Abstract
The increasing use of so-called quality of life assessments in clinical trials can be seen as a laudable attempt to gather information about the impact of treatment on patients which goes beyond the purely clinical. However, there is a growing tendency for pharmaceutical companies to use quality of life claims in marketing strategies. The varying protocols and study populations, together with multicentre and multicountry trials and the variety of implied definitions of quality of life raise serious issues concerning the scientific credibility of conclusions about quality of life as an endpoint. This paper reviews reports of randomized controlled trials of anti-hypertensive therapy which used ‘quality of life’, assessed by patient-completed questionnaires, as one of the outcome variables. Criteria referring to definitions of quality of life, the validity and reliability of the measures used, administration procedures, treatment of data, adequacy of discussion of alternative explanations of the findings and the legitimacy of the findings are spelled out. It is concluded that none of the studies reviewed were justified in the claims made concerning differential effects of therapies on ‘quality of life’.
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References
Medical Research Council Working Party. MRS trial of treatment of mild hypertension: principal results. BMJ 1985; 291: 97-204.
Heller R, Rose G. Current management of hypertension in general practice. BMJ 1977; 1: 1442-1444.
Medical Research Council Working Party. Adverse effects to bendrofluazide and propranolol for the treatment of mild hypertension. Lancet 1981; 2:539-543.
Solomon S, Hotchkiss E, Saravay S, Bayer C, Ramsey P, Blum R. Impairment of memory function by anti-hypertensive medication. Arch Gen Psychiat 1983; 40: 1109-1112.
McGee H, O'Boyle C, Hickey A. Assessing the quality of life of the individual: the SEIQoL with a healthy and a gastroenterology unit population. Psychol Med 1991; 21: 749-759.
Hunt S, McKenna S. The QLDS: A scale for the measurement of quality of life in depression. Health Policy 1992; 22: 307-319.
Grimley Evans J. Quality of life assessments and elderly people. In: Hopkins A, ed. Do We Need Measures Other than QALYS ?London, UK: Royal College of Physicians of London, 1992: 107-116.
Grimley Evans J. The sanctity of life. In: Elford J, ed. Medical Ethics and Elderly People. Edinburgh, UK: Churchill Livingstone, 1987: 16-25.
Hodge J. The quality of life: a contrast between utilitarian and existential approaches. In: Baldwin S, ed. Quality of Life; Perspectives and Policies. London, UK: Routledge, 1990: 119-128.
Hunt SM. Measuring health in clinical care and clinical trials. In: Teeling Smith G, ed. Measuring Health: APractical Approach.Chichester: John Wiley & Sons, 1988: 7-14.
Bergner M. Quality of life, health status and clinical research. Med Care Suppl 1989; 27: S148-S156.
McDowell I, Newell C. Measuring Health: a Guide to Rating Scales and Questionnaires. London, UK: Oxford University Press, 1989.
Streiner DL, Norman GR. Health Measurement Scales.Oxford: Oxford University Press, 1989.
Hunt SM, Alonso J, Bucquet D, Niero M, Wiklund I, McKenna S. Cross-cultural adaptation of health measures. Health Policy 1991; 19: 33-44.
Hunt SM Cross-cultural comparability of quality of life. Brit J Med Econ 1992; 4: 395-400.
Nunnally JC. Psychometric Theory.2nd Edition. New York, NY (USA): McGraw-Hill, 1978.
Fletcher AE, Chester PC, Hawkins CMA, Latham AN, Pike LA, Bulpitt CJ. The effects of verapamil and propranolol on quality of life in hypertension. J Hum Hypert 1989; 3: 125-130.
Herrick AL, Waller PC, Berkin KE, et al. Comparison of enalapril and atenolol in mild to moderate hypertension. Amer J Med 1989; 86: 421-426.
Croog S, Kong W, Levine S, Weir MR, Baume RM, Saunders E. Hypertensive black men and women. Quality of life and effects of hypertensive medications. Arch Int Med 1990; 150: 1733-1741.
Blumenthal J, Ekelund L-G, Emery C. Quality of life among hypertensive patients with a diuretic background who are taking atenolol and enalapril. Clin Pharmacol Ther 1990; 48: 447-454.
Palmer A, Fletcher A, Hamilton G, Muriss S, Bulpitt C. A comparison of verapamil and nifedipine on quality of life. Brit J Clin Pharmacol 1990; 30: 365-370.
Steiner SS, Friedhoff AJ, Wilson BL, Wecker JR, Santo JP. Antihypertensive therapy and quality of life: a comparison of atenolol, captopril and propranolol. J Hum Hypert 1990; 4: 217-225.
Fletcher AE, Bulpitt CJ, Hawkins CM, et al. Quality of life on antihypertensive therapy: a randomized double-blind controlled trial of captopril and atenolol. J Hypert 1990; 8: 463-466.
Frimodt-Moeller J, Poulsen DL, Kornerup HJ, Bech P. Quality of life, side effects and efficacy of lisiopril compared with metoprolol in patients with mild to moderate essential hypertension. J Hum Hypert 1991; 5: 215-221.
Weir MR, Josselson J, Ekelund L-G, et al. Nicardipine as antihypertensive monotherapy: positive effects on quality of life. J Hum Hypert 1991; 5: 205-213.
Ameling EH, de Korte DF, Man in 't Veld AJ. Impact of diagnosis and treatment of hypertension on quality of life: a double-blind randomized placebo-controlled crossover study of betaxolol. J Cardiovasc Pharmacol 1991; 18: 752-760.
