GEM/cochrane-simplification huggingface dataset:
Abstract: We included 1 RCT and 9 CCTs (total number of participants = 770). None of the included studies reported clinical outcomes. All included studies reported on influenza immunity and adverse reactions to vaccination. In five studies, immune responses to influenza vaccine were compared in 272 children receiving chemotherapy and 166 children not receiving chemotherapy. In four studies, responses to influenza vaccine were assessed in 236 children receiving chemotherapy compared with responses in 142 healthy children. Measures used to assess immune responses included a four-fold rise in antibody titre after vaccination, development of a haemagglutination inhibition (HI) titre > 32 and pre- and post-vaccination geometric mean titres (GMTs). Immune responses in children receiving chemotherapy were consistently weaker (four-fold rise of 38% to 65%) than those in children who had completed chemotherapy (50% to 86%) and in healthy children (53% to 89%). In terms of adverse effects, 391 paediatric oncology patients received influenza vaccine, and the adverse effects described included mild local reactions and low-grade fever. No life-threatening or persistent adverse effects were reported. Paediatric oncology patients receiving chemotherapy are able to generate an immune response to the influenza vaccine, but it remains unclear whether this immune response protects them from influenza infection or its complications. We are awaiting results from well-designed RCTs addressing the clinical benefit of influenza vaccination in these patients.

Plain-language summary: This review therefore focused on the efficacy of influenza vaccination in children with cancer. We identified no studies that assessed the clinical efficacy of influenza vaccination; however, we identified one additional controlled clinical trial in our update, which brings the total to nine studies that assessed immune responses after vaccination in children with cancer. It was shown that children receiving chemotherapy mount poorer immune responses than healthy children, but that the vaccine can be safely administered. On the basis of this updated review, it is not possible to recommend or discourage influenza vaccination in children with cancer who are treated with chemotherapy. A future trial should address the clinical benefits of influenza vaccination in children with cancer who are treated with chemotherapy.
Abstract: For the purpose of this review, STI strategies were classified either as a timed-cycle STI strategy or a CD4-guided STI strategy. In timed-cycle STI strategy, a predetermined period of fixed duration (e.g. one week, one month) off ART was attempted followed by resumption of ART, while closely monitoring changes in CD4 levels and viral load levels. Predetermined criteria for interruption and resumption were laid out in this strategy. Timed-cycle STI fell out of favor due to reports of development of resistance in many studies. Moreover, there were no significant immunological and virological benefits, and no reduction in toxicities, reported in these studies. In CD4-guided STI strategy, ART was interrupted for variable durations guided by CD4 levels. Participants with high nadir CD4 levels qualified for this approach. A reduction in costs of ART, a reduction in mutation, and a better tolerability of this CD4-guided STI strategy was reported. However, concerns about long-term safety of this strategy on immunological, virological, and clinical outcomes were also raised. Timed-cycle STI have not been proven to be safe in the short term. Although CD4-guided STI strategy has reported favorable outcomes in the short term, the long-term safety, efficacy and tolerability of this strategy has not been fully investigated. Based on the studies we reviewed, the evidence to support the use of timed-cycle STI and CD4-guided STI cycles as a standard of care in the management of chronic suppressed HIV infection is inconclusive.

Plain-language summary: This systematic review aims to synthesize the evidence for use of STI as an alternative strategy in the management of chronic suppressed HIV infection. STI is a planned, experimental intervention, and the evidence from 33 available intervention trials has been summarized. Currently, several large STI trials are underway, investigating long-term effects of STI strategies. Their results will be available in a few years. Based on the studies we reviewed, we find that there is insufficient evidence to support the use of STI as a standard of care in the management of chronic suppressed HIV infection.
Abstract: Overall, 102 studies have been included in this review. Interventions explored were: 'positive distracters', to include aromas (two studies), audiovisual distractions (five studies), decoration (one study), and music (85 studies); interventions to reduce environmental stressors through physical changes, to include air quality (three studies), bedroom type (one study), flooring (two studies), furniture and furnishings (one study), lighting (one study), and temperature (one study); and multifaceted interventions (two studies). We did not find any studies meeting the inclusion criteria to evaluate: art, access to nature for example, through hospital gardens, atriums, flowers, and plants, ceilings, interventions to reduce hospital noise, patient controls, technologies, way-finding aids, or the provision of windows. Overall, it appears that music may improve patient-reported outcomes such as anxiety; however, the benefit for physiological outcomes, and medication consumption has less support. There are few studies to support or refute the implementation of physical changes, and except for air quality, the included studies demonstrated that physical changes to the hospital environment at least did no harm. Music may improve patient-reported outcomes in certain circumstances, so support for this relatively inexpensive intervention may be justified. For some environmental interventions, well designed research studies have yet to take place.

