GEM/cochrane-simplification huggingface dataset:
Abstract: No additional studies were identified in this 2015 review update, in total leading to no studies meeting the criteria for inclusion in this review. The efficacy of ECP in the treatment of chronic GvHD in paediatric patients after haematopoietic stem cell transplantation based on RCTs cannot be evaluated since the original version of this review and the first review update found no RCTs. Current recommendations are based on retrospective or observational studies only. Thus, ideally, ECP should be applied in the context of controlled trials only. However, performing RCTs in this patient population will be challenging due to the limited number of patients, the variable disease presentation and the lack of well-defined response criteria. International collaboration, multicentre trials and appropriate funding for such trials will be needed. If treatment decisions based on clinical data are made in favour of ECP, patients should be carefully monitored for beneficial and harmful effects. In addition, efforts should be made to share this information with other clinicians, for example by setting up registries for paediatric patients that are treated with ECP.

Plain-language summary: We searched scientific databases for randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) that were designed to evaluate the effectiveness and safety of ECP for the management of chronic graft-versus-host disease in children and adolescents (under 18 years of age) after HSCT. The original version of this review and this 2015 review update found no RCTs that analysed the efficacy of ECP for paediatric patients with chronic graft-versus-host disease after HSCT. Current recommendations are based on retrospective (a study in which the outcomes have occurred to the participants before the study began) or observational (a study in which the investigators do not seek to intervene, and simply observed the course of events) studies only. Thus, ideally, ECP should be applied in paediatric patients in the context of RCTs only. ECP may be considered in people with steroid-refractory chronic GvHD, keeping in mind that such a treatment is not supported by high-level evidence. If treatment decisions based on clinical data in favour of ECP are made, patients should be carefully monitored for beneficial and harmful effects and efforts should be made to share this information with other clinicians, for example by setting up registries for paediatric patients that are treated with ECP.
Abstract: Three trials involving a total of 79 participants were included. All three trials, which compared topical nasal steroids against placebo for perennial rhinitis, provided some, albeit limited data, relevant to our primary outcomes; but in two of the trials the data analysis was flawed and in the third trial it was incomprehensible. None of the trials provided data relevant to our secondary outcomes. There were no adverse events reported from any of the interventions. The three included trials provided some weak and unreliable evidence for the effectiveness of Beconase® and flunisolide used topically intranasally for the treatment of intermittent and persistent allergic rhinitis in children. The reduction of severity in symptoms as assessed by the trialists could not be confirmed with the data provided and decisions on the use of these medications should, until such time as more robust evidence is available, be guided by the physician's clinical experience and patients' individual circumstances and preferences.

Plain-language summary: The three included trials provided some weak and unreliable evidence for the effectiveness of Beconase® and flunisolide used topically in the nose for the treatment of intermittent and persistent allergic rhinitis in children. The review authors concluded that until more research is available, decisions on the use of topical steroids should be guided by the physician's clinical experience and patients' individual circumstances and preferences.
Abstract: Twenty-eight studies (reporting a total of thirty-two comparisons) were included. Computer reminders achieved a median improvement in process adherence of 4.2% (interquartile range (IQR): 0.8% to 18.8%) across all reported process outcomes, 3.3% (IQR: 0.5% to 10.6%) for medication ordering, 3.8% (IQR: 0.5% to 6.6%) for vaccinations, and 3.8% (IQR: 0.4% to 16.3%) for test ordering. In a sensitivity analysis using the best outcome from each study, the median improvement was 5.6% (IQR: 2.0% to 19.2%) across all process measures and 6.2% (IQR: 3.0% to 28.0%) across measures of medication ordering. In the eight comparisons that reported dichotomous clinical endpoints, intervention patients experienced a median absolute improvement of 2.5% (IQR: 1.3% to 4.2%). Blood pressure was the most commonly reported clinical endpoint, with intervention patients experiencing a median reduction in their systolic blood pressure of 1.0 mmHg (IQR: 2.3 mmHg reduction to 2.0 mmHg increase). Point of care computer reminders generally achieve small to modest improvements in provider behaviour. A minority of interventions showed larger effects, but no specific reminder or contextual features were significantly associated with effect magnitude. Further research must identify design features and contextual factors consistently associated with larger improvements in provider behaviour if computer reminders are to succeed on more than a trial and error basis.

