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Shared decision making (SDM) may result in treatment plans that best reflect the goals and wishes of patients, increasing patient satisfaction with the decision-making process. There is a knowledge gap to support the use of decision aids in SDM for anticoagulation therapy in patients with atrial fibrillation (AF). We describe the development and testing of a new decision aid, including a multicenter, randomized, controlled, 2-arm, open-label ENHANCE-AF clinical trial (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention) to evaluate its effectiveness in 1,200 participants.Participants will be randomized to either usual care or to a SDM pathway incorporating a digital tool designed to simplify the complex concepts surrounding AF in conjunction with a clinician tool and a non-clinician navigator to guide the participants through each step of the tool. The participant-determined primary outcome for this study is the Decisional Conflict Scale, measured at 1 month after the index visit during which a decision was made regarding anticoagulation use. Secondary outcomes at both 1 and 6 months will include other decision making related scales as well as participant and clinician satisfaction, oral anticoagulation adherence, and a composite rate of major bleeding, death, stroke, or transient ischemic attack. The study will be conducted at four sites selected for their ability to enroll participants of varying racial and ethnic backgrounds, health literacy, and language skills. Participants will be followed in the study for 6 months.The results of the ENHANCE-AF trial will determine whether a decision aid facilitates high quality shared decision making in anticoagulation discussions for stroke reduction in AF. An improved shared decision-making experience may allow patients to make decisions better aligned with their personal values and preferences, while improving overall AF care.

Background Shared decision-making (SDM) is an approach in which patients and clinicians act as partners in making medical decisions. Patients receive the information needed to decide and are encouraged to balance risks, benefits, and preferences. Informative materials are vital to SDM. Atrial fibrillation (AF) is the most common cardiac arrhythmia and responsible for 10% of ischemic strokes, however 1/3 of patients are not on appropriate anticoagulation. Decision sharing may facilitate treatment acceptance, improving outcomes. Aims To develop a framework of the components needed to create novel SDM tools and to provide practical examples through a case-study of stroke prevention in AF. Methods We analyze the design values of a web-based SDM tool created to better inform AF patients about anticoagulation. The tool was developed in partnership with patient advocates, multi-disciplinary investigators, and private design firms. It was refined through iterative, recursive testing in patients with AF. Its effectiveness is being evaluated in a multisite clinical trial led by Stanford University and sponsored by the American Heart Association. Findings The main components considered when creating the Stanford AFib tool included: design and software; content identification; information delivery; inclusive communication, user engagement; patient feedback; clinician experience; and anticipation of implementation and dissemination. We also highlight the ethical principles underlying SDM; matters of diversity and inclusion, linguistic variety, accessibility, and health literacy. The Stanford AFib Guide patient tool is available at: https://afibguide.com and the clinician tool at https://afibguide.com/clinician. Conclusion Attention to a range of vital development and design factors can facilitate tool adoption and information acquisition by diverse cultural, educational, and socioeconomic subpopulations. With thoughtful design, digital tools may decrease decision regret and improve treatment outcomes across many decision-making situations in healthcare.

Nearly 80% of new cases of myopia arise between 9 and 13 years old when puberty development also progresses rapidly. However, little is known about the association between myopia and puberty. We aim to evaluate the association between myopia and menarche, the most important puberty indicator for girls, and to test whether menarche could modify the effects of myopia-related behaviors. The participants came from two consecutive national surveys conducted in 30 provinces in mainland China in 2010 and 2014. We included 102,883 girls (61% had experienced menarche) aged 10–15 years. Risk behaviors for myopia which included sleep duration, homework time, and outdoor activity were measured by self-administrated questionnaire. Myopia was defined according to a validated method, and its relationships with menarche status and behaviors were evaluated by robust Poisson regression models based on generalized estimated equation adjusting for cluster effect of school. We found that postmenarche girls were at 13% (95% confidence interval: 11%–16%) higher risk of myopia than premenarche girls, after adjusting for exact age, urban–rural location, survey year, and four behavioral covariates. Short sleep duration (1 h/d) and low frequency of weekend outdoor activity tended to be stronger (with higher prevalence ratios associated with myopia) risk factors for myopia in postmenarche girls than in premenarche girls, and their interaction with menarche status was all statistically significant (P < 0.05). Overall, our study suggests that menarche onset may be associated with increased risk of myopia among school-aged girls and could also enhance girls’ sensitivity to myopia-related risk behaviors.

AIMS –: To determine the association with cardiovascular (CV) outcomes of sodium glucose cotransporter-2 (SGLT-2) inhibitors compared with dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). MATERIALS AND METHODS –: We conducted a population-based cohort study of new users of SGLT-2 inhibitors and DPP-4 inhibitors with T2DM and CKD using data from Optum Clinformatics DataMart. We assembled three cohorts: T2DM/no CKD, T2DM/CKD 1–2, and T2DM/ CKD 3a. Study outcomes were 1) time to first heart failure (HF) hospitalization; and 2) time to a composite CV endpoint comprised of non-fatal myocardial infarction (MI) or stroke. After inverse probability of treatment weighting, we used proportional hazards regression to estimate hazard ratios (HR) and 95% confidence intervals (CI). RESULTS –: New users of SGLT-2 inhibitors versus of DPP-4 inhibitors had lower risks of HF hospitalization in the T2DM/no CKD (HR, 0.76; 95% CI, 0.70, 0.82) and T2DM/CKD 1–2 (HR, 0.63; 95% CI, 0.48, 0.84), but no significant association was present in the T2DM/CKD 3a cohort. Compared with prescription of DPP-4 inhibitors, SGLT-2 inhibitors were associated with lower risks of non-fatal MI or stroke of 23% (HR, 0.77; 95% CI, 0.70, 0.85) in the T2DM/no CKD cohort, but no significant associations were present in the T2DM/CKD 1–2 and T2DM/CKD 3a cohorts. CONCLUSIONS –: Incident prescription of SGLT-2 inhibitors was associated with lower risks of HF hospitalization but not with non-fatal MI or stroke despite suggesting benefit, relative to prescription of DPP-4 inhibitor across different stages of CKD.

