Capturing the patient's experience: using qualitative methods to develop a measure of patient-reported symptom burden: an example from ovarian cancer

Context: Experts in patient-reported outcome (PRO) measurement emphasize the importance of including patient input in the development of PRO measures. Although best methods for acquiring this input are not yet identified, patient input early in instrument development ensures that instrument content captures information most important and relevant to patients in understandable terms.

Objectives: The M. D. Anderson Symptom Inventory (MDASI) is a reliable valid PRO instrument for assessing cancer symptom burden. We report a qualitative (open-ended, in-depth) interviewing method that can be used to incorporate patient input into PRO symptom measure development, with our experience in constructing an MDASI module for ovarian cancer (MDASI-OC) as a model.

Methods: Fourteen patients with ovarian cancer (OC) described symptoms experienced at the time of the study, at diagnosis, and during prior treatments. Researchers and clinicians used content analysis of interview transcripts to identify symptoms in patient language. Symptoms were ranked on the basis of the number of patients mentioning them and by clinician assessment of relevance.

Results: Forty-two symptoms were mentioned. Eight OC-specific items will be added to the 13 core symptom items and six interference items of the MDASI in a test version of the MDASI-OC on the basis of the number of patients mentioning them and clinician assessment of importance. The test version is undergoing psychometric evaluation.

Conclusion: The qualitative interviewing process, used to develop the test MDASI-OC, systematically captures common symptoms important to patients with OC. This methodology incorporates the patient experience recommended by experts in PRO instrument development.