with clipping showed significantly more SSIs associated with shaving (RR 2.09, 95% CI 1.15 to 3.80). Seven trials (1213 participants) found no significant difference in SSI rates when hair removal by shaving was compared with depilatory cream (RR 1.53, 95% CI 0.73 to 3.21), however this comparison is also underpowered. One trial compared two groups that shaved or clipped hair on the day of surgery compared with the day before surgery; there was no statistically significant difference in the number of SSIs between groups however this comparison was also underpowered. We identified no trials that compared clipping with depilatory cream; or investigated application of depilatory cream at different pre-operative time points, or hair removal in different settings (e.g. ward, anaesthetic room). Whilst this review found no statistically significant effect on SSI rates of hair removal insufficient numbers of people have been involved in this research to allow confidence in a conclusion. When it is necessary to remove hair, the existing evidence suggests that clippers are associated with fewer SSIs than razors. There was no significant difference in SSI rates between depilatory creams and shaving, or between shaving or clipping the day before surgery or on the day of surgery however studies were small and more research is needed.\nOutput:\n" }, { "from": "agent", "value": "Existing research studies are too small and methodologically flawed to allow us to draw strong conclusions; on the basis of existing evidence it is not clear whether hair removal pre-operatively affects rates of surgical site infections. However if hair has to be removed to facilitate surgery or the application of adhesive dressings, clipping rather than shaving appears to result in fewer surgical site infections." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 244 randomised clinical trials with 28,619 participants that met our inclusion criteria. We considered all trials to be at high risk of bias. Two trials accounted for one-third of all included participants. The included participants were heterogenous with regard to disease (20 different medical specialties). The experimental interventions were parenteral nutrition (86 trials); enteral nutrition (tube-feeding) (80 trials); oral nutrition support (55 trials); mixed experimental intervention (12 trials); general nutrition support (9 trials); and fortified food (2 trials). The control interventions were treatment as usual (122 trials); no intervention (107 trials); and placebo (15 trials). In 204/244 trials, the intervention lasted three days or more. We found no evidence of a difference between nutrition support and control for short-term mortality (end of intervention). The absolute risk was 8.3% across the control groups compared with 7.8% (7.1% to 8.5%) in the intervention groups, based on the risk ratio (RR) of 0.94 (95% confidence interval (CI) 0.86 to 1.03, P = 0.16, 21,758 participants, 114 trials, low quality of evidence). We found no evidence of a difference between nutrition support and control for long-term mortality (maximum follow-up). The absolute risk was 13.2% in the control group compared with 12.2% (11.6% to 13%) following nutritional interventions based on a RR of 0.93 (95% CI 0.88 to 0.99, P = 0.03, 23,170 participants, 127 trials, low quality of evidence). Trial Sequential Analysis showed we only had enough information to assess a risk ratio reduction of approximately 10% or more. A risk ratio reduction of 10% or more could be rejected. We found no evidence of a difference between nutrition support and control for short-term serious adverse events. The absolute risk was 9.9% in the control groups versus 9.2% (8.5% to 10%), with nutrition based on the RR of 0.93 (95% CI 0.86 to 1.01, P = 0.07, 22,087 participants, 123 trials, low quality of evidence). At long-term follow-up, the reduction in the risk of serious adverse events was 1.5%, from 15.2% in control groups to 13.8% (12.9% to 14.7%) following nutritional support (RR 0.91, 95% CI 0.85 to 0.97, P = 0.004, 23,413 participants, 137 trials, low quality of evidence). However, the Trial Sequential Analysis showed we only had enough information to assess a risk ratio reduction of approximately 10% or more. A risk ratio reduction of 10% or more could be rejected. Trial Sequential Analysis of enteral nutrition alone showed that enteral nutrition might reduce serious adverse events at maximum follow-up in people with different diseases. We could find no beneficial effect of oral nutrition support or parenteral nutrition support on all-cause mortality and serious adverse events in any subgroup. Only 16 trials assessed health-related quality of life. We performed a meta-analysis of two trials reporting EuroQoL utility score at long-term follow-up and found very low quality of evidence for effects of nutritional support on quality of life (mean difference (MD) -0.01, 95% CI -0.03 to 0.01; 3961 participants, two trials). Trial Sequential Analyses showed that we did not have enough information to confirm or reject clinically relevant intervention effects on quality of life. Nutrition support may increase weight at short-term follow-up (MD 1.32 kg, 95% CI 0.65 to 2.00, 5445 participants, 68 trials, very low quality of evidence). There is low-quality evidence for the effects of nutrition support on mortality and serious adverse events. Based on the results of our review, it does not appear to lead to a risk ratio reduction of approximately 10% or more in either all-cause mortality or serious adverse events at short-term and long-term follow-up. There is very low-quality evidence for an increase in weight with nutrition support at the end of treatment in hospitalised adults determined to be at nutritional risk. The effects of nutrition support on all remaining outcomes are unclear. Despite the clinically heterogenous population and the high risk of bias of all included trials, our analyses showed limited signs of statistical heterogeneity. Further trials may be warranted, assessing enteral nutrition (tube-feeding) for different patient groups. Future trials ought to be conducted with low risks of systematic errors and low risks of random errors, and they also ought to assess health-related quality of life.\nOutput:\n" }, { "from": "agent", "value": "We included 244 trials, with 28,619 participants. The included trials assessed the effects of different kinds of nutrition support (i.e. dietary advice, enriching regular food with extra protein and calories, protein shakes, feeding through a catheter directly into a vein or through a tube directly into the stomach or gut). The nutrition support was provided to people in the trial who were ill with many different types of diseases and undergoing different procedures. What they all had in common was that they were at risk by at least one measure, including the trialists' clinical opinion. We found no evidence of a difference between nutrition support and control for risk of death. We found that 8.3% people died at short-term follow-up in the control groups compared with 7.8% in those who had been given nutritional support (low quality of evidence). At the longest point of follow-up 13.2% people in the control groups died compared with 12.2% in those who had been given nutritional support (low quality of evidence). We found no evidence of a difference between nutrition support and control for risk of a serious complications in the short term. People in the control groups had a serious complication rate of 9.9% at short-term follow-up compared with 9.2% with nutrition (low quality of evidence). At long-term follow-up 15.2% of people in the control groups had a serious complication compared with 13.8% in the nutrition groups (low quality of evidence). These results are based on just over 21,000 participants. Nutrition may increase weight by about 1.32 kg compared with people in the control groups. The increase in weight of 1.32 kg on average is of uncertain benefit. We could not reliably assess the effects on quality of life due to the variation in the reporting of this information. When we looked at the different types of nutrition support, a secondary analysis suggested that tube-feeding might be beneficial, reducing serious complications at maximum follow-up, but the strength of this finding is low. The evidence for our conclusions is of low quality for death and serious complications, and very low quality for weight. All trials had a high risk of bias (i.e. the trials were all conducted in a way that may overestimate the benefits and underestimate the harms of nutrition support). The results were consistent for death and serious complications, but there was a high level of variation in the effects on weight across the studies." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Six studies were selected for inclusion (106 participants). No results were combined as the studies were all of a crossover design. EFFECTS OF NEGATIVE ION GENERATORS (five studies) No study reported a significant difference in lung function between ionised and control air (morning Peak expiratory flow (PEF) - three studies; forced expiratory flow in one second (FEV1) - one study). There were no significant differences in symptoms or beta-2 agonist usage between ionised and control air in three studies. EFFECTS OF POSITIVE ION GENERATORS (one study) This study demonstrated that although positively ionised air was associated with a larger fall in FEV1 with exercise, this did not reach statistical significance. Baseline FEV1 was not demonstrated to be significantly different between treatment groups. Based on the evidence currently available from randomised controlled trials, a recommendation cannot be given for the use of room air ionisers to reduce symptoms in patients with chronic asthma.\nOutput:\n" }, { "from": "agent", "value": "Although complex laboratory studies show that ion generators alter airways function, the few studies which have been conducted in the homes of people with asthma, demonstrate no significant benefit in improving lung function or symptoms." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three multifaceted and six monofaceted intervention studies (3271 children). Physician diagnosed asthma in children less than five years, and asthma as defined by respiratory symptoms and lung function criteria in children aged five years and older, both favoured treatment with a multifaceted intervention compared to usual care (< 5 years: odds ratio (OR) 0.72, 95% confidence interval (CI) 0.54 to 0.96, and > 5 years: OR 0.52, 95% CI 0.32 to 0.85). However, there was no significant difference in outcome between monofaceted intervention and control interventions (< 5 years: OR 1.12, 95% CI 0.76 to 1.64, and > 5 years: OR 0.83, 95% CI 0.59 to 1.16). Indirect comparison between these treatments did not demonstrate a significant difference between multiple interventions and mono-interventions in reducing the frequency of asthma diagnosis in children under five years (relative OR 0.64 (95% CI 0.40 to 1.04, P = 0.07) or five years and older (relative OR 0.63, 95% CI 0.35 to 1.13, P = 0.12). There was also no significant difference between either mono- and multifaceted intervention and control in reducing the likelihood of symptoms of nocturnal coughing at follow up. Wheezing, however, showed a significant difference between multifaceted and mono-interventions (relative OR 0.59, 95% CI 0.35 to 0.99, P = 0.04), but the significance was lost when data on treatment only was analysed. The available evidence suggests that the reduction of exposure to multiple allergens compared to usual care reduces the likelihood of a current diagnosis of asthma in children (at ages < 5 years and 5 years and older). Mono-intervention studies have not produced effects which are statistically significant compared with control. In children who are at risk of developing childhood asthma, multifaceted interventions, characterised by dietary allergen reduction and environmental remediation, reduce the odds of a physician diagnosis of asthma later in childhood by half. This translates to a number needed to treat (NNT) of 17. The effect of multi-faceted interventions on parent reported wheeze was inconsistent and had no significant impact on nocturnal coughing or dyspnoea. Data from monofaceted intervention exposed children studies were not significantly different from those of control groups for all outcomes. There remains uncertainty as to whether multiple interventions are more effective than mono-component interventions. The comparisons made were indirect, making the conclusions drawn uncertain. To our knowledge there are no ongoing studies in which both intervention strategies are randomly compared. The findings, however, warrant further direct comparison between multiple- and monofaceted interventions aimed at reducing the prevalence of asthma in children.\nOutput:\n" }, { "from": "agent", "value": "This review asks whether the risk of developing asthma, which is a disease caused by many factors, can be decreased by reducing single allergen levels in children with genetic susceptibility, or whether the reduction of more than one type of allergen exposure simultaneously will lead to a better outcome. As a direct comparison could not be made using current research we made indirect comparisons using trials that had compared single or multiple interventions with a control. In children who are at risk of developing childhood asthma 'multifaceted' interventions, which involve both dietary allergen reduction and environmental change to reduce exposure to inhaled allergens, reduce the odds of a doctor diagnosing asthma later in childhood by half. However, the effect of these multifaceted interventions on wheeze reported by parents was inconsistent and there was no beneficial effect on night-time coughing or breathlessness. Single ('monofaceted') interventions were not significantly more effective than controls in the reduction of all outcomes, but there remains uncertainty as to whether multiple interventions are more effective than single component interventions." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Our searches identified 28 references to eight trials; five trials were excluded (three were cross-over and one was not randomised and one did not have relevant outcomes), one cross-over trial is awaiting classification pending provision of data and one trial is ongoing. The included parallel randomised controlled trial compared ataluren to placebo for a duration of 48 weeks in 238 participants (age range 6 to 53 years) with cystic fibrosis who had at least one nonsense mutation (a type of class I mutation). The quality of evidence and risk of bias assessments for the trial were moderate overall. Random sequence generation, allocation concealment and blinding of trial personnel were well-documented; participant blinding was less clear. Some participant data were excluded from the analysis. The trial was assessed as high risk of bias for selective outcome reporting, especially when reporting on the trial's post hoc subgroup of participants by chronic inhaled antibiotic use. The trial was sponsored by PTC Therapeutics Incorporated with grant support by the Cystic Fibrosis Foundation, the Food and Drug Administration's Office of Orphan Products Development and the National Institutes of Health (NIH). The trial reported no significant difference between treatment groups in quality of life, assessed by the Cystic Fibrosis Questionnaire-Revised respiratory domain score and no improvement in respiratory function measures (mean difference of relative change in forced expiratory volume at one second 2.97% (95% confidence interval -0.58 to 6.52)). Ataluren was associated with a significantly higher rate of episodes of renal impairment, risk ratio 17.70 (99% confidence interval 1.28 to 244.40). The trial reported no significant treatment effect for ataluren for the review's secondary outcomes: pulmonary exacerbation; computerised tomography score; weight; body mass index; and sweat chloride. No deaths were reported in the trial. A post hoc subgroup analysis of participants not receiving chronic inhaled tobramycin (n = 146) demonstrated favourable results for ataluren (n = 72) for relative change in % predicted forced expiratory volume at one second and pulmonary exacerbation rate. Participants receiving chronic inhaled tobramycin appeared to have a reduced rate of pulmonary exacerbation compared to those not receiving chronic inhaled tobramycin. This drug interaction was not anticipated and may affect the interpretation of the trial results. There is currently insufficient evidence to determine the effect of ataluren as a therapy for people with cystic fibrosis with class I mutations. Future trials should carefully assess for adverse events, notably renal impairment and consider the possibility of drug interactions. Cross-over trials should be avoided given the potential for the treatment to change the natural history of cystic fibrosis.\nOutput:\n" }, { "from": "agent", "value": "We found one trial (238 people took part) comparing ataluren to placebo (a dummy treatment with no active medication). The trial lasted 48 weeks and included both males and females aged six years and older. Everyone taking part had at least one copy of a nonsense mutation (a type of class I mutation that causes cystic fibrosis). In those people who took ataluren, there was no improvement in clinical outcomes such as quality of life, lung function, exacerbations (flare up of disease), sweat chloride (salt) levels or weight. The trial found that kidney damage was more common in people who took ataluren. The trial investigators then analysed the results in a way that they hadn't planned originally and looked at how ataluren or placebo affected people depending on whether they were using inhaled tobramycin on a long-term basis or not. They found that amongst those not taking inhaled tobramycin, lung function declined at a slower rate and there were fewer exacerbations in the ataluren group compared to the placebo group. We have not found enough high-quality evidence currently to determine the effect of ataluren for treating people with cystic fibrosis. We recommend that future trials are designed and reported clearly so that their results can be included in a systematic review. We judged the quality of the evidence was moderate with uncertainty due to how widely the results varied between participants. We are satisfied that everyone taking part had an equal chance of being in either group (ataluren or placebo) and that no one could work out which group the next person would be put into, so that healthier people did not receive the treatment and make the results seem better. We believe that the clinicians running the trial and those taking part in the trial did not know which treatment each person was receiving. We have some concerns on the emphasis the investigators have placed on the results of a comparison they had not planned (use of long-term inhaled tobramycin). Unfortunately, the trial did not report all their results clearly; sometimes they did not report them in a way that we could use in the review and sometimes they did not report the data at all. This affected the certainty with which we judged the overall results. The trial was sponsored by PTC Therapeutics Incorporated. The Cystic Fibrosis Foundation, the Food and Drug Administration's Office of Orphan Products Development and the National Institutes of Health (NIH) also supported the trial." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified 3745 citations through electronic searches and reviews of reference lists after deduplication of search results. We excluded 3619 records during title and abstract review and assessed 126 articles at full-text review for eligibility. We included one controlled study enrolling 46 participants. We rated this RCT at high risk for performance and detection bias due to a lack of blinding. The included RCT compared preventive use of mindfulness-based cognitive therapy (MBCT) with treatment as usual (TAU) in participants with a history of SAD. MBCT was administered in spring in eight weekly individual 45- to 60-minute sessions. In the TAU group participants did not receive any preventive treatment but were invited to start light therapy as first depressive symptoms occurred. Both groups were assessed weekly for occurrence of a new depressive episode measured with the Inventory of Depressive Syptomatology-Self-Report (IDS-SR, range 0-90) from September 2011 to mid-April 2012. The incidence of a new depressive episode in the upcoming winter was similar in both groups. In the MBCT group 65% of 23 participants developed depression (IDS-SR ≥ 20), compared to 74% of 23 people in the TAU group (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.30; 46 participants; very low quality-evidence). For participants with depressive episodes, severity of depression was comparable between groups. Participants in the MBCT group had a mean score of 26.5 (SD 7.0) on the IDS-SR, and TAU participants a mean score of 25.3 (SD 6.3) (mean difference (MD) 1.20, 95% CI -3.44 to 5.84; 32 participants; very low quality-evidence). The overall discontinuation rate was similar too, with 17% discontinuing in the MBCT group and 13% in the TAU group (RR 1.33, 95% CI 0.34 to 5.30; 46 participants; very low quality-evidence). Reasons for downgrading the quality of evidence included high risk of bias of the included study and imprecision. Investigators provided no information on adverse events. We could not find any studies that compared psychological therapy with other interventions of interest such as second-generation antidepressants, light therapy, melatonin or agomelatine. The evidence on psychological therapies to prevent the onset of a new depressive episode in people with a history of SAD is inconclusive. We identified only one study including 46 participants focusing on one type of psychological therapy. Methodological limitations and the small sample size preclude us from drawing a conclusion on benefits and harms of MBCT as a preventive intervention for SAD. Given that there is no comparative evidence for psychological therapy versus other preventive options, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences and other preventive interventions that are supported by evidence.\nOutput:\n" }, { "from": "agent", "value": "The proportion of participants developing a depression in the upcoming winter was similar in both groups as well as the severity of these depressive episodes. However, the quality of the evidence was very low, so we can draw no valid conclusion if MBCT is really ineffective in preventing SAD or not. The included study reported no information on side effects of the intervention. Doctors need to discuss with patients the advantages and disadvantages of MBCT and other potentially preventive treatments for winter depression, such as other psychological therapies, drug treatments, or lifestyle interventions. As no available studies have compared these treatments, treatment selection should be strongly based on patient preferences and other preventive interventions that are supported by evidence. Review authors recommend that future studies should evaluate the efficacy of different psychological therapies in preventing SAD in larger study samples and should directly compare these interventions versus other preventive treatments, such as light therapy, antidepressants and agomelatine, to determine the best treatment option for prevention of SAD." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative account of studies where we identified an analysis of more than 10 women, as this forms the only evidence base in this rare disease. Surgery continues to be the mainstay of treatment in the current literature, with other treatments limited to case reports or treatment of inoperable or recurrent disease. This update between September 2013 and May 2018 identified 35 new studies. None of these met the inclusion criteria. There was only one prospective study of 5% imiquimod in recurrent Paget's disease of the vulva, which although of good quality only included eight women. Since the last version of the review was published there are many more cases in the literature reporting a clinical response to 5% imiquimod cream. There is one prospective study of eight women treated with 5% imiquimod for recurrent Paget's disease of the vulva, and one prospective trial of 20 women was due to be reported. This increasing evidence for the safety and efficacy of 5% imiquimod will be helpful for women and clinicians alike. Ideally, a multicentre RCT of reasonable size is needed, but ongoing publications of high-quality non-randomised prospective studies will enhance the current available literature.\nOutput:\n" }, { "from": "agent", "value": "We searched for randomised controlled trials (trials where treatment is allocated to women in a random manner) and well-designed non-randomised studies that compared different treatments in women aged 18 years or older with biopsy-confirmed Paget's disease of the vulva. We searched scientific databases and contacted experts and identified and checked the titles and abstracts of 635 possibly relevant articles and retrieved 31 of these references in full text. However, we found no studies that met our inclusion criteria. We identified several non-randomised studies and drafted a detailed narrative of their results, but these studies were of poor quality and were at high risk of bias. Therefore, there is currently no evidence to determine whether any form of treatment is better or worse in terms of prolonging survival, delaying progression or recurrence, improving QoL or minimising toxicity. The review highlights the need for good-quality studies comparing different interventions for the management of Paget's disease of the vulva. Women and clinicians would value more evidence for guiding surgical and non-surgical management of this disease. In particular, non-invasive medical management would spare women from the side effects and consequences of surgery." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: For this update we included one RCT with 17,802 participants that assessed rosuvastatin compared with placebo for the prevention of VTE. The quality of the evidence was moderate because of imprecision, as the required sample size for the outcomes of this review was not achieved. Analysis showed that when compared with placebo rosuvastatin reduced the incidence of VTE (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.37 to 0.86) and deep vein thrombosis (DVT) (OR 0.45, 95% CI 0.25 to 0.79), the risk of any (fatal and non-fatal) myocardial infarction (MI) (OR 0.45, 95% CI 0.30 to 0.69), and any (fatal and non-fatal) stroke (OR 0.51, 95% CI 0.34 to 0.78). There was no difference in the incidence of pulmonary embolism (PE) (OR 0.77, 95% CI 0.41 to 1.46), fatal MI (OR 1.50, 95% CI 0.53 to 4.22), fatal stroke (OR 0.30, 95% CI 0.08 to 1.09) or death after VTE (OR 0.50, 95% CI 0.20 to 1.24). The incidence of any serious adverse events was no different between the rosuvastatin and placebo groups (OR 1.07, 95% CI 0.95 to 1.20). Available evidence showed that rosuvastatin was associated with a reduced incidence of VTE, but the evidence was limited to a single RCT and any firm conclusions and suggestions could be not drawn. Randomised controlled trials of statins (including rosuvastatin) are needed to evaluate their efficacy in the prevention of VTE.\nOutput:\n" }, { "from": "agent", "value": "Our review included one published randomised controlled trial, involving 17,802 participants, which reported outcomes of VTE. This trial investigated rosuvastatin compared with placebo for the primary prevention of VTE. Analysis showed that, compared with placebo, rosuvastatin reduced the incidence of VTE and DVT, the risk of any (fatal and non-fatal) myocardial infarction, and any (fatal and non-fatal) stroke. There were no differences between rosuvastatin and placebo in the incidence of pulmonary embolism, fatal myocardial infarction, fatal stroke, and death after VTE. The incidence of any serious adverse events was not different between rosuvastatin and placebo. No firm conclusions or suggestions could be made from these findings. More randomised controlled trials of statins (including rosuvastatin) are needed to evaluate the efficacy of statins in the prevention of VTE. Quality of the evidence The quality of the evidence was moderate because of imprecision, as the required sample size for the outcomes of this review was not achieved." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Twenty-three studies (2344 participants) were included in this update, including nine new studies. A broad variety of conservative interventions were evaluated. Two studies included patients with chronic symptoms (longer than three months), two included subacute (four to six weeks) symptoms, two had undefined duration of symptoms, and 17 studied patients with acute (less than three weeks) symptoms. Only eight studies (33.3%) satisfied one of our criteria of high quality, indicating overall, a poor methodological quality. Interventions were divided into passive (such as rest, immobilisation, ultrasound, etc) and active interventions (such as exercises, act as usual approach, etc.) and were compared with no treatment, a placebo or each other. Clinical and statistical heterogeneity and lack of data precluded pooling. Individual studies demonstrated effectiveness of one treatment over another, but the comparisons were varied and results inconsistent. Therefore, the evidence neither supports nor refutes the effectiveness of either passive or active treatments to relieve the symptoms of WAD, Grades 1 or 2. The current literature is of poor methodological quality and is insufficiently homogeneous to allow the pooling of results. Therefore, clearly effective treatments are not supported at this time for the treatment of acute, subacute or chronic symptoms of whiplash-associated disorders.\nOutput:\n" }, { "from": "agent", "value": "We included 23 studies (2344 participants with WAD Grades 1 or 2), nine of which were new for this update. Overall, the methodological quality was poor and the studies included populations and interventions that were too different to pool. Two studies examined treatments for patients with chronic pain (longer than three months), two looked at subacute pain (four to six weeks), two were unclear (but one was probably chronic), and the rest looked at patients with acute symptoms of less than three weeks. In 11 studies, an active treatment approach (treatment strategy including exercises or advice to 'act as usual') was compared to a passive strategy, no treatment or was an additional treatment. Eight studies compared an active intervention with a passive one (the patient received a treatment such as advice to rest and wear a neck collar, an educational video, electrotherapy, manipulation, hot and cold packs, traction, or acupuncture). Eight studies compared an intervention with a placebo or no treatment. In seven studies, two active treatments were compared against each other and in one, a passive intervention was compared to injections. Since we were unable to pool any of the studies, we remain unable to either support or refute the effects of conservative treatments for acute, subacute or chronic whiplash-associated disorders with the current evidence." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Sixteen trials were identified, including 558 participants. Eleven trials were of cross-over design. Eleven trials included only people with faecal incontinence related to liquid stool (either chronic diarrhoea, following ileoanal pouch or rectal surgery, or due to use of a weight-reducing drug). Two trials were amongst people with weak anal sphincters, one in participants with faecal impaction and bypass leakage, and one in geriatric patients. In one trial there was no specific cause for faecal incontinence. Seven trials tested anti-diarrhoeal drugs to reduce faecal incontinence and other bowel symptoms (loperamide, diphenoxylate plus atropine, and codeine). Six trials tested drugs that enhance anal sphincter function (phenylepinephrine gel and sodium valproate). Two trials evaluated osmotic laxatives (lactulose) for the treatment of faecal incontinence associated with constipation in geriatric patients. One trial assessed the use of zinc-aluminium ointment for faecal incontinence. No studies comparing drugs with other treatment modalities were identified. There was limited evidence that antidiarrhoeal drugs and drugs that enhance anal sphincter tone may reduce faecal incontinence in patients with liquid stools. Loperamide was associated with more adverse effects (such as constipation, abdominal pain, diarrhoea, headache and nausea) than placebo. However, the dose may be titrated to the patient's symptoms to minimise side effects while achieving continence. The drugs acting on the sphincter sometimes resulted in local dermatitis, abdominal pain or nausea. Laxative use in geriatric patients reduced faecal soiling and the need for help from nurses. Zinc-aluminium ointment was associated with improved quality of life, with no reported adverse effects. However, the observed improvement in quality of life was seen in the placebo group as well as the treatment group. It should be noted that all the included trials in this review had small sample sizes and short duration of follow-up. 'Risk of bias' assessment was unclear for most of the domains as there was insufficient information. There were no data suitable for meta-analysis. The small number of trials identified for this review assessed several different drugs in a variety of patient populations. The focus of most of the included trials was on the treatment of diarrhoea, rather than faecal incontinence. There is little evidence to guide clinicians in the selection of drug therapies for faecal incontinence. Larger, well-designed controlled trials, which use the recommendations and principles set out in the CONSORT statement, and include clinically important outcome measures, are required.\nOutput:\n" }, { "from": "agent", "value": "This review looked at drugs for the treatment of faecal incontinence. These included anti-diarrhoea drugs or laxatives to regulate stools, and drugs to try to enhance the tone of muscle around the anus which help to keep it closed. Sixteen small trials were found, including 558 participants. The review of these trials found some evidence that anti-diarrhoea drugs may reduce faecal incontinence for people having liquid stools. However, these drugs were associated with some side effects. There was some evidence that drugs to enhance the tone of the muscle around the anus may help, but more research is needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three studies involving 102 preterm or low birth weight infants in the review. The studies compared dilute (double-volume, half-strength) formula with full-strength (20 kcal/oz (˜ 68 to 70 kcal/100 mL)) formula. We assessed all three studies as having unclear risk of bias due to the likely absence of blinding of study personnel and the potential for selection bias in the largest trial. Data for the primary outcome of necrotising enterocolitis were not reported in any of the studies. We could combine two of the studies (88 infants) in the meta-analysis. The evidence suggests that dilute formula with double-volume (half-strength) may lead to fewer episodes of gastric residuals per day (one study; mean difference (MD) −1.20, 95% confidence interval (CI) −2.20 to −0.20; low-certainty evidence), fewer episodes of gastric residuals per baby until attaining 100 kcal/kg (one study; MD −0.80, 95% CI −1.32 to −0.28; low-certainty evidence), fewer episodes of vomiting per day (one study; MD −0.04, 95% CI −0.07 to −0.01; low-certainty evidence) and fewer occurrences of abdominal distension greater than 2 cm (two studies; MD −0.16, 95% CI −0.19 to −0.13; low-certainty evidence). For the secondary outcomes, data suggest that infants in the dilute formula with double-volume (half-strength) group may have attained an adequate energy intake earlier than infants in the full-strength group (two studies; MD −2.26, 95% CI −2.85 to −1.67; low-certainty evidence). There was no evidence of a difference between groups for weight gain one week after commencement of intragastric feeds (one study; MD 0.05 kg, 95% CI −0.06 to 0.15; low-certainty evidence). Data were not reported for length of hospital stay. There is low-certainty evidence from three small, old trials that use of dilute formula in preterm or low birth weight formula-fed infants may lead to an important reduction in the time taken for preterm infants to attain an adequate energy intake. However, our confidence in this result is limited due to uncertainty over risk of bias and sparsity of available data. Dilute formula may reduce incidence of feeding intolerance, but the clinical significance of the reduction is uncertain. The impact on serious gastrointestinal problems, including necrotising enterocolitis, was not reported in any of the trials. Further randomised trials are needed to confirm these results.\nOutput:\n" }, { "from": "agent", "value": "The evidence for this review is current as of 1 October 2018. We included three trials that compared dilute formula milk (half-strength, double-volume) with full-strength formula milk. The trials involved 102 preterm or low birth weight infants; two were conducted in the USA and one in India. The trials were small (14, 38 and 50 infants, respectively) and conducted between 25 and 30 years ago. The quality of two trials was judged to be poor due to insufficient information being provided in the trial publications, but judged to be moderate in the third trial (of 38 infants). None of the trials assessed necrotising enterocolitis as an outcome. Infants receiving dilute formula (half-strength, double-volume) experienced fewer episodes of feeding intolerance and achieved full energy intake earlier than infants receiving full-strength formula (20 kcal/oz (˜ 68 to 70 kcal/100 mL)). Feeding intolerance Two measures of feeding intolerance (abdominal distension and episodes of gastric residuals) were reported across the trials. Two trials (88 infants) provided data for abdominal distension and gastric residuals. Infants fed dilute formula experienced 19% (CI 16% to 23%) fewer episodes of abdominal distension (> 2 cm), equivalent to 0.67 episodes per infant in the half-strength group compared to 0.83 episodes in the full-strength group. It was not possible to combine data on gastric residuals but both trials reported fewer episodes of gastric residuals in the dilute formula group. The third trial (14 infants) only reported that there was no difference between the groups with respect to these two outcomes. Time to establish full enteral feeding In two trials (88 infants) infants receiving dilute formula experienced a 22% (CI 16% to 28%) reduction in the number of days required to reach an adequate energy intake (420 joules/kilogram), equivalent to 8 days in the half-strength group compared to 10.3 days in the full-strength group. In exclusively formula-fed preterm or low birth weight infants, low-certainty evidence shows that diluted formula may lead to an important reduction in the time taken to attain adequate enteral fluid and energy requirements, without increasing indicators of feeding intolerance. The clinical importance of the reduction in episodes of feeding intolerance is unclear. These findings are based on three small, old trials that may be of less relevance to current practice. A lack of data on other important outcomes, such as the incidence of necrotising enterocolitis and weight gain, limits the usefulness of the studies." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Five trials that randomly assigned 144 participants with overt hepatic encephalopathy that were published during 1979 to 1982 were included. Three trials assessed levodopa, and two trials assessed bromocriptine. The mean daily dose was 4 grams for levodopa and 15 grams for bromocriptine. The median duration of treatment was 14 days (range seven to 56 days). None of the trials followed participants after the end of treatment. Only one trial reported adequate bias control; the remaining four trials were considered to have high risk of bias. Random-effects model meta-analyses showed that dopamine agents had no beneficial or detrimental effect on hepatic encephalopathy in the primary analyses (15/80 (19%) versus 14/80 (18%); odds ratio (OR) 2.99, 95% confidence interval (CI) 0.09 to 100.55; two trials) or when paired data from cross-over trials were included (OR 1.04, 95% CI 0.75 to 1.43). Clear evidence of intertrial heterogeneity was identified both in the primary analysis (I2 = 65%) and when paired data from cross-over trials were included (I2 = 40%). Dopamine agents had no beneficial or harmful effect on mortality (42/144 (29%) versus 38/144 (26%); OR 1.11, 95% CI 0.35 to 3.54; five trials). Trial sequential analyses demonstrated that we lacked information to refute or recommend the interventions for all outcomes. Dopamine agonists did not seem to increase the risk of adverse events. This review found no evidence to recommend or refute the use of dopamine agents for hepatic encephalopathy. More randomised placebo-controlled clinical trials without risks of systematic errors and risks of random errors seem necessary to permit firm decisions on dopamine agents for patients with hepatic encephalopathy.