GEM/cochrane-simplification huggingface dataset:
Abstract: We included four randomised trials (257 participants). The overall risk of bias in the included studies was low. Two trials compared the addition of intravenous acyclovir to a steroid (prednisolone). One included 43 participants, the other 70 patients. Neither demonstrated any hearing improvement with ISSHL. Another (84 patients) did not show any statistically significant difference between groups with the addition of valacyclovir to prednisolone (compared to steroid plus placebo) with respect to change in pure-tone audiogram. Comparing the addition of intravenous acyclovir to hydrocortisone with hydrocortisone alone, the final trial did not show any statistically significant difference between groups (60 patients). No trial documented any serious adverse effects related to the use of antiviral treatment. One study reported slight to moderate nausea equally in the acyclovir and placebo groups (one patient in each). Another reported insomnia, nervousness and weight gain with valacyclovir (number not specified). Even though no meta-analysis was possible, evidence from the four RCTs has demonstrated no statistically significant advantage in the use of antivirals in the treatment of ISSHL. There is currently no evidence to support the use of antiviral drugs in the treatment of ISSHL. The four trials included in this review were, however, small and with a low risk of bias. Further randomised controlled trials with larger patient populations, using standardised inclusion criteria, antiviral regimes and outcome measures, are needed in order for adequate meta-analysis to be performed to reach definitive conclusions. A uniform definition of ISSHL should also be established, together with what constitutes adequate recovery.

Plain-language summary: Antiviral drugs are often used, usually in conjunction with steroids, to treat sudden hearing loss of unknown cause, based on the theory that the deafness is caused by a viral infection. We searched for randomised controlled trials (RCTs) which compared treatment of sudden hearing loss with antiviral drugs (either alone or in combination with another treatment) with placebo or no antiviral drug, in patients of any age. We found four RCTs (257 patients). The overall risk of bias in the studies was low. All four trials compared steroid treatment (either alone or plus a placebo drug) with steroid plus antiviral treatment. None of the trials found a statistically significant difference between groups. No trial documented any serious adverse effects related to using antiviral treatments. One study reported slight to moderate nausea equally in the acyclovir and placebo groups (one patient in each), both attributable to the steroid treatment. Another reported insomnia, nervousness and weight gain with valacyclovir (number not specified). The effectiveness of antiviral drugs in the treatment of sudden hearing loss of unknown origin is questionable. Certainly, this review of the clinical trials did not identify any substantial evidence to support their use. Further research is required with larger patient numbers and standardised inclusion criteria, antiviral regimes and outcome measures.
Abstract: We found no RCTs or quasi-RCTs in the original review or updates in 20011 and 2012. Cure or improvement have been described in high quality observational studies:  (1) A single study describes spontaneous improvement of meralgia paraesthetica in 20 (69%) of 29 cases.  (2) Four studies evaluating the injection of corticosteroid and local anaesthetic found cure or improvement in 130 (83%) out of a combined total of 157 cases.  (3) Surgical treatments have been found to be beneficial in 264 (88%) out of 300 cases treated with decompression (nine studies); and 45 (94%) out of 48 cases treated with neurectomy (three studies).  (4) Ninety-nine (97%) out of 102 patients with iatrogenic meralgia paraesthetica recovered completely (three studies). In the absence of any published RCTs or quasi-RCTs, the objective evidence base for treatment choices in meralgia paraesthetica is weak. High quality observational studies report comparable high improvement rates for meralgia paraesthetica following local injection of corticosteroid and surgical interventions (either nerve decompression or neurectomy). However, a similar outcome has been reported without any intervention in a single natural history study.

Plain-language summary: We found no randomised controlled trials (RCTs) in the original review or when searches were updated in 2010 and 2012. Local injections of corticosteroid and surgical operations were found to be effective treatments in observational studies. However, a single observational study also showed that meralgia paraesthetica improved spontaneously in the majority of cases. RCTs of treatments for meralgia paraesthetica are needed.
Abstract: We included 21 trials (2588 patients). The drugs did not reduce mortality significantly (relative risk 0.97, 95% confidence interval (CI) 0.75 to 1.25, for the trials with a low risk of bias, and 0.80, 95% CI 0.63 to 1.01, for the other trials). Units of blood transfused were 0.7 (0.2 to 1.1) less with drugs in the trials with a low risk of bias and 1.5 (0.9 to 2.0) less in the other trials. Number of patients failing initial haemostasis was reduced, relative risk 0.68 (0.54 to 0.87). Number of patients with rebleeding was not significantly reduced for the trials with a low risk of bias, relative risk 0.84 (0.52 to 1.37) while it was substantially reduced in the other trials, relative risk 0.36 (0.19 to 0.68). Use of balloon tamponade was rarely reported. The need for blood transfusions corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled trials of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality might have been overlooked.

