Development and validation of a patient‐reported outcome measure for patients with chronic respiratory failure: The CRF‐PROM scale

BACKGROUND: Various health‐related quality‐of‐life (HRQOL) tools are used to evaluate patients with chronic respiratory failure (CRF), but there is a relative lack of tools available for the evaluation of social support and treatment in these patients. The present study focused on the development of a systematic patient‐reported outcome measure (PROM) tool for use in patients with CRF. METHODS: The CRF‐PROM scale conceptual framework and item bank were generated after reviewing the corresponding literature and HRQOL scales, interviewing CRF patients and focus groups. After creation of the initial scale, the items in the scale were selected through two item selection theories, and the final scale was created. The reliability, validity and feasibility of the final scale were assessed. RESULTS: The CRF‐PROM scale includes four domains (i.e., physiological domain, psychological domain, social domain and therapeutic domain) and 10 dimensions. After the item selection process, the final scale included 50 items. Cronbach's α coefficients, which were all above 0.7, indicated the reliability of the scale. The results of structural validity met the relevant standards of confirmatory factor analysis. The response rates of the preinvestigation and the formal investigation were 93.3% and 97.6%, respectively. CONCLUSIONS: The CRF‐PROM scale developed in the present study is effective and reliable. It could be used widely in the posthospital management of patients, in CRF studies and in clinical trials of new medical products and interventions. PATIENT OR PUBLIC CONTRIBUTION: Participants from eight different hospitals and communities participated in the development or validation phase of the CRF‐PROM scale.