Comparison of No-Test Telehealth and In-Person Medication Abortion.

Importance: In the US, access to medication abortion using history-based (no-test) eligibility assessment, including through telehealth and mailing of mifepristone, has grown rapidly. Additional evidence on the effectiveness and safety of these models is needed. Objective: To evaluate whether medication abortion with no-test eligibility assessment and mailing of medications is as effective as in-person care with ultrasonography and safe overall. Design, Setting, and Participants: Prospective, observational study with noninferiority analysis. Sites included 4 abortion-providing organizations in Colorado, Illinois, Maryland, Minnesota, Virginia, and Washington from May 2021 to March 2023. Eligible patients were seeking medication abortion up to and including 70 days' gestation, spoke English or Spanish, and were aged 15 years or older. Exposure: Study groups reflected the model of care selected by the patient and clinicians and included: (1) no-test (telehealth) eligibility assessment and mailing of medications (no-test + mail) (n = 228); (2) no-test eligibility assessment and pickup of medications (no-test + pickup) (n = 119); or (3) in-person with ultrasonography (n = 238). Main Outcomes and Measures: Effectiveness, defined as a complete abortion without the need for repeating the mifepristone and misoprostol regimen or a follow-up procedure, and safety, defined as an abortion-related serious adverse event, including overnight hospital admission, surgery, or blood transfusion. Outcomes were derived from patient surveys and medical records. Primary analysis focused on the comparison of the no-test + mail group with the in-person with ultrasonography group. Results: The mean age of the participants (N = 585) was 27.3 years; most identified as non-Hispanic White (48.6%) or non-Hispanic Black (28.1%). Median (IQR) gestational duration was 45 days (39-53) and comparable between study groups (P = .30). Outcome data were available for 91.8% of participants. Overall effectiveness was 94.4% (95% CI, 90.7%-99.2%) in the no-test + mail group and 93.3% (95% CI, 88.3%-98.2%) in the in-person with ultrasonography group in adjusted models (adjusted risk difference, 1.2 [95% CI, -4.1 to 6.4]), meeting the prespecified 5% noninferiority margin. Serious adverse events included overnight hospitalization (n = 4), blood transfusion (n = 2), and emergency surgery (n = 1) and were reported by 1.1% (95% CI, 0.4%-2.4%) of participants, with 3 in the no-test + mail group, 3 in the in-person with ultrasonography group, and none in the no-test + pickup group. Conclusions and Relevance: This prospective, observational study found that medication abortion obtained following no-test telehealth screening and mailing of medications was associated with similar rates of complete abortion compared with in-person care with ultrasonography and met prespecified criteria for noninferiority, with a low prevalence of adverse events.

Contraceptive use and access among deployed US servicewomen: findings from an online survey.

BACKGROUND/INTRODUCTION: This study aimed to survey US servicewomen on their contraceptive access and use during deployment. METHODS: Between June 2016 and July 2017, we conducted a cross-sectional online survey among a convenience sample of current and former members of the US Military, National Guard and Reserves who had a deployment ending in 2010 or later. Participants were asked open-ended and closed-ended questions about their demographics and contraceptive use and access before and during their last deployment. Descriptive statistics were run on closed-ended questions and responses to open-ended questions were inductively coded. RESULTS: A total of 353 participants were included. Sixty-five per cent reported using contraception during all or part of their last deployment. Nearly half (49.3%) did not have or remember having a discussion with a military care provider about contraception prior to deployment. Both prior to and during deployment, the free or low cost of birth control and ability to get a full supply for deployment facilitated contraceptive use. Difficulty obtaining an appointment and the inability to get a full supply of birth control were barriers to contraception access both before and during deployment. Half (49.1%) of respondents who had to start or refill contraception during deployment said it was somewhat or very difficult to do so. CONCLUSIONS: For at least some servicewomen, there are barriers to contraceptive access and use prior to and during overseas deployment. Programmes to increase contraceptive access should be expanded and monitoring systems should be implemented to ensure all servicemembers receive predeployment contraceptive counselling.

Telehealth Interventions to Improve Obstetric and Gynecologic Health Outcomes: A Systematic Review.

