GEM/cochrane-simplification huggingface dataset:
Abstract: In this review update, we included five new trials, bringing the total number of included studies to eight. The included trials (pertaining to 10 papers), provided data on 1973 participants and assessed the impact of cancer genetic risk assessment on outcomes including perceived risk of inherited cancer, and psychological distress. This review suggests that cancer genetic risk-assessment services help to reduce distress, improve the accuracy of the perceived risk of breast cancer, and increase knowledge about breast cancer and genetics. The health professional delivering the risk assessment does not appear to have a significant impact on these outcomes. This review found favourable outcomes for patients after risk assessment for familial breast cancer. However, there were too few papers to make any significant conclusions about how best to deliver cancer genetic risk-assessment services. Further research is needed assessing the best means of delivering cancer risk assessment, by different health professionals, in different ways and in alternative locations.

Plain-language summary: This review included eight trials (10 papers) which covered the process of risk assessment for familial breast cancer. These focused on the psychosocial impact on patients, as well as other outcomes and aspects of service delivery, and provided data on 1973 participants. Due to the limited number of trials, this review found insufficient evidence to make any firm conclusions about the best way to deliver risk-assessment services for individuals concerned about a family history of breast cancer. All eight included studies did, however, demonstrate improvements in psychological well-being and a decrease in the levels of cancer worry as a result of the risk-assessment service. Although limited, the findings of this review suggest that cancer genetic risk-assessment services can help to reduce distress, improve the accuracy of the individual's perceived risk of breast cancer, and increase knowledge about breast cancer and genetics. Existing evidence suggests that such services do not cause patients any harm and, in the short-term, can have a positive effect by helping to ease distress and decrease cancer worry. From this review, it does not appear that the health professional delivering the risk assessment has a significant impact on these outcomes.
Abstract: Three randomised controlled trials with a total of 63 participants were found comparing SLT with placebo for speech disorders in Parkinson's disease. Data were available from 41 participants in two trials. Vocal loudness for reading a passage increased by 6.3 dB (P = 0.0007) in one trial, and 11.0 dB (P = 0.0002) in another trial. An increase was also seen in both of these trials for monologue speaking of 5.4 dB (P = 0.002) and 11.0 dB (P = 0.0002), respectively. It is likely that these areclinically significant improvements. After six months, patients from the first trial were still showing a statistically significant increase of 4.5 dB (P = 0.0007) for reading and 3.5 dB for monologue speaking. Some measures of speech monotonicity and articulation were investigated; however, all these results were non-significant. Although improvements in speech impairments were noted in these studies, due to the small number of patients examined, methodological flaws, and the possibility of publication bias, there is insufficient evidence to conclusively support or refute the efficacy of SLT for speech problems in Parkinson's disease. A large well designed placebo-controlled RCT is needed to demonstrate SLT's effectiveness in Parkinson's disease. The trial should conform to CONSORT guidelines. Outcome measures with particular relevance to patients with Parkinson’s disease should be chosen and patients followed for at least six months to determine the duration of any improvement.

