Characteristics associated with response to subcutaneously administered anti-CGRP monoclonal antibody medications in a real-world community cohort of persons living with migraine: A retrospective clinical and genetic study.

OBJECTIVE: To evaluate response to anti-calcitonin gene-related peptide (CGRP) migraine preventives in a real-world community cohort of persons living with migraine and to identify clinical and genetic characteristics associated with efficacious response. BACKGROUND: Erenumab-aooeb, fremanezumab-vrfm, and galcanezumab-gnlm target CGRP or its receptor; however, many patients are non-responsive. METHODS: In this retrospective clinical and genetic study, we identified 1077 adult patients who satisfied the International Classification of Headache Disorders, 3rd edition, criteria for migraine without aura, migraine with aura, or chronic migraine and who were prescribed an anti-CGRP migraine preventive between May 2018 and May 2021. Screening of 558 patients identified 289 with data at baseline and first follow-up visits; data were available for 161 patients at a second follow-up visit. The primary outcome was migraine days per month (MDM). In 198 genotyped patients, we evaluated associations between responders (i.e., patients with ≥50% reduction in MDM at follow-up) and genes involved in CGRP signaling or pharmacological response, and genetic and polygenic risk scores. RESULTS: The median time to first follow-up was 4.4 (0.9-22) months after preventive start. At the second follow-up, 5.7 (0.9-13) months later, 145 patients had continued on the same preventive. Preventives had strong, persistent effects in reducing MDM in responders (follow-up 1: η2 = 0.26, follow-up 2: η2 = 0.22). At the first but not second follow-up: galcanezumab had a larger effect than erenumab, while no difference was seen at either follow-up between galcanezumab and fremanezumab or fremanezumab and erenumab. The decrease in MDM at follow-up was generally proportional to baseline MDM, larger in females, and increased with months on medication. At the first follow-up only, patients with prior hospitalization for migraine or who had not responded to more preventive regimens had a smaller decrease in MDM. Reasons for stopping or switching a preventive varied between medications and were often related to cost and insurance coverage. At both follow-ups, patient tolerance (1: 92.2% [262/284]; 2: 95.2% [141/145]) and continued use (1: 77.5% [224/289]; 2: 80.6% [116/145]) were high and similar across preventives. Response consistency (always non-responders: 31.7% [46/145]; always responders: 56.5% [82/145], and one-time only responders: 11.7% [17/145]) was also similar across preventives. Non-responder status had nominally significant associations with rs12615320-G in RAMP1 (odds ratio [95% confidence interval]: 4.7 [1.5, 14.7]), and rs4680-A in COMT (0.6[0.4, 0.9]). Non-responders had a lower mean genetic risk score than responders (1.0 vs. 1.1; t(df) = -1.75(174.84), p = 0.041), and the fraction of responders increased with genetic and polygenic risk score percentile. CONCLUSIONS: In this real-world setting, anti-CGRP preventives reduced MDM persistently and had similar and large effect sizes on MDM reduction; however, clinical and genetic factors influenced response.

A data extraction algorithm for assessment of contraceptive counseling and provision.

