Cluster randomized trials: opportunities and barriers identified by leaders of eight health plans.
BACKGROUND
Cluster randomized trials (CRTs) offer unique advantages over standard randomized controlled clinical trials (RCTs) and observational methodologies, and may provide a cost-efficient alternative for answering questions about the best treatments for common conditions.


OBJECTIVE
To describe health plan leaders' views on CRTs, identify barriers to conducting CRTs, and solicit recommendations for increasing the acceptability of CRTs.


METHODS
Qualitative in-depth telephone interviews with leaders from 8 health plans.


METHODS
: Thirty-four health plan leaders (medical directors, pharmacy directors, Institutional Review Board leaders, ethics leaders, compliance leaders, and others).


METHODS
Qualitative analysis of interview transcripts to identify barriers, factors influencing leaders' views, ethical issues, aspects of CRTs that appeal to leaders, and recommendations for increasing acceptability of CRTs.


RESULTS
Multiple barriers were identified, including financial costs, concerns about stakeholders' perceptions of CRTs, impact on physicians' prescribing habits, and formulary changes. Most leaders recognized the potential value of studying the comparative effectiveness of therapeutics, and many stressed the need for head-to-head trials. Leaders' views would be influenced by variations in study design and implementation. Recommendations for increasing acceptability of CRTs included ensuring that the fiscal impact of a CRT be budget neutral, and that researchers educate stakeholders and decision-makers about CRTs.


CONCLUSIONS
Overall, health plan leaders recognized the need for studies of the comparative effectiveness of therapeutics under real world conditions, and many expressed support for CRTs. However, researchers seeking to conduct CRTs in health plans are likely to face numerous barriers, and preparatory work will be essential.
Mazor
Kathleen M
KM
Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Clinic Foundation, and Fallon Community Health Plan, Worcester, Massachusetts, USA. Kathleen.Mazor@umassmed.edu
Sabin
James E
JE
Boudreau
Denise
D
Goodman
Michael J
MJ
Gurwitz
Jerry H
JH
Herrinton
Lisa J
LJ
Raebel
Marsha A
MA
Roblin
Douglas
D
Smith
David H
DH
Meterko
Vanessa
V
Platt
Richard
R
D000328:Adult; D000368:Aged; D001291:Attitude of Health Personnel; D003669:Deductibles and Coinsurance; D004341:Drug Evaluation / Q000191:economics / Q000941:ethics / Q000379:methods*; D005260:Female; D006279:Health Maintenance Organizations; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000941:ethics / Q000379:methods*; D012107:Research Design; D014481:United States