A series of eight papers has been published in the Journal of Clinical Epidemiology. In this series we integrate the theoretical design options with the practice of conducting pragmatic trials. Each paper focuses on a specific trial area such as patient selection and recruitment or the choice of comparator. For each of these areas, we discuss the pragmatic design choices; their specific operational challenges and the impact on operational feasibility and (ethical) acceptability of the trial; as well as generalisability, validity, and precision of the trial findings.
- Introduction - Introduction: Pragmatic trials and Real World Evidence
- Site - Selection and inclusion of usual care sites
- Participant - Participant eligibility, recruitment and retention
- Informed Consent - Challenges of informed consent
- Comparator - Questions, comparators and treatment strategies
- Outcome - Outcome selection and measurement
- Safety & Quality - Monitoring safety and trial conduct
- Data - Data collection