GEM/cochrane-simplification huggingface dataset:
Abstract: We included six RCTs with 527 participants. Only one RCT was judged to be at low risk of bias. The remaining five RCTs were at unclear or high risk of bias. No trial mentioned the primary outcomes of longest follow-up mortality, Glasgow Outcome Scale score at three months or any adverse events related to mannitol or hypertonic saline. Three trials mentioned the secondary outcomes of intraoperative brain relaxation, hospital stay and ICU stay; quality of life was not reported in any of the trials. Brain relaxation was inadequate in 42 of 197 participants in the hypertonic saline group and in 68 of 190 participants in the mannitol group. The risk ratio for brain bulge or tense brain in the hypertonic saline group was 0.60 (95% confidence interval (CI) 0.44 to 0.83, low-quality evidence). One trial reported ICU and hospital stay. The mean (standard deviation (SD)) duration of ICU stay in the mannitol and hypertonic saline groups was 1.28 (0.5) and 1.25 (0.5) days (P value 0.64), respectively; the mean (SD) duration of hospital stay in the mannitol and hypertonic saline groups was 5.7 (0.7) and 5.7 (0.8) days (P value 1.00), respectively From the limited data available on the use of mannitol and hypertonic saline for brain relaxation during craniotomy, it is suggested that hypertonic saline significantly reduces the risk of tense brain during craniotomy. A single trial suggests that ICU stay and hospital stay are comparable with the use of mannitol or hypertonic saline. However, focus on other related important issues such as long-term mortality, long-term outcome, adverse events and quality of life is needed.

Plain-language summary: The evidence is current to October 2013. We included studies in children (age > 28 days and < 18 years) and adult patients (age > 18 years) of either gender who received mannitol or hypertonic saline during craniotomy for brain tumour. We reran the search in January 2017 and found five potential studies of interest which have been added to a list of ‘Studies Awaiting Classification' and will be incorporated into the formal review findings during the review update. We found six studies with 527 participants. Three studies reported the level of brain relaxation. Hypertonic saline may provide better brain relaxation than mannitol. The length of intensive care unit stay and hospital stay was reported by one study. No study reported on the effects of mannitol and hypertonic saline on mortality, the condition of the patient three months after the operation or patient quality of life. Based on our results, we would expect that of 100 patients who received hypertonic saline during surgery, around 22 patients would fail to have adequate brain relaxation compared with 36 patients given mannitol. The quality of evidence for brain relaxation with use of hypertonic saline is low. Further research is needed to assess more important issues such as long-term mortality, long-term outcomes, adverse events and quality of life with use of the two fluids.
Abstract: We included 35 studies of which 31 provided data on 7697 women. For the main comparison between cephalosporins versus penicillins, there were 30 studies of which 27 provided data on 7299 women. There was a lack of good quality data and important outcomes often included only small numbers of women. For the comparison of a single cephalosporin versus a single penicillin (Comparison 1 subgroup 1), we found no significant difference between these classes of antibiotics for our chosen most important seven outcomes namely: maternal sepsis - there were no women with sepsis in the two studies involving 346 women; maternal endometritis (risk ratio (RR) 1.11, 95% confidence interval (CI) 0.81 to 1.52, nine studies, 3130 women, random effects, moderate quality of the evidence); maternal wound infection (RR 0.83, 95% CI 0.38 to 1.81, nine studies, 1497 women, random effects, low quality of the evidence), maternal urinary tract infection (RR 1.48, 95% CI 0.89 to 2.48, seven studies, 1120 women, low quality of the evidence) and maternal composite adverse effects (RR 2.02, 95% CI 0.18 to 21.96, three studies, 1902 women, very low quality of the evidence). None of the included studies looked for infant sepsis nor infant oral thrush. This meant we could only conclude that the current evidence shows no overall difference between the different classes of antibiotics in terms of reducing maternal infections after caesarean sections. However, none of the studies reported on infections diagnosed after the initial postoperative hospital stay. We were unable to assess what impact, if any, the use of different classes of antibiotics might have on bacterial resistance. Based on the best currently available evidence, cephalosporins and penicillins have similar efficacy at caesarean section when considering immediate postoperative infections. We have no data for outcomes on the baby, nor on late infections (up to 30 days) in the mother. Clinicians need to consider bacterial resistance and women's individual circumstances.

