Document Type : Original Article(s)

Authors

1 PhD Candidate, Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

2 Assistant Professor, Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

3 Associate Professor, Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran

4 Associate Professor, Rehabilitation Research Center, Department of Rehabilitation Management, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran

5 Assistant Professor, Department of Cardiovascular Disease, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Abstract

BACKGROUND: Decision making and the quality of care provided for ‎chronic diseases have been shown to improve through patient participation. The HeartQoL questionnaire is a core health-related quality of life (HRQOL) tool specifically designed for individuals with ischemic heart disease (IHD) who have undergone interventions such as cardiac rehabilitation (CR).METHODS: In this observational and multicenter study, 150 patients were recruited. The participants completed the HeartQoL, MacNew Heart Disease Questionnaire,‎ and Short Form Health Survey ‎(SF-36) on entering CR for validity assessment. The HeartQoL along with a Global Rating of Change (GRoC) scale (for responsiveness measurement) were completed by 100 participants 3 months later.RESULTS: The mean age of all participants in validity assessment was 61.87 ± 8.13 years. Cronbach’s alphas of the total scales ranged from 0.70 to 0.81 and of the subscales from 0.70 to 0.82. The Pearson correlation coefficient was used to determine construct validity; similar constructs were confirmed with correlation coefficients ranging from 0.50 to 0.69 and dissimilar constructs with correlation coefficients ranging from 0.28 to 0.29 (P < 0.010). The assessment of the responsiveness of the questionnaire indicated that the area under curve (AUC) was greater than 0.70 (range: 0.74 to 0.91) and the optimal cut-off point was 0.65.CONCLUSION: The Persian version of the HeartQoL questionnaire demonstrated satisfactory psychometric properties in the sample of participants admitted to CR after coronary artery bypass grafting (CABG). The present study results showed that the HRQOL can be used by clinicians and researchers‎ in conjunction with other outcome measures to gain additional information about symptoms relevant to HRQOL in patients referred to CR and to evaluate change over time. 

