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Background: Health and Wellness Coaching (HWC) may be beneficial in chronic condition care. We sought to appraise its effectiveness on quality of life (QoL), self-efficacy (SE), depression, and anxiety., Methods: We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane CENTRAL for randomized trials published January 2005 - March 2023 that compared HWC to standard clinical care or another intervention without coaching. We examined QoL, SE, depression, or anxiety outcomes. Meta-analysis utilizing the random-effects model was used to estimate the pooled standardized mean difference (SMD)., Results: Thirty included studies demonstrated that HWC improved QoL within 3 months (SMD 0.62 95 % CI 0.22-1.02, p = 0.002), SE within 1.5 months (SMD 0.38, 95 % CI 0.03-0.73, p = 0.03), and depression at 3, 6, and 12 months (SMD 0.67, 95 % CI 0.13-1.20, p = 0.01), (SMD 0.72, 95 % CI 0.19-1.24, p = 0.006), and (SMD 0.41, 95 % CI 0.09-0.73, p = 0.01) Certainty in the evidence for most outcomes was either very low or low primarily due to the high risk of bias, heterogeneity, and imprecision., Conclusion: HWC improves QoL, SE, and depression across chronic illness populations. Future research needs to standardize intervention reporting and outcome collection., Practice Implications: Future HWC studies should standardize intervention components, reporting, and outcome measures, apply relevant chronic illness theories, and aim to follow participants for greater than one year., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: There remains uncertainty regarding optimal primary atherosclerotic cardiovascular disease (ASCVD) prevention practices for older adults., Objective: To assess statin treatment patterns and incident ASCVD among older patients for primary prevention across the spectrum of ASCVD risk., Design: Retrospective cohort study of participants without ASCVD aged 65-79 years. Patients were stratified by age (65-69, 70-75, > 75 years) and 10-year ASCVD risk category (low/borderline, intermediate, high) based on the Pooled Cohort Equations. Multivariable logistic regressions were used to identify predictors of moderate- or high-intensity statin prescriptions. Cox proportional models were used to estimate hazard ratios (HRs) for incident ASCVD., Participants: Patients aged 65-79 years without ASCVD from a Northern California health system., Main Measures: Statin prescriptions and incident ASCVD events., Key Results: There were 54,066 patients, with 10,288 (19%) aged > 75 years and 57% women. Compared with younger groups, adults > 75 years were less likely to be prescribed moderate- or high-intensity statin prescriptions across ASCVD risk groups (all p < 0.001); this persisted after multivariable adjustment including for ASCVD risk (odds ratio [OR] 0.80, 95% confidence interval [CI] 0.74-0.86). Adults > 75 years were more likely to experience incident ASCVD (HR 1.42, 95% CI 1.23-1.63). Women (OR 0.85, 95% CI 0.81-0.89) and underweight older adults (OR 0.45, 95% CI 0.33-0.61) were also less likely to receive moderate- or high-intensity statins., Conclusions: Among older adults aged 65-79 years without prior ASCVD, those > 75 years of age were less likely to receive moderate- or high-intensity statins regardless of ASCVD risk compared with their younger counterparts, while experiencing more incident ASCVD. Efforts are warranted to study the reasons for age-based differences in statin use in older adults, particularly those at highest ASCVD risk., (© 2021. Society of General Internal Medicine.)

Importance: How patients with atrial fibrillation (AF) and their clinicians consider cost in forming care plans remains unknown., Objective: To identify factors that inform conversations regarding costs of anticoagulants for treatment of AF between patients and clinicians and outcomes associated with these conversations., Design, Setting, and Participants: This cohort study of recorded encounters and participant surveys at 5 US medical centers (including academic, community, and safety-net centers) from the SDM4AFib randomized trial compared standard AF care with and without use of a shared decision-making (SDM) tool. Included patients were considering anticoagulation treatment and were recruited by their clinicians between January 30, 2017, and June 27, 2019. Data were analyzed between August and November 2019., Main Outcomes and Measures: The incidence of and factors associated with cost conversations, and the association of cost conversations with patients' consideration of treatment cost burden and their choice of anticoagulation., Results: A total of 830 encounters (out of 922 enrolled participants) were recorded. Patients' mean (SD) age was 71.0 (10.4) years; 511 patients (61.6%) were men, 704 (86.0%) were White, 303 (40.9%) earned between $40 000 and $99 999 in annual income, and 657 (79.2%) were receiving anticoagulants. Clinicians' mean (SD) age was 44.8 (13.2) years; 75 clinicians (53.2%) were men, and 111 (76%) practiced as physicians, with approximately half (69 [48.9%]) specializing in either internal medicine or cardiology. Cost conversations occurred in 639 encounters (77.0%) and were more likely in the SDM arm (378 [90%] vs 261 [64%]; OR, 9.69; 95% CI, 5.77-16.29). In multivariable analysis, cost conversations were more likely to occur with female clinicians (66 [47%]; OR, 2.85; 95% CI, 1.21-6.71); consultants vs in-training clinicians (113 [75%]; OR, 4.0; 95% CI, 1.4-11.1); clinicians practicing family medicine (24 [16%]; OR, 12.12; 95% CI, 2.75-53.38]), internal medicine (35 [23%]; OR, 3.82; 95% CI, 1.25-11.70), or other clinicians (21 [14%]; OR, 4.90; 95% CI, 1.32-18.16) when compared with cardiologists; and for patients with an annual household income between $40 000 and $99 999 (249 [82.2%]; OR, 1.86; 95% CI, 1.05-3.29) compared with income below $40 000 or above $99 999. More patients who had cost conversations reported cost as a factor in their decision (244 [89.1%] vs 327 [69.0%]; OR 3.66; 95% CI, 2.43-5.50), but cost conversations were not associated with the choice of anticoagulation agent., Conclusions and Relevance: Cost conversations were common, particularly for middle-income patients and with female and consultant-level primary care clinicians, as well as in encounters using an SDM tool; they were associated with patients' consideration of treatment cost burden but not final treatment choice. With increasing costs of care passed on to patients, these findings can inform efforts to promote cost conversations in practice., Trial Registration: ClinicalTrials.gov Identifier: NCT02905032.

