The impact of antifibrotic use on long-term clinical outcomes in the pulmonary fibrosis foundation registry.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a devastating interstitial lung disease (ILD) with a high mortality rate. The antifibrotic medications pirfenidone and nintedanib have been in use since 2014 for this disorder and are associated with improved rate of lung function decline. Less is known about their long-term outcomes outside of the clinical trial context. METHODS: The Pulmonary Fibrosis Foundation Patient Registry was used for this study. Patients with an IPF diagnosis made within a year of enrollment were included. The treated group was defined as patients receiving either pirfenidone or nintedanib for at least 180 days. The untreated group did not have any record of antifibrotic use. Demographic data, comorbidities, serial lung function, hospitalization, and vital status data were collected from the registry database. The primary outcomes were transplant-free survival, time to first respiratory hospitalization, and time to 10% absolute FVC decline. Time-to-event analyses were performed utilizing Cox proportional hazards models and the log-rank test. Model covariates included age, gender, smoking history, baseline lung function, comorbidities, and oxygen use. RESULTS: The registry contained 1212 patients with IPF; ultimately 288 patients met inclusion criteria for the treated group, and 101 patients were designated as untreated. Patients treated with antifibrotics were significantly younger (69.8 vs. 72.6 years, p = 0.008) and less likely to have smoked (61.1% ever smokers vs. 72.3% never smokers, p = 0.04). No significant differences were seen in race, gender, comorbidities, or baseline pulmonary function between groups. The primary outcome of transplant-free survival was not significantly different between the two groups (adjusted HR 0.799, 95% CI 0.534-1.197, p = 0.28). Time to respiratory hospitalization was significantly shorter in the treated group (adjusted HR 2.12, 95% CI 1.05-4.30, p = 0.04). No significant difference in time to pulmonary function decline was seen between groups. CONCLUSIONS: This multicenter study demonstrated 63% of newly diagnosed IPF patients had continuous antifibrotic usage. Antifibrotics were not associated with improved transplant-free survival or pulmonary function change but was associated with an increased hazard of respiratory hospitalization. Future studies should further investigate the role of antifibrotic therapy in clinically important outcomes in real-world patients with IPF and other progressive ILDs.

Validity and Reliability of the Fatigue Severity Scale in a Real-World Interstitial Lung Disease Cohort.

Rationale: Fatigue is a common and debilitating symptom for people living with interstitial lung disease (ILD). Studies on fatigue in ILD are limited, and little headway has been made toward developing interventions targeting the alleviation of fatigue. A barrier to progress is a lack of knowledge around the performance characteristics of a patient-reported outcome measure to assess fatigue in patients with ILD. Objectives: To assess the validity and reliability of the Fatigue Severity Scale (FSS) for measuring fatigue in a national cohort of patients with ILD. Methods: FSS scores and several anchors were measured in 1,881 patients from the Pulmonary Fibrosis Foundation Patient Registry. Anchors included the Short Form 6D Health Utility Index (SF-6D) score and a single vitality question from the SF-6D; the University of California, San Diego, Shortness of Breath Questionnaire; FVC; DlCO; and 6-minute-walk distance. Internal consistency reliability, concurrent validity, and known-groups validity were assessed. Structural validity was assessed using confirmatory factor analysis. Measurements and Main Results: The FSS demonstrated high internal consistency (Cronbach's α = 0.96). There were moderate to strong correlations between FSS score and patient-reported anchors (vitality question from the SF-6D [r = 0.55] and University of California, San Diego, Shortness of Breath Questionnaire total score [r = 0.70]) and weak correlations between FSS score and physiological measures (FVC [r = -0.24], percentage predicted DlCO [r = -0.23], and 6-minute-walk distance [r = -0.29]). Higher mean FSS scores, indicating greater fatigue, were observed among patients using supplemental oxygen, those prescribed steroids, and those with lower percentage predicted FVC and percentage predicted DlCO. The confirmatory factor analysis results suggest that the nine questions of the FSS reflect one dimension of fatigue. Conclusions: Fatigue is an important patient-centered outcome in ILD that is poorly correlated with physiological measures of disease severity, including lung function and walk distance. These findings further support the need for a reliable and valid measure of patient-reported fatigue in ILD. The FSS possesses acceptable performance characteristics for assessing fatigue and distinguishing different degrees of fatigue among patients with ILD.

Adherence to hydroxyurea and clinical outcomes among children with sickle cell anemia.

