TY - JOUR
T1 - Development of an updated, standardized, patient-centered outcome set for lung cancer
AU - de Rooij, Belle H.
AU - van den Hurk, Corina
AU - Smaardijk, Veerle
AU - Fernandez-Ortega, Paz
AU - Navarro-Martin, Arturo
AU - Barberio, Lidia
AU - Guckenberger, Matthias
AU - Schmid, Severin
AU - Walraven, Iris
AU - Vallow, Susan
AU - Kotsi, Christina
AU - Preusser, Matthias
AU - Mosor, Erika
AU - Klok, Jente M.
AU - Becker, Annemarie
AU - Milani, Alessandra
AU - Ninov, Lyudmil
AU - van de Poll-Franse, Lonneke V.
N1 - Funding Information: H2O has received funding from the Innovative Medicines Initiative 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, EFPIA, Trial Nation and JDRF. The public grant funding is matched with in-kind contributions of EFPIA partners. CH has received Institutional funding for implementation of symptom monitoring in lung cancer from AstraZeneca, Boeringer Ingelheim, BMS, Merck. LB has received Institutional funding from Abbvie, AstraZeneca, Boehringer-Inghelheim, BM-S, Lilly, Janssen-Cilag, MSD, Novartis, Pfizer, Roche, Takeda. MP has received honoraria for lectures, consultation or advisory board participation from the following for-profit companies: Bayer, Bristol-Myers Squibb, Novartis, Gerson Lehrman Group (GLG), CMC Contrast, GlaxoSmithKline, Mundipharma, Roche, BMJ Journals, MedMedia, Astra Zeneca, AbbVie, Lilly, Medahead, Daiichi Sankyo, Sanofi, Merck Sharp & Dome, Tocagen, Adastra, Gan & Lee Pharmaceuticals. CK and SV are employees at Novartis. Publisher Copyright: © 2022 The Authors
PY - 2022/11/1
Y1 - 2022/11/1
N2 - Background: In 2016, the International Consortium for Health Outcomes Measurement (ICHOM) defined an international consensus recommendation of the most important outcomes for lung cancer patients. The European Health Outcomes Observatory (H2O) initiative aimed to develop an updated patient-centered core outcome set (COS) for lung cancer, to capture the patient perspective of the impact of lung cancer and (novel) treatments using a combination of patient-reported outcome (PRO) instruments and clinical data as a means to drive value-based health-care. Material and methods: An international, expert team of patient representatives, multidisciplinary healthcare professionals, academic researchers and pharmaceutical industry representatives (n = 17) reviewed potential outcomes generated through literature review. A broader group of patients/patient representatives (n = 31), healthcare professionals / academic researchers (n = 83), pharmaceutical industry representatives (n = 26), and health authority representatives (n = 6) participated in a Delphi study. In two survey rounds, participants scored the relevance of outcomes from a preliminary list. The threshold for consensus was defined as ≥ 70 % of participants scoring an outcome as ‘highly relevant’. In concluding consensus-meeting rounds, the expert multidisciplinary team finalized the COS. Results: The preliminary list defined by the core group consisted of 102 outcomes and was prioritized in the Delphi procedure to 64. The final lung cancer COS includes: 1) case-mix factors (n = 27); 2) PROs related to health-related quality of life (HRQoL) (n = 25); 3) clinical outcomes (n = 12). Patient-reported symptoms beyond domains included in the ICHOM lung cancer set in 2016 were insomnia, nausea, vomiting, anxiety, depression, lack of appetite, gastric problems, constipation, diarrhoea, dysphagia, and haemoptysis. Conclusions: We will implement the lung cancer COS in Europe within the H2O initiative by collecting the outcomes through a combination of clinician-reported measures and PRO measures. The COS will support the adoption and reporting of lung cancer measures in a standardized way across Europe and empower patients with lung cancer to better manage their health care.
AB - Background: In 2016, the International Consortium for Health Outcomes Measurement (ICHOM) defined an international consensus recommendation of the most important outcomes for lung cancer patients. The European Health Outcomes Observatory (H2O) initiative aimed to develop an updated patient-centered core outcome set (COS) for lung cancer, to capture the patient perspective of the impact of lung cancer and (novel) treatments using a combination of patient-reported outcome (PRO) instruments and clinical data as a means to drive value-based health-care. Material and methods: An international, expert team of patient representatives, multidisciplinary healthcare professionals, academic researchers and pharmaceutical industry representatives (n = 17) reviewed potential outcomes generated through literature review. A broader group of patients/patient representatives (n = 31), healthcare professionals / academic researchers (n = 83), pharmaceutical industry representatives (n = 26), and health authority representatives (n = 6) participated in a Delphi study. In two survey rounds, participants scored the relevance of outcomes from a preliminary list. The threshold for consensus was defined as ≥ 70 % of participants scoring an outcome as ‘highly relevant’. In concluding consensus-meeting rounds, the expert multidisciplinary team finalized the COS. Results: The preliminary list defined by the core group consisted of 102 outcomes and was prioritized in the Delphi procedure to 64. The final lung cancer COS includes: 1) case-mix factors (n = 27); 2) PROs related to health-related quality of life (HRQoL) (n = 25); 3) clinical outcomes (n = 12). Patient-reported symptoms beyond domains included in the ICHOM lung cancer set in 2016 were insomnia, nausea, vomiting, anxiety, depression, lack of appetite, gastric problems, constipation, diarrhoea, dysphagia, and haemoptysis. Conclusions: We will implement the lung cancer COS in Europe within the H2O initiative by collecting the outcomes through a combination of clinician-reported measures and PRO measures. The COS will support the adoption and reporting of lung cancer measures in a standardized way across Europe and empower patients with lung cancer to better manage their health care.
KW - Core outcome set
KW - Lung cancer
KW - Patient-reported outcomes
KW - Quality of life
KW - Value-based healthcare
UR - http://www.scopus.com/inward/record.url?scp=85137625051&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.lungcan.2022.08.021
DO - https://doi.org/10.1016/j.lungcan.2022.08.021
M3 - Article
C2 - 36103777
SN - 0169-5002
VL - 173
SP - 5
EP - 13
JO - Lung cancer (Amsterdam, Netherlands)
JF - Lung cancer (Amsterdam, Netherlands)
ER -