Plain-language summary: Only randomised controlled trials were included in this review. These were studies where two groups of patients were compared, one group had speech and language therapy, the other did not receive any therapy intended to improve speech. The patients were assigned to each of the groups in a random fashion so as to reduce the potential for bias. Three trials with a total of 63 patients were found comparing speech and language therapy with an untreated group. The quality of the methods used in these trials was variable, with all studies failing in at least one critical area. All three of the controlled trials reported a positive effect of speech and language therapy for speech disorders in Parkinson's disease. Many of the outcome measures examined appeared to improve by a clinically significant amount after therapy. However, it should be noted that there were flaws in the methods used in these studies and only a small number of patients with Parkinson’s disease were examined. This means that there is insufficient evidence to absolutely prove or disprove the benefit of speech and language therapy for the treatment of speech disorders in Parkinson's disease patients, but lack of evidence does not mean lack of effect. A large well designed placebo-controlled randomised trial is needed to assess the effectiveness of speech and language therapy for speech disorders in Parkinson's disease. Outcome measures with particular relevance to people with Parkinson’s disease should be chosen and the patients followed for at least six months to determine the duration of any improvement.
Abstract: We found 13 trials (1960 patients). Lipid-based amphotericin B was not more effective than conventional amphotericin B on mortality (relative risk (RR) 0.5; 95% confidence interval (CI) 0.64 to 1.14) but decreased invasive fungal infection (RR 0.65; 95% CI 0.44 to 0.97), nephrotoxicity defined as a 100% increase in serum creatinine (RR 0.45; 95% CI 0.37 to 0.54), and number of dropouts (RR 0.78; 95% CI 0.62 to 0.97). For the drug used in most patients, AmBisome (4 trials, 1214 patients), there was no significant difference in mortality (RR 0.77; 95% CI 0.54 to 1.10) whereas it tended to be more effective than conventional amphotericin B on invasive fungal infection (RR 0.63; 95% CI 0.39 to 1.01, P value 0.053). AmBisome, amphotericin B in Intralipid (6 trials, 379 patients), amphotericin B colloidal dispersion (ABCD) (2 trials, 262 patients), and amphotericin B lipid complex (ABLC) (1 trial, 105 patients) all decreased the occurrence of nephrotoxicity, but conventional amphotericin B was rarely administered under optimal circumstances. It is not clear whether there are any advantages of lipid-based formulations if conventional amphotericin B is administered under optimal circumstances, and their high cost prohibits routine use in most settings. There is a need for large trials comparing lipid-based formulations of amphotericin B with conventional amphotericin B given in the same dose, with routine premedication for prevention of infusion-related toxicity, and with supplementation with fluid, potassium, and magnesium for prevention of nephrotoxicity.

Plain-language summary: The review found that lipid formulations of amphotericin B had fewer adverse effects (less nephrotoxicity and fewer dropouts) than conventional amphotericin B. However, it is not clear whether there are any advantages of these formulations if conventional amphotericin B is administered under optimal circumstances.
Abstract: Fifteen studies were included in the review. Studies included children with a range of severe neurological impairments in differing settings, for example, home and critical care. Several different treatment modalities were assessed, and a wide range of outcome measures were used. Most studies used a non-randomised design and included small sample groups. Only four randomised controlled trials were identified. Non-randomised design, lack of information about how participants were selected and who completed outcome measures and incomplete reporting led to high or unclear risk of bias in many studies. Results from low-quality studies suggest that use of non-invasive ventilation, mechanically assisted coughing, high-frequency chest wall oscillation (HFCWO), positive expiratory pressure and supportive seating may confer potential benefits. No serious adverse effects were reported for ventilatory support or airway clearance interventions other than one incident in a clinically unstable child following mechanically assisted coughing. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect for some participants. However, these findings must be considered as tentative and require testing in future randomised trials. This review found no high-quality evidence for any single intervention for the management of respiratory morbidity in children with severe global developmental delay. Our search yielded data on a wide range of interventions of interest. Significant differences in study design and in outcome measures precluded the possibility of meta-analysis. No conclusions on efficacy or safety of interventions for respiratory morbidity in children with severe global developmental delay can be made based upon the findings of this review. A co-ordinated approach to future research is vital to ensure that high-quality evidence becomes available to guide treatment for this vulnerable patient group.

