Historically, authors reporting the results of randomized clinical trials (RCTs) to address mental health problems have insufficiently described sample characteristics pertaining to the ethnic/racial, linguistic, socioeconomic, and immigrant backgrounds of participants. RCTs have also had inadequate representation of participants from diverse backgrounds. This study reports on the trends in the reporting and representation of various sample demographic characteristics in RCTs of psychotherapy and other psychosocial interventions for depression over a 36-year period, and on the extent to which ethnicity, in particular, is considered in the analyses of treatment effects. A total of 342 trials (85.1% comprised of adult samples), representing 61,283 participants, are summarized in the review. Reporting for ethnicity and socioeconomic indicators improved over time, and RCTs for depression have also increasingly included significant numbers of ethnic minority and low-income groups. However, trials are far more likely to exclude, rather than include, linguistic minorities, and have not enrolled a meaningful number of Asian American, Native Hawaiian/Pacific Islander, Native American/Native Alaskan and multi-ethnic participants. Finally, treatment effects are almost never presented separately across racial/ethnic groups and ethnicity moderation analyses are only sporadically conducted. These findings have implications for generalizability, policy, journal reporting guidelines, and dissemination and implementation.
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http://dx.doi.org/10.1016/j.cpr.2018.09.004 | DOI Listing |
: Dual-pathway inhibition (DPI) with aspirin and rivaroxaban exhibited a net clinical benefit for patients with cardiovascular disease in the randomized COMPASS trial. The non-observational, international XATOA registry showed that the COMPASS results can be reproduced in clinical practice in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). Here we report patient characteristics and clinical outcomes for the subgroup of German PAD patients of the XATOA registry and compare them to COMPASS PAD patients.
View Article and Find Full Text PDFInt J Ment Health Nurs
February 2025
Department of Paediatrics, The First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, China.
Simulation-based training in mental health is increasingly recognised as an effective tool within nursing education. This systematic review and meta-analysis aimed to evaluate the effectiveness of various simulation modalities, including standardised participants (SPs), role-plays, virtual reality (VR), mannequins and voice simulations, in improving educational outcomes for nursing students. A comprehensive literature search was conducted to identify studies evaluating the impact of mental health simulation on nursing education.
View Article and Find Full Text PDFClin Trials
January 2025
Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Background/aims: When conducting a randomised controlled trial in surgery, it is important to consider surgical learning, where surgeons' familiarity with one, or both, of the interventions increases during the trial. If present, learning may compromise trial validity. We demonstrate a statistical investigation into surgical learning within a trial of cleft palate repair.
View Article and Find Full Text PDFCommunity Dent Oral Epidemiol
January 2025
School of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Aim: To explore the views of patients, caregivers, and dental professionals on the factors that influence implementation, processes, and effectiveness of a guided self-help cognitive behavioural therapy (CBT) intervention, 'Your teeth, you are in control' (YTYAIC), in the CALM trial.
Methods: Semi-structured interviews were conducted as part of this qualitative component of the process evaluation, and data were analysed using a framework approach based on the Consolidated Framework for Implementation Research (CFIR) and the Five Areas Model of CBT.
Results: Thirty-seven participants were recruited.
Endocr Metab Immune Disord Drug Targets
January 2025
Sheba Medical Center, Institute of Endocrinology, Tel-Hashomer, Israel.
SGLT2 inhibitors are a family of drugs that were developed to treat diabetes mellitus. In randomized controlled trials, SGLT2 inhibitors seem to prevent kidney deterioration in patients with nephropathies, both diabetic and non-diabetic. However, in contrast to biochemical/physiological results (proteinuria and serum creatinine levels) that improve in all studies, the clinical results (all-cause mortality, cardiovascular death, need for dialysis, or renal transplant) do not consistently improve.
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