OBJECTIVE: Hydroxyurea lowers the incidence of vaso-occlusive pain crises (VOC) and acute chest syndrome (ACS) among children with sickle cell anemia (SCA). Our objective was to assess the relationship between levels of adherence to hydroxyurea and clinical outcomes among children and adolescents with SCA. METHODS: This retrospective cohort study included Medicaid data (2005-2012) from Florida, Illinois, Louisiana, Michigan, South Carolina, and Texas. The study population consisted of children 1-17 years old with SCA enrolled in Medicaid for 3 years. Among children that initiated hydroxyurea, the medication possession ratio (MPR) was calculated as the proportion of days covered by hydroxyurea. Six months after initiation of hydroxyurea, clinical outcomes were assessed through the end of the study period: numbers of VOC-related inpatient admissions and emergency department visits, and encounters for ACS. Multivariable Poisson models were used to predict outcomes by MPR quartile adjusting for previous healthcare utilization, state, and age. RESULTS: Hydroxyurea was initiated by 515 children. The median MPR was 0.53 (interquartile range = 0.3-0.8). The annual median number of visits was 0.0 for ACS, 1.3 for VOC-related emergency department, and 1.4 for VOC-related inpatient admissions. For each outcome, the highest quartile of MPR had the lowest predicted count; this difference was significant for ACS visits when compared with the lowest quartile of MPR. CONCLUSION: This study demonstrated a high level of adherence (>75%) was essential to achieve a lower incidence of common negative clinical outcomes. Further, moderate and severe hydroxyurea nonadherence may be more common than previously appreciated among children, emphasizing the importance of developing and testing innovative strategies to increase adherence.

Feasibility and acceptability of a toolkit-based process to implement patient-centered, immediate postpartum long-acting reversible contraception services.

BACKGROUND: National guidelines recommend that maternity systems provide patient-centered access to immediate postpartum long-acting reversible contraception (ie, insertion of an intrauterine device or implant during the delivery hospitalization). Hospitals face significant barriers to offering these services, and efforts to improve peripartum contraception care quality have met with mixed success. Implementation toolkits-packages of resources and strategies to facilitate the implementation of new services-are a promising approach for guiding clinical practice change. OBJECTIVE: This study aimed to develop a theory-informed toolkit, evaluate the feasibility of toolkit-based implementation of immediate postpartum long-acting reversible contraception care in a single site, and refine the toolkit and implementation process for future effectiveness testing. STUDY DESIGN: We conducted a single-site feasibility study of the toolkit-based implementation of immediate postpartum contraception services at a large academic medical center in 2017 to 2020. Based on previous qualitative work, we developed a theory-informed implementation toolkit. A stakeholder panel selected toolkit resources to use in a multicomponent implementation intervention at the study site. These resources included tools and strategies designed to optimize implementation conditions (ie, implementation leadership, planning, and evaluation; the financial environment; engagement of key stakeholders; patient needs; compatibility with workflow; and clinician and staff knowledge, skills, and attitudes). The implementation intervention was executed from January 2018 to April 2019. Study outcomes included implementation outcomes (ie, provider perceptions of the implementation process and implementation tools [assessed via online provider survey]) and healthcare quality outcomes (ie, trends in prenatal contraceptive counseling, trends in immediate postpartum long-acting reversible contraceptive utilization [both ascertained by institutional administrative data], and the patient experience of contraceptive care [assessed via serial, cross-sectional, online patient survey items adapted from the National Quality Forum-endorsed, validated Person-Centered Contraceptive Counseling measure]). RESULTS: In the implementation process, among 172 of 401 eligible clinicians (43%) participating in surveys, 70% were "extremely" or "somewhat" satisfied with the implementation process overall. In the prenatal contraceptive counseling, among 4960 individuals undergoing childbirth at the study site in 2019, 1789 (36.1%) had documented prenatal counseling about postpartum contraception. Documented counseling rates increased overall throughout 2019 (Q1, 12.5%; Q4, 51.0%) but varied significantly by clinic site (Q4, range 30%-79%). Immediate postpartum long-acting reversible contraception utilization increased throughout the study period (before implementation, 5.46% of deliveries; during implementation, 8.95%; after implementation, 8.58%). In the patient experience of contraceptive care, patient survey respondents (response rate, 15%-29%) were largely White (344/425 [81%]) and highly educated (309/425 [73%] with at least a 4-year college degree), reflecting the study site population. Scores were poor across settings, with modest improvements in the hospital setting from 2018 to 2020 (prenatal visits, 67%-63%; hospitalization, 45%-58%; outpatient after delivery, 69%-65%). Based on these findings, toolkit refinements included additional resources designed to routinize prenatal contraceptive counseling and support a more patient-centered experience of contraceptive care. CONCLUSION: A toolkit-based process to implement immediate postpartum long-acting reversible contraceptive services at a single academic center was associated with high acceptability but mixed healthcare quality outcomes. Toolkit resources were added to optimize counseling rates and the patient experience of contraceptive care. Future research should formally test the effectiveness of the refined toolkit in a multisite, prospective trial.