Purpose of Review: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a life-threatening disease that disproportionately affects older adults and people of African descent. This review discusses current knowledge regarding racial and ethnic disparities in the diagnosis and management of ATTR-CM., Recent Findings: Historically, ATTR-CM was thought to be a rare cause of heart failure. Recent evidence has shown that ATTR-CM is more common among older adults, men, and people of African descent. In addition, significant geographic variation exists in the identification of amyloid cardiomyopathy. Despite the high burden of ATTR-CM among Black individuals, most clinical data for ATTR-CM are from North America and Europe. Moreover, only a minority of clinical trial participants thus far have been Black patients. In addition to racial differences, socioeconomic disparities may be further compounded by the potentially prohibitive cost and limited accessibility of disease-modifying ATTR therapies., Summary: ATTR-CM is an important cause of heart failure that disproportionately affects people of African descent. Efforts to promote earlier identification of ATTR-CM in general practice will likely improve clinical outcomes for all groups. Future trials should strive to enroll a higher proportion of Black patients. Furthermore, enhanced efforts are warranted to improve treatment accessibility among racial and ethnic minority groups that may be more likely to be affected by ATTR-CM.

Objective: To use quantitative and qualitative methods to characterize the work patients with type 2 diabetes mellitus (T2DM) enact and explore the interactions between illness, treatment, and life., Patients and Methods: In this mixed-methods, descriptive study, adult patients with T2DM seen at the outpatient diabetes clinic at Mayo Clinic in Rochester, Minnesota, from February 1, 2016, through March 31, 2017, were invited to participate. The study had 3 phases. In phase 1, the Patient Experience with Treatment and Self-management (PETS) scale was used to quantify treatment burden. In phase 2, a convenience sample of patients used a smartphone application to describe, in real time, time spent completing diabetes self-management tasks and to upload descriptive digital photographs. In phase 3, these data were explored in qualitative interviews that were analyed by 2 investigators using deductive analysis., Results: Of 162 participants recruited, 160 returned the survey (phase 1); of the 50 participants who used the smartphone application (phase 2), we interviewed 17 (phase 3). The areas in which patients reported highest treatment burden were difficulty with negotiating health services (eg, coordinating medical appointments), medical expenses, and mental/physical exhaustion with self-care. Participants reported that medical appointments required about 2.5 hours per day, and completing administrative tasks related to health care required about 45 minutes. Time spent on health behaviors varied widely-from 2 to 60 minutes in a given 3-hour period. Patients' experience of a task's burden did not always correlate with the time spent on that task., Conclusion: The most burdensome tasks to patients with T2DM included negotiating health care services, affording medications, and completing administrative tasks even though they were not the most time-consuming activities. To be minimally disruptive, diabetes care should minimize the delegation of administrative tasks to patients., (© 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc.)

Background/objectives: Older adults (>75 years of age) represent two-thirds of atherosclerotic cardiovascular disease (ASCVD) deaths. The 2013 and 2018 American multi-society cholesterol guidelines recommend using at least moderate intensity statins for older adults with ASCVD. We examined annual trends and statin prescribing patterns in a multiethnic population of older adults with ASCVD., Design: Retrospective longitudinal study using electronic health record (EHR) data from 2007 to 2018., Setting: A large multi-specialty health system in Northern California., Participants: A total of 24,651 adults older than 75 years with ASCVD., Measurements: Statin prescriptions for older adults with known ASCVD were trended over time. Multivariable regression models were used to identify predictors of statin prescription (logistic) after controlling for relevant demographic and clinical factors., Results: The study cohort included 24,651 patients older than 75 years; 48% were women. Although prescriptions for moderate/high intensity statins increased over time for adults over 75, fewer than half of the patients (45%) received moderate/high intensity statins in 2018. Women (odds ratio (OR) = 0.77; 95% confidence interval (CI) = 0.74, 0.80), patients who had heart failure (OR = 0.69; 95% CI = 0.65, 0.74), those with dementia (OR = 0.88; 95% CI = 0.82, 0.95) and patients who were underweight (OR = 0.64; 95% CI = 0.57, 0.73) were less likely to receive moderate/high intensity statins., Conclusions: Despite increasing prescription rates between 2007 and 2018, guideline-recommended statins remained underused in older adults with ASCVD, with more pronounced disparities among women and those with certain comorbidities. Future studies are warranted to examine reasons for statin underuse in older adults with ASCVD., (© 2021 The American Geriatrics Society.)

