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Open Access Publications from the University of California

Open Access Policy Deposits

This series is automatically populated with publications deposited by UCSF Department of Epidemiology and Biostatistics researchers in accordance with the University of California’s open access policies. For more information see Open Access Policy Deposits and the UC Publication Management System.

Cover page of Differential Use of Diagnostic Ultrasound in U.S. Emergency Departments by Time of Day

Differential Use of Diagnostic Ultrasound in U.S. Emergency Departments by Time of Day

(2011)

Background: Survey data over the last several decades suggests that emergency department (ED) access to diagnostic ultrasound performed by the radiology department is unreliable, particularly outside of regular business hours.

Objective: To evaluate the association between the time of day of patient presentation and the use of diagnostic ultrasound services in United States (U.S.) EDs.

Methods: This was a cross-sectional study of ED patient visits using the National Hospital Ambulatory Medical Care Survey for the years 2003 to 2005. Our main outcome measure was the use of diagnostic ultrasound during the ED patient visit as abstracted from the medical record. We performed multivariate analyses to identify any association between ultrasound use and time of presentation for all patients, as well as for two subgroups who are more likely to need ultrasound as part of their routine workup: patients at risk of deep venous thrombosis, and patients at risk for ectopic pregnancy.

Results: During the three-year period, we analyzed 110,447 patient encounters, representing 39 million national visits. Of all ED visits, 2.6% received diagnostic ultrasound. Presenting to the ED “off hours” (defined as Monday through Friday 7pm to 7am and weekends) was associated with a lower rate of ultrasound use independent of potential confounders (odds ratio [OR] 0.73, 95% confidence interval [CI]: 0.65 - 0.82). Patients at increased risk of deep venous thrombosis who presented to the ED during “off hours” were also less likely to undergo diagnostic ultrasound (OR 0.34, 95% CI: 0.15 - 0.79). Similarly, patients at increased risk of ectopic pregnancy received fewer diagnostic ultrasounds during “off hours” (OR 0.56, 95% CI 0.35 - 0.91).

Conclusion: In U.S. EDs, ultrasound use was lower during “off hours,” even among patient populations where its use would be strongly indicated. [West J Emerg Med. 2011;12(1):90-95.]

Cover page of The contribution of community transmission to the burden of hospital-associated pathogens: A systematic scoping review of epidemiological models.

The contribution of community transmission to the burden of hospital-associated pathogens: A systematic scoping review of epidemiological models.

(2025)

Healthcare-associated infections (HAI), particularly those involving multi-drug resistant organisms (MDRO), pose a significant public health threat. Understanding the transmission of these pathogens in short-term acute care hospitals (STACH) is crucial for effective control. Mathematical and computational models play a key role in studying transmission but often overlook the influence of long-term care facilities (LTCFs) and the broader community on transmission. In a systematic scoping review of 4,733 unique studies from 2016 to 2022, we explored the modeling landscape of the hospital-community interface in HAI-causing pathogen transmission. Among the 29 eligible studies, 28 % (n = 8) exclusively modeled LTCFs, 45 % (n = 13) focused on non-healthcare-related community settings, and 31 % (n = 9) considered both settings. Studies emphasizing screening and contact precautions were more likely to include LTCFs but tended to neglect the wider community. This review emphasizes the crucial need for comprehensive modeling that incorporates the communitys impact on both clinical and public health outcomes.

The Family and Pregnancy Pop-Up Village: Developing a one-stop shop of services to reduce pregnancy care-related inequities in San Francisco.

