The incidence of dermatitis following application of foam tape in healthy volunteers-A prospective trial.

BACKGROUND: Foam tape is commonly used in the emergency department as a dressing over chest tubes owing to its occlusive and compressible properties. There is a paucity of data regarding the incidence of significant cutaneous reactions to this material. We conducted a prospective trial to evaluate the incidence of dermatitis following application of foam tape to the upper arm of a cohort of healthy volunteers. METHODS: This was a prospective, interventional trial. We enrolled a cohort of consenting, healthy physicians, nurses, and ancillary staff at a teaching facility who did not have known hypersensitivity to foam tape. Study investigators applied a 2 × 2 inch piece of 3 M microfoam adhesive to the medial aspect of each subject's upper arm. The contralateral arm served as a reference for comparison. The adhesive remained in place for 48 h and the study authors assessed patients utilizing the previously validated Cutaneous Irritancy Scoring System (CISS). Categorical variables analyzed by chi-square, continuous variables with t-tests. RESULTS: There were 40 subjects in the study group; 52% female, mean age 40±7 years, 55% non-White race. 10/40 (25%; 95%CI[14%, 41%]) of subjects had erythema; 9/40 (22%) had an erythema score of 1 and 1/40 (2.5%) had a score of 2. With respect to edema, 2/40 (5%; 95% CI[1%,18%]); 1/40(2.5%) had an edema score of 1, and 1/40(2.5%) had a score of 2. There were 9/40 subjects with an irritancy score > 0; (22%; 95%CI[12%,38%]); 7/40(18%) had an irritancy score of 1, and 2/4(5.0%) had a score of 2. In terms of the severity score, 10/40 (25%; 95%CI[14%, 41%]) had a score > 0; 9/40(22%) had a score of 1, and 1/40(2.5%) had a score of 2. Overall, 10/40 (25%; 95%CI[14%, 41%]) of subjects had at least one positive measure of a reaction of any kind. Subjects' age, gender and race were not found to be statistically significantly associated with the incidence of erythema, edema, or irritancy. In addition, these characteristics were not statistically significantly associated with severity score > 0. The p values for all the above bivariate analyses were > 0.05. CONCLUSIONS: Cutaneous reactions occurred in 25% of healthy volunteers after the application of foam tape to the arm. Patient characteristics were not associated with risk of a skin reaction. CLINICAL TRIALS REGISTRATION: #NCT06059417.

An Evaluation of Nephrology Literature for Transparency and Reproducibility Indicators: Cross-Sectional Review.

INTRODUCTION: Reproducibility is critical to diagnostic accuracy and treatment implementation. Concurrent with clinical reproducibility, research reproducibility establishes whether the use of identical study materials and methodologies in replication efforts permits researchers to arrive at similar results and conclusions. In this study, we address this gap by evaluating nephrology literature for common indicators of transparent and reproducible research. METHODS: We searched the National Library of Medicine catalog to identify 36 MEDLINE-indexed, English-language nephrology journals. We randomly sampled 300 publications published between January 1, 2014, and December 31, 2018. RESULTS: Our search yielded 28,835 publications, of which we randomly sampled 300 publications. Of the 300 publications, 152 (50.7%) were publicly available, whereas 143 (47.7%) were restricted through paywall and 5 (1.7%) were inaccessible. Of the remaining 295 publications, 123 were excluded because they lack empirical data necessary for reproducibility. Of the 172 publications with empirical data, 43 (25%) reported data availability statements and 4 (2.3%) analysis scripts. Of the 71 publications analyzed for preregistration and protocol availability, 0 (0.0%) provided links to a protocol and 8 (11.3%) were preregistered. CONCLUSION: Our study found that reproducible and transparent research practices are infrequently used by the nephrology research community. Greater efforts should be made by both funders and journals. In doing so, an open science culture may eventually become the norm rather than the exception.