Background Persistent racial/ethnic disparities in cardiovascular disease (CVD) mortality are partially explained by healthcare access and socioeconomic, demographic, and behavioral factors. Little is known about the association between race/ethnicity-specific CVD mortality and county-level factors. Methods and Results Using 2017 county-level data, we studied the association between race/ethnicity-specific CVD age-adjusted mortality rate (AAMR) and county-level factors (demographics, census region, socioeconomics, CVD risk factors, and healthcare access). Univariate and multivariable linear regressions were used to estimate the association between these factors; R 2 values were used to assess the factors that accounted for the greatest variation in CVD AAMR by race/ethnicity (non-Hispanic White, non-Hispanic Black, and Hispanic/Latinx individuals). There were 659 740 CVD deaths among non-Hispanic White individuals in 2698 counties; 100 475 deaths among non-Hispanic Black individuals in 717 counties; and 49 493 deaths among Hispanic/Latinx individuals across 267 counties. Non-Hispanic Black individuals had the highest mean CVD AAMR (320.04 deaths per 100 000 individuals), whereas Hispanic/Latinx individuals had the lowest (168.42 deaths per 100 000 individuals). The highest CVD AAMRs across all racial/ethnic groups were observed in the South. In unadjusted analyses, the greatest variation ( R 2 ) in CVD AAMR was explained by physical inactivity for non-Hispanic White individuals (32.3%), median household income for non-Hispanic Black individuals (24.7%), and population size for Hispanic/Latinx individuals (28.4%). In multivariable regressions using county-level factor categories, the greatest variation in CVD AAMR was explained by CVD risk factors for non-Hispanic White individuals (35.3%), socioeconomic factors for non-Hispanic Black (25.8%), and demographic factors for Hispanic/Latinx individuals (34.9%). Conclusions The associations between race/ethnicity-specific age-adjusted CVD mortality and county-level factors differ significantly. Interventions to reduce disparities may benefit from being designed accordingly.

SGLT2 inhibitors have risen to prominence in recent years as Type 2 diabetes mellitus medications with favorable effects on cardiovascular (CV) and renal outcomes. Canagliflozin is a US FDA-approved SGLT2 inhibitor that has demonstrated CV and renal outcome benefits in large scale placebo-controlled randomized trials of patients with Type 2 diabetes mellitus and elevated CV risk. Canagliflozin use may also be associated with serious and nonserious adverse effects requiring ongoing monitoring in patients initiated on this medication. This paper provides a detailed overview of canagliflozin including its pharmacologic profile, clinical efficacy and safety data, with discussion of both clinical trial results, as well as real-world evidence.

Introduction: Population-level and individual-level analyses have strengths and limitations as do 'blackbox' machine learning (ML) and traditional, interpretable models. Diabetes mellitus (DM) is a leading cause of morbidity and mortality with complex sociodemographic dynamics that have not been analyzed in a way that leverages population-level and individual-level data as well as traditional epidemiological and ML models. We analyzed complementary individual-level and county-level datasets with both regression and ML methods to study the association between sociodemographic factors and DM., Research Design and Methods: County-level DM prevalence, demographics, and socioeconomic status (SES) factors were extracted from the 2018 Robert Wood Johnson Foundation County Health Rankings and merged with US Census data. Analogous individual-level data were extracted from 2007 to 2016 National Health and Nutrition Examination Survey studies and corrected for oversampling with survey weights. We used multivariate linear (logistic) regression and ML regression (classification) models for county (individual) data. Regression and ML models were compared using measures of explained variation (area under the receiver operating characteristic curve (AUC) and R 2 )., Results: Among the 3138 counties assessed, the mean DM prevalence was 11.4% (range: 3.0%-21.1%). Among the 12 824 individuals assessed, 1688 met DM criteria (13.2% unweighted; 10.2% weighted). Age, gender, race/ethnicity, income, and education were associated with DM at the county and individual levels. Higher county Hispanic ethnic density was negatively associated with county DM prevalence, while Hispanic ethnicity was positively associated with individual DM. ML outperformed regression in both datasets (mean R 2 of 0.679 vs 0.610, respectively (p<0.001) for county-level data; mean AUC of 0.737 vs 0.727 (p<0.0427) for individual-level data)., Conclusions: Hispanic individuals are at higher risk of DM, while counties with larger Hispanic populations have lower DM prevalence. Analyses of population-level and individual-level data with multiple methods may afford more confidence in results and identify areas for further study., Competing Interests: Competing interests: DMM acts as an advisor for Sanofi-Aventis US LLC, Novo Nordisk Inc, WL Gore and Associates, Inc, and Medtronic Minimed, Inc. DS acts as an advisor for Carta Healthcare. No other potential conflicts of interest relevant to this article were reported., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The percentage of Hispanics in a county has a negative association with prevalence of obesity. Because Hispanic individuals are unevenly distributed in the United States, this study examined whether this protective association persists when stratifying counties into quartiles based on the size of the Hispanic population and after adjusting for county-level demographic, socioeconomic, healthcare, and environmental factors., Methods: Data were extracted from the 2018 Robert Wood Johnson Foundation County Health Rankings. Counties were categorized into quartiles based on their percentage of Hispanics, 0%-5% ( n = 1794), 5%-20% ( n = 962), 20%-50% ( n = 283), and >50% ( n = 99). For each quartile, univariate and multivariate regression models were used to evaluate the association between prevalence of obesity and demographic, socioeconomic, healthcare, and environmental factors., Results: Counties with the top quartile of Hispanic individuals had the lowest prevalence of obesity compared to counties at the bottom quartile (28.4 ± 3.6% vs. 32.7 ± 4.0%). There was a negative association between county-level percentage of Hispanics and prevalence of obesity in unadjusted analyses that persisted after adjusting for all county-level factors., Conclusions: Counties with a higher percentage of Hispanics have lower levels of obesity, even after controlling for demographic, socioeconomic, healthcare, and environmental factors. More research is needed to elucidate why having more Hispanics in a county may be protective against county-level obesity., (© 2020 The Authors. Obesity Science & Practice published by World Obesity and The Obesity Society and John Wiley & Sons Ltd.)

