Premium
The use of a run‐in to enhance compliance
Author(s) -
Lang Janet M.
Publication year - 1990
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780090115
Subject(s) - blinding , randomization , protocol (science) , computer science , compliance (psychology) , medicine , randomized controlled trial , alternative medicine , psychology , surgery , pathology , social psychology
With a run‐in, potential subjects are given practice with all or part of the study protocol prior to randomization. The purpose is to exclude poor compliers from the trial and randomize only proven, good compliers. The feasibility of a run‐in and the net benefit derived from that strategy depend upon the difficulty of the protocol; the availability of compliance aids during the trial; and the impact of the chosen common practices for all subjects during the run‐in on the post‐randomization event rates of the groups and the post‐randomization blinding of study subjects to their treatment assignments. Two detailed examples of the use of a run‐in are presented along with six general recommendations to guide the use of a run‐in.