Cardiovascular Disease and Risk Management: Review of the American Diabetes Association Standards of Medical Care in Diabetes 2018

Description: The American Diabetes Association (ADA) annually updates its Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes. Methods: For the 2018 standards, the ADA Professional Practice Committee searched MEDLINE through November 2017 to add, clarify, or revise recommendations on the basis of new evidence. The committee rated the recommendations as A, B, or C depending on the quality of evidence or E for expert consensus or clinical experience. The standards were reviewed and approved by the Executive Committee of the ADA Board of Directors, which includes health care professionals, scientists, and laypersons. Feedback from the larger clinical community informed revisions. Recommendations: This synopsis focuses on guidance relating to cardiovascular disease and risk management in nonpregnant adults with diabetes. Recommendations address diagnosis and treatment of cardiovascular risk factors (hypertension and dyslipidemia), aspirin use, screening for and treatment of coronary heart disease, and lifestyle interventions.

Comparison of Rates of Firearm and Nonfirearm Homicide and Suicide in Black and White Non-Hispanic Men, by U.S. State

Background: The extent to which differences in homicide and suicide rates in black versus white men vary by U.S. state is unknown. Objective: To compare the rates of firearm and nonfirearm homicide and suicide in black and white non-Hispanic men by U.S. state and to examine whether these deaths are associated with state prevalence of gun ownership. Design: Surveillance study. Setting: 50 states and the District of Columbia, 2008 to 2016. Cause-of-death data were abstracted by using the Centers for Disease Control and Prevention's WONDER (Wide-ranging Online Data for Epidemiologic Research) database. Participants: Non-Hispanic black and non-Hispanic white males, all ages. Measurements: Absolute rates of and rate differences in firearm and nonfirearm homicide and suicide in black and white men. Results: During the 9-year study period, 84 113 homicides and 251 772 suicides occurred. Black–white differences in rates of firearm homicide and suicide varied widely across states. Relative to white men, black men had between 9 and 57 additional firearm homicides per 100 000 per year, with black men in Missouri, Michigan, Illinois, Indiana, and Pennsylvania having more than 40 additional firearm homicides per 100 000 per year. White men had between 2 fewer and 16 more firearm suicides per 100 000 per year, with the largest inequalities observed in southern and western states and the smallest in the District of Columbia and densely populated northeastern states. Limitations: Some homicides and suicides may have been misclassified as deaths due to unintentional injury. Survey data on state household gun ownership were collected in 2004 and may have shifted during the past decade. Conclusion: The large state-to-state variation in firearm homicide and suicide rates, as well as the racial inequalities in these numbers, highlights states where policies may be most beneficial in reducing homicide and suicide deaths and the racial disparities in their rates. Primary Funding Source: McGill University and the National Institutes of Health.

Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1): A Systematic Review: Annals of Internal Medicine: Vol 168, No 8

This article has been corrected. To see what has changed, please read the Letter to the Editor and the authors' response. The original version (PDF) is appended to this article as a Supplement. Background: The Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), the sepsis performance measure introduced in 2015 by the Centers for Medicare & Medicaid Services (CMS), requires the reporting of up to 5 hemodynamic interventions, as many as 141 tasks, and 3 hours to document for a single patient. Purpose: To evaluate whether moderate- or high-level evidence shows that use of the 2015 SEP-1 or its hemodynamic interventions improves survival in adults with sepsis. Data Sources: PubMed, Embase, Scopus, Web of Science, and ClinicalTrials.gov from inception to 28 November 2017 with no language restrictions. Study Selection: Randomized and observational studies of death among adults with sepsis who received versus those who did not receive either the entire SEP-1 bundle or 1 or more SEP-1 hemodynamic interventions, including serial lactate measurements; a fluid infusion of 30 mL/kg of body weight; and assessment of volume status and tissue perfusion with a focused examination, bedside cardiovascular ultrasonography, or fluid responsiveness testing. Data Extraction: Two investigators independently extracted study data and assessed each study's risk of bias; 4 authors rated level of evidence by consensus using CMS criteria published in 2013. High- or moderate-level evidence required studies to have no confounders and low risk of bias. Data Synthesis: Of 56 563 references, 20 studies (18 reports) met inclusion criteria. One single-center observational study reported lower in-hospital mortality after implementation of the SEP-1 bundle. Sixteen studies (2 randomized and 14 observational) reported increased survival with serial lactate measurements or 30-mL/kg fluid infusions. None of the 17 studies were free of confounders or at low risk of bias. In 3 randomized trials, fluid responsiveness testing did not alter survival. Limitations: Few trials, poor-quality and confounded studies, and no studies (with survival outcomes) of the focused examination or bedside cardiovascular ultrasonography. Use of the 2015 version of SEP-1 and 2013 version of CMS evidence criteria, both of which were updated in 2017. Conclusion: No high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis. Primary Funding Source: National Institutes of Health. (PROSPERO: CRD42016052716)