BACKGROUND: Contraception counseling and provision is an essential preventative service. Real-time assessment of these services is critical for quality improvement and comparative study. Direct observation is not feasible on a large scale, so indirect measures (such as chart review) have been determined to be acceptable tools for this assessment. Computer-aided chart review has significant benefits over manual chart review as far as greater efficiency and ease of repeated measurements. The wide use of electronic medical records provides an opportunity to create a data extraction algorithm for computer-aided chart review that is sharable among institutions. We provide a useful schema for others who use electronic medical record systems and are interested in real-time assessment of contraception counseling and provision for the purposes of baseline assessment of services and quality improvement. OBJECTIVE: The purpose of this study was to create a comprehensive and accurate data extraction algorithm that is useful in the assessment of contraception counseling and provision rates in the outpatient setting. STUDY DESIGN: We included all visits between August 2015 and May 2016 at 8 outpatient clinics that are affiliated with a large, urban academic medical center in which nonpregnant women who were 14-45 years old were seen by a nurse practitioner, physician's assistant, or physician. Contraception-related prescriptions, International Classification of Diseases codes, current procedural terminology codes, and search-term capture were extracted with the use of structured query language from electronic medical record data that were stored in a relational database. The algorithm's hierarchy was designed to query prescription data first, followed by International Classification of Diseases and current procedural terminology codes, and finally search-term capture. Visits were censored when the first positive evidence of contraceptive service was obtained. Search terms were selected based on group discussion of investigators and providers. This algorithm was then compared with manual chart review and refined 3 times until high sensitivity and specificity, when compared with manual chart review, were achieved. RESULTS: There were 22,134 visits of reproductive-aged women who our inclusion criteria. Electronic medical record evidence of contraception counseling or provision was found in 56.9% of these visits. Of these, 21.3% were captured by prescriptions; 8.9% were captured by International Classification of Diseases codes, and 69.7% were captured by search-term capture with the use of our algorithm. Among visits with evidence of contraception counseling without provision, 15.7% were captured by diagnosis codes and 84.3% were captured by search-term capture. When compared with manual chart review, sensitivity and specificity improved from 0.79 and 0.85 to 0.99 and 0.98, respectively, over the 3 rounds of testing and revision. CONCLUSION: Data extraction algorithms can be used effectively for computer-aided chart review of contraception counseling and provision measures, but testing and refinement are extremely important. Search-term capture from unstructured data is a critical component of a comprehensive algorithm, especially for the capture of instances of contraception counseling without provision. The algorithm that we developed here could be used by others with an electronic medical record system who are interested in real-time assessment, quality improvement, and comparative study of the delivery of contraceptive services. The ease of execution of this algorithm also allows for its repeated use for ongoing assessments over time.

Structured Clinical Documentation to Improve Quality and Support Practice-Based Research in Headache.

OBJECTIVE: To use the electronic medical record (EMR) to optimize patient care, facilitate documentation, and support quality improvement and practice-based research, in a headache specialty clinic. BACKGROUND: Many physicians enter data into the EMR as unstructured free text and not as discrete data. This makes it challenging to use data for quality improvement or research initiatives. METHODS: We describe the process of building a customized structured clinical documentation support toolkit, specific for patients seen in a headache specialty clinic. The content was developed through frequent physician meetings to reach consensus on elements that define clinical Best Practices. Tasks were assigned to the care team and data mapped to the progress note. RESULTS: The toolkit collects hundreds of fields of discrete, standardized data. Auto scored and interpreted score tests include the Generalized Anxiety Disorder 7-item, Center for Epidemiology Studies Depression Scale, Migraine Disability Assessment questionnaire, Insomnia Sleep Index, and Migraine-Specific Quality of Life. We have developed Best Practice Advisories (BPA) and other clinical documentation support tools that alert physicians, when appropriate. As of April 1, 2018, we have used the toolkits at 4346 initial patient visits. We provide screenshots of our toolkits, details of data fields collected, and diagnoses of patients at the initial visit. CONCLUSIONS: The EMR can be used to effectively structure and standardize headache clinic visits for quality improvement and practice-based research. We are sharing our proprietary toolkit with other clinics as part of the Neurology Practice-Based Research Network. These tools are also facilitating clinical research enrollment and a pragmatic trial of comparative effectiveness at the point-of-care among migraine patients.

Structured clinical documentation in the electronic medical record to improve quality and to support practice-based research in epilepsy.

