GEM/cochrane-simplification huggingface dataset:
Abstract: For the primary outcome, pregnancy, two controlled studies of LAM users reported life table pregnancy rates at six months of 0.45% and 2.45%, one controlled study reported 5% pregnancies in the absence of life table rates per month, and eight uncontrolled studies of LAM users reported pregnancy rates of 0% to 7.5%. Life table pregnancy rates for fully breastfeeding women who were amenorrheic but not using any contraceptive method were 0.88% in one study and 0.9% to 1.2% (95% confidence interval 0.0 to 2.4) in a second study, depending on the definition of menstruation used. The life table menstruation rate at six months in all studies varied between 11.1% and 39.4%. We found no clear differences in life table pregnancy rates between women using LAM and being supported in doing so, and fully breastfeeding amenorrheic women not using any method. As the length of lactation amenorrhoea in women using LAM differed greatly between the populations studied, and was population specific, it is uncertain whether LAM extends lactational amenorrhoea.

Plain-language summary: In this review we have studied the effectiveness of LAM as a contraceptive method in fully breastfeeding women in comparison to breastfeeding women without any support. We found no clear differences in effectiveness (pregnancy) between women using LAM and being supported in doing so, and fully breastfeeding amenorrheic women not using any method. Apart from this we recommend breastfeeding itself from a public health point of view.
Abstract: We identified 4 RCTs (1,194 adolescents). No RCT reported enough detail to assess whether a strong  randomisation method was used or allocation was concealed. Blinding was not possible as the intervention was mentoring. Three RCTs provided complete data. No selective reporting. Three RCTs provided evidence about mentoring and preventing alcohol use. We pooled two RCTs (RR for mentoring compared to no intervention = 0.71 (95% CI = 0.57 to 0.90, P value = 0.005). A third RCT found no significant differences. Three RCTs provided evidence about mentoring and preventing drug use, but could not be pooled. One found significantly less use of “illegal" drugs," one did not, and one assessed only marijuana use and found no significant differences. One RCT measured “substance use” without separating alcohol and drugs, and found no difference for mentoring. All four RCTs were in the US, and included “deprived” and mostly minority adolescents. Participants were young (in two studies age 12, and in two others 9-16). All students at baseline were non-users of alcohol and drugs. Two RCTs found mentoring reduced the rate of initiation of alcohol, and one of drug usage. The ability of the interventions to be effective was limited by the low rates of commencing alcohol and drug use during the intervention period in two studies (the use of marijuana in one study increased to 1% in the experimental and to 1.6% in the control group, and in another study drug usage rose to 6% in the experimental and 11% in the control group). However, in a third study there was scope for the intervention to have an effect as alcohol use rose to 19% in the experimental and 27% in the control group. The studies assessed structured programmes and not informal mentors.

Plain-language summary: Four randomised controlled trials (RCTs) were identified. All four RCTs were in the US and with adolescents described as deprived, and most were minority group adolescents. Two RCTs tested the "Across Ages" mentoring programme, one the Big Brothers/Big Sisters mentoring programme, and one an intervention with adolescents whose parents were HIV+. Two RCTs found that mentoring reduced rates of initiation of use of alcohol, and one reduced initiation of use of drugs. No adverse effects were identified. The relative youth of three of the samples made it unlikely that the interventions would be effective due to low baseline rates of usage. The studies assessed formal programmes, and as most mentors are informal their work remains un assessed.
Abstract: Eighteen trials are included in the review. The majority were in family care settings. For fourteen studies, FA was just one aspect of a broad multi-component programme of care. Assessing the effect of FA was compromised by ill-defined protocols for the duration of component parts of these programmes (i.e. frequency of the intervention or actual time spent). Therefore, establishing the real effect of the FA component was not possible. Overall, positive effects were noted at post-intervention for the frequency of reported challenging behaviour (but not for incidence or severity) and for caregiver reaction (but not burden or depression). These effects were not seen at follow-up. The delivery of FA has been incorporated within wide ranging multi-component programmes and study designs have varied according to setting - i.e. family care, care homes and hospital, with surprisingly few studies located in care homes. Our findings suggest potential beneficial effects of multi-component interventions, which utilise FA. Whilst functional analysis for challenging behaviour in dementia care shows promise, it is too early to draw conclusions about its efficacy.

