Veterans

Recommendations from the Depts of Veterans Affairs and Defense regarding diagnosis and management of PTSD and acute stress disorders. James W. Mold, MD, MPH

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Description: The U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) worked together to revise the 2017 VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder. This article summarizes the 2023 clinical practice guideline (CPG) and its development process, focusing on assessments and treatments for which evidence was sufficient to support a recommendation for or against.

Methods: Subject experts from both departments developed 12 key questions and reviewed the published literature after a systematic search using the PICOTS (population, intervention, comparator, outcomes, timing of outcomes measurement, and setting) method. The evidence was then evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. Recommendations were made after consensus was reached; they were based on quality and strength of evidence and informed by other factors, including feasibility and patient perspectives. Once the draft was peer reviewed by an external group of experts and their inputs were incorporated, the final document was completed.

Recommendations: The revised CPG includes 34 recommendations in the following 5 topic areas: assessment and diagnosis, prevention, treatment, treatment of nightmares, and treatment of posttraumatic stress disorder (PTSD) with co-occurring conditions. Six recommendations on PTSD treatment were rated as strong. The CPG recommends use of specific manualized psychotherapies over pharmacotherapy; prolonged exposure, cognitive processing therapy, or eye movement desensitization and reprocessing psychotherapy; paroxetine, sertraline, or venlafaxine; and secure video teleconferencing to deliver recommended psychotherapy when that therapy has been validated for use with video teleconferencing or when other options are unavailable. The CPG also recommends against use of benzodiazepines, cannabis, or cannabis-derived products. Providers are encouraged to use this guideline to support evidence-based, patient-centered care and shared decision making to optimize individuals' health outcomes and quality of life.

Author/s:

Paula P Schnurr, Jessica L Hamblen, Jonathan Wolf, Rachael Coller, Claire Collie, Matthew A Fuller, Paul E Holtzheimer, Ursula Kelly, Ariel J Lang, Kate McGraw, Joshua C Morganstein, Sonya B Norman, Katie Papke, Ismene Petrakis, David Riggs, James A Sall, Brian Shiner, Ilse Wiechers, Marija S Kelber

The Management of Substance Use Disorders: Synopsis of the 2021 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

Saige Blanchard — Thu, 10 Mar 2022 06:00:00 +0000

Date Added:

March 22, 2022

Journal/Publication:

Annals of Internal Medicine

Publisher:

American College of Physicians

Publication Date:

March 22, 2022

URL:

The Management of Substance Use Disorders: Synopsis of the 2021 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.7326/M21-4011

Keywords

Substance Use

Department of Veterans Affairs

Department of Defense

Clinical Practice Guideline

PMID (1):

35313113

MeSH

Humans

Veterans

alcoholism

National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division

Algorithms

A synopsis of the VA guidelines for management of substance use disorders. James W. Mold, MD, MPH

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Description: In August 2021, leadership within the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved a joint clinical practice guideline (CPG) for the management of substance use disorders (SUDs). This synopsis summarizes key recommendations.

Methods: In March 2020, the VA/DoD Evidence-Based Practice Work Group assembled a team to update the 2015 VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders that included clinical stakeholders and conformed to the National Academy of Medicine's tenets for trustworthy CPGs. The guideline panel developed key questions, systematically searched and evaluated the literature, created two 1-page algorithms, and distilled 35 recommendations for care using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. This synopsis presents the recommendations that were believed to be the most clinically impactful.

Recommendations: The scope of the CPG is broad; however, this synopsis focuses on key recommendations for the management of alcohol use disorder, use of buprenorphine in opioid use disorder, contingency management, and use of technology and telehealth to manage patients remotely.

Author/s:

Perry, C., Liberto, J., Milliken, C., Burden, J., Hagedorn, H., Atkinson, T., McKay, J. R., Mooney, L., Sall, J., Sasson, C., Saxon, A., Spevak, C., Gordon, A, J,, VA/DoD Guideline Development Group

Effect of 7 vs 14 Days of Antibiotic Therapy on Resolution of Symptoms Among Afebrile Men With Urinary Tract Infection: A Randomized Clinical Trial

Bethie Seay — Thu, 23 Sep 2021 05:00:00 +0000

Date Added:

September 23, 2021

Journal/Publication:

JAMA

Publication Date:

July 27, 2021

Issue:

Volume:

326

Pages:

324-331

Type:

Clinical Research Results

DOI (1):

doi:10.1001/jama.2021.9899

MeSH

Humans

male

trimethoprim, sulfamethoxazole drug combination

Ciprofloxacin

anti-bacterial agents

urinary tract infections

Communicable Diseases

Treatment Adherence and Compliance

This RCT found that 7 days of antibiotics were sufficient for treatment of symptomatic UTI in afebrile men.

