Core Outcome Measures in Effectiveness Trials

Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey

General Information

Abstract:
BACKGROUND: To define a core set of geriatric data to be methodically collected in clinical cancer trials of older adults, enabling comparison across trials. PATIENTS AND METHODS: Following a consensus approach, a panel of 14 geriatricians from oncology clinics identified seven domains of importance in geriatric assessment. Based on the international recommendations, geriatricians selected the mostly commonly used tools/items for geriatric assessment by domain (January-October 2015). The Geriatric Core Dataset (G-CODE) was progressively developed according to RAND appropriateness ratings and feedback during three successive Delphi rounds (July-September 2016). The face validity of the G-CODE was assessed with two large panels of health professionals (55 national and 42 international experts) involved both in clinical practice and cancer trials (March-September 2017). RESULTS AND DISCUSSION: After the last Delphi round, the tools/items proposed for the G-CODE were the following: (1) social assessment: living alone or support requested to stay at home; (2) functional autonomy: Activities of Daily Living (ADL) questionnaire and short instrumental ADL questionnaire; (3) mobility: Timed Up and Go test; (4) nutrition: weight loss during the past 6 months and body mass index; (5) cognition: Mini-Cog test; (6) mood: mini-Geriatric Depression Scale and (7) comorbidity: updated Charlson Comorbidity Index. More than 70% of national experts (42 from 20 cities) and international experts (31 from 13 countries) participated. National and international surveys showed good acceptability of the G-CODE. Specific points discussed included age-year cut-off, threshold of each tool/item and information about social support, but no additional item was proposed. CONCLUSION: We achieved formal consensus on a set of geriatric data to be collected in cancer trials of older patients. The dissemination and prospective use of the G-CODE is needed to assess its utility.

Authors:
Paillaud, E. Soubeyran, P. Caillet, P. Cudennec, T. Brain, E. Terret, C. Etchepare, F. Mourey, L. Aparicio, T. Pamoukdjian, F. Audisio, R. A. Rostoft, S. Hurria, A. Bellera, C. Mathoulin-Pelissier, S. G. Code collaborators

Publication

Journal:
Eur J Cancer
Volume:
103
Issue:
Pages:
61 - 68
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Cancer

Disease Name
Solid tumor

Target Population

Age Range
70 -

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

Unknown

Stakeholders Involved

Unknown

Study Type

COS for clinical trials or clinical research

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