PragMagic

Pragmatic Trial resources

PRAGMATIC TRIAL PAPER SERIES

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.

  1. Introduction - Introduction: Pragmatic trials and Real World Evidence
  2. Site - Selection and inclusion of usual care sites
  3. Participant - Participant eligibility, recruitment and retention
  4. Informed Consent - Challenges of informed consent
  5. Comparator - Questions, comparators and treatment strategies
  6. Outcome - Outcome selection and measurement
  7. Safety & Quality - Monitoring safety and trial conduct
  8. Data - Data collection

OTHER GETREAL WORKPACKAGE 3 PUBLICATIONS

Work package 3 of the IMI GetReal project is aiming to provide guidance and tools to help pragmatic trial designers be aware of practical consequences of their choices and maximize the pragmatic nature of the study design while ensuring operational feasibility. This will assist in making use of the full potential of pragmatic trials conducted in clinical practice.

Below you can find a list of publications which were written as part of GetReal Workpackage 3, and do not belong to the Pragmatic Trial Paper Series.