GEM/cochrane-simplification huggingface dataset:
Abstract: The search strategy identified 183 unique references of which 22 were identified as being potentially eligible on the basis of title and abstract. Only one study met our inclusion criteria and was included in the review. It analysed retrospective data for 47 women who received either palliative surgery (n = 27) or medical management with Octreotide (n = 20) and reported overall survival and perioperative mortality and morbidity. Women with poor performance status were excluded from surgery. Although six (22%) women who received surgery had serious complications of the operation and three (11%) died of complications, multivariable analysis found that women who received surgery had significantly (p < 0.001) better survival than women who received Octreotide, after adjustment for important prognostic factors. However, the magnitude of this effect was not reported. Quality of life (QoL) was not reported and adverse events were incompletely documented. We found only low quality evidence comparing palliative surgery and medical management for bowel obstruction in ovarian cancer. Therefore we are unable to reach definite conclusions about the relative benefits and harms of the two forms of treatment, or to identify sub-groups of women who are likely to benefit from one treatment or the other. However, there is weak evidence in support of surgical management to prolong survival.

Plain-language summary: We found only one relevant study. It included only 47 cases: 27 had an operation to relieve bowel obstruction and the 20 who did not have an operation were given a drug called Octreotide to control the amount of vomiting that often results from bowel obstruction. Among the 27 women who had an operation, six women could not have their bowel obstruction corrected because the cancer had spread too far, six women had serious complications of surgery and three died of these complications.  Nevertheless, the authors of the study reported that women who had the operation survived longer, on average, than those who did not, even after allowing for their underlying better health. It was unclear how much of the difference in survival could be ascribed to the differences in treatment and how much to the better health of women undergoing surgery. Unfortunately the study did not assess their QoL or level of pain. The study reported the numbers of women who could start eating again after their treatment (surgery or Octreotide) but it didn't analyse this allowing for the underlying difference in health of women in the two groups, so it is impossible to interpret these results. We were therefore unable to reach definite conclusions about the relative benefits and harms of the two forms of treatment and we were unable to identify sub-groups of women who are likely to benefit from one treatment or the other.
Abstract: Four trials fulfilled the criteria for inclusion. They comprised a total of 244 women with PCOS receiving 12 weeks or 6 weeks of treatment. Two trials (184 women randomised) studied the effects of simvastatin and two trials (60 women randomised) studied the effects of atorvastatin. There was no good evidence that statins improved menstrual regularity, spontaneous ovulation rate, hirsutism or acne, either alone or in combination with the combined oral contraceptive pill (OCP). Nor were there any significant effects on body mass index (BMI). Statins were effective in lowering testosterone levels (nmol/L) (mean difference (MD) -0.90, 95% CI -1.18 to -0.62, P < 0.00001, 3 RCTs, 105 women) when used alone or with the OCP. Statins also improved total cholesterol, low-density lipoprotein (LDL) and triglycerides but had no significant effect on high-density lipoprotein (HDL) levels, high sensitivity (HS) C-reactive protein (HS-CRP), fasting insulin or homeostatic model assessment (HOMA) insulin resistance. No serious adverse events were reported in any of the included studies. Although statins improve lipid profiles and reduce testosterone levels in women with PCOS, there is no evidence that statins improve resumption of menstrual regularity or spontaneous ovulation, nor is there any improvement of hirsutism or acne. There is a need for further research to be performed with large sample sizes and well-designed RCTs to assess clinical outcomes.

Plain-language summary: There is no good evidence from this review that statins improve menstrual regularity, spontaneous ovulation rate, hirsutism or acne, either alone or in combination with the combined oral contraceptive pill. There is also no good evidence that statins have a beneficial effect on hirsutism or acne (pimples) associated with PCOS. In women with PCOS, statins are effective in reducing serum androgen levels and decreasing bad cholesterol (LDL), but statins are not effective in reducing fasting insulin or insulin resistance. There is no good evidence available on the long-term use of statins (alone or in combination) for the management of PCOS.
Abstract: The search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer. Since the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.

