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Objective: To assess whether indicators of limited access to services explained changes in rates of second-trimester abortion after implementation of a restrictive abortion law in Texas., Methods: We used cross-sectional vital statistics data on abortions performed in Texas before (November 1, 2011-October 31, 2012) and after (November 1, 2013-October 31, 2014) implementation of Texas' abortion law. We conducted monthly mystery client calls for information about abortion facility closures and appointment wait times to calculate distance from women's county of residence to the nearest open Texas facility, the number of open abortion facilities in women's region of residence (facility network size), and days until the next consultation visit. We estimated mixed-effects logistic regression models to assess the association between obtaining abortion care after the law's implementation and having a second-trimester abortion (12 weeks of gestation or more), after adjustment for distance, network size, and wait times., Results: Overall, 64,902 Texas-resident abortions occurred in the period before the law was introduced and 53,174 occurred after its implementation. After implementation, 14.5% of abortions were performed at 12 weeks of gestation or more, compared with 10.5% before the law (P<.001; unadjusted odds ratio [OR] 1.45; 95% CI 1.40-1.50). Adjusting for distance to the nearest facility and facility network size reduced the odds of having a second-trimester abortion after implementation (OR 1.17; 95% CI 1.10-1.25). Women living 50-99 miles from the nearest facility (vs less than 10 miles) had higher odds of second-trimester abortion (OR 1.24; 95% CI 1.11-1.39), as did women in regions with less than one facility per 250,000 reproductive-aged women compared with women in areas that had 1.5 or more facilities (OR 1.57; 95% CI 1.41-1.75). After implementation, women waited 1 to 14 days for a consultation visit; longer waits were associated with higher odds of second-trimester abortion., Conclusion: Increases in second-trimester abortion after the law's implementation were due to women having more limited access to abortion services.

Background and Purpose: The proinflammatory cytokine IL-1 (interleukin-1) has a deleterious role in cerebral ischemia, which is attenuated by IL-1 receptor antagonist (IL-1Ra). IL-1 induces peripheral inflammatory mediators, such as interleukin-6, which are associated with worse prognosis after ischemic stroke. We investigated whether subcutaneous IL-1Ra reduces the peripheral inflammatory response in acute ischemic stroke., Methods: SCIL-STROKE (Subcutaneous Interleukin-1 Receptor Antagonist in Ischemic Stroke) was a single-center, double-blind, randomized, placebo-controlled phase 2 trial of subcutaneous IL-1Ra (100 mg administered twice daily for 3 days) in patients presenting within 5 hours of ischemic stroke onset. Randomization was stratified for baseline National Institutes of Health Stroke Scale score and thrombolysis. Measurement of plasma interleukin-6 and other peripheral inflammatory markers was undertaken at 5 time points. The primary outcome was difference in concentration of log(interleukin-6) as area under the curve to day 3. Secondary outcomes included exploratory effect of IL-1Ra on 3-month outcome with the modified Rankin Scale., Results: We recruited 80 patients (mean age, 72 years; median National Institutes of Health Stroke Scale, 12) of whom 73% received intravenous thrombolysis with alteplase. IL-1Ra significantly reduced plasma interleukin-6 ( P <0.001) and plasma C-reactive protein ( P <0.001). IL-1Ra was well tolerated with no safety concerns. Allocation to IL-1Ra was not associated with a favorable outcome on modified Rankin Scale: odds ratio (95% confidence interval)=0.67 (0.29-1.52), P =0.34. Exploratory mediation analysis suggested that IL-1Ra improved clinical outcome by reducing inflammation, but there was a statistically significant, alternative mechanism countering this benefit., Conclusions: IL-1Ra reduced plasma inflammatory markers which are known to be associated with worse clinical outcome in ischemic stroke. Subcutaneous IL-1Ra is safe and well tolerated. Further experimental studies are required to investigate efficacy and possible interactions of IL-1Ra with thrombolysis., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: ISRCTN74236229., (© 2018 American Heart Association, Inc.)

