Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials.

Background: The effectiveness of acupuncture for chronic low back pain (cLBP) has not been studied specifically in the 65-and-older population. To inform the validity and generalizability of future acupuncture studies among older adults, we characterized elderly participants' prior experience with and views toward acupuncture and tested for clinical and sociodemographic differences between acupuncture-naïve and non-naïve participants. Methods: Data for this study were collected during the baseline telephone interview from the participants enrolled in the Kaiser Permanente Northern California site of an NIH-funded, multicenter clinical trial of acupuncture for cLBP in older adults. Results: Nearly two-thirds (65.6 %) of participants surveyed reported they had previously received acupuncture treatment with the vast majority seeking acupuncture treatment for pain-related issues (84.8 %). The majority of these participants reported relatively modest levels of exposure to acupuncture with most participants (63.1 %) reporting fewer than 10 treatment sessions over their lifetimes. There were no significant differences in age, sex, race, ethnicity, disability scores, income levels, or pain levels between the acupuncture-naïve and non-naïve groups. Conclusion: Contextual consideration for prior acupuncture utilization rates is warranted and may be higher than expected or previously reported. We found few differences in baseline characteristics between participants who were acupuncture-naïve and those with prior acupuncture experience; thus, future pragmatic clinical trials might relax previous acupuncture-use considerations in their recruitment criteria. For trials focused on acupuncture-naive patients, it may be more feasible to expand the definition of "acupuncture-naive" based on lifetime acupuncture visits or time since last treatment. Trial registration: The protocol was registered at clinicaltrials.gov (#NCT04982315).

A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE).

BACKGROUND: Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. Recently, an enhanced group prenatal care program, "Glow! Group Prenatal Care and Support," was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes. METHODS: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medicaid-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials. CONCLUSIONS: This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04154423.

Homelessness Among Acute Care Patients Within a Large Health Care System in Northern California.

The impacts of homelessness on health and health care access are detrimental. Intervention and efforts to improve outcomes and increase availability of affordable housing have mainly originated from the public health sector and government. The role that large community-based health systems may play has yet to be established. This study characterizes patients self-identified as homeless in acute care facilities in a large integrated health care system in Northern California to inform the development of collaborative interventions addressing unmet needs of this vulnerable population. The authors compared sociodemographic characteristics, clinical conditions, and health care utilization of individuals who did and did not self-identify as homeless and characterized their geographical distribution in relation to Sutter hospitals and homeless resources. Between July 1, 2019 and June 30, 2020, 5% (N = 20,259) of the acute care settings patients had evidence of homelessness, among which 51.1% age <45 years, 66.4% males, and 24% non-Hispanic Black. Patients experiencing homelessness had higher emergency department utilization and lower utilization of outpatient and urgent care services. Mental health conditions were more common among patients experiencing homelessness. More than half of the hospitals had >5% of patients who identified as homeless. Some hospitals with higher proportions of patients experiencing homelessness are not located near many shelter resources. By understanding patients who self-identify as homeless, it is possible to assess the role of the health system in addressing their unmet needs. Accurate identification is the first step for the health systems to develop and deliver better solutions through collaborations with nonprofit organizations, community partners, and government agencies.

Examining paradoxical session attendance and weight loss relationships in a clinic based lifestyle modification intervention.