Plain-language summary: the searches were updated to March 2018. We found no randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) for inclusion, so there is an absence of evidence that tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology techniques or other interventions are as effective or safe as radiotherapy for palliative control of bleeding from the vagina in advanced cervical cancer. There is a need for randomised controlled trials or good-quality non-randomised comparative studies to determine the effectiveness and safety of these interventions when compared with radiotherapy in terms of symptom control, quality of life and side events. no studies fulfilled the inclusion criteria and so there is no good-certainty evidence.
Abstract: For primary therapy three RCTs were identified, enrolling a total of 745 patients, that investigated temozolomide in combination with radiotherapy versus radiotherapy alone for glioblastoma multiforme (GBM). Temozolomide increased OS (hazard ratio (HR) 0.60, 95% confidence interval (CI) 0.46 to 0.79, P value 0.0003) and increased PFS (HR 0.63, 95% CI 0.43 to 0.92, P value 0.02), when compared with radiotherapy alone, although these benefits only appear to emerge when therapy is given in both concomitant and adjuvant phases of treatment. A single RCT found that temozolomide did not have a statistically significant effect on QoL. Risk of haematological complications, fatigue and infections were increased with temozolomide. In recurrent HGG, two RCTs enrolling 672 patients in total found that temozolomide did not increase OS compared to standard chemotherapy (HR 0.9, 95% CI 0.76 to 1.06, P value 0.2) but it did increase PFS in a subgroup analysis of grade IV GBM tumours (HR 0.68, 95% CI 0.51 to 0.90, P value 0.008). Adverse events were similar between arms. In the elderly, 2 RCTs of 664 patients found OS and PFS was similar with temozolomide alone versus radiotherapy alone. QoL did not appear to differ between arms in a single trial but certain adverse events were significantly more common with temozolomide. Temozolomide when given in both concomitant and adjuvant phases is an effective primary therapy in GBM compared to radiotherapy alone. It prolongs survival and delays progression without impacting on QoL but it does increase early adverse events. In recurrent GBM, temozolomide compared with standard chemotherapy improves time-to-progression (TTP) and may have benefits on QoL without increasing adverse events but it does not improve overall. In the elderly, temozolomide alone appears comparable to radiotherapy in terms of OS and PFS but with a higher instance of adverse events.

Plain-language summary: Three randomised controlled trials (RCTs) enrolling patients with newly diagnosed glioblastoma multiforme (GBM - a form of HGG) have studied chemotherapy with temozolomide during and after radiotherapy. This was compared with radiotherapy only. Those who received temozolomide had an improved survival and delayed progression of the disease. The short-term adverse events associated with temozolomide are low but can be severe, while the long-term effects are unknown. No RCTs investigated the use of temozolomide in HGGs other than GBM. In recurrent GBM, temozolomide delayed progression but did not improve overall survival. In the elderly population (age over 60 years), temozolomide alone appears to be a suitable alternative to radiotherapy alone for primary therapy of GBM. Either treatment has similar overall survival, progression-free survival and quality of life, but there are possibly more adverse events with temozolomide. All these trials enrolled highly selected patients with good prognostic features that are not entirely representative of all patients with HGG limiting the general applicability of these results.
Abstract: Two studies met our inclusion criteria. The findings of one study conducted in Cambodia provide low quality evidence that private contracts with international nongovernmental organizations (NGOs) for district health systems management ('contracting-in') may improve health care access and utilization. Contracting-in increased use of antenatal care by 28% and use of public facilities by 14%. However, contracting-in was not found to have an effect on population health outcomes. The findings of the other study provide low quality evidence that intermittent training courses over 18 months may improve district health system managers’ performance. In three countries in Latin America, managers who did not receive the intermittent training courses had between 2.4 and 8.3 times more management deficiencies than managers who received the training courses. No studies that aimed to investigate interventions for retaining district health systems managers met our study selection criteria for inclusion in this review. There is low quality evidence that contracting-in may improve health care accessibility and utilization and that intermittent training courses may improve district health systems managers’ performance. More evidence is required before firm conclusions can be drawn regarding the effectiveness of these interventions in diverse settings. Other interventions that might be promising candidates for hiring and retaining (e.g., government regulations, professional support programs) as well as training district health systems managers (e.g., in-service workshops with on-site support) have not been adequately investigated.