Objective: To assess women's preferences for contraception after delivery and to compare use with preferences., Methods: In a prospective cohort study of women aged 18-44 years who wanted to delay childbearing for at least 2 years, we interviewed 1,700 participants from eight hospitals in Texas immediately postpartum and at 3 and 6 months after delivery. At 3 months, we assessed contraceptive preferences by asking what method women would like to be using at 6 months. We modeled preference for highly effective contraception and use given preference according to childbearing intentions using mixed-effects logistic regression testing for variability across hospitals and differences between those with and without immediate postpartum long-acting reversible contraception (LARC) provision., Results: Approximately 80% completed both the 3- and 6-month interviews (1,367/1,700). Overall, preferences exceeded use for both-LARC: 40.8% (n=547) compared with 21.9% (n=293) and sterilization: 36.1% (n=484) compared with 17.5% (n=235). In the mixed-effects logistic regression models, several demographic variables were associated with a preference for LARC among women who wanted more children, but there was no significant variability across hospitals. For women who wanted more children and had a LARC preference, use of LARC was higher in the hospital that offered immediate postpartum provision (P<.035) as it was for U.S.-born women (odds ratio [OR] 2.08, 95% CI 1.17-3.69) and women with public prenatal care providers (OR 2.04, 95% CI 1.13-3.69). In the models for those who wanted no more children, there was no significant variability in preferences for long-acting or permanent methods across hospitals. However, use given preference varied across hospitals (P<.001) and was lower for black women (OR 0.26, 95% CI 0.12-0.55) and higher for U.S.-born women (OR 2.32, 95% CI 1.36-3.96), those 30 years of age and older (OR 1.82, 95% CI 1.07-3.09), and those with public prenatal care providers (OR 2.04, 95% CI 1.18-3.51)., Conclusion: Limited use of long-acting and permanent contraceptive methods after delivery is associated with indicators of health care provider and system-level barriers. Expansion of immediate postpartum LARC provision as well as contraceptive coverage for undocumented women could reduce the gap between preference and use.

Objective: To assess pregnancies that could have been averted through improved access to contraceptive methods in the 2 years after delivery., Methods: In this cohort study, we interviewed 403 postpartum women in a hospital in Austin, Texas, who wanted to delay childbearing for at least 2 years. Follow-up interviews were completed at 3, 6, 9, 12, 18, and 24 months after delivery; retention at 24 months was 83%. At each interview, participants reported their pregnancy status and contraceptive method. At the 3- and 6-month interviews, participants were also asked about their preferred contraceptive method 3 months in the future. We identified types of barriers among women unable to access their preferred method and used Cox models to analyze the risk of pregnancy from 6 to 24 months after delivery., Results: Among women interviewed 6 months postpartum (n=377), two thirds had experienced a barrier to accessing their preferred method of contraception. By 24 months postpartum, 89 women had reported a pregnancy; 71 were unintended. Between 6 and 24 months postpartum, 77 of 377 women became pregnant (20.4%), with 56 (14.9%) lost to follow-up. Women who encountered a barrier to obtaining their preferred method were more likely to become pregnant less than 24 months after delivery. They had a cumulative risk of pregnancy of 34% (95% confidence interval [CI] 0.25-0.43) as compared with 12% (95% CI 0.05-0.18) for women with no barrier. All but three of the women reporting an unintended pregnancy had earlier expressed interest in using long-acting reversible contraception or a permanent method., Conclusion: In this study, most unintended pregnancies less than 24 months after delivery could have been prevented or postponed had women been able to access their desired long-acting and permanent methods.

Purpose: We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial., Methods: A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy., Results: Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures., Conclusions: This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