Objective: Evaluations of lifestyle modification interventions (LMIs), modeled after the Diabetes Prevention Program, have repeatedly shown a dose-response relationship between session attendance and weight loss. Despite this, not all participants had "average" weight loss experiences. Nearly one-third of LMI participants experienced unexpected, paradoxical outcomes (i.e., high attendance with little weight loss, and low attendance with clinically significant weight loss). Paradoxical weight-loss outcomes were characterized based on session attendance among participants in a group-based LMI in a real-world healthcare setting. This group-based LMI was delivered over 1 year to participants with the possibility of attending up to 25 sessions total. Methods: LMI participants identified in 2010-2017 from electronic health records were characterized as having low (<75%) or high (≥75%) session attendance. Weight-loss outcomes were defined as expected (≥5%, high-attendance; <5%, low-attendance) or paradoxical (≥5%, low-attendance; <5%, high-attendance). Paradoxical-outcome-associated characteristics were identified using logistic regression. Results: Among 1813 LMI participants, 1498 (82.6%) had low and 315 (17.4%) high session attendance; 555 (30.6%) had paradoxical outcomes, comprising 415 (74.8%) responders (≥5% weight-loss) and 140 (25.2%) non-responders (<5% weight-loss). Among participants with high session attendance, paradoxical non-responders were more likely to be female (odds ratio [OR]: 2.76; 95% confidence interval [CI]: 1.32, 5.77) and have type 2 diabetes (OR: 3.32; 95% CI: 1.01, 10.95). Among low-attendance participants, paradoxical responders were more likely to be non-Hispanic White and less likely to be non-Hispanic Black (OR: 0.35; 95% CI: 0.18, 0.69), non-Hispanic Asian (OR: 0.40; 95% CI: 0.22, 0.73), or Hispanic (OR: 0.53; 95% CI: 0.35, 0.80). Conclusions: In a healthcare setting, nearly one-third of LMI participants experienced paradoxical outcomes. More research is needed to understand the facilitators and barriers to weight loss above and beyond session attendance.

Characterizing obesity in a large health care delivery system.

OBJECTIVES: To characterize the prevalence of obesity and associated health care use within an integrated health care system in California. STUDY DESIGN: Cross-sectional study using electronic health records. METHODS: Primary care patients 18 years and older receiving care at Sutter Health between 2015 and 2020 were included in the study. Obesity was classified and health care utilization was ascertained at index and during the follow-up periods. Differences in prevalence by demographic and clinical characteristics among patients with and without obesity were assessed. Logistic regression was used to estimate the relationship between obesity class and health care utilization (outpatient encounters). RESULTS: Of the 1,094,790 primary care patients included in the analysis, 35% were classified as having obesity, defined as a body mass index of 30 kg/m2 or more or 25 kg/m2 or more for Asian individuals. Obesity prevalence was greater in Hispanic patients (46%) than in non-Hispanic White patients (30%). Patients without obesity had fewer outpatient visits (mean [SD], 3.7 [3.8]) than those with class 1 (4.1 [4.0]), class 2 (4.6 [4.4]), and class 3 (5.2 [4.8]) obesity. In the fully adjusted regression model, the odds of being a high utilizer among patients with obesity were 1.1 (class 1), 1.2 (class 2), and 1.3 (class 3) times that of patients without obesity (P < .001). CONCLUSION: Obesity prevalence is high among patients in the Sutter Health system, varying by race/ethnicity, and was associated with increased outpatient visit utilization. There is a need for greater awareness of the impact of obesity and the specific patient populations affected by the disease.

Learning health system, positive deviance analysis, and electronic health records: Synergy for a learning health system.

Introduction: Over the past decade, numerous efforts have encouraged the realization of the learning health system (LHS) in the United States. Despite these efforts, and promising aims of the LHS, the full potential and value of research conducted within LHSs have yet to be realized. New technology coupled with a catalyzing global pandemic have spurred momentum. In addition, the LHS has lacked a consistent framework within which "best evidence" can be identified. Positive deviance analysis, itself reinvigorated by recent advances in health information technology (IT) and ubiquitous adoption of electronic health records (EHRs), may finally provide a framework through which LHSs can be operationalized and optimized. Methods: We describe the synergy between positive deviance and the LHS and how they may be integrated to achieve a continuous cycle of health system improvement. Results: As we describe below, the positive deviance approach focuses on learning from high-performing teams and organizations. Conclusion: Such learning can be enabled by EHRs and health IT, providing a lens into how digital clinical interventions are successfully developed and deployed.

Transcriptome-wide association study identifies novel candidate susceptibility genes for migraine.

