TY - JOUR
T1 - Telephone-based assessments to minimize missing data in longitudinal depression trials
T2 - A project IMPACTS study report
AU - Claassen, Cindy
AU - Kurian, Ben
AU - Trivedi, Madhukar H.
AU - Grannemann, Bruce D.
AU - Tuli, Ekta
AU - Pipes, Ronny
AU - Preston, Anne Marie
AU - Flood, Ariell
N1 - Funding Information:
Grant Support: This work is supported by R01 MH-164062-01A1, Computerized Decision Support System for Depression (CDSS-D), awarded through the National Institute of Mental Health, Madhukar H. Trivedi, M.D., Principal Investigator.
PY - 2009/1
Y1 - 2009/1
N2 - Purpose: Missing data in clinical efficacy and effectiveness trials continue to be a major threat to the validity of study findings. The purpose of this report is to describe methods developed to ensure completion of outcome assessments with public mental health sector subjects participating in a longitudinal, repeated measures study for the treatment of major depressive disorder. We developed longitudinal assessment procedures that included telephone-based clinician interviews in order to minimize missing data commonly encountered with face-to-face assessment procedures. Methods: A pre-planned, multi-step strategy was developed to ensure completeness of data collection. The procedure included obtaining multiple pieces of patient contact information at baseline, careful education of both staff and patients concerning the purpose of assessments, establishing good patient rapport, and finally being flexible and persistent with phone appointments to ensure the completion of telephone-based follow-up assessments. A well-developed administrative and organizational structure was also put in place prior to study implementation. Results: The assessment completion rate for the primary outcome for 310 of 504 subjects who enrolled and completed 52 weeks (at the time of manuscript) of telephone-based follow-up assessments was 96.8%. Conclusion: By utilizing telephone-based follow-up procedures and adapting our easy-to-use pre-defined multi-step approach, researchers can maximize patient data retention in longitudinal studies.
AB - Purpose: Missing data in clinical efficacy and effectiveness trials continue to be a major threat to the validity of study findings. The purpose of this report is to describe methods developed to ensure completion of outcome assessments with public mental health sector subjects participating in a longitudinal, repeated measures study for the treatment of major depressive disorder. We developed longitudinal assessment procedures that included telephone-based clinician interviews in order to minimize missing data commonly encountered with face-to-face assessment procedures. Methods: A pre-planned, multi-step strategy was developed to ensure completeness of data collection. The procedure included obtaining multiple pieces of patient contact information at baseline, careful education of both staff and patients concerning the purpose of assessments, establishing good patient rapport, and finally being flexible and persistent with phone appointments to ensure the completion of telephone-based follow-up assessments. A well-developed administrative and organizational structure was also put in place prior to study implementation. Results: The assessment completion rate for the primary outcome for 310 of 504 subjects who enrolled and completed 52 weeks (at the time of manuscript) of telephone-based follow-up assessments was 96.8%. Conclusion: By utilizing telephone-based follow-up procedures and adapting our easy-to-use pre-defined multi-step approach, researchers can maximize patient data retention in longitudinal studies.
KW - Appointment adherence
KW - Compliance
KW - Follow-up strategies
KW - Longitudinal study
KW - Patient contact
KW - Rapport
KW - Retention
KW - Telephone assessments
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U2 - 10.1016/j.cct.2008.08.001
DO - 10.1016/j.cct.2008.08.001
M3 - Article
C2 - 18761427
AN - SCOPUS:57549091032
SN - 1551-7144
VL - 30
SP - 13
EP - 19
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 1
ER -