Plain-language summary: When comparing cephalosporins against penicillins, we found 27 studies, involving 7299 women as of September 2014. The quality of the studies was generally unclear and three studies reported drug company funding. Cephalosporins and penicillins had similar effects in reducing infections after caesareans and similar adverse effects. However, none of the studies considered infections after the women left hospital. None of the studies looked at outcomes on the babies. Other evidence show tetracyclines can cause discolouration of teeth in children and are best avoided. Consideration also needs to be given to antibiotics compatible with breastfeeding. We were unable to assess bacterial resistance, and this is crucial when considering which antibiotic might be used. At caesarean sections, cephalosporins and penicillins have similar benefits and side effects for mothers when considering infections immediately following the operation but there is no information on babies. Clinicians need to consider bacterial resistance and women's individual circumstances.
Abstract: No completed studies met the inclusion criteria for the review. Two ongoing trials fulfilled the selection criteria, however neither are complete. 'Early-stage squamous cell carcinoma of the oropharynx: radiotherapy versus trans-oral robotic surgery (ORATOR)' is a phase II randomised controlled trial comparing primary radiation therapy with primary transoral robotic surgery for small-volume primary (T1-2, N0-2) OPSCC. It is currently in progress with an estimated completion date of June 2021. 'European Organisation for Research and Treatment of Cancer 1420 (EORTC 1420-HNCG-ROG)' is a phase III, randomised study assessing the "best of" radiotherapy compared to transoral robotic surgery/transoral laser microsurgery in patients with T1-T2, N0 squamous cell carcinoma of the oropharynx and base of tongue. It was due to start accrual mid-2016. The role of endoscopic head and neck surgery in the management of OPSCC is clearly expanding as evidenced by its more overt incorporation into the current National Comprehensive Cancer Network guidelines. Data are mounting regarding its outcomes both in terms of survival and lower morbidity. As confidence increases, it is being used in the management of more advanced OPSCC. Based on this review, there is currently no high-quality evidence from randomised controlled trials regarding clinical outcomes for patients with oropharyngeal cancer receiving endoscopic head and neck surgery compared with primary chemoradiotherapy.

Plain-language summary: We found no completed studies that compared keyhole surgery and radiotherapy alone or combined with chemotherapy. Two ongoing trials did fulfil our selection criteria, however neither are yet complete. One has an estimated completion date of June 2021 and the other planned to start recruiting patients mid-2016. There are not yet any completed studies to include in the review so there are no results. The role of keyhole surgery in the management of throat cancer is expanding as is demonstrated by its incorporation into the current national guidelines in the USA. Evidence is mounting regarding its outcomes both in terms of survival and fewer side effects. Based on this review, there is currently no high-quality evidence from randomised controlled trials that compare keyhole surgery with radiotherapy and chemotherapy for patients with throat cancer.
Abstract: We included 26 trials (2051 participants). All studies used listening to pre-recorded music. The results suggested that music listening may have a beneficial effect on preoperative anxiety. Specifically, music listening resulted, on average, in an anxiety reduction that was 5.72 units greater (95% CI -7.27 to -4.17, P < 0.00001) than that in the standard care group as measured by the Stait-Trait Anxiety Inventory (STAI-S), and -0.60 standardized units (95% CI -0.90 to -0.31, P < 0.0001) on other anxiety scales. The results also suggested a small effect on heart rate and diastolic blood pressure, but no support was found for reductions in systolic blood pressure, respiratory rate, and skin temperature. Most trials were assessed to be at high risk of bias because of lack of blinding. Blinding of outcome assessors is often impossible in music therapy and music medicine studies that use subjective outcomes, unless in studies in which the music intervention is compared to another treatment intervention. Because of the high risk of bias, these results need to be interpreted with caution. None of the studies included wound healing, infection rate, time to discharge, or patient satisfaction as outcome variables. One large study found that music listening was more effective than the sedative midazolam in reducing preoperative anxiety and equally effective in reducing physiological responses. No adverse effects were identified. This systematic review indicates that music listening may have a beneficial effect on preoperative anxiety. These findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. Therefore, we conclude that music interventions may provide a viable alternative to sedatives and anti-anxiety drugs for reducing preoperative anxiety.

