GEM/cochrane-simplification huggingface dataset:
Abstract: We found 15 randomised-controlled trials of pedestrian safety education programmes, conducted between 1976 and 1997. The methodological quality of the included trials was generally poor. Allocation concealment was adequate in three trials, outcome assessment was blinded in eight, and in most of the studies large numbers of participants were lost to follow up. Study participants were children in 14 studies and institutionalised adults in one. Eight studies involved direct education of participants, seven used parents as educators. No trials were conducted in a developing country and there were none of pedestrian safety training in the elderly. None of the trials assessed the effect of pedestrian safety education on the occurrence of pedestrian injury, but six assessed the effect on observed behaviour. Some trials showed evidence of behavioural change following pedestrian safety education but it is difficult to predict what effect this might have on pedestrian injury risk. Pedestrian safety education can result in improvement in children's knowledge and can change observed road crossing behaviour, but whether this reduces the risk of pedestrian motor vehicle collision and injury occurrence is unknown. There is evidence that changes in safety knowledge and observed behaviour decline with time, suggesting that safety education must be repeated at regular intervals.

Plain-language summary: The review of trials (mostly in children) found that pedestrian safety education can improve children's road safety knowledge and their observed road crossing behaviour. Education may need to be repeated at regular intervals, as the effect can decline with time. However, whether these changes to knowledge or behaviour can be linked to a reduction in pedestrian deaths and injuries is unknown.
Abstract: A total of 29 RCTs (n = 4974), mostly following up the participants for six weeks in outpatient clinics and inadequately reporting the risk of bias, were included. In comparison with tricyclic antidepressants (10 trials, n = 1553) there was no robust evidence to detect a difference between mirtazapine and tricyclics in terms of response at two weeks (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.64 to 1.13) or at the end of acute-phase treatment (at 6 to 12 weeks) (OR 0.89, 95% CI 0.72 to 1.10). In comparison with selective serotonin reuptake inhibitors (SSRIs) (12 trials, n = 2626) mirtazapine was significantly more effective at two weeks (OR 1.57, 95% CI 1.30 to 1.88) and at the end of acute-phase treatment (OR 1.19, 95% CI 1.01 to 1.39). Mirtazapine was significantly more effective than a serotonin-noradrenaline reuptake inhibitor (venlafaxine only, two trials, n = 415) at two weeks (OR 2.29, 95% CI 1.45 to 3.59) and at the end of acute-phase treatment (OR 1.53, 95% CI 1.03 to 2.25). In terms of dropouts, there was no robust evidence to detect a difference between mirtazapine and other antidepressants. Mirtazapine was more likely to cause weight gain or increased appetite and somnolence than SSRIs but less likely to cause nausea or vomiting and sexual dysfunction. Some statistically significant and possibly clinically meaningful differences between mirtazapine and other antidepressive agents were found for the acute-phase treatment of major depression. Mirtazapine is likely to have a faster onset of action than SSRIs during the acute-phase treatment. Dropouts occur similarly in participants treated with mirtazapine and those treated with other antidepressants, although the adverse event profile of mirtazapine is unique.

Plain-language summary: The evidence from this review, which included findings from 29 randomised controlled trials (4974 participants in total), suggests that mirtazapine is likely to have a faster onset of action than the most frequently used type of antidepressants, which are the selective serotonin reuptake inhibitors (SSRIs). It would appear that mirtazapine is superior to SSRIs at the end of treatment over 6 to 12 weeks. Mirtazapine causes adverse events that lead to a similar frequency of dropouts as SSRIs and tricyclic antidepressants, although adverse event profile of mirtazapine is unique. Mirtazapine is likely to cause weight gain or increased appetite and somnolence but is less likely to cause nausea or vomiting and sexual dysfunction than SSRIs.
Abstract: Included are three randomised controlled trials involving 184 people (predominantly active young men) with unidirectional anterior shoulder instability generally following a traumatic event. All three trials compared arthroscopic versus open surgery, generally involving the repair of Bankart lesions. The three trials were inadequately reported but appeared well-conducted with minimum follow-ups of two years. Pooled results showed no statistically significant difference between the two groups in recurrent instability or re-injury (7/92 versus 5/85, risk ratio (RR) 0.89, 95% confidence interval (CI) 0.09 to 8.72; random-effects model), in subsequent instability-related surgery (RR 0.66, 95% CI 0.05 to 8.97; random-effects model) or surgery for all reasons (RR 0.55, 95% CI 0.04 to 7.18; random-effects model). For other outcomes, including shoulder function, there were either no statistically significant differences between the two groups or the differences were clinically insignificant where statistically significant differences occurred. There is insufficient evidence from randomised trials comparing arthroscopic with open surgery for treating anterior shoulder instability. Further research is needed on this subject and for other surgical interventions. Sufficiently powered, good quality, well reported randomised controlled trials with validated outcome measures and long-term follow up are required.