Background: Shared decision making (SDM) implementation remains challenging. The factors that promote or hinder implementation of SDM tools for use during the consultation, including contextual factors such as clinician burnout and organizational support, remain unclear. We explored these factors in the context of a practical multicenter randomized trial evaluating the effectiveness of an SDM conversation tool for patients with atrial fibrillation considering anticoagulation therapy., Methods: In this cross-sectional study, we recruited clinicians who were regularly involved in conversations with patients regarding anticoagulation for atrial fibrillation. Clinicians reported their characteristics and burnout symptoms using the two-item Maslach Burnout Inventory. Clinicians were trained in using the SDM tool, and they recorded their perceptions of the tool's normalization potential using the Normalization MeAsure Development (NoMAD) survey instrument and verbally reflected on their answers to these survey questions. When possible, the training sessions and clinicians' verbal responses to the conversation tool were recorded., Results: Our study comprised 183 clinicians recruited into the trial (168 with survey responses and 112 with recordings). Overall, clinicians gave high scores to the normalization potential of the intervention; they endorsed all domains of normalization to the same extent, regardless of site, clinician characteristics, or burnout ratings. In interviews, clinicians paid significant attention to making sense of the tool. Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and "evidence-based" and their perceptions of having time in the consultation to use it., Conclusions: While time in the consultation remains a barrier, we did not find a significant association between burnout symptoms and normalization of an SDM conversation tool. Possible areas for improving the normalization of SDM conversation tools in clinical practice include enabling collaboration among clinicians to implement the tool and reporting how clinicians elsewhere use the tool. Direct measures of normalization (i.e., observing how often clinicians access the tool in practice outside of the clinical trial) may further elucidate the role that contextual factors, such as clinician burnout, play in the implementation of SDM., Trial Registration: ClinicalTrials.gov, NCT02905032. Registered on 9 September 2016.

Background and Objectives : Thyroid hormones (TH) affect cardiac function through effects on cardiac contractility and systemic vascular resistance. While TH replacement for patients with hypothyroidism might be necessary for restoration of cardiac output after an acute myocardial infarction (AMI), it could theoretically lead to excessively rapid restoration of the metabolic rate. The appropriate management of hypothyroidism in patients with AMI is unknown. We describe the practice patterns in the management of hypothyroidism in the setting of AMI as well as patients' clinical outcomes. Material and Methods : Retrospective study of patients that were admitted to a tertiary care hospital with AMI and newly diagnosed or uncontrolled hypothyroidism (TSH ≥ 10 mIU/L) between 2011-2018. Eligible patients were identified using diagnosis codes for AMI and laboratory values, followed by medical record review. We categorized patients according to treatment status with TH and by degree of hypothyroidism. Clinical outcomes included: 30-day mortality/readmission, bleeding, stroke, arrhythmia, sudden cardiac death, and new or worsening heart failure. Summary statistics and group comparisons are presented. Results : Sixty-four patients were included, their median age was 64 years and 61% ( n = 39) were women. Most of the patients (59%) had a documented history of hypothyroidism. Of these, all were restarted on levothyroxine (LT4) during the index admission when compared to patients without a history of hypothyroidism, of which 54% received LT4 treatment ( p = 0.001). The median TSH in those treated with LT4 was higher (25 mIU/L) when compared to those who were not (12 mIU/L), ( p = 0.007). Patients who received intravenous LT4 had higher TSH levels and other variables suggesting worse clinical presentation, but these differences were not statistically significant. No statistically significant differences were noted on clinical outcomes according to LT4 treatment status. Conclusion : A history of hypothyroidism and the degree of TSH elevation seem to guide the management of hypothyroidism in patients with AMI. The clinical effect of correcting hypothyroidism in this setting requires further evaluation.

Purpose: To examine the proportion of diabetes-focused clinical encounters in primary care and endocrinology practices where the evaluation for hypoglycemia is documented; and when it is, identify clinicians' stated actions in response to patient-reported events., Methods: A total of 470 diabetes-focused encounters among 283 patients nonpregnant adults (≥18 years) with type 1 or type 2 diabetes mellitus in this retrospective cohort study. Participants were randomly identified in blocks of treatment strategy and care location (95 and 52 primary care encounters among hypoglycemia-prone medications (i.e. insulin, sulfonylurea) and others patients, respectively; 94 and 42 endocrinology encounters among hypo-treated and others, respectively). Documentation of hypoglycemia and subsequent management plan in the electronic health record were evaluated., Results: Overall, 132 (46.6%) patients had documentation of hypoglycemia assessment, significantly more prevalent among hypo-treated patients seen in endocrinology than in primary care (72.3% vs. 47.4%; P = 0.001). Hypoglycemia was identified by patient in 38.2% of encounters. Odds of hypoglycemia assessment documentation was highest among the hypo-treated (OR 13.6; 95% CI 5.5-33.74, vs. others) and patients seen in endocrine clinic (OR 4.48; 95% CI 2.3-8.6, vs. primary care). After documentation of hypoglycemia, treatment was modified in 30% primary care and 46% endocrine clinic encounters; P = 0.31. Few patients were referred to diabetes self-management education and support (DSMES)., Conclusions: Continued efforts to improve hypoglycemia evaluation, documentation, and management are needed, particularly in primary care. This includes not only screening at-risk patients for hypoglycemia, but also modifying their treatment regimens and/or leveraging DSMES.

