Development of a core outcome set for basal cell carcinoma.
Schlessinger DI., Reynolds KA., Dirr MA., Ibrahim SA., Yanes AF., Lazaroff JM., Godinez-Puig V., Chen BR., Kurta AO., Cotseones JK., Chiren SG., Furlan KC., Iyengar S., Behshad R., DeHoratius DM., Denes P., Drucker AM., Dzubow LM., Etzkorn JR., Harwood CA., Kim JYS., Lawrence N., Lee EH., Lissner GS., Marghoob AA., Matin RN., Mattox AR., Mittal BB., Thomas JR., Zhou XA., Zloty D., Schmitt J., Kirkham JJ., Armstrong AW., Basset-Seguin N., Billingsley EM., Bordeaux JS., Brewer J., Brown M., Brown M., Collins SAB., Fargnoli MC., De Azevedo SJ., Dummer R., Eggermont A., Goldman GD., Haedersdal M., Hale EK., Hanlon A., Harms KL., Huang CC., Hurst EA., In GK., Kelleners-Smeets N., Kheterpal M., Leshin B., Mcdonald M., Miller SJ., Miller A., Mostow EN., Trakatelli M., Nehal KS., Ratner D., Rogers H., Sarin KY., Soon SL., Stasko T., Storrs PA., Tagliaferri L., Vidimos AT., Wong SL., Yu SS., Zalaudek I., Zeitouni NC., Zitelli JA., Poon E., Sobanko JF., Cartee TV., Maher IA., Alam M.
BACKGROUND: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. OBJECTIVE: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. METHODS: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. RESULTS: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. LIMITATIONS: English-speaking patients and professionals rated outcomes extracted from English language studies. CONCLUSION: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.