Cost sharing, postpartum contraceptive use, and short interpregnancy interval rates among commercially insured women.

BACKGROUND: Increasing access to effective birth control after childbirth may meet many women's preferences and reduce short interpregnancy interval rates. Eliminating out-of-pocket costs for contraception has been reported to increase the use of the most effective methods among women with employer-based insurance, but the prevalence and effects of patient cost sharing for contraception have not been studied during the postpartum period. OBJECTIVE: This study aimed to examine the association between cost sharing for long-acting reversible contraception and postpartum contraception use patterns and pregnancies in the 12 months after delivery. STUDY DESIGN: We conducted a retrospective cohort analysis of commercially insured women undergoing childbirth from 2014 to 2018 using Optum's (Eden Prairie, MN) de-identified Clinformatics Data Mart database. This large national database includes nonretired employees and their dependents who are enrolled in health insurance plans sponsored by large- or medium-sized US-based employers. Women with 12 months of continuous enrollment postpartum were included. Childbirth, pregnancy, and contraceptive method (female sterilization, long-acting reversible contraceptives, other hormonal methods, and no prescription method observed) were identified using claims data. Contraceptive use patterns were observed at 3, 6, and 12 months postpartum and adjusted for individual and plan characteristics. Median out-of-pocket costs were $0 for sterilization and other hormonal methods but nonzero for long-acting reversible contraception. We therefore used simple and multivariable logistic regressions to examine the association between plan-level cost sharing (no cost sharing, $0; low cost sharing, >$0-<$200; and high cost sharing, ≥$200 out-of-pocket cost) for any long-acting reversible contraceptive insertion and contraceptive use patterns and short interpregnancy interval rates, controlling for age, household income, race and ethnicity, region, and insurance plan type. RESULTS: Among 25,298 plans with cost sharing data, we identified 172,941 women with continuous enrollment for 12 months postpartum, including 82,500 (47.7%) in no cost sharing, 22,595 (13.1%) in low cost sharing, and 67,846 (39.2%) in high cost sharing plans. The percentage of postpartum women in the study sample using any prescription contraceptive method was 39.5% by 3 months, 43.8% by 6 months, and 46.0% by 12 months. At all time points, postpartum women in no cost sharing plans had a higher predicted probability of long-acting reversible contraceptive use (eg, at 12 months: no cost sharing, 22.0%; low cost-sharing, 17.5%; high cost sharing, 18.3%; P<.001) and a lower predicted probability of no prescription method use (eg, at 12 months: no cost sharing, 51.8%; low cost sharing, 55.0%; high cost sharing, 54.9%; P<.001) than those in low or high cost sharing plans. Predicted probabilities of female sterilization and other hormonal method use did not differ substantively by plan cost sharing for long-acting reversible contraception at any time point. The proportion of women experiencing a short interpregnancy interval was low (1.9% by 3 months, 1.9% by 6 months, 2.0% by 12 months) and did not differ by plan cost sharing for long-acting reversible contraception at any time point. CONCLUSION: Out-of-pocket costs for long-acting reversible contraception influence the method of contraception used by postpartum women with employer-based insurance. Eliminating financial barriers to long-acting reversible contraception access after childbirth may help women initiate their preferred method and increase the use of long-acting reversible contraceptives among interested women who otherwise might utilize less effective methods.

Mechanisms of hiatus failure in prolapse: a multifaceted evaluation.

INTRODUCTION AND HYPOTHESIS: We investigated whether factors influencing pelvic floor hiatal closure are inter-related or independent, hypothesizing that (1) hiatus size is moderately correlated with levator defect, pelvic floor muscle strength, and change in hiatus size with contraction and (2) urogenital hiatus (UGH) and levator hiatus (LH) measures are similar in patients with anterior wall (AW) and posterior wall (PW) prolapse. METHODS: This cross-sectional case-control study included subjects with AW prolapse (n = 50), PW prolapse (n = 50), and normal support (n = 50). Hiatus measurements and levator defects were assessed on MRI, and vaginal closure force was measured with an instrumented speculum. Pearson correlation coefficients and simple and multivariable linear regression models were performed. RESULTS: During contraction, LH narrowed 47% more in the PW compared to AW group (p = 0.001). With straining, LH lengthened 34% more in the PW than AW group (p < 0.001). With straining, UGH and LH lengthening was greater by 72% and 44% in those with major compared to no/minor defect (p < 0.001 and p = 0.004). Contraction strength explained, at most, 4% of UGH (r = 0.17) or LH (r = 0.20) shortening during contraction (r = 0.17 and r = 0.20, respectively), indicating that these factors are largely independent. After controlling for prolapse size, resting UGH and levator defect status were associated with straining UGH (p < 0.001, p = 0.004), but muscle strength and resting tone were not. CONCLUSIONS: Hiatus measures are complex and differ according to prolapse occurrence and type. They are, at best, only weakly correlated with pelvic floor muscle strength and movement during contraction.

