TY - JOUR
T1 - Quality improvement methods as applied to a multicenter effectiveness trial - STAR*D
AU - Warden, Diane
AU - Rush, A. John
AU - Trivedi, Madhukar
AU - Ritz, Louise
AU - Stegman, Diane
AU - Wisniewski, Stephen R.
N1 - Funding Information:
This project has been funded with Federal funds from the National Institute of Mental Health, National Institutes of Health, under Contract N01MH90003 to The University of Texas Southwestern Medical Center at Dallas (P.I.: A. John Rush, M.D.).
PY - 2005/2
Y1 - 2005/2
N2 - In multicenter clinical trials, important aspects of trial performance (e.g., the number of participants who enter the trial within the required time frame, the number of participants who remain in the trial, and/or the completeness of the outcome data collected) directly affect the extent to which the study can achieve its aims. Obtaining the maximum amount of data from the maximum number of participants at each step in the trial increases the likelihood of identifying real differences in outcome. These aspects of trial performance can, therefore, be considered intermediate performance goals of the study since success in achieving each of them is directly related to success in achieving study aims. A quality improvement system was introduced to improve efficiency and performance in the multicenter Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Four intermediate performance goals were targeted for quality improvement efforts: (1) initial enrollment of subjects, (2) collection of entry/exit primary outcome data, (3) retention of subjects to enter subsequent "levels" of the trial, and (4) collection of blood samples for genetics studies. The identification of numerical targets for these goals provides a basis for monitoring performance and for implementing attempts to improve performance, since success in achieving each goal is directly related to success in achieving the study aims. This paper describes the background, rationale, development, and potential utility of implementing a quality improvement system to improve the performance and efficiency of the trial.
AB - In multicenter clinical trials, important aspects of trial performance (e.g., the number of participants who enter the trial within the required time frame, the number of participants who remain in the trial, and/or the completeness of the outcome data collected) directly affect the extent to which the study can achieve its aims. Obtaining the maximum amount of data from the maximum number of participants at each step in the trial increases the likelihood of identifying real differences in outcome. These aspects of trial performance can, therefore, be considered intermediate performance goals of the study since success in achieving each of them is directly related to success in achieving study aims. A quality improvement system was introduced to improve efficiency and performance in the multicenter Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Four intermediate performance goals were targeted for quality improvement efforts: (1) initial enrollment of subjects, (2) collection of entry/exit primary outcome data, (3) retention of subjects to enter subsequent "levels" of the trial, and (4) collection of blood samples for genetics studies. The identification of numerical targets for these goals provides a basis for monitoring performance and for implementing attempts to improve performance, since success in achieving each goal is directly related to success in achieving the study aims. This paper describes the background, rationale, development, and potential utility of implementing a quality improvement system to improve the performance and efficiency of the trial.
KW - Depression
KW - Efficiency in clinical trials
KW - Improving outcomes collection in clinical trials
KW - Improving recruitment and retention in clinical trials
KW - Multicenter clinical trials
KW - Quality improvement
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U2 - 10.1016/j.cct.2004.11.011
DO - 10.1016/j.cct.2004.11.011
M3 - Article
C2 - 15837455
AN - SCOPUS:17844369733
SN - 1551-7144
VL - 26
SP - 95
EP - 112
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 1
ER -