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Objective To create a shared vision for the content, delivery, measurement, and sustainment of patient-centered high value care. Methods We performed a scoping review and translated findings into toolkit for system leaders. For our scoping review, we searched Medline, 2005-November 2015, for literature on patient-centered care (PCC) and its relationship to a high value care change model. We supplemented searches with key author, Google Scholar, and key website searches. One author reviewed all titles, abstracts, and articles for inclusion; another reviewed a random 20%. To develop our toolkit, we translated evidence into simple, actionable briefs on key topics and added resources. We then iteratively circulated briefs and the overall toolkit to potential users, making updates as needed. Results In our scoping review, we found multiple interventions and measures to support the components of PCC and our change model. We found little on the overall effects of PCC or how PCC creates value. Potential users reported our toolkit was simple, understandable, thorough, timely, and likely to be globally useful. Conclusions Considerable evidence supports patient-centered high value care and a toolkit garnered enthusiasm. Practice Implications The toolkit is ready for use, but needs comparison to other approaches.

Importance Office blood pressure (BP) measurements are not the most accurate method to diagnose hypertension. Home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM) are out-of-office alternatives, and ABPM is considered the reference standard for BP assessment. Objective To systematically review the accuracy of oscillometric office and home BP measurement methods for correctly classifying adults as having hypertension, defined using ABPM. Data Sources PubMed, Cochrane Library, Embase, ClinicalTrials.gov, and DARE databases and the American Heart Association website (from inception to April 2021) were searched, along with reference lists from retrieved articles. Data Extraction and Synthesis Two authors independently abstracted raw data and assessed methodological quality. A third author resolved disputes as needed. Main Outcomes and Measures Random effects summary sensitivity, specificity, and likelihood ratios (LRs) were calculated for BP measurement methods for the diagnosis of hypertension. ABPM (24-hour mean BP ≥130/80 mm Hg or mean BP while awake ≥135/85 mm Hg) was considered the reference standard. Results A total of 12 cross-sectional studies (n = 6877) that compared conventional oscillometric office BP measurements to mean BP during 24-hour ABPM and 6 studies (n = 2049) that compared mean BP on HBPM to mean BP during 24-hour ABPM were included (range, 117-2209 participants per analysis); 2 of these studies (n = 3040) used consecutive samples. The overall prevalence of hypertension identified by 24-hour ABPM was 49% (95% CI, 39%-60%) in the pooled studies that evaluated office measures and 54% (95% CI, 39%-69%) in studies that evaluated HBPM. All included studies assessed sensitivity and specificity at the office BP threshold of 140/90 mm Hg and the home BP threshold of 135/85 mm Hg. Conventional office oscillometric measurement (1-5 measurements in a single visit with BP ≥140/90 mm Hg) had a sensitivity of 51% (95% CI, 36%-67%), specificity of 88% (95% CI, 80%-96%), positive LR of 4.2 (95% CI, 2.5-6.0), and negative LR of 0.56 (95% CI, 0.42-0.69). Mean BP with HBPM (with BP ≥135/85 mm Hg) had a sensitivity of 75% (95% CI, 65%-86%), specificity of 76% (95% CI, 65%-86%), positive LR of 3.1 (95% CI, 2.2-4.0), and negative LR of 0.33 (95% CI, 0.20-0.47). Two studies (1 with a consecutive sample) that compared unattended automated mean office BP (with BP ≥135/85 mm Hg) with 24-hour ABPM had sensitivity ranging from 48% to 51% and specificity ranging from 80% to 91%. One study that compared attended automated mean office BP (with BP ≥140/90 mm Hg) with 24-hour ABPM had a sensitivity of 87.6% (95% CI, 83%-92%) and specificity of 24.1% (95% CI, 16%-32%). Conclusions and Relevance Office measurements of BP may not be accurate enough to rule in or rule out hypertension; HBPM may be helpful to confirm a diagnosis. When there is uncertainty around threshold values or when office and HBPM are not in agreement, 24-hour ABPM should be considered to establish the diagnosis.

Importance Vitamin D is a fat-soluble vitamin that performs an important role in calcium homeostasis and bone metabolism and also affects many other cellular regulatory functions outside the skeletal system. Vitamin D requirements may vary by individual; thus, no one serum vitamin D level cutpoint defines deficiency, and no consensus exists regarding the precise serum levels of vitamin D that represent optimal health or sufficiency. Objective To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on screening for vitamin D deficiency, including the benefits and harms of screening and early treatment. Population Community-dwelling, nonpregnant adults who have no signs or symptoms of vitamin D deficiency or conditions for which vitamin D treatment is recommended. Evidence Assessment The USPSTF concludes that the overall evidence on the benefits of screening for vitamin D deficiency is lacking. Therefore, the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults cannot be determined. Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. (I statement)

Importance Lung cancer is the second most common cancer and the leading cause of cancer death in the US. In 2020, an estimated 228 820 persons were diagnosed with lung cancer, and 135 720 persons died of the disease. The most important risk factor for lung cancer is smoking. Increasing age is also a risk factor for lung cancer. Lung cancer has a generally poor prognosis, with an overall 5-year survival rate of 20.5%. However, early-stage lung cancer has a better prognosis and is more amenable to treatment. Objective To update its 2013 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the accuracy of screening for lung cancer with low-dose computed tomography (LDCT) and on the benefits and harms of screening for lung cancer and commissioned a collaborative modeling study to provide information about the optimum age at which to begin and end screening, the optimal screening interval, and the relative benefits and harms of different screening strategies compared with modified versions of multivariate risk prediction models. Population This recommendation statement applies to adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Evidence Assessment The USPSTF concludes with moderate certainty that annual screening for lung cancer with LDCT has a moderate net benefit in persons at high risk of lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking. Recommendation The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. (B recommendation) This recommendation replaces the 2013 USPSTF statement that recommended annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.

Importance Carotid artery stenosis is atherosclerotic disease that affects extracranial carotid arteries. Asymptomatic carotid artery stenosis refers to stenosis in persons without a history of ischemic stroke, transient ischemic attack, or other neurologic symptoms referable to the carotid arteries. The prevalence of asymptomatic carotid artery stenosis is low in the general population but increases with age. Objective To determine if its 2014 recommendation should be reaffirmed, the US Preventive Services Task Force (USPSTF) commissioned a reaffirmation evidence review. The reaffirmation update focused on the targeted key questions on the potential benefits and harms of screening and interventions, including revascularization procedures designed to improve carotid artery blood flow, in persons with asymptomatic carotid artery stenosis. Population This recommendation statement applies to adults without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms referable to the carotid arteries. Evidence Assessment The USPSTF found no new substantial evidence that could change its recommendation and therefore concludes with moderate certainty that the harms of screening for asymptomatic carotid artery stenosis outweigh the benefits. Recommendation The USPSTF recommends against screening for asymptomatic carotid artery stenosis in the general adult population. (D recommendation)

