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Background There is a need for patient involvement when selecting trial outcomes, since their priorities may differ from healthcare professionals. Qualitative research can be used to identify outcomes that matter to patients in the development of core outcome sets (COS) and in trial feasibility studies that aim to feed patient perspectives into outcome domain selection for the definitive trial. For example, the COMET database currently includes 24 published (2-3/year) and 33 ongoing COS studies utilising interviews or focus groups with patients, carers and their representatives. However, it is unclear whether direct approaches to eliciting outcomes or indirect approaches focusing on the disease and treatment are most useful in informing trial design and outcome selection.

Using qualitative research to understand what outcomes matter to patients: direct and indirect approaches to outcome elicitation