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. 2022 Sep;87(3):573-581.
doi: 10.1016/j.jaad.2022.04.059. Epub 2022 May 10.

Development of a core outcome set for basal cell carcinoma

Daniel I Schlessinger  1 , Kelly A Reynolds  2 , McKenzie A Dirr  3 , Sarah A Ibrahim  3 , Arianna F Yanes  4 , Jake M Lazaroff  3 , Victoria Godinez-Puig  3 , Brian R Chen  3 , Anastasia O Kurta  5 , Jill K Cotseones  6 , Sarah G Chiren  3 , Karina C Furlan  7 , Sanjana Iyengar  8 , Ramona Behshad  5 , Danielle M DeHoratius  9 , Pablo Denes  10 , Aaron M Drucker  11 , Leonard M Dzubow  12 , Jeremy R Etzkorn  9 , Catherine A Harwood  13 , John Y S Kim  14 , Naomi Lawrence  15 , Erica H Lee  16 , Gary S Lissner  17 , Ashfaq A Marghoob  18 , Rubeta N Matin  19 , Adam R Mattox  20 , Bharat B Mittal  21 , J Regan Thomas  22 , Xiaolong Alan Zhou  3 , David Zloty  23 , Jochen Schmitt  24 , Jamie J Kirkham  25 , April W Armstrong  26 , Nicole Basset-Seguin  27 , Elizabeth M Billingsley  28 , Jeremy S Bordeaux  29 , Jerry Brewer  30 , Marc Brown  31 , Mariah Brown  32 , Scott A B Collins  33 , Maria Concetta Fargnoli  34 , Sergio Jobim De Azevedo  35 , Reinhard Dummer  36 , Alexander Eggermont  37 , Glenn D Goldman  38 , Merete Haedersdal  39 , Elizabeth K Hale  40 , Allison Hanlon  41 , Kelly L Harms  42 , Conway C Huang  43 , Eva A Hurst  44 , Gino K In  45 , Nicole Kelleners-Smeets  46 , Meenal Kheterpal  47 , Barry Leshin  48 , Michel Mcdonald  49 , Stanley J Miller  50 , Alexander Miller  51 , Eliot N Mostow  52 , Myrto Trakatelli  53 , Kishwer S Nehal  16 , Desiree Ratner  54 , Howard Rogers  55 , Kavita Y Sarin  56 , Seaver L Soon  57 , Thomas Stasko  58 , Paul A Storrs  59 , Luca Tagliaferri  60 , Allison T Vidimos  61 , Sandra L Wong  62 , Siegrid S Yu  63 , Iris Zalaudek  64 , Nathalie C Zeitouni  65 , John A Zitelli  66 , Emily Poon  3 , Joseph F Sobanko  67 , Todd V Cartee  68 , Ian A Maher  20 , Murad Alam  69
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Free article

Development of a core outcome set for basal cell carcinoma

Daniel I Schlessinger et al. J Am Acad Dermatol. 2022 Sep.
Free article

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.

Keywords: basal cell carcinoma; core; measure; outcome; set; skin cancer.

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Conflict of interest statement

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.

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