Associations between Self-Reported Daily Affect Ratings and Sleep Duration during the First Two Weeks of Antidepressant Therapy.

Background: In the context of a randomized controlled trial evaluating the efficacy of augmenting fluoxetine treatment in young adults with major depressive disorder (MDD) using a modified repeated partial sleep deprivation protocol contrasting 2 weeks of restricted time in bed (i.e., 6 h TIB) to no time in bed restriction (i.e., 8 h TIB) the study examines whether sleep duration and the timing of repeated partial sleep deprivation predicts patient-reported affect ratings. Participants: Participants included 58 young adults with DSM-IV-diagnosed MDD. Methods: Daily ratings of affect and sleep were collected during the first 2 weeks of initiating fluoxetine treatment, yielding 630 person-days. Actigraphy monitoring was employed to assess compliance with time in bed condition. Results: Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group. Participants whose bedtime was delayed by 2-h nightly demonstrated the most significant improvement in negative affect and positivity ratio during the first 2 weeks of fluoxetine therapy. Moreover, the trajectory of morning negative affect ratings in the first 2 weeks was predictive of remission after 4 weeks of fluoxetine therapy. Conclusions: These findings suggest that monitoring changes in daily affect may be a valuable marker of early treatment response in young adults with MDD.

Breakdown in the expedited partner therapy treatment cascade: from reproductive healthcare provider to the pharmacist.

BACKGROUND: The rising incidence rates of sexually transmitted infections in the United States highlight the need for concurrent treatment of patients and their sexual partners. Expedited partner therapy allows healthcare providers to offer antibiotic prescriptions or medications to an index patient for distribution to their sexual partner(s) without evaluating the partner. We hypothesized that there was a gap between expedited partner therapy policy at the state level and its downstream implementation by community pharmacists. OBJECTIVE: The objectives of our study were to evaluate pharmacists' expedited partner therapy knowledge and practices in 41 expedited partner therapy-permissible US states, to determine whether there were differences in practice based on the length of time expedited partner therapy was permissible in the state and chlamydia incidence rates, and to measure the cost of expedited partner therapy treatment. STUDY DESIGN: A randomized cohort of pharmacists (n=335) was invited to complete a telephone interview from November 2017 through January 2018. Descriptive statistics were calculated and stratified by early, mid, and late expedited partner therapy-adopter status based on the year of the state's expedited partner therapy enactment and the state's chlamydia incidence rate. Fisher's exact test and 1-way analyses of variance were used to compare measures across strata. RESULTS: We had 143 pharmacists (42.7%) agree to complete the survey. Among our respondents, 40.6% (n=58/143) indicated that they were aware of expedited partner therapy; 14.7% (n=21/143) reported that they had ever received an expedited partner therapy prescription, and 97% (n=139/143) reported that they would dispense an expedited partner therapy prescription if they received 1 in the future. These findings were stable across the 6 strata defined by early, mid, or late expedited partner therapy-adopter and high or low incidence rates of chlamydia status. Mean cost of azithromycin 1000 mg and cefixime 400 mg for treatment of chlamydia and gonorrhea was $22.17 (95% confidence interval, 20.29-24.05) and $30.46 (95% confidence interval, 28.65-32.26), respectively. CONCLUSION: Fewer than one-half of the pharmacists were aware of expedited partner therapy. A small minority of pharmacists reported ever having received an expedited partner therapy prescription, regardless of the length of time expedited partner therapy had been legal in their states and the incidence of chlamydia. However, almost all pharmacists reported that they would dispense an expedited partner therapy prescription if they received 1. Additionally, costs were high for expedited partner therapy for self-pay patients. These data suggest that there are opportunities to increase expedited partner therapy utilization by healthcare providers, patients, and pharmacists.

Insurance Coverage and Use of Hormones Among Transgender Respondents to a National Survey.

PURPOSE: We undertook a study to assess the associations between barriers to insurance coverage for gender-affirming hormones (either lack of insurance or claim denial) and patterns of hormone use among transgender adults. METHODS: We used data from the US Transgender Survey, a large national sample of 27,715 transgender adults, collected from August to September 2015. We calculated weighted proportions and performed multivariate logistic regression analyses. RESULTS: Of 12,037 transgender adults using hormones, 992 (9.17%) were using nonprescription hormones. Among insured respondents, 2,528 (20.81%) reported that their claims were denied. Use of nonprescription hormones was more common among respondents who were uninsured (odds ratio = 2.64; 95% CI, 1.88-3.71; P <.001) or whose claims were denied (odds ratio = 2.53; 95% CI, 1.61-3.97; P <.001). Uninsured respondents were also less likely to be using hormones (odds ratio = 0.37; 95% CI, 0.24-0.56; P <.001). CONCLUSIONS: Lack of insurance coverage for gender-affirming hormones is associated with lower overall odds of hormone use and higher odds of use of nonprescription hormones; such barriers may thus be linked to unmonitored and unsafe medication use, and increase the risks for adverse health outcomes. Ensuring access to hormones can decrease the economic burden transgender people face, and is an important part of harm-reduction strategies.

