The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus.
Rheumatology (Oxford)
; 61(8): 3329-3340, 2022 08 03.
Article
em En
| MEDLINE
| ID: mdl-34897375
ABSTRACT
OBJECTIVES:
This study aimed to implement a patient-centred and evidence-based approach to develop a novel patient-reported outcome (PRO) instrument to measure fatigue in patients with SLE.METHODS:
A three-step mixed methods psychometric (MMP) approach was followed. Steps comprised first draft item generation and review using interview data; evaluation and refinement of second draft items using mixed methods data, including interview and quantitative data from a phase 2 clinical study in SLE analysed using Rasch Measurement Theory (RMT) analysis; and evaluation of the final FATIGUE-PRO items using RMT and complementary Classical Test Theory (CTT) analyses. Guided by MMP criteria, a team of clinicians and outcome-measurement experts assessed evidence to inform instrument development.RESULTS:
Step 1 culminated in 55 items (n = 39 patients interviewed). Their refinement in step 2 using mixed methods evidence led to the final FATIGUE-PRO instrument comprising 31 items across three scales of fatigue physical fatigue (9 items), mental and cognitive fatigue (11 items) and susceptibility to fatigue (11 items). Qualitative (n = 43 patients) and quantitative (n = 106 patients) evidence strongly supported the scales' content comprehensiveness and targeting, item quality and fit, conceptual uniqueness and appropriateness of the response scale. The FATIGUE-PRO further benefited from excellent reliability (RMT 0.92-0.94 and CTT 0.95-0.96) and supportive evidence of construct validity from assessments against other PROs.CONCLUSION:
The conceptual advances, comprehensive coverage and strong psychometric properties of the FATIGUE-PRO will significantly advance the measurement and management of fatigue in SLE, both in clinical trials and routine practice. TRIAL REGISTRATION ClinicalTrials.gov (https//clinicaltrials.gov), NCT02804763.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Medidas de Resultados Relatados pelo Paciente
/
Lúpus Eritematoso Sistêmico
Tipo de estudo:
Qualitative_research
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article