Plain-language summary: The review included 26 trials with a total of 2051 participants. The findings suggested that music listening may have a beneficial effect on preoperative anxiety. Most trials presented some methodological weakness. Therefore, these results need to be interpreted with caution. However, these findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. Therefore, we conclude that music interventions may provide a viable alternative to sedatives and anti-anxiety drugs for reducing preoperative anxiety.
Abstract: We included eight studies with 513 participants, providing a total of 47 comparisons of outcome between intervention and control conditions. Nineteen comparisons were statistically significant, all favouring the intervention group. We conducted nine meta-analyses using data from four studies in total (each meta-analysis included data from two studies). Four meta-analyses showed statistically significant findings favouring the intervention group for the following outcomes: parent responsiveness to the child post-intervention (SMD -0.91, 95% CI -1.52 to -0.30, P = 0.04); infant responsiveness to mother at follow-up (SMD -0.65, 95% CI -1.25 to -0.06, P = 0.03); and an overall measure of parent-child interactions post-intervention (SMD -0.71, 95% CI -1.31 to -0.11, P = 0.02), and at follow-up (SMD -0.90, 95% CI -1.51 to -0.30, P = 0.004). The results of the remaining five meta-analyses were inconclusive. Variation in the measures used, the included populations and interventions, and the risk of bias within the included studies limit the conclusions that can be reached. The findings provide some evidence to suggest that parenting programmes may be effective in improving a number of aspects of parent-child interaction both in the short- and long-term, but further research is now needed.

Plain-language summary: The findings are based on eight studies measuring a variety of outcomes, using a range of standardised measures. It was possible to combine results (meta-analysis) for nine comparisons. Results from four of these meta-analyses suggest that parenting programmes may be effective in improving parent responsiveness to the child, and parent-child interaction, both post-intervention and at follow-up. Infant responsiveness to the mother also showed improvement at follow-up. The results of the other five meta-analyses we carried out were inconclusive. Further rigorous research is needed that provides both short- and long-term follow-up of the children of teenage parents, and that assesses the benefits of parenting programmes for young fathers as well as young mothers.
Abstract: Only one study from developing countries met the inclusion criteria and was included in the review. The study, a cluster randomised trial (10 clusters, n=849) compared VCT uptake between an optional location (including home-based) and a local clinic location in a population-based HIV survey. The study showed a higher uptake of VCT among participants in the optional-location group. Uptake was significantly greater in the optional-location group in those who were pre-test counselled only (RR=4.6; 95% CI 3.58 to 5.91); pretest counselled and tested (RR=4.6; 95% CI 3.51 to 5.92); and post-test counselled and received the test result (RR=4.8; 95% CI 3.62 to 6.21). This study, however, had significant methodological problems limiting further analysis and interpretation. Although home-based HIV VCT has the potential to enhance VCT uptake in developing countries, insufficient data exist to recommend large-scale implementation of home-based HIV testing. Further studies are needed to determine if home-based VCT is better than facility-based VCT in improving VCT uptake.

Plain-language summary: This review attempted to evaluate this assumption. We found only one published study from developing countries and none from developed countries. The only study included in the review showed an increase in VCT uptake after home-based VCT intervention. Because of the limited evidence to date, however, further research is needed to evaluate if home-based VCT is better than facility-based VCT or other testing methods.
Abstract: Three cross-over and two parallel trials were included with a total of 246 participants. The methodological quality of all studies was unclear. As the trials tested different comparisons, or had a different design or dealt with different outcome measures, meta-analysis was not performed. In one cross-over trial (10 participants) femoxetine had no significant effect in eliminating or reducing EDS but significantly reduced cataplexy. Mild and transient side effects were reported in the femoxetine treatment period by two participants. In a second cross-over trial (56 participants) viloxazine significantly reduced EDS and cataplexy. In a third cross-over trial the authors inappropriately treated the trial design as a parallel study and no conclusions can be reached in favour of either drug. Two more trials with parallel design tested ritanserin versus placebo without finding differences of effectiveness in reducing EDS or cataplexy. Since the last version of this review no new studies were found. There was no good quality evidence that antidepressants are effective for narcolepsy or improve quality of life. Despite the clinical consensus recommending antidepressants for cataplexy there is scarce evidence that antidepressants have a positive effect on this symptom. There is a clear need for well-designed randomised controlled trials to assess the effect of antidepressants on narcolepsy.

