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Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review.

ABSTRACT: Importance:Racial/ethnic minority groups, women, and elderly people experience a disproportionate burden of disease in rheumatoid arthritis (RA), making it particularly important to examine drug therapies in these populations. Despite a national health agenda to improve representation of diverse populations in randomized clinical trials (RCTs), there have been few large-scale analyses examining RCT demographic characteristics within rheumatology and none focusing on RA. Objective:To characterize the representation of racial/ethnic minority groups, women, and elderly people through a comprehensive systematic review of RA RCTs. Data Sources:A literature search of PubMed's MEDLINE database was conducted to identify RA RCTs in adults 19 years and older published in English between January 1, 2008, and January 1, 2018. Study Selection:Randomized double-blind RCTs examining any systemic, disease-modifying therapy were included. Secondary analyses of previously published RCTs were excluded. Of 1195 identified records, 240 articles (20.1%) met final selection criteria. The analysis focused on RCTs with at least 1 US-based site. Data Extraction and Synthesis:Data were extracted and synthesized according to the PRISMA guidelines for systematic reviews. Studies were screened for eligibility criteria. Demographic data on the age, sex, and race/ethnicity of RCT participants were extracted. Data analysis was conducted from October 25, 2018, to March 15, 2019. Main Outcomes and Measures:Representation of race/ethnicity and sex, defined as the proportion of total participants that belonged to each racial/ethnic group or sex. Trends in proportions over time were examined and compared with US demographic data. Results:A total of 240 RCTs with 77?071 participants were included. Of 126 RCTs with at least 1 US-based site (52.5%), the enrollment of minority racial/ethnic groups was significantly lower than their representation within the US Census population (16% vs 40%; P?

SUBMITTER: Strait A

PROVIDER: S-EPMC6902779 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review.

Strait Adrienne A Castillo Francine F Choden Sonam S Li Jing J Whitaker Evans E Falasinnu Titilola T Schmajuk Gabriela G Yazdany Jinoos J

JAMA network open 20191101 11

<h4>Importance</h4>Racial/ethnic minority groups, women, and elderly people experience a disproportionate burden of disease in rheumatoid arthritis (RA), making it particularly important to examine drug therapies in these populations. Despite a national health agenda to improve representation of diverse populations in randomized clinical trials (RCTs), there have been few large-scale analyses examining RCT demographic characteristics within rheumatology and none focusing on RA.<h4>Objective</h4> ...[more]

PMID: 31722023

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Project description:We aimed to provide a systematic review and meta-analysis of randomized controlled trials assessing the effect of probiotics supplementation on symptoms and disease activity in patients with chronic inflammatory rheumatic diseases (rheumatoid arthritis (RA), spondylarthritis (SpA), or psoriatic arthritis). A systematic literature review and meta-analysis from RA and SpA randomized controlled trials were conducted searching for articles in MEDLINE/PubMed and abstracts from recent international rheumatology meetings. The control group was a placebo or another dietary intervention. The risk of bias of the selected studies was evaluated using the Cochrane Collaboration tool and the Jadad scale. The initial search yielded 173 articles. Of these, 13 studies were included in the qualitative synthesis, 8 concerning a total of 344 RA patients and 2 concerning a total of 197 SpA patients. Three meta-analyses were also analyzed. Probiotic strains and quantities used were different among trials (5 studies using Lactobacillus sp., 1 trial Bacillus coagulans and the others a mix of different probiotic strains). Time to assess response ranged from 8 weeks to one year. Two studies associated probiotic supplementation with a dietary intervention. Meta-analysis showed a statistically significant decrease of C-reactive protein (CRP) concentration (mean difference (MD)) -3.04 (95% CI -4.47, -1.62) mg/L, p < 0.001; I2 = 20%, n patients = 209) with probiotics in RA. However, after excluding high-risk-of-bias trials of meta-analysis, there was no difference between probiotics and placebo on DAS28 (standard MD -0.54; 95% CI -1.94 to 0.85, p = 0.45, I2 93%, n patients = 143). The two studies on SpA patients showed no efficacy of probiotics. Probiotic supplementation might decrease RA activity with a moderate decrease effect on CRP, but lack of evidence and studies' heterogeneity do not allow us to propose them to patients with inflammatory arthritis to control their disease. Further RCTs are required in the future to determinate the efficacy of probiotics and the optimal administration design.

