GEM/cochrane-simplification huggingface dataset:
Abstract: A total of 3239 citations were identified through the searches. Only one RCT, with 15-year follow-up met the inclusion criteria (n = 13 clusters: 191,873 participants). There was no statistically significant difference in the oral cancer mortality rates for the screened group (15.4/100,000 person-years) and the control group (17.1/100,000 person-years), with a RR of 0.88 (95% CI 0.69 to 1.12). A 24% reduction in mortality was reported between the screening group (30/100,000 person-years) and the control group (39.0/100,000) for high-risk individuals who used tobacco or alcohol or both, which was statistically significant (RR 0.76; 95% CI 0.60 to 0.97). No statistically significant differences were found for incidence rates. A statistically significant reduction in the number of individuals diagnosed with stage III or worse oral cancer was found for those in the screening group (RR 0.81; 95% CI 0.70 to 0.93). No harms were reported. The study was assessed as at high risk of bias. There is evidence that a visual examination as part of a population-based screening programme reduces the mortality rate of oral cancer in high-risk individuals. In addition, there is a stage shift and improvement in survival rates across the population as a whole. However, the evidence is limited to one study, which has a high risk of bias and did not account for the effect of cluster randomisation in the analysis. There was no evidence to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging as a screening tool to reduce oral cancer mortality. Further RCTs are recommended to assess the efficacy and cost-effectiveness of a visual examination as part of a population-based screening programme in low, middle and high-income countries.

Plain-language summary: The evidence on which this review is based is up to date as of 22 July 2013. The only study included was based in rural areas of the city of Trivandrum in Kerala, India. The study included 191,873 apparently healthy adults aged 35 years or older living in 13 clusters with an average of 14,759 participants in each cluster. Screening took place in seven clusters (96,517 participants) and six clusters acted as a control (95,356 participants). Participants were excluded if they were bedridden, if they had open tuberculosis, other debilitating diseases or were already suffering from oral cancer. Healthcare workers trained in the detection of oral lesions undertook the screening of participants and the social history of participants including use of paan, tobacco, alcohol and dietary supplements was recorded. The review found that overall there is not enough evidence to decide whether screening by visual inspection reduces the death rate for oral cancer and there is no evidence for other screening methods. However, there is some evidence that it might help reduce death rates in patients who use tobacco and alcohol although the only included study may be affected by bias. The evidence presented is of low quality and limited to one study assessed as at high risk of bias.
Abstract: We included six randomised clinical trials with 173 participants. All participants had Child-Pugh stage A or B cirrhosis. The intervention groups participated in eight to 14 weeks of physical exercise (aerobic: three trials; resistance: one trial; or aerobic plus resistance training: two trials). Control groups underwent sham exercise (supervised relaxation: one trial) or no intervention (five trials). None of the 89 participants allocated to exercise versus two of 84 participants in the control group died (RR 0.19, 95% CI 0.01 to 3.73; moderate-quality evidence). The cause of death was acute-on-chronic liver disease for both participants. Nine participants in the exercise group and 13 in the control group experienced serious adverse events (RR 0.61, 95% CI 0.19 to 1.94; low-quality evidence). Physical exercise showed no beneficial or detrimental effect on health-related quality of life assessed by the Chronic Liver Disease Questionnaire (MD 0.11, 95% CI –0.44 to 0.67; low-quality evidence). Likewise, physical exercise had no clear effect on physical fitness measured by peak exercise oxygen uptake (MD 0.3 mL/kg/minute, 95 % CI –2.74 to 3.35; low-quality evidence) and Six-Minute Walk Test (MD 56.06 min, 95% CI –9.14 to 121.26; very low-quality evidence). Physical exercise showed no clear effect on mid-thigh circumference (MD 1.76 cm, 95% CI –0.26 to 3.77; low-quality evidence), but showed an increase in mid-arm circumference (MD 2.61 cm, 95% CI 0.36 to 4.85; low-quality evidence). We found no clear beneficial or harmful effect of physical exercise on mortality, morbidity, or health-related quality of life. Further evidence is needed to evaluate the beneficial and harmful effects of physical exercise on clinical outcomes.

