Multidisciplinary Development of a Geriatric COre DatasEt (G-CODE) for clinical research in older patients with cancer: a French initiative with international survey.

European journal of cancer, Nov.2018

  1. Paillaud, P. Soubeyran, P. Caillet , T. Cudennec e, E. Brain, C. Terret g, F. Etchepare, L. Mourey i, T. Aparicio, F. Pamoukdjian, R.A. Audisio , S. Rostoft, A. Hurria, C. Bellera, S. Mathoulin-Pélissier for the G-CODE collaborators

doi: 10.1016/j.ejca.2018.07.137

https://www.ncbi.nlm.nih.gov/pubmed/?term=10.1016%2Fj.ejca.2018.07.137

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.

Copyright © 2018 Elsevier Ltd. All rights reserved.

KEYWORDS :

Cancer; Clinical trials; Data set; Delphi consensus; Geriatric assessment; Older patients