Digital health tools (DHT) are increasingly poised to change healthcare delivery given the Coronavirus Disease 2019 (COVID-19) pandemic and the drive to telehealth. Establishing the potential utility of a given DHT could aid in identifying how it could be best used and further opportunities for healthcare improvement. We propose a metric, a Utility Factor Score, which quantifies the benefits of a DHT by explicitly defining adherence and linking it directly to satisfaction and health goals met. To provide data for how the comparative utility score can or should work, we illustrate in detail the application of our metrics across four DHTs with two simulated users. The Utility Factor Score can potentially facilitate integration of DHTs into various healthcare settings and should be evaluated within a clinical study.

Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.

Introduction: Women, ethnic, and racial group representation in clinical trials is low or uncertain in various fields of medicine. Hypothesis: Ethnic/racial information is underreported in atrial fibrillation clinical Trials. Methods: We systematically reviewed 85 randomized atrial fibrillation clinical trials (RCT), published with results on ClinicalTrials.gov, encompassing 2,546,351 participants from January 2011 to May 2021. We determined the representation of women and ethnic/racial groups, and the frequency of information reporting. Results: All of the studies reported gender information; women represented 33.73% of the participants. Only 56.5% (48/75) reported racial/ethnic data. The distribution of the participants were 87% White and 5.1% Black. Data on Latinx were reported in 38% (33/85) of RCTs and represented 5% of reported samples. Only 3.8% of participants were Asian and reported in 34 studies. Ethnic and racial group underrepresentation and underreporting were observed in trials involving device/procedure as well as drug therapy, with more underrepresentation and underreporting observed in drug therapy trials (Table). Conclusions: Gender reporting is consistent for all RCTs but with women representing only one-third of participants. However, the ethnic and racial characteristics, particularly in drug therapy trials, are underreported. In RCTs that report ethnic and racial data, Black and Latinx patients are underrepresented compared to their proportion in the overall population. These limitations may significantly impact the generalizability of the RCT results.

Background Multimorbidity is the co-occurrence of two or more chronic diseases. Objective This study, based on self-reported medical diagnosis, aims to investigate the dynamic distribution of multimorbidity across sociodemographic levels and its impacts on health-related issues over 15 years in Brazil using national data. Methods Data were analyzed using descriptive statistics, hypothesis tests, and logistic regression. The study sample comprised 679,572 adults (18-59 years of age) and 115,699 elderly people (≥60 years of age) from the two latest cross-sectional, multiple-cohort, national-based studies: the National Sample Household Survey (PNAD) of 1998, 2003, and 2008, and the Brazilian National Health Survey (PNS) of 2013. Results Overall, the risk of multimorbidity in adults was 1.7 times higher in women (odds ratio [OR] 1.73, 95% CI 1.67-1.79) and 1.3 times higher among people without education (OR 1.34, 95% CI 1.28-1.41). Multiple chronic diseases considerably increased with age in Brazil, and people between 50 and 59 years old were about 12 times more likely to have multimorbidity than adults between 18 and 29 years of age (OR 11.89, 95% CI 11.27-12.55). Seniors with multimorbidity had more than twice the likelihood of receiving health assistance in community services or clinics (OR 2.16, 95% CI 2.02-2.31) and of being hospitalized (OR 2.37, 95% CI 2.21-2.56). The subjective well-being of adults with multimorbidity was often worse than people without multiple chronic diseases (OR=12.85, 95% CI: 12.07-13.68). These patterns were similar across all 4 cohorts analyzed and were relatively stable over 15 years. Conclusions Our study shows little variation in the prevalence of the multimorbidity of chronic diseases in Brazil over time, but there are differences in the prevalence of multimorbidity across different social groups. It is hoped that the analysis of multimorbidity from the two latest Brazil national surveys will support policy making on epidemic prevention and management.

RATIONALE AND OBJECTIVE: The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in those with and without CKD. STUDY DESIGN: Neuroimaging substudy of a randomized trial. SETTING & PARTICIPANTS: A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). INTERVENTION: Participants were randomly assigned to intensive (systolic BP 30 mg/g (N=151), the effects of intensive versus standard BP treatment on change in global cerebral blood flow, WMLs and total brain volume were 1.91 ml/100g/min (95% CI −3.01, 6.82), 0.003 cm(3) (asinh transformed, 95% CI −0.13, 0.13), and −7.0 cm(3) (95% CI −13.3, −0.3), respectively. The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04). LIMITATIONS: Measurement variability due to multi-site design. CONCLUSIONS: Among hypertensive adults with primarily early kidney disease, intensive versus standard blood pressure treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive blood pressure treatment targets on brain health in persons with early kidney disease. FUNDING: The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: SPRINT was registered at ClinicalTrials.gov with the study number NCT01206062.