Plain-language summary: This systematic review compared different techniques of surgical repair for anterior shoulder instability. Only three randomised controlled trials, involving a total of 184 people with anterior shoulder instability that usually followed a traumatic event, are included in the review. All three trials compared arthroscopic (key hole) surgery with open surgery, generally involving the repair of Bankart lesions. All three trials were inadequately reported but appeared well-conducted with minimum follow-ups of two years. The limited data available showed no statistically significant differences between the two groups in recurrent instability or re-injury, in subsequent instability-related surgery or surgery for all reasons. Data for other outcomes, including shoulder function, also showed no significance differences between the two groups. In all the available evidence was insufficient to draw conclusions and further well designed randomised controlled trials are required.
Abstract: Ten trials (involving 2685 people) met the inclusion criteria. We obtained individual patient data for four trials (involving 646 people). We found no difference in the number lost to follow-up by one year between day hospital care and inpatient care (5 RCTs, n = 1694, RR 0.94 CI 0.82 to 1.08). There is moderate evidence that the duration of index admission is longer for patients in day hospital care than inpatient care (4 RCTs, n = 1582, WMD 27.47 CI 3.96 to 50.98). There is very low evidence that the duration of day patient care (adjusted days/month) is longer for patients in day hospital care than inpatient care (3 RCTs, n = 265, WMD 2.34 days/month CI 1.97 to 2.70). There is no difference between day hospital care and inpatient care for the being readmitted to in/day patient care after discharge (5 RCTs, n = 667, RR 0.91 CI 0.72 to 1.15). It is likely that there is no difference between day hospital care and inpatient care for being unemployed at the end of the study (1 RCT, n = 179, RR 0.88 CI 0.66 to 1.19), for quality of life (1 RCT, n = 1117, MD 0.01 CI -0.13 to 0.15) or for treatment satisfaction (1 RCT, n = 1117, MD 0.06 CI -0.18 to 0.30). Caring for people in acute day hospitals is as effective as inpatient care in treating acutely ill psychiatric patients. However, further data are still needed on the cost effectiveness of day hospitals.

Plain-language summary: This review compares acute day hospital care to inpatient care. We found that at least one in five patients currently admitted to inpatient care could feasibly be cared for in an acute day hospital. Patients treated in the day hospital had the same levels of treatment satisfaction and quality of life as those cared for as inpatients. The day hospital patients were also no more likely to be unemployed at the end of their care.
Abstract: Two trials, 1378 participants, employing randomised, double-blind, parallel-group methodology were included. Both trials were of six months duration and were testing a galantamine dose of 16-24 mg/day in two divided doses. Both trials had an overall low risk of bias. The GAL-INT-6 trial included 592 patients with vascular dementia diagnosed according to recognised criteria and patients with Alzheimer's disease and coincidental radiographic findings of cerebrovascular disease. Limited outcome data were reported for the subgroup data with vascular dementia. In the whole trial population, statistically significant treatment effects in favour of galantamine compared with placebo in cognition (ADAS-cog, mean difference (MD) -2.29, 95% confidence interval (CI) -3.46 to -1.12, P = 0.0001 ), activities of daily living (DAD, MD 4.10, 95% CI 1.25 to 6.95, P = 0.005) and behaviour (NPI, MD -2.06, 95% CI -4.09 to -0.03, P = 0.05 ) were noted. Significantly higher numbers of patients dropped out, (102/396 galantamine, 33/196 placebo odds ratio (OR) 1.71, 95% CL 1.11 to 2.65, P = 0.02) and withdrew due to an adverse event from the group treated with galantamine compared with the placebo group (79/396 galantamine, 16/196 placebo, OR 2.80, 95% CI 1.59 to 4.95, P =0.0004). Data were also included from a second larger trial (GAL-INT-26) involving 788 patients with vascular dementia diagnosed using standard criteria. Statistically significant benefits favouring galantamine over placebo in assessments of cognition (ADAS-cog, MD -1.50, 95% CI -2.39 to -0.61, P = 0.0009), and favouring placebo compared with galantamine for behaviour (NPI, MD 1.80, 95% CI 0.29 to 3.31, P = 0.02) are recorded. Significantly higher numbers of patients dropped out from the group treated with galantamine compared with the placebo group (50/396 galantamine, 25/390 placebo OR 2.11, 95% CL 1.28 to 3.49, P = 0.004). Limited data were available when considering the impact of galantamine on vascular dementia or vascular cognitive impairment. The data available suggest some advantage over placebo in the areas of cognition and global clinical state. In both included trials galantamine produced higher rates of gastrointestinal side-effects. More studies are needed before firm conclusions can be drawn.