Background: Clinicians' satisfaction with encounter decision aids is an important component in facilitating implementation of these tools. We aimed to determine the impact of decision aids supporting shared decision making (SDM) during the clinical encounter on clinician outcomes., Methods: We searched nine databases from inception to June 2017. Randomised clinical trials (RCTs) of decision aids used during clinical encounters with an unaided control group were eligible for inclusion. Due to heterogeneity among included studies, we used a narrative evidence synthesis approach., Results: Twenty-five papers met inclusion criteria including 22 RCTs and 3 qualitative or mixed-methods studies nested in an RCT, together representing 23 unique trials. These trials evaluated healthcare decisions for cardiovascular prevention and treatment (n=8), treatment of diabetes mellitus (n=3), treatment of osteoporosis (n=2), treatment of depression (n=2), antibiotics to treat acute respiratory infections (n=3), cancer prevention and treatment (n=4) and prenatal diagnosis (n=1). Clinician outcomes were measured in only a minority of studies. Clinicians' satisfaction with decision making was assessed in only 8 (and only 2 of them showed statistically significantly greater satisfaction with the decision aid); only three trials asked if clinicians would recommend the decision aid to colleagues and only five asked if clinicians would use decision aids in the future. Outpatient consultations were not prolonged when a decision aid was used in 9 out of 13 trials. The overall strength of the evidence was low, with the major risk of bias related to lack of blinding of participants and/or outcome assessors., Conclusion: Decision aids can improve clinicians' satisfaction with medical decision making and provide helpful information without affecting length of consultation time. Most SDM trials, however, omit outcomes related to clinicians' perspective on the decision making process or the likelihood of using a decision aid in the future., Competing Interests: Competing interests: MRG has conducted consulting work around shared decision making for Pfizer with travel costs and honoraria paid to his institution. MRG was also paid by Hillcrest Medical Center (Tulsa, OK) to speak on SDM at a continuing medical education event with travel costs and an honorarium paid to his institution; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Shared decision making (SDM) is a patient-centered approach in which clinicians and patients work together to find and choose the best course of action for each patient's particular situation. Six SDM key elements can be identified: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences, and making the decision. The International Patient Decision Aid Standards (IPDAS) require that a decision aid (DA) support these key elements. Yet, the extent to which DAs support these six key SDM elements and how this relates to their impact remain unknown., Methods: We searched bibliographic databases (from inception until November 2017), reference lists of included studies, trial registries, and experts for randomized controlled trials of DAs in patients with cardiovascular, or chronic respiratory conditions or diabetes. Reviewers worked in duplicate and independently selected studies for inclusion, extracted trial, and DA characteristics, and evaluated the quality of each trial., Results: DAs most commonly clarified options (20 of 20; 100%) and discussed their harms and benefits (18 of 20; 90%; unclear in two DAs); all six elements were clearly supported in 4 DAs (20%). We found no association between the presence of these elements and SDM outcomes., Conclusions: DAs for selected chronic conditions are mostly designed to transfer information about options and their harms and benefits. The extent to which their support of SDM key elements relates to their impact on SDM outcomes could not be ascertained., Systematic Review Registration: PROSPERO registration number: CRD42016050320 .

Background: This systematic review summarizes the benefits of treating blood pressure (BP) in individuals 65 years and older., Methods: We included randomized trials that evaluated BP-lowering medications or BP targets in individuals 65 years and older. Trials were selected and appraised by pairs of independent reviewers., Results: We included 19 trials (42,134 patients). In individuals 65 years or older, antihypertensive therapy was associated with a reduction in all-cause mortality [relative risk: 0.88 (95% CI: 0.81 to 0.94); high certainty evidence; mean follow-up 31 months], cardiovascular mortality, myocardial infarction, heart failure, stroke, and chronic kidney disease. Individuals 75 years or older had a significant reduction in the risk of all-cause and cardiovascular mortality, stroke, and heart failure. Strict systolic BP targets (<120 mm Hg and <130 mm Hg) were associated with a significant reduction in the risk of all-cause and cardiovascular mortality and heart failure, whereas more liberal systolic targets (<150 mm Hg and <160 mm Hg) were associated with lower risk of heart failure and stroke. Older adults with type 2 diabetes mellitus (DM) had lower risk of chronic kidney disease without a significant reduction in other outcomes. However, there was no significant difference in estimates (i.e., interaction) between those with and without DM., Conclusions: Individuals aged 65 years and older or 75 years and older who receive antihypertensive therapy have statistically significant reduction in the risk of all-cause and cardiovascular mortality, heart failure, and stroke. There was no statistically significant difference in estimates between those with and without DM., (Copyright © 2019 Endocrine Society.)

