Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30
Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30
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.
Administration mode, Core cancer symptoms, EORTC QLQ-C30, Equivalence testing, Health-related quality of life, Patient-reported outcomes, Remote questionnaire administration, Voice script
Piccinin, Claire
d180fced-b5b7-475c-bfce-51844014a4b4
Pe, Madeline
f8974edd-ce99-4dd1-aef2-917866cba650
Kuliś, Dagmara
deaca519-4adf-4d72-b86e-c6eb8b81ba53
Shaw, James W.
891a7321-4476-4bbf-a99e-8e97e6e60f4b
Wheelwright, Sally J.
2df90681-fb0a-4871-ae7d-75c88b35024b
Bottomley, Andrew
aa0c035f-f787-4557-8b12-9e757c413cd0
Piccinin, Claire
d180fced-b5b7-475c-bfce-51844014a4b4
Pe, Madeline
f8974edd-ce99-4dd1-aef2-917866cba650
Kuliś, Dagmara
deaca519-4adf-4d72-b86e-c6eb8b81ba53
Shaw, James W.
891a7321-4476-4bbf-a99e-8e97e6e60f4b
Wheelwright, Sally J.
2df90681-fb0a-4871-ae7d-75c88b35024b
Bottomley, Andrew
aa0c035f-f787-4557-8b12-9e757c413cd0
Piccinin, Claire, Pe, Madeline, Kuliś, Dagmara, Shaw, James W., Wheelwright, Sally J. and Bottomley, Andrew
(2021)
Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30.
Quality of Life Research.
(doi:10.1007/s11136-021-02955-6).
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.
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EQUIVALENCE TESTING OF A NEWLY DEVELOPED INTERVIEWER-LED TELEPHONE SCRIPT (Abstract)
- Accepted Manuscript
Text
Piccinin2021_Article_EquivalenceTestingOfANewlyDeve
- Version of Record
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EQUIVALENCE TESTING OF A NEWLY DEVELOPED INTERVIEWER-LED TELEPHONE SCRIPT (Manuscript)
- Other
More information
Accepted/In Press date: 14 July 2021
e-pub ahead of print date: 20 July 2021
Additional Information:
Funding Information:
The authors would like to acknowledge and thank the EORTC for their support of this work, Bristol-Meyers Squibb for their financial support, and Mapi/ICON plc for their scientific support, involving patient recruitment and data collection, management, and analysis.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
Keywords:
Administration mode, Core cancer symptoms, EORTC QLQ-C30, Equivalence testing, Health-related quality of life, Patient-reported outcomes, Remote questionnaire administration, Voice script
Identifiers
Local EPrints ID: 453495
URI: http://eprints.soton.ac.uk/id/eprint/453495
ISSN: 0962-9343
PURE UUID: 2f3f5127-e0de-428f-9c83-9b348382d415
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Date deposited: 18 Jan 2022 17:52
Last modified: 16 Mar 2024 13:45
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Contributors
Author:
Claire Piccinin
Author:
Madeline Pe
Author:
Dagmara Kuliś
Author:
James W. Shaw
Author:
Andrew Bottomley
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