Plain-language summary: The review identified 102 relevant studies, 85 of which were on the use of music in hospital. Other environmental aspects considered were: aromas (two studies), audiovisual distractions (five studies), decoration (one study), air quality (three studies), bedroom type (one study), flooring (two studies), furniture and furnishings (one study), lighting (one study), temperature (one study), and multiple design changes (two studies). No studies meeting the inclusion criteria were found to evaluate: art, access to nature for example through hospital gardens, atriums, flowers, and plants, ceilings, interventions to reduce hospital noise, patient controls, technologies, way-finding aids, or the provision of windows. Overall, it appears that music in hospital may help improve patient-reported outcomes such as anxiety; however, there is less evidence to support the use of music for physiological outcomes (such as reducing heart rate and blood pressure) and for reducing the use of medications. For other aspects of hospital environments, there are not very many well designed studies to help with making evidence-based design decisions. The studies that have been included in this review show that physical changes made to 'improve' the hospital environment on the whole do no harm.
Abstract: Twenty trials were included. These involved a total of 2562 mostly young active adult males. All trials had methodological weaknesses. Specifically, concealment of allocation was confirmed in only one trial. Data for pooling individual outcomes were only available for a maximum of 12 trials and under 60% of participants. The findings of statistically significant differences in favour of the surgical treatment group for the four primary outcomes (non-return to pre-injury level of sports; ankle sprain recurrence; long-term pain; subjective or functional instability) when using the fixed-effect model were not robust when using the random-effects model, nor on the removal of one low quality (quasi-randomised) trial that had more extreme results. A corresponding drop in the I² statistics showed the remaining trials to be more homogeneous. The functional implications of the statistically significantly higher incidence of objective instability in conservatively treated trial participants are uncertain. There was some limited evidence for longer recovery times, and higher incidences of ankle stiffness, impaired ankle mobility and complications in the surgical treatment group. There is insufficient evidence available from randomised controlled trials to determine the relative effectiveness of surgical and conservative treatment for acute injuries of the lateral ligament complex of the ankle. High quality randomised controlled trials of primary surgical repair versus the best available conservative treatment for well-defined injuries are required.

Plain-language summary: Twenty trials were included. These involved a total of 2562 mostly young active adult males. All trials had methodological flaws that could have affected their results. Data for pooling individual outcomes were only available for a maximum of 12 trials. Additionally, there was one low quality and potentially biased trial with very positive results in favour of surgery. When this trial was excluded, the findings of better results for surgery in terms of return to sports, re-injury, persistent pain and ankle instability as judged by the patient were no longer statistically significant. Thus, the trend to a better result from surgery remains unproven. Ankle stability, as judged by the clinician using standard tests, was better after surgery than with conservative treatment. Conversely, there was some limited evidence for longer recovery times, and higher incidences of ankle stiffness, impaired ankle mobility and complications in the surgical treatment group. We concluded that there was not enough evidence from randomised controlled trials to say whether surgery gives a better result than conservative treatment for acute ankle sprain in adults.
Abstract: We included 13 trials (1135 participants, 1923 eyes) in this review. Nine of these trials randomised eyes to treatment, two trials randomised people to treatment and treated both eyes, and two trials randomised people to treatment and treated one eye. None of the paired trials reported an appropriate paired analysis. We considered the overall quality of evidence to be low for most outcomes because of the risk of bias in the included trials. There was evidence that LASIK gives a faster visual recovery than PRK and is a less painful technique. Results at one year after surgery were comparable: most analyses favoured LASIK but they were not statistically significant. LASIK gives a faster visual recovery and is a less painful technique than PRK. The two techniques appear to give similar outcomes one year after surgery. Further trials using contemporary techniques are required to determine whether LASIK and PRK as currently practised are equally safe. Randomising eyes to treatment is an efficient design, but only if analysed properly. In future trials, more efforts could be made to mask the assessment of outcome.

