Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion After In-Person Screening.

Importance: Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion. Objective: To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy. Design, Setting, and Participants: This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023. Intervention: Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person. Main Outcomes and Measures: Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications. Results: Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing. Conclusions and Relevance: The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.

Hepatitis C Exposure Diagnosis and Testing in Infants Born to Hepatitis C Virus-infected Mothers.

BACKGROUND: There has been a 5-fold increase in the number of cases of hepatitis C virus (HCV) infection among pregnant women, which is potentially associated with the increase in opioid use. METHODS: This study was a retrospective review of infants born at a tertiary urban hospital in New Jersey, from January 1, 2011 to January 1, 2021, who were born to mothers with a prenatal diagnosis of HCV. RESULTS: Of the 142 mothers with a prenatal diagnosis of HCV, 114 (80%) infants had a diagnosis of HCV exposure in the electronic health records. Of the HCV-exposed infants with follow-up data at 24 months of age, 52 (46%) were tested, with 34 of 52 (65%) receiving adequate testing. Infants documented as HCV exposed were more likely to be born to a mother with nonopioid drug use in pregnancy (P = 0.01) and have a higher birth weight (P = 0.03). Of tested infants, those with a higher number of well-child pediatrician visits (P = 0.01) were more likely to receive adequate testing. Trends showed more polymerase chain reaction testing than antibody testing for those who were inadequately tested. CONCLUSIONS: A significant proportion of infants born to HCV-infected mothers were either not identified at birth (20%) or did not receive adequate testing on follow-up (35%). Further work needs to be done to improve documentation of HCV exposure at birth and follow-up testing to avoid missing congenitally acquired HCV.

Interest in and Support for Alternative Models of Medication Abortion Provision Among Patients Seeking Abortion in the United States.

INTRODUCTION: Medication abortion is safe and effective, but restrictions still limit patients from accessing this method. Alternative models of medication abortion provision, namely advance provision, over-the-counter (OTC), and online, could help improve access to care for some, although there is limited evidence about abortion patients' interest in these models. METHODS: Between 2017 and 2019, we administered a cross-sectional survey to abortion patients at 45 clinics across 15 U.S. states to explore their interest in and support for advance provision, OTC, and online abortion access. We assessed relationships between sociodemographic characteristics and interest in and support for each model using bivariate logistic regressions and present perceived advantages and disadvantages of each model, as described by a subset of participants. RESULTS: Among 1,965 people enrolled, 1,759 (90%) initiated the survey. Interest in and support for advance provision was highest (72% and 82%, respectively), followed by OTC (63% and 72%) and online access (57% and 70%). In bivariate analyses, non-Hispanic Black and Asian/Pacific Islander respondents expressed lower interest and support for the online model and Alaska Native/Native American respondents expressed higher interest in an OTC model, as compared with white respondents. Among 439 participants naming advantages and disadvantages of each model, the most common advantages included convenience and having the abortion earlier. The most common disadvantages were not seeing a provider first and possibly taking pills incorrectly. CONCLUSIONS: Although most abortion patients expressed interest in and support for alternative models of medication abortion provision, variation in support across race/ethnicity highlights a need to ensure that abortion care service models meet the needs and preferences of all patients, particularly people from historically underserved populations.

Abortion pills on TV: An exploratory study of the associations between abortion plotline viewership and beliefs regarding in-clinic and self-managed medication abortion.

OBJECTIVES: Entertainment television is an influential source of health information, including about reproductive health. We investigated the association between exposure to television plotlines about medication abortion on audience awareness and beliefs about medication abortion. STUDY DESIGN: We administered a national cross-sectional online survey from December 2021 to January 2022 with a probability-based sample of people assigned female at birth. We asked respondents to select plotlines they had seen from a list of seven that portrayed medication abortion. Among the 3425 people who responded to plotline items, 3340 responded to our outcome measures. Using weighed multivariable analyses, we examined adjusted relationships between exposure to specific types of abortion plotlines and awareness of and beliefs about medication abortion medical safety. RESULTS: We found that audience exposure to medication abortion plotlines in which the medication abortion was obtained from a clinic and portrayed as safe was associated with greater awareness of medication abortion compared to nonexposure (RR: 1.68; 95% CI: 1.17, 2.40). Exposure to plotlines that portrayed MA or self-managed MA as safe was associated with audience beliefs that medication abortion is safe. CONCLUSIONS: This study demonstrates that the content of abortion plotlines and exposure to accurate information may be connected to audience awareness of and beliefs about abortion. IMPLICATIONS: In a climate of misinformation about abortion, audience exposure to medically accurate television plotlines about medication abortion may be an effective way to increase awareness of medication abortion and influence beliefs about medication abortion safety.