\nOutput:\n" }, { "from": "agent", "value": "We performed the present systematic review to determine the beneficial and harmful effects of dopamine agents for patients with hepatic encephalopathy. Our analyses included five small trials published in 1982 or earlier. All trials but one had high risks of bias (i.e., risks of systematic errors or risks of overestimation of beneficial effects or risks of underestimation of harmful effects). Only 144 patients were included in the five trials, and accordingly risks of random errors (i.e., play of chance) are present. Our analyses showed no significant differences regarding symptoms of hepatic encephalopathy or mortality in patients treated with dopamine agents compared with patients who received an inactive placebo or no intervention. The number of patients with adverse events seemed comparable in the two intervention groups. Based on the available evidence, we conclude that no evidence can be found to recommend or refute the use of dopamine agents for hepatic encephalopathy. More randomised placebo-controlled clinical trials without risks of systematic errors and risks of random errors seem necessary to obtain firm evidence on dopamine agents for patients with hepatic encephalopathy." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 15 studies with 724 participants. We found a range of treatment protocols in terms of duration of care, TENS application times and intensity of application. Briefly, duration of care ranged from four days through to three months. Similarly, we found variation of TENS application times; from 15 minutes up to hourly sessions applied four times daily. We typically found intensity of TENS set to comfortable perceptible tingling with very few studies titrating the dose to maintain this perception. Of the comparisons, we had planned to explore, we were only able to undertake a quantitative synthesis for TENS versus sham TENS. Insufficient data and large diversity in the control conditions prevented us from undertaking a quantitative synthesis for the remaining comparisons. For TENS compared to sham TENS, five studies were suitable for pooled analysis. We described the remainder of the studies in narrative form. Overall, we judged 11 studies at high risk of bias, and four at unclear risk. Due to the small number of eligible studies, the high levels of risk of bias across the studies and small sample sizes, we rated the quality of the evidence as very low for the pooled analysis and very low individual GRADE rating of outcomes from single studies. For the individual studies discussed in narrative form, the methodological limitations, quality of reporting and heterogeneous nature of interventions compared did not allow for reliable overall estimates of the effect of TENS. Five studies (across various neuropathic conditions) were suitable for pooled analysis of TENS versus sham TENS investigating pain intensity using a visual analogue scale. We found a mean postintervention difference in effect size favouring TENS of -1.58 (95% confidence interval (CI) -2.08 to -1.09, P < 0.00001, n = 207, six comparisons from five studies) (very low quality evidence). There was no significant heterogeneity in this analysis. While this exceeded our prespecified minimally important difference for pain outcomes, we assessed the quality of evidence as very low meaning we have very little confidence in this effect estimate and the true effect is likely to be substantially different from that reported in this review. Only one study of these five investigated health related quality of life as an outcome meaning we were unable to report on this outcome in this comparison. Similarly, we were unable to report on global impression of change or changes in analgesic use in this pooled analysis. Ten small studies compared TENS to some form of usual care. However, there was great diversity in what constituted usual care, precluding pooling of data. Most of these studies found either no difference in pain outcomes between TENS versus other active treatments or favoured the comparator intervention (very low quality evidence). We were unable to report on other primary and secondary outcomes in these single trials (health-related quality of life, global impression of change and changes in analgesic use). Of the 15 included studies, three reported adverse events which were minor and limited to 'skin irritation' at or around the site of electrode placement (very low quality evidence). Three studies reported no adverse events while the remainder did not report any detail with regard adverse events. In this review, we reported on the comparison between TENS and sham TENS. The quality of the evidence was very low meaning we were unable to confidently state whether TENS is effective for pain control in people with neuropathic pain. The very low quality of evidence means we have very limited confidence in the effect estimate reported; the true effect is likely to be substantially different. We make recommendations with respect to future TENS study designs which may meaningfully reduce the uncertainty relating to the effectiveness of this treatment modality.\nOutput:\n" }, { "from": "agent", "value": "We reviewed all eligible clinical trials comparing TENS to 'fake' TENS (known as 'sham'), usual care or no treatment, or comparing TENS plus usual care versus usual care alone, for neuropathic pain in adults. As of September 2016, we found 15 studies eligible for inclusion. Of these 15 studies, we were able to combine results from five studies to investigate the effect of TENS compared to sham TENS for treatment of pain. The studies involved a range of neuropathic pain problems (e.g. people with spinal cord injury, back pain with nerve involvement, complications associated with diabetes, etc.). We found the quality of the studies overall to be low. We were unable to confidently state whether TENS is effective in relieving pain compared to sham TENS in people with neuropathic pain. This is due to the very low quality of the evidence, which means we have very limited confidence in this result and that future studies are likely to change this result. Lack of reported data meant we were unable to draw any conclusion on the effect of TENS treatment on health related quality of life, pain relieving medicine use or people's impression of how TENS changed their condition. We described the results of 10 further studies comparing TENS against other types of treatment. These 10 studies were quite varied and so we could not combine them and analyse them together. This, together with the very low quality of these 10 studies, meant we were unable to judge pain relief, health related quality of life, pain medication use or impression of change. In three of the 15 studies, some people using TENS experienced skin irritation under the electrode pads. Three studies reported no problems and the remaining studies did not provide any details on side effects. Based on this, it is not realistic to comment on side effects associated with TENS use." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three studies, enrolling 1158 participants. Each study reported an increased rate of recovery with intraoperative mild hypothermia, but the effect sizes were not sufficient for certainty. A total of 1086 of the 1158 participants (93.8%) had good grade aneurysmal subarachnoid haemorrhage. Seventy-six of 577 participants (13.1%) who received hypothermia and 93 of 581 participants (16.0%) who did not receive hypothermia were dead or dependent (RR 0.82; 95% CI 0.62 to 1.09; RD -0.03; 95% CI -0.07 to 0.01, moderate-quality evidence) after three months. Reported unfavourable outcomes did not differ between participants with or without hypothermia. The quality of evidence for these outcomes remains unclear because the outcomes were reported in a variety of ways. No decompressive craniectomy or corticectomy was reported. Thirty-six of 577 (6.2%) participants with hypothermia and 40 of 581 (6.9%) participants without hypothermia had infarction. Thirty-four of 577 (6%) participants with hypothermia and 32 of the 581 (5.5%) participants without hypothermia had clinical vasospasm (temporary deficits). Duration of hospital stay was not reported. Only one study with 112 participants reported discharge destinations: 43 of 55 (78.2%) participants with hypothermia and 39 of 57 (68.4%) participants in the control group were discharged home. The remaining participants were discharged to other facilities. Thirty-nine of 577 (6.8%) participants with hypothermia and 39 of 581 (6.7%) participants without hypothermia had infections. Six of 577 (1%) participants with hypothermia and 6 of 581 (1%) participants without hypothermia had cardiac arrhythmia. It remains possible that intraoperative mild hypothermia could prevent death or dependency in activities of daily living in people with good grade aneurysmal subarachnoid haemorrhage. However, the confidence intervals around this estimate include the possibility of both benefit and harm. There was insufficient information to draw any conclusions about the effects of intraoperative mild hypothermia in people with poor grade aneurysmal subarachnoid haemorrhage or without subarachnoid haemorrhage. We did not identify any reliable evidence to support the routine use of intraoperative mild hypothermia. A high-quality randomised clinical trial of intraoperative mild hypothermia for postoperative neurological deficits in people with poor grade aneurysmal subarachnoid haemorrhage might be feasible.\nOutput:\n" }, { "from": "agent", "value": "The updated evidence is current to August 2015. We found only three appropriate studies with a total of 1158 participants to include. Data primarily came from one high-quality study with 1000 participants. Our analysis showed that in good grade patients, it remains possible that cooling the brain during surgery might prevent death or dependency in everyday activities. Very limited information was available for those without bleeding or those with poor grade bleeding. Unfavourable outcomes did not differ between participants with or without hypothermia. The quality of evidence for these outcomes remains unclear because they were reported in a variety of ways. We do not have enough data to be certain about the effect of cooling on death or dependency. The evidence for other outcomes was more uncertain, since we could not combine the data due to variation in the definition and reporting of outcome data. Data in our analyses were primarily from one high quality trial on good grade participants." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: The review contains four studies with a total of 149 participants. Two studies compared NPWT with dressings; one study compared NPWT with a series of gel treatments and one study compared NPWT with 'moist wound healing'. One study had a 24-week follow-up period, and two had a six-week follow-up period, the follow-up time was unclear for one study. Three of the four included studies were deemed to be at a high risk of bias from one or more 'Risk of bias' domains and all evidence was deemed to be of very low quality. Only one study reported usable primary outcome data (complete wound healing), but this had only 12 participants and there were very few events (only one participant healed in the study). There was little other useful data available from the included studies on positive outcomes such as wound healing or negative outcomes such as adverse events. There is currently no rigorous RCT evidence available regarding the effects of NPWT compared with alternatives for the treatment of pressure ulcers. High uncertainty remains about the potential benefits or harms, or both, of using this treatment for pressure ulcer management.\nOutput:\n" }, { "from": "agent", "value": "We searched the medical literature up to May 2015 for robust medical studies (randomised controlled studies) that compared NPWT with other treatments for pressure ulcers. We identified four studies involving a total of 149 participants. Two studies compared NPWT with dressings, one compared NPWT with a series of topical treatments and one study compared it with what was described only as 'moist wound healing'. The trials were small, and poorly described, of fairly short or unclear duration, and contained little in the way of useful data. As a result of the limited amount of research evidence available, we were not able to draw any conclusions regarding the potential value (or harm) of NPWT as a treatment for pressure ulcers. More, better quality research is needed if this is an important and relevant question for decision makers. This plain language summary is up-to-date as of May 2015." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: No new studies were included for this update. Seven studies with a combined total of 802 participants were included in this review. No significant difference was observed between heparin treatment and control groups for pain-free walking distance or maximum walking distance at the end of treatment. There were no data to indicate that LMWHs benefit walking distance. Revascularisation or amputation-free survival rates were reported in one study only with a five year follow-up. No study reported a significant effect on overall mortality or cardiovascular events and the pooled odds ratios were not significant for these outcomes either. Major and minor bleeding events were significantly more frequent in the group treated with oral anticoagulants compared to control, with a non-significant increase in fatal bleeding events. No major bleeding events were reported in the study evaluating heparin, while a non-significant increase in minor bleeding events was reported. The benefit of heparin, LMWHs and oral anticoagulants for treatment of intermittent claudication has not been established while an increased risk of major bleeding events has been observed, especially with oral anticoagulants. There is no clear evidence to support the use of anticoagulants for intermittent claudication at this stage.\nOutput:\n" }, { "from": "agent", "value": "No new studies were included for this update. Seven studies with 802 participants were included in this review. The review of trials found that the benefit of heparin, LMWHs and oral anticoagulants for treatment of intermittent claudication has not been established while an increased risk of major bleeding events has been observed, especially with oral anticoagulants. There is no clear evidence to support the use of anticoagulants for intermittent claudication at this stage. More research is needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 29 trials (n = 2431) in this review. The study sample sizes ranged from 20 to 323 participants. We considered a total of 76.6% of the included trials to have a low risk of bias, representing 86% of all participants. There is low to high quality evidence that MCE is not clinically more effective than other exercises for all follow-up periods and outcomes tested. When compared with minimal intervention, there is low to moderate quality evidence that MCE is effective for improving pain at short, intermediate and long-term follow-up with medium effect sizes (long-term, MD –12.97; 95% CI –18.51 to –7.42). There was also a clinically important difference for the outcomes function and global impression of recovery compared with minimal intervention. There is moderate to high quality evidence that there is no clinically important difference between MCE and manual therapy for all follow-up periods and outcomes tested. Finally, there is very low to low quality evidence that MCE is clinically more effective than exercise and electrophysical agents (EPA) for pain, disability, global impression of recovery and quality of life with medium to large effect sizes (pain at short term, MD –30.18; 95% CI –35.32 to –25.05). Minor or no adverse events were reported in the included trials. There is very low to moderate quality evidence that MCE has a clinically important effect compared with a minimal intervention for chronic low back pain. There is very low to low quality evidence that MCE has a clinically important effect compared with exercise plus EPA. There is moderate to high quality evidence that MCE provides similar outcomes to manual therapies and low to moderate quality evidence that it provides similar outcomes to other forms of exercises. Given the evidence that MCE is not superior to other forms of exercise, the choice of exercise for chronic LBP should probably depend on patient or therapist preferences, therapist training, costs and safety.\nOutput:\n" }, { "from": "agent", "value": "In total, 2431 participants were enrolled in 29 trials. The study sample sizes ranged from 20 to 323 participants, and most of them were middle-aged people recruited from primary or tertiary care. The duration of the treatment programmes ranged from 20 days to 12 weeks, and the number of treatment sessions ranged from one to five sessions per week. Sixteen trials compared MCE with other types of exercises, seven trials compared MCE with minimal intervention, five trials compared MCE with manual therapy, three trials compared MCE with a combination of exercise and electrophysical agents, and one trial compared MCE with telerehabilitation based on home exercises. MCE probably provides better improvements in pain, function and global impression of recovery than minimal intervention at all follow-up periods. MCE may provide slightly better improvements than exercise and electrophysical agents for pain, disability, global impression of recovery and the physical component of quality of life in the short and intermediate term. There is probably little or no difference between MCE and manual therapy for all outcomes and follow-up periods. Little or no difference is observed between MCE and other forms of exercise. Given the minimal evidence that MCE is superior to other forms of exercise, the choice of exercise for chronic LBP should probably depend on patient or therapist preferences, therapist training, costs and safety." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 51 studies with 9052 participants. Of these, 45 trials assessed treatment outcomes at five weeks or less after commencement of treatment, and six trials assessed outcomes over a longer time frame. We believe that 24 trials had some form of conflict of interest, such as funding by pharmaceutical companies. Among the included studies were 12 ketoconazole trials (N = 3253), 11 ciclopirox trials (N = 3029), two lithium trials (N = 141), two bifonazole trials (N = 136) and one clotrimazole trial (N = 126) that compared the effectiveness of these treatments versus placebo or vehicle. Nine ketoconazole trials (N = 632) and one miconazole trial (N = 47) compared these treatments versus steroids. Fourteen studies (N = 1541) compared one antifungal versus another or compared different doses or schedules of administration of the same agent versus one another. Ketoconazole Topical ketoconazole 2% treatment showed a 31% lower risk of failed clearance of rashes compared with placebo (risk ratio (RR) 0.69, 95% confidence interval (CI) 0.59 to 0.81, eight studies, low-quality evidence) at four weeks of follow-up, but the effect on side effects was uncertain because evidence was of very low quality (RR 0.97, 95% CI 0.58 to 1.64, six studies); heterogeneity between studies was substantial (I² = 74%). The median proportion of those who did not have clearance in the placebo groups was 69%. Ketoconazole treatment resulted in a remission rate similar to that of steroids (RR 1.17, 95% CI 0.95 to 1.44, six studies, low-quality evidence), but occurrence of side effects was 44% lower in the ketoconazole group than in the steroid group (RR 0.56, 95% CI 0.32 to 0.96, eight studies, moderate-quality evidence). Ketoconozale yielded a similar remission failure rate as ciclopirox (RR 1.09, 95% CI 0.95 to 1.26, three studies, low-quality evidence). Most comparisons between ketoconazole and other antifungals were based on single studies that showed comparability of treatment effects. Ciclopirox Ciclopirox 1% led to a lower failed remission rate than placebo at four weeks of follow-up (RR 0.79, 95% CI 0.67 to 0.94, eight studies, moderate-quality evidence) with similar rates of side effects (RR 0.9, 95% CI 0.72 to 1.11, four studies, moderate-quality evidence). Other antifungals Clotrimazole and miconazole efficacies were comparable with those of steroids on short-term assessment in single studies. Treatment effects on individual symptoms were less clear and were inconsistent, possibly because of difficulties encountered in measuring these symptoms. Evidence was insufficient to conclude that dose or mode of delivery influenced treatment outcome. Only one study reported on treatment compliance. No study assessed quality of life. One study assessed the maximum rash-free period but provided insufficient data for analysis. One small study in patients with HIV compared the effect of lithium versus placebo on seborrhoeic dermatitis of the face, but treatment outcomes were similar. Ketoconazole and ciclopirox are more effective than placebo, but limited evidence suggests that either of these agents is more effective than any other agent within the same class. Very few studies have assessed symptom clearance for longer periods than four weeks. Ketoconazole produced findings similar to those of steroids, but side effects were fewer. Treatment effect on overall quality of life remains unknown. Better outcome measures, studies of better quality and better reporting are all needed to improve the evidence base for antifungals for seborrhoeic dermatitis.