OBJECTIVE: To systematically review the effectiveness of telehealth interventions for improving obstetric and gynecologic health outcomes. DATA SOURCES: We conducted a comprehensive search for primary literature in ClinicalTrials.gov, Cochrane Library, Cochrane Collaboration Registry of Controlled Trials, EMBASE, PubMed, and MEDLINE. METHODS OF STUDY SELECTION: Qualifying primary studies had a comparison group, were conducted in countries ranked very high on the United Nations Human Development Index, published in English, and evaluated obstetric and gynecologic health outcomes. Cochrane Collaboration's tool and ROBINS-I tool were used for assessing risk of bias. Summary of evidence tables were created using the United States Preventive Services Task Force Summary of Evidence Table for Evidence Reviews. TABULATION, INTEGRATION, RESULTS: Of the 3,926 published abstracts identified, 47 met criteria for inclusion and included 31,967 participants. Telehealth interventions overall improved obstetric outcomes related to smoking cessation and breastfeeding. Telehealth interventions decreased the need for high-risk obstetric monitoring office visits while maintaining maternal and fetal outcomes. One study found reductions in diagnosed preeclampsia among women with gestational hypertension. Telehealth interventions were effective for continuation of oral and injectable contraception; one text-based study found increased oral contraception rates at 6 months. Telehealth provision of medication abortion services had similar clinical outcomes compared with in-person care and improved access to early abortion. Few studies suggested utility for telehealth to improve notification of sexually transmitted infection test results and app-based intervention to improve urinary incontinence symptoms. CONCLUSION: Telehealth interventions were associated with improvements in obstetric outcomes, perinatal smoking cessation, breastfeeding, early access to medical abortion services, and schedule optimization for high-risk obstetrics. Further well-designed studies are needed to examine these interventions and others to generate evidence that can inform decisions about implementation of newer telehealth technologies into obstetrics and gynecology practice.

Safety of Medical Abortion Provided Through Telemedicine Compared With In Person.

OBJECTIVE: To compare the proportion of medical abortions with a clinically significant adverse event among telemedicine and in-person patients at a clinic system in Iowa during the first 7 years of the service. METHODS: We conducted a retrospective cohort study. We analyzed data on clinically significant adverse events (hospital admission, surgery, blood transfusion, emergency department treatment, and death) for all medical abortions performed by telemedicine or in person at a clinic system in Iowa between July 1, 2008, and June 30, 2015. Data on adverse events came from required reporting forms submitted to the mifepristone distributor. We calculated the prevalence of adverse events and 95% CIs comparing telemedicine with in-person patients. The analysis was designed as a noninferiority study. Assuming the prevalence of adverse events to be 0.3%, telemedicine provision was considered to be inferior to in-person provision if the prevalence were 0.6% or higher. The required sample size was 6,984 in each group (one-sided α=0.025, power 90%). To explore whether patients with adverse events presented to emergency departments and were not reported, we conducted a survey of the 119 emergency departments in Iowa, asking whether they had treated a woman with an adverse event in the prior year. RESULTS: During the study period, 8,765 telemedicine and 10,405 in-person medical abortions were performed. Forty-nine clinically significant adverse events were reported (no deaths or surgery; 0.18% of telemedicine patients with any adverse event [95% CI 0.11-0.29%] and 0.32% of in-person patients [95% CI 0.23-0.45%]). The difference in adverse event prevalence was 0.13% (95% CI -0.01% to 0.28%, P=.07). Forty-two emergency departments responded to the survey (35% response rate); none reported treating a woman with an adverse event after medical abortion. CONCLUSION: Adverse events are rare with medical abortion, and telemedicine provision is noninferior to in-person provision with regard to clinically significant adverse events.

Prescription Birth Control Access Among U.S. Women at Risk of Unintended Pregnancy.

