Descriptive study of the real-world, long-term cost estimates and duration of use for hormonal and nonhormonal intrauterine devices using US commercial insurance claims.

BACKGROUND: Intrauterine devices (IUDs) have comparable efficacy to permanent surgical contraceptive methods; however, long-term costs are infrequently considered. Existing estimates inconsistently account for costs outside of IUD insertion or removal, actual duration of use, or differences between hormonal and nonhormonal IUDs. OBJECTIVE: To describe health care resource utilization and commercial payer costs that arise throughout hormonal and nonhormonal IUD use. METHODS: In this retrospective cohort study, paid claims data (Merative, MarketScan) from a large US commercial claims database were evaluated between 2013 and 2019. Claims were included from individuals aged 12 to 45 years who had an IUD inserted in 2014, continuous insurance coverage for 1 year prior to insertion and throughout follow-up, and no insertion, removal, or reinsertion in the previous year. Procedures and services that could be IUD-related were identified using Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Edition codes. Duration of IUD use was evaluated by Kaplan-Meier analysis of time to IUD removal. Event rates were determined for identified procedures and services; costs were calculated as the sum of payer reimbursements per enrolled individual. All IUD types available during the study period were described: 2 hormonal IUDs (52-mg and 13.5-mg levonorgestrel-releasing [LNG]) and the nonhormonal (380-mm2 copper) IUD. RESULTS: Of 195,009 individuals meeting the age requirement and receiving an IUD in 2014, 63,386 met the inclusion criteria and 53,744 had their IUD type on record-42,777 (67.5%) 52-mg LNG, 2,932 (4.6%) 13.5-mg LNG, and 8,035 (12.7%) nonhormonal IUD users. Despite differences in their indicated duration (13.5-mg LNG, 3 years; 52-mg LNG, 5 years; and nonhormonal, 10 years), most individuals had their IUD removed before its indicated full duration of use (13.5-mg LNG, 56.1%; 52-mg LNG, 61.3%; nonhormonal [at 5 years], 54.6%). The event rate per 100 individuals during the follow-up period was highest for abnormal uterine bleeding (16.2), ovarian cysts (9.3), and surgical management of uterine perforations (4.5). IUD insertion costs (mean ± SE) per enrolled individual for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $931 ± $9, $1,107 ± $4, and $897 ± $6, respectively. Cumulative mean ± SE 5-year postinsertion costs for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $2,892 ± $232, $1,514 ± $31, and $1,389 ± $97, respectively, among the remaining enrolled individuals. CONCLUSIONS: In this descriptive study of commercially insured IUD users, at least half had their IUD removed before its indicated duration. IUD improvements that reduce the frequency of abnormal uterine bleeding, ovarian cysts, and uterine perforations may help reduce long-term IUD costs.

Data Equity for Asian American and Native Hawaiian and Other Pacific Islander People in Reproductive Health Research.

Though racial and ethnic disparities in sexual and reproductive health outcomes are receiving greater interest and research funding, the experiences of Asian American and Native Hawaiian and Other Pacific Islander (NHPI) people are often combined with those of other racial and ethnic minority groups or excluded from data collection altogether. Such treatment is often rationalized because Asian American and NHPI groups comprise a smaller demographic proportion than other racial or ethnic groups, and the model minority stereotype assumes that these groups have minimal sexual and reproductive health needs. However, Asian American and NHPI people represent the fastest-growing racial-ethnic groups in the United States, and they face disparities in sexual and reproductive health access, quality of care, and outcomes compared with those of other races and ethnicities. Disaggregating further by ethnicity, people from certain Asian American and NHPI subgroups face disproportionately poor reproductive health outcomes that suggest the need for culturally targeted exploration of the unique drivers of these inequities. This commentary highlights the evidence for sexual and reproductive health disparities both in and between Asian American and NHPI groups. We also examine the failures of national data sets and clinical studies to recruit Asian American and NHPI people in proportion to their share of the U.S. population or to consider how the cultural and experiential diversity of Asian American and NHPI people influence sexual and reproductive health. Lastly, we provide recommendations for the equitable inclusion of Asian American and NHPI people to promote and systematize the study and reporting of sexual and reproductive health behaviors and outcomes in these culturally, religiously, and historically diverse groups.

Surveying the persistence of age- and gender-based restrictions on over-the-counter emergency contraception across pharmacies in Los Angeles County, CA.