Rare Metastasis of Esophageal Adenocarcinoma to the Female Reproductive Tract.

Esophageal cancer is common and typically metastasizes to the liver, lung, and lymph nodes. Reproductive tract metastases are extremely rare. In fact, to the best of our knowledge, only 2 cases of esophageal carcinoma metastasizing to the ovaries have been reported. Thus, increased recognition of unusual metastatic sites is necessary to decrease the morbidity and mortality from distant esophageal metastases. We present a case of ovarian and fallopian tube metastases from esophageal adenocarcinoma in a 59-year-old woman.

Subpectoral Implant Placement Is Not Protective against Postmastectomy Radiotherapy-Related Complications Compared to Prepectoral Placement.

BACKGROUND: Postmastectomy radiotherapy (PMRT) is associated with altered cosmetic outcomes and higher complication rates in implant-based breast reconstruction (IBR). Conventional wisdom suggests that muscle coverage is somewhat protective against PMRT-related complications. In this study, the authors compared surgical outcomes in patients who underwent two-stage prepectoral versus subpectoral IBR in the setting of PMRT. METHODS: The authors performed a retrospective cohort study of patients who underwent mastectomy and PMRT with two-stage IBR from 2016 to 2019. The primary outcome was breast-related complications, including device infection; the secondary outcome was device explantation. RESULTS: The authors identified 179 reconstructions (101 prepectoral and 78 subpectoral) in 172 patients with a mean follow-up time of 39.7 ± 14.4 months. There were no differences between the prepectoral and subpectoral reconstructions in rates of breast-related complications (26.7% and 21.8%, respectively; P = 0.274), device infection (18.8% and 15.4%, respectively; P = 0.307), skin flap necrosis (5.0% and 1.3%, respectively; P = 0.232), or device explantation (20.8% and 14.1%, respectively; P = 0.117). In adjusted models, compared with prepectoral device placement, subpectoral device placement was not associated with a lower risk of breast-related complications [hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.41 to 1.36], device infection (HR, 0.73; 95% CI, 0.35 to 1.49), or device explantation (HR, 0.58; 95% CI, 0.28 to 1.19). CONCLUSIONS: Device placement plane was not predictive of complication rates in IBR in the setting of PMRT. Two-stage prepectoral IBR provides safe long-term outcomes with acceptable postoperative complication rates comparable to those with subpectoral IBR, even in the setting of PMRT. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Impact of Obesity on Outcomes of Prepectoral vs Subpectoral Implant-Based Breast Reconstruction.

BACKGROUND: The impact of obesity on outcomes of prepectoral vs subpectoral implant-based reconstruction (IBR) is not well-established. OBJECTIVES: The goal of this study was to assess the surgical and patient-reported outcomes of prepectoral vs subpectoral IBR. The authors hypothesized that obese patients would have similar outcomes regardless of device plane. METHODS: We conducted a retrospective review of obese patients who underwent 2-stage IBR from January 2017 to December 2019. The primary endpoint was the occurrence of any breast-related complication; the secondary endpoint was device explantation. RESULTS: The authors identified a total of 284 reconstructions (184 prepectoral, 100 subpectoral) in 209 patients. Subpectoral reconstruction demonstrated higher rates of overall complications (50% vs 37%, P = .047) and device explantation (25% vs 12.5%, P = .008) than prepectoral reconstruction. In multivariable regression, subpectoral reconstruction was associated with higher risk of infection (hazard ratio [HR], 1.65; P = .022) and device explantation (HR, 1.97; P = .034). Subgroup analyses demonstrated significantly higher rates of complications and explantation in the subpectoral group in those with a body mass index (BMI) ≥ 35 and BMI ≥40. The authors found no significant differences in mean scores for satisfaction with the breast (41.57 ± 13.19 vs 45.50 ± 11.91, P = .469), psychosocial well-being (39.43 ± 11.23 vs 39.30 ± 12.49, P = .915), and sexual well-being (17.17 ± 7.83 vs 17.0 ± 9.03, P = .931) between subpectoral and prepectoral reconstruction. CONCLUSIONS: Prepectoral reconstruction was associated with significantly decreased overall complications, infections, and device explantation in obese patients compared with subpectoral reconstruction. Prepectoral reconstruction provides superior outcomes to subpectoral reconstruction with comparable patient-reported outcomes.

