GEM/cochrane-simplification huggingface dataset:
Abstract: Four trials (2300 women) are included. The interventions ranged from brief advice through to education on health and lifestyle over several sessions. For most outcomes, data were only available from individual studies. Only one study followed up through pregnancy and there was no strong evidence of a difference between groups for preterm birth, congenital anomalies or weight for gestational age; only one finding (mean birthweight) reached statistical significance (mean difference -97.00, 95% confidence interval (CI) -168.05 to -25.95). This finding needs to be interpreted with caution as pregnancy outcome data were available for only half of the women randomised. There was some evidence that health promotion interventions were associated with positive maternal behavioural change including lower rates of binge drinking (risk ratio 1.24, 95% CI 1.06 to 1.44). Overall, there has been little research in this area and there is a lack of evidence on the effects of pre-pregnancy health promotion on pregnancy outcomes. There is little evidence on the effects of pre-pregnancy health promotion and much more research is needed in this area. There is currently insufficient evidence to recommend the widespread implementation of routine pre-pregnancy health promotion for women of childbearing age, either in the general population or between pregnancies.

Plain-language summary: The review looks at randomised controlled trials examining routine health promotion before pregnancy to see whether it changes behaviour and leads to improved health for mothers and babies. Four trials with 2300 women provided information for the review. The health promotion offered to women in these studies ranged from very brief advice on a specific topic through to more general advice and education on health and lifestyle over several sessions. In only one study were women followed up through pregnancy and there was little evidence of any differences between groups, although the babies of women who had received the health promotion intervention had slightly lower birthweights. There was some evidence that health promotion interventions encourage women to have more healthy lifestyles, such as lower rates of binge drinking. Overall, there was little evidence on the effects of pre-pregnancy health promotion on the health of mothers and babies, and more evidence is needed before its widespread implementation can be recommended.
Abstract: We included two studies (212 participants) comparing antibiotics versus no treatment, and identified three on-going studies. Overall, incidence of symptomatic UTI varied between 19% and 31% in the groups not treated for asymptomatic bacteriuria. Antibiotic treatment had uncertain effects on preventing symptomatic UTI (2 studies, 200 participants: RR 0.86, 95% CI 0.51 to 1.45). Risk for selecting multidrug-resistant organisms was uncertain with antibiotic treatment (1 study, 112 participants: RR 1.21, 95% CI 0.60 to 2.41). Persistence of asymptomatic bacteriuria was high regardless of treatment. Antibiotics also have uncertain effects on other important patient and graft outcomes, for instance on all-cause mortality (1 study, 112 participants: RR 2.23, 95% CI 0.21 to 23.86), graft loss (1 study, 112 participants: RR 1.11, 95% CI 0.07 to 17.36), acute rejection (1 study, 112 participants: RR 0.93, 95% CI 0.44 to 1.97), hospitalisation for UTI (1 study, 112 participants: RR 0.74, 95% CI 0.13 to 4.27), graft function (2 studies, 200 participants, MD in serum creatinine concentration -0.06 mg/dL, 95% CI -0.19 to 0.08) and adverse reactions (1 study, 112 participants: no severe adverse event attributable to the antibiotic treatment). Evidence quality was low for all outcomes. Currently, there is insufficient evidence to support routinely treating kidney transplant recipients with antibiotics in case of asymptomatic bacteriuria after transplantation, but data are scarce. Further studies assessing routine antibiotic treatment would inform practice and we await the results of three ongoing randomised studies, which may help resolve existing uncertainties.

