BackgroundObservational epidemiologic studies provide critical data for the evaluation of the potential effects of environmental, occupational and behavioural exposures on human health. Systematic reviews of these studies play a key role in informing policy and practice. Systematic reviews should incorporate assessments of the risk of bias in results of the included studies.ObjectiveTo develop a new tool, Risk Of Bias In Non-randomized Studies - of Exposures (ROBINS-E) to assess risk of bias in estimates from cohort studies of the causal effect of an exposure on an outcome.Methods and resultsROBINS-E was developed by a large group of researchers from diverse research and public health disciplines through a series of working groups, in-person meetings and pilot testing phases. The tool aims to assess the risk of bias in a specific result (exposure effect estimate) from an individual observational study that examines the effect of an exposure on an outcome. A series of preliminary considerations informs the core ROBINS-E assessment, including details of the result being assessed and the causal effect being estimated. The assessment addresses bias within seven domains, through a series of ‘signalling questions’. Domain-level judgements about risk of bias are derived from the answers to these questions, then combined to produce an overall risk of bias judgement for the result, together with judgements about the direction of bias.ConclusionROBINS-E provides a standardized framework for examining potential biases in results from cohort studies. Future work will produce variants of the tool for other epidemiologic study designs (e.g. case-control studies). We believe that ROBINS-E represents an important development in the integration of exposure assessment, evidence synthesis and causal inference.

Importance Telemedicine use was common during the COVID-19 pandemic, expanding many patients' approaches to accessing health care. Of concern is whether telemedicine access was poorer among higher-needs and disadvantaged populations. Objective To assess patient characteristics associated with telemedicine use and telemedicine mode and describe telemedicine visit experiences by telemedicine mode. Design, Setting, and Participants This cross-sectional study included data from the 2022 Health Information National Trends Survey and included US adults with a health care visit. Data were analyzed from May to September 2023. Exposure Patient characteristics. Main Outcomes and Measures Any telemedicine visits vs in-person visits only; telemedicine mode (video vs audio-only). Multivariable logistic models assessed patient characteristics associated with telemedicine visits and mode. Bivariate analyses compared telemedicine experiences by mode. Results The study included 5437 adult patients (mean [SE] age, 49.4 [0.23] years; 3136 females [53.4%]; 1928 males [46.6%]). In 2022, 2384 patients (43%) had a telemedicine visit; 1565 (70%) had a video visit while 819 (30%) had an audio-only visit. In multivariable models, older age (>= 75 years: adjusted odds ratio [aOR], 0.63; 95% CI, 0.42-0.94), no internet use (aOR, 0.62; 95% CI, 0.48-0.81), and living in the Midwest (aOR, 0.50; 95% CI, 0.35-0.70) were negatively associated with having telemedicine visits. Female sex (aOR, 1.43; 95% CI, 1.12-1.83), having chronic conditions (aOR, 2.13; 95% CI, 1.66-2.73), and multiple health care visits (2-4 visits: aOR, 1.77; 95% CI, 1.23-2.54; >= 5 visits: aOR, 3.29; 95% CI, 2.20-4.92) were positively associated. Among individuals who used telemedicine, older age (65-74 years: aOR, 2.13; 95% CI, 1.09-4.14; >= 75 years: aOR, 3.58; 95% CI, 1.60-8.00), no health insurance (aOR, 2.84; 95% CI, 1.42-5.67), and no internet use (aOR, 2.11; 95% CI, 1.18-3.78) were positively associated with having audio-only visits. We observed no significant differences in telemedicine use or mode by education, race and ethnicity, or income. Patients' experiences using telemedicine were generally similar for video and audio-only except more individuals who used audio-only had privacy concerns (20% vs 12%, P = .02). Conclusions and Relevance In this cross-sectional study of adults with health care visits, many patients, including those with the greatest care needs, chose telemedicine even after in-person visits were available. These findings support continuing this care delivery approach as an option valued by patients. Differences were not observed by most common measures of socioeconomic status. Continued monitoring of telemedicine use is needed to ensure equitable access to health care innovations.

