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Background Telehealth has become widely used as a novel way to provide outpatient care during the COVID-19 pandemic, but data about telehealth use in primary care remain limited. Studies in other specialties raise concerns that telehealth may be widening existing health care disparities, requiring further scrutiny of trends in telehealth use. Objective Our study aims to further characterize sociodemographic differences in primary care via telehealth compared to in-person office visits before and during the COVID-19 pandemic and determine if these disparities changed throughout 2020. Methods We conducted a retrospective cohort study in a large US academic center with 46 primary care practices from April-December 2019 to April-December 2020. Data were subdivided into calendar quarters and compared to determine evolving disparities throughout the year. We queried and compared billed outpatient encounters in General Internal Medicine and Family Medicine via binary logic mixed effects regression model and estimated odds ratios (ORs) with 95% CIs. We used sex, race, and ethnicity of the patient attending each encounter as fixed effects. We analyzed socioeconomic status of patients in the institution’s primary county based on the patient’s residence zip code. Results A total of 81,822 encounters in the pre–COVID-19 time frame and 47,994 encounters in the intra–COVID-19 time frame were analyzed; in the intra–COVID-19 time frame, a total of 5322 (11.1%) of encounters were telehealth encounters. Patients living in zip code areas with high utilization rate of supplemental nutrition assistance were less likely to use primary care in the intra–COVID-19 time frame (OR 0.94, 95% CI 0.90-0.98; P=.006). Encounters with the following patients were less likely to be via telehealth compared to in-person office visits: patients who self-identified as Asian (OR 0.74, 95% CI 0.63-0.86) and Nepali (OR 0.37, 95% CI 0.19-0.72), patients insured by Medicare (OR 0.77, 95% CI 0.68-0.88), and patients living in zip code areas with high utilization rate of supplemental nutrition assistance (OR 0.84, 95% CI 0.71-0.99). Many of these disparities persisted throughout the year. Although there was no statistically significant difference in telehealth use for patients insured by Medicaid throughout the whole year, subanalysis of quarter 4 found encounters with patients insured by Medicaid were less likely to be via telehealth (OR 0.73, 95% CI 0.55-0.97; P=.03). Conclusions Telehealth was not used equally by all patients within primary care throughout the first year of the COVID-19 pandemic, specifically by patients who self-identified as Asian and Nepali, insured by Medicare, and living in zip code areas with low socioeconomic status. As the COVID-19 pandemic and telehealth infrastructure change, it is critical we continue to reassess the use of telehealth. Institutions should continue to monitor disparities in telehealth access and advocate for policy changes that may improve equity.

Importance Type 2 diabetes is common and is a leading cause of morbidity and disability. Objective To review the evidence on screening for prediabetes and diabetes to inform the US Preventive Services Task Force (USPSTF). Data Sources PubMed/MEDLINE, Cochrane Library, and trial registries through September 2019; references; and experts; literature surveillance through May 21, 2021. Study Selection English-language controlled studies evaluating screening or interventions for prediabetes or diabetes that was screen detected or recently diagnosed. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings; meta-analyses conducted when at least 3 similar studies were available. Main Outcomes and Measures Mortality, cardiovascular morbidity, diabetes-related morbidity, development of diabetes, quality of life, and harms. Results The review included 89 publications (N = 68 882). Two randomized clinical trials (RCTs) (25 120 participants) found no significant difference between screening and control groups for all-cause or cause-specific mortality at 10 years. For harms (eg, anxiety or worry), the trials reported no significant differences between screening and control groups. For recently diagnosed (not screen-detected) diabetes, 5 RCTs (5138 participants) were included. In the UK Prospective Diabetes Study, health outcomes were improved with intensive glucose control with sulfonylureas or insulin. For example, for all-cause mortality the relative risk (RR) was 0.87 (95% CI, 0.79 to 0.96) over 20 years (10-year posttrial assessment). For overweight persons, intensive glucose control with metformin improved health outcomes at the 10-year follow-up (eg, all-cause mortality: RR, 0.64 [95% CI, 0.45 to 0.91]), and benefits were maintained longer term. Lifestyle interventions (most involving >360 minutes) for obese or overweight persons with prediabetes were associated with reductions in the incidence of diabetes (23 RCTs; pooled RR, 0.78 [95% CI, 0.69 to 0.88]). Lifestyle interventions were also associated with improved intermediate outcomes, such as reduced weight, body mass index, systolic blood pressure, and diastolic blood pressure (pooled weighted mean difference, −1.7 mm Hg [95% CI, −2.6 to −0.8] and −1.2 mm Hg [95% CI, −2.0 to −0.4], respectively). Metformin was associated with a significant reduction in diabetes incidence (pooled RR, 0.73 [95% CI, 0.64 to 0.83]) and reduction in weight and body mass index. Conclusions and Relevance Trials of screening for diabetes found no significant mortality benefit but had insufficient data to assess other health outcomes; evidence on harms of screening was limited. For persons with recently diagnosed (not screen-detected) diabetes, interventions improved health outcomes; for obese or overweight persons with prediabetes, interventions were associated with reduced incidence of diabetes and improvement in other intermediate outcomes.

The Centers for MedicareMedicaid Services requires decision aid use for lung cancer screening (LCS) shared decision-making. However, it does not require information about incidental findings, a potential harm of screening.To assess the effect of incidental findings information in an LCS decision aid on screening intent as well as knowledge and valuing of screening benefits and harms.Randomized controlled trial conducted online between July 16, 2020, and August 22, 2020.Adults 55-80 years, eligible for LCS.LCS video decision aid including information on incidental findings or a control video decision aid.Intent to undergo LCS; knowledge regarding the benefit and harms of LCS using six knowledge questions; and valuing of six benefits and harms using rating (1-5 scale, 5 most important) and ranking (ranked 1-6) exercises.Of 427 eligible individuals approached, 348 (83.1%) completed the study (173 intervention, 175 control). Mean age was 64.5 years, 48.6% were male, 73.0% white, 76.3% with less than a college degree, and 64.1% with income$50,000. There was no difference between the intervention and controls in percentage intending to pursue screening (70/173, 40.5% vs 73/175, 41.7%, diff 1.2%, 95% CI - 9.1 to 11.5%, p = 0.81). Intervention participants had a higher percentage of correct answers for the incidental findings knowledge than controls (164/173, 94.8% vs 129/175, 73.7%, 95% CI - 28.4 to - 13.8%, p0.01). Incidental findings had the fifth highest mean importance rating (4.0 ± 1.1) and the third highest mean ranking (3.6 ± 1.5). There was no difference in mean rating or ranking of incidental findings between intervention and control groups (rating 4.0 vs 3.9, diff 0.1, 95% CI - 0.2, 0.3, p = 0.51; ranking 3.6 vs 3.6, diff 0.02, 95% CI - 0.3, 0.3, p = 0.89).Incidental findings information in a LCS decision aid did not affect LCS intent, but it resulted in more informed individuals regarding these findings. In formulating screening preferences, incidental findings were less important than other benefits and harms.ClinicalTrials.gov identifier: NCT04432753.