Plain-language summary: This review found 28 studies that evaluated the effects of different on-screen computer reminders. The studies tested reminders to prescribe specific medications, to warn about drug interactions, to provide vaccinations, or to order tests.  The review found small to moderate benefits. The reminders improved physician practices by a median of 4%. In eight of the studies, patients' health improved by a median of 3%. Although some studies showed larger benefits than these median effects, no specific reminders or features of how they worked were consistently associated with these larger benefits. More research is needed to identify what types of reminders work and when.
Abstract: Thirty-five placebo-controlled trials (4060 participants) provided data in a form suitable for inclusion in the meta-analyses. When compared with placebo, the use of IS was shown to reduce ARTIs measured as the total numbers of ARTIs (MD -1.24; 95% CI -1.54 to -0.94) and the difference in ARTI rates (MD -38.84%; 95% CI -46.37% to -31.31%). Trial quality was generally poor and a high level of statistical heterogeneity was evident. The subgroup analysis of bacterial IS, D53 and OM-85 studies produced similar results, with lower heterogeneity. No difference in adverse events was evident between the placebo and IS groups. This review shows that IS reduce the incidence of ARTIs by 40% on average in susceptible children. Studies in healthy children are not available. Although the safety profile in the studies was good, some IS may be unsafe. ARTI-susceptible children may benefit from IS treatment. Further high-quality trials are needed and we encourage national health authorities to conduct large, multicentre, double-blind, placebo-controlled RCTs on the role of IS in preventing ARTIs in children.

Plain-language summary: By combining results, immunostimulants reduced 1.24 ARTIs in a six-month period, equivalent to a 39% reduction in ARTIs compared to the placebo group. Only 20 studies provided adequate data on adverse events: the most frequent were rash, nausea, vomiting, abdominal pain and diarrhea. The main limitations of this review were the poor methodological quality and diverse trial results. We conclude that ARTI-susceptible children may benefit from immunostimulants, but more high-quality studies are needed. We suggest that national health authorities conduct high-quality randomized controlled trials to assess the true effects of immunostimulant preparations.
Abstract: With this current update, a total of five eligible studies (215 patients) were identified. Only one outcome, the proportion of patients with Expanded Disability Status Scale (EDSS) improvement at four weeks, was common to three trials, while two trials examined magnetic resonance imaging (MRI) outcomes. The results of this review shows there is no significant difference in relapse recovery at week four (MD -0.22, 95% confidence interval (95% CI), 0.71 to 0.26, P = 0.20) nor differences in magnetic resonance imaging (MRI) gadolinium enhancement activity based on oral versus intravenous steroid treatment. However, only two of the five studies employed more current and rigorous methodological techniques, so these results must be taken with some caution. The Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) trial and the "Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses" (COPOUSEP) trial, designed to address such limitations, are currently underway. The analysis of the five included trials comparing intravenous versus oral steroid therapy for MS relapses do not demonstrate any significant differences in clinical (benefits and adverse events), radiological or pharmacological outcomes. Based on the evidence, oral steroid therapy may be a practical and effective alternative to intravenous steroid therapy in the treatment of MS relapses.