Defining "normal recovery" of pelvic floor function and appearance in a high-risk vaginal delivery cohort.

INTRODUCTION AND HYPOTHESIS: Childbirth pelvic floor trauma leads to pelvic floor disorders. Identification of significant injuries would facilitate intervention for recovery. Our objectives were to identify differences in pelvic floor appearance and function following delivery and patterns of normal recovery in women sustaining high-risk labor events. METHODS: We completed a prospective cohort study comparing women undergoing vaginal births involving risk factors for pelvic floor injury with women undergoing cesareans. Data were collected on multidimensional factors including levator ani muscle (LA) tears. Descriptive and bivariate statistics were used to compare the groups. We identified potential markers of pelvic floor injury based on effect size. RESULTS: Eighty-two women post-vaginal delivery and 30 women post-cesarean enrolled. The vaginal group had decreased perineal body length between early postpartum, 6 weeks (p < 0.001), and 6 months (p = 0.001). POP-Q points did not change between any time point (all p > 0.05). Measures of strength improved between each time point (all p < 0.002). When compared with cesarean delivery, women post-vaginal birth had longer genital hiatus and lower anterior and posterior vaginal walls (all p < 0.05). Based on theoretical considerations and effect sizes, those with Bp ≥0 cm, Kegel force ≤1.50 N, and/or an LA tear on imaging were considered to have significant pelvic floor injury. Using this definition, at 6 weeks, 27 (46.4%) women were classified as injured. At 6 months, 13 (29.6%) remained injured. CONCLUSIONS: We propose that pelvic floor muscle strength, posterior vaginal wall support, and imaging consistent with LA tear are potential indicators of abnormal or prolonged recovery in this cohort with high-risk labor events.

Substance Use Treatment Patient and Provider Perspectives on Accessing Sexual and Reproductive Health Services: Barriers, Facilitators, and the Need for Integration of Care.

Background: Women with substance use disorders have high rates of adverse sexual and reproductive health (SRH) outcomes, including unintended pregnancy, sexually transmitted infections, and contraceptive nonuse. Little research has explored barriers and facilitators to accessing SRH services experienced by women with substance use disorders. Objectives: To investigate barriers and facilitators to accessing SRH services experienced by women with substance use disorders. To assess perspectives on integration of SRH services into substance use treatment. Methods: Twenty-nine semi-structured interviews were conducted with female patients (N = 17) and providers (N = 12) at four substance use treatment facilities in Michigan between October 2015 and January 2016. Respondents were asked about experiences accessing SRH services and perspectives on integration of SRH services into substance use treatment. Data were analyzed using the constant comparative method. Results: Patients and providers discussed barriers to accessing SRH services, including competing priorities, structural barriers, lack of knowledge on SRH services and substance use, fear of Child Protective Services and law enforcement, and stigma. Facilitators included reprioritization of SRH, accessible transportation, insurance coverage and funding for SRH services, and education and training on SRH. Finally, participants expressed support for integration of SRH services into substance use treatment. Conclusions/Importance: Understanding the barriers to accessing SRH services is essential to reducing the adverse SRH outcomes experienced by women with substance use disorders. Substance use treatment is a critical time to offer SRH services. Integration of care is a potential model for improving the SRH of women with substance use disorders.

Comparison of measurement systems for posterior vaginal wall prolapse on magnetic resonance imaging.

INTRODUCTION AND HYPOTHESIS: A wide variety of reference lines and landmarks have been used in imaging studies to diagnose and quantify posterior vaginal wall prolapse without consensus. We sought to determine which is the best system to (1) identify posterior vaginal wall prolapse and its appropriate cutoff values and (2) assess the prolapse size. METHODS: This was a secondary analysis of sagittal maximal Valsalva dynamic MRI scans from 52 posterior-predominant prolapse cases and 60 comparable controls from ongoing research. All eight existing measurement lines and a new parameter, the exposed vaginal length, were measured. Expert opinions were used to score the prolapse sizes. Simple linear regressions, effect sizes, area under the curve, and classification and regression tree analyses were used to compare these reference systems and determine cutoff values. Linear and ordinal logistic regressions were used to assess the effectiveness of the prolapse size. RESULTS: Among existing parameters, "the perineal line-internal pubis," a reference line from the inside of the pubic symphysis to the front tip of the perineal body (cutoff value 0.9 cm), had the largest effect size (1.61), showed the highest sensitivity and specificity to discriminate prolapse with area under the curve (0.91), and explained the most variation (68%) in prolapse size scores. The exposed vaginal length (cutoff value 2.9) outperformed all the existing lines, with the largest effect size (2.09), area under the curve (0.95), and R-squared value (0.77). CONCLUSIONS: The exposed vaginal length performs slightly better than the best of the existing systems, for both diagnosing and quantifying posterior prolapse size. Performance characteristics and evidence-based cutoffs might be useful in clinical practice.