Applegate WB, Phillips HL, Schnaper H, et al. A randomized controlled trial of the effects of three antihypertensive agents on blood pressure control and quality of life in older women. Arch Int Med 1991; 151: 1817-1823.
Jern S, Hansson L, Schersten B, et al. Swedish isradipine study in hypertension: evaluation of quality of life, safety and efficacy. JCardiovasc Pharmacol 1991; 18( Suppl): S7-S8.
Wassertheil-Smoller S, Blaufox D, Oberman A, et al. Effect of anti-hypertensives on sexual function and quality of life: The TAIM study. Ann Int Med 1991; 8: 613-662.
Fletcher A, Beevers D, Dollery C, Wilkinson R, Bulpitt CJ. The effects of two centrally acting anti-hypertensive drugs on the quality of life. Eur J Clin Pharmacol 1991; 41: 397-400.
Testa MA, Hollenberg NK, Anderson RB, Williams GH. Assessment of quality of life by patient and spouse during antihypertensive therapy with atenolol and nifedipine gastrointestinal therapeutic system. Am J Hypert 1991; 4: 363-373.
Dahlof C, Hedner T, Thulin T, Gustafsson S, Olsson S-O. Effects of diltiazem and metoprolol on blood pressure, adverse symptoms and general well-being. Euro J Clin Pharmacol 1991; 40: 453-460.
Hunter Hypertension Research Group. Well-being and its measurement in hypertension: a randomized double blind crossover comparison of 5mg clopamide with 25mg hydrochlorothiazide. Clin Exper Hyper Theory Practice 1991; A13: 189-195.
Os I, Bratland B, Dahlof B, Gisholt K, Syvertsen J-O, Tretli S. Lisinopril or nifedipine in essential hypertension? A Norwegian multicentre study on efficacy, tolerability and quality of life in 828 patients. J Hypert 1991; 9: 1097-1104.
Wassertheil-Smoller S, Oberman A, Blaufox D, Davis, B Langford H. The trial of antihypertensive interventions and management (TAIM) study: Final results with regard to blood pressure, cardiovascular risk and quality of life. Am J Hypert 1992; 5: 37-44.
Fletcher A, Battersby C, Adnitt P, Underwood N, Jurgensen HJ, Bulpitt CJ. Quality of life on antihypertensive therapy: a double blind trial comparing quality of life on pinacidil and nifedipine in combination with a thiazide diuretic. J Cardiovasc Pharmacol 1992; 20: 108-114.
Dahlof C, Dimenas E. General well-being during treatment with different ACE inhibitors: two double blind placebo controlled cross over studies in healthy volunteers. Eur J Clin Pharmacol 1992; 43: 375-379.
Kostis JB, Rosen RC, Brondolo E, Taska L, Smith DE, Wilson AC. Superiority of nonpharmacological therapy compared to propranolol and placebo in men with mild hypertension: a randomized prospective study. Amer Heart J 1992; 123: 466-474.
Bursztyn M, Ghanem J, Kobrin I, Fidel J, Ben-Ishay D. Comparison of verapamil and captopril in elderly hypertensive subjects: results of a randomized double-blind crossover study. J Cardiovasc Pharmacol 1993; 21: 84-88.
Omvik P, Thaulow E, Herland O, Eide I, Midha R, Turner RR. Double blind parallel comparative study on quality of life during treatment with amlodipine or enalapril in mild or moderate hypertensive patients: a multicentre study. J Hypert 1993; 11: 103-113.
Fletcher A, Bulpitt CJ, Chase DM, et al. Quality of life with three antihypertensive treatments: cilazapril, atenolol, nifedipine. Hypertension 1993; 19: 499-507.
Testa MA, Anderson RB, Nackley JF, Hollenberg NK, The Quality of Life Hypertension Group. Quality of life and anti-hypertensive therapy in men. New Eng J Med 1993; 328: 907-913.
Deyo R. Pitfalls in measuring the health status of Mexican- Americans: comparative validity of the English and Spanish Sickness Impact Profile. Am J Pub Health 1984; 74: 569-573.
Hendrickson WD, Russell J, Prihoda T, et al. An approach to developing a valid Spanish translation of a health status questionnaire. Med Care 1989; 27: 959-63.
Seigel S, Castellan N Jr. Nonparametric Statistics for the Behavioral Sciences, 2nd edition. New York, NY (USA): McGraw-Hill International Editions, 1988.
Hill AB. Principles of Medical Statistics, 12th edition. London, UK: Edward Arnold, 1991: 218.
Grimley Evans J. Quality of life assessments and elderly people. In: Hopkins A, ed. Do We Need Measures Other than QALYS ?London, UK: Royal College of Physicians, 1992: 107-116.
Raspe H. Quality of life measurement in rheumatology. In: Guggenmoos-Holzman I, et al,eds. Quality of Life and Health: Concepts, Methods and Applications .Berlin: Blackwell Wissenschafts-Verlag, 1995: 97-106.
Hunt SM. Quality of life: an unsuitable case for measurement? In Cancer, AIDS and Quality of Life: Proceedings of a Conference.The International Council for Global Health Progress. Paris, 1996 (in press).
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Hunt, S.M. Quality of life claims in trials of anti-hypertensive therapy. Qual Life Res 6, 185–191 (1997). https://doi.org/10.1023/A:1026498318938
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DOI: https://doi.org/10.1023/A:1026498318938