\nOutput:\n" }, { "from": "agent", "value": "We included 51 studies with 9052 participants. Trials typically were four weeks long, and very few trials were longer. In all, 24 studies had some involvement of pharmaceutical companies such as funding or employment of the researchers. Particpants taking ketoconazole were 31% less likely than those given placebo to have symptoms that persisted at four weeks of follow-up. This was seen in eight studies with 2520 participants, but wide variation was noted between studies. Ketoconazole was as effective as steroids but had 44% fewer side effects. Without causing more side effects, ciclopirox was 21% more effective than placebo in achieving clinical clearance of rashes. Treatment effect on redness, itching or scaling symptoms of the skin was less clear. Evidence was insufficient to conclude that that one antifungal was superior to other antifungals, but this observation was based on few studies. Ketoconazole and ciclopirox are the most heavily investigated antifungals and are more effective than placebo. Other antifungals might have similar effects, but data are insufficient to underpin this. Common side effects were increased skin redness or itching, burning sensation and hair loss. No studies measured quality of life. Only one study reported on percentage of compliance in different treatment groups. Other studies used surrogates such as acceptability to represent compliance. We therefore could not assess the effect of compliance on treatment outcomes. One study on patients with HIV reported no clear effects of treatments. Evidence for the effects of ketoconazole compared with placebo or a steroid was assessed to be of low quality. Evidence derived from comparison of ciclopirox versus placebo was assessed to be of moderate quality. Better quality studies with longer follow-up and better reporting are needed to enlarge the evidence base for antifungals." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 15 studies with a total of 1326 women. All included studies compared a vasodilator versus placebo or no treatment. We judged most of these studies as having unclear risk of bias. Overall, the quality of evidence was low to moderate for most outcomes. The main limitations were imprecision due to low numbers of events and participants and risk of bias due to unclear methods of randomisation. Vasodilators probably make little or no difference in rates of live birth compared with placebo or no treatment (RR 1.18, 95% confidence interval (CI) 0.83 to 1.69; three RCTs; N = 350; I² = 0%; moderate-quality evidence) but probably increase overall rates of side effects including headache and tachycardia (RR 2.35, 95% CI 1.51 to 3.66; four RCTs; N = 418; I² = 0%; moderate-quality evidence). Evidence suggests that if 236 per 1000 women achieve live birth with placebo or no treatment, then between 196 and 398 per 1000 will do so with the use of vasodilators. Compared with placebo or no treatment, vasodilators may slightly improve clinical pregnancy rates (RR 1.45, 95% CI 1.19 to 1.77; 11 RCTs; N = 1054; I² = 6%; low-quality evidence). Vasodilators probably make little or no difference in rates of multiple gestation (RR 1.15, 95% CI 0.55 to 2.42; three RCTs; N = 370; I² = 0%; low-quality evidence), miscarriage (RR 0.83, 95% CI 0.37 to 1.86; three RCTs; N = 350; I² = 0%; low-quality evidence), or ectopic pregnancy (RR 1.48, 95% CI 0.25 to 8.69; two RCTs; N = 250; I² = 5%; low-quality evidence). All studies found benefit for endometrial thickening, but reported effects varied (I² = 92%) and ranged from a mean difference of 0.80 higher (95% CI 0.18 to 1.42) to 3.57 higher (95% CI 3.01 to 4.13) with very low-quality evidence, so we are uncertain how to interpret these results. Evidence was insufficient to show whether vasodilators increase the live birth rate in women undergoing fertility treatment. However, low-quality evidence suggests that vasodilators may slightly increase clinical pregnancy rates. Moderate-quality evidence shows that vasodilators increase overall side effects in comparison with placebo or no treatment. Adequately powered studies are needed so that each treatment can be evaluated more accurately.\nOutput:\n" }, { "from": "agent", "value": "We found 15 randomised controlled trials (a type of experiment in which people are randomly allocated to one or more treatment groups) that compared the use of vasodilators versus placebo or no treatment in a total of 1326 women undergoing fertility treatment. The evidence is current to October 2017. Only three of the included studies reported live birth rates. Overall, vasodilators probably make little or no difference in rates of live birth. Moderate-quality evidence shows that vasodilators probably increase overall rates of side effects (including headache and tachycardia (faster than normal heartbeat)) in comparison with placebo or no treatment. However, low-quality evidence suggests that vasodilators may increase the chance of becoming pregnant. The evidence is of low to moderate quality. More research is needed (one study is ongoing and will be incorporated into this review in a subsequent update)." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Four trials involving 132 people were included. Two studies compared nasal mask with the Oracle oral mask and showed no significant difference in compliance at one month (mean difference (MD) 0.17 hours per night, 95%CI 0.54 to 0.87). There were also no significant differences in any of the physiological parameters (e.g. AHI, arousal index, minimum oxygen saturation), Epworth Sleepiness Scale (ESS), or symptoms of OSA. A single study comparing nasal mask with nasal pillows showed a significant difference in compliance when expressed as the percentage of days used in favour of nasal pillows (nasal pillows mean 94.1± SD 8.3%; nasal mask 85.7 ± 23.5%, P = 0.02), however there were no significant differences in the mean daily use for all days or when use was greater than 0 minutes per day. Nasal pillows were also associated with fewer overall adverse effects (P < 0.001) and greater interface satisfaction (P = 0.001). One study comparing nasal mask with face mask showed that compliance was significantly greater with use of a nasal mask (MD 1.0 hour per night,95% CI 0.3 to 1.8). Nasal mask was also associated with significantly lower ESS scores and was the preferred interface in almost all patients. Due to the limited number of studies available comparing various interface types, the optimum form of CPAP delivery interface remains unclear. The results of our review suggest that nasal pillows or the Oracle oral mask may be useful alternatives when a patient is unable to tolerate conventional nasal masks. The face mask can not be recommended as a first line interface, but may be considered if nasal obstruction or dryness limits the use of a nasal mask. Further randomised studies comparing the different forms of CPAP delivery interface now available for the treatment of OSA, in larger groups of patients and for longer durations, are required.\nOutput:\n" }, { "from": "agent", "value": "This review compares the different interface options for CPAP in patients with OSA. Four trials involving 132 people were included. Two studies compared nasal masks with an oral mask called the Oracle, and there did not appear to any significant differences between the two in terms of compliance, sleep study recordings, sleepiness or other symptoms of OSA. One study assessing nasal masks versus nasal pillows (consisting of prongs that rest within the nostrils) showed that patients using the nasal pillows had fewer overall side effects and reported greater satisfaction. The nose mask performed better than the face mask (which covers both the nose and mouth) with one study showing greater compliance and less sleepiness, and was the preferred mask in almost all patients. The choice of interface for a particular person will need to be tailored to the individual. Further trials comparing the many interfaces for CPAP in the treatment of OSA are needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified seven RCTs, one register, and five ongoing trials from a total of 347 references. The published trials for VEGF-targeting drugs in MBC were limited to bevacizumab. Four trials, including a total of 2886 patients, were available for the comparison of first-line chemotherapy, with versus without bevacizumab. PFS (HR 0.67; 95% confidence interval (CI) 0.61 to 0.73) and response rate were significantly better for patients treated with bevacizumab, with moderate heterogeneity regarding the magnitude of the effect on PFS. For second-line chemotherapy, a smaller, but still significant benefit in terms of PFS could be demonstrated for patients treated with bevacizumab (HR 0.85; 95% CI 0.73 to 0.98), as well as a benefit in tumour response. However, OS did not differ significantly, neither in first- (HR 0.93; 95% CI 0.84 to 1.04), nor second-line therapy (HR 0.98; 95% CI 0.83 to 1.16). Quality of life (QoL) was evaluated in four trials but results were published for only two of these with no relevant impact. Subgroup analysis stated a significant greater benefit for patients with previous (taxane) chemotherapy and patients with hormone-receptor negative status. Regarding toxicity, data from RCTs and registry data were consistent and in line with the known toxicity profile of bevacizumab. While significantly higher rates of adverse events (AEs) grade III/IV (odds ratio (OR) 1.77; 95% CI 1.44 to 2.18) and serious adverse events (SAEs) (OR 1.41; 95% CI 1.13 to 1.75) were observed in patients treated with bevacizumab, rates of treatment-related deaths were lower in patients treated with bevacizumab (OR 0.60; 95% CI 0.36 to 0.99). The overall patient benefit from adding bevacizumab to first- and second-line chemotherapy in metastatic breast cancer can at best be considered as modest. It is dependent on the type of chemotherapy used and limited to a prolongation of PFS and response rates in both first- and second-line therapy, both surrogate parameters. In contrast, bevacizumab has no significant impact on the patient-related secondary outcomes of OS or QoL, which indicate a direct patient benefit. For this reason, the clinical value of bevacizumab for metastatic breast cancer remains controversial.\nOutput:\n" }, { "from": "agent", "value": "One of these drugs is bevacizumab (Avastin) which has been studied in clinical trials in metastatic breast cancer. Trials with other drugs are ongoing. Data are available from seven randomised trials, which evaluated the effect of bevacizumab on the primary endpoint in a total of 4032 patients with metastatic breast cancer. These patients were either-hormone receptor negative or had progressed on hormonal treatment. The primary end point was progression-free survival and secondary end points included overall survival, response rate measuring the change in size of the tumour, quality of life and toxicity of the treatment. Progression-free survival is considered a surrogate end point, i.e. a substitute for overall survival as an end point. The addition of bevacizumab to chemotherapy significantly prolongs progression-free survival and response rates in patients who have had previous chemotherapy and those who have not had previous chemotherapy for metastatic disease. The magnitude of this benefit is dependent on the type of chemotherapy used. Best results have been observed for the combination of weekly paclitaxel and bevacizumab in patients without prior chemotherapy for metastatic disease. Although progression-free survival was significantly longer with bevacizumab, there was no significant effect observed on either overall survival or quality of life. Quality of life is a direct measure of benefit to the patient. Adverse effects of bevacizumab in breast cancer are generally manageable, but may be serious and include increased frequencies of high blood pressure, blood clots in arteries and bowel perforations. However, overall rates of treatment-related deaths were lower in patients treated with bevacizumab. Because of the lack of effect on overall survival and quality of life, it is regarded as controversial whether bevacizumab is associated with a true patient benefit in spite of the increase in progression-free survival." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Twentyone reports have been found eligible for inclusion in the review, encompassing 31,698 women having had 6,028 CDs and 25,170 VDs as the index event prior to anal continence assessment . Only one report randomised women (with breech presentation) to CD or VD, but because of extensive crossing over, 52.1%, after randomisation, it was analysed along with the other 20 studies as treated, i.e. as a non-randomised trial. Only one of these reports demonstrated a significant benefit of CD in the preservation of anal continence, a report in which incontinence incidence was extremely high, 39% in CD and 48% in VD, questioning, relative to other reports, the timing and nature of continence assessment. The greater the quality of the report, the closer its Odds ratio approached 1.0. There was no difference in continence preservation in women have emergency versus elective CD. Without demonstrable benefit, preservation of anal continence should not be used as a criterion for choosing elective primary CD. The strength of this conclusion would be greatly strengthened if there were studies that randomised women with average risk pregnancies to CD versus VD.\nOutput:\n" }, { "from": "agent", "value": "In this systematic review of non-randomised studies, no benefit could be demonstrated for CD over vaginal delivery (VD) in the prevention of anal incontinence. This review encompasses 21 published studies, involving 31,698 women, delivered by 6,028 CD and by 25,170 VD. No randomised studies comparing CD to VD in average risk pregnancies exist. The above conclusion is therefore based upon less than optimal evidence." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Five trials, with a total of 336 randomised participants, were included. A total of 105 participants (31%) died. Of the five included trials, four (80%) had a high risk of bias. Meta-analysis using all five trials showed that pentoxifylline reduced mortality compared with control (RR 0.64; 95% CI 0.46 to 0.89). However, this result was not supported by trial sequential analysis, which adjusts for multiple testing on accumulating data. Furthermore, four of the five trials were judged to have a high risk of bias, thus risking an overestimated intervention effect. Meta-analysis showed that pentoxifylline reduced the hepatic-related mortality due to hepatorenal syndrome (RR 0.40; 95% CI 0.22 to 0.71), but trial sequential analysis did not support this result. Data from one trial suggests that pentoxifylline may increase the occurrence of serious and non-serious adverse events compared to control. The current available data may indicate a possible positive intervention effect of pentoxifylline on all-cause mortality and mortality due to hepatorenal syndrome, and conversely, an increase in serious and non-serious adverse events. However, the evidence is not firm; no conclusions can be drawn regarding whether pentoxifylline has a positive, negative, or neutral effect on participants with alcoholic hepatitis.\nOutput:\n" }, { "from": "agent", "value": "We found five randomised trials, which together included 336 participants; half received pentoxifylline, and the other half received placebo or no intervention. We performed this systematic review and statistical analyses but could not show firm evidence of beneficial effects of pentoxifylline on mortality or on complications of liver diseases in patients with alcoholic hepatitis. Pentoxifylline did appear to cause more serious and non-serious side effects. In order to help decide whether pentoxifylline should be used to treat alcoholic hepatitis or not, we need well-designed, well-conducted, large randomised clinical trials, with short-term (less than one month) and long-term (more than one month) data on benefits and harms." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 31 studies that explored the views and experiences of different types of SBAs, including doctors, midwives, nurses, auxiliary nurses and their managers. The included studies took place in Africa, Asia, and Latin America. Our synthesis pointed to a number of factors affecting SBAs’ provision of quality care. The following factors were based on evidence assessed as of moderate to high confidence. Skilled birth attendants reported that they were not always given sufficient training during their education or after they had begun clinical work. Also, inadequate staffing of facilities could increase the workloads of skilled birth attendants, make it difficult to provide supervision and result in mothers being offered poorer care. In addition, SBAs did not always believe that their salaries and benefits reflected their tasks and responsibilities and the personal risks they undertook. Together with poor living and working conditions, these issues were seen to increase stress and to negatively affect family life. Some SBAs also felt that managers lacked capacity and skills, and felt unsupported when their workplace concerns were not addressed. Possible causes of staff shortages in facilities included problems with hiring and assigning health workers to facilities where they were needed; lack of funding; poor management and bureaucratic systems; and low salaries. Skilled birth attendants and their managers suggested factors that could help recruit, keep, and motivate health workers, and improve the quality of care; these included good-quality housing, allowances for extra work, paid vacations, continuing education, appropriate assessments of their work, and rewards. Skilled birth attendants’ ability to provide quality care was also limited by a lack of equipment, supplies, and drugs; blood and the infrastructure to manage blood transfusions; electricity and water supplies; and adequate space and amenities on maternity wards. These factors were seen to reduce SBAs’ morale, increase their workload and infection risk, and make them less efficient in their work. A lack of transport sometimes made it difficult for SBAs to refer women on to higher levels of care. In addition, women’s negative perceptions of the health system could make them reluctant to accept referral. We identified some other factors that also may have affected the quality of care, which were based on findings assessed as of low or very low confidence. Poor teamwork and lack of trust and collaboration between health workers appeared to negatively influence care. In contrast, good collaboration and teamwork appeared to increase skilled birth attendants’ motivation, their decision-making abilities, and the quality of care. Skilled birth attendants’ workloads and staff shortages influenced their interactions with mothers. In addition, poor communication undermined trust between skilled birth attendants and mothers. Many factors influence the care that SBAs are able to provide to mothers during childbirth. These include access to training and supervision; staff numbers and workloads; salaries and living conditions; and access to well-equipped, well-organised healthcare facilities with water, electricity, and transport. Other factors that may play a role include the existence of teamwork and of trust, collaboration, and communication between health workers and with mothers. Skilled birth attendants reported many problems tied to all of these factors.