BACKGROUND: Access to contraception is a vital component of preventing unintended pregnancies. This study was conducted to assess the prevalence of and factors associated with U.S. women's difficulty accessing prescription contraception (pill, patch, or ring). MATERIALS AND METHODS: We performed a nationally representative survey of adult women at risk of unintended pregnancy (aged 18-44, not pregnant or seeking pregnancy, sexually active, not sterilized) using a probability-based web panel. In November to December 2011, 2046 women completed the survey. Weighted proportions were calculated and logistic regression was used to identify covariates associated with difficulty obtaining or refilling prescription contraception. RESULTS: A total of 1385 (68%) women had ever tried to get a prescription for hormonal contraception. Among this population, 29% reported ever having problems obtaining a prescription or refills. In multivariable regression, uninsured (vs. privately insured) and Spanish-speaking (vs. English-speaking) women were significantly more likely to report difficulties; women with a high school degree and those with some college (vs. a college degree or higher) were significantly less likely to report difficulty. Difficulties included cost barriers or lack of insurance (14%), challenges obtaining an appointment or getting to a clinic (13%), the clinician requiring a clinic visit, exam, or Pap smear (13%), not having a regular doctor/clinic (10%), difficulty accessing a pharmacy (4%), and other reasons (4%). CONCLUSIONS: One-third of adult U.S. women who have ever tried to obtain prescription contraception reported access barriers. While the Affordable Care Act may resolve some of these issues, these data indicate that additional factors may still need to be addressed.

Complications from first-trimester aspiration abortion: a systematic review of the literature.

OBJECTIVE: We conducted a systematic review to examine the prevalence of minor and major complications following first-trimester aspiration abortion requiring medical or surgical intervention. STUDY DESIGN: We searched PubMed, Cumulative Index to Nursing and Allied Health Literature, Scopus and the Cochrane Library for articles published between 1980 and April 2015 that reported on repeat aspiration, hemorrhage, infection, cervical/vaginal trauma, uterine perforation, abdominal surgery, hospitalization, anesthesia-related complications and death. We limited our review to studies that included ≥100 abortions performed by physicians in North America, Western Europe, Scandinavia and Australia/New Zealand. We compared the prevalence of complications that required additional interventions for abortions performed in office-based clinics and surgical center or hospital clinic settings. RESULTS: From 11,369 articles retrieved, 57 studies met our inclusion criteria. Evidence from 36 studies suggests that ≤3.0% of procedures performed in any setting necessitates repeat aspiration. Hemorrhage not requiring transfusion occurred in 0-4.7% of office-based procedures and 0-4.1% of hospital-based procedures but was ≤1.0% in 23 studies. Major complications requiring intervention, including hemorrhage requiring transfusion and uterine perforation needing repair, occurred in ≤0.1% of procedures, and hospitalization was necessary in ≤0.5% of cases in most studies. Anesthesia-related complications occurred in ≤0.2% of procedures in six office-based studies and ≤0.5% of procedures performed in surgical centers or hospital-based clinics. No abortion-related deaths were reported. CONCLUSIONS: The percentage of first-trimester aspiration abortions that required interventions for minor and major complications was very low. Overall, the prevalence of major complications was similar across clinic contexts, indicating that this procedure can be safely performed in an office setting. IMPLICATIONS: Laws requiring abortion providers to have hospital admitting privileges or facilities to meet ambulatory surgical center standards would be unlikely to improve the safety of first-trimester aspiration abortion in office settings.

Continuing pregnancy after mifepristone and "reversal" of first-trimester medical abortion: a systematic review.

OBJECTIVE: We conducted a systematic review of the literature on the effectiveness of medical abortion "reversal" treatment. Since the usual care for women seeking to continue pregnancies after ingesting mifepristone is expectant management with fetal surveillance, we also performed a systematic review of continuing pregnancy after mifepristone alone. STUDY DESIGN: We searched PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus and the Cochrane Library for articles published through March 2015 reporting the proportion of pregnancies continuing after treatment with either mifepristone alone or after an additional treatment following mifepristone aimed at reversing its effect. RESULTS: From 1115 articles retrieved, 1 study met inclusion criteria for abortion reversal, and 13 studies met criteria for continuing pregnancy after mifepristone alone. The one report of abortion reversal was a case series of 7 patients receiving varying doses of progesterone in oil intramuscularly or micronized progesterone orally or vaginally; 1 patient was lost to follow-up. The study was of poor quality and lacked clear information on patient selection. Four of six women continued the pregnancy to term [67%, 95% confidence interval (CI) 30-90%]. Assuming the lost patient aborted resulted in a continuing pregnancy proportion of 57% (95% CI 25-84%). The proportion of pregnancies continuing 1-2 weeks after mifepristone alone varied from 8% (95% CI 3-22%) to 46% (95% CI 37-56%). Continuing pregnancy was more common with lower mifepristone doses and advanced gestational age. CONCLUSIONS: In the rare case that a woman changes her mind after starting medical abortion, evidence is insufficient to determine whether treatment with progesterone after mifepristone results in a higher proportion of continuing pregnancies compared to expectant management. IMPLICATIONS: Legislation requiring physicians to inform patients about abortion reversal transforms an unproven therapy into law and represents legislative interference in the patient-physician relationship.

