Introduction: Research into the impact of Crohn's Disease (CD) and its treatment on the patient relies on outdated and inappropriate generic questionnaires. These do not address important impacts of the illness and ask questions of limited relevance. As part of a study to develop CD-specific patient-reported outcome measures (PROMS), qualitative interviews were conducted with CD patients.
Methods: Item generation was based on the International Classification of Functioning, Disability and Health (ICF) and the needs-based quality of life (QoL) models. Interviewees were recruited via out-patient clinics and interviewed in a private room or at the researcher's offices. Interviews covered all aspects of the impact of CD and its treatment and were audio-recorded. Transcripts were content analysed to identify impacts on symptoms, activity limitations and QoL.
Results: 26 patients (69.2% female; aged 25–68; mean (SD): 46.2 (14.7) years) were interviewed. Participants had a wide range of duration of CD (2–40; mean (SD): 13.0 (12.9) years). 2641 statements relating to the impact of CD were identified. These statements fell into three major categories with a number of sub-themes identified: Symptoms (such as pain, fatigue and emotional impairment), activity limitations (such as difficulties with walking, lifting and jobs around the house) and QoL (including preoccupation with the disease, self-conscious of appearance and reduced socialisation).
Conclusion: The study was successful in identifying the most important impacts of CD from the patients' perspective. In addition to generating potential items for the new measure the findings of the interviews have implications for clinical practice and clinical trial design. Audit of services and assessment of new interventions for CD should assess whether or not these impacts of CD are improved. Only then will it be possible to determine whether interventions are of true benefit to the patient.
