Cardiff cardiac ablation patient-reported outcome measure (C-CAP): validation of a new questionnaire set for patients undergoing catheter ablation for cardiac arrhythmias in the UK

Judith White; Kathleen L Withers; Mauro Lencioni; Grace Carolan-Rees; Antony R Wilkes; Kathryn A Wood; Hannah Patrick; David Cunningham; Michael Griffith

doi:10.1007/s11136-015-1194-1

Cardiff cardiac ablation patient-reported outcome measure (C-CAP): validation of a new questionnaire set for patients undergoing catheter ablation for cardiac arrhythmias in the UK

Qual Life Res. 2016 Jun;25(6):1571-83. doi: 10.1007/s11136-015-1194-1. Epub 2015 Dec 10.

Authors

Judith White¹, Kathleen L Withers², Mauro Lencioni³, Grace Carolan-Rees², Antony R Wilkes², Kathryn A Wood⁴, Hannah Patrick⁵, David Cunningham⁶, Michael Griffith³

Affiliations

¹ Cedar, Cardiff University, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK. Judith.white3@wales.nhs.uk.
² Cedar, Cardiff & Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK.
³ University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
⁴ Duke University School of Nursing, 307 Trent Drive, DUMC 3322, Durham, NC, 27710, USA.
⁵ National Institute for Health and Care Excellence, 10 Spring Gardens, London, SW1A 2BU, UK.
⁶ National Institute for Cardiovascular Outcomes Research (NICOR), UCL Institute of Cardiovascular Science, 3rd Floor 170 Tottenham Court Road, London, W1T 7HA, UK.

Abstract

Purpose: To formally test and validate a patient-reported outcome measure (PROM) for patients with cardiac arrhythmias undergoing catheter ablation procedures in the UK [Cardiff Cardiac Ablation PROM (C-CAP)].

Methods: A multicentre, prospective, observational cohort study with consecutive patient enrolment from three UK sites was conducted. Patients were sent C-CAP questionnaires before and after an ablation procedure. Pre-ablation C-CAP1 (17 items) comprised four domains: patient expectations; condition and symptoms; restricted activity and healthcare visits; medication and general health. Post-ablation C-CAP2 (19 items) comprised five domains including change in symptoms and procedural complications. Both questionnaires also included the generic EQ-5D-5L tool (EuroQol). Reliability, validity, and responsiveness measures were calculated.

Results: A total of 517 valid pre-ablation and 434 post-ablation responses were received; questionnaires showed good feasibility and item acceptability. Internal consistency was good (Cronbach's alpha >0.7) and test-retest reliability was acceptable for all scales. C-CAP scales showed high responsiveness (effect size >0.8). Patients improved significantly (p < 0.001) following ablation across all disease-specific and global scales. Minimal clinically important difference was calculated. Improvement beyond the smallest detectable change of 9 points (symptom severity scale), 3 points (frequency and duration of symptoms scale), and 8 points (impact on life scale) indicates an important change. Amendments to the C-CAP questionnaires were identified through the validation process and made to produce the final tools.

Conclusions: The final C-CAP questionnaires are valid, reliable, and responsive tools for measuring symptom change, impact, and expectations in patients undergoing ablation for cardiac arrhythmias. C-CAP questionnaires provide a tool with disease-specific and generic domains to explore how cardiac ablation procedures in the UK impact upon patients' lives.

Keywords: Arrhythmia; Cardiac ablation; Patient-reported outcome measures (PROMs); Quality of life (QoL); Questionnaires; Validation.

Publication types

Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Aged
Arrhythmias, Cardiac / therapy*
Catheter Ablation / psychology*
Female
Humans
Male
Middle Aged
Patient Reported Outcome Measures*
Prospective Studies
Psychometrics / instrumentation*
Quality of Life / psychology*
Reproducibility of Results
Surveys and Questionnaires*
United Kingdom