Global parameter optimisation and sensitivity analysis of antivenom pharmacokinetics and pharmacodynamics.

In recent years it has become possible to design snakebite antivenoms with diverse pharmacokinetic properties. Owing to the pharmacokinetic variability of venoms, the choice of antivenom scaffold may influence a treatment's neutralisation coverage. Computation offers a useful medium through which to assess the pharmacokinetics and pharmacodynamics of envenomation-treatment systems, as antivenoms with identical neutralising capacities can be simulated. In this study, we simulate envenomation and treatment with a variety of antivenoms, to define the properties of effective antivenoms. Systemic envenomation and treatment were described using a two-compartment pharmacokinetic model. Treatment of Naja sumatrana and Cryptelytrops purpureomaculatus envenomation was simulated with a set of 200,000 theoretical antivenoms across 10 treatment time delays. These two venoms are well-characterised and have differing pharmacokinetic properties. The theoretical antivenom set varied across molecular weight, dose, kon, koff, and valency. The best and worst treatments were identified using an area under the curve metric, and a global sensitivity analysis was performed to quantify the influence of the input parameters on treatment outcome. The simulations show that scaffolds of diverse molecular formats can be effective. Molecular weight and valency have a negligible direct impact on treatment outcome, however low molecular weight scaffolds offer more flexibility across the other design parameters, particularly when treatment is delayed. The simulations show kon to primarily mediate treatment efficacy, with rates above 105 M-1s-1 required for the most effective treatments. koff has the greatest impact on the performance of less effective scaffolds. While the same scaffold preferences for improved treatment are seen for both model snakes, the parameter bounds for C. purpureomaculatus envenomation are more constrained. This paper establishes a computational framework for the optimisation of antivenom design.

Artificial Intelligence Modeling to Predict Periprosthetic Infection and Explantation following Implant-Based Reconstruction.

BACKGROUND: Despite improvements in prosthesis design and surgical techniques, periprosthetic infection and explantation rates following implant-based reconstruction (IBR) remain relatively high. Artificial intelligence is an extremely powerful predictive tool that involves machine learning (ML) algorithms. We sought to develop, validate, and evaluate the use of ML algorithms to predict complications of IBR. METHODS: A comprehensive review of patients who underwent IBR from January of 2018 to December of 2019 was conducted. Nine supervised ML algorithms were developed to predict periprosthetic infection and explantation. Patient data were randomly divided into training (80%) and testing (20%) sets. RESULTS: The authors identified 481 patients (694 reconstructions) with a mean ± SD age of 50.0 ± 11.5 years, mean ± SD body mass index of 26.7 ± 4.8 kg/m 2 , and median follow-up time of 16.1 months (range, 11.9 to 3.2 months). Periprosthetic infection developed in 113 of the reconstructions (16.3%), and explantation was required with 82 (11.8%) of them. ML demonstrated good discriminatory performance in predicting periprosthetic infection and explantation (area under the receiver operating characteristic curve, 0.73 and 0.78, respectively), and identified nine and 12 significant predictors of periprosthetic infection and explantation, respectively. CONCLUSIONS: ML algorithms trained using readily available perioperative clinical data accurately predict periprosthetic infection and explantation following IBR. The authors' findings support incorporating ML models into perioperative assessment of patients undergoing IBR to provide data-driven, patient-specific risk assessment to aid individualized patient counseling, shared decision-making, and presurgical optimization.

Feasibility and Acceptability of At-Home Routine Pregnancy Testing in the United States: A Pilot Study.