BACKGROUND: Over-the-counter levonorgestrel emergency contraception (OTC EC) is safe and effective but underutilized for postcoital pregnancy prevention. Unnecessary restrictions imposed by pharmacies and pharmacy workers may impede EC uptake. OBJECTIVE: To assess the persistence of age- and gender-based barriers to OTC EC access among pharmacists and pharmacy staff across Los Angeles, CA. METHODS: We conducted a cross-sectional survey of registered community pharmacies randomly chosen from regions with the highest unintended pregnancy rates in Los Angeles County. Using an adaptation of the 2017 American Society for Emergency Contraception EC Access and Price Survey, we interviewed pharmacy staff about their attitudes and practices related to OTC EC, with attention to age- and gender-based barriers. RESULTS: We surveyed 139 staff members (45% pharmacists, 20% technicians, 26% retail) from 93 publicly accessible pharmacies. Thirteen pharmacies did not stock EC. Half of respondents cited age-based restrictions; only 4% noted gender-based restrictions. More than 75% reported being asked for EC by a man; 7% reported refusing to sell to a man. Nearly 40% reported that men never or rarely purchased EC. Pharmacists were more likely than technicians or retail staff to believe men rarely purchased EC (P = 0.01). The most frequently cited concern about selling to men was inability to confirm the female partner's age. CONCLUSION: Although gender-based restrictions to EC are rare, more than half of pharmacy staff continue to report age-based restrictions. Inability to verify the female partner's age may underlie cases where men are unable to purchase OTC EC.

Discrepant abortion reporting by interview methodology among men from the United States National Survey of Family Growth (2015-2017).

OBJECTIVE: To examine discrepancies in men's abortion reporting when queried via face-to-face interview versus audio computer-assisted self-interviewing (ACASI) in the National Survey of Family Growth (NSFG). STUDY DESIGN: The NSFG collects nationally representative data on family life, sexual behavior, and reproductive health in the United States. The questionnaire is administered to participants via face-to-face interview (FTF), with selected items also asked of the same participant via ACASI for direct comparison. As the 2015-2017 NSFG queried individuals' abortion history via both methods, we examined discrepant reporting among respondents. We additionally explored sociodemographic and reproductive characteristics associated with discrepant abortion reporting in a multivariable logistic regression model. RESULTS: Of 4540 male respondents ages 15-49, 45.3% reported a pregnancy. Via FTF, 12.3% reported an abortion, compared to 19.9% via ACASI (p < 0.01). With respect to discrepancies in the number of reported abortions, 8.5% of respondents reported more abortions via ACASI versus FTF. Multivariable logistic regression modeling noted independently greater odds of abortion reporting in ACASI among non-Hispanic Black men (aOR 2.31, 95% CI 1.19-4.45), men living below the Federal Poverty Level (less than 100% FPL: aOR 3.65, 95% CI 1.93-6.89; 100-400% FPL: aOR 2.04, 95% CI 1.20-3.45), and those desiring more children in the future (aOR 1.91, 95% CI 1.20-3.04). CONCLUSION: Men were more likely to disclose their abortions in ACASI compared to FTF interview. Disproportionate, discrepant abortion reporting among low-income, minority men who report desiring more children in the future warrants further research. IMPLICATIONS: Surveys utilizing ACASI as an adjunct to FTF interviews may more accurately capture men's abortion experience.

Access to male sexual and reproductive health services in publicly funded California clinics in 2018.

OBJECTIVES: To characterize the sexual and reproductive health (SRH) services available to men from publicly funded family planning clinics in California. STUDY DESIGN: We conducted a cross-sectional telephone survey in 2018 to compare the accessibility of SRH services for male clients at Planned Parenthood clinics in California to those visiting a random sample of 200 other publicly funded family planning clinics, selected from a California Department of Health Care Services list of 773 that had served at least 15 male clients in the prior year. A representative at each clinic answered questions about provision of 20 clinical services. We examined differences in individual service provision by clinic affiliation using χ2 tests. RESULTS: Only one-third (773/2348) of publicly funded clinics in California served more than 15 male clients each year, with rural clinics less likely than urban counties to do so. We were able to contact 62 of 107 Planned parenthood clinics and 81 of the 200 other publicly-funded family planning clinics that we attempted to reach. Most (95%) offered HIV and STI screening; 65% offered vasectomy consultation, but only 5% provided vasectomy services. Planned Parenthood clinics were more likely than other publicly funded clinics to provide condom demonstrations, emergency contraception, STI testing, HPV vaccination, penile/testicular exams, and infertility testing (p < 0.05 for all comparisons). CONCLUSIONS: Male family planning services are less frequently offered by rural clinics and by publicly funded clinics in California that are not affiliated with Planned Parenthood. IMPLICATIONS: Men's underutilization of family planning may be partially explained by a lack of access to clinical services.

