Functional status and quality of life as main outcome measures of therapeutic efficacy in the elderly

Archives of Gerontology and Geriatrics

Volumn 22, Issue SUPPL.1, 1996, Pages 567-572

  Senin, U ^a   Cherubini, A ^a  

^a UNIVERSITY OF PERUGIA   (Italy)

Author keywords

Assessment of functional status; Clinical trials in elderly; Quality of life in elderly

Indexed keywords

AGED; ARTICLE; DRUG EFFICACY; DRUG RESEARCH; DRUG USE; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 3042599259     PISSN: 01674943     EISSN: None     Source Type: Journal    
DOI: 10.1016/0167-4943(96)87000-2     Document Type: Article

References (34)

1. Abernethy, D.R., Schwartz, J.B., Tood, E.L., Luchi, R. and Snow, E. (1986): Verapamil pharmacodynamics and disposition in young elderly hypertensive patients. Ann. Intern. Med., 105, 329-336.
2. AMA (American Medical Association) Report of the Council on Scientific Affairs (1990): White Paper on Elderly Health. Arch. Intern. Med., 150, 2459-2472.
3. Applegate, W.B. and Curb, J.D. (1990): Designing and executing randomized clinical trials involving elderly persons. J. Am. Geriatr. Soc., 38, 943-950.
4. Balducci, L. (1994): Perspective on quality of life of older patients with cancer. Drugs and Aging, 4, 313-324.
5. Beers, M.H. and Ouslander, J.G. (1989): Risk factors in geriatric drug prescribing: A practical guide to avoiding problems. Drugs, 37, 104-112.
6. Bombardier, C., Ware, J., Russel, J.I., Larson, M., Chalmers, A., Read, J.L. and the Auranofin Cooperating Group (1986): Auranofin therapy and quality of life in patients with reumathoid arthritis. Am. J. Med., 81, 565-578.
7. Bowes, S.G., Dobbs, S.M., Dobbs, R.J. and Weller, C. (1990): Outcome criteria in clinical trials with elderly subjects. Age Ageing, 19, 353-355.
8. Brody, J.A. and Schneider, E.L. (1986): Diseases and disorders of aging: a hypothesis. J. Chron. Dis., 39, 871-876.
9. Brody, A.J., Freels, S. and Miles, T.P. (1992): Epidemiological issues in the developed world. In: E.J. Grimley and F.T. Williams (editors): Oxford Textbook of Geriatric Medicine, pp.: 14-19. University Press, Oxford.
10. Carbonin, P., Pahor, M., Bernabei, R. and Sgadari, A. (1991): Is age an independent risk factor of adverse drug reactions in hospitalized elderly patients? J. Am. Geriatr. Soc., 39, 1093-1099.
11. FDA (Food and Drug Administration) (1989) : Guideline for the study of drugs likely to be used in the elderly. Publication of the Department of Health and Human Services. Public Health Service. Center for Drug Evaluation and Research.
12. FDA (Food and Drug Administration) (1994): Studies in support of special populations: Geriatrics. Federal Register, 59, 39397-39400.
13. Franciosa, J.A., Ziesch, E.S. and Wylan, M. (1979): Functional capacity of patients with chronic left ventricular failure. Am. J. Med., 67, 460-465.
14. Golini, A. (1987): L'invecchiamento della popolazione italiana in un quadro internazionale. In: L'invecchiamento delle popolazione italiana e nelle societá occidentali. pp.: 9-100. Published by Istituto Ricerche sulla Popolazione (IRP), CNR, Roma (in Italian).
15. Guralnik, J.M. and Avorn, J. (1991): The ambiguous relationship between aging and adverse drug reactions. Ann. Intern. Med., 114, 956-966.
16. Gurwitz, J.H., Nananda, F. and Avorn, J. (1992): The exclusion of the elderly and women from clinical trials in acute myocardial infarction. J. Am. Med. Assoc., 268, 1417-1422.
17. Guyatt, G.H., Feeny, D.H. and Patrick, D.L. (1993): Measuring health-related quality of life. Ann. Intern. Med., 118, 622-629.
18. Hutchinson, T.A., Flegel, K.M., Kramer, M.S., Leduc, D.G. and Kong, H.M. (1986): Frequency, severity and risk factors for adverse drug reactions in adult out-patients: A prospective study. J. Chronic Dis., 39, 533-542.
19. Magaziner, J., Simonsick, R.M., DaSheur, J.M. and Hebel, J.R. (1988): Patient-proxy response comparability on measures of patient health and function status. J. Clin. Epidemiol., 41, 1065-1074.
20. Meyer, R.B. and Reidenberg, M.M. (1992): Clinical pharmacology and ageing. In: E.J. Grimley and F.T. Williams (editors): Oxford Textbook of Geriatric Medicine. pp.: 105-116. University Press, Oxford.
21. Miller, S.T., Applegate, W.B. and Perry, C. (1985): Clinical trials in elderly persons. J. Am. Geriatr. Soc., 33, 91-92.
22. Montamat, S.C., Cusack, B.J. and Vestal, R.E. (1989): Management of drug therapy in the elderly. N. Engl. J. Med., 321, 303-309.
23. Mardi, R. and Cavazzuti, F. (1991): Terapia Farmacologica in Geriatria. p. 465, Masson, Milano (in Italian).
24. Schipper, H., Clinch, J. and Powell, V. (1990): Definition and conceptual issues. In: B. Spilker (editor): Quality of Life Assessment in Clinical Trials, pp.: 11-24. Raven Press, New York.
25. Schroder, S.A., Zones, J.S. and Showstack, J.A. (1989): Academic medicine as a public trust. J. Amer. Med. Assoc., 262, 803-812.
26. Senin, U., Longo, A., Mecocci, P. and Parnetti, L. (1993): Trials clinici e qualitá della vita. Giorn. Gerontol., 41, 553-556 (in Italian).
27. Senin, U., Cherubini, A. and Parnetti, L. (1994): Problematiche nella formulazione di linee guida terapeutiche in campo geriatrico. Cronache Farmaceutiche, 3, 140-143 (in Italian).
28. Spilker, B. (1990): Introduction. In: B. Spilker (editor): Quality of Life Assessment in Clinical Trials, pp.: 3-9. Raven Press, New York.
29. Summerbell, J., Yelland, C. and Woodhouse, K. (1990): The kinetics of plasma aspirin esterase in relation to old age and frailty. Age Ageing, 19, 128-130.
30. Tornatore, K.M., Logue, G., Venuto, R.C. and Davis, P.J. (1994): Pharmacokinetics of methylprednisolone in elderly and young healthy males. J. Am. Geriatr. Soc., 42, 1118-1122.
31. Watchel, T., Piette, J., Mor, V., Stein, M., Fleishman, J. and Carpenter, B. (1992): Quality of life in persons with human immunodeficiency virus infection: measurement by the Medical Outcomes Study Instrument. Ann. Intern. Med., 116, 129-137.
32. Williams, F.M., Wynne, H., Woodhouse, K.W. and Rawlins, M.D. (1989): Plasma aspirin esterase: the influence of old age and frailty. Age Ageing, 18, 39-42.
33. Wynne, H.A., Yelland, C., Boddy, A., Woodhouse, K.W. and Bateman, D.N. (1993): The association of age and frailty with the pharmacokinetics and pharmacodynamics of metoclopramide. Age Ageing, 22, 354-359.
34. Zimmer, A.W. , Calkins, E., Hadley, E., Ostfeld, A.M., Kaye, J.M. and Kaye, D. (1985): Conduction clinical research in geriatric population. Ann. Intern. Med., 103, 276-283.