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.
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.
Authors: Kevin E Thorpe; Merrick Zwarenstein; Andrew D Oxman; Shaun Treweek; Curt D Furberg; Douglas G Altman; Sean Tunis; Eduardo Bergel; Ian Harvey; David J Magid; Kalipso Chalkidou Journal: J Clin Epidemiol Date: 2009-05 Impact factor: 6.437
Authors: Paul J Karanicolas; Victor M Montori; P J Devereaux; Holger Schünemann; Gordon H Guyatt Journal: J Clin Epidemiol Date: 2009-05 Impact factor: 6.437
Authors: Paul J Karanicolas; Victor M Montori; P J Devereaux; Holger Schünemann; Gordon H Guyatt Journal: J Clin Epidemiol Date: 2008-05-12 Impact factor: 6.437
Authors: Michael A Sanchez; Borsika A Rabin; Bridget Gaglio; Michelle Henton; M Khair Elzarrad; Peyton Purcell; Russell E Glasgow Journal: Transl Behav Med Date: 2013-12 Impact factor: 3.046
Authors: Daniel J Bratton; Andrew J Nunn; Fenella Wojnarowska; Gudula Kirtschig; Anna Sandell; Hywel C Williams Journal: Trials Date: 2012-04-27 Impact factor: 2.279
Authors: Daniel L Riddle; James Slover; Francis J Keefe; Dennis C Ang; Levent Dumenci; Robert A Perera Journal: Arthritis Care Res (Hoboken) Date: 2021-06 Impact factor: 5.178