Plain-language summary: The efficacy of galantamine has been tested in two randomised controlled trials for the treatment of vascular dementia and for a mixed population of Alzheimer's disease patients with evidence of cerebrovascular disease on scanning. The rationale behind its use is to correct the cholinergic deficit seen in vascular dementia. This review found evidence of benefit for galantamine compared with placebo in measures of cognition in both studies. Both studies indicated higher rates of nausea and vomiting in patients taking galantamine compared with placebo.
Abstract: One double-blind randomised controlled trial with 26 participants who were on antiretroviral therapy (ART), comparing hepatitis B vaccine to placebo conducted in Spain met our eligibility criteria and was included in this review. The study ran for three years and participants were followed up on a monthly basis. The study reported adequate humoral response to vaccine at 12 months and no local or systematic side effects in both intervention and control groups. This humoral response was lost when the participants stopped taking ART. The sample size of the study was small and the study was conducted in a high income setting unlike the areas of highest burden of hepatitis B and HIV co-infections. The evidence from this study is insufficient to support any recommendations regarding the use of hepatitis B vaccine in PLHIV. Neither does this evidence demonstrate that hepatitis B vaccine is unsafe in PLHIV. Further randomised controlled trials in high prevalence areas are required to generate evidence on the long term efficacy and safety of hepatitis B vaccine in PLHIV with and without ART. Different regimens and routes of administration should also be explored.

Plain-language summary: Our search for eligible papers was updated in August 2014 and we found one trial with 26 adult participants in Spain. The study sought to test if hepatitis B virus vaccine was better than placebo in preventing PLHIV from getting hepatitis B. The single study in this review showed improved immunity against hepatitis B among people living with HIV and taking antiretroviral therapy at 12 months. This immunity was lost once they stopped taking antiretroviral therapy. No side-effects were reported. The quality of evidence was assessed as very low.
Abstract: Thirteen RCTs of variable quality involving 1066 participants met the inclusion criteria of the review. The oral steroid dose was equivalent to prednisolone 4-40 mg/day. OCS: there was an improvement in CXR over 3-24 months (Relative Risk (RR): 1.46 [1.01 to 2.09], 3 studies), but this finding requires cautious interpretation. No other significant differences were identified on secondary outcomes. ICS: Data were inadequate to perform meaningful analysis of data on CXR. Two studies showed no improvement in lung function, In one study there was an improvement in diffusing capacity in the treated group. There were no data on side-effects. In one study symptoms improved at the end of six months of treatment. Oral steroids improved the chest X-ray and a global score of CXR, symptoms and spirometry over 3-24 months. However, there is little evidence of an improvement in lung function. There are limited data beyond two years to indicate whether oral steroids have any modifying effect on long-term disease progression. Oral steroids may be of benefit for patients with Stage 2 and 3 disease with moderate to severe or progressive symptoms or CXR changes.

Plain-language summary: The review of trials found that using corticosteroids for lung sarcoidosis leads to some short-term benefit in terms of chest x-ray, but there is limited evidence that this benefit lasts or affects the long term outcomes of the disease.
Abstract: We identified nine studies comprising 338,467 individuals randomised to screening and 405,919 individuals to the control groups. Five studies compared flexible sigmoidoscopy to no screening and four studies compared repetitive guaiac-based FOBT (annually and biennially) to no screening. We did not consider that study risk of bias reduced our confidence in our results. We did not identify any studies comparing the two screening methods directly. When compared with no screening, colorectal cancer mortality was lower with flexible sigmoidoscopy (relative risk 0.72; 95% CI 0.65 to 0.79, high quality evidence) and FOBT (relative risk 0.86; 95% CI 0.80 to 0.92, high quality evidence). In the analyses based on indirect comparison of the two screening methods, the relative risk of dying from colorectal cancer was 0.85 (95% credibility interval 0.72 to 1.01, low quality evidence) for flexible sigmoidoscopy screening compared to FOBT. No complications occurred after the FOBT test itself, but 0.03% of participants suffered a major complication after follow-up. Among more than 60,000 flexible sigmoidoscopy screening procedures and almost 6000 work-up colonoscopies, a major complication was recorded in 0.08% of participants. Adverse event data should be interpreted with caution as the reporting of adverse effects was incomplete. There is high quality evidence that both flexible sigmoidoscopy and faecal occult blood testing reduce colorectal cancer mortality when applied as screening tools. There is low quality indirect evidence that screening with either approach reduces colorectal cancer deaths more than the other. Major complications associated with screening require validation from studies with more complete reporting of harms.