Plain-language summary: In this review we analysed the effectiveness of functional analysis-based interventions for challenging behaviour in dementia. We found eighteen randomised controlled trials suitable for analysis in all four types of care settings. The majority were in family care settings and there were surprisingly few care home based studies. Most evaluated broad programmes of care, where FA was just one component of a wide range of other interventions. This made it hard to determine the real effect of FA for the management of challenging behaviour in dementia. However, positive results were noted in the frequency of the person’s reported problem behaviours and the caregiver’s reaction to them. No significant effects were found for incidence or severity of mood and other problem behaviours. Similarly, no significant effects were found for caregiver mood or burden. Whilst it is too early to reach a firm conclusion on the evidence for FA in the management of challenging behaviour in dementia, we note emerging beneficial effects on challenging behaviour where multi-component psychosocial interventions have used FA as part of the programme of care.
Abstract: Two randomized trials were included, enrolling 722 HIV-positive pregnant women from Malawi and Zambia. Both compared monthly regimens of sulfadoxine-pyrimethamine (SP) to the standard 2-dose regimen given in the second and third trimesters. In women in their first or second pregnancy, monthly SP may reduce both maternal parasitaemia (two trials, 463 participants, RR 0.25, 95% CI 0.14 to 0.43, low quality evidence), and placental parasitaemia at delivery (two trials, 459 participants, RR 0.38, 95% CI 0.21 to 0.70, low quality evidence). Monthly SP may have a small effect on the prevalence of maternal anaemia at delivery (two trials, 447 participants, RR 0.93, 95% CI 0.72 to 1.20, low quality evidence), and the number of babies born with low birth weight (two trials, 469 participants, RR 0.80, 95% CI 0.52 to 1.23, low quality evidence), but larger trials are necessary to reliably prove or exclude clinically important benefits on these outcomes. There is currently insufficient evidence to make conclusions regarding an effect on neonatal mortality (one study, 253 participants, very low quality evidence). In women in their third or higher pregnancy, there is insufficient evidence to make any conclusions on the benefits of monthly SP compared to the two dose regimen (one trial, 166 participants, very low quality evidence). There were no trials that assessed other treatment regimens for intermittent preventive treatment in HIV-positive pregnant women. Three or more doses of SP may have some advantages over the standard two doses in HIV-positive pregnant women, but larger trials would be necessary to confirm an effect on patient important outcomes. However, since SP cannot be administered concurrently with co-trimoxazole - a drug often recommended for infection prophylaxis in HIV-positive pregnant women, new drugs and research is needed to address needs of HIV-positive pregnant women.