Background Multiple national organizations recommend screening and counseling adults for unhealthy alcohol use. Methods An evidence-based approach to screening and counseling using Epic electronic health record (EHR) tools was implemented in a general medicine clinic. A dissemination package with actionable steps for clinics and systems wishing to implement similar processes was then produced. To evaluate the initial implementation and quality improvement project, run charts were created to track patients screened, patients counseled, and fidelity to protocols, and members of the original project team were interviewed to assess facilitators and barriers. The draft dissemination package was revised after feedback from health system representatives (key informants). Results More than 9,000 patients (73.9% of those eligible) were screened in 20 months. Sixty-four percent of patients with positive initial screens had documented screening-related assessment; 39.7% (141/355) were offered counseling when indicated. Initial project team members identified EHR tools, clinic leadership, quality improvement culture, a multidisciplinary team, and training for providers and nurses as facilitators; and competing demands, patient population size, and nursing staff/resident turnover as barriers. Six key informants evaluated the dissemination package. Most rated 10 of the 12 sections as very useful; all rated components specific to implementing alcohol screening and counseling as very useful. Ratings for general guidance on implementing evidence-based services in primary care were more mixed. Conclusion Evidence-based screening and counseling for unhealthy alcohol use can be implemented with EHR tools. A dissemination guide was viewed favorably by key informants and can serve as a guide for other clinics and systems.

Background Unhealthy alcohol use is a leading cause of preventable deaths in the USA and is associated with many societal and health problems. Less than a third of people who visit primary care providers in the USA are asked about or ever discuss alcohol use with a health professional. Methods/design This study is an adaptive, randomized, controlled trial to evaluate the effect of primary care practice facilitation and telehealth services on evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use in small-to-medium-sized primary care practices. Study participants will include primary care practices in North Carolina with 10 or fewer providers. All enrolled practices will receive a practice facilitation intervention that includes quality improvement (QI) coaching, electronic health record (EHR) support, training, and expert consultation. After 6 months, practices in the lower 50th percentile (based on performance) will be randomized to continued practice facilitation or provision of telehealth services plus ongoing facilitation for the next 6 months. Practices in the upper 50th percentile after the initial 6 months of intervention will continue to receive practice facilitation alone. The main outcome measures include the number (and %) of patients in the target population who are screened for unhealthy alcohol use, screen positive, and receive brief counseling. Additional measures include the number (and %) of patients who receive pharmacotherapy for AUD or are referred for AUD services. Sample size calculations determined that 35 practices are needed to detect a 10% increase in the main outcome (percent screened for unhealthy alcohol use) over 6 months. Discussion A successful intervention would significantly reduce morbidity among adults from unhealthy alcohol use by increasing counseling and other treatment opportunities. The study will produce important evidence about the effect of practice facilitation on uptake of evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use when delivered on a large scale to small and medium-sized practices. It will also generate scientific knowledge about whether embedded telehealth services can improve the use of evidence-based screening and interventions for practices with slower uptake. The results of this rigorously conducted evaluation are expected to have a positive impact by accelerating the dissemination and implementation of evidence related to unhealthy alcohol use into primary care practices. Trial registration ClinicalTrials.govNCT04317989. Registered on March 23, 2020.

Evidence-based depression treatment in primary care is well established. However, clinicians are less likely to be trained to diagnose and treat anxiety disorder, which is frequently comorbid, poses an independent risk for suicidality, and complicates disease management. The University of North Carolina's Internal Medicine Clinic developed a measurement-guided approach to identifying and treating anxiety disorder using the seven-item Generalized Anxiety Disorder Scale, treatment algorithms, medication charts, case-based training for best practices, onsite behavioral counseling, and psychiatric consultation. NAMASTE (new anxiety management algorithm standardizing treatment experience) offers a treatment approach for primary care and addresses a major unmet need in public health and medical education.

Atrial fibrillation (AF), the most common arrhythmia, increases the risk of stroke.To review the evidence on screening for AF in adults without prior stroke to inform the US Preventive Services Task Force.PubMed, Cochrane Library, and trial registries through October 5, 2020; references, experts, and literature surveillance through October 31, 2021.Randomized clinical trials (RCTs) of screening among asymptomatic persons without known AF or prior stroke; test accuracy studies; RCTs of anticoagulation among persons with AF; systematic reviews; and observational studies reporting harms.Two reviewers assessed titles/abstracts, full-text articles, and study quality and extracted data; when at least 3 similar studies were available, meta-analyses were conducted.Detection of undiagnosed AF, test accuracy, mortality, stroke, stroke-related morbidity, and harms.Twenty-six studies (N = 113 784) were included. In 1 RCT (n = 28 768) of twice-daily electrocardiography (ECG) screening for 2 weeks, the likelihood of a composite end point (ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause mortality, and hospitalization for bleeding) was lower in the screened group over 6.9 years (hazard ratio, 0.96 [95% CI, 0.92-1.00]; P = .045), but that study had numerous limitations. In 4 RCTs (n = 32 491), significantly more AF was detected with intermittent and continuous ECG screening compared with no screening (risk difference range, 1.0%-4.8%). Treatment with warfarin over a mean of 1.5 years in populations with clinical, mostly persistent AF was associated with fewer ischemic strokes (pooled risk ratio [RR], 0.32 [95% CI, 0.20-0.51]; 5 RCTs; n = 2415) and lower all-cause mortality (pooled RR, 0.68 [95% CI, 0.50-0.93]) compared with placebo. Treatment with direct oral anticoagulants was also associated with lower incidence of stroke (adjusted odds ratios range, 0.32-0.44) in indirect comparisons with placebo. The pooled RR for major bleeding for warfarin compared with placebo was 1.8 (95% CI, 0.85-3.7; 5 RCTs; n = 2415), and the adjusted odds ratio for major bleeding for direct oral anticoagulants compared with placebo or no treatment ranged from 1.38 to 2.21, but CIs did not exclude a null effect.Although screening can detect more cases of unknown AF, evidence regarding effects on health outcomes is limited. Anticoagulation was associated with lower risk of first stroke and mortality but with increased risk of major bleeding, although estimates for this harm are imprecise; no trials assessed benefits and harms of anticoagulation among screen-detected populations.

Controversy over blood pressure (BP) treatment targets for individuals with diabetes is in part due to conflicting perspectives about generalizability of available trial data.The authors sought to estimate how results from the largest clinical trial of intensive BP treatment among adults with diabetes would generalize to the U.S.The authors used transportability methods to reweight individual patient data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) BP trial (N = 4,507) of intensive (goal systolic BP 120 mm Hg) versus standard (goal systolic BP 140 mm Hg) treatment to better represent the demographic and clinical risk factors of the U.S. population of adults with diabetes (data from NHANES [National Health and Nutrition Examination Survey] 2005 to 2014, n = 1,943). The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Analysis used weighted Cox proportional hazards regression models with robust standard errors.The ACCORD BP sample had less racial/ethnic diversity and more elevated cardiovascular risk factors than the NHANES participants. Weighted results significantly favored intensive BP treatment, unlike unweighted results (hazard ratio for primary outcome in intensive versus standard treatment in weighted analyses: 0.67, 95% confidence interval: 0.49 to 0.91; in unweighted analyses: hazard ratio: 0.88, 95% confidence interval: 0.73 to 1.07). Over 5 years, the weighted results estimate a number needed to treat of 34, and number needed to harm of 55.After reweighting to better reflect the U.S. adult population with diabetes, intensive BP therapy was associated with significantly lower risk for cardiovascular events. However, data were limited among racial/ethnic minorities and those with lower cardiovascular risk.