(2025)

INTRODUCTION: Centering affected individuals and forming equitable institutional-community partnerships are necessary to meaningfully transform care delivery systems. We describe our use of the PRECEDE-PROCEED framework to design, plan, and implement a novel care delivery system to address perinatal inequities in San Francisco. METHODS: Community engagement (PRECEDE phases 1-2) informed the Pregnancy Village prototype, which would unite key organizations to deliver valuable services alongside one another, as a recurring one-stop-shop community-based event, delivered in an uplifting, celebratory, and healing environment. Semi-structured interviews with key partners identified participation facilitators and barriers (PRECEDE phases 3-4) and findings informed our implementation roadmap. We measured feasibility through the number of events successfully produced and attended, and organizational engagement through meeting attendance and surveys. RESULTS: The goals of Pregnancy Village resonated with key partners. Most organizations identified resource constraints and other participation barriers; all committed to the requested 12-month pilot. During its first year, 10 pilot events were held with consistent organizational participation and high provider engagement. CONCLUSION: Through deep engagement and equitable partnerships between community and institutional stakeholders, novel systems of care delivery can be implemented to better meet comprehensive community needs.

Cover page of Financial conflicts among physician speakers at the April 12, 2024 Oncology Drug Advisory Meeting: Who decided that MRD can be a novel regulatory endpoint in myeloma?

Financial conflicts among physician speakers at the April 12, 2024 Oncology Drug Advisory Meeting: Who decided that MRD can be a novel regulatory endpoint in myeloma?

(2025)

Background

In April 2024, the Oncology Drug Advisory Committee (ODAC) voted to approve minimal residual disease (MRD) as a new regulatory endpoint for multiple myeloma (MM) despite its poor trial-level surrogacy. This is expected to result in faster MM drug approvals, a potential boon for the pharmaceutical companies that make them. This study investigates the prevalence of financial conflicts of interest (FCOIs) with these companies among United States (US)-based physician speakers at the meeting.

Methods

Public data regarding the past 3 years of pharmaceutical company payments to US-based physician speakers at the ODAC meeting discussing MRD (available at https://openpaymentsdata.cms.gov/) were collected. For each general payment (GP), we recorded the amount, company payor, reason for payment, and associated products. Descriptive analyses were performed on payments from companies who manufacture MM therapeutics (MM payments).

Results

12 of the 20 physician speakers (60 %) eligible to have FCOIs recorded on the OpenPayments database received MM payments from 2021 to 2023, totaling more than $792,200. A majority of both voting and non-voting members had MM payments (median $11,800 and $764), most of which were consulting fees. Speakers earned more than 3.7 times as much from GPs associated with MM-related products compared to those associated with non-MM-related products.

Conclusion

Most US-based physician speakers at the April 2024 ODAC meeting had FCOIs from MM companies, including those with voting power.

Policy summary

Our findings highlight the need for greater policing of FCOIs among US-based physicians involved in cancer drug regulatory policy.

Cover page of Trend of sales revenue by year for top selling cancer drugs in the US and the effect of loss of market exclusivity

Trend of sales revenue by year for top selling cancer drugs in the US and the effect of loss of market exclusivity

(2025)

Biosimilars and generics have led to reduced cancer drug prices. The effect of biosimilar or generic drug competition on drug manufacturer revenue has not been previously described. In this study, the majority of top selling cancer drugs had a greater than 50 % decline in sales revenue within 2 years of generic or biosimilar market entry, reflecting both the decline in market share and reduction in unit drug price. This results in important drug manufacturer incentives, which may shape clinical trial agendas. The market structure incentives are unique for pharmaceutical companies due to the relatively short and limited duration of profitability. Policy changes such as patent reform leading to shorter duration of exclusivity may lead to greater incentive to expand low value indications in oncology.

Cover page of Trajectories and patterns of US counties policy responses to the COVID-19 pandemic: A sequence analysis approach.

Trajectories and patterns of US counties policy responses to the COVID-19 pandemic: A sequence analysis approach.

(2025)

Background

It is increasingly recognized that policies played a role in mitigating or exacerbating health inequities during the COVID-19 pandemic. While US counties were particularly active in policymaking, limited work has characterized geographic and temporal variation in pandemic-era policymaking at the local level, a prerequisite for later studies examining the health effects of these policies. This paper fills this gap by characterizing county-level COVID-19-related policy trajectories over time using a novel national policy database and innovative methods.

