Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Health and Quality of Life Outcomes

Research

Andrea Denicoff¹  Deborah Schrag²  Lauren J. Rogak³  Ethan Basch⁴  Antonia V. Bennett⁵  Bryce B. Reeve⁵  Thomas M. Atkinson⁶  Tito R. Mendoza⁷  Kathleen M. Castro⁸  Sandra A. Mitchell⁸  Amylou C. Dueck⁹  James D. Bearden^1,10  Robert D. Siegel^1,11  Donna Bryant^1,12  Jay K. Harness^1,13 

[1] Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, MSC 9737, 20892, Bethesda, MD, USA;Dana Farber Cancer Institute, 450 Brookline Ave, D-1008, 02215, Boston, MA, USA;Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, 10017, New York, NY, USA;Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, 10017, New York, NY, USA;Department of Medicine, University of North Carolina at Chapel Hill, Campus Box 7305, 27599, Chapel Hill, NC, USA;Department of Health Policy and Management, University of North Carolina at Chapel Hill, Campus Box 7411, 27599, Chapel Hill, NC, USA;Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, 7th Floor, 10022, New York, NY, USA;Department of Symptom Research, The University of Texas M. D. Anderson Cancer Center, 1400 Pressler Street, Unit 1450, 77030, Houston, TX, USA;Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, 9609 Medical Center Drive, East Tower, Suite 3-448, 20850, Rockville, MD, USA;Division of Health Sciences Research, College of Medicine, Mayo Clinic, 13400 E. Shea Blvd, 85259, Scottsdale, AZ, USA;Gibbs Cancer Center and Research Institute, Spartanburg Regional Healthcare System, 101 East Wood Street, 29303, Spartanburg, SC, USA;Hartford Hospital-Helen and Harry Gray Cancer Center, 85 Retreat Avenue, 06106, Hartford, CT, USA;The Cancer Program of Our Lady of the Lake and Mary Bird Perkins, 1950 Essen Lane, 70809, Baton Rouge, LA, USA;The Center for Cancer Prevention and Treatment, St. Joseph Hospital of Orange, 1100 West Stewart Drive, 92868, Orange, CA, USA;

关键词: PRO-CTCAE;    Patient-Reported Outcomes;    Symptoms;    Adverse Events;    Mode of Administration;    Interactive Voice Response System;   

DOI  :  10.1186/s12955-016-0426-6

 received in 2015-06-10, accepted in 2016-02-10,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundPRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system.MethodsParticipants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0–4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed.Results103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55–0.90); tablet vs paper: 0.81 (0.62–0.96); IVRS vs paper: 0.78 (0.60–0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = −0.04 [−0.16–0.22]; tablet vs paper = −0.02 [−0.11–0.14]; IVRS vs paper = 0.02 [−0.07–0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/−0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported “no problems” responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper.ConclusionsMode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration.Trial registrationNCT Clinicaltrials.gov identifier: NCT02158637

【 授权许可】

CC BY   
© Bennett et al. 2016