Plain-language summary: Five trials with 246 participants were included. There is no evidence that antidepressants have a beneficial effect on narcolepsy. Moreover, despite the clinical consensus recommending their use for cataplexy, there is scarce evidence to support the use of antidepressant drugs to treat this symptom.
Abstract: Only two small studies, with a combined total of 57 participants, met our inclusion criteria and were finally included. They were classified as having a moderate risk of bias with unclear issues regarding their methods, and according to the GRADE approach, the overall quality of the evidence would be considered as moderate. In one study the effects of intramuscular injections of BMMNCs in the ischaemic lower limbs of patients with CLI were compared with control (standard conservative treatment). No deaths were reported and no significant difference was observed between the two groups for either pain (P = 0.37) or the ankle brachial index (ABI) parameter. However, the treatment group showed a significantly smaller proportion of participants undergoing amputation compared with the control group (P = 0.026). In the other study, following subcutaneous injections of granulocyte colony-stimulating factor (G-CSF) for five days, peripheral blood derived mononuclear cells were collected and then transplanted by intramuscular injections into ischaemic lower limbs. The effects were compared with daily intravenous prostaglandin E1 injections (control group). No deaths were reported. Pain reduction was greater in the treatment group than in the control group (P < 0.001) as was increase in ABI (mean increase 0.13 versus 0.02, P < 0.01). The treatment group experienced a statistically significant increase in pain-free walking distance (PFWD) compared with the control group (mean increase 306.4 m versus 78.6 m, P = 0.007). A smaller proportion of participants underwent amputation in the treatment group compared with the control group (0% versus 36%, P = 0.007). The data from the published trials suggest that there is insufficient evidence to support this treatment. These results were based on only two trials which had a very small number of participants. Therefore evidence from larger randomised controlled trials is needed in order to provide adequate statistical power to assess the role of intramuscular mononuclear cell implantation in patients with CLI.

Plain-language summary: The review authors identified only two small randomised controlled trials with a combined total of 57 participants testing the safety and effectiveness of this treatment. The findings were inconsistent. In one trial, pain at rest, pain-free walking distance, ankle brachial blood pressure index, and the number of amputations all clearly improved in the group receiving mononuclear cell implantation. In the other trial only the number of amputations showed a significant improvement in the treatment group compared with the control group. No deaths were reported during the study period. Quality of the evidence The two included studies differed from each other in how they obtained the cells for injection and assessed the clinical effects at different time points, up to three months in one trial, and six months in the other. They were classified as having a moderate risk of bias with unclear issues regarding their methods and the overall quality of the evidence was considered moderate.
Abstract: Twelve studies (1187 participants) were included in the review. Risk of bias was unclear for the majority of domains in each study. Uric acid lowering therapy may make little or no difference in death at six months (2 studies, 498 participants: RR 1.66, 95% CI 0.61 to 4.48) or two years (2 studies, 220 participants): RR 0.13, 95% CI 0.02 to 1.06) (low certainty evidence). Uric acid lowering therapy may make little of no difference (low certainty evidence) in the incidence of ESKD at one or two years. Kidney function may be improved by uric acid lowering therapy at one year with a reduction in serum creatinine (2 studies, 83 participants: MD -73.35 µmol/L, 95% CI -107.28 to -39.41) and a rise in eGFR (1 study, 113 participants: MD 5.50 mL/min/1.73 m2, 95% CI 0.59 to 10.41). However it probably makes little or no difference to eGFR at two years (2 studies, 164 participants: MD 4.00 mL/min, 95% CI -3.28 to 11.28). Uric acid lowering therapy reduced uric acid levels at all time points (3, 4, 6, 12 and 24 months) (high certainty evidence). There is insufficient evidence to support an effect on blood pressure, proteinuria or other cardiovascular markers by uric acid lowering therapy. It should be noted that the apparent benefits of treatment were not apparent at all time points, introducing the potential for bias. There is limited data which suggests uric acid lowering therapy may prevent progression of chronic kidney disease but the conclusion is very uncertain. Benefits were not observed at all time points and study quality was generally low. Larger studies are required to study the effect of uric acid lowering therapy on CKD progression. Three ongoing studies will hopefully provide much needed high quality data.

Plain-language summary: The quality of the included studies was difficult to grade due to a lack of information. These are not, therefore, high quality studies. We found a small amount of evidence that reducing uric acid levels may slow down damage to kidneys but no evidence that it improves blood pressure or any of the other cardiovascular markers that were investigated. The number of patients requiring dialysis treatment for complete kidney failure appears unchanged. Two measures of kidney failure (serum creatinine and glomerular filtration rate) were improved at six and 12 months but not at two years. The amount of protein in the urine was also reduced by treatment. We found no clear effect on death, blood pressure, rates of hospitalisation, or side effects of treatment. There is limited data which suggests urate lowering therapy may slow down damage to the kidneys but the conclusion is very uncertain. Benefits were not observed at all time points and study quality was generally low. Larger studies are required to study the effect of uric acid lowering therapy on CKD progression.