Relating Chronic Pelvic Pain and Endometriosis to Signs of Sensitization and Myofascial Pain and Dysfunction.

Chronic pelvic pain is a frustrating symptom for patients with endometriosis and is frequently refractory to hormonal and surgical management. While these therapies target ectopic endometrial lesions, they do not directly address pain due to central sensitization of the nervous system and myofascial dysfunction, which can continue to generate pain from myofascial trigger points even after traditional treatments are optimized. This article provides a background for understanding how endometriosis facilitates remodeling of neural networks, contributing to sensitization and generation of myofascial trigger points. A framework for evaluating such sensitization and myofascial trigger points in a clinical setting is presented. Treatments that specifically address myofascial pain secondary to spontaneously painful myofascial trigger points and their putative mechanisms of action are also reviewed, including physical therapy, dry needling, anesthetic injections, and botulinum toxin injections.

Contributions of Charged Residues in Structurally Dynamic Capsid Surface Loops to Rous Sarcoma Virus Assembly.

UNLABELLED: Extensive studies of orthoretroviral capsids have shown that many regions of the CA protein play unique roles at different points in the virus life cycle. The N-terminal domain (NTD) flexible-loop (FL) region is one such example: exposed on the outer capsid surface, it has been implicated in Gag-mediated particle assembly, capsid maturation, and early replication events. We have now defined the contributions of charged residues in the FL region of the Rous sarcoma virus (RSV) CA to particle assembly. Effects of mutations on assembly were assessed in vivo and in vitro and analyzed in light of new RSV Gag lattice models. Virus replication was strongly dependent on the preservation of charge at a few critical positions in Gag-Gag interfaces. In particular, a cluster of charges at the beginning of FL contributes to an extensive electrostatic network that is important for robust Gag assembly and subsequent capsid maturation. Second-site suppressor analysis suggests that one of these charged residues, D87, has distal influence on interhexamer interactions involving helix α7. Overall, the tolerance of FL to most mutations is consistent with current models of Gag lattice structures. However, the results support the interpretation that virus evolution has achieved a charge distribution across the capsid surface that (i) permits the packing of NTD domains in the outer layer of the Gag shell, (ii) directs the maturational rearrangements of the NTDs that yield a functional core structure, and (iii) supports capsid function during the early stages of virus infection. IMPORTANCE: The production of infectious retrovirus particles is a complex process, a choreography of protein and nucleic acid that occurs in two distinct stages: formation and release from the cell of an immature particle followed by an extracellular maturation phase during which the virion proteins and nucleic acids undergo major rearrangements that activate the infectious potential of the virion. This study examines the contributions of charged amino acids on the surface of the Rous sarcoma virus capsid protein in the assembly of appropriately formed immature particles and the maturational transitions that create a functional virion. The results provide important biological evidence in support of recent structural models of the RSV immature virions and further suggest that immature particle assembly and virion maturation are controlled by an extensive network of electrostatic interactions and long-range communication across the capsid surface.

Atomic Modeling of an Immature Retroviral Lattice Using Molecular Dynamics and Mutagenesis.

Defining the molecular interaction between Gag proteins in an assembled hexagonal lattice of immature retrovirus particles is crucial for elucidating the mechanisms of virus assembly and maturation. Recent advances in cryo-electron microscopy have yielded subnanometer structural information on the morphology of immature Gag lattices, making computational modeling and simulations feasible for investigating the Gag-Gag interactions at the atomic level. We have examined the structure of Rous sarcoma virus (RSV) using all-atom molecular dynamics simulations and in vitro assembly, to create the first all-atom model of an immature retroviral lattice. Microseconds-long replica exchange molecular dynamics simulation of the spacer peptide (SP)-nucleocapsid (NC) subdomains results in a six-helix bundle with amphipathic properties. The resulting model of the RSV Gag lattice shows features and dynamics of the capsid protein with implications for the maturation process, and confirms the stabilizing role of the upstream and downstream regions of Gag, namely p10 and SP-NC.