Plain-language summary: The objective of this review was to assess if oral and intravenous steroids are equally effective and safe in aiding in the recovery from relapses. Among the pertinent literature, only five studies met the inclusion criteria, comprising a total of 215 participants. Despite some limitations in the methods used to conduct the studies (i.e. incomplete reporting of the participants who dropped out the studies and appropriateness of the sample size) and in the analysis of the data, all five studies found that there were no significant differences in term of benefits and adverse events and in the pharmacological and radiological outcomes in patients taking oral or intravenous steroids. Both treatments appear to be equally effective and safe. Based on this evidence, oral steroid therapy may be a practical and effective alternative to intravenous steroid therapy for the treatment of MS relapses.
Abstract: 35 short-term (14 weeks or less) RCTs were included in the analysis (4597 participants). Symptom severity for 17 trials was significantly reduced in the medication groups, relative to placebo (weighted mean difference -5.76, 95% confidence intervals (CI) -8.16 to -3.36, number of participants (N) = 2507). Similarly, summary statistics for responder status from 13 trials demonstrated overall superiority of a variety of medication agents to placebo (relative risk 1.49, 95% CI 1.28 to 1.73, number needed to treat = 4.85, 95% CI 3.85 to 6.25, N = 1272). Medication and placebo response occurred in 59.1% (N = 644) and 38.5% (628) of patients, respectively. Of the medication classes, evidence of treatment efficacy was most convincing for the SSRIs. Medication was superior to placebo in reducing the severity of PTSD symptom clusters, comorbid depression and disability. Medication was also less well tolerated than placebo. A narrative review of 3 maintenance trials suggested that long term medication may be required in treating PTSD. Medication treatments can be effective in treating PTSD, acting to reduce its core symptoms, as well as associated depression and disability. The findings of this review support the status of SSRIs as first line agents in the pharmacotherapy of PTSD, as well as their value in long-term treatment. However, there remain important gaps in the evidence base, and a continued need for more effective agents in the management of PTSD.

Plain-language summary: This was a systematic review of 35 short-term randomised controlled trials of pharmacotherapy for PTSD (4597 participants). A significantly larger proportion of patients responded to medication (59.1%) than to placebo (38.5%) (13 trials, 1272 participants). Symptom severity was significantly reduced in 17 trials (2507 participants). The largest trials showing efficacy were of the selective serotonin reuptake inhibitors, with long-term efficacy also observed for these medications.
Abstract: One ongoing study (Pellicer 2003) was identified. One study comparing adrenaline with dopamine infusion was included but was published in abstract form only (Phillipos 1996). It enrolled hypotensive, predominately preterm infants in the first 24 hours. Only infants >1750g are included in this review (report for infants <=1750g appears incomplete). The study was reported as being randomised and double blinded, but methods were not reported. Both adrenaline and dopamine significantly increased heart rate and mean BP, with no statistically significant effect on left or right ventricular outputs. No other clinical outcomes were reported. No studies were identified that compared adrenaline to other inotropes, placebo or no treatment. There are insufficient data on the use of adrenaline infusions in preterm infants with cardiovascular compromise to make recommendations for practice. There is a need for larger trials to determine whether adrenaline is effective in reducing morbidity and mortality in preterm infants with cardiovascular compromise.