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Importance Determination of optimal treatment durations for common infectious diseases is an important strategy to preserve antibiotic effectiveness.

Objective To determine whether 7 days of treatment is noninferior to 14 days when using ciprofloxacin or trimethoprim/sulfamethoxazole to treat urinary tract infection (UTI) in afebrile men.

Design, Setting, and Participants Randomized, double-blind, placebo-controlled noninferiority trial of afebrile men with presumed symptomatic UTI treated with ciprofloxacin or trimethoprim/sulfamethoxazole at 2 US Veterans Affairs medical centers (enrollment, April 2014 through December 2019; final follow-up, January 28, 2020). Of 1058 eligible men, 272 were randomized.

Interventions Participants continued the antibiotic prescribed by their treating clinician for 7 days of treatment and were randomized to receive continued antibiotic therapy (n = 136) or placebo (n = 136) for days 8 to 14 of treatment.

Main Outcomes and Measures The prespecified primary outcome was resolution of UTI symptoms by 14 days after completion of active antibiotic treatment. A noninferiority margin of 10% was selected. The as-treated population (participants who took ≥26 of 28 doses and missed no more than 2 consecutive doses) was used for the primary analysis, and a secondary analysis included all patients as randomized, regardless of treatment adherence. Secondary outcomes included recurrence of UTI symptoms and/or adverse events within 28 days of stopping study medication.

Results Among 272 patients (median [interquartile range] age, 69 [62-73] years) who were randomized, 100% completed the trial and 254 (93.4%) were included in the primary as-treated analysis. Symptom resolution occurred in 122/131 (93.1%) participants in the 7-day group vs 111/123 (90.2%) in the 14-day group (difference, 2.9% [1-sided 97.5% CI, –5.2% to ∞]), meeting the noninferiority criterion. In the secondary as-randomized analysis, symptom resolution occurred in 125/136 (91.9%) participants in the 7-day group vs 123/136 (90.4%) in the 14-day group (difference, 1.5% [1-sided 97.5% CI, –5.8% to ∞]) Recurrence of UTI symptoms occurred in 13/131 (9.9%) participants in the 7-day group vs 15/123 (12.9%) in the 14-day group (difference, –3.0% [95% CI, –10.8% to 6.2%]; P = .70). Adverse events occurred in 28/136 (20.6%) participants in the 7-day group vs 33/136 (24.3%) in the 14-day group.

Conclusions and Relevance Among afebrile men with suspected UTI, treatment with ciprofloxacin or trimethoprim/sulfamethoxazole for 7 days was noninferior to 14 days of treatment with regard to resolution of UTI symptoms by 14 days after antibiotic therapy. The findings support the use of a 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole as an alternative to a 14-day course for treatment of afebrile men with UTI.

Trial Registration ClinicalTrials.gov identifier: NCT01994538

Author/s:

Drekonja, D. M., Trautner, B., Amundson, C.

Existing methods of screening for substance abuse (standardized questionnaires or clinician’s simply asking) have proven difficult to initiate and maintain in primary care settings. This article reports on how predictive modeling can be used to screen for

Devin Evans — Wed, 03 Mar 2021 06:00:00 +0000

Date Added:

March 3, 2021

Journal/Publication:

Big Data

Publication Date:

September 1, 2018

Issue:

Volume:

Pages:

214-224

URL:

Existing methods of screening for substance abuse (standardized questionnaires or clinician’s simply asking) have proven difficult to initiate and maintain in primary care settings. This article reports on how predictive modeling can be used to screen for

Type:

Practice Management Research Results

Format:

Article

DOI (1):

10.1089/big.2018.0002

Keywords

PMID (1):

30283729

MeSH

Veterans

substance-related disorders

primary health care

outpatients

This article provides guidance on how to identify patients with substance use disorders from data available in the EMR. James W. Mold, MD, MPH