Project description:ImportanceRandomized clinical trials (RCTs) provide the highest level of evidence to evaluate 2 or more surgical interventions. Surgical RCTs, however, face unique challenges in design and implementation.ObjectiveTo evaluate the design, conduct, and reporting of contemporary surgical RCTs.Evidence reviewA literature search performed in the 2 journals with the highest impact factor in general medicine as well as 6 key surgical specialties was conducted to identify RCTs published between 2008 and 2020. All RCTs describing a surgical intervention in both experimental and control arms were included. The quality of included data was assessed by establishing an a priori protocol containing all the details to extract. Trial characteristics, fragility index, risk of bias (Cochrane Risk of Bias 2 Tool), pragmatism (Pragmatic Explanatory Continuum Indicator Summary 2 [PRECIS-2]), and reporting bias were assessed.FindingsA total of 388 trials were identified. Of them, 242 (62.4%) were registered; discrepancies with the published protocol were identified in 81 (33.5%). Most trials used superiority design (329 [84.8%]), and intention-to-treat as primary analysis (221 [56.9%]) and were designed to detect a large treatment effect (50.0%; interquartile range [IQR], 24.7%-63.3%). Only 123 trials (31.7%) used major clinical events as the primary outcome. Most trials (303 [78.1%]) did not control for surgeon experience; only 17 trials (4.4%) assessed the quality of the intervention. The median sample size was 122 patients (IQR, 70-245 patients). The median follow-up was 24 months (IQR, 12.0-32.0 months). Most trials (211 [54.4%]) had some concern of bias and 91 (23.5%) had high risk of bias. The mean (SD) PRECIS-2 score was 3.52 (0.65) and increased significantly over the study period. Most trials (212 [54.6%]) reported a neutral result; reporting bias was identified in 109 of 211 (51.7%). The median fragility index was 3.0 (IQR, 1.0-6.0). Multiplicity was detected in 175 trials (45.1%), and only 35 (20.0%) adjusted for multiple comparisons.Conclusions and relevanceIn this systematic review, the size of contemporary surgical trials was small and the focus was on minor clinical events. Trial registration remained suboptimal and discrepancies with the published protocol and reporting bias were frequent. Few trials controlled for surgeon experience or assessed the quality of the intervention.

