Patient reported outcome measures for cardiac ablation procedures: a multicentre pilot to develop a new questionnaire

Abstract

AimTo assess the feasibility of administering Patient Reported Outcomes Measures (PROMs) in patients treated with ablation for cardiac arrhythmias, and to conduct the first stage of development and testing of a new PROM tool.Methods and resultsA new tool was developed by a multidisciplinary team and tested alongside an adaptation of the patient perception of arrhythmia questionnaire (PPAQ) and EQ-5D-5L in a multicentre retrospective audit involving 791 consecutive cardiac arrhythmia patients treated with catheter ablation at three UK centres over 13 months. Data were recorded in the National Cardiac Rhythm Management Database, part of the National Institute for Cardiovascular Outcomes Research. The response rate was 71.9% (n = 569). Patients reported significant improvements across all outcomes and impacts, with reductions in symptoms of 51.7% (heart racing), 33.9% (fatigue) 31.8% (heart flutters), 43.5% (dizziness), 38.6% (breathlessness), 44.2% (chest pressure), 33.1% (trouble concentrating), 15.9% (headache), 28.3% (neck pressure), and 23.4% (fainting) (P < 0.001). The mean number of social days affected reduced by 7.49 days/month (P < 0.001); mean work/school days affected/month reduced by 6.26 (P < 0.001); mean GP/hospital visits reduced by 1.36 days/month (P < 0.001). The procedure met patient expectations in 72% of responders.ConclusionsThe high response rate suggests that the use of PROMs in this patient group is feasible, with rates equalling those of the National PROMs Programme. The results showed that patients experienced significant improvements in their quality of life following ablation, while feedback allowed the tools to be improved. Further work is required to validate these tools; however, the findings suggest that PROMs could be useful in the audit of ablation techniques.

Living on a knife edge-the daily struggle of coping with symptomatic cardiac arrhythmias

“…Sessions were tape-recorded with patients’ permission (one patient declined, two were not recorded due to technical issues), with recordings supported by field notes. Interviews used a semi-structured guide based on the draft questionnaire developed by Withers et al [21] and modified utilising feedback from the 2010 multi-centre audit. Using “think-aloud” techniques participants were instructed to read the questionnaire out loud, and verbalise their thoughts, with the interviewer asking probing questions throughout the process.…”

“…In total 791 patients were invited to participate with a response rate of 74 %. Findings indicated many patients quality of life prior to ablation was severely affected by their arrhythmia, with significant impacts on their work, social and family life [21]. Feedback from the audit was used to update and improve the questionnaires.…”

Verifying participant reported clinical outcomes: challenges and implications

“…In both research and in routine health service provision, review of outcomes following medical intervention (including, for example, drug treatment, surgery, psychological interventions) is important to assess the effects of the intervention. These outcomes may include quality of life, disease specific symptoms, impairment, disability, results of laboratory tests, complications of treatment and the need for further treatment [1][2][3].…”

Verifying participant-reported clinical outcomes: challenges and implications

“…In both research and in routine health service provision, a review of outcomes following medical intervention (including, for example, drug treatment, surgery, psychological interventions) is important to assess the effects of the intervention. These outcomes may include quality of life, disease-specific symptoms, impairment, disability, results of laboratory tests, complications of treatment and the need for further treatment [1][2][3].…”