Genome-wide association studies (GWASs) have identified more than 130 genetic susceptibility loci for migraine; however, how most of these loci impact migraine development is unknown. To identify novel genes associated with migraine and interpret the transcriptional products of those genes, we conducted a transcriptome-wide association study (TWAS). We performed tissue-specific and multi-tissue TWAS analyses to assess associations between imputed gene expression from 53 tissues and migraine susceptibility using FUSION software. Meta-analyzed GWAS summary statistics from 26,052 migraine cases and 487,214 controls, all of European ancestry and from two cohorts (the Kaiser Permanente GERA and the UK Biobank), were used. We evaluated the associations for genes after conditioning on variant-level effects from GWAS, and we tested for colocalization of GWAS migraine-associated loci and expression quantitative trait loci (eQTLs). Across tissue-specific and multi-tissue analyses, we identified 53 genes for which genetically predicted gene expression was associated with migraine after correcting for multiple testing. Of these 53 genes, 10 (ATF5, CNTNAP1, KTN1-AS1, NEIL1, NEK4, NNT, PNKP, RUFY2, TUBG2, and VAT1) did not overlap known migraine-associated loci identified from GWAS. Tissue-specific analysis identified 45 gene-tissue pairs and cardiovascular tissues represented the highest proportion of the Bonferroni-significant gene-tissue pairs (n = 22 [49%]), followed by brain tissues (n = 6 [13%]), and gastrointestinal tissues (n = 4 [9%]). Colocalization analyses provided evidence of shared genetic variants underlying eQTL and GWAS signals in 18 of the gene-tissue pairs (40%). Our TWAS reports novel genes for migraine and highlights the important contribution of brain, cardiovascular, and gastrointestinal tissues in migraine susceptibility.

Impact of California's Senate Bill 27 on Antimicrobial-Resistant Escherichia coli Urinary Tract Infection in Humans: Protocol for a Study of Methods and Baseline Data.

BACKGROUND: Overuse of antibiotics contributes to antimicrobial resistance (AMR) and is a growing threat to human health worldwide. Previous work suggests a link between antimicrobial use in poultry and human AMR extraintestinal pathogenic Escherichia coli (E coli) urinary tract infections (UTIs). However, few US-based studies exist, and none have comprehensively assessed both foodborne and environmental pathways using advanced molecular and spatial epidemiologic methods in a quasi-experimental design. Recently, California enacted Senate Bill 27 (SB27), which changed previous policy to require a veterinarian's prescription for the use of antibiotic drugs, and which banned antibiotic use for disease prevention in livestock. This provided an opportunity to evaluate whether SB27 will result in a reduction in antimicrobial-resistant infections in humans. OBJECTIVE: We describe in detail the methods implemented to achieve the overarching objective of this study to evaluate the impact of SB27 on downstream antibiotic resistance rates in human UTIs. METHODS: A summary of the overall approach and the partnerships between Columbia University, George Washington University (GWU), Johns Hopkins Bloomberg School of Public Health, Kaiser Permanente Southern California (KPSC) Research and Evaluation, the Natural Resources Defense Council, Sanger Institute at Stanford University, Sutter Health Center for Health Systems Research, the University of Cambridge, and the University of Oxford is presented. The collection, quality control testing, and shipment of retail meat and clinical samples are described. Retail meat (chicken, beef, turkey, and pork) was purchased from stores throughout Southern California from 2017 to 2021. After processing at KPSC, it was shipped to GWU for testing. From 2016 to 2021, after clinical specimens were processed for routine clinical purposes and immediately before discarding, those with isolated colonies of E coli, Campylobacter, and Salmonella from KPSC members were collected and processed to be shipped for testing at GWU. Detailed methods of the isolation and testing as well as the whole-genome sequencing of the meat and clinical samples at GWU are described. KPSC electronic health record data were used to track UTI cases and AMR patterns among the cultured specimens. Similarly, Sutter Health electronic health record data were used to track UTI cases in its Northern California patient population. RESULTS: From 2017 to 2021, overall, 12,616 retail meat samples were purchased from 472 unique stores across Southern California. In addition, 31,643 positive clinical cultures were collected from KPSC members during the same study period. CONCLUSIONS: Here, we presented data collection methods for the study, which was conducted to evaluate the impact of SB27 on downstream antibiotic resistance rates in human UTI. To date, it is one of the largest studies of its kind to be conducted. The data collected during this study will be used as the foundation for future analyses specific to the various objectives of this large body of work. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45109.

