Core Outcome Measures in Effectiveness Trials

Defining a standard set of patient-centred outcomes for lung cancer

General Information

In lung cancer, outcome measurement has been mostly limited to survival. Proper assessment of the value of lung cancer treatments, and the performance of institutions delivering care, requires more comprehensive measurement of standardised outcomes. The International Consortium for Health Outcomes Measurement convened an international, multidisciplinary working group of patient representatives, medical oncologists, surgeons, radiation oncologists, pulmonologists, palliative care specialists, registry experts and specialist nurses to review existing data and practices. Using a modified Delphi method, the group developed a consensus recommendation (“the set”) on the outcomes most essential to track for patients with lung cancer, along with baseline demographic, clinical and tumour characteristics (case-mix variables) for risk adjustment. The set applies to patients diagnosed with nonsmall cell lung cancer and small cell lung cancer. Our working group recommends the collection of the following outcomes: survival, complications during or within 6 months of treatment and patient-reported domains of health-related quality of life including pain, fatigue, cough and dyspnoea. Case-mix variables were defined to improve interpretation of comparisons. We defined an international consensus recommendation of the most important outcomes for lung cancer patients, along with relevant case-mix variables, and are working to support adoption and reporting of these measures globally.

To define a recommended standard set of outcomes and corresponding baseline demographic, clinical and tumour characteristics (case-mix variables) for patients with lung cancer.

Kimberley S. Mak, Annelotte C.M. van Bommel, Caleb Stowell, Janet L. Abrahm, Matthew Baker, Clarissa S. Baldotto, David R. Baldwin, Diana Borthwick, David P. Carbone, Aileen B. Chen, Jesme Fox, Tom Haswell, Marianna Koczywas, Benjamin D. Kozower, Reza J. Mehran, Franz M. Schramel, Suresh Senan, Robert G. Stirling, Jan P. van Meerbeeck, Michel W.J.M. Wouters and Michael D. Peake on behalf of the Lung Cancer Working Group of ICHOM


Lung Cancer
852 - 860
Further Study Information

Not stated
Funding source(s):

Health Area

Disease Category

Disease Name
Lung cancer

Target Population

Age Range


Nature / type of Intervention


Delphi process
Literature review

The project team performed a literature search in MEDLINE to identify outcomes and case-mix measures to guide discussions of the working group (online supplementary material, appendices 2–4). From July to December 2014, the group convened for six structured teleconferences to share evidence and expert opinions, including scope and outcome domains; outcome definitions; outcome measures including clinical data and patient-reported outcome measures (PROMs); case-mix domains; and case-mix measures. Five surveys were sent to the working group to gather feedback and make decisions on points discussed during the teleconference calls. In the survey, a structured, consensus-driven modified-Delphi method was used to debate proposals from the project team (online supplementary material, appendix 4). Using a two-thirds (66%) majority as the threshold for inclusion, the group determined which outcomes and case-mix variables were essential, and reached consensus on their precise definitions and methods for their measurement. Outcomes and case-mix variables not meeting the threshold of 66%, but >40% were discussed in the next call after the survey. A second round of voting was conducted during the call after an open discussion. If needed, additional discussion occurred before a third vote during the call. Most outcomes were decided in one or two rounds, and a minority required a maximum of three rounds.

Stakeholders Involved

Clinical experts
Patient/ support group representatives
Registry experts

Study Type

COS for practice

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