Plain-language summary: We included six randomised clinical trials (where people are randomly allocated to one of two groups) with 173 participants. All participants had cirrhosis. Interventions consisted of different types of exercise including bicycling, treadmill walking, and weight lifting. Programmes were home-based or supervised and lasted between eight and 14 weeks. Physical exercise did not seem to affect mortality (death), side effects or quality of life. Overall, the evidence for the effect of physical exercise was of low or very low quality. Factors that downgraded the quality of the evidence included lack of trials with a low risk of bias, small trials, and not similar results across trials.
Abstract: We identified three trials (κ = 1.00) involving 1272 participants. Comparing the capnography group to the standard monitoring group, there were no differences in the rates of oxygen desaturation (RR 0.89, 95% CI 0.48 to 1.63; n = 1272, 3 trials; moderate quality evidence) and hypotension (RR 2.36, 95% CI 0.98 to 5.69; n = 986, 1 trial; moderate quality evidence). There was only one episode of emesis recorded without significant difference between the groups (RR 3.10, 95% CI 0.13 to 75.88, n = 986, 1 trial; moderate quality evidence). The quality of evidence for the primary outcomes was moderate with downgrades primarily due to heterogeneity and reporting bias. There were no differences in the rate of airway interventions performed (RR 1.26, 95% CI 0.94 to 1.69; n = 1272, 3 trials; moderate quality evidence). In the subgroup analysis, we found a higher rate of airway interventions for adults in the capnography group (RR 1.44, 95% CI 1.16 to 1.79; n = 1118, 2 trials; moderate quality evidence) with a number needed to treat for an additional harmful outcome of 12. Although statistical heterogeneity was reduced, there was moderate quality of evidence due to outcome definition heterogeneity and limited reporting bias. None of the studies reported recovery time. There is a lack of convincing evidence that the addition of capnography to standard monitoring in ED PSA reduces the rate of clinically significant adverse events. Evidence was deemed to be of moderate quality due to population and outcome definition heterogeneity and limited reporting bias. Our review was limited by the small number of clinical trials in this setting.

Plain-language summary: We searched for studies using multiple research databases, conference research abstracts, and by contacting experts in the field. The evidence is current to August 2016. We only considered studies with participants being sedated for procedures in the emergency department. We only included studies that compared capnography and standard monitoring to standard monitoring only. The main outcomes involved events of low blood oxygen content, low blood pressure, and vomiting. We also recorded how many times the healthcare providers had to help the patient breathe easier. This could mean simple actions such as opening of the mouth to more serious manoeuvres such as mechanically breathing for the patient. Three studies with 1272 people, containing moderate evidence, were included in our study. There was no difference in heart, lung, or airway complications with the addition of capnography. When only adults were studied, healthcare providers performed more manoeuvres to help the patient breathe when capnography was used. This could be due to false alarms. The level of evidence was determined to be moderate.
Abstract: Ten trials (9 RCTs and 1 CCT) (954 participants and 73 caregivers) met the inclusion criteria. Eight RCTs scored well; while one RCT and one CCT scored poorly on the methodological quality assessment. Despite no change in the level of impairment, there was ’strong evidence’ to support inpatient MD rehabilitation in producing short-term gains at the levels of activity (disability) and participation in patients with MS. There is ‘moderate evidence’ to support inpatient or outpatient rehabilitation programmes (compared with control wait-list groups) in improving disability; and bladder related activity and participation outcomes up to 12 months following MD rehabilitation intervention. For outpatient and home-based rehabilitation programmes there was 'limited evidence' for short-term improvements in symptoms and disability with high intensity programmes, which translated into improvement in participation and quality of life. For low intensity programmes conducted over a longer period there was 'strong evidence' for longer-term gains in quality of life; and also 'limited evidence' for benefits to carers. Although some studies reported potential for cost-savings, there is no convincing evidence regarding the long-term cost-effectiveness of these programmes. It was not possible to suggest best 'dose' of therapy or supremacy of one therapy over another. This review highlights the limitations of RCTs in rehabilitation settings and need for better designed randomized and multiple centre trials. MD rehabilitation programmes do not change the level of impairment, but can improve the experience of people with MS in terms of activity and participation. Regular evaluation and assessment of these persons for rehabilitation is recommended. Further research into appropriate outcome measures, optimal intensity, frequency, cost and effectiveness of rehabilitation therapy over a longer time period is needed. Future research in rehabilitation should focus on improving methodological and scientific rigour of clinical trials.