Plain-language summary: We identified four trials which compared FOBT to no screening and five trials which compared flexible sigmoidoscopy to no screening. No studies compared the two methods directly. Mortality from colorectal cancer was reduced with FOBT screening and screening with flexible sigmoidoscopy. When we compared the two methods, we could not conclude that one was better than the other. No complications occurred after the FOBT test itself, but 0.03% of participants suffered a major complication after follow-up. Among more than 60,000 flexible sigmoidoscopy screening procedures and almost 6000 work-up colonoscopies, a major complication was recorded in 0.08% of participants. These findings should be interpreted with caution as the reporting of adverse effects was incomplete.
Abstract: The search resulted in four potential studies; after inspection, all were excluded. Three studies were excluded because they involved people with clozapine-induced hypersalivation - a topic covered in another Cochrane review. The fourth study was excluded because it involved people with schizophrenia, mood disorders or other mental disorders who were suffering from clozapine- and non-clozapine induced hypersalivation and were treated with Chinese medicines with unknown anticholinergic properties. People in the control group received an anticholinergic drug (artane) or an antihistamine (phenergan). It was not possible to separate clozapine- from non-clozapine-treated people in the intervention group, or to separate artane-treated people from phenergan-treated people in the control group. We have been unable to locate any studies addressing the question raised in this review. Accordingly, this empty review points out an important clinical problem that needs to be investigated via well-designed and well-conducted randomised trials. Clinicians and patients are likely to continue with their current dependence on clinical judgement and personal experience. Policy makers have no trial-based evidence upon which to base guidelines for the treatment of hypersalivation induced by neuroleptics other than clozapine. They are likely to continue to rely on opinion and habit when making recommendations. Funders of studies may wish to make this important subgroup of people a priority in future research.

Plain-language summary: The search was carried out 15 November 2012 and resulted in identification of four potential studies, but none could be included. Three of these were excluded because they involved clozapine-related hypersalivation. The fourth study was excluded because it involved people with mood or other mental disorders and Chinese medicines. Dribbling or hypersalivation is an important problem that needs to be investigated via well-designed research and randomised trials. Until such time, psychiatrists and patients are likely to continue their treatment of hypersalivation on the basis of daily clinical judgement and personal experience rather than hard evidence. Treatment of hypersalivation caused by antipsychotics or neuroleptics other than clozapine does not seem to have received adequate research attention to help guide practice. The review authors conclude that using anticholinergics to treat dribbling or hypersalivation caused by antipsychotic drugs other than clozapine cannot be justified without further study. This plain language summary has been written by Benjamin Gray, Service User and Service User Expert: Rethink Mental Illness. Email: [email protected]
Abstract: Five studies were included in the review. Human growth hormone with or without glutamine appears to provide benefit in terms of increased weight (MD 1.66 Kg; 95% CI 0.69 to 2.63;P = 0.0008), lean body mass (MD 1.93 Kg; 95% CI 0.97 to 2.90; P = 0.0001) energy absorption (MD 4.42 Kcal; 95% CI 0.26 to 8.58; P = 0.04) and nitrogen absorption (MD 44.85 g; 95%CI 0.20 to 9.49; P = 0.04) for patients with short bowel syndrome. The single RCT that focused on parenteral nutrition (PN) requirements demonstrated decreased PN volume and calories and number of infusions in patients who received HGH with or without glutamine supplementation.  Only patients who received HGH with glutamine maintained statistically significant PN reductions at 3 month follow-up. The results suggest a positive effect of human growth hormone on weight gain and energy absorption. However, in the majority of trials, the effects are short-lived returning to baseline shortly after cessation of therapy. The temporary benefit calls into question the clinical utility of this treatment.  To date, the evidence is inconclusive to recommend this therapy.  Consideration should be made to studying patients during the active phase of intestinal adaptation rather than in the setting of chronic intestinal failure.  The role of HGH in paediatric short bowel syndrome remains unknown.

Plain-language summary: Several small studies have assessed the benefit of providing drugs such as human growth hormone and glutamine in an attempt to improve intestinal function and wean intravenous nutrition (liquid food). The results of this review of 5 small studies suggest that human growth hormone used with or without glutamine may provide short term benefit for patients with short bowel syndrome in terms of weight gain and intestinal absorption of nutrients. However the benefits of treatment do not continue after treatment is stopped. Common side effects of treatment include peripheral edema (swelling of tissues, usually in the lower limbs), and carpal tunnel syndrome (numbness and muscle weakness in the hand). Conclusive evidence is not available to recommend this treatment. Further studies that evaluate human growth hormone treatment during the immediate phase of bowel adaptation are needed.