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Clinical NLP Lab 28

[ { "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: Only three trials tested the efficacy of interferon (IFN) beta including a total of 1160 participants (639 treatment, 521 placebo); no trial tested the efficacy of glatiramer acetate (GA). The metanalyses showed that the proportion of patients converting to CDMS was significantly lower in IFN beta-treated than in placebo-treated patients both after one year (pooled OR 0.53; 95% CI, 0.40 to 0.71; p <0.0001) as well as after two years of follow-up (pooled OR 0.52; 95% CI, 0.38 to 0.70; p <0.0001). Early treatment with IFN beta was associated with the side effect profile reported by the randomised controlled trials with this drug. Since side effects were reported with some heterogeneity in the three studies the metanalysis was possible only for the frequency of serious adverse events, not significantly different in IFN beta-treated or placebo-treated patients. The efficacy of IFN beta treatment on preventing the conversion from CIS to CDMS was confirmed over two years of follow-up. Since patients had some clinical heterogeneity (length of follow-up, clinical findings of initial attack), it could be useful for the clinical practice to further analyse the efficacy of IFN beta treatment in different patient subgroups.\nOutput:\n" }, { "from": "agent", "value": "IFN and GA demonstrated only partial efficacy that could be ascribed to the fact that in the studies that lead to their approval they have been initiated in patients with a disease history of several years. The objective of this review was to assess IFN beta and GA efficacy in preventing the conversion to clinically defined multiple sclerosis in patients after the first demyelinating events. Among the pertinent literature, only three studies were found to test the efficacy of IFN beta including a total of 1160 participants (639 under treatment, 521 under placebo); while no published study testing the efficacy of GA was found. The review found that early interferon beta-1a treatment is effective in preventing the conversion of the first isolated demyelinating episodes into clinically definite MS both after one year and two years of follow-up. Side effects and adverse events occurrence was the same as reported by the many studies on IFN beta treatments in MS patients with different levels of the disease. More research is however needed to evaluate the long term preventing efficacy of these drugs and dosages." } ]

[ { "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 24 trials involving 23,748 participants. The quality of the trials varied considerably. The anticoagulants tested were standard unfractionated heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants, and thrombin inhibitors. Over 90% of the evidence relates to the effects of anticoagulant therapy initiated within the first 48 hours of onset. Based on 11 trials (22,776 participants) there was no evidence that anticoagulant therapy started within the first 14 days of stroke onset reduced the odds of death from all causes (odds ratio (OR) 1.05; 95% confidence interval (CI) 0.98 to 1.12) at the end of follow-up. Similarly, based on eight trials (22,125 participants), there was no evidence that early anticoagulation reduced the odds of being dead or dependent at the end of follow-up (OR 0.99; 95% CI 0.93 to 1.04). Although early anticoagulant therapy was associated with fewer recurrent ischaemic strokes (OR 0.76; 95% CI 0.65 to 0.88), it was also associated with an increase in symptomatic intracranial haemorrhages (OR 2.55; 95% CI 1.95 to 3.33). Similarly, early anticoagulation reduced the frequency of symptomatic pulmonary emboli (OR 0.60; 95% CI 0.44 to 0.81), but this benefit was offset by an increase in extracranial haemorrhages (OR 2.99; 95% CI 2.24 to 3.99). Since the last version of the review, no new relevant studies have been published and so there is no additional information to change the conclusions. Early anticoagulant therapy is not associated with net short- or long-term benefit in people with acute ischaemic stroke. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis and pulmonary embolism, but increased bleeding risk. The data do not support the routine use of any of the currently available anticoagulants in acute ischaemic stroke.\nOutput:\n" }, { "from": "agent", "value": "This systematic review was designed to find out whether people treated with anticoagulants soon after having a stroke got better or not, and whether they had problems with bleeding. There is a lot of information in this systematic review - 23,748 people with stroke have been involved in 24 included randomised trials to answer this question. People treated with anticoagulants did not have less long-term disability, and experienced more bleeding. Anticoagulant treated patients had less chance of developing blood clots in their legs and in their lungs following their stroke, but these benefits were offset by the increased number of bleeds. This review did not provide any evidence that the early use of anticoagulants is of overall benefit to people with strokes caused by blood clots. More research is needed to find out if there are ways to select the people with stroke who will benefit from anticoagulants without suffering the bleeding 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: Fifteen studies were included in the review. Studies included children with a range of severe neurological impairments in differing settings, for example, home and critical care. Several different treatment modalities were assessed, and a wide range of outcome measures were used. Most studies used a non-randomised design and included small sample groups. Only four randomised controlled trials were identified. Non-randomised design, lack of information about how participants were selected and who completed outcome measures and incomplete reporting led to high or unclear risk of bias in many studies. Results from low-quality studies suggest that use of non-invasive ventilation, mechanically assisted coughing, high-frequency chest wall oscillation (HFCWO), positive expiratory pressure and supportive seating may confer potential benefits. No serious adverse effects were reported for ventilatory support or airway clearance interventions other than one incident in a clinically unstable child following mechanically assisted coughing. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect for some participants. However, these findings must be considered as tentative and require testing in future randomised trials. This review found no high-quality evidence for any single intervention for the management of respiratory morbidity in children with severe global developmental delay. Our search yielded data on a wide range of interventions of interest. Significant differences in study design and in outcome measures precluded the possibility of meta-analysis. No conclusions on efficacy or safety of interventions for respiratory morbidity in children with severe global developmental delay can be made based upon the findings of this review. A co-ordinated approach to future research is vital to ensure that high-quality evidence becomes available to guide treatment for this vulnerable patient group.\nOutput:\n" }, { "from": "agent", "value": "We carried out a wide database search to look for studies of interventions for the management of breathing problems in children with severe neurological impairment. We found 15 studies of interest, which included a number of different types of treatment. The results showed that several different treatments provided potential benefits, and for most interventions no serious adverse effects were reported. However, the quality of the studies was not good enough to inspire confidence in the findings. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect in some participants. Although some studies looked at the same type of treatment, they used it in different ways or used different measures to assess effectiveness, so we could not put the results together. Of the 15 studies included here, only four used the 'gold standard' study design for health interventions. The remainder of the studies used less robust study designs, which limits the strength of the results. Further well-designed randomised studies including larger numbers of participants are required to guide healthcare professionals to select the most effective 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: Twelve studies with 13 comparisons were included. Four studies compared dietitian with doctor, seven with self-help resources, and only one study was found for dietitian versus nurse and dietitian versus counsellor comparisons. Participants receiving advice from dietitians experienced a greater reduction in blood cholesterol than those receiving advice only from doctors (-0.25 mmol/L (95% CI -0.37, -0.12 mmol/L)). There was no statistically significant difference in change in blood cholesterol between dietitians and self-help resources (-0.10 mmol/L (95% CI -0.22, 0.03 mmol/L)). No statistically significant differences were detected for secondary outcome measures between any of the comparisons with the exception of dietitian versus nurse for HDLc, where the dietitian group showed a greater reduction (-0.06 mmol/L (95% CI -0.11, -0.01)) and dietitian versus counsellor for body weight, where the dietitian group showed a greater reduction (-5.80 kg (95% CI -8.91, -2.69 kg)). Dietitians were better than doctors at lowering blood cholesterol in the short to medium term, but there was no evidence that they were better than self-help resources. There was no evidence that dietitians provided better outcomes than nurses. The results should be interpreted with caution as the studies were not of good quality and the analysis was based on a limited number of trials.\nOutput:\n" }, { "from": "agent", "value": "This review looked at the effectiveness of dietary advice given by dietitians to lower blood cholesterol, compared with the effectiveness of dietary advice given by other types of health professional or using self-help resources. The review found that advice by dietitians to lower blood cholesterol was more effective than that of doctors (in the short to medium term), but possibly not more effective than using self-help resources. There was no evidence to suggest that dietary advice given by dietitians was more effective than that given by nurses." } ]

[ { "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: Eighty-two studies met the inclusion criteria. These showed considerable diversity in the targeted health issue and the aims, content, and outcomes of interventions. The majority were conducted in high income countries (n = 55) but many of these focused on low income and minority populations. The diversity of included studies limited meta-analysis to outcomes for four study groups. These analyses found evidence of moderate quality of the effectiveness of LHWs in promoting immunisation childhood uptake (RR 1.22, 95% CI 1.10 to 1.37; P = 0.0004); promoting initiation of breastfeeding (RR = 1.36, 95% CI 1.14 to 1.61; P < 0.00001), any breastfeeding (RR 1.24, 95% CI 1.10 to 1.39; P = 0.0004), and exclusive breastfeeding (RR 2.78, 95% CI 1.74 to 4.44; P <0.0001); and improving pulmonary TB cure rates (RR 1.22 (95% CI 1.13 to 1.31) P <0.0001), when compared to usual care. There was moderate quality evidence that LHW support had little or no effect on TB preventive treatment completion (RR 1.00, 95% CI 0.92 to 1.09; P = 0.99). There was also low quality evidence that LHWs may reduce child morbidity (RR 0.86, 95% CI 0.75 to 0.99; P = 0.03) and child (RR 0.75, 95% CI 0.55 to 1.03; P = 0.07) and neonatal (RR 0.76, 95% CI 0.57 to 1.02; P = 0.07) mortality, and increase the likelihood of seeking care for childhood illness (RR 1.33, 95% CI 0.86 to 2.05; P = 0.20). For other health issues, the evidence is insufficient to draw conclusions regarding effectiveness, or to enable the identification of specific LHW training or intervention strategies likely to be most effective. LHWs provide promising benefits in promoting immunisation uptake and breastfeeding, improving TB treatment outcomes, and reducing child morbidity and mortality when compared to usual care. For other health issues, evidence is insufficient to draw conclusions about the effects of LHWs.\nOutput:\n" }, { "from": "agent", "value": "A lay health worker is a member of the community who has received some training to promote health or to carry out some healthcare services, but is not a healthcare professional. In the studies in this review, lay health workers carried out different tasks. These included giving help and advice about issues such as child health, child illnesses, and medicine taking. In some studies, lay health workers also treated people for particular health problems. The studies took place in different settings. In many of the studies, lay health workers worked among people on low incomes in wealthy countries, or among people living in poor countries. What the research says The use of lay health workers, compared to usual healthcare services: - probably leads to an increase in the number of women who start to breastfeed their child; who breastfeed their child at all; and who feed their child with breastmilk only; - probably leads to an increase in the number of children who have their immunization schedule up to date; - may lead to slightly fewer children who suffer from fever, diarrhoea and pneumonia; - may lead to fewer deaths among children under five; - may increase the number of parents who seek help for their sick child. The use of lay health workers, compared to people helping themselves or going to a clinic: - probably leads to an increase in the number of people with tuberculosis who are cured; - probably makes little or no difference in the number of people who complete preventive treatment for tuberculosis." } ]

[ { "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 four trials, containing 2018 patients. The subjects were mostly white people (female: 26% to 56%), with a median age of 58 to 66 years. About half of them had histologically proven adenocarcinoma. Of the 2018 patients, 83% to 99% had their status measured using the Eastern Cooperative Oncology Group performance status, and had a score of 0 to 1 (which is usually considered as physically \"fit\"). All four studies provided data on overall survival, progression-free survival, one-year survival rate, objective response rate, and serious adverse events, with two studies (1901 patients) investigating the effect of cetuximab on quality of life as well. The risk of bias was low for the data on overall survival and one-year survival rate, and high for the data on all other outcomes, mainly due to lack of blinding. Compared with chemotherapy alone, chemotherapy plus cetuximab improved overall survival (10.5 months versus 8.9 months; HR 0.87, 95% CI 0.79 to 0.96), one-year survival rate (45% versus 40%; RR 1.13, 95% CI 1.02 to 1.25), and objective response rate (30% versus 23%; RR 1.31, 95% CI 1.14 to 1.51). The difference in progression-free survival was at the limit of the statistical significance (4.9 months versus 4.4 months; HR 0.91, 95% CI 0.83 to 1.00). No significant difference in quality of life between the two treatment arms was reported by the two relevant studies. Patients in the cetuximab group experienced more acneiform rash (11.2% versus 0.3%; RR 37.36, 95% CI 10.66 to 130.95), hypomagnesemia (5.3% versus 0.8%; RR 6.57, 95% CI 1.13 to 38.12), infusion reaction (3.9% versus 1.1%; RR 3.50, 95% CI 1.76 to 6.94), diarrhoea (4.8% versus 2.3%; RR 2.10, 95% CI 1.26 to 3.48), hypokalaemia (6.3% versus 3.6%; RR 1.74, 95% CI 1.02 to 2.99), febrile neutropenia (10.6% versus 7.6%; RR 1.40, 95% CI 1.10 to 1.77), and leukopenia (58.1% versus 42.7%; RR 1.36, 95% CI 1.17 to 1.58) than did those in the control group. The difference in other adverse events did not reach statistical significance. According to the reports of original studies, the adverse events were generally manageable. There were no cetuximab-related deaths. The quality of the evidence is high for overall survival and one-year survival rate, but low for most secondary outcomes. The combination of chemotherapy plus cetuximab is better than chemotherapy alone as the first-line treatment of advanced NSCLC in improving overall survival, while inducing higher rates of some reportedly manageable adverse events.\nOutput:\n" }, { "from": "agent", "value": "This review of 2018 patients, from four trials, found that adding cetuximab (a newly developed agent) to standard treatment, prolonged the survival time of advanced NSCLC patients by about 1.5 months, and deferred the progression of cancer by about 0.5 month. One year after the treatment, 45% of the patients receiving standard treatment plus cetuximab, and 40% of the patients receiving standard treatment alone were still alive. However, the effects of cetuximab on quality of life of patients were uncertain. Seven types of adverse events, mainly involving skin and blood, occurred much more in the patients receiving cetuximab, while other adverse events seemed to occur equally in both groups. The adverse events were reported as generally manageable. No deaths related to cetuximab were reported. In summary, high quality evidence shows that the use of cetuximab combined with standard treatment leads to better survival than standard treatment alone, in improving survival of patients with advanced NSCLC." } ]

[ { "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 studies involving 1257 women met our inclusion criteria. Cord drainage reduced the length of the third stage of labour (mean difference (MD) -2.85 minutes, 95% confidence interval (CI) -4.04 to -1.66; three trials, 1257 women (heterogeneity: T² = 0.87; Chi²P=17.19, I² = 88%)) and reduced the average amount of blood loss (MD -77.00 ml, 95% CI -113.73 to -40.27; one trial, 200 women). No incidence of retained placenta at 30 minutes after birth was observed in the included studies, therefore, it was not possible to compare this outcome. The differences between the cord drainage and the control group were not statistically significant for postpartum haemorrhage or manual removal of the placenta. None of the included studies reported fetomaternal transfusion outcomes and there were no data relating to maternal pain or discomfort during the third stage of labour. There was a small reduction in the length of the third stage of labour and also in the amount of blood loss when cord drainage was applied compared with no cord drainage. The clinical importance of such observed statistically significant reductions, is open to debate. There is no clear difference in the need for manual removal of placenta, blood transfusion or the risk of postpartum haemorrhage. Due to small trials with medium risk of bias, the results should be interpreted with caution.\nOutput:\n" }, { "from": "agent", "value": "This review included three studies involving 1257 birthing women. The findings showed that placental cord drainage in the management of third stage of labour reduced the length of third stage of labour by a mean of about three minutes and reduced blood loss by average of 77 ml. There was no clear difference in the manual removal of placenta or the risk of postpartum haemorrhage or incidence of blood transfusion. The trials did not report on maternal pain or discomfort during the third stage of labour. Some of the outcomes were not reported in the same way in all trials, limiting the amount of information available for analysis. Other desired outcomes were either not reported or were not reported in an appropriate way for statistical analysis (e.g. placenta not delivered within 30 minutes after birth, maternal haemoglobin changes). Further investigation of the effect of placental cord drainage on maternal outcomes would be useful although it is not a priority area for maternity research." } ]

[ { "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 original review was based on nineteen trials (17 published and two unpublished) including 4580 patients. This update includes twenty four trials (21 published, 3 unpublished) and 4921 patients, although due to patient exclusion and differential reporting 61% to 75% were available for the analyses. The review strongly suggests chemoradiation improves overall survival and progression free survival, whether or not platinum was used with absolute benefits of 10% and 13% respectively. There was, however, statistical heterogeneity for these outcomes. There was some evidence that the effect was greater in trials including a high proportion of stage I and II patients. Chemoradiation also showed significant benefit for local recurrence and a suggestion of a benefit for distant recurrence. Acute haematological and gastrointestinal toxicity was significantly greater in the concomitant chemoradiation group. Late effects of treatment were not well reported and so the impact of chemoradiation on these effects could not be determined adequately. Treatment-related deaths were rare. Concomitant chemoradiation appears to improve overall survival and progression-free survival in locally advanced cervical cancer. It also appears to reduce local and distant recurrence suggesting concomitant chemotherapy may afford radiosensitisation and systemic cytotoxic effects. Some acute toxicity is increased, but the long-term side effects are still not clear.\nOutput:\n" }, { "from": "agent", "value": "The effect appeared to be greater in trials including a high proportion of patients with early stage disease. Combined chemotherapy/radiotherapy also delayed tumour recurrence and reduced the risk of re-growth near the original cancer site as well as in other parts of the body. There was an increase in side-effects, principally affecting the blood and bowel, but these generally only lasted a short time. Long-term effects were poorly reported." } ]

[ { "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 open-label randomised controlled trial of 63 neonates was eligible for inclusion. Thirty-three neonates in the propofol group were compared to 30 infants in the morphine-atropine-suxamethonium group. There was no statistically significant difference in the number of infants who required multiple intubation attempts (39% in the propofol group versus 57% in the morphine-atropine-suxamethonium group; RR 1.40, 95% CI 0.85 to 2.29). Times required to prepare medication, to complete the procedure and for recovery to previous clinical status were shorter in the propofol group. No difference in clinically significant side effects was observed; however, the number of events was small. No practice recommendation can be made based on the available evidence regarding the use of propofol in neonates. Further research is needed on the pharmacokinetics of propofol in neonates and once a relatively safe dose is identified, randomised controlled trials assessing the safety and efficacy of propofol are needed.\nOutput:\n" }, { "from": "agent", "value": "Its use in newborn babies is studied in only one study of 63 babies. Propofol helped to reduce time to complete procedure, time of recovery and time to prepare drugs. However, with this small number of newborns studied, the safety can not be proven. Further studies are 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 58 trials, involving 2797 participants, which comprised cardiorespiratory interventions (28 trials, 1408 participants), resistance interventions (13 trials, 432 participants), and mixed training interventions (17 trials, 957 participants). Thirteen deaths occurred before the end of the intervention and a further nine before the end of follow-up. No dependence data were reported. Diverse outcome measures restricted pooling of data. Global indices of disability show moderate improvement after cardiorespiratory training (standardised mean difference (SMD) 0.52, 95% confidence interval (CI) 0.19 to 0.84; P value = 0.002) and by a small amount after mixed training (SMD 0.26, 95% CI 0.04 to 0.49; P value = 0.02); benefits at follow-up (i.e. after training had stopped) were unclear. There were too few data to assess the effects of resistance training. Cardiorespiratory training involving walking improved maximum walking speed (mean difference (MD) 6.71 metres per minute, 95% CI 2.73 to 10.69), preferred gait speed (MD 4.28 metres per minute, 95% CI 1.71 to 6.84), and walking capacity (MD 30.29 metres in six minutes, 95% CI 16.19 to 44.39) at the end of the intervention. Mixed training, involving walking, increased preferred walking speed (MD 4.54 metres per minute, 95% CI 0.95 to 8.14), and walking capacity (MD 41.60 metres per six minutes, 95% CI 25.25 to 57.95). Balance scores improved slightly after mixed training (SMD 0.27, 95% CI 0.07 to 0.47). Some mobility benefits also persisted at the end of follow-up. The variability, quality of the included trials, and lack of data prevents conclusions about other outcomes and limits generalisability of the observed results. Cardiorespiratory training and, to a lesser extent, mixed training reduce disability during or after usual stroke care; this could be mediated by improved mobility and balance. There is sufficient evidence to incorporate cardiorespiratory and mixed training, involving walking, within post-stroke rehabilitation programmes to improve the speed and tolerance of walking; some improvement in balance could also occur. There is insufficient evidence to support the use of resistance training. The effects of training on death and dependence after stroke are still unclear but these outcomes are rarely observed in physical fitness training trials. Cognitive function is under-investigated despite being a key outcome of interest for patients. Further well-designed randomised trials are needed to determine the optimal exercise prescription and identify long-term benefits.\nOutput:\n" }, { "from": "agent", "value": "By February 2015 we identified 58 trials for inclusion in the review. The trials involved at total of 2797 participants at all stages of care including being in hospital or back living at home. Most of the people who took part were able to walk on their own. The trials tested different forms of fitness training; these included 1) cardiorespiratory or 'endurance' training, 2) resistance or 'strength' training, or 3) mixed training, which is a combination of cardiorespiratory plus resistance training. We found that cardiorespiratory fitness training, particularly involving walking, can improve exercise ability and walking after stroke. Mixed training improves walking ability and improves balance. However, there was not enough information to draw reliable conclusions about the impact of fitness training on other areas such as quality of life, mood, or cognitive function. Cognitive function is under-investigated despite being a key outcome of interest for stroke survivors. There was no evidence that any of the different types of fitness training caused injuries or other health problems; exercise appears to be a safe intervention. We need more studies to examine the benefits that are important to stroke survivors, in particular for those with more severe stroke who are unable to walk. Studies of fitness training can be difficult to carry out. This means most of the studies were small and of moderate quality. However, some consistent findings did emerge with different studies all tending to show the same effect." } ]