Plain-language summary: The review of 21 trials (2588 patients) found that the tested drugs did not reduce deaths. There was a small reduction in the need for blood transfusions, corresponding to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile.
Abstract: A total of 770 participants were involved in the 11 included studies. Data from five included randomised double-blind studies showed beneficial effects of antipsychotics in the treatment of acute and chronic pain. Quantitative analysis of these studies showed a significant reduction of mean pain intensity after administration of the antipsychotic compared to placebo or another active compound, weighted mean difference (WMD) -1.78 (95% CI -2.71 to -0.85) for the continuous data; and relative risk (RR) 0.43 (95% CI 0.25 to 0.73), number needed to treat to benefit (NNT) 2.6 for the dichotomous data. Nevertheless, the test for heterogeneity was significant for both the continuous data (P = 0.0007) and the dichotomous data (P = 0.04). Obviously this makes the calculated NNT less reliable and caution is warranted when interpreting these results. The most frequently reported adverse effects were extrapyramidal (that is involuntary movements, parkinsonism and akathisia) and sedating effects. The recent search found five new studies which were all excluded, so the review remains the same as previously. Antipsychotics might be used as an add-on therapy in the treatment of painful conditions. Nevertheless, extrapyramidal and sedating side effects have to be considered before using antipsychotics for treating painful conditions. Results for antipsychotics in the treatment of different painful conditions are mixed and most sample sizes in the reviewed RCTs are small. Further studies on atypical antipsychotics in larger double-blind placebo-controlled studies that include standardised pain assessment and documentation are warranted.

Plain-language summary: The review authors assessed the effect of these medicines on pain and their side effects. Based on 5 out of 11 included trials there were some beneficial effects of antipsychotics in the treatment of acute and chronic pain. Analysis of these studies showed a significant reduction in pain after administration of the antipsychotic compared to placebo or another medicine, however these results were based on small studies and therefore they may be unreliable. It is also important to consider the unwanted effects that these medicines might cause.
Abstract: Two studies fitting the selection criteria were found for computer aided prescribing and one study for computer aided physiological monitoring. Computer-aided prescribing: one study (Cade 1997) examined the effects of computerised prescribing of parenteral nutrition ordering. No significant effects on short-term outcomes were found and longer term outcomes were not studied. The second study (Balaguer 2001) investigated the effects of a database program in aiding the calculation of neonatal drug dosages. It was found that the time taken for calculation was significantly reduced and there was a significant reduction in the number of calculation errors. Computer-aided physiological monitoring: one eligible study (Cunningham 1998) was found which examined the effects of computerised cot side physiological trend monitoring and display. There were no significant effects on mortality, volume of colloid infused, frequency of blood gases sampling (samples per day) or severe intraventricular haemorrhage (Papile Grade IV). Published data did not permit us to analyse effects on long-term neurodevelopmental outcome. There are very limited data from randomised trials on which to assess the effects of clinical decision support systems in neonatal care. Further evaluation of CDSS using randomised controlled trials is warranted.

Plain-language summary: The review authors searched the medical literature and contacted experts to find studies on CDSS used with newborns. They identified three randomised controlled studies that met the criteria for the review. Two of these three studies were on computer-aided drug prescribing and one was on computerized physiological monitoring of newborns. One of the studies on computer-aided prescribing showed that the CDSS used resulted in fewer drug dosage errors. The studies found no other benefits. The studies did not consider long-term outcomes in the newborns, just short-term effects. Also, with rapid changes in computer technology, current CDSS are more advanced than those used in the three studies. The Cochrane review authors conclude that there is not enough data to determine whether or not CDSS are beneficial for newborn care.
Abstract: Treatment with naftidrofuryl tended to show reduction of pain evaluated by both analogue score and analgesic consumption, but the effect was statistically non-significant (mean difference (MD): 0.42; 95% confidence interval (CI)1.19 to 0.35). Similarly, improvement in rest pain or skin necrosis occurred, but these effects were also non-significant. The effect on mean ankle systolic pressure was inconclusive. Based on the results of these trials, it cannot be confirmed that intravenous naftidrofuryl is effective in the treatment of people with critical limb ischaemia. However, these results were based on trials of generally low methodological quality which had only a small number of participants, the duration of treatment was extremely short, and the methods varied between the trials. The wide range of endpoints effectively precluded any meaningful pooling of the results. Intravenous naftidrofuryl was withdrawn as a treatment for severe peripheral arterial disease in 1995 because of reported side effects.