The preferred mode of delivery of medical professionals and non-medical professional mothers-to-be and the impact of additional information on their decision: an online questionnaire cohort study.

PURPOSE: It was the aim to evaluate the personal preference of mode of delivery and to analyze differences between medical professionals and non-medical professionals. Interest in participating in a risk stratification system was evaluated. We hypothesized that gaining information about risk stratification provided in the survey could potentially change participants' decision regarding the preferred mode of delivery; therefore, subjects were asked twice (before and after providing information). METHODS: Five cohorts [four professionals (MP) including participants of the German Urogynecology Congress 2017, employees of two major university hospitals in Germany, and members of the German Society of Gynecology and Obstetrics, and one non-professional group (NP) including pregnant women] were invited online to participate in this survey. RESULTS: Vaginal delivery was the preferred mode of delivery in both groups (MP 90.4% vs. NP 88.8%; p = 0.429). MP are more likely to opt for CS due to concerns regarding pelvic floor disorders (MP 56.6% vs. NP 9.1%; p < 0.001). Likewise, parity and prior experienced CS (pCS) had a significant impact on the decision towards vaginal delivery (parity MP OR 7.5 95% CI 4.6-12.3, NP OR 9.3 95% CI 1.9-44.2; (pCS) MP OR 0.12 95% CI 0.07-0.19, NP OR 0.05 95% CI 0.01-0.25). There is great interest in participating in risk stratification systems in the majority of participants (68.9%). CONCLUSIONS: MP and NP prefer vaginal birth for themselves or their partners. Within the group that opted for CS, MP were significantly more often concerned about pelvic floor disorders. Future prevention aspects might include education about pelvic floor disorders.

Impact of expedited partner therapy (EPT) implementation on chlamydia incidence in the USA.

OBJECTIVES: The diagnosis and treatment of Chlamydia trachomatis infection is important in preventing persistent or recurrent infection. Expedited partner therapy (EPT) is the favoured and supported method for STI treatment of the Centers for Disease Control and Prevention when the provider cannot be assured that all recent sexual partner(s) will seek therapy. EPT is legally permissible in 38 states and is endorsed by healthcare organisations to decrease the rates of chlamydia and gonorrhoea infection. Our study investigated the impact of EPT legal status (permissible, potentially allowable or prohibited) on C. trachomatis infection rates for each state. METHODS: Our ecological study modelled the number of reported chlamydia cases from 2000 to 2013 as a function of year, legal status and the interaction between year and legality. We used a negative binomial regression model that included state fixed effects (including the District of Columbia) to account for both the repeated measures per state and state-specific characteristics that could not be measured for inclusion in this study. The lagged number of C. trachomatis cases was included as a covariate and each state's total population for a given year was included in the model as an exposure parameter. States were designated Y (EPT permissible), N (EPT prohibited) and M (EPT potentially allowable), and the legal status of each state could vary over time. RESULTS: Each legal category saw an increase in the incidence rate of C. trachomatis infection, but on average, the incidence rate for states with prohibitive EPT legislation grew significantly faster over time compared with the rate for the states where EPT was permissible. The average increase in predicted incidence rates per year for states with Y, N and M legal status were 14.1 (95% CI (12.0 to 16.2)), 17.5 (95% CI (15.9 to 19.2)) and 16.8 (95% CI (15.0 to 18.6)) cases per 100 000 persons per year, respectively, when controlling for state-specific effects. CONCLUSIONS: Our model suggests that a lack of EPT legislation is associated with an increase in STI rates. States with potentially allowable EPT legislation as of 2013 (n=8) should consider permitting EPT as a component of a multipronged strategy for treatment of sexual partners to prevent C. trachomatis infection.

The impact of cost sharing on women's use of annual examinations and effective contraception.