BACKGROUND:Individuals with limited English proficiency (LEP) have long faced barriers in navigating the health care system. More information is needed to understand whether their care was limited further during the early period of the COVID-19 pandemic. OBJECTIVE:To assess the impact of English proficiency on delayed and forgone health care during the early COVID-19 pandemic. RESEARCH DESIGN:Multivariate logistic regression analysis of National Health Interview Survey data (July-December 2020; n=16,941). Outcomes were self-reported delayed and forgone health care because of cost or the COVID-19 pandemic. Delayed health care included medical, dental, mental health, and pharmacy care. Forgone health care also included care at home from a health professional. RESULTS:A greater percentage of LEP adults reported delayed (49%) and forgone (41%) health care than English-proficient adults (40% and 30%, respectively). However, English proficiency was not significantly associated with delayed or forgone health care, after adjusting for demographic, socioeconomic, and health factors. Among LEP adults, multivariate models showed that being uninsured, having a disability, and having chronic conditions increased the risk of delaying and forgoing health care. LEP adults of Asian race and Hispanic ethnicity were also more likely to forgo health care while those with 65+ years were less likely to forgo health care. CONCLUSIONS:Adults with LEP were more likely to experience challenges accessing health care early in the pandemic. Delayed and forgone health care were explained by low socioeconomic status and poor health. These findings highlight how during a period of limited health resources, deficiencies in the health care system resulted in an already disadvantaged group being at greater risk of inequitable access to care.

BackgroundThe unprecedented use of telemedicine during the COVID-19 pandemic provided an opportunity to examine its uptake among individuals with limited English proficiency (LEP).ObjectiveTo assess telemedicine use among nonelderly adults with LEP and the association between use of telehealth and emergency department (ED) and hospital visits.DesignCross-sectional study using the National Health Interview Survey (July 2020-December 2021)ParticipantsAdults (18-64 years), with LEP (N=1488) or English proficiency (EP) (N=25,873)Main MeasuresTelemedicine, ED visits, and hospital visits in the past 12 months. We used multivariate logistic regression to assess (1) the association of English proficiency on having telemedicine visits; and (2) the association of English proficiency and telemedicine visits on having ED and hospital visits.Key ResultsBetween July 2020 and December 2021, 22% of adults with LEP had a telemedicine visit compared to 35% of adults with EP. After controlling for predisposing, enabling, and need factors, adults with LEP had 20% lower odds of having a telemedicine visit than adults with EP (p=0.02). While English proficiency was not associated with ED or hospital visits during this time, adults with telemedicine visits had significantly greater odds of having any ED (aOR: 1.80, p<0.001) and hospital visits (aOR: 2.03, p<0.001) in the past 12 months.ConclusionsWhile telemedicine use increased overall during the COVID-19 pandemic, its use remained much less likely among adults with LEP. Interventions targeting structural barriers are needed to address disparities in access to telemedicine. More research is needed to understand the relationship between English proficiency, telemedicine visits, and downstream ED and hospital visits.

ImportanceEating disorders are associated with adverse health and social outcomes.ObjectiveTo review the evidence on screening for eating disorders in adolescents and adults to inform the US Preventive Services Task Force.Data SourcesMEDLINE, Cochrane Library, PsycINFO, and trial registries through December 19, 2020; surveillance through January 1, 2022.Study SelectionEnglish-language studies of screening test accuracy, randomized clinical trials (RCTs) of screening or interventions for eating disorders in populations with screen-detected or previously untreated eating disorders (trials limited to populations who are underweight were ineligible).Data Extraction and SynthesisDual review of abstracts, full-text articles, and study quality. Meta-analysis of test accuracy studies and intervention trials.Main Outcomes and MeasuresTest accuracy, eating disorder symptom severity, quality of life, depression, and harms.ResultsFifty-seven studies were included (N = 10 773); 3 (n = 1073) limited to adolescents (mean or median age, 14-15 years). No study directly evaluated the benefits and harms of screening. Seventeen studies (n = 6804) evaluated screening test accuracy. The SCOFF questionnaire (cut point ≥2) had a pooled sensitivity of 84% (95% CI, 74% to 90%) and pooled specificity of 80% (95% CI, 65% to 89%) in adults (10 studies, n = 3684). Forty RCTs (n = 3969) evaluated interventions for eating disorders; none enrolled a screen-detected population. Lisdexamfetamine for binge eating disorder (4 RCTs; n = 900) was associated with larger reductions in eating disorder symptom severity on the Yale-Brown Obsessive Compulsive Scale modified for binge eating (YBOCS-BE) than placebo (pooled mean difference, -5.75 [95% CI, -8.32 to -3.17]). Two RCTs (n = 465) of topiramate for binge eating disorder found larger reductions in YBOCS-BE scores associated with topiramate than placebo, from -6.40 (95% CI, -8.16 to -4.64) to -2.55 (95% CI, -4.22 to -0.88). Nine pharmacotherapy trials (n = 2006) reported on harms. Compared with placebo, lisdexamfetamine was associated with higher rates of dry mouth, headache, and insomnia, and topiramate was associated with higher rates of paresthesia, taste perversion, confusion, and concentration difficulty. Twenty-four trials (n = 1644) assessed psychological interventions. Guided self-help for binge eating disorder improved eating disorder symptom severity more than control (pooled standardized mean difference, -0.96 [95% CI, -1.26 to -0.67]) (5 studies, n = 391). Evidence on other interventions was limited.Conclusions and RelevanceNo studies directly assessed the benefits and harms of screening. The SCOFF questionnaire had adequate accuracy for detecting eating disorders among adults. No treatment trials enrolled screen-detected populations; guided self-help, lisdexamfetamine, and topiramate were effective for reducing eating disorder symptom severity among referred populations with binge eating disorder, but pharmacotherapies were also associated with harms.