Plain-language summary: Not enough evidence from trials on the use of adrenaline (epinephrine) for preterm babies with poor heart rates and circulation. Sustained poor blood flow in preterm babies can lead to complications, including impaired development. Inotrope drugs, particularly dopamine and dobutamine, are commonly used to increase heart rate and blood pressure in preterm babies with poor circulation. Adrenaline (epinephrine) is another inotrope drug that can be used. The review found that there is not enough evidence from trials to show the effects of adrenaline on preterm babies with poor circulation, and more research is needed.
Abstract: 24 studies met the inclusion for the review (3907 participants). In non-oral steroid treated, mild to moderately severe asthma, no clinically worthwhile differences in FEV1, morning PEFR, symptom scores or rescue beta2 agonist use were apparent across a dose range of 200-1600 mcg/d. However, in moderate to severe asthma a significant reduction in the likelihood of trial withdrawal due to asthma exacerbation was apparent when treating patients with BUD 800 mcg/d compared to 200 mcg/d: Relative Risk 3.93 (95% confidence interval, 1.4 to 10.9). This result was weighted largely by a single, large, high quality RCT. In severe asthma significant improvements favouring high dose BUD (1600 mcg/d) over low dose (200 mcg/d) were apparent for FEV1 but not morning PEFR. This finding was based on two large RCTs of good quality. In oral steroid treated asthmatics no dose dependent oral steroid sparing effect was apparent for BUD 1600 mcg/d v 800 or 400 mcg/d. Statistically significant, dose dependent suppression of 24 hour urinary free cortisol excretion and serum cortisol post synthetic ACTH infusion over the dose range 800-3200 mcg/d was apparent but the clinical significance of these findings is unclear. Budesonide exhibits a significant dose response effect between low and high dose for improvement in FEV1 in severe asthma and reduction of exacerbations in moderate to severe asthma. No significant dose dependent improvements in FEV1, PEFR or symptoms are evident in non-oral steroid treated asthmatics with mild to moderate disease. Dose dependent alterations in sensitive measures of hypothalamic-pituitary-adrenal function were evident but the clinical significance of these changes is unclear.

Plain-language summary: This review presents the effects of budesonide at different doses for people with varying degrees of asthma. In patients with mild-moderate asthma no important differences were apparent between the lowest dose (200 mcg/d) and the highest dose (1600 mcg/d) for measures of airway opening and symptoms. However, patients with more severe asthma are less likely to experience an acute worsening of their asthma control when a higher dose (1600 mcg/d) is used regularly compared to a lower dose (200 mcg/d). Future research should report results more comprehensively, and should use quality of life questionnaires.
Abstract: Seven RCTs, involving 1671 women were identified for inclusion. The review found that giving women information about the procedure prior to the mammogram may reduce pain and discomfort. Increasing women's control over breast compression could reduce pain experienced during the procedure, though mammogram image quality was only maintained if the technologist controlled the first compression. If the technologist reduced compression force of the mammogram, discomfort experienced was unchanged. The use of breast cushions reduced pain of mammography; however, image quality was impaired in 2% of women in the intervention group. Acetoaminophen as a premedication did not affect discomfort of mammography. Differences in interventions, and inconsistency in measures, validation of pain scales, and in assessment of mammogram quality, mean that results of these studies cannot be combined. All results are based on single studies. Further research is required. Currently there are very few proven interventions to reduce pain and discomfort of screening mammography, especially procedures that can be readily introduced to screening programmes. With mammography continuing as the preferred method for breast screening, more research on such interventions is needed.

Plain-language summary: Each study included in this review looked at a different intervention to reduce pain in mammography. The trial results show that giving women written or verbal information about the procedure prior to the mammogram can reduce pain or discomfort of the examination. Also increasing women's control of breast compression could reduce the pain they experience, though there was no change in the pain women experienced when a mammography-technologist reduced the compression force. Use of breast cushions also reduced the pain; however, it caused a poor quality of X-ray in 2% of women screened, which meant that they would need to have a further mammogram. Paracetamol taken before the procedure did not change the pain the women experienced. Further research is needed on interventions to relieve the pain and discomfort of screening mammography.
Abstract: In total we have identified 43 studies examining 4265 participants. The original review included 938 patients from 25 studies. The updated search identified an additional 18 studies with a combined total of 3327 participants between 1997 and June 2015. The results of these studies did not change the conclusions of the original review. No firm conclusions can be drawn from the many retrospective case series so the role of surgery in malignant bowel obstruction remains controversial. Clinical resolution varies from 26.7% to over 68%, though it is often unclear how this is defined. Despite being an inadequate proxy for symptom resolution or quality of life, the ability to feed orally was a popular outcome measure, with success rates ranging from 30% to 100%. Rates of re-obstruction varied, ranging from 0% to 63%, though time to re-obstruction was often not included. Postoperative morbidity and mortality also varied widely, although again the definition of both of these surgical outcomes differed between many of the papers. There were no data available for quality of life. The reporting of adverse effects was variable and this has been described where available. Where discussed, surgical procedures varied considerably and outcomes were not reported by specific intervention. Using the 'Risk of bias' assessment tool, most included studies were at high risk of bias for most domains. The role of surgery in malignant bowel obstruction needs careful evaluation, using validated outcome measures of symptom control and quality of life scores. Further information could include re-obstruction rates together with the morbidity associated with the various surgical procedures. Currently, bowel obstruction is managed empirically and there are marked variations in clinical practice by different units. In order to compare outcomes in malignant bowel obstruction, there needs to be a greater degree of standardisation of management. Since the last version of this review none of the new included studies have provided additional information to change the conclusions.

