TY - JOUR
T1 - International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients
AU - the Innovative Medicines Initiative - Health Outcomes Observatory (H2O) consortium
AU - de Ligt, K. M.
AU - de Rooij, B. H.
AU - Hedayati, E.
AU - Karsten, M. M.
AU - Smaardijk, V. R.
AU - Velting, M.
AU - Saunders, C.
AU - Travado, L.
AU - Cardoso, F.
AU - Lopez, E.
AU - Carney, N.
AU - Wengström, Y.
AU - Ives, A.
AU - Velikova, G.
AU - Sousa Fialho, M. D.L.
AU - Seidler, Y.
AU - Stamm, T. A.
AU - Koppert, L. B.
AU - van de Poll-Franse, L. V.
N1 - Funding Information:
This work was supported by the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 945345-2. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme, The European Federation of Pharmaceutical Industries and Associations (EFPIA), Trial Nation and Juvenile Diabetes Research Foundation (JDRF). The public grant funding is matched with in-kind contributions of EFPIA partners. IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is working to improve health by speeding up the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in health research, including universities, research centers, pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organizations, and medicines regulators. IMI is the world's most extensive public–private partnership (PPP) in the life sciences. BH de Rooij, E Hedayati, VR Smaardijk, N Carney, Y Seidler, TA Stamm, LB Koppert, LV van de Poll-Franse, are members of the H2O Health Outcomes Observatory (H2O). The funder had no role in the conception of this work. This manuscript reflects only the authors’ view. The European Union and IMI are not responsible for any use that may be made of the information it contains.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/4
Y1 - 2023/4
N2 - 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).
AB - 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).
KW - Health-related quality of life
KW - Metastatic breast cancer
KW - Outcome measures
UR - http://www.scopus.com/inward/record.url?scp=85146570273&partnerID=8YFLogxK
U2 - 10.1007/s10549-022-06827-6
DO - 10.1007/s10549-022-06827-6
M3 - Article
C2 - 36662394
AN - SCOPUS:85146570273
SN - 0167-6806
VL - 198
SP - 265
EP - 281
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
IS - 2
ER -