Importance Tobacco use is the leading preventable cause of disease, disability, and death in the US. In 2014, it was estimated that 480 000 deaths annually are attributed to cigarette smoking, including second hand smoke exposure. Smoking during pregnancy can increase the risk of numerous adverse pregnancy outcomes (eg, miscarriage and congenital anomalies) and complications in the offspring (including sudden infant death syndrome and impaired lung function in childhood). In 2019, an estimated 50.6 million US adults (20.8% of the adult population) used tobacco; 14.0% of the US adult population currently smoked cigarettes and 4.5% of the adult population used electronic cigarettes (e-cigarettes). Among pregnant US women who gave birth in 2016, 7.2% reported smoking cigarettes while pregnant. Objective To update its 2015 recommendation, the USPSTF commissioned a review to evaluate the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons. Population This recommendation statement applies to adults 18 years or older, including pregnant persons. Evidence assessment The USPSTF concludes with high certainty that the net benefit of behavioral interventions and US Food and Drug Associated (FDA)-approved pharmacotherapy for tobacco smoking cessation, alone or combined, in nonpregnant adults who smoke is substantial. The USPSTF concludes with high certainty that the net benefit of behavioral interventions for tobacco smoking cessation on perinatal outcomes and smoking cessation in pregnant persons is substantial. The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons is insufficient because few studies are available, and the balance of benefits and harms cannot be determined. The USPSTF concludes that the evidence on the use of e-cigarettes for tobacco smoking cessation in adults, including pregnant persons, is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed, randomized clinical trials on e-cigarettes that report smoking abstinence or adverse events as a critical gap in the evidence. Recommendations The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and FDA-approved pharmacotherapy for cessation to nonpregnant adults who use tobacco. (A recommendation) The USPSTF recommends that clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who use tobacco. (A recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant persons. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults, including pregnant persons. The USPSTF recommends that clinicians direct patients who use tobacco to other tobacco cessation interventions with proven effectiveness and established safety. (I statement).

An estimated 862 000 persons in the US are living with chronic infection with hepatitis B virus (HBV). Persons born in regions with a prevalence of HBV infection of 2% or greater, such as countries in Africa and Asia, the Pacific Islands, and parts of South America, often become infected at birth and account for up to 95% of newly reported chronic infections in the US. Other high-prevalence populations include persons who inject drugs; men who have sex with men; persons with HIV infection; and sex partners, needle-sharing contacts, and household contacts of persons with chronic HBV infection. Up to 60% of HBV-infected persons are unaware of their infection, and many remain asymptomatic until onset of cirrhosis or end-stage liver disease.To update its 2014 recommendation, the USPSTF commissioned a review of new randomized clinical trials and cohort studies published from 2014 to August 2019 that evaluated the benefits and harms of screening and antiviral therapy for preventing intermediate outcomes or health outcomes and the association between improvements in intermediate outcomes and health outcomes. New key questions focused on the yield of alternative HBV screening strategies and the accuracy of tools to identify persons at increased risk.This recommendation statement applies to asymptomatic, nonpregnant adolescents and adults at increased risk for HBV infection, including those who were vaccinated before being screened for HBV infection.The USPSTF concludes with moderate certainty that screening for HBV infection in adolescents and adults at increased risk for infection has moderate net benefit.The USPSTF recommends screening for HBV infection in adolescents and adults at increased risk for infection. (B recommendation).

Importance Approximately 20 million new cases of bacterial or viral sexually transmitted infections (STIs) occur each year in the US, and about one-half of these cases occur in persons aged 15 to 24 years. Rates of chlamydial, gonococcal, and syphilis infection continue to increase in all regions. Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others. Serious consequences of STIs include pelvic inflammatory disease, infertility, cancer, and AIDS. Objective To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a review of the evidence on the benefits and harms of behavioral counseling interventions for preventing STI acquisition. Population This recommendation statement applies to all sexually active adolescents and to adults at increased risk for STIs. Evidence Assessment The USPSTF concludes with moderate certainty that behavioral counseling interventions reduce the likelihood of acquiring STIs in sexually active adolescents and in adults at increased risk, including for example, those who have a current STI, do not use condoms, or have multiple partners, resulting in a moderate net benefit. Recommendation The USPSTF recommends behavioral counseling for all sexually active adolescents and for adults at increased risk for STIs. (B recommendation)

Importance An estimated 12% of adults 18 years or older and 8% of adolescents aged 12 to 17 years report unhealthy use of prescription or illegal drugs in the US. Objective To update its 2008 recommendation, the USPSTF commissioned reviews of the evidence on screening by asking questions about drug use and interventions for unhealthy drug use in adults and adolescents. Population This recommendation statement applies to adults 18 years or older, including pregnant and postpartum persons, and adolescents aged 12 to 17 years in primary care settings. This statement does not apply to adolescents or adults who have a currently diagnosed drug use disorder or are currently undergoing or have been referred for drug use treatment. This statement applies to settings and populations for which services for accurate diagnosis, effective treatment, and appropriate care can be offered or referred. Evidence Assessment In adults, the USPSTF concludes with moderate certainty that screening by asking questions about unhealthy drug use has moderate net benefit when services for accurate diagnosis of unhealthy drug use or drug use disorders, effective treatment, and appropriate care can be offered or referred. In adolescents, because of the lack of evidence, the USPSTF concludes that the benefits and harms of screening for unhealthy drug use are uncertain and that the balance of benefits and harms cannot be determined. Recommendation The USPSTF recommends screening by asking questions about unhealthy drug use in adults 18 years or older. Screening should be implemented when services for accurate diagnosis, effective treatment, and appropriate care can be offered or referred. (Screening refers to asking questions about unhealthy drug use, not testing biological specimens.) (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for unhealthy drug use in adolescents. (I statement)

Importance In 2017, an estimated 7.9% of persons aged 12 to 17 years reported illicit drug use in the past month, and an estimated 50% of adolescents in the US had used an illicit drug by the time they graduated from high school. Young adults aged 18 to 25 years have a higher rate of current illicit drug use, with an estimated 23.2% currently using illicit drugs. Illicit drug use is associated with many negative health, social, and economic consequences and is a significant contributor to 3 of the leading causes of death among young persons (aged 10-24 years): unintentional injuries including motor vehicle crashes, suicide, and homicide. Objective To update its 2014 recommendation, the USPSTF commissioned a review of the evidence on the potential benefits and harms of interventions to prevent illicit drug use in children, adolescents, and young adults. Population This recommendation applies to children (11 years and younger), adolescents (aged 12-17 years), and young adults (aged 18-25 years), including pregnant persons. Evidence Assessment Because of limited and inadequate evidence, the USPSTF concludes that the benefits and harms of primary care–based interventions to prevent illicit drug use in children, adolescents, and young adults are uncertain and that the evidence is insufficient to assess the balance of benefits and harms. More research is needed. Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care–based behavioral counseling interventions to prevent illicit drug use, including nonmedical use of prescription drugs, in children, adolescents, and young adults. (I statement)

ObjectiveTo qualitatively analyse different types of dissemination of information during monthly group calls between researchers, providers and clinical staff used to establish best practices for implementing an asthma shared decision-making (SDM) intervention. Evaluating dissemination of information can provide a better understanding of how best practices are shared, informing implementation approaches to improve the uptake of new evidence and overcome barriers.Setting10 primary care practices in North Carolina.ParticipantsProviders and clinical staff participated in monthly group phone calls with researchers to share best practices during implementation of a SDM intervention for asthma patients.DesignThe research team transcribed and coded statements using content analysis into three different knowledge types: Knowledge Position, Knowledge Form and Knowledge Object. Knowledge Objects were further classified using directed content analysis where the research team interpreted the content objects through a classification process of identifying themes or patterns to describe three different types of dissemination of information: (A) Confirmation of Existing Knowledge, (B) Generation of New Knowledge and (C) Spreading of New Knowledge.ResultsAcross the 8 transcripts, 4 Knowledge Positions, 7 Knowledge Forms and 18 types of Knowledge Objects were identified. From the Knowledge Objects, Confirmation of Existing Knowledge occurred during the training of participating practices. The review also identified Generation of New Knowledge by providers and clinical staff raised in these calls. This Generation of New Knowledge was later documented being used by other practices with the identification of Spreading of New Knowledge.ConclusionThe research team described the types of dissemination of information that occurred between researchers, providers and clinical staff during implementation of an asthma SDM intervention. Both Confirmation of Existing Knowledge and Generation of New Knowledge in response to barriers occurred. These exploratory dissemination of information results provide additional mechanisms for evaluating implementation science.Trial registration numberNCT02047929; Post-results

