Release bias in accessing medical records in clinical trials: a STAR*D report.
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.
Kashner
T Michael
TM
Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, TX 75390-9086, USA. michael.kashner@va.gov
Trivedi
Madhukar H
MH
Wicker
Annie
A
Fava
Maurizio
M
Shores-Wilson
Kathy
K
Wisniewski
Stephen R
SR
Rush
A John
AJ
D000328:Adult; D000368:Aged; D015982:Bias; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic; D003863:Depression / Q000453:epidemiology / Q000523:psychology* / Q000628:therapy*; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008499:Medical Records / Q000706:statistics & numerical data*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016017:Odds Ratio; D055815:Young Adult
Med Care. 1996 Mar;34(3):220-33
8628042
Biol Psychiatry. 2003 Sep 1;54(5):573-83
12946886
J Health Econ. 1998 Jun;17(3):283-95
10180919
Psychol Med. 1996 May;26(3):477-86
8733206
J Clin Psychiatry. 2003 Apr;64(4):357-69
12716235
N Engl J Med. 2006 Mar 23;354(12):1243-52
16554526
Br J Soc Clin Psychol. 1967 Dec;6(4):278-96
6080235
Psychol Med. 1994 Feb;24(1):233-7
8208888
Med Care. 2009 Feb;47(2):184-90
19169119
Am J Manag Care. 2009 Mar;15(3):153-62
19298096
Am J Psychiatry. 2006 Jan;163(1):28-40
16390886
J Ment Health Policy Econ. 1999 Sep 1;2(3):111-121
11967419
Psychol Med. 1990 Aug;20(3):721-4
2236382
Med Care. 1994 Jun;32(6):603-8
8189777
Health Serv Res. 2003 Feb;38(1 Pt 1):311-31
12650393
Psychol Med. 2004 Jan;34(1):73-82
14971628
Control Clin Trials. 2004 Feb;25(1):119-42
15061154
Med Care. 2003 Apr;41(4):479-89
12665712
N Engl J Med. 2006 Mar 23;354(12):1231-42
16554525
Biol Psychiatry. 2001 Nov 15;50(10):792-801
11720698
J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62
14399272
Biol Psychiatry. 2006 Mar 15;59(6):493-501
16199008
CNS Neurosci Ther. 2009 Winter;15(4):320-32
19712127
Adv Health Econ Health Serv Res. 1993;14:37-53
10172899
Psychiatr Serv. 2006 May;57(5):648-59
16675759
Psychiatr Clin North Am. 2003 Jun;26(2):457-94, x
12778843