Plain-language summary: We carried out a wide database search to look for studies of interventions for the management of breathing problems in children with severe neurological impairment. We found 15 studies of interest, which included a number of different types of treatment. The results showed that several different treatments provided potential benefits, and for most interventions no serious adverse effects were reported. However, the quality of the studies was not good enough to inspire confidence in the findings. Night-time positioning equipment and spinal bracing were shown to have a potentially negative effect in some participants. Although some studies looked at the same type of treatment, they used it in different ways or used different measures to assess effectiveness, so we could not put the results together. Of the 15 studies included here, only four used the 'gold standard' study design for health interventions. The remainder of the studies used less robust study designs, which limits the strength of the results. Further well-designed randomised studies including larger numbers of participants are required to guide healthcare professionals to select the most effective treatments.
Abstract: We included 18 trials (633 participants) in this update of this review. Treadmill training improved gait speed (MD = 0.09 m/s; 95% confidence interval (CI) 0.03 to 0.14; P = 0.001; I2 = 24%; moderate quality of evidence), stride length (MD = 0.05 metres; 95% CI 0.01 to 0.09; P = 0.01; I2 = 0%; low quality of evidence), but walking distance (MD = 48.9 metres; 95% CI -1.32 to 99.14; P = 0.06; I2 = 91%; very low quality of evidence) and cadence did not improve (MD = 2.16 steps/minute; 95% CI -0.13 to 4.46; P = 0.07; I2 = 28%; low quality of evidence) at the end of study. Treadmill training did not increase the risk of patients dropping out from intervention (RD = -0.02; 95% CI -0.06 to 0.02; P = 0.32; I2 = 13%; moderate quality of evidence). Adverse events were not reported in included studies. This update of our systematic review provides evidence from eighteen trials with moderate to low risk of bias that the use of treadmill training in patients with PD may improve clinically relevant gait parameters such as gait speed and stride length (moderate and low quality of evidence, respectively). This apparent benefit for patients is, however, not supported by all secondary variables (e.g. cadence and walking distance). Comparing physiotherapy and treadmill training against other alternatives in the treatment of gait hypokinesia such as physiotherapy without treadmill training this type of therapy seems to be more beneficial in practice without increased risk. The gain seems small to moderate clinically relevant. However, the results must be interpreted with caution because it is not known how long these improvements may last and some studies used no intervention in the control group and underlie some risk of bias. Additionally the results were heterogenous and we found variations between the trials in patient characteristics, the duration and amount of training, and types of treadmill training applied.

Plain-language summary: We identified 18 relevant trials, involving 633 participants which evaluated this type of therapy, up to September 2014. Treadmill training did improve gait speed, and stride length; but walking distance and cadence did not improve. Acceptability of treadmill training for study participants was good and adverse events were rare. It seems that such devices could be beneficial and could be applied in routine rehabilitation. However, it is still not clear when and how often they should be used and how long a benefit lasts. The quality of this evidence for the primary outcomes was moderate to low. Adverse events were not reported in studies and drop outs did not occur more frequently in people receiving treadmill training. Also we investigated only gait parameters, improvements of activities and/or quality of life were not investigated.
Abstract: We scanned more than 6800 citations and included six studies with a total of 333 participants in the analysis. There were insufficient data to assess the effect on survival. The use of CSF significantly reduced the number of episodes of febrile neutropenia episodes (Rate Ratio = 0.63; 95% confidence interval (CI) 0.46 to 0.85; P = 0.003, with substantial heterogeneity), the length of hospitalisation (weighted mean difference (WMD) = -1.58; 95% CI -3.00 to -0.15; P = 0.03), and number of infectious disease episodes (Rate Ratio = 0.56; 95% CI 0.39 to 0.80; P = 0.002). Despite these results, CSF did not influence the length of episodes of neutropenia (WMD = -1.11; 95% CI -3.55 to 1.32; P = 0.4) or delays in chemotherapy courses (Rate Ratio = 0.75; 95% CI 0.47 to 1.20; P = 0.23) . Children with ALL treated with CSF benefit from shorter hospitalisation and fewer infections. However, there was no evidence of shortened duration of neutropenia nor fewer treatment delays. There was also no useful information about survival.   The role of CSF in the context of febrile neutropenia episodes is still uncertain. Although current data show statistical benefit with CSF use, substantial heterogeneity between included trials does not allow this conclusion.