Methods

Data came from the US COVID-19 County Policy (UCCP) Database, including 309 counties in 50 states plus Washington DC during January 2020 to December 2021. We examined measures of overall policy comprehensiveness, as well as three domains including containment and closure, economic response, and public health. We applied sequence analysis to characterize county-level trajectories overall and within each policy domain, and cluster analysis to group similar trajectories.

Results

There was wide variation in policymaking, with nearly half of counties demonstrating consistently comprehensive policymaking, about 15-20% with consistently low comprehensiveness, and the remainder exhibiting intermittent comprehensiveness. Economic policies were less comprehensive than containment/closure and public health policies. There was also substantial variation within and across states, and associations with county characteristics.

Conclusion

This study is among the first to document substantial geographic and temporal variation in a variety of US county-level COVID-19-related policies, which likely contributed to health disparities during and after the pandemic. Future work should evaluate how these different policy trajectories differentially affected health and social outcomes.

Cover page of Identifying malaria risks amongst forest going populations in Mondulkiri province and Kampong Speu province, Cambodia: a large cross-sectional survey.

Identifying malaria risks amongst forest going populations in Mondulkiri province and Kampong Speu province, Cambodia: a large cross-sectional survey.

(2025)

BACKGROUND: Cambodia strives to eliminate all species of human malaria by 2025, requiring that foci among forest-exposed populations in remote settings be addressed. This study explores malaria risks amongst forest-exposed groups in Mondulkiri and Kampong Speu Provinces, Cambodia as part of a multi-stage study on novel mosquito bite prevention tools (Project BITE). METHODS: A serial cross-sectional survey explored the demographics, housing structure openness, mosquito bite prevention habits, and protection from malaria amongst three target groups: forest goers who work in the forest, forest dwellers who live in the forest, and forest rangers who patrol forested regions. Malaria prevalence data was collected at three time points using rapid diagnostic tests (RDTs) for febrile individuals and qPCR for all participants. Infection locations and travel patterns of Plasmodium falciparum-infected individuals were analysed for clustering and the potential movement of infections. RESULTS: 2935 participants were enrolled between October 2022 and February 2023, consisting of 1093 (37%) forest goers and 1787 (61%) forest dwellers across both provinces, and 55 (5%) forest rangers in Mondulkiri province. Most worked outdoors as farmers, day labourers, and forest collectors, and reported going to the forest five to seven days a week. For housing, 29% and 39% of participants reported living in partially open primary and secondary structures, respectively. The main methods of mosquito bite protection used were insecticide-treated nets, wearing long sleeves, and burning mosquito coils, with limited protection during the daytime and outside at night. All febrile individuals had negative RDT test results. For qPCR, 24 P. falciparum infections (< 1%) were detected among forest goers and dwellers, clustered in Pu Trom and Pu Nhav villages in Mondulkiri Province, and Banteay Roka and Banteay Roka Kirisenchey (M) villages in Kampong Speu Province. Plasmodium vivax cases were detected (216 cases, 5%) across all enrolled villages. Only two infections were found in forest rangers. CONCLUSION: Malaria elimination strategies for forest-exposed populations in Cambodia should focus on vector intervention strategies that offer protection during the day and outside at night, and drug-based strategies to clear subpatent infections, targeting forest goers and dwellers in villages where cases are detected.

MRI-based analysis of thigh intramuscular fat and its associations with age, sex, and BMI using data from the osteoarthritis initiative data.

