title: Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations.
abstract: OBJECTIVE
  To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability.
  
  
  METHODS
  Eighty-four qualitative in-depth telephone interviews were conducted; 50 with health plan members, 21 with providers, and 13 with purchasers. Interviews focused on stakeholders' concerns about and recommendations for conducting CRTs in health plans.
  
  
  RESULTS
  Members expressed concerns that CRTs might compromise their healthcare. Providers and purchasers recognized the value of and the need for comparative effectiveness research. Providers expressed concerns that they would not have sufficient time to discuss a CRT with patients, and that participation in such a study could negatively impact their relationships with patients. Purchasers would want assurances that study participation would not result in members receiving lesser care, and that benefits would remain equitable for all members.
  
  
  CONCLUSIONS
  This study provides insight into how health plan members, providers and purchasers might react to a CRT being conducted in their health plan. The recommendations reported here provide guidance for researchers and policy makers considering this methodological approach and suggest that with sufficient preparation and planning CRTs can be an acceptable and efficient methodology for studying the comparative effectiveness of therapeutics in real world settings.
authors.affiliation: Meyers Primary Care Institute, Fallon Clinic, Fallon Community Health Plan and University of Massachusetts Medical School, Worcester, MA 01605, USA. Kathleen.Mazor@umassmed.edu
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Mazor
authors.forename: James E
authors.initials: JE
authors.lastname: Sabin
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Goff
authors.forename: David H
authors.initials: DH
authors.lastname: Smith
authors.forename: Sharon
authors.initials: S
authors.lastname: Rolnick
authors.forename: Douglas
authors.initials: D
authors.lastname: Roblin
authors.forename: Marsha A
authors.initials: MA
authors.lastname: Raebel
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Herrinton
authors.forename: Jerry H
authors.initials: JH
authors.lastname: Gurwitz
authors.forename: Denise
authors.initials: D
authors.lastname: Boudreau
authors.forename: Vanessa
authors.initials: V
authors.lastname: Meterko
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Dodd
authors.forename: Richard
authors.initials: R
authors.lastname: Platt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016000:Cluster Analysis; D005260:Female; D019981:Health Care Sector / Q000706:statistics & numerical data; D006287:Health Planning Guidelines; D006801:Humans; D007348:Insurance, Health / Q000706:statistics & numerical data; D007407:Interviews as Topic / Q000379:methods; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D055815:Young Adult