The Italian MacNew heart disease health-related quality of life questionnaire: a validation study
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Patient-centered treatment outcomes such as health-related quality of life are recommended in clinical care and research studies. Health-related quality of life questionnaires need to be validated in the language of the target population. The reliability and validity of the Italian version of the MacNew Questionnaire was determined in patients with angina, myocardial infarction, or ischemic heart failure. Sociodemographic and clinical data were collected on 298 patients [angina, n = 88; MI, n = 106; heart failure, n = 104; mean age, 64.8 (±10.6) years] at three centers in Italy. MacNew mean scores were higher (p < 0.001) in patients with myocardial infarction than in patients with either angina or heart failure with no floor and minimal ceiling effects. The three-factor structure of the original MacNew form was largely confirmed explaining 54.6 % of the total variance. The Italian MacNew version demonstrates high internal consistency reliability (Cronbach’s α ≥ 0.86), confirms the convergent validity hypotheses with strong correlations on six of eight comparisons (r ≥ 0.86), partially confirms discriminative validity with the SF-36 health transition item, and fully confirms discriminative validity with the Hospital Anxiety and Depression Scale. The Italian version of the MacNew Questionnaire demonstrates satisfactory psychometric properties, and is reliable and valid in Italian-speaking patients with angina, MI, or heart failure. Responsiveness could not be tested due to the cross-sectional design of the parent study, and needs to be investigated in an intervention study.
KeywordsHealth-related quality of life Angina Myocardial infarction Heart failure Validity
We thank all the patients who provided extensive personal information, and all those who recruited patients and collected data. The HeartQoL Project received partial funding from the European Society of Cardiology and the European Association of Cardiovascular Prevention and Rehabilitation.
Conflict of interest
None of the authors have a declared conflict of interest.
The procedures followed were in accordance with the 1964 Declaration of Helsinki and its later amendments; the Ethics Committee at each of the study sites approved the project, and informed consent was obtained from all patients.
- 1.Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ (2013) Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation 127(22):2233–2249. doi: 10.1161/CIR.0b013e3182949a2e CrossRefPubMedGoogle Scholar
- 2.Anker SD, Agewall S, Borggrefe M, Calvert M, Jaime Caro J, Cowie MR, Ford I, Paty JA, Riley JP, Swedberg K, Tavazzi L, Wiklund I, Kirchhof P (2014) The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J 35(30):2001–2009. doi: 10.1093/eurheartj/ehu205 CrossRefPubMedGoogle Scholar
- 3.Committee for Medicinal Products for Human Use (2005) Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. European Medicines Agency. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003637. Accessed 12 March 2014
- 4.U.S. Department of Health and Human Services, Food and Drug Administration (2009) Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf Accessed 12 March 2014
- 5.Austrian Government Act (2013) Federal act on Quality of Health services (Gesundheitsqualitätsgesetz), Federal Law Gazette Nr. I 179/2004, amended by Federal Law Gazette Nr. I 81/2013Google Scholar
- 7.Krumholz HM, Peterson ED, Ayanian JZ, Chin MH, DeBusk RF, Goldman L, Kiefe CI, Powe NR, Rumsfeld JS, Spertus JA, Weintraub WS (2005) Report of the National Heart, Lung, and Blood Institute working group on outcomes research in cardiovascular disease. Circulation 111(23):3158–3166CrossRefPubMedGoogle Scholar
- 9.Rector TS, Kubo SH, Cohn JN (1987) Patients’ self-assessment of their congestive heart failure: Part 2. content, reliability, and validity of a new measure, the Minnesota Living with Heart Failure questionnaire. Heart Failure 3:198–209Google Scholar
- 11.Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H, for the HeartQoL Project investigators (2014) 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 21(1):98–106. doi: 10.1177/2047487312450545 CrossRefGoogle Scholar
- 12.Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376CrossRefPubMedGoogle Scholar
- 14.Bellamy N, Buchanan W, Goldsmith C, Campbell J, Stitt L (1988) Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to anti-rheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatology 15(12):1833–1840Google Scholar
- 17.MacNew.org (2013) MacNew health-related quality of life instrument. http://www.macnew.org/wp/. Accessed 12 Mar 2014
- 27.Hays RD, Anderson RT, Revicki D (1998) Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Fayers P (eds) Quality of life assessment in clinical trials: methods and practice. Oxford University Press, New York, pp 169–182Google Scholar
- 33.Dzau VJ, Antman EM, Black HR, Hayes DL, Manson JE, Plutzky J, Popma JJ, Stevenson W (2006) The cardiovascular disease continuum validated: clinical evidence of improved patient outcomes: Part I: Pathophysiology and clinical trial evidence (risk factors through stable coronary artery disease). Circulation 114(25):2850–2870. doi: 10.1161/CIRCULATIONAHA.106.655688 CrossRefPubMedGoogle Scholar
- 34.Reeve BB, Wyrwich KW, Wu AW, Velikova G, Terwee CB, Snyder CF, Schwartz C, Revicki DA, Moinpour CM, McLeod LD, Lyons JC, Lenderking WR, Hinds PS, Hays RD, Greenhalgh J, Gershon R, Feeny D, Fayers PM, Cella D, Brundage M, Ahmed S, Aaronson NK, Butt Z (2013) ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 22(8):1889–1905. doi: 10.1007/s11136-012-0344-y CrossRefPubMedGoogle Scholar
- 37.Pavy B, Iliou M-C, Höfer S, Vergès-Patois B, Corone C, Aeberhard P, Curnier D, Henry J, Ponchon-Weess A, Oldridge N (2014) Validation of the French version of the MacNew Heart Disease Health-related Quality of Life questionnaire. Arch Cardiovasc Dis. doi: 10.1016/j.acvd.2014.09.006 PubMedGoogle Scholar
- 38.Alphin S, Höfer S, Perk J, Slørdahl S, Zwisler A-D, Oldridge N, on behalf of the Scandinavian HeartQoL Project investigators (2015) The MacNew Heart Disease Health-related Quality of Life questionnaire; A Scandinavian validation study. Social Indicators Research (In press)Google Scholar
- 41.Ribera A, Permanyer-Miralda G, Alonso J, Cascant P, Soriano N, Brotons C (2006) Is psychometric scoring of the MacNew Quality of Life after Myocardial Infarction questionnaire superior to the clinimetric scoring? A comparison of the two approaches. Qual Life Res 15(3):357–365CrossRefPubMedGoogle Scholar
- 43.Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H, for the HeartQoL Project investigators (2014) 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 21(1):90–97. doi: 10.1177/2047487312450544 CrossRefGoogle Scholar
- 44.Bakai J, Höfer S, Oldridge N, Lukács M (2011) MacNew Heart Disease Health-related Quality of Life kérdoív magyarországi validálása. Kardiovaskuláris prevenció és rehabilitáció 4(1):13–20Google Scholar