Low Prevalence of Hepatitis B Vaccination Among Patients Receiving Medical Care for HIV Infection in the United States, 2009 to 2012

Background: Persons with HIV infection are at increased risk for hepatitis B virus infection. In 2016, the World Health Organization resolved to eliminate hepatitis B as a public health threat by 2030. Objective: To estimate the prevalence of hepatitis B vaccination among U.S. patients receiving medical care for HIV infection (“HIV patients”). Design: Nationally representative cross-sectional survey. Setting: United States. Participants: 18 089 adults receiving HIV medical care who participated in the Medical Monitoring Project during 2009 to 2012. Measurements: Primary outcomes were prevalence of 1) no documentation of hepatitis B vaccination or laboratory evidence of immunity or infection (candidates to initiate vaccination), and 2) initiation of vaccination among candidates, defined as documentation of at least 1 vaccine dose in a 1-year surveillance period during which patients received ongoing HIV medical care. Results: At the beginning of the surveillance period, 44.2% (95% CI, 42.2% to 46.2%) of U.S. HIV patients were candidates to initiate vaccination. By the end of the surveillance period, 9.6% (CI, 8.4% to 10.8%) of candidates were vaccinated, 7.5% (CI, 6.4% to 8.6%) had no documented vaccination but had documented infection or immunity, and 82.9% (CI, 81.1% to 84.7%) remained candidates. Among patients at facilities funded by the Ryan White HIV/AIDS Program (RWHAP), 12.5% (CI, 11.1% to 13.9%) were vaccinated during the surveillance period versus 3.7% (CI, 2.6% to 4.7%) at facilities not funded by RWHAP. At the end of surveillance, 36.7% (CI, 34.4% to 38.9%) of HIV patients were candidates to initiate vaccination. Limitation: The study was not designed to describe vaccine series completion or actual prevalence of immunity. Conclusion: More than one third of U.S. HIV patients had missed opportunities to initiate hepatitis B vaccination. Meeting goals for hepatitis B elimination will require increased vaccination of HIV patients in all practice settings, particularly at facilities not funded by RWHAP. Primary Funding Source: Centers for Disease Control and Prevention.

Comparative Effectiveness of Management Strategies for Renal Artery Stenosis: An Updated Systematic Review: Annals of Internal Medicine: Vol 165, No 9

Background: Atherosclerotic renal artery stenosis (ARAS) is associated with high blood pressure (BP), decreased kidney function, renal replacement therapy (RRT), and death. Purpose: To compare benefits and harms of percutaneous transluminal renal angioplasty with stent placement (PTRAS) versus medical therapy alone in adults with ARAS. Data Sources: MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from 1993 to 16 March 2016; gray literature; and prior systematic reviews. Study Selection: Randomized, controlled trials (RCTs); nonrandomized, comparative studies (NRCSs); single-group studies; and selected case reports that reported all-cause and cardiovascular mortality, RRT, kidney function, BP, and adverse events. Data Extraction: Six researchers extracted data on design, interventions, outcomes, and study quality into a Web-based database. Data Synthesis: Eighty-three studies met eligibility criteria. In 5 of 7 RCTs, PTRAS and medical therapy led to similar BP control in patients with ARAS, and no RCTs showed statistically significant differences in kidney function, mortality, RRT, cardiovascular events, or pulmonary edema. Eight NRCSs had more variable results, finding mostly no significant differences in mortality, RRT, or cardiovascular events but heterogeneous effects on kidney function and BP. Procedure-related adverse events were rare, and medication-related adverse events were not reported. Two RCTs found no patient characteristics that were associated with outcomes with either PTRAS or medical therapy. Single-group studies found various but inconsistent factors that predict outcomes. Case reports provided examples of clinical improvement after PTRAS in patients with acute decompensation. Limitation: Limited clinical applicability and power in RCTs, and possible publication bias and lack of adjusted analyses in NRCSs. Conclusion: The strength of evidence regarding the relative benefits and harms of PTRAS versus medical therapy alone for patients with ARAS is low. Studies have generally focused on patients with less severe ARAS. Primary Funding Source: Agency for Healthcare Research and Quality.

