The development of a patient reported outcome measure for fatigue and breathlessness for patients with chronic heart failure (OxFAB).

BACKGROUND: Fatigue and breathlessness are the two most common and distressing symptoms for patients with chronic heart failure. They affect a patient's quality of life and ability to undertake activities of daily living. Currently there are no symptom specific measures for fatigue and breathlessness available or developed and validated for use with this patient group and no questionnaire that incorporates both symptoms into one measure. OBJECTIVE: To develop a patient-reported outcome measure for patients with chronic heart failure for their fatigue and breathlessness symptoms. METHODS: A three-staged, approach was used. In stage One in-depth qualitative patient-interviews on factors of fatigue and breathlessness in chronic heart failure were undertaken to provide question themes. Items from these interviews were generated and pilot questionnaires developed and tested. In Stage Two, exploratory factor analysis with item reduction and final testing of the questionnaire was performed. Stage Three involved validation testing. RESULTS: In Stage One, issues raised in interviews (n = 25) were used to generate items. Pilot questionnaires were developed and tested. Items were refined in the context of cognitive debrief interviews (n = 7) for possible inclusion in the final measure. Final testing of questionnaire properties with item reduction was carried out in Stage Two (n = 112). Validity and reliability were assessed in Stage Three (n = 96). Psychometric testing showed positive results, in internal consistency (Cronbach's alpha ranging from 0.8 to 0.94) and test-retest (no difference in means), content validity and relevance to patients. CONCLUSIONS: This questionnaire could be useful in the assessment of fatigue and breathlessness in patients living with chronic heart failure.