Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Quality of Life Research
Published in: Quality of Life Research 6/2016

Open Access 01-06-2016

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

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

Published in: Quality of Life Research | Issue 6/2016

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Withers, K. L., White, J., Carolan-Rees, G., Patrick, H., Callaghan, P., Murray, S., et al. (2014). Patient reported outcome measures for cardiac ablation procedures: A multicentre pilot to develop a new questionnaire. Europace, 16(11), 1626–1633.CrossRefPubMedPubMedCentral
2.
Thrall, G., Lane, D., Carroll, D., & Lip, G. Y. H. (2006). Quality of life in patients with atrial fibrillation: A systematic review. American Journal of Medicine, 119(5), 448.CrossRefPubMed
3.
Stewart, S., Murphy, N., Walker, A., McGuire, A., & McMurray, J. J. V. (2004). Cost of an emerging epidemic: An economic analysis of atrial fibrillation in the UK. Heart, 90(3), 286–292.CrossRefPubMedPubMedCentral
4.
Aliot, E., Botto, G. L., Crijns, H. J., & Kirchhof, P. (2014). Quality of life in patients with atrial fibrillation: How to assess it and how to improve it. Europace, 16(6), 787–796.CrossRefPubMed
5.
Black, N. (2013) Patient reported outcome measures could help transform healthcare. BMJ, 346, f167.
6.
Arribas, F., Ormaetxe, J. M., Peinado, R., Perulero, N., Ramirez, P., & Badia, X. (2010). Validation of the AF-QoL, a disease-specific quality of life questionnaire for patients with atrial fibrillation. Europace, 12(3), 364–370.CrossRefPubMed
7.
Fayers, P. M., & Machin, D. (2007). Quality of life: The assessment, analysis and interpretation of patient-reported outcomes (2nd ed.). Chichester: Wiley.CrossRef
8.
Withers, K. L., Wood, K. A., Carolan-Rees, G., Patrick, H., Lencioni, M., & Griffith, M. (2015). Establishing content validity in a novel patient reported outcome measure for cardiac arrhythmia ablation patients. Health and Quality of Life Outcomes, 13, 38.CrossRefPubMedPubMedCentral
9.
Browne, J., Jamieson, L., Lewsey, J., van der Meulen, J., Black, N., Cairns, J., et al. (2007). Patient reported outcome measures (PROMs) in elective surgery: Report to the Department of Health. London School of Hygiene and Tropical Medicine.
10.
Herdman, M., Gudex, C., Lloyd, A., Janssen, M. F., Kind, P., Parkin, D., et al. (2011). Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality of Life Research, 20(10), 1727–1736.CrossRefPubMedPubMedCentral
11.
Janssen, M. F., Simon Pickard, A., Golicki, Dominik, Gudex, Claire, Niewada, Maciej, Scalone, Luciana, et al. (2013). Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Quality of Life Research, 22(7), 1717–1727.CrossRefPubMedPubMedCentral
12.
Terwee, C. B., Bot, D. M., de Boer, M. R., van der Windt, D. A. W. M., Knol, D. L., Dekker, J., et al. (2007). Quality criteria were proposed for measurement properties of health status questionnaires. Journal of Clinical Epidemiology, 60(1), 34–42.CrossRefPubMed
13.
Bland, M. J., & Altman, D. G. (1986). Statistical methods for assessing agreement between two methods of clinical measurement. Lancet, 327(8476), 307–310.CrossRef
14.
Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of Clinical Epidemiology, 56(5), 395–407.CrossRefPubMed
15.
Beckerman, H., Roebroeck, M. E., Lankhorst, G. J., Becher, J. G., Bezemer, P. D., & Verbeek, A. L. M. (2001). Smallest real difference, a link between reproducibility and responsiveness. Quality of Life Research, 10(7), 571–578.CrossRefPubMed
16.
Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status: Ascertaining the minimal clinically important difference. Controlled Clinical Trials, 10(4), 407–415.CrossRefPubMed
17.
Barefoot, J. C., Brummett, B. H., Williams, R. B., Siegler, I. C., Helms, M. J., Boyle, S. H., et al. (2011). Recovery expectations and long-term prognosis of patients with coronary heart disease. JAMA Internal Medicine, 171(10), 929–935.
18.
McHorney, C. A., & Tarlov, A. R. (1995). Individual-patient monitoring in clinical practice: Are available health status surveys adequate? Quality of Life Research, 4(4), 293–307.CrossRefPubMed
19.
de Vet, H., Terwee, C., Ostelo, R., Beckerman, H., Knol, D., & Bouter, L. (2006). Minimal changes in health status questionnaires: Distinction between minimally detectable change and minimally important change. Health and Quality of Life Outcomes, 4(1), 54.CrossRefPubMedPubMedCentral
20.
Lin, K., Fu, T., Wu, C., & Hsieh, C. (2011). Assessing the stroke-specific quality of life for outcome measurement in stroke rehabilitation: Minimal detectable change and clinically important difference. Health and Quality of Life Outcomes, 9(1), 5.CrossRefPubMedPubMedCentral
21.
Wood, K. A., Stewart, A. L., Drew, B. J., Scheinman, M. M., & Frolicher, E. S. (2009). Development and initial psychometric evaluation of the Patient Perspective of Arrhythmia Questionnaire. Research in Nursing & Health, 32(5), 504–516.CrossRef
Metadata
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
Authors
Judith White
Kathleen L. Withers
Mauro Lencioni
Grace Carolan-Rees
Antony R. Wilkes
Kathryn A. Wood
Hannah Patrick
David Cunningham
Michael Griffith
Publication date
01-06-2016
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 6/2016
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-015-1194-1

Other articles of this Issue 6/2016

Quality of Life Research 6/2016 Go to the issue

OriginalPaper

Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation

Review

Quality of life among patients after bilateral prophylactic mastectomy: a systematic review of patient-reported outcomes

OriginalPaper

Using the Three-Step Test Interview to understand how patients perceive the St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C)

OriginalPaper

Quality of life in patients with chronic venous disease in Turkey: influence of different treatment modalities at 6-month follow-up

OriginalPaper

Health-related quality of life in Parkinson’s: impact of ‘off’ time and stated treatment preferences

Special Section: Response Shift Effects at Item Level (by invitation only)

An item-level response shift study on the change of health state with the rating of asthma-specific quality of life: a report from the PROMIS® Pediatric Asthma Study