Background: Early heart failure (HF) recognition can reduce morbidity, yet HF is often initially diagnosed only after a patient clinically worsens. We sought to identify characteristics that predict diagnosis in the acute care setting versus the outpatient setting. Methods: We estimated the proportion of incident HF diagnosed in the acute care setting (inpatient hospital or emergency department) versus outpatient setting based on diagnostic codes from a claims database covering commercial insurance and Medicare Advantage between 2003 and 2019. After excluding new-onset HF potentially caused by a concurrent acute cause (eg, acute myocardial infarction), we identified demographic, clinical, and socioeconomic predictors of diagnosis setting. Patients were linked to their primary care clinicians to evaluate diagnosis setting variation across clinicians. Results: Of 959 438 patients with new HF, 38% were diagnosed in acute care. Of these, 46% had potential HF symptoms in the prior 6 months. Over time, the relative odds of acute care diagnosis increased by 3.2% annually after adjustment for patient characteristics (95% CI, 3.1%–3.3%). Acute care diagnosis setting was more likely for women compared with men (adjusted odds ratio, 1.11 [95% CI, 1.10–1.12]) and for Black patients compared with White patients (adjusted odds ratio, 1.18 [95% CI, 1.16–1.19]). The proportion of acute care diagnosis varied substantially (interquartile range: 24%–39%) among clinicians after adjusting for patient-level risk factors. Conclusions: A large proportion of first HF diagnoses occur in the acute care setting, particularly among women and Black patients, yet many had potential HF symptoms in the months before acute care visits. These results raise concerns that many HF diagnoses are missed in the outpatient setting. Earlier diagnosis could allow for timelier high-value interventions, addressing disparities and reducing the progression of HF.

BACKGROUND About 1 in 3 adults aged 65 and older falls annually. Exercise interventions are effective in reducing the fall risk and fall rate among older adults. In 2020, startup company Age Bold Inc. disseminated the Bold Fall Prevention Program, aiming to reduce falls among older adults through a remotely delivered, digital exercise program. OBJECTIVE We conducted a feasibility study to assess the delivery of the Bold Fall Prevention Program remotely and evaluate the program's impact on 2 primary outcomes—annualized fall rate and weekly minutes of physical activity (PA)—over 6 months of follow-up. METHODS Older adults at high risk of falling were screened and recruited for the feasibility study via nationwide digital advertising strategies. Self-reported outcomes were collected via surveys administered at the time of enrollment and after 3 and 6 months. Responses were used to calculate changes in the annualized fall rate and minutes of PA per week. RESULTS The remote delivery of a progressive digital fall prevention program and associated research study, including remote recruitment, enrollment, and data collection, was deemed feasible. Participants successfully engaged at home with on-demand video exercise classes, self-assessments, and online surveys. We enrolled 65 participants, of whom 48 (74%) were women, and the average participant age was 72.6 years. Of the 65 participants, 54 (83%) took at least 1 exercise class, 40 (62%) responded to at least 1 follow-up survey at either 3 or 6 months, 20 (31%) responded to both follow-up surveys, and 25 (39%) were lost to follow-up. Among all participants who completed at least 1 follow-up survey, weekly minutes of PA increased by 182% (ratio change=2.82, 95% CI 1.26-6.37, n=35) from baseline and annualized falls per year decreased by 46% (incidence rate ratio [IRR]=0.54, 95% CI 0.32-0.90, n=40). Among only 6-month survey responders (n=31, 48%), weekly minutes of PA increased by 206% (ratio change=3.06, 95% CI 1.43-6.55) from baseline to 6 months (n=30, 46%) and the annualized fall rate decreased by 28% (IRR=0.72, 95% CI 0.42-1.23) from baseline to 6 months. CONCLUSIONS The Bold Fall Prevention Program provides a feasible strategy to increase PA and reduce the burden of falls among older adults.

BACKGROUND Multimorbidity is the co-occurrence of two or more chronic diseases. OBJECTIVE This study, based on self-reported medical diagnosis, aims to investigate the dynamic distribution of multimorbidity across sociodemographic levels and its impacts on health-related issues over 15 years in Brazil using national data. METHODS Data were analyzed using descriptive statistics, hypothesis tests, and logistic regression. The study sample comprised 679,572 adults (18-59 years of age) and 115,699 elderly people (≥60 years of age) from the two latest cross-sectional, multiple-cohort, national-based studies: the National Sample Household Survey (PNAD) of 1998, 2003, and 2008, and the Brazilian National Health Survey (PNS) of 2013. RESULTS Overall, the risk of multimorbidity in adults was 1.7 times higher in women (odds ratio [OR] 1.73, 95% CI 1.67-1.79) and 1.3 times higher among people without education (OR 1.34, 95% CI 1.28-1.41). Multiple chronic diseases considerably increased with age in Brazil, and people between 50 and 59 years old were about 12 times more likely to have multimorbidity than adults between 18 and 29 years of age (OR 11.89, 95% CI 11.27-12.55). Seniors with multimorbidity had more than twice the likelihood of receiving health assistance in community services or clinics (OR 2.16, 95% CI 2.02-2.31) and of being hospitalized (OR 2.37, 95% CI 2.21-2.56). The subjective well-being of adults with multimorbidity was often worse than people without multiple chronic diseases (OR=12.85, 95% CI: 12.07-13.68). These patterns were similar across all 4 cohorts analyzed and were relatively stable over 15 years. CONCLUSIONS Our study shows little variation in the prevalence of the multimorbidity of chronic diseases in Brazil over time, but there are differences in the prevalence of multimorbidity across different social groups. It is hoped that the analysis of multimorbidity from the two latest Brazil national surveys will support policy making on epidemic prevention and management.

The impact of agonist dose and of physician, staff and patient engagement on treatment have not been evaluated together in an analysis of treatment for opioid use disorder. Our hypotheses were that greater agonist dose and therapeutic engagement would be associated with reduced illicit opiate use in a time-dependent manner. Publicly-available treatment data from six buprenorphine efficacy and safety trials from the Federally-supported Clinical Trials Network were used to derive treatment variables. Three novel predictors were constructed to capture the time weighted effects of buprenorphine dosage (mg buprenorphine per day), dosing protocol (whether physician could adjust dose), and clinic visits (whether patient attended clinic). We used time-in-trial as a predictor to account for the therapeutic benefits of treatment persistence. The outcome was illicit opiate use defined by self-report or urinalysis. Trial participants (N = 3022 patients with opioid dependence, mean age 36 years, 33% female, 14% Black, 16% Hispanic) were analyzed using a generalized linear mixed model. Treatment variables dose, Odds Ratio (OR) = 0.63 (95% Confidence Interval (95%CI) 0.59–0.67), dosing protocol, OR = 0.70 (95%CI 0.65–0.76), time-in-trial, OR = 0.75 (95%CI 0.71–0.80) and clinic visits, OR = 0.81 (95%CI 0.76–0.87) were significant (p-values < 0.001) protective factors. Treatment implications support higher doses of buprenorphine and greater engagement of patients with providers and clinic staff.

