Release bias in accessing medical records in clinical trials: a STAR*D report.

Journal Article (Journal Article)

Clinical trials often require subjects to sign medical record releases to allow investigators to measure treatment fidelity, off-protocol care use, and care costs. Little is known, however, if limiting samples to those willing to sign releases impacts external validity. Data came from outpatients with non-psychotic major depressive disorder who enrolled in the multisite Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Differences between those who signed (n = 3116) and who did not sign (n = 925) releases were assessed using logistic regression and two-part, three-level log-transformed regression models, corrected for site clustering and repeated measures. Patients who released records tended to believe care was helpful, were younger, and married. However, release status had little material or consistent associations with patient health outcomes or use of care. With appropriate adjustments to data, requiring patient medical records may pose only minimal challenges to external validity in cost-outcome studies.

Full Text

Duke Authors

Cited Authors

  • Kashner, TM; Trivedi, MH; Wicker, A; Fava, M; Shores-Wilson, K; Wisniewski, SR; Rush, AJ

Published Date

  • September 2009

Published In

Volume / Issue

  • 18 / 3

Start / End Page

  • 147 - 158

PubMed ID

  • 19701922

Pubmed Central ID

  • PMC6878547

Electronic International Standard Serial Number (EISSN)

  • 1557-0657

Digital Object Identifier (DOI)

  • 10.1002/mpr.286


  • eng

Conference Location

  • United States