GEM/cochrane-simplification huggingface dataset:
Abstract: None of the studies of clinically-relevant hyperkalaemia reported mortality or cardiac arrhythmias. Reports focused on serum potassium levels. Many studies were small, and not all intervention groups had sufficient data for meta-analysis to be performed. On the basis of small studies, inhaled beta-agonists, nebulised beta-agonists, and intravenous (IV) insulin-and-glucose were all effective, and the combination of nebulised beta agonists with IV insulin-and-glucose was more effective than either alone. Dialysis is effective. Results were equivocal for IV bicarbonate. K-absorbing resin was not effective by four hours, and longer follow up data on this intervention were not available from RCTs. Nebulised or inhaled salbutamol, or IV insulin-and-glucose are the first-line therapies for the management of emergency hyperkalaemia that are best supported by the evidence. Their combination may be more effective than either alone, and should be considered when hyperkalaemia is severe. When arrhythmias are present, a wealth of anecdotal and animal data suggests that IV calcium is effective in treating arrhythmia. Further studies of the optimal use of combination treatments and of the adverse effects of treatments are needed.

Plain-language summary: No trials with clinically-important outcomes were identified. Many of the studies were conducted in convenience samples of patients. Many of the trials were methodologically flawed. Adverse events were rarely reported. Decrease in serum potassium was the most frequently reported outcome: for this outcome beta agonists and intravenous insulin-and-glucose were effective. The combination may be more effective than either alone.
Abstract: One study (34 patients) met our inclusion criteria although it was not yet a peer reviewed publication. The study randomised patients with chronic frontal sinusitis who had failed a prolonged course of medical treatment into two groups: balloon dilatation of the frontal recess (plus conventional FESS of other involved sinuses) versus conventional FESS (Draf type 1/2a procedures on the frontal sinuses). At 12 months follow up there was no statistically significant difference in radiological resolution of frontal sinuses between the two groups. The percentages of directly observed patent frontal recesses at 12 months were 75% in the balloon dilation group versus 63% in the FESS-only group. The authors state that this was statistically significant but details of the analysis were not presented. Indeed the study as a whole suffers from a bias in the way its outcome measures were reported. No major complications were reported. Three patients in the FESS-only group required further revision frontal sinus surgery compared to one in the balloon dilation group, although synechiae were more common in the latter. At present there is no convincing evidence supporting the use of endoscopic balloon sinus ostial dilation compared to conventional surgical modalities in the management of CRS refractory to medical treatment. With the escalating use of balloon sinuplasty, there is an urgent need for more randomised controlled trials to determine its efficacy over conventional surgical treatment modalities.

Plain-language summary: One unpublished trial met our inclusion criteria. This randomised 34 patients with chronic frontal sinusitis into two groups: in one group balloon dilation was used to open up the drainage pathways of the frontal sinuses; in the other group conventional endoscopic sinus surgery was used to do the same. For both groups all other sinuses were treated using conventional functional endoscopic sinus surgery. Balloon dilation did not show an improvement in the resolution of frontal sinusitis as demonstrated by imaging studies, however the technique was associated with an increased likelihood that someone observing a frontal sinus opening would find this open. However, it is not clear whether this was a statistically significant result. The study report appeared to be biased in the way it reported its outcome measures. At present, therefore, we cannot recommend the use of balloon dilation of sinus ostia over conventional surgical treatment modalities in this setting.
Abstract: Of seventeen included studies, thirteen found no evidence of an effect for continuous smoking abstinence following the intervention. Meta-analysis of 14 studies for point prevalence of smoking produced a statistically and clinically significant effect in favour of the intervention (OR 1.36, 95% CI 1.20 to 1.55, p= 0.004). Meta-analysis of eight studies that reported continuous abstinence was also statistically significant (OR 1.60, 95% CI 1.26 to 2.03, p= 0.03). Healthcare professionals who had received training were more likely to perform tasks of smoking cessation than untrained controls, including: asking patients to set a quit date (p< 0.0001), make follow-up appointments (p< 0.00001), counselling of smokers (p< 0.00001), provision of self-help material (p< 0.0001) and prescription of a quit date (p< 0.00001). No evidence of an effect was observed for the provision of nicotine gum/replacement therapy. Training health professionals to provide smoking cessation interventions had a measurable effect on the point prevalence of smoking, continuous abstinence and professional performance. The one exception was the provision of nicotine gum or replacement therapy, which did not differ between groups.

