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01-06-2016 | Uitgave 6/2016 Open Access

Quality of Life Research 6/2016

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

Tijdschrift:
Quality of Life Research > Uitgave 6/2016
Auteurs:
Judith White, Kathleen L. Withers, Mauro Lencioni, Grace Carolan-Rees, Antony R. Wilkes, Kathryn A. Wood, Hannah Patrick, David Cunningham, Michael Griffith
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (doi:10.​1007/​s11136-015-1194-1) contains supplementary material, which is available to authorized users.
Work was done at University Hospital of Wales, Cardiff, UK; Queen Elizabeth Hospital, Birmingham, UK; Freeman Hospital, Newcastle-upon-Tyne, 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.

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Extra materiaal
Supplementary material 1 (PDF 158 kb)
11136_2015_1194_MOESM1_ESM.pdf
Supplementary material 2 (PDF 239 kb)
11136_2015_1194_MOESM2_ESM.pdf
Literatuur
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