A qualitative validation of the Minnesota Living with Heart Failure Questionnaire

Background: In an overview of quality-of-life questionnaires that have been used to measure treatment effects in clinical trials in congestive heart failure (CHF), it was concluded that 'no QoL instrument has measured quality of life in CHF trials in a reliable or reproducible fashion' and that the usefulness of these instruments in clinical trials was hampered by a lack of sensitivity to changes in health status. Aim: The aim of our study was to qualitatively explore issues of validity, specificity, and sensitivity with regard to the Minnesota Living with Heart Failure (MLHF) questionnaire in patients with severe heart failure. Methods: We included 31 patients with severe heart failure in a 2-year prospective longitudinal case study. Each patient was interviewed two or three times in a semi-structured way, resulting in a total of 76 interviews. We used simple qualitative techniques such as respondent observation and respondent debriefing to collect data on practical and interpretative problems that patients experience in conducting the task of completing the questionnaire. Results: The introduction to the questionnaire, which contains essential instructions, was almost never read. Patients did not interpret items as intended. Some items posed problems to respondents because of their wording or because they were considered not applicable to the respondents' circumstances. Conclusions: Our findings suggest that the MLHF does not measure the concept that it is intended to measure, but our study does not provide a remedy. However, problems regarding individual items and response categories can be remedied.