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Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: Findings from an international, multidisciplinary working group

Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: Findings from an international, multidisciplinary working group
Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: Findings from an international, multidisciplinary working group
The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

0140-6736
e86-e95
Piccinin, Claire
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Basch, Ethan
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Bhatnagar, Vishal
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Calvert, melanie
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Campbell, Alicyn
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Cella, David
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Cleeland, Charles S
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Coens, Corneel
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Darlington, Anne-Sophie
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Piccinin, Claire
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Basch, Ethan
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Bhatnagar, Vishal
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Calvert, melanie
213d9d4e-a8d0-44b6-8d19-cfefea37356d
Campbell, Alicyn
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Cella, David
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Cleeland, Charles S
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Coens, Corneel
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Darlington, Anne-Sophie
472fcfc9-160b-4344-8113-8dd8760ff962

Piccinin, Claire, Basch, Ethan, Bhatnagar, Vishal, Calvert, melanie, Campbell, Alicyn, Cella, David, Cleeland, Charles S, Coens, Corneel and Darlington, Anne-Sophie (2023) Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: Findings from an international, multidisciplinary working group. The Lancet, 24 (2), e86-e95. (doi:10.1016/S1470-2045(22)00654-4).

Record type: Review

Abstract

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

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ILs for PROs in onc. trials - intl. recs revised - Accepted Manuscript
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Accepted/In Press date: 18 October 2022
e-pub ahead of print date: 30 January 2023
Published date: February 2023
Additional Information: Funding Information: This Policy Review reflects the views of the individual authors and should not be construed to represent official views or policies of the US Food and Drug Administration, US National Cancer Institute, Medicines and Healthcare products Regulatory Agency, the UK National Health Service, the National Institute for Health Research, the UK Department of Health and Social Care, or the European Medicines Agency. The views expressed in this Policy Review are the personal views of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency or agencies or organisations with which the authors are employed or affiliated. Publisher Copyright: © 2023 Elsevier Ltd

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Local EPrints ID: 475256
URI: http://eprints.soton.ac.uk/id/eprint/475256
ISSN: 0140-6736
PURE UUID: edcca219-3a0d-4522-ad31-6038deba44aa

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Date deposited: 14 Mar 2023 17:53
Last modified: 17 Mar 2024 07:40

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Contributors

Author: Claire Piccinin
Author: Ethan Basch
Author: Vishal Bhatnagar
Author: melanie Calvert
Author: Alicyn Campbell
Author: David Cella
Author: Charles S Cleeland
Author: Corneel Coens

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