Plain-language summary: It is difficult to draw any conclusions about the effects of these types of interventions as the review only found two relevant studies. In addition, the evidence that the review did identify was of low quality. Training: The available evidence suggests that in-service district manager training: ·       may lead to more knowledge about planning processes ·       may lead to better monitoring and evaluation skills None of the studies assessed the effects of district manager training on people’s health, on their access to or use of health care, or on the quality or efficiency of care. Contracting-in: The available evidence suggests that private contracts with international NGOs for district health systems management: ·       may not affect people’s illness reporting, diarrhea incidence or infant death ·       may increase the likelihood that a health facility is open 24 hours ·       may increase the availability of medical equipment and supplies ·       may increase people’s use of antenatal care and public facilities None of the studies assessed the effects of contracting-in district management on the quality or efficiency of health care, on job vacancy rates, or on district manager knowledge and skills.
Abstract: We included three studies that involved 123 people. The methods used for blinding the participants and researchers to the treatment group were not reported, but as the comparison is surgical treatment with medical treatment this bias is hard to avoid. There was no description of concealment of the randomization sequence in two studies. All three studies reported on mortality, and deaths occurred in two studies. There was no clear evidence of a difference in mortality between treatment groups (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.13 to 2.42); however, the analysis was underpowered to detect a difference between groups. Out of the 123 people randomized and treated, six people died; the causes of death were pneumonia, pulmonary embolism, mediastinitis, and septic shock. Among people randomized to surgery, there were reductions in pneumonia (RR 0.36, 95% 0.15 to 0.85; three studies, 123 participants), chest deformity (RR 0.13, 95% CI 0.03 to 0.67; two studies, 86 participants), and tracheostomy (RR 0.38, 95% CI 0.14 to 1.02; two studies, 83 participants). Duration of mechanical ventilation, length of intensive care unit stay (ICU), and length of hospital stay were measured in the three studies. Due to differences in reporting, we could not combine the results and have listed them separately. Chest pain, chest tightness, bodily pain, and adverse effects were each measured in one study. There was some evidence from three small studies that showed surgical treatment was preferable to nonsurgical management in reducing pneumonia, chest deformity, tracheostomy, duration of mechanical ventilation, and length of ICU stay. Further well-designed studies with a sufficient sample size are required to confirm these results and to detect possible surgical effects on mortality.

Plain-language summary: We searched scientific databases for studies comparing surgical treatment with nonsurgical treatment in adults or children with flail chest. We included three studies in this review, which involved 123 people. In these studies, people with flail chest were randomly allocated into the surgery or no surgery study groups. The results show that surgery to repair the broken ribs reduces pneumonia, chest deformity, tracheostomy, duration of mechanical ventilation and length of ICU stay. There was no difference in deaths between people treated with surgery or no surgery. Since only six people died across the three studies, due to a variety of causes, more research is needed in order to know for certain which treatment is better for reducing deaths. These three small studies have shown that surgical treatment is preferable to nonsurgical treatment in reducing pneumonia, chest deformity, tracheostomy, mechanical ventilation and length of stay in the ICU. More research is needed in order to know which treatment is better for reducing deaths. Three more studies are being undertaken by researchers in the USA and Canada at the moment, and the results will be incorporated into the review in the future.
Abstract: We retrieved 12,490 citations, obtained full texts for 58 studies and included 12 trials (three from the 2008 search and nine from the 2014 search) with 703 participants. Eight trials primarily investigated the efficacy in treating PSF, of which six trials with seven comparisons provided data suitable for meta-analysis (five pharmacological interventions: fluoxetine, enerion, (-)-OSU6162, citicoline and a combination of Chinese herbs; and two non-pharmacological interventions: a fatigue education programme and a mindfulness-based stress reduction programme). The fatigue severity was lower in the intervention groups than in the control groups (244 participants, pooled SMD -1.07, 95% confidence interval (CI) -1.93 to -0.21), with significant heterogeneity between trials (I2 = 87%, degrees of freedom (df) = 6, P value < 0.00001). The beneficial effect was not seen in trials that had used adequate allocation concealment (two trials, 89 participants, SMD -0.38, 95% CI -0.80 to 0.04) or trials that had used adequate blinding of outcome assessors (four trials, 198 participants, SMD -1.10, 95% CI -2.31 to 0.11). No trial primarily investigated the efficacy in preventing PSF. Four trials (248 participants) did not primarily investigate the efficacy on fatigue but other symptoms after stroke. None of these interventions showed any benefit on reducing PSF, which included tirilazad mesylate, continuous positive airway pressure for sleep apnoea, antidepressants and a self management programme for recovery from chronic diseases. There was insufficient evidence on the efficacy of any intervention to treat or prevent fatigue after stroke. Trials to date have been small and heterogeneous, and some have had a high risk of bias. Some of the interventions described were feasible in people with stroke, but their efficacy should be investigated in RCTs with a more robust study design and adequate sample sizes.