OBJECTIVES: We aimed to investigate the acceptability of regular self-testing among people with increased risk for delayed pregnancy recognition when provided with free at-home pregnancy tests and to explore the feasibility of this intervention among a larger sample. MATERIALS AND METHODS: In 2019-2020, we recruited participants across the United States by using flyers posted online and in community settings and abortion clinics. We purposively sampled people with pregnancy capacity who were 18 to 24 years old, had irregular menses, or had a recent second-trimester abortion. Participants were mailed pregnancy tests and instructions. Participants received text message reminders to test monthly over a 3-month period and were asked to text back results. Participants also completed online surveys at baseline, after 1 month, and after 3 months. A purposive subsample of participants was selected to participate in semi-structured interviews. Interviews were analyzed using thematic analysis of interview guide topics and emergent themes. RESULTS: 61 participants were enrolled. Fifty-four participants (90%) responded to the text reminders and 52 (85%) reported testing in all 3 months. Fifty-eight (95%) said tests were easy to use, 59 (97%) said the results were clear, and all participants found it convenient to text their results. Fourteen participants completed qualitative interviews. All described continuing to test after the study and indicated high acceptability for text reminders. Interviewees described convenience and cost as primary benefits for preferring at-home pregnancy testing. CONCLUSIONS: Regular self-testing and texting results is feasible and acceptable to participants provided with free at-home urine pregnancy tests. These results can inform future studies designed to investigate the effect of regular self-testing on timing of pregnancy detection to facilitate early entry to prenatal care or early abortion.

No Differences in Surgical and Patient-Reported Outcomes among AlloDerm, SurgiMend, and Dermacell for Prepectoral Implant-Based Breast Reconstruction.

BACKGROUND: Prepectoral implant-based breast reconstruction (IBR) has become the standard of care for many reconstructive surgeons and is often supplemented with coverage using acellular dermal matrix (ADM). However, more clinical data examining the use of ADM in breast reconstruction are needed. The current study compares complications and patient-reported outcomes (PROs) among three different types of ADM used in IBR. METHODS: The authors performed a retrospective review of consecutive patients who underwent immediate prepectoral IBR from January of 2018 through December of 2019. Surgical outcomes and PROs (using the BREAST-Q) were compared among the AlloDerm, SurgiMend, and Dermacell ADMs. RESULTS: Overall, 557 breasts (383 patients) were included (78.6% AlloDerm, 14% SurgiMend, 7.4% Dermacell). Patients in the Dermacell group were older ( P = 0.001) and more likely to have diabetes ( P = 0.001) compared with AlloDerm and SurgiMend patients. Other patient characteristics were similar among the three groups. The overall complication rate was equivalent among the three ADM groups (AlloDerm 27% vs SurgiMend 33% vs Dermacell 39%; P = 0.209). Multivariable frailty models demonstrated that the type of ADM was not significantly associated with overall complications, infection, major complications, or device explantation. BREAST-Q satisfaction with breasts, psychosocial well-being, and sexual well-being were also similar among the three ADM groups ( P = 0.109, P = 0.439, P = 0.152, respectively). CONCLUSIONS: Three of the most commonly used ADMs in the United States have similar surgical outcomes and PROs when used for prepectoral IBR. No significant differences in infection, overall complications, or device removal rates were identified among AlloDerm, SurgiMend, and Dermacell. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Electronic Patient Reported Outcomes for Miscarriage Research in Tommy's Net.

The Tommy's National Centre for Miscarriage Research aims to support the diagnosis and treatment for couples suffering from recurrent miscarriage. Tommy's Net is an electronic data gathering tool, collecting miscarriage data and links with hospital Clinical Information System databases. The gathering of patient reported data is an important aspect, especially as data relating to pregnancy and miscarriage events are often left unreported. METHODS: Both traditional paper-based and electronic patient reported outcome (ePRO) solutions have been explored to improve response rates, minimize data redundancy and reduce burden on staff. Popular ePRO survey solutions have been compared, including REDCap, SurveyMonkey, Qualtrics and LimeSurvey. RESULTS: LimeSurvey was selected as the most appropriate solution as it provided self-hosting capability, SMS integration and ease of use. CONCLUSION: We have implemented a LimeSurvey based ePRO system for collection of baseline and follow-up data for participants on the Tommy's study.