Plain-language summary: This review analyses the results from 13 clinical trials where 1923 eyes of 1135 participants were randomly treated with either LASIK or PRK. We considered the overall quality of evidence from these studies to be low. There was some evidence that LASIK gives a faster visual recovery than PRK, and is a less painful technique, although visual results one year after surgery were comparable. Surgical techniques are improving all the time and further trials are needed to see whether LASIK and PRK, as currently practised, are equally safe.
Abstract: We included 24 studies (2,610 patients) in this review. Teicoplanin reduced the risk of nephrotoxicity compared to vancomycin (RR 0.66, 95% CI 0.48 to 0.90).The effects of teicoplanin or vancomycin were similar for clinical cure (RR 1.03, 95% CI 0.98 to 1.08), microbiological cure (RR 0.98, 95% CI 0.93 to 1.03) and mortality (RR 1.02, 95% CI 0.79 to1.30). Six studies reported no cases of acute kidney injury (AKI) needing dialysis. Adverse events were less frequent with teicoplanin including cutaneous rash (RR 0.57, 95% CI 0.35 to 0.92), red man syndrome (RR 0.21, 95% CI 0.08 to 0.59) and total adverse events (RR 0.73, 95% CI 0.53 to 1.00). A lower risk of nephrotoxicity with teicoplanin was observed in patients either with (RR 0.51, 95% CI 0.30 to 0.88) or without aminoglycosides (RR 0.31, 95% 0.07 to 1.50), and also when vancomycin dosing was guided by serum levels (RR 0.22, 95% CI 0.10 to 0.52). Teicoplanin and vancomycin are both effective in treating those with proven or suspected infection; however the incidence of adverse effects including nephrotoxicity was lower with teicoplanin. There were no cases of AKI needing dialysis. It remains unclear whether the differential effect on kidney function should influence which antibiotic be prescribed, although it may be reasonable to consider teicoplanin for patients at higher risk for AKI needing dialysis.

Plain-language summary: This review identified 24 studies enrolling 2,610 patients comparing teicoplanin and vancomycin in those with either proven or suspected infection. Teicoplanin was as effective as vancomycin for treating infections caused by Staphylococcus aureus with similar results for clinical cure, microbiological cure and death. However, there were less adverse events (skin rash and red man syndrome) and it caused significantly less damage to the kidneys.
Abstract: Seven low quality randomised trials were included. All studies included a total of 310 patients, but due to selective outcome reporting bias, less patients could be included in our analyses. Pooled analysis of three homogenous trials showed that needle aspiration did not significantly increase the proportion of patients with fever resolution (RR 0.60, 95% confidence interval (CI) 0.22 to 1.61). Sensitivity analysis according to trial quality preserved these findings. Trials that evaluated resolution of abdominal pain, days to resolution of fever, pain, resolution of abscess cavities, reduction in liver size, and duration of hospitalisation were heterogeneous. The benefits in the number of days to resolution of pain (MD -1.59, 95%CI -2.73 to -0.42), number of days to resolution of abdominal tenderness (MD -1.70, 95%CI -2.86 to -0.54), and duration of hospitalisation (MD -1.31, 95%CI -2.05 to -0.57) were observed in the needle aspiration group only. Therapeutic aspiration in addition to metronidazole to hasten clinical or radiologic resolution of uncomplicated amoebic liver abscesses cannot be supported or refuted by the present evidence. The trials lack methodological rigour and adequate sample size to conclude on the presence of effectiveness of adjunctive image-guided aspiration plus metronidazole versus metronidazole alone. Further randomised trials are necessary.

Plain-language summary: This review compares the standard treatment with a more invasive alternative, where pus-filled mass is drained by image-guided percutaneous procedure (performed through the skin). Seven low quality randomised trials were included. All the seven studies included a total of 310 patients, but due to selective outcome reporting bias, less patients could be included in our analyses. Pooled analysis of three homogenous trials showed that needle aspiration did not significantly increase the proportion of patients with fever resolution. Benefits could be observed in resolution time of pain and tenderness. No additional benefit has been found with percutaneous needle aspiration plus metronidazole versus metronidazole alone for uncomplicated amoebic liver abscesses in hastening clinical and radiologic resolution. However, this conclusion is based on trials with methodological flaws and with insufficient sample sizes, and requires further confirmation in larger well-designed, randomised trials.
Abstract: Randomised evidence was sparse. Only four trials were eligible for inclusion, one comparing the efficacy of real ECT versus simulated ECT, two comparing the efficacy of unilateral versus bilateral ECT and the other comparing the efficacy of ECT once a week with ECT three times weekly. All trials had major methodological shortcomings; reports were mostly lacking essential information to perform a quantitative analysis. Although the findings from one study (35 participants) concluded that real ECT was superior to simulated ECT, these conclusions need to be interpreted cautiously. Only results from one of the trials (29 participants) comparing unilateral versus bilateral ECT could be analysed, and did not show convincing efficacy of unilateral ECT over bilateral ECT, WMD 6.06 (CI -5.20 to 17.32). Randomised evidence on the efficacy and safety of ECT in depressed elderly with concomitant dementia, cerebrovascular disorders or Parkinson's disease was lacking completely. Possible side-effects could not be adequately examined because of the lack of randomised evidence and methodological shortcomings. None of the objectives of this review could be adequately tested because of the lack of firm, randomised evidence. Given the specific problems in the treatment of depressed elderly, a well designed randomised controlled trial should be conducted in which the efficacy of ECT is compared to one or more antidepressants.