Plain-language summary: The bacterial infection of the urine often persisted, whether antibiotics were given or not. It was uncertain whether antibiotics prevented symptomatic urinary infection or increased the risk of selecting bacteria resistant to antibiotics, because there were too few data and several limitations in the included studies. Also, it was unclear whether the use of antibiotics in case of urinary infection without symptoms reduced the risks of graft rejection, need for hospitalisation due to symptoms of urinary infection, or mortality, or whether antibiotics improved the function of the kidney transplant. One study with 112 participants suggested there were no severe harmful reactions caused by the antibiotic treatment, and non-severe adverse events appeared to be rare. It is uncertain whether antibiotics are beneficial in kidney transplant recipients with bacteria in their urine but no symptoms. In one study, participants were assigned to antibiotics or no therapy by a method that was not random (i.e. according to patients' transplant code). In both studies, participants knew which treatment they were receiving (i.e. antibiotics or no therapy), which may have influenced the results. Last, we had not enough data to estimate with precision some effects of antibiotics. More research is needed.
Abstract: We added nine studies to this review to bring the total number of included studies to 32 comparing an intervention tailored to address identified determinants of practice to no intervention or an intervention(s) not tailored to the determinants. The outcome was implementation of recommended practice, e.g. clinical practice guideline recommendations. Fifteen studies provided enough data to be included in the quantitative analysis. The pooled odds ratio was 1.56 (95% confidence interval (CI) 1.27 to 1.93, P value < 0.001). The 17 studies not included in the meta-analysis had findings showing variable effectiveness consistent with the findings of the meta-regression. Despite the increase in the number of new studies identified, our overall finding is similar to that of the previous review. Tailored implementation can be effective, but the effect is variable and tends to be small to moderate. The number of studies remains small and more research is needed, including trials comparing tailored interventions to no or other interventions, but also studies to develop and investigate the components of tailoring (identification of the most important determinants, selecting interventions to address the determinants). Currently available studies have used different methods to identify determinants of practice and different approaches to selecting interventions to address the determinants. It is not yet clear how best to tailor interventions and therefore not clear what the effect of an optimally tailored intervention would be.

Plain-language summary: In a previous review, we included 26 studies and we concluded that tailoring can change professional practice. However, more studies of tailoring have been published and therefore we have incorporated the new studies into an update of the review. We have included 32 studies in the new review. The findings continue to indicate that tailored interventions can change professional practice, although they are not always effective and, when they are, the effect is small to moderate. There is insufficient evidence on the most effective approaches to tailoring, including how determinants should be identified, how decisions should be made on which determinants are most important to address, and how interventions should be selected to account for the important determinants. In addition, there is no evidence about the cost-effectiveness of tailored interventions compared to other interventions to change professional practice. Therefore, future research studies should seek to develop and evaluate more systematic approaches to tailoring.
Abstract: The updated search resulted in the identification of one ongoing trial comparing surgery versus conservative treatment. Four trials, involving a total of 237 participants, were included. All four trials were methodologically flawed and potentially biased. Three trials tested conservative treatment interventions. One trial, which compared short arm (below elbow) pre-fabricated functional braces with long arm (elbow included) plaster casts, found there was no significant difference in the time it took for fracture union. Patient satisfaction and return to work during treatment were significantly better in the brace group. The other two trials, both quasi-randomised, had three treatment groups. One trial compared Ace Wrap elastic bandage versus short arm plaster cast versus long arm plaster cast. The large loss to follow-up in this trial makes any data analysis tentative. However, the need for replacement of the Ace wrap by other methods due to pain indicates the potential for a serious problem with this intervention. The other trial, which compared immediate mobilisation versus short arm plaster cast versus long arm plaster cast for minimally displaced fractures, found no significant differences in outcome between these three interventions. The fourth trial, which compared two types of plates for surgical fixation, found no significant differences in functional or anatomical outcomes nor complications between the two groups. There is insufficient evidence from randomised trials to determine which method of treatment is the most appropriate for isolated fractures of the ulnar shaft in adults. Well designed and reported randomised trials of current forms of conservative treatment are recommended.

Plain-language summary: Four trials, involving a total of 237 participants, were included in the review. These trials had methodological weaknesses that could have resulted in serious bias. One trial compared 'short arm' (splintage stopping below the elbow) pre-fabricated functional braces with 'long arm' (splintage includes the elbow) plaster casts. It found no clear difference between the two groups in the time taken for the fracture to heal. However, significantly more people in the brace group were satisfied with their treatment and significantly more returned to work during their treatment. One trial compared Ace Wrap elastic bandage, short arm plaster cast and long arm plaster cast. The large loss to follow-up in this trial makes any findings tentative. However, the need for replacement of the Ace wrap by other methods due to pain does indicate the potential for a serious problem with this intervention. The third trial, which compared immediate mobilisation versus short arm plaster cast versus long arm plaster cast for minimally displaced fractures, found no clear differences in outcome between these three interventions. The fourth trial found no significant differences in functional or anatomical outcomes nor complications between the two types of plates used for surgical fixation of the fracture. Overall, there was not enough evidence from randomised controlled trials to show which methods of treatment are better for these injuries.
Abstract: We found five relevant trials (total n=537), but no usable data on service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment or economic outcomes. Overall, reporting of data was poor. Those data we were able to use suggested that equal proportions of people allocated lamotrigine or placebo had no global response (n=208, 1 RCT, RR 1.06 CI 0.73 to 1.54). There was no significant difference between groups in the proportions of people whose mental state did not improve (n=297, 3 RCT, RR 1.26 CI 0.81 to 1.97). There was, however, a significant reduction in the PANSS total scores (n=67, 2 RCT, WMD -16.88 CI -8.57 to -25.18, p=0.0001), positive symptom sub-scale scores (n=65, 2 RCTs, WMD -5.10 CI -8.86 to -1.34) and negative symptom sub-scale scores (n=67, 2 RCTs, WMD -5.25, CI -7.07 to -3.43). Most cognitive measures showed no differences (n=329, 2 RCTs, RR not attaining BACS composite score of 0.5 1.10 CI 0.59 to 2.04). The proportion of participants leaving studies was about 25% at 12 weeks (n=537, 5 RCTs, RR 0.96 CI 0.71 to 1.29). The lamotrigine group did experience the outcome of any adverse effects significantly more frequent than people allocated placebo (n=429, 2 RCTs, RR 1.19 CI 1.02 to 1.38, NNH 10 CI 5 to 90). Among the many effects listed, only nausea was found to be significantly more (9%) in the lamotrigine group compared with placebo (n=465, 3 RCTs, RR 2.26 CI 1.05 to 4.88). Evidence for use of lamotrigine as an adjuvant for people with schizophrenia is not robust and large well-designed, conducted and reported real-world randomised trials are needed to determine its place in everyday clinical practice.