Keywords

  1. Tardif TC. Coronary artery disease in 2010. European Heart Journal Supplements 2010; 12(suppl_C): C2-C10.
  2. Guilbert JJ. The world health report 2. Educ Health (Abingdon) 2003; 16(2): 230.
  3. Ebrahimi M, Kazemi-Bajestani SM, Ghayour-Mobarhan M, Ferns GA. Coronary artery disease and its risk factors status in Iran: A review. Iran Red Crescent Med J 2011; 13(9): 610-23.
  4. Cepeda-Valery B, Cheong AP, Lee A, Yan BP. Measuring health related quality of life in coronary heart disease: The importance of feeling well. Int J Cardiol 2011; 149(1): 4-9.
  5. Anker SD, Agewall S, Borggrefe M, Calvert M, Jaime CJ, Cowie MR, et al. The importance of patient-reported outcomes: A call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J 2014; 35(30): 2001-9.
  6. Longtin Y, Sax H, Leape LL, Sheridan SE, Donaldson L, Pittet D. Patient participation: Current knowledge and applicability to patient safety. Mayo Clin Proc 2010; 85(1): 53-62.
  7. European Medicines Agency. Regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products [Online]. [cited 2005]; Available from: URL:
  8. https://www.ema.europa.eu/en/regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation-medicinal-products
  9. U.S. Food and Drug. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims [Online]. [cited 2009]; Available from: URL:
  10. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims
  11. Krumholz HM, Peterson ED, Ayanian JZ, Chin MH, DeBusk RF, Goldman L, et al. Report of the National Heart, Lung, and Blood Institute working group on outcomes research in cardiovascular disease. Circulation 2005; 111(23): 3158-66.
  12. Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, et al. Cardiovascular health: The importance of measuring patient-reported health status: A scientific statement from the American Heart Association. Circulation 2013; 127(22): 2233-49.
  13. Cooper JK, Kohlmann T, Michael JA, Haffer SC, Stevic M. Health outcomes. New quality measure for Medicare. Int J Qual Health Care 2001; 13(1): 9-16.
  14. Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: A clarification of its content. BMC Med Res Methodol 2010; 10: 22.
  15. Verrill DE, Barton C, Beasley W, Lippard M, King CN. Six-minute walk performance and quality of life comparisons in North Carolina cardiac rehabilitation programs. Heart Lung 2003; 32(1): 41-51.
  16. Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol 2014; 21(1): 90-7.
  17. Gronset CN, Thygesen LC, Berg SK, Zangger G, Kristensen MS, Sibilitz KL, et al. Measuring HRQoL following heart valve surgery: The HeartQoL questionnaire is a valid and reliable core heart disease instrument. Qual Life Res 2019; 28(5): 1245-53.
  18. Kristensen MS, Zwisler AD, Berg SK, Zangger G, Gronset CN, Risom SS, et al. Validating the HeartQoL questionnaire in patients with atrial fibrillation. Eur J Prev Cardiol 2016; 23(14): 1496-503.
  19. Zangger G, Zwisler AD, Kikkenborg Berg S, Kristensen MS, Gronset CN, Uddin J, et al. Psychometric properties of HeartQoL, a core heart disease-specific health-related quality of life questionnaire, in Danish implantable cardioverter defibrillator recipients. Eur J Prev Cardiol 2018; 25(2): 142-9.
  20. Hojskov IE, Moons P, Hansen NV, La Cour S, Olsen PS, Gluud C, et al. SheppHeartCABG trial-comprehensive early rehabilitation after coronary artery bypass grafting: A protocol for a randomised clinical trial. BMJ Open 2017; 7(1): e013038.
  21. Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol 2014; 21(1): 98-106.
  22. Ranjandish F, Mahmoodi H, Shaghaghi A. Psychometric responsiveness of the health-related quality of life questionnaire (HeartQoL-P) in the Iranian post-myocardial infarction patients. Health Qual Life Outcomes 2019; 17(1): 10.
  23. MacNew. Information [Online]. [cited 2020]; Available from: URL:
  24. http://www.macnew.org/wp/information
  25. Hofer S, Lim L, Guyatt G, Oldridge N. The MacNew Heart Disease health-related quality of life instrument: A summary. Health Qual Life Outcomes 2004; 2: 3.
  26. Asadi-Lari M, Javadi HR, Melville M, Oldridge NB, Gray D. Adaptation of the MacNew quality of life questionnaire after myocardial infarction in an Iranian population. Health Qual Life Outcomes 2003; 1: 23.
  27. Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976) 2000; 25(24): 3130-9.
  28. Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): Translation and validation study of the Iranian version. Qual Life Res 2005; 14(3): 875-82.
  29. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: A review of strengths and weaknesses and considerations for design. J Man Manip Ther 2009; 17(3): 163-70.
  30. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007; 60(1): 34-42.
  31. Aaronson N, Alonso J, Burnam A, Lohr KN, Patrick DL, Perrin E, et al. Assessing health status and quality-of-life instruments: Attributes and review criteria. Qual Life Res 2002; 11(3): 193-205.
  32. Pettersen KI, Kvan E, Rollag A, Stavem K, Reikvam A. Health-related quality of life after myocardial infarction is associated with level of left ventricular ejection fraction. BMC Cardiovasc Disord 2008; 8: 28.
  33. de Vet HC, Terwee CB, Mokkink LB, Knol DL. Measurement in medicine: A practical guide. Cambridge, UK: Cambridge University Press; 2011.
  34. Lehman LA, Velozo CA. Ability to detect change in patient function: Responsiveness designs and methods of calculation. J Hand Ther 2010; 23(4): 361-70.
  35. Mukaka MM. Statistics corner: A guide to appropriate use of correlation coefficient in medical research. Malawi Med J 2012; 24(3): 69-71.
  36. van Kampen DA, Willems WJ, van Beers LW, Castelein RM, Scholtes VA, Terwee CB. Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs). J Orthop Surg Res 2013; 8: 40.
  37. Lee WL, Chinna K, Bulgiba A, Abdullah KL, Abidin IZ, Hofer S. Test-retest reliability of HeartQoL and its comparability to the MacNew heart disease health-related quality of life questionnaire. Qual Life Res 2016; 25(2): 351-7.
  38. Oldridge N, Cho C, Thomas R, Low M, Hofer S. Validation of the English version of the heartqol health-related quality of life questionnaire in patients with coronary heart disease. J Cardiopulm Rehabil Prev 2018; 38(2): 92-9.