GEM/cochrane-simplification huggingface dataset:
Abstract: Of 1041 publications obtained from the search strategy, we examined nine studies. Four studies were excluded, and five studies with 211 participants were eligible for inclusion. There was no difference in the immediate success rate of IAL when compared with IVAS in the closed manual reduction of acute anterior shoulder dislocation (RR 0.95; 95% CI 0.83 to 1.10). There were significantly fewer adverse effects associated with IAL compared with IVAS (RR 0.16; 95% CI 0.06 to 0.43). The mean time spent in the emergency department was significantly less with IAL compared with IVAS (MD 109.46 minutes; 95% CI 84.60 to 134.32). One trial reported significantly less time for reduction with IVAS (105 seconds; 95% CI 84.0 to 126.1) compared with IAL (284.6 seconds; 95% CI 185.3 to 383.9). One trial reported no joint infection associated with intra-articular lignocaine injection and no mortality associated with either IAL or IVAS. We observed no significant difference between IAL and IVAS with regard to the immediate success rate of reduction, pain during reduction, post-reduction pain relief and reduction failure. Compared to IVAS, IAL may be less expensive and may be associated with fewer adverse effects and a shorter recovery time.

Plain-language summary: The review authors searched the medical literature and identified five studies comparing these two methods. The studies included 211 patients with acute anterior shoulder dislocation; 113 patients underwent intra-articular lignocaine injection and 98 underwent intravenous analgesia with sedation. The review found that there may be no difference in the immediate success of manual reduction of the dislocated shoulder between patients receiving intra-articular lignocaine injection and those who received intravenous analgesia and sedation. However, intra-articular lignocaine injection may be associated with fewer side effects and a shorter stay in the emergency department before discharge from hospital. Compared with intravenous analgesia and sedation, intra-articular lignocaine may also be cheaper. However, the relatively small number of studies included in the review and the relatively small number of patients in each study means that the results of the review preclude definitive conclusions regarding the superiority of either method..
Abstract: Seven trials, totaling 542 participants, met the eligibility criteria. Studies varied widely on risk of bias, interventions used and outcome measures reported. From these studies, there was no evidence to suggest that psychosocial intervention promotes global quality of life for patients with head and neck cancer at end of intervention (MD 1.23, 95% CI -5.82 to 8.27) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This quality of life tool includes five functional scales, namely cognitive, physical, emotional, social and role. There was no evidence to demonstrate that psychosocial intervention provides an immediate or medium-term improvement on any of these five functional scales. From the data available, there was no significant change in levels of anxiety (SMD -0.09, 95% CI -0.40 to 0.23) or depression following intervention (SMD -0.03, 95% CI -0.24 to 0.19). At present, there is insufficient evidence to refute or support the effectiveness of psychosocial intervention for patients with head and neck cancer. The evidence for psychosocial intervention is limited by the small number of studies, methodological shortcomings such as lack of power, difficulties with comparability between types of interventions and a wide divergence in outcome measures used. Future research should be targeted at patients who screen positive for distress and use validated outcome measures, such as the EORTC scale, as a measure of quality of life. These studies should implement interventions that are theoretically derived. Other shortcomings should be addressed in future studies, including using power calculations that may encourage multi-centred collaboration to ensure adequate sample sizes are recruited.

Plain-language summary: We identified seven studies, with a total of 542 adult patients who had head and neck cancer. However, many of the studies had shortcomings in their design or reporting. This has made it difficult to draw reliable conclusions. Overall, this review did not find any improvement in general quality of life or in levels of anxiety and depression following psychosocial intervention. In conclusion, there was limited good-quality evidence in this area, making it difficult to draw conclusions about the effectiveness of psychosocial interventions. Future good-quality research is required in this field and should target those in need of psychosocial intervention, in order to guide service development.
Abstract: No studies were included in this review. Although it is generally recognised that CFA may be episodic and resolve spontaneously, treatment with analgesics and anti-inflammatory agents may be needed. While this approach may be sufficient to manage symptoms, it is disappointing that no randomised controlled trials to rigorously evaluate these agents were found, nor could the authors identify any quasi-randomised. This systematic review has identified the need for a well-designed adequately-powered randomised controlled trial to assess the efficacy and safety of pharmacological agents for the symptomatic management of cystic fibrosis-related arthritis (CFA and HPO) in adults and children with cystic fibrosis. Studies should also better define the two conditions. A study has recently been conducted in CFA and may help fill this gap when analysed and published. There are no trials included in the review up to January 2016. We will continue to run searches to identify any potentially relevant studies; however, we do not plan to update other sections of the review until new studies are published.

