Background Cutaneous reactions after mRNA-based COVID-19 vaccines have been reported but are not well characterized. Objective To evaluate morphology and timing of cutaneous reactions after mRNA COVID-19 vaccines. Methods A provider-facing registry-based study collected cases of cutaneous manifestations after COVID-19 vaccination. Results From December 2020-February 2021, we recorded 414 cutaneous reactions to mRNA COVID-19 vaccines from Moderna (83%) and Pfizer (17%). Delayed large local reactions were most common, followed by local injection site reactions, urticarial eruptions, and morbilliform eruptions. Forty-three percent of patients with first dose reactions experienced second dose recurrence. Limitations Registry analysis does not measure incidence. Morphologic misclassification is possible. Conclusion We report a spectrum of cutaneous reactions after COVID-19 mRNA vaccines. Most patients with first dose reactions did not develop a second dose reaction, and no patients in the registry developed serious adverse events after the first or second dose. These data provide reassurance to patients and providers.
Background HIV-associated Kaposi sarcoma (KS) is one of the most common malignancies in sub-Saharan Africa. The diagnosis is often based on clinical suspicion, without histopathologic confirmation. When biopsies are performed, the accuracy of interpretation by local pathologists is poorly understood. We assessed the accuracy of clinical suspicion and pathologic diagnosis of KS in two East African countries. Methods At two large HIV care sites in Uganda and Kenya, we evaluated consecutive biopsies performed from October 2008 to January 2013 upon HIV-infected adults with clinically suspected KS. Biopsies were interpreted by both local African pathologists and a group of U.S.-based dermatopathologists from a high volume medical center. For the purpose of this analysis, the U.S.-based dermatopathologist interpretation was used as the gold standard. Positive predictive value was used to characterize accuracy of local African clinical suspicion of KS, and concordance, sensitivity, and specificity were used to characterize accuracy of local pathologic diagnosis. Results Among 1106 biopsies, the positive predictive value of clinical suspicion of KS was 77% (95% CI: 74%-79%). When KS was not histopathologically diagnosed, clinically banal conditions were found in 35%, medically significant disorders which required different therapy in 59%, and life-threatening diseases in 6%. Concordance between African pathologists and U.S.-based dermatopathologists was 69% (95% CI: 66%-72%). Sensitivity and specificity of African pathologic diagnoses were 68% and 89%, respectively. Conclusions Among East African HIV-infected patients, we found suboptimal positive predictive value of clinical suspicion of KS and specific, but not sensitive, histopathologic interpretation. The findings call for abandonment of isolated clinical diagnosis of KS in the region as well as augmentation of local dermatopathologic services.
In resource‐limited areas, such as sub‐Saharan Africa, problems in accurate cancer case ascertainment and enumeration of the at‐risk population make it difficult to estimate cancer incidence. We took advantage of a large well‐enumerated healthcare system to estimate the incidence of Kaposi sarcoma (KS), a cancer which has become prominent in the HIV era and whose incidence may be changing with the rollout of antiretroviral therapy (ART). To achieve this, we evaluated HIV‐infected adults receiving care between 2007 and 2012 at any of three medical centers in Kenya and Uganda that participate in the East Africa International Epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium. Through IeDEA, clinicians received training in KS recognition and biopsy equipment. We found that the overall prevalence of KS among 102,945 HIV‐infected adults upon clinic enrollment was 1.4%; it declined over time at the largest site. Among 140,552 patients followed for 319,632 person‐years, the age‐standardized incidence rate was 334/100,000 person‐years (95% CI: 314–354/100,000 person‐years). Incidence decreased over time and was lower in women, persons on ART, and those with higher CD4 counts. The incidence rate among patients on ART with a CD4 count >350 cells/mm3 was 32/100,000 person‐years (95% CI: 14–70/100,000 person‐years). Despite reductions over time coincident with the expansion of ART, KS incidence among HIV‐infected adults in East Africa equals or exceeds the most common cancers in resource‐replete settings. In resource‐limited settings, strategic efforts to improve cancer diagnosis in combination with already well‐enumerated at‐risk denominators can make healthcare systems attractive platforms for estimating cancer incidence.