Background: The efficacy of lipid-lowering agents on patient-important outcomes in older individuals is unclear., Methods: We included randomized trials that enrolled individuals aged 65 years or older and that included at least 1 year of follow-up.Pairs of reviewers selected and appraised the trials., Results: We included 23 trials that enrolled 60,194 elderly patients. For primary prevention, statins reduced the risk of coronary artery disease [CAD; relative risk (RR): 0.79, 95% CI: 0.68 to 0.91] and myocardial infarction (MI; RR: 0.45, 95% CI: 0.31 to 0.66) but not all-cause or cardiovascular mortality or stroke. These effects were imprecise in patients with diabetes, but there was no significant interaction between diabetes status and the intervention effect. For secondary prevention, statins reduced all-cause mortality (RR: 0.80, 95% CI: 0.73 to 0.89), cardiovascular mortality (RR: 0.68, 95% CI: 0.58 to 0.79), CAD (RR: 0.68, 95% CI: 0.61 to 0.77), MI (RR: 0.68, 95% CI: 0.59 to 0.79), and revascularization (RR: 0.68, 95% CI: 0.61 to 0.77). Intensive (vs less-intensive) statin therapy reduced the risk of CAD and heart failure. Niacin did not reduce the risk of revascularization, and fibrates did not reduce the risk of stroke, cardiovascular mortality, or CAD., Conclusion: High-certainty evidence supports statin use for secondary prevention in older individuals. Evidence for primary prevention is less certain. Data in older individuals with diabetes are limited; however, no empirical evidence has shown a significant difference based on diabetes status., (Copyright © 2019 Endocrine Society.)

Objective: To assess the extent to which evaluations of shared decision making (SDM) assess the extent and quality of humanistic communication (i.e., respect, compassion, empathy)., Methods: We systematically searched Web of Science and Scopus for prospective studies published between 2012 and February 2018 that evaluated SDM in actual clinical decisions using validated SDM measures. Two reviewers working independently and in duplicate extracted all statements from eligible studies and all items from SDM measurement instruments that referred to humanistic patient-clinician communication., Results: Of the 154 eligible studies, 14 (9%) included ≥1 statements regarding humanistic communication, either in framing the study (N = 2), measuring impact (e.g., empathy, respect, interpersonal skills; N = 9), as patients'/clinicians' accounts of SDM (N = 2), in interpreting study results (N = 3), and in discussing implications of study findings (N = 3). Of the 192 items within the 11 SDM measurement instruments deployed in the included studies, 7 (3.6%) items assessed humanistic communication., Conclusion: Assessments of the quality of SDM focus narrowly on SDM technique and rarely assess humanistic aspects of patient-clinician communication., Practice Implications: Considering SDM as merely a technique may reduce SDM's patient-centeredness and undermine its' contribution to patient care., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: How non-verbal data may influence observer-administered ratings of shared decision making is unknown. Our objective for this exploratory analysis was to determine the effect of mode of data collection (audio+video vs. audio only) on the scoring of the OPTION 5 instrument, an observer rated measure of shared decision making., Methods: We analyzed recordings of 15 encounters between cancer patients and clinicians in which a clinical decision was made. Audio+video or audio only recordings of the encounters were randomly assigned to four trained raters, who reviewed them independently. We compared the adjusted mean scores of audio+video and audio only., Results: Forty-one unique decisions were identified within the 15 encounters. The mean OPTION 5 score for audio+video was 17.5 (95% CI 13.5, 21.6) and for audio only was 21.8 (95% CI 17.2, 26.4) with a mean difference of 4.28 (95% CI = 0.36, 8.21; p = 0.032)., Conclusion: A rigorous and well established measure of shared decision making performs differently when the data source is audio only. Data source may influence rating of observer administered measures of shared decision making. This potential bias needs to be confirmed as video recording to examine communication behaviors becomes more common.

Context: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood., Objective: To conduct a systematic review and meta-analysis of randomized clinical trials (RCT) to determine the effects of TRT on patient-important outcomes and adverse events in hypogonadal men., Data Sources: We searched Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus from inception to March 2th, 2017., Study Selection: RCTs that assessed the efficacy and adverse events of TRT of at least 12 weeks compared with placebo in adult men with hypogonadism, defined by morning testosterone ≤300 ng/dL and at least one symptom or sign of hypogonadism., Data Extraction: Reviewers working independently and in duplicate assessed the quality of the trials and collected data on patient characteristics, interventions, and outcomes., Data Synthesis: We found 11 publications, reporting on 4 eligible trials (including 1,779 patients) at low risk of bias. Compared to placebo, TRT was associated with a small but significant increase in sexual desire or libido [standardized mean difference (SMD): 0.17, 95% CI 0.01, 0.34] (n=1383), erectile function [SMD: 0.16, 95% CI 0.06, 0.27] (n=1344), and sexual satisfaction [SMD: 0.16, 95% CI 0.01, 0.31] (n=676), but had no effect on energy or mood. TRT was associated with an increased risk of developing erythrocytosis [relative risk: 8.14, 95% CI: 1.87, 35.40] (n=1579) compared to placebo, but had no significant effect on lower urinary tract symptoms (LUTS)., Conclusion: In hypogonadal men TRT improves sexual desire, erectile function, and sexual satisfaction, however it increases the risk of erythrocytosis.

Interventions that grow patient capacity to do the work of health care and life are needed to support the health of cancer survivors. Health coaching may grow capacity. This systematic review of health coaching interventions explored coaching's ability to grow capacity of cancer survivors. The authors included randomized trials or quasi-experimental studies comparing coaching to alternative interventions, and adhered to PRISMA reporting guidelines. Data were analyzed using the Theory of Patient Capacity (BREWS: Capacity is affected by factors that influence ability to reframe Biography ["B"], mobilize or recruit Resources ["R"], interact with the Environment of care ["E"], accomplish Work ["W"]), and function Socially ["S"]). The authors reviewed 2210 references and selected 12 studies (6 randomized trials and 6 pre-post). These studies included 1038 cancer survivors, mean age 57.2 years, with various type of cancers: breast, colorectal, prostate, and lung. Health coaching was associated with improved quality of life, mood, and physical activity but not self-efficacy. Classified by potential to support growth in patient capacity, 67% of included studies reported statistically significant outcomes that support "B" (quality of life, acceptance, spirituality), 75% "R" (decreased fatigue, pain), 67% "W" (increased physical activity), and 33% "S" (social deprivation index). None addressed changing the patient's environment of care. In cancer survivors, health coaching improved quality of life and supported patient capacity by several mechanisms, suggesting an important role for "Capacity Coaching." Future interventions that improve self-efficacy and patients' environments of care are needed. Capacity Coaching may improve health and quality of life of cancer survivors.