Objective. To measure the association between health literacy and both patient-reported and clinical outcomes in patients with non–insulin-treated type 2 diabetes. Research Design and Methods. We surveyed patients with non–insulin-treated type 2 diabetes (n = 448) from 15 primary care practices. The association between health literacy and patient-reported and clinical outcomes, including numeracy of self-monitoring of blood glucose (SMBG) use, how often physicians advised patients to conduct SMBG testing, and glycemic control (as measured by A1C), was investigated. Results. Study participants included 448 patients with non–insulin-treated type 2 diabetes located within central North Carolina. Participants with limited health literacy had poorer glycemic control (A1C 7.7 ± 1.1% vs. 7.5 ± 1.0%, P = 0.016) despite using SMBG testing more frequently (daily SMBG testing 49.3 vs. 30.7%, P = 0.001) compared to individuals with adequate health literacy. The difference in how often physicians advised patients to conduct SMBG testing between limited and adequate health literacy groups was not significant (P = 0.68). Conclusion. Limited health literacy was associated with poorer glycemic control and an increased frequency of SMBG testing in patients with non–insulin-treated type 2 diabetes. There was no significant difference in how often physicians advised patients to conduct SMBG testing between patients with limited and adequate health literacy.

Importance US life expectancy and health outcomes for preventable causes of disease have continued to lag in many populations that experience racism. Objective To propose iterative changes to US Preventive Services Task Force (USPSTF) processes, methods, and recommendations and enact a commitment to eliminate health inequities for people affected by systemic racism. Design and evidence In February 2021, the USPSTF began operational steps in its work to create preventive care recommendations to address the harmful effects of racism. A commissioned methods report was conducted to inform this process. Key findings of the report informed proposed updates to the USPSTF methods to address populations adversely affected by systemic racism and proposed pilots on implementation of the proposed changes. Findings The USPSTF proposes to consider the opportunity to reduce health inequities when selecting new preventive care topics and prioritizing current topics; seek evidence about the effects of systemic racism and health inequities in all research plans and public comments requested, and integrate available evidence into evidence reviews; and summarize the likely effects of systemic racism and health inequities on clinical preventive services in USPSTF recommendations. The USPSTF will elicit feedback from its partners and experts and proposed changes will be piloted on selected USPSTF topics. Conclusions and relevance The USPSTF has developed strategies intended to mitigate the influence of systemic racism in its recommendations. The USPSTF seeks to reduce health inequities and other effects of systemic racism through iterative changes in methods of developing evidence-based recommendations, with partner and public input in the activities to implement the advancements.

Importance Preeclampsia is one of the most serious health problems that affect pregnant persons. It is a complication in approximately 4% of pregnancies in the US and contributes to both maternal and infant morbidity and mortality. Preeclampsia also accounts for 6% of preterm births and 19% of medically indicated preterm births in the US. There are racial and ethnic disparities in the prevalence of and mortality from preeclampsia. Non-Hispanic Black women are at greater risk for developing preeclampsia than other women and experience higher rates of maternal and infant morbidity and perinatal mortality. Objective To update its 2014 recommendation, the USPSTF commissioned a systematic review to evaluate the effectiveness of low-dose aspirin use to prevent preeclampsia. Population Pregnant persons at high risk for preeclampsia who have no prior adverse effects with or contraindications to low-dose aspirin. Evidence assessment The USPSTF concludes with moderate certainty that there is a substantial net benefit of daily low-dose aspirin use to reduce the risk for preeclampsia, preterm birth, small for gestational age/intrauterine growth restriction, and perinatal mortality in pregnant persons at high risk for preeclampsia. Recommendation The USPSTF recommends the use of low-dose aspirin (81 mg/d) as preventive medication for preeclampsia after 12 weeks of gestation in persons who are at high risk for preeclampsia. (B recommendation).

Importance Chlamydia and gonorrhea are among the most common sexually transmitted infections in the US. Infection rates are highest among adolescents and young adults of both sexes. Chlamydial and gonococcal infections in women are usually asymptomatic and may lead to pelvic inflammatory disease and its associated complications. Newborns of pregnant persons with untreated infection may develop neonatal chlamydial pneumonia or gonococcal or chlamydial ophthalmia. Infection in men may lead to urethritis and epididymitis. Both types of infection can increase risk of acquiring or transmitting HIV. Objective To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for chlamydia and gonorrhea in sexually active adolescents and adults, including pregnant persons. Population Asymptomatic, sexually active adolescents and adults, including pregnant persons. Evidence Assessment The USPSTF concludes with moderate certainty that screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection has moderate net benefit. The USPSTF concludes with moderate certainty that screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection has moderate net benefit. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men. Recommendation The USPSTF recommends screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF recommends screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men. (I statement)

Importance An estimated 13% of all US adults (18 years or older) have diabetes, and 34.5% meet criteria for prediabetes. The prevalences of prediabetes and diabetes are higher in older adults. Estimates of the risk of progression from prediabetes to diabetes vary widely, perhaps because of differences in the definition of prediabetes or the heterogeneity of prediabetes. Diabetes is the leading cause of kidney failure and new cases of blindness among adults in the US. It is also associated with increased risks of cardiovascular disease, nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis and was estimated to be the seventh leading cause of death in the US in 2017. Screening asymptomatic adults for prediabetes and type 2 diabetes may allow earlier detection, diagnosis, and treatment, with the ultimate goal of improving health outcomes. Objective To update its 2015 recommendation, the USPSTF commissioned a systematic review to evaluate screening for prediabetes and type 2 diabetes in asymptomatic, nonpregnant adults and preventive interventions for those with prediabetes. Population Nonpregnant adults aged 35 to 70 years seen in primary care settings who have overweight or obesity (defined as a body mass index ≥25 and ≥30, respectively) and no symptoms of diabetes. Evidence Assessment The USPSTF concludes with moderate certainty that screening for prediabetes and type 2 diabetes and offering or referring patients with prediabetes to effective preventive interventions has a moderate net benefit. Conclusions and Recommendation The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. Clinicians should offer or refer patients with prediabetes to effective preventive interventions. (B recommendation)

Importance Gestational diabetes is diabetes that develops during pregnancy. Prevalence of gestational diabetes in the US has been estimated at 5.8% to 9.2%, based on traditional diagnostic criteria, although it may be higher if more inclusive criteria are used. Pregnant persons with gestational diabetes are at increased risk for maternal and fetal complications, including preeclampsia, fetal macrosomia (which can cause shoulder dystocia and birth injury), and neonatal hypoglycemia. Gestational diabetes has also been associated with an increased risk of several long-term health outcomes in pregnant persons and intermediate outcomes in their offspring. Objective The USPSTF commissioned a systematic review to evaluate the accuracy, benefits, and harms of screening for gestational diabetes and the benefits and harms of treatment for the pregnant person and infant. Population Pregnant persons who have not been previously diagnosed with type 1 or type 2 diabetes. Evidence assessment The USPSTF concludes with moderate certainty that there is a moderate net benefit to screening for gestational diabetes at 24 weeks of gestation or after to improve maternal and fetal outcomes. The USPSTF concludes that the evidence on screening for gestational diabetes before 24 weeks of gestation is insufficient, and the balance of benefits and harms of screening cannot be determined. Recommendation The USPSTF recommends screening for gestational diabetes in asymptomatic pregnant persons at 24 weeks of gestation or after. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for gestational diabetes in asymptomatic pregnant persons before 24 weeks of gestation. (I statement).