Plain-language summary: There is a lack of studies to determine the best CSF dose for children and only a small number of RCTs evaluating the role of CSF in children's ALL. The prophylactic administration of CSF reduces hospital stay, and risk of infections. The authors did not find evidence that CSF reduces febrile neutropenia episodes, their duration, or treatment delays in children with ALL undergoing chemotherapy. Follow up was too short to provide useful information on any possible effect on relapse or survival.
Abstract: Eighteen studies (7446 participants) compared cinacalcet in addition to standard therapy with no treatment or placebo plus standard therapy. In adults with GFR category G5 (GFR below 15 mL/min/1.73 m²) treated with dialysis, routine cinacalcet treatment had little or no effect on all-cause mortality (RR 0.97, 95% CI 0.89 to 1.05), imprecise effects on cardiovascular mortality (RR 0.67, 95% CI 0.16 to 2.87), and prevented surgical parathyroidectomy (RR 0.49, 95% CI 0.40 to 0.59) and hypercalcaemia (RR 0.23, 95% CI 0.05 to 0.97), but increased hypocalcaemia (RR 6.98, 95% CI 5.10 to 9.53), nausea (RR 2.02, 95% CI 1.45 to 2.81) and vomiting (RR 1.97, 95% CI 95% CI 1.73 to 2.24). Cinacalcet decreased serum PTH (MD -281.39 pg/mL, 95% CI -325.84 to -234.94) and calcium (MD -0.87 mg/dL, 95% CI -0.96 to -0.77) levels, but had little or no effect on serum phosphorous levels (MD -0.23 mg/dL, 95% CI -0.58 to 0.12). Data were sparse for adults with GFR categories G3a to G4 (GFR 15 to 60 mL/min/1.73 m²) and kidney transplant recipients. Overall, based on GRADE criteria, evidence for cinacalcet in adults with GFR category G5 treated with dialysis (mortality, parathyroidectomy, hypocalcaemia, and nausea) is of high or moderate quality. High quality evidence suggests "further research is very unlikely to change our confidence in the estimate of treatment effect" and moderate quality evidence is "further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate". Information for adults with less severe CKD GFR category G3a to G4 is of low or very low quality. This means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Routine cinacalcet therapy reduced the need for parathyroidectomy in adults treated with dialysis and elevated PTH levels but does not improve all-cause or cardiovascular mortality. Cinacalcet increases risks of nausea, vomiting and hypocalcaemia, suggesting harms may outweigh benefits in this population.

Plain-language summary: A newer treatment called cinacalcet showed promise for improving abnormal mineral levels but the effects of this drug on patient outcomes (the way patients feel function and survive) were unclear from early studies. We have updated an earlier review dated 2006 to include studies that assessed the effects of cinacalcet in about 7500 people with chronic kidney disease. While cinacalcet improves some blood abnormalities, it does not improve risk of death or heart disease in people treated with dialysis. In addition, people who take cinacalcet may experience increased nausea, vomiting and the need for blood tests to check blood calcium levels. The current research is high-quality and means that additional new studies are unlikely to change our confidence in these results. Information for the use of cinacalcet in people with milder forms of kidney disease and those with a kidney transplant is insufficient to guide decision making.
Abstract: We identified two eligible studies: one of CPAP and one of CNEP (published as an abstract). Both were unblinded studies with mainly unclear risk of bias due to lack of adequate information to assess this. The CPAP study enrolled 37 children to oxygen mask and CPAP and reported improvement in respiratory rate and oxygen saturation in both arms after 30 minutes of application. The CNEP study was published as an abstract and included 33 infants with bronchiolitis. In the CNEP study there was a reduction in the fraction of inspired oxygen (FiO2) (less than 30% within one hour of initiation of therapy) in four participants in the CNEP group compared to none in the control group (RR 10.7, 95% CI 0.6 to 183.9). One infant required CPAP and mechanical ventilation in the control group while all infants in the CNEP group were managed without intubation (RR for both outcomes 0.40, 95% CI 0.02 to 9.06). None of the trials reported on mortality. No adverse events were reported in ether of the included trials. There is a lack of well-designed, controlled trials of non-invasive modes of respiratory support in children with AHRF. Studies assessing the outcomes mortality, avoidance of intubation and its associated complications, hospital stay and patient comfort are needed.

