American Journal of Epidemiology Vol. 153, No. 1 : 72-78
Copyright © 2001 by The Johns Hopkins University School of Hygiene and Public Health
ORIGINAL CONTRIBUTIONS |
Dementia and Disability Outcomes in Large Hypertension Trials: Lessons Learned from the Systolic Hypertension in the Elderly Program (SHEP) Trial
1 Department of Gerontology and Geriatrics, University of Florence, and Azienda Ospedaliera "Careggi," Florence, Italy.
2 Sticht Center on Aging, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC.
3 Department of Preventive Medicine, University of Tennessee, Memphis, TN.
4 Geriatric Department, Ospedale "I Fraticini," Florence, Italy.
5 Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC.
In the Systolic Hypertension in the Elderly Program (SHEP) trial (1985–1990), active treatment reduced the incidence of cardiovascular events, but not that of dementia and disability, as compared with placebo. This study aims to evaluate if assessment of cognitive and functional outcomes was biased by differential dropout. Characteristics of subjects who did or did not participate in follow-up cognitive and functional evaluations were compared. The relative risks of incident cognitive impairment and disability were assessed in the two treatment groups, with the use of the reported findings and under the assumption that the proportions of cognitive and functional impairment among dropouts increased. Assignment to the placebo group and the occurrence of cardiovascular events independently predicted missed assessments. From the reported findings, the risk of cognitive and functional impairment was similar between the two treatment groups. However, when 20–30% and 40–80% of the subjects who missed the assessment were assumed to be cognitively and, respectively, functionally impaired, assignment to active treatment reduced the risk of these outcomes. In the SHEP, the cognitive and functional evaluations were biased toward the null effect by differential dropout. This might have obscured the appraisal of a protective effect of treatment on the cognitive and functional decline of older hypertensive adults.
bias (epidemiology); clinical trials; dementia; disability evaluation; hypertension
Abbreviations: SHEP, Systolic Hypertension in the Elderly Program; short-CARE, short-Comprehensive Assessment and Referral Evaluation.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  B. K. Saxby, F. Harrington, K. A. Wesnes, I. G. McKeith, and G. A. Ford Candesartan and cognitive decline in older patients with hypertension: A substudy of the SCOPE trial Neurology, May 6, 2008; 70(19_Part_2): 1858 - 1866. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. Reitz, M.-X. Tang, J. Manly, R. Mayeux, and J. A. Luchsinger Hypertension and the Risk of Mild Cognitive Impairment Arch Neurol, December 1, 2007; 64(12): 1734 - 1740. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. S. Elkins, S. C. Johnston, E. Ziv, D. Kado, J. A. Cauley, and K. Yaffe Methylenetetrahydrofolate Reductase C677T Polymorphism and Cognitive Function in Older Women Am. J. Epidemiol., September 15, 2007; 166(6): 672 - 678. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. V. Chobanian Isolated Systolic Hypertension in the Elderly N. Engl. J. Med., August 23, 2007; 357(8): 789 - 796. [Full Text] [PDF]
|
|
|
|
 |
|
 J. A. Staessen, T. Richart, and W. H. Birkenhager Less Atherosclerosis and Lower Blood Pressure for a Meaningful Life Perspective With More Brain Hypertension, March 1, 2007; 49(3): 389 - 400. [Full Text] [PDF]
|
|
|
|
|
|
J. A. Luchsinger, C. Reitz, L. S. Honig, M. X. Tang, S. Shea, and R. Mayeux Aggregation of vascular risk factors and risk of incident Alzheimer disease Neurology, August 23, 2005; 65(4): 545 - 551. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. V. Chobanian, G. L. Bakris, H. R. Black, W. C. Cushman, L. A. Green, J. L. Izzo Jr, D. W. Jones, B. J. Materson, S. Oparil, J. T. Wright Jr, et al. Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Hypertension, December 1, 2003; 42(6): 1206 - 1252. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 PROGRESS Effects of a Perindopril-Based Blood Pressure-Lowering Regimen on Disability and Dependency in 6105 Patients With Cerebrovascular Disease: A Randomized Controlled Trial Stroke, October 1, 2003; 34(10): 2333 - 2338. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Coca Cerebral involvement in hypertensive cardiovascular disease Eur. Heart J. Suppl., August 1, 2003; 5(suppl_F): F19 - F25. [Abstract] [PDF]
|
|
|
|
 |
|
 A. V. Chobanian, G. L. Bakris, H. R. Black, W. C. Cushman, L. A. Green, J. L. Izzo Jr, D. W. Jones, B. J. Materson, S. Oparil, J. T. Wright Jr, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report JAMA, May 21, 2003; 289(19): 2560 - 2571. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 The PROGRESS Collaborative Group* Effects of Blood Pressure Lowering With Perindopril and Indapamide Therapy on Dementia and Cognitive Decline in Patients With Cerebrovascular Disease Arch Intern Med, May 12, 2003; 163(9): 1069 - 1075. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. H. Young, M. J. Klag, P. Muntner, J. L. Whyte, M. Pahor, and J. Coresh Blood Pressure and Decline in Kidney Function: Findings from the Systolic Hypertension in the Elderly Program (SHEP) J. Am. Soc. Nephrol., November 1, 2002; 13(11): 2776 - 2782. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Forette, M.-L. Seux, J. A. Staessen, L. Thijs, M.-R. Babarskiene, S. Babeanu, A. Bossini, R. Fagard, B. Gil-Extremera, T. Laks, et al. The Prevention of Dementia With Antihypertensive Treatment: New Evidence From the Systolic Hypertension in Europe (Syst-Eur) Study Arch Intern Med, October 14, 2002; 162(18): 2046 - 2052. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 O. Hanon and D. Leys Cognitive decline and dementia in the elderly hypertensive Journal of Renin-Angiotensin-Aldosterone System, March 1, 2002; 3(1_suppl): S32 - S38. [PDF]
|
|
|
|
|
|
H. B. Posner, M.-X. Tang, J. Luchsinger, R. Lantigua, Y. Stern, and R. Mayeux The relationship of hypertension in the elderly to AD, vascular dementia, and cognitive function Neurology, April 23, 2000; 58(8): 1175 - 1181. [Abstract] [Full Text] [PDF]
|
|