Internal and Emergency Medicine

, Volume 10, Issue 3, pp 359–368 | Cite as

The Italian MacNew heart disease health-related quality of life questionnaire: a validation study

  • Francesco FattirolliEmail author
  • Niccolò Marchionni
  • Stefan Höfer
  • Pantaleo Giannuzzi
  • Elisabetta Angelino
  • Paolo Fioretti
  • Daniela Miani
  • Neil Oldridge


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.


Health-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.

Ethical standard

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. 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. 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. 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. Accessed 12 March 2014
  4. 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. Accessed 12 March 2014
  5. 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
  6. 6.
    Testa MA, Simonson DC (1996) Assessment of quality of life outcomes. N Engl J Med 334(13):835–840CrossRefPubMedGoogle Scholar
  7. 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
  8. 8.
    Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD (1994) Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol 74(12):1240–1244CrossRefPubMedGoogle Scholar
  9. 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
  10. 10.
    Höfer S, Saleem A, Stone J, Thomas RJ, Tulloch H, Oldridge N (2012) The MacNew Heart Disease Health-related Quality of Life questionnaire in patients with angina and patients with ischemic heart failure. Value in Health 15:147–150CrossRefGoogle Scholar
  11. 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. 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
  13. 13.
    Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J et al (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11(3):570–579PubMedGoogle Scholar
  14. 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
  15. 15.
    Lim LL-Y, Valenti LA, Knapp JC, Dobson AJ, Plotnikoff R, Higginbotham N, Heller RF (1993) A self-administered quality of life questionnaire after acute myocardial infarction. J Clin Epidemiol 46(11):1249–1256CrossRefPubMedGoogle Scholar
  16. 16.
    Valenti L, Lim L, Heller RF, Knapp J (1996) An improved questionnaire for assessing quality of life after myocardial infarction. Qual Life Res 5(1):151–161CrossRefPubMedGoogle Scholar
  17. 17. (2013) MacNew health-related quality of life instrument. Accessed 12 Mar 2014
  18. 18.
    Oldridge N, Saner H, McGee HM (2005) The Euro Cardio-QoL Project. An international study to develop a core heart disease health-related quality of life questionnaire, the HeartQoL. Eur J Cardiovasc Prev Rehabil 12(2):87–94PubMedGoogle Scholar
  19. 19.
    Ware JE Jr (2000) SF-36 health survey update. Spine 25(24):3130–3139CrossRefPubMedGoogle Scholar
  20. 20.
    Bjelland I, Dahl AA, Haug TT, Neckelmann D (2002) The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 52(2):69–77CrossRefPubMedGoogle Scholar
  21. 21.
    Apolone G, Mosconi P (1998) The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 51(11):1025–1036CrossRefPubMedGoogle Scholar
  22. 22.
    Costantini M, Musso M, Viterbori P, Bonci F, Del Mastro L, Garrone O, Venturini M, Morasso G (1999) Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer 7(3):121–127CrossRefPubMedGoogle Scholar
  23. 23.
    Oldridge N, Guyatt G, Jones N, Crowe J, Singer J, Feeny D, McKelvie R, Runions J, Streiner D, Torrance G (1991) Effects on quality of life with comprehensive rehabilitation after acute myocardial infarction. Am J Cardiol 67(13):1084–1089CrossRefPubMedGoogle Scholar
  24. 24.
    Dixon T, Lim L, Oldridge N (2002) The MacNew health-related quality of life instrument: Reference data for users. Qual Life Res 11(2):173–183CrossRefPubMedGoogle Scholar
  25. 25.
    Scientific Advisory Committee of Medical Outcomes Trust (2002) Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 11(3):193–205CrossRefGoogle Scholar
  26. 26.
    Steiger JH (1980) Tests for comparing elements of a correlation matrix. Psychol Bull 87:245–251CrossRefGoogle Scholar
