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Development of a core outcome set for basal cell carcinoma.

Authors :: 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
Source :: Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2022 Sep; Vol. 87 (3), pp. 573-581. Date of Electronic Publication: 2022 May 10.
Publication Year :: 2022
Abstract: 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. Competing Interests: Conflicts of interest Dr Kirkham is involved with the COMET and CS-COUSIN Methods groups. Drs Schmitt and Alam are involved with the CS-COUSIN Methods group. Dr Armstrong has served as a research investigator and/or scientific advisor to AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, BI, BMS, EPI, Incyte, Leo, UCB, Janssen, Lilly, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, Pfizer, and Modmed. The remaining authors have no relevant conflicts to disclose. (Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)