Evaluation of mode equivalence of the MSKCC Bowel Function Instrument, LASA Quality of Life, and Subjective Significance Questionnaire items administered by Web, interactive voice response system (IVRS), and paper
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To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration.
Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1–6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7–8 completed the survey twice, either by Web or by IVRS. The 20-item survey, including the MSKCC Bowel Function Instrument (BFI), the LASA Quality of Life (QOL) scale, and the Subjective Significance Questionnaire (SSQ) adapted to bowel function, was completed from home on consecutive days. Mode equivalence was assessed by comparison of mean scores across modes and intraclass correlation coefficients (ICCs) and was compared to the test–retest reliability of Web and IVRS.
Of 170 patients, 157 completed at least one survey and were included in analysis. Patients had mean age 56 (SD = 11), 53 % were male, 81 % white, 53 % colon, and 47 % rectal cancer; 78 % completed all assigned surveys. Mean scores for BFI total score, BFI subscale scores, LASA QOL, and adapted SSQ varied by mode by less than one-third of a score point. ICCs across mode were: BFI total score (Web–paper = 0.96, Web–IVRS = 0.97, paper–IVRS = 0.97); BFI subscales (range = 0.88–0.98); LASA QOL (Web–paper = 0.98, Web–IVRS = 0.78, paper–IVRS = 0.80); and SSQ (Web–paper = 0.92, Web–IVRS = 0.86, paper–IVRS = 0.79).
Mode equivalence was demonstrated for the BFI total score, BFI subscales, LASA QOL, and adapted SSQ, supporting the use of multiple modes of PRO data capture in clinical trials.
KeywordsMode equivalence Electronic PRO capture Rectal cancer Quality of life
This study was funded by Cancer and Leukemia Group B Foundation (US) (Grant Number: 2U10CA037447-26). This study was also funded in part by the Memorial Sloan Kettering Cancer Center Core Grant P30 CA008748. The core grant provides support to institutional cores, such as Biostatistics and Pathology, which were used in this study.
Compliance with ethical standards
Conflict of interest
All authors declared that they have no conflict of interest.
This article does not contain any studies with human participants or animals performed by any of the authors.
- 2.Coons, S. J., Gwaltney, C. J., Hays, R. D., et al. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value in Health, 12(4), 419–429.CrossRefPubMedGoogle Scholar
- 5.Wong, C., Chen, J., Yu, C. L., Sham, M., & Lam, C. L. (2015). Systemic review recommends the European Organization for Research and Treatment of Cancer colorectal cancer-specific module for measuring quality of life in colorectal cancer patients. Journal of Clinical Epidemiology, 68(3), 266–278.CrossRefPubMedGoogle Scholar
- 8.Bennett, A. V., Jensen, R. E., & Basch, E. (2012). Electronic patient-reported outcome systems in oncology clinical practice. CA: Cancer Journal for Clinicians, 62(5), 337–347.Google Scholar
- 10.Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). London: Routledge.Google Scholar
- 11.Yarandi, H. (2004). Crossover designs and proc mixed in SAS. Paper SD04. In The proceedings of the SouthEast SAS Users Group, Nashville, TN, 2004. http://analytics.ncsu.edu/sesug/2004/SD04-Yarandi.pdf.
- 12.Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric theory (3rd ed.). New York: McGraw-Hill.Google Scholar
- 17.Rush, A. J., Bernstein, I. H., Trivedi, M. H., et al. (2006). An evaluation of the quick inventory of depressive symptomatology and the Hamilton rating scale for depression: A sequenced treatment alternatives to relieve depression trial report. Biological Psychiatry, 59(6), 493–501.CrossRefPubMedPubMedCentralGoogle Scholar