Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention.
OBJECTIVE
We evaluated the usefulness of a simple run-in period to reduce drop-outs in a behavioral intervention to improve blood pressure (BP). In a pilot study where a run-in period was not used, we had a 25% drop-out rate.


METHODS
A prospective evaluation was performed in the context of a blinded 3-arm randomized trial. Participants are eligible if they have uncontrolled BP on 2 consecutive visits. Potential participants are approached during a routine visit, informed, consented and enrolled. After a 1-month run-in period during which all participants receive a phone call to: i) verify phone availability, ii) get basic information on treatment, and iii) confirm the baseline visit, participants return for a baseline visit. They are then randomized to one of the three treatment arms: usual care, non-tailored counseling, or tailored counseling. Participants make return visits at 3, 6 and 12 months.


RESULTS
Of the 1275 potential participants who received detailed study information, 301 consented to participate, of whom 226 were enrolled. During the run-in period, 73 withdrew consent and 153 participants were randomized; 7 subsequently dropped out. There were no differences (p>.1) between the 73 cancelled and the 153 randomized patients. There were fewer drop-outs than in the pilot study (5% vs. 25%, p<.0001).


CONCLUSIONS
The run-in period reduces the number of drop-outs after randomization and improves statistical power. In order to retain external validity, it is important to compare participants who remain in the study and those that cancel, and incorporate that in generalizing from the study.
Ulmer
Michelle
M
VA New York Harbor Healthcare System, New York, NY, USA.
Robinaugh
Donald
D
Friedberg
Jennifer P
JP
Lipsitz
Stuart R
SR
Natarajan
Sundar
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001521:Behavior Therapy; D001794:Blood Pressure; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D013689:Telephone