\nOutput:\n" }, { "from": "agent", "value": "We included 31 studies conducted in Africa, Asia, and Latin America. Participants were skilled birth attendants including doctors, midwives, nurses, auxiliary nurses and their managers. Our synthesis pointed to several factors that affected skilled birth attendants’ provision of quality care. The following factors are based on evidence assessed as of moderate to high confidence. Skilled birth attendants reported that they sometimes had insufficient training during their education or after they had begun work. Where facilities lacked staff, skilled birth attendants’ workloads could increase, it could become difficult to provide supervision, and mothers could receive poorer care. In addition, skilled birth attendants did not always believe that their salaries and benefits reflected their tasks and responsibilities and the personal risks they undertook. Together with poor living and working conditions, these issues could lead to stress and affect skilled birth attendants' family life. Some skilled birth attendants felt that managers lacked capacity and skills, and they felt unsupported when their workplace concerns were not addressed. Possible causes of staff shortages included problems with hiring and assigning health workers to health facilities; lack of funding; poor management and bureaucratic systems; and low salaries. Skilled birth attendants and their managers suggested factors that could help recruit, keep, and motivate health workers, and improve the quality of their work; these included good-quality housing, allowances for extra work, paid vacations, continued education, proper assessments of their work, and rewards. Skilled birth attendants’ ability to provide quality care was also limited by a lack of equipment, drugs, and supplies; blood and the infrastructure to manage blood transfusions; electricity and water supplies; and adequate space and amenities on maternity wards. These factors were seen to reduce skilled birth attendants’ morale, increase their workload and infection risk, and make them less efficient in their work. A lack of transport sometimes made it difficult for skilled birth attendants to refer women to higher levels of care. In addition, women’s negative perceptions of the health system could make them reluctant to accept referral. We identified some other factors that also may have affected the quality of care, which were based on findings assessed as of low or very low confidence. Poor teamwork and lack of trust and collaboration between health workers appeared to negatively influence care. In contrast, good collaboration and teamwork appeared to increase skilled birth attendants’ motivation, their decision-making abilities, and the quality of care. Skilled birth attendants’ workloads and staff shortages influenced their interactions with mothers. In addition, poor communication undermined trust between skilled birth attendants and mothers. We searched for studies published before November 2016." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Three RCTs met our inclusion criteria. The trials randomised 153 participants (74 participants to oral vitamin B12 and 79 participants to IM vitamin B12). Treatment duration and follow-up ranged between three and four months. The mean age of participants ranged from 38.6 to 72 years. The treatment frequency and daily dose of vitamin B12 in the oral and IM groups varied among trials. Only one trial had low or unclear risk of bias across all domains and outcome measures. Two trials reported data for serum vitamin B12 levels. The overall quality of evidence for this outcome was low due to serious imprecision (low number of trials and participants). In two trials employing 1000 μg/day oral vitamin B12, there was no clinically relevant difference in vitamin B12 levels when compared with IM vitamin B12. One trial used 2000 μg/day vitamin B12 and demonstrated a mean difference of 680 pg/mL (95% confidence interval 392.7 to 967.3) in favour of oral vitamin B12. Two trials reported data on adverse events (very low-quality evidence due to risk of performance bias, detection bias, and serious imprecision). One trial stated that no treatment-related adverse events were seen in both the oral and IM vitamin B12 groups. One trial reported that 2 of 30 participants (6.7%) in the oral vitamin B12 group left the trial early due to adverse events. Orally taken vitamin B12 showed lower treatment-associated costs than IM vitamin B12 in one trial (low-quality evidence due to serious imprecision). No trial reported on clinical signs and symptoms of vitamin B12 deficiency, health-related quality of life, or acceptability of the treatment scheme. Low quality evidence shows oral and IM vitamin B12 having similar effects in terms of normalising serum vitamin B12 levels, but oral treatment costs less. We found very low-quality evidence that oral vitamin B12 appears as safe as IM vitamin B12. Further trials should conduct better randomisation and blinding procedures, recruit more participants, and provide adequate reporting. Future trials should also measure important outcomes such as the clinical signs and symptoms of vitamin B12 deficiency, health related-quality of life, socioeconomic effects, and report adverse events adequately, preferably in a primary care setting.\nOutput:\n" }, { "from": "agent", "value": "We found three randomised controlled studies (clinical studies where people are randomly put into one of two or more treatment groups). The studies randomised 153 participants (74 participants to oral vitamin B12 and 79 participants to intramuscular vitamin B12). Treatment duration and follow-up ranged between three and four months. The mean age of participants ranged from 39 to 72 years. Two studies used 1000 μg/day oral vitamin B12 and showed no relevant difference to intramuscularly applied vitamin B12 with regard to vitamin B12 blood levels. One trial used 2000 μg/day vitamin B12 and showed higher vitamin B12 blood levels in favour of oral vitamin B12. Two studies reported side effects. One study stated that no treatment-related side effects were seen in both the oral and intramuscular vitamin B12 groups. One study reported that 2 of 30 participants in the oral vitamin B12 group left the trial early due to side effects. Orally taken vitamin B12 showed lower treatment-associated costs than intramuscular vitamin B12 in one trial. No study reported on clinical signs and symptoms of vitamin B12 deficiency (e.g. fatigue, depression, neurological complications), health-related quality of life, or acceptability of the treatment scheme. The overall quality of the evidence was low or very low, mainly due to the small number of included studies and the low numbers of participants in these studies." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia (no sperm detected). Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however. For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. RCTs examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques.\nOutput:\n" }, { "from": "agent", "value": "In February 2014, we updated the computer searches for studies of vasectomy methods. For the initial review, we also looked at reference lists of articles and book chapters. We included randomized controlled trials in any language. We found six studies. One trial compared closing the vas with clips versus the usual cutting of the vas. The groups did not differ in reaching a low sperm count or in side effects. Three trials looked at flushing fluids through the vas: two compared vasectomy with water flushing versus vasectomy alone, and one compared using water versus euflavine (which kills sperm). None found a difference between the groups in time to low sperm count. However, one trial found that the usual number of ejaculations before low sperm count was lower with euflavine than with water. One trial that compared vasectomy with and without fascial interposition was a high-quality large study. The fascial interposition group was less likely to have vasectomy failure. However, the surgery was more difficult. Side effects were about the same in the two groups. Lastly, one trial looked at a device placed into the vas versus vasectomy without a scalpel. The intra-vas device did not work as well for reaching a low sperm count but more men liked the method. Most of the studies that looked at vasectomy methods were small, not done well, or had poor reports. Therefore, we cannot say if the methods work well, are safe or are liked by men. Vasectomy with fascial interposition worked better than simply cutting and tying the vas, but the surgery was more difficult. More and better research is needed on vasectomy methods." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified 19 studies of which we included five, involving 3130 women. We excluded eight studies, one awaits classification and five are ongoing studies. All the included studies looked at women in active labour and at low risk of potentially requiring a general anaesthetic. One study looked at complete restriction versus giving women the freedom to eat and drink at will; two studies looked at water only versus giving women specific fluids and foods and two studies looked at water only versus giving women carbohydrate drinks. When comparing any restriction of fluids and food versus women given some nutrition in labour, the meta-analysis was dominated by one study undertaken in a highly medicalised environment. There were no statistically significant differences identified in: caesarean section (average risk ratio (RR) 0.89, 95% confidence interval (CI) 0.63 to 1.25, five studies, 3103 women), operative vaginal births (average RR 0.98, 95% CI 0.88 to 1.10, five studies, 3103 women) and Apgar scores less than seven at five minutes (average RR 1.43, 95% CI 0.77 to 2.68, four studies, 2902 infants), nor in any of the other outcomes assessed. Women's views were not assessed. The pooled data were insufficient to assess the incidence of Mendelson's syndrome, an extremely rare outcome. Other comparisons showed similar findings, except one study did report a significant increase in caesarean sections for women taking carbohydrate drinks in labour compared with water only, but these results should be interpreted with caution as the sample size was small. Since the evidence shows no benefits or harms, there is no justification for the restriction of fluids and food in labour for women at low risk of complications. No studies looked specifically at women at increased risk of complications, hence there is no evidence to support restrictions in this group of women. Conflicting evidence on carbohydrate solutions means further studies are needed and it is critical in any future studies to assess women's views.\nOutput:\n" }, { "from": "agent", "value": "This review looked at any restriction of fluids and food in labour compared with women able to eat and drink. The review identified five studies involving 3130 women. Most studies had looked at specific foods being recommended, though one study let women choose what they wished to eat and drink. The review identified no benefits or harms of restricting foods and fluids during labour in women at low risk of needing anaesthesia. There were no studies identified on women at increased risk of needing anaesthesia. None of the studies looked at women's views of restricting fluids and foods during labour. Thus, given these findings, women should be free to eat and drink in labour, or not, as they wish." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: The 12 included studies involved 10,953 residents in 355 (range 1 to 85) care homes in ten countries. Nine studies were cluster-randomised controlled trials and three studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of ten studies. Four studies involved multidisciplinary case-conferencing, five studies involved an educational element for health and care professionals and one study evaluated the use of clinical decision support technology. We did not combine the results in a meta-analysis due to heterogeneity across studies. Interventions to optimise prescribing may lead to fewer days in hospital (one study out of eight; low certainty evidence), a slower decline in health-related quality of life (one study out of two; low certainty evidence), the identification and resolution of medication-related problems (seven studies; low certainty evidence), and may lead to improved medication appropriateness (five studies out of five studies; low certainty evidence). We are uncertain whether the intervention improves/reduces medicine costs (five studies; very low certainty evidence) and it may make little or no difference on adverse drug events (two studies; low certainty evidence) or mortality (six studies; low certainty evidence). The risk of bias across studies was heterogeneous. We could not draw robust conclusions from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems and improvements in medication appropriateness, however evidence of a consistent effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.\nOutput:\n" }, { "from": "agent", "value": "We found 12 studies involving 10,953 residents in 355 care homes in ten countries that evaluated interventions to optimise prescribing for care home residents. Most of the interventions had several components, often involving a review of medicines with a pharmacist and doctor. Some interventions included a teaching component and one study used Information Technology (IT). We found no evidence of benefit of the interventions with respect to reducing adverse drug events (harmful effects caused by medicines) or death. One study led to residents having fewer days in hospital; however, the majority of studies did not show a benefit in relation to reducing hospital admissions. One study led to a slower decline in health-related quality of life. Problems relating to medicines were found and addressed through the interventions used in the studies. Prescribing was improved based on criteria used to assess the appropriateness of prescribing in five studies. We judged the overall quality of the evidence for the reported outcomes to be low for adverse drug events (harmful effects caused by medicines), hospital admissions, death, quality-of-life, medication-related problems, medication appropriateness, and very low for the cost of medicines. More high-quality studies need to be done to gather more evidence for these and other types of interventions. Further studies are needed to evaluate new technologies, including computer systems that support prescribing decisions. More work needs to be done to make sure that researchers are consistently measuring outcomes that are important to care home residents." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified six randomised controlled trials with a total of 597 participants that were eligible for inclusion in the 2013 review. No new studies were eligible for inclusion in this update. Participants in the included studies, where dementia severity was reported, had mild to moderate severity of vascular dementia (four trials). The included studies tested varying doses and duration of Cerebrolysin treatment. Follow-up ranged from 15 days to three years. Five of included studies were conducted in China (three studies), Russia (one study), and Romania (one study), while relevant information of other study was unclear. Where details of funding were available, all studies were supported by the pharmaceutical industry (three studies). Cognitive function was measured using the Mini-Mental State Examination (MMSE) or Alzheimer's Disease Assessment Scale Cognitive Subpart, extended version (ADAS-cog+). Combining the MMSE and ADAS-cog+ data (three studies, 420 people), there was a beneficial effect of Cerebrolysin (SMD 0.36, 95% CI 0.13 to 0.58; very low-quality evidence). Global function was measured by Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC+) or Investigator's Clinical Global Impression (CGI). We assessed response rates on these measures (the proportion of participants with a CIBIC+ score of < 3; or at least moderate improvement of the CGI rating at the last visit). There was a beneficial effect of Cerebrolysin (two studies, 379 participants, RR 2.69, 95% CI 1.82 to 3.98; very low-quality evidence). Only one trial described mortality and reported no deaths. Four studies reported adverse events; data from two studies (379 people) were in a format that permitted meta-analysis, and there was no difference in rates of adverse effects (RR 0.91, 95% CI 0.29 to 2.85; very low-quality evidence). No studies reported on quality of life or caregiver burden. Courses of intravenous Cerebrolysin improved cognition and general function in people living with vascular dementia, with no suggestion of adverse effects. However, these data are not definitive. Our analyses were limited by heterogeneity, and the included papers had high risk of bias. If there are benefits of Cerebrolysin, the effects may be too small to be clinically meaningful. There have been no new studies of Cerebrolysin in vascular dementia since the last Cochrane Review. Cerebrolysin continues to be used and promoted as a treatment for vascular dementia, but the supporting evidence base is weak. Adequately powered, methodologically robust trials are needed to properly assess the effects of Cerebrolysin in vascular dementia.\nOutput:\n" }, { "from": "agent", "value": "We found six studies including a total of 597 people living with vascular dementia. The method of Cerebrolysin treatment differed across studies, with varying strengths of Cerebrolysin and treatment durations. The studies reported that Cerebrolysin had beneficial effects on memory and thinking and on daily functioning. There was no reported risk of side effects with treatment. None of the studies described quality of life of people living with vascular dementia or their caregivers. Although the studies suggested a benefit of Cerebrolysin treatment, the results are not definitive. The included studies had several issues that may have led to misleading results. Even if the benefit reported in the studies is real, the effect was modest and may not be important to people living with dementia. There is a need for a large, well-conducted study to better understand if Cerebrolysin is a useful treatment for people living with vascular dementia." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Seventeen studies (14 ITS and 3 CBA studies) met the inclusion criteria in this updated version of the review. The ITS studies evaluated the effects of: introducing or changing regulations that laid down safety and health requirements for the construction sites (nine studies), a safety campaign (two studies), a drug-free workplace programme (one study), a training programme (one study), and safety inspections (one study) on fatal and non-fatal occupational injuries. One CBA study evaluated the introduction of occupational health services such as risk assessment and health surveillance, one evaluated a training programme and one evaluated the effect of a subsidy for upgrading to safer scaffoldings. The overall risk of bias of most of the included studies was high, as it was uncertain for the ITS studies whether the intervention was independent from other changes and thus could be regarded as the main reason of change in the outcome. Therefore, we rated the quality of the evidence as very low for all comparisons. Compulsory interventions Regulatory interventions at national or branch level may or may not have an initial effect (effect size (ES) of −0.33; 95% confidence interval (CI) −2.08 to 1.41) and may or may not have a sustained effect (ES −0.03; 95% CI −0.30 to 0.24) on fatal and non-fatal injuries (9 ITS studies) due to highly inconsistent results (I² = 98%). Inspections may or may not have an effect on non-fatal injuries (ES 0.07; 95% CI −2.83 to 2.97; 1 ITS study). Educational interventions Safety training interventions may result in no significant reduction of non-fatal injuries (1 ITS study and 1 CBA study). Informational interventions We found no studies that had evaluated informational interventions alone such as campaigns for risk communication. Persuasive interventions We found no studies that had evaluated persuasive interventions alone such as peer feedback on workplace actions to increase acceptance of safe working methods. Facilitative interventions Monetary subsidies to companies may lead to a greater decrease in non-fatal injuries from falls to a lower level than no subsidies (risk ratio (RR) at follow-up: 0.93; 95% CI 0.30 to 2.91 from RR 3.89 at baseline; 1 CBA study). Multifaceted interventions A safety campaign intervention may result in an initial (ES −1.82; 95% CI −2.90 to −0.74) and sustained (ES −1.30; 95% CI −1.79 to −0.81) decrease in injuries at the company level (1 ITS study), but not at the regional level (1 ITS study). A multifaceted drug-free workplace programme at the company level may reduce non-fatal injuries in the year following implementation by −7.6 per 100 person-years (95% CI −11.2 to −4.0) and in the years thereafter by −2.0 per 100 person-years (95% CI −3.5 to −0.5) (1 ITS study). Introducing occupational health services may result in no decrease in fatal or non-fatal injuries (one CBA study). The vast majority of interventions to adopt safety measures recommended by standard texts on safety, consultants and safety courses have not been adequately evaluated. There is very low-quality evidence that introducing regulations as such may or may not result in a decrease in fatal and non-fatal injuries. There is also very low-quality evidence that regionally oriented safety campaigns, training, inspections or the introduction of occupational health services may not reduce non-fatal injuries in construction companies. There is very low-quality evidence that company-oriented safety interventions such as a multifaceted safety campaign, a multifaceted drug workplace programme and subsidies for replacement of scaffoldings may reduce non-fatal injuries among construction workers. More studies, preferably cluster-randomised controlled trials, are needed to evaluate different strategies to increase the employers' and workers' adherence to the safety measures prescribed by regulation.