Plain-language summary: This review only identified two trials which compared the impact of using three or more doses of sulphadoxine-pyrimethamine to using only two doses. Using three or more doses was more effective at preventing the presence of malaria parasites in the placenta and in the peripheral blood of the pregnant woman than using the standard two doses only. Also, children born to HIV-positive pregnant women who used three or more doses of sulphadoxine-pyrimethamine weighed more than those born to mothers who used only the standard two doses. Although more frequent doses of this drug are effective in preventing malaria, HIV-positive pregnant women with low CD4 count can not use the drug since the current policy requires that they use co-trimoxazole (Bactrim®) to prevent opportunistic infections. There is need, therefore, to investigate alternative drugs and regimens in preventing malaria in HIV-positive pregnant women.
Abstract: We included one single blind study (total n = 24). The overall risk of bias in the study was considered to be unclear although the randomisation was adequate. It compared a package of horticultural therapy which consisted of one hour per day of horticultural activity plus standard care with standard care alone over two weeks (10 consecutive days) with no long-term follow-up. Only two people were lost to follow-up in the study, both in the horticultural therapy group (1 RCT n = 24,RR 5.00 95% CI 0.27 to 94.34, very low quality evidence). There was no clear evidence of a difference in Personal Wellbeing Index (PWI-C) change scores between groups, however confidence intervals were wide (1 RCT n = 22, MD -0.90 95% CI -10.35 to 8.55, very low quality evidence). At the end of treatment, the Depression Anxiety Stress Scale (DASS21) change scores in horticultural therapy group were greater than that in the control group (1 RCT n = 22, MD -23.70 CI -35.37 to - 12.03, very low quality evidence). The only included study did not report on adverse effects of interventions. Based on the current very low quality data, there is insufficient evidence to draw any conclusions on benefits or harms of horticultural therapy for people with schizophrenia. This therapy remains unproven and more and larger randomised trials are needed to increase high quality evidence in this area.

Plain-language summary: This review focuses on the effects of horticultural therapy for people with schizophrenia. An electronic search for relevant randomised trials was run in January 2013. Only one trial was included, it randomised a total of 24 people with schizophrenia to received either their standard care plus horticultural therapy or standard care only. The trial only lasted 2 weeks (10 consecutive days) with no long-term follow-up. There are few results and the quality of evidence was rated by the review authors to be very low quality. Some of the information from this one study favoured horticultural therapy but there is insufficient evidence to draw any conclusions on benefits or harms of horticultural therapy for people with schizophrenia. More large, better conducted and reported trials are required to determine the effectiveness and benefits of horticultural therapy. This plain language summary has been written by a consumer Ben Gray, Service User and Service User Expert, Rethink Mental Illness.
Abstract: Fifty studies met the inclusion criteria. Six additional studies were identified since the original review. Only 31 of these studies involving 7104 participants were judged to have used a sufficiently robust measure of fatigue and thus were deemed suitable for detailed analysis. The drugs were still analysed by class (psychostimulants; haemopoietic growth factors; antidepressants and progestational steroids). Methylphenidate showed a small but significant improvement in fatigue over placebo (Z = 2.83; P = 0.005). Since the publication of the original review increased safety concerns have been raised regarding erythropoietin and this cannot now be recommended in practice.There was a very high degree of statistical and clinical heterogeneity in the trials and the reasons for this are discussed. There is increasing evidence that psychostimulant trials provide evidence for improvement in CRF at a clinically meaningful level. There is still a requirement for a large scale RCT of methylphenidate to confirm the preliminary results from this review. There is new safety data which indicates that the haemopoietic growth factors are associated with increased adverse outcomes. These drugs can no longer be recommended in the treatment of CRF. Readers of the first review should re-read the document in full.

Plain-language summary: This review has examined drug treatment for fatigue as it represents one of the ways this problem can be tackled. The review authors looked at trials in all types of cancer and at all stages of treatment. Fifty studies met the inclusion criteria but only 31 (7104 participants) were deemed suitable for detailed analysis as they explored fatigue in sufficient detail. They found mixed results with some drugs showing an effect on fatigue - most notably drugs that stimulate red blood cell production and also drugs that improve levels of concentration. Methylphenidate, a stimulant drug that improves concentration, is effective for the management of cancer-related fatigue but the small samples used in the available studies mean more research is needed to confirm its role. Erythropoietin and darbopoetin, drugs that improve anaemia, are effective in the management of cancer-related fatigue. However safety concerns and side effects from these drugs mean that they can no longer be recommended to treat cancer fatigue.
Abstract: Only two RCTs were eligible. One was a cross-over trial with 18 participants. The other randomised 400 participants to one of four treatments, of which two (L-carnitine and placebo) were relevant to this review, but the exact numbers of participants in these two treatment groups was not reported. All participants were young adults. Methodological details were poorly reported, and we considered the risk of bias in both studies to be unclear. The trials assessed different cognitive outcomes. We could extract cognitive data on approximately 200 participants from one trial. We found no evidence that L-carnitine has any effect on reaction time, vigilance, immediate memory, or delayed recall after three days of treatment. This trial report stated that there was a small number of adverse effects, none of which were serious. The small cross-over trial also reported no effect of L-carnitine on cognition, but did not provide data; no information was provided on adverse effects. We considered the available evidence to be of very low quality for all reported outcomes. Due to the limited number of included trials, short-term treatment, and inadequate reporting, we were unable to draw any conclusions about the efficacy or safety of L-carnitine for cognitive enhancement in healthy adults. Well-designed, randomised, placebo-controlled trials of L-carnitine for cognition enhancement in cognitively healthy people, with large samples and relatively long-term follow-up, are still needed.