Racial and sociodemographic predictors of COVID-19 compared with influenza, appendicitis, and all-cause hospitalization: retrospective cohort analysis.

OBJECTIVE: To determine whether inequities in COVID-19 infection and hospitalization differ from those for common medical conditions: influenza, appendicitis, and all-cause hospitalization. DESIGN: Retrospective study based on electronic health records of three healthcare systems in San Francisco (university, public, and community) examining (1) racial/ethnic distribution in cases and hospitalization among patients with diagnosed COVID-19 (March-August 2020) and patients with diagnosed influenza, diagnosed appendicitis, or all-cause hospitalization (August 2017-March 2020), and (2) sociodemographic predictors of hospitalization among those with diagnosed COVID-19 and influenza. RESULTS: Patients 18 years or older with diagnosed COVID-19 (N = 3934), diagnosed influenza (N = 5932), diagnosed appendicitis (N = 1235), or all-cause hospitalization (N = 62,707) were included in the study. The age-adjusted racial/ethnic distribution of patients with diagnosed COVID-19 differed from that of patients with diagnosed influenza or appendicitis for all healthcare systems, as did hospitalization from these conditions compared to any cause. For example, in the public healthcare system, 68% of patients with diagnosed COVID-19 were Latine, compared with 43% of patients with diagnosed influenza, and 48% of patients with diagnosed appendicitis (p < 0.05). In multivariable logistic regressions, COVID-19 hospitalizations were associated with male sex, Asian and Pacific Islander race/ethnicity, Spanish language, and public insurance in the university healthcare system, and Latine race/ethnicity and obesity in the community healthcare system. Influenza hospitalizations were associated with Asian and Pacific Islander and other race/ethnicity in the university healthcare system, obesity in the community healthcare system, and Chinese language and public insurance in both the university and community healthcare systems. CONCLUSIONS: Racial/ethnic and sociodemographic inequities in diagnosed COVID-19 and hospitalization differed from those for diagnosed influenza and other medical conditions, with consistently higher odds among Latine and Spanish-speaking patients. This work highlights the need for disease-specific public health efforts in at-risk communities in addition to structural upstream interventions.

Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial.

BACKGROUND: Back pain prevalence and burden increase with age; approximately one-third of U.S. adults 65 years of age and older experience lower back pain (LBP). For chronic low back pain (cLBP), typically defined as lasting three months or longer, many treatments for younger adults may be inappropriate for older adults given their greater prevalence of comorbidities with attendant polypharmacy. While acupuncture has been demonstrated to be safe and effective for cLBP in adults overall, few studies of acupuncture have either included or focused on adults ≥65 years old. METHODS: The BackInAction study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial designed to test the effectiveness of acupuncture needling for improving back pain-related disability among 807 older adults ≥65 years old with cLBP. Participants are randomized to standard acupuncture (SA; up to 15 treatment sessions across 12 weeks), enhanced acupuncture (EA; SA during first 12 weeks and up to 6 additional sessions across the following 12 weeks), and usual medical care (UMC) alone. Participants are followed for 12 months with study outcomes assessed monthly with the primary outcome timepoint at 6 months. DISCUSSION: The BackInAction study offers an opportunity to further understand the effectiveness, dose-dependence, and safety of acupuncture in a Medicare population. Additionally, study results may encourage broader adoption of more effective, safer, and more satisfactory options to the continuing over-reliance on opioid- and invasive medical treatments for cLBP among older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.

Disparities in COVID-19 testing and outcomes among Asian American and Pacific Islanders: an observational study in a large health care system.