Objective: To compare the estimated proportion of contraindications to combined oral contraceptives between women who obtained combined oral contraceptives in U.S. public clinics compared with women who obtained combined oral contraceptives over the counter (OTC) in Mexican pharmacies., Methods: We recruited a cohort of 501 women who were residents of El Paso, Texas, who obtained OTC combined oral contraceptives in Mexico and 514 women who obtained combined oral contraceptives from family planning clinics in El Paso. Based on self-report of World Health Organization category 3 and 4 contraindications and interviewer-measured blood pressure, we estimated the proportion of contraindications and, using multivariable-adjusted logistic regression, identified possible predictors of contraindications., Results: The estimated proportion of any category 3 or 4 contraindication was 18%. Relative contraindications (category 3) were more common among OTC users (13% compared with 9% among clinic users, P=.006). Absolute contraindications (category 4) were not different between the groups (5% for clinic users compared with 7% for OTC users, P=.162). Hypertension was the most prevalent contraindication (5.6% of clinic users and 9.8% of OTC users). After multivariable adjustment, OTC users had higher odds of having contraindications compared with clinic users (odds ratio [OR] 1.59, 95% confidence interval [CI] 1.11-2.29). Women aged 35 years or older (OR 5.30, 95% CI 3.59-7.81) and those with body mass index 30.0 or more (OR 2.24, 95% CI 1.40-3.56) also had higher odds of having contraindications., Conclusion: Relative combined oral contraceptive contraindications are more common among OTC users in this setting. Progestin-only pills might be a better candidate for the first OTC product given their fewer contraindications.

Objective: To estimate differences in continuation of oral contraceptive pills (OCPs) between U.S. resident women obtaining pills in U.S. family planning clinics compared with over-the-counter in Mexican pharmacies., Methods: In El Paso, Texas, we recruited 514 OCP users who obtained pills over the counter from a Mexican pharmacy and 532 who obtained OCPs by prescription from a family planning clinic in El Paso. A baseline interview was followed by three consecutive surveys over 9 months. We asked about date of last supply, number of pill packs obtained, how long they planned to continue use, and experience of side effects. Retention was 90%, with only 105 women lost to follow-up., Results: In a multivariable Cox proportional hazards model, discontinuation was higher for women who obtained pills in El Paso clinics compared with those who obtained their pills without a prescription in Mexico (hazard ratio 1.6, 95% confidence interval [CI] 1.1-2.3). Considering the number of pill packs dispensed to clinic users, discontinuation rates were higher (hazard ratio 1.8, 95% CI 1.2-2.7) for clinic users who received one to five pill packs. However, there was no difference in discontinuation between clinic users receiving six or more pill packs and users obtaining pills without a prescription., Conclusion: Results suggest providing OCP users with more pill packs and removing the prescription requirement would lead to increased continuation.

Objective: To estimate how well a convenience sample of women from the general population could self-screen for contraindications to combined oral contraceptives using a medical checklist., Methods: Women 18-49 years old (N=1,271) were recruited at two shopping malls and a flea market in El Paso, Texas, and asked first whether they thought birth control pills were medically safe for them. They then used a checklist to determine the presence of level 3 or 4 contraindications to combined oral contraceptives according to the World Health Organization Medical Eligibility Criteria. The women then were interviewed by a blinded nurse practitioner, who also measured blood pressure., Results: The sensitivity of the unaided self-screen to detect true contraindications was 56.2% (95% confidence interval [CI] 51.7-60.6%), and specificity was 57.6% (95% CI 54.0-61.1%). The sensitivity of the checklist to detect true contraindications was 83.2% (95% CI 79.5-86.3%), and specificity was 88.8% (95% CI 86.3-90.9%). Using the checklist, 6.6% (95% CI 5.2-8.0%) of women incorrectly thought they were eligible for use when, in fact, they were contraindicated, largely because of unrecognized hypertension. Seven percent (95% CI 5.4-8.2%) of women incorrectly thought they were contraindicated when they truly were not, primarily because of misclassification of migraine headaches. In regression analysis, younger women, more educated women, and Spanish speakers were significantly more likely to correctly self-screen (P<.05)., Conclusion: Self-screening for contraindications to oral contraceptives using a medical checklist is relatively accurate. Unaided screening is inaccurate and reflects common misperceptions about the safety of oral contraceptives. Over-the-counter provision of this method likely would be safe, especially for younger women and if independent blood pressure screening were encouraged.

