VALIDATION OF THE MACNEW QUESTIONNAIRE FOR THE ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH ISHEMIC HEART DISEASE

Background. Recently, a greater emphasis is being placed on health-related quality of life (HRQL) in both global and Russian practice. In many countries HRQL in patients with ischemic heart disease (IHD) is assessed by a disease-specific questionnaire – The MacNew Heart Disease HRQL questionnaire (MacNew) – that has been validated in many countries, but not yet in Russia.

Aim. To validate Russian MacNew questionnaire in patients with different clinical types of ICD.

Material and methods. Direct and reverse translation of the MacNew questionnaire was performed in accordance with the protocol of international HeartQol study. The patients (n=322) with angina, myocardial infarction, and heart failure were enrolled into the study and completed the Short-Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HADS) and the Mac-New at the baseline; approximately 20% of the patients were reexamined 2 weeks later. The conceptual framework, reliability and validity of the Russian version of MacNew HRQL questionnaire were assessed.

Results. The Russian version of MacNew questionnaire demonstrated sufficient internal consistency with Cronbach’s α exceeding 0.80. High test-retest reliability of the questionnaire was established in the total sample of ICD patients (0.949; p<0.01). Factor analysis in general substantiated the conceptual model of the Russian version of MacNew and its satisfactory content validity. Convergent validity was confirmed by strong correlations between the subscales of Russian MacNew questionnaire and conceptually similar subscales of the SF-36 survey (in the total sample and in separated clinical groups. Discriminant validity of the Russian version of MacNew was also confirmed differentiating patients with different SF-36 health transition and patients with and without anxiety and depression (HADS questionnaire).

Conclusions. The Russian version of MacNew HRQL questionnaire has demonstrated adequate reliability and validity as compared with the original method. It can be recommended for the assessment of life quality in Russian-speaking patients with various types of ICD in daily clinical practice and research work.

1. Asadi-Lari M., Tamburini M., Gray D. Patient’s needs, satisfaction, and health-related quality of life: Towards a comprehensive model. Health Qual Life Outcomes 2004;2: 32.

2. Anker SD, Agewall S, Borggrefe M, Calvert M, Jaime Caro J, Cowie MR, et al. The importance of patientreported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J. 2014;35:2001-9.

3. Shevchenko JL, ed. Quality of life research in medicine: a textbook for high schools. Moscow: GEOTARMED; 2004. Russian (Шевченко Ю.Л., ред. Исследование качества жизни в медицине: учебное пособие для вузов. М.: ГЭОТАР-МЕД; 2004).

4. Perk J, de Backer BG, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C,Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G,Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL,Zannad F. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J 2012; 33: 1635-1701

5. Oganov RG, Boytsov SA. National guidelines for cardiovascular prevention. Kardiovaskulyarnaya Terapiya i Profilaktika 2011; 10 (6) suppl 2: 1-64. Russian (Оганов Р.Г., Бойцов С.А. Национальные рекомендации по кардиоваскулярной профилактике. Кардиоваскулярная Терапия и Профилактика 2011; 10(6) приложение 2: 1-64).

6. Testa MA, Simonson DC. Assessment of quality of life outcomes. N Engl J Med 1996;334:835-40.

7. Ware JE, Jr. SF-36 health survey update. Spine. 2000;25:3130-9.

8. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11:570-9

9. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994;74:1240-4

10. Rector TS, Kubo SH, Cohn JN. 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. 1987;3:198-209

11. Oldridge N, Guyatt G, Jones N, Crowe J, Singer J, Feeny D, et al. Effects on quality of life with comprehensive rehabilitation after acute myocardial infarction. Am J Cardiol. 1991;67:1084-9;

12. Hillers TK, Guyatt GH, Oldridge N, Crowe J, Willan A, Griffith L, et al. Quality of life after myocardial infarction. J Clin Epidemiol. 1994;47:1287-96.

13. Lim LL-Y, Valenti LA, Knapp JC, Dobson AJ, Plotnikoff R, Higginbotham N, et al. A self-administered quality of life questionnaire after acute myocardial infarction. J Clin Epidemiol. 1993;46:1249-56;

14. Valenti L, Lim L, Heller RF, Knapp.J. An improved questionnaire for assessing quality of life after myocardial infarction. Qual Life Res. 1996;5:151-61

15. MacNew.org. MacNew health-related quality of life instrument. 2013 (Accessed 12 March 2014). Available from: http://www.macnew.org/wp/.

16. Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H, et al. 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;21:90-7

17. Novik AA, Ionova TI. Guide to study the quality of life in medicine. SPb.: Publishing House Neva; Moscow: Olma-Press Star World; 2002. Russian (Новик А. А., Ионова Т. И. Руководство по исследованию качества жизни в медицине. СПб.: Издательский Дом Нева; М.: ОЛМА-ПРЕСС Звездный мир; 2002).

18. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361-70

19. Andryushenko AV, Drobizhev MY, Dobrovolsky AV. Comparative assessment scale CES-D, BDI and HADS (d) in the diagnosis of depression in general practice. Zhurnal Nevrologii i Psikhiatrii 2003; 5: 11-7. Russian (Андрюшенко А.В., Дробижев М.Ю., Добровольский А.В. Сравнительная оценка шкал CES-D, BDI и HADS(d) в диагностике депрессий в общемедицинской практике. Журнал Неврологии и Психиатрии 2003; 5: 11-7).

20. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52:69-77.

21. Höfer S, Lim LL, Guyatt GH, Oldridge N. The MacNew Heart Disease Health-related Quality of Life Instrument: A Summary. Health Qual Life Outcomes. 2004;2:3

22. Dixon T, Lim L, Oldridge N. The MacNew health-related quality of life instrument: Reference data for users. Qual Life Research. 2002;11:173-83.

23. Bullinger M, Alonso J, Apolone G, Leplege A, Sullivan M, Wood-Dauphinee S, et al. Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:913-23

24. Scientific Advisory Committee of Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11:193-205

25. Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Assoc.; 1988

26. Hays RD, Anderson RT, Revicki D. Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Fayers P, editors. Quality of Life Assessment in Clinical Trials: Methods and Practice. New York: Oxford University Press; 1998. p. 169-82

27. Oldridge N, Saner H, McGee HM. 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. 2005;12:87-94.