Development of a core outcome set for basal cell carcinoma.
basal cell carcinoma
core
measure
outcome
set
skin cancer
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
received:
11
02
2020
revised:
18
04
2022
accepted:
23
04
2022
pubmed:
14
5
2022
medline:
24
8
2022
entrez:
13
5
2022
Statut:
ppublish
Résumé
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. To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. 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. 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. English-speaking patients and professionals rated outcomes extracted from English language studies. 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.
Sections du résumé
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.
Identifiants
pubmed: 35551965
pii: S0190-9622(22)00789-7
doi: 10.1016/j.jaad.2022.04.059
pii:
doi:
Types de publication
Journal Article
Systematic Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
573-581Informations de copyright
Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
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.