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


METHODS
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.


CONCLUSIONS
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.
Riddle
Daniel L
DL
Departments of Physical Therapy and Orthopaedic Surgery, Virginia Commonwealth University, Richmond, VA, USA. dlriddle@vcu.edu
Johnson
Robert E
RE
Jensen
Mark P
MP
Keefe
Francis J
FJ
Kroenke
Kurt
K
Bair
Matthew J
MJ
Ang
Dennis C
DC
D019645:Arthroplasty, Replacement, Knee / Q000706:statistics & numerical data*; D003661:Decision Support Techniques; D019983:Guideline Adherence; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design