Unloading Shoes for Self-management of Knee Osteoarthritis: A Randomized Trial: Annals of Internal Medicine: Vol 165, No 6

Background: Appropriate footwear is recommended for self-management of knee osteoarthritis. Shoes that reduce harmful knee loads are available, but symptomatic effects are uncertain. Objective: To evaluate the efficacy of unloading shoes in alleviating knee osteoarthritis symptoms. Design: Participant- and assessor-blinded comparative effectiveness randomized, controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12613000851763) Setting: Community. Participants: 164 persons with medial knee osteoarthritis. Intervention: Walking shoes with triple-density, variable-stiffness midsoles and mild lateral-wedge insoles designed to unload the medial knee and worn daily (intervention) versus conventional walking shoes (comparator). Measurements: Primary outcomes were pain with walking (assessed on a numerical rating scale [NRS]) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) at 6 months. Secondary outcomes were knee pain and stiffness (WOMAC), average pain (NRS), intermittent and constant knee pain (Intermittent and Constant Osteoarthritis Pain questionnaire), quality of life (Assessment of Quality of Life instrument), physical activity (Physical Activity Scale for the Elderly), and global change in pain and function (Likert scales). Results: A total of 160 participants (98%) completed primary outcome measures at 6 months. Changes in pain (mean difference, 0.0 units [95% CI, −0.9 to 0.8 unit]) and function (mean difference, 0.3 unit [CI, −3.2 to 3.7 units]) did not differ between groups at 6 months, with both groups showing clinically relevant improvements in function and the intervention group showing clinically relevant improvements in pain. There were no differences in secondary outcomes. Pain was globally improved in 54% of participants, and function was globally improved in 44% to 48%. Unloading shoes were not associated with increased probability of improvement (odds ratios, 0.99 [CI, 0.53 to 1.86] for pain and 0.85 [CI, 0.45 to 1.61] for function). Limitation: Effects on joint structure were not evaluated. Conclusion: Shoes with modified midsoles to unload the medial knee conferred no additional benefit over conventional walking shoes. Both improved pain and function by clinically relevant amounts. Primary Funding Source: Australian National Health and Medical Research Council.

Nonrandomized Intervention Study of Naloxone Coprescription for Primary Care Patients Receiving Long-Term Opioid Therapy for Pain

Background: Unintentional overdose involving opioid analgesics is a leading cause of injury-related death in the United States. Objective: To evaluate the feasibility and effect of implementing naloxone prescription to patients prescribed opioids for chronic pain. Design: 2-year nonrandomized intervention study. Setting: 6 safety-net primary care clinics in San Francisco, California. Participants: 1985 adults receiving long-term opioid therapy for pain. Intervention: Providers and clinic staff were trained and supported in naloxone prescribing. Measurements: Outcomes were proportion of patients prescribed naloxone, opioid-related emergency department (ED) visits, and prescribed opioid dose based on chart review. Results: 38.2% of 1985 patients receiving long-term opioids were prescribed naloxone. Patients prescribed higher doses of opioids and with an opioid-related ED visit in the past 12 months were independently more likely to be prescribed naloxone. Patients who received a naloxone prescription had 47% fewer opioid-related ED visits per month in the 6 months after receipt of the prescription (incidence rate ratio [IRR], 0.53 [95% CI, 0.34 to 0.83]; P  = 0.005) and 63% fewer visits after 1 year (IRR, 0.37 [CI, 0.22 to 0.64]; P < 0.001) compared with patients who did not receive naloxone. There was no net change over time in opioid dose among those who received naloxone and those who did not (IRR, 1.03 [CI, 0.91 to 1.27]; P = 0.61). Limitation: Results are observational and may not be generalizable beyond safety-net settings. Conclusion: Naloxone can be coprescribed to primary care patients prescribed opioids for pain. When advised to offer naloxone to all patients receiving opioids, providers may prioritize those with established risk factors. Providing naloxone in primary care settings may have ancillary benefits, such as reducing opioid-related adverse events. Primary Funding Source: National Institutes of Health.

Pharmacologic Treatment of Primary Osteoporosis or Low Bone Mass to Prevent Fractures in Adults: A Living Clinical Guideline From the American College of Physicians (Version 1, Update Alert)

Prevalence and Management of Obesity in U.S. Adults With Type 1 Diabetes

Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women