Developing a computational pharmacokinetic model of systemic snakebite envenomation and antivenom treatment.

Snakebite envenomation is responsible for over 100,000 deaths and 400,000 cases of disability annually, most of which are preventable through access to safe and effective antivenoms. Snake venom toxins span a wide molecular weight range, influencing their absorption, distribution, and elimination within the body. In recent years, a range of scaffolds have been applied to antivenom development. These scaffolds similarly span a wide molecular weight range and subsequently display diverse pharmacokinetic behaviours. Computational simulations represent a powerful tool to explore the interplay between these varied antivenom scaffolds and venoms, to assess whether a pharmacokinetically optimal antivenom exists. The purpose of this study was to establish a computational model of systemic snakebite envenomation and treatment, for the quantitative assessment and comparison of conventional and next-generation antivenoms. A two-compartment mathematical model of envenomation and treatment was defined and the system was parameterised using existing data from rabbits. Elimination and biodistribution parameters were regressed against molecular weight to predict the dynamics of IgG, F(ab')2, Fab, scFv, and nanobody antivenoms, spanning a size range of 15-150 kDa. As a case study, intramuscular envenomation by Naja sumatrana (equatorial spitting cobra) and its treatment using Fab, F(ab')2, and IgG antivenoms was simulated. Variable venom dose tests were applied to visualise effective antivenom dose levels. Comparisons to existing antivenoms and experimental rescue studies highlight the large dose reductions that could result from recombinant antivenom use. This study represents the first comparative in silico model of snakebite envenomation and treatment.

Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product.

OBJECTIVE: To develop a drug facts label prototype for a combination mifepristone and misoprostol product and to conduct a label-comprehension study to assess understanding of key label concepts. METHODS: We followed U.S. Food and Drug Administration guidance, engaged a multidisciplinary group of experts, and conducted cognitive interviews to develop a drug facts label prototype for medication abortion. To assess label comprehension, we developed 11 primary and 13 secondary communication objectives related to indications for use, eligibility, dosing regimen, contraindications, warning signs, side effects, and recognizing the risk of treatment failure, with corresponding target performance thresholds (80-90% accuracy). We conducted individual structured video interviews with people with a uterus aged 12-49 years, recruited through social media. Participants reviewed the drug facts label and responded to questions to assess their understanding of each communication objective. After transcribing and coding interviews, we estimated the proportion of correct responses and exact binomial 95% CIs by age and literacy group. RESULTS: We interviewed 851 people (of 1,507 people scheduled); responses from 844 were eligible for analysis, and 35.7% (n=301) of participants were aged 12-17 years. The overall sample met performance criteria for 10 of the 11 primary communication objectives (93-99% correct) related to indications for use, eligibility for use, the dosing regimen, and contraindications; young people met nine and people with limited literacy met eight of the 11 performance criteria. Only 79% (95% CI 0.76-0.82) of the overall sample understood to contact a health care professional if little or no bleeding occurred soon after taking misoprostol, not meeting the prespecified threshold of 85.0%. CONCLUSION: Overall, high levels of comprehension suggest that people can understand most key drug facts label concepts for a medication abortion product without clinical supervision and recommend minor modifications.

A cross-sectional survey of U.S. abortion patients' interest in obtaining medication abortion over the counter.

OBJECTIVE: To assess abortion patients' perspectives about a hypothetical option to access medication abortion over the counter without a prescription. STUDY DESIGN: From October 2019 to March 2020, people ages 15 and over seeking abortion at 7 facilities across the United States completed a cross-sectional, self-administered survey regarding their personal interest in and general support for accessing medication abortion over the counter, including the advantages and disadvantages of over-the-counter access. We used multivariable logistic regression with generalized estimating equations to assess associations between experiencing barriers that led to delay in obtaining abortion care and personal interest in and general support for accessing medication abortion over the counter. RESULTS: Of the 1687 people approached, 1202 (71%) wanted to participate, and 1178 completed the survey. Most people were personally interested in (725/1119, 65%) and in favor of (925/1120, 83%) over-the-counter medication abortion. The most common advantages noted of the over-the-counter model included privacy (772/1124, 69%), earlier access (774/1124, 69%), and convenience (733/1124, 65%). The most common disadvantages noted included incorrect use (664/1124, 59%), not seeing a clinician beforehand (439/1124, 39%), and could be less effective (271/1124, 24%). In adjusted analyses, cost barriers that resulted in delays to the appointment, White race/ethnicity (vs Black), and higher educational attainment were significantly associated with greater personal interest in and support for over-the-counter medication abortion. CONCLUSIONS: People accessing facility-based abortion care are very supportive of and interested in being able to access abortion over the counter. Those facing financial barriers obtaining facility-based care may benefit from allowing medication abortion to be available over the counter without a prescription. IMPLICATIONS: Given people's interest in over-the-counter access to medication abortion, research is needed to assess whether people can use medication abortion appropriately without clinical supervision. Such research could help determine whether medication abortion is suitable for an over-the counter switch.

Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment.

OBJECTIVE(S): To estimate the effectiveness, acceptability, and feasibility of medication abortion with mifepristone dispensed by a mail-order pharmacy after in-person clinical assessment. STUDY DESIGN: This is an interim analysis of an ongoing prospective cohort study conducted at five sites. Clinicians assessed patients in clinic and, if they were eligible for medication abortion and ≤ 63 days' gestation, electronically sent prescriptions for mifepristone 200 mg orally and misoprostol 800 mcg buccally to a mail-order pharmacy, which shipped medications for next-day delivery. Participants completed surveys three and 14 days after enrollment, and we abstracted medical chart data. RESULTS: Between January 2020 and April 2021 we enrolled 240 participants and obtained clinical outcome information for 227 (94.6%); 3 reported not taking either medication. Of those with abortion outcome information (N = 224), 216 (96.4%) completed day-3 and 212 (94.6%) day-14 surveys. Of the 224 that took medications, none reported taking past 70 days' gestation, and complete medication abortion occurred for 217 participants (96.9%, 95% CI 93.7%-98.7%). Most received medications within three days (82.1%, 95% CI 76.5%-86.9%). In the day-3 survey, 95.4% (95% CI 91.7%-97.8%) reported being very (88.4%) or somewhat (6.9%) satisfied with receiving medications by mail. In the day-14 survey, 89.6% (95% CI 84.7%-93.4%) said they would use the mail-order service again if needed. Eleven (4.9%, 95% CI 2.5%-8.6%) experienced adverse events; two were serious (one blood transfusion, one hospitalization), and none were related to mail-order pharmacy dispensing. CONCLUSIONS: Medication abortion with mail-order pharmacy dispensing of mifepristone appears effective, feasible, and acceptable to patients. IMPLICATIONS: The in-person dispensing requirement for mifepristone, codified in the drug's Risk Evaluation and Mitigation Strategy, should be removed.

Accuracy of self-assessment of gestational duration among people seeking abortion.

BACKGROUND: Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period. OBJECTIVE: In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations. STUDY DESIGN: We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of >70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being >10 weeks or >2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84). CONCLUSION: In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.

Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion.

BACKGROUND: The U.S. Food and Drug Administration (FDA) restricts dispensing of mifepristone for medication abortion to certified health care providers at clinical facilities, thus prohibiting pharmacist dispensing. Allowing mifepristone dispensing by pharmacists could improve access to medication abortion. OBJECTIVE: To assess the feasibility of pharmacists dispensing mifepristone to patients who have undergone evaluation for eligibility and counseling for medication abortion by a clinician. METHODS: Before providing a study training on medication abortion, we administered baseline surveys to pharmacists who participated in a multisite mifepristone-dispensing intervention. The survey assessed medication abortion knowledge-using a 15-item score-and perceptions about the benefits and challenges of the model. We administered follow-up surveys in the study's final month that also assessed the pharmacists' satisfaction and experiences with mifepristone dispensing. To investigate the association of the study intervention with the pharmacists' knowledge, perceptions, and experiences dispensing mifepristone, we conducted multivariable linear regression analyses using generalized estimating equation models, accounting for clustering by individual. RESULTS: Among the 72 pharmacists invited from 6 pharmacies, 47 (65%) completed the baseline surveys, and 56 (78%) received training. At the study's end (mean 18 months later), 43 of the 56 pharmacists who received training (77%) completed the follow-up surveys. At follow-up, 36 (83%) respondents were very or somewhat satisfied with mifepristone dispensing, and 24 (56%) reported experiencing no challenges dispensing mifepristone. Four (6%) of the 72 pharmacists invited objected to participating in mifepristone dispensing. In regression analyses, average knowledge scores, perceived ease of implementation, and level of support for the pharmacist-dispensing model were higher at follow-up (P < 0.001). CONCLUSION: Most pharmacists were willing to be trained, dispensed mifepristone with few challenges when given the opportunity, were satisfied with the model, and had higher knowledge levels at follow-up. Our findings support removal of FDA's restriction on pharmacist dispensing of mifepristone.

