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)

on behalf of the National Cancer Institute PRO-CTCAE Study Group

Research output: Contribution to journalArticle

26 Citations (Scopus)

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 3.4min; 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. Trial registration: NCT Clinicaltrials.gov identifier: NCT02158637

Original languageEnglish (US)
Article number24
JournalHealth and Quality of Life Outcomes
Volume14
Issue number1
DOIs
StatePublished - Feb 19 2016

Fingerprint

Handheld Computers
National Cancer Institute (U.S.)
Terminology
Tablets
Second Primary Neoplasms
Contracts
Patient Reported Outcome Measures
Reproducibility of Results
Cross-Over Studies
Libraries
Research Personnel
Surveys and Questionnaires

Keywords

  • Adverse Events
  • Interactive Voice Response System
  • Mode of Administration
  • Patient-Reported Outcomes
  • PRO-CTCAE
  • Symptoms

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

@article{76a1e3ac6caa4d39bd6846f4867fc30f,
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 3.4min; 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. Trial registration: NCT Clinicaltrials.gov identifier: NCT02158637",
keywords = "Adverse Events, Interactive Voice Response System, Mode of Administration, Patient-Reported Outcomes, PRO-CTCAE, Symptoms",
author = "{on behalf of the National Cancer Institute PRO-CTCAE Study Group} and Bennett, {Antonia V.} and Amylou Dueck and Mitchell, {Sandra A.} and Mendoza, {Tito R.} and Reeve, {Bryce B.} and Atkinson, {Thomas M.} and Castro, {Kathleen M.} and Andrea Denicoff and Rogak, {Lauren J.} and Harness, {Jay K.} and Bearden, {James D.} and Donna Bryant and Siegel, {Robert D.} and Deborah Schrag and Ethan Basch and Narre Heon and Mary Shaw and Sean Ryan and Stark, {Liora P.} and Donna Malveaux and Wendy Pettus and Lucy Gansauer and Jennifer Wind and Amy Thomassie and Gitana Davila and Kathy Alexander",
year = "2016",
month = "2",
day = "19",
doi = "10.1186/s12955-016-0426-6",
language = "English (US)",
volume = "14",
journal = "Health and Quality of Life Outcomes",
issn = "1477-7525",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - 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)

AU - on behalf of the National Cancer Institute PRO-CTCAE Study Group

AU - Bennett, Antonia V.

AU - Dueck, Amylou

AU - Mitchell, Sandra A.

AU - Mendoza, Tito R.

AU - Reeve, Bryce B.

AU - Atkinson, Thomas M.

AU - Castro, Kathleen M.

AU - Denicoff, Andrea

AU - Rogak, Lauren J.

AU - Harness, Jay K.

AU - Bearden, James D.

AU - Bryant, Donna

AU - Siegel, Robert D.

AU - Schrag, Deborah

AU - Basch, Ethan

AU - Heon, Narre

AU - Shaw, Mary

AU - Ryan, Sean

AU - Stark, Liora P.

AU - Malveaux, Donna

AU - Pettus, Wendy

AU - Gansauer, Lucy

AU - Wind, Jennifer

AU - Thomassie, Amy

AU - Davila, Gitana

AU - Alexander, Kathy

PY - 2016/2/19

Y1 - 2016/2/19

N2 - 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 3.4min; 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. Trial registration: NCT Clinicaltrials.gov identifier: NCT02158637

AB - 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 3.4min; 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. Trial registration: NCT Clinicaltrials.gov identifier: NCT02158637

KW - Adverse Events

KW - Interactive Voice Response System

KW - Mode of Administration

KW - Patient-Reported Outcomes

KW - PRO-CTCAE

KW - Symptoms

UR - http://www.scopus.com/inward/record.url?scp=84959343077&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84959343077&partnerID=8YFLogxK

U2 - 10.1186/s12955-016-0426-6

DO - 10.1186/s12955-016-0426-6

M3 - Article

C2 - 26892667

AN - SCOPUS:84959343077

VL - 14

JO - Health and Quality of Life Outcomes

JF - Health and Quality of Life Outcomes

SN - 1477-7525

IS - 1

M1 - 24

ER -