Chronic disease patients who are the greatest users of healthcare services are often referred to as high-need, high-cost (HNHC). Payers, providers, and policymakers in the United States are interested in identifying interventions that can modify or reduce preventable healthcare use among these patients, without adversely impacting their quality of care and health. We systematically reviewed the evidence on the effectiveness of complex interventions designed to change the healthcare of HNHC patients, modifying cost and utilization, as well as clinical/functional, and social risk factor outcomes. We searched 8 electronic databases (January 2000 to March 2021) and selected non-profit organization and government agency websites for randomized controlled trials and observational studies with comparison groups that targeted HNHC patients. Two investigators independently screened each study and abstracted data into structured forms. Study quality was assessed using standard risk of bias tools. Random-effects meta-analysis was conducted for outcomes reported by at least 3 comparable samples. Forty studies met our inclusion criteria. Interventions were heterogenous and classified into 7 categories, reflecting the predominant service location/modality (home, primary care, ambulatory intensive caring unit [aICU], emergency department [ED], community, telephonic/mail, and system-level). Home-, primary care-, and ED-based interventions resulted in reductions in high-cost healthcare services (ED and hospital use). ED-based interventions also resulted in greater use of primary care. Primary care- and ED-based interventions reduced costs. System-level transformation interventions did not reduce costs. We found limited evidence of intervention effectiveness in relation to cost and use, and additional evidence is needed to strengthen our confidence in the findings. Few studies reported patient clinical/functional or social risk factor outcomes (e.g., homelessness) or sufficient details for determining why individual interventions work, for whom, and when. Future evaluations could provide additional insights, by including intermediate process outcomes and patients’ experiences, in assessing the impact of these complex interventions. CRD42020161179

Background: Accurately identifying high-need, high-cost (HNHC) patients to reduce their preventable or modifiable health care use for their chronic conditions is a priority and a challenge for U.S. policymakers, health care delivery systems, and payers. Purpose: To identify characteristics and criteria to distinguish HNHC patients. Data Sources: Searches of multiple databases and gray literature from 1 January 2000 to 22 January 2022. Study Selection: English-language studies of characteristics and criteria to identify HNHC adult patients, defined as those with high use (emergency department, inpatient, or total services) or high cost. Data Extraction: Independent, dual-review extraction and quality assessment. Data Synthesis: The review included 64 studies comprising multivariate exposure studies (n = 47), cluster analyses (n = 11), and qualitative studies (n = 6). A National Academy of Medicine (NAM) taxonomy was an initial "best-fit" framework for organizing the synthesis of the findings. Patient characteristics associated with being HNHC included number and severity of comorbid conditions and having chronic clinical conditions, particularly heart disease, chronic kidney disease, chronic lung disease, diabetes, cancer, and hypertension. Patients' risk for being HNHC was often amplified by behavioral health conditions and social risk factors. The reviewers revised the NAM taxonomy to create a final framework, adding chronic pain and prior patterns of high health care use as characteristics associated with an increased risk for being HNHC. Limitation: Little evidence distinguished potentially preventable or modifiable health care use from overall use. Conclusion: A combination of characteristics can be useful for identifying HNHC patients. Because of the complexity of their conditions and circumstances, improving their quality of care will likely also require an individualized assessment of care needs and availability of support services.

