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78,509 result(s) for "randomized controlled-trial"
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Lawmakers’ use of scientific evidence can be improved
Core to the goal of scientific exploration is the opportunity to guide future decision-making. Yet, elected officials often miss opportunities to use science in their policymaking. This work reports on an experiment with the US Congress—evaluating the effects of a randomized, dual-population (i.e., researchers and congressional offices) outreach model for supporting legislative use of research evidence regarding child and family policy issues. In this experiment, we found that congressional offices randomized to the intervention reported greater value of research for understanding issues than the control group following implementation. More research use was also observed in legislation introduced by the intervention group. Further, we found that researchers randomized to the intervention advanced their own policy knowledge and engagement as well as reported benefits for their research following implementation.
Association between type 2 diabetes and risk of cancer mortality: a pooled analysis of over 771,000 individuals in the Asia Cohort Consortium
Aims/hypothesis The aims of the study were to evaluate the association between type 2 diabetes and the risk of death from any cancer and specific cancers in East and South Asians. Methods Pooled analyses were conducted of 19 prospective population-based cohorts included in the Asia Cohort Consortium, comprising data from 658,611 East Asians and 112,686 South Asians. HRs were used to compare individuals with diabetes at baseline with those without diabetes for the risk of death from any cancer and from site-specific cancers, including cancers of the oesophagus, stomach, colorectum, colon, rectum, liver, bile duct, pancreas, lung, breast, endometrium, cervix, ovary, prostate, bladder, kidney and thyroid, as well as lymphoma and leukaemia. Results During a mean follow-up of 12.7 years, 37,343 cancer deaths (36,667 in East Asians and 676 in South Asians) were identified. Baseline diabetes status was statistically significantly associated with an increased risk of death from any cancer (HR 1.26; 95% CI 1.21, 1.31). Significant positive associations with diabetes were observed for cancers of the colorectum (HR 1.41; 95% CI 1.26, 1.57), liver (HR 2.05; 95% CI 1.77, 2.38), bile duct (HR 1.41; 95% CI 1.04, 1.92), gallbladder (HR 1.33; 95% CI 1.10, 1.61), pancreas (HR 1.53; 95% CI 1.32, 1.77), breast (HR 1.72; 95% CI 1.34, 2.19), endometrium (HR 2.73; 95% CI 1.53, 4.85), ovary (HR 1.60; 95% CI 1.06, 2.42), prostate (HR 1.41; 95% CI 1.09, 1.82), kidney (HR 1.84; 95% CI 1.28, 2.64) and thyroid (HR 1.99; 95% CI 1.03, 3.86), as well as lymphoma (HR 1.39; 95% CI 1.04, 1.86). Diabetes was not statistically significantly associated with the risk of death from leukaemia and cancers of the bladder, cervix, oesophagus, stomach and lung. Conclusions/interpretation Diabetes was associated with a 26% increased risk of death from any cancer in Asians. The pattern of associations with specific cancers suggests the need for better control (prevention, detection, management) of the growing epidemic of diabetes (as well as obesity), in order to reduce cancer mortality.
Unknown confounders did not bias the treatment effect when improving balance of known confounders in randomized trials
The objective of the study was to measure if improving balance in known and observed confounders by propensity score (PS) matching yields different treatment effect estimates in randomized controlled trials (RCTs), thus indirectly measuring the influence of unknown confounders. This is an analysis of individual patient data of 26 large RCTs and comparison of agreement between PS-matched samples and the RCT results on one hand with the agreement between subsamples of RCTs (with sample sizes equal to the sample sizes of the PS-matched samples) and RCTs by Bland-Altman plots and corresponding intraclass correlation coefficients on the other. We included data on 213 outcomes from 37 treatment comparisons with 193,620 patients from 26 trials. Bland-Altman plots and intraclass correlation coefficients showed better agreement between PS-matched analysis and RCTs than between reduced RCTs and RCTs. We found no indication for a detrimental influence of unknown confounders in PS-matched samples of RCTs.
