International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients.

Autor: de Ligt KM; Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006 BE, Amsterdam, The Netherlands. k.d.ligt@nki.nl., de Rooij BH; Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.; Department of Medical and Clinical Psychology, Center of Research on Psychological and Somatic Disorders (CoRPS), Tilburg University, Tilburg, The Netherlands., Hedayati E; Department of Oncology-Pathology, Bioclinicum, Karolinska Institutet, Solna, Stockholm, Sweden.; Breast Cancer Center, Cancer Theme, Karolinska University Hospital and Karolinska Comprehensive Cancer Centre, Stockholm, Sweden., Karsten MM; Department of Gynecology with Breast Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.; Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Smaardijk VR; Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands., Velting M; Dutch Breast Cancer Patient Association (Borstkankervereniging Nederland), Utrecht, The Netherlands., Saunders C; Department of Surgery, Melbourne Medical School, Melbourne, Australia., Travado L; Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal., Cardoso F; Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal., Lopez E; Department of Radiation Oncology, Vithas Hospital La Milagrosa, GenesisCare, Madrid, Spain., Carney N; F.Hoffmann-La Roche Ltd, Basel, Switzerland., Wengström Y; Department of Oncology-Pathology, Bioclinicum, Karolinska Institutet, Solna, Stockholm, Sweden.; Department of Oncology, Karolinska University Hospital, Stockholm, Sweden., Ives A; Cancer and Palliative Care Research and Evaluation Unit, University of Western Australia, Crawley, WA, Australia., Velikova G; Leeds Institute of Medical Research at St James's, St James's University Hospital, University of Leeds, Leeds, UK.; Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds, UK., Sousa Fialho MDL; International Consortium for Health Outcomes Measurement UK, London, UK., Seidler Y; Section for Outcomes Research, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria., Stamm TA; Section for Outcomes Research, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Vienna, Austria., Koppert LB; Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands., van de Poll-Franse LV; Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006 BE, Amsterdam, The Netherlands.; Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.; Department of Medical and Clinical Psychology, Center of Research on Psychological and Somatic Disorders (CoRPS), Tilburg University, Tilburg, The Netherlands.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2023 Apr; Vol. 198 (2), pp. 265-281. Date of Electronic Publication: 2023 Jan 20.
DOI: 10.1007/s10549-022-06827-6
Abstrakt: Purpose: For patients living with metastatic breast cancer (MBC), achieving best possible health-related quality of life, along with maximizing survival, is vital. Yet, we have no systemic way to determine if we achieve these goals. A Core Outcome Set (COS) that allows standardized measurement of outcomes important to patients, but also promotes discussing these outcomes during clinical encounters, is long overdue.
Methods: An international expert group (EG) of patient advocates, researchers, medical specialists, nurse specialists, and pharmaceutical industry representatives (n = 17) reviewed a list of relevant outcomes retrieved from the literature. A broader group (n = 141: patients/patient advocates (n = 45), health care professionals/researchers (n = 64), pharmaceutical industry representatives (n = 28), and health authority representatives (n = 4)) participated in a modified Delphi procedure, scoring the relevance of outcomes in two survey rounds. The EG finalized the COS in a consensus meeting.
Results: The final MBC COS includes 101 variables about: (1) health-related quality of life (HRQoL, n = 26) and adverse events (n = 24); (2) baseline patient characteristics (n = 9); and (3) clinical variables (n = 42). Many outcome that cover aspects of HRQoL relevant to MBC patients are included, e.g. daily functioning (including ability to work), psychosocial/emotional functioning, sexual functioning, and relationship with the medical team.
Conclusion: The COS developed in this study contains important administrative data, clinical records, and clinician-reported measures that captures the impact of cancer. The COS is important for standardization of clinical research and implementation in daily practice and has received accreditation by the International Consortium for Health Outcomes Measurement (ICHOM).
(© 2023. The Author(s).)
Databáze: MEDLINE
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