BACKGROUND: The COVID-19 pandemic has disproportionately impacted racial and ethnic minorities in the United States, including Asian Americans, Native Hawaiians and Pacific Islanders (Asian Americans and NH/PIs). However, few studies have highlighted nor disaggregated these disparities by Asian Americans and NH/PIs ethnic subgroups. METHODS: This retrospective, cross-sectional observational study aimed to assess variation of Asian Americans and NH/PIs COVID-19 testing and outcomes compared to non-Hispanic Whites (NHW). The study utilized data from the electronic health records (EHR) and the COVID-19 Universal Registry for Vital Evaluations (CURVE) from all patients tested for SARS-CoV-2 (n = 556,690) at a large, health system in Northern and Central California between February 20, 2020 and March 31, 2021. Chi-square tests were used for testing differences in the severity of COVID-19 (hospitalization, ICU admission, death) and patient demographic and clinical characteristics across the Asian Americans and NH/PIs subgroups and NHW. Unadjusted and adjusted Odds Ratios (ORs) were estimated for measuring effect of race ethnicity on severity of COVID-19 using multivariable logistic regression. RESULTS: Of the entire tested population, 70,564/556,690 (12.7%) tested positive for SARS-CoV-2. SARS-CoV-2 positivity of Asian subgroups varied from 4% in the Chinese and Korean populations, to 11.2%, 13.5%, and 12.5% for Asian Indian, Filipino, and "other Asian" populations respectively. Pacific Islanders had the greatest subgroup test positivity at 20.1%. Among Asian Americans and NH/PIs patients with COVID-19 disease, Vietnamese (OR = 2.06, 95% CI = 1.30-3.25), "Other Asian" (OR = 2.13, 95% CI = 1.79-2.54), Filipino (OR = 1.78, 95% CI = 1.34-2.23), Japanese (OR = 1.78, 95% CI = 1.10-2.88), and Chinese (OR = 1.73, 95% CI = 1.34-2.23) subgroups had almost double the odds of hospitalization compared to NHW. Pacific Islander (OR = 1.58, 95% CI = 1.19-2.10) and mixed race subgroups (OR = 1.55, 95% CI = 1.10-2.20) had more than one and a half times odds of hospitalization compared to NHW. Adjusted odds of ICU admission or death among hospitalized patients by different Asian subgroups varied but were not statistically significant. CONCLUSIONS: Variation of COVID-19 testing and hospitalization by Asian subgroups was striking in our study. A focus on the Asian Americans and NH/PIs population with disaggregation of subgroups is crucial to understand nuances of health access, utilization, and outcomes among subgroups to create health equity for these underrepresented populations.

Impact of a Statewide Livestock Antibiotic Use Policy on Resistance in Human Urine Escherichia coli Isolates: A Synthetic Control Analysis.

BACKGROUND: On 1 January 2018, California implemented Senate Bill 27 (SB27), banning, for the first time in the United States, routine preventive use of antibiotics in food-animal production and any antibiotic use without a veterinarian's prescription. OBJECTIVES: Our objective was to assess whether SB27 was associated with decreased antimicrobial resistance among E. coli isolated from human urine. METHODS: We used U.S. nationwide monthly state-level data from BD Insights Research Database (Becton, Dickinson, and Co.) spanning 1 January 2013 to 30 June 2021 on antibiotic-resistance patterns of 30-d nonduplicate E. coli isolated from urine. Tested antibiotic classes included aminoglycosides, extended-spectrum cephalosporins (ESC), fluoroquinolones, and tetracyclines. Counts of tested and not-susceptible (resistant and intermediate, hereafter resistant) urine isolates were available by sex, age group (<65, 65+ year), month, and state. We applied a synthetic control approach to estimate the causal effect of SB27 on resistance patterns. Our approach created a synthetic California based on a composite of other states without the policy change and contrasted its counterfactual postpolicy trends with the observed postpolicy trends in California. FINDINGS: We included 7.1 million E. coli urine isolates, 90% among women, across 33 states. From 2013 to 2017, the median (interquartile range) resistance percentages in California were 11.9% (7.4, 17.6), 13.8% (5.8, 20.0), 24.6% (9.6, 36.4), 7.9% (2.1, 13.1), for aminoglycosides, ESC, fluoroquinolones, and tetracyclines, respectively. SB27 was associated with a 7.1% reduction in ESC resistance (p-value for joint null: <0.01), but no change in resistance to aminoglycosides, fluoroquinolones, or tetracyclines. DISCUSSION: Further research is needed to determine the role of SB27 in the observed reduction in ESC resistance E. coli in human populations, particularly as additional states implement similar legislation. https://doi.org/10.1289/EHP11221.

