Novel core outcome set aims to improve utility of basal cell carcinoma trials

Researchers have recently created a core outcome set for basal cell carcinoma clinical trials.

This was done in response to variations in outcomes reported in clinical studies of basal cell carcinoma. Such variations can preclude effective meta-analysis from answering important clinical questions.

A study was conducted to establish a recommended minimum set of core outcomes for basal cell carcinoma in trials. Researchers employed patient and professional Delphi process to cull a long list, which was capped by a consensus meeting.

For the outcomes to be provisionally accepted, they must be deemed important (score, 7‒9, with 9 being the highest) by 70 percent of each stakeholder group.

A systematic literature review and survey of key stakeholders identified a total of 235 candidate outcomes. This number was cut down to 74 outcomes, which were rated by 100 healthcare professionals and patients in two Delphi rounds. Twenty-seven outcomes were provisionally accepted.

In the end, only five outcomes were included in the final core set following the consensus meeting. These outcomes included complete response, persistent or serious adverse events, recurrence-free survival, quality of life, and patient satisfaction including cosmetic outcome.

“The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians,” researchers said.

As a limitation, the outcomes were extracted from English language studies and rated by English-speaking patients and professionals.