[ { "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 cluster-RCTs of 111 schools met the review eligibility criteria. Investigators measured outcomes in participating staff and often in children or parents, most often at between 1 and 12 months. All interventions were educational programmes but duration, content and delivery varied; some involved elements of training for pupils or primary care providers. We noted risk of selection, performance, detection and attrition biases, although to a differing extent across studies and outcomes. Quanitative and qualitative analyses were limited. Only one study reported visits to the ED or hospital and provided data that were too skewed for analysis. No studies reported any deaths or adverse events. Studies did not report asthma control consistently, but results showed no difference between groups on the paediatric asthma quality of life questionnaire (mean difference (MD) 0.14, 95% confidence interval (CI) -0.03 to 0.31; 1005 participants; we downgraded the quality of evidence to low for risk of bias and indirectness). Data for symptom days, night-time awakenings, restricted activities of daily living and school absences were skewed or could not be analysed; some mean scores were better in the trained group, but most differences between groups were small and did not persist to 24 months. Schools that received asthma education were more adherent to asthma policies, and staff were better prepared; more schools that had received staff asthma training had written asthma policies compared with control schools, more intervention schools showed improvement in measures taken to prevent or manage exercise-induced asthma attacks and more staff at intervention schools reported that they felt able to administer salbutamol via a spacer. However, the quality of the evidence was low; results show imbalances at baseline, and confidence in the evidence was limited by risk of bias and imprecision. Staff knowledge was higher in groups that had received asthma education, although results were inconsistent and difficult to interpret owing to differences between scales (low quality). Available information about the interventions was insufficient for review authors to conduct a meaningful qualitative synthesis of the content that led to a successful intervention, or of the resources required to replicate results accurately. Asthma education for school staff increases asthma knowledge and preparedness, but studies vary and all available evidence is of low quality. Studies have not yet captured whether this improvement in knowledge has led to appreciable benefits over the short term or the longer term for the safety and health of children with asthma in school. Randomised evidence does not contribute to our knowledge of content or attributes of interventions that lead to the best outcomes, or of resources required for successful implementation. Complete reporting of the content and resources of educational interventions is essential for assessment of their effectiveness and feasibility for implementation. This applies to both randomised and non-randomised studies, although the latter may be better placed to observe important clinical outcomes such as exacerbations and mortality in the longer term.\nOutput:\n" }, { "from": "agent", "value": "We found five studies including more than 100 schools that compared an asthma education programme for school staff against a control. Researchers measured outcomes for teachers and staff, and often for children or parents as well, most often at between 1 and 12 months. We conducted the most recent search for studies on 29 November 2016. We could not tell whether educating school staff reduced the number of children who needed to visit the emergency department (ED) or hospital, and no studies reported any deaths. Study authors measured asthma control in different ways but found little benefit, especially more than a year after the intervention was provided. Schools that received asthma education stuck to asthma policies better and staff were better prepared; more schools that had received staff asthma training had written asthma policies compared with control schools, more intervention schools showed improvement in measures taken to prevent or manage exercise-induced asthma attacks and more staff at intervention schools felt that they were able to administer salbutamol using a spacer. We wanted to assess what the education sessions should cover and how they could best be delivered, but we did not find enough information to do this. To sum up, asthma education for school staff increases asthma knowledge and preparedness in the schools, but we do not know much about actual benefits of this education for children with asthma. The small number of studies and the variation between them mean that we cannot be sure of the overall effect of educating school staff about asthma. The ways researchers allocated schools, teachers or children to groups may have caused some bias. Also, the fact that teachers knew whether they were in the active or control group may have affected how they behaved and answered questionnaires, and this may have led to overestimation of benefits. Lots of people who were included in the studies did not return questionnaires at the end of the study, which means that we do not have a full picture of the results of asthma education 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: Seventeen trials with 1466 women contribute data to the review. Thirteen examined TENS applied to the back, two to acupuncture points, and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (average risk ratio 0.41, 95% confidence interval 0.31 to 0.54; measured in two studies). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No adverse events were reported. There is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact (either positive or negative) on other outcomes for mothers or babies. The use of TENS at home in early labour has not been evaluated. TENS is widely available in hospital settings and women should have the choice of using it in labour.\nOutput:\n" }, { "from": "agent", "value": "The purpose of the review was to see whether TENS is effective in relieving pain in labour. The review includes results from 17 studies with a total of 1466 women. Thirteen studies examined TENS applied to the back, two to acupuncture points and two to the cranium (head). Results show that pain scores were similar in women using TENS and in control groups. There was some evidence that women using TENS were less likely to rate their pain as severe but results were not consistent. Many women said they would be willing to use TENS again in a future labour. TENS did not seem have an effect on the length of labour, interventions in labour, or the well-being of mothers and babies. It is not known whether TENS would help women to manage pain at home in early labour. Although it is not clear that it reduces pain, women should have the choice of using TENS in labour if they think it will be helpful." } ]

[ { "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: Twelve studies, assessed as high (six) and unclear (six) risk of bias, comprising 689 participants (830 fractures), were included. Interventions examined different plate materials and morphology; use of one or two lag screws; microplate versus miniplate; early and delayed mobilization; eyelet wires versus Rapid IMF™ and the management of angle fractures with intraoral access alone or combined with a transbuccal approach. Patient-oriented outcomes were largely ignored and post-operative pain scores were inadequately reported. Unfortunately, only one or two trials with small sample sizes were conducted for each comparison and outcome. Our results and conclusions should therefore be interpreted with caution. We were able to pool the results for two comparisons assessing one outcome. Pooled data from two studies comparing two miniplates versus one miniplate revealed no significant difference in the risk of post-operative infection of surgical site (risk ratio (RR) 1.32, 95% CI 0.41 to 4.22, P = 0.64, I2 = 0%). Similarly, no difference in post-operative infection between the use of two 3-dimensional (3D) and standard (2D) miniplates was determined (RR 1.26, 95% CI 0.19 to 8.13, P = 0.81, I2 = 27%). The included studies involved a small number of participants with a low number of events. This review illustrates that there is currently inadequate evidence to support the effectiveness of a single approach in the management of mandibular fractures without condylar involvement. The lack of high quality evidence may be explained by clinical diversity, variability in assessment tools used and difficulty in grading outcomes with existing measurement tools. Until high level evidence is available, treatment decisions should continue to be based on the clinician's prior experience and the individual circumstances.\nOutput:\n" }, { "from": "agent", "value": "The evidence on which this review is based is up to date as of 28 February 2013. Twelve studies with a combined total of 689 participants were included in this review. Participants ranged in age from 16 to 68 years and most participants (90%) were male. All of the studies compared different types of surgical treatments, and each study evaluated a different aspect of surgical treatment such as different types of plates, screws, or wires or how long the jaw was immobilized after surgery. There were concerns about the design and quality of all the studies. All the studies evaluated different aspects of surgical treatment. None of the studies evaluated non-surgical treatments such as intermaxillary fixation and no study compared surgical treatment with non-surgical treatment. As a result there is no clear evidence to indicate which approach is the best to manage these fractures. The quality of the evidence found is poor. Recommendations are made for further well-conducted research studies in this area to be undertaken." } ]

[ { "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 33 trials with a total of 2293 participants from 0.9 to 12 (mean or median) years of age. Most trials were at low risk of selection, detection, attrition, and reporting bias, however the lack of blinding of participants and personnel caring for participants resulted in 25 trials being judged as at high or unclear risk of bias. We identified five ongoing trials. Ultrasound guidance probably reduces the risk of failed block (risk difference (RD) −0.16, 95% confidence interval (CI) −0.25 to −0.07; 22 trials; 1789 participants; moderate-quality evidence). When ultrasound guidance was used, there was a small to moderate reduction in pain one hour after surgery, equivalent to a reduction of 1.3 points on the revised Bieri FACES pain scale (scale; 0 = no pain, 10 = maximal pain) (standardized mean difference (SMD) −0.41, 95% CI −0.74 to −0.07 (medium effect size); 15 trials; 982 participants; moderate-quality evidence). Ultrasound guidance increases block duration by the equivalent of 42 minutes (SMD 1.24, 95% CI 0.72 to 1.75; 10 trials; 460 participants; high-quality evidence). There is probably little or no difference in the time taken to perform the block (SMD −0.46, 95% CI −1.06 to 0.13; 9 trials; 680 participants; moderate-quality evidence). It is uncertain whether the number of needle passes required is reduced with the use of ultrasound guidance (SMD −0.63, 95% CI −1.08 to −0.18; 3 trials; 256 participants; very low-quality evidence). There were no occurrences of major complications in either the intervention or control arms of the trials (cardiac arrest from local anaesthetic toxicity (22 trials; 1576 participants; moderate-quality evidence); lasting neurological injury (19 trials; 1250 participants; low-quality evidence)). There may be little of no difference in the risk of bloody puncture (RD −0.02, 95% CI −0.05 to 0.00; 13 trials; 896 participants; low-quality evidence) or transient neurological injury (RD −0.00, 95% CI −0.01 to 0.01; 18 trials; 1230 participants; low-quality evidence). There were no occurrences of seizure from local anaesthetic toxicity (22 trials; 1576 participants; moderate-quality evidence) or block infections without neurological injury (18 trials; 1238 participants; low-quality evidence). Ultrasound guidance for regional blockade in children probably decreases the risk of failed block. It increases the duration of the block and probably decreases pain scores at one hour after surgery. There may be little or no difference in the risks of some minor complications. The five ongoing studies may alter the conclusions of the review once published and assessed.\nOutput:\n" }, { "from": "agent", "value": "We included 33 well-designed studies with a total of 2293 children in which ultrasound guidance was compared with another method of nerve localization (traditional landmarks techniques or nerve stimulator) for regional blockade in children. Sources of funding included a government organization (two studies), a charitable organization (two studies), and an institutional department (13 studies). Two studies declared that they received industry help (equipment loan). The source of funding was unclear for 14 studies. Ultrasound guidance for regional blockade in children may decrease the occurrence of failed block. It may also increase duration of the block and reduce pain at one hour after surgery. Ultrasound guidance may decrease the number of needle passes required to perform the block. However, because the vast majority of blocks in children are performed with the child under deep sedation or general anaesthesia, the true value of this finding might be arguable. There were no major complications in the included trials. There may be little or no difference between study groups in risks of minor complications. Altogether, whether or not these findings justify the extra cost of ultrasound guidance should probably also take into account the anaesthesiologist's expertise and local resources. The five ongoing studies may alter the conclusions of the review once published and assessed. We assessed the quality of the evidence as moderate for decreased occurrence of a failed block and improved pain scores at one hour; high for prolonged block duration; and very low for decreased number of needle passes." } ]

[ { "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: Two trials enrolling 54 infants in total, fulfilled the inclusion criteria. Both reported only the short term results (4 to 6 hours) of the interventions. Only one infant (randomised to NCPAP) required intubation during this period. In a cross-over study of 20 infants, Ryan 1989 showed no significant difference in rates of apnea (events/hr) between the two interventions [WMD -0.10 (-0.53,0.33)]. Lin (1998) randomised 34 infants and demonstrated a greater reduction in frequency of apneas (events/hr) with NIPPV compared to NCPAP [WMD -1.19 (-2.31,-0.07)]. Meta-analysis of both trials showed no difference in pC02 (mmHg) at the end of the 4-6 hour study period [WMD 0.95 (-3.05,4.94)]. No data were reported on gastrointestinal complications. Implications for practice: NIPPV may be a useful method of augmenting the beneficial effects of NCPAP in preterm infants with apnea that is frequent or severe. Its use appears to reduce the frequency of apneas more effectively than NCPAP. Additional safety and efficacy data are required before recommending NIPPV as standard therapy for apnea. Implications for research: Future trials with sufficient power should assess the efficacy (reduction in failure of therapy) and safety (GI complications) of NIPPV. Outcomes should be assessed throughout the entire period during which the infant requires assisted ventilation. The recent ability to synchronise NIPPV with an infant's spontaneous respirations is a promising development requiring further assessment.\nOutput:\n" }, { "from": "agent", "value": "This review of two small trials suggests that nasal intermittent positive pressure ventilation (NIPPV) delivered via nasal prongs may be more effective than NCPAP alone in preterm babies whose apneas are frequent or severe. Further research is needed to confirm effectiveness and safety as few babies have been studied so far." } ]

[ { "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 one trial comparing early versus delayed laparoscopic cholecystectomy for people with mild acute pancreatitis. Fifty participants with mild acute gallstone pancreatitis were randomised either to early laparoscopic cholecystectomy (within 48 hours of admission irrespective of whether the abdominal symptoms were resolved or the laboratory values had returned to normal) (n = 25), or to delayed laparoscopic cholecystectomy (surgery after resolution of abdominal pain and after the laboratory values had returned to normal) (n = 25). This trial is at high risk of bias. There was no short-term mortality in either group. There was no significant difference between the groups in the proportion of participants who developed serious adverse events (RR 0.33; 95% CI 0.01 to 7.81). Health-related quality of life was not reported in this trial. There were no conversions to open cholecystectomy in either group. The total hospital stay was significantly shorter in the early laparoscopic cholecystectomy group than in the delayed laparoscopic cholecystectomy group (MD -2.30 days; 95% CI -4.40 to -0.20). This trial reported neither the number of work-days lost nor the costs. We did not identify any trials comparing early versus delayed laparoscopic cholecystectomy after severe acute pancreatitis. There is no evidence of increased risk of complications after early laparoscopic cholecystectomy. Early laparoscopic cholecystectomy may shorten the total hospital stay in people with mild acute pancreatitis. If appropriate facilities and expertise are available, early laparoscopic cholecystectomy appears preferable to delayed laparoscopic cholecystectomy in those with mild acute pancreatitis. There is currently no evidence to support or refute early laparoscopic cholecystectomy for people with severe acute pancreatitis. Further randomised controlled trials at low risk of bias are necessary in people with mild acute pancreatitis and severe acute pancreatitis.\nOutput:\n" }, { "from": "agent", "value": "We identified one trial comparing early versus delayed laparoscopic cholecystectomy for people with mild acute pancreatitis. Out of the 50 participants included in this trial, 25 underwent early laparoscopic cholecystectomy while the remaining 25 underwent delayed laparoscopic cholecystectomy. All 50 participants were alive at the end of the trial. There was no significant difference between the two groups in the proportion of participants who developed complications. Health-related quality of life was not reported in this trial. There were no conversions to open cholecystectomy in either group. The total hospital stay was shorter by approximately two days in the early laparoscopic cholecystectomy group than in the delayed laparoscopic cholecystectomy group. The trial did not report the number of work-days lost or the costs. We did not identify any trials comparing early versus delayed laparoscopic cholecystectomy after severe acute pancreatitis. Based on the observations in the one trial included in this review, there appears to be no evidence of increased risk of complications after early laparoscopic cholecystectomy. Early laparoscopic cholecystectomy may shorten the total hospital stay in people with mild acute pancreatitis. If appropriate facilities and expertise are available, early laparoscopic cholecystectomy appears preferable to delayed laparoscopic cholecystectomy in people with mild acute pancreatitis. There is currently no evidence to support or refute early laparoscopic cholecystectomy for people with severe acute pancreatitis. Further well-designed randomised controlled trials are necessary in people with mild acute pancreatitis and severe acute pancreatitis. The one trial identified is at high risk of bias, i.e. there was potential to arrive at wrong conclusions because of the way that the study was designed and conducted." } ]

[ { "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: There were minimal differences identified between multi-session psychosocial interventions and standard educational interventions for both injection and sexual risk behaviour. Although it should be noted there were large pre-post changes for both groups suggesting both were effective in reducing risk behaviours. In addition, there was some evidence of benefit for multi-session psychosocial interventions when compared with minimal controls. Subgroup analyses suggest that people in formal treatment are likely to respond to multi-session psychosocial interventions. It also appears single-gender groups may be associated with greater benefit. There is limited support for the widespread use of formal multi-session psychosocial interventions for reducing injection and sexual risk behaviour. Brief standard education interventions appear to be a more cost-effective option. Further research is required to assess if there are particular groups of drug users more likely to respond to such interventions.\nOutput:\n" }, { "from": "agent", "value": "There were 35 trials on 11,867 participants that examined whether these interventions are effective in reducing sexual and injection behaviour associated with greater risk of developing HIV. There are not large differences in effectiveness between multi-session psychosocial interventions and briefer interventions. This suggests brief educational interventions are more likely to be cost-effective and may be more readily implemented in a variety of different contexts." } ]

[ { "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: Overall, 10 RCTs with 565 participants which investigated different non-pharmacological interventions for the management of chronic pain in MS fulfilled the review inclusion criteria. The non-pharmacological interventions evaluated included: transcutaneous electrical nerve stimulation (TENS), psychotherapy (telephone self-management, hypnosis and electroencephalogram (EEG) biofeedback), transcranial random noise stimulation (tRNS), transcranial direct stimulation (tDCS), hydrotherapy (Ai Chi) and reflexology. There is very low-level evidence for the use of non-pharmacological interventions for chronic pain such as TENS, Ai Chi, tDCS, tRNS, telephone-delivered self-management program, EEG biofeedback and reflexology in pain intensity in pwMS. Although there were improved changes in pain scores and secondary outcomes (such as fatigue, psychological symptoms, spasm in some interventions), these were limited by methodological biases within the studies. Despite the use of a wide range of non-pharmacological interventions for the treatment of chronic pain in pwMS, the evidence for these interventions is still limited or insufficient, or both. More studies with robust methodology and greater numbers of participants are needed to justify the effect of these interventions for the management of chronic pain in pwMS.\nOutput:\n" }, { "from": "agent", "value": "Overall, we found 10 studies evaluating different non-medication treatments to treat chronic pain in persons with MS. The treatments evaluated included: transcutaneous electrical nerve stimulation, transcranial direct stimulation, transcranial random noise stimulation, reflexology, psychotherapy and hydrotherapy. These studies included 565 participants and used a range of different methods to measure pain and other outcomes. Comparison groups also varied. Results from these studies show a very low level of evidence for the use of any non-medication treatments for chronic pain in persons with MS. We assessed the overall quality of the studies as very low, as many studies included only small numbers of participants and had other methodological issues. More research with good methodological quality and greater number of participants are needed to determine the effectiveness of such 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: Twenty-one trials (n = 3286) were included in the review. Seventeen trials (n = 2617) were included in the meta-analysis. Antispasmodics used included valethamate bromide, hyoscine butyl-bromide, drotaverine hydrochloride, rociverine and camylofin dihydrochloride. Most studies included antispasmodics as part of their package of active management of labour. Overall, the quality of studies was poor, as only four trials were assessed as low risk of bias. Thirteen trials (n = 1995) reported on the duration of first stage of labour, which was significantly reduced by an average of 74.34 minutes when antispasmodics were administered (mean difference (MD) -74.34 minutes; 95% confidence Interval (CI) -98.76 to -49.93). Seven studies (n = 797) reported on the total duration of labour, which was significantly reduced by an average of 85.51 minutes (MD -85.51 minutes; 95% CI -121.81 to -49.20). Six studies (n = 820) had data for the outcome: rate of cervical dilatation. Administration of antispasmodics significantly increased the rate of cervical dilatation by an average of 0.61 cm/hour (MD 0.61 cm/hour; 95% CI 0.34 to 0.88). Antispasmodics did not affect the duration of second and third stage of labour. The rate of normal vertex deliveries was not affected either. Only one study explored pain relief following administration of antispasmodics and no conclusions can be drawn on this outcome. There was significant heterogeneity for most outcomes and therefore, we undertook random-effects meta-analysis. Subgroup analysis was undertaken to explore heterogeneity, but remained largely unexplained. Maternal and neonatal adverse events were reported inconsistently. The main maternal adverse event reported was tachycardia. No serious neonatal adverse events were reported. There is low quality evidence that antispasmodics reduce the duration of first stage of labour and increase the cervical dilatation rate. There is very low quality evidence that antispasmodics reduce the total duration of labour. There is moderate quality evidence that antispasmodics do not affect the rate of normal vertex deliveries. There is insufficient evidence to make any conclusions regarding the safety of these drugs for both mother and baby. Large, rigorous randomised controlled trials are needed to evaluate the effect of antispasmodics on prolonged labour and to evaluate their effect on labour in a context of expectant management of labour.\nOutput:\n" }, { "from": "agent", "value": "Twenty-one randomised controlled studies with a total of 3286 participants were included. The data were combined in an analysis to get an overall result. All types of antispasmodics were given at the beginning of established labour. They decreased the first stage of labour, the time from beginning of labour until the baby is about to be born, by 49 to 98 minutes, as well as the total duration of labour, from the beginning of labour until the delivery of the afterbirth, by 49 to 121 minutes. The drugs did not affect the number of women requiring emergency caesarean sections and did not have serious side effects for either mother or her baby. The most commonly reported adverse events for the mothers were fast heart rates and mouth dryness, but since both maternal and neonatal adverse events were poorly reported, more information is needed to make conclusions about the safety of these drugs during labour. The included studies were mostly of poor quality and good studies are needed to assess what happens when these drugs are given to women whose labour is already prolonged." } ]

[ { "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 seven studies (2185 participants) were included in this review. There was no significant difference in the risk for CMV disease (16 studies, 770 patients: RR 0.80, 95% CI 0.61 to 1.05), CMV infection (14 studies, 775 patients: RR 0.94, 95% CI 0.80 to 1.10) or all-cause mortality (8 studies, 502 patients: RR 0.57, 95% CI 0.32 to 1.03) with IgG compared with placebo/no treatment. However IgG significantly reduced the risk of death from CMV disease (6 studies, 346 patients: RR 0.33, 95% CI 0.14 to 0.80). There was no difference in the risk for CMV disease (4 studies, 298 patients: RR 1.17, 95% CI 0.74 to 1.86), CMV infection (4 studies, 298 patients: RR 1.16, 95% CI 0.89 to 1.52) or all-cause mortality (2 studies, 217 patients: RR 0.92, 95% CI 0.37 to 2.29) between antiviral medication combined with IgG and antiviral medication alone. There was no significant difference in the risk of CMV disease with anti CMV vaccine or interferon compared with placebo or no treatment. Currently there are no indications for IgG in the prophylaxis of CMV disease in recipients of solid organ transplants.\nOutput:\n" }, { "from": "agent", "value": "This review looked at the benefits and harms of IgG, anti CMV vaccines and interferon to prevent CMV disease in solid organ transplant recipients. Thirty seven studies (2185 participants) were identified. This review shows that IgG did not reduce the risk of CMV disease or all-cause mortality compared with placebo or no treatment. The combination of IgG with antiviral medications (aciclovir or ganciclovir) were not more effective than antiviral medications alone in reducing the risk of CMV disease or all-cause mortality. Anti CMV vaccines and interferon did not reduce the risk of CMV disease compared with placebo or no treatment. Currently there are no indications for IgG in the prevention of CMV disease in recipients of solid organ transplants." } ]

