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Objectives/hypothesisDuring the current COVID-19 pandemic, the demand for direct-to-home telemedicine services has risen to an unprecedented level. Equal access to specialty care was assessed to identify potential barriers that may negatively impact telemedicine utilization.Study designRetrospective case series.MethodsWe examined the 6-week period between March and May 2020 when the only access to nonurgent pediatric otolaryngology service was through telemedicine and compared it to in-person visits during the same period in 2019. We compared patient demographics, including age, gender, preferred language, zip code of residence, and primary insurance plan.ResultsA total of 1,495 visits were conducted through telemedicine from March 23, 2020 to May 1, 2020, and 1983 in-person visits were completed in 2019. There was no difference in patient age and gender. The proportions of Spanish-speaking families were similar (15.8% in 2019 vs. 14.4% in 2020, P = .96). The percentage of Medi-Cal-insured patients (51.4% in 2019 vs. 49.8% in 2020, P = .73) and the mean poverty level (12.6% in 2019 vs. 12.2% in 2020, P = .38) also remained the same. Spanish-speaking families were statistically more likely to require rescheduling of their telemedicine visits (17.2%) when compared to the overall rescheduling rate of 11.9% (P = .0083).ConclusionsWe were able to successfully provide access to telemedicine services to our vulnerable populations during the current COVID-19 pandemic. Telemedicine is likely to remain an essential mode of delivering patient care going forward. It is important to evaluate and identify potential disparities to telemedicine access and proactively implement changes to address these barriers.Level of evidence4. Laryngoscope, 131:1175-1179, 2021.

Autoinflammatory disorders of the innate immune system present with recurrent episodes of inflammation often beginning in early childhood. While there are now more than 30 genetically-defined hereditary fever disorders, many patients lack a clear diagnosis. Many pediatric patients are often grouped with patients with periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) syndrome despite failing to meet diagnostic criteria. Here, we categorize these patients as syndrome of undifferentiated recurrent fever (SURF), and identify the unique features which distinguish them from the PFAPA syndrome. SURF patients were more likely to report gastrointestinal symptoms of nausea, vomiting and abdominal pain, and experienced inconsistent responses to on-demand steroid therapy compared to PFAPA patients. For this previously undefined cohort, an optimal course of therapy remains uncertain, with medical and surgical therapies largely driven by parental preference. A subset of patients with SURF underwent tonsillectomy with complete resolution. Flow cytometric evaluation demonstrates leukocytic populations distinct from PFAPA patients, with reduced CD3+ T cell numbers. SURF patient tonsils were predominantly characterized by an IL-1 signature compared to PFAPA, even during the afebrile period. Peripheral blood signatures were similar between groups suggesting that PFAPA and SURF patient tonsils have localized, persistent inflammation, without clinical symptoms. These data suggest that SURF is a heterogenous syndrome on the autoinflammatory disease spectrum.

Periodic Fever, Aphthous stomatitis, Pharyngitis and Adenitis (PFAPA) syndrome is an inflammatory disorder of childhood classically characterized by recurrent fevers, pharyngitis, stomatitis, cervical adenitis, and leukocytosis. While the mechanism is unclear, previous studies have shown that tonsillectomy can be a therapeutic option with improvement in quality of life in many patients with PFAPA, but the mechanisms behind surgical success remain unknown. In addition, long-term clinical follow-up is lacking. In our tertiary care center cohort, 62 patients with PFAPA syndrome had complete resolution of symptoms after surgery (95.3%). Flow cytometric evaluation demonstrates an inflammatory cell population, distinct from patients with infectious pharyngitis, with increased numbers of CD8+ T cells (5.9% vs. 3.8%, p

ObjectiveTo quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.MethodsOver 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.ResultsStaffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.ConclusionsUnderstanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.