Increasing Racial and Ethnic Equity, Diversity, and Inclusion in Cancer Treatment Trials: Evaluation of an ASCO-Association of Community Cancer Centers Site Self-Assessment.

Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) and helped identify specific strategies (63%) to increase EDI in trials. Although most sites (65%) were able to provide some data on the number of patients that consented, only two sites were able to provide all requested trial screening, offering, and enrollment data by race and ethnicity. Documenting and evaluating such data are critical steps toward improving EDI and are key to identifying and addressing disparities more broadly. ASCO and Association of Community Cancer Centers will partner with sites to better understand their processes and the feasibility of collecting screening, offering, and enrollment data in systematic and automated ways.

Racial Disparities in Pulse Oximeter Device Inaccuracy and Estimated Clinical Impact on COVID-19 Treatment Course.

Arterial blood oxygen saturation as measured by pulse oximetry (peripheral oxygen saturation (SpO2)) may be differentially less accurate for people with darker skin pigmentation, which could potentially affect the course of coronavirus disease 2019 (COVID-19) treatment. We analyzed pulse oximeter accuracy and its association with COVID-19 treatment outcomes using electronic health record data from Sutter Health, a large, mixed-payer, integrated health-care delivery system in Northern California. We analyzed 2 cohorts: 1) 43,753 non-Hispanic White (NHW) or non-Hispanic Black/African-American (NHB) adults with concurrent arterial blood gas oxygen saturation/SpO2 measurements taken between January 2020 and February 2021; and 2) 8,735 adults who went to a hospital emergency department with COVID-19 between July 2020 and February 2021. Pulse oximetry systematically overestimated blood oxygenation by 1% more in NHB individuals than in NHW individuals. For people with COVID-19, this was associated with lower admission probability (-3.1 percentage points), dexamethasone treatment (-3.1 percentage points), and supplemental oxygen treatment (-4.5 percentage points), as well as increased time to treatment: 37.2 minutes before dexamethasone initiation and 278.5 minutes before initiation of supplemental oxygen. These results call for additional investigation of pulse oximeters and suggest that current guidelines for development, testing, and calibration of these devices should be revisited, investigated, and revised.

A population-health approach to characterizing migraine by comorbidity: Results from the Mindfulness and Migraine Cohort Study.

BACKGROUND: The heterogeneity of migraine has been reported extensively, with identified subgroups usually based on symptoms. Grouping individuals with migraine and similar comorbidity profiles has been suggested, however such segmentation methods have not been tested using real-world clinical data. OBJECTIVE: To gain insights into natural groupings of patients with migraine using latent class analysis based on electronic health record-determined comorbidities. METHODS: Retrospective electronic health record data analysis of primary-care patients at Sutter Health, a large open healthcare system in Northern California, USA. We identified migraine patients over a five-year time period (2015-2019) and extracted 29 comorbidities. We then applied latent class analysis to identify comorbidity-based natural subgroups. RESULTS: We identified 95,563 patients with migraine and found seven latent classes, summarized by their predominant comorbidities and population share: fewest comorbidities (61.8%), psychiatric (18.3%), some comorbidities (10.0%), most comorbidities - no cardiovascular (3.6%), vascular (3.1%), autoimmune/joint/pain (2.2%), and most comorbidities (1.0%). We found minimal demographic differences across classes. CONCLUSION: Our study found groupings of migraine patients based on comorbidity that have the potential to be used to guide targeted treatment strategies and the development of new therapies.