Background: Accurately identifying high-need, high-cost (HNHC) patients to reduce their preventable or modifiable health care use for their chronic conditions is a priority and a challenge for U.S. policymakers, health care delivery systems, and payers. Purpose: To identify characteristics and criteria to distinguish HNHC patients. Data Sources: Searches of multiple databases and gray literature from 1 January 2000 to 22 January 2022. Study Selection: English-language studies of characteristics and criteria to identify HNHC adult patients, defined as those with high use (emergency department, inpatient, or total services) or high cost. Data Extraction: Independent, dual-review extraction and quality assessment. Data Synthesis: The review included 64 studies comprising multivariate exposure studies (n = 47), cluster analyses (n = 11), and qualitative studies (n = 6). A National Academy of Medicine (NAM) taxonomy was an initial "best-fit" framework for organizing the synthesis of the findings. Patient characteristics associated with being HNHC included number and severity of comorbid conditions and having chronic clinical conditions, particularly heart disease, chronic kidney disease, chronic lung disease, diabetes, cancer, and hypertension. Patients' risk for being HNHC was often amplified by behavioral health conditions and social risk factors. The reviewers revised the NAM taxonomy to create a final framework, adding chronic pain and prior patterns of high health care use as characteristics associated with an increased risk for being HNHC. Limitation: Little evidence distinguished potentially preventable or modifiable health care use from overall use. Conclusion: A combination of characteristics can be useful for identifying HNHC patients. Because of the complexity of their conditions and circumstances, improving their quality of care will likely also require an individualized assessment of care needs and availability of support services. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42020161179)

Objective Payers, providers and policymakers in the USA are interested in developing interventions that reduce preventable or modifiable healthcare use among high-need, high-cost (HNHC) patients. This study seeks to describe how and why complex interventions for HNHC patients lead to more appropriate use of healthcare services. Design A realist review which develops programme theories from causal explanations generated and articulated through the creation of context–mechanism–outcome configurations. Methods Electronic databases (including PubMed and Embase) and gray literature from January 2000 to March 2021 were searched. All study designs were included if the article provided data to develop our programme theories. Included studies were conducted in the USA and focused on interventions for adult, HNHC patients. Results Data were synthesised from 48 studies. Identifying HNHC patients for inclusion in interventions requires capturing a combination of characteristics including their prior use of healthcare services, complexity of chronic disease(s) profile, clinician judgment and willingness to participate. Once enrolled, engaging HNHC patients in interventions requires intervention care providers and patients to build a trusting relationship. Tailored, individualised assistance for medical and non-medical needs, emotional support and self-management education empowers patients to increase their participation in managing their own care. Engagement of care providers in interventions to expand support of HNHC patients is facilitated by targeted outreach, adequate staffing support with shared values and regular and open communication. Conclusions Building relationships with HNHC patients and gaining their trust is a key component for interventions to successfully change HNHC patients’ behaviors. Identifying HNHC patients for an intervention can be best achieved through a multipronged strategy that accounts for their clinical and psychosocial complexity and prior experiences with the healthcare system. Successful interventions recognise that relationships with HNHC patients require the sustained engagement of care providers. To succeed, providers need ongoing emotional, financial, logistical and practical resources. PROSPERO registration number CRD42020161179.

Background. In the United States, patients referred to as high-need, high-cost (HNHC) constitute a very small percentage of the patient population but account for a disproportionally high level of healthcare use and cost. Payers, health systems, and providers would like to improve the quality of care and health outcomes for HNHC patients and reduce their costly use of potentially preventable or modifiable healthcare services, including emergency department (ED) and hospital visits. Methods. We assessed evidence of criteria that identify HNHC patients (best fit framework synthesis); developed program theories on the relationship among contexts, mechanisms, and outcomes of interventions intended to change HNHC patient behaviors (realist review); and assessed the effectiveness of interventions (systematic review). We searched databases, gray literature, and other sources for evidence available from January 1, 2000, to March 4, 2021. We included quantitative and qualitative studies of HNHC patients (high healthcare use or cost) age 18 and over who received intervention services in a variety of settings. Results. We included 110 studies (117 articles). Consistent with our best fit framework, characteristics associated with HNHC include patient chronic clinical conditions, behavioral health factors including depression and substance use disorder, and social risk factors including homelessness and poverty. We also identified prior healthcare use and race as important predictors. We found limited evidence of approaches for distinguishing potentially preventable or modifiable high use from all high use. To understand how and why interventions work, we developed three program theories in our realist review that explain (1) targeting HNHC patients, (2) engaging HNHC patients, and (3) engaging care providers in these interventions. Theories identify the need for individualizing and tailoring services for HNHC patients and the importance of building trusting relationships. For our systematic review, we categorized evidence based on primary setting. We found that ED-, primary care–, and home-based care models result in reduced use of healthcare services (moderate to low strength of evidence [SOE]); ED, ambulatory intensive caring unit, and primary care-based models result in reduced costs (low SOE); and system-level transformation and telephonic/mail models do not result in changes in use or costs (low SOE). Conclusions. Patient characteristics can be used to identify patients who are potentially HNHC. Evidence focusing specifically on potentially preventable or modifiable high use was limited. Based on our program theories, we conclude that individualized and tailored patient engagement and resources to support care providers are critical to the success of interventions. Although we found evidence of intervention effectiveness in relation to cost and use, the studies identified in this review reported little information for determining why individual programs work, for whom, and when.