The U.S. Preventive Services Task Force (USPSTF) is an independent body of experts who make evidence-based recommendations about clinical preventive services using a transparent and objective process. Developing recommendations on a clinical preventive service requires evidence of its effect on health outcomes. Health outcomes are symptoms, functional levels, and conditions that affect a patient's quantity or quality of life and are measured by assessments of physical or psychologic well-being. Intermediate outcomes are pathologic, physiologic, psychologic, social, or behavioral measures related to a preventive service. Given the frequent lack of evidence on health outcomes, the USPSTF uses evidence on intermediate outcomes when appropriate. The ultimate goal is to determine precisely a consistent relationship between the direction and magnitude of change in an intermediate outcome with a predictable resultant direction and magnitude of change in the health outcomes. The USPSTF reviewed its historical use of intermediate outcomes, reviewed methods of other evidence-based guideline-making bodies, consulted with other experts, and reviewed scientific literature. Most important were the established criteria for causation, tenets of evidence-based medicine, and consistency with its current standards. Studies that follow participants over time following early treatment, stratify patients according to treatment response, and adjust for important confounders can provide useful information about the association between intermediate and health outcomes. However, such studies remain susceptible to residual confounding. The USPSTF will exercise great caution when making a recommendation that depends on the evidence linking intermediate and health outcomes because of inherent evidence limitations.

Since the 1980s, the U.S. Preventive Services Task Force (USPSTF) has developed and used rigorous methods to make evidence-based recommendations about preventive services to promote health and well-being for all Americans. Recommendations are based on the evidence of magnitude of net benefit (benefits minus harms). Expert opinion is not substituted when evidence is lacking. Evidence gaps are common. Few preventive services are supported by high-quality studies that directly and comprehensively determine the overall magnitude of benefits and harms in the same study. When assessing the body of evidence, studies may not have been conducted in primary care settings, studies may not have sufficiently included populations of interest, and long-term outcomes may not have been directly assessed. When direct evidence is not available, the USPSTF uses the methodologies of applicability to determine whether evidence can be generalized to an asymptomatic primary care population; coherence to link bodies of evidence and create an indirect evidence pathway; extrapolation to make inferences across the indirect evidence pathway, extend evidence to populations not specifically studied, consider service delivery intervals, and infer long-term outcomes; and conceptual bounding to set theoretical lower or upper limits for plausible benefits or harms. The USPSTF extends the evidence only so far as to maintain at least moderate certainty that its findings are preserved. This manuscript details with examples of how the USPSTF uses these methods to make recommendations that truly reflect the evidence.

BACKGROUND The emerging dual imperatives of personalized medicine and technologic advances make population screening for preventable conditions resulting from genetic alterations a realistic possibility. Lynch syndrome is a potential screening target due to its prevalence, penetrance, and the availability of well-established, preventive interventions. However, while population screening may lower incidence of preventable conditions, implementation without evidence may lead to unintentional harms. We examined the literature to determine whether evidence exists that screening for Lynch-associated mismatch repair (MMR) gene mutations leads to improved overall survival, cancer-specific survival, or quality of life. Documenting evidence and gaps is critical to implementing genomic approaches in public health and guiding future research. MATERIALS AND METHODS Our 2014-2015 systematic review identified studies comparing screening with no screening in the general population, and controlled studies assessing analytic validity of targeted next-generation sequencing, and benefits or harms of interventions or screening. We conducted meta-analyses for the association between early or more frequent colonoscopies and health outcomes. RESULTS Twelve studies met our eligibility criteria. No adequate evidence directly addressed the main question or the harms of screening in the general population. Meta-analyses found relative reductions of 68% for colorectal cancer incidence (relative risk: 0.32, 95% confidence interval: 0.23-0.43, three cohort studies, 590 participants) and 78% for all-cause mortality (relative risk: 0.22, 95% confidence interval: 0.09-0.56, three cohort studies, 590 participants) for early or more frequent colonoscopies among family members of people with cancer who also had an associated MMR gene mutation. CONCLUSION Inadequate evidence exists examining harms and benefits of population-based screening for Lynch syndrome. Lack of evidence highlights the need for data that directly compare benefits and harms.

Importance Hearing loss is common in older adults and associated with adverse health and social outcomes. Objective To update the evidence review on screening for hearing loss in adults 50 years or older to inform the US Preventive Services Task Force. Data sources MEDLINE, Cochrane Library, EMBASE, and trial registries through January 17, 2020; references; and experts; literature surveillance through October 8, 2020. Study selection English-language studies of accuracy, screening, and interventions for screen-detected or newly detected hearing loss. Data extraction and synthesis Dual review of abstracts, full-text articles, and study quality. Meta-analysis of screening test accuracy studies. Main outcomes and measures Quality of life and function, other health and social outcomes, test accuracy, and harms. Results Forty-one studies (N = 26 386) were included, 18 of which were new since the previous review. One trial enrolling US veterans (n = 2305) assessed the benefits of screening; there was no significant difference in the proportion of participants experiencing a minimum clinically important difference in hearing-related function at 1 year (36%-40% in the screened groups vs 36% in the nonscreened group). Thirty-four studies (n = 23 228) evaluated test accuracy. For detecting mild hearing loss (>20-25 dB), single-question screening had a pooled sensitivity of 66% (95% CI, 58%-73%) and a pooled specificity of 76% (95% CI, 68%-83%) (10 studies, n = 12 637); for detecting moderate hearing loss (>35-40 dB), pooled sensitivity was 80% (95% CI, 68%-88%) and pooled specificity was 74% (95% CI, 59%-85%) (6 studies, n = 8774). In 5 studies (n = 2820) on the Hearing Handicap Inventory for the Elderly-Screening to detect moderate hearing loss (>40 dB), pooled sensitivity was 68% (95% CI, 52%-81%) and pooled specificity was 78% (95% CI, 67%-86%). Six trials (n = 853) evaluated amplification vs control in populations with screen-detected or recently detected hearing loss over 6 weeks to 4 months. Five measured hearing-related function via the Hearing Handicap Inventory for the Elderly; only 3 that enrolled veterans (n = 684) found a significant difference considered to represent a minimal important difference (>18.7 points). Few trials reported on other eligible outcomes, and no studies reported on harms of screening or interventions. Conclusions and relevance Several screening tests can adequately detect hearing loss in older adults; no studies reported on the harms of screening or treatment. Evidence showing benefit from hearing aids on hearing-related function among adults with screen-detected or newly detected hearing loss is limited to studies enrolling veterans.

Importance Lung cancer is the leading cause of cancer-related death in the US. Objective To review the evidence on screening for lung cancer with low-dose computed tomography (LDCT) to inform the US Preventive Services Task Force (USPSTF). Data sources MEDLINE, Cochrane Library, and trial registries through May 2019; references; experts; and literature surveillance through November 20, 2020. Study selection English-language studies of screening with LDCT, accuracy of LDCT, risk prediction models, or treatment for early-stage lung cancer. Data extraction and synthesis Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings. Data were not pooled because of heterogeneity of populations and screening protocols. Main outcomes and measures Lung cancer incidence, lung cancer mortality, all-cause mortality, test accuracy, and harms. Results This review included 223 publications. Seven randomized clinical trials (RCTs) (N = 86 486) evaluated lung cancer screening with LDCT; the National Lung Screening Trial (NLST, N = 53 454) and Nederlands-Leuvens Longkanker Screenings Onderzoek (NELSON, N = 15 792) were the largest RCTs. Participants were more likely to benefit than the US screening-eligible population (eg, based on life expectancy). The NLST found a reduction in lung cancer mortality (incidence rate ratio [IRR], 0.85 [95% CI, 0.75-0.96]; number needed to screen [NNS] to prevent 1 lung cancer death, 323 over 6.5 years of follow-up) with 3 rounds of annual LDCT screening compared with chest radiograph for high-risk current and former smokers aged 55 to 74 years. NELSON found a reduction in lung cancer mortality (IRR, 0.75 [95% CI, 0.61-0.90]; NNS to prevent 1 lung cancer death of 130 over 10 years of follow-up) with 4 rounds of LDCT screening with increasing intervals compared with no screening for high-risk current and former smokers aged 50 to 74 years. Harms of screening included radiation-induced cancer, false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, and increases in distress. For every 1000 persons screened in the NLST, false-positive results led to 17 invasive procedures (number needed to harm, 59) and fewer than 1 person having a major complication. Overdiagnosis estimates varied greatly (0%-67% chance that a lung cancer was overdiagnosed). Incidental findings were common, and estimates varied widely (4.4%-40.7% of persons screened). Conclusions and relevance Screening high-risk persons with LDCT can reduce lung cancer mortality but also causes false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, increases in distress, and, rarely, radiation-induced cancers. Most studies reviewed did not use current nodule evaluation protocols, which might reduce false-positive results and invasive procedures for false-positive results.