OBJECTIVE: Using the electronic medical record (EMR) to capture structured clinical data at the point of care would be a practical way to support quality improvement and practice-based research in epilepsy. METHODS: We describe our stepwise process for building structured clinical documentation support tools in the EMR that define best practices in epilepsy, and we describe how we incorporated these toolkits into our clinical workflow. RESULTS: These tools write notes and capture hundreds of fields of data including several score tests: Generalized Anxiety Disorder-7 items, Neurological Disorders Depression Inventory for Epilepsy, Epworth Sleepiness Scale, Quality of Life in Epilepsy-10 items, Montreal Cognitive Assessment/Short Test of Mental Status, and Medical Research Council Prognostic Index. The tools summarize brain imaging, blood laboratory, and electroencephalography results, and document neuromodulation treatments. The tools provide Best Practices Advisories and other clinical decision support when appropriate. The tools prompt enrollment in a DNA biobanking study. We have thus far enrolled 231 patients for initial visits and are starting our first annual follow-up visits and provide a brief description of our cohort. SIGNIFICANCE: We are sharing these EMR tools and captured data with other epilepsy clinics as part of a Neurology Practice Based Research Network, and are using the tools to conduct pragmatic trials using subgroup-based adaptive designs.

Chronic inflammation and risk of colorectal and other obesity-related cancers: The health, aging and body composition study.

Evidence of the association between chronic inflammation and the risk of colorectal cancer (CRC) and other obesity-related cancers (OBRC) remains inconsistent, possibly due to a paucity of studies examining repeated measures of inflammation. In the Health ABC prospective study of 2,490 adults aged 70-79 years at baseline, we assessed whether circulating levels of three markers of systemic inflammation, IL-6, CRP and TNF-α, were associated with the risk of CRC and OBRC, a cluster including cancers of pancreas, prostate, breast and endometrium. Inflammatory markers were measured in stored fasting blood samples. While only baseline measures of TNF-α were available, IL-6 and CRP were additionally measured at Years 2, 4, 6 and 8. Multivariable Cox models were fit to determine whether tertiles and log-transformed baseline, updated and averaged measures of CRP and IL-6 and baseline measures of TNF-α were associated with the risk of incident cancer(s). During a median follow-up of 11.9 years, we observed 55 and 172 cases of CRC and OBRC, respectively. The hazard of CRC in the highest tertile of updated CRP was more than double that in the lowest tertile (HR = 2.29; 95% CI: 1.08-4.86). No significant associations were seen between colorectal cancer and IL-6 or TNF-α. Additionally, no significant associations were found between obesity-related cancers and the three inflammatory markers overall, but we observed a suggestion of effect modification by BMI and NSAID use. In summary, in this population, higher CRP levels were associated with increased risk of CRC, but not of OBRC. The findings provide new evidence that chronically elevated levels of CRP, as reflected by repeated measures of this marker, may play a role in colorectal carcinogenesis in older adults.

Antidepressant Use and Recurrent Falls in Community-Dwelling Older Adults: Findings From the Health ABC Study.

BACKGROUND: Few studies have compared the risk of recurrent falls across various antidepressant agents-using detailed dosage and duration data-among community-dwelling older adults, including those who have a history of a fall/fracture. OBJECTIVE: To examine the association of antidepressant use with recurrent falls, including among those with a history of falls/fractures, in community-dwelling elders. METHODS: This was a longitudinal analysis of 2948 participants with data collected via interview at year 1 from the Health, Aging and Body Composition study and followed through year 7 (1997-2004). Any antidepressant medication use was self-reported at years 1, 2, 3, 5, and 6 and further categorized as (1) selective serotonin reuptake inhibitors (SSRIs), (2) tricyclic antidepressants, and (3) others. Dosage and duration were examined. The outcome was recurrent falls (≥2) in the ensuing 12-month period following each medication data collection. RESULTS: Using multivariable generalized estimating equations models, we observed a 48% greater likelihood of recurrent falls in antidepressant users compared with nonusers (adjusted odds ratio [AOR] = 1.48; 95% CI = 1.12-1.96). Increased likelihood was also found among those taking SSRIs (AOR = 1.62; 95% CI = 1.15-2.28), with short duration of use (AOR = 1.47; 95% CI = 1.04-2.00), and taking moderate dosages (AOR = 1.59; 95% CI = 1.15-2.18), all compared with no antidepressant use. Stratified analysis revealed an increased likelihood among users with a baseline history of falls/fractures compared with nonusers (AOR = 1.83; 95% CI = 1.28-2.63). CONCLUSION: Antidepressant use overall, SSRI use, short duration of use, and moderate dosage were associated with recurrent falls. Those with a history of falls/fractures also had an increased likelihood of recurrent falls.