Background. Untreated maternal mental health disorders can have devastating sequelae for the mother and child. For women who are currently or planning to become pregnant or are breastfeeding, a critical question is whether the benefits of treating psychiatric illness with pharmacologic interventions outweigh the harms for mother and child. Methods. We conducted a systematic review to assess the benefits and harms of pharmacologic interventions compared with placebo, no treatment, or other pharmacologic interventions for pregnant and postpartum women with mental health disorders. We searched four databases and other sources for evidence available from inception through June 5, 2020 and surveilled the literature through March 2, 2021; dually screened the results; and analyzed eligible studies. We included studies of pregnant, postpartum, or reproductive-age women with a new or preexisting diagnosis of a mental health disorder treated with pharmacotherapy; we excluded psychotherapy. Eligible comparators included women with the disorder but no pharmacotherapy or women who discontinued the pharmacotherapy before pregnancy. Results. A total of 164 studies (168 articles) met eligibility criteria. Brexanolone for depression onset in the third trimester or in the postpartum period probably improves depressive symptoms at 30 days (least square mean difference in the Hamilton Rating Scale for Depression, -2.6; p=0.02; N=209) when compared with placebo. Sertraline for postpartum depression may improve response (calculated relative risk [RR], 2.24; 95% confidence interval [CI], 0.95 to 5.24; N=36), remission (calculated RR, 2.51; 95% CI, 0.94 to 6.70; N=36), and depressive symptoms (p-values ranging from 0.01 to 0.05) when compared with placebo. Discontinuing use of mood stabilizers during pregnancy may increase recurrence (adjusted hazard ratio [AHR], 2.2; 95% CI, 1.2 to 4.2; N=89) and reduce time to recurrence of mood disorders (2 vs. 28 weeks, AHR, 12.1; 95% CI, 1.6 to 91; N=26) for bipolar disorder when compared with continued use. Brexanolone for depression onset in the third trimester or in the postpartum period may increase the risk of sedation or somnolence, leading to dose interruption or reduction when compared with placebo (5% vs. 0%). More than 95 percent of studies reporting on harms were observational in design and unable to fully account for confounding. These studies suggested some associations between benzodiazepine exposure before conception and ectopic pregnancy; between specific antidepressants during pregnancy and adverse maternal outcomes such as postpartum hemorrhage, preeclampsia, and spontaneous abortion, and child outcomes such as respiratory issues, low Apgar scores, persistent pulmonary hypertension of the newborn, depression in children, and autism spectrum disorder; between quetiapine or olanzapine and gestational diabetes; and between benzodiazepine and neonatal intensive care admissions. Causality cannot be inferred from these studies. We found insufficient evidence on benefits and harms from comparative effectiveness studies, with one exception: one study suggested a higher risk of overall congenital anomalies (adjusted RR [ARR], 1.85; 95% CI, 1.23 to 2.78; N=2,608) and cardiac anomalies (ARR, 2.25; 95% CI, 1.17 to 4.34; N=2,608) for lithium compared with lamotrigine during first- trimester exposure. Conclusions. Few studies have been conducted in pregnant and postpartum women on the benefits of pharmacotherapy; many studies report on harms but are of low quality. The limited evidence available is consistent with some benefit, and some studies suggested increased adverse events. However, because these studies could not rule out underlying disease severity as the cause of the association, the causal link between the exposure and adverse events is unclear. Patients and clinicians need to make an informed, collaborative decision on treatment choices.

The authors systematically reviewed evidence on pharmacotherapy for perinatal mental health disorders. The authors searched for studies of pregnant, postpartum, or reproductive-age women with mental health disorders treated with pharmacotherapy in MEDLINE, EMBASE, PsycINFO, the Cochrane Library, and trial registries from database inception through June 5, 2020 and surveilled literature through March 2, 2021. Outcomes included symptoms; functional capacity; quality of life; suicidal events; death; and maternal, fetal, infant, or child adverse events. 164 studies were included. Regarding benefits, brexanolone for third-trimester or postpartum depression onset may be associated with improved depressive symptoms at 30 days when compared with placebo. Sertraline for postpartum depression may be associated with improved response, remission, and depressive symptoms when compared with placebo. Discontinuing mood stabilizers during pregnancy may be associated with increased recurrence of mood episodes for bipolar disorder. Regarding adverse events, most studies were observational and unable to fully account for confounding. Evidence on congenital and cardiac anomalies for treatment compared with no treatment was inconclusive. Brexanolone for depression onset in the third trimester or the postpartum period may be associated with risk of sedation or somnolence, leading to dose interruption or reduction when compared with placebo. Evidence from few studies supports the use of pharmacotherapy for perinatal mental health disorders. Although many studies report on adverse events, they could not rule out underlying disease severity as the cause of the association between exposures and adverse events. Patients and clinicians need to make informed, collaborative decisions on treatment choices.

