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How to develop a condition‐specific PROM
Author(s) -
Comins Jonathan D.,
Brodersen John,
Siersma Volkert,
Jensen Jonas,
Hansen Christian Fugl,
Krogsgaard Michael R.
Publication year - 2021
Publication title -
scandinavian journal of medicine and science in sports
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.575
H-Index - 115
eISSN - 1600-0838
pISSN - 0905-7188
DOI - 10.1111/sms.13868
Subject(s) - prom , content validity , face validity , patient reported outcome , cognitive interview , relevance (law) , psychology , physical therapy , medicine , content analysis , applied psychology , cognition , physical medicine and rehabilitation , clinical psychology , psychometrics , psychiatry , quality of life (healthcare) , psychotherapist , obstetrics , political science , law , social science , sociology
Developing new patient‐reported outcome measures (PROMs) for application in clinical studies can be necessary if an adequate PROM does not exist. For adequate measurement, it is essential that the PROM has face validity (ie, is perceived to be relevant by clinicians and researchers) and has high content validity (ie, content relevance and content coverage for the targeted patient group). The steps needed to create PROMs that possess face and content validity for a specific condition are described in this paper. Face validity is achieved by item identification and generation through literature review. Content validity is confirmed through repetitive cognitive interviews of patients from the targeted patient group in order to generate a consensus‐based pilot‐version of the new PROM. This qualitative process ensures that items are appropriately worded, understandable, and minimizes doubts about how items should be answered. A practical example of this process is presented, which shows the development of the Knee Numeric‐Entity Evaluation Score (KNEES‐ACL), a condition‐specific PROM for patients with deficiency of the anterior cruciate ligament (ACL).