TY - JOUR

T1 - Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials

T2 - findings from an international, multidisciplinary working group

AU - Piccinin, Claire

AU - Basch, Ethan

AU - Bhatnagar, Vishal

AU - Calvert, Melanie

AU - Campbell, Alicyn

AU - Cella, David

AU - Cleeland, Charles S

AU - Coens, Corneel

AU - Darlington, Anne-Sophie

AU - Dueck, Amylou C

AU - Groenvold, Mogens

AU - Herold, Ralf

AU - King-Kallimanis, Bellinda L

AU - Kluetz, Paul G

AU - Kuliś, Dagmara

AU - O'Connor, Daniel

AU - Oliver, Kathy

AU - Pe, Madeline

AU - Reeve, Bryce B

AU - Reijneveld, Jaap C

AU - Wang, Xin Shelley

AU - Bottomley, Andrew

N1 - Copyright © 2023 Elsevier Ltd. All rights reserved.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Humans

KW - Quality of Life

KW - Neoplasms/therapy

KW - Patient Reported Outcome Measures

KW - Medical Oncology

KW - Patient Outcome Assessment

U2 - 10.1016/S1470-2045(22)00654-4

DO - 10.1016/S1470-2045(22)00654-4

M3 - Review

C2 - 36725153

VL - 24

SP - e86-e95

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 2

ER -