Numerous guidelines have been developed over the past decade regarding treatments for Posttraumatic stress disorder (PTSD). However, given differences in guideline recommendations, some uncertainty exists regarding the selection of effective PTSD therapies. The current manuscript assessed the efficacy, comparative effectiveness, and adverse effects of psychological treatments for adults with PTSD. We searched MEDLINE, Cochrane Library, PILOTS, Embase, CINAHL, PsycINFO, and the Web of Science. Two reviewers independently selected trials. Two reviewers assessed risk of bias and graded strength of evidence (SOE). We included 64 trials; patients generally had severe PTSD. Evidence supports efficacy of exposure therapy (high SOE) including the manualized version Prolonged Exposure (PE); cognitive therapy (CT), cognitive processing therapy (CPT), cognitive behavioral therapy (CBT)-mixed therapies (moderate SOE); eye movement desensitization and reprocessing (EMDR) and narrative exposure therapy (low-moderate SOE). Effect sizes for reducing PTSD symptoms were large (e.g., Cohen's d ~-1.0 or more compared with controls). Numbers needed to treat (NNTs) were

The US Preventive Services Task Force recommends that individuals at high risk for lung cancer consider benefits and harms before pursuing lung cancer screening. Medical centers develop websites for their lung cancer screening programs, but to date little is known about the websites' portrayal of benefits and harms or what next steps they recommend for individuals considering screening.To assess the presentation of potential benefits and harms and recommended next steps on lung cancer screening program websites.Cross-sectional content analysis of 162 lung cancer screening program websites of academic medical centers (n = 81) and state-matched community medical centers (n = 81) that were randomly selected from American College of Radiology lung cancer screening-designated centers was conducted. The study was performed from December 1, 2018, to January 31, 2019.Website presentation of screening-associated benefits and harms was the primary outcome. Benefit was defined as any description related to the potential reduction in lung cancer mortality. Harms were based on the US Preventive Services Task Force recommendations and included false positives, false negatives, overdiagnosis, radiation exposure, and incidental findings. The secondary outcome was next steps that are recommended by websites.Overall, the 162 lung cancer screening program websites described the potential benefits more frequently than they described any potential harms (159 [98%] vs 78 [48%], P .01). False-positive findings were the most frequently reported (72 [44%]) potential harm. Community centers were less likely than academic centers to report any potential harm (32 [40%] vs 46 [57%], P = .03), potential harm from radiation (20 [25%] vs 35 [43%], P = .01), and overdiagnosis (0% vs 11 [14%], P .01). One hundred nineteen websites (73%) did not explicitly recommend that individuals personally consider the potential benefits and harms of screening; community centers were less likely than academic centers to give this recommendation (15 [19%] vs 28 [35%], P = .02). Most institutions (157 [97%]) listed follow-up steps for screening, but few institutions (35 [22%]) recommended that individuals discuss benefits and harms with a health care professional.Information on public-facing websites of US lung cancer screening programs appears to lack balance with respect to portrayal of potential benefits and harms of screening. Important harms, such as overdiagnosis, were commonly ignored in the sites evaluated, and most of the centers did not explicitly guide individuals toward a guideline-recommended, shared decision-making discussion of harms and benefits.

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.

BACKGROUND: The transition from pediatric to adult care is a critical period for young adults with childhood-onset conditions. General internists are tasked with participating in the care of this vulnerable population. Existing guidelines regarding transition do not fully address structural or organizational characteristics of practices that facilitate transition. Moreover, literature regarding transition has focused on pediatric subspecialty settings, leaving internists with little guidance after transfer. OBJECTIVES: To better understand post-transfer transitional care by describing care models that primary care providers have implemented, and examining common features of generalist physicians’ experiences providing transitional care. DESIGN: Qualitative methods, semi-structured interviews. PARTICIPANTS: Nineteen generalist-trained physicians from across the USA, engaged in transition-focused and/or ongoing care of adolescents and young adults with childhood-onset conditions. APPROACH: Content and grounded theory analyses. KEY RESULTS: Participants included nineteen physicians from seventeen institutions. Most (89%) were from academic medical centers. About 80% had completed a combined internal medicine-pediatrics residency. About 70% worked with clinic staff who were dedicated to transition. Practice structures fell into four main care models: (1) primary care in adult settings; (2) transition support and primary care in pediatric settings; (3) a blend of pediatric and adult care elements forming a bridge during transition; and (4) a transition consultative service. Most provided primary care for adults with childhood-onset conditions within larger adult-oriented primary care practices. Common features across interviews included taking extra time with patients both during and between visits and an interdisciplinary team-based approach. Shared practice strategies and philosophies emphasized care coordination, focus on the whole patient beyond immediate health concerns, and willingness to learn from practice and from families. CONCLUSIONS: Participants used disparate care models. Common features and strategies among interviews highlight key functions and attributes of transitional care across settings, suggest important elements of care post-transfer, and clarify the role of generalists.

To describe the characteristics and outcomes of patients discharged from the emergency department (ED) by hospitalist physicians.Retrospective cohort study at a tertiary academic medical center.We used consultation Current Procedural Technology codes to identify patients discharged from the ED after referral for hospitalist admission from April 2011 to April 2014. We report patient demographics and primary diagnoses. Main outcome measures included return to the ED, hospitalization, or mortality, all within 30 days.There were 710 discharges from the ED for 670 patients referred for hospitalist admission; 21.7% returned to the ED, 12.3% were hospitalized, and 0.4% died within 30 days. Chest pain was the most common diagnosis (38.2%); 18.1% of these patients returned to the ED within 30 days. Patients with the following 3 diagnoses returned to the ED most frequently: sickle cell disease (82.4%), alcohol-related diagnoses (43.5%), and abdominal pain (35.7%). In multivariate analysis, abdominal pain (odds ratio [OR], 3.2; P.001) and alcohol dependence (OR, 3.1; P = .003) increased the odds of ED revisits, whereas syncope (OR, 0.23; P = .049) reduced the odds. Chest pain reduced the odds of hospitalization (OR, 0.37; P = .005).A majority of patients discharged from the ED after referral for hospitalist admission did not return to the ED within 30 days, and the 30-day hospitalization rate was low. Our data suggest that hospitalists can safely aid patients by reducing the costs and adverse outcomes associated with unnecessary hospitalization.