Background For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting. Methods/Design Using stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control. Discussion This pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed. Trial registration ClinicalTrials.gov NCT02033499 , January 9, 2014.

INTRODUCTIONNearly one third of U.S. adults have hypertension (HTN), increasing their risk for cardiovascular morbidity and mortality (National Center for Health Statistics, 2013). The costs of HTN in the United states have been estimated to be $93.5 billion, including costs of healthcare services, medications, and missed work days (Heidenreich et al., 2011). Patients who adhere to therapeutic regimens can reduce their cardiovascularrelated risk (Estruch et al., 2006, 2013; Keyserling et al., 2014) and use of hospitals and emergency departments, thus positively affecting lives and better controlling these healthcare costs (Pittman, Tao, Chen, & Stettin, 2010). Identifying feasible and fiscally sound interventions to improve blood pressure (BP) control is a key objective for patients, physicians, and payers (Barton, Andronis, Briggs, McPherson, & Capewell, 2011; Keyserling et al., 2014; Kilpatrick et al., 2005) and may be of heightened importance in communities and medical practices with limited financial resources.As primary care practices shift their focus toward managing patient populations and ongoing performance improvement, data-driven quality improvement (QI) approaches to optimize BP control are attractive options to help guide the change process. Practice leaders can review the practice-based QI activities that are effective in improving BP metrics and adapt relevant strategies for their unique settings (Mueller, Purnell, Mensah, & Cooper, 2015; Shojania, McDonald, Wachter, & Owens, 2004; Walsh et al., 2006). However, providers and practice administrators also need to understand the costs their practices may incur in taking on these new endeavors.A limited number of publications describe the costs incurred by practices to implement practice improvement activities. Some authors calculate societal level costs, including patient, health system, and nonmedical costs (Allen, Dennison Himmelfarb, Szanton, & Frick, 2014; Brunenberg et al., 2007; Chung et al., 2014; Reed et al., 2010), whereas others describe practice level costs to finance individual programs such as a self-management support program (Hollenback, Weiner, & Turner, 2014; Schroeder, Fahey, Hollinghurst, & Peters, 2005).With this article, we add to the growing literature by detailing the practice level costs of participating in the National Heart, Lung, and Blood Institute-funded Heart Healthy Lenoir (HHL) HTN multilevel intervention cohort trial that took place in an economically distressed and rural region of North Carolina from 2010 to 2015 (North Carolina Department of Commerce, 2015). As part of the larger study, we performed an activity-based costing analysis for each of the four most engaged practices. We present information about how we engaged with various stakeholders to develop and implement the HHL intervention and describe the practice level costs incurred to cover staff time to perform key tasks.our objectives are twofold: (a) to describe the cost estimates such that primary care practice stakeholders have insights into potential expenses incurred when investing staff time and other resources in HTN QI initiatives and (b) to gain insights into the nature of the key Qi tasks staff members may need to perform.METHODSSettingThe HHL study is a practice-based multilevel QI effort designed to improve HTN control and to narrow racial disparities in HTN control in rural North carolina. We focused on this region because of the elevated rates of HTN, cardiovascular morbidity and mortality, noted racial disparities in HTN prevalence, relative economic distress, and existing collaborative community and healthcare infrastructure. Six primary care practices without experience in HTN QI work participated in the trial.Development of the HHL QI InterventionWe engaged with practice stakeholders and patients to develop the QI intervention. Our approach is based on our team's extensive experience in developing QI methods, processes, and tools (DeWalt et al. …

Background Comparative effectiveness of early rheumatoid arthritis (RA) treatments remains uncertain. Purpose Compare benefits and harms of biologic drug therapies for adults with early RA within 1 year of diagnosis. Data Sources English language articles from the 2012 review to October 2017 identified through MEDLINE, Cochrane Library and International Pharmaceutical Abstracts, gray literature, expert recommendations, reference lists of published literature, and supplemental evidence data requests. Study Selection Two persons independently selected studies based on predefined inclusion criteria. Data Extraction One reviewer extracted data; a second reviewer checked accuracy. Two independent reviewers assigned risk of bias ratings. Data Synthesis We identified 22 eligible studies with 9934 participants. Combination therapy with tumor necrosis factor (TNF) or non-TNF biologics plus methotrexate (MTX) improved disease control, remission, and functional capacity compared with monotherapy of either MTX or a biologic. Network meta-analyses found higher ACR50 response (50% improvement) for combination therapy of biologic plus MTX than for MTX monotherapy (relative risk range 1.20 [95% confidence interval (CI), 1.04 to 1.38] to 1.57 [95% CI, 1.30 to 1.88]). No significant differences emerged between treatment discontinuation rates because of adverse events or serious adverse events. Subgroup data (disease activity, prior therapy, demographics, serious conditions) were limited. Limitations Trials enrolled almost exclusively selected populations with high disease activity. Network meta-analyses were derived from indirect comparisons relative to MTX due to the dearth of head-to-head studies comparing interventions. No eligible data on biosimilars were found. Conclusions Qualitative and network meta-analyses suggest that the combination of MTX with TNF or non-TNF biologics reduces disease activity and improves remission when compared with MTX monotherapy. Overall adverse event and discontinuation rates were similar between treatment groups. Registration PROSPERO (available at http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017079260).

Author(s): US Preventive Services Task Force; Davidson, Karina W; Barry, Michael J; Mangione, Carol M; Cabana, Michael; Caughey, Aaron B; Davis, Esa M; Donahue, Katrina E; Doubeni, Chyke A; Krist, Alex H; Kubik, Martha; Li, Li; Ogedegbe, Gbenga; Pbert, Lori; Silverstein, Michael; Simon, Melissa; Stevermer, James; Tseng, Chien-Wen; Wong, John B | Abstract: ImportanceThe prevalence of overweight and obesity is increasing among persons of childbearing age and pregnant persons. In 2015, almost half of all persons began pregnancy with overweight (24%) or obesity (24%). Reported rates of overweight and obesity are higher among Black, Alaska Native/American Indian, and Hispanic women and lower among White and Asian women. Excess weight at the beginning of pregnancy and excess gestational weight gain have been associated with adverse maternal and infant health outcomes such as a large for gestational age infant, cesarean delivery, or preterm birth.ObjectiveThe USPSTF commissioned a systematic review to evaluate the benefits and harms of behavioral counseling interventions to prevent adverse health outcomes associated with obesity during pregnancy and to evaluate intermediate outcomes, including excess gestational weight gain. This is a new recommendation.PopulationPregnant adolescents and adults in primary care settings.Evidence assessmentThe USPSTF concludes with moderate certainty that behavioral counseling interventions aimed at promoting healthy weight gain and preventing excess gestational weight gain in pregnancy have a moderate net benefit for pregnant persons.RecommendationThe USPSTF recommends that clinicians offer pregnant persons effective behavioral counseling interventions aimed at promoting healthy weight gain and preventing excess gestational weight gain in pregnancy. (B recommendation).