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Existing methods of screening for substance abuse (standardized questionnaires or clinician's simply asking) have proven difficult to initiate and maintain in primary care settings. This article reports on how predictive modeling can be used to screen for substance abuse using extant data in electronic health records (EHRs). We relied on data available through Veterans Affairs Informatics and Computing Infrastructure (VINCI) for the years 2006 through 2016. We focused on 4,681,809 veterans who had at least two primary care visits; 829,827 of whom had a hospitalization. Data included 699 million outpatient and 17 million inpatient records. The dependent variable was substance abuse as identified from 89 diagnostic codes using the Agency for Healthcare Quality and Research classification of diseases. In addition, we included the diagnostic codes used for identification of prescription abuse. The independent variables were 10,292 inpatient and 13,512 outpatient diagnoses, plus 71 dummy variables measuring age at different years between 20 and 90 years. A modified naive Bayes model was used to aggregate the risk across predictors. The accuracy of the predictions was examined using area under the receiver operating characteristic (AROC) curve in 20% of data, randomly set aside for the evaluation. Many physical/mental illnesses were associated with substance abuse. These associations supported findings reported in the literature regarding the impact of substance abuse on various diseases and vice versa. In randomly set-aside validation data, the model accurately predicted substance abuse for inpatient (AROC = 0.884), outpatient (AROC = 0.825), and combined inpatient and outpatient (AROC = 0.840) data. If one excludes information available after substance abuse is known, the cross-validated AROC remained high, 0.822 for inpatient and 0.817 for outpatient data. Data within EHRs can be used to detect existing or predict potential future substance abuse.

Author/s:

Alemi, Farrokh, Avramovic, Sanja, Schwartz, Mark D.

Stepped Exercise Program for Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Devin Evans — Thu, 14 Jan 2021 06:00:00 +0000

Date Added:

January 14, 2021

Journal/Publication:

BMC Musculoskeletal Disorder

Publication Date:

May 28, 2019

Issue:

254

Volume:

URL:

Stepped Exercise Program for Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1186/s12891-019-2627-8

Keywords

PMID (1):

31138256

MeSH

Physical Therapy Modalities

Patient-Centered Care

exercise therapy

An interesting type of stepped intervention that could be applied to other health conditions as well. James W. Mold, MD, MPH

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Background: Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.

Methods / design: Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.

Discussion: STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.

Author/s:

Allen, Kelli D., Bongiorni, Dennis, Caves, Kevin, Coffman, Cynthia J., Floegel, Theresa A., Greysen, Heather M., Hall, Katherine S., Heiderscheit, Bryan, Hoenig, Helen M., Huffman, Kim M., Morey, Miriam D., Ramasunder, Shalini, Severson, Herbert, Smith, Battista, Van Houtven, Courtney, Woolson, Sandra

Association of Statin Use With All-Cause and Cardiovascular Mortality in US Veterans 75 Years and Older

Brian Desmarais — Mon, 13 Jul 2020 15:51:50 +0000

Date Added:

July 13, 2020

Journal/Publication:

Journal of the American Medical Association

Publisher:

JAMA Network

Publication Date:

July 7, 2020

Issue:

Volume:

324

Pages:

68-78

URL:

Association of Statin Use With All-Cause and Cardiovascular Mortality in US Veterans 75 Years and Older

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2020.7848

MeSH

Hydroxymethylglutaryl-CoA Reductase Inhibitors

primary prevention

Veterans

Arteriosclerosis

Cardiovascular System

risk

Additional evidence that statins taken for primary prevention helps old people (>75 years of age) live longer. James W. Mold, MD, MPH

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Importance: Data are limited regarding statin therapy for primary prevention of atherosclerotic cardiovascular disease (ASCVD) in adults 75 years and older.

Objective: To evaluate the role of statin use for mortality and primary prevention of ASCVD in veterans 75 years and older.

Design, setting, and participants: Retrospective cohort study that used Veterans Health Administration (VHA) data on adults 75 years and older, free of ASCVD, and with a clinical visit in 2002-2012. Follow-up continued through December 31, 2016. All data were linked to Medicare and Medicaid claims and pharmaceutical data. A new-user design was used, excluding those with any prior statin use. Cox proportional hazards models were fit to evaluate the association of statin use with outcomes. Analyses were conducted using propensity score overlap weighting to balance baseline characteristics.

Exposures: Any new statin prescription.

Main outcomes and measures: The primary outcomes were all-cause and cardiovascular mortality. Secondary outcomes included a composite of ASCVD events (myocardial infarction, ischemic stroke, and revascularization with coronary artery bypass graft surgery or percutaneous coronary intervention).