Background: It is unclear whether testing for novel risk factors, such as a cardiovascular genetic risk score (cGRS), improves clinical decision making or health outcomes when used for targeting statin initiation in the primary prevention of atherosclerotic cardiovascular disease (ASCVD). Our objective was to estimate the cost-effectiveness of cGRS testing to inform clinical decision making about statin initiation in individuals with low-to-intermediate (2.5%–7.5%) 10-year predicted risk of ASCVD. Methods and Results: We evaluated the cost-effectiveness of testing for a 27-single-nucleotide polymorphism cGRS comparing 4 test/treat strategies: treat all, treat none, test/treat if cGRS is high, and test/treat if cGRS is intermediate or high. We tested a set of clinical scenarios of men and women, aged 45 to 65 years, with 10-year ASCVD risks between 2.5% and 7.5%. Our primary outcome measure was cost per quality-adjusted life-year gained. Under base case assumptions for statin disutility and cost, the preferred strategy is to treat all patients with ASCVD risk >2.5% without cGRS testing. For certain clinical scenarios, such as a 57-year-old man with a 10-year ASCVD risk of 7.5%, cGRS testing can be cost-effective under a limited set of assumptions; for example, when statins cost $15 per month and statin disutility is 0.013 (ie, willing to trade 3 months of life in perfect health to avoid 20 years of statin therapy), the preferred strategy (using a willingness-to-pay threshold of $50 000 per quality-adjusted life-year gained) is to test and treat if cGRS is intermediate or high. Overall, the results were not sensitive to assumptions about statin efficacy and harms. Conclusions: Testing for a 27-single-nucleotide polymorphism cGRS is generally not a cost-effective approach for targeting statin therapy in the primary prevention of ASCVD for low- to intermediate-risk patients.

Introduction Groups making recommendations need evidence about whether preventive services improve health outcomes (HOs). When such evidence is not available, groups may choose to evaluate evidence about effects on intermediate outcomes (IOs) and the link between IOs and HOs. This paper aims to describe considerations for assessing the evidence linking changes in IOs to changes in HOs. Methods Working definitions of IOs, HOs, and other outcomes were developed. All current U.S. Preventive Services Task Force (USPSTF) recommendations through April 2016 were examined to identify how evidence of the IO–HO link was gathered and the criteria that appeared to be used to determine the adequacy of the evidence. Methods of other expert and recommendation-making groups were also examined. Results Forty-four USPSTF recommendations involved a relevant IO–HO link. The approaches used most commonly to gather evidence about the link were selected review (19 of 44, 43%) and systematic review (12 of 44, 27%). Some key considerations when assessing the adequacy of evidence about the IO–HO link include adjustment for confounding, proximity of the IO to the HO in the causal pathway, and independence of IO–HO relationship from specific treatments. Conclusions Considerations were identified for recommendation-making groups to use when gathering and assessing the adequacy of evidence about the IO–HO link. Using a standard set of written principles could improve the transparency of assessments of the IO–HO link, especially if used together with judgment in a reasoned conjecture and refutation process. Ideally, the process would result in an estimate of the magnitude of change in HOs that is expected for specified changes in IOs.

Background Guideline developers and other users of systematic reviews need information about whether a medical or preventive intervention is likely to benefit or harm some patients more (or less) than the average in order to make clinical practice recommendations tailored to these populations. However, guidance is lacking on how to include patient subpopulation considerations into the systematic reviews upon which guidelines are often based. In this article, we describe methods developed to consistently consider the evidence for relevant subpopulations in systematic reviews conducted to support primary care clinical preventive service recommendations made by the U.S. Preventive Services Task Force (USPSTF). Proposed approach Our approach is grounded in our experience conducting systematic reviews for the USPSTF and informed by a review of existing guidance on subgroup analysis and subpopulation issues. We developed and refined our approach based on feedback from the Subpopulation Workgroup of the USPSTF and pilot testing on reviews being conducted for the USPSTF. This paper provides processes and tools for incorporating evidence-based identification of important sources of potential heterogeneity of intervention effects into all phases of systematic reviews. Key components of our proposed approach include targeted literature searches and key informant interviews to identify the most important subpopulations a priori during topic scoping, a framework for assessing the credibility of subgroup analyses reported in studies, and structured investigation of sources of heterogeneity of intervention effects. Conclusions Further testing and evaluation are necessary to refine this proposed approach and demonstrate its utility to the producers and users of systematic reviews beyond the context of the USPSTF. Gaps in the evidence on important subpopulations identified by routinely applying this process in systematic reviews will also inform future research needs.

Unhealthy alcohol use is the third leading cause of preventable death in the United States. The U.S. Preventive Services Task Force (USPSTF) recommends screening for unhealthy alcohol use but little is known about how best to do so. We used quality improvement techniques to implement a systematic approach to screening and counseling primary care patients for unhealthy alcohol use. Components included use of validated screening and assessment instruments; an evidence-based two-visit counseling intervention using motivational interviewing techniques for those with risky drinking behaviors who did not have an alcohol use disorder (AUD); shared decision making about treatment options for those with an AUD; support materials for providers and patients; and training in motivational interviewing for faculty and residents. Over the course of one year, we screened 52% (N = 5,352) of our clinic's patients and identified 294 with positive screens. Of those 294, appropriate screening-related assessments and interventions were documented for 168 and 72 patients, respectively. Although we successfully implemented a systematic screening program and structured processes of care, ongoing quality improvement efforts are needed to screen the rest of our patients and to improve the consistency with which we provide and document appropriate interventions.

Pharmacogenomics offers the hope of greater individualization of treatment. Therapies that exemplify the promise of pharmacogenomics include anticoagulation with warfarin and the use of antiplatelet medications (eg, clopidogrel) for secondary prevention after acute coronary syndrome. Good evidence of clinical utility must be obtained before pharmacogenomic testing is widely implemented.

Aims: To evaluate the impact of systematic reviews on research funded by the Agency for Healthcare Research and Quality (AHRQ) through Evidence-based Practice Centers (EPCs), and to identify barriers to and facilitators for the effects of these documents on future research. Methods & materials: Two AHRQ systematic reviews were selected as case studies to evaluate their impact on future research. Key citations generated by these reports were identified through ISI Web of Science and PubMed Central and traced forward to identify effects on subsequent studies through citation analysis from updated systematic reviews on the topics. Requests for applications and program announcements from the NIH Guide for Grants and Contracts website were reviewed and dissemination data were obtained from AHRQ. Finally, interviews were conducted with 13 key informants to help identify short-, medium- and long-term impacts of the EPC reviews. Results: The measurable impact of the two EPC reviews is demonstrably greater on short-term outcomes (greater awareness of the issues) than on medium-term (e.g., the generation of new knowledge) or long-term outcomes (e.g., changes in patient practice or health outcomes). Factors such as the topic and the timing of the report relative to the development of the field may explain the impact of these two AHRQ reports. The degree to which the new research can be directly attributed to the AHRQ reviews remains unclear. Key informants discussed several benefits stemming from the EPC reports, including providing a foundation for the research community on which to build, heightening awareness of the gaps in knowledge, increasing the quality of research and sparking new directions of research. However, the degree to which these reports were influential hinged on several factors including marketing efforts, the very nature of the reports and other influences external to the EPC domain. Conclusions: The findings outlined in this article illustrate the importance of numerous factors influencing future research: the breadth, specificity and readiness of the topic for more research, ongoing developments in the field, availability of funding and active engagement of champions. AHRQ and the EPCs may be able to improve the likelihood of impact by creating more targeted products, planning for and expanding dissemination activities, improving the readability and other attributes of the reports themselves, and actively involving funders early on and throughout the process of creating and publishing the reviews.

