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Development of a core outcome set for basal cell carcinoma


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.

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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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Dermatology Clinic
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Dermatology
Uncontrolled Keywords:Dermatology
Language:English
Date:1 September 2022
Deposited On:03 Aug 2022 10:15
Last Modified:27 Jun 2024 01:38
Publisher:Elsevier
ISSN:0190-9622
OA Status:Closed
Publisher DOI:https://doi.org/10.1016/j.jaad.2022.04.059
PubMed ID:35551965