Establishing content validity in a novel patient reported outcome measure for cardiac arrhythmia ablation patients

AIM: Preliminary content validity testing of a UK Patient Reported Outcome Measure (PROM) for use in cardiac arrhythmia patients undergoing ablation treatment. METHODS: Twenty five patients diagnosed with symptomatic cardiac arrhythmias participated in qualitative interviews to obtain their perspective of a draft PROM. As part of the process to establish preliminary content validity, patients were asked to complete the questionnaires and to identify missing and redundant items within the PROM, while also reviewing the instructions and formatting. The questionnaires were updated iteratively to reflect patient feedback. RESULTS: Recurring themes were identified during qualitative interviews leading to improvements to the tool. Following modification of the PROM, based on patient feedback, subjects reported that the tool was fully inclusive and easy to comprehend. Patients found the instructions and layout of the tool acceptable and easy to use. CONCLUSION: Qualitative patient interviews are an important part of PROM tool development. In the case of this cardiac ablation PROM, it enabled end users to assess the tool for inclusivity and accessibility, and to ensure that it addressed concerns important to the patient. Cognitive interviews were able to obtain patients’ perspectives to establish face validity and content validity of the PROM. This is part of a process which will ensure that this disease-specific PROM measures cardiac arrhythmia patient symptoms and impact on patients’ lives accurately and sensitively. The next study will use the PROM prospectively in over 450 arrhythmia patients to prospectively validate the tool. CONDENSED ABSTRACT: Patients diagnosed with symptomatic cardiac arrhythmias provided feedback through cognitive interviews to facilitate improvements in a new disease specific PROM establishing preliminary face and content validity.