Plain-language summary: This review looked for evidence of MD rehabilitation in adults with multiple sclerosis. The authors concluded there was strong evidence that inpatient or outpatient rehabilitation can lead to improvement in activity (disability) and in overall ability to participate in society, even though there is no reduction in actual impairment. There was limited evidence for short-term improvements in symptoms and disability, and in participation and quality of life with the high intensity outpatient and home-based rehabilitation programmes. For low intensity programmes conducted over a longer period there were longer term gains in quality of life; and for benefits to carers in terms of general health and engagement in social activities. The evidence available for other aspects of MD rehabilitation, including outpatient and home based therapy is not yet sufficient to allow many conclusions to be drawn.
Abstract: No RCTs meeting the selection criteria were identified. Since it is unlikely, for ethical and practical reasons that an RCT of SCUs will be conducted, a systematic review of non-RCTs using the same protocol and criteria was conducted. There were eight non-RCTs that fulfilled the criteria for inclusion. Only four studies had data which could be extracted for pooling in meta-analysis.  Differences between comparator groups in these nonRCTs ? for example in severity of dementia - were not adequately adjusted for and were common in the trial which accounted for almost all of the positive outcomes of SCUs (Nobili, 2006) All of the results of the outcomes came only from single studies except for "physical restraint use" at 6 months, which included data from two studies.  A small improvement in total Neuropsychiatric Inventory scores, favouring SCU was noted in one study at 6, 12 and 18 months.  The use of physical restraints was less common in SCUs at 6 and 12 months (OR= 0.46 (95% CI 0.27 to 0.80), p=0.006; and OR=0.49 (0.27 to 0.88), p=0.02 respectively).  Patients in SCUs were less depressed at 3 months than those in traditional nursing home (WMD -6.30 (-7.88 to -4.72) Cornell points, p<0.00001). There was only one observation that favoured the control group: a small but significant effect favouring traditional nursing home care was observed at 6 months in the mean number of psychotropic medications used (WMD 0.20, CI 0.00 to 0.40, z=1.96, P=0.05). There are no identified RCTs investigating the effects of SCUs on behavioural symptoms in dementia, and  no strong evidence of benefit from the available non-RCTs.  It is probably more important to implement best practice than to provide a specialized care environment.  The routine collection of data on behaviour, restraint and psychotropic drug use across multiple nursing home settings offers the best modality for formal evaluation of the benefit or otherwise of SCUs.

Plain-language summary: No randomized controlled trials (RCTs) can be found comparing the effect of SCUs against traditional nursing units in managing agitated behaviours in people suffering from dementia. This review has examined the results of non-RCTs. The findings about the outcomes of this review arise just from one study except for the outcome of "physical restraint use" at 6 months, which includes data from two studies. Selection bias is a major problem in non-RCTs, and confounds the limited evidence that favoured SCU care with regard to a decrease in agitated behaviour and in the use of physical restraints. A convincing case for the benefits of SCU care cannot be made and further studies are necessary.
Abstract: Nine safety and efficacy trials, and two safety trials, with over 3000 participants were included. In semi-immune children, RTS,S vaccine reduced clinical episodes of malaria by 26% (95% CI 13% to 37%) and severe malaria by 58% (95% CI 15% to 79%) for up to 18 months. Prevalence of parasitaemia was also reduced by 26% (95% CI 11% to 38%) at six months after immunization. RTS,S also reduced clinical malaria episodes by 63% (95% CI 18% to 83%) in semi-immune adult men in the second year of follow up after a booster dose. No severe adverse events were judged to be related to RTS,S vaccine, although the frequencies of injection site pain, swelling, arm motion limitation, headache, and malaise were increased in the vaccine groups. There was no evidence for effect of the CS-NANP vaccines (307 participants, 3 trials), CS102 peptide vaccine (14 participants, 1 trial), or the ME-TRAP vaccine (372 participants, 1 trial). RTS,S vaccine was effective in preventing a significant number of clinical malaria episodes, including good protection against severe malaria in children for 18 months. No severe adverse events were attributable to the vaccine. Progression of this vaccine towards licensing is justified while efforts to increase its efficacy continue. The other vaccines do not look promising and further research is a priority.

Plain-language summary: This review looks at vaccines targeted at the 'pre-erythrocytic' phase of the parasite's life, the phase before the parasites first enter the bloodstream from the liver. Trials of four types of vaccine against P. falciparum, the most important human malaria species, were available for this review. One of these (the RTS,S vaccine) significantly reduced the number of episodes of clinical malaria and severe malaria in children, while the other three vaccines were not effective under the conditions of the trials. No severe adverse events observed following the RTS,S vaccination were judged to be related to vaccination, though minor adverse events like headache, swelling, and malaise were.
Abstract: Only one study evaluating lamotrigine in secondary progressive MS was eligible. One hundred and twenty people were included, 61 randomly assigned to lamotrigine treatment and 59 to placebo treatment. The average age of participants in the two groups was 51.9 years and 50.1 years, respectively. The proportion of male participants was 27.5%. The period of follow-up was 2 years. No data were found on disability progression and people who experienced relapses. No significant differences were found for serious adverse events between the two groups. Treatment with lamotrigine was associated with more rashes (20% vs 5%, P value 0.03) and transient, dose-related deterioration of mobility (66% vs 34%, P value 0.001) than placebo. Furthermore, no significant difference between the two groups was found in the magnetic resonance imaging (MRI) measurements of cerebral atrophy, Expanded Disability Status Score changes, Multiple Sclerosis Functional Composite score changes. This study was judged to be at high risk of bias. This review will be updated when the three ongoing studies we identified are completed. The quality of evidence was judged to be very low due to the low number of available studies and included participants. There is a lack of evidence to address the review question on the efficacy of sodium channel blockers for people with MS. Assessment of the three ongoing trials might change this conclusion. Further high-quality large scale studies are needed.

