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

E Paillaud; P Soubeyran; P Caillet; T Cudennec; E Brain; C Terret; F Etchepare; L Mourey; T Aparicio; F Pamoukdjian; R A Audisio; S Rostoft; A Hurria; C Bellera; S Mathoulin-Pélissier; G-CODE collaborators

doi:10.1016/j.ejca.2018.07.137

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

Eur J Cancer. 2018 Nov:103:61-68. doi: 10.1016/j.ejca.2018.07.137. Epub 2018 Sep 11.

Authors

E Paillaud¹, P Soubeyran², P Caillet³, T Cudennec⁴, E Brain⁵, C Terret⁶, F Etchepare⁷, L Mourey⁸, T Aparicio⁹, F Pamoukdjian¹⁰, R A Audisio¹¹, S Rostoft¹², A Hurria¹³, C Bellera¹⁴, S Mathoulin-Pélissier¹⁴; G-CODE collaborators

Collaborators

G-CODE collaborators:
R Boulahssass, L De Decker, V Fossey-Diaz, E Liuu, C Mertens, L Balardy, F Retornaz, A L Couderc, F Rollot-Trad, D Azria, G Bacciarello, E Barranger, L Bengrine, L Bernat-Piazza, J Y Blay, E Bourdolle, E Carola, O Chinot, J M Classe, R Corre, S Culine, H Cure, S Delaloge S, J Y Delattre, G Desolneux, G Freyer, P Graff, J Guigay, C Herlin, K Hoang-Xuan, A Italiano, J E Kurtz, E Lartigau, C Lazarovicci-Nagera, I Lebas, H Le Caer, C Maguire, O Mir, S Natur, C Ortholan, A Pigneux, M Prou, R Qabbal, F Rousseau, R Rouzier, A Roveri, P Sargos, S Servagi, V Servent, L Ysebaert, S Alibhai, R A Audisio, L Balducci, E Bastiaannet, D Bron, K Cheng, H J Cohen, F Cornelis, N De Glas, T Kalsi, R Kanesvaran, C Kenis, M Hamaker, H Holmes, T Hsu, S Lichtman, S Mohile, A O'Donovan, M Puts, L Repetto, N Singhal, C Steer, P Stolz Baskett, W Van De Water, B Van Leuven, U Wedding, T Wildes, H Wildiers, G Zulian

Affiliations

¹ Department of Geriatrics, Geriatric Oncology Unit, APHP, Hopital Europeen Georges Pompidou, Paris, France; Clinical Epidemiology and Ageing Unit, EA 7376, Université Paris-Est, Creteil, France. Electronic address: [email protected].
² Department of Medical Oncology, SIRIC BRIO, Institut Bergonié, Bordeaux, France; Inserm UMR 1218, Université de Bordeaux, Bordeaux, France.
³ Department of Geriatrics, Geriatric Oncology Unit, APHP, Hopital Europeen Georges Pompidou, Paris, France; Clinical Epidemiology and Ageing Unit, EA 7376, Université Paris-Est, Creteil, France.
⁴ Department of Geriatrics, APHP, Amboise Pare Hospital, Boulogne-Billancourt, France.
⁵ Department of Medical Oncology, Institut Curie - Hôpital René Huguenin, Saint-Cloud, France.
⁶ Department of Medical Oncology, Centre Léon Bérard, Claude-Bernard Lyon-1 University, Lyon, France.
⁷ Bordeaux Population Health Research Center, Inserm UMR 1219, Bordeaux University, Bordeaux, France.
⁸ Medical Oncology Department, Institut Claudius Regaud, IUCT-O, Toulouse, France.
⁹ Department of Gastroenterology and Digestive Oncology, APHP, Saint Louis Hospital, Paris, France.
¹⁰ Clinical Epidemiology and Ageing Unit, EA 7376, Université Paris-Est, Creteil, France; Coordination Unit in Geriatric Oncology, APHP, Avicenne Hospital, Bobigny, France.
¹¹ Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Hospital Gothenburg, University of Gothenburg Sahlgrenska, Gothenburg, Sweden.
¹² Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.
¹³ Department of Medical Oncology, Center for Cancer and Aging, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
¹⁴ Bordeaux Population Health Research Center, Inserm UMR 1219, Bordeaux University, Bordeaux, France; Clinical and Epidemiological Research Unit, INSERM CIC1401, Comprehensive Cancer Center, Institut Bergonie, Bordeaux, France.

PMID: 30212804
DOI: 10.1016/j.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.

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

MeSH terms

Aged
Aged, 80 and over
Biomedical Research / methods*
Female
France
Geriatric Assessment / methods*
Humans
Male
Neoplasms / epidemiology*
Surveys and Questionnaires