Low literacy skills are common and associated with a variety of poor health outcomes. This may be particularly important in patients with chronic illnesses such as chronic obstructive pulmonary disease (COPD) that require appropriate inhaler technique to maintain quality of life and avoid exacerbations.To explore the impact of a literacy-sensitive self-management intervention on inhaler technique scores in COPD patients and to determine if effects differ by literacy.Randomized controlled trial.Ninety-nine patients with COPD.Patients were randomly assigned to a one-on-one self-management educational intervention or usual care. The intervention focused on inhaler technique, smoking cessation, and using a COPD action plan.At baseline, an inhaler technique assessment, literacy assessment, health-related quality of life questionnaires, and pulmonary function tests were completed. Inhaler technique was re-evaluated after two to eight weeks.Mean age 63, 65% female, 69% Caucasian, moderate COPD severity on average, 36% with low literacy, moderately impaired health-related quality of life, and similar baseline metered dose inhaler technique scores. Patients in the intervention group had greater mean improvement from baseline in metered dose inhaler technique score compared to those in the usual care group (difference in mean change 2.1, 95% CI 1.1, 3.0). The patients in the intervention group also had greater mean improvements in metered dose inhaler technique score than those in the usual care group whether they had low health literacy (difference in mean change 2.8, 95% CI 0.6, 4.9) or higher health literacy (1.8, 95% CI 0.7, 2.9).A literacy-sensitive self-management intervention can lead to improvements in inhaler technique, with benefits for patients with both low and higher health literacy.

Background Clopidogrel's effectiveness is likely reduced significantly for prevention of thrombotic events after acute coronary syndrome (ACS) in patients exhibiting a decreased ability to metabolize clopidogrel into its active form. A genetic mutation responsible for this reduced effectiveness is detectable by genotyping. Ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater clinical efficacy than clopidogrel in a recent secondary prevention trial. In 2011, clopidogrel will lose its patent protection and likely will be substantially less expensive than ticagrelor. Objective To determine the cost-effectiveness of ticagrelor compared with a genotype-driven selection of antiplatelet agents. Methods A hybrid decision tree/Markov model was used to estimate the 5-year medical costs (in 2009 US$) and outcomes for a cohort of ACS patients enrolled in Medicare receiving either genotype-driven or ticagrelor-only treatment. Outcomes included life years and quality-adjusted life years (QALYs) gained. Data comparing the clinical performance of ticagrelor and clopidogrel were derived from the Platelet Inhibition and Patient Outcomes trial. Results The incremental cost-effectiveness ratio (ICER) for universal ticagrelor was $10,059 per QALY compared to genotype-driven treatment, and was most sensitive to the price of ticagrelor and the hazard ratio for death for ticagrelor compared with clopidogrel. The ICER remained below $50,000 per QALY until a monthly ticagrelor price of $693 or a 0.93 hazard ratio for death for ticagrelor relative to clopidogrel. In probabilistic analyses, universal ticagrelor was below $50,000 per QALY in 97.7% of simulations. Conclusion Prescribing ticagrelor universally increases quality-adjusted life years for ACS patients at a cost below a typically accepted threshold.

Genomic screening of the general adult population: key concepts for assessing net benefit with systematic evidence reviews

Child maltreatment, also referred to as child abuse and neglect, can result in lifelong negative consequences.To update the evidence on interventions provided in or referable from primary care to prevent child maltreatment for the US Preventive Services Task Force.PubMed, Cochrane Library, EMBASE, and trial registries through December 18, 2017; references; experts; literature surveillance through July 17, 2018.English-language fair- and good-quality randomized clinical trials that (1) included children with no known exposure to maltreatment and no signs or symptoms of current or past maltreatment, (2) evaluated interventions feasible in a primary care setting or that could result from a referral from primary care, and (3) reported abuse or neglect outcomes or proxies for abuse or neglect (eg, injury with a specificity for abuse, visits to the emergency department, hospitalization).Two reviewers independently assessed titles/abstracts, full-text articles, and study quality; a third resolved conflicts when needed. When at least 3 similar trials were available, random-effects meta-analyses were conducted.Direct measures (including reports to child protective services and removal of the child from the home) or proxy measures of abuse or neglect; behavioral, emotional, mental, or physical well-being; and harms.Twenty-two trials (33 publications) were included (N = 11 132). No significant association was found between interventions and reports to child protective services within 1 year of intervention completion (10.6% vs 11.9%; pooled odds ratio [OR], 0.94 [95% CI, 0.72-1.23]; 10 trials [n = 2444]) or removal of the child from the home within 1 to 3 years of follow-up (3.5% vs 3.7%; pooled OR, 1.09 [95% CI, 0.16-7.28]; 4 trials [n = 609]). No statistically significant associations were observed between interventions and outcomes for emergency department visits in the short term (2 years), hospitalizations, child development, school performance, and prevention of death. Nonsignificant results from single trials led to a conclusion of insufficient evidence for injuries, failure to thrive, failure to immunize, school attendance, and other measures of abuse or neglect. Inconsistent results led to a conclusion of insufficient evidence for long-term (≥2 years) outcomes for reports to child protective services (ORs range from 0.48 to 1.13; 3 trials [n = 1690]), emergency department visits (1 of 2 trials reported significant differences) and internalizing and externalizing behavior symptoms (3 of 6 trials reported reductions in behavior difficulties). No eligible trials on harms of interventions were identified.Interventions provided in or referable from primary care did not consistently prevent child maltreatment. No evidence on harms is available.

Importance Unhealthy alcohol use is common, increasing, and a leading cause of premature mortality. Objective To review literature on the effectiveness and harms of screening and counseling for unhealthy alcohol use to inform the US Preventive Services Task Force. Data Sources MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through October 12, 2017; literature surveillance through August 1, 2018. Study Selection Test accuracy studies and randomized clinical trials of screening and counseling to reduce unhealthy alcohol use. Data Extraction and Synthesis Independent critical appraisal and data abstraction by 2 reviewers. Counseling trials were pooled using random-effects meta-analyses. Main Outcomes and Measures Sensitivity, specificity, drinks per week, exceeding recommended limits, heavy use episodes, abstinence (for pregnant women), and other health, family, social, and legal outcomes. Results One hundred thirteen studies (N = 314 466) were included. No studies examined benefits or harms of screening programs to reduce unhealthy alcohol use. For adolescents (10 studies [n = 171 363]), 1 study (n = 225) reported a sensitivity of 0.73 (95% CI, 0.60 to 0.83) and specificity of 0.81 (95% CI, 0.74 to 0.86) using the AUDIT-C (Alcohol Use Disorders Identification Test–Consumption) to detect the full spectrum of unhealthy alcohol use. For adults (35 studies [n = 114 182]), brief screening instruments commonly reported sensitivity and specificity between 0.70 and 0.85. Two trials of the effects of interventions to reduce unhealthy alcohol use in adolescents (n = 588) found mixed results: one reported a benefit in high-risk but not moderate-risk drinkers, and the other reported a statistically significant reduction in drinking frequency for boys but not girls; neither reported health or related outcomes. Across all populations (68 studies [n = 36 528]), counseling interventions were associated with a decrease in drinks per week (weighted mean difference, −1.6 [95% CI, −2.2 to −1.0]; 32 studies [37 effects; n = 15 974]), the proportion exceeding recommended drinking limits (odds ratio [OR], 0.60 [95% CI, 0.53 to 0.67]; 15 studies [16 effects; n = 9760]), and the proportion reporting a heavy use episode (OR, 0.67 [95% CI, 0.58 to 0.77]; 12 studies [14 effects; n = 8108]), and an increase in the proportion of pregnant women reporting abstinence (OR, 2.26 [95% CI, 1.43 to 3.56]; 5 studies [n = 796]) after 6 to 12 months. Health outcomes were sparsely reported and generally did not demonstrate group differences in effect. There was no evidence that these interventions could be harmful. Conclusions and Relevance Among adults, screening instruments feasible for use in primary care are available that can effectively identify people with unhealthy alcohol use, and counseling interventions in those who screen positive are associated with reductions in unhealthy alcohol use. There was no evidence that these interventions have unintended harmful effects.