Plain-language summary: The evidence is current to May 2014. We found 12 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 703 people with stroke. Of these 12 trials, eight trials recruited only people with fatigue and were primarily intended to treat fatigue, no trial was primarily intended to prevent fatigue and the other four trials were not primarily intended to treat or prevent fatigue but reported fatigue as an outcome. There was insufficient evidence to support the use of any intervention to treat or prevent fatigue in people with stroke. The general study quality was low. The available data were limited as each identified intervention was only investigated in a single trial. In addition, some trials were small and used poor study designs. Therefore, further trials of better quality are needed.
Abstract: Three randomised trials, enrolling 74 preterm infants (outcome data available on 71 infants) evaluated interventions for hyperkalaemia. Urine output was ascertained in only one study (Hu 1999). In none of the trials could we ascertain that allocation to the comparison groups was concealed. The sample sizes of the three trials were very small with 12 (Malone 1991), 19 (Singh 2002) and 40 infants enrolled (Hu 1999). The intervention and the outcome assessments could not be blinded to the clinical staff in two trials (Malone 1991; Hu 1999). One study (Malone 1991), glucose and insulin, compared to cation-exchange resin, caused a reduction in all cause mortality that was of borderline statistical significance: RR 0.18 (95% CI 0.03 to 1.15); RD -0.66 (95% CI -1.09 to -0.22); NNTB 2 (95% CI 1 to 5)]. In the study of Hu (Hu 1999), the incidence of intraventricular haemorrhage ≥ grade 2 was significantly reduced [RR 0.30 (95% CI 0.10 to 0.93); RD -0.35 (95% CI -0.62 to -0.08); NNTB 3 (95% CI 2 to 13). Albuterol inhalation versus saline inhalation changed serum K+ from baseline at four hours [WMD -0.69 mmol/L (95% CI -0.87 to -0.51)] and at eight hours [WMD -0.59 mmol/L (95% CI -0.78 to -0.40)] after initiation of treatment. No differences noted in mortality or other clinical outcomes (Singh 2002). No serious side effects were noted with either the combination of insulin and glucose or albuterol inhalation. Other interventions listed in our objectives have not been studied to date. In view of the limited information from small studies of uncertain quality, no firm recommendations for clinical practice can be made. It appears that the combination of insulin and glucose is preferred over treatment with rectal cation-resin for hyperkalaemia in preterm infants. Both the combination of insulin and glucose and albuterol inhalation deserve further study. The two interventions could possibly be tested against each other. The effectiveness of other potentially effective interventions for non-oliguric hyperkalaemia (diuretics, exchange transfusion, peritoneal dialysis and calcium) have not been tested in randomised controlled trials.

Plain-language summary: The objective of this review was to determine the effectiveness and safety of interventions for this serious condition. Two studies enrolling 52 infants that assessed the use of a combination of insulin and sugar to reduce the blood levels of potassium were identified. This combination reduced the duration of high blood levels of potassium and the risk for bleeds in the brains of the infants. One study that enrolled 19 patients reported on the use of albuterol (a medication that helps to move potassium from the blood to the body cells). Albuterol lowered the blood levels of potassium both at four and at eight hours after the treatment had started. Because of the few infants enrolled in the studies to date, no firm recommendations for the treatment of too high blood levels of potassium in neonates can be made. Further research is needed.
Abstract: Twelve studies were included, nine RCTs and three before and after studies. Only one study explored all-cause mortality and end-stage renal disease (ESRD) as endpoints. The relative risk (RR) of ESRD or death was 0.23 (95% confidence interval (CI) 0.07 to 0.72) for patients assigned to a low protein diet (LPD). Pooling of the seven RCTs in patients with type 1 diabetes resulted in a non-significant reduction in the decline of glomerular filtration rate (GFR) of 0.1 ml/min/month (95% CI -0.1 to 0.3) in the LPD group. For type 2 diabetes, one trial showed a small insignificant improvement in the rate of decline of GFR in the protein-restricted group and a second found a similar decline in both the intervention and control groups. Actual protein intake in the intervention groups ranged from 0.7 to 1.1 g/kg/day. One study noted malnutrition in the LPD group. We found no data on the effects of LPDs on health-related quality of life and costs. The results show that reducing protein intake appears to slightly slow progression to renal failure but not statistically significantly so. However, questions concerning the level of protein intake and compliance remain. Further longer-term research on large representative groups of patients with both type 1 and type 2 diabetes mellitus is necessary. Because of the variability amongst patients, there might perhaps be a six month therapeutic trial of protein restriction in all individuals, with continuation only in those who responded best. Trials are required of different types of protein.

Plain-language summary: Based on 12 studies, including from eight to 160 people with type 1 and type 2 diabetes for at least an average four-month period, restricted protein intake appeared to slow progression of diabetic kidney disease, but not by much on average. However, individual variation existed, therefore a low-protein diet may benefit some individuals. A low-protein diet can be difficult to adhere to, especially over the long term. Reducing the amount of animal protein is the usual method but some evidence suggests that a shift from red meat to white meat and fish or vegetables may give similar results. We found no data on the effects of low-protein diet on health-related quality of life and costs.