Testing Decision-making Competency of Schizophrenia Participants in Clinical Trials. a Meta-analysis and Meta-regression

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735

Download Full-text

Virologic Response to Tipranavir-Ritonavir or Darunavir-Ritonavir Based Regimens in Antiretroviral Therapy Experienced HIV-1 Patients: A Meta-Analysis and Meta-Regression of Randomized Controlled Clinical Trials

PLoS ONE ◽

10.1371/journal.pone.0060814 ◽

2013 ◽

Vol 8 (4) ◽

pp. e60814 ◽

Cited By ~ 3

Author(s):

Asres Berhan ◽

Yifru Berhan

Keyword(s):

Clinical Trials ◽

Antiretroviral Therapy ◽

Meta Analysis ◽

Virologic Response ◽

Controlled Clinical Trials ◽

Randomized Controlled Clinical Trials ◽

Randomized Controlled ◽

Meta Regression ◽

Hiv 1

Download Full-text

“When offered to participate”: A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.29_suppl.92 ◽

2020 ◽

Vol 38 (29_suppl) ◽

pp. 92-92

Author(s):

Joseph M. Unger ◽

Dawn L. Hershman ◽

Cathee Till ◽

Lori M. Minasian ◽

Raymond U Osarogiagbon ◽

...

Keyword(s):

Systematic Review ◽

Decision Making ◽

Clinical Trials ◽

Meta Analysis ◽

Trial Participation ◽

Participation Rates ◽

Patient Decision Making ◽

Asian Patients ◽

Patient Decision ◽

Black Patients

92 Background: Patient participation in clinical trials (CTs) is vital for knowledge advancement and outcomes improvement. The rate of CT participation for adult cancer patients is between 5%-8%; many CTs fail due to poor accrual. Although patient decision-making is a common focus of studies examining barriers to CT participation, the rate of trial participation for patients actually offered a CT is unknown. Methods: We conducted a systematic review and meta-analysis using PubMed, Web of Science, and Ovid Medline search engines to identify studies over 20 years (1/1/2000-1/1/2020) that examined CT participation. Studies must have been conducted in the United States and specified the number of patients offered a CT and the number enrolled. We conducted a meta-analysis of single proportions using random effects. Rates were examined for both treatment trials and cancer control (CC) studies. We also compared the rates of enrollment between Black, Hispanic, and Asian patients versus White patients. Clinical care setting (academic vs community) was examined as a potential moderator. Results: We screened 3,241 unique citations and identified 35 (30 treatment and 5 CC) studies among which n = 9,759 patients were offered CT participation. Overall, 55.0% (95% CI: 49.4%-60.5%) of patients offered a CT agreed to enroll. Trial participation rates did not differ between treatment (55.0%, 95% CI: 48.9%-60.9%) and CC trials (55.3%, 95% CI: 38.9%-71.1%, p = .98); however, participation rates were significantly higher at academic centers (58.4%, 95% CI: 52.2%-64.5%) versus community centers (45.0%, 95% CI: 34.5%-55.7%, p = .04). In common studies, Black patients agreed to participate at similar rates (58.4%, 95% CI: 46.8%-69.7%) compared to White patients (55.1%, 95% CI: 44.3%-65.6%, p = .88). Results were also similar comparing White versus Hispanic or Asian patients. The main reasons for non-participation were treatment choice or lack of interest. Conclusions: More than half of all cancer patients who are offered CTs do participate; results were consistent between major race/ethnicity groups. This finding upends several conventional beliefs about cancer clinical trial participation, including that Black patients are less likely to agree to participate and that patient decision-making is the primary barrier to participation. Policies and interventions to improve CT participation should focus more on modifiable systemic structural and clinical barriers, such as improving access to existing trials and broadening trial eligibility.

Download Full-text

Effects of Aerobic Training Progression on Blood Pressure in Individuals With Hypertension: A Systematic Review With Meta-Analysis and Meta-Regression

10.21203/rs.3.rs-156120/v1 ◽

2021 ◽

Author(s):

Guilherme Tadeu de Barcelos¹ ◽

Isabel Heberle¹ ◽

Juliana Cavestré Coneglian¹ ◽

Bruno Allan Vieira¹ ◽

Rodrigo Sudatti Delevatti¹ ◽

...

Keyword(s):

Systematic Review ◽

Blood Pressure ◽

Clinical Trials ◽

Systolic Blood Pressure ◽

Aerobic Training ◽

Data Extraction ◽

Meta Analysis ◽

Control Group ◽

Meta Regression ◽

Selection Of

Abstract Objective: To analyze, through a systematic review with meta-analysis, the effects of aerobic training with and without progression on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in hypertensive adults.Method: The search for the studies was carried out in the PubMed, Cochrane Central, SPORTDiscus and LILACS databases. Clinical trials that analyzed the effect of aerobic training, lasting at least six weeks, on blood pressure in hypertensive individuals comparing with a control group without intervention were selected. The selection of studies and data extraction were carried out independently by two pairs of researchers. Results: Of the 13028 studies found, 24 were selected and included in this review. There was a reduction in SBP after aerobic training with progression (-10.67 mmHg; 95% CI -15.421, -5.926; p <0.001) and without progression (-10.17 mmHg; CI -12.213, -8.120; p <0.001). DBP also decreased after aerobic training with progression (-5.49 mmHg; 95% CI -8.663, -2.310; p <0.001) and without progression (-6.51 mmHg; 95% CI -9.147, -3.868; p < 0.001). Conclusion: Aerobic training promotes a reduction in the SBP and DBP levels of adults with hypertension, regardless of whether or not the training variables progression.

Download Full-text