Bacterial vaginosis is common and is caused by a disruption of the microbiological environment in the lower genital tract. In the US, reported prevalence of bacterial vaginosis among pregnant women ranges from 5.8% to 19.3% and is higher in some races/ethnicities. Bacterial vaginosis during pregnancy has been associated with adverse obstetrical outcomes including preterm delivery, early miscarriage, postpartum endometritis, and low birth weight.To update its 2008 recommendation, the USPSTF commissioned a review of the evidence on the accuracy of screening and the benefits and harms of screening for and treatment of bacterial vaginosis in asymptomatic pregnant persons to prevent preterm delivery.This recommendation applies to pregnant persons without symptoms of bacterial vaginosis.The USPSTF concludes with moderate certainty that screening for asymptomatic bacterial vaginosis in pregnant persons not at increased risk for preterm delivery has no net benefit in preventing preterm delivery. The USPSTF concludes that for pregnant persons at increased risk for preterm delivery, the evidence is conflicting and insufficient, and the balance of benefits and harms cannot be determined.The USPSTF recommends against screening for bacterial vaginosis in pregnant persons not at increased risk for preterm delivery. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in pregnant persons at increased risk for preterm delivery. (I statement).

This systematic review to support the 2020 US Preventive Services Task Force Recommendation Statement on screening for bacterial vaginosis (BV) summarizes published evidence on the benefits and harms of BV screening and treatment in pregnant adolescents and adults to prevent preterm delivery. Importance Preterm delivery results in adverse outcomes; identifying and treating bacterial vaginosis may reduce its occurrence. Objective To update the evidence on screening and treatment of asymptomatic bacterial vaginosis in pregnancy for the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, and trial registries through May 29, 2019; bibliographies from retrieved articles, experts, and surveillance of the literature through December 31, 2019. Study Selection Fair- or good-quality English-language studies evaluating diagnostic accuracy of tests feasible within primary care; randomized clinical trials (RCTs); nonrandomized controlled intervention studies (for harms only); or meta-analyses of metronidazole or clindamycin. Data Extraction and Synthesis Two reviewers independently assessed titles/abstracts and full-text articles, extracted data, and assessed study quality; when at least 3 similar studies were available, meta-analyses were conducted. Main Outcomes and Measures Sensitivity, specificity, preterm delivery, maternal adverse effects, congenital birth defects, childhood cancer. Results Forty-four studies (48 publications) were included. No studies evaluated the benefits or harms of screening. Twenty-five studies (n = 15 785) evaluated the accuracy of screening tests; across individual studies and tests, sensitivity ranged from 0.36 to 1.0 and specificity ranged from 0.49 to 1.0. Among trials reporting findings from general obstetric populations (n = 7953), no significant association was observed between treatment and spontaneous delivery before 37 weeks (pooled absolute risk difference [ARD], -1.44% [95% CI, -3.31% to 0.43%]; 8 RCTs, n = 7571) or any delivery before 37 weeks (pooled ARD, 0.20% [95% CI, -1.13% to 1.53%]; 6 RCTs, n = 6307). Among 5 trials reporting findings among women with a prior preterm delivery, findings were inconsistent; 3 showed a significant beneficial effect, while 2 did not. Maternal adverse events from treatment were infrequent and minor (eg, candidiasis) but were slightly more common with active treatment compared with placebo across 8 RCTs. Two meta-analyses of observational studies reported no significant association between metronidazole exposure and congenital malformations (odds ratio, 0.96 [95% CI, 0.75 to 1.22]; odds ratio, 1.08 [95% CI, 0.90 to 1.29]). One cohort study reported no significantly increased incidence of childhood cancer among metronidazole-exposed children (adjusted relative risk, 0.81 [95% CI, 0.41 to 1.59]). However, studies of in utero exposure had important limitations. Conclusions and Relevance Accuracy of screening tests for bacterial vaginosis varies. The evidence suggests no difference in the incidence of preterm delivery and related outcomes from treatment for asymptomatic bacterial vaginosis in a general obstetric population but was inconclusive for women with a prior preterm delivery. Maternal adverse events from treatment appear to be infrequent and minor, but the evidence about harms from in utero exposure was inconclusive.