\nOutput:\n" }, { "from": "agent", "value": "We conducted a systematic search of the literature on preventing occupational injuries among construction workers. We included 17 studies in this updated review, rating the evidence as very low quality. Multifaceted interventions and company incentives for upgrading equipment may be effective in reducing injury. However, an evidence base is still needed for the vast majority of safety measures that safety manuals, consultants and safety courses routinely recommend. What was studied in the review? We looked at different types of workplace interventions, including the introduction of new regulations, safety campaigns, training, inspections, occupational health services, and company subsidies. We evaluated the quality of the studies and the effectiveness of interventions, rating the evidence as very low quality. What are the main results of the review? Introducing regulations alone may or may not be effective for preventing non-fatal and fatal injuries in construction workers. Regionally oriented interventions such as a safety campaigns, training, inspections or occupational health services may not be effective for reducing non-fatal injuries in construction workers. However, a multifaceted safety campaign and a multifaceted drug-free workplace programme at the company level, along with subsidies for replacement of scaffoldings, may be effective in reducing non-fatal injuries. Additional strategies are needed to increase the employers' and workers' adherence to the safety measures that are prescribed by regulation. How up-to-date is this review? We searched for studies that had been published up to 1 April 2017." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We identified seven RCTs (1728 participants) evaluating prolonged thromboprophylaxis with LMWH compared with in-hospital thromoprophylaxis followed by placebo or no thromboprophylaxis after discharge. The searches resulted in 1632 studies, of which we excluded 1528. One hundred and four abstracts, eligible for inclusion, were assessed of which seven studies met the inclusion criteria. For the primary outcome, the incidence of overall VTE after major abdominal or pelvic surgery was 13.2% in the control group compared to 5.3% in the patients receiving out-of-hospital LMWH (Mantel Haentzel (M-H) odds ratio (OR) 0.38, 95% confidence interval (CI) 0.26 to 0.54; I2 = 28%; moderate-quality evidence). For the secondary outcome of all DVT, seven studies, n = 1728, showed prolonged thromboprophylaxis with LMWH to be associated with a statistically significant reduction in the incidence of all DVT (M-H OR 0.39, 95% CI 0.27 to 0.55; I2 = 28%; moderate-quality evidence). We found a similar reduction when analysis was limited to incidence in proximal DVT (M-H OR 0.22, 95% CI 0.10 to 0.47; I2 = 0%; moderate-quality evidence). The incidence of symptomatic VTE was also reduced from 1.0% in the control group to 0.1% in patients receiving prolonged thromboprophylaxis, which approached significance (M-H OR 0.30, 95% CI 0.08 to 1.11; I2 = 0%; moderate-quality evidence). No difference in the incidence of bleeding between the control and LMWH group was found, 2.8% and 3.4%, respectively (M-H OR 1.10, 95% CI 0.67 to 1.81; I2 = 0%; moderate-quality evidence). No difference in mortality between the control and LMWH group was found, 3.8% and 3.9%, respectively (M-H OR 1.15, 95% CI 0.72 to 1.84; moderate-quality evidence). Estimates of heterogeneity ranged between 0% and 28% depending on the analysis, suggesting low or unimportant heterogeneity. Prolonged thromboprophylaxis with LMWH significantly reduces the risk of VTE compared to thromboprophylaxis during hospital admittance only, without increasing bleeding complications or mortality after major abdominal or pelvic surgery. This finding also holds true for DVT alone, and for both proximal and symptomatic DVT. The quality of the evidence is moderate and provides moderate support for routine use of prolonged thromboprophylaxis. Given the low heterogeneity between studies and the consistent and moderate evidence of a decrease in risk for VTE, our findings suggest that additional studies may help refine the degree of risk reduction but would be unlikely to significantly influence these findings. This updated review provides additional evidence and supports the previous results reported in the 2009 review.\nOutput:\n" }, { "from": "agent", "value": "Seven studies were found that addressed this question, including a total of 1728 patients. Continuing blood thinning injections after hospital discharge decreased the risk of both blood clots in the limbs and in the lungs. This review determined that the overall incidence of having a blood clot is reduced from 13.2%, when no post-discharge blood thinner injections are used, to 5.3% when a blood thinner injection is prescribed for at least 14 days following discharge in 30 days follow-up. Both symptomatic and asymptomatic blood clots decreased with the use of prolonged duration blood thinner injections in postoperative patients. No increase in bleeding complications or death, common concerns when blood thinners are used, were observed in patients treated with prolonged duration blood thinner injections. Continuation of blood thinning injections for at least 14 days after abdominal or pelvic surgery reduces the risk of blood clots." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Of 157 records reviewed, 16 were included, representing five trials. In general, the studies were small and had inconsistent methodological rigor. Overall, the quality of evidence was rated as low. Each study used a different MOIT protocol. A total of 196 patients were studied (106 MOIT, 90 control) and all were children. Three studies were blinded and two used an avoidance diet control.  Sixty-six patients (62%) in the MOIT group were able to tolerate a full serving of milk (about 200 mL) compared to seven (8%) of the control group (RR 6.61, 95% CI 3.51 to 12.44). In addition, 27 (25%) in the MOIT group could ingest a partial serving of milk (10 to 184 mL) while none could in the control group (RR 9.34, 95% CI 2.72 to 32.09). None of the studies assessed the patients following a period off immunotherapy. Adverse reactions were common (97 of 106 MOIT patients had at least one symptom), although most were local and mild. Because of variability in reporting methods, adverse effects could not be combined quantitatively. For every 11 patients receiving MOIT, one required intramuscular epinephrine. One patient required it on two occasions. Studies to date have involved small numbers of patients and the quality of evidence is generally low. The current evidence shows that MOIT can lead to desensitization in the majority of individuals with IMCMA although the development of long-term tolerance has not been established. A major drawback of MOIT is the frequency of adverse effects, although most are mild and self-limited. The use of parenteral epinephrine is not infrequent. Because there are no standardized protocols, guidelines would be required prior to incorporating desensitization into clinical practice.\nOutput:\n" }, { "from": "agent", "value": "We identified randomized controlled trials that compared oral immunotherapy to placebo or continued avoidance diet in children and adults with cow's milk allergy. Five studies satisfied our inclusion criteria. In total there were 196 participants (106 in the treatment group and 90 in the control), all of whom were children. In general, the quality of the studies was low. Because the trials involved small numbers and there were problems with the way they were done, further research is needed. The current evidence shows that oral immunotherapy can help a majority of allergic children tolerate a full serving of milk, as long as they continue drinking this amount each day. However, it is not known if this protection is continued if the immunotherapy is stopped for some time. Side effects during oral immunotherapy are frequent and most patients will have at least some mild symptoms. In the studies we included, for every 11 patients who received oral immunotherapy, one needed to be treated with epinephrine injection at some point for a serious allergic reaction to the therapy." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included five randomised controlled trials (RCTs) with 232 participants comparing haloperidol discontinuation with haloperidol continuation. Discontinuation was achieved in all five studies by replacing haloperidol with placebo. The trials' size ranged between 23 and 87 participants. The methods of randomisation, allocation concealment and blinding were poorly reported. Participants allocated to discontinuing haloperidol treatment were more likely to show no improvement in global state compared with those in the haloperidol continuation group (n = 49; 1 RCT; RR 2.06, 95% CI 1.33 to 3.20; very low quality evidence: our confidence in the effect estimate is limited due to relevant methodological shortcomings of included trials). Those who continued haloperidol treatment were less likely to experience a relapse compared to people who discontinued taking haloperidol (n = 165; 4 RCTs; RR 1.80, 95% CI 1.18 to 2.74; very low quality evidence). Satisfaction with treatment (measured as numbers leaving the study early) was similar between groups (n = 43; 1 RCT; RR 0.13, 95% CI 0.01 to 2.28; very low quality evidence). No usable mental state, general functioning, general behaviour or adverse effect data were reported by any of the trials. This review provides limited evidence derived from small, short-term studies. The longest study was for one year, making it difficult to generalise the results to a life-long disorder. Very low quality evidence shows that discontinuation of haloperidol is associated with an increased risk of relapse and a reduction in the risk of 'global state improvement'. However, participant satisfaction with haloperidol treatment was not different from participant satisfaction with haloperidol discontinuation as measured by leaving the studies early. Due to the very low quality of these results, firm conclusions cannot be made. In addition, the available studies did not report usable data regarding the adverse effects of haloperidol treatment. Considering that haloperidol is one of the most widely used antipsychotic drugs, it was surprising that only a small number of studies into the benefit and harm of haloperidol discontinuation were available. Moreover, the available studies did not report on outcomes that are important to clinicians and to people with schizophrenia, particularly adverse effects and social outcomes. Better designed trials are warranted.\nOutput:\n" }, { "from": "agent", "value": "We ran electronic searches of Cochrane Schizophrenia's trial register, most recently on 24 January 2019, for trials that randomised people with schizophrenia and are stable on haloperidol treatment to either discontinue taking haloperidol or to continue taking haloperidol. The review authors found and checked 54 records. Five trials met the review requirements and provided usable data. The evidence currently available from randomised controlled trials is of very low quality and suggests that haloperidol discontinuation is associated with poorer outcomes for people with schizophrenia in terms of their overall symptom improvement (global state). It also shows that people discontinuing haloperidol treatment are more likely to experience relapse (reoccurrence of symptoms) during the first year post treatment. There were no trials providing evidence on what happens after the first year. The number of participants leaving the study early (which can be an indication of satisfaction with treatment) was similar between the two treatments. The very low quality of the currently available evidence is due to methodological shortcomings of the included trials. This lowers our confidence in the reliability of results, and hampers their generalisability to real-world situations. It is disappointing that only a small number of studies were identified, and the size and quality of these studies were limited. The evidence available does not enable us to fully answer important questions regarding the effects of discontinuing haloperidol treatment. In particular there is no evidence available related to the side effects of haloperidol. New trials of better quality are needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 11 studies (2635 women) in the review. Six trials compared carbetocin with oxytocin; four of these were conducted for women undergoing caesarean deliveries, one was for women following vaginal deliveries and one did not state the mode of delivery clearly. The carbetocin was administered as 100 µg intravenous dosage across the trials, while oxytocin was administered intravenously but at varied dosages. Four trials compared intramuscular carbetocin and intramuscular syntometrine for women undergoing vaginal deliveries. Three of the trials were on women with no risk factor for PPH, while one trial was on women with risk factors for PPH. One trial compared the use of intravenous carbetocin with placebo. Use of carbetocin resulted in a statistically significant reduction in the need for therapeutic uterotonics (risk ratio (RR) 0.62; 95% confidence interval (CI) 0.44 to 0.88; four trials, 1173 women) compared to oxytocin for those who underwent caesarean section, but not for vaginal delivery. Compared to oxytocin, carbetocin was associated with a reduced need for uterine massage following both caesarean delivery (RR 0.54; 95% CI 0.37 to 0.79; two trials, 739 women) and vaginal delivery (RR 0.70; 95% CI 0.51 to 0.94; one trial, 160 women). There were no statistically significant differences between carbetocin and oxytocin in terms of risk of any PPH (blood loss greater than 500 ml) or in risk of severe PPH (blood loss greater than 1000 ml). Comparison between carbetocin and syntometrine showed a lower mean blood loss in women who received carbetocin compared to syntometrine (mean difference (MD) -48.84 ml; 95% CI -94.82 to -2.85; four trials, 1030 women). There was no statistically significant difference in terms of the need for therapeutic uterotonic agents, but the risk of adverse effects such as nausea and vomiting were significantly lower in the carbetocin group: nausea (RR 0.24; 95% CI 0.15 to 0.40; four trials, 1030 women); vomiting (RR 0.21; 95% CI 0.11 to 0.39; four trials, 1030 women). The incidence of postpartum hypertension was also significantly lower in women who received carbetocin compared to those who received syntometrine. Cost-effectiveness of carbetocin was investigated by one study published as an abstract, with limited data. For women who undergo caesarean section, carbetocin resulted in a statistically significant reduction in the need for therapeutic uterotonics compared to oxytocin, but there is no difference in the incidence of postpartum haemorrhage. Carbetocin is associated with less blood loss compared to syntometrine in the prevention of PPH for women who have vaginal deliveries and is associated with significantly fewer adverse effects. Further research is needed to analyse the cost-effectiveness of carbetocin as a uterotonic agent.\nOutput:\n" }, { "from": "agent", "value": "This review includes 11 randomised controlled trials involving 2635 women. The trials compared carbetocin against either oxytocin or syntometrine given after delivery, vaginally or by caesarean section. The comparison between intramuscular carbetocin and oxytocin showed that there was no difference in the risk of heavy bleeding, but that women who received carbetocin were less likely to require other medications to produce uterine contractions following caesarean sections. Comparisons between carbetocin and syntometrine showed that women who received carbetocin had less blood loss compared to women who received syntometrine after vaginal delivery, and were much less likely to experience side effects such as nausea and vomiting. The incidence of hypertension at 30 and 60 minutes post delivery was also significantly lower in women who received carbetocin compared to those who received syntometrine. Five of the 11 studies were known to be supported by a pharmaceutical company." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: From the 12,966 citations screened, we assessed 26 full-text articles and included five RCTs (643 participants). Low-quality evidence from the meta-analysis performed on two trials using the Oswestry Disability Index (pain-related disability) to compare direct decompression with or without fusion versus multi-modal non-operative care showed no significant differences at six months (mean difference (MD) -3.66, 95% confidence interval (CI) -10.12 to 2.80) and at one year (MD -6.18, 95% CI -15.03 to 2.66). At 24 months, significant differences favoured decompression (MD -4.43, 95% CI -7.91 to -0.96). Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care (bracing and exercise) at three months (risk ratio (RR) 1.38, 95% CI 0.22 to 8.59), four years (RR 7.50, 95% CI 1.00 to 56.48) and 10 years (RR 4.09, 95% CI 0.95 to 17.58). Low-quality evidence from one small study suggested no differences at six weeks in the Oswestry Disability Index for patients treated with minimally invasive mild decompression versus those treated with epidural steroid injections (MD 5.70, 95% CI 0.57 to 10.83; 38 participants). Zurich Claudication Questionnaire (ZCQ) results were better for epidural injection at six weeks (MD -0.60, 95% CI -0.92 to -0.28), and visual analogue scale (VAS) improvements were better in the mild decompression group (MD 2.40, 95% CI 1.92 to 2.88). At 12 weeks, many cross-overs prevented further analysis. Low-quality evidence from a single study including 191 participants favoured the interspinous spacer versus usual conservative treatment at six weeks, six months and one year for symptom severity and physical function. All remaining studies reported complications associated with surgery and conservative side effects of treatment: Two studies reported no major complications in the surgical group, and the other study reported complications in 10% and 24% of participants, including spinous process fracture, coronary ischaemia, respiratory distress, haematoma, stroke, risk of reoperation and death due to pulmonary oedema. We have very little confidence to conclude whether surgical treatment or a conservative approach is better for lumbar spinal stenosis, and we can provide no new recommendations to guide clinical practice. However, it should be noted that the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. No clear benefits were observed with surgery versus non-surgical treatment. These findings suggest that clinicians should be very careful in informing patients about possible treatment options, especially given that conservative treatment options have resulted in no reported side effects. High-quality research is needed to compare surgical versus conservative care for individuals with lumbar spinal stenosis.