Physical activity can improve cognition in patients with Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials
Alzheimer's disease (AD) is mainly characterized by decline of cognitive functions such as memory and learning, which has a high prevalence and poor drug efficacy in treatment regimes. A systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted to evaluate the effectiveness of exercise on cognitive function in patients diagnosed with AD. The bibliographic databases (PubMed, Cochrane Library and Embase, and Web of Science) and four Chinese databases (Wanfang data, CBM, CNKI, and VIP) were searched to identify RCTs published in any language between January 1, 1960, and January 1, 2018. Only peer-reviewed articles and RCTs were included. The collected data were analyzed by Review Manager (5.3). Overall, 869 patients diagnosed with AD were included from 13 RCTs. Patients in the intervention group received pure exercise interventions and a cognitive test. Although there was heterogeneity in intervention methods and cognitive measures among studies, meta-analysis (seven studies) supports positive effects of physical activity on cognitive function of patients with AD (mean difference [MD] =2.53, the 95% CI=0.84 to 4.22, test for overall effect: =2.93 [ =0.003]). Eight studies demonstrated that exercise improves cognitive function for individuals with AD. However, the remaining five studies did not display a beneficial effect of exercise on cognitive function in patients with AD. This meta-analysis and systematic review indicated that exercise intervention might improve the cognitive function of AD or slow down the decline of cognition; however, this relationship was not always true across studies. RCTs with clear intervention criteria, large samples, and long-term follow-up are needed in the future to demonstrate the benefits of exercise for cognitive function in AD patients.
Effects of improved information and volunteer support on segregation of solid waste at the household level in urban settings in Madhya Pradesh, India (I-MISS): protocol of a cluster randomized controlled trial
Background Segregation of household waste at the source is an effective and sustainable strategy for management of municipal waste. However, household segregation levels remain insufficient as waste management approaches are mostly top down and lack local support. The realisation and recognition of effective, improved and adequate waste management may be one of the vital drivers for attaining environmental protection and improved health and well-being. The presence of a local level motivator may promote household waste segregation and ultimately pro-environmental behaviour. The present cluster randomized control trial aims to understand if volunteer based information on waste segregation (I-MISS) can effectively promote increased waste segregation practices at the household level when compared with existing routine waste segregation information in an urban Indian setting. Methods This paper describes the protocol of an 18 month two-group parallel,cluster randomised controlled trialin the urban setting of Ujjain, Madhya Pradesh, India. Randomization will be conducted at ward level, which is the last administrative unit of the municipality. The study will recruit 425 households in intervention and control groups. Assessments will be performed at baseline (0 months), midline (6 months), end line (12 months) and post intervention (18 months). The primary outcome will be the comparison of change in proportion of households practicing waste segregation and change in proportion of mis-sorted waste across the study period between the intervention and control groups as assessed by pick analysis. Intention to treat analysis will be conducted. Written informed consent will be obtained from all participants. Discussion The present study is designed to study whether an external motivator, a volunteer selected from the participating community and empowered with adequate training, could disseminate waste segregation information to their community, thus promoting household waste segregation and ultimately pro-environmental behaviour. The study envisages that the volunteers could link waste management service providers and the community, give a local perspective to waste management, and help to change community habits through information, constant communication and feedback. Trial registration The study is registered prospectively with Indian Council of Medical Research- Clinical Trial Registry of India ( CTRI/2020/03/024278 ).