Plain-language summary: We planned to report evidence from clinical studies to evaluate the effectiveness and safety of different anti-inflammatory analgesic drugs compared with placebo, with each other or with no treatment. However, we were disappointed that we could not find any completed randomised controlled studies of these treatments or any evidence from non-randomised controlled studies. One study in cystic fibrosis-related arthropathy has finished and may provide some evidence when published. We suggest that there should be a randomised controlled study to look at the effects and the safety of using anti-inflammatory drugs or painkillers or both to manage the symptoms of cystic fibrosis-related arthritis. This is an update of a previously published review (date of last search 19 January 2016). Since no studies have been included in the review up until January 2016, we will still search for studies every two years, but will not publish an updated version of this review until we can include any new studies.
Abstract: We included three RCTs (four reports) of 246 children aged under 16 years undergoing tonsillectomy. Children were given weight-appropriate doses of the study medication, either PRN or ATC, by a parent or carer at home for up to four days following surgery. We did not identify any studies assessing the management of postoperative pain in children in any other setting (i.e. as an inpatient). All studies included in this review were based on the use of paracetamol, and an opioid was added to paracetamol in two studies. Analgesics were administered either orally (tablet or elixir) or rectally (suppository). Reporting quality was poor and there were fewer than 50 children in each arm. Mean pain intensity scores decreased over time, as did medication use. However, children were still reporting pain at the final assessment, suggesting that no administration schedule provided adequate analgesia. There were no significant differences in pain intensity scores at any time point. The studies reported adverse events that may have been related to the study medication, such as nausea and vomiting, and constipation, but no statistically significant differences were noted between the groups. There were too few data from only three small studies and meta-analysis was not possible. One study reported that a higher amount of analgesics was consumed in the ATC group compared with the PRN group: it would have been helpful to show that the higher volume in the ATC group led to better analgesia but we were not able to demonstrate this. There was limited evidence available to draw any conclusions about the efficacy of PRN versus ATC analgesic administration for the management of postoperative pain in children.

Plain-language summary: In July 2014, we found three studies (randomised controlled trials) of 246 children under the age of 16 years. All studies compared the two ways of giving medicine for pain relief after tonsillectomy (an operation to remove the tonsils). The studies were small, and generally of low quality. One study showed that the children in the 'around the clock' group took more medication, but they did not have better pain relief. There were no differences in pain relief or side effects between the two groups. There was not enough evidence to be sure which method is better for a child's pain relief after surgery. More high quality, large studies are needed.
Abstract: Sixty-two trials with 10,187 randomised participants have been included in the review. Maximum duration of intervention was 18 months. Most included trials had poor study quality. The pooled weighted mean difference (WMD) for percentage weight change showed a benefit of supplementation of 2.2% (95% confidence interval (CI) 1.8 to 2.5) from 42 trials. There was no significant reduction in mortality in the supplemented compared with control groups (relative risk (RR) 0.92, CI 0.81 to 1.04) from 42 trials. Mortality results were statistically significant when limited to trials in which participants (N = 2461) were defined as undernourished (RR 0.79, 95% CI 0.64 to 0.97). The risk of complications was reduced in 24 trials (RR 0.86, 95% CI 0.75 to 0.99). Few trials were able to suggest any functional benefit from supplementation. The WMD for length of stay from 12 trials also showed no statistically significant effect (-0.8 days, 95% CI -2.8 to 1.3). Adverse effects included nausea or diarrhoea. Supplementation produces a small but consistent weight gain in older people. Mortality may be reduced in older people who are undernourished. There may also be a beneficial effect on complications which needs to be confirmed. However, this updated review found no evidence of improvement in functional benefit or reduction in length of hospital stay with supplements. Additional data from large-scale multi-centre trials are still required.

