The completeness and accuracy of DataDerm: The database of the American Academy of Dermatology.

The utility of any database or registry depends on the completeness and accuracy of the data it contains. This report documents the validity of data elements within DataDerm, the clinical registry database of the American Academy of Dermatology. An external audit of DataDerm, performed by a third-party vendor, involved the manual review of 1098 individual patient charts from calendar year 2018 from 8 different dermatology practices that used 4 different electronic health records. At each site, 142 discrete data fields were assessed, comparing the data within DataDerm to the source data within the electronic health record. Audited data included 3 domains of data elements (diagnoses, medications, and procedures) and a performance measure ("Biopsy Reporting Time-Clinician to Patient"), which is 1 of several measures used by DataDerm as a Qualified Clinical Data Registry. Overall completeness of data was 95.3%, with a range among practices of 90.6% to 98.5%. Overall accuracy of data was 89.8%, with a range of accuracy among practices of 81.2% to 94.1%. These levels of completeness and accuracy exceed the rates in the literature for registries that are based on data that is extracted from electronic health records; and therefore, this audit validates the excellent quality of data in DataDerm.

The 2021 annual report of DataDerm: The database of the American Academy of Dermatology.

The American Academy of Dermatology launched DataDerm in 2016 as the clinical data registry platform of the American Academy of Dermatology. DataDerm has evolved to be the largest database containing information about dermatology patients in the world. As of December 31, 2020, DataDerm contained data from 11.3 million unique patients and 40.0 million unique patient visits, with 782 practices representing 2290 clinicians actively participating in DataDerm. This article is the second in a series of annual reports about the status of DataDerm. While last year's 2020 first annual report presented the history of DataDerm as well as the rationale for its creation, maintenance, and expansion, this year's 2021 annual report presents the progress DataDerm has made over the past year along with its current status and future plans.

The 2020 annual report of DataDerm: The database of the American Academy of Dermatology.

The American Academy of Dermatology launched DataDerm in 2016 as the clinical data registry platform of the American Academy of Dermatology. DataDerm is approved by the Centers for Medicare & Medicaid Services as a Qualified Clinical Data Registry for the Merit-Based Incentive Payment System. The ultimate purpose of DataDerm is to provide dermatologists with a registry and database that will serve as a vehicle to advance the specialty in the domains of science, discovery, education, quality assessment, quality improvement, advocacy, and practice management. DataDerm is currently the largest clinical registry and database of patients receiving dermatologic care in the world. As of December 31, 2019, DataDerm contained data from 10,618,879 unique patients and 32,309,389 unique patient visits. Depending on the reporting period, 800 to 900 practices (representing 2400-2600 clinicians) actively participate in DataDerm by submitting data. This article provides the first of a planned series of annual updates of the status of DataDerm. The purpose of this article is to present the rationale for the creation, maintenance, history, and current status of DataDerm, as well as the future plans for DataDerm.

A 1% Colloidal Oatmeal Cream Alone is Effective in Reducing Symptoms of Mild to Moderate Atopic Dermatitis: Results from Two Clinical Studies.

BACKGROUND: The epidermal barrier in patients with atopic dermatitis (AD) is deficient in ceramides and cathelicidins. Such epidermal defects may be a trigger for AD, thereby encouraging research toward development of skin-barrier-targeted preventive strategies.

METHODS: Two single-center, single-arm clinical trials were conducted (study 1, age greater than equal to 8 years and study 2, greater than equal to 10 years) in patients with mild to moderate AD to evaluate the effects of an over-the-counter 1% colloidal oatmeal cream administered for 14 days. Study 1 assessed the Eczema Area and Severity Index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA) on day 3, and itch severity using a Visual Analogue Scale (VAS) immediately after application as primary efficacy endpoints. In study 2, the primary efficacy endpoint was change from baseline in patients' assessment of itch. Both studies assessed safety through adverse event (AE) recording.

RESULTS: Study 1: 29 patients were enrolled (mean age [range], 27.07 [8 -67]). Comparing to baseline, EASI, IGADA, and itch were improved after the application, and improvements were maintained until day 14. Improvements of greater than/equal to 20% over baseline were noted in 53.6% and 25.0% patients at day 3 for EASI and IGADA scores, respectively, and in 37.9% patients for itch score immediately after the product application. On day 14, these percentages were 82.8%, 62.1%, and 85.7%, respectively.

STUDY 2: 30 patients were enrolled (mean age [range], 32.9 [10-80]). Itch severity and EASI score were significantly improved after product application and improvements were maintained until day 14. Transepidermal water loss values were significantly reduced and skin hydration was significantly increased at all assessment time points. No adverse events (AEs) were reported in study 2 and 2 AEs were reported by 1 patient in study 1.

CONCLUSIONS: The colloidal oatmeal cream was well tolerated and clinically effective in patients with mild to moderate AD.