Plain-language summary: The review of 17 trials found that these training programs help health professionals to identify smokers and increase the number of people who quit smoking. The programs also increase the number of people offered advice and support for quitting by health professionals.
Abstract: Eight studies are included in this review; six employed a crossover design. In the overall comparison of radiant warmers vs incubators, radiant warmers caused a statistically significant increase in insensible water loss (IWL) [WMD 0.94g/Kg/day (95% CI 0.47, 1.41)] and a trend towards increased oxygen consumption which was not statistically significant [WMD 0.27mL/kg/min (95% CI -0.09, 0.63)]. Due to small numbers, effects on important clinical outcomes could not be adequately assessed. A comparison of radiant warmers with heat shields vs incubators without heat shields showed a trend for increased IWL in the radiant warmer group, which was not statistically significant. No difference was shown in oxygen consumption. Radiant warmers result in increased IWL compared to incubators. This needs to be taken into account when calculating daily fluid requirements. The results of this review do not provide sufficient evidence concerning effects on important outcomes to guide clinical practice. Further randomised controlled trials are required to assess the effects of radiant warmers versus incubators in neonatal care on important short and long term outcomes, with particular attention to extremely low birthweight infants in the early neonatal period.

Plain-language summary: The review of trials found that radiant warmers increase water loss in low birthweight babies in the newborn period when compared to incubators and that this water loss needs to be taken into account when daily fluid requirements are calculated. However, there was not enough information available for this review to enable assessment of other important effects of radiant warmers. Therefore, at the present time, it is not clear which method of maintaining body temperature is best for newborn babies - radiant warmers or incubators. More research is necessary.
Abstract: We included six studies that reported data on 2452 participants with ESKD. Interventions investigated were folic acid with or without other vitamins (vitamin B6, vitamin B12). Participants' mean age was 48 to 65 years, and proportions of male participants ranged from 50% to 98%. Homocysteine-lowering therapy probably leads to little or no effect on cardiovascular mortality (4 studies, 1186 participants: RR 0.93, 95% CI 0.70 to 1.22). There was no evidence of heterogeneity among the included studies (I² = 0%). Homocysteine-lowering therapy had little or no effect on all-cause mortality or any other of this review's secondary outcomes. All prespecified subgroup and sensitivity analyses demonstrated little or no difference. Reported adverse events were mild and there was no increase in the incidence of adverse events from homocysteine-lowering therapies (3 studies, 1248 participants: RR 1.12, 95% CI 0.51 to 2.47; I2 = 0%). Overall, studies were assessed as being at low risk of bias and there was no evidence of publication bias. Homocysteine-lowering therapies were not found to reduce mortality (cardiovascular and all-cause) or cardiovascular events among people with ESKD.

Plain-language summary: From a search of the literature in January 2016, we identified six randomised controlled trials that involved 2452 participants aged between 48 and 65 years to be analysed. We found that homocysteine-lowering therapies had no benefits for heart health in people with advanced kidney disease who were on dialysis. These therapies did not achieve any reduction in rates of heart disease-related death. However, homocysteine-lowering therapies were generally well tolerated, and had a mild side effect profile. Overall, studies were assessed as high quality.
Abstract: The four trials (three USA and one UK) recruited clinically similar groups of babies. Two trials excluded infants with congenital diaphragmatic hernias. In two trials, transfer for ECMO implied transport over long distances. Two trials had follow-up information. One study included economic evaluation. The three USA trials had very small numbers of patients. Two trials used conventional randomisation with low potential for bias. Two used less usual designs, which led to difficulties in their interpretation. All four trials showed strong benefit of ECMO on mortality (typical RR 0.44; 95% CI 0.31 to 0.61), especially for babies without congenital diaphragmatic hernia (typical RR 0.33, 95% CI 0.21 to 0.53). The UK trial provided follow up information about death or severe disability, and cost-effectiveness, and showed benefit of ECMO at one year (RR 0.56, 95% CI 0.40 to 0.78), four years (RR 0.62, 95% CI 0.45 to 0.86), and seven years (RR 0.64, 95% CI 0.47 to 0.86). Overall nearly half of the children recruited had died or were severely disabled by seven years of age, reflecting the severity of their underlying conditions. A policy of ECMO is as cost-effective as other intensive care technologies in common use. A policy of using ECMO in mature infants with severe but potentially reversible respiratory failure results in significantly improved survival without increased risk of severe disability. The benefit of ECMO for babies with diaphragmatic hernia is unclear. Further studies are needed to consider the optimal timing for introducing ECMO; to identify which infants are most likely to benefit; and to address the implications of neonatal ECMO during later childhood and adult life.