Virtual Music Therapy for Substance Use Disorders in a Federally Qualified Health Center.

BACKGROUND: Music therapy (MT) is an effective adjunctive treatment for substance use disorders (SUD), which is primarily available in inpatient treatment centers and rarely provided in outpatient primary care. METHODS: We evaluated the feasibility and acceptability of a virtual group MT program for SUD in a Federally Qualified Health Center (FQHC), and secondarily assessed patient perceptions of its effect. Feasibility was measured by implementation-related process measures, attendance and use of technology. Qualitative interviews eliciting participant perceptions were conducted to evaluate acceptability and effect. Mood scores, substance use and craving were measured before and after the intervention. RESULTS: Onboarding of the music therapist took 3.5 months. All MT sessions were attended by 1 to 5 individuals out of 6. Participants reported that group MT was "soothing" and "calming," gave them tools to treat cravings and stress, and created a sense of community. They reported that during sessions their cravings decreased. Anxiety and depression scores trended down, as did the number of days of substance use. They all stated they would seek out MT again. DISCUSSION: Our results suggest that remote group MT is feasible and acceptable to our FQHC patients with SUD. Patients reported an improvement in mood and their ability to manage stress, and a decrease in substance use. CONCLUSION: We wish to build on the results of this study to enhance our understanding of the effects of MT in the outpatient setting, and broaden our patients' access to MT in primary care.

Lessons learned from implementing a diversity, equity, and inclusion curriculum for health research professionals at a large academic research institution.

Objective: Despite advances in incorporating diversity and structural competency into medical education curriculum, there is limited curriculum for public health research professionals. We developed and implemented a four-part diversity, equity, and inclusion (DEI) training series tailored for academic health research professionals to increase foundational knowledge of core diversity concepts and improve skills. Methods: We analyzed close- and open-ended attendee survey data to evaluate within- and between-session changes in DEI knowledge and perceived skills. Results: Over the four sessions, workshop attendance ranged from 45 to 82 attendees from our 250-person academic department and represented a mix of staff (64%), faculty (25%), and trainees (11%). Most identified as female (74%), 28% as a member of an underrepresented racial and ethnic minority (URM) group, and 17% as LGBTQI. During all four sessions, attendees increased their level of DEI knowledge, and within sessions two through four, attendees' perception of DEI skills increased. We observed increased situational DEI awareness as higher proportions of attendees noted disparities in mentoring and opportunities for advancement/promotion. An increase in a perceived lack of DEI in the workplace as a problem was observed; but only statistically significant among URM attendees. Discussion: Developing applied curricula yielded measurable improvements in knowledge and skills for a diverse health research department of faculty, staff, and students. Nesting this training within a more extensive program of departmental activities to improve climate and address systematic exclusion likely contributed to the series' success. Additional research is underway to understand the series' longer-term impact on applying skills for behavior change.

Unhealthy lifestyles do not mediate the relationship between socioeconomic status and incident depressive symptoms: the Health ABC study.

