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Mortality Outcomes in Dermatology: An Exploration of Core Outcome Sets and Cochrane Skin Systematic Reviews

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eMediNexus    25 February 2022

Cochrane′s dermatology-specific editorial team (Cochrane Skin Review Group) is the pre-eminent source of systematic reviews in dermatology. Detailed standardized Cochrane review methods minimize bias and maximize the reliability of reported outcomes, thus affirming benchmarks for decision-making. 

Mortality has shown heterogeneity in reporting, which may affect its utility in clinical research. Thus mortality outcome expression and execution in the Cochrane Skin portfolio was assessed and mortality in core outcome sets (outcomes that, at a minimum, should be measured in clinical trials) was analyzed by searching dermatology studies registered in the COMET (Core Outcome Measures in Effectiveness Trials) database.

113 Cochrane Skin dermatology reviews were sorted, among which 13 reported mortalities as an outcome measure (10 all-cause, 2 cause-specific, 5 survival, and 1 infant/maternal).

4 of 13 reviews reported more than one mortality outcome. 5 of 13 reviews were melanoma-related. Reviews on cutaneous squamous cell carcinoma (cSCC), nonmelanoma skin cancer, pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, toxic epidermal necrolysis (TEN), necrotizing fasciitis, drug-induced skin rash, and topical steroids used during pregnancy were the other dermatologic conditions reporting mortality. 

The time frame of mortality outcome reporting varied widely, from 10 days to 10 years, but generally correlated properly with the condition (eg, 30 days for TEN capturing acute onset and progression vs 10-year survival for melanoma).

COMET database searches showed 13 core outcomes set studies of 13 skin conditions; only 15% included mortality as a core outcome (survival for head and neck lymphatic malformations, death from cSCC).

These results indicate substantial variability in the reporting and timing of mortality outcomes in Cochrane Skin reviews and COMET dermatology-related core outcome sets. Allowance of potentially unclear metrics (eg, “death”) and instabilities in the time frame considered may be dangerous to the downstream harmonization and generalizability of research findings. Guidelines to assist researchers during trial design and registration will help in selecting clear metrics and facilitate consistent outcome reporting at the later stages. 

SOURCE- Sivesind TE, Szeto MD, Hassan S, Tugwell P, Dellavalle RP. Mortality Outcomes in Dermatology: An Exploration of Core Outcome Sets and Cochrane Skin Systematic Reviews. JMIR Dermatol. 2022;5(1):e34140. doi: 10.2196/34140

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