Plain-language summary: We included two studies in the review: one study of CNEP included 33 participants younger than one year old who had bronchiolitis and one study of CPAP included 37 participants who had dengue fever related illness. Both studies reported short-term improvements but no reports of clinically significant outcomes are available. With a small number of patients in both studies, the safety of either approach could not be evaluated. Both studies have methodological issues and were under-powered (had too few patients to detect a significant difference). No adverse events were reported in ether of the included trials. Well-designed, multicentre, controlled studies with adequate numbers of infants and which assess clinically important outcomes are needed, as we cannot comment on the safety of the intervention as it was not evaluated in the current studies. The major limitation of this review is that it has a very limited number of studies which include a very small sample of children.
Abstract: Thirteen relevant trials with 1770 participants were included. All of them were of low quality. Fifty-two studies still need to be assessed because the original authors could not be interviewed. None of these trials analysed mortality, health related quality of life, economic outcomes or compliance. Compared to antithyroid drugs alone the results showed that Chinese herbal medicines combined with antithyroid drugs may offer benefits in lowering relapse rates, reducing the incidence of adverse effects, relieving symptoms, improving thyroid antibody status and thyroid function. Two trials investigated Chinese herbal medicine versus radioiodine and reported improvements in anxiety, tachycardia and heat intolerance. However, thyroid function - with the exception of restored thyroid stimulating hormone (TSH) - was not significantly altered. The results suggest that traditional Chinese herbal medicines added to other routine treatment have a therapeutic potential for people with hyperthyroidism. However, due to methodological limitations, we could not identify a well-designed trial to provide strong evidence for Chinese traditional herbal medicine in the treatment of hyperthyroidism. Thus, we currently cannot recommend any single preparation or formulation for clinical use.

Plain-language summary: Thirteen relevant trials with 1770 participants were analysed. All of them were of low quality. None of these trials analysed mortality, health related quality of life, economic outcomes or compliance with treatments. Some of these herbs may show benefits in improving symptoms, thyroid function and adverse effects. Unfortunately, we were unable to find reliable evidence to recommend a specific herbal preparation from 103 investigated formulations.
Abstract: Thirty-eight studies, involving some 12,400 participants, were included. The majority were descriptive studies, or randomisation processes did not relate to the data extracted, and most studies were judged to be at high risk of bias. Studies consistently show that oral substitution treatment for opioid-dependent injecting drug users with methadone or buprenorphine is associated with statistically significant reductions in illicit opioid use, injecting use and sharing of injecting equipment. It is also associated with reductions in the proportion of injecting drug users reporting multiple sex partners or exchanges of sex for drugs or money, but has little effect on condom use. It appears that the reductions in risk behaviours related to drug use do translate into reductions in cases of HIV infection. However, because of the high risk of bias and variability in several aspects of the studies, combined totals were not calculated. Oral substitution treatment for injecting opioid users reduces drug-related behaviours with a high risk of HIV transmission, but has less effect on sex-related risk behaviours. The lack of data from randomised controlled studies limits the strength of the evidence presented in this review.

Plain-language summary: This review looks at original studies that reported the frequency or prevalence of risk behaviours, or information on HIV infection related to substitution treatment of opioid dependence to assess the extent to which oral substitution treatment prevents the transmission of HIV infection. It was not possible to accurately estimate the extent of reduction, but it is clear that oral substitution treatment reduces risk behaviours and also the probability of HIV infection amongst injecting drug users in substitution treatment.