  27. 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
  28. 28.
    Höfer S, Benzer W, Schussler G, von Steinbuchel N, Oldridge NB (2003) Health-related quality of life in patients with coronary artery disease treated for angina: validity and reliability of German translations of two specific questionnaires. Qual Life Res 12(2):199–212CrossRefPubMedGoogle Scholar
  29. 29.
    Höfer S, Benzer W, Brandt D, Laimer H, Schmid P, Bernardo A, Oldridge N (2004) MacNew Heart Disease questionnaire after myocardial infarction: The German version. Zeitschrift Klinische Psychol Psychother 33(4):270–280CrossRefGoogle Scholar
  30. 30.
    Maes S, De Gucht V, Goud R, Hellemans I, Peek N (2008) Is the MacNew quality of life questionnaire a useful diagnostic and evaluation instrument for cardiac rehabilitation? Eur J Cardiovasc Prev Rehabil 15(5):516–520. doi: 10.1097/HJR.0b013e328303402b CrossRefPubMedGoogle Scholar
  31. 31.
    Yu DS, Thompson DR, Yu CM, Oldridge NB (2008) Validation of the Chinese version of the MacNew heart disease health-related quality of life questionnaire. J Eval Clin Pract 14(2):326–335CrossRefPubMedGoogle Scholar
  32. 32.
    Vandereyt F, Dendale P, Vanhees L, Roosen J, Höfer S, Oldridge N (2012) Psychometric properties of the Flemish version of the MacNew heart disease health-related quality of Life questionnaire. Acta Cardiol 67(1):31–39PubMedGoogle Scholar
  33. 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. 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
  35. 35.
    Barton JL, Imboden J, Graf J, Glidden D, Yelin EH, Schillinger D (2010) Patient-physician discordance in assessments of global disease severity in rheumatoid arthritis. Arthritis Care Res (Hoboken) 62(6):857–864. doi: 10.1002/acr.20132 CrossRefGoogle Scholar
  36. 36.
    Subramanian U, Weiner M, Gradus-Pizlo I, Wu J, Tu W, Murray MD (2005) Patient perception and provider assessment of severity of heart failure as predictors of hospitalization. Heart Lung 34(2):89–98. doi: 10.1016/j.hrtlng.2004.05.002 CrossRefPubMedGoogle Scholar
  37. 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. 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
  39. 39.
    Leal A, Paiva C, Höfer S, Amado J, Gomes L, Oldridge N (2005) Evaluative and discriminative properties of the Portuguese MacNew health-related quality of life questionnaire. Qual Life Res 14(10):2335–2341CrossRefPubMedGoogle Scholar
  40. 40.
    Dempster M, Donnelly M, O’Loughlin C (2004) The validity of the MacNew Quality of Life in heart disease questionnaire. Health Qual Life Outcomes 2(1):6CrossRefPubMedCentralPubMedGoogle Scholar
  41. 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
  42. 42.
    Asadi-Lari M, Javadi H, Melville M, Oldridge N, Gray D (2003) Adaptation and administration of the MacNew quality of life questionnaire after myocardial infarction in an Iranian population. Health and Qual Life 1:23CrossRefGoogle Scholar
  43. 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. 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
  45. 45.
    Höfer S, Lim LL, Guyatt GH, Oldridge N (2004) The MacNew Heart Disease Health-related Quality of Life Instrument: A Summary. Health Qual Life Outcomes 2(1):3CrossRefPubMedCentralPubMedGoogle Scholar

Copyright information

© SIMI 2015

Authors and Affiliations

  • Francesco Fattirolli
    • 1
    Email author
  • Niccolò Marchionni
    • 1
  • Stefan Höfer
    • 2
  • Pantaleo Giannuzzi
    • 3
  • Elisabetta Angelino
    • 3
  • Paolo Fioretti
    • 4
  • Daniela Miani
    • 4
  • Neil Oldridge
    • 5
  1. 1.Department of Experimental and Clinical MedicineUniversity of Florence and Azienda Ospedaliero Universitaria CareggiFlorenceItaly
  2. 2.Department of Medical PsychologyInnsbruck Medical UniversityInnsbruckAustria
  3. 3.Salvatore Maugeri FoundationIRCCS, Scientific Institutes of Torino and VerunoVerunoItaly
  4. 4.Azienda Ospedaliero Universitaria S. Maria della Misericordia and IRCAB FoundationUdineItaly
  5. 5.College of Health SciencesUniversity of Wisconsin-MilwaukeeWisconsinUSA

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