We systematically reviewed the research on patients' and prescribers' perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) (For ease of reading we use the term "advertising" to encompass advertising and promotional labeling. Broad use of this term does not imply endorsement by FDA) of prescription drugs that occurs in the context of a clinical encounter. This research offers an important perspective on the broader goal of incorporating patient and prescriber voices in decision-making. Outcomes included patient information seeking, medication adherence, patient requests for DTCA-promoted prescription drugs, prescribing behaviors, and perceptions of the patient-prescriber relationship and interactions. We searched PubMed and other databases from 1982-2017 and identified 38 studies meeting our study criteria. Of these, 24 studies used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Studies suggested some potential benefits of exposure to DTCA, including patients' enhanced information-seeking, increased patient requests for appropriate prescriptions (when addressing potential underuse) and patients' perceptions of higher-quality interactions with prescribers. Most prescribers perceived a neutral influence on the quality of their clinical interactions with patients regarding DTCA. Harms included patients receiving prescriptions for drugs that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medication adherence in some populations, such as those with mental illness. The potential benefits of DTCA on the patient-provider encounter must be balanced with the potential for harms.

IMPORTANCE Intimate partner violence (IPV), elder abuse, and abuse of vulnerable adults are common and result in adverse health outcomes. OBJECTIVE To review the evidence on screening and interventions for IPV, elder abuse, and abuse of vulnerable adults to inform the US Preventive Services Task Force. DATA SOURCES MEDLINE, Cochrane Library, EMBASE, and trial registries through October 4, 2017; references; experts; literature surveillance through August 1, 2018. STUDY SELECTION English-language randomized clinical trials (RCTs), studies evaluating test accuracy, and cohort studies with a concurrent control group assessing harms. DATA EXTRACTION AND SYNTHESIS Dual review of titles and abstracts, full-text articles, and study quality; qualitative synthesis of findings. Data were not pooled, primarily because of heterogeneity of populations, interventions, and outcomes. MAIN OUTCOMES AND MEASURES Abuse or neglect, morbidity caused by abuse, test accuracy, and harms. RESULTS Thirty studies were included (N = 14 959). Three RCTs (n = 3759) compared IPV screening with no screening; none found significant improvements in outcomes (eg, IPV or quality of life) over 3 to 18 months and 2 (n = 935) reported no harms of screening. Nine studies assessed tools to detect any past-year or current IPV in women; for past-year IPV (5 studies [n = 6331]), sensitivity of 5 tools ranged from 65% to 87% and specificity ranged from 80% to 95%. The accuracy of 5 tools (4 studies [n = 1795]) for detecting current abuse varied widely; sensitivity ranged from 46% to 94% and specificity ranged from 38% to 95%. Eleven RCTs (n = 6740) evaluated interventions for women with screen-detected IPV. Two enrolling pregnant women (n = 575) found significantly less IPV among women in the intervention group: 1 home visiting intervention (standardized mean difference [SMD], -0.34 [95% CI, -0.59 to -0.08]) and 1 behavioral counseling intervention for multiple risks (IPV, smoking, depression, tobacco exposure) (SMD, -0.40 [95% CI, -0.68 to -0.12]). No studies evaluated screening or interventions for elder abuse or abuse of vulnerable adults. One study assessing a screening tool for elder abuse had poor accuracy (sensitivity, 46% and specificity, 73% for detecting physical or verbal abuse). CONCLUSIONS AND RELEVANCE Although available screening tools may reasonably identify women experiencing IPV, trials of IPV screening in adult women did not show a reduction in IPV or improvement in quality of life over 3 to 18 months. Limited evidence suggested that home visiting and behavioral counseling interventions that address multiple risk factors may lead to reduced IPV among pregnant or postpartum women. No studies assessed screening or treatment for elder abuse and abuse of vulnerable adults.