Impact of Behavioral Feeding Intervention on Child Emotional and Behavioral Functioning, Parenting Stress, and Parent-Child Attachment.

OBJECTIVES: Behavioral intervention is the only treatment for pediatric feeding problems with well documented empirical support. However, parents may be hesitant to pursue behavioral intervention because of concerns about possible negative side effects on child behavioral health and the parent-child relationship. This study investigated associations between behavioral feeding treatment and parenting stress, internalizing and externalizing behavior problems in young children, and parent-child attachment quality. METHODS: Participants included 16 mother-child dyads seeking treatment from a behavioral feeding clinic at a large Midwestern university medical center. Children were between the ages of 30 and 45 months (adjusted) at baseline. Caregivers completed the Child Behavior Checklist for ages 1.5 to 5 (CBCL/1.5-5), the Parenting Stress Index, 3rd Edition Short Form (PSI/SF), and mother-child dyads participated in the Strange Situation procedure at baseline and again after 6 months. The treatment group (n = 12) began outpatient behavioral feeding intervention following the baseline evaluation, whereas the control group (n = 12) remained on the clinic waitlist until after the 6-month follow-up. RESULTS: The treatment group demonstrated decreases in internalizing and externalizing child behavior problems and parenting stress compared with the control group. No significant differences were demonstrated in parent-child attachment quality within or between groups. CONCLUSIONS: Behavioral feeding intervention had positive effects on perceptions of child emotional and behavioral functioning and maternal parenting stress. Intervention also did not impact the quality of the mother-child attachment relationship. Further research with a larger sample size and additional observational measures of behavior is needed to support the replicability and generalizability of these results.

Abortion history and its association with current use of modern contraceptive methods in Luanda, Angola.

BACKGROUND: Women in sub-Saharan Africa often use abortion as a method of limiting their fertility and spacing births. However, it is not well understood whether having an abortion influences contraceptive behavior. The goal of this study was to examine associations between abortion history and use of a modern contraceptive method among women in Luanda, Angola. MATERIALS AND METHODS: We analyzed data on 1,176 women aged 15-49 years from a 2012 cross-sectional study conducted in Luanda, Angola, which aimed to obtain general information on sexual and reproductive health indicators. The outcome and exposure were based on participant reports of past induced abortions and current use of a modern method. We used a modified Poisson regression with robust standard errors to estimate the relative risks of using a modern contraceptive method, given history of induced abortion. RESULTS: Among all respondents, 736 (62.6%) reported using a modern contraceptive method. The clear majority of the respondents (73.21%), regardless of abortion history, were using either no method, a traditional method, or condoms. Long-acting reversible contraceptive use was very low across all respondents (2.73%). The most common family planning method reported by women with a history of abortion was condoms (32.76%). Regression analysis demonstrated that women who had a history of abortion were 1.23 times more likely to use a modern contraceptive method as compared to those who never had an abortion (relative risk: 1.23; 95% CI: 1.10-1.36), after adjusting for potential confounders. Postregression estimations of predicted probabilities demonstrated that women with a history of abortion had an 80% probability of using a modern method (95% CI: 0.76-0.84), while those who never had an abortion had a 60% probability of using a modern method (95% CI: 0.59-0.61). CONCLUSION: History of induced abortion was associated with use of a modern contraceptive method in our study population. The most common contraceptive used by women with a history of induced abortion was condoms, indicating that despite adoption of a modern method, many women are still at risk for an unintended pregnancy. Further research is needed to understand the causal factors underlying women's postabortion contraceptive choices.