[ { "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 36 studies (33 RCTs) with a total of 3523 participants. Included studies were conducted in sub-Saharan Africa, the Middle East and North Africa, and Asia. Studies were implemented in response to armed conflicts; disasters triggered by natural hazards; and other types of humanitarian crises. Together, the 33 RCTs compared eight psychological treatments against a control comparator. Four studies included children and adolescents between 5 and 18 years of age. Three studies included mixed populations (two studies included participants between 12 and 25 years of age, and one study included participants between 16 and 65 years of age). Remaining studies included adult populations (18 years of age or older). Included trials compared a psychological therapy versus a control intervention (wait list in most studies; no treatment; treatment as usual). Psychological therapies were categorised mainly as cognitive-behavioural therapy (CBT) in 23 comparisons (including seven comparisons focused on narrative exposure therapy (NET), two focused on common elements treatment approach (CETA), and one focused on brief behavioural activation treatment (BA)); eye movement desensitisation and reprocessing (EMDR) in two comparisons; interpersonal psychotherapy (IPT) in three comparisons; thought field therapy (TFT) in three comparisons; and trauma or general supportive counselling in two comparisons. Although interventions were described under these categories, several psychotherapeutic elements were common to a range of therapies (i.e. psychoeducation, coping skills). In adults, psychological therapies may substantially reduce endpoint PTSD symptoms compared to control conditions (standardised mean difference (SMD) -1.07, 95% confidence interval (CI) -1.34 to -0.79; 1272 participants; 16 studies; low-quality evidence). The effect is smaller at one to four months (SMD -0.49, 95% CI -0.68 to -0.31; 1660 participants; 18 studies) and at six months (SMD -0.37, 95% CI -0.61 to -0.14; 400 participants; five studies). Psychological therapies may also substantially reduce endpoint depression symptoms compared to control conditions (SMD -0.86, 95% CI -1.06 to -0.67; 1254 participants; 14 studies; low-quality evidence). Similar to PTSD symptoms, follow-up data at one to four months showed a smaller effect on depression (SMD -0.42, 95% CI -0.63 to -0.21; 1386 participants; 16 studies). Psychological therapies may moderately reduce anxiety at endpoint (SMD -0.74, 95% CI -0.98 to -0.49; 694 participants; five studies; low-quality evidence) and at one to four months' follow-up after treatment (SMD -0.53, 95% CI -0.66 to -0.39; 969 participants; seven studies). Dropout rates are probably similar between study conditions (19.5% with control versus 19.1% with psychological therapy (RR 0.98 95% CI 0.82 to 1.16; 2930 participants; 23 studies, moderate quality evidence)). In children and adolescents, we found very low quality evidence for lower endpoint PTSD symptoms scores in psychotherapy conditions (CBT) compared to control conditions, although the confidence interval is wide (SMD -1.56, 95% CI -3.13 to 0.01; 130 participants; three studies;). No RCTs provided data on major depression or anxiety in children. The effect on withdrawal was uncertain (RR 1.87 95% CI 0.47 to 7.47; 138 participants; 3 studies, low quality evidence). We did not identify any studies that evaluated psychological treatments on (symptoms of) somatoform disorders or MUPS in LMIC humanitarian settings. There is low quality evidence that psychological therapies have large or moderate effects in reducing PTSD, depressive, and anxiety symptoms in adults living in humanitarian settings in LMICs. By one to four month and six month follow-up assessments treatment effects were smaller. Fewer trials were focused on children and adolescents and they provide very low quality evidence of a beneficial effect of psychological therapies in reducing PTSD symptoms at endpoint. Confidence in these findings is influenced by the risk of bias in the studies and by substantial levels of heterogeneity. More research evidence is needed, particularly for children and adolescents over longer periods of follow-up.\nOutput:\n" }, { "from": "agent", "value": "In adults, low-quality evidence shows greater benefit from psychological therapies than from control comparators in reducing (symptoms of) PTSD, major depression, and anxiety disorders. This evidence supports the approach of providing psychological therapies to populations affected by humanitarian crises, although we identified no studies that looked at the effectiveness or acceptability of psychological therapies for depressive and anxiety symptoms beyond six months. Only a small proportion of included trials reported data on children and adolescents, which provided very low-quality evidence of greater benefit derived from psychological treatments. With regard to acceptability, moderate- to low-quality evidence suggests no differences in dropout rates among adults and children and adolescents. Reviewers found no studies evaluating psychological treatments for (symptoms of) somatoform disorders or medically unexplained physical symptoms (MUPS) in adults, nor in children or adolescents, respectively. Researchers should conduct higher-quality trials to further evaluate the effectiveness of psychological therapies provided over longer periods to adults and to children and adolescents. Ideally, trials should be randomised, should use culturally appropriate and validated instruments to evaluate outcomes, and should assess correlates of reductions in treatment effects over time; in addition, researchers should make every effort to ensure high rates of follow-up beyond six months after completion of 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: Twelve trials were included in the review. There were seven crossover trials and five parallel group studies. For the comparisons between anticholinergic drugs with tricyclic antidepressants, alpha adrenergic agonists, afferent nerve inhibitors, and calcium channel blocker a single trial was identified for each. Nine trials compared flavoxate with anticholinergics. There was no evidence of a difference in cure rates between anticholinergics and flavoxate. Adverse effects were more frequent in anticholinergic groups versus flavoxate groups (RR 2.28 95% CI 1.45 to 3.56). There was no strong evidence to favour either anticholinergic drugs or the comparators. Many of the drugs considered in trials in this review are no longer used in clinical practice (and this includes the most commonly tested - flavoxate). There is inadequate evidence as to determine whether any of the available druge are better or worse than anticholinergic medications. Larger randomised controlled trials in clinical settings are required to further establish the role of these medications in the management of overactive bladder syndrome.\nOutput:\n" }, { "from": "agent", "value": "This review sought evidence to compare other types of drugs with anticholinergics. Only a few, small-scale randomised trials were found, many testing drugs that are no longer used clinically. The review found inadequate evidence to assess whether or not available alternative drugs are better or worse than anticholinergics in the management of people with symptoms of overactive bladder syndrome." } ]

[ { "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: Only one trial, involving 256 children, met the inclusion criteria for this review. This study was assessed as having high risk of bias because of non-random allocation, incomplete outcome data and insufficient control of confounding factors. Results from this study suggest that centre-based day care may have a positive effect on child cognitive ability compared with no treatment (care at home) (assessed using a modified version of the British Ability Scale-II (BAS-II) (standardised mean difference (SMD) 0.74, 95% confidence interval (CI) 0.48 to 1.00, 256 participants, 1 study, very low-quality evidence). This study did not measure other variables relevant to this review. The single study included in this review provides limited evidence on the effects of centre-based day care for children younger than five years of age in low- and middle-income countries. This study was at high risk of bias and may have limited generalisability to other low- and middle-income countries. Many of the studies excluded from this review paired day care attendance with co-interventions that are unlikely to be provided in normal day care centres. Effectiveness studies on centre-based day care without these co-interventions are few, and the need for such studies is significant. In future studies, comparisons might include home visits or alternative day care arrangements.\nOutput:\n" }, { "from": "agent", "value": "We included studies that assessed the effects of centre-based day care for children younger than five years of age in low- and middle-countries. To isolate the effects of day care, we excluded interventions that involved medical, psychological or non–child-focused co-interventions. Of the 34,902 citations identified through electronic searches, we found only one study that met our inclusion criteria. This study was based in Kenya, Uganda and Tanzania/Zanzibar and included 256 children. Evidence is current to April 2014. The one included study reported positive effects of centre-based day care on the cognitive development of children. It did not report the effects of centre-based day care on children's psychosocial development, the incidence or prevalence of infectious diseases, parental employment or household income. This review includes only one trial. This study did not assign participants to the intervention by chance, so the comparison groups may have differed in important ways. Therefore results must be interpreted with caution. Although current studies do not now allow for conclusive judgements regarding the effects of centre-based day care on the development of children and the economic situation of parents, this does not imply that these services are not important in low- and middle-income countries. Effectiveness studies of centre-based day care without co-interventions are few, and the need for such studies is significant. This review is one of a pair of reviews; researchers and practitioners may find evidence from the high-income country review to be informative also (Van Urk 2014)." } ]

[ { "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 RCTs were included in the review, of which 14 were included in the meta-analyses (in total 2279 couples). The evidence was current to October 2013. The quality of the evidence was low or very low for most comparisons . The main limitations in the evidence were failure to describe study methods, serious imprecision and attrition bias. Ten RCTs compared different methods of timing for IUI. We found no evidence of a difference in live birth rates between hCG injection versus LH surge (odds ratio (OR) 1.0, 95% confidence interval (CI) 0.06 to 18, 1 RCT, 24 women, very low quality evidence), urinary hCG versus recombinant hCG (OR 1.17, 95% CI 0.68 to 2.03, 1 RCT, 284 women, low quality evidence) or hCG versus GnRH agonist (OR 1.04, 95% CI 0.42 to 2.6, 3 RCTS, 104 women, I2 = 0%, low quality evidence). Two RCTs compared the optimum time interval from hCG injection to IUI, comparing different time frames that ranged from 24 hours to 48 hours. Only one of these studies reported live birth rates, and found no difference between the groups (OR 0.52, 95% CI 0.27 to 1.00, 1 RCT, 204 couples). One study compared early versus late hCG administration and one study compared different dosages of hCG, but neither reported the primary outcome of live birth. We found no evidence of a difference between any of the groups in rates of pregnancy or adverse events (multiple pregnancy, miscarriage, ovarian hyperstimulation syndrome (OHSS)). However, most of these data were very low quality. There is insufficient evidence to determine whether there is any difference in safety and effectiveness between different methods of synchronization of ovulation and insemination. More research is needed.\nOutput:\n" }, { "from": "agent", "value": "We found 18 randomised controlled trials, all comparing different timing methods in one treatment cycle for IUI, with a total of 2279 couples. The evidence was current to October 2013. We found no evidence of a difference in live birth rates between timing methods. We also found no evidence of a difference between any of the groups in rates of pregnancy or adverse events (multiple pregnancy, miscarriage, ovarian hyperstimulation syndrome (OHSS)). Most of the evidence was of low or very low quality. The main limitations were poor reporting of study methods, imprecision and losses to follow up. 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 only one small trial (60 participants randomised) which overall was judged to be at low risk of bias. The study examined two doses of menaquinone (vitamin K2) over 3 months in healthy participants aged 40 to 65 years. The primary focus of the trial was to examine the effects of menaquinone (subtype MK7) on different matrix Gla proteins (MGP - vitamin K dependent proteins in the vessel wall) at different doses, but the authors also reported blood pressure and lipid levels. The trial did not report on our primary outcomes (cardiovascular disease clinical events) as it was small, short term and conducted in healthy participants. In terms of cardiovascular disease risk factors, no effects were seen for vitamin K2 on blood pressure or lipid levels, although the trial was small and findings are limited. The trial did not report any of our other secondary outcomes. The very limited results of this review highlight the lack of evidence currently available to determine the effectiveness of vitamin K supplementation for the primary prevention of cardiovascular disease, and demonstrate the need for further high quality trials in this area.\nOutput:\n" }, { "from": "agent", "value": "We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of vitamin K supplementation in healthy adults or those at high risk of developing CVD. We did not include people who already had CVD (e.g. heart attacks and strokes). The evidence is current to September 2014. Only one small trial met our inclusion criteria. It included 60 participants aged 40 to 65 years. This study looked at the effects of vitamin K2 supplements on CVD risk factors (blood pressure and lipid levels) over three months in healthy participants. No differences in these risk factors were seen between the comparison groups, but this was a small study and the findings are limited. The trial did not look at fatal and non-fatal cardiovascular endpoints as it was small and short term. The evidence is currently extremely limited and further high-quality trials are needed so that the effectiveness of vitamin K supplementation for CVD prevention can be determined. The only trial identified for this review was judged to be at low risk of bias (so there was less chance of arriving at the wrong conclusions because of favouritism by the participants or researchers). However the evidence is limited to one small trial and no firm conclusions can be reached at this time." } ]

[ { "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 13 eligible studies with 2001 participants (mean or median age range 58 to 73 years) and two ongoing studies. We categorised studies into eight comparisons, all against cardiac care and additional other active drugs or placebo. These comparisons investigated the efficacy of levosimendan versus dobutamine, enoximone or placebo, epinephrine versus norepinephrine-dobutamine, amrinone versus dobutamine, dopexamine versus dopamine, enoximone versus dopamine and nitric oxide versus placebo. All trials were published in peer-reviewed journals, and analysis was done by the intention-to-treat (ITT) principle. Twelve of 13 trials were small with few included participants. Acknowledgement of funding by the pharmaceutical industry or missing conflict of interest statements emerged in five of 13 trials. In general, confidence in the results of analysed studies was reduced due to serious study limitations, very serious imprecision or indirectness. Domains of concern, which show a high risk of more than 50%, include performance bias (blinding of participants and personnel) and bias affecting the quality of evidence on adverse events. Levosimendan may reduce short-term mortality compared to a therapy with dobutamine (RR 0.60, 95% CI 0.37 to 0.95; 6 studies; 1776 participants; low-quality evidence; NNT: 16 (patients with moderate risk), NNT: 5 (patients with CS)). This initial short-term survival benefit with levosimendan vs. dobutamine is not confirmed on long-term follow up. There is uncertainty (due to lack of statistical power) as to the effect of levosimendan compared to therapy with placebo (RR 0.48, 95% CI 0.12 to 1.94; 2 studies; 55 participants, very low-quality evidence) or enoximone (RR 0.50, 95% CI 0.22 to 1.14; 1 study; 32 participants, very low-quality evidence). All comparisons comparing other positive inotropic, inodilative or vasodilative drugs presented uncertainty on their effect on short-term mortality with very low-quality evidence and based on only one RCT. These single studies compared epinephrine with norepinephrine-dobutamine (RR 1.25, 95% CI 0.41 to 3.77; 30 participants), amrinone with dobutamine (RR 0.33, 95% CI 0.04 to 2.85; 30 participants), dopexamine with dopamine (no in-hospital deaths from 70 participants), enoximone with dobutamine (two deaths from 40 participants) and nitric oxide with placebo (one death from three participants). Apart from low quality of evidence data suggesting a short-term mortality benefit of levosimendan compared with dobutamine, at present there are no robust and convincing data to support a distinct inotropic or vasodilator drug-based therapy as a superior solution to reduce mortality in haemodynamically unstable people with cardiogenic shock or LCOS. Considering the limited evidence derived from the present data due to a generally high risk of bias and imprecision, it should be emphasised that there remains a great need for large, well-designed randomised trials on this topic to close the gap between daily practice in critical care medicine and the available evidence. It seems to be useful to apply the concept of 'early goal-directed therapy' in cardiogenic shock and LCOS with early haemodynamic stabilisation within predefined timelines. Future clinical trials should therefore investigate whether such a therapeutic concept would influence survival rates much more than looking for the 'best' drug for haemodynamic support.\nOutput:\n" }, { "from": "agent", "value": "This evidence is current to June 2017. We included 13 studies with 2001 participants with CS or LCOS as complications of myocardial infarction, heart failure or cardiac surgery, with follow-up periods between the length of the recovery period up to 12 months. Four studies were funded by a drug manufacturer. We compared different approaches to standard therapies with possible addition of inotropic or vasoconstrictive drugs as levosimendan, dobutamine, enoximone, epinephrine. This review presents low-quality evidence that levosimendan compared to dobutamine reduces short-term mortality. The survival benefit with levosimendan vs. dobutamine is not confirmed on long-term follow up. Very low-quality evidence shows uncertainty around the effect of levosimendan compared to placebo or enoximone. Very low-quality evidence shows uncertainty on the comparison of epinephrine with norepinephrine-dobutamine, amrinone or enoximone with dobutamine, dopexamine with dopamine, and nitric oxide with placebo. We have reduced confidence in the results of the studies that we analysed (low- or very low-quality evidence) due to serious study limitations, very serious imprecision or indirectness." } ]

[ { "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: Nineteen studies were identified that met the inclusion criteria.  Most patients in the studies had neurogenic OAB, but some included patients with idiopathic OAB.  All studies demonstrated superiority of botulinum toxin to placebo.  Lower doses of botulinum toxin (100 to 150 U) appeared to have beneficial effects, but larger doses (300 U) may have been more effective and longer lasting, but with more side effects.  Suburothelial injection had comparable efficacy to intradetrusor injection. The effect of botulinum toxin may last for a number of months and is dependent upon dose and type of toxin used. Patients receiving repeated doses do not seem to become refractory to botulinum toxin. Botulinum toxin appeared to have beneficial effects in OAB that quantitatively exceeded the effects of intravesical resiniferatoxin. Intravesical botulinum toxin appeared to be reasonably safe; however, one study was halted due to a perceived unacceptable rate of urinary retention. Intravesical botulinum toxin appears to be an effective therapy for refractory OAB symptoms, but as yet little controlled trial data exist on benefits and safety compared with other interventions, or with placebo. Further robust data are required on long term outcomes, safety, and optimal dose of botulinum toxin for OAB.\nOutput:\n" }, { "from": "agent", "value": "We found that there were several comparative studies, but these involved a relatively small number of patients. There was evidence that botulinum toxin improves the symptoms of OAB. It was unclear what the best dose of botulinum toxin was. Botulinum toxin injections into the bladder appeared to give few side effects or complications, but there were no long-term follow-up studies, and there could be rare side effects that have not been discovered yet." } ]

[ { "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: Due to the level of heterogeneity among studies, studies were divided into two groups; those conducted in Japan and those conducted outside Japan. Study length ranged between 12 and 13 weeks. Meta-analysis of six studies conducted outside Japan showed a mean difference (MD) in weight loss of -0.04 kg (95% CI -0.5 to 0.4; P = 0.88; I2 = 18%; 532 participants). The eight studies conducted in Japan were not similar enough to allow pooling of results and MD in weight loss ranged from -0.2 kg to -3.5 kg (1030 participants) in favour of green tea preparations. Meta-analysis of studies measuring change in body mass index (BMI) conducted outside Japan showed a MD in BMI of -0.2 kg/m2 (95% CI -0.5 to 0.1; P = 0.21; I2 = 38%; 222 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed a reduction in BMI ranging from no effect to -1.3 kg/m2 (1030 participants), in favour of green tea preparations over control. Meta-analysis of five studies conducted outside Japan and measuring waist circumference reported a MD of -0.2 cm (95% CI -1.4 to 0.9; P = 0.70; I2 = 58%; 404 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed effects on waist circumference ranging from a gain of 1 cm to a loss of 3.3 cm (1030 participants). Meta-analysis for three weight loss studies, conducted outside Japan, with waist-to-hip ratio data (144 participants) yielded no significant change (MD 0; 95% CI -0.02 to 0.01). Analysis of two studies conducted to determine if green tea could help to maintain weight after a period of weight loss (184 participants) showed a change in weight loss of 0.6 to -1.6 kg, a change in BMI from 0.2 to -0.5 kg/m2 and a change in waist circumference from 0.3 to -1.7 cm. In the eight studies that recorded adverse events, four reported adverse events that were mild to moderate, with the exception of two (green tea preparations group) that required hospitalisation (reported as not associated with the intervention). Nine studies reported on compliance/adherence, one study assessed attitude towards eating as part of the health-related quality of life outcome. No studies reported on patient satisfaction, morbidity or cost. Green tea preparations appear to induce a small, statistically non-significant weight loss in overweight or obese adults. Because the amount of weight loss is small, it is not likely to be clinically important. Green tea had no significant effect on the maintenance of weight loss. Of those studies recording information on adverse events, only two identified an adverse event requiring hospitalisation. The remaining adverse events were judged to be mild to moderate.\nOutput:\n" }, { "from": "agent", "value": "Green tea has a long history of many uses, one of which is helping overweight people to lose weight and to maintain weight loss. Believed to be able to increase a person's energy output, green tea weight loss preparations are extracts of green tea that contain a higher concentration of ingredients (catechins and caffeine) than the typical green tea beverage prepared from a tea bag and boiling water. This review looked at 15 weight loss studies and three studies measuring weight maintenance where some form of a green tea preparation was given to one group and results compared to a group receiving a control. Neither group knew whether they were receiving the green tea preparation or the control. A total of 1945 participants completed the studies, ranging in length from 12 to 13 weeks. In summary, the loss in weight in adults who had taken a green tea preparation was statistically not significant, was very small and is not likely to be clinically important. Similar results were found in studies that used other ways to measure loss in weight (body mass index, waist circumference). Studies examining the effect of green tea preparations on weight maintenance did not show any benefit compared to the use of a control preparation. Most adverse effects, such as nausea, constipation, abdominal discomfort and increased blood pressure, were judged to be mild to moderate and to be unrelated to the green tea or control intervention. No deaths were reported, although adverse events required hospitalisation. One study attempted to look at health-related quality of life by asking participants about their attitudes towards eating. Nine studies tracked participants' compliance with green tea preparations. Studies did not include any information about the effects of green tea preparations on morbidity, costs or patient satisfaction." } ]

[ { "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 orlistat (n = 10,631), 10 sibutramine (n = 2623) and four rimonabant trials (n = 6365) met inclusion criteria. Attrition rates averaged 30% to 40%. Compared to placebo, orlistat reduced weight by 2.9 kg (95% confidence interval (CI) 2.5 to 3.2 kg), sibutramine by 4.2 kg (95% CI 3.6 to 4.7 kg), and rimonabant by 4.7 kg (95% CI 4.1 to 5.3 kg). Patients on active drug therapy were significantly more likely to achieve 5% and 10% weight loss thresholds. Placebo-controlled weight losses were consistently lower in patients with diabetes. Orlistat reduced diabetes incidence, improved total cholesterol, LDL-cholesterol, blood pressure, and glycaemic control in patients with diabetes but increased rates of gastrointestinal side effects and slightly lowered HDL levels. Sibutramine improved HDL and triglyceride levels but raised blood pressure and pulse rate. Rimonabant improved HDL-cholesterol, triglyceride and blood pressure levels and glycaemic control in patients with diabetes but increased the risk of mood disorders. Orlistat, sibutramine and rimonabant have been studied in trials of one year or longer. Internal validity of studies was limited by high attrition rates. All three antiobesity agents are modestly effective in reducing weight and have differing effects on cardiovascular risk and adverse effects profiles. Longer and more methodologically rigorous studies of anti-obesity drugs that are powered to examine endpoints such as mortality and cardiovascular morbidity are required.\nOutput:\n" }, { "from": "agent", "value": "This review assessed the long-term benefits and risks of approved anti-obesity drugs in clinical trials of 1 to 4 years duration. Sixteen orlistat (10,631 patients), 10 sibutramine (2623 patients) and four rimonabant (6635 patients) studies were examined. High drop-out rates (30% to 40%) were a limitation of nearly all studies. Compared to placebo, all three drugs reduced weight by around five kg or less and orlistat reduced the number of high-risk patients who developed diabetes. No data to show that any of the three drugs lowers the risk of death or cardiovascular disease were found. The most prominent side effects were gastrointestinal for orlistat, cardiovascular for sibutramine (raised blood pressure and/or pulse rate) and psychiatric for rimonabant (mood disorders). In Europe, rimonabant is contraindicated for patients with severe depression and/or patients who are treated with antidepressive medications. Rimonabant is furthermore not recommended for patients with other untreated psychiatric conditions. We conclude that: 1. average weight losses with current anti-obesity agents appear modest but may be of clinical benefit, and 2. better studies designed to examine mortality and cardiovascular morbidity are required to fully evaluate any potential benefit of such agents." } ]

[ { "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 studies (313 participants) met the inclusion criteria. One study compared INF versus intramuscular morphine (IMM); another study compared INF versus intravenous morphine (IVM); and another study compared standard concentration INF (SINF) versus high concentration INF (HINF). All three studies reported a reduction in pain score following INF administration. INF produced a greater reduction in pain score at 10 minutes post administration when compared with IMM (INF group pain score: 1/5 vs IMM group pain score: 2/5; P value 0.014). No other statistically significant differences in pain scores were reported at any other time point. When INF was compared with IVM and HINF, no statistically significant differences in pain scores were noted between treatment arms, before analgesia or at 5, 10, 20 and 30 minutes post analgesia. Specifically, when INF was compared with IVM, both agents were seen to produce a statistically significant reduction in pain score up to 20 minutes post analgesia. No further reduction in pain score was noted after this time. When SINF was compared with HINF, a statistically and clinically significant reduction in pain scores over study time was observed (median decrease for both groups 40 mm, P value 0.000). No adverse events (e.g. opiate toxicity, death) were reported in any study following INF administration. One study described better patient tolerance to INF compared with IMM, which achieved statistical significance. The other studies described reports of a “bad taste” and vomiting with INF. Overall the risk of bias in all studies was considered low. INF may be an effective analgesic for the treatment of patients with acute moderate to severe pain, and its administration appears to cause minimal distress to children. However, this review of published studies does not allow any definitive conclusions regarding whether INF is superior, non-inferior or equivalent to intramuscular or intravenous morphine. Limitations of this review include the following: few eligible studies for inclusion (three); no study examined the use of INF in children younger than three years of age; no study included children with pain from a \"medical\" cause (e.g. abdominal pain seen in appendicitis); and all eligible studies were conducted in Australia. Consequently, the findings may not be generalizable to other healthcare settings, to children younger than three years of age and to those with pain from a \"medical\" cause.\nOutput:\n" }, { "from": "agent", "value": "We included studies with children (younger than 18 years of age) suffering from acute severe pain as a result of injury or medical illness. The target intervention was INF administered for pain relief compared with any other drug intervention for pain relief (e.g. intravenous morphine) or non-drug intervention (e.g. limb splinting, wound dressing) provided in the emergency setting. The evidence is current to January 2014. We identified three studies that included 313 children with acute severe pain resulting from broken bones of the upper and lower limbs. These trials compared INF versus morphine administered by a needle into a muscle (intramuscular morphine) or via a drip into a vein (intravenous morphine), as well as standard concentration INF versus high concentration INF. The collective study population in these trials consisted of children three to 15 years of age. Males accounted for approximately two-thirds of the overall study population. The review concluded that INF may be an effective analgesic for the treatment of children in acute moderate to severe pain, and its administration appears to cause minimal distress to children; however, the evidence is insufficient to permit judgement of the effects of INF compared with intramuscular or intravenous morphine. No serious adverse events (e.g. opiate toxicity, death) were reported. Limitations of this review include the following: Few studies (three) were eligible for inclusion; no study examined the use of INF in children younger than three years of age; no study included children with pain resulting from a \"medical\" cause (e.g. abdominal pain seen in appendicitis); and all eligible studies were conducted in Australia. Consequently, the findings may not be generalizable to other healthcare settings, to children younger than three years of age and to those with pain from a \"medical\" cause." } ]