IntroductionThe time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.Methods807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.ResultsHigh workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.ConclusionsReducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Abstract Background The ongoing pandemic of coronavirus disease 2019 (COVID-19) has the potential to reverse progress towards global targets. This study examines the risks that the COVID-19 pandemic poses to equitable access to essential medicines and vaccines (EMV) for universal health coverage in Africa. Methods We searched medical databases and grey literature up to 2 October 2020 for studies reporting data on prospective pathways and innovative strategies relevant for the assessment and management of the emerging risks in accessibility, safety, quality, and affordability of EMV in the context of the COVID-19 pandemic. We used the resulting pool of evidence to support our analysis and to draw policy recommendations to mitigate the emerging risks and improve preparedness for future crises. Results Of the 310 records screened, 134 were included in the analysis. We found that the disruption of the international system affects more immediately the capability of low- and middle-income countries to acquire the basket of EMV. The COVID-19 pandemic may facilitate dishonesty and fraud, increasing the propensity of patients to take substandard and falsified drugs. Strategic regional cooperation in the form of joint tenders and contract awarding, joint price negotiation and supplier selection, as well as joint market research, monitoring, and evaluation could improve the supply, affordability, quality, and safety of EMV. Sustainable health financing along with international technology transfer and substantial investment in research and development are needed to minimize the vulnerability of African countries arising from their dependence on imported EMV. To ensure equitable access, community-based strategies such as mobile clinics as well as fees exemptions for vulnerable and under-served segments of society might need to be considered. Strategies such as task delegation and telephone triage could help reduce physician workload. This coupled with payments of risk allowance to frontline healthcare workers and health-literate healthcare organization might improve the appropriate use of EMV. Conclusions Innovative and sustainable strategies informed by comparative risk assessment are increasingly needed to ensure that local economic, social, demographic, and epidemiological risks and potentials are accounted for in the national COVID-19 responses.

Objective: Provide clinicians with current evidence for biologic therapy in children with chronic rhinosinusitis with nasal polyposis (CRSwNP). Data Sources: PubMed, MEDLINE, Cochrane, and clinical trial registries. Review Methods: Key search terms related to biologic therapy in pediatric CRSwNP were identified via a structured query of current medical literature and clinical trial databases. Conclusions: There is a dearth of active clinical trials and research studies for biologics targeting pediatric CRSwNP. There is an ongoing compassionate‐use clinical trial involving Dupilumab for children with nasal polyps as well as only 1 published work specifically focused on Dupilumab for pediatric CRSwNP in the setting of aspirin‐exacerbated respiratory disease. Implications for Practice: For children with atopic dermatitis, asthma, and chronic idiopathic urticaria, biologic therapies such as Omalizumab, Dupilumab, and Mepolizumab have gained Food and Drug Administration approval. The role of biologic therapy in pediatric CRSwNP demonstrates significant promise in the comprehensive management of the unified airway. Additional Phase III trials are necessary to broaden clinical indications for children with comorbid conditions and complex sinonasal disease. [ABSTRACT FROM AUTHOR]

Abstract Despite its current relatively low global share of cases and deaths in Africa compared to other regions, coronavirus disease 2019 (COVID-19) has the potential to trigger other larger crises in the region. This is due to the vulnerability of health and economic systems, coupled with the high burden of human immunodeficiency virus (HIV), tuberculosis (TB), and malaria. Here we examine the potential implications of COVID-19 on the control of these major epidemic diseases in Africa. We use current evidence on disease burden of HIV, TB, and malaria, and epidemic dynamics of COVID-19 in Africa, retrieved from the literature. Our analysis shows that the current measures to control COVID-19 neglect important and complex context-specific epidemiological, social, and economic realities in Africa. There is a similarity of clinical features of TB and malaria, with those used to track COVID-19 cases. This coupled with institutional mistrust and misinformation might result in many patients with clinical features similar to those of COVID-19 being hesitant to voluntarily seek care in a formal health facility. Furthermore, most people in productive age in Africa work in the informal sector, and most of those in the formal sector are underemployed. With the current measures to control COVID-19, these populations might face unprecedented difficulties to access essential services, mainly due to reduced ability of patients to support direct and indirect medical costs, and unavailability of transportation means to reach health facilities. Therefore, if not accompanied with appropriate economic and epidemiological considerations, we anticipate that these measures might result in unprecedented difficulties among vulnerable segments of society to access essential services, including antiretroviral and prophylactic drugs among people living with HIV and Acquired Immune Deficiency Syndrome, anti-tuberculosis drugs, and curative and preventive treatments for malaria among pregnant women and children. This might increase the propensity of patients taking substandard doses and/or medicines, which has the potential to compromise drug efficacy, and worsen health inequalities in the region. COVID-19 responses at country level should include measures to protect vulnerable and under-served segments of society.