Plain-language summary: It was difficult to properly assess the quality of the included trials because of poor reporting. We considered there to be a serious risk of bias due to poor study methods, and further uncertainty about the results because the studies were so small. We also considered the studies to be too short to adequately address our research question. Due to these factors, we considered the quality of the evidence to be very low. Given the limited amount of evidence of very low quality, we were not able to draw any conclusions about the effect of L-carnitine on cognitive function or its safety in healthy people. Larger, better-quality studies conducted over a longer period of time are needed to answer our review question.
Abstract: We included 18 studies involving 549 relevant participants, of which 14 (421 participants) were included in the analysis (one within both comparisons). Four of the 14 studies compared the effects of bilateral training with usual care. Primary outcomes: results were not statistically significant for performance in ADL (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) -0.14 to 0.63); functional movement of the arm (SMD -0.07, 95% CI -0.42 to 0.28) or hand (SMD -0.04, 95% CI -0.50 to 0.42). Secondary outcomes: no statistically significant results. Eleven of the 14 studies compared the effects of bilateral training with other specific upper limb (arm) interventions. Primary outcomes: no statistically significant results for performance of ADL (SMD -0.25, 95% CI -0.57 to 0.08); functional movement of the arm (SMD -0.20, 95% CI -0.49 to 0.09) or hand (SMD -0.21, 95% CI -0.51 to 0.09). Secondary outcomes: one study reported a statistically significant result in favour of another upper limb intervention for performance in extended ADL. No statistically significant differences were found for motor impairment outcomes. There is insufficient good quality evidence to make recommendations about the relative effect of simultaneous bilateral training compared to placebo, no intervention or usual care. We identified evidence that suggests that bilateral training may be no more (or less) effective than usual care or other upper limb interventions for performance in ADL, functional movement of the upper limb or motor impairment outcomes.

