Abstract
Background: To overcome the weak evidence base coming from often poor and insufficient clinical research in older people, a minimum data set to achieve harmonisation is highly advisable. This will lead to uniform nomenclature and to the standardisation of the assessment tools. Our primary objective was to develop a Geriatric Minimum Data Set (GMDS) for clinical research.Methods: Investigators from 33 leading Research Centres in Europe (selected based on pre-defined criteria), agreed to establish GerontoNet, a network for research collaboration. Following a systematic review of literature performed before the meeting, the expert panel identified 79 functional, cognitive, nutritional and social statements.Results: Of the initial 79 statements, 49 were found appropriate for a GMDS. After an additional stage of evaluation, a 25-item data set was proposed as the minimum set of information to be included in any future clinical trial involving older people. The GMDS covers 7 domains: general information including data on clinical diagnosis and medication use (5 items), functional performance (5 items), cognitive and emotional status (4 items), cardiovascular risk profile (3 items), nutritional status (3 items), biochemical parameters (1 set and 1 item), and social status (3 items).Conclusion: The proposed GMDS provides an enhanced opportunity for research in elderly populations with appropriate outcome measures, and would greatly facilitate meta-analysis of relevant clinical trials.
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Abellan van Kan G, Andrieu S, Vellas B. GerontoNet: a Network of excellence for clinical trials with geriatric patients. J Nutr Health Aging 2007;11(3): 251–253
Keime-Guibert F, Abellan van Kan G, Nourhashemi F, Tsouderos Y, Merdes A, Vellas B. Rational for a minimum data set for clinical trials with geriatric patients. J Nutr Health Aging 2007;11(3): 273–277
Le Quintrec JL, Bussy C, Golmard JL, Herve C, Baulon A, Piette F. Randomized controlled drag trials on very elderly subjects: descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adults. J Gerontol Med Sci 2005 (60A);3: 340–344
McMurdo MET, Witham MD, Gillespie ND. Including older people in clinical research. BMJ 2005;331: 1036–1037
van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals. JAMA 2007;297: 1233–1240
Siu LL. Clinical trials in the elderly — A concept comes of age. NEJM 2007;356(15): 1575–1576
Sinclair AJ. Towards a minimum data set for interventions studies in type 2 diabetes in older people. J Nutr Health Aging 2007;11(3):
Faes M, van Iersel M, Olde-Rikkert M. Methodological issues in geriatric research. J Nutr Health Aging 2007;11(3):
Salva A, Becker C. Minimum data set for research studies in falls and osteoporosis. GerontoNet. J Nutr Health Aging 2007;11(3):
Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive Geriatric Assessment: a meta-analysis of controlled trials. Lancet 1993;342: 1032–1036
Lamb SE, Jorstad-Stein E, Hauer K, Becker C. Development of a common outcome data set for fall injury prevention trials: The Prevention of Falls Network Europe Consensus. J Am Geriatr Soc 2005;3: 1618–1622
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and classification. J Chron Dis 1987; 40: 373–383
Mahoney FI, Barthel DW. Functional Assessment: The Barthel Index. Maryland State J 1695;14: 61–65
Katz S, Ford AB, Moskowitz RW. Studies of illness in the aged. The index of ADL. A standardized measure of biological and psychosocial function. JAMA 1963;185: 914–919
Lawton MP, Brody EM. Assessment of older people: self-maintaining and intrumental activities of dialy living. The Gerontologist 1969;9: 179–186
Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991;39: 142–148
Folstein MF, Folstein SE, McHugh PR. Mini-mental State: a practical method for grading the cognitive status of patients for the clinician. J Psychiatr Res 1975; 12: 189–198
Hughes CP, Berg L, Danziger WL, Cohen LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatr 1982;140: 566–572
Yesavage JA, Brink TL, Rose TL. Development and validation of a geriatric depression screening scale: a preliminary report. J Psych Research 1983;17: 37–49
Cummings JL, Mega M, Gray K. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994;169: 2308–2314
Rubenstein LZ, Harker JO, Salva A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric practice: developing the short-form Mini-Nutritional Assessment (MNA-SF). J Gerontol A Biol Sci Med Sci 2001;56: M366–372
Vellas B, Guigoz Y, Garry PJ. The Mini-Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition 1999;15: 116–122
Zarit SH, Reever KE, Bach-Petersen J. Relatives of the impaired elderly: correlates of feeling of burden. The Gerontologist 1980;20: 649–655
Yancik R, Ershler W, Satariano W, Hazzard W, Cohen HJ, Ferrucci L. Report of the National Institute on Aging Task Force on Comorbidity. J Gerontol A Biol Sci Med Sci 2007;62: 275–280
Guralnik JM, Simonsick EM, Ferrucci L et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 1994;49: M85–94
Guralnik JM, Ferracci L, Simonsick E. Lower extremity function in persons over 70 years as a predictor of subsequent disability. N Engl J Med 1995;332: 556–561
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Van Kan, G.A., Sinclair, A., Andrieu, S. et al. The geriatric minimum data set for clinical trials (GMDS). J Nutr Health Aging 12, 197–200 (2008). https://doi.org/10.1007/BF02982620
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DOI: https://doi.org/10.1007/BF02982620