Author(s): US Preventive Services Task Force; Krist, Alex H; Davidson, Karina W; Mangione, Carol M; Cabana, Michael; Caughey, Aaron B; Davis, Esa M; Donahue, Katrina E; Doubeni, Chyke A; Kubik, Martha; Li, Li; Ogedegbe, Gbenga; Pbert, Lori; Silverstein, Michael; Stevermer, James; Tseng, Chien-Wen; Wong, John B | Abstract: ImportanceHypertension is a prevalent condition that affects approximately 45% of the adult US population and is the most commonly diagnosed condition at outpatient office visits. Hypertension is a major contributing risk factor for heart failure, myocardial infarction, stroke, and chronic kidney disease.ObjectiveTo reaffirm its 2015 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for hypertension in adults, the accuracy of office blood pressure measurement for initial screening, and the accuracy of various confirmatory blood pressure measurement methods.PopulationAdults 18 years or older without known hypertension.Evidence assessmentUsing a reaffirmation deliberation process, the USPSTF concludes with high certainty that screening for hypertension in adults has substantial net benefit.RecommendationThe USPSTF recommends screening for hypertension in adults 18 years or older with office blood pressure measurement. The USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation before starting treatment. (A recommendation).

Importance Age-related sensorineural hearing loss is a common health problem among adults. Nearly 16% of US adults 18 years or older report difficulty hearing. The prevalence of perceived hearing loss increases with age. Hearing loss can adversely affect an individual’s quality of life and ability to function independently and has been associated with increased risk of falls, hospitalizations, social isolation, and cognitive decline. Objective To update its 2012 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on screening for hearing loss in adults 50 years or older. Population Asymptomatic adults 50 years or older with age-related hearing loss. Evidence Assessment Because of a lack of evidence, the USPSTF concludes that the benefits and harms of screening for hearing loss in asymptomatic older adults are uncertain and that the balance of benefits and harms cannot be determined. More research is needed. Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for hearing loss in older adults. (I statement)

Importance Cardiovascular disease (CVD) is a leading cause of death in the US. Known modifiable risk factors for CVD include smoking, overweight and obesity, diabetes, elevated blood pressure or hypertension, dyslipidemia, lack of physical activity, and unhealthy diet. Adults who adhere to national guidelines for a healthy diet and physical activity have lower cardiovascular morbidity and mortality than those who do not. All persons, regardless of their CVD risk status, benefit from healthy eating behaviors and appropriate physical activity. Objective To update its 2014 recommendation, the USPSTF commissioned a review of the evidence on behavioral counseling to promote a healthy diet and physical activity for CVD prevention in adults with cardiovascular risk factors. Population This recommendation statement applies to adults 18 years or older with known hypertension or elevated blood pressure, those with dyslipidemia, or those who have mixed or multiple risk factors such as metabolic syndrome or an estimated 10-year CVD risk of 7.5% or greater. Adults with other known modifiable cardiovascular risk factors such as abnormal blood glucose levels, obesity, and smoking are not included in this recommendation. Evidence Assessment The USPSTF concludes with moderate certainty that behavioral counseling interventions have a moderate net benefit on CVD risk in adults at increased risk for CVD. Recommendation The USPSTF recommends offering or referring adults with CVD risk factors to behavioral counseling interventions to promote a healthy diet and physical activity. (B recommendation)

Importance Prevalence of hypertension (both primary and secondary) in children and adolescents in the US ranges from 3% to 4%. Primary hypertension in children and adolescents occurs primarily in children older than 13 years and has no known cause but is associated with several risk factors, including family history and higher body mass index. Secondary hypertension occurs primarily in younger children and is most commonly caused by genetic disorders, renal disease, endocrine disorders, or cardiovascular abnormalities. Objective To update its 2013 recommendation, the USPSTF commissioned a review of the evidence on the benefits and harms of screening, test accuracy, the effectiveness and harms of treatment, and the association between hypertension and markers of cardiovascular disease in childhood and adulthood. Population This recommendation statement applies to children and adolescents aged 3 to 18 years not known to have hypertension or who are asymptomatic. Evidence Assessment The USPSTF concludes that the evidence to support screening for high blood pressure in children and adolescents is insufficient and that the balance of benefits and harms cannot be determined. Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for high blood pressure in children and adolescents. (I statement)

Importance Tobacco use is the leading cause of preventable death in the US. An estimated annual 480 000 deaths are attributable to tobacco use in adults, including from secondhand smoke. It is estimated that every day about 1600 youth aged 12 to 17 years smoke their first cigarette and that about 5.6 million adolescents alive today will die prematurely from a smoking-related illness. Although conventional cigarette use has gradually declined among children in the US since the late 1990s, tobacco use via electronic cigarettes (e-cigarettes) is quickly rising and is now more common among youth than cigarette smoking. e-Cigarette products usually contain nicotine, which is addictive, raising concerns about e-cigarette use and nicotine addiction in children. Exposure to nicotine during adolescence can harm the developing brain, which may affect brain function and cognition, attention, and mood; thus, minimizing nicotine exposure from any tobacco product in youth is important. Objective To update its 2013 recommendation, the USPSTF commissioned a review of the evidence on the benefits and harms of primary care interventions for tobacco use prevention and cessation in children and adolescents. The current systematic review newly included e-cigarettes as a tobacco product. Population This recommendation applies to school-aged children and adolescents younger than 18 years. Evidence Assessment The USPSTF concludes with moderate certainty that primary care–feasible behavioral interventions, including education or brief counseling, to prevent tobacco use in school-aged children and adolescents have a moderate net benefit. The USPSTF concludes that there is insufficient evidence to determine the balance of benefits and harms of primary care interventions for tobacco cessation among school-aged children and adolescents who already smoke, because of a lack of adequately powered studies on behavioral counseling interventions and a lack of studies on medications. Recommendation The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use among school-aged children and adolescents. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care–feasible interventions for the cessation of tobacco use among school-aged children and adolescents. (I statement)

Importance 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. Objective 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. Population This recommendation applies to pregnant persons without symptoms of bacterial vaginosis. Evidence Assessment 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. Conclusions and Recommendation 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)

Background Diabetes management is influenced by a number of factors beyond the individual-level. This study examined how neighborhood social disorganization (i.e., neighborhoods characterized by high economic disadvantage, residential instability, and ethnic heterogeneity), is associated with diabetes-related outcomes. Methods We used a multilevel modeling approach to investigate the associations between census-tract neighborhood social disorganization, A1c, and self-reported use of acute or emergency health care services for a sample of 424 adults with type 2 diabetes. Results Individuals living in neighborhoods with high social disorganization had higher A1c values than individuals living in neighborhoods with medium social disorganization (B = 0.39, p = 0.01). Individuals living in neighborhoods with high economic disadvantage had higher self-reported use of acute or emergency health care services than individuals living in neighborhoods with medium economic disadvantage (B = 0.60, p = 0.02). Conclusions High neighborhood social disorganization was associated with higher A1c values and high neighborhood economic disadvantage was associated with greater self-reported use of acute or emergency health care services. Controlling for individual level variables diminished this effect for A1c, but not acute or emergency health care use. Comprehensive approaches to diabetes management should include attention to neighborhood context. Failure to do so may help explain the continuing disproportionate diabetes burden in many neighborhoods despite decades of attention to individual-level clinical care and education. Trial registration For this study, we used baseline data from a larger study investigating the impacts on patient-centered outcomes of three different approaches to self-monitoring of blood glucose among 450 adults with non-insulin dependent type 2 diabetes living in North Carolina. This study was registered as a clinical trial on 1/7/2014 ( https://clinicaltrials.gov/ct2/show/NCT02033499 ).