Plain-language summary: A total of 10,187 randomised participants from the 62 trials has been included. Maximum duration of intervention was 18 months. The reviewers suggest that supplementation appears to produce a small but consistent weight gain. There was no evidence in this updated review of a beneficial effect on mortality overall, but there may be a beneficial effect on mortality in people who are undernourished. Supplementation may also reduce the number of complications. The reported acceptance of supplements was variable between trials. Some adverse effects such as nausea or diarrhoea were reported. However, there were problems of study design and quality. More studies are required to confirm the beneficial effect on the number of complications, to establish whether there is a beneficial effect on mortality for undernourished elderly people and to provide evidence about whether protein and energy supplements can improve morbidity and functional status in frail older people.
Abstract: No new RCTs of biopsy or resection for LGG were identified. No additional ineligible non-randomized studies (NRS) were included in this updated review. Twenty other ineligible studies were previously retrieved for further analysis despite not meeting the pre-specified criteria. Ten studies were retrospective or were literature reviews. Three studies were prospective, however they were limited to tumor recurrence and volumetric analysis and extent of resection. One study was a population-based parallel cohort in Norway, but not an RCT. Four studies were RCTs, however patients were randomized with respect to varying radiotherapy regimens to assess timing and dose of radiation. One RCT was on high-grade gliomas (HGGs) and not LGG. Finally, one RCT evaluated diffusion tensor imaging (DTI)-based neuro-navigation for surgical resection. Since the last version of this review, no new studies have been identified for inclusion and currently there are no RCTs or CCTs available on which to base definitive clinical decisions. Therefore, physicians must approach each case individually and weigh the risks and benefits of each intervention until further evidence is available. Some retrospective studies and non-randomized prospective studies do seem to suggest improved OS and seizure control correlating to higher extent of resection. Future research could focus on RCTs to determine outcomes benefits for biopsy versus resection.

Plain-language summary: Conclusions: There are no randomized clinical trials on this topic; some institutional, non-clinical trials studies have suggested improved overall survival and seizure control with higher extent of resection. However, physicians should approach each case individually and weigh the risks and benefits of biopsy versus surgical resection, as well as incorporate patient preference into their clinical decision-making. Prognostic factors such as patient age, tumor size, and tumor location as well as potential implications for quality of life should be taken into account.
Abstract: Four studies, including 83 participants, are included in this review. Two studies used mantra meditation while the other two used yoga compared with drugs, relaxation training, non-specific exercises and standard treatment control. Design limitations caused high risk of bias across the studies. Only one out of four studies provided data appropriate for analysis. For this study there was no statistically significant difference between the meditation therapy group and the drug therapy group on the teacher rating ADHD scale (MD -2.72, 95% CI -8.49 to 3.05, 15 patients). Likewise, there was no statistically significant difference between the meditation therapy group and the standard therapy group on the teacher rating ADHD scale (MD -0.52, 95% CI -5.88 to 4.84, 17 patients). There was also no statistically significant difference between the meditation therapy group and the standard therapy group in the distraction test (MD -8.34, 95% CI -107.05 to 90.37, 17 patients). As a result of the limited number of included studies, the small sample sizes and the high risk of bias, we are unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. The adverse effects of meditation have not been reported. More trials are needed.

Plain-language summary: The objective of this review was to assess the efficacy of this treatment. As a result of the small number of studies that we were able to include in this review and the limitations of those studies, we were unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. No adverse effects of meditation in children have been reported. More trials are needed on meditation therapies for ADHD so that conclusions can be drawn regarding its effectiveness.
Abstract: We included one unpublished RCT, randomising 180 children aged three years at study commencement. The setting was nursery schools in an area with high prevalence of dental caries and a low level of fluoride in drinking water. Data from 166 participants were available for analysis. The study carried a high risk of bias. After three years, there was a reduction of caries in permanent teeth (mean difference (MD) −0.13, 95% confidence interval (CI) −0.24 to −0.02) and in primary teeth (MD −1.14, 95% CI −1.86 to −0.42), as measured by the decayed, missing and filled teeth index (DMFT for permanent teeth and dmft for primary teeth). For primary teeth, this is a substantial reduction, equivalent to a prevented fraction of 31%. For permanent teeth, the disease level was very low in the study, resulting in a small absolute effect size. The included study did not report any other outcomes of interest for this review (adverse events, dental pain, antibiotic use or requirement for general anaesthesia due to dental procedures). There is low-quality evidence to suggest fluoridated milk may be beneficial to schoolchildren, contributing to a substantial reduction in dental caries in primary teeth. Due to the low quality of the evidence, further research is likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. There was only one relatively small study, which had important methodological limitations on the data for the effectiveness in reducing caries. Furthermore, there was no information about the potential harms of the intervention. Additional RCTs of high quality are needed before we can draw definitive conclusions about the benefits of milk fluoridation.