(2025)

The degree of thigh intramuscular fat in individuals without OA is fundamental for distinguishing natural variations in intramuscular fat from pathological changes. The goals of this study were to estimate the degree of thigh intramuscular fat in individuals without radiographic OA or frequent pain and assess the associations of age, sex, and BMI with the degree of intramuscular fat. Individuals without knee or hip radiographic OA, without total knee/hip arthroplasty, and without frequent knee/hip pain were selected from the OAI database (n = 710). Goutallier Grades (GGs) of the quadriceps and hamstring muscles were assessed based on 3 T MR images on a scale from 0 (normal muscle) to 4 (more fat than muscle). The associations between demographic variables and GG outcomes were evaluated using mixed effects models. The most prevalent GGs among the muscles were Grades 1 and 2; Grade 4 was infrequent (< 1%). Greater BMI (p < 0.001) and age (p < 0.001) were each associated with greater GG. Women had greater GG than men (greatest difference in the vastus medialis: coeff. = 0.214, p < 0.001). At lower BMI, women had greater intramuscular fat than men; at higher BMI, men had greater intramuscular fat than women (p = 0.029 for BMI-sex interaction). While individuals without radiographic OA or frequent pain generally had low thigh intramuscular fat, higher BMI and age were associated with greater intramuscular fat, and GGs were greater in women than men. The relationship between BMI and intramuscular fat was sex-dependent. Thus, demographic variables must be considered when evaluating intramuscular fat.

Gender-differences in imaging phenotypes of osteoarthritis in the osteoarthritis initiative.

(2025)

In osteoarthritis (OA) research it is increasingly recognized that stratification according to disease phenotypes is essential for optimizing treatment regimens. Gender-specific differences in clinical OA manifestations have been identified, and this analysis aimed to assess whether these differences extend to imaging phenotypes.From the Osteoarthritis Initiative database 2523 participants (1409 women and 1114 men) with completed 3T MRI and whole-organ magnetic resonance imaging scores (WORMS) of the right knee at baseline were included. Imaging phenotypes were assigned based on modified Rapid OsteoArthritis MRI Eligibility Score: the inflammatory, meniscus-cartilage, and bone phenotype. Logistic regression was performed to investigate the effect of gender on phenotype, independent of BMI, race, Kellgren & Lawrence (KL) grade and level of physical activity. Female gender was independently associated with lower odds for the meniscus-cartilage (OR 0.61, 95%CI 0.47-0.80, p < 0.001) but not for the inflammatory (OR 1.04, 95%CI 0.89-1.24, p = 0.697) or the subchondral bone phenotype (OR 1.13, 95%CI 0.95-1.36, p = 0.166). This difference highlights an opportunity for future refinements to better accommodate gender/sex differences in disease trajectories while investigating different treatment regimes in knee OA.

Cover page of Galectin 9 Levels as a Potential Predictor of Intact HIV Reservoir Decay.

Galectin 9 Levels as a Potential Predictor of Intact HIV Reservoir Decay.

(2025)

BACKGROUND: During antiretroviral therapy (ART), the HIV reservoir shows variability, with cells carrying intact genomes decaying faster than those with defective genomes, particularly in the first years. The host factors influencing this decay remain unclear. METHODS: Observational study of 74 PWH on ART, 70 (94.6%) of whom were male. Intact proviruses were measured using the intact proviral DNA assay, and 32 inflammatory cytokines were quantified using Luminex immunoassay. Linear spline models assessed the impact of baseline cytokine levels and their trajectories on intact HIV kinetics over seven years. RESULTS: Baseline Gal-9 was the strongest predictor, with lower levels predicting faster decay. A 10-fold decrease in baseline Gal-9 correlated with a 45% (95% CI, 14%-84%) greater annual decay of intact HIV genomes. Higher baseline interferon-inducible T-cell α chemoattractant (ITAC), interleukin 17 (IL-17), and macrophage inflammatory protein 1α (MIP-1α) levels also predicted faster decay. Longitudinal increases in MIP-3α and decreases in IL-6 were linked to a 9.5% and 10% faster decay, respectively. CONCLUSIONS: The association between lower baseline Gal-9 and faster intact HIV decay suggests targeting Gal-9 could enhance reservoir reduction. The involvement of MIP-3α and IL-6 highlights a broader cytokine regulatory network, suggesting potential multi-targeted interventions.