Uncomplicated urinary tract infections are one of the most common bacterial infections in the United States. Clinical practice guidelines from the Infectious Diseases Society of America recommend nitrofurantoin, trimethoprim-sulfamethoxazole, and Fosfomycin as first-line antibiotic treatments and discourage the use of fluoroquinolone antibiotic agents. US Food and Drug Administration released several black box warnings about fluoroquinolones over the past decade owing to antibiotic resistance and a high burden of adverse events. Historically, uncomplicated urinary tract infections have high rates of guideline-discordant treatment with past studies noting substantial use of fluoroquinolones, directly contradicting clinical practice guidelines.This study aimed to assess the current concordance of physician prescribing practices with Infectious Diseases Society of America guidelines for the treatment of uncomplicated urinary tract infections in women and identify patient and physician predictors of guideline concordance.A retrospective observational secondary analysis was conducted using a series of cross-sectional data extracted from the IQVIA (Plymouth Meeting, Pennsylvania) National Disease and Therapeutic Index from 2015 to 2019. An estimated 44.9 million women with uncomplicated urinary tract infections at the age of 18 to 75 years were treated as outpatients. This population was selected to lack relevant comorbidities or urological abnormalities so that it matched the Infectious Diseases Society of America guidelines. The proportion of prescriptions for each antibiotic drug class were reported with 95% confidence intervals and compared with the Infectious Diseases Society of America guidelines. Patient and physician characteristics were included in a multivariate logistic regression model to identify independent predictors of antibiotic selection and thereby guideline concordance.Of the visits that resulted in antibiotic treatment, the overall concordance rate was 58.4% (26.2 million visits of 44.9 million visits) and increased from 48.2% (3.9 million visits of 8.1 million visits) in 2015 to 64.6% (6.3 million visits of 9.8 million visits) in 2019. The most commonly prescribed antibiotic agents were fluoroquinolones (36.4%, 16.3 million visits of 44.9 million visits), nitrofurantoin (31.8%, 14.3 million visits of 44.9 million visits), and trimethoprim-sulfamethoxazole (26.3%, 11.8 million visits of 44.9 million visits). From 2015 to 2019, fluoroquinolone use decreased whereas nitrofurantoin and beta-lactam use increased. Based on the logistic regression, patients aged 18 to 29 years (odds ratio, 1.60; 95% confidence interval, 1.36-1.88; P.001) and 30 to 44 years (odds ratio, 1.21; 95% confidence interval, 1.03-1.42; P=.020) had a statistically significantly higher likelihood of receiving guideline-concordant treatment than patients aged 45 to 75 years (reference group). Obstetricians-gynecologists (odds ratio, 3.56; 95% confidence interval, 2.91-4.37; P.001) and urologists (odds ratio, 3.51; 95% confidence interval, 2.45-5.13; P.001) had a statistically significantly higher likelihood of concordant treatment than all other specialties combined (reference group).Guideline discordance continues in the treatment of uncomplicated urinary tract infections with the overuse of fluoroquinolones and the underuse of first-line antibiotic agents. Although improving, continued misuse of antibiotic agents may contribute to the growing rates of antibiotic resistance. Actions such as educating physicians about antibiotic resistance and clinical practice guidelines and providing feedback on prescription habits are needed to increase guideline concordance and therefore reduce the use of fluoroquinolones, especially for physicians in family and internal medicine.

Background: It is estimated that over 46 million individuals have atrial fibrillation (AF) worldwide, and the incidence and prevalence of AF are increasing globally. There is an urgent need to accelerate the academic development of scientists possessing the skills to conduct innovative, collaborative AF research. Methods: We designed and implemented a virtual AF Strategically Focused Research Network Cross-Center Fellowship program to enhance the competencies of early-stage AF basic, clinical, and population health researchers through experiential education and mentorship. The pedagogical model involves significant cross-center collaboration to produce a curriculum focused on enhancing AF scientific competencies, fostering career/professional development, and cultivating grant writing skills. Outcomes for success involve clear expectations for fellows to produce manuscripts, presentations, and—for those at the appropriate career stage–grant applications. We evaluated the effectiveness of the fellowship model via mixed methods formative and summative surveys. Results: In 2 years of the fellowship, fellows generally achieved the productivity metrics sought by our pedagogical model, with outcomes for the 12 fellows including 50 AF-related manuscripts, 7 publications, 28 presentations, and 3 grant awards applications. Participant evaluations reported that the fellowship effectively met its educational objectives. All fellows reported medium to high satisfaction with the overall fellowship, webinar content and facilitation, staff communication and support, and program organization. Conclusions: The fellowship model represents an innovative educational strategy by providing a virtual AF training and mentoring curriculum for early-career basic, clinical, and population health scientists working across multiple institutions, which is particularly valuable in the pandemic era.