Incidence of emergency department visits and complications after abortion.

OBJECTIVE: To conduct a retrospective observational cohort study to estimate the abortion complication rate, including those diagnosed or treated at emergency departments (EDs). METHODS: Using 2009-2010 abortion data among women covered by the fee-for-service California Medicaid program and all subsequent health care for 6 weeks after having an abortion, we analyzed reasons for ED visits and estimated the abortion-related complication rate and the adjusted relative risk. Complications were defined as receiving an abortion-related diagnosis or treatment at any source of care within 6 weeks after an abortion. Major complications were defined as requiring hospital admission, surgery, or blood transfusion. RESULTS: A total of 54,911 abortions among 50,273 fee-for-service Medi-Cal beneficiaries were identified. Among all abortions, 1 of 16 (6.4%, n=3,531) was followed by an ED visit within 6 weeks but only 1 of 115 (0.87%, n=478) resulted in an ED visit for an abortion-related complication. Approximately 1 of 5,491 (0.03%, n=15) involved ambulance transfers to EDs on the day of the abortion. The major complication rate was 0.23% (n=126, 1/436): 0.31% (n=35) for medication abortion, 0.16% (n=57) for first-trimester aspiration abortion, and 0.41% (n=34) for second-trimester or later procedures. The total abortion-related complication rate including all sources of care including EDs and the original abortion facility was 2.1% (n=1,156): 5.2% (n=588) for medication abortion, 1.3% (n=438) for first-trimester aspiration abortion, and 1.5% (n=130) for second-trimester or later procedures. CONCLUSION: Abortion complication rates are comparable to previously published rates even when ED visits are included and there is no loss to follow-up. LEVEL OF EVIDENCE: II.

Mortality of induced abortion, other outpatient surgical procedures and common activities in the United States.

OBJECTIVE: The recent surge of new legislation regulating induced abortion in the United States is ostensibly motivated by the desire to protect women's health. To provide context for interpreting the risk of abortion, we compared abortion-related mortality to mortality associated with other outpatient surgical procedures and selected nonmedical activities. METHODS: We calculated the abortion-related mortality rate during 2000-2009 using national data. We searched PubMed and other sources for contemporaneous data on mortality associated with other outpatient procedures commonly performed on healthy young women, marathon running, bicycling and driving. RESULTS: The abortion-related mortality rate in 2000-2009 in the United States was 0.7 per 100,000 abortions. Studies in approximately the same years found mortality rates of 0.8-1.7 deaths per 100,000 plastic surgery procedures, 0-1.7deaths per 100,000 dental procedures, 0.6-1.2 deaths per 100,000 marathons run and at least 4 deaths among 100,000 cyclists in a large annual bicycling event. The traffic fatality rate per 758 vehicle miles traveled by passenger cars in the United States in 2007-2011 was about equal to the abortion-related mortality rate. CONCLUSIONS: The safety of induced abortion as practiced in the United States for the past decade met or exceeded expectations for outpatient surgical procedures and compared favorably to that of two common nonmedical voluntary activities. The new legislation restricting abortion is unnecessary; indeed, by reducing the geographic distribution of abortion providers and requiring women to travel farther for the procedure, these laws are potentially detrimental to women's health.

A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa.

OBJECTIVE: To compare complication rates, efficacy and acceptability of buccal misoprostol to laminaria for cervical preparation before dilation and evacuation (D&E) in South Africa. STUDY DESIGN: We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1-2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13-19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power. RESULTS: Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0-18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20-5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostol participants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4-16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups. CONCLUSIONS: Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea. IMPLICATIONS: Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.

Changes in service delivery patterns after introduction of telemedicine provision of medical abortion in Iowa.