Plain-language summary: We first looked at the evidence in 2000 and this is an update of the original review. In total we found 43 studies examining 4265 people. We looked at adults with advanced gynaecological or gastrointestinal cancer who developed bowel obstruction and had either surgical or non-surgical treatment. The studies we found were of low quality and measured success and benefit in different ways. It was therefore not possible to compare these studies and conclude whether surgery was of benefit or harm in this situation. Research in this area is problematic and the type of study needed to answer this question would be very difficult to conduct.
Abstract: We included twelve randomised studies in this update of which five are additional studies. One trial compared fluspirilene and placebo and did not report important differences in the global improvement (n=60, 1 RCT, RR "no important improvement "0.97 CI 0.9 to 1.1). Though movement disorders (n=60, 1 RCT, RR 31.0 CI 1.9 to 495.6, NNH 4) were found only in the fluspirilene group, there were no convincing data showing the advantage of oral chlorpromazine or other depot antipsychotics over fluspirilene decanoate. We found no difference between depot fluspirilene and other oral antipsychotics with regard to relapses or to the number of people leaving the study early. Global state data (CGI) were not significantly different, in the short term when comparing fluspirilene with other depots (n=90, 2 RCTs, RR "no important improvement" 0.80 CI 0.2 to 2.8). No significant difference were apparent between fluspirilene and other depots with respect to the number of people leaving the trial early (n=83, 2 RCTs, RR 0.55 CI 0.1 to 2.3) or relapse rates (n=109, 3 RCTs, RR 0.55 CI 0.1 to 2.3). Extrapyramidal adverse effects were significantly less prevalent in the fluspirilene groups (n=164, 4 RCTs, RR 0.50 CI 0.3 to 0.8, NNH 5). Other adverse effects were not significantly different. Attrition in the one comparison between fluspirilene in weekly versus biweekly administration (n=34, RR 3.00 CI 0.1 to 68.8) and relapse rates (n=34 RR 3.18 CI 0.1 to 83.8) were not significantly different. There were no significant difference for movement disorders in one short term study. No study reported on hospital and service outcomes or commented on participants' overall satisfaction with care. Economic outcomes were not recorded by any of the included studies. Participant numbers in each comparison were small and we found no clear differences between fluspirilene and oral medication or other depots. The choice of whether to use fluspirilene as a depot medication and whether it has advantages over other depots cannot, at present, be informed by trial-derived data. Well-conducted and reported randomised trials are still needed to inform practice.

Plain-language summary: Fluspirilene is a relatively long-acting injectable depot antipsychotic drug used for schizophrenia. We updated the original systematic review (David 1999) on Depot fluspirilene for schizophrenia with five additional studies. Twelve randomised trials are included. Study sizes are small and most were of short term duration. This cannot be very informative for a drug that is meant for long-term maintenance treatment. However, from the studies we were able to include, fluspirilene decanoate does not differ greatly from other depot antipsychotics (fluphenazine decanoate, fluphenazine enathate, perphenazine onanthat, pipotiazine undecylenate) with respect to treatment efficacy, response or tolerability. Outcomes suggest that fluspirilene does not differ significantly from oral antipsychotics or in different weekly regimens, although much cannot be inferred because of the shortage of trials.