Little is known about the association between the coronavirus disease 2019 (COVID-19) pandemic and the level and content of primary care delivery in the US.To quantify national changes in the volume, type, and content of primary care delivered during the COVID-19 pandemic, especially with regard to office-based vs telemedicine encounters.Analysis of serial cross-sectional data from the IQVIA National Disease and Therapeutic Index, a 2-stage, stratified nationally representative audit of outpatient care in the US from the first calendar quarter (Q1) of 2018 to the second calendar quarter (Q2) of 2020.Visit type (office-based or telemedicine), overall and stratified by patient population and geographic region; assessment of blood pressure or cholesterol measurement; and initiation or continuation of prescription medications.In the 8 calendar quarters between January 1, 2018, and December 31, 2019, between 122.4 million (95% CI, 117.3-127.5 million) and 130.3 million (95% CI, 124.7-135.9 million) quarterly primary care visits occurred in the US (mean, 125.8 million; 95% CI, 121.7-129.9 million), most of which were office-based (92.9%). In 2020, the total number of encounters decreased to 117.9 million (95% CI, 112.6-123.2 million) in Q1 and 99.3 million (95% CI, 94.9-103.8 million) in Q2, a decrease of 21.4% (27.0 million visits) from the average of Q2 levels during 2018 and 2019. Office-based visits decreased 50.2% (59.1 million visits) in Q2 of 2020 compared with Q2 2018-2019, while telemedicine visits increased from 1.1% of total Q2 2018-2019 visits (1.4 million quarterly visits) to 4.1% in Q1 of 2020 (4.8 million visits) and 35.3% in Q2 of 2020 (35.0 million visits). Decreases occurred in blood pressure level assessment (50.1% decrease, 44.4 million visits) and cholesterol level assessment (36.9% decrease, 10.2 million visits) in Q2 of 2020 compared with Q2 2018-2019 levels, and assessment was less common during telemedicine than during office-based visits (9.6% vs 69.7% for blood pressure; P .001; 13.5% vs 21.6% for cholesterol; P .001). New medication visits in Q2 of 2020 decreased by 26.0% (14.1 million visits) from Q2 2018-2019 levels. Telemedicine adoption occurred at similar rates among White individuals and Black individuals (19.3% vs 20.5% of patient visits, respectively, in Q1/Q2 of 2020), varied by region (low of 15.1% of visits [East North Central region], high of 26.8% of visits [Pacific region]), and was not correlated with regional COVID-19 burden.The COVID-19 pandemic has been associated with changes in the structure of primary care delivery, with the content of telemedicine visits differing from that of office-based encounters.

Key Points Question What is the effect of electroacupuncture vs sham treatment on pain severity in adults with chronic low back pain? Findings In this randomized clinical trial including 121 adults with chronic low back pain, there was no significant difference between real and sham electroacupuncture conditions in reduction in pain scores 2 weeks after treatment; however, real electroacupuncture resulted in statistically and clinically greater reduction in back pain–specific disability compared with the sham control. Having coping strategies and not being White race were associated with treatment response to real electroacupuncture. Meaning This randomized clinical trial found no difference in pain reduction between real and sham electroacupuncture, but there was greater reduction in back pain–specific disability compared with sham control., This randomized clinical trial examines real vs sham electropuncture in treating chronic low back pain in adults., Importance Chronic low back pain has high societal and personal impact but remains challenging to treat. Electroacupuncture has demonstrated superior analgesia compared with placebo in animal studies but has not been extensively studied in human chronic pain conditions. Objective To evaluate the treatment effect of real electroacupuncture vs placebo in pain and disability among adults with chronic low back pain and to explore psychophysical, affective, and demographic factors associated with response to electroacupuncture vs placebo in treating chronic low back pain. Design, Setting, and Participants This double-blind randomized clinical trial was conducted between August 2, 2016, and December 18, 2018, at a single center in Stanford, California. Primary outcomes were collected at approximately 2 weeks before and after intervention. Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy. Data analyses for this intent-to-treat study were conducted from June 2019 to June 2020. Interventions Twelve sessions of real or placebo (sham) electroacupuncture administered twice a week over 6 weeks. Main Outcomes and Measures The main outcome was change in pain severity from baseline to 2 weeks after completion of treatment, measured by the National Institutes of Health PROMIS pain intensity scale. A secondary outcome was change in the Roland Morris Disability Questionnaire (RMDQ). Baseline factors potentially associated with these outcomes included psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant’s self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race). Results A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women) were randomized to real electroacupuncture and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women) were randomized to sham electroacupuncture. At baseline, the mean (SD) PROMIS T-score was 50.49 (3.36) in the real electroacupuncture group and 51.71 (4.70) in the sham acupuncture group, and the mean (SD) RMDQ score was 10.16 (4.76) in the real electroacupuncture group and 10.03 (5.45) in the sham acupuncture group. After adjusting for baseline pain scores, there was no statistically significant difference between groups in change in T-scores 2 weeks after completion of treatment (real electroacupuncture: −4.33; 95% CI, −6.36 to −2.30; sham acupuncture: −2.90; 95% CI, −4.85 to −0.95; difference: −2.09; 95% CI, −4.27 to 0.09; P = .06). After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (−2.77; 95% CI, −4.11 to −1.43) compared with the sham electroacupuncture group (−0.67; 95% CI, −1.88 to 0.55; difference: −2.11; 95% CI, −3.75 to −0.47; P = .01). Within the real electroacupuncture group, effective coping at baseline was associated with greater RMDQ reduction (r = −0.32; 95% CI, −0.54 to −0.05; P = .02), and White race was associated with worse outcomes in PROMIS score (β = 3.791; 95% CI, 0.616 to 6.965; P = .02) and RMDQ (β = 2.878; 95% CI, 0.506 to 5.250; P = .02). Conclusions and Relevance This randomized clinical trial found no statistically significant difference in change in PROMIS pain score in real electroacupuncture vs sham electroacupuncture. There was a statistically significant treatment effect for the secondary outcome of RMDQ compared with sham electroacupuncture. Effective coping skills and non-White race were associated with response to electroacupuncture. Trial Registration ClinicalTrials.gov Identifier: NCT02890810

Myopia (or short-sightedness) is a global health and social problem. Researchers have estimated that in China, myopia caused a 244 billion United States dollars loss in productivity in 2015.1 China’s approach to its burden of childhood myopia illustrates the problem’s magnitude, but also outlines solutions that could be potentially relevant to other countries. Here we outline China’s national myopia policy, discuss the related scientific evidence and conclude with specific recommendations for the way forward.