BACKGROUND: The relationship between low socioeconomic status (SES) and depressive symptoms is well described, also in older persons. Although studies have found associations between low SES and unhealthy lifestyle factors, and between unhealthy lifestyle factors and depressive symptoms, not much is known about unhealthy lifestyles as a potential explanation of socioeconomic differences in depressive symptoms in older persons. METHODS: To study the independent pathways between SES (education, income, perceived income, and financial assets), lifestyle factors (smoking, alcohol use, body mass index, and physical activity), and incident depressive symptoms (Center for Epidemiologic Studies-Depression [CES-D 10] and reported use of antidepressant medication), we used 9 years of follow-up data (1997-2007) from 2,694 American black and white participants aged 70-79 years from the Health, Aging, and Body Composition (Health ABC) study. At baseline, 12.1% of the study population showed prevalent depressive symptoms, use of antidepressant medication, or treatment of depression in the 5 years prior to baseline. These persons were excluded from the analyses. RESULTS: Over a period of 9 years time, 860 participants (31.9%) developed depressive symptoms. Adjusted hazard ratios for incident depressive symptoms were higher in participants from lower SES groups compared with the highest SES group. The strongest relationships were found for black men. Although unhealthy lifestyle factors were consistently associated with low SES, they were weakly related to incident depressive symptoms. Lifestyle factors did not significantly reduce hazard ratios for depressive symptoms by SES. CONCLUSION: In generally healthy persons aged 70-79 years, lifestyle factors do not explain the relationship between SES and depressive symptoms.

New york city physicians' views of providing long-acting reversible contraception to adolescents.

PURPOSE: Although the US adolescent pregnancy rate is high, use of the most effective reversible contraceptives-intrauterine devices (IUDs) and implantable contraception-is low. Increasing use of long-acting reversible contraception (LARC) could decrease adolescent pregnancy rates. We explored New York City primary care physicians' experiences, attitudes, and beliefs about counseling and provision of LARC to adolescents. METHODS: We conducted in-depth telephone interviews with 28 family physicians, pediatricians, and obstetrician-gynecologists using an interview guide based on an implementation science theoretical framework. After an iterative coding and analytic process, findings were interpreted using the capability (knowledge and skills), opportunity (environmental factors), and motivation (attitudes and beliefs) conceptual model of behavior change. RESULTS: Enablers to IUD counseling and provision include knowledge that nulliparous adolescents are appropriate IUD candidates (capability) and opportunity factors, such as (1) a clinical environment supportive of adolescent contraception, (2) IUD availability in clinic, and (3) the ability to insert IUDs or easy access to an someone who can. Factors enabling motivation include belief in the overall positive consequences of IUD use; this is particularly influenced by a physicians' perception of adolescents' risk of pregnancy and sexually transmitted disease. Physicians rarely counsel about implantable contraception because of knowledge gaps (capability) and limited access to the device (opportunity). CONCLUSION: Knowledge, skills, clinical environment, and physician attitudes, all influence the likelihood a physician will counsel or insert LARC for adolescents. Interventions to increase adolescents' access to LARC in primary care must be tailored to individual clinical practice sites and practicing physicians, the methods must be made more affordable, and residency programs should offer up-to-date, evidence-based teaching.

Patient's experience and satisfaction with self-administered subcutaneous depot medroxyprogesterone acetate use during the first year of COVID-19.

OBJECTIVES: Self-administered subcutaneous (SC) depot medroxyprogesterone acetate (DMPA) can improve contraception access by eliminating a health center visit for administration. For patients at our New York City health centers who were offered a switch to self-administered DMPA-SC at the onset of the coronavirus 2019 (COVID-19) pandemic, we sought to understand their experience of choosing to switch, of accessing and using the method, and their method satisfaction. STUDY DESIGN: Individual interview study of 22 patients using intramuscular DMPA prior to the start of the pandemic. All had a telehealth visit to discuss switching to self-administered DMPA-SC and received a DMPA-SC prescription during the first months of COVID-19. We used a grounded theory analysis approach. RESULTS: Respondents viewed switching to self-administered DMPA-SC as a decision they had to make if they wanted to continue DMPA. Most respondents experienced logistical challenges acquiring DMPA-SC from their pharmacy. Issues around convenience were important to respondents; however what respondents found convenient varied. Despite all this, respondents appreciated having the option of DMPA-SC and felt it to be overall empowering. CONCLUSIONS: This study exploring patients' experience with self-administered DMPA-SC during the initial year of the COVID-19 pandemic found that, notwithstanding initial hesitation about self-administered injections and logistical challenges getting the SC formulation, many found the experience of trying self-administered DMPA-SC to be empowering and appreciated having this option. Thus, self-administered DMPA-SC should be included in clinicians' routine contraception counseling and provision, insurance companies should cover DMPA-SC without requiring prior authorization, and pharmacies should consistently stock DMPA-SC. IMPLICATIONS: Self-administered DMPA-SC is an acceptable contraception option that provides an opportunity to maintain contraception access while eliminating need for an in-person visit. Thus, self-administered DMPA-SC should be included in clinicians' routine contraception counseling and provision, insurance companies need to cover this contraceptive without need for prior authorization, and pharmacies should consistently stock DMPA-SC.

