TY - JOUR
T1 - Release bias in accessing medical records in clinical trials
T2 - A STAR*D report
AU - Kashner, T. Michael
AU - Trivedi, Madhukar H.
AU - Wicker, Annie
AU - Fava, Maurizio
AU - Shores-Wilson, Kathy
AU - Wisniewski, Stephen R.
AU - Rush, A. John
PY - 2009/9
Y1 - 2009/9
N2 - 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 nonpsychotic 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.
AB - 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 nonpsychotic 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.
KW - Informed consent
KW - Major depression
KW - Sample selection bias
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U2 - 10.1002/mpr.286
DO - 10.1002/mpr.286
M3 - Article
C2 - 19701922
AN - SCOPUS:70350747589
SN - 1049-8931
VL - 18
SP - 147
EP - 158
JO - International Journal of Methods in Psychiatric Research
JF - International Journal of Methods in Psychiatric Research
IS - 3
ER -