Plain-language summary: The review authors identified eight controlled trials that randomly allocated a total of 269 participants from five different countries to receive intravenous naftidrofuryl, other treatments, and placebo alone or with another treatment. There was no clear indication that short-term intravenous naftidrofuryl significantly improves either symptoms of ischaemic rest pain or skin necrosis. Treatment with naftidrofuryl tended to reduce pain, measured using a scale or with analgesic consumption, and improve rest pain and skin necrosis but the effects were not clear (statistically significant). The trials were generally of low methodological quality, included small numbers of predominantly elderly participants with varying levels of severity of critical limb ischaemia and used different measures of effect. The duration of treatment was short, from three to 42 days, most often seven days. Other treatments were haemodilution, anti-coagulant medication, prostaglandins, bed rest and reflex heating, and gingko biloba. Side effects included mild blood clotting (thrombophlebitis) at the injection site and in one trial two participants experienced renal insufficiency. Intravenous naftidrofuryl was withdrawn as a treatment for severe peripheral arterial disease in 1995 because of reported side effects.
Abstract: We found no trials assessing the effect of visibility aids on pedestrian and cyclist-motor vehicle collisions and injuries. To date we have identified 42 trials assessing the effect of visibility aids on drivers' responses. Fluorescent materials in yellow, red and orange colours improve detection and recognition in the daytime. For night-time visibility, lamps, flashing lights and retroreflective materials in red and yellow colours increase detection and recognition. Retroreflective materials enhance recognition, in particular when arranged in a 'biomotion' configuration, taking advantage of the motion from a pedestrian's limbs. Substantial heterogeneity between and within the trials limited the possibility for meta-analysis. Summary statistics and descriptive summaries of the outcomes were presented for individual trials when appropriate. Visibility aids have the potential to increase visibility and enable drivers to detect pedestrians and cyclists earlier. Biomotion markings, which highlight the movement and form of the pedestrian, showed evidence of improving pedestrians' conspicuity at night. Public acceptability of various effective strategies which improve visibility would merit further development. However, the effect of visibility aids on pedestrian and cyclist safety remains unknown. A cluster randomised controlled trial involving large communities may provide an answer to this question. It would, however, be a challenging trial to conduct. Studies that collect data of road traffic injuries relating to the use of visibility aids also warrant consideration.

Plain-language summary: The authors of this Cochrane review looked for studies which showed how effective visibility aids are for protecting pedestrians and cyclists. They focused their search on a type of study called a randomised controlled trial, which compares two similar groups of people who only differ on the issue being studied, for instance, the rate of crashes in communities with and without introduction of visibility aids. The authors found no studies that compared number of crashes but to date they have found 42 studies which compare driver detection of people with or without visibility aids. These studies showed that fluorescent materials in yellow, red and orange improved driver detection during the day; while lamps, flashing lights and retroreflective materials in red and yellow, particularly those with a 'biomotion' configuration (taking advantage of the motion from a pedestrian's limbs), improved pedestrian recognition at night. Although these visibility measures help drivers see pedestrians and cyclists, more research should be done to determine whether the increased visibility actually does prevent deaths and serious injuries.
Abstract: Two prospective controlled clinical trials involving 167 patients were included. All of them were of low quality. Radioiodine treatment versus ATD showed benefits in achieving euthyroidism (relative risk (RR) 1.70, 95% confidence interval (CI) 1.29 to 2.24). Radioiodine treatment showed a higher incidence of hypothyroidism compared with ATD (RR 6.46, 95% CI 1.16 to 35.81). No significant differences in modifying Graves' opthalmopathy (worsening or appearance) between radioiodine treatment and ATD (RR 1.30, 95% CI 0.56 to 3.00) were observed. No trial evaluated mortality, health related quality of life, economic outcomes or compliance with treatments. The limited results in Chinese suggest that a gland specific lower dosage of radioiodine treatment is potentially effective for pediatric GD, but a significant higher incidence of hypothyroidism compared with ATD was observed. However, we could not identify a well-designed trial to provide strong evidence for radioiodine in the treatment of pediatric GD. High-quality randomised controlled clinical trials are needed to guide treatment choice.