J Drugs Dermatol. 2017;16(7):671-676.

Development of a scoliotic spine model for biomechanical in vitro studies.

BACKGROUND: In vitro experiments are important to compare surgical treatments. Especially new implants need preclinical evaluation. However, in vitro experiments with scoliotic specimens are impossible because they are not available. The purpose of this study was to develop an in vitro scoliosis model with cadaveric calf spine specimens, which may serve as a surrogate for human scoliotic spines. METHODS: Six cadaveric calf spine specimens (T8-L6) were modified in three different steps to create a thoracolumbar scoliosis, convex to the right. First, all intervertebral discs received a nucleotomy. In the second step the cavity was filled with silicone. The silicone hardened in a bend position to obtain an asymmetrical nucleus. Finally, a wedge profile of the vertebral bodies was achieved by unilateral horizontal cuts (T9-L5), followed by spreading and fixation. Flexibility tests in a spine tester were performed in all motion planes with the original spine and after the different steps during the creation of the model. FINDINGS: A Cobb angle >40° in the frontal plane could be achieved. Additionally, the vertebrae showed an axial rotation to the convex side. The range of motion increased due to the nucleotomy, decreased slightly after replacement with silicone, and decreased below the values of the intact spine after producing the wedge shape of the vertebrae. In each loading direction there was no significant asymmetry in the motion behavior. INTERPRETATION: This study suggests a method to modify a straight spine specimen into a scoliotic one, which can be used for biomechanical in vitro experiments.

Distribution of central corneal thickness and its association with ocular parameters in a large central European cohort: the Gutenberg health study.

MAIN OBJECTIVE: To evaluate the distribution of central corneal thickness (CCT) in a large German cohort and to analyse its relationship with intraocular pressure and further ocular factors. DESIGN: Population-based, prospective, cohort study. METHODS: The Gutenberg Health Study (GHS) cohort included 4,698 eligible enrollees of 5,000 subjects (age range 35-74 years) who participated in the survey from 2007 to 2008. All participants underwent an ophthalmological examination including slitlamp biomicroscopy, intraocular pressure measurement, central corneal thickness measurement, fundus examination, and were given a questionnaire regarding glaucoma history. Furthermore, all subjects underwent fundus photography and visual field testing using frequency doubling perimetry. RESULTS: Mean CCT was 557.3 ± 34.3 µm (male) and 551.6±35.2 µm in female subjects (Mean CCT from right and left eyes). Younger male participants (35-44 years) presented slightly thicker CCT than those older. We noted a significant CCT difference of 4 µm between right and left eyes, but a high correlation between eyes (Wilcoxon test for related samples: p<0.0001). Univariable linear regression stratified by gender showed that IOP was correlated with CCT (p<0.0001). A 10 µm increase in CCT led to an increase in IOP between 0.35-0.38 mm Hg, depending on the eye and gender. Multivariable linear regression analysis revealed correlations between gender, spherical equivalent (right eyes), and CCT (p<.0001 and p=0.03, respectively). CONCLUSIONS: We observed positive correlations between CCT and IOP and gender. CCT was not correlated with age, contact lens wear, positive family history for glaucoma, lens status, or iris colour.

Immune response to pneumococcal polysaccharide vaccine in adults with chronic plaque psoriasis treated with alefacept.

BACKGROUND: Alefacept is a T cell-modulating biologic therapy for psoriasis that could affect patients' ability to mount immune responses. OBJECTIVE: This open-label, phase IV, multicenter study assessed the ability of adults with chronic plaque psoriasis receiving alefacept to generate antibodies to a pneumococcal polysaccharide vaccine (PPV). METHODS: Patients were treated with a standard 12-week course of alefacept and administered the 23-valent PPV at week 6. Antipneumococcal antibodies were measured at baseline and weeks 6, 9, 12, and 33. The primary end point was the percentage of patients with a 2-fold or greater increase from prevaccination (week 6) to 6 weeks postvaccination (week 12) in antibody titers to 2 or more of 5 designated PPV antigens. RESULTS: Of 43 patients enrolled, 42 were included in the full analysis set, with 86% of patients exhibiting a 2-fold or greater increase and 57% of patients exhibiting a 4-fold or greater increase in antibody titers to 2 or more of 5 designated antigens from prevaccination to 6 weeks postvaccination. At 6 months postvaccination, 78% of patients had a 2-fold or greater increase and 47% of patients had a 4-fold or greater increase in antibody titers to 2 or more of the 5 designated antigens. There were statistically significant increases in mean antibody titers to all 23 antigens in PPV from prevaccination to 6 weeks postvaccination. LIMITATIONS: This was an open-label study with no comparator. CONCLUSIONS: Most patients mounted immune responses to PPV; increases in antibody titers in these patients were consistent with those seen in healthy individuals.