Plain-language summary: We searched major medical databases for studies that have examined the use of lamotrigine for people with schizophrenia. We identified five relevant studies that were conducted according to existing standards of research. A total of 537 people with schizophrenia participated in these five studies. The participants were resistant to various degrees to usual treatments and were randomised to receive either lamotrigine or placebo in addition to their usual drugs. The data regarding effectiveness could only be usefully analysed in less than 70 participants. Lamotrigine was considered to be effective if the questionnaire scores showed a greater reduction than for those who received placebo. The magnitude of this effect was small when compared to placebo. Data regarding adverse effects were available from three studies. There was a higher occurrence of nausea in those receiving lamotrigine. Apart from this the common side effects were headache and dizziness. The current evidence does not suggest that the addition of lamotrigine is a remarkable strategy for people with resistant schizophrenia, but the results are suggestive of a positive effect on the symptoms of schizophrenia. However, more studies with larger number of participants are needed to confirm the true magnitude of benefit and safety. This review is limited by the poor presentation of data from the individual studies.
Abstract: Four trials compared the short-term effects of ipratropium bromide versus a beta2-agonist. Short-term changes in FEV1 (up to 90 minutes) showed no significant difference between beta2-agonist and ipratropium bromide treated patients. The differences were similar among the studies and when combined: Weighted Mean Difference (WMD) 0.0 liters (95% Confidence Interval (95% CI) -0.19 to 0.19). There was no significant additional increase in change in FEV1 on adding ipratropium to beta2-agonist: WMD 0.02 liter (95% CI -0.08 to 0.12). Long-term effects (24 hours) of the ipratropium bromide and beta2-agonist treatment combination were similar: WMD 0.05 liters (95% CI -0.14 to 0.05). Neither of two studies found significant changes in PaO2, either short- or long-term, with ipratropium versus beta-agonist, although one showed an increase in PaO2 in subjects receiving ipratropium bromide at 60 minutes. Adverse drug reactions included dry mouth and tremor. There was no evidence that the degree of bronchodilation achieved with ipratropium bromide was greater than that using a short-acting beta2-agonist. The combination of a beta2-agonist and ipratropium did not appear to increase the effect on FEV1 more than either used alone.

Plain-language summary: Trials comparing ipratropium bromide versus beta-agonists showed no significant difference in short-term or long-term effects (24 hours) on ease of breathing. Side effects of these drugs were reported by only a minority of patients and include dry mouth and tremor, and a 'strange feeling' after drug administration.
Abstract: We included 14 trials involving 1014 women. The trials were small and not of high methodologic quality. Of the nine trials reporting on physical fitness, six reported significant improvement in physical fitness in the exercise group, although inconsistencies in summary statistics and measures used to assess fitness prevented quantitative pooling of results. Eleven trials reported on pregnancy outcomes. A pooled increased risk of preterm birth (risk ratio 1.82, 95% confidence interval (CI) 0.35 to 9.57) with exercise, albeit statistically non-significant, does not cohere with the absence of effect on mean gestational age (mean difference +0.10, 95% CI -0.11 to +0.30 weeks), while the results bearing on growth of the fetus are inconsistent. One small trial reported that physically fit women who increased the duration of exercise bouts in early pregnancy and then reduced that duration in later pregnancy gave birth to larger infants with larger placentas. Regular aerobic exercise during pregnancy appears to improve (or maintain) physical fitness. Available data are insufficient to infer important risks or benefits for the mother or infant. Larger and better trials are needed before confident recommendations can be made about the benefits and risk of aerobic exercise in pregnancy.