Plain-language summary: We searched for randomised controlled trials (RCTs), in which participants were randomly assigned to a treatment group or a control group. In most settings these studies provide the highest quality evidence. We were interested in studies that compared a sodium channel blocker with placebo, or used it as an add-on to any approved treatments for MS. We found only one study including a total of 120 participants. No data were found on disability progression and people who experienced relapses. No significant difference between two groups was found in measurements of cerebral atrophy, expanded disability score changes, or MS functional composite score changes. Treatment with lamotrigine was associated with more rashes (20% versus 5%) and transient, dose-related deterioration of mobility. There is a lack of evidence to address the review question on the efficacy of sodium channel blockers for people with MS. This review will be updated when the three ongoing studies we identified are completed. The quality of evidence was judged as very low due to the low number of available studies and included population. There is a lack of evidence to address the review question on the efficacy of sodium channel blockers for people with MS. Assessment of the three ongoing trials might change this conclusion. Further high-quality large-scale studies are needed.
Abstract: Three randomised controlled trials (340 patients) and 12 non-randomised studies (4081 patients) were included. There was significant statistical heterogeneity in the analysis of many of the outcomes. We found no significant difference between care pathway and control groups in terms of death or discharge destination. Patients managed with a care pathway were: (1) more dependent at discharge (P = 0.04); (2) less likely to suffer a urinary tract infection (Odds Ratio (OR) 0.51, 95% Confidence Interval (CI) 0.34 to 0.79); (3) less likely to be readmitted (OR 0.11, 95% CI 0.03 to 0.39); and (4) more likely to have neuroimaging (OR 2.42, 95% CI 1.12 to 5.25). Evidence from randomised trials suggested that patient satisfaction and quality of life were significantly lower in the care pathway group (P = 0.02 and P < 0.005 respectively). Use of stroke care pathways may be associated with positive and negative effects. Since most of the results have been derived from non-randomised studies, they are likely to be influenced by potential biases and confounding factors. There is currently insufficient supporting evidence to justify the routine implementation of care pathways for acute stroke management or stroke rehabilitation.

Plain-language summary: The review found that patients treated within a care pathway may be less likely to suffer some complications (e.g. urine infections), and more likely to have certain tests (e.g. brain scans). However, the use of care pathways may also reduce the patient's likelihood of functioning independently when discharged from hospital, their quality of life, and their satisfaction with hospital care. Currently, there is not enough evidence to justify introducing care pathways for the routine care of all patients with stroke. Further research is needed to find out if care pathways for stroke do more good than harm.
Abstract: Three trials, conducted between 1982 and 1984, met the inclusion criteria (n=17,965). Two trials examined the effect of driver education on licensing. In the trial by Stock (USA) 87% of students in the driver education group obtained their driving licence as compared to 84.3% in the control group (RR 1.04; 95% CI 1.02 to 1.05). In the trial by Wynne-Jones (New Zealand) the time from trial enrolment to licensing was 111 days in males receiving driver education compared with 300 days in males who did not receive driver education, and 105 days in females receiving driver education compared with 415 days in females who did not receive driver education. All three trials examined the effect of driver education on road traffic crashes. In the trial by Strang (Australia), 42% of students in each group had one or more crashes since being licensed (RR 1.01, 95% CI 0.83 to 1.23). In the trial by Stock, the number of students involved in one or more crashes as a driver was 27.5% in the driver education group compared to 26.7% in the control group (RR 1.03; 95% CI 0.98 to 1.09). In the trial by Wynne-Jones, the number of students who experienced crashes was 16% in the driver education group as compared to 14.5% in the control group (RR 1.10; 95% CI 0.76 to 1.59). The results show that driver education leads to early licensing. They provide no evidence that driver education reduces road crash involvement, and suggest that it may lead to a modest but potentially important increase in the proportion of teenagers involved in traffic crashes.

Plain-language summary: The results of this systematic review show that driver education in schools leads to early licensing. They provide no evidence that driver education reduces road crash involvement, and suggest that it may lead to a modest but potentially important increase in the proportion of teenagers involved in traffic crashes.