The Geriatric Minimum Data Set for clinical trials.

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.