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
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.
ContributorsBelle H.de Rooij, Corinavan den Hurk, Veerle Smaardijk, Paz Fernandez-Ortega,
Arturo Navarro-Martin, Lidia BarberioeMatthias Guckenberger, SeverinSchmid, Iris Walraven, Susan Vallow, Christina Kotsi, Matthias Preusser, Erika Mosor, Jente M.Klok,
Anne marie Becker, Alessandra Milani, Lyudmil Ninov, Lonneke V.van de Poll-Franse
Disease Category: Cancer
Disease Name: Lung cancer
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Other
- Pharmaceutical industry representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Systematic review
The final agreed process steps include: 1) reviewing and critically appraising the existing standards using a literature review and discussions in a multidisciplinary expert team; 2) conducting a Delphi study with a broader reference group; and 3) holding final consensus meeting.