OBJECTIVE: To compare three dissemination approaches for implementing an asthma shared decision-making (SDM) intervention into primary care practices. METHODS: We randomized thirty practices into three study arms: (1) a facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention. Patient perceptions of SDM were assessed in the active intervention arms using a one-question anonymous survey. Logistic regression models compared the frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions) between the three arms. RESULTS: We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites. Patients were more likely to report that they participated equally with the provider in making the treatment decision in the facilitator-led sites (75% vs. 66%, p = 0.001). Comparisons of outcomes for patients in the facilitator-led (n = 1,658) and lunch-and-learn (n = 2,613) arms respectively vs. control (n = 2,273) showed no significant differences for ED visits (Odds Ratio [OR] [95%CI] = 0.77[0.57–1.04]; 0.83[0.66–1.07]), hospitalizations (OR [95%CI] = 1.30[0.59–2.89]; 1.40 [0.68–3.06]), or oral steroids (OR [95%CI] = 0.95[0.79–1.15]; 1.03[0.81–1.06]). CONCLUSION: Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach. While there was no significant difference in health outcomes between the three arms, the results were most likely confounded by a concurrent statewide asthma initiative and the pragmatic implementation of the intervention. These results offer support for the use of structured approaches such as facilitator-led dissemination of complex interventions into primary care practices.

Background: As part of the Heart Healthy Lenoir Project, we developed a practice level intervention to improve blood pressure control. The goal of this study was: i) determine if single nucleotide polymorphisms (SNPs) that associate with blood pressure variation, identified in large case-control studies, are applicable to blood pressure control in subjects from a rural population; ii) measure the association of these SNPs with subjects’ responsiveness to the hypertension intervention; and iii) identify other SNPs that may help understand patient-specific responses to an intervention. Methods and Results: We used a combination of candidate SNPs and genome-wide analyses to test associations with either baseline systolic blood pressure (SBP) or change in systolic blood pressure one year after the intervention in two genetically defined ancestral groups: African Americans (AA) or Caucasian Americans (CAU). Of the 48 candidate SNPs, 13 SNPs associated with baseline SBP in our study; however, one candidate SNP, rs592582, also associated with a change in SBP after one year. Using our study data, we identified 4 and 15 additional loci that associated with a change in SBP in the AA and CAU groups, respectively. Our analysis of gene-age interactions identified genotypes associated with SBP improvement within different age groups of our populations. Moreover, our integrative analysis identified AQP4-AS1 and PADI2 as genes whose expression levels may contribute to the pleiotropy of complex traits involved in cardiovascular health and blood pressure regulation in response to an intervention targeting hypertension. Conclusions: Identification of SNPs associated with the success of a hypertension treatment intervention suggests that genetic factors in combination with age may contribute to an individual’s success in lowering SBP. If these findings prove to be applicable to other populations, the use of this genetic variation in making patient-specific interventions may help providers with making decisions to improve patient outcomes. Further investigation is required to determine the role of this genetic variance with respect to the management of hypertension such that more precise treatment recommendations may be made in the future as part of personalized medicine.

Background and Objectives: The I3 POP Collaborative sought to improve health of patients attending North Carolina, South Carolina, and Virginia primary care teaching practices using the triple aim framework of better quality, appropriate utilization, and enhanced patient experience. We examined change in triple aim measures over 3 years, and identified correlates of improvement. Methods: Twenty-nine teaching practices representing 23 residency programs participated. The Institute for Health Care Improvement Breakthrough Series Collaborative model was tailored to focus on at least one triple aim goal and programs submitted data annually on all collaborative measures. Outcome measures included quality (chronic illness, prevention); utilization (hospitalization, emergency department visits, referrals) and patient experience (access, continuity). Participant interviews explored supports and barriers to improvement. Results: Six of 29 practices (21%) were unable to extract measures from their electronic health records (EHR). All of the remaining 23 practices reported improvement in at least one measure, with 11 seeing at least 10% improvement; seven (24%) improved measures in all three triple aim areas, with two experiencing at least 10% improvement. Practices with a greater number of patient visits were more likely to show improved measures (odds ratio [OR] 10.8, 95% confidence interval [CI]: .68-172.2, P=0.03). Practice interviews revealed that engaged leadership and systems supports were more common in higher performing practices. Conclusions: Simultaneous attainment of improvement in all three triple aim goals by teaching practices is difficult. I3 POP practices that were able to pull and report data improved on at least one measure. Future work needs to focus on cultivating leadership and systems supporting large scale improvement.

Background: The National Committee for Quality Assurance patient-centered medical home recognition program provides practices an opportunity to implement medical home activities. Understanding the costs to apply for recognition may enable practices to plan their work. Methods: Practice coaches identified 5 exemplar practices (3 pediatric and 2 family medicine practices) that received level 3 recognition. This analysis focuses on 4 that received recognition in 2011. Clinical, informatics, and administrative staff participated in 2- to 3-hour interviews. We determined the time required to develop, implement, and maintain required activities. We categorized costs as (1) nonpersonnel, (2) developmental, (3) those used to implement activities, (4) those used to maintain activities, (5) those to document the work, and (6) consultant costs. Only incremental costs were included and are presented as costs per full-time equivalent (pFTE) provider. Results: Practice size ranged from 2.5 to 10.5 pFTE providers, and payer mixes ranged from 7% to 43% Medicaid. There was variation in the distribution of costs by activity by practice, but the costs to apply were remarkably similar ($11,453–15,977 pFTE provider). Conclusion: The costs to apply for 2011 recognition were noteworthy. Work to enhance care coordination and close loops were highly valued. Financial incentives were key motivators. Future efforts to minimize the burden of low-value activities could benefit practices.

Purpose Little is known about how perceived social standing versus traditional socioeconomic characteristics influence medication adherence and blood pressure (BP) among African American and white patients with hypertension in the rural southeastern United States. Methods Perceived social standing, socioeconomic characteristics, self-reported antihypertensive medication adherence, and BP were measured at baseline in a cohort of rural African American and white patients (n = 495) with uncontrolled hypertension attending primary care practices. Multivariate models examined the relationship of perceived social standing and socioeconomic indicators with medication adherence and systolic BP. Findings Medication nonadherence was reported by 40% of patients. Younger age [β = 0.20; P = .001], African American race [β = -0.30; P = .03], and lower perceived social standing [β = 0.08; P = .002] but not sex or traditional socioeconomic characteristics including education and household income, were significantly associated with lower medication adherence. Race-specific analyses revealed that this pattern was limited to African Americans and not observed in whites. In stepwise modeling, older age [β = 0.57, P = .001], African American race [β = 4.4; P = .03], and lower medication adherence [β = -1.7, P = .01] but not gender, education, or household income, were significantly associated with higher systolic BP. Conclusions Lower perceived social standing and age, but not traditional socioeconomic characteristics, were significantly associated with lower medication adherence in African Americans. Lower medication adherence was associated with higher systolic BP. These findings suggest the need for tailored, culturally relevant medication adherence interventions in rural communities.

Background: Engaging stakeholders in research carries the promise of enhancing the research relevance, transparency, and speed of getting findings into practice. By describing the context and functional aspects of stakeholder groups, like those working as community advisory boards (CABs), others can learn from these experiences and operationalize their own CABs. Our objective is to describe our experiences with diverse CABs affiliated with our community engagement group within our institution’s Clinical Translational Sciences Award (CTSA). We identify key contextual elements that are important to administering CABs. Methods: A group of investigators, staff, and community members engaged in a 6-month collaboration to describe their experiences of working with six research CABs. We identified the key contextual domains that illustrate how CABS are developed and sustained. Two lead authors, with experience with CABs and identifying contextual domains in other work, led a team of 13 through the process. Additionally, we devised a list of key tips to consider when devising CABs. Results: The final domains include (1) aligned missions among stakeholders (2) resources/support, (3) defined operational processes/shared power, (4) well-described member roles, and (5) understanding and mitigating challenges. The tips are a set of actions that support the domains. Conclusions: Identifying key contextual domains was relatively easy, despite differences in the respective CAB’s condition of focus, overall mission, or patient demographics represented. By contextualizing these five domains, other research and community partners can take an informed approach to move forward with CAB planning and engaged research.