BackgroundThe efficacy and safety of buprenorphine alone and in combination with naloxone for treatment of opioid dependence were evaluated in Federally-sponsored randomized clinical trials. Meta-analysis of pooled individual participant data provides an opportunity to identify multiple predictors of buprenorphine treatment outcome.MethodsWe selected six buprenorphine efficacy and safety trials from NIDA’s Data Share database for analysis. Treatment, sociodemographic, and drug use history variable domains were systematically harmonized and included in analysis. After exclusions, 3,022 participants randomized or enrolled in buprenorphine treatment for opioid dependence (mean (SD) age 36.1 (9.8) years, 33% female, 66% White, 16% Hispanic, 14% Black), were analyzed using a generalized linear mixed model with time-weighted treatment variables and participant covariates. We defined positive urinalysis or self-reported lapse as the primary outcome.ResultsFour treatment variables were significantly associated (p < 0.001) with lapse. Time-weighted dose and time-weighted adaptive dose had greater estimated effects than time-in-trial and time-weighted clinic visit. All treatment variables were novel predictors of lapse.ConclusionsIn a large cohort of trial participants treated with buprenorphine and behavioral counseling for opioid dependence, we identified and ranked four novel treatment factors reflecting components of buprenorphine dose, clinical provider engagement and patient engagement. Additional research to explore the effects of pharmacologic and non- pharmacologic treatment factors, and to explore relations with provider and patient factors will help our understanding of buprenorphine treatment outcomes. Continued analyses of publicly available data will extend discovery and support development of personalized opioid use disorder treatments.Highlights (3 to 5 bullet point max 85 characters each including spaces)Treatment and participant variables were harmonized in six buprenorphine trialsTime-weighted treatment variables were used in a random effects mixed model of lapseBuprenorphine dose and three clinical interactions were protective against lapseSupport of protective treatment factors may improve buprenorphine treatment success

The recently released 2017 High Blood Pressure Guidelines depart from past guidelines in both their approach and recommendations. Developed by multiple health organizations, including the American College of Preventive Medicine, the guidelines continue to define normal blood pressure as

Objective To determine an association between opioid use upon hospital discharge (ongoing and newly started) in surgical patients and risks of opioid overdose and delirium for the first year. Design Retrospective, cohort study. Setting Population-level study of Veterans Health Administration patients. Subjects All Veterans Health Administration patients (N = 64,391) who underwent surgery in 2011, discharged after one or more days, and without a diagnosis of opioid overdose or delirium from 90 days before admission through 30 days postdischarge (to account for additional opioid dosing in the context of chronic use). Methods Patients' opioid use was categorized as 1) no opioids, 2) tramadol only, 3) short-acting only, 4) long-acting only, 5) short- and long-acting. We calculated unadjusted incidence rates and the incidence rate ratio (IRR) for opioid overdose and drug delirium for two time intervals: postdischarge days 0-30 and days 31-365. We then modeled outcomes of opioid overdose and delirium for postdischarge days 31-365 using a multivariable extended Cox regression model. Sensitivity analysis examined risk factors for overdose for postdischarge days 0-30. Results Incidence of overdose was 11-fold greater from postdischarge days 0-30 than days 31-365: 26.3 events/person-year (N = 68) vs 2.4 events/person-year (N = 476; IRR = 10.80, 95% confidence interval [CI] = 8.37-13.92). Higher-intensity opioid use was associated with increasing risk of overdose for the year after surgery, with the highest risk for the short- and long-acting group (hazard ratio = 4.84, 95% CI = 3.28-7.14). Delirium (IRR = 10.66, 95% CI = 7.96-14.29) was also associated with higher opioid intensity. Conclusions Surgical patients should be treated with the lowest effective intensity of opioids and be monitored to prevent opioid-related adverse events.

We sought to examine changes in regional and sex disparities in stunting, thinness, and overweight among Chinese school-aged children from 1985 to 2014. We analyzed data on 1,489,953 children aged 7–18 years in the Chinese National Survey on Students’ Constitution and Health. Stunting, thinness, and overweight were defined according to WHO anthropomorphic definitions. After adjustment for age, socioeconomic status, and school, logistic regression was used to estimate the prevalence of stunting, thinness, and overweight by region and sex over 30 years’ time. From 1985 to 2014, the prevalence of stunting progressively decreased from 16.4% in 1985 to 2.3% in 2014, thinness prevalence also declined overtime, from 8.4 to 4.0% and overweight prevalence continually increased from 1.1% in 1985 to 20.4% in 2014 in Chinese school-aged children. Stunting and thinness were more common in rural areas, although urban/rural differences declined over time. Overweight was a greater problem in urban than rural areas, and this difference increased over time. Some provinces showed high levels of stunting, thinness, and overweight. The stunting prevalence of boys was higher than girls from 1985 and 1995, but lower than girls for the past 15 years. Thinness was consistently more common in boys than girls across regions and time. Overweight continuously increased for boys and girls; however, the increase was more rapid in boys. Over the past 30 years, Chinese children have shifted in anthropomorphic measures indicating a shift from problems of under-nutrition to measures consistent with over-nutrition, particularly in urban areas and among boys. Some regions are burdened by problems of both under- and over-nutrition. Regional and sex-specific guidelines and public health policies for childhood nutrition are needed in China.