\nOutput:\n" }, { "from": "agent", "value": "Study characteristics: We included five studies that compared surgical versus non-surgical treatment in a total of 643 people with lumbar spinal stenosis. Average age of participants in all studies was over 59 years. Follow-up periods ranged from six weeks to 10 years. Key results: We cannot conclude on the basis of this review whether surgical or non-surgical treatment is better for individuals with lumbar spinal stenosis. Nevertheless, we can report on the high rate of effects reported in three of five surgical groups, ranging from 10% to 24%. No side effects were reported for any of the conservative treatment options. Three studies compared spine surgery versus various types of non-surgical treatment. It is difficult for review authors to draw conclusions from these studies because non-surgical treatments were inadequately described. One study that compared surgery versus bracing and exercise found no differences in pain. Another study compared surgery versus spinal injections and found better physical function with injections, and better pain relief with surgery at six weeks. Still another trial compared surgery with an implanted device versus non-surgical care. This study reported favourable outcomes of surgery for symptoms and physical function. Quality of the evidence: Evidence obtained by comparing surgery versus non-surgical treatment is of low quality. Well-designed studies are needed to examine this problem. In particular, researchers need to do a better job of describing the details of non-surgical treatments." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included three RCTs, one from New Zealand, one from Japan and one from China, published between 2015 and 2019. Together, these trials enrolled 114 adults (228 eyes). Two studies used a paired-eye (inter-eye comparison) design to evaluate the effects of a sham (control) IPL treatment relative to an actual IPL treatment. One study randomised individuals to either an IPL intervention combined with meibomian gland expression (MGX), or MGX alone (standard therapy). The study follow-up periods ranged from 45 days to nine months. None of the trials were at low risk of bias in all seven domains. The first authors of two included studies were in receipt of funding from patents or the manufacturers of IPL devices. The funding sources and declaration of interests were not given in the report of the third included trial. All three trials evaluated the effect of IPL on dry eye symptoms, quantified using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. Pooling data from two trials that used a paired-eye design, the summary estimate for these studies indicated little to no reduction in dry eye symptoms with IPL relative to a sham intervention (mean difference (MD) –0.33 units, 95% confidence interval (CI) –2.56 to 1.89; I² = 0%; 2 studies, 144 eyes). The other study was not pooled as it had a unit-of-analysis error, but reported a reduction in symptoms in favour of IPL (MD –4.60, 95% CI –6.72 to –2.48; 84 eyes). The body of evidence for this outcome was of very low certainty, so we are uncertain about the effect of IPL on dry eye symptoms. There were no relevant combinable data for any of the other secondary outcomes, thus the effect of IPL on clinical parameters relevant to dry eye disease are currently unclear. For sodium fluorescein TBUT, two studies indicated that there may be an improvement in favour of IPL (MD 2.02 seconds, 95% CI 0.87 to 3.17; MD 2.40 seconds, 95% CI 2.27 to 2.53; 172 eyes total; low-certainty evidence). We are uncertain of the effect of IPL on non-invasive tear break-up time (MD 5.51 seconds, 95% CI 0.79 to 10.23; MD 3.20, 95% CI 3.09 to 3.31 seconds; two studies; 140 eyes total; very low-certainty evidence). For tear osmolarity, one study indicated that there may be an improvement in favour of IPL (MD –7.00 mOsmol/L, 95% –12.97 to –1.03; 56 eyes; low-certainty evidence). We are uncertain of the effect of IPL on meibomian gland orifice plugging (MD –1.20 clinical units, 95% CI –1.24 to –1.16; 84 eyes; very low-certainty evidence). We are uncertain of the effect of IPL on corneal sodium fluorescein staining. One study reported no evidence of a difference between the IPL and sham intervention arms at three months of follow-up (P = 0.409), and a second study reported data favouring IPL (MD –1.00 units, 95% CI –1.07 to –0.93 units; 172 eyes in total; very low-certainty evidence). We considered the incidence of adverse events at the study endpoint, as a measure of safety. As most trials did not specifically report adverse events, the safety of IPL as a treatment for MGD could also not be determined with any certainty. Very low-certainty results from individual studies suggest some adverse effects that may be experienced by participants, include mild pain and burning, and the potential for partially losing eyelashes (due to clinician error). This systematic review finds a scarcity of RCT evidence relating to the effectiveness and safety of IPL as a treatment for MGD. Whether IPL is of value for modifying the symptoms or signs of evaporative dry eye disease is currently uncertain. Due to a lack of comprehensive reporting of adverse events, the safety profile of IPL in this patient population is also unclear. The current limitations in the evidence base should be considered by clinicians using this intervention to treat MGD, and outlined to individuals potentially undergoing this procedure with the intent of treating dry eye disease. The results of the 14 RCTs currently in progress will be of major importance for establishing a more definitive answer regarding the effectiveness and safety of IPL for treating MGD. We intend to update this review when results from these trials become available.\nOutput:\n" }, { "from": "agent", "value": "we searched for studies that had been published up to 1 August 2019. We identified three randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) involving 114 adults (228 eyes) from three countries (New Zealand, Japan and China) that had been published between 2015 and 2019. The maximum time that people in the studies were followed up for after the treatment was nine months. because of very low-quality evidence, we are unclear about the effect of IPL on dry eye symptoms. IPL may be helpful to improve some of the clinical signs of MGD (such as tear stability and tear composition - both signs of how healthy the tears produced by the eye are). We are uncertain about the effect of IPL on meibomian gland blockage or corneal sodium fluorescein staining. As most studies did not report side effects, we are uncertain about the safety of IPL as a treatment for MGD. Very low-quality results from individual studies suggest there may be some side effects, including mild eye pain and burning, and partially losing eyelashes (due to mistakes when using the IPL device). the evidence for how effective and safe IPL is for treating MGD was of low or very low quality. due to limited information in the clinical trials, we could not determine with certainty whether IPL treatment for MGD is effective or safe. The review findings indicate that more research is needed. It is important that eye care clinicians, and people considering having IPL as a dry eye treatment, are aware that there is limited high-quality research to understand whether the procedure is effective or safe." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Our search identified no RCTs investigating the role of increased water intake for the prevention of urinary stone formation in participants with no history of urinary stones (primary prevention). We found one RCT assessing the effects of increased water intake versus standard water intake for the prevention of urinary stone formation in people with a history of urinary stones (secondary prevention). This trial randomised 220 participants (110 participants in the intervention group with increased water intake and 110 in the control group with standard water intake). Increased water intake was defined as achieving a urine volume of at least 2.0 L per day by drinking water. Based on this study, increased water intake may decrease stone recurrences (RR 0.45, 95% CI 0.24 to 0.84; 199 participants; low-certainty evidence); this corresponds to 149 fewer (43 fewer to 205 fewer) stone recurrences per 1000 participants with 270 stone recurrence per 1000 participants over five years in the control group. Increased water intake may also prolong the time to urinary stone recurrence compared to standard water intake (HR 0.40, 95% CI 0.20 to 0.79; 199 participants; low-certainty evidence); based on a stone recurrence rate of 270 per 1000 participants over five years, this corresponds to 152 fewer (209 fewer to 50 fewer) recurrences per 1000 participants. For both outcomes we downgraded the certainty of evidence for study limitations and imprecision. We found no evidence for the outcome of adverse events We found no RCT evidence on the role of increased water intake for primary prevention of urinary stones. For secondary prevention, increased water intake achieving a urine volume of at least 2.0 L/day may reduce urinary stone recurrence and prolong time to recurrence for people with a history of urinary stone disease. However, our confidence in these findings is limited. We did not find evidence for adverse events.\nOutput:\n" }, { "from": "agent", "value": "We examined research published up to October 2019. We included studies which by chance decided whether people were asked to drink more water (to produce at least 2 litres of urine) or were given no special instructions. We found no studies of people who had never had kidney stones. We found one study, performed in 220 people who had calcium-containing stones in the past, but were stone-free when they started the study. The average age was approximately 41 years, and two-thirds of participants were men. We found that drinking more water may reduce the risk of stones coming back. It may also prolong the time it takes for stones to come back. We found no evidence of unwanted effects. The certainty of evidence for both outcomes for which we found evidence was low. This means that the true results may be quite different." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included 15 studies (1722 participants) in the review. There are also four ongoing studies and four studies await classification. The 15 included studies evaluated four comparisons: removable retainers versus fixed retainers (three studies); different types of fixed retainers (four studies); different types of removable retainers (eight studies); and one study compared a combination of upper thermoplastic and lower bonded versus upper thermoplastic with lower adjunctive procedures versus positioner. Four studies had a low risk of bias, four studies had an unclear risk of bias and seven studies had a high risk of bias. Removable versus fixed retainers Thermoplastic removable retainers provided slightly poorer stability in the lower arch than multistrand fixed retainers: MD (Little's Irregularity Index, 0 mm is stable) 0.6 mm (95% CI 0.17 to 1.03). This was based on one trial with 84 participants that was at high risk of bias; it was low quality evidence. Results on retainer failure were inconsistent. There was evidence of less gingival bleeding with removable retainers: RR 0.53 (95% CI 0.31 to 0.88; one trial, 84 participants, high risk of bias, low quality evidence), but participants found fixed retainers more acceptable to wear, with a mean difference on a visual analogue scale (VAS; 0 to 100; 100 being very satisfied) of -12.84 (95% CI -7.09 to -18.60). Fixed versus fixed retainers The studies did not report stability, adverse effects or participant satisfaction. It was possible to pool the data on retention failure from three trials that compared polyethylene ribbon bonded retainer versus multistrand retainer in the lower arch with an RR of 1.10 (95% CI 0.77 to 1.57; moderate heterogeneity; three trials, 228 participants, low quality evidence). There was no evidence of a difference in failure rates. It was also possible to pool the data from two trials that compared the same types of upper fixed retainers, with a similar finding: RR 1.25 (95% CI 0.87 to 1.78; low heterogeneity; two trials, 174 participants, low quality evidence). Removable versus removable retainers One study at low risk of bias comparing upper and lower part-time thermoplastic versus full-time thermoplastic retainer showed no evidence of a difference in relapse (graded moderate quality evidence). Another study, comparing part-time and full-time wear of lower Hawley retainers, found no evidence of any difference in relapse (low quality evidence). Two studies at high risk of bias suggested that stability was better in the lower arch for thermoplastic retainers versus Hawley, and for thermoplastic full-time versus Begg (full-time) (both low quality evidence). In one study, participants wearing Hawley retainers reported more embarrassment more often than participants wearing thermoplastic retainers: RR 2.42 (95% CI 1.30 to 4.49; one trial, 348 participants, high risk of bias, low quality evidence). They also found Hawley retainers harder to wear. There was conflicting evidence about survival rates of Hawley and thermoplastic retainers. Other retainer comparisons Another study with a low risk of bias looked at three different approaches to retention for people with crowding, but normal jaw relationships. The study found that there was no evidence of a difference in relapse between the combination of an upper thermoplastic and lower canine to canine bonded retainer and the combination of an upper thermoplastic retainer and lower interproximal stripping, without a lower retainer. Both these approaches are better than using a positioner as a retainer. We did not find any evidence that wearing thermoplastic retainers full-time provides greater stability than wearing them part-time, but this was assessed in only a small number of participants. Overall, there is insufficient high quality evidence to make recommendations on retention procedures for stabilising tooth position after treatment with orthodontic braces. Further high quality RCTs are needed.\nOutput:\n" }, { "from": "agent", "value": "We searched scientific databases to find all the new evidence up to 26 January 2016. This review updates a previous one published in 2006. We included 15 studies that compared different types of fixed and removable retainers and different durations of wear. There were 1722 participants including adults and children. Nine studies took place in a hospital or university setting, five studies in specialist practice and one in a National Health Service Clinic. The studies evaluated four comparisons: removable retainers versus fixed retainers (three studies); different types of fixed retainers (four studies); different types of removable retainers (eight studies); and one study compared a combination of removable and fixed retainers, use of an adjunctive procedure and a positioner. We also found four ongoing studies and four studies await classification. Most of the evidence was of low quality. One small but well conducted study that compared full-time and part-time wear of thermoplastic retainers did not find evidence of a difference in stability (moderate quality evidence). There is not enough high quality evidence to recommend any one approach to retention over another. Further high-quality studies are needed." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Of twenty eligible studies, ten evaluated breastfeeding and ten evaluated supplemental breast milk. Sixteen studies analysed used heel lance and four used venepuncture as procedure. We noted marked heterogeneity in control intervention and pain assessment measures among the studies. Neonates in the breastfeeding group had statistically a significantly lower increase in heart rate, reduced proportion of crying time and reduced duration of first cry and total crying time compared to positioning (swaddled and placed in a crib), holding by mother, placebo, pacifier use, no intervention or oral sucrose group, or both. Premature Infant Pain Profile (PIPP) scores were significantly lower in the breastfeeding group compared to positioning, placebo or oral sucrose group, or both. However, there was no statistically significant difference in PIPP scores when compared to no intervention. Douleur Aigue Nouveau-ne scores (DAN) were significantly lower in the breastfeeding group compared to the placebo group and the group held in mother's arms, but not when compared to the glucose group. Neonatal Infant Pain Scale (NIPS) was significantly lower in the breastfeeding group compared to the no intervention group, but there was no difference when compared to the oral sucrose group. The Neonatal Facial Coding System (NFCS) was significantly lower in the breastfeeding group when compared to oral glucose, pacifier use, holding by mother and no intervention, but no difference was found when compared to formula feeding. Supplemental breast milk yielded variable results. Neonates in the supplemental breast milk group had a significantly lower increase in heart rate, a reduction in duration of crying and a lower NFCS compared to the placebo group. Neonates in the supplemental breast milk group had a significantly higher increase in heart rate changes when compared to the sucrose group. Sucrose (in any concentration, i.e. 12.5%, 20%, 25%) was found to reduce the duration of cry when compared to breast milk, as did glycine, pacifier use, rocking, or no intervention. Breast milk was found not to be effective in reducing validated and non-validated pain scores such as NIPS, NFCS, and DAN; only being significantly better when compared to placebo (water) or massage. We did not identify any study that has evaluated safety/effectiveness of repeated administration of breastfeeding or supplemental breast milk for pain relief. If available, breastfeeding or breast milk should be used to alleviate procedural pain in neonates undergoing a single painful procedure rather than placebo, positioning or no intervention. Administration of glucose/sucrose had similar effectiveness as breastfeeding for reducing pain. The effectiveness of breast milk for painful procedure should be studied in the preterm population, as there are currently a limited number of studies in the literature that have assessed it's effectiveness in this population.\nOutput:\n" }, { "from": "agent", "value": "Different studies done in babies have shown that breastfeeding is a good way to reduce the pain babies feel when subjected to minor painful procedures. These studies have been done in full-term babies and they have shown that breastfeeding is effective by demonstrating that it reduces babies' crying time and reduces different pain scores that have been validated for babies. Breast milk given by syringe has not shown the same efficacy as breastfeeding itself. No studies have been done in premature babies, and so new studies are needed to determine if the use of supplemental breast milk in these small babies is effective in reducing their pain." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included seven trials (1789 participants). Four studies had high risk of bias and the risk of bias in the other three trials was unclear. In addition, it was difficult to assess possible reporting bias. We pooled 1070 participants from four RCTs to evaluate corporal atrophy development revealing an insignificantly increased OR of 1.50 (95% CI 0.59 to 3.80; P value = 0.39; low-quality evidence) for long-term PPI users relative to non-PPI users. In five eligible trials, corporal intestinal metaplasia was assessed among 1408 participants, also with uncertain results (OR 1.46; 95% CI 0.43 to 5.03; P value = 0.55; low-quality evidence). However, by pooling data of 1705 participants from six RCTs, our meta-analysis showed that participants with PPI maintenance treatment were more likely to experience either diffuse (simple) (OR 5.01; 95% CI 1.54 to 16.26; P value = 0.007; very-low-quality evidence) or linear/micronodular (focal) ECL hyperplasia (OR 3.98; 95% CI 1.31 to 12.16; P value = 0.02; low-quality evidence) than controls. No participant showed any dysplastic or neoplastic change in any included studies. There is presently no clear evidence that the long-term use of PPIs can cause or accelerate the progression of corpus gastric atrophy or intestinal metaplasia, although results were imprecise. People with PPI maintenance treatment may have a higher possibility of experiencing either diffuse (simple) or linear/micronodular (focal) ECL cell hyperplasia. However, the clinical importance of this outcome is currently uncertain.