Purpose To review evidence about screening to prevent osteoporotic fractures for the U.S. Preventive Services Task Force (USPSTF). Data Sources PubMed, the Cochrane Library, Embase, and trial registries from November 1, 2009, through October 1, 2016, and surveillance of the literature through March 23, 2018; bibliographies from retrieved articles. Study Selection Two investigators independently selected studies using a priori inclusion and exclusion criteria. We selected studies with a majority of adults age 40 years or older conducted in countries with a very high human development index. For screening studies, we required that studies include a majority of participants without prevalent low-trauma fractures. For treatment studies, we required that studies include a majority of participants with increased fracture risk. We selected studies of screening tests (fracture risk prediction instruments, bone measurement testing, or a combination of fracture risk prediction instruments and bone measurement testing) that were feasible for primary care settings and available in the United States. We selected studies of treatment approved by the U.S. Food and Drug Administration for synthesis of benefits and harms. We excluded studies of poor quality and of fracture risk prediction instruments without external validation. Data Extraction One investigator extracted data and a second checked accuracy. Two reviewers independently rated quality for included studies using predefined criteria. Data Synthesis One fair-quality trial demonstrated reduction in hip fractures when comparing screening with no screening (2.6% v 3.5%, Hazard rate [HR] 0.72; 95% confidence interval [CI], 0.59 to 0.89). The study reported no other statistically significant benefits (osteoporotic or clinical fractures, mortality) or harms (anxiety, quality of life). We included 168 articles of fair or good quality; 105 articles assessed screening accuracy and 65 articles assessed benefits and harms of treatment. Using centrally measured dual-energy X-ray absorptiometry (DXA) as the reference standard for identifying osteoporosis, the pooled estimate of accuracy as measured by the area under the curve (AUC) for clinical risk assessment instruments for women ranges from 0.65 to 0.76 and for men from 0.76 to 0.80. AUCs for the accuracy of calcaneal quantitative ultrasound in identifying central DXA—measured osteoporosis for women is 0.77 (95% CI, 0.72 to 0.82, 7 studies) and for men is 0.80 (95% CI, 0.67 to 0.94, 3 studies). The AUCs of machine-based tests, including centrally measured DXA (areal bone mineral density and trabecular bone score) and calcaneal quantitative ultrasound, for predicting fractures ranged from 0.59 to 0.86 (21 studies). The AUCs for instruments predicting fractures, some of which incorporate machine-based tests, have similar accuracy (pooled AUC range for the Fracture Risk Assessment Tool: 0.62 to 0.79; 24 studies). Available but limited evidence in studies including participants with a wide spectrum of baseline bone mineral density from normal to osteoporosis suggests no benefit from repeating a bone measurement test between 4 and 8 years after the initial screen. Evidence from placebo-controlled trials demonstrates the following benefits. For women, the risk of vertebral fractures can be reduced by bisphosphonates, parathyroid hormone, raloxifene, and denosumab by 36 percent to 68 percent. Relative risks (RRs) range from 0.32 (parathyroid hormone or denosumab) to 0.64 (raloxifene). The risk of nonvertebral fractures can be reduced by 16 percent to 20 percent by bisphosphonates and denosumab (RR, 0.84 and 0.80, respectively). The risk of hip fractures can be reduced by 40 percent by denosumab (RR, 0.60). Evidence from bisphosphonates does not demonstrate benefit for hip fractures. Evidence is very limited for men. The risk of morphometric vertebral fractures can be reduced by 67 percent by zoledronic acid (RR, 0.33). No studies demonstrate reductions in risk of clinical vertebral fractures or hip fractures for men. Evidence on variations in effectiveness for subgroups is also limited; a single trial each for five drugs suggests no differences in effectiveness by age, baseline bone mineral density, prior fractures, or a combination of risk factors. Bisphosphonates are not consistently associated with discontinuations, serious adverse events, gastrointestinal events, or cardiovascular events. No included studies reported cases of osteonecrosis of the jaw or atypical femur fracture, although evidence from excluded studies (including active comparisons, case series, and secondary prevention populations) suggests an increased but rare risk of these outcomes. Raloxifene increases the risk of deep vein thrombosis (0.7% vs. 0.3%, RR, 2.14; 95% CI, 0.99 to 4.66; I2=0%, 3 studies, N=5,839) and hot flashes (11.2% vs. 7.6%, RR, 1.42; 95% CI, 1.22 to 1.66; I2=0%, 5 trials; N=6,249) when compared with placebo. Limitations The evidence is limited on the direct question of the benefits and harms of screening for elevated osteoporotic fracture risk. The indirect evidence pathway rests on studies evaluating (1) the accuracy of screening approaches in identifying osteoporosis and predicting fractures and (2) the benefits of treatment among those with osteoporosis or at high risk for fractures. Other limitations of the evidence base relate to underlying heterogeneity in baseline risk, prior fractures, prior treatment, and duration of followup. Conclusions Evidence from one trial of screening to prevent osteoporotic fractures suggests a reduction in hip fractures. The accuracy of clinical risk assessment tools for identifying osteoporosis or predicting fractures generally ranges from very poor (0.50) to good (0.90). Treatments reduce the risk of vertebral and nonvertebral fractures. Studies do not consistently demonstrate an increased risk of harms for drugs, although studies of raloxifene suggest a trend toward higher risk of deep vein thrombosis. Rare harms, such as osteonecrosis of the jaw and atypical femur fractures were not reported in this body of evidence but they may occur. The evidence is limited for subpopulations characterized by age, sex, baseline bone mineral density, and baseline fracture risk.