TY - JOUR
T1 - Electronic source materials in clinical research
T2 - Acceptability and validity of symptom self-rating in major depressive disorder
AU - Cook, Ian A.
AU - Balasubramani, G. K.
AU - Eng, Heather
AU - Friedman, Edward
AU - Young, Elizabeth A.
AU - Martin, Jeff
AU - Nay, William T.
AU - Ritz, Louise
AU - Rush, A. John
AU - Stegman, Diane
AU - Warden, Diane
AU - Trivedi, Madhukar H.
AU - Wisniewski, Stephen R.
N1 - Funding Information:
This project has been supported with Federal funds from the National Institute of Mental Health, National Institutes of Health, under Contract N01MH90003 to UT Southwestern Medical Center at Dallas (P.I.: A.J. Rush). We would like to acknowledge the editorial support of Jon Kilner, MS, MA, and the secretarial support of FastWord Information Processing Inc. (Dallas, TX).
PY - 2007/11
Y1 - 2007/11
N2 - Objectives: Clinical research projects gather large amounts of data. Typically, information is captured on paper source documents for later transcription to an electronic format, where responses can be checked, and errors, omissions, and inconsistencies can be resolved. These steps contribute delays, cost, and complexity to clinical research, particularly in large-scale multi-site investigations. To address these issues, we used a mobile computing device with a touch-screen display ("tablet PC") to capture clinical data from depressed patients directly into electronic format. We then examined ease of use, the equivalence of responses between paper and electronic methods, and the acceptability of the tablet PC for this clinical population. Settings: Outpatient clinics at four medical centers. Methods: 80 adults with major depressive disorder (MDD) completed the 16-item Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR16), using both traditional paper forms and an electronic representation of the same questions; participants also completed a survey to evaluate their experience. Results: QIDS-SR16 responses from paper and electronic versions were highly correlated (mean total: 15.3 (SD = 5.2) electronic vs. 15.1 (SD = 5.2) paper format), and showed high inter-rating reliability for overall score (intra-class correlation 0.987 (with a 95%CI [0.979, 0.992])) and high degree of association for individual symptom items. Participants found both methods acceptable and overall found the electronic implementation easier to use. Conclusions: QIDS-SR16 values collected electronically from research participants were equivalent to those collected using traditional paper self-assessment forms. Participants with MDD found the tablet PC version to be acceptable and easier to use than the paper forms.
AB - Objectives: Clinical research projects gather large amounts of data. Typically, information is captured on paper source documents for later transcription to an electronic format, where responses can be checked, and errors, omissions, and inconsistencies can be resolved. These steps contribute delays, cost, and complexity to clinical research, particularly in large-scale multi-site investigations. To address these issues, we used a mobile computing device with a touch-screen display ("tablet PC") to capture clinical data from depressed patients directly into electronic format. We then examined ease of use, the equivalence of responses between paper and electronic methods, and the acceptability of the tablet PC for this clinical population. Settings: Outpatient clinics at four medical centers. Methods: 80 adults with major depressive disorder (MDD) completed the 16-item Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR16), using both traditional paper forms and an electronic representation of the same questions; participants also completed a survey to evaluate their experience. Results: QIDS-SR16 responses from paper and electronic versions were highly correlated (mean total: 15.3 (SD = 5.2) electronic vs. 15.1 (SD = 5.2) paper format), and showed high inter-rating reliability for overall score (intra-class correlation 0.987 (with a 95%CI [0.979, 0.992])) and high degree of association for individual symptom items. Participants found both methods acceptable and overall found the electronic implementation easier to use. Conclusions: QIDS-SR16 values collected electronically from research participants were equivalent to those collected using traditional paper self-assessment forms. Participants with MDD found the tablet PC version to be acceptable and easier to use than the paper forms.
KW - Acceptability
KW - Assessment
KW - Clinical trial
KW - Computer
KW - Depression
KW - Informatics
UR - http://www.scopus.com/inward/record.url?scp=34247546215&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34247546215&partnerID=8YFLogxK
U2 - 10.1016/j.jpsychires.2006.07.015
DO - 10.1016/j.jpsychires.2006.07.015
M3 - Article
C2 - 17275840
AN - SCOPUS:34247546215
SN - 0022-3956
VL - 41
SP - 737
EP - 743
JO - Journal of Psychiatric Research
JF - Journal of Psychiatric Research
IS - 9
ER -