Plain-language summary: Aerobic exercise is physical activity that stimulates a person's breathing and blood circulation. The review of 14 trials, involving 1014 pregnant women, found that pregnant women who engage in vigorous exercise at least two to three times per week improve (or maintain) their physical fitness, and there is some evidence that these women have pregnancies of the same duration as those who maintain their usual activities. There is too little evidence from trials to show whether there are other effects on the woman and her baby. The trials reviewed included non-contact exercise such as swimming, static cycling and general floor exercise programs. Most of the trials were small and of insufficient methodologic quality, and larger, better trials are needed before confident recommendations can be made about the benefits and risks of aerobic exercise in pregnancy.
Abstract: There are sixteen included trials, all of which included participants with mild-moderate dementia or cognitive decline. All trials assessed the cognitive effects of ALC and in addition most considered severity of dementia, functional ability and clinical global impression.  When considering clinical global impression (CGI-I) as a dichotomous variable (numbers improved versus numbers unchanged or worse) there were statistically significant treatment effects in favour of ALC at 12 and 24 weeks, (Peto odds ratio (OR) 1.90, 95% Confidence Interval (CI) 1.31 to 2.76) and (OR 2.33, 95% CI 1.31 to 4.14) but not at 52 weeks (OR 0.91, 95% CI 0.58 to 1.43). There was also a statistically significant treatment effect on MMSE at 24 weeks (Weighted Mean Difference (WMD) 0.69, 95% CI 0.09 to 1.29, P = 0.02), but not at 12 or 52 weeks. There was no evidence of benefit of ALC in the areas of severity of dementia, functional ability or Clinical Global Impression as a continuous measure.  Various adverse events were reported, but from the meta-analyses there were no statistically significant differences between treated and placebo groups. There is evidence for benefit of ALC on clinical global impression as a categorical measure and on MMSE at 24 weeks, but there is no evidence using objective assessments in any other area of outcome. Given the large number of comparisons made, the statistically significant results may be due to chance. At present there is no evidence to recommend its routine use in clinical practice. Many of the trials used rather vague descriptions of dementia and trials using more strictly defined groups may be informative. Individual patient data may add to the findings, as would trials including other outcomes (e.g. mood and caregiver quality of life). However, the evidence does not suggest that ALC is likely to prove an important therapeutic agent. More work on the pharmacokinetics of ALC in humans is also required.

Plain-language summary: Early studies suggested a beneficial effect of ALC on cognition and behaviour in aging subjects. However, later, larger studies have not supported these findings. The early and later studies differ widely in methodology and assessment tools used, and are therefore difficult to compare. There is no evidence of benefit of ALC in the areas of cognition, severity of dementia, functional ability or Clinical Global Impression as a continuous measure. An apparent beneficial effect on Clinical Global Impression assessed as a dichotomous variable may be due to chance. There was also a significant treatment effect on the Mini Mental State Examination (MMSE) at 24 weeks, but this result must be interpreted with caution in the context of significant heterogeneity in these trials. ALC is not currently in routine clinical use.
Abstract: We identified no RCTs or quasi-RCTs that fulfilled the inclusion criteria. Our searches retrieved eight potentially relevant studies, but after assessment of the full-text reports we excluded all of them due to the absence of randomisation or because the patients did not have Frey's syndrome. We excluded one randomised controlled trial that compared two different doses of botulinum toxin in patients with Frey's syndrome because the comparator was not an alternative treatment. We are unable to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome. RCTs are urgently needed to assess the effectiveness of interventions for the treatment of Frey's syndrome. Future RCTs should include patients with Frey's syndrome of different ranges of severity and report these patients separately. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective assessment of Frey's syndrome should be considered as one of the outcome measures.

Plain-language summary: We carried out a comprehensive search for randomised controlled trials (RCTs) in participants diagnosed with Frey's syndrome. We planned to include trials in which participants received any intervention compared to no treatment (observation) or an alternative intervention, with or without a second active treatment. Despite extensive searching, we were unable to identify any studies that met our inclusion criteria. There is no high-quality evidence to establish which type of treatment is most effective for the treatment of Frey's syndrome. High-quality clinical trials in this area should be urgently conducted. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective (patient) assessment of Frey's syndrome should be one of the outcome measures used. This review is up to date to 28 April 2014.