\nOutput:\n" }, { "from": "agent", "value": "We searched databases in August 2013 for randomised controlled trials (clinical trials where people are randomly allocated to one of two or more treatment groups) conducted in adults (aged 18 years or over) who did not have gastric cancer at the start of the trial. Treatment had to be with PPI for six months or more and be compared with no treatment, surgery/endoscopic treatment (where a tube is passed down the food pipe and into the stomach), or any other antacid treatment. We found seven randomised controlled trials with 1789 participants. Some trials only partially reported gastric pre-cancerous lesions, and there was a substantial proportion of participants with missing data. We concluded that there was no clear evidence to support the notion that the long-term use of PPIs could promote the development of pre-cancerous lesions. However, there was a potentially elevated risk of developing a thickening of the stomach lining (hyperplasia) among participants with long-term PPI use, which is considered as a possible pre-condition of gastric carcinoid (a relatively benign (non-cancerous) tumour that develops within the stomach lining). Currently, available evidence was of low or very low quality, due to their study design and the large proportion of missing data. We therefore suggest future well-designed clinical trials should be performed for providing better understandings regarding this question." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: Seven trials met the inclusion criteria and had a total of 4526 women. Five were multi-site studies. Four trials were conducted in the USA, while Nigeria and Zambia were represented by one study each, and one trial was done in both Jamaica and India. Two trials provided multiple sessions for participants. In one study that examined contraceptive choice, women in the expanded program were more likely to choose sterilization (OR 4.26; 95% CI 2.46 to 7.37) or use a modern contraceptive method (OR 2.35; 95% CI 1.82 to 3.03), i.e., sterilization, pills, injectable, intrauterine device or barrier method. For the other study, the groups received educational interventions with differing format and intensity. Both groups reportedly had increases in contraceptive use, but they did not differ significantly by six months in consistent use of an effective contraceptive, i.e., sterilization, IUD, injectable, implant, and consistent use of oral contraceptives, diaphragm, or male condoms. Five trials provided one session and focused on testing educational material or media. In one study, knowledge gain favored a slide-and-sound presentation versus a physician's oral presentation (MD -19.00; 95% CI -27.52 to -10.48). In another trial, a table with contraceptive effectiveness categories led to more correct answers than a table based on pregnancy numbers [ORs were 2.42 (95% CI 1.43 to 4.12) and 2.19 (95% CI 1.21 to 3.97)] or a table with effectiveness categories and pregnancy numbers [ORs were 2.58 (95% CI 1.5 to 4.42) and 2.03 (95% CI 1.13 to 3.64)]. Still another trial provided structured counseling with a flipchart on contraceptive methods. The intervention and usual-care groups did not differ significantly in choice of contraceptive method (by effectiveness category) or in continuation of the chosen method at three months. Lastly, a study with couples used videos to communicate contraceptive information (control, motivational, contraceptive methods, and both motivational and methods videos). The analyses showed no significant difference between the groups in the types of contraceptives chosen. These trials varied greatly in the types of participants and interventions to communicate contraceptive effectiveness. Therefore, we cannot say overall what would help consumers choose an appropriate contraceptive method. For presenting pregnancy risk data, one trial showed that effectiveness categories were better than pregnancy numbers. In another trial, audiovisual aids worked better than the usual oral presentation. Strategies should be tested in clinical settings and measured for their effect on contraceptive choice. More detailed reporting of intervention content would help in interpreting results. Reports could also include whether the instruments used to assess knowledge or attitudes were tested for validity or reliability. Follow-up should be incorporated to assess retention of knowledge over time. The overall quality of evidence was considered to be low for this review, given that five of the seven studies provided low or very low quality evidence.\nOutput:\n" }, { "from": "agent", "value": "Through February 2013, we did computer searches for randomized trials of ways to inform people about how well family planning methods prevent pregnancy. We wrote to researchers to find other trials. The new program could be compared to the usual practice or to another program or means of informing people. We found seven trials with a total of 4526 women. Two had several sessions for participants. One of those looked at the choice of birth control method. Women in the test program more often chose to be sterilized or to use modern birth control than women with the usual counseling. In the other study, the groups had different sessions on family planning. Both groups increased their birth control use. However, the groups were similar at six months in using methods that work well to prevent pregnancy. Five trials had a single session for each group. In one, women learned more from a slide-and-sound format than from having a doctor talk to them. Another trial found that effectiveness categories were better than pregnancy numbers for comparing the methods. Still another study provided structured counseling using a flipchart on family planning methods. The groups were similar in choice of birth control and in numbers who still used their chosen method at three months. The last study used videos to inform couples about family planning. The groups were mostly similar in birth control use after the videos. But those who watched videos on motivation and on family planning did not choose pills or an injectable method as often as those who watched only the family planning video. The studies had different types of participants and programs. We cannot say overall what would help consumers choose their method of birth control. Ways to inform women about family planning options should be tested in clinics. Trials should look at the choice of birth control method, along with how much consumers remember later." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: This updated review includes a total of 24 studies (six cross-over studies, 11 parallel group studies with two arms; five with three arms, and two studies with a factorial design) with a total of 4473 participants. Ten studies were included in the 2008 update, and 14 studies have been added to this update. Thirteen studies (2380 participants) evaluated cranberry juice/concentrate; nine studies (1032 participants) evaluated cranberry tablets or capsules; one study compared cranberry juice and tablets; and one study compared cranberry capsules and tablets. The comparison/control arms were placebo, no treatment, water, methenamine hippurate, antibiotics, or lactobacillus. Eleven studies were not included in the meta-analyses because either the design was a cross-over study and data were not reported separately for the first phase, or there was a lack of relevant data. Data included in the meta-analyses showed that, compared with placebo, water or not treatment, cranberry products did not significantly reduce the occurrence of symptomatic UTI overall (RR 0.86, 95% CI 0.71 to 1.04) or for any the subgroups: women with recurrent UTIs (RR 0.74, 95% CI 0.42 to 1.31); older people (RR 0.75, 95% CI 0.39 to 1.44); pregnant women (RR 1.04, 95% CI 0.97 to 1.17); children with recurrent UTI (RR 0.48, 95% CI 0.19 to 1.22); cancer patients (RR 1.15 95% CI 0.75 to 1.77); or people with neuropathic bladder or spinal injury (RR 0.95, 95% CI: 0.75 to 1.20). Overall heterogeneity was moderate (I² = 55%). The effectiveness of cranberry was not significantly different to antibiotics for women (RR 1.31, 95% CI 0.85, 2.02) and children (RR 0.69 95% CI 0.32 to 1.51). There was no significant difference between gastrointestinal adverse effects from cranberry product compared to those of placebo/no treatment (RR 0.83, 95% CI 0.31 to 2.27). Many studies reported low compliance and high withdrawal/dropout problems which they attributed to palatability/acceptability of the products, primarily the cranberry juice. Most studies of other cranberry products (tablets and capsules) did not report how much of the 'active' ingredient the product contained, and therefore the products may not have had enough potency to be effective. Prior to the current update it appeared there was some evidence that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly for women with recurrent UTIs. The addition of 14 further studies suggests that cranberry juice is less effective than previously indicated. Although some of small studies demonstrated a small benefit for women with recurrent UTIs, there were no statistically significant differences when the results of a much larger study were included. Cranberry products were not significantly different to antibiotics for preventing UTIs in three small studies. Given the large number of dropouts/withdrawals from studies (mainly attributed to the acceptability of consuming cranberry products particularly juice, over long periods), and the evidence that the benefit for preventing UTI is small, cranberry juice cannot currently be recommended for the prevention of UTIs. Other preparations (such as powders) need to be quantified using standardised methods to ensure the potency, and contain enough of the 'active' ingredient, before being evaluated in clinical studies or recommended for use.\nOutput:\n" }, { "from": "agent", "value": "This review identified 24 studies (4473 participants) comparing cranberry products with control or alternative treatments. There was a small trend towards fewer UTIs in people taking cranberry product compared to placebo or no treatment but this was not a significant finding. Many people in the studies stopped drinking the juice, suggesting it may not be an acceptable intervention. Cranberry juice does not appear to have a significant benefit in preventing UTIs and may be unacceptable to consume in the long term. Cranberry products (such as tablets or capsules) were also ineffective (although had the same effect as taking antibiotics), possibly due to lack of potency of the 'active ingredient'." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We included ten studies with a total of 1592 patients. Eight included studies reported sufficiently detailed results to enter into analyses related to antidepressant efficacy. We split one study which included two different antidepressants and therefore had nine groups of patients treated with antidepressants compared with nine groups receiving placebo treatment. Information needed to make 'Risk of bias' judgements was often missing. We found high-quality evidence of little or no difference in scores on depression symptom rating scales between the antidepressant and placebo treated groups after 6 to 13 weeks (standardised mean difference (SMD) -0.10, 95% confidence interval (CI) -0.26 to 0.06; 614 participants; 8 studies). There was probably also little or no difference between groups after six to nine months (mean difference (MD) 0.59 point, 95% CI -1.12 to 2.3, 357 participants; 2 studies; moderate-quality evidence). The evidence on response rates at 12 weeks was of low quality, and imprecision in the result meant we were uncertain of any effect of antidepressants (antidepressant: 49.1%, placebo: 37.7%; odds ratio (OR) 1.71, 95% CI 0.80 to 3.67; 116 participants; 3 studies). However, the remission rate was probably higher in the antidepressant group than the placebo group (antidepressant: 40%, placebo: 21.7%; OR 2.57, 95% CI 1.44 to 4.59; 240 participants; 4 studies; moderate-quality evidence). The largest of these studies continued for another 12 weeks, but because of imprecision of the result we could not be sure of any effect of antidepressants on remission rates after 24 weeks. There was evidence of no effect of antidepressants on performance of activities of daily living at weeks 6 to 13 (SMD -0.05, 95% CI -0.36 to 0.25; 173 participants; 4 studies; high-quality evidence) and probably also little or no effect on cognition (MD 0.33 point on the Mini-Mental State Examination, 95% CI -1.31 to 1.96; 194 participants; 6 studies; moderate-quality evidence). Participants on antidepressants were probably more likely to drop out of treatment than those on placebo over 6 to 13 weeks (OR 1.51, 95% CI 1.07 to 2.14; 836 participants; 9 studies). The meta-analysis of the number of participants suffering at least one adverse event showed a significant difference in favour of placebo (antidepressant: 49.2%, placebo: 38.4%; OR 1.55, 95% CI 1.21 to 1.98, 1073 participants; 3 studies), as did the analyses for participants suffering one event of dry mouth (antidepressant: 19.6%, placebo: 13.3%; OR 1.80, 95% CI 1.23 to 2.63, 1044 participants; 5 studies), and one event of dizziness (antidepressant: 19.2%, placebo: 12.5%; OR 2.00, 95% CI 1.34 to 2.98, 1044 participants; 5 studies). Heterogeneity in the way adverse events were reported in studies presented a major difficulty for meta-analysis, but there was some evidence that antidepressant treatment causes more adverse effects than placebo treatment does. The available evidence is of variable quality and does not provide strong support for the efficacy of antidepressants for treating depression in dementia, especially beyond 12 weeks. On the only measure of efficacy for which we had high-quality evidence (depression rating scale scores), antidepressants showed little or no effect. The evidence on remission rates favoured antidepressants but was of moderate quality, so future research may find a different result. There was insufficient evidence to draw conclusions about individual antidepressant drugs or about subtypes of dementia or depression. There is some evidence that antidepressant treatment may cause adverse events.\nOutput:\n" }, { "from": "agent", "value": "We found ten studies with 1592 people to include in the review. On average, the studies lasted only 12 weeks, although one study ran for nine months. Each of them used a set of formal criteria to diagnose both depression and dementia and compared an antidepressant against a dummy pill (placebo). The older studies used more old-fashioned antidepressants (imipramine, clomipramine, and moclobemide) and the newer studies used more modern ones, such as venlafaxine, mirtazapine and so-called SSRI antidepressants (sertraline, fluoxetine, citalopram and escitalopram). The people taking part in the studies had an average age of 75 and they had mild or moderate dementia. With the exception of two studies, they were being treated as outpatients. We found that there was little or no difference in scores on depression rating scales between people treated with antidepressants and those treated with placebo for 12 weeks. The evidence to support this finding was of high quality, which suggests that further research is unlikely to find a different result. There was probably also little or no difference after six to nine months of treatment. Another way to assess the effect of antidepressants is to count the number of people in the antidepressant and placebo groups who show significant clinical improvement (response) or who recover from depression (remission). There was low-quality evidence on the number of people showing a significant clinical improvement and the result was imprecise so we were unable to be sure of any effect on this measure. People taking an antidepressant were probably more likely to recover from depression than were those taking placebo (antidepressant: 40%, placebo: 21.7%). There was moderate-quality evidence for this finding, so it is possible that further research could find a different result. We found that antidepressants did not affect the ability to manage daily activities and probably had little or no effect on a test of cognitive function (which includes attention, memory, and language). People taking an antidepressant were probably more likely to drop out of treatment and to have at least one unwanted side effect. The quality of the evidence varied, mainly due to poorly conducted studies and problems with the relevance of the outcome measures used. This should be taken into consideration when interpreting the different results on depression rating scales and recovery rates, as evidence was of a higher quality for the former than for the latter. Another major problem is that side effects are very rarely well-reported in studies. Therefore, further research will still be useful to reach conclusions that are more reliable and can better help doctors and patients to know what works for whom." } ]

[ { "from": "human", "value": "***TASK***\nthe task is to simplify the input abstract of a biomedical literature\n\n***INPUT***\nthe input is the abstract of a biomedical literature\n\n***OUTPUT***\nthe output is the simplified abstract for the input abstract of a biomedical literature\n\n***DOCUMENTATION***\n\n***EXAMPLES***\n\nInput: We found six randomised, double-blind trials of at least two weeks' duration eligible for inclusion. These trials included 460 participants with neuropathic pain, with most participants having painful diabetic neuropathy. Four studies were of cross-over design and two were parallel trials. Only one trial was both parallel design and placebo-controlled. Mean age of participants ranged from 48 to 59 years. In three studies (Forssell 2004, Jia 2006 and Tasmuth 2002), only mean data were reported. Comparators included placebo, imipramine, and carbamazepine and duration of treatment ranged from two to eight weeks. The risk of bias was considerable overall in the review, especially due to the small size of most studies and due to attrition bias. Four of the six studies reported some positive benefit for venlafaxine. In the largest study by Rowbotham, 2004, 56% of participants receiving venlafaxine 150 to 225 mg achieved at least a 50% reduction in pain intensity versus 34% of participants in the placebo group and the number needed to treat for an additional beneficial outcome was 4.5. However, this study was subject to significant selection bias. Known adverse effects of venlafaxine, including somnolence, dizziness, and mild gastrointestinal problems, were reported in all studies but were not particularly problematic and, overall, adverse effects were equally prominent in placebo or other active comparator groups. We found little compelling evidence to support the use of venlafaxine in neuropathic pain. While there was some third-tier evidence of benefit, this arose from studies that had methodological limitations and considerable risk of bias. Placebo effects were notably strong in several studies. Given that effective drug treatments for neuropathic pain are in current use, there is no evidence to revise prescribing guidelines to promote the use of venlafaxine in neuropathic pain. Although venlafaxine was generally reasonably well tolerated, there was some evidence that it can precipitate fatigue, somnolence, nausea, and dizziness in a minority of people.\nOutput:\n" }, { "from": "agent", "value": "In detailed searches of the medical literature, we found six trials that were suitable for inclusion in our analysis, that together included 460 adults. All six trials were conducted in an approved statistical manner (randomised and double-blinded); however, all had limitations that could lead to an overestimation of efficacy in treating this type of pain. Four were of very small size and five were of short duration, both of which can bias the results of chronic pain trials. Although it was not possible to combine the results of all trials to make an overall conclusion, individually they did all show some, albeit moderate, benefit for venlafaxine in treating neuropathic pain. Usually this benefit was achieved at doses of 75 to 225 mg per day. Known side effects of venlafaxine, including sleepiness, dizziness, and mild gastrointestinal problems, were reported by some studies, but were not particularly problematic. Overall, there is currently an inadequate amount of information available to warrant any change in current prescribing practice and we cannot recommend venlafaxine as a first-line treatment for neuropathic pain. However, it is a reasonably well-tolerated drug and may be of some benefit in people who cannot tolerate other antidepressants or anticonvulsant drugs that are more widely prescribed to people with neuropathic pain. Larger clinical trials may provide more robust evidence for the effectiveness of venlafaxine in treating neuropathic pain." } ]