Ambient temperature and risk of urinary tract infection in California: A time-stratified case-crossover study using electronic health records.

BACKGROUND: In the United States (US), urinary tract infections (UTI) lead to more than 10 million office visits each year. Temperature and season are potentially important risk factors for UTI, particularly in the context of climate change. METHODS: We examined the relationship between ambient temperature and outpatient UTI diagnoses among patients followed from 2015 to 2017 in two California healthcare systems: Kaiser Permanente Southern California (KPSC) and Sutter Health in Northern California. We identified UTI diagnoses in adult patients using diagnostic codes and laboratory records from electronic health records. We abstracted patient age, sex, season of diagnosis, and linked community-level Index of Concentration at the Extremes (ICE-I, a measure of wealth and poverty concentration) based on residential address. Daily county-level average ambient temperature was assembled from the Parameter-elevation Regressions on Independent Slopes Model (PRISM). We implemented distributed lag nonlinear models (DLNM) to assess the association between UTI and lagged daily temperatures. Main analyses were confined to women. In secondary analyses, we stratified by season, healthcare system, and community-level ICE-I. RESULTS: We observed 787,186 UTI cases (89% among women). We observed a threshold association between ambient temperature and UTI among women: an increase in daily temperature from the 5th percentile (6.0 ˚C) to the mean (16.2 ˚C) was associated with a 3.2% (95% CI: 2.4, 3.9%) increase in same-day UTI diagnosis rate, whereas an increase from the mean to 95th percentile was associated with no change in UTI risk (0.0%, 95% CI: -0.7, 0.6%). In secondary analyses, we observed the clearest monotonic increase in the rate of UTI diagnosis with higher temperatures in the fall. Associations did not differ meaningfully by healthcare system or community-level ICE-I. Results were robust to alternate model specifications. DISCUSSION: Increasing temperature was related to higher rate of outpatient UTI, particularly in the shoulder seasons (spring, autumn).

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

COVID-19 in pregnancy by race and ethnicity: Implications for development of a vaccination strategy.

OBJECTIVE: COVID-19 and associated morbidity and mortality has disproportionately affected minoritized populations. The epidemiology of spread of COVID-19 among pregnant women by race/ethnicity is not well described. Using data from a large healthcare system in California, we estimated prevalence and spread during pregnancy and recommend a vaccination approach based on minimizing adverse outcomes. METHODS: Patients delivering at Sutter Health are tested (molecular) for COVID-19. These results were combined with antibody test results, using samples drawn at delivery. For each racial/ethnic group, we estimated prevalence of COVID-19, using logistic regression to adjust for known sociodemographic and comorbid risk factors. Testing for immunoglobulin G and immunoglobulin M provided insight into timing of infections. RESULTS: Among 17,446 women delivering May-December, 460 (2.6%) tested positive (molecular). Hispanic women were at 2.6 times the odds of being actively infected as White women (odds ratio = 2.6, 95% confidence interval = 2.0-3.3). August and December were the highest risk periods for active infection (odds ratio = 3.5, 95% confidence interval = 2.1-5.7 and odds ratio = 6.1, 95% confidence interval = 3.8-9.9, compared with May, respectively). Among 4500 women delivering October-December, 425 (9.4%) had positive molecular or antibody tests, ranging from 4.0% (Asian) to 15.7% (Hispanic). Adjusting for covariables, compared with White patients, odds of infection was similar for Black and Asian patients, with Hispanic at 2.4 (1.8-3.3) times the odds. CONCLUSION: COVID-19 prevalence was higher among Hispanic women at delivery and in the last trimester than their White counterparts. Higher rates in Black patients are explained by other risk factors. Resources should be directed to increase vaccination rates among Hispanic women in early stages of pregnancy.

Evaluation of a social determinants of health screening questionnaire and workflow pilot within an adult ambulatory clinic.