[ { "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: Individual participant data were obtained for five studies, which recruited a total of 635 participants, representing 80% of 798 individuals from all seven identified eligible trials. For remission outcomes, an HR of less than 1 indicates an advantage for phenytoin and for first seizure and treatment failure outcomes an HR of less than 1 indicates an advantage for phenobarbitone. Results for the primary outcome of the review were: time to treatment failure for any reason related to treatment (pooled HR adjusted for seizure type for 499 participants: 1.61, 95% CI 1.22 to 2.12, low-certainty evidence), time to treatment failure due to adverse events (pooled HR adjusted for seizure type for 499 participants: 1.99, 95% CI 1.37 to 2.87, low-certainty evidence), time to treatment failure due to lack of efficacy (pooled HR adjusted for seizure type for 499 participants: 1.87, 95% CI 1.32 to 2.66, moderate-certainty evidence), showing a statistically significant advantage for phenytoin compared to phenobarbitone. For our secondary outcomes, we did not find any statistically significant differences between phenytoin and phenobarbitone: time to first seizure post-randomisation (pooled HR adjusted for seizure type for 624 participants: 0.85, 95% CI 0.69 to 1.06, moderate-certainty evidence), time to 12-month remission (pooled HR adjusted for seizure type for 588 participants: 0.90, 95% CI 0.69 to 1.19, moderate-certainty evidence), and time to six-month remission pooled HR adjusted for seizure type for 588 participants: 0.91, 95% CI 0.71 to 1.15, moderate-certainty evidence). For individuals with focal onset seizures (73% of individuals contributing to analysis), numerical results were similar and conclusions the same as for analyses of all individuals and for individuals with generalised onset seizures (27% of individuals contributing to analysis), results were imprecise and no clear differences between the drugs were observed. Several confounding factors, most notably the differences in design of the trials with respect to blinding, were likely to have impacted on the results of the primary outcome 'time to treatment failure', and in turn, the treatment failure rates may have impacted on the secondary efficacy outcomes of time to first seizure and time to 12-month and six-month remission. Low-certainty evidence from this review suggests that phenytoin may be a more effective drug than phenobarbitone in terms of treatment retention (treatment failures due to lack of efficacy or adverse events or both). Moderate-certainty evidence from this review also indicates no differences between the drugs in terms of time to seizure recurrence and seizure remission. However, the trials contributing to the analyses had methodological inadequacies and methodological design differences that may have impacted upon the results of this review. Therefore, we do not suggest that results of this review alone should form the basis of a treatment choice for a patient with newly onset seizures. We recommend that future trials should be designed to the highest quality possible with consideration of masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.\nOutput:\n" }, { "from": "agent", "value": "The last search for trials was in August 2018. We assessed the evidence from seven clinical trials in which people received either phenobarbitone or phenytoin and their treatment was decided randomly. We were able to combine data for 635 people from five of the seven trials; for the remaining 163 people from two trials, data were not available to use in this review Key results This review found no evidence to suggest a difference between phenobarbitone and phenytoin in terms of the time to seizure recurrence and time to seizure remission (seizure free period of six or 12 months). Phenobarbitone treatment was more likely to be withdrawn than phenytoin treatment, however, this may have been influenced by the design of the included studies (whether the people and the clinicians treating them knew which treatment the person was receiving). Quality of the evidence Some of the trials contributing data to the review had methodological problems, which may have introduced bias and inconsistent results into this review. Also, we believe that the difference in study design with regards to whether the treatment was masked from the patients and clinicians (e.g. with a placebo tablet) had an impact on the rates of withdrawal from the study treatments, which also is likely to have impacted on the outcomes related to seizure control These problems may have affected the results of this review and we judged the quality of the evidence provided by this review to be moderate to low quality. We do not suggest using the results of this review alone for making a choice between phenytoin or phenobarbitone for the treatment of epilepsy. Future trials comparing these drugs or any other antiepileptic drugs should be designed using high-quality methods to ensure results are also of high quality." } ]

[ { "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 one new study with 100 participants for the pooled analysis. We identified two additional reports of a study using an enriched enrolment randomised withdrawal (EERW) design that included participants from earlier randomised controlled trials and an open-label study. Because this study used the same participants already included in our main analysis, and a different design, we dealt with it separately. The main analysis included six studies (five from the earlier review; 4238 participants in total), all of which were placebo-controlled, and used titration to a target dose of milnacipran 100 or 200 mg, with assessment after 8 to 24 weeks of stable treatment. There were no studies with active comparators. Study quality was generally good, although the imputation method used in analyses of the primary outcomes could overestimate treatment effect. Both doses of milnacipran provided moderate levels of pain relief (at least 30% pain intensity reduction) to about 40% of participants treated, compared to 30% with placebo, giving a number needed to treat for an additional beneficial outcome (NNT) of 6 to 10 (high quality evidence). Using a stricter definition for responder and a more conservative method of analysis gave lower levels of response (while maintaining a 10% difference between milnacipran and placebo) and increased the NNT to 11 (high quality evidence). One EERW study was broadly supportive. Adverse events were common in both milnacipran (86%) and placebo (78%) groups (high quality evidence), but serious adverse events did not differ between groups (less than 2%) (low quality evidence). Nausea, constipation, and headache were the most common events showing the greatest difference between groups (number needed to treat for an additional harmful outcome (NNH) of 5.7 for nausea, 13 for constipation, and 29 for headache) (moderate quality evidence). Withdrawals for any reason were more common with milnacipran than placebo, and more common with 200 mg (NNH 9) than 100 mg (NNH 23), compared with placebo. This was largely driven by adverse event withdrawals, where the NNH compared with placebo was 14 for 100 mg and 7.0 for 200 mg (high quality evidence). Withdrawals due to lack of efficacy were less common with milnacipran than placebo but did not differ between doses (number needed to treat to prevent an additional unwanted outcome (NNTp) of 41) (moderate quality evidence). The evidence available indicates that milnacipran 100 mg or 200 mg is effective for a minority in the treatment of pain due to fibromyalgia, providing moderate levels of pain relief (at least 30%) to about 40% of participants, compared with about 30% with placebo. There were insufficient data to assess substantial levels of pain relief (at least 50%), and the use of last observation carried forward imputation may overestimate drug efficacy. Using stricter criteria for 'responder' and a more conservative method of analysis gave lower response rates (about 26% with milnacipran versus 17% with placebo). Milnacipran was associated with increased adverse events and adverse event withdrawals, which were significantly greater for the higher dose.\nOutput:\n" }, { "from": "agent", "value": "We searched scientific databases for studies that looked at the effects of milnacipran in adults with fibromyalgia who had moderate or severe pain. The treatment had to last at least eight weeks. The evidence is current to May 2015. We identified six studies that satisfied the inclusion criteria, including one new study for this update. Over 4000 participants were treated with milnacipran 100 or 200 mg, or placebo, for 8 to 24 weeks at the target dose. Overall study quality was good, although the method of analysis for our primary outcomes of pain relief could overestimate treatment effect. Milnacipran at either dose provided moderate pain relief (at least 30% reduction in pain intensity) to 1 in 10 (10%) more people than did placebo (high quality evidence). This relatively modest effect may be clinically important in this difficult-to-treat condition. Adverse events were reported by most participants in all treatment groups, but were more common with milnacipran than placebo (high quality evidence), with nausea (feeling sick) and constipation showing the greatest differences (moderate quality evidence). Serious adverse events were uncommon, fewer than 1 in 50 (2%) participants, and did not differ between treatment groups (low quality evidence). The numbers of participants dropping out of the studies (withdrawals) because of adverse events were also more common with milnacipran than placebo, and were more common with 200 mg than 100 mg (high quality evidence), while withdrawals due to lack of effect were less common with milnacipran, with no difference between doses (moderate quality evidence). Milnacipran gives good pain relief to some people with fibromyalgia, but only a minority; it will not work for most people." } ]

[ { "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 one randomized controlled study recruiting 97 low birthweight infants that met the inclusion criteria. The study was conducted in the UK in 1987 and 1988. Randomized infants received ETT suctioning every six or 12 hours during the first three days of life. The quality of reporting was limited and we rated the trial at high risk of bias. Furthermore, the trial lacked adequate power. There were no statistically significant differences in any of reported outcomes: bronchopulmonary dysplasia (defined as oxygen at more than 30 days; risk ratio (RR) 0.49, 95% confidence interval (CI) 0.20 to 1.20); incidence of pneumothorax (RR 0.70, 95% CI 0.24 to 2.05); intraventricular hemorrhage (RR 1.12, 95% CI 0.44 to 2.85); neonatal death (RR 1.40, 95% CI 0.58 to 3.37); and time on ventilation (median time 39 hours in the 12-hourly group and 28 hours in the six-hourly group; RD not applicable for this outcome as mean and standard deviation were not reported). Tests for heterogeneity were not applicable as only one study was included. There was insufficient evidence to identify the ideal frequency of ETT suctioning in ventilated neonates. Future research should focus on the effects in the very preterm newborns, that is, the most vulnerable population as concerns the risk of both lung and brain damage. Assessment should include the cases of prolonged ventilation, when more abundant, dense secretions are common. Clinical trials might include comparisons between 'as-scheduled' versus 'as-needed' endotracheal suctioning, that is, based on specific indications, as well frequent versus less frequent suctioning schedules.\nOutput:\n" }, { "from": "agent", "value": "We searched medical databases for clinical studies comparing different strategies regarding the frequency of endotracheal tube suction in newborn babies on ventilators. We found only one study recruiting 97 newborns with bodyweights under 2.5 kg (these are called low birthweight infants). Suctioning was performed every six or 12 hours during the first three days of life. There were no important differences on the time the babies were on the ventilator, occurrence of pneumothorax (collapsed lung), need for ventilation or oxygen at more than 30 days, bleeding in the brain, and death in the first month of life. In addition, the study reported no side effects. We only identified one study, which was conducted in 1987 and 1988 and had several shortcomings. We cannot advise health professionals and parents about the optimal frequency of suctioning when newborns are ventilated." } ]

[ { "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-one RCTs were identified that involved non-surgical management of chronic pelvic pain: 13 trials were included in the review, and eight were excluded. The studies included a total of 750 women—406 women in the intervention groups and 344 in the control groups. Included studies had high attrition rates, and investigators often did not blind adequately or did not clearly describe randomisation procedures. Medical treatment versus placebo Progestogen (medroxyprogesterone acetate (MPA)) was more effective than placebo at the end of treatment in terms of the number of women achieving a greater than 50% reduction in visual analogue scale (VAS) pain score immediately after treatment (Peto OR 3.00, 95% CI 1.70 to 5.31, two studies, n = 204, I2 = 22%, moderate-quality evidence). Evidence of benefit was maintained up to nine months after treatment (Peto OR 2.09, 95% CI 1.18 to 3.71, two studies, n = 204, I2 = 0%, moderate-quality evidence). Women treated with progestogen reported more adverse effects (e.g. weight gain, bloatedness) than those given placebo (high-quality evidence). The estimated effect of lofexidine on pain outcomes when compared with placebo was compatible with benefit and harm (Peto OR 0.42, 95% CI 0.11 to 1.61, one study, 39 women, low-quality evidence). Women in the lofexidine group reported more adverse effects (including drowsiness and dry mouth) than women given placebo (moderate-quality evidence). Head-to-head comparisons of medical treatments Head-to-head comparisons showed that women taking goserelin had greater improvement in pelvic pain score (MD 3, 95% CI 2.08 to 3.92, one study, n = 47, moderate-quality evidence) at one year than those taking progestogen. Women taking gabapentin had a lower VAS pain score than those taking amytriptyline (MD -1.50, 95% CI -2.06 to -0.94, n = 40, low-quality evidence). Study authors reported that no statistically significant difference was observed in the rate of adverse effects among women taking gabapentin compared with women given amytriptyline. The study comparing goserelin versus progestogen did not report on adverse effects. Psychological treatment Women who underwent reassurance ultrasound scans and received counselling were more likely to report improved pain than those treated with a standard 'wait and see' policy (Peto OR 6.77, 95% CI 2.83 to 16.19, n = 90, low-quality evidence). Significantly more women who had writing therapy as a disclosure reported improvement in pain than those in the non-disclosure group (Peto OR 4.47, 95% CI 1.41 to 14.13, n = 48, very low-quality evidence). No difference between groups in pain outcomes was noted when other psychological therapies were compared with standard care or placebo (quality of evidence ranged from very low to low). Studies did not report on adverse effects. Complementary therapy Distension of painful pelvic structures was more effective for pain when compared with counselling (MD 35.8, 95% CI 23.08 to 48.52 on a zero to 100 scale, one study, n = 48, moderate-quality evidence). No difference in pain levels was observed when magnetic therapy was compared with use of a control magnet (very low-quality evidence). Studies did not report on adverse effects. The results of studies examining psychological and complementary therapies could not be combined to yield meaningful results. Evidence of moderate quality supports progestogen as an option for chronic pelvic pain, with efficacy reported during treatment. In practice, this option may be most acceptable among women unconcerned about progestogenic adverse effects (e.g. weight gain, bloatedness—the most common adverse effects). Although some evidence suggests possible benefit of goserelin when compared with progestogen, gabapentin as compared with amytriptyline, ultrasound versus 'wait and see' and writing therapy versus non-disclosure, the quality of evidence is generally low, and evidence is drawn from single studies. Given the prevalence and healthcare costs associated with chronic pelvic pain in women, RCTs of other medical, lifestyle and psychological interventions are urgently required.\nOutput:\n" }, { "from": "agent", "value": "Twenty-one randomised controlled studies were identified, of which 13 were included. Eight studies were excluded. The studies included a total of 750 women—406 women in the intervention groups and 344 women in the control groups. The interventions assessed included medical treatment and psychological, cognitive, behavioural, complementary and physical therapies. The evidence is current to February 2014. The review concludes that evidence shows improvement of pain in women given a high dose of progestogen (50 mg medroxyprogesterone acetate) immediately post-treatment and for up to nine months after treatment. However, progestogen was associated with adverse effects such as weight gain and bloating. Women who underwent reassurance ultrasound scans and who received counselling were more likely to report improved pain than those whose treatment involved a 'wait and see' policy. Some evidence of benefit was seen with writing disclosure therapy and with distension of painful pelvic structures. No good evidence of benefit was noted with other interventions when compared with standard care or placebo. The quality of the evidence was low or moderate for most comparisons, and in most cases evidence was derived from single small studies. Moreover, we were unable to draw meaningful conclusions on quality of life and physical and functional outcomes because of the large variation in outcome measures used by the included studies. Many interventions identified in this review involved only single studies with small sample sizes. Additional studies will be required in the future to replicate results obtained with the use of specific medical 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: Previous versions of this review included no trials. From the 2015 search, we identified three cross-over trials that could be included. The 2017 search found no new studies relevant to this review. The included trials randomised 47 inpatients with chronic mental illnesses in the USA and China. Trials were published in the 1990s and were of short duration (six to 10 weeks). Overall, the risk of bias was unclear, mainly due to poor reporting; allocation concealment was not described, generation of the sequence was not explicit, studies were not clearly blinded, and attrition and outcome data were not fully reported. Findings were sparse, no study reported on the primary outcome 'no clinically important improvement in tardive dyskinesia symptoms,' but two small studies (37 participants) found no difference on the tardive dyskinesia symptoms scale Abnormal Involuntary Movement Scale (AIMS) scores between diltiazem or flunarizine and placebo after three to four weeks' treatment (MD -0.71, 95% CI -2.68 to 1.26, very low quality evidence). Only one study randomising 20 participants reported on adverse events, and reported that there were no adverse events with flunarizine or with placebo (very low quality evidence). One study with 18 participants reported no events of deterioration in mental state with diltiazem or with placebo (very low quality evidence). No studies reported on acceptability of treatment or on social confidence, social inclusion, social networks or personalised quality of life outcomes designated important to patients. Available evidence from randomised controlled trials is extremely limited and very low quality, conclusions cannot be drawn. The effects of calcium channel blockers for antipsychotic-induced tardive dyskinesia are unknown. Their use is experimental and should only be given in the context of well-designed randomised trials.\nOutput:\n" }, { "from": "agent", "value": "We searched for clinical trials (up to April 2017) using Cochrane Schizophrenia's specialised register of trials. The review includes three small, short trials published in the 1990s. The trials randomised 47 people with schizophrenia or other chronic mental illnesses who had also developed tardive dyskinesia because they were taking antipsychotic medicines. The treatments the participants received were the calcium channel blockers, flunarizine, nifedipine or diltiazem hydrochloride or placebo (dummy treatment). A small set of very low quality data were available from three small and poorly reported trials. Currently, it is uncertain whether calcium channel blockers are helpful in the treatment of tardive dyskinesia that is caused by taking antipsychotic medicines. Therefore, the use of calcium channel blockers for this purpose remains experimental. Evidence was limited and small scale. It is not possible to recommend these drugs as a treatment for antipsychotic-induced tardive dyskinesia. To fully investigate whether calcium channel blockers have any positive effects, there would have to be more well-designed, conducted and reported clinical trials. This plain language summary was adapted by the review authors from a summary originally written by Ben Gray, Senior Peer Researcher, McPin Foundation (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: We identified 32 studies for inclusion in this current review. Twenty studies evaluated five anti-tumour necrosis factor (anti-TNF) biologic agents (adalimumab, certolizumab, etanercept, golimumab and infliximab), and 12 studies focused on five non-anti-TNF biologic agents (abatacept, canakinumab, rituximab, tocilizumab and an anti-interferon gamma monoclonal antibody). All but two of the studies were double-blind randomised placebo-controlled trials. In some trials, patients could receive concomitant disease-modifying anti-rheumatic drugs (DMARDs). These studies added either biologics or placebo to DMARDs. Investigators did not change the dose of the latter from baseline. In total, these studies included 9946 participants in the intervention groups and 4682 participants in the control groups. Overall, quality of randomised controlled trials was moderate with a low to unclear risk of bias in the reporting of the outcome of fatigue. We downgraded the quality of the studies from high to moderate because of potential reporting bias (studies included post hoc analyses favouring reporting of positive result and did not always include all randomised individuals). Some studies recruited only participants with early disease. The studies used five different instruments to assess fatigue in these studies: the Functional Assessment of Chronic Illness Therapy Fatigue Domain (FACIT-F), Short Form-36 Vitality Domain (SF-36 VT), Visual Analogue Scale (VAS) (0 to 100 or 0 to 10) and the Numerical Rating Scale (NRS). We calculated standard mean differences for pooled data in meta-analyses. Overall treatment by biologic agents led to statistically significant reduction in fatigue with a standardised mean difference of −0.43 (95% confidence interval (CI) −0.38 to −0.49). This equates to a difference of 6.45 units (95% CI 5.7 to 7.35) of FACIT-F score (range 0 to 52). Both types of biologic agents achieved a similar level of improvement: for anti-TNF agents, this stood at −0.42 (95% CI −0.35 to −0.49), equivalent to 6.3 units (95% CI 5.3 to 7.4) on the FACIT-F score; and for non-anti-TNF agents, it was −0.46 (95% CI −0.39 to −0.53), equivalent to 6.9 units (95% CI 5.85 to 7.95) on the FACIT-F score. In most studies, the double-blind period was 24 weeks or less. No study assessed long-term changes in fatigue. Treatment with biologic interventions in patients with active RA can lead to a small to moderate improvement in fatigue. The magnitude of improvement is similar for anti-TNF and non-anti-TNF biologics. However, it is unclear whether the improvement results from a direct action of the biologics on fatigue or indirectly through reduction in inflammation, disease activity or some other mechanism.\nOutput:\n" }, { "from": "agent", "value": "We searched for all research published up to 1 April 2014, finding 32 relevant studies. There were 19 studies on five anti-TNF biologics (adalimumab, certolizumab, etanercept, golimumab and infliximab) and 12 studies on five non-anti-TNF biologics (abatacept, canakinumab, rituximab, tocilizumab and an anti-interferon gamma monoclonal antibody). Altogether 9,946 participants received biologics and 4,682 participants received standard therapy. All but two of the studies were randomised placebo-controlled trials, the gold standard in terms of study quality. We compared the effects of biologics versus placebo. In some studies, participants may have been taking standard therapy for rheumatoid arthritis at the start of the trial. In these studies, investigators added either biologics or placebo treatment to standard therapy. Overall, treatment by biologics led to small to moderate reductions (9 units reduction on a 0-52 scale) in patient-reported fatigue compared with 3 units in participants treated by placebo. It is unclear whether this improvement is due to a reduction in overall disease activity, a direct effect of the biologics or some other mechanism. There may have been some potential bias in the way investigators analysed data, and some studies did not include all randomised individuals, so we judged the quality of the evidence to be only moderate rather than high." } ]