Objective Nurse practitioners (NPs) and physician assistants (PAs) have increasingly broad prescribing authority in the United States, yet little is known regarding how the quality of their prescribing practices compares with that of physicians. The objective of this study was to compare the quality of prescribing practices of physicians and nonphysician providers. Methods A serial cross-sectional analysis of the 2006-2012 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey was performed. Ambulatory care services in physician offices, hospital emergency departments, and outpatient departments were evaluated using a nationally representative sample of patient visits to physicians, NPs, and PAs. Main outcome measures were 13 validated outpatient quality indicators focused on pharmacologic management of chronic diseases and appropriate medication use. Results A total of 701,499 sampled patient visits were included during the study period, representing ~8.33 billion visits nationwide. Physicians were the primary provider for 96.8% of all outpatient visits examined; NPs and PAs each accounted for 1.6% of these visits. The proportion of eligible visits where quality standards were met ranged from 34.1% (angiotensin-converting enzyme inhibitor use for congestive heart failure) to 89.5% (avoidance of inappropriate medications among elderly). The median overall performance across all indicators was 58.7%. On unadjusted analyses, differences in quality of care between nonphysicians and physicians for each indicator did not consistently favor one practitioner type over others. After adjustment for potentially confounding patient and provider characteristics, the quality of prescribing by NPs and PAs was similar to the care delivered by physicians for 10 of the 13 indicators evaluated, and no consistent directional association was found between provider type and indicator fulfillment for the remaining measures. Conclusions Although significant shortfalls exist in the quality of ambulatory prescribing across all practitioner types, the quality of care delivered by nonphysicians and physicians was generally comparable.

Objectives Off-label drug use is highly prevalent but controversial and often discouraged assuming generally inferior medical effects associated with off-label use. Study Design and Setting We searched PubMed, MEDLINE, PubMed Health, and the Cochrane Library up to May 2015 for systematic reviews including meta-analyses of randomized clinical trials (RCTs) comparing off-label and approved drugs head-to-head in any population and on any medical outcome. We combined the comparative effects in meta-analyses providing summary odds ratios (sOR) for each treatment comparison and outcome, and then calculated an overall summary of the sOR across all comparisons (ssOR). Results We included 25 treatment comparisons with 153 RCTs and 24,592 patients. In six of 25 comparisons (24%), off-label drugs were significantly superior (five of 25) or inferior (one of 25) to approved treatments. There was substantial statistical heterogeneity across comparisons (I2 = 43%). Overall, off-label drugs were more favorable than approved treatments (ssOR 0.72; 95% CI = 0.54–0.95). Analyses of patient-relevant outcomes were similar (statistical significant differences in 24% (six of 25); ssOR 0.74; 95% CI = 0.56–0.98; I2 = 60%). Analyses of primary outcomes of the systematic reviews (n = 22 comparisons) indicated less heterogeneity and no statistically significant difference overall (ssOR 0.85; 95% CI = 0.67–1.06; I2 = 0%). Conclusion Approval status does not reliably indicate which drugs are more favorable in situations with clinical trial evidence comparing off-label with approved use. Drug effectiveness assessments without considering off-label use may provide incomplete information. To ensure that patients receive the best available care, funding, policy, reimbursement, and treatment decisions should be evidence based considering the entire spectrum of available therapeutic choices.

Background About 1 in 3 adults aged 65 and older falls annually. Exercise interventions are effective in reducing the fall risk and fall rate among older adults. In 2020, startup company Age Bold Inc. disseminated the Bold Fall Prevention Program, aiming to reduce falls among older adults through a remotely delivered, digital exercise program. Objective We conducted a feasibility study to assess the delivery of the Bold Fall Prevention Program remotely and evaluate the program's impact on 2 primary outcomes—annualized fall rate and weekly minutes of physical activity (PA)—over 6 months of follow-up. Methods Older adults at high risk of falling were screened and recruited for the feasibility study via nationwide digital advertising strategies. Self-reported outcomes were collected via surveys administered at the time of enrollment and after 3 and 6 months. Responses were used to calculate changes in the annualized fall rate and minutes of PA per week. Results The remote delivery of a progressive digital fall prevention program and associated research study, including remote recruitment, enrollment, and data collection, was deemed feasible. Participants successfully engaged at home with on-demand video exercise classes, self-assessments, and online surveys. We enrolled 65 participants, of whom 48 (74%) were women, and the average participant age was 72.6 years. Of the 65 participants, 54 (83%) took at least 1 exercise class, 40 (62%) responded to at least 1 follow-up survey at either 3 or 6 months, 20 (31%) responded to both follow-up surveys, and 25 (39%) were lost to follow-up. Among all participants who completed at least 1 follow-up survey, weekly minutes of PA increased by 182% (ratio change=2.82, 95% CI 1.26-6.37, n=35) from baseline and annualized falls per year decreased by 46% (incidence rate ratio [IRR]=0.54, 95% CI 0.32-0.90, n=40). Among only 6-month survey responders (n=31, 48%), weekly minutes of PA increased by 206% (ratio change=3.06, 95% CI 1.43-6.55) from baseline to 6 months (n=30, 46%) and the annualized fall rate decreased by 28% (IRR=0.72, 95% CI 0.42-1.23) from baseline to 6 months. Conclusions The Bold Fall Prevention Program provides a feasible strategy to increase PA and reduce the burden of falls among older adults.