In the original publication, the given and family name of the author Mohammad Hassan Murad was incorrect. This has been corrected with this erratum.

Purpose: Sex hormones play a role in bone density, cardiovascular health, and wellbeing throughout reproductive lifespan. Women with primary ovarian insufficiency (POI) have lower estrogen levels requiring hormone therapy (HT) to manage symptoms and to protect against adverse long-term health outcomes. Yet, the effectiveness of HT in preventing adverse outcomes has not been systematically assessed. We summarize the evidence regarding effects of HT on bone and cardiovascular health in women with POI., Methods: A comprehensive search of the electronic databases MEDLINE, EMBASE, and Scopus was conducted by a medical reference librarian from database inception to January 2016. Randomized trials and observational cohort studies with an estrogen-based HT intervention in women with POI under the age of 40 were included. Reviewers worked independently and in duplicate to assess eligibility and risk of bias, and extract data of interest from each study., Results: The search identified 1670 articles; 12 met inclusion criteria. Four randomized clinical trials and eight cohort studies at high risk of bias enrolled 806 women with POI. The most common HT formulations were transdermal estradiol and oral conjugated equine estrogen combined with medroxyprogesterone acetate. Bone mineral density was the most frequent outcome, with three out of eight studies showing HT associated increase benefits. Only one study reported effects on fractures or vasomotor symptoms and none on cardiovascular mortality. Results regarding lipid profiles were inconsistent., Conclusions: Evidence supporting bone and cardiovascular benefits of HT in women with POI is limited by high risk of bias, reliance on surrogate outcomes, and heterogeneity of trials regarding the formulation, dose, route of administration, and regimen of HT. Further research addressing patient important outcomes such as fractures, stroke, and cardiovascular mortality are crucial to optimize benefits of this therapy.

Current healthcare systems and guidelines are not designed to adapt to care for the large and growing number of patients with complex care needs and those with multimorbidity. Minimally disruptive medicine (MDM) is an approach to providing care for complex patients that advances patients' goals in health and life while minimizing the burden of treatment. Measures of treatment burden assess the impact of healthcare workload on patient function and well-being. At least two of these measures are now available for use with patients living with chronic conditions. Here, we describe these measures and how they can be useful for clinicians, researchers, managers, and policymakers. Their work to improve the care of high-cost, high-use, complex patients using innovative patient-centered models such as MDM should be supported by periodic large-scale assessments of treatment burden.

Background: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes., Methods: This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA 2 DS 2 -VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records., Discussion: This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke., Trial Registration: ClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.

Purpose of Review: Patients with diabetes must deal with the burden of symptoms and complications (burden of illness). Simultaneously, diabetes care demands practical and emotional work from patients and their families, work to access and use healthcare and to enact self-care (burden of treatment). Patient work must compete with the demands of family, job, and community life. Overwhelmed patients may not have the capacity to access care or enact self-care and will thus experience suboptimal diabetes outcomes., Recent Findings: Minimally disruptive medicine (MDM) is a patient-centered approach to healthcare that prioritizes patients' goals for life and health while minimizing the healthcare disruption on patients' lives. In patients with diabetes, particularly in those with complex lives and multimorbidity, MDM coordinates healthcare and community responses to improve outcomes, reduce treatment burden, and enable patients to pursue their life's hopes and dreams.

Objectives: In the care of patients with type 2 diabetes, self-management is emphasised and studied while theory and observations suggest that patients also benefit from social support. We sought to assess the effect of social network interventions on social support, glycaemic control and quality of life in patients with type 2 diabetes., Research Design and Methods: We searched Ovid MEDLINE, Ovid EBM Reviews, Cochrane Central Register of Controlled Trials, EMBASE, PsycINFO and CINAHL through April 2017 for randomised clinical trials (RCTs) of social network interventions in patients with type 2 diabetes. Reviewers working independently and in duplicate assessed eligibility and risk of bias, and extracted data from eligible RCTs. We pooled estimates using inverse variance random effects meta-analysis., Results: We found 19 eligible RCTs enrolling 2319 participants. Social network interventions were commonly based on individual behaviour change rather than social or interpersonal theories of self-management, were educational, and sought to engage social network members for their knowledge and experience. Interventions improved social support (0.74 SD (95% CI 0.32 to 1.15), I 2 =89%, 8 RCTs) and haemoglobin A1c at 3 months (-0.25 percentage points (95% CI -0.40 to -0.11), I 2 =12%, 9 RCTs), but not quality of life., Conclusions: Despite a compelling theoretical base, researchers have only minimally studied the value of interventions targeting patients' social networks on diabetes care. Although the body of evidence to date is limited, and based on individual behaviour change theories, the results are promising. This review challenges the scientific community to design and test theory-based interventions that go beyond self-management approaches to focus on the largely untapped potential of social networks to improve diabetes care., Prospero Registration: CRD42016036117., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Shared decision-making (SDM) is a patient-centred approach in which clinicians and patients work side-by-side to decide together on the best course of action for each patient's particular situation. Six key elements of SDM can be distinguished: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences and making the decision. Decision aids (DAs) are tools that facilitate SDM. The impact of DAs for chronic illnesses on SDM, clinical and patient reported outcomes remains uncertain., Methods: We will perform a systematic review aiming to describe (a) which SDM elements are incorporated in DAs for adult patients with chronic conditions and (b) the effects of DA use on SDM, clinical and patient reported outcomes. This manuscript reports on the protocol for this systematic review. The following databases will be searched for relevant articles: PubMed, Embase, Web of Science, CINAHL and PsycINFO, from their inception to October 2016. We will ascertain ongoing research by querying experts and searching trial registries. To enhance feasibility, we will limit the review to randomized controlled trials (RCTs) including patients with chronic cardiovascular and/or respiratory diseases and/or diabetes. SDM elements incorporated in DAs, DA effects and DA itself will be described., Discussion: This study will characterize DAs for chronic illness and will provide an overview of their effects on SDM, clinical and patient reported outcomes. We anticipate this review will bring to light knowledge gaps and inform further research into the design and use of DAs for patients with chronic conditions., Systematic Review Registration: PROSPERO registration number: CRD42016050320 .