[ { "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 met our inclusion criteria, all of which were conducted in Africa. Of these four were randomised controlled trials while the remaining six were cohort studies. From the trial data, when nurses initiated and provided follow-up HIV therapy, there was high quality evidence of no difference in death at one year, unadjusted risk ratio was 0.96 (95% CI 0.82 to 1.12), one trial, cluster adjusted n = 2770. There was moderate quality evidence of lower rates of losses to follow-up at one year, relative risk of 0.73 (95% CI 0.55 to 0.97). From the cohort data, there was low quality evidence that there may be an increased risk of death in the task shifting group, relative risk 1.23 (95% CI 1.14 to 1.33, two cohorts, n = 39 160) and very low quality data reporting no difference in patients lost to follow-up between groups, relative risk 0.30 (95% CI 0.05 to 1.94). From the trial data, when doctors initiated therapy and nurses provided follow-up, there was moderate quality evidence that there is probably no difference in death compared with doctor-led care at one year, relative risk of 0.89 (95% CI 0.59 to 1.32), two trials, cluster adjusted n = 4332. There was moderate quality evidence that there is probably no difference in the numbers of patients lost to follow-up at one year, relative risk 1.27 (95% CI 0.92 to 1.77), P = 0.15. From the cohort data, there is very low quality data that death at one year may be lower in the task shifting group, relative risk 0.19 (95% CI 0.05 to 0.78), one cohort, n = 2772, and very low quality evidence that loss to follow-up was reduced, relative risk 0.34 (95% CI 0.18 to 0.66). From the trial data, for maintenance therapy delivered in the community there was moderate quality evidence that there is probably no difference in mortality when doctors deliver care in the hospital or specially trained field workers provide home-based maintenance care and antiretroviral therapy at one year, relative risk 1.0 (95% CI 0.62 to 1.62), 1 trial, cluster adjusted n = 559. There is moderate quality evidence from this trial that losses to follow-up are probably no different at one year, relative risk 0.52 (0.12 to 2.3), P = 0.39. The cohort studies did not report on one year follow-up for these outcomes. Across the studies that reported on virological and immunological outcomes, there was no clear evidence of difference whether a doctor or nurse or clinical officer delivered therapy. Three studies report on costs to patients, indicating a reduction in travel costs to treatment facilities where task shifting was occurring closer to patients homes. There is conflicting evidence regarding the relative cost to the health system, as implementation of the strategy may increase costs. The two studies reporting the patient and staff perceptions of the quality of care, report good acceptability of the service by patients, and general acceptance by doctors of the shifting of roles. One trial reported on the time to initiation of antiretroviral therapy, finding no clear evidence of a difference between groups. The same trial reports on new diagnosis of tuberculosis which favours nurse initiation of HIV care for increasing the numbers of diagnoses of tuberculosis made. Our review found moderate quality evidence that shifting responsibility from doctors to adequately trained and supported nurses or community health workers for managing HIV patients probably does not decrease the quality of care and, in the case of nurse initiated care, may decrease the numbers of patients lost to follow-up.\nOutput:\n" }, { "from": "agent", "value": "We searched for studies up to March 2014. We found 10 studies, including four randomised controlled trials and 6 cohort studies collecting data from HIV care programmes. All the studies were conducted in Africa in adults who were followed up for up to one year. We describe three types of care: - Doctor versus nurse or clinical officer care for initiation and maintenance of antiretrovirals - Doctor versus nurse or clinical officer care for maintenance of antiretroviral therapy - Doctor versus community health workers for maintenance of antiretroviral therapy. We found high quality evidence from trial data that when nurses initiated and provided follow-up HIV therapy, there was no difference in death and lower rates of losses to follow up at one year, (n = 2770). However, lower quality data from two cohort studies suggests that there may be an increased risk of death in the task shifting group, (n = 39 160) but no difference in patients lost to follow-up between groups, We found moderate quality evidence from two trials that when doctors initiated therapy and nurses provided follow-up, that there was probably no difference in death or number of patients lost to follow up at one year (n = 4332). Lower quality evidence from the cohort study showed that death as well as the number of patients lost to follow-up at one year may be lower in the group treated by nurses. Compared to doctor led care, we found moderate quality evidence from a single trial that when antiretroviral therapy was provided in the community, by trained field workers, there was probably no difference in death or losses to follow-up (n= 559)." } ]

[ { "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 (124 participants), two of which we assessed as at high risk of bias and one at unclear risk of bias. All studies were hospital-based and recruited participants undergoing superficial parotidectomy. Most participants were diagnosed with benign lesions of the parotid gland. Participants were followed up for more than six months. The studies evaluated the two comparisons shown below: Sternocleidomastoid muscle flap versus no flap Two studies assessed this comparison. Both assessed the effects of the sternocleidomastoid muscle flap procedure on the incidence rate of Frey's syndrome assessed clinically but neither showed a significant difference between groups (risk ratio (RR) 0.08, 95% confidence interval (CI) 0.00 to 1.23; 24 participants and RR 1.23, 95% CI 0.88 to 1.73; 36 participants; very low-certainty evidence). We did not pool the data due to the high heterogeneity (I² = 87%). One study found that the sternocleidomastoid muscle flap may result in little or no difference in other complications including haematoma (RR 2.18, 95% CI 0.09 to 50.16; 36 participants; low-certainty evidence), subjective painful or restricted cervical movement (RR 0.54, 95% CI 0.14 to 2.05; 36 participants; low-certainty evidence) and scar spread in the cervical region (RR 0.71, 95% CI 0.05 to 10.54; 36 participants; low-certainty evidence). Both studies reported the incidence rate of Frey's syndrome assessed by participants, with one reporting no events in either group and the other finding no evidence of a difference (RR 0.63, 95% CI 0.32 to 1.26; 36 participants; low-certainty evidence). Acellular dermal matrix versus no graft Only one study assessed this comparison. Use of an acellular dermal matrix graft may result in little or no difference to the incidence rate of Frey's syndrome (assessed clinically) in comparison with the no graft group, but the evidence is very uncertain (RR 0.08, 95% CI 0.00 to 1.25; 30 participants; very low-certainty evidence). Acellular dermal matrix may slightly increase the wound infection rate compared with control (RR 17.00, 95% CI 1.02 to 282.67; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence of seromas or sialoceles (RR 2.33, 95% CI 0.66 to 8.23; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence rate of Frey's syndrome (assessed by participants) in comparison with the no graft group (RR 0.33, 95% CI 0.04 to 3.04; 64 participants; low-certainty evidence). The evidence for the effectiveness of graft interposition in preventing Frey's syndrome is of low or very low certainty. The use of acellular dermal matrix may be associated with an increase in the wound infection rate, and little or no difference in the incidence of seromas or sialoceles. Further studies are needed to draw reliable conclusions.\nOutput:\n" }, { "from": "agent", "value": "We included three studies with 124 participants in this review, but the quality of these studies was not ideal. All of the participants in the studies had tumours of the parotid glands and were undergoing surgery to part of the glands. The studies assessed two types of grafts, tissue obtained from the sternocleidomastoid muscle and a biomaterial (a collagen framework without cells). Two studies compared a tissue graft obtained from the sternocleidomastoid muscle to no graft. It is not known whether this type of tissue graft can prevent Frey's syndrome because the available evidence is very uncertain. One study compared a biomaterial graft to no graft. This type of graft may result in little or no difference to the incidence rate of Frey's syndrome, but the evidence is very uncertain. It may make the patient's wound slightly more likely to become infected. The evidence in this review is mostly of low or very low certainty, because of the small number of studies on this question and the risk of bias in these studies. The findings must therefore be treated with caution and further studies are needed to draw reliable conclusions. The evidence in this review is up to date to 5 February 2019." } ]

[ { "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: Only two trials of limited quality met our inclusion criteria. One study compared two biphasic pills and one triphasic pill, each containing levonorgestrel and ethinyl estradiol. No important differences emerged, and the frequency of discontinuation due to medical problems was similar with all three pills. The other trial compared a biphasic pill containing norethindrone (Ortho 10/11) with a triphasic pill containing levonorgestrel (Triphasil) and with another triphasic containing norethindrone (Ortho 7/7/7). The biphasic pill had inferior cycle control compared with the levonorgestrel triphasic. The odds ratio of cycles with intermenstrual bleeding was 1.70 (95% confidence interval (CI) 1.29 to 2.24) for the biphasic compared with the triphasic levonorgestrel pill. The odds ratio of cycles without withdrawal bleeding was 6.48 (95% CI 3.13 to 13.39). In contrast, cycle control with the biphasic pill was comparable to that of the triphasic containing the same progestin (norethindrone). The available evidence is limited and the internal validity of these trials is questionable. Given the high losses to follow up, these reports may even be considered observational. Given that caveat, the biphasic pill containing norethindrone was associated with inferior cycle control compared with the triphasic pill containing levonorgestrel. The choice of progestin may be more important than the phasic regimen in determining bleeding patterns.\nOutput:\n" }, { "from": "agent", "value": "We did a computer search for studies of birth control pills with two phases versus pills with three phases. We also wrote to researchers and manufacturers to find other trials. We included randomized trials in any language. We found only two trials that looked at two-phase versus three-phase birth control pills. The studies did not have good methods and the authors did not report all their methods. Many women dropped out of the studies, which affects what can be said about the results. One study compared two types of two-phase pills with a three-phase pill. The pills did not differ in any major ways, including the numbers of women who stopped using the pills due to health problems. The other trial compared a two-phase pill with two different three-phase pills. The two-phase pill had worse bleeding patterns than the three-phase pill with a different hormone (levonorgestrel). In contrast, bleeding with the two-phase pill was like that of the three-phase pill with the same hormone (norethindrone). The type of hormone may be more important than the phases for cycle control. These trials did not provide enough evidence to say if three-phase pills worked any better than two-phase types for birth control, bleeding patterns, or staying on the pill. More research would be needed to show whether three-phase pills were better than two-phase pills. However, two-phase pills are not used enough to justify further research." } ]

[ { "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: Two trials randomised in total 106 patients to piggy-back method (n = 53) versus conventional method with veno-venous bypass (n = 53). Both trials were at high risk of bias. There was no significant difference in post-operative mortality, primary graft non-function, vascular complications, renal failure, transfusion requirements, intensive therapy unit (ITU) stay, or hospital stay between the two groups. The warm ischaemic time was significantly shorter in the piggy-back method than the conventional method (MD -11.50 minutes; 95% CI -19.35 to -3.65; P < 0.01). The proportion of patients who developed chest complications were significantly higher in the the piggy-back method than the conventional method (75.8% versus 44.1%; P = 0.01). One trial randomised 80 patients to piggy-back with porto-caval bypass (n = 40) versus piggy-back without porto-caval bypass (n = 40). This trial was at high risk of bias. There was no significant difference in post-operative mortality, re-transplantation due to primary graft non-function, vascular complications, renal failure, or hospital stay between the two groups. Fewer patients required blood transfusion in the piggy-back with porto-caval bypass group (55%) than the piggy-back without porto-caval bypass group (75%) (P = 0.02). There was no significant difference in the mean amount of blood transfused between the groups (MD -1.00 unit; 95% CI -2.19 to 0.19; P = 0.10). The ITU stay was significantly shorter in the piggy-back with porto-caval bypass group (2.9 days) than the piggy-back without porto-caval bypass group (4.9 days; MD -2.00 days; 95% CI -3.82 to -0.18; P = 0.03). There were no trials comparing piggy-back method with conventional method without veno-venous bypass or different techniques of piggy-back method. There is currently no evidence to recommend or refute the use of piggy-back method of liver transplantation.\nOutput:\n" }, { "from": "agent", "value": "We systematically searched various medical databases to determine how the piggy-back method compares with the standard method of liver transplantation or with different piggy-back techniques. Two clinical trials randomised 106 patients to the piggy-back method (53 patients) versus the standard method (53 patients). Both trials were at high risk of systematic errors. There was no significant difference in post-operative death, primary graft non-function (the liver graft does not start functioning at all), complications related to the blood vessels, kidney failure, blood transfusion requirements, intensive therapy unit (ITU) stay, or hospital stay between the two groups. The proportion of patients who developed chest complications were significantly higher with the piggy-back method than with the conventional method (76% in piggy-back method versus 44% in conventional method; statistically significant). One trial randomised 80 patients to a variant of piggy-back (in which blood from the intestines is temporarily diverted; 40 patients) versus standard piggy-back method (in which blood from the intestines is blocked; 40 patients). This trial was at high risk of systematic error. There was no significant difference in post-operative death, re-transplantation due to primary graft non-function (liver graft does not start functioning at all), vascular complications, kidney failure, or hospital stay between the two groups. Significantly fewer patients required blood transfusion with the variant piggy-back method (55%) than with the standard piggy-back method (75%). The ITU stay was significantly shorter in the variant (2.9 days) than with the standard piggy-back method (4.9 days). There were no trials comparing piggy-back method and standard method of liver transplantation without diversion of venous blood or different techniques of piggy-back method. We conclude that there is currently no evidence to recommend or refute the use of piggy-back method of liver transplantation." } ]

[ { "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: Nineteen studies involving a total of 2,159 participants met criteria for inclusion. It was not possible to conduct a meta-analysis due to study heterogeneity with respect to populations, interventions, comparison groups, outcomes, and length of follow-up. Sample sizes ranged from 22 to 367. The populations studied ranged from general HIV-positive populations to studies focusing exclusively on children, women, Latinos, or adults with a history of alcohol dependence, to studies focusing almost exclusively on men. Study interventions included cognitive behavioral therapy, motivational interviewing, medication management strategies, and interventions indirectly targeting adherence, such as programs directed to reduce risky sexual behaviours. Ten studies demonstrated a beneficial effect of the intervention on adherence. We found that interventions targeting practical medication management skills, those administered to individuals vs groups, and those interventions delivered over 12 weeks or more were associated with improved adherence outcomes. We also found that interventions targeting marginalized populations such as women, Latinos, or patients with a past history of alcoholism were not successful at improving adherence. We were unable to determine whether effective adherence interventions were associated with improved virological or immunological outcomes. Most studies had several methodological shortcomings leaving them vulnerable to potential biases. We found evidence to support the effectiveness of patient support and education interventions intended to improve adherence to antiretroviral therapy. Interventions targeting practical medication management skills, those interventions administered to individuals vs groups, and those interventions delivered over 12 weeks or more were associated with improved adherence outcomes. There is a need for standardization and increased methodological rigour in the conduct of adherence trials.\nOutput:\n" }, { "from": "agent", "value": "This review identified 19 studies involving a total of 2,159 participants that evaluated an intervention intended to improve adherence. Ten of these studies demonstrated a beneficial effect of the intervention. We found that interventions targeting practical medication management skills, those administered to individuals vs groups, and those interventions delivered over 12 weeks or more were associated with improved adherence to antiretroviral therapy. We also found that interventions targeting marginalized populations such as women, Latinos, or patients with a past history of alcoholism were not successful at improving adherence. We did not find studies that evaluated the quality of the patient-provider relationship or the clinical setting. Most studies had several methodological shortcomings." } ]

[ { "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: Sixty-six randomised trials, involving 8302 participants, met the inclusion criteria. Methodological quality was generally low. Sixty-nine different herbal medicines were tested in the included trials, which compared herbal medicines with placebo, hypoglycaemic drugs, or herbal medicines plus hypoglycaemic drugs. Compared with placebo, Holy basil leaves, Xianzhen Pian, Qidan Tongmai, traditional Chinese formulae (TCT), Huoxue Jiangtang Pingzhi, and Inolter showed significantly hypoglycaemic response. Compared with hypoglycaemic drugs including glibenclamide, tolbutamide, or gliclazide, seven herbal medicines demonstrated a significant better metabolic control, including Bushen Jiangtang Tang, Composite Trichosanthis, Jiangtang Kang, Ketang Ling, Shenqi Jiangtang Yin, Xiaoke Tang, and Yishen Huoxue Tiaogan. In 29 trials that evaluated herbal medicines combined with hypoglycaemic drugs, 15 different herbal preparations showed additional better effects than hypoglycaemic drugs monotherapy. Two herbal therapies combined with diet and behaviour change showed better hypoglycaemic effects than diet and behaviour change alone. No serious adverse effects from the herbal medicines were reported. Some herbal medicines show hypoglycaemic effect sin type 2 diabetes. However, these findings should be carefully interpreted due to the low methodological quality, small sample size, and limited number of trials. In the light of some positive findings, some herbal medicines deserve further examination in high-quality trials.\nOutput:\n" }, { "from": "agent", "value": "This systematic review evaluates the effects of various herbal preparations (including single herbs or mixtures of different herbs) for treating people with type 2 diabetes. The review shows that some herbal medicines lower blood sugar and relieving symptoms in patients with diabetes. However, the methodological quality of the clinical trials evaluating these herbs is generally poor. The analyses also indicate that trials with positive findings are more likely to be associated with exaggerated effects. However, the trials did not report significant adverse effects. In conclusion, herbal medicines should not be recommended for routine use in diabetic patients of type 2 diabetes until we get scientifically sound trials. Testing the herbs in larger, well-designed trials is needed in order to establish the necessary evidence for their 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: Primary outcome Mean improvement in the maintenance of wakefulness test was available for two of the five identified trials accounting for 48 participants. The mean difference +2.52(95% confidence interval (CI) -2.32 to +7.37), was not significant and there was marked heterogeneity across these studies (I2= 50%). Secondary outcomes Mean improvement in the Epworth Sleepiness Scale was available in four trials accounting for 101 participants. The mean difference was -2.26 (95% CI -3.78to -0.73), significantly in favor of modafinil with marked heterogeneity across the studies (I2= 84%). There was no evidence for any treatment benefit on the multiple sleep latency test or quality of life. There is low quality evidence from two small trials that psychostimulants do not significantly improve the maintenance of wakefulness test in myotonic dystrophy. There is low quality evidence from four studies that modafinil significantly improves the Epworth Sleepiness Scale. More randomized trials are needed to evaluate the efficacy and safety of psychostimulants.\nOutput:\n" }, { "from": "agent", "value": "In this updated review there were few randomized controlled trials which evaluated the efficacy and safety of psychostimulants in myotonic dystrophy. One randomized controlled trial of selegiline involving 11 participants did not demonstrate any benefit. Four studies of another drug modafinil suggested inconsistent and slight benefits. Only two of these studies used the gold standard test, a sleepiness scale, to evaluate hypersomnia and found non significant improvement. In these four studies modafinil seemed well tolerated. Further randomized trials are needed to determine the utility of psychostimulants for myotonic dystrophy." } ]

[ { "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 trials (of high risk of bias) involving 152 patients randomised to gastrojejunostomy (80 patients) and no gastrojejunostomy (72 patients). In both trials, patients were found to be unresectable during exploratory laparotomy. Most of the patients also underwent biliary-enteric drainage. There was no evidence of difference in the overall survival (HR 1.02; 95% CI 0.84 to 1.25), peri-operative mortality or morbidity, quality of life, or hospital stay (MD 0.97 days; 95%CI -0.18 to 2.12) between the two groups. The proportion of patients who developed long-term gastric outlet obstruction was significantly lower in the prophylactic gastrojejunostomy group (2/80; 2.5%) compared with no gastrojejunostomy group (20/72; 27.8%) (RR 0.10; 95%CI 0.03 to 0.37). The operating time was significantly longer in the gastrojejunostomy group compared with no gastrojejunostomy group (MD 45.00 minutes; 95%CI 21.39 to 68.61). Routine prophylactic gastrojejunostomy is indicated in patients with unresectable periampullary cancer undergoing exploratory laparotomy (with or without hepaticojejunostomy).\nOutput:\n" }, { "from": "agent", "value": "We identified two trials (of high risk of bias or systematic error) involving 152 patients randomised to gastrojejunostomy (80) and no gastrojejunostomy (72). In both studies, patients were found to be unresectable during operations aimed at surgical removal i.e. the stomach was opened to remove the cancer but the cancer could not be removed. There was no evidence of any difference in the overall survival, surgical complications, quality of life, or hospital stay between the two groups. The proportion of patients who developed long-term stomach outflow obstruction was significantly lower in the prophylactic gastrojejunostomy group (2.5%) compared with no gastrojejunostomy group (27.8%). The operating time was significantly longer in the gastrojejunostomy group compared with no gastrojejunostomy group by about 45 minutes. Routine prophylactic gastrojejunostomy is indicated in patients with unresectable periampullary cancer undergoing open operation of the stomach. There is no information available currently about the necessity for prophylactic gastrojejunostomy in patients with periampullary cancer diagnosed to be unresectable by investigations such as scans. Further trials of low risk of bias are necessary to assess the role of prophylactic gastrojejunostomy in patients with unresectable periampullary cancer." } ]

[ { "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: Eight randomised controlled trials, enrolling 10,037 children, met our inclusion criteria. Seven of the trials were conducted in Africa. In general, the included studies were at a low risk of bias. There may have been a risk of performance bias as trial participants were aware which intervention group they were in, but we did not consider this likely to have biased the outcome measurement. We were unable to assess the risk of reporting bias in half of the trials and two trials were at high risk of attrition bias. Any specially formulated food versus standard care - the provision of food increased the recovery rate by 29% (RR 1.29, 95% CI 1.20 to 1.38; 2152 children, two trials; moderate quality evidence), decreased the number dropping out by 70% (RR 0.30, 95% CI 0.22 to 0.39; 1974 children, one trial; moderate quality evidence), and improved weight-for-height (MD 0.20 z-score, 95% CI 0.03 to 0.37; 1546 children, two trials; moderate quality evidence). The reduction in mortality did not reach statistical significance (RR 0.44; 95% CI 0.14 to 1.36; 1974 children, one trial; low quality evidence). Lipid-based nutrient supplements versus any blended foods (dry food mixtures, without high lipid content), at full doses - there was no significant difference in mortality (RR 0.93, 95% CI 0.54 to 1.62; 6367 children, five trials; moderate quality evidence), progression to severe malnutrition (RR 0.88, 95% CI 0.72 to 1.07; 4537 children, three trials; high quality evidence), or the number of dropouts from the nutritional programme (RR 1.14, 95% CI 0.62 to 2.11; 5107 children, four trials; moderate quality evidence). However, lipid-based nutrient supplements significantly increased the number of children recovered (RR 1.10, 95% CI 1.04 to 1.16; 6367 children, five trials; moderate quality evidence), and decreased the number of non-recovering children (RR 0.53, 95% CI 0.40 to 0.69; 4537 children, three trials; high quality evidence). LNS also improved weight gain, weight-for-height, and mid-upper arm circumference, although for these outcomes, the improvement was modest (moderate quality evidence). One trial observed more children with vomiting in the lipid-based nutrient supplements group compared to those receiving blended food (RR 1.43, 95% CI 1.11 to 1.85; 2712 children, one trial; low quality evidence). Foods at complementary doses - no firm conclusion could be drawn on the comparisons between LNS at complementary dose and blended foods at complementary or full dose (low quality evidence). Lipid-based nutrient supplements versus specific types of blended foods - a recently developed enriched blended food (CSB++) resulted in similar outcomes to LNS (4758 children, three trials; moderate to high quality evidence). Different types of blended foods - in one trial, CSB++ did not show any significant benefit over locally made blended food, for example, Misola, in number who recovered, number who died, or weight gain (moderate to high quality evidence). Improved adequacy of home diet - no study evaluated the impact of improving adequacy of local diet, such as local foods prepared at home according to a given recipe or of home processing of local foods (soaking, germination, malting, fermentation) in order to increase their nutritional content. In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with MAM. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. Most of the research so far has focused on industrialised foods, and on short-term outcomes of MAM. There are no studies evaluating interventions to improve the quality of the home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent.\nOutput:\n" }, { "from": "agent", "value": "We searched eight electronic databases and three trials registers (in October 2012 for all except Embase, which was searched in August 2012). We also searched the reference lists of relevant papers and contacted nutrition-related organisations and researchers in this field. We found eight relevant randomised controlled trials, enrolling 10,037 children under five years of age. All but one study was conducted in Africa. The risk of bias in the studies was generally low, though two studies had a high dropout rate. The participants were aware which intervention group they were in and this may have influenced their behaviour but we thought it unlikely it would have influenced the results since the outcomes measured were objective ones. For four of the studies, we were unable to assess if the study authors reported all the outcomes they intended to measure. When any type of specially formulated food was compared to standard care (medical care and counselling without foods), the children treated with foods had a higher chance of recovering from moderate malnutrition (two studies), greater improvement in nutritional status (two studies), and a lower number of dropouts (one study). A reduction in mortality was not shown. When lipid-based nutrient supplements (which are food with high energy density and high lipid content) at full dose were compared to blended foods at full dose (which are dry food mixtures without high lipid content), there was no difference between these two types of foods in terms of number of deaths (five studies), children progressing to severe acute malnutrition (three studies), and children dropping out (four studies). However, lipid-based nutrient supplements increased the number recovered by 10% (five studies), decreased the number of children non-recovering (three studies), and slightly improved the nutritional status among the recovered. One study observed more children vomiting when given lipid-based nutrient supplements compared to blended foods, but this was not reported by the other studies. No other side effects were reported. Few studies evaluated foods at complementary dosage (i.e. foods given in low quantity, just to complement the diet and not to fully substitute it), and no conclusion could be drawn from these studies. When specific foods were compared to each other, a type of corn-soy blended food called CSB++ compared to lipid-based nutrient supplements resulted in similar outcomes, while results of another blended food (CSB pre-mix) versus lipid-based nutrient supplements were unclear. In one study, CSB++ did not show any significant benefit over locally-made blended foods, for example, Misola. No study evaluated the impact of improving adequacy of local diet, such as local foods prepared at home according to a given recipe or of home processing of local foods (soaking, germination, malting, fermentation) in order to increase their nutritional content. In conclusion, there is moderate to high quality evidence that both lipid-based nutrient supplements and blended foods are effective in treating children with moderate acute malnutrition. Although lipid-based nutrient supplements (LNS) led to a clinically significant benefit in the number of children recovered in comparison with blended foods, LNS did not reduce mortality, the risk of default or progression to SAM. It also induced more vomiting. Blended foods such as CSB++ may be equally effective and cheaper than LNS. There are no studies evaluating special recipes to improve the adequacy of the usual home diet, an approach that should be evaluated in settings where food is available, and nutritional education and habits are the main determinants of malnutrition. There are no studies from Asia, where moderate acute malnutrition is most prevalent." } ]