BACKGROUND: We sought to describe the relationship between the elimination of out-of-pocket costs and women's use of preventive care office visits and long-acting reversible contraception after accounting for baseline levels of cost sharing. OBJECTIVES: The objective of this analysis was to describe the relationship between the elimination of out-of-pocket costs and utilization of preventive care visits and long-acting reversible contraception insertion while taking baseline cost sharing levels under consideration. STUDY DESIGN: In 2017, we used administrative health plan data to examine changes in out-of-pocket costs and service utilization among 2,172,065 women enrolled in 15,118 employer-based health plans between 2008 and 2015. We used generalized estimating equations to examine utilization patterns. RESULTS: Women in this sample generally had low costs at baseline ($24 and $29 for preventive care visits and long-acting reversible contraception insertion, respectively). The elimination of baseline out-of-pocket costs were related to changes in the utilization of both services but more consistently for contraceptive device placement. Women whose low/moderate out-of-pocket costs were eliminated were more likely to use a preventive care office visit than women with persistent low/moderate costs (odds ratio, 1.05; 95% confidence interval, 1.04-1.05), but women with high out-of-pocket costs had lower utilization rates, even after their costs were eliminated. In contrast, the odds of having a contraceptive device placed was higher among all groups of women when out-of-pocket costs were zero, as compared with women with low/moderate costs. For instance, when compared with women with low/moderate costs, women were less likely to have a contraceptive device inserted (odds ratio, 0.92; 95% confidence interval, 0.86-0.97) when they had high costs but more likely after their costs were eliminated (odds ratio, 1.15; 95% confidence interval, 1.09-1.20). CONCLUSION: Out-of-pocket costs were low prior to the Affordable Care Act. Eliminating costs was associated with increases in preventive service use among those with high levels of cost, but effect sizes were low, suggesting that cost is only 1 barrier. Failing to recognize that cost sharing was already low could cause us to falsely conclude that the elimination of cost sharing was ineffective.

Structural, functional, and symptomatic differences between women with rectocele versus cystocele and normal support.

BACKGROUND: Prolapse of the anterior and posterior vaginal walls has been generally associated with apical descent and levator ani muscle defects. However, the relative contributions of these factors to the pathophysiology of descent in the different vaginal compartments is not well understood. Furthermore, symptoms uniquely associated with prolapse in these compartments have not been well characterized. OBJECTIVES: The objectives of the study were to compare the associations between the following: (1) apical support, (2) levator ani muscles, and (3) pelvic floor symptoms in women with posterior-predominant prolapse, anterior-predominant prolapse, and normal support. STUDY DESIGN: This is a cross-sectional study with 2 case arms: 60 women with posterior prolapse, 90 with anterior prolapse, and a referent control arm with 103 asymptomatic subjects with normal support, determined from pelvic organ prolapse quantification examinations. Levator muscle defects were graded from magnetic resonance imaging. Vaginal closure forces above resting were measured with an instrumented speculum during maximal contraction. Pelvic floor symptoms were measured via the Pelvic Floor Distress Inventory-Short Form. RESULTS: Mean point C location in controls was -6.9 cm [1.5] (mean [standard deviation]); and was higher in posterior prolapse (-4.7 cm [2.7], 2.2 cm below controls) than the anterior prolapse group (-1.2 cm [4.1]; 5.6 cm below controls, P < .001 for all comparisons). Normal-appearing muscles (ie, muscle without a visible defect) occurred at similar frequencies in posterior prolapse (45%) and controls (51%, P = .43) but less often in anterior prolapse (28%, P ≤ .03 for pairwise comparisons). Major levator ani defects occurred at similar rates in women with posterior (33%) and anterior prolapse (42%, P = .27) but less often in controls (16%, P ≤ .012 for both pairwise comparisons). Similarly, there were significant differences in generated vaginal closure forces across the 3 groups, with the prolapse groups generating weaker closure forces than the control group (P = .004), but the differences between the 2 prolapse groups were not significant after controlling for prolapse size (P = .43). Pelvic floor symptoms were more severe for the posterior (mean Pelvic Floor Distress Inventory score, 129) and anterior prolapse groups (score, 128) than the controls (score, 40.2, P < .001 for both comparisons); the difference between the 2 prolapse groups was not significant (P = .83). CONCLUSION: Posterior-predominant prolapse involves an almost 3-fold less apical descent below normal than anterior-predominant vaginal prolapse. Levator ani defects and muscle impairment also have a lower impact. Pelvic floor symptoms reflect the presence and size of prolapse more than the predominant lax vaginal compartment.

Intraoperative cervix location and apical support stiffness in women with and without pelvic organ prolapse.

