title: 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).
abstract: BACKGROUND
  PRO-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.
  
  
  METHODS
  Participants (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.
  
  
  RESULTS
  103 (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.
  
  
  CONCLUSIONS
  Mode 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.
  
  
  BACKGROUND
  NCT Clinicaltrials.gov identifier: NCT02158637.
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Campus Box 7411, Chapel Hill, NC, 27599, USA. avbenn@unc.edu.
authors.forename: Antonia V
authors.initials: AV
authors.lastname: Bennett
authors.affiliation: Division of Health Sciences Research, College of Medicine, Mayo Clinic, 13400 E. Shea Blvd, Scottsdale, AZ, 85259, USA. dueck@mayo.edu.
authors.forename: Amylou C
authors.initials: AC
authors.lastname: Dueck
authors.affiliation: Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, 9609 Medical Center Drive, East Tower, Suite 3-448, Rockville, MD, 20850, USA. mitchlls@mail.nih.gov.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: Department of Symptom Research, The University of Texas M. D. Anderson Cancer Center, 1400 Pressler Street, Unit 1450, Houston, TX, 77030, USA. tmendoza@mdanderson.org.
authors.forename: Tito R
authors.initials: TR
authors.lastname: Mendoza
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Campus Box 7411, Chapel Hill, NC, 27599, USA. bbreeve@email.unc.edu.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, 7th Floor, New York, NY, 10022, USA. atkinsot@mskcc.org.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Atkinson
authors.affiliation: Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, 9609 Medical Center Drive, East Tower, Suite 3-448, Rockville, MD, 20850, USA. kathleen.castro@nih.gov.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Castro
authors.affiliation: Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, MSC 9737, Bethesda, MD, 20892, USA. denicofa@mail.nih.gov.
authors.forename: Andrea
authors.initials: A
authors.lastname: Denicoff
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA. rogakl@mskcc.org.
authors.forename: Lauren J
authors.initials: LJ
authors.lastname: Rogak
authors.affiliation: The Center for Cancer Prevention and Treatment, St. Joseph Hospital of Orange, 1100 West Stewart Drive, Orange, CA, 92868, USA. jkharness@gmail.com.
authors.forename: Jay K
authors.initials: JK
authors.lastname: Harness
authors.affiliation: Gibbs Cancer Center and Research Institute, Spartanburg Regional Healthcare System, 101 East Wood Street, Spartanburg, SC, 29303, USA. jbearden@srhs.com.
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.affiliation: The Cancer Program of Our Lady of the Lake and Mary Bird Perkins, 1950 Essen Lane, Baton Rouge, LA, 70809, USA. dbryantnp@cox.net.
authors.forename: Donna
authors.initials: D
authors.lastname: Bryant
authors.affiliation: Hartford Hospital-Helen and Harry Gray Cancer Center, 85 Retreat Avenue, Hartford, CT, 06106, USA. ROBERT_SIEGEL@bshsi.org.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Siegel
authors.affiliation: Dana Farber Cancer Institute, 450 Brookline Ave, D-1008, Boston, MA, 02215, USA. deb_schrag@dfci.harvard.edu.
authors.forename: Deborah
authors.initials: D
authors.lastname: Schrag
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA. ebasch@med.unc.edu.|Department of Medicine, University of North Carolina at Chapel Hill, Campus Box 7305, Chapel Hill, NC, 27599, USA. ebasch@med.unc.edu.
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000145:classification*; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D034201:Computers, Handheld; D018592:Cross-Over Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D063868:Patient Outcome Assessment; D011832:Radiation Injuries / Q000145:classification*; D011878:Radiotherapy / Q000009:adverse effects; D015203:Reproducibility of Results; D057566:Self Report; D009626:Terminology as Topic; D014481:United States
chemical_list: D000970:Antineoplastic Agents