Fueled by HIV, sub-Saharan Africa has the highest incidence of Kaposi's sarcoma (KS) in the world. Despite this, KS diagnosis in the region is based mostly on clinical grounds. Where biopsy is available, it has traditionally been excisional and performed by surgeons, resulting in multiple appointments, follow-up visits for suture removal, and substantial costs. We hypothesized that a simpler approach - skin punch biopsy - would make histologic diagnosis more accessible. To address this, we provided training and equipment for skin punch biopsy of suspected KS to three HIV clinics in East Africa. The procedure consisted of local anesthesia followed by a disposable cylindrical punch blade to obtain specimens. Hemostasis is facilitated by Gelfoam®. Patients removed the dressing after 4 days. From 2007 to 2013, 2,799 biopsies were performed. Although originally targeted to be used by physicians, biopsies were performed predominantly by nurses (62%), followed by physicians (15%), clinical officers (12%) and technicians (11%). There were no reports of recurrent bleeding or infection. After minimal training and provision of inexpensive equipment (USD 3.06 per biopsy), HIV clinics in East Africa can integrate same-day skin punch biopsy for suspected KS. Task shifting from physician to non-physician greatly increases access. Skin punch biopsy should be part of any HIV clinic's essential procedures. This example of task shifting may also be applicable to the diagnosis of other cancers (e.g., breast) in resource-limited settings.
TD) enables remote triage and management of dermatology patients. Previous analyses of TD systems have demonstrated improved access to care but an inconsistent fiscal impact.OBJECTIVE To compare the organizationwide cost of managing newly referred dermatology patients within a TD triage system vs a conventional dermatology care model at the Zuckerberg San Francisco General Hospital and Trauma Center (hereafter referred to as the ZSFG) in California. DESIGN, SETTING, AND PARTICIPANTSA retrospective cost minimization analysis was conducted of 2098 patients referred to the dermatology department at the ZSFG between June 1 and December 31, 2017.INTERVENTION Implementation of the TD triage system in January 2015. MAIN OUTCOMES AND MEASURESThe main outcome was mean cost to the health care organization to manage newly referred dermatology patients with or without TD triage. To estimate costs, decision-tree models were constructed to characterize possible care paths with TD triage and within a conventional dermatology care model. Costs associated with primary care visits, dermatology visits, and TD visits were then applied to the decision-tree models to estimate the mean cost of managing patients following each care path for 6 months. The mean cost for each visit type incorporated personnel costs, with the mean cost per TD consultation also incorporating software implementation and maintenance costs. Finally, ZSFG patient data were applied within the models to evaluate branch probabilities, enabling calculation of mean cost per patient within each model. RESULTSThe analysis captured 2098 patients (1154 men [55.0%]; mean [SD] age, 53.4 [16.8] years), with 1099 (52.4%) having Medi-Cal insurance and 879 (41.9%) identifying as non-White. In the decision-tree model with TD triage, the mean (SD) cost per patient to the health care organization was $559.84 ($319.29). In the decision-tree model for conventional dermatology care, the mean (SD) cost per patient was $699.96 ($390.24). Therefore, the TD model demonstrated a statistically significant mean (SE) cost savings of $140.12 ($11.01) per patient. Given an annual dermatology referral volume of 3150 patients, the analysis estimates an annual savings of $441 378.CONCLUSIONS AND RELEVANCE Implementation of a TD triage system within the dermatology department at the ZSFG was associated with cost savings, suggesting that managed health care settings may experience significant cost savings from using TD to triage and manage patients.
Martin et al.: Prospective evaluation of the impact of potent antiretroviral therapy on the incidence of Kaposi's Sarcoma in East Africa: findings from the International Epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium. Infectious Agents and Cancer 2012 7 (Suppl 1):O19.
Background COVID-19 vaccines, primarily mRNA types, are administered to 2,000,000 individuals per day in the US under FDA emergency use authorization. Methods Observational cohort study of hospital workers who received their first SARS-CoV2 mRNA vaccination between December 14, 2020 and January 8, 2021, including cases reporting onset of an injection site reaction > 48 hours after administration of their first or second dose to an employee hotline. Results Thirteen female employees, who received mRNA-1273 SARS-CoV2 vaccine (Moderna) during the first three weeks of SARS-CoV2 vaccine rollout at San Francisco General Hospital, reported a pruritic rash at the injection site appearing 3-9 days after receiving their initial dose. Five had milder or similar reactions with earlier onset after the second dose. One additional female employee reported this delayed reaction only after the second dose. None of these 14 employees reported serious adverse events, such as anaphylaxis, or had symptoms severe enough to seek medical attention. These cases represented 1.1% of the 1,275 female employees who received their first mRNA-1273 dose, and 2.0% of the 557 who were 31-45 years old, during this initial vaccine rollout. None of 675 males initiating mRNA-1273 or 3,612 employees of either sex initiating BNT162b (Pfizer) vaccination during this period reported this delayed onset reaction. Conclusions These results suggest that delayed-onset, injection-site pruritic rashes after mRNA-1273 SARS-CoV2 vaccine administration, lasting up to a week, occur commonly in females, do not lead to serious sequela, and should not deter receipt of the second vaccine dose.
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