Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

AbstractObjectiveTo assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use.Study DesignNulliparous and parous women aged 16–45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16–35 years calculated as the Pearl Index. Women aged 36–45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study.ResultsA total of 1600 women aged 16–35 years and 151 women aged 36–45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02–0.55) through Year 1, 0.26 (95% CI 0.10–0.57) through Year 2, and 0.22 (95% CI 0.08–0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24–1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints.ConclusionThe LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women.Implications statementA new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years

Rural and Urban Differences in the Adoption of New Health Information and Medical Technologies

Background This statewide survey sought to understand the adoption level of new health information and medical technologies, and whether these patterns differed between urban and rural populations. Methods A random sample of 7,979 people aged 18‐75 years, stratified by rural status and race, who lived in 1 of 34 Indiana counties with high cancer mortality rates and were seen at least once in the past year in a statewide health system were surveyed. Results Completed surveys were returned by 970 participants. Rural patients were less likely than urban to use electronic health record messaging systems (28.3% vs 34.5%, P = .045) or any communication technology (43.0% vs 50.8%, P = .017). Rural patients were less likely to look for personal health information for someone else's medical record (11.0% vs 16.3%, P = .022), look‐up test results (29.5% vs 38.3%, P = .005), or use any form of electronic medical record (EMR) access (57.5% vs 67.1%, P = .003). Rural differences in any use of communication technology or EMRs were no longer significant in adjusted models, while education and income were significantly associated. There was a trend in the higher use of low‐dose computed tomography (CT) scan among rural patients (19.1% vs 14.4%, P = .057). No significant difference was present between rural and urban patients in the use of the human papilloma virus test (27.1% vs 26.6%, P = .880). Conclusions Differences in health information technology use between rural and urban populations may be moderated by social determinants. Lower adoption of new health information technologies (HITs) than medical technologies among rural, compared to urban, individuals may be due to lower levels of evidence supporting HITs

Validity of self-reported history of Chlamydia trachomatis infection

BACKGROUND: Chlamydia trachomatis infection is common and largely asymptomatic in women. If untreated, it can lead to sequelae such as pelvic inflammatory disease and infertility. It is unknown whether a patient's self-reported history of Chlamydia trachomatis infection is a valid marker of past infection. OBJECTIVE: Our objective was to evaluate the validity of women's self-reported history of Chlamydia trachomatis infection compared with Chlamydia trachomatis serology, a marker for previous infection. STUDY DESIGN: We analyzed data from the Fertility After Contraception Termination study. We compared participants' survey responses with the question, "Have you ever been told by a health care provider that you had Chlamydia?" to serological test results indicating the presence or absence of antibodies to Chlamydia trachomatis as assessed by a microimmunofluorescence assay. Prevalence of past infection, sensitivity, specificity, predictive values, and likelihood ratios were calculated. The Cohen's kappa statistic was computed to assess agreement between self-report and serology. RESULTS: Among 409 participants, 108 (26%) reported having a history of Chlamydia trachomatis infection, whereas 146 (36%) had positive serological test results. Relative to positive microimmunofluorescence assay, the sensitivity and specificity of self-reported history of Chlamydia trachomatis infection were 52.1% (95% confidence interval, 43.6-60.4%) and 87.8% (95% confidence interval, 83.3-91.5%), respectively. The positive predictive value of the self-report was 70.4% (95% confidence interval, 60.8-78.8%), and the negative predictive value was 76.7% (95% confidence interval, 71.6-81.4%). The likelihood ratio was found to be 4.28. Agreement between self-report and serology was found to be moderate (kappa = 0.42, P < .001). CONCLUSION: Self-reported history of Chlamydia trachomatis infection commonly yields false-negative and false-positive results. When definitive status of past Chlamydia trachomatis infection is needed, serology should be obtained

Racial and Socioeconomic Disparities in Cancer-Related Knowledge, Beliefs, and Behaviors in Indiana

Background: This statewide survey examined differences in cancer-related knowledge, beliefs, and behaviors between racial and socioeconomic groups in select counties in Indiana. Methods: A stratified random sample of 7,979 people aged 18–75 who lived in one of 34 Indiana counties with higher cancer mortality rates than the state average, and were seen at least once in the past year in a statewide health system were mailed surveys. Results: Completed surveys were returned by 970 participants, yielding a 12% response rate. Black respondents were less likely to perceive they were at risk for cancer and less worried about getting cancer. Individuals most likely to perceive that they were unlikely to get cancer were more often black, with low incomes (less than $20,000) or high incomes ($50,000 or more), or less than a high school degree. Black women were greater than six times more likely to be adherent to cervical cancer screening. Higher income was associated with receiving a sigmoidoscopy in the last 5 years and a lung scan in the past year. Those with the highest incomes were more likely to engage in physical activity. Both income and education were inversely related to smoking. Conclusions: Socioeconomic and racial disparities were observed in health behaviors and receipt of cancer screening. Black individuals had less worry about cancer. Impact: Understanding populations for whom cancer disparities exist and geographic areas where the cancer burden is disproportionately high is essential to decision-making about research priorities and the use of public health resources