Plain-language summary: In this review, four randomized trials that compared the use of ECMO to the conventional approach to supporting these infants with severe breathing problems were identified. Overall, these trials showed a strong benefit for ECMO regarding survival at the time of hospital discharge. This is particularly true for infants without a specific problem of lung formation (congenital diaphragmatic hernia). The result implies that for every three babies with breathing problems and lung failure who were treated with ECMO rather than conventional ventilation, one more infant will survive. Although little information is available regarding long-term follow-up, one trial in the United Kingdom shows both benefits of ECMO and cost-effectiveness of the use of ECMO.
Abstract: We included 12 trials representing 2607 randomised participants. We combined data from six trials in meta-analyses of 1206 randomised participants. The overall RR for reduction in seizure frequency of 50% or more compared to placebo was 1.89 (95% confidence interval (CI) 1.40 to 2.55; 6 trials, 1206 participants; moderate-quality evidence). Dose regression analysis (for trials in adults) showed increasing efficacy with increasing dose, with 25.3% (19.3 to 32.3) of people responding to gabapentin 1800 mg compared to 9.7% on placebo, a 15.5% increase in response rate (8.5 to 22.5). The RR for treatment withdrawal compared to placebo was 1.05 (95% CI 0.74 to 1.49; 6 trials, 1206 participants; moderate-quality evidence). Adverse effects were significantly associated with gabapentin compared to placebo. RRs were as follows: ataxia 2.01 (99% CI 0.98 to 4.11; 3 studies, 787 participants; low-quality evidence), dizziness 2.43 (99% CI 1.44 to 4.12; 6 studies, 1206 participants; moderate-quality evidence), fatigue 1.95 (99% CI 0.99 to 3.82; 5 studies, 1161 participants; low-quality evidence) and somnolence 1.93 (99% CI 1.22 to 3.06; 6 studies, 1206 participants; moderate-quality evidence). There were no significant differences for the adverse effects of headache (RR 0.79, 99% CI 0.46 to 1.35; 6 studies, 1206 participants; moderate-quality evidence) or nausea (RR 0.95, 99% CI 0.52 to 1.73; 4 trials, 1034 participants; moderate-quality evidence). Overall, the studies were rated at low to unclear risk of bias due to information on each risk of bias domain not being available. We judged the overall quality of evidence (using the GRADE approach) as low to moderate due to potential attrition bias resulting from missing outcome data and imprecise results with wide confidence intervals. Gabapentin has efficacy as an add-on treatment in people with drug-resistant focal epilepsy. However, the trials reviewed were of relatively short duration and provide no evidence for the long-term efficacy of gabapentin beyond a three-month period. The results cannot be extrapolated to monotherapy or to people with other epilepsy types.

Plain-language summary: Data from six of the studies were combined in the analysis. All the participants (including adults and children) were previously taking at least one antiepileptic medicine and all were continuing to have seizures. Either gabapentin (an antiepileptic medicine) or a placebo (a tablet that contains no medicine) was added to the medicine regimen. The results showed that gabapentin effectively reduced seizures when used as an additional treatment. Compared to a placebo, gabapentin was almost twice as likely to reduce seizures by 50% or more. The most common side effects associated with gabapentin ware ataxia (poor co-ordination and unsteady gait), dizziness, fatigue and drowsiness. Overall the quality of evidence was low to moderate as information was not reported for all participants in some of the trials and some of the results were imprecise. Research is needed into the effects of the long-term use of gabapentin. The evidence is current to 20 March 2018.
Abstract: Eleven studies, 1592 participants, fulfilled the criteria of inclusion and were included in the review. The studies considered five different psychosocial interventions and two pharmacological treatments (methadone and buprenorphine). Compared to any pharmacological treatment alone, the association of any psychosocial with any pharmacological was shown to significantly reduce dropouts RR 0.71 (95% CI 0.59 to 0.85), use of opiate during the treatment, RR 0.82 (95% CI 0.71 to 0.93), at follow up RR 0.66 (95% IC 0.53 to 0.82) and clinical absences during the treatment RR 0.48 (95%CI 0.38 to 0.59). Moreover, with the evidence currently available, there are no data supporting a single psychosocial approach. Psychosocial treatments offered in addition to pharmacological detoxification treatments are effective in terms of completion of treatment, use of opiate, participants abstinent at follow-up and clinical attendance. The evidence produced by this review is limited due to the small number of participants included in the studies, the heterogeneity of the assessment or the lack of detailed outcome information that prevented the possibility of cumulative analysis for several outcomes. Nevertheless it seems desirable to develop adjunct psychosocial approaches that might make detoxification more effective.

