Protocol for the development of a Core Outcome Set (COS) for Adolescents and Young Adults (AYAs) with cancer

Olga Husson; Silvie H M Janssen; Bryce B Reeve; Samantha C Sodergren; Christabel K Cheung; Martin G McCabe; John M Salsman; Winette T A van der Graaf; Anne-Sophie Darlington

doi:10.1186/s12885-023-11716-2

Protocol for the development of a Core Outcome Set (COS) for Adolescents and Young Adults (AYAs) with cancer

BMC Cancer. 2024 Jan 24;24(1):126. doi: 10.1186/s12885-023-11716-2.

Authors

Olga Husson^{1

2

3}, Silvie H M Janssen^{1

3}, Bryce B Reeve^{4

5}, Samantha C Sodergren⁶, Christabel K Cheung⁷, Martin G McCabe^{8

9}, John M Salsman¹⁰, Winette T A van der Graaf^#^{1

11}, Anne-Sophie Darlington^#¹²

Affiliations

¹ Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
² Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
³ Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
⁴ Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
⁵ Duke Cancer Institute, Durham, NC, USA.
⁶ School of Health Sciences, University of Southampton, Southampton, UK.
⁷ School of Social Work, University of Maryland, Baltimore, MD, USA.
⁸ Division of Cancer Sciences, University of Manchester, Manchester, UK.
⁹ The Christie NHS Foundation Trust, Manchester, UK.
¹⁰ Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Wake Forest Baptist Comprehensive Cancer Center, Winston Salem, NC, USA.
¹¹ Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands.
¹² School of Health Sciences, University of Southampton, Southampton, UK. A.Darlington@soton.ac.uk.

^# Contributed equally.

Abstract

Background: Adolescents and young adults (AYAs) with cancer, defined as individuals aged 15-39 years at initial cancer diagnosis, form a unique population; they face age-specific issues as they transition to adulthood. This paper presents the protocol for the development of a core outcome set (COS) for AYAs with cancer.

Methods: The methodological standards from the Core Outcome Measures in Effectiveness Trials (COMET) and the International Consortium for Health Outcomes Measurement (ICHOM) for COS development will guide the development of the COS for AYAs with cancer. The project will consist of the following phases: (1) define the scope of the COS; (2) establish the need for a COS in this field (3) assemble an international, multi-stakeholder working group; (4) develop a detailed protocol; (5) determine "what to measure" (i.e., outcomes); (6) determine "how to measure" (i.e., measures); and (7) determine "case-mix" variables.

Conclusions: The development of a COS for AYAs with cancer will facilitate the implementation of efficient and relevant standards for data collection, both for clinical trials and in routine healthcare, thereby increasing the usefulness of these data to improve the value of the care given to these underserved young cancer patients.

Keywords: AYAs; Adolescents and young adults; COMET; Consensus; Core measurement set; Core outcome set; Oncology; Outcome.

MeSH terms

Adolescent
Data Collection
Health Facilities*
Humans
Neoplasms* / diagnosis
Neoplasms* / therapy
Vulnerable Populations
Young Adult