Objectives: Brain metastases (BM) are a significant complication of metastatic breast cancer (MBC). The high incidence of BM in HER2 overexpressing MBC is now well recognized, however, the optimal management of such patients is not yet clearly defined. We aimed to analyze factors affecting survival after diagnosis of BM in patients treated in our center., Materials and Methods: Retrospective analysis of survival in all patients treated with antineoplastic therapy for BM from MBC in our institution between May 1st 2002 and April 30th 2005, according to HER2 expression and use of trastuzumab after diagnosis of BM., Results: The median survival of the 26 patients with HER2 overexpressing disease after diagnosis of BM was significantly longer than that of the 60 patients with HER2 nonoverexpressing disease (6.2 vs. 3.8 months, P = 0.027). Further analysis revealed that this seems to be due to the favorable outcome of the 70% (n = 18) of HER2 overexpressing patients who received trastuzumab after BM were diagnosed. Median survival of this group was 11.9 months, compared with 3.8 months (HER2 nonoverexpressing disease, P = 0.002) and 3.0 months (HER2 overexpressing disease not treated with trastuzumab after development of BM, P = 0.05)., Conclusion: Patients with HER2 overexpressing MBC who received trastuzumab after diagnosis of BM survived longer than expected. This finding justifies an active therapeutic approach: disease progression within central nervous system does not preclude benefit from trastuzumab treatment.

The Collaborative Corneal Transplantation Studies are a pair of multicenter prospective clinical trials evaluating the effectiveness of histocompatibility matching in high risk keratoplasty patients. The antigen matching study (AMS) evaluated HLA matching in patients without circulating lymphocytotoxic antibody to HLA antigens and the cross-match study (CS) evaluated the effect of using cross-match-negative donors in patients with identified circulating lymphocytotoxic antibodies to HLA antigens. Sera from 510 patients considered for enrollment in the studies were screened preoperatively for the presence of anti-class I lymphocytotoxic antibodies (LA). The 42 patients (8%) found to have detectable LA entered the CS. The 468 patients found not to have detectable LA preoperatively entered the AMS. Fifteen of the 37 transplanted CS patients were found to have donor-specific anti-class I antibody (before or after surgery). These patients were also screened for anti-class II LA and 25 had anti-class II panel reactive antibody > or = 5%. Forty-nine of the 419 transplanted AMS patients (12%) were found to have produced anti-class I LA after surgery, and in 19 patients, antibody specificities were those of donor HLA antigens. There was a significant association between the number of mismatched class I antigens and the number of donor-specific LA produced. The production of LA by AMS patients was significantly associated with reaction episodes; eighty-two percent of patients (40 of 49) with LA had reaction, compared with 63% of patients (230 of 365) without LA (P = 0.02). Likewise, production of donor-specific LA was significantly associated with immune-mediated graft failure (P = 0.025). For CS patients, there was no correlation between the production of donor-specific anti-class I or nonspecific anti-class II antibodies and graft outcome. However, the CS patients had poorer graft survival than did AMS patients at 3 years (57% vs. 66%, P = 0.01). These data demonstrate that LA, especially directed against donor class I HLA antigens following corneal transplantation in high risk patients, are associated with immune graft rejection and can be an indicator of allograft rejection.

We present a patient with a craniofacial meningioma that had been considered inoperable for 8 years but has now been successfully treated using the combined neurosurgical and craniomaxillofacial approach. The tumor extensively involved the meninges, skull, face, left orbit, and maxilla. Vision and mild proptosis of the left eye had worsened over the last several years. Computed tomography and magnetic resonance imaging scans revealed an extensive intraosseous meningioma with intracranial and extracranial extension. An angiogram revealed an intensely vascularized mass supplied by a markedly enlarged ophthalmic artery. The tumor was approached through a bicoronal incision. The meningioma that extended into the dura was removed entirely from the brain. The left orbital roof and the lateral and medial walls were resected along with the meningioma, which extended through the orbit into the maxilla. The defect in the dura was closed with a pericranial flap. Split parietal bone and lyophilized cartilage were used for reconstruction of the cranial and orbital defects. Three and a half months after the initial surgery, further reconstruction was performed using calvarial, rib, and iliac bone and lyophilized cartilage. A methylmethacrylate implant was inserted but then removed due to chronic wound drainage. It was substituted with demineralized perforated bone implants from Pacific Coast Tissue Bank. Seventeen months after the initial surgery, there was no evidence of the tumor.