Experimental designs for multicomponent interventions among persons with multifactorial geriatric syndromes

Clinical Trials

Volumn 2, Issue 1, 2005, Pages 13-21

  Allore, Heather G ^a   Tinetti, Mary E ^a   Gill, Thomas M ^a   Peduzzi, Peter N ^a,b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; EXPERIMENTAL DESIGN; GERIATRIC DISORDER; HUMAN; MEDICAL RESEARCH; MULTIFACTORIAL INHERITANCE; PRIORITY JOURNAL; PUBLICATION; REVIEW; RISK FACTOR; SAMPLING; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

ACCIDENTAL FALLS; AGED; CLINICAL TRIALS; COMORBIDITY; GERIATRICS; HUMANS; RESEARCH DESIGN; RISK ASSESSMENT; RISK FACTORS; SAMPLE SIZE; SYNDROME;

EID: 14744299711     PISSN: 17407745     EISSN: None     Source Type: Journal    
DOI: 10.1191/1740774505cn067oa     Document Type: Review

References (32)

1. Sattin RW. Falls among older persons: a public health perspective. Annu Rev Public Health 1992; 13: 489-508.
2. Tinetti ME, Speechley M, Ginter SF. Risk factors among elderly persons living in the community. N Engl J Med 1988; 319: 1701-07.
3. Robbins AS, Rubenstein LZ, Josephson KR et al. Predictors of falls among elderly people. Results of two population-based studies. Arch Intern Med 1989; 149: 1628-33.
4. Tinetti ME, McAvary G, Claus E. Does multiple risk factor reduction explain the reduction in fall rate in the Yale FICSIT trial? Am J Epidemiol 1996; 144: 389-99.
5. Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database System Review. 2003; 4: CD000340.
6. Chang JT, Morton SC, Rubenstein LZ et al. Interventions for the prevention of falls in older adults: systemic review and meta-analysis of randomized clinical trials. Br Med J 2004; 328: 680-87.
7. Inouye SK, Bogardus ST, Charpentier PA et al. A multifactorial intervention to prevent delirium in hospitalized older patients. N Engl J Med 1999; 340: 669-76.
8. Tinetti ME, Baker DI, McAvary G et al. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med 1994; 331: 821-27.
9. Shaw FE, Bond J, Richardson DA et al. Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomized controlled trial. Br Med J 2003; 326: 73-78.
10. Strandberg TE, Pitkala K, Berglind S, Nieminen MS, Tilvis RS. Multifactorial cardiovascular disease prevention in patients aged 75 years and older. A randomized controlled trial. Am Heart J 2001; 142: 945-51.
11. Gulberg B. Design and statistical problems in prevention. Scand J Rheumatol 1996; 25(suppl. 103): 108-10.
12. Belsey D, Kuh E, Welsch RE. Regression diagnostics. New York: John Wiley and Sons, 1980.
13. Stamler J. Risk factors modification trials: implications for the elderly. European Heart J 1988; 9(suppl. D): 9-53.
14. Counsell SR, Holder CM, Liebnauer LL et al. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of acute care for elders (ACE) in a community hospital. J Am Geriatrics Soc 2000; 48: 1572-81.
15. van Haastregt JCM, Diederiks JPM, van Rossum E et al. Effects of a programme of multifactorial home visits on falls and mobility impairments in elderly people at risk: randomized controlled trial. Br Med J 2000; 321: 994-98.
16. Jensen, J, Nyberg, L, Gustafson Y, Ludin-Olsson L. Fall and Injury prevention in residential care - effects in residents with higher and lower levels of cognition. J Am Geriatrics Soc 2003; 51: 627-35.
17. Beyth RJ, Quinn L, Landefeld CS. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin: a randomized controlled trial. Ann Intern Med 2000; 133: 687-95.
18. Timonen L, Rantanen T, Ryynänen OP et al. A randomized controlled trial of rehabilitation after hospitalization in frail older women: effects on strength, balance and mobility. Scand J Med Sci Sports 2002; 12: 186-92.
19. Byar DP. Factorial and reciprocal control designs. Statist Med 1990; 9: 55-64.
20. Ioannidia JPA, Lau J. Heterogeneity of the baseline risk within patient populations of clinical trials: a proposed evaluation algorithm. Am J Epidemiol 1998; 148: 1117-26.
21. Medical Research Council. Cluster randomized trials: methodological and ethical considerations. MRC clinical trials series. London: Medical Research Council, 2002; http://www.mrc.ac.uk/index/publications/pdf- cluster_randomised_trials-link (accessed 29 July 2004).
22. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408-12.
23. Halpern SD. Evaluating preference effect in partially unblinded, randomized clinical trials. J Clin Epidemiol 2003; 56: 109-15.
24. Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Blood Pressure 1992; 1: 113-19.
25. Byar DP. Design considerations for AIDS trials. J Acquired Immune Deficiency Syndromes 1990; 3(suppl. 2): S16-S19.
26. Finkelstein MO, Levin B, Robbins H. Clinical and prophylactic trials with assured new treatment for those at greater risk: I. A design proposal. Am J Public Health 1996; 86: 691-95.
27. Wynder EL, Stellman SD. The "over-exposed" control group. Am J Epidemiol 1992; 135: 459-61.
28. Byar DP, Piantadois S. Factorial designs for randomized clinical trials. Cancer Treatment Reports 1985; 69: 1055-63.
29. Li B, Taylor PR, Li JY et al. Linxian nutrition intervention trials. Design, methods, participant characteristics, and compliance. Ann Epidemiol 1993; 3: 577-85.
30. Stolle DP, Robbennolt JK, Patry M, Penrod SD. Fractional Factorial designs for legal psychology. Behav Sci Law 2002; 20: 5-17.
31. Lavori PW, Rush AJ, Wisniewski SR et al. Strengthening clinical effectiveness trials: equipoise-stratified randomization. Biol Psychiatry 2001; 50: 792-801.
32. Flynn TN, Whitley E, Peters TJ. 2002. Recruitment strategies in cluster randomization trial - cost implications. Statist Med 2002; 21: 397-405.