Background: Systematic reviews provide clinicians and policymakers estimates of diagnostic test accuracy and their usefulness in clinical practice. We identified all available systematic reviews of diagnosis in endocrinology, summarized the diagnostic accuracy of the tests included, and assessed the credibility and clinical usefulness of the methods and reporting., Methods: We searched Ovid MEDLINE, EMBASE, and Cochrane CENTRAL from inception to December 2015 for systematic reviews and meta-analyses reporting accuracy measures of diagnostic tests in endocrinology. Experienced reviewers independently screened for eligible studies and collected data. We summarized the results, methods, and reporting of the reviews. We performed subgroup analyses to categorize diagnostic tests as most useful based on their accuracy., Results: We identified 84 systematic reviews; half of the tests included were classified as helpful when positive, one-fourth as helpful when negative. Most authors adequately reported how studies were identified and selected and how their trustworthiness (risk of bias) was judged. Only one in three reviews, however, reported an overall judgment about trustworthiness and one in five reported using adequate meta-analytic methods. One in four reported contacting authors for further information and about half included only patients with diagnostic uncertainty., Conclusion: Up to half of the diagnostic endocrine tests in which the likelihood ratio was calculated or provided are likely to be helpful in practice when positive as are one-quarter when negative. Most diagnostic systematic reviews in endocrine lack methodological rigor, protection against bias, and offer limited credibility. Substantial efforts, therefore, seem necessary to improve the quality of diagnostic systematic reviews in endocrinology.

Patients with diabetes mellitus often have several medical problems and carry a burden imposed by their illness and treatment. Health care often ignores the values, preferences and context of patients, leading to treatments that do not fit into patients’ overwhelmed lives. Shared Decision Making (SDM) emerges as a way to answer the question: “What’s best for the patient?”. SDM promotes an empathic conversation between patients and clinicians that integrates the best evidence available with their values, preferences and context. We discuss three SDM approaches for patients with diabetes: one focused on sharing information, another on making choices, and a third one on helping patients and clinicians to talk about how to address the problems of living with diabetes and its comorbidities. Despite the benefits demonstrated in studies conducted in the U.S. and Europe, the implementation of SDM continues to be a challenge. In Latin America, healthcare and socio-economic conditions render the implementation of SDM more challenging. Research aimed to respond to this challenge is necessary. Meanwhile, clinicians can practice SDM by sharing evidence-based information, giving voice to patients’ values and preferences in making choices, and creating empathic conversations aimed at decisions aligned with patients’ context, dreams, goals, and life expectations.

Sleep complaints are reported by 40-60 % of menopausal women. Poor sleep is a risk factor for cardiovascular disease, diabetes, and obesity. The effect of menopausal hormone therapy on sleep quality is unclear. A systematic review and meta-analysis were conducted to summarize the efficacy of menopausal hormone therapy on self-reported sleep quality. Electronic databases (PubMed, Scopus, Ovid MEDLINE, EMBASE, EBM Reviews CENTRAL, and PsycInfo) were searched from 2002 to October 2015. Randomized trials assessing the effect of menopausal hormone therapy with a minimum follow up of 8 weeks were included. Titles, abstracts, and full texts were screened independently and in duplicate. Primary outcome included sleep items within a questionnaire, scale or diary. Standardized mean differences across trials were pooled using random-effects models. The search identified 424 articles, from which 42 trials were included. Seven trials at a moderate to high risk of bias enrolling 15,468 women were pooled in meta-analysis. Menopausal hormone therapy improved sleep quality in women who had vasomotor symptoms at baseline [standardized mean difference -0.54 (-0.91 to -0.18), moderate quality evidence]. No difference was noted when women without such symptoms were analyzed separately or combined. Across 31 sleep quality questionnaires, daytime dysfunction was the most evaluated sleep domain. Menopausal hormone therapy improves sleep in women with concomitant vasomotor symptoms. Heterogeneity of trials regarding study population, formulations, and sleep scales; limit overall certainty in the evidence. Future menopausal hormone therapy trials should include assessment of self-reported sleep quality using standardized scales and adhere to reporting guidelines.

Competing Interests: Author Disclosure Statement No competing financial interests exist.