Key Points Question Has the COVID-19 pandemic been associated with any changes in the clinical content of ambulatory care in the US? Findings In this cross-sectional study of serial data from the IQVIA National Disease and Therapeutic Index, there was a moderate rebound in office-based care during the second half of 2020, while telemedicine accounted for 23.9% of care observed. Office-based care during the pandemic (quarters 2-4 of 2020) involved 58.0% long-term, 23.0% short-term, and 25.6% preventive diagnoses, while telemedicine care involved substantially greater long-term (77.2%), modestly greater short-term (26.8%), and almost no preventive (2.7%) diagnoses. Meaning In contrast to office-based care, telemedicine was more commonly used for established patients and substantially greater delivery of psychiatric or behavioral treatments than preventive care., Importance While the COVID-19 pandemic has been associated with some substitution of telemedicine for office-based care in the US, to our knowledge, little is known regarding the pandemic’s association with the clinical content of ambulatory care. Objective To characterize changes in the clinical content of ambulatory care among office-based vs telemedicine encounters in the US before vs during the COVID-19 pandemic. Design, Settings, and Participants This analysis of serial cross-sectional data from the IQVIA National Disease and Therapeutic Index was a 2-stage, stratified nationally representative audit of outpatient care in the US from January 1, 2018, through December 31, 2020. The National Disease and Therapeutic Index generates approximately 33 617 quarterly visits that are projected to 306.7 million national visits based on the survey design. Main Outcomes and Measures (1) Prevalence of common diagnoses and (2) mix of long-term, short-term, and preventive care. Results The mean (SD) number of projected quarterly, in-person, office-based visits was 282.1 (1.4) million in 2018 and 284.7 (10.3) in 2019 before declining to 250.8 million in quarter 1 of 2020 and 147.8 million in quarter 2 of 2020 and then increasing moderately to 181.5 million in quarter 3 of 2020 and 180.2 million in quarter 4 of 2020. The mean (SD) number of telemedicine visits was 2.8 (0.4) million in 2018 and 3.0 (0.1) million in 2019 before increasing to 8.6 million in quarter 1 of 2020 and 72.2 million in quarter 2 of 2020 and then declining notably to 43.8 million in quarter 3 of 2020 and 44.2 million in quarter 4 of 2020. Office-based care during the second through fourth quarters of 2020 involved 58.0% long-term, 23.0% short-term, and 25.6% preventive care. In contrast to office-based care, 4 of the top 10 diagnoses that were treated by telemedicine during 2020 were for psychiatric or behavioral conditions: depression, attention deficit/hyperactivity, anxiety, and bipolar disorders. Throughout this period, approximately half of office-based visits and nearly two-thirds of telemedicine visits were for established rather than new patients. Conclusions and Relevance This cross-sectional study’s findings suggest that while telemedicine rapidly increased early during course of the COVID-19 pandemic, its use declined modestly since then. In contrast to office-based care, telemedicine was more commonly used for established patients and substantially greater delivery of psychiatric or behavioral treatments rather than preventive care., This cross-sectional study of data from the IQVIA National Disease and Therapeutic Index examines changes in the clinical content of ambulatory care among office-based vs telemedicine encounters in the US during the COVID-19 pandemic.

Evidence of whether behavioral weight-loss interventions reduce depressive symptoms among Latino immigrants is limited. The effect of a behavioral weight-loss intervention on depressive symptoms was assessed using data from a clinical trial among Latino immigrants. Participants were randomized to a usual care (UC) control (n = 41), case management (CM) alone (n = 84), or CM with community health worker support (CM+CHW) (n = 82). Generalized estimating equation models were used to compare the impact of each intervention with UC. Effect modification by poverty level was further investigated. Overall, treatment groups were not significantly associated with 24-month changes in CES-D scores. Among participants below the 100% federal poverty level (FPL), those randomized to CM+CHW had 24-month CES-D scores significantly lower (Β coefficient = 0.72; 95% CI 0.55-0.93) than those in UC (p = 0.01). A behavioral weight-loss intervention providing case management and support from a CHW reduced depressive symptoms among Latino immigrants below the 100% FPL.

It is unclear whether metabolic syndrome (MetS) is associated with atrial fibrillation (AF) in an older population with greater cardiovascular risk, including those with chronic kidney disease. The authors investigated the association between MetS and AF in participants in SPRINT (Systolic Blood Pressure Intervention Trial). MetS was defined based on the Modified Third National Cholesterol Education Program. The baseline prevalence rate for MetS was 55%, while 8.2% of the participants had AF. In multivariate regression analyses, AF was not associated with presence of MetS in either chronic kidney disease or non–chronic kidney disease subgroups. Age, race, history of cardiovascular diseases, decreased triglycerides, decreased pulse pressure, and albuminuria remained significantly associated with AF risk. In contrast to the general population, MetS was not associated with AF in the older population with increased cardiovascular risk studied in SPRINT.

Objective The purpose of this study was to examine the relationship between dynapenia and metabolic risk factors in obese and nonobese older adults. Methods A total of 1453 men and women (age ≥70 years) from the Lifestyle Interventions and Independence for Elders (LIFE) Study were categorized as (1) nondynapenic/nonobese (NDYN-NO), (2) dynapenic/nonobese (DYN-NO), (3) nondynapenic/obese (NDYN-O), or (4) dynapenic/obese (DYN-O), based on muscle strength (Foundation for the National Institute of Health criteria) and body mass index. Dependent variables were blood lipids, fasting glucose, blood pressure, presence of at least 3 metabolic syndrome (MetS) criteria, and other chronic conditions. Results A significantly higher likelihood of having abdominal obesity criteria in NDYN-NO compared with DYN-NO groups (55.6 vs 45.1%, P ≤ .01) was observed. Waist circumference also was significantly higher in obese groups (DYN-O = 114.0 ± 12.9 and NDYN-O = 111.2 ± 13.1) than in nonobese (NDYN-NO = 93.1 ± 10.7 and DYN-NO = 92.2 ± 11.2, P ≤ .01); and higher in NDYN-O compared with DYN-O ( P = .008). Additionally, NDYN-O demonstrated higher diastolic blood pressure compared with DYN-O (70.9 ± 10.1 vs 67.7 ± 9.7, P ≤ .001). No significant differences were found across dynapenia and obesity status for all other metabolic components ( P > .05). The odds of having MetS or its individual components were similar in obese and nonobese, combined or not with dynapenia (nonsignificant odds ratio [95% confidence interval]). Conclusion Nonobese dynapenic older adults had fewer metabolic disease risk factors than nonobese and nondynapenic older adults. Moreover, among obese older adults, dynapenia was associated with lower risk of meeting MetS criteria for waist circumference and diastolic blood pressure. Additionally, the presence of dynapenia did not increase cardiometabolic disease risk in either obese or nonobese older adults.