Introduction The rising burden of drug resistance is a major challenge to the global fight against malaria. We estimated national Plasmodium falciparum resistance to sulfadoxine-pyrimethamine (SP) across Africa, from 2000 to 2020.Methods We assembled molecular, clinical and endemicity data covering malaria-endemic African countries up to December 2018. Subsequently, we reconstructed georeferenced patient data, using pfdhps540E and pfdhps581G to measure mid-level and high-level SP resistance. Gaussian process regression was applied to model spatiotemporal standardised prevalence.Results In eastern Africa, mid-level SP resistance increased by 64.0% (95% uncertainty interval, 30.7%–69.8%) in Tanzania, 55.4% (31.3%–65.2%) in Sudan, 45.7% (16.8%–54.3%) in Mozambique, 29.7% (10.0%–45.2%) in Kenya and 8.7% (1.4%–36.8%) in Malawi from 2000 to 2010. This was followed by a steady decline of 76.0% (39.6%–92.6%) in Sudan, 65.7% (25.5%–85.6%) in Kenya and 17.4% (2.6%–37.5%) in Tanzania from 2010 to 2020. In central Africa, the levels increased by 28.9% (7.2%–62.5%) in Equatorial Guinea and 85.3% (54.0%–95.9%) in the Congo from 2000 to 2020, while in the other countries remained largely unchanged. In western Africa, the levels have remained low from 2000 to 2020, except for Nigeria, with a reduction of 14.4% (0.7%–67.5%) and Mali, with an increase of 7.0% (0.8%–25.6%). High-level SP resistance increased by 5.5% (1.0%–20.0%) in Malawi, 4.7% (0.5%–25.4%) in Kenya and 2.0% (0.1%–39.2%) in Tanzania, from 2000 to 2020.Conclusion Under the WHO protocols, SP is no longer effective for intermittent preventive treatment in pregnancy and infancy in most of eastern Africa and parts of central Africa. Strengthening health systems capacity to monitor drug resistance at subnational levels across the endemicity spectrum is critical to achieve the global target to end the epidemic.

ObjectiveTo quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.MethodsOver 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.ResultsStaffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.ConclusionsUnderstanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.

Context: In the face of rising mortality rates from cervical cancer (CC) among women of reproductive age, a nationwide screening program based on visual inspection with acetic acid was introduced in Mozambique in 2009. Objective: The objective of the study is to examine the impact of per capita income on the effectiveness of school-based health education programs to promote the utilization of CC screening services. Materials and Methods: We conducted a cross-sectional study in 2013 involving 105 women randomly selected from households of different economic backgrounds. Marginal effect estimates derived from a logit model were used to explore the patterns in the effectiveness of school-based health education to promote CC screening uptake according to household per capita income, based on purchasing power parity. Results: We found a CC screening uptake of 16.1% (95% confidence interval [CI], 9.7%–24.6%) even though 64.6% (95% CI, 54.2%–74.1%) of women had heard of it. There are important economic differentials in the effectiveness of school-based health education to influence women's decision to receive CC screening. Among women with primary school or less, the probability of accessing CC screening services increases with increasing income (P < 0.05). However, income significantly reduces the effect that school-based health education has on the probability of screening uptake among those women with more than 7 years of educational attainment (P = 0.02). Conclusion: These results show that CC screening programs in resource-constrained settings need approaches tailored to different segments of women with respect to education and income to achieve equitable improvement in the levels of screening uptake.

Introduction The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework. Methods 807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times. Results High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times. Conclusions Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Byline: David P. Magit, MD (Kerlan Jobe Orthopaedic Clinic, Los Angeles, California); James E. Tibone, MD (Kerlan Jobe Orthopaedic Clinic, Los Angeles, California); Thay Q. Lee, PhD (Orthopaedic Biomechanics Laboratory, [...]

Byline: David P. Magit, MD (Kerlan Jobe Orthopaedic Clinic, Los Angeles, California); Michelle McGarry, MS (Orthopaedic Biomechanics Laboratory, VA Long Beach Healthcare System, Long Beach, and University of California, Irvine, [...]