Common Methodological Problems in Randomized Controlled Trials of Preventive Interventions
Randomized controlled trials (RCTs) are often considered the gold standard in evaluating whether intervention results are in line with causal claims of beneficial effects. However, given that poor design and incorrect analysis may lead to biased outcomes, simply employing an RCT is not enough to say an intervention “works.” This paper applies a subset of the Society for Prevention Research (SPR) Standards of Evidence for Efficacy, Effectiveness, and Scale-up Research, with a focus on internal validity (making causal inferences) to determine the degree to which RCTs of preventive interventions are well-designed and analyzed, and whether authors provide a clear description of the methods used to report their study findings. We conducted a descriptive analysis of 851 RCTs published from 2010 to 2020 and reviewed by the Blueprints for Healthy Youth Development web-based registry of scientifically proven and scalable interventions. We used Blueprints’ evaluation criteria that correspond to a subset of SPR’s standards of evidence. Only 22% of the sample satisfied important criteria for minimizing biases that threaten internal validity. Overall, we identified an average of 1–2 methodological weaknesses per RCT. The most frequent sources of bias were problems related to baseline non-equivalence (i.e., differences between conditions at randomization) or differential attrition (i.e., differences between completers versus attritors or differences between study conditions that may compromise the randomization). Additionally, over half the sample (51%) had missing or incomplete tests to rule out these potential sources of bias. Most preventive intervention RCTs need improvement in rigor to permit causal inference claims that an intervention is effective. Researchers also must improve reporting of methods and results to fully assess methodological quality. These advancements will increase the usefulness of preventive interventions by ensuring the credibility and usability of RCT findings.
Effectiveness of E-Self-help Interventions for Curbing Adult Problem Drinking: A Meta-analysis
Self-help interventions without professional contact to curb adult problem drinking in the community are increasingly being delivered via the Internet. The objective of this meta-analysis was to assess the overall effectiveness of these eHealth interventions. In all, 9 randomized controlled trials (RCTs), all from high-income countries, with 9 comparison conditions and a total of 1553 participants, were identified, and their combined effectiveness in reducing alcohol consumption was evaluated by means of a meta-analysis. An overall medium effect size (g = 0.44, 95% CI 0.17-0.71, random effect model) was found for the 9 studies, all of which compared no-contact interventions to control conditions. The medium effect was maintained (g = 0.39; 95% CI 0.23-0.57, random effect model) after exclusion of two outliers. Type of control group, treatment location, type of analysis, and sample size did not have differential impacts on treatment outcome. A significant difference (P = .04) emerged between single-session personalized normative feedback interventions (g = 0.27, 95% CI 0.11-0.43) and more extended e- self-help (g = 0.61, 95% CI 0.33-0.90). E-self-help interventions without professional contact are effective in curbing adult problem drinking in high-income countries. In view of the easy scalability and low dissemination costs of such interventions, we recommend exploration of whether these could broaden the scope of effective public health interventions in low- and middle-income countries as well.
DURABILITY OF THE ANTIDEPRESSANT EFFECT OF THE HIGH-FREQUENCY REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (rTMS) IN THE ABSENCE OF MAINTENANCE TREATMENT IN MAJOR DEPRESSION: A SYSTEMATIC REVIEW AND META-ANALYSIS OF 16 DOUBLE-BLIND, RANDOMIZED, SHAM-CONTROLLED TRIALS
Background The aim of the current meta‐analysis was to investigate predictors of the durability of the antidepressant effect of high‐frequency (>1 Hz) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex in the absence of active maintenance treatment. Methods Following a systematic literature search of Medline and PsycInfo, N = 16 double‐blind, parallel‐design, randomized‐controlled trials (RCTs) with high‐frequency rTMS and inactive sham were included in the current meta‐analysis. The effect size (Cohen's d) was the standardized mean difference in depression scores between sham and rTMS groups (baseline –follow‐up). Meta‐analysis was conducted according to a random‐effects model with inverse‐variance weights. Results Most RCTs reported only short follow‐up phases of 2 weeks (range of 1–16 weeks). The antidepressant effect was observed during follow‐up (in the absence of maintenance treatment) compared to baseline (overall mean weighted d = –.48, 95% confidence interval: –.70, –.25, P < .001, N = 16 RCTs with 495 patients). Such an antidepressant effect during follow‐up was higher in RCTs with patients who were less severely ill, unipolar, nonpsychotic, treatment‐resistant, and on antidepressants (either started with rTMS or continued at stable doses during acute treatment phases). The effect sizes were lower in RCTs with longer (8–16 weeks) compared to shorter (1–4 weeks) follow‐up periods. The risk of publication bias was low. Conclusions High‐frequency rTMS has only a small antidepressant effect during follow‐up after short acute treatment (5–15 sessions) in the absence of active maintenance treatment. This effect depends on illness severity, decreases over time, and appears to be enhanced by antidepressants.
