Cluster Randomized Trials

Opportunities and Barriers Identified by Leaders of Eight Health Plans

Dados Bibliográficos

ID9101537
AutoresKathleen M Mazor (0000-0002-9491-9872, Kaiser Permanente, autor correspondente), James E Sabin (Harvard Pilgrim Health Care), Denise M Boudreau (0000-0003-4300-4901, Group Health Cooperative), Denise Boudreau, Michael J Goodman, Jerry H Gurwitz (0000-0003-1630-8213, Kaiser Permanente, autor correspondente), Lisa J Herrinton (0000-0002-5702-7162, University of Massachusetts Chan Medical School, autor correspondente), Marsha A Raebel (0000-0002-8485-7161, Kaiser Permanente), Douglas W Roblin (Harvard Pilgrim Health Care), Douglas Roblin, David H Smith (0000-0001-7184-8947, Group Health Cooperative), Vanessa Meterko (0000-0002-1207-8812, Kaiser Permanente, autor correspondente), Richard Platt (0000-0002-3248-3583, Harvard Pilgrim Health Care)
Ano2007
Volume45
Fascículo10
PáginasS29-S37
Data de publicação2007-10-01
Peer ReviewedSim
Open AccessNão
TipoARTICLE
PeriódicoMedical Care (JOURNAL)
Identificadores do periódicoISSN: 0025-7079 • E-ISSN: 1537-1948
EditoraOvid Technologies (Wolters Kluwer Health) (PUBLISHER)
DOI10.1097/mlr.0b013e31806728c4
PMID17909379
OpenAlexW2045673370
IdiomaEN
Citações recebidas3
Referências citadas20

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. OBJECTIVES: To describe health plan leaders' views on CRTs, identify barriers to conducting CRTs, and solicit recommendations for increasing the acceptability of CRTs. RESEARCH DESIGN: Qualitative in-depth telephone interviews with leaders from 8 health plans. SUBJECTS: : Thirty-four health plan leaders (medical directors, pharmacy directors, Institutional Review Board leaders, ethics leaders, compliance leaders, and others). MEASURES: 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

Cluster (spacecraft) · Randomized controlled trial · Computer Science · Ethics in Clinical Research · Health Policy Implementation Science · Internal Medicine · Medicine · Meta-analysis and systematic reviews