Importance The value of self-monitoring of blood glucose (SMBG) levels in patients with non–insulin-treated type 2 diabetes has been debated. Objective To compare 3 approaches of SMBG for effects on hemoglobin A 1c levels and health-related quality of life (HRQOL) among people with non–insulin-treated type 2 diabetes in primary care practice. Design, Setting, and Participants The Monitor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non–insulin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A 1c ) levels higher than 6.5% but lower than 9.5% within the 6 months preceding screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. Of the 1032 assessed for eligibility, 450 were randomized. Interventions No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the meter. Main Outcomes and Measures Coprimary outcomes included hemoglobin A 1c levels and HRQOL at 52 weeks. Results A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A 1c levels across all 3 groups ( P = .74; estimated adjusted mean hemoglobin A 1c difference, SMBG with messaging vs no SMBG, −0.09%; 95% CI, −0.31% to 0.14%; SMBG vs no SMBG, −0.05%; 95% CI, −0.27% to 0.17%). There were also no significant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation. Conclusions and Relevance In patients with non–insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addition of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control. Trial Registration clinicaltrials.gov Identifier:NCT02033499

Background: Health coaching is increasingly important in patient-centered medical homes. Objectives: Describe formative evaluation results and lessons learned from implementing health coaching to improve hypertension self-management in rural primary care. Methods: A hypertension collaborative was formed consisting of six primary care sites. Twelve monthly health coaching phone calls were attempted for 487 participants with hypertension. Lessons Learned: Participant engagement was challenging; 58% remained engaged, missing fewer than three consecutive calls. Multivariate analyses revealed that older age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01–1.05), African American race (O,R 1.73; 95% CI, 1.15–2.60), greater number of comorbidities (OR, 1.17; 95% CI, 1.05–1.30) and receiving coaching closer to enrollment (OR, 5.03; 95% CI, 2.53–9.99) were correlated independently with engagement. Participants reported the coaching valuable; 96% would recommend health coaching to others. Conclusions: Health coaching in hypertension care can be successful strategy for engaging more vulnerable groups. A more tailored approach may improve engagement with counseling.

Primary care organizations must transform care delivery to realize the Institute for Healthcare Improvement's Triple Aim of better healthcare, better health, and lower healthcare costs. However, few studies have considered the financial implications for primary care practices engaged in transformation. In this qualitative, comparative case study, we examine the practice-level personnel and nonpersonnel costs and the benefits involved in transformational change among 12 primary care practices participating in North Carolina's Improving Performance in Practice (IPIP) program. We found average annual opportunity costs of $21,550 ($6,659 per full-time equivalent provider) for maintaining core IPIP activities (e.g., data management, form development and maintenance, meeting attendance). This average represents the cost of a 50% full-time equivalent registered nurse or licensed practical nurse. Practices were able to limit transformation costs by scheduling meetings during relatively slow patient care periods and by leveraging resources such as the assistance of IPIP practice coaches. Still, the costs of practice transformation were not trivial and would have been much higher in the absence of these efforts. Benefits of transformation included opportunities for enhanced revenue through reimbursement incentives and practice growth, improved efficiency and care quality, and maintenance of certification. Given the potentially high costs for some practices, policy makers may need to consider reimbursement and other strategies to help primary care practices manage the costs of practice redesign.

Chronic disease collaboratives help practices redesign care delivery. The North Carolina Improving Performance in Practice program provides coaches to guide implementation of 4 key practice changes: registries, planned care templates, protocols, and self-management support. Coaches rate progress using the Key Drivers Implementation Scales (KDIS). This study examines whether higher KDIS scores are associated with improved diabetes outcomes.We analyzed clinical and KDIS data from 42 practices. We modeled whether higher implementation scores at year 1 of participation were associated with improved diabetes measures during year 2. Improvement was defined as an increase in the proportion of patients with hemoglobin A1C values9%, blood pressure values130/80 mmHg, and low-density lipoprotein (LDL) levels100 mg/dL.Statistically significant improvements in the proportion of patients who met the LDL threshold were noted with higher "registry" and "protocol" KDIS scores. For hemoglobin A1C and blood pressure values, none of the odds ratios were statistically significant.Practices that implement key changes may achieve improved patient outcomes in LDL control among their patients with diabetes. Our data confirm the importance of registry implementation and protocol use as key elements of improving patient care. The KDIS tool is a pragmatic option for measuring practice changes that are rooted in the Chronic Care Model.

Although lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial.We conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35-79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up.We randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%.We have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.

PURPOSE Practice transformation is the cornerstone of the future of family medicine and health care reform, but little is known about how the process occurs. We sought to develop and test a model of the natural history of practice transformation. METHODS We developed an outcomes-based model of how a practice moves through practice transformation in 2 phases: (1) initial model created through meetings with collaborative experts and practice facilitators, and (2) clinical and practice systems change reports examined from the fi rst group of participating North Carolina Improving Performance In Practice practices to test and further refi ne the model. RESULTS The resultant model described motivators and supports to trans- formation. Three emerging practice patterns were identifi ed with the model: transformed practices experiencing robust improvement, activated practices with moderate change, and engaged practices with minimal change in mea- sured quality over a 2-year period. Transformed practices showed broad-based improvement; some reached a threshold and others continued to improve. These practices had highly engaged leadership and used data to drive decisions. Acti- vated practices had a slower improvement trajectory, usually encountering a barrier that took time to overcome (eg, extracting population data, spreading practice changes). Engaged practices did not improve or were unable to sustain change; despite good intentions, multiple competing distractions interfered with practice transformation. CONCLUSIONS Practice transformation is a continuous and long-term process. Internal and external practice motivations and specifi c practice supports provided by a community-based quality improvement program appear to have an impact on engagement, rate of quality improvement, and long-term sustainability. Early successes play a key role as practices learn how to change their performance.

Objective Lower health literacy is associated with poorer health outcomes. Few interventions poised to mitigate the impact of health literacy in hypertensive patients have been published. We tested if a multi-level quality improvement intervention could differentially improve Systolic Blood Pressure (SBP) more so in patients with low vs. higher health literacy. Methods We conducted a non-randomized prospective cohort trial of 525 patients referred with uncontrolled hypertension. Stakeholder informed and health literacy sensitive strategies were implemented at the practice and patient level. Outcomes were assessed at 0, 6, 12, 18 and 24 months. Results At 12 months, the low and higher health literacy groups had statistically significant decreases in mean SBP (6.6 and 5.3 mmHg, respectively), but the between group difference was not significant (Δ 1.3 mmHg, P = 0.067). At 24 months, the low and higher health literacy groups reductions were 8.1 and 4.6 mmHg, respectively, again the between group difference was not significant (Δ 3.5 mmHg, p = 0.25). Conclusions/practice implications A health literacy sensitive multi-level intervention may equally lower SBP in patients with low and higher health literacy. Practical health literacy appropriate tools and methods can be implemented in primary care settings using a quality improvement approach.