OBJECTIVES: We assessed the effect of a telemedicine model providing medical abortion on service delivery in a clinic system in Iowa. METHODS: We reviewed Iowa vital statistic data and billing data from the clinic system for all abortion encounters during the 2 years prior to and after the introduction of telemedicine in June 2008 (n = 17,956 encounters). We calculated the distance from the patient's residential zip code to the clinic and to the closest clinic providing surgical abortion. RESULTS: The abortion rate decreased in Iowa after telemedicine introduction, and the proportion of abortions in the clinics that were medical increased from 46% to 54%. After telemedicine was introduced, and with adjustment for other factors, clinic patients had increased odds of obtaining both medical abortion and abortion before 13 weeks' gestation. Although distance traveled to the clinic decreased only slightly, women living farther than 50 miles from the nearest clinic offering surgical abortion were more likely to obtain an abortion after telemedicine introduction. CONCLUSIONS: Telemedicine could improve access to medical abortion, especially for women living in remote areas, and reduce second-trimester abortion.

Reproductive health preventive screening among clinic vs. over-the-counter oral contraceptive users.

BACKGROUND: Interest is growing in moving oral contraceptives over-the-counter (OTC), although concerns exist about whether women would continue to get preventive health screening. STUDY DESIGN: We recruited cohorts of US-resident women who obtained oral contraceptives from US family planning clinics (n=532) and OTC from pharmacies in Mexico (n=514) and interviewed them four times over 9 months. Based on self-reports of having a Pap smear within 3 years or ever having had a pelvic exam, clinical breast exam and testing for sexually transmitted infections (STIs), we assessed the prevalence of preventive screening using Poisson regression models. RESULTS: The prevalence of screening was high for both groups (>88% for Pap smear, pelvic exam and clinical breast exam and >71% for STI screening), while the prevalence ratios for screening were higher for clinic users, even after multivariable adjustment. CONCLUSIONS: Results suggest that most women would obtain reproductive health preventive screening if oral contraceptives were available OTC, and also highlight the need to improve access to preventive screening for all low-income women.

Contraindications to progestin-only oral contraceptive pills among reproductive-aged women.

BACKGROUND: Progestin-only oral contraceptive pills (POPs) have fewer contraindications to use compared to combined pills. However, the overall prevalence of contraindications to POPs among reproductive-aged women has not been assessed. STUDY DESIGN: We collected information on contraindications to POPs in two studies: (1) the Self-Screening Study, a sample of 1267 reproductive-aged women in the general population in El Paso, TX, and (2) the Prospective Study of OC Users, a sample of current oral contraceptive (OC) users who obtained their pills in El Paso clinics (n=532) or over the counter (OTC) in Mexican pharmacies (n=514). In the Self-Screening Study, we also compared women's self-assessment of contraindications using a checklist to a clinician's evaluation. RESULTS: Only 1.6% of women in the Self-Screening Study were identified as having at least one contraindication to POPs. The sensitivity of the checklist for identifying women with at least one contraindication was 75.0% [95% confidence interval (CI): 50.6%-90.4%], and the specificity was 99.4% (95% CI: 98.8%-99.7%). In total, 0.6% of women in the Prospective Study of OC Users reported having any contraindication to POPs. There were no significant differences between clinic and OTC users. CONCLUSION: The prevalence of contraindications to POPs was very low in these samples. POPs may be the best choice for the first OTC oral contraceptive in the United States.

Effectiveness and acceptability of medical abortion provided through telemedicine.