Plain-language summary: Authors from Cochrane Oral Health reviewed existing studies to find all available evidence up to November 2014. We searched scientific databases for clinical trials testing the effects of fluoridated milk compared with non-fluoridated milk. Treatment had to be used and monitored for a minimum of two years. We found one unpublished study that included 180 three-year olds who were given either fluoridated or non-fluoridated milk at nursery schools in an area with high prevalence of dental cavities and a low level of fluoride in drinking water. After three years, 92% of the children were available for analysis. The evidence suggests fluoridated milk may be beneficial to schoolchildren, substantially reducing the formation of cavities in baby teeth. There was no information available about any possible adverse events. The evidence was considered to be low quality due to the lack of relevant studies, the risk of bias in the identified study and concerns over the applicability of the results to different settings and populations. Additional studies of high quality are needed before we can draw definitive conclusions about the benefits of milk fluoridation.
Abstract: Seven randomised controlled trials were identified that satisfied the inclusion criteria. In patients with moderate to severe ulcerative colitis whose disease was refractory to conventional treatment using corticosteroids and/or immunosuppressive agents, infliximab (three intravenous infusions at 0, 2, and 6 weeks) was more effective than placebo in inducing clinical remission (Relative Risk (RR) 3.22, 95% CI 2.18 to 4.76); inducing endoscopic remission (RR 1.88, 95% CI 1.54 to 2.28); and in inducing clinical response (RR 1.99, 95% CI 1.65 to 2.41) at 8 weeks. A single infusion of infliximab was also more effective than placebo in reducing the need for colectomy within 90 days after infusion (RR 0.44, 95% CI 0.22 to 0.87). In patients with moderate to severe ulcerative colitis whose disease is refractory to conventional treatment using corticosteroids and/or immunosuppressive agents, infliximab is effective in inducing clinical remission, inducing clinical response, promoting mucosal healing, and reducing the need for colectomy at least in the short term. Serious adverse events attributable to infliximab were not common in the included studies but physicians should be aware of and be prepared to deal with potential adverse events such as anaphylactic reactions and infections.

Plain-language summary: This review shows that intravenous infusions of infliximab, a TNF-α blocking agent is effective in inducing clinical remission, promoting mucosal healing, and reducing the need for colectomy in patients with active ulcerative colitis whose disease has not responded to conventional treatment.
Abstract: We included three randomised controlled trials (351 participants) investigating immediate versus delayed chemotherapy in people diagnosed with asymptomatic, metastatic, incurable colorectal cancer. Giving immediate versus delayed chemotherapy may make little or no difference to overall survival (hazard ratio (HR) 1.17, 95% confidence interval (CI) 0.93 to 1.46; 3 studies, 351 persons; low-quality evidence). For toxicity, giving immediate versus delayed chemotherapy may make little or no difference to the risk of grade 3 or 4 nausea and vomiting (risk ratio (RR) 0.84, 95% CI 0.31 to 2.25; 2 studies, 140 persons; very low-quality evidence), stomatitis (RR 1.10, 95% CI 0.47 to 2.55; 2 studies, 140 persons; very low-quality evidence), or diarrhoea (RR 0.69, 95% CI 0.34 to 1.40; 2 studies, 140 persons, very low-quality evidence). We are uncertain whether delayed chemotherapy made a difference to quality of life (very low-quality evidence), progression-free survival (low-quality evidence), or compliance with chemotherapy (low-quality evidence), as we had insufficient data to pool for these outcomes. Based on a limited number of trials, very sparse data, and uncertainty of the evidence, this review was unable to establish whether there was a difference in overall survival or other clinically relevant outcomes, between immediate or delayed chemotherapy in persons with metastatic, incurable, colorectal cancer. The results should be interpreted with caution.

Plain-language summary: We included three randomised clinical trials. In these trials, people with metastatic and incurable colorectal cancer, without symptoms, received chemotherapy straight away (standard group) or their chemotherapy was delayed (intervention group). There were a total of 176 participants In the standard groups and 175 in the intervention groups. The available data allowed us to complete analyses for overall survival and toxicities. Participants with metastatic, incurable colorectal cancer without symptoms, who received chemotherapy straight away, did not live longer than those whose chemotherapy was delayed until symptoms appeared. For toxicities measures, our findings were inconclusive due to sparse data from only two trials and few participants. There were insufficient data to compare other outcomes of interest, such as quality of life, progression-free survival (the length of time during and after treatment that a person lives with the disease, but it does not get worse), and compliance with chemotherapy (whether a participant was able to complete the chemotherapy regimen). Based on very sparse data and uncertainty of the evidence, we were unable to establish whether there was a difference in overall survival and other important outcomes in people with metastatic, incurable, colorectal cancer, who received chemotherapy either straight away or waited until after symptoms had appeared.