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Randomized Controlled Trial
. 2022 Mar;31(3):877-888.
doi: 10.1007/s11136-021-02955-6. Epub 2021 Jul 20.

Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30

Claire Piccinin  1 , Madeline Pe  2 , Dagmara Kuliś  2 , James W Shaw  3 , Sally J Wheelwright  4 , Andrew Bottomley  2
Affiliations
Randomized Controlled Trial

Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30

Claire Piccinin et al. Qual Life Res. 2022 Mar.

Abstract

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone.

Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required.

Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48-0.86) to 0.90 (global health status/QoL, 95% CI 0.80-0.95; pain, 95% CI 0.79-0.95; constipation, 95% CI 0.80-0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24-0.76) and financial difficulties (ICC 0.60; 95% CI 0.31-0.79). For phone first administration, all ICCs were above 0.70.

Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone.

Keywords: Administration mode; Core cancer symptoms; EORTC QLQ-C30; Equivalence testing; Health-related quality of life; Patient-reported outcomes; Remote questionnaire administration; Voice script.

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Conflict of interest statement

James W. Shaw is an employee and shareholder of Bristol-Myers Squibb. All other authors have no financial interests/personal relationships, which may be considered as potential competing interests, to declare.

References

    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, Haes JCJMD, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F. The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute. 1993 doi: 10.1093/jnci/85.5.365. - DOI - PubMed
    1. Mierzynska J, Piccinin C, Pe M, Martinelli F, Gotay C, Coens C, Mauer M, Eggermont A, Groenvold M, Bjordal K, Reijneveld J, Velikova G, Bottomley A. Prognostic value of patient-reported outcomes from international randomised clinical trials on cancer: A systematic review. The Lancet Oncology. 2019;20:e685–e698. doi: 10.1016/S1470-2045(19)30656-4. - DOI - PubMed
    1. Aaronson NK, Bullinger M, Ahmedzai S. A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results in Cancer Research. 1988;111:231–249. doi: 10.1007/978-3-642-83419-6_27. - DOI - PubMed
    1. Reeve BB, Mitchell SA, Dueck AC, Basch E, Cella D, Reilly CM, Minasian LM, Denicoff AM, O’Mara AM, Fisch MJ, Chauhan C, Aaronson NK, Coens C, Bruner DW. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. Journal of the National Cancer Institute. 2014 doi: 10.1093/jnci/dju129. - DOI - PMC - PubMed
    1. Gundy CM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MAG, Velikova G, Aaronson NK. Comparing higher order models for the EORTC QLQ-C30. Quality of Life Research. 2012 doi: 10.1007/s11136-011-0082-6. - DOI - PMC - PubMed

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