Neurosurgical Randomized Controlled Trials—Distance Travelled
Abstract BACKGROUND The evidence base for many neurosurgical procedures has been limited. We performed a comprehensive and systematic analysis of study design, quality of reporting, and trial results of neurosurgical randomized controlled trials (RCTs). OBJECTIVE To systematically assess the design and quality characteristics of neurosurgical RCTs. METHODS From January 1961 to June 2016, RCTs with >5 patients assessing any 1 neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. RESULTS The median sample size in the 401 eligible RCTs was 73 patients with a mean patient age of 49.6. Only 111 trials (27.1%) described allocation concealment, 140 (34.6%) provided power calculations, and 117 (28.9%) were adequately powered. Significant efficacy or trend for efficacy was claimed in 226 reports (56.4%), no difference between the procedures was found in 166 trials (41.4%), and significant harm was reported in 9 trials (2.2%). Trials with a larger sample size were more likely to report randomization mode, specify allocation concealment, and power calculations (all P < .001). Government funding was associated with better specification of power calculations (P = .008) and of allocation concealment (P = .026), while industry funding was associated with reporting significant efficacy (P = .02). Reporting of funding, specification of randomization mode and primary outcomes, and mention of power calculations improved significantly (all, P < .05) over time. CONCLUSION Several aspects of the design and reporting of RCTs on neurosurgical procedures have improved over time. Better powered and accurately reported trials are needed in neurosurgery to deliver evidence-based care and achieve optimal outcomes.
Effect of Workplace-Versus Home-based Physical Exercise on Musculoskeletal Pain among Healthcare Workers: A Cluster Randomized Controlled Trial
Objective Numerous studies has shown that regular physical exercise can reduce musculoskeletal pain, but the optimal setting to achieve high adherence and effectiveness remains unknown. This study investigated the effect of workplace versus home-based physical exercise on musculoskeletal pain among healthcare workers. Methods The randomized controlled trial (RCT) comprised 200 female healthcare workers from 18 departments at 3 hospitals. Participants were randomly allocated at the cluster level to ten weeks of: (i) workplace physical exercise (WORK) performed during working hours for 5×10 minutes per week and up to 5 group-based coaching sessions on motivation for regular physical exercise, or (ii) home-based physical exercise (HOME) performed during leisure time for 5×10 minutes per week. Both groups received ergonomic counseling on patient handling and use of lifting aides. Average pain intensity (0–10 scale) in the low back and neck/shoulder was the primary outcome. Results Per week, 2.2 (SD 1.1) and 1.0 (SD 1.2) training sessions were performed in WORK and HOME groups, respectively. Pain intensity, back muscle strength and use of analgesics improved more following WORK than HOME (P<0.05). Between-group differences at follow-up (WORK versus HOME) was −0.7 points for pain intensity [95% confidence interval (95% CI) −1.0–−0.3], 5.5 Nm for back muscle strength (95% CI 2.0–9.0), and −0.4 days per week for use of analgesics (95% CI −0.7–−0.2). The effect size for between-group differences in pain intensity was small (Cohen's d=0.31). Conclusions Workplace physical exercise is more effective than home-based exercise in reducing musculoskeletal pain, increasing muscle strength and reducing the use of analgesics among healthcare workers.