Importance Atrial fibrillation is the most common arrhythmia and increases the risk of stroke. Objective To review the evidence on screening for nonvalvular atrial fibrillation with electrocardiography (ECG) and stroke prevention treatment in asymptomatic adults 65 years or older to inform the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, and trial registries through May 2017; references; experts; literature surveillance through June 6, 2018. Study Selection English-language randomized clinical trials (RCTs), prospective cohort studies evaluating detection rates of atrial fibrillation or harms of screening, and systematic reviews evaluating stroke prevention treatment. Eligible treatment studies compared warfarin, aspirin, or novel oral anticoagulants (NOACs) with placebo or no treatment. Studies were excluded that focused on persons with a history of cardiovascular disease. Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality. When at least 3 similar studies were available, random-effects meta-analyses were conducted. Main Outcomes and Measures Detection of previously undiagnosed atrial fibrillation, mortality, stroke, stroke-related morbidity, and harms. Results Seventeen studies were included (n = 135 300). No studies evaluated screening compared with no screening and focused on health outcomes. Systematic screening with ECG identified more new cases of atrial fibrillation than no screening (absolute increase, from 0.6% [95% CI, 0.1%-0.9%] to 2.8% [95% CI, 0.9%-4.7%] over 12 months; 2 RCTs, n = 15 803), but a systematic approach using ECG did not detect more cases than an approach using pulse palpation (2 RCTs, n = 17 803). For potential harms, no eligible studies compared screening with no screening. Warfarin (mean, 1.5 years) was associated with a reduced risk of ischemic stroke (relative risk [RR], 0.32 [95% CI, 0.20-0.51]) and all-cause mortality (RR, 0.68 [95% CI, 0.50-0.93]) and with increased risk of bleeding (5 trials, n = 2415). Participants in treatment trials were not screen detected, and most had long-standing persistent atrial fibrillation. A network meta-analysis reported that NOACs were associated with a significantly lower risk of a composite outcome of stroke and systemic embolism (adjusted odds ratios compared with placebo or control ranged from 0.32-0.44); the risk of bleeding was increased (adjusted odds ratios, 1.4-2.2), but confidence intervals were wide and differences between groups were not statistically significant. Conclusions and Relevance Although screening with ECG can detect previously unknown cases of atrial fibrillation, it has not been shown to detect more cases than screening focused on pulse palpation. Treatments for atrial fibrillation reduce the risk of stroke and all-cause mortality and increase the risk of bleeding, but trials have not assessed whether treatment of screen-detected asymptomatic older adults results in better health outcomes than treatment after detection by usual care or after symptoms develop.

Background. Most patients receiving warfarin are managed in outpatient office settings or anticoagulation clinics that require frequent visits for monitoring. Objective. To measure the amount and value of time required of patients for chronic anticoagulation therapy with warfarin. Design/Participants. Prospective observation of a cohort of adult patients treated at a university-based anticoagulation program. Measurements. Participants completed a questionnaire and a prospective diary of the time required for 1 visit to the anticoagulation clinic, including travel, waiting, and the clinic visit. The authors reviewed subjects’ medical records to obtain additional information, including the frequency of visits to the anticoagulation clinic. They used the human capital method to estimate the value of time. Results. Eighty-five subjects completed the study. The mean (median) total time per visit was 147 minutes (123). Subjects averaged 15 visits per year (14) and spent 39.0 hours (29.3) per year on their visits. Other anticoagulation-related activities, such as communication with providers, pharmacy trips, and extra time preparing food, added an average of 52.7 hours (19.0) per year. The mean annual value of patient time spent traveling, waiting, and attending anticoagulation visits was $707 (median $591). The mean annual value when also including other anticoagulation-related activities was $1799 (median $1132). Conclusions. The time required of patients for anticoagulation visits was considerable, averaging approximately 2.5 hours per visit and almost 40 hours per year. Methods for reducing patient time requirements, such as home-based testing, could reduce costs for patients, employers, and companions.

Richard A Hansen1, Gerald Gartlehner2, Aaron P Webb1, Laura C Morgan3, Charity G Moore4, Daniel E Jonas31School of Pharmacy, 3Cecil G Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA; 2Department for Evidence-based Medicine and Clinical Epidemiology, Danube University, Krems, Austria; 4Center for Research on Health Care Data Center; University of Pittsburgh, Pittsburgh, PA, USAAbstract: Pharmacologic treatments for Alzheimer’s disease include the cholinesterase inhibitors donepezil, galantamine, and rivastigmine. We reviewed their evidence by searching MEDLINE®, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts from 1980 through 2007 (July) for placebo-controlled and comparative trials assessing cognition, function, behavior, global change, and safety. Thirty-three articles on 26 studies were included in the review. Meta-analyses of placebo-controlled data support the drugs’ modest overall benefits for stabilizing or slowing decline in cognition, function, behavior, and clinical global change. Three open-label trials and one double-blind randomized trial directly compared donepezil with galantamine and rivastigmine. Results are conflicting; two studies suggest no differences in efficacy between compared drugs, while one study found donepezil to be more efficacious than galantamine, and one study found rivastigmine to be more efficacious than donepezil. Adjusted indirect comparison of placebo-controlled data did not find statistically significant differences among drugs with regard to cognition, but found the relative risk of global response to be better with donepezil and rivastigmine compared with galantamine (relative risk = 1.63 and 1.42, respectively). Indirect comparisons also favored donepezil over galantamine with regard to behavior. Across trials, the incidence of adverse events was generally lowest for donepezil and highest for rivastigmine.Keywords: Alzheimer’s disease, cholinesterase inhibitor, donepezil, galantamine, rivastigmine, systematic review, meta-analysis, indirect comparison

Background Nearly 25% of patients hospitalized with heart failure (HF) are readmitted within 30 days. Purpose To assess the efficacy, comparative effectiveness, and harms of transitional care interventions to reduce readmission and mortality rates for adults hospitalized with HF. Data sources MEDLINE, Cochrane Library, CINAHL, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (1 January 1990 to late October 2013). Study selection Two reviewers independently selected randomized, controlled trials published in English reporting a readmission or mortality rate within 6 months of an index hospitalization. Data extraction One reviewer extracted data, and another checked accuracy. Two reviewers assessed risk of bias and graded strength of evidence (SOE). Data synthesis Forty-seven trials were included. Most enrolled adults with moderate to severe HF and a mean age of 70 years. Few trials reported 30-day readmission rates. At 30 days, a high-intensity home-visiting program reduced all-cause readmission and the composite end point (all-cause readmission or death; low SOE). Over 3 to 6 months, home-visiting programs and multidisciplinary heart failure (MDS-HF) clinic interventions reduced all-cause readmission (high SOE). Home-visiting programs reduced HF-specific readmission and the composite end point (moderate SOE). Structured telephone support (STS) interventions reduced HF-specific readmission (high SOE) but not all-cause readmissions (moderate SOE). Home-visiting programs, MDS-HF clinics, and STS interventions produced a mortality benefit. Neither telemonitoring nor primarily educational interventions reduced readmission or mortality rates. Limitations Few trials reported 30-day readmission rates. Usual care was heterogeneous and sometimes not adequately described. Conclusion Home-visiting programs and MDS-HF clinics reduced all-cause readmission and mortality; STS reduced HF-specific readmission and mortality. These interventions should receive the greatest consideration by systems or providers seeking to implement transitional care interventions for persons with HF. Primary funding source Agency for Healthcare Research and Quality.