Plain-language summary: This review involved searching the literature for well-conducted (randomised) studies that compared ECT to both simulated ECT and to antidepressants. The review found only four studies, all of which had serious problems in their methods. At present, therefore, it is not possible to draw firm conclusions on whether ECT is more effective than antidepressants,.or on the safety or side effects of ECT in elderly people with depression.
Abstract: Seven RCTs were included in the review, involving a total of 393 participants. All of the included studies assessed psychoeducational methods, and one study also assessed a type of systems psychotherapy. In all trials, participants continued to receive pharmacotherapy treatment. Due to the diversity of interventions, outcome measures and endpoints used across studies, it was not possible to perform meta-analyses for primary outcomes. Five studies compared a variety of family interventions, involving carers, families or spouses, against no intervention, with individual findings indicating no significant added effect for family interventions. Three studies compared one type or modality of family intervention against another family intervention, with inconsistent findings. To date there is only a small and heterogeneous body of evidence on the effectiveness of family oriented approaches for bipolar disorder, and it is not yet possible to draw any definite conclusions to support their use as an adjunctive treatment for bipolar disorder. Further well designed RCTs should be a research priority.

Plain-language summary: Studies on psychosocial interventions for mental disorders such as schizophrenia and anxiety show that they are effective treatments. Reports in the literature suggest that they may be useful for people with bipolar disorder as well. The role of the family is important in the care of people with bipolar disorder, with effective family functioning helping to maintain a person's psychological balance. This systematic review investigated the effectiveness of any psychosocial family intervention for people with bipolar disorder and/or their families and carers. Seven randomised controlled trials (393 participants) were included in the review, all of which evaluated psychoeducational interventions. Five studies compared family interventions against no treatment, and three studies compared one type or delivery of family intervention against another family intervention. Differences in the interventions, outcome measures and end points used in the trials did not allow us to perform a meta-analysis. Whilst results from individual studies did not suggest a significant effect for family interventions when added to drug therapy, the studies provide insufficient evidence to draw conclusions which can be generalised to everyday practice. Further research using appropriate randomised controlled trial methodology and evaluating family interventions other than psychoeducation is called for in this under-researched and important topic.
Abstract: We could not identify any studies in which the only difference between the treatment groups was the use of intracystic bleomycin. We did identify a RCT comparing intracystic bleomycin with intracystic phosphorus32 (32P) (seven children). In this update we identified no additional studies. The included study had a high risk of bias. Survival could not be evaluated. There was no clear evidence of a difference between the treatment groups in cyst reduction (MD -0.15, 95% confidence interval (CI) -0.69 to 0.39, P value = 0.59, very low quality of evidence), neurological status (Fisher's exact P value = 0.429, very low quality of evidence), third nerve paralysis (Fischer's exact P value = 1.00, very low quality of evidence), fever (RR 2.92, 95% CI 0.73 to 11.70, P value = 0.13, very low quality of evidence) or total adverse effects (RR 1.75, 95% CI 0.68 to 4.53, P value = 0.25, very low quality of evidence). There was a significant difference in favour of the 32P group for the occurrence of headache and vomiting (Fischer's exact P value = 0.029, very low quality of evidence for both outcomes). Since we identified no RCTs, quasi-randomised trials or CCTs of the treatment of cystic craniopharyngiomas in children in which only the use of intracystic bleomycin differed between the treatment groups, no definitive conclusions could be made about the effects of intracystic bleomycin in these patients. Only one low-power RCT comparing intracystic bleomycin with intracystic 32P treatment was available, but no definitive conclusions can be made about the effectiveness of these agents in children with cystic craniopharyngiomas. Based on the currently available evidence, we are not able to give recommendations for the use of intracystic bleomycin in the treatment of cystic craniopharyngiomas in children. High-quality RCTs are needed.

Plain-language summary: This systematic review focused on (randomised) controlled studies. We could not identify any randomised controlled trials (RCTs), quasi-randomised trials or controlled clinical trials (CCTs) in which the only difference between the intervention and control group was the use of intracystic bleomycin. However, we did identify one RCT comparing intracystic bleomycin with intracystic phosphorus32 (32P), which is a radioactive isotope of phosphorous used for intracystic irradiation. Only seven children were included in this study. The study has a high risk of bias and the sample size is too small to detect a difference in outcomes. The therapeutic use of intracystic bleomycin in children with cystic craniopharyngiomas currently remains uncertain. Although there was no significant difference in total adverse effects between the two treatment groups, there was a significant difference in both headache and vomiting in favour of the 32P group. The quality of the evidence is, however, very low. More high-quality studies are needed but will be difficult as so few children get these tumours.