Development of a core outcome set for cutaneous squamous cell carcinoma trials: identification of core domains and outcomes.

BACKGROUND: The lack of uniformity in the outcomes reported in clinical studies of the treatment of cutaneous squamous cell carcinoma (cSCC) complicates efforts to compare treatment effectiveness across trials. OBJECTIVES: To develop a core outcome set (COS), a minimum set of agreed-upon outcomes to be measured in all clinical trials of a given disease or outcome, for the treatment of cSCC. METHODS: One hundred and nine outcomes were identified via a systematic literature review and interviews with 28 stakeholders. After consolidation of this long list, 55 candidate outcomes were rated by 19 physician and 10 patient stakeholders, in two rounds of Delphi exercises. Outcomes scored 'critically important' (score of 7, 8 or 9) by ≥ 70% of patients and ≥ 70% of physicians were provisionally included. At the consensus meeting, after discussion and voting of 44 international experts and patients, the provisional list was reduced to a final core set, for which consensus was achieved among all meeting participants. RESULTS: A core set of seven outcomes was finalized at the consensus meeting: (i) serious or persistent adverse events, (ii) patient-reported quality of life, (iii) complete response, (iv) partial response, (v) recurrence-free survival, (vi) progression-free survival and (vii) disease-specific survival. CONCLUSIONS: In order to increase the comparability of results across trials and to reduce selective reporting bias, cSCC researchers should consider reporting these core outcomes. Further work needs to be performed to identify the measures that should be reported for each of these outcomes.

Atopic dermatitis and risk of hypertension, type 2 diabetes, myocardial infarction and stroke in a cross-sectional analysis from the Canadian Partnership for Tomorrow Project.

BACKGROUND: Atopic dermatitis (AD) has been associated with cardiovascular risk factors and diseases, but epidemiological studies to date have found conflicting results. OBJECTIVES: To determine the associations of AD with hypertension, type 2 diabetes (T2D), myocardial infarction (MI) and stroke. METHODS: We conducted a cross-sectional analysis of baseline data from the Canadian Partnership for Tomorrow Project, which includes Canadian residents aged 30-74 years living in British Columbia, Alberta, Ontario, Quebec and the Atlantic Provinces. We excluded participants with incomplete data on AD, hypertension, T2D, MI or stroke, who had type 1 or gestational diabetes or who developed any of the outcomes at an age prior to a diagnosis of AD. This left 259 119 participants in our analysis. We used logistic regression to calculate age- and sex-, and multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) between AD and subsequent hypertension, T2D, MI and stroke. RESULTS: AD was reported by 21 379 (8·4%) participants. In total, 52 787 cases of hypertension, 12 739 cases of T2D, 4390 cases of MI and 2235 cases of stroke were reported by participants at enrolment. In the multivariable-adjusted model, AD was associated with decreased odds of hypertension (OR 0·87, 95% CI 0·83-0·90), T2D (OR 0·78, 95% CI 0·71-0·84), MI (OR 0·87, 95% CI 0·75-1·00) and stroke (OR 0·79, 95% CI 0·66-0·95). CONCLUSIONS: We did not find evidence of a positive association between AD and subsequent hypertension, T2D, MI or stroke; AD was inversely associated with these outcomes in our study. Given our findings and the conflicting literature, AD is likely not a major risk factor for cardiovascular disease.

Loss of Work Productivity and Quality of Life in Patients With Autoimmune Bullous Dermatoses.

BACKGROUND: Little is known about quality of life and work productivity in autoimmune bullous dermatoses (AIBDs). OBJECTIVE: To determine the impact of AIBDs on quality of life and work productivity. METHODS: An observational cross-sectional study took place between February and May 2013 at an AIBD tertiary referral centre. Ninety-four patients were included. All participants completed the Dermatology Life Quality Index and the Work Productivity and Activity Impairment-Specific Health Problem questionnaires. RESULTS: Responders to treatment had less impairment (P<.001) than nonresponders. Patients with severe AIBD had significantly more impairment that those with mild (P<.001) and moderate (P=.002) AIBD. Greater impairment was associated with higher percentage of work missed. Those with a higher Dermatology Life Quality Index score had greater work impairment and overall activity impairment (P=.041, P=.024). Nonresponders had increased impairment while working (P<.001), overall work impairment (P<.001), and activity impairment (P<.001). Severely affected patients had worse impairment in all Work Productivity and Activity Impairment Questionnaire domains. CONCLUSIONS: AIBD has the potential to be a large burden on ability to work and quality of life. Larger studies are needed to clarify how these domains change over time and whether or not they improve with treatment.