[ { "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 trials were included from the 2012 search. The review still includes two trials of short duration comparing sulpiride with placebo (total n = 113). No study reported our primary outcome of interest of 'global state: clinically significant response', nor our secondary outcomes of interest of 'quality of life', 'severe adverse effects', and 'safety assessments'. As regards mental state, there were no clear differences between groups for either positive or negative symptoms; measured positive symptoms using the Manchester scale were skewed and therefore not included in meta-analysis (n = 18, 1 RCT, very low quality evidence). Measured negative symptoms using the Manchester scale also demonstrated no clear difference (n = 18, 1 RCT, MD -3.0 CI -1.66 to 1.06, very low quality evidence). Few people left these studies by three months (n = 113, 2 RCTs, RR 1.00 CI 0.25 to 4.00). One subscore finding demonstrated a significant improvement in social behaviour using the Current Behaviour Schedule (CBS) when receiving placebo (n = 18, 1 RCT, MD -2.90 CI -5.60 to -0.20). There were no data for many important outcomes such as global outcomes, service use or adverse effects. Sulpiride may be an effective antipsychotic drug but evidence of its superiority over placebo from randomised trials is very limited. Practice will have to use evidence from sources other than trials until better evidence is generated.\nOutput:\n" }, { "from": "agent", "value": "The aim of this review was to evaluate the effects of sulpiride for schizophrenia compared to placebo (‘dummy’ treatment). Two short-term (12 weeks) studies with a total of 113 people are included. Information was limited and poorly reported. The inclusion of two small studies with small sample sizes meant that resulting data were not overly robust or meaningful. Overall no clear difference was noted between those receiving sulpiride and those receiving placebo for mental state or for leaving the study early. There was no information on other important outcomes, including: general functioning, service use, hospital admission, employment, family burden, satisfaction with care and side effects. The use of sulpiride seems to be based on clinical experience rather than strong evidence. Its widespread use in developing countries might have more to do with its lower cost than its effectiveness. Longer, well-planned, better conducted and reported randomised control trials would contribute to our knowledge about the effectiveness and potential side effects of this drug. This plain language summary has been written by a consumer Benjamin Gray: Service User and Service User Expert: Rethink Mental Illness. Email: [email protected]" } ]

[ { "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 11 trials (800 participants) and two ongoing studies. Style and duration of yoga differed between trials. Half of the participants recruited to the studies were at high risk of CVD. Most of studies were at risk of performance bias, with inadequate details reported in many of them to judge the risk of selection bias. No study reported cardiovascular mortality, all-cause mortality or non-fatal events, and most studies were small and short-term. There was substantial heterogeneity between studies making it impossible to combine studies statistically for systolic blood pressure and total cholesterol. Yoga was found to produce reductions in diastolic blood pressure (mean difference (MD) -2.90 mmHg, 95% confidence interval (CI) -4.52 to -1.28), which was stable on sensitivity analysis, triglycerides (MD -0.27 mmol/l, 95% CI -0.44 to -0.11) and high-density lipoprotein (HDL) cholesterol (MD 0.08 mmol/l, 95% CI 0.02 to 0.14). However, the contributing studies were small, short-term and at unclear or high risk of bias. There was no clear evidence of a difference between groups for low-density lipoprotein (LDL) cholesterol (MD -0.09 mmol/l, 95% CI -0.48 to 0.30), although there was moderate statistical heterogeneity. Adverse events, occurrence of type 2 diabetes and costs were not reported in any of the included studies. Quality of life was measured in three trials but the results were inconclusive. The limited evidence comes from small, short-term, low-quality studies. There is some evidence that yoga has favourable effects on diastolic blood pressure, HDL cholesterol and triglycerides, and uncertain effects on LDL cholesterol. These results should be considered as exploratory and interpreted with caution.\nOutput:\n" }, { "from": "agent", "value": "We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of yoga on adults at high risk of developing CVD. We did not included people who had already had CVD (e.g. heart attacks and strokes). The evidence is current to December 2013. We found 11 trials (800 participants), none of them were large enough or of long enough duration to examine the effects of yoga on decreasing death or non-fatal endpoints.There were variations in the style and duration of yoga and the follow-up of the interventions ranged from three to eight months.The results showed that yoga has favourable effects on diastolic blood pressure, high-density lipoprotein (HDL) cholesterol and triglycerides (a blood lipid), and uncertain effects on low-density lipoprotein (LDL) cholesterol. None of the included trials reported adverse events, the occurrence of type 2 diabetes or costs. Longer-term, high-quality trials are needed in order to determine the effectiveness of yoga for CVD prevention. These results should be considered as exploratory and interpreted with caution. This is because the included studies were of short duration, small and at risk of bias (where there was a risk of arriving at the wrong conclusions because of favouritism by the participants or researchers)." } ]

[ { "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 studies of vitamin A or other retinoid supplementation were eligible for inclusion. However, one randomised study of beta (β)-carotene supplementation involving 24 people with CF who were receiving pancreatic enzyme substitution was included. The study compared successive β-carotene supplementation periods (high dose followed by low dose) compared to placebo. The results for the low-dose supplementation period should be interpreted with caution, due to the lack of a wash-out period after the high-dose supplementation. The included study did not report on two of the review's primary outcomes (vitamin A deficiency disorders and mortality); results for our third primary outcome of growth and nutritional status (reported as z score for height) showed no difference between supplementation and placebo, mean difference (MD) -0.23 (95% confidence interval (CI) -0.89 to 0.43) (low-quality evidence). With regards to secondary outcomes, supplementation with high-dose β-carotene for three months led to significantly fewer days of systemic antibiotics required to treat pulmonary exacerbations, compared to controls, MD -15 days (95% CI -27.60 to -2.40); however, this was not maintained in the second three-month section of the study when the level of β-carotene supplementation was reduced, MD -8 days (95% CI -18.80 to 2.80) (low-quality evidence). There were no statistically significant effects between groups in lung function (low-quality evidence) and no adverse events were observed (low-quality evidence). Supplementation affected levels of β-carotene in plasma, but not vitamin A levels. The study did not report on quality of life or toxicity. Since no randomised or quasi-randomised controlled studies on retinoid supplementation were identified, no conclusion on the supplementation of vitamin A in people with CF can be drawn. Additionally, due to methodological limitations in the included study, also reflected in the low-quality evidence judged following the specific evidence grading system (GRADE), no clear conclusions on β-carotene supplementation can be drawn. Until further data are available, country- or region-specific guidelines regarding these practices should be followed.\nOutput:\n" }, { "from": "agent", "value": "No studies comparing vitamin A or other retinoid supplements to placebo (dummy drug containing no vitamin A) were included, but we did find one study comparing beta-carotene supplementation (a precursor of vitamin A) to placebo. A total of 24 people with cystic fibrosis (aged 6.7 to 27.7 years) were put into groups at random and treated either with β-carotene capsules (at a high dose for three months followed by a low dose for a further three months) or with placebo (for six months). No studies on vitamin A supplementation were included in this review. The single included study revealed that high-dose beta-carotene supplementation for three months led to fewer days on which people with CF required antibiotics compared to placebo, but this was not the case in the following three-month section of the study when low-dose beta-carotene supplementation was compared to placebo. Other clinical outcome measures (growth, nutritional status and lung function) showed no statistical significant differences between treatment and placebo groups. No side effects were observed. The other outcomes in this review, such as vitamin A deficiency symptoms, mortality, toxicity and quality of life, were not reported. We could only include one study in this review and that study had several limitations. This is reflected in the assessment of low-quality evidence, judged using the specific evidence grading system (GRADE). So, we feel that the strength of evidence is low. Not all outcome measures were reported after each supplementation dose and results should be viewed with some caution as some beta-carotene from the high-dose period was probably still present in the blood during the low-dose supplementation period. Since no studies on vitamin A supplementation were included in the review, no conclusions can be drawn regarding the routine use of vitamin A supplements. Due to limitations of the included study of beta-carotene supplementation, no definitive conclusions regarding its use can be drawn either. Until further evidence is available, local guidelines should be followed regarding supplementation." } ]

[ { "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 four RCTs (N = 238 participants) that explored: a two-day workshop-based transition preparation training for adolescents with spina bifida; a nurse-led, one-on-one, teaching session with the additional support of a ‘health passport’ for adolescents with heart disease; a web- and SMS-based educational intervention for adolescents with a range of different conditions; and a structured comprehensive transition programme with a transition co-ordinator for adolescents with type 1 diabetes. One study evaluating a one-on-one nurse-led intervention, and one evaluating a technology-based intervention suggested that these interventions may lead to slight improvements in transitional readiness and chronic disease self-management measured at six- to eight-month follow-ups (low certainty evidence). Results with the TRAQ self-management tool were: MD 0.20; 95% CI -0.16 to 0.56 and MD 0.43; 95% CI; -0.09 to 0.95; with the TRAQ self-advocacy tool: MD 0.37; 95% CI -0.06 to 0.80; and with the PAM tool were: MD 10; 95% CI 2.96 to 17.04. In contrast, transition-preparation training delivered via a two-day workshop for patients with spina bifida may lead to little or no difference in measures of self-care practice and general health behaviours when measured using the DSCPI-90©. Two studies evaluated the use of health services. One study evaluated a technology-based intervention and another a comprehensive transition programme; these interventions may lead to slightly more young people taking positive steps to initiate contact with health professionals themselves (Relative risk (RR): 4.87; 95% CI 0.24 to 98.12 and RR 1.50; 95% CI 0.32 to 6.94, respectively; low certainty evidence. Young people’s knowledge of their disease may slightly improve with a nurse-led, one-on-one intervention to prepare young people for transition to an adult congenital heart programme (MD 14; 95% CI 2.67 to 25.33; one study; low certainty evidence). Disease-specific outcome measures were reported in two studies, both of which led to little or no difference in outcomes (low certainty evidence). One study found little or no difference between intervention and control groups. A second study found that follow-up HbA1c in young people with type 1 diabetes mellitus increased by 1.2% for each percentage increase in baseline HbA1c, independent of treatment group (1.2%; 95% CI 0.4 to 1.9; P = 0.01). Transition interventions may lead to little or no difference in well-being or quality of life as measured with the PARS III or PedsQ (two studies; low certainty evidence). Both the technology-based intervention and the two-day workshop for young people with spina bifida found little or no difference between intervention and control groups (MD 1.29; 95% CI -4.49 to 7.07). One study did not report the data. Four telephone support calls from a transition co-ordinator may lead to little or no difference in rates of transfer from paediatric to adult diabetes services (one study; low certainty evidence). At 12-month follow-up, there was little or no difference between groups of young people receiving usual care or a telephone support (RR 0.80; 95% CI 0.59 to 1.08)). They may slightly reduce the risk of disease-related hospital admissions at 12-month follow-up (RR 0.29; 95% CI 0.03 to 2.40). The available evidence (four small studies; N = 238), covers a limited range of interventions developed to facilitate transition in a limited number of clinical conditions, with only four to 12 months follow-up. These follow-up periods may not be long enough for any changes to become apparent as transition is a lengthy process. There was evidence of improvement in patients' knowledge of their condition in one study, and improvements in self-efficacy and confidence in another, but since few studies were eligible for this review, and the overall certainty of the body of this evidence is low, no firm conclusions can be drawn about the effectiveness of the evaluated interventions. Further research is very likely to have an important impact on our confidence in the intervention effect and likely could change our conclusions. There is considerable scope for the rigorous evaluation of other models of transitional care, reporting on clinical outcomes with longer term follow-up.\nOutput:\n" }, { "from": "agent", "value": "We searched the literature up to 19 June 2015 and found four studies (N = 238 participants) for this review. The studies evaluated four different types of educational interventions, all targeting adolescents with different clinical conditions. All sought to improve knowledge and self-management skills of adolescents in preparation for transition to adult care. Three of the transitional-care programmes found that the intervention may slightly improve transitional readiness in young people, enabling them to better self-manage and adjust to using adult health services. One transitional-care programme that evaluated a two-day workshop for young people with spina bifida found little or no difference in measures of transitional readiness. Transitional-care programmes may slightly improve a young persons knowledge of their condition and their own appropriate use of health services. Transitional-care programmes led to little or no difference in health status, quality of life or well-being, or rates of transfer from child to adult health services. While there is a wide range of transition programmes that are being developed in different countries, often within particular clinical specialties, this review only identified four small studies that provided low certainty evidence about educational interventions targeting participating adolescents, and no studies of interventions that targeted the organisation of care (for example, joint clinics or provision of a key worker). Other limitations with the evidence are the small number of adolescents recruited, the limited number of clinical conditions studied, the short follow up (12 months or less), and the fact that only two of the included studies reported on the primary outcome (that is, condition-specific clinical outcomes). Despite the challenges in designing studies that can test these types of interventions, such as evaluating a complex intervention, a stronger evidence base is needed to inform the development of these services." } ]

[ { "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 industry-sponsored randomised controlled trials (3327 participants) in the review. Seven trials compared pregabalin to placebo. For the primary outcome, participants randomised to pregabalin were significantly more likely to attain a 50% or greater reduction in seizure frequency compared to placebo (RR 2.28, 95% CI 1.52 to 3.42, 7 trials, 2193 participants, low-certainty evidence). The odds of response doubled with an increase in dose from 300 mg/day to 600 mg/day (OR 1.99, 95% CI 1.74 to 2.28), indicating a dose-response relationship. Pregabalin was significantly associated with seizure freedom (RR 3.94, 95% CI 1.50 to 10.37, 4 trials, 1125 participants, moderate-certainty evidence). Participants were significantly more likely to withdraw from pregabalin treatment than placebo for any reason (RR 1.35, 95% CI 1.11 to 1.65, 7 trials, 2193 participants, moderate-certainty evidence) and for adverse effects (RR 2.65, 95% CI 1.88 to 3.74, 7 trials, 2193 participants, moderate-certainty evidence). Three trials compared pregabalin to three active-control drugs: lamotrigine, levetiracetam, and gabapentin. Participants allocated to pregabalin were significantly more likely to achieve a 50% or greater reduction in seizure frequency than those allocated to lamotrigine (RR 1.47, 95% CI 1.03 to 2.12, 1 trial, 293 participants) but not those allocated to levetiracetam (RR 0.94, 95% CI 0.80 to 1.11, 1 trial, 509 participants) or gabapentin (RR 0.96, 95% CI 0.82 to 1.12, 1 trial, 484 participants). We found no significant differences between pregabalin and lamotrigine (RR 1.39, 95% CI 0.40 to 4.83) for seizure freedom, however, significantly fewer participants achieved seizure freedom with add-on pregabalin compared to levetiracetam (RR 0.50, 95% CI 0.30 to 0.85). No data were reported for this outcome for pregabalin versus gabapentin. We found no significant differences between pregabalin and lamotrigine (RR 1.07, 95% CI 0.75 to 1.52), levetiracetam (RR 1.03, 95% CI 0.71 to 1.49), or gabapentin (RR 0.78, 95% CI 0.57 to 1.07) for treatment withdrawal due to any reason or due to adverse effects (pregabalin versus lamotrigine: RR 0.89, 95% CI 0.53 to 1.48; versus levetiracetam: RR 1.29, 95% CI 0.66 to 2.54; versus gabapentin: RR 1.07, 95% CI 0.54 to 2.11). Ataxia, dizziness, somnolence, weight gain, and fatigue were significantly associated with pregabalin. We rated the overall risk of bias in the included studies as low or unclear due to the possibility of publication bias and lack of methodological details provided. We rated the certainty of the evidence as very low to moderate using the GRADE approach. Pregabalin, when used as an add-on drug for treatment-resistant focal epilepsy, is significantly more effective than placebo at producing a 50% or greater seizure reduction and seizure freedom. Results demonstrated efficacy for doses from 150 mg/day to 600 mg/day, with increasing effectiveness at 600 mg doses, however issues with tolerability were noted at higher doses. The trials included in this review were of short duration, and longer-term trials are needed to inform clinical decision making.\nOutput:\n" }, { "from": "agent", "value": "This review examined data from 9 trials including a total of 3327 participants. Study participants were assigned using a random method to take pregabalin, placebo, or another antiepileptic drug in addition to their usual antiepileptic drugs. Participants taking pregabalin were more than twice as likely to have their seizure frequency reduced by 50% or more during a 12-week treatment period compared to those taking placebo, and were nearly four times more likely to be completely free of seizures. Pregabalin was shown to be effective across a range of doses (150 mg to 600 mg), with increasing effectiveness at higher doses. There was also an increased likelihood of treatment withdrawal with pregabalin. Side effects associated with pregabalin included ataxia, dizziness, fatigue, somnolence, and weight gain. When pregabalin was compared to three other antiepileptic drugs (lamotrigine, levetiracetam, and gabapentin), participants taking pregabalin were more likely to achieve a 50% reduction in seizure frequency than those taking lamotrigine. We found no significant differences between pregabalin and levetiracetam or gabapentin as add-on drugs. We rated all included studies as at low or unclear in risk of bias due to missing information about the methods used to conduct the trial and a suspicion of publication bias. Publication bias can occur when studies that report non-significant findings are not published. We suspected publication bias because the majority of included studies showed significant findings and were sponsored by the same drug company. We assessed the certainty of the evidence for the primary outcome of reduction in seizure frequency as low, meaning that we cannot be certain that the finding reported is accurate. However, we rated the certainty of the evidence for the outcomes seizure freedom and treatment withdrawal as moderate, so we can be fairly confident that these results are accurate. There were no data regarding the longer-term effectiveness of pregabalin, which should be investigated in future studies. The evidence is current to 5 July 2018." } ]

[ { "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 11 studies for potential inclusion. Of those, we included three studies involving 97 women. Two additional studies are ongoing. Two trials examined in-utero fetal tracheal occlusion with standard (postnatal) care in fetuses with severe diaphragmatic hernia. Whilst the trials utilised fetal interventions that were similar, there were important differences in how access was gained to the fetus and in the timing and mode of delivery. Therefore, we did not combine these trials in meta-analysis and the results are examined in separate comparisons. One trial examined the effect of antenatal corticosteroids versus placebo. Overall, the methodological quality of the trials was variable and no data were available for a number of this review's secondary outcomes. In-utero fetal occlusion by maternal laparotomy versus standard postnatal management (one trial, 24 women) For the primary infant outcome (perinatal mortality), there were no data suitable for inclusion in the analysis. There was no difference between groups in terms of long-term infant survival (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.66 to 1.69). In-utero fetal occlusion by minimally invasive fetoscopy versus standard postnatal management (one trial, 41 women) The primary infant outcome (perinatal mortality) was not reported. Minimally invasive fetoscopy was associated with a small reduction in the mean gestational age at birth (mean difference (MD) -1.80 weeks, 95% CI -3.13 to -0.47), but there was no clear difference in the risk of preterm birth before 37 weeks (RR 1.75, 95% CI 0.78 to 3.92). Long-term infant survival (three to six months) (RR 10.50, 95% CI 1.48 to 74.71) was increased with the intervention when compared with standard management, and there was a corresponding reduction in pulmonary hypertension (RR 0.58, 95% CI 0.36 to 0.93) associated with the intervention. There was no difference between groups in terms of preterm ruptured membranes (< 37 weeks) (RR 1.47, 95% CI 0.56 to 3.88) or maternal infectious morbidity (RR 3.14, 95% CI 0.14 to 72.92), and there were no maternal blood transfusions. Antenatal corticosteroids versus placebo (one trial, 32 women) We also included one trial (involving 32 women) examining the effect of antenatal corticosteroids versus placebo. There was no clear difference in the incidence of perinatal mortality (our primary infant outcome) between the group of women who received antenatal corticosteroids and the placebo control (RR 1.24, 95% CI 0.50 to 3.08). Data (mean only) were reported for two of our secondary outcomes (mechanical ventilation and days of hospital admission) but standard deviations (SDs) were not provided. For the purposes of this review and to permit further analysis we have estimated the SDs based on the reported P values reported in the trial report, although our estimation does assume that the SD is the same in both the intervention and control groups. There were no differences between the antenatal corticosteroid group and the placebo control in terms of days of mechanical ventilation (MD 18.00 days, 95% CI -14.77 to 50.77) or days of hospital admission (MD 17.00 days, 95% CI -13.93 to 47.93) . There is currently insufficient evidence to recommend in-utero intervention for fetuses with CDH as a part of routine clinical practice. We identified three small studies, with only one study adequately reporting on the primary outcome of this review - perinatal mortality, and there were few data pertaining to many of this review's secondary outcomes. WIth regard to the administration of antenatal corticosteroids, there remains a gap in current research, and a large multicentre trial with adequate statistical power should be undertaken to answer this unresolved question. More studies are needed to further examine the effect of in-utero fetal tracheal occlusion on important neonatal outcomes and long-term infant survival and health. Long-term follow-up is of particular importance, and should include morbidity and mortality measures. Further studies should examine the benefits of an in-utero intervention on subgroups with moderate and severe congenital diaphragmatic hernia. Indeed, there are three ongoing studies, being conducted by European, North and South American fetal medicine centres, which will contribute to this gap. Ongoing research and any implementation into clinical practice should include standardisation of the procedure, inclusion criteria and long-term childhood follow-up.\nOutput:\n" }, { "from": "agent", "value": "We included three randomised controlled studies (involving 97 women). The quality of the studies was variable and a number of this review's important outcomes were not reported in the trials. Two studies compared in-utero fetal tracheal occlusion with standard postnatal repair, but differences between the two studies meant that we were unable to combine the data in our analyses. Neither study reported on perinatal deaths. In single studies, in-utero fetal occlusion was associated with a slightly lower gestational age at birth but no clear difference in the risk of preterm birth before 37 weeks; the occurrence of pulmonary hypertension was reduced. there was no difference between groups in terms of preterm rupture of membranes < 37 weeks or maternal infectious morbidity and there were no maternal blood transfusions. Long-term infant survival was improved with in-utero tracheal occlusion in one study, but not in the other. In the third study, antenatal corticosteroids were compared with placebo and there was no difference in the number of perinatal deaths. Nor was there any difference in terms of the number of days that babies were given mechanical ventilation or the number of days babies spent in hospital. We conclude that the current evidence is too limited by small numbers of pregnancies and the variable methodological quality of the trials to recommend intervention (treatment) in pregnancy for women and their unborn babies with CDH. Further high-quality trials are needed in this area. WIth regard to the administration of antenatal corticosteroids, there remains a gap in current research, and a large, high-quality trial should be undertaken to answer this unresolved question. More studies are needed to further examine the effect of in-utero fetal tracheal occlusion on important neonatal outcomes and long-term infant survival and health. Long-term follow-up is of particular importance, and should include morbidity and mortality measures. Further studies should examine the benefits of an in-utero intervention in relation to the severity of the congenital diaphragmatic hernia (i.e. moderate and severe). Indeed, there are three ongoing studies, being conducted by European, North and South American fetal medicine centres, which will contribute to this gap. Ongoing research and any implementation into clinical practice should include standardisation of the procedure, inclusion criteria and long-term childhood follow-up." } ]

