title: 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.
abstract: 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)].
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Cedar, Cardiff University, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK. Judith.white3@wales.nhs.uk.
authors.forename: Judith
authors.initials: J
authors.lastname: White
authors.affiliation: Cedar, Cardiff & Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK.
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Withers
authors.affiliation: University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
authors.forename: Mauro
authors.initials: M
authors.lastname: Lencioni
authors.affiliation: Cedar, Cardiff & Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK.
authors.forename: Grace
authors.initials: G
authors.lastname: Carolan-Rees
authors.affiliation: Cedar, Cardiff & Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK.
authors.forename: Antony R
authors.initials: AR
authors.lastname: Wilkes
authors.affiliation: Duke University School of Nursing, 307 Trent Drive, DUMC 3322, Durham, NC, 27710, USA.
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Wood
authors.affiliation: National Institute for Health and Care Excellence, 10 Spring Gardens, London, SW1A 2BU, UK.
authors.forename: Hannah
authors.initials: H
authors.lastname: Patrick
authors.affiliation: National Institute for Cardiovascular Outcomes Research (NICOR), UCL Institute of Cardiovascular Science, 3rd Floor 170 Tottenham Court Road, London, W1T 7HA, UK.
authors.forename: David
authors.initials: D
authors.lastname: Cunningham
authors.affiliation: University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Griffith
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D017115:Catheter Ablation / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D006113:United Kingdom
keywords: Arrhythmia; Cardiac ablation; Patient-reported outcome measures (PROMs); Quality of life (QoL); Questionnaires; Validation