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Andres Jung; Tobias Braun; Susan Armijo-Olivo; Dimitris Challoumas; Kerstin Luedtke – Research Synthesis Methods, 2024
External validity is an important parameter that needs to be considered for decision making in health research, but no widely accepted measurement tool for the assessment of external validity of randomized controlled trials (RCTs) exists. One of the most limiting factors for creating such a tool is probably the substantial heterogeneity and lack…
Descriptors: Randomized Controlled Trials, Validity, Delphi Technique, Definitions
Kylie E. Hunter; Mason Aberoumand; Sol Libesman; James X. Sotiropoulos; Jonathan G. Williams; Wentao Li; Jannik Aagerup; Ben W. Mol; Rui Wang; Angie Barba; Nipun Shrestha; Angela C. Webster; Anna Lene Seidler – Research Synthesis Methods, 2024
Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting…
Descriptors: Integrity, Randomized Controlled Trials, Data Use, Individual Characteristics
Konstantina Chalkou; Tasnim Hamza; Pascal Benkert; Jens Kuhle; Chiara Zecca; Gabrielle Simoneau; Fabio Pellegrini; Andrea Manca; Matthias Egger; Georgia Salanti – Research Synthesis Methods, 2024
Some patients benefit from a treatment while others may do so less or do not benefit at all. We have previously developed a two-stage network meta-regression prediction model that synthesized randomized trials and evaluates how treatment effects vary across patient characteristics. In this article, we extended this model to combine different…
Descriptors: Medical Research, Outcomes of Treatment, Risk, Randomized Controlled Trials
Tiwonge K. Mtande; Carl Lombard; Gonasagrie Nair; Stuart Rennie – Research Ethics, 2024
Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted…
Descriptors: Stakeholders, Ethics, Randomized Controlled Trials, Medical Research
Norman Porticella; Julie S. Cannon; Chung Li Wu; Stuart G. Ferguson; James F. Thrasher; Emily E. Hackworth; Jeff Niederdeppe – Health Education & Behavior, 2024
Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to…
Descriptors: Recruitment, Disproportionate Representation, Medical Research, Compliance (Psychology)
Srisombat Nawanopparatsakul; Surawut Watana; Theerada Taesotikul; Patamawan Phuagphong; Chatchai Chinpaisal – International Society for Technology, Education, and Science, 2024
One of the essential skills that pharmacy students should develop is the ability to evaluate randomized controlled trials (RCTs) to assess the clinical efficacy and safety of pharmaceuticals. This study aimed to enhance the RCT evaluation skills of fifth-year pharmacy students. It employed the CASP checklist application to assess clinical studies…
Descriptors: Pharmaceutical Education, Skill Development, Randomized Controlled Trials, Medical Students
Emma Law; Isabel Smith – Research Ethics, 2024
During the COVID-19 pandemic, the race to find an effective vaccine or treatment saw an 'extraordinary number' of clinical trials being conducted. While there were some key success stories, not all trials produced results that informed patient care. There was a significant amount of waste in clinical research during the pandemic which is said to…
Descriptors: Ethics, Research Methodology, Integrity, COVID-19