BACKGROUND: There is increased recognition in clinical settings of the importance of documenting, understanding, and addressing patients' social determinants of health (SDOH) to improve health and address health inequities. This study evaluated a pilot of a standardized SDOH screening questionnaire and workflow in an ambulatory clinic within a large integrated health network in Northern California. METHODS: The pilot screened for SDOH needs using an 11-question Epic-compatible paper questionnaire assessing eight SDOH and health behavior domains: financial resource, transportation, stress, depression, intimate partner violence, social connections, physical activity, and alcohol consumption. Eligible patients for the pilot receiving a Medicare wellness, adult annual, or new patient visits during a five-week period (February-March, 2020), and a comparison group from the same time period in 2019 were identified. Sociodemographic data (age, sex, race/ethnicity, and payment type), visit type, length of visit, and responses to SDOH questions were extracted from electronic health records, and a staff experience survey was administered. The evaluation was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. RESULTS: Two-hundred eighty-nine patients were eligible for SDOH screening. Responsiveness by domain ranged from 55 to 67%, except for depression. Half of patients had at least one identified social need, the most common being stress (33%), physical activity (22%), alcohol (12%), and social connections (6%). Physical activity needs were identified more in females (81% vs. 19% in males, p < .01) and at new patient/transfer visits (48% vs. 13% at Medicare wellness and 38% at adult wellness visits, p < .05). Average length of visit was 39.8 min, which was 1.7 min longer than that in 2019. Visit lengths were longer among patients 65+ (43.4 min) and patients having public insurance (43.6 min). Most staff agreed that collecting SDOH data was relevant and accepted the SDOH questionnaire and workflow but highlighted opportunities for improvement in training and connecting patients to resources. CONCLUSION: Use of evidence-based SDOH screening questions and associated workflow was effective in gathering patient SDOH information and identifying social needs in an ambulatory setting. Future studies should use qualitative data to understand patient and staff experiences with collecting SDOH information in healthcare settings.

Combining patient reported outcomes and EHR data to understand population level treatment needs: correcting for selection bias in the migraine signature study.

BACKGROUND: Electronic health records (EHR) data can be used to understand population level quality of care especially when supplemented with patient reported data. However, survey non-response can result in biased population estimates. As a case study, we demonstrate that EHR and survey data can be combined to estimate primary care population prescription treatment status for migraine stratified by migraine disability, without and with adjustment for survey non-response bias. We selected disability as it is associated with survey participation and patterns of prescribing for migraine. METHODS: A stratified random sample of Sutter Health adult primary care (PC) patients completed a digital survey about headache, migraine, and migraine related disability. The survey data from respondents with migraine were combined with their EHR data to estimate the proportion who had prescription orders for acute or preventive migraine treatments. Separate proportions were also estimated for those with mild disability (denoted "mild migraine") versus moderate to severe disability (denoted mod-severe migraine) without and with correction, using the inverse propensity weighting method, for non-response bias. We hypothesized that correction for non-response bias would result in smaller differences in proportions who had a treatment order by migraine disability status. RESULTS: The response rate among 28,268 patients was 8.2%. Among survey respondents, 37.2% had an acute treatment order and 16.8% had a preventive treatment order. The response bias corrected proportions were 26.2% and 11.6%, respectively, and these estimates did not differ from the total source population estimates (i.e., 26.4% for acute treatments, 12.0% for preventive treatments), validating the correction method. Acute treatment orders proportions were 32.3% for mild migraine versus 37.3% for mod-severe migraine and preventive treatment order proportions were 12.0% for mild migraine and 17.7% for mod-severe migraine. The response bias corrected proportions for acute treatments were 24.8% for mild migraine and 26.6% for mod-severe migraine and the proportions for preventive treatment were 8.1% for mild migraine and 12.0% for mod-severe migraine. CONCLUSIONS: In this study, we combined survey data with EHR data to better understand treatment needs among patients diagnosed with migraine. Migraine-related disability is directly related to preventive treatment orders but less so for acute treatments. Estimates of treatment status by self-reported disability status were substantially over-estimated among those with moderate to severe migraine-related disability without correction for non-response bias.