[ { "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 studies, including 83 participants, are included in this review. Two studies used mantra meditation while the other two used yoga compared with drugs, relaxation training, non-specific exercises and standard treatment control. Design limitations caused high risk of bias across the studies. Only one out of four studies provided data appropriate for analysis. For this study there was no statistically significant difference between the meditation therapy group and the drug therapy group on the teacher rating ADHD scale (MD -2.72, 95% CI -8.49 to 3.05, 15 patients). Likewise, there was no statistically significant difference between the meditation therapy group and the standard therapy group on the teacher rating ADHD scale (MD -0.52, 95% CI -5.88 to 4.84, 17 patients). There was also no statistically significant difference between the meditation therapy group and the standard therapy group in the distraction test (MD -8.34, 95% CI -107.05 to 90.37, 17 patients). As a result of the limited number of included studies, the small sample sizes and the high risk of bias, we are unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. The adverse effects of meditation have not been reported. More trials are needed.\nOutput:\n" }, { "from": "agent", "value": "The objective of this review was to assess the efficacy of this treatment. As a result of the small number of studies that we were able to include in this review and the limitations of those studies, we were unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. No adverse effects of meditation in children have been reported. More trials are needed on meditation therapies for ADHD so that conclusions can be drawn regarding its effectiveness." } ]

[ { "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 no new studies for this update. We included five trials with a total of 1292 participants; agents used for thrombolysis were recombinant tissue plasminogen activator and urokinase. Trials were generally of moderate methodological quality. The quality of evidence according to GRADE was generally low owing to risk of bias (lack of blinding), imprecision in estimates, and heterogeneity. Trial results showed no clear differences in limb salvage, amputation, or death at 30 days (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.41 to 2.55, 4 studies, 636 participants; OR 0.97, 95% CI 0.51 to 1.85, 3 studies, 616 participants; OR 0.59, 95% CI 0.31 to 1.14, 4 studies, 636 participants, respectively), and we rated the evidence as low, low, and moderate quality, respectively. Trial results show no clear differences for any of the three outcomes at six months or one year between initial surgery and initial thrombolysis. A single study evaluated vessel patency, so no overall association could be determined (OR 0.46, 95% CI 0.08 to 2.76, 20 participants; very low-quality evidence). Evidence of increased risk of major haemorrhage (OR 3.22, 95% CI 1.79 to 5.78, 4 studies, 1070 participants; low-quality evidence) and distal embolisation (OR 31.68, 95% CI 6.23 to 161.07, 3 studies, 678 participants; very low-quality evidence) was associated with thrombolysis treatment at 30 days, and there was no clear difference in stroke (OR 5.33, 95% CI 0.95 to 30.11, 5 studies, 1180 participants; low-quality evidence). Participants treated by initial thrombolysis had a greater reduction in the level of intervention required, compared with a pre-intervention prediction, at 30 days (OR 9.06, 95% CI 4.95 to 16.56, 2 studies, 502 participants). None of the included studies evaluated time to thrombolysis as an outcome. There is currently no evidence in favour of either initial thrombolysis or initial surgery as the preferred option in terms of limb salvage, amputation, or death at 30 days, six months, or one year. Low-quality evidence suggests that thrombolysis may be associated with higher risk of haemorrhagic complications and ongoing limb ischaemia (distal embolisation). The higher risk of complications must be balanced against risks of surgery in each individual case. Trial results show no statistical difference in stroke, but the confidence interval is very wide, making it difficult to interpret whether this finding is clinically important. We used GRADE criteria to assess the quality of the evidence as generally low. We downgraded quality owing to risk of bias, imprecision, and heterogeneity between included studies.\nOutput:\n" }, { "from": "agent", "value": "Authors of the review identified five controlled trials with a total of 1292 participants who needed immediate care for reduced blood flow in the leg(s) (current until 7 May 2018). Participants were randomly assigned to one of two groups for initial treatment: (1) non-surgical thrombolysis, or (2) surgery. The specific agents used to break up clots (thrombolytic agents) were called recombinant tissue plasminogen activator and urokinase. The included studies provided no clear evidence about which treatment - thrombolysis or surgery - was a better option for preventing limb amputation (limb salvage) and no clear evidence about which treatment was better for preventing death or improving amputation rates within one month, six months, or one year after initial treatment. Evidence for these three outcomes at one month was rated between low and very low quality. No conclusion can be made about which treatment was better for keeping vessels unblocked after treatment (vessel patency) because this outcome was not well reported. More major complications, including bleeding (haemorrhage) and continued ischaemia or blockage (distal embolisation), were reported in the group receiving thrombolysis. There was no difference in the occurrence of stroke at one month between the two treatment groups. Although people receiving initial thrombolysis had increased risk of some complications, they showed greater reduction in the level of intervention required compared with that predicted before intervention. The higher risks of complications with thrombolysis have to be weighted against individual risks in surgery. The quality of the evidence was generally low. We downgraded the quality owing to risk of bias. Bias is a way to describe how researchers, clinicians, or participants might influence results unintentionally. Blinding is a method used to prevent people involved in the trial from knowing what treatment group a participant was in and reducing measurement bias. None of the studies included in this review used methods to stop participants or researchers or outcome assessors from knowing what treatment they were assigned to. Also, there was uncertainty about the true effect of each treatment type. Results show wide differences in outcome measures (effects) between studies (heterogeneity). For example, following surgical treatment, one-year mortality ranged from 9.8% to 42%. Such a wide range in percentages may indicate that the studies compared were quite different. In addition, both selection criteria (duration of treatment and severity of ischaemia) and method of thrombolysis (agent, dose, and duration) varied between studies, making comparison more difficult. This review found no evidence of a difference between thrombolysis and surgery for treatment of acute limb ischaemia for our outcomes of interest. Those receiving thrombolysis treatment may be at higher risk of complications such as bleeding. The quality of data generated by the included studies is 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 found no randomised controlled trials for inclusion in this review. As we did not identify any randomised controlled trials for inclusion in this review, we are unable to comment on implications for practice. Although evidence from animal studies has supported a fetal neuroprotective role for creatine when administered to the mother during pregnancy, no trials assessing creatine in pregnant women for fetal neuroprotection have been published to date. If creatine is established as safe for the mother and her fetus, research efforts should first be directed towards randomised trials comparing creatine with either no intervention (ideally using a placebo), or with alternative agents aimed at providing fetal neuroprotection (including magnesium sulphate for the very preterm infant). If appropriate, these trials should then be followed by studies comparing different creatine regimens (dosage and duration of exposure). Such trials should be high quality and adequately powered to evaluate maternal and infant short and longer-term outcomes (including neurodevelopmental disabilities such as cerebral palsy), and should consider utilisation/costs of health care.\nOutput:\n" }, { "from": "agent", "value": "We found no completed (or ongoing) randomised controlled trials that assessed whether creatine given to the mother at times of known, suspected, or potential fetal compromise during pregnancy helps to protect the baby's brain. Randomised controlled trials are needed to establish whether creatine can protect against brain injury for the baby in the womb. The babies in these trials need to be followed up over a long period so that we can monitor the effects of creatine on their development into childhood and adulthood." } ]

[ { "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 trials with 8487 participants on five SGAs: amisulpride, aripiprazole, olanzapine, quetiapine and risperidone. Three studies (1092 participants) provided data on aripiprazole augmentation in MDD. All efficacy data (response n = 1092, three RCTs, OR 0.48; 95% CI 0.37 to 0.63), (MADRS n = 1077, three RCTs, MD -3.04; 95% CI -4.09 to -2) indicated a benefit for aripiprazole but  more side effects (weight gain, EPS) . Seven trials (1754 participants) reported data on olanzapine. Compared to placebo fewer people discontinued treatment due to inefficacy; compared to antidepressants there were no efficacy differences, olanzapine augmentation showed symptom reduction (MADRS n = 808, five RCTs, MD -2.84; 95% CI -5.48 to -0.20), but also more weight or prolactin increase. Quetiapine data are based on seven trials (3414 participants). Compared to placebo, quetiapine monotherapy (response n = 1342, three RCTs, OR 0.52; 95% CI 0.41 to 0.66) and quetiapine augmentation (response n = 937, two RCTs, OR 0.68; 95% CI 0.52 to 0.90) showed symptom reduction, but quetiapine induced more sedation. Four trials (637 participants) presented data on risperidone augmentation, response data were better for risperidone (n = 371, two RCTs, OR 0.57; 95% CI 0.36 to 0.89) but augmentation showed more prolactin increase and weight gain. Five studies (1313 participants) presented data on amisulpride treatment for dysthymia. There were some beneficial effects compared to placebo or antidepressants but tolerability was worse. Quetiapine was more effective than placebo treatment. Aripiprazole and quetiapine and partly also olanzapine and risperidone augmentation showed beneficial effects compared to placebo. Some evidence indicated beneficial effects of low-dose amisulpride for dysthymic people. Most SGAs showed worse tolerability.\nOutput:\n" }, { "from": "agent", "value": "This review found 28 studies on five second-generation antipsychotic drugs (amisulpride, aripiprazole, olanzapine, quetiapine and risperidone) comparing the effects of the drugs alone or adding them or placebo to antidepressants for major depressive disorder and dysthymia. There is evidence that amisulpride might lead to symptom reduction in dysthymia, while no important differences were seen for major depression. There is limited evidence that aripiprazole leads to symptom reduction when added to antidepressants. Olanzapine had no beneficial effects for treatment of depression when compared to antidepressants or compared to placebo but there was limited evidence for the benefits of olanzapine as additional treatment. Data on quetiapine indicated beneficial effects for quetiapine alone or as additional treatment when compared to placebo; data on quetiapine versus duloxetine did not show beneficial effects in terms of symptom reduction for either group, but quetiapine treatment was less well tolerated. The data, however, are very limited. Slight benefits of risperidone as additional treatment, in terms of symptom reduction, are also based on a rather small number of randomised participants. Generally, treatment with second-generation antipsychotic drugs was associated with worse tolerability, mainly due to sedation, weight gain or laboratory values such as prolactin increase." } ]

[ { "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: 60 studies recruiting 6542 participants met the inclusion criteria. CFC-BDP (57 studies): In non-oral steroid treated patients, at doses of 400mcg/day or less CFC-BDP produced significant improvements from baseline in a number of efficacy measures compared with placebo, including forced expiratory volume in one second (FEV1) 360 ml (95% CI 260 to 460); FEV1 (% predicted) WMD 12.41% (95% CI 8.18 to 16.64) and morning peak expiratory flow rate (am PEF) WMD 35.95 L/min (95% CI 27.85 to 44.04). BDP also led to reductions in rescue beta-2 agonist use compared with placebo of -2.32 puffs/d (95% CI -2.55 to -2.09) and reduced the relative risk (RR) of trial withdrawal due to an asthma exacerbation 0.25 (95% CI 0.12 to 0.51). Subgroup analyses based on treatment duration provide support to the proposal that a treatment period of greater than four weeks is required to realise a fuller treatment effect. In oral steroid treated patients BDP led to significantly greater reductions in oral prednisolone use WMD -4.91 mg/d (95% CI -5.88 to -3.94 mg/d) and greater likelihood of withdrawing oral steroid treatment RR 8.02 (95% CI 3.23 to 19.92). HFA-BDP (3 studies): In non-oral steroid-treated patients, HFA-BDP was significantly more effective than placebo in improving FEV1, morning and evening PEF, FEF25 to 75%, reduced asthma symptoms and beta2-agonists daily consumption. Significant effects for such outcomes were apparent after six weeks of treatment. In oral steroid treated patients, HFA-BDP improved significantly FEV1 and am PEF. The summary estimates for these outcomes suggested a high level of heterogeneity, and divergent aims of the studies may contribute to the variation we observed. Limited data on adverse events were reported. This review has quantified the efficacy of CFC-BDP and HFA-BDP in the treatment of chronic asthma and strongly supports its use. Current asthma guidelines recommend titration of dose to individual patient response, but the published data provide little support for dose titration above 400 mcg/d in patients with mild to moderate asthma. There are insufficient data to draw any conclusions concerning dose-response in people with severe asthma.\nOutput:\n" }, { "from": "agent", "value": "This review of trials found that BDP delivered with the old and new propellant is effective in helping people with chronic asthma. BDP at all doses improves airflow, reduces symptoms and the need for rescue bronchodilators. The review only included studies conducted for more than 4 weeks. The drug was well tolerated and the safety profile was comparable with placebo. The findings apply to both children and adults. The effects of the new propellant suggest that it could be more effective than the older version, although a different review will address that particular 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: Of the 370 records that we identified as a result of the search (excluding duplicates), we regarded six abstracts and titles as potentially relevant studies. Of these six studies, three met the inclusion criteria involving 708 participants; most trials were at moderate or high risk of bias (risk mainly due to lack of blinding and high rate of incomplete data). We did not identify any ongoing trials. Although all included studies had been published in peer-reviewed journals at the time of the search and data extraction, numerical data regarding the outcome measured in one trial involving 77 participants were insufficient for inclusion in a meta-analyses. The difference in the rates of prolonged vaginal discharge or presumed cervicitis (one study; 348 participants; risk ratio (RR), 1.29; 95% confidence interval (CI) 0.72 to 2.31; low-quality evidence) and severe vaginal bleeding (two studies; 638 participants; RR 1.21; 95% CI 0.52 to 2.82; very low-quality evidence) among the two comparison groups did not reach the level for clinically important effect. In addition, there was no difference in adverse events related to antibiotics i.e. nausea/vomiting, diarrhoea, and headache among the two comparison groups (two studies; 638 participants; RR 1.69; 95% CI 0.85 to 3.34; very low-quality evidence). There were no differences in the incidence of fever (RR, 2.23; 95% CI 0.20 to 24.36), lower abdominal pain (RR, 1.03; 95% CI 0.61 to 1.72), unscheduled medical consultation (RR 2.68, 95% CI 0.97 to 7.41), and additional self-medication (RR 1.22; 95% CI 0.56 to 2.67) between the two comparison groups (one study; 290 participants; low to very low-quality evidence). As only limited data are available from three trials with overall moderate to high risk of bias, there is insufficient evidence to support use of antibiotics to reduce infectious complications following excision of the cervical transformation zone. In addition, there were minimal data about antibiotic-related adverse events and no information on the risk of developing antibiotic resistance. Antibiotics given for infection prevention after excision of the cervical transformation zone should only be used in the context of clinical research, to avoid unnecessary prescription of antibiotics and to prevent further increases in antibiotic resistance.\nOutput:\n" }, { "from": "agent", "value": "We searched the literature to May 2016 and found three published randomised trials that met the review inclusion criteria. We did not identify any ongoing trials. The three included studies involved 708 participants who had undergone excisional treatment to the cervix (known as laser or large loop excision of transformation zone (LLETZ) or loop electrosurgical excision procedure (LEEP)). Two studies tested a antimicrobial vaginal pessary versus no treatment; the other tested oral antibiotics compared with placebo. We found that there was no benefit to prophylactic antibiotics after LLETZ to reduce or prevent prolonged vaginal discharge, severe vaginal bleeding, fever, lower abdominal pain, unscheduled medical consultation, and additional self-medication. There was little information on antibiotic-related adverse effects. The limited evidence available does not support routinely giving antibiotics for infection prevention after LLETZ. As there are growing concerns with antibiotic resistance, antibiotics for infection prevention after excision of the cervical transformation zones should only be used in the context of clinical trials. The quality of the evidence regarding prophylactic antibiotics for preventing severe vaginal bleeding, fever, and adverse events was very low, with evidence from other comparisons being of low quality." } ]

[ { "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: There are no included trials. We found no randomised controlled trials that assessed the effect of antenatal fetal surveillance regimens of a suspected LGA fetus on important health outcomes for the mother and baby. There has been a rise in the prevalence of LGA babies over the past few decades in many countries. Research is therefore required on regimens of antenatal surveillance of suspected LGA infants, in order to guide practice and improve the health outcomes for the mother and infant. In particular, randomised control trials to investigate whether serial antenatal clinic and ultrasound assessments of suspected LGA infants (including liquor volume and markers of fetal adiposity) would be useful, to assess whether surveillance methods improve health outcomes. In addition, as there are concerns that identifying suspected LGA fetuses may lead to unnecessary maternal anxiety, investigations and interventions, any such trial would need to assess the risks as well as benefits of regimens of fetal surveillance for suspected LGA fetuses.\nOutput:\n" }, { "from": "agent", "value": "We searched for studies on 10 August 2015 but did not find any randomised controlled trials looking at the effects of performing extra tests on health outcomes in pregnant women with overgrowth of the baby after 20 weeks gestation. There is a need for randomised controlled trials in this area in order to inform clinical practice when large babies are identified during a pregnancy, to assess if extra tests or surveillance can improve the health of these women and their babies. It is also important to identify any harms associated with extra tests and surveillance, as identifying women with suspected large babies may lead to unnecessary maternal anxiety with additional investigations and interventions, including induction of labour or caesarean section." } ]

[ { "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: While five studies addressed the interventions of interest, we did not include them in the review because the investigators of the studies did not report any information specific to people with cystic fibrosis. Our attempts to obtain this information have not yet been successful. We will include any provided data in future updates of the review. The lack of currently available evidence makes it impossible to draw conclusions about the comparative efficacy and safety of the various immunosuppressive drugs among people with cystic fibrosis after lung transplantation. A 2013 Cochrane Review comparing tacrolimus with cyclosporine in all lung transplant recipients (not restricted to those with cystic fibrosis) reported no significant difference in mortality and risk of acute rejection. However, tacrolimus use was associated with lower risk of broncholitis obliterans syndrome and arterial hypertension and higher risk of diabetes mellitus. It should be noted that this wider review contained only a small number of included studies (n = 3) with a high risk of bias. Additional randomised studies are required to provide evidence for the benefit and safety of the use of immunosuppressive therapy among people with cystic fibrosis after lung transplantation.\nOutput:\n" }, { "from": "agent", "value": "Although we found five studies which looked at anti-rejection drugs, they included people with a number of chronic conditions and not just cystic fibrosis. The studies we found reported results from all volunteers combined and we were not able to isolate the results that were specific to people with cystic fibrosis. We contacted the researchers who conducted these studies, but they have not yet sent us the specific results we need. If we receive these results, we will include them in the future when we update this systematic review. There is a review of drugs to suppress the immune systems of people who have had lung transplants (not restricted to those with cystic fibrosis) and this only included three studies which the review authors judged to have a high risk of bias. The review did not find that any one drug was better than another for reducing the chances of death or acute rejection; but one drug (tacrolimus) led to a lower risk of long-term rejection and high blood pressure, although there was a higher risk of diabetes. Research is needed on the use of drugs that suppress the immune system in people with cystic fibrosis who have received a lung transplant." } ]

[ { "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: In the initial review, we included one ITS study that evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site tooth extractions. The intervention included examination of previous cases of wrong-site tooth extractions, educational intervention including a presentation of cases of erroneous extractions, explanation of relevant clinical guidelines and feedback by an instructor. Data were reported from all patients on the surveillance system of a University Medical centre in Taiwan with a total of 24,406 tooth extractions before the intervention and 28,084 tooth extractions after the intervention. We re-analysed the data using the Prais-Winsten time series and the change in level for annual number of mishaps was statistically significant at -4.52 (95% confidence interval (CI) -6.83 to -2.217) (standard error (SE) 0.5380). The change in slope was statistically significant at -1.16 (95% CI -2.22 to -0.10) (SE 0.2472; P < 0.05). This update includes an additional study reporting on the incidence of neurological WSS at a university hospital both before and after the Universal Protocol’s implementation. A total of 22,743 patients undergoing neurosurgical procedures at the University of Illionois College of Medicine at Peoria, Illinois, United States of America were reported. Of these, 7286 patients were reported before the intervention and 15,456 patients were reported after the intervention. The authors found a significant difference (P < 0.001) in the incidence of WSS between the before period, 1999 to 2004, and the after period, 2005 to 2011.  Similarly, data were re-analysed using Prais-Winsten regression to correct for autocorrelation. As the incidences were reported by year only and the intervention occurred in July 2004, the intervention year 2004 was excluded from the analysis. The change in level at the point the intervention was introduced was not statistically significant at -0.078 percentage points (pp) (95% CI -0.176 pp to 0.02 pp; SE 0.042; P = 0.103). The change in slope was statistically significant at 0.031 (95% CI 0.004 to 0.058; SE 0.012; P < 0.05). The findings of this update added one additional ITS study to the previous review which contained one ITS study. The original review suggested that the use of a specific educational intervention in the context of a dental outpatient setting, which targets junior dental staff using a training session that included cases of wrong-site surgery, presentation of clinical guidelines and feedback by an instructor, was associated with a reduction in the incidence of wrong-site tooth extractions. The additional study in this update evaluated the annual incidence rates of wrong-site surgery in a neurosurgical population before and after the implementation of the Universal Protocol. The data suggested a strong downward trend in the incidence of wrong-site surgery prior to the intervention with the incidence rate approaching zero. The effect of the intervention in these studies however remains unclear, as data reflect only two small low-quality studies in very specific population groups.\nOutput:\n" }, { "from": "agent", "value": "This updated review contains two interrupted-time-series (ITS) studies (studies in which data are collected at multiple time points before and after an intervention), one from the original review, which evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site surgery, and which was found to reduce its incidence. An additional study evaluated the incidence of wrong-site surgery before and after the introduction of the Universal Protocol, however the relevance of these findings regarding the impact of the intervention is unclear given that prior to its introduction, the incidence was decreasing due to other unclear factors. Overall, this review now contains two studies, of relatively low quality evidence, on very specific populations and their generalisability to a larger audience is 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 (165 participants) that examined the short- and medium-term effect of music therapy interventions (one week to seven months) for children with ASD. Music therapy was superior to 'placebo' therapy or standard care with respect to the primary outcomes social interaction within the therapy context (SMD 1.06, 95% CI 0.02 to 2.10, 1 RCT, n = 10); generalised social interaction outside of the therapy context (SMD 0.71, 95% CI 0.18 to 1.25, 3 RCTs, n = 57, moderate quality evidence), non-verbal communicative skills within the therapy context (SMD 0.57, 95% CI 0.29 to 0.85, 3 RCTs, n = 30), verbal communicative skills (SMD 0.33, 95% CI 0.16 to 0.49, 6 RCTs, n = 139), initiating behaviour (SMD 0.73, 95% CI 0.36 to 1.11, 3 RCTs, n = 22, moderate quality evidence), and social-emotional reciprocity (SMD 2.28, 95% CI 0.73 to 3.83, 1 RCT, n = 10, low quality evidence). There was no statistically significant difference in non-verbal communicative skills outside of the therapy context (SMD 0.48, 95% CI -0.02 to 0.98, 3 RCTs, n = 57, low quality evidence). Music therapy was also superior to 'placebo' therapy or standard care in secondary outcome areas, including social adaptation (SMD 0.41, 95% CI 0.21 to 0.60, 4 RCTs, n = 26), joy (SMD 0.96, 95% CI 0.04 to 1.88, 1 RCT, n = 10), and quality of parent-child relationships (SMD 0.82, 95% CI 0.13 to 1.52, 2 RCTs, n = 33, moderate quality evidence). None of the included studies reported any adverse effects. The small sample sizes of the studies limit the methodological strength of these findings. The findings of this updated review provide evidence that music therapy may help children with ASD to improve their skills in primary outcome areas that constitute the core of the condition including social interaction, verbal communication, initiating behaviour, and social-emotional reciprocity. Music therapy may also help to enhance non-verbal communication skills within the therapy context. Furthermore, in secondary outcome areas, music therapy may contribute to increasing social adaptation skills in children with ASD and to promoting the quality of parent-child relationships. In contrast to the studies included in an earlier version of this review published in 2006, the new studies included in this update enhanced the applicability of findings to clinical practice. More research using larger samples and generalised outcome measures is needed to corroborate these findings and to examine whether the effects of music therapy are enduring. When applying the results of this review to practice, it is important to note that the application of music therapy requires specialised academic and clinical training.\nOutput:\n" }, { "from": "agent", "value": "We included 10 studies with a total number of 165 participants. The studies examined the short- and medium-term effect of music therapy interventions (one week to seven months) for children with ASD. Music therapy was superior to 'placebo' therapy or standard care with respect to social interaction, non-verbal and verbal communicative skills, initiating behaviour, and social-emotional reciprocity. Music therapy was also superior to 'placebo' therapy or standard care in the areas of social adaptation, joy, and the quality of parent-child relationships. None of the included studies reported any side effects caused by music therapy. The quality of the evidence was moderate for social interaction outside of the therapy context, initiating behaviour, social adaptation, and the quality of the parent-child relationship, and low for the other three main outcomes (nonverbal communicative skills outside of the therapy context, verbal communicative skills outside of the therapy context, and social-emotional reciprocity). Reasons for limited quality of the evidence were issues with study design and small number of patients who participated in the studies. Music therapy may help children with ASD to improve their skills in important areas such as social interaction and communication. Music therapy may also contribute to increasing social adaptation skills in children with ASD and to promoting the quality of parent-child relationships. Some of the included studies featured interventions that correspond well with treatment in clinical practice. More research with adequate design and using larger numbers of patients is needed. It is important to specifically examine how long the effects of music therapy last. The application of music therapy requires specialised academic and clinical training. This is important when applying the results of this review to practice." } ]