OBJECTIVE: To estimate the effectiveness and acceptability of telemedicine provision of early medical abortion compared with provision with a face-to-face physician visit at a Planned Parenthood affiliate in Iowa. METHODS: Between November 2008 and October 2009, we conducted a prospective cohort study of women obtaining medical abortion by telemedicine or face-to-face physician visits. We collected clinical data, and women completed a self-administered questionnaire at follow-up. We also compared the prevalence of reportable adverse events between the two service delivery models among all patients seen between July 2008 and October 2009. RESULTS: Of 578 enrolled participants, follow-up data were obtained for 223 telemedicine patients and 226 face-to-face patients. The proportion with a successful abortion was 99% for telemedicine patients (95% confidence interval [CI] 96-100%) and 97% for face-to-face patients (95% CI 94-99%). Ninety-one percent of all participants were very satisfied with their abortion, although in multivariable analysis, telemedicine patients had a higher odds of saying they would recommend the service to a friend compared with face-to-face patients (odds ratio, 1.72; 95% CI 1.26-2.34). Twenty-five percent of telemedicine patients said they would have preferred being in the same room with the doctor. Younger age, less education, and nulliparity were significantly associated with preferring face-to-face communication. There was no significant difference in the prevalence of adverse events reported during the study period among telemedicine patients (n = 1,172) (1.3%; 95% CI 0.8-2.1%) compared with face-to-face patients (n = 2,384) (1.3%; 95% CI 0.9-1.8%) (82% power to detect difference of 1.3%). CONCLUSION: Provision of medical abortion through telemedicine is effective and acceptability is high among women who choose this model. LEVEL OF EVIDENCE: II.

Severe adverse events after cataract surgery among medicare beneficiaries.

PURPOSE: To determine rates and risk factors associated with severe postoperative complications after cataract surgery and whether they have been changing over the past decade. DESIGN: Retrospective longitudinal cohort study. PARTICIPANTS: A total of 221 594 Medicare beneficiaries who underwent cataract surgery during 1994-2006. METHODS: Beneficiaries were stratified into 3 cohorts: those who underwent initial cataract surgery during 1994-1995, 1999-2000, or 2005-2006. One-year rates of postoperative severe adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) were determined for each cohort. Cox regression analyses determined the hazard of developing severe adverse events for each cohort with adjustment for demographic factors, ocular and medical conditions, and surgeon case-mix. MAIN OUTCOME MEASURES: Time period rates of development of severe postoperative adverse events. RESULTS: Among the 221 594 individuals who underwent cataract surgery, 0.5% (1086) had at least 1 severe postoperative complication. After adjustment for confounders, individuals who underwent cataract surgery during 1994-1995 had a 21% increased hazard of being diagnosed with a severe postoperative complication (hazard ratio [HR] 1.21; 95% confidence interval [CI], 1.05-1.41) relative to individuals who underwent cataract surgery during 2005-2006. Those who underwent cataract surgery during 1999-2000 had a 20% increased hazard of experiencing a severe complication (HR 1.20; 95% CI, 1.04-1.39) relative to the 2005-2006 cohort. Risk factors associated with severe adverse events include a prior diagnosis of proliferative diabetic retinopathy (HR 1.62; 95% CI, 1.07-2.45) and cataract surgery combined with another intraocular surgical procedure on the same day (HR 2.51; 95% CI, 2.07-3.04). Individuals receiving surgery by surgeons with the case-mix least prone to developing a severe adverse event (HR 0.52; 95% CI, 0.44-0.62) had a 48% reduced hazard of a severe adverse event relative to recipients of cataract surgery performed by surgeons with the case-mix most prone to developing such outcomes. CONCLUSIONS: Rates of sight-threatening adverse events after cataract surgery declined during 1994-2006. Future efforts should be directed to identifying ways to reduce severe adverse events in high-risk groups.

Ocular complications after anti-vascular endothelial growth factor therapy in Medicare patients with age-related macular degeneration.

PURPOSE: To determine longitudinal rates of ocular complications after anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD) in a nationally representative longitudinal sample. DESIGN: Retrospective, longitudinal case-control study. METHODS: Using the Medicare 5% claims database, diagnoses of neovascular AMD and anti-VEGF injections of ranibizumab, bevacizumab, or pegaptanib were identified from International Classification of Diseases and Current Procedural Terminology procedure codes. Six thousand one hundred fifty-four individuals undergoing anti-VEGF treatment for neovascular AMD (total of 40 903 injections) were compared with 6154 matched controls with neovascular AMD who did not undergo anti-VEGF treatment. Propensity score matching was used to match individuals receiving anti-VEGF injections with controls. Rates of postinjection adverse outcomes (endophthalmitis, rhegmatogenous retinal detachment, retinal tear, uveitis, and vitreous hemorrhage) were analyzed by cumulative incidence and Cox proportional hazards model to control for demographic factors and ocular comorbidities. RESULTS: At the 2-year follow-up, the rates of endophthalmitis per injection (0.09%; P<.01), uveitis (0.11%; P<.01), and vitreous hemorrhage per injection (0.23%; P < .01) were significantly higher in the anti-VEGF treatment group. With Cox proportional hazards modeling, the anti-VEGF treatment group had a 102% higher risk of severe ocular complications overall and a 4% increased risk per injection, both of which were statistically significant (P<.01). CONCLUSIONS: Rates of endophthalmitis, uveitis, and vitreous hemorrhage were higher in the group treated with anti-VEGF injection than in the control group, although these nevertheless were rare in both groups. The overall risk of severe ocular complications was significantly higher in the anti-VEGF treatment group.