Purpose: This study describes the effects of the collaboration between the South East Area Health Education Center and Improving Performance in Practice (IPIP) on the improvement in quality markers in chronic disease states in a southeastern North Carolina family practice. Methods: Teams were created throughout 6 counties to implement strategies at biweekly quality team meetings that would ultimately improve patient quality, as measured by adherence to IPIP benchmarks. Grant-funded cash incentives were given to the practice to create a chronic care registry. Quarterly learning network meetings encouraged the exchange of quality improvement techniques. Results: The practice9s quality team succeeded in creating a chronic care registry, improving patient care as measured by benchmark chronic disease states, and extending this knowledge to other areas of their practice. Discussion: With mounting economic barriers to quality preventive services and medical access of any kind, the quality improvement in diabetic care and asthma is notable. The SEAHEC collaborative helped the practice achieve better results in approaching quality benchmarks than state averages, despite serving a more economically challenged population.

Care management (CM) is a promising team-based, patient-centered approach “designed to assist patients and their support systems in managing medical conditions more effectively.” As little is known about its implementation, this article describes CM implementation and associated lessons from 12 Agency for Healthcare Research and Quality–sponsored projects. Two rounds of data collection resulted in project-specific narratives that were analyzed using an iterative approach analogous to framework analysis. Informants also participated as coauthors. Variation emerged across practices and over time regarding CM services provided, personnel delivering these services, target populations, and setting(s). Successful implementation was characterized by resource availability (both monetary and nonmonetary), identifying as well as training employees with the right technical expertise and interpersonal skills, and embedding CM within practices. Our findings facilitate future context-specific implementation of CM within medical homes. They also inform the development of medical home recognition programs that anticipate and allow for contextual variation.

Background: Lower adherence to anti-hypertensive medications contributes to sub-optimal patient outcomes, yet there are few successful interventions in rural primary care that target improved adherence. The purpose of this study was to determine whether a multi-component quality improvement intervention that included literacy-sensitive health coaching with motivational interviewing was associated with improved medication adherence and reductions in blood pressure (BP) in patients with a history of uncontrolled hypertension (HTN). Methods: Adult patients in six rural primary care settings with one or more visits in the last year with a systolic BP > 150 mmHg were recruited. Project faculty facilitated systematic changes in care delivery in local practices. Patients also received monthly phone-based literacy-sensitive health coaching including a focus on medication adherence, and a BP cuff for home monitoring. Data regarding medication adherence (Morisky Medication Adherence Scale-8) and BP were collected at baseline, 6, 12, 18, and 24 months. Linear mixed effects modeling was used to determine the effects of the multi-component intervention on medication adherence and whether changes in medication adherence were associated with changes in systolic and diastolic BP. Results: There were 477 patients enrolled; the majority were female, black, and reported an annual household income of < $40,000. At baseline, 39% of the patients had low medication adherence (MMAS-8 score < 6). In linear mixed effects models, the intervention resulted in modest increases in medication adherence [5.75 ± 1.37 at baseline to 5.94 ± 1.33 at 24 months (p = .04)]. Corresponding changes in BP were: from 138.6 ± 21.8/81.6 ± 12.9 mmHg at baseline to 132.7 ± 19.5/76.1 ± 14.5 mmHg at 24 months follow-up [mean 0.22-0.25/0.24-0.26 mmHg per month before and after adjustment for covariates (p < .001)]. Changes in medication adherence were significantly associated with reductions in diastolic BP longitudinally (p = .047). Conclusion: A practice-based quality improvement intervention that includes health coaching is associated with improvements in medication adherence and BP, and offers promise as a clinically applicable intervention in rural primary care.

Background Because residents of the southeastern United States experience disproportionally high rates of cardiovascular disease (CVD), it is important to develop effective lifestyle interventions for this population. Methods The primary objective was to develop and evaluate a dietary, physical activity (PA) and weight loss intervention for residents of the southeastern US. The intervention, given in eastern North Carolina, was evaluated in a 2 year prospective cohort study with an embedded randomized controlled trial (RCT) of a weight loss maintenance intervention. The intervention included: Phase I (months 1–6), individually-tailored intervention promoting a Mediterranean-style dietary pattern and increased walking; Phase II (months 7–12), option of a 16-week weight loss intervention for those with BMI ≥ 25 kg/m2 offered in 2 formats (16 weekly group sessions or 5 group sessions and 10 phone calls) or a lifestyle maintenance intervention; and Phase III (months 13–24), weight loss maintenance RCT for those losing ≥ 8 lb with all other participants receiving a lifestyle maintenance intervention. Change in diet and PA behaviors, CVD risk factors, and weight were assessed at 6, 12, and 24 month follow-up. Results Baseline characteristics (N = 339) were: 260 (77 %) females, 219 (65 %) African Americans, mean age 56 years, and mean body mass index 36 kg/m2. In Phase I, among 251 (74 %) that returned for 6 month follow-up, there were substantial improvements in diet score (4.3 units [95 % CI 3.7 to 5.0]), walking (64 min/week [19 to 109]), and systolic blood pressure (−6.4 mmHg [−8.7 to −4.1]) that were generally maintained through 24 month follow-up. In Phase II, 138 (57 group only, 81 group/phone) chose the weight loss intervention and at 12 months, weight change was: −3.1 kg (−4.9 to −1.3) for group (N = 50) and −2.1 kg (−3.2 to −1.0) for group/phone combination (N = 75). In Phase III, 27 participants took part in the RCT. At 24 months, weight loss was −2.1 kg (−4.3 to 0.0) for group (N = 51) and −1.1 kg (−2.7 to 0.4) for combination (N = 72). Outcomes for African American and whites were similar. Conclusions The intervention yielded substantial improvement in diet, PA, and blood pressure, but weight loss was modest. Trial registration clinicaltrials.gov Identifier: NCT01433484 Electronic supplementary material The online version of this article (doi:10.1186/s12889-016-3370-9) contains supplementary material, which is available to authorized users.

BACKGROUND: Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has considerably changed treatment options for rheumatoid arthritis (RA) over the past decade. Very little information is available on comparative discontinuation rates of the biologics. OBJECTIVE: To compare treatment discontinuations for 9 biologic DMARDs in adults with RA. METHODS: We searched electronic databases through May 2012 to retrieve randomized controlled trials (RCTs) of patients with RA that compared biologic DMARDs with placebo or another biologic DMARD. The primary outcome was treatment discontinuation during the blinded phase of the trials, measured as overall withdrawals, withdrawals resulting from lack of efficacy, and withdrawals resulting from adverse events. Random-effects meta-analysis estimated the effect size for individual agents, and adjusted indirect comparisons were made between biologics using mixed treatment comparisons (MTC) meta-analysis. RESULTS: Forty-four trials were included in the analysis. In comparison with placebo, biologics were less likely to be withdrawn because of lack of efficacy (OR 0.22, 95% CI 0.17 to 0.27) and more likely to be withdrawn because of an adverse event (OR 1.41, 95% CI 1.16 to 1.70). Based on the MTC, certolizumab had the most favorable overall withdrawal profile, followed by etanercept and rituximab. Certolizumab had lower relative withdrawal rates resulting from lack of efficacy than adalimumab, anakinra, and infliximab. Anakinra had higher relative withdrawal rates resulting from lack of efficacy than most other biologics. Certolizumab and infliximab had more, while etanercept had fewer, withdrawals because of adverse events than most other drugs. CONCLUSIONS: Based on MTC using data from RCTs, differences in discontinuation rates were observed, generally favoring certolizumab, etanercept, and rituximab over other biologic DMARDs. These potential differences need to be further explored in head-to-head trials or well-conducted observational studies.