BACKGROUND: It is unknown how initial cervix location and cervical support resistance to traction, which we term "apical support stiffness," compare in women with different patterns of pelvic organ support. Defining a normal range of apical support stiffness is important to better understand the pathophysiology of apical support loss. OBJECTIVE: The aims of our study were to determine whether: (1) women with normal apical support on clinic Pelvic Organ Prolapse Quantification, but with vaginal wall prolapse (cystocele and/or rectocele), have the same intraoperative cervix location and apical support stiffness as women with normal pelvic support; and (2) all women with apical prolapse have abnormal intraoperative cervix location and apical support stiffness. A third objective was to identify clinical and biomechanical factors independently associated with clinic Pelvic Organ Prolapse Quantification point C. STUDY DESIGN: We conducted an observational study of women with a full spectrum of pelvic organ support scheduled to undergo gynecologic surgery. All women underwent a preoperative clinic examination, including Pelvic Organ Prolapse Quantification. Cervix starting location and the resistance (stiffness) of its supports to being moved steadily in the direction of a traction force that increased from 0-18 N was measured intraoperatively using a computer-controlled servoactuator device. Women were divided into 3 groups for analysis according to their pelvic support as classified using the clinic Pelvic Organ Prolapse Quantification: (1) "normal/normal" was women with normal apical (C < -5 cm) and vaginal (Ba and Bp < 0 cm) support; (2) normal/prolapse had normal apical support (C < -5 cm) but prolapse of the anterior or posterior vaginal walls (Ba and/or Bp ≥ 0 cm); and (3) prolapse/prolapse had both apical and vaginal wall prolapse (C > -5 cm and Ba and/or Bp ≥ 0 cm). Demographics, intraoperative cervix locations, and apical support stiffness values were then compared. Normal range of cervix location during clinic examination and operative testing was defined by the total range of values observed in the normal/normal group. The proportion of women in each group with cervix locations within and outside the normal range was determined. Linear regression was performed to identify variables independently associated with clinic Pelvic Organ Prolapse Quantification point C. RESULTS: In all, 52 women were included: 14 in the normal/normal group, 11 in the normal/prolapse group, and 27 in the prolapse/prolapse group. At 1 N of traction force in the operating room, 50% of women in the normal/prolapse group had cervix locations outside the normal range while 10% had apical support stiffness outside the normal range. Of women in the prolapse/prolapse group, 81% had cervix locations outside the normal range and 8% had apical support stiffness outside the normal range. Similar results for cervix locations were observed at 18 N of traction force; however the proportion of women with apical support stiffness outside the normal range increased to 50% in the normal/prolapse group and 59% in the prolapse/prolapse group. The prolapse/prolapse group had statistically lower apical support stiffness compared to the normal/normal group with increased traction from 1-18 N (0.47 ± 0.18 N/mm vs 0.63 ± 0.20 N/mm, P = .006), but all other comparisons were nonsignificant. After controlling for age, parity, body mass index, and apical support stiffness, cervix location at 1 N traction force remained an independent predictor of clinic Pelvic Organ Prolapse Quantification point C, but only in the prolapse/prolapse group. CONCLUSION: Approximately 50% of women with cystocele and/or rectocele but normal apical support in the clinic had cervix locations outside the normal range under intraoperative traction, while 19% of women with uterine prolapse had normal apical support. Identifying women whose apical support falls outside a defined normal range may be a more accurate way to identify those who truly need a hysterectomy and/or an apical support procedure and to spare those who do not.

Obesity and stress urinary incontinence in women: compromised continence mechanism or excess bladder pressure during cough?

INTRODUCTION AND HYPOTHESIS: We compared two hypotheses as to why obesity is associated with stress urinary incontinence (SUI): (1) obesity increases demand on the continence system (e.g. higher cough pressure) and (2) obesity compromises urethral function and urethrovaginal support. METHODS: A secondary analysis was performed using data from a case-control study of SUI in women. Measurements of urethrovaginal support (POP-Q point Aa, urethral axis), urethral function (maximal urethral closure pressure, MUCP), and measures of continence system demand (intravesical pressures at rest and during maximal cough) were analyzed. Cases and controls were divided into three body mass index (BMI) groups: normal (18.5-24.9 kg/m2); overweight (25.0-29.9 kg/m2); and obese (≥30 kg/m2). Logistic regression models where created to investigate variables related to SUI for each BMI group. Structural equation modeling was used to test the direct and indirect relationships among BMI, SUI, maximal cough pressure, MUCP, and POP-Q point Aa. RESULTS: The study included 108 continent controls and 103 women with SUI. MUCP was the factor most strongly associated with SUI in all BMI groups. Maximal cough pressure was significantly associated with SUI in obese women (OR 3.191, 95% CI 1.326, 7.683; p < 0.01), but not in normal weight or overweight women. Path model analysis showed a significant relationship between BMI and SUI through maximal cough pressure (indirect effect, p = 0.038), but not through MUCP (indirect effect, p = 0.243) or POP-Q point Aa (indirect effect, p = 0.410). CONCLUSIONS: Our results support the first hypothesis that obesity is associated with SUI because of increased intravesical pressure, which therefore increases demand on the continence mechanism.