Development and initial validation of the AL-PROfile patient-reported outcome measure in light chain (AL) amyloidosis. Eur J Haematol 2024 Jun;112(6):900-909
Date
02/14/2024Pubmed ID
38350661DOI
10.1111/ejh.14183Scopus ID
2-s2.0-85185450309 (requires institutional sign-in at Scopus site)Abstract
OBJECTIVE: To evaluate the psychometric properties of the AL-PROfile, a patient-reported outcome measure combining the Patient-Reported Outcomes Measurement Information System (PROMIS)-29, two items from PROMIS Cognitive Function, and select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items.
METHODS: Content validity was assessed through cognitive debriefing interviews of 20 patients who completed the AL-PROfile (Study 1). Study 2 involved 297 participants who completed the AL-PROfile and Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Reliability (internal consistency and test-retest reliability) and validity (convergent and discriminant validity, known groups validity by stage/organ involvement) were calculated.
RESULTS: Study 1 participants found the AL-PROfile straightforward confirming the relevance of the included content. Some felt that certain questions were not related to their amyloidosis experience. Study 2 demonstrated acceptable internal consistency for all domains/items except PROMIS Cognitive Function and acceptable test-retest reliability for all except PROMIS Cognitive Function and PRO-CTCAE nausea. Large correlations were seen for the same domain across measures while correlations for divergent domains within a measure and different domains across different measures were small. The PRO-CTCAE items showed small to medium correlations with each other and with PROMIS and SF-36 domains. Stage was associated with physical function, fatigue, social roles, swelling, and shortness of breath scores.
CONCLUSION: The AL-PROfile has acceptable reliability and validity for use in systemic light chain amyloidosis patients.
Author List
D'Souza A, Szabo A, Akinola I, Finkel M, Flynn KEAuthors
Anita D'Souza MD Associate Professor in the Medicine department at Medical College of WisconsinKathryn Eve Flynn PhD Vice Chair, Professor in the Medicine department at Medical College of Wisconsin
Aniko Szabo PhD Professor in the Institute for Health and Equity department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
AdultAged
Aged, 80 and over
Female
Humans
Immunoglobulin Light-chain Amyloidosis
Male
Middle Aged
Patient Reported Outcome Measures
Psychometrics
Quality of Life
Reproducibility of Results
Surveys and Questionnaires