Risk of glaucoma among patients with benign essential blepharospasm.

PURPOSE: Debate exists whether intraocular pressure fluctuation is a risk factor for glaucoma. Patients with benign essential blepharospasm (BEB) experience intermittent, ultra-short-term intraocular pressure elevations from frequent blinking and spastic eyelid closure. This article explores the development of incident glaucoma after BEB diagnosis. METHODS: Medicare claims files were used to identify patients with a diagnosis of BEB from 1994 to 2000. An equal-sized control group consisting of patients without BEB was created using one-to-one propensity score matching. The patients with BEB and those in the control group were followed for the development of one of the following main outcome measures: primary open angle glaucoma (POAG), closed angle glaucoma (CAG), or other glaucoma (besides POAG and CAG) over the following 2,190 days. RESULTS: There were 1,350 persons in each group, consisting of 29% men, 94% of whom were white, with a mean age of 76 years. In the unadjusted model, BEB patients did not develop POAG (hazard ratio [HR], 1.159; 95% confidence interval [CI], 0.876-1.534), CAG (HR, 1.477; 95% CI, 0.711-3.066), or other glaucoma (HR, 1.306; 95% CI, 0.904-1.886) more often than controls. Adjusting for age, gender, race, number of visits to the ophthalmologist, and other eye disease, a diagnosis of BEB did not affect the risk of POAG (HR, 1.152; 95% CI, 0.870-1.525), CAG (HR, 1.448; 95% CI, 0.696-3.015), or other glaucoma (HR, 1.296; 95% CI, 0.896-1.873). CONCLUSIONS: BEB is not a risk indicator for POAG, CAG, or other forms of glaucoma.

One-year outcomes after retinal detachment surgery among medicare beneficiaries.

PURPOSE: To determine longitudinal rates of second retinal detachment operation and postoperative adverse outcomes after retinal detachment surgery in a nationally representative sample of older Americans. DESIGN: Retrospective, longitudinal cohort analysis. METHODS: A total of 9216 Medicare beneficiaries were identified from the Medicare 5% sample who were diagnosed with rhegmatogenous retinal detachment and underwent primary pars plana vitrectomy (PPV), scleral buckle, pneumatic retinopexy, or laser photocoagulation or cryotherapy alone. Rhegmatogenous retinal detachment, PPV, scleral buckle, pneumatic retinopexy, or laser photocoagulation/cryotherapy was ascertained from International Classification of Diseases and Current Procedural Terminology procedure codes. Rates of second retinal detachment operation and postoperative adverse outcomes were analyzed by cumulative incidence and logistic regression to control for prior adverse outcome measures and demographic factors. RESULTS: At 1-year follow-up, the rate of receipt of a second retinal detachment operation for beneficiaries who had undergone primary pneumatic retinopexy was much higher (40.6%, P < .0001) relative to the scleral buckle (19.2%) group. After controlling for demographic variables and ocular comorbidities, pneumatic retinopexy individuals were nearly 3 times more likely to receive a second retinal detachment surgery than scleral buckle individuals. No significant differences exist in risk of second retinal detachment surgery for the PPV compared to the scleral buckle group. Individuals receiving PPV were 2 times more likely to suffer adverse outcomes than were those undergoing scleral buckle. Results were robust in sensitivity analysis. CONCLUSIONS: Rates of second operation were much higher after pneumatic retinopexy than PPV or scleral buckle, and rates of adverse outcomes were higher in PPV, even after controlling for risk factors and demographic variables.