The methodology for developing a prospective meta-analysis in the family planning community

<p>Abstract</p> <p>Background</p> <p>Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration agree upon specific research interventions and outcome measures, ideally before initiation but at least prior to any individual trial publishing results. This allows for uniform reporting of primary and secondary outcomes. With this approach, heterogeneity among trials contributing data for the final meta-analysis is minimized while each site maintains the freedom to design a specific trial. This paper describes the process of creating a PMA collaboration to evaluate the impact of misoprostol on ease of intrauterine device (IUD) insertion in nulliparous women.</p> <p>Methods</p> <p>After the principal investigator developed a preliminary PMA protocol, he identified potential collaborating investigators at other sites. One site already had a trial underway and another site was in the planning stages of a trial meeting PMA requirements. Investigators at six sites joined the PMA collaborative. Each site committed to enroll subjects to meet a pre-determined total sample size. A final common research plan and site responsibilities were developed and agreed upon through email and face-to-face meetings. Each site committed to contribute individual patient data to the PMA collaboration, and these data will be analyzed and prepared as a multi-site publication. Individual sites retain the ability to analyze and publish their site's independent findings.</p> <p>Results</p> <p>All six sites have obtained Institutional Review Board approval and each has obtained individual funding to meet the needs of that site's study. Sites have shared resources including study protocols and consents to decrease costs and improve study flow. This PMA protocol is registered with the Cochrane Collaboration and data will be analyzed according to Cochrane standards for meta-analysis.</p> <p>Conclusions</p> <p>PMA is a novel research method that improves meta-analysis by including several study sites, establishing uniform reporting of specific outcomes, and yet allowing some independence on the part of individual sites with respect to the conduct of research. The inclusion of several sites increases statistical power to address important clinical questions. Compared to multi-center trials, PMA methodology encourages collaboration, aids in the development of new investigators, decreases study costs, and decreases time to publication.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00613366">NCT00613366</a>, <a href="http://www.clinicaltrials.gov/ct2/show/NCT00886834">NCT00886834</a>, <a href="http://www.clinicaltrials.gov/ct2/show/NCT01001897">NCT01001897</a>, <a href="http://www.clinicaltrials.gov/ct2/show/NCT01147497">NCT01147497</a> and <a href="http://www.clinicaltrials.gov/ct2/show/NCT01307111">NCT01307111</a></p

Patient Views on Religious Institutional Health Care

Importance: Federal protections allow health facilities to limit options to patients on the basis of religious values. Little is known about whether US adults consider religious affiliation when selecting facilities and whether they agree with such limitations. Objective: To understand patient views on religious institutional care. Design, Setting, and Participants: This is a population-based, cross-sectional survey study of US adults recruited from the probability-based AmeriSpeak Omnibus panel available from NORC (formerly the National Opinion Research Center) at the University of Chicago. Surveys were administered via internet or telephone during a 3-day fielding period in November 2017. Data analysis was performed from January 2018 to October 2019. Exposures: Participant characteristics, including religiosity measures. Main Outcomes and Measures: Whether patients consider religious affiliation when selecting a health care facility and their views on whether an institution's religious values should take precedence over their health choices. Responses were compared by gender. When gender differences existed, regression models were performed, and thematic content analysis was applied to open-ended responses. Results: There were 1446 participants (745 [51.5%] male; mean [SD] age, 46 [17] years), for a survey completion rate of 24.5% and weighted cumulative response weight of 7.3%. Most respondents (62.6%) were white, and the most common religion was Protestant (28.2%). When specifically asked, only 6.4% reported that they considered religious affiliation when selecting a health care facility; most participants (71.3%) reported when selecting a health care facility that they did not care whether it is religiously affiliated, 13.4% preferred a religious affiliation, and 15.3% preferred no religious affiliation. There were no gender differences. Most participants (71.4%) believed that their health choices should take priority over an institution's religious affiliation in services offered, and this was more common for women than for men (74.9% vs 68.1%; difference, 6.8%; 95% CI, 5.6%-8.2%; P = .005), who more commonly endorsed concerns for personal choice and autonomy over one's own body. Conclusions and Relevance: This study suggests that most patients value their personal choices, yet do not consider an institution's religious affiliation when choosing their source of health care. Women placed greater emphasis on their autonomy in comparison with an institution's right to invoke religious restrictions to care. Given the growth in ownership of health care facilities by religious entities in the United States and increasing attention to conscientious objections, these findings point to a need for advocacy and legislation that effectively balances protections for religious institutions with protections for patients.</p