The prevalence of traumatic events in both civilian and military populations and the emotional, financial, physical, and psychosocial burdens of PTSD are high. We conducted two rigorous, protocol-based systematic reviews of the published literature assessing the benefits and harms of psychological and pharmacological interventions to prevent or treat symptoms of post-traumatic stress disorder (PTSD) in adults exposed to trauma. We did not find reliable evidence supporting efficacy for most interventions to prevent PTSD. Evidence does support the effectiveness of several psychological and pharmacological interventions to treat patients with PTSD. Although some psychological interventions produced significant decreases in traumatic stress symptoms and related psychopathology, limitations in the study methods precluded definitive guidelines for preventing PTSD in those exposed to trauma. Lack of definitive evidence on interventions to prevent PTSD in adults makes clinical and policy decision making challenging. Several psychological and pharmacological interventions can reduce symptoms of PTSD in adults, but what treatment to select for individual patients remains uncertain. Practical considerations such as access to care may dictate many clinical choices. Numerous interventions warrant additional investigation, especially in comparative trials. Subgroups require more attention to clarify which interventions are efficacious for different patient populations, and research methods must be strengthened.

The purpose of this project was to engage a diverse group of stakeholders (N=38) to help establish priorities to guide patient-centered outcomes research (PCOR) in serious mental illness.Three meetings, two Web-based and one on site, were held to generate and prioritize an initial list of topics. Topics were then sorted and organized into common themes.About 140 topics were identified and sorted into 21 main themes, ranked by priority. Three of the top four themes focused on how research was conducted, particularly the need to develop consensus measurement and outcomes definitions; improving infrastructure for research, longitudinal studies, and new data sets and investigators; and developing PCOR methodology. Stakeholders also identified a need to focus on service delivery, treatment settings, and structure of the delivery of care.Engagement by a broad group of stakeholders in a transparent process resulted in the identification of priority areas for PCOR. Stakeholders clearly indicated a need to fundamentally change how research on serious mental illness is conducted and a critical need for the development of methodology and infrastructure. Most current PCOR has been focused on relatively short-term outcomes, but real world, long-term studies providing guidance for treatment over the lifetime of a serious mental illness are needed.

The Authors Reply:—We thank Shapiro et al. for their comments concerning what role poor vision might have played in the results of the Short Test of Functional Health Literacy in Adults (S-TOFHLA) and thus classification of participants’ health literacy in our study—"A Randomized Controlled Trial of a Literacy-Sensitive Self-Management Intervention for Chronic Obstructive Pulmonary Disease Patients".1 We would like to clarify that we used the large print (14-point font) version of the S-TOFHLA and did not assess the participant’s vision or if they used corrective lenses before administering the S-TOFHLA. We did allow patients to opt out if they indicated their vision was not sufficient to take the test. During development and validation of the S-TOFHLA, participants with 20/70 to 20/100, which is classified as moderate vision loss based on ICD-9-CM, were administered the large print version and those with worse vision were excluded (three percent were excluded for vision worse than 20/100).2 In lay terms, a visual acuity of 20/100 means a person would require letters to be five times larger or closer to be able to read compared to 20/20 vision. Press et al. assessed participant’s vision in their study and classified vision as insufficient to complete the S-TOFHLA (large print version) if their acuity scores for both eyes were worse than 20/50.3 Although the cut point for poor vision is more stringent than required by the developers of the S-TOFHLA, such a high rate of poor vision (29 % in Press et al.) is an important clinical finding with important implications. Other estimates of poor vision are much lower (1.98 % of Americans older than age 40 have best corrected vision worse than 20/40).4 It is possible that the inpatient location of the Press et al. study contributed to the high prevalence of poor vision. Since we did not screen vision, we are unable to definitively say that vision did not affect our S-TOFHLA results. We agree with Press and colleagues that poor vision may be an underappreciated factor for many patients managing chronic diseases and that poor vision alone or in conjunction with low health literacy may require alternative interventions to improve outcomes. Another concern is that patients may have the visual acuity necessary to complete the S-TOFHLA (large print version), but have barriers to other elements of their health care such as reading prescription bottles or patient education handouts that may not have sufficient font style or size for their vision.

PURPOSE: To compare two techniques for eliciting and clarifying patient values for decision making about colorectal cancer (CRC) screening: choice-based conjoint analysis and a rating and ranking task. METHODS: Using our decision lab registry and university e-mail lists, we recruited average risk adults ages 48–75 for a written, mailed survey. Eligible participants were given basic information about CRC screening and six attributes of CRC screening tests, then randomized to complete either a choice-based conjoint analysis with 16 discrete choice tasks or a rating and ranking task. The main outcome was the most important attribute, as determined from conjoint analysis or participant ranking. Conjoint analysis-based most important attribute was determined from individual patient-level utilities generated using multinomial logistic regression and hierarchical Bayesian modeling. RESULTS: Of the 114 eligible participants, 104 completed and returned questionnaires. Mean age was 57 (range 48–73), 70% were female, 88% were white, 71% were college graduates, and 62% were up to date with CRC screening. Ability to reduce CRC incidence and mortality was the most frequent most important attribute for both the conjoint analysis (56% of respondents) and rating/ranking (76% of respondents) groups, and these proportions differed significantly between groups (absolute difference 20%, 95% CI 3%, 37%, p =0.03). There were no significant differences between groups in proportion with clear values (p = 0.352), intent to be screened (p = 0.226) or unlabelled test preference (p = 0.521) CONCLUSIONS: Choice-based conjoint analysis produced somewhat different patterns of attribute importance than a rating and ranking task, but had little effect on other outcomes. Refereed/Peer-reviewed

The Clinical and Translational Science Award (CTSA) Workgroup for Comparative Effectiveness Research (CER) Education, Training, and Workforce Development identified a need to delineate the competencies that practitioners and users of CER for patient‐centered outcomes research, should acquire. With input from CTSA representatives and collaborators, we began by describing the workforce. We recognize the workforce that conducts CER and the end users who use CER to improve the health of individuals and communities. We generated a preliminary set of competencies and solicited feedback from the CER representatives at each member site of the CTSA consortium. We distinguished applied competencies (i.e., skills needed by individuals who conduct CER) from foundational competencies that are needed by the entire CER workforce, including end users of CER. Key competency categories of relevance to both practitioners and users of CER were: (1) asking relevant research questions; (2) recognizing or designing ideal CER studies; (3) executing or using CER studies; (4) using appropriate statistical analyses for CER; and (5) communicating and disseminating CER study results to improve health. Although CER is particularly broad concept, we anticipate that these preliminary, relatively generic competencies will be used in tailoring curricula to individual learners from a variety of programmatic perspectives. Clin Trans Sci 2012; Volume 5: 476–479