Plain-language summary: The review authors searched the medical literature and found evidence that providing a psychosocial treatment in addition to pharmacological detoxification treatment to adults who are dependent on heroin use is effective in facilitating opioid detoxification. This conclusion is based on eleven controlled studies involving 1592 adults. The addition of a psychosocial treatment to substitution detoxification treatment improved the number of people who completed treatment (relative risk (RR) 1.47), reduced the use of opiate (RR 0.82), increased abstinence from opiate at follow up (RR 2.43) and halved the number of failures to attend clinic absences (RR 0.48). The findings of an improved rate of clinical attendance may help in suppressing illicit drug use and provides clinical staff with more opportunities to counsel patients in psychiatric, employment and other drug and non-drug related areas. Variations in the populations who are substance users and use of a wide range of different psychosocial interventions means that it is difficult to single out particular therapeutic interventions.
Abstract: Eleven studies met our eligibility criteria and all were at medium or high risk of bias. Only five studies gave the total number of participants (totalling 7372 participants). Three studies used a randomised design, with the others using pre-post comparisons. Several different strategies were investigated. Four studies examined the impact of additional visits or information for the study site, with no increases in recruitment demonstrated. Increased recruitment rates were reported in two studies that used a dedicated clinical recruiter, and five studies that introduced an automated alert system for identifying eligible participants. The studies were embedded into trials evaluating care in oncology mainly but also in emergency departments, diabetes and lower back pain. There is no strong evidence for any single strategy to help healthcare professionals to recruit participants in research studies. Additional visits or information did not appear to increase recruitment by healthcare professionals. The most promising strategies appear to be those with a dedicated resource (e.g. a clinical recruiter or automated alert system) for identifying suitable participants that reduced the demand on healthcare professionals, but these were assessed in studies at high risk of bias.

Plain-language summary: We found 11 studies that assessed recruitment strategies used with healthcare staff in search of the literature in January 2015. Five included the total number of participants (7372). There were three main strategies: 1. Using an alert system, either a computer system or member of staff to check patient records, to alert staff recruiting participants that someone might be suitable for the study (five studies). 2. Giving additional information about the study to the staff at hospitals or clinics who are recruiting people through visits from the researchers, educational seminars or leaflets (four studies). 3. Using a designated member of staff whose primary role was to recruit participants (two studies). All the studies identified were of quite low quality, so it is difficult to draw firm conclusions from them. Five studies examined the alert system to identify participants who might be suitable for a study. Alert systems showed some promising results but were not unanimous in their findings. The four studies that evaluated the provision of additional information, visits or education to the sites recruiting participants found that none of the tested strategies led to improved recruitment. The most promising strategy appears to be the employment of someone such as a clinical trials officer or research nurse with the specific task of recruiting participants to research studies. The two studies using this strategy showed improvement in recruitment rates but both were at high risk of bias. More research is still needed to evaluate the role of a designated person to recruit to research studies.
Abstract: Eleven studies (3912 participants) met the inclusion criteria of the review. Small benefits of ipratropium over a short-acting beta-2 agonist were demonstrated on lung function outcomes. There were small benefits in favour of ipratropium on quality of life (HRQL), as well as a reduction in the requirement for oral steroids. Combination therapy with ipratropium plus a short-acting beta-2 agonist conferred benefits over a short-acting beta-2 agonist alone in terms of post-bronchodilator lung function. There was no significant benefit of combination therapy in subjective improvements in HRQL, but again there was a reduction in the requirement for oral steroids. The available data from the trials included in this review suggest that the advantage of regular long term use of ipratropium alone or in combination with a short-acting beta-2 agonist or over a beta-2 agonist alone are small, if the aim is to improve lung function, symptoms and exercise tolerance. Until further data are available, the strategy of providing a short-acting beta-2 agonist on a PRN basis, and then either continuing with the short-acting beta-2 agonist regularly or conducting an "n of 1" trial of regular beta-2 agonist or regular anticholinergic to determine the treatment that gives the best relief of symptoms (and continuing with it), would seem cost effective. This strategy does need formal evaluation. Patient preference is also important, as is the relative importance of avoiding the use of systemic corticosteroids.

Plain-language summary: This review looks at studies that compare the regular use for at least four weeks of different types of inhaled short-acting bronchodilator medication in people with chronic obstructive pulmonary disease (COPD, or emphysema/chronic bronchitis). There were eleven trials included. There were no major differences seen between the responses to ipratropium and salbutamol, or the combination. Where there were benefits, they were small and would not support a general recommendation for the use of ipratropium bromide or a combination with beta-2 agonist over a beta-2 agonist alone in COPD. People with COPD could use the short-acting bronchodilator that gives them the most improvement in their symptoms.