Plain-language summary: This review of 18 studies with 549 relevant participants looked at whether performing identical activities with both arms at the same time (simultaneous bilateral training) could improve performance in daily (or extended daily) activities, movement of the arm and/or reduce arm impairments. In comparison with usual care, bilateral training had no effect on performance in activities of daily living, functional movement of the arm or hand, performance in extended activities of daily living or motor impairment outcomes. In comparison with other arm interventions, bilateral training had no effect on performance in activities of daily living, functional movement of the arm or hand or motor impairment outcomes. One study found that people who undertook bilateral training showed less improvement in performance in extended activities of daily living than people doing another arm intervention. The evidence in this area is limited. Further research is needed to determine the effects of bilateral training.
Abstract: Overall, more than 3500 references were considered and 19 original reports with a total of 3599 patients were included. There were 9 trials analysing antibiotics versus placebo/no treatment, with all outcomes significantly favouring antibiotic use (P < 0.05) (I2 = 0%), including bacteriuria (risk ratio (RR) 0.25 (95% confidence interval (CI) 0.15 to 0.42), bacteremia (RR 0.67, 95% CI 0.49 to 0.92), fever (RR 0.39, 95% CI 0.23 to 0.64), urinary tract infection (RR 0.37, 95% CI 0.22 to 0.62), and hospitalization (RR 0.13, 95% CI 0.03 to 0.55). Several classes of antibiotics were effective prophylactically for TRPB, while the quinolones, with the highest number of studies (5) and patients (1188), were the best analysed. For 'antibiotics versus enema', we analysed four studies with a limited number of patients. The differences between groups for all outcomes were not significant. For 'antibiotic versus antibiotic + enema', only the risk of bacteremia (RR 0.25, 95% CI 0.08 to 0.75) was diminished in the 'antibiotic + enema group'. Seven trials reported the effects of short-course (1 day) versus long-course (3 days) antibiotics. Long course was significantly better than short-course treatment only for bacteriuria (RR 2.09, 95% CI 1.17 to 3.73). For 'single versus multiple dose', there was significantly greater risk of bacteriuria for single-dose treatment (RR 1.98, 95% CI 1.18 to 3.33). Comparing oral versus systemic administration - intramuscular injection (IM), or intravenous (IV) - of antibiotics, there were no significant differences in the groups for bacteriuria, fever, UTI and hospitalization. Antibiotic prophylaxis is effective in preventing infectious complications following TRPB. There is no definitive data to confirm that antibiotics for long-course (3 days) are superior to short-course treatments (1 day), or that multiple-dose treatment is superior to single-dose.

Plain-language summary: In nine trials we observed that antibiotic prophylaxis is effective in preventing infectious complications (bacteriuria, bacteremia, fever, urinary tract infection, sepsis) and hospitalization following prostate biopsy. Several classes of antibiotics are effective for prophylaxis in prostate biopsy, with the quinolones the best analysed class. There are no definitive data to confirm that antibiotic for long-course is superior to short-course treatment, or that multiple-dose treatment is superior to single-dose treatment.
Abstract: Fifteen studies met the inclusion criteria, enrolling 1926 participants. The trial size varied from 20 to 598 patients. Most studies compared corticosteroids, particularly dexamethasone, to standard therapy. We included six studies with data at one week in the meta-analysis for pain intensity; no data were available at that time point for the remaining studies. Corticosteroid therapy resulted in less pain (measured on a scale of 0 to 10 with a lower score indicating less pain) compared to control at one week (MD 0.84 lower pain, 95% CI 1.38 to 0.30 lower; low quality evidence). Adverse events were poorly documented. Factors limiting statistical analysis included the lack of standardised measurements of pain and the use of different agents, dosages, comparisons and routes of drug delivery. Subgroup analysis according to type of cancer was not possible. The quality of this evidence was limited by the risk of bias of the studies and small sample size. The results were also compromised by attrition, with data missing for the enrolled patients. The evidence for the efficacy of corticosteroids for pain control in cancer patients is weak. Significant pain relief was noted in some studies, albeit only for a short period of time. This could be important for patients with poor clinical status. Further trials, with increased numbers of participants, are needed to evaluate the safety and effectiveness of corticosteroids for the management cancer pain in adults, and to establish an ideal dose, duration of therapy and route of administration.

Plain-language summary: Study characteristics: We found 15 relevant studies with 1926 participants. The trial size varied from 20 to 598 patients and the duration of the included studies ranged from seven days to 42 weeks. Most studies compared corticosteroids, particularly dexamethasone, to standard therapy. Key results and quality of the evidence: Overall, we found that the current evidence is based on studies that contain only a small number of patients. The following conclusions can be made from the available evidence: 1) the evidence for the efficacy of corticosteroids for pain control in cancer patients is weak (GRADE quality of evidence for pain outcome was low); 2) significant pain relief was noted in some studies, albeit only for a short period of time; this could be important for patients who have only a short time to live; 3) overall, more studies found corticosteroids not to be of benefit; 4) it was not possible to determine whether steroids are more effective for pain in specific cancers; and 5) the side effect profile of steroids, especially in the longer term, is not well described.