[ { "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 following statistically significant treatment effects in favour of propentofylline are reported. Cognition at 3, 6 and 12 months including MMSE at 12 months. [MD 1.2, 95%CI 0.12 to 2.28, P=0.03] Severity of dementia at 3, 6 and 12 months including CGI at 12 months [MD -0.21, 95%CI -0.39 to -0.03, P=0.03]. Activities of Daily Living (NAB) at 6 and 12 months [MD -1.20, 95%CI -2.22 to -0.18, P=0.02]. Global Assessment (CGI) at 3 months [MD -0.48, 95% CI -0.75 to -0.21, P=0.0006], but not at later times. Tolerability There were minimal data on adverse effects and drop-outs. There were a statistically significant treatment effects in favour of placebo at 12 months, for the number of dropouts [OR=1.43, 95%CI 1.04 to 1.90, P=0.03]. There is limited evidence that propentofylline might benefit cognition, global function and activities of daily living of people with Alzheimer's disease and/or vascular dementia. The meta-analyses reported here are far from satisfactory as a summary of the efficacy of propentofylline, considering the unpublished information on another 1200 patients in randomized trials that exists. Unfortunately Aventis has been unwilling to correspond with the authors, significantly limiting the scope of this review.\nOutput:\n" }, { "from": "agent", "value": "Although a number of randomized controlled trials have been undertaken, data were available from only a very limited number of these studies. These limited data suggest that propentofylline may have a beneficial effect on measures of cognitive and global function of people with Alzheimer's or vascular dementia. The unavailability of data, due to failure of Aventis, the manufacturing pharmaceutical company, to release information about unpublished studies prevented a comprehensive systematic review and meta-analysis." } ]

[ { "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: Twelve trials of six to 14 months duration involving 350 people were included. Eleven trials investigated levothyroxine replacement with placebo, one study compared levothyroxine replacement with no treatment. We did not identify any trial that assessed (cardiovascular) mortality or morbidity. Seven studies evaluated symptoms, mood and quality of life with no statistically significant improvement. One study showed a statistically significant improvement in cognitive function. Six studies assessed serum lipids, there was a trend for reduction in some parameters following levothyroxine replacement. Some echocardiographic parameters improved after levothyroxine replacement therapy, like myocardial relaxation, as indicated by a significant prolongation of the isovolumic relaxation time as well as diastolic dysfunction. Only four studies reported adverse events with no statistically significant differences between groups. In current RCTs, levothyroxine replacement therapy for subclinical hypothyroidism did not result in improved survival or decreased cardiovascular morbidity. Data on health-related quality of life and symptoms did not demonstrate significant differences between intervention groups. Some evidence indicates that levothyroxine replacement improves some parameters of lipid profiles and left ventricular function.\nOutput:\n" }, { "from": "agent", "value": "To answer this question twelve studies of six to 14 months duration involving 350 people were analysed. Thyroid hormone therapy for subclinical hypothyroidism did not result in improved survival or decreased cardiovascular morbidity (for example less heart attacks or strokes). Data on health-related quality of life and symptoms did not demonstrate significant differences between placebo and thyroid hormone therapy. Some evidence indicated that thyroid hormone had some effects on blood lipids and technical measurements of heart function. Adverse effects were inadequately addressed in most of the included studies and have to be urgently investigated in future studies, especially in older 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: A total of 10 RCTs and four quasi-randomised trials with 6466 participants met the inclusion criteria. Six studies involved minor procedures conducted in an outpatient or emergency department setting; eight studies involved major surgery conducted in theatre. Nine different topical antibiotics were included. We included two three-arm trials, two four-arm trials and 10 two-arm trials. The control groups comprised; an alternative topical antibiotic (two studies), topical antiseptic (six studies) and no topical antibiotic (10 studies), which comprised inert ointment (five studies) no treatment (four studies) and one study with one arm of each. The risk of bias of the 14 studies varied. Seven studies were at high risk of bias, five at unclear risk of bias and two at low risk of bias. Most risk of bias concerned risk of selection bias. Twelve of the studies (6259 participants) reported infection rates, although we could not extract the data for this outcome from one study. Four studies (3334 participants) measured allergic contact dermatitis as an outcome. Four studies measured positive wound swabs for patterns of antimicrobial resistance, for which there were no outcomes reported. No episodes of anaphylaxis were reported. Topical antibiotic versus no topical antibiotic We pooled the results of eight trials (5427 participants) for the outcome of SSI. Topical antibiotics probably reduce the risk of SSI in people with surgical wounds healing by primary intention compared with no topical antibiotic (RR 0.61, 95% CI 0.42 to 0.87; moderate-quality evidence downgraded once for risk of bias). This equates to 20 fewer SSIs per 1000 patients treated with topical antibiotics (95% CI 7 to 29) and a number needed to treat for one additional beneficial outcome (NNTB) (i.e. prevention of one SSI) of 50. We pooled the results of three trials (3012 participants) for the outcome of allergic contact dermatitis, however this comparison was underpowered, and it is unclear whether topical antibiotics affect the risk of allergic contact dermatitis (RR 3.94, 95% CI 0.46 to 34.00; very low-quality evidence, downgraded twice for risk of bias, once for imprecision). Topical antibiotic versus antiseptic We pooled the results of five trials (1299 participants) for the outcome of SSI. Topical antibiotics probably reduce the risk of SSI in people with surgical wounds healing by primary intention compared with using topical antiseptics (RR 0.49, 95% CI 0.30 to 0.80; moderate-quality evidence downgraded once for risk of bias). This equates to 43 fewer SSIs per 1000 patients treated with topical antibiotics instead of antiseptics (95% CI 17 to 59) and an NNTB of 24. We pooled the results of two trials (541 participants) for the outcome of allergic contact dermatitis; there was no clear difference in the risk of dermatitis between topical antibiotics and antiseptics, however this comparison was underpowered and a difference cannot be ruled out (RR 0.97, 95% CI 0.52 to 1.82; very low-quality evidence, downgraded twice for risk of bias and once for imprecision). Topical antibiotic versus topical antibiotic One study (99 participants) compared mupirocin ointment with a combination ointment of neomycin/polymyxin B/bacitracin zinc for the outcome of SSI. There was no clear difference in the risk of SSI, however this comparison was underpowered (very low-quality evidence downgraded twice for risk of bias, once for imprecision). A four-arm trial involved two antibiotic arms (neomycin sulfate/bacitracin zinc/polymyxin B sulphate combination ointment versus bacitracin zinc, 219 participants). There was no clear difference in risk of SSI between the combination ointment and the bacitracin zinc ointment. The quality of evidence for this outcome was low, downgraded once for risk of bias, and once for imprecision. Topical antibiotics applied to surgical wounds healing by primary intention probably reduce the risk of SSI relative to no antibiotic, and relative to topical antiseptics (moderate quality evidence). We are unable to draw conclusions regarding the effects of topical antibiotics on adverse outcomes such as allergic contact dermatitis due to lack of statistical power (small sample sizes). We are also unable to draw conclusions regarding the impact of increasing topical antibiotic use on antibiotic resistance. The relative effects of different topical antibiotics are unclear.\nOutput:\n" }, { "from": "agent", "value": "In May 2016 we searched for as many relevant studies as we could find that investigated the use of topical antibiotics on surgical wounds healing by primary intention. We managed to identify 14 studies which compared topical antibiotics with no treatment, or with antiseptics (i.e. other treatments applied to the skin to prevent bacterial infection), and with other topical antibiotics. Eight of these trials involved general surgery and six involved dermatological surgery (surgery involving only the skin). Many of the studies were small, and of low quality or at risk of bias. After examining them all, the authors concluded that the risk of having a surgical site infection was probably reduced by the use of topical antibiotics applied to wounds after surgery, whether the antibiotics were compared with an antiseptic, or to no treatment. As infection is a relatively rare event after surgery, the actual reduction in the rate of infection was 4.3% on average when the use of topical antibiotic was compared with antiseptic, and 2% when use of the topical antibiotic was compared with no treatment. It would require 24 patients on average to be treated with topical antibiotics instead of antiseptic, and 50 patients to be treated with topical antibiotic compared to no treatment in order to prevent one wound infection. Four studies reported on allergic contact dermatitis, but there was insufficient evidence to determine whether allergic contact dermatitis occurred any more frequently with topical antibiotics than with antiseptics or no treatment, and this should also be considered before deciding to use them. This plain language summary is up to date as of May 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: We included four studies with a total of 746 participants. All studies included adult patients undergoing surgery for primary tumour resection. Two studies enrolled male and female participants undergoing major abdominal surgery for cancer. One study enrolled male participants undergoing surgery for prostate cancer, and one study male participants undergoing surgery for colon cancer. Follow-up time ranged from nine to 17 years. All four studies compared general anaesthesia alone versus general anaesthesia combined with epidural anaesthesia and analgesia. All four studies are secondary data analyses of previously conducted prospective randomized controlled trials. Of the four included studies, only three contributed to the outcome of overall survival, and two each to the outcomes of progression-free survival and time to tumour progression. In our meta-analysis, we could not find an advantage for either study group for the outcomes of overall survival (hazard ratio (HR) 1.03, 95% confidence interval (CI) 0.86 to 1.24) and progression-free survival (HR 0.88, 95% CI 0.56 to 1.38). For progression-free survival, the level of inconsistency was high. Pooled data for time to tumour progression showed a slightly favourable outcome for the control group (general anaesthesia alone) compared with the intervention group (epidural and general anaesthesia) (HR 1.50, 95% CI 1.00 to 2.25). Quality of evidence was graded low for overall survival and very low for progression-free survival and time to tumour progression. The outcome of overall survival was downgraded for serious imprecision and serious indirectness. The outcomes of progression-free survival and time to tumour progression were also downgraded for serious inconsistency and serious risk of bias, respectively. Reporting of adverse events was sparse, and data could not be analysed. Currently, evidence for the benefit of regional anaesthesia techniques on tumour recurrence is inadequate. An encouraging number of prospective randomized controlled trials are ongoing, and it is hoped that their results, when reported, will add evidence for this topic in the near future.\nOutput:\n" }, { "from": "agent", "value": "We found four studies with a total of 746 adult men and women undergoing abdominal surgery for removal of cancer. All studies were reanalyses of previously conducted trials, which means that none of the included studies was actually designed to investigate tumour recurrence. All patients underwent primary cancer surgery, which means that surgery on cancer metastases was not included. A total of 354 participants received general anaesthesia and 392 participants received a general anaesthesia along with an epidural anaesthesia. Epidural anaesthesia is a certain type of regional anaesthesia by which a numbing medication is injected continuously via a catheter into the epidural space. The epidural space serves as the outermost surrounding of the spinal cord. Numbing medication injected into the epidural space causes certain parts of the belly area to go numb and be insensitive to pain. Study participants were followed for at least 7.8 years after they had undergone cancer surgery. We did not find a benefit for either study group on cancer recurrence or survival. Because of incomplete reporting and the low number of reported adverse events, we cannot estimate possible differences in adverse effects between the different anaesthesia techniques used. The quality of the evidence for outcomes was graded low for overall survival and very low for progression-free survival and time to tumour progression. The main limitations of the evidence we identified were that the results could have been influenced by the background treatments given to people who participated in the 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: One randomised clinical trial met inclusion criteria, including infants born more than 12 weeks preterm. The trial employed adequate methodologies and was assessed at low risk of bias. One hundred and sixty-six infants were randomised to start continuous cerebral NIRS monitoring less than 3 hours after birth until 72 hours after birth plus appropriate interventions if NIRS was out of normal range according to a guideline versus conventional monitoring with blinded NIRS. There was no effect of NIRS plus guideline of mortality until term-equivalent age (RR 0.50, 95% CI 0.29 to 1.00; one trial; 166 participants). There were no effects of NIRS plus guideline on intraventricular haemorrhages: all grades (RR 0.93, 95% CI 0.65 to 1.34; one trial; 166 participants); grade III/IV (RR 0.57, 95% CI 0.25 to 1.31; one trial; 166 participants); and cystic periventricular leukomalacia (which did not occur in either group). Likewise, there was no effect of NIRS plus guideline on the occurrence of a patent ductus arteriosus (RR 1.96, 95% CI 0.94 to 4.08; one trial; 166 participants); chronic lung disease (RR 1.27, 95% CI 0.94 to 1.50; one trial; 166 participants); necrotising enterocolitis (RR 0.83, 95% CI 0.33 to 1.94; one trial; 166 participants); and retinopathy of prematurity (RR 1.64, 95% CI 0.75 to 3.00; one trial; 166 participants). There were no serious adverse events in any of the intervention groups. NIRS plus guideline caused more skin marks from the NIRS sensor in the control group than in the experimental group (unadjusted RR 0.31, 95% CI 0.10 to 0.92; one trial; 166 participants). There are no data regarding neurodevelopmental outcome, renal impairment or air leaks. The quality of evidence for all comparisons discussed above was assessed as very low apart from all-cause mortality and adverse events: these were assessed as low and moderate, respectively. The validity of all comparisons is hampered by a small sample of randomised infants, risk of bias due to lack of blinding, and indirectness of outcomes. The only eligible randomised clinical trial did not demonstrate any consistent effects of NIRS plus a guideline on the assessed clinical outcomes. The trial was, however, only powered to detect difference in cerebral oxygenation, not morbidities or mortality. Our systematic review did not reach sufficient power to prove or disprove effects on clinical outcomes. Further randomised clinical trials with low risks of bias and low risks of random errors are needed.\nOutput:\n" }, { "from": "agent", "value": "In evidence current to September 2016, we found one trial that primarily tested if brain oxygenation can be stabilised by combining NIRS measurements of the brain with a treatment guideline on how to intervene when the brain oxygenation is outside the normal range. The 166 infants included were born more than 12 weeks before term. They were monitored during the first three days of life. The study was funded by government agency, and we found that the methods used in trial were as good as possible. The single trial we found showed a large and significant difference in brain oxygenation between the experimental group and the control group. Low oxygenation was far more common in the control group. It did not, however, find that monitoring with NIRS reduces mortality or the occurrence of the most common complications of very preterm birth, i.e. intracranial bleedings, chronic lung disease, damage of the intestines (necrotising enterocolitis), and blindness (retinopathy of prematurity). The NIRS monitoring did not cause serious harm, but skin marks from the NIRS sensor were seen in about 1 in 10 patients. The accrued information size with one small randomised trial is too small to conclude anything about the benefits and harms of cerebral near-infrared spectroscopy in preterm infants. Thus further 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: Twenty-two out of 29 included studies (1793 women) contributed data to this review. The included studies did not report some our primary outcomes: maternal death, incidence of maternal postoperative wound infection, maternal postoperative other infection such as endometritis and urinary tract infection, neonatal death. Compared to women who had GA, women who had either epidural anaesthesia or spinal anaesthesia were found to have a significantly lower difference between pre and postoperative haematocrit. For epidural, the mean difference (MD) was 1.70% and 95% confidence interval (CI) 0.47 to 2.93 (one trial, 231 women) and for spinal anaesthesia, the MD was 3.10% and 95% CI 1.73 to 4.47 (one trial, 209 women). Compared with GA, women having either an epidural anaesthesia or spinal anaesthesia had a lower estimated maternal blood loss (epidural versus GA: standardised mean difference (SMD) -0.32 mL; 95% CI -0.56 to -0.07; two trials, 256 women; spinal versus GA anaesthesia: SMD -0.59 mL; 95% CI -0.83 to 0.35; two trials, 279 women). There was evidence of a significant difference in terms of satisfaction with anaesthetic technique -  compared with the epidural or spinal group, more women in the GA group stated they would use the same technique again if they needed CS for a subsequent pregnancy (epidural versus GA: risk ratio (RR) 0.80; 95% CI 0.65 to 0.98; one trial, 223 women; spinal versus GA anaesthesia: RR 0.80; 95% CI 0.65 to 0.99; one trial, 221 women). No significant difference was seen in terms of neonatal Apgar scores of six or less and of four or less at five minutes and the need for neonatal resuscitation with oxygen. There is no evidence from this review to show that RA is superior to GA in terms of major maternal or neonatal outcomes. Further research to evaluate neonatal morbidity and maternal outcomes, such as satisfaction with technique, will be useful.\nOutput:\n" }, { "from": "agent", "value": "This review of trials sought to assess these benefits and harms. Twenty-two out of 29 included studies (1793 women) contributed data to this review. There were some differences that favoured regional anaesthesia, for example, less blood loss. The evidence on the differences in pain relief was difficult to evaluate. There were not enough participants to assess the very rare outcome of mortality for the mother, which may be an important aspect. None of the trials addressed important outcomes for women such as recovery times, effects on breastfeeding, effects on the mother-child relationship and length of time before mother feels well enough to care for her baby. As there is insufficient evidence on benefits and adverse effects, women are most likely to choose anaesthesia for caesarean section, depending on whether they wish to be awake or asleep for the birth." } ]

[ { "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 RCTs with 1162 participants were included: three trials compared 2 g of preoperative amoxicillin versus placebo (927 participants), one compared 3 g of preoperative amoxicillin versus placebo (55 participants), one compared 1 g of preoperative amoxicillin plus 500 mg four times a day for two days versus no antibiotics (80 participants), and one compared four groups: (1) 2 g of preoperative amoxicillin; (2) 2 g of preoperative amoxicillin plus 1 g twice a day for seven days; (3) 1 g of postoperative amoxicillin twice a day for seven days, and (4) no antibiotics (100 participants). The overall body of evidence was considered to be of moderate quality. The meta-analyses of the six trials showed a statistically significant higher number of participants experiencing implant failures in the group not receiving antibiotics (RR 0.33; 95% CI 0.16 to 0.67, P value 0.002, heterogeneity: Tau2 0.00; Chi2 2.87, df = 5 (P value 0.57); I2 0%). The number needed to treat for one additional beneficial outcome (NNTB) to prevent one person having an implant failure is 25 (95% CI 14 to 100), based on an implant failure rate of 6% in participants not receiving antibiotics. There was borderline statistical significance for prosthesis failures (RR 0.44; 95% CI 0.19 to 1.00), with no statistically significant differences for infections (RR 0.69; 95% CI 0.36 to 1.35), or adverse events (RR 1; 95% CI 0.06 to 15.85) (only two minor adverse events were recorded, one in the placebo group). No conclusive information can be derived from the only trial that compared three different durations of antibiotic prophylaxis since no event (implant/prosthesis failures, infections or adverse events) occurred in any of the 25 participants included in each study group. There were no trials that evaluated different antibiotics or different antibiotic dosages. Scientific evidence suggests that, in general, antibiotics are beneficial for reducing failure of dental implants placed in ordinary conditions. Specifically 2 g or 3 g of amoxicillin given orally, as a single administration, one hour preoperatively significantly reduces failure of dental implants. No significant adverse events were reported. It might be sensible to suggest the use of a single dose of 2 g prophylactic amoxicillin prior to dental implant placement. It is still unknown whether postoperative antibiotics are beneficial, and which antibiotic is the most effective.\nOutput:\n" }, { "from": "agent", "value": "The evidence on which this review is based was up to date as of 17 June 2013. Six trials were included with a total of 1162 participants. All six of these trials compared the use of antibiotics to prevent infection (failures and complications) with no treatment or treatment with a placebo (a fake medicine with no active ingredient). The antibiotic used in all the trials was amoxicillin; doses and timing of doses varied, although most used a single dose taken just before the implant was placed. One of the trials, with 100 participants, also looked at different doses of amoxicillin taken at different times. There were no trials that looked at alternative antibiotics. Participants were people over 18 years of age who were able to give consent to taking part in a medical trial. Potential participants were excluded for a variety of reasons that included: if they were at risk of heart disease, had artificial joints, had problems with their immune system, were affected by diabetes, had received radiotherapy in the head and neck area, had need of additional procedures at the time of implant placement, were allergic to penicillin, had chronic/acute infections near the planned implant site, were already receiving antibiotic treatment for any other reasons (or had taken them up to six months previously), had been treated with or were receiving intravenous amino-bisphosphonates, were pregnant or breast feeding, were receiving long-term nonsteroidal anti-inflammatory drug therapy, or had blood clotting problems. The follow-up period in all the trials was at least three months. It appears that the oral administration of two grams of amoxicillin one hour before placement of dental implants is effective in reducing implant failures. More specifically, giving antibiotics to 25 people will avoid one person experiencing early implant losses. It is still unclear whether postoperative antibiotics are beneficial, or which antibiotics work best. The evidence from the six trials (1162 participants) that compared the use of antibiotics with placebo or no treatment was considered to be of moderate quality. However, the one trial (100 participants) that investigated antibiotics given for different lengths of time was found to be at high risk of bias." } ]