The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) instrument was useful for refining a randomized trial design: experiences from an investigative team.

Published

Journal Article

OBJECTIVE: A recently published instrument (PRECIS) was designed to assist investigative teams in understanding the various design decisions that need to be made regarding pragmatic vs. explanatory trials. Our team used this instrument during an investigators' meeting to organize our discussion regarding the design of a planned trial and to determine the extent of consensus among the study investigators. STUDY DESIGN AND SETTING: The study was descriptive in nature and occurred during an investigator meeting. After reading and reviewing the 10 PRECIS criteria, the team made quantitative judgments of the planned study regarding each PRECIS criteria to reflect initial, ideal, and final study design perceptions. RESULTS: Data indicated that the final study design was more explanatory in nature than the preliminary plan. Evidence of consensus was obtained. CONCLUSION: The investigative team found that applying PRECIS principles were useful for (1) detailing points of discussion related to trial design, (2) making revisions to the design to be consistent with the project goals, and (3) achieving consensus. We believe our experiences with PRECIS may prove valuable for trial researchers in much the same way that case reports can provide valuable insights for clinicians.

Full Text

Duke Authors

Cited Authors

  • Riddle, DL; Johnson, RE; Jensen, MP; Keefe, FJ; Kroenke, K; Bair, MJ; Ang, DC

Published Date

  • November 2010

Published In

Volume / Issue

  • 63 / 11

Start / End Page

  • 1271 - 1275

PubMed ID

  • 20670911

Pubmed Central ID

  • 20670911

Electronic International Standard Serial Number (EISSN)

  • 1878-5921

Digital Object Identifier (DOI)

  • 10.1016/j.jclinepi.2010.03.006

Language

  • eng

Conference Location

  • United States