Racial differences in mortality in older adults: factors beyond socioeconomic status.

BACKGROUND: Little is known about the simultaneous effect of socioeconomic status (SES), psychosocial, and health-related factors on race differences in mortality in older adults. PURPOSE: This study examined the association between race and mortality and the role of SES, health insurance, psychosocial factors, behavioral factors, and health-related factors in explaining these differences. METHODS: Data consisted of 2,938 adults participating in the Health, Aging and Body Composition study. Mortality was assessed over 8 years. RESULTS: SES differences accounted for 60% of the racial differences in all-cause mortality; behavioral factors and self-rated health further reduced the disparity. The racial differences in coronary heart disease mortality were completely explained by SES. Health insurance and behavioral factors accounted for some, but not all, of the race differences in cancer mortality. CONCLUSIONS: Race-related risk factors for mortality may differ by the underlying cause of mortality.

Hearing loss and risk of depressive symptoms in older adults in the Health ABC study.

Objective: Hearing loss (HL) is highly prevalent among older adults and may lead to increased risk of depressive symptoms. In both cross-sectional and longitudinal analysis, we quantified the association between HL and depressive symptoms, incorporating the variable nature of depressive symptoms and characterizing by race and gender. Methods: Data were from the Health, Aging, and Body Composition study. Depressive symptoms were measured using the Center for Epidemiologic Study Depression Scale short form (CES-D 10), defined as CES-D 10 score ≥10 or treatment for depression. Hearing was defined via four-frequency pure-tone average (PTA) decibel hearing level (dB HL), categorized as normal hearing (PTA ≤25 dB HL), mild HL (PTA26-40 dB HL), and ≥moderate HL (PTA > 40 dB HL). Associations at baseline were quantified using logistic regression, incident depressive symptoms using Cox proportional hazard models, and change in depressive symptoms over time using growth mixture models and multinomial logistic regression. Results: Among 2,089 older adults (1,082 women, 793 Black; mean age 74.0 SD: 2.8), moderate or greater HL was associated with greater odds of concurrent [Odds Ratio (OR):2.45, 95% CI:1.33, 4.51] and incident depressive symptoms [Hazard Ratio (HR):1.26, 95% CI:1.00, 1.58]. Three depressive symptom trajectory patterns were identified from growth mixture models: low, moderate increasing, and borderline high depressive symptom levels. Those with moderate or greater HL were more likely to be in the borderline high depressive-symptom trajectory class than the low trajectory class [Relative Risk Ratio (RRR):1.16, 95% CI:1.01, 1.32]. Conclusions: HL was associated with greater depressive symptoms. Although findings were not statistically significantly different by gender and race, estimates were generally stronger for women and Black participants. Investigation of psychosocial factors and amelioration by hearing aid use could have significant benefit for older adults' quality of life.

Challenges of providing confidential care to adolescents in urban primary care: clinician perspectives.