Plain-language summary: Two relevant trials with 167 patients were identified. The limited data suggest that a gland specific lower dosage of radioiodine treatment is potentially effective for pediatric GD, but a significant higher incidence of hypothyroidism compared with ATD was observed. However, all of the analysed studies were of low quality. No trial evaluated mortality, health related quality of life, economic outcomes or compliance with treatments.
Abstract: Six studies compared optimal self-management allowing self-adjustment of medications according to an individualised written action plan to adjustment of medications by a doctor. These two styles of asthma management gave equivalent effects for hospitalisation, emergency room (ER) visits, unscheduled doctor visits and nocturnal asthma. Self-management using a written action plan based on peak expiratory flow (PEF) was found to be equivalent to self-management using a symptoms based written action plan in the six studies which compared these interventions. Three studies compared self-management options. In one, that provided optimal therapy but tested the omission of regular review, the latter was associated with more health centre visits and sickness days. In another, comparing high and low intensity education, the latter was associated with more unscheduled doctor visits. In a third, no difference in health care utilisation or lung function was reported between verbal instruction and written action plans. Optimal self-management allowing for optimisation of asthma control by adjustment of medications may be conducted by either self-adjustment with the aid of a written action plan or by regular medical review. Individualised written action plans based on PEF are equivalent to action plans based on symptoms. Reducing the intensity of self-management education or level of clinical review may reduce its effectiveness.

Plain-language summary: Guidelines for the treatment of asthma recommend that patients be educated about their condition, obtain regular medical review, monitor their condition at home with either peak flow or symptoms and use a written action plan. This is known to improve health outcomes when compared to usual medical care. A number of variations on optimal self-management have now been described. This review examines the efficacy of some of these options. The results showed that self-adjustment of medications according to a written action plan gave a similar improvement in health outcomes to adjustment of medications by a doctor. Either symptom diaries or peak expiratory flow monitoring may be used for monitoring asthma and reducing the intensity of the education appears to dilute the effect.
Abstract: Thirteen studies from six countries covering over 33,400 children and adults in rural, urban, and school settings met the review's inclusion criteria. In all studies the intervention was allocated at the community level. While the studies reported a wide range of effects, 11 of the 13 studies found the intervention was protective against diarrhoea. Differences in study populations and settings, in baseline sanitation levels, water, and hygiene practices, in types of interventions, study methodologies, compliance and coverage levels, and in case definitions and outcome surveillance limit the comparability of results of the studies included in this review. The validity of most individual study results are further compromised by the non-random allocation of the intervention among study clusters, an insufficient number of clusters, the lack of adjustment for clustering, unclear loss to follow-up, potential for reporting bias and other methodological shortcomings. This review provides some evidence that interventions to improve excreta disposal are effective in preventing diarrhoeal disease. However, this conclusion is based primarily on the consistency of the evidence of beneficial effects. The quality of the evidence is generally poor and does not allow for quantification of any such effect. The wide range of estimates of the effects of the intervention may be due to clinical and methodological heterogeneity among the studies, as well as to other important differences, including exposure levels, types of interventions, and different degrees of observer and respondent bias. Rigorous studies in multiple settings are needed to clarify the potential effectiveness of excreta disposal on diarrhoea.

Plain-language summary: This review examined trials of interventions to improve the safe disposal of human faeces to prevent diarrhoea. In low-income settings, among the estimated 2.6 billion people who lack basic sanitation, this mainly consists of introducing or expanding the number and use of latrines and other facilities to contain or dispose of faeces. We identified 13 studies of such interventions involving more than 33,400 people in six countries. These trials provide some evidence that excreta disposal interventions are effective in preventing diarrhoeal diseases. However, major differences among the studies, including the conditions in which they were conducted and the types of interventions deployed, as well as methodological deficiencies in the studies themselves, makes it impossible to estimate with precision the protective effective of sanitation against diarrhoea. Further research, including randomized controlled trials, is necessary to understand the full impact of these interventions.
Abstract: Nine randomised trials studied 2119 women receiving primary treatment for ovarian cancer. We considered six trials to be of high quality. Women were less likely to die if they received an IP component to chemotherapy (eight studies, 2026 women; HR = 0.81; 95% confidence interval (CI): 0.72 to 0.90). Intraperitoneal component chemotherapy prolonged the disease-free interval (five studies, 1311 women; HR = 0.78; 95% CI: 0.70 to 0.86). There was greater serious toxicity with regard to gastrointestinal effects, pain, fever and infection but less ototoxicity with the IP than the IV route. Intraperitoneal chemotherapy increases overall survival and progression-free survival from advanced ovarian cancer. The results of this meta-analysis provide the most reliable estimates of the relative survival benefits of IP over IV therapy and should be used as part of the decision making process. However, the potential for catheter related complications and toxicity needs to be considered when deciding on the most appropriate treatment for each individual woman. The optimal dose, timing and mechanism of administration cannot be addressed from this meta-analysis. This needs to be addressed in the next phase of clinical trials.

Plain-language summary: This review compared the effectiveness of IV chemotherapy to chemotherapy administered directly into the peritoneal cavity (intraperitoneal, or IP). The evidence suggests an improvement in survival if some of the chemotherapy is administered via the intraperitoneal route. The disadvantage is an increase in adverse effects principally relating to the presence of a peritoneal catheter, including pain, catheter blockage, gastrointestinal effects and infection.