Project description:Importance:Randomized clinical trials (RCTs) of lipid-lowering therapies form the evidence base for national and international guidelines. However, concerns exist that women and older patients are underrepresented in RCTs. Objective:To determine the trends of representation of women and older patients (?65 years) in RCTs of lipid-lowering therapies from 1990 to 2018. Data Sources:The electronic databases of MEDLINE and ClinicalTrials.gov were searched from January 1990 through December 2018. Study Selection:RCTs of lipid-lowering therapies with sample sizes of at least 1000 patients and follow-up periods of at least 1 year were included. Data Extraction and Synthesis:Two independent investigators abstracted the data on a standard data collection form. Main Outcomes and Measures:Patterns of representation of women and older adults were examined overall in lipid-lowering RCTs and according to RCT-level specific characteristics. The participation-to-prevalence ratio (PPR) metric was used to estimate the representation of women compared with their share of disease burden. Results:A total of 60 RCTs with 485?409 participants were included. The median (interquartile range) number of participants per trial was 5264 (1062-27?564). Overall, representation of women was 28.5% (95% CI, 24.4%-32.4%). There was an increase in the enrollment of women from the period 1990 to 1994 (19.5%; 95% CI, 18.4%-20.5%) to the period 2015 to 2018 (33.6%; 95% CI, 33.4%-33.8%) (P for trend?=?.01). Among common limiting factors were inclusion of only postmenopausal women or surgically sterile women (28.3%; 95% CI, 18.5%-40.7%) or exclusion of pregnant (23.3%; 95% CI, 14.4%-35.4%) and lactating (16.6%; 95% CI, 9.3%-28.1%) women. Women were underrepresented compared with their disease burden in lipid RCTs of diabetes (PPR, 0.74), heart failure (PPR, 0.27), stable coronary heart disease (PPR, 0.48), and acute coronary syndrome (PPR, 0.51). Only 23 RCTs with 263?628 participants reported the proportion of older participants. Overall representation of older participants was 46.7% (95% CI, 46.5%-46.9%), which numerically increased from 31.6% (95% CI, 30.8%-32.3%) in the period 1995 to 1998 to 46.2% (95% CI, 46.0%-46.5%) in the period 2015 to 2018 (P for trend?=?.43). A total of 53.0% (95% CI, 41.8%-65.3%) and 36.6% (95% CI, 25.6% to 49.3%) trials reported outcomes according to sex and older participants, respectively, which did not improve over time. Conclusions and Relevance:In this systematic review of RCTs of lipid-lowering therapies, the enrollment of women and older participants increased over time, but women and older participants remained consistently underrepresented. This limits the evidence base for efficacy and safety in these subgroups.

Project description:ObjectiveAcupuncture has been used by rehabilitation specialists as an adjunctive treatment for the symptomatic treatment of rheumatoid arthritis (RA). This meta-analysis aims to evaluate the efficacy of acupuncture in treating patients with RA.MethodsA comprehensive search was conducted in CBM, CNKI, PubMed, CENTRAL, Web of Science, and Embase from their inception up to March 2022. All randomized controlled trials (RCTs) without the language restriction, concerning the patients with RA treated with acupuncture, were included. Two reviewers independently assessed the risk of bias with the Cochrane Risk of Bias Assessment tool. Weight mean difference (MD) and 95% CI were calculated, and data were pooled with random effects model.ResultsA total of eleven RCTs involving 796 patients with RA met the established inclusion criteria. This systematic review indicated the efficacy of acupuncture as an adjunctive treatment for patients with RA. Invasive acupuncture could reduce significantly in pain (MD = -1.00, 95% CI: -1.96 to -0.05, P=0.040), health assessment questionnaire (HAQ, MD = -0.20, 95% CI: -0.30 to -0.11, P < 0.001), physician global assessment (PhGA, MD = -0.98, 95% CI: -1.23 to -0.72, P < 0.001), tender joint count (TJC, MD = -1.24, 95% CI: -2.11 to -0.37, P=0.005), C-reactive protein (CRP, MD = -1.81, 95% CI: -3.32 to -0.29, P=0.019), and erythrocyte sedimentation rate (ESR, MD = -3.03, 95% CI: -5.80 to -0.26, P=0.032), while compared to control group. Laser acupuncture could reduce HAQ (MD = -0.15, 95% CI: -0.28 to -0.01, P=0.034), the RA quality of life questionnaire (RAQoL, MD = -2.32, 95% CI: -4.40 to -0.25, P=0.028), CRP (MD = -35.24, 95% CI: -36.49 to -33.99, P < 0.001), and interleukin-6 (IL-6, MD = -29.63, 95% CI: -49.34 to -9.92, P=0.003), while compared to control group. No adverse events associated with acupuncture were reported.ConclusionAvailable evidence suggests that acupuncture is beneficial for relieving pain and ameliorating quality of life and health index in patients with RA; thereby, it should be available as an adjunctive nonpharmacological treatment in rehabilitation programmes.

Dataset Information

Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review.

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Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review.

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