Journal Article

Development and initial psychometric validation of a patient-reported outcome measure for Crohn’s perianal fistula: the Crohn’s Anal Fistula Quality of Life (CAF-QoL) scale

Warusavitarne, Janindra, Mannick, Sameer, Sahnan, Kapil, Bassett, Paul, Verjee, Azmina, Phillips, Robin, Wade, Tiffany, Yassin, Nuha, Adegbola, Samuel O, Norton, Christine, Hart, Ailsa L, Sawyer, Rachel, McCluskey, Damian, Dibley, Lesley, Faiz, Omar, Tozer, Phil J

2021

Overview

IntroductionCrohn’s perianal fistulas are challenging for patients and clinicians. Many do not respond to available treatments and despite recommendations by a global consensus, there are currently no specific patient-derived quality of life tools to measure response to treatment. We present a new validated patient-reported outcome measure (PROM) for this complicated disease phenotype.MethodsA draft questionnaire was generated using unstructured qualitative patient interviews on the experience of living with Crohn’s perianal fistula, a nationwide multidisciplinary consensus exercise, a systematic review of outcomes assessing medical/surgical/combined treatment and a patient and public involvement day. Psychometric properties were assessed including construct validity (by comparison with the Hospital Anxiety and Depression Scale (HADS) and the UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ)), and reliability and responsiveness was assessed by test–retest analysis.ResultsData from 211 patients contributed to development of a final 28-item questionnaire. The Crohn’s Anal Fistula Quality of Life (CAF-QoL) demonstrated good internal consistency (Cronbach’s alpha 0.88), excellent stability (intraclass correlation 0.98) and good responsiveness and construct validity, with positive correlation with the UK-IBDQ and HADS.ConclusionThe CAF-QoL scale is ready for use as a PROM in research and clinical practice. It complements objective clinical evaluation of fistula by capturing impact on the patient.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Crohn Disease - complications / Crohn Disease - psychology / Crohn Disease - therapy / Disease / Female / Fistula / Fistulae / Humans / Inflammatory Bowel Disease / Inflammatory bowel diseases / Likert scale / Male / Patient Reported Outcome Measures / Patients / Phenotypes / Psychiatric Status Rating Scales / Psychometrics / Quality of life / Quality of Life - psychology / Quantitative psychology / Questionnaires / Rectal Fistula - etiology / Rectal Fistula - psychology / Rectal Fistula - therapy / Reproducibility of Results / Surveys and Questionnaires / Systematic review / Treatment Outcome