PURPOSE: Clinician time alone with an adolescent has a major impact on disclosure of risk behavior. This study sought to describe primary care clinicians' patterns of delivering time alone, decision making about introducing time alone to adolescents and their parents, and experiences delivering confidential services. METHODS: We undertook qualitative interviews with 18 primary care clinicians in urban health centers staffed by specialists in pediatrics, family medicine, and adolescent medicine. RESULTS: The annual preventive care visit is the primary context for provision of time alone with adolescents; clinicians consider the parent-child dynamic and the nature of the chief complaint for including time alone during visits for other than preventive care. Time constraints are a major barrier to offering time alone more frequently. Clinicians perceive that parental discomfort with time alone is rare. Many clinicians wrestle with internal conflict about providing confidential services to adolescents with serious health threats and regard their role as facilitating adolescent-parent communication. Health systems factors can interfere with delivery of confidential services, such as inconsistent procedures for determining whether unaccompanied youth would be seen. CONCLUSION: Despite competing time demands, clinicians report commitment to offering time alone during preventive care visits and infrequently offer it at other times. Experienced clinicians can gain skills in the art of managing complex relationships between adolescents and their parents. Office systems should be developed that enhance the consistency of delivery of confidential services.

US clinicians' perspectives on how mifepristone regulations affect access to medication abortion and early pregnancy loss care in primary care.

OBJECTIVE: Protocols including mifepristone are the most effective medication regimens for medication abortion and early pregnancy loss (EPL) management. Both can be safely and effectively offered in primary care settings. Despite mifepristone's excellent safety record, the United States (US) Food and Drug Administration (FDA) heavily regulates provision. This exploratory study examines US primary care clinicians' perspectives on the effects of mifepristone restrictions, including FDA regulations, on access to medication abortion and EPL management in primary care. STUDY DESIGN: In 2019, we conducted an online qualitative survey of US primary care clinicians recruited from six reproductive health-focused listservs. Open-ended questions queried about barriers to providing mifepristone and effects on patients when unable to access mifepristone in primary care. We iteratively coded and analyzed qualitative data using inductive thematic analysis. RESULTS: Of our analytic sample of 113 respondents, one-third had mifepristone available in their current primary practice setting. Key barriers to provision stemmed from the FDA rule to stock and dispense mifepristone onsite, including logistical difficulties and resistance from health center leadership. Clinicians believed that lack of mifepristone in primary care resulted in negative patient experiences, including disrupted continuity of care, medically-unnecessary appointments, and undesired aspiration procedures. CONCLUSIONS: FDA regulations that inhibit mifepristone provision in primary care create structural barriers to provision. This may result in physical, emotional, and financial burdens for patients. IMPLICATIONS: When mifepristone is unavailable in primary care, some patients in need of abortion or EPL care may experience physical, emotional, and financial harms. Removing FDA restrictions is a critical step in reducing primary care barriers to mifepristone provision and improving access to timely, patient-centered medication abortion and EPL care.

Barriers and Enablers to Family Physicians' Provision of Early Pregnancy Loss Management in the United States.

BACKGROUND: Early pregnancy loss (EPL) is a common experience. Treatment options include expectant management, medication, and uterine aspiration. Although family physicians can offer comprehensive EPL treatment in their office-based settings, few actually do. This study explored the postresidency provision of EPL management and factors that inhibit or enable providing this care among family physicians trained in early abortion during residency. METHODS: Using an exploratory sequential mixed-methods design, we studied a sample of family physicians trained in early abortion during residency. We initially interviewed a subset trained in uterine aspiration during residency, then surveyed the entire sample. Interview transcripts were coded and analyzed using grounded theory; results informed survey development. On survey responses, we used Pearson χ2 to examine the association between certain variables and provision of EPL care options. RESULTS: Most of the 15 interview and 231 survey respondents provided expectant management of EPL. Of the survey respondents, 47.2% provided medication management and 11.4% manual vacuum aspiration. Key challenges and facilitators involved referral, training, ultrasound access, and managing systems-level issues. In bivariate analyses, providing prenatal care, offering abortion care, access to ultrasound, and competency were positively associated with providing EPL management options (p < .05). CONCLUSIONS: Clinical training alone is insufficient to expand access to comprehensive EPL care in family medicine office-based settings. Supporting family physicians during and after residency with training and technical assistance to address barriers to care may strengthen their abilities to champion practice change and expand access to comprehensive EPL management options.