Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov: A cross-sectional analysis.
Shelley M VanderhoutDean A FergussonJonathan A CookMonica TaljaardPublished in: PLoS medicine (2022)
In this study, we observed that pragmatic trials rarely report patient and public engagement and do not commonly use PROs as primary outcomes. When provided, target differences are often not justified and rarely informed by patients and stakeholders. Research funders, scientific journals, and institutions should support trialists to incorporate patient engagement to fulfill the mandate of pragmatic trials to be patient centered.
Keyphrases
- patient reported outcomes
- end stage renal disease
- study protocol
- case report
- social media
- ejection fraction
- healthcare
- newly diagnosed
- chronic kidney disease
- peritoneal dialysis
- type diabetes
- mental health
- clinical trial
- metabolic syndrome
- systematic review
- adipose tissue
- emergency department
- insulin resistance
- glycemic control