Results: Of 326 981 eligible veterans (mean [SD] age, 81.1 [4.1] years; 97% men; 91% white), 57 178 (17.5%) newly initiated statins during the study period. During a mean follow-up of 6.8 (SD, 3.9) years, a total 206 902 deaths occurred including 53 296 cardiovascular deaths, with 78.7 and 98.2 total deaths/1000 person-years among statin users and nonusers, respectively (weighted incidence rate difference [IRD]/1000 person-years, -19.5 [95% CI, -20.4 to -18.5]). There were 22.6 and 25.7 cardiovascular deaths per 1000 person-years among statin users and nonusers, respectively (weighted IRD/1000 person-years, -3.1 [95 CI, -3.6 to -2.6]). For the composite ASCVD outcome there were 123 379 events, with 66.3 and 70.4 events/1000 person-years among statin users and nonusers, respectively (weighted IRD/1000 person-years, -4.1 [95% CI, -5.1 to -3.0]). After propensity score overlap weighting was applied, the hazard ratio was 0.75 (95% CI, 0.74-0.76) for all-cause mortality, 0.80 (95% CI, 0.78-0.81) for cardiovascular mortality, and 0.92 (95% CI, 0.91-0.94) for a composite of ASCVD events when comparing statin users with nonusers.

Conclusions and relevance: Among US veterans 75 years and older and free of ASCVD at baseline, new statin use was significantly associated with a lower risk of all-cause and cardiovascular mortality. Further research, including from randomized clinical trials, is needed to more definitively determine the role of statin therapy in older adults for primary prevention of ASCVD.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Djousse reported receiving grants from Merck. No other disclosures were reported.

Author/s:

Orkaby, A.R., Driver, J.A., Ho, Y., et al.

Tinnitus

John Bayhi — Mon, 23 Mar 2020 21:17:31 +0000

Date Added:

March 23, 2020

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

March 16, 2020

URL:

Tinnitus

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2020.0697

Keywords

tinnitus

hearing loss

noise

PMID (1):

32176246

MeSH

A nice review of what we currently know about tinnitus. James W. Mold, MD, MPH

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Tinnitus is an auditory perception in the absence of an auditory stimulus. It may be associated with acoustic trauma (eg, exposure to loud noise), chronic hearing loss, emotional stressors, or spontaneous occurrence. The psychopathological reaction to the perceived auditory stimulus is an enormous source of distress and disability for many patients with tinnitus. National health surveys estimate that nearly 10 in 100 adults experience some form of tinnitus. Among workers exposed to occupational noise, the prevalence of tinnitus is 15 per 100. Of these, tinnitus is burdensome and chronic for roughly 20 million and extreme and debilitating tinnitus for 2 million US residents. Many patients with tinnitus report that the auditory perception impairs sleep, concentration, and cognitive function required for day-to-day functioning. Among the nearly 4.5 million US military veterans receiving service-connected compensation, 42% receive compensation for tinnitus, which makes it the most prevalent service-connected disability. The number of veterans who receive compensation due to tinnitus is nearly 60% greater than the number of veterans who receive compensation for hearing loss, which is the condition with the second most disability claims.

Author/s:

Piccirillo, JF, Rodebaugh, TL, Lenze, EJ

The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines

Brian Desmarais — Tue, 18 Feb 2020 17:15:18 +0000

Date Added:

February 18, 2020

Journal/Publication:

Annals of Internal Medicine

Publication Date:

February 18, 2020

URL:

The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.7326/M19-3575

Keywords

evaluation

sleep apnea

chronic insomnia

MeSH

sleep initiation and maintenance disorders

This is a guideline for evaluation and management of obstructive sleep apnea and chronic insomnia developed by the VA and DoD. The recommendations are concise and useful. James W. Mold, MD, MPH

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Abstract

Description:

In September 2019, the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) approved a new joint clinical practice guideline for assessing and managing patients with chronic insomnia disorder and obstructive sleep apnea (OSA). This guideline is intended to give health care teams a framework by which to screen, evaluate, treat, and manage the individual needs and preferences of VA and DoD patients with either of these conditions.

Methods:

In October 2017, the VA/DoD Evidence-Based Practice Work Group initiated a joint VA/DoD guideline development effort that included clinical stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions, systematically searched and evaluated the literature, created three 1-page algorithms, and advanced 41 recommendations using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

Recommendations:

This synopsis summarizes the key recommendations of the guideline in 3 areas: diagnosis and assessment of OSA and chronic insomnia disorder, treatment and management of OSA, and treatment and management of chronic insomnia disorder. Three clinical practice algorithms are also included.

The National Institutes of Health has estimated that insomnia and obstructive sleep apnea (OSA) are 2 of the most common sleep disorders in the general U.S. population and in the military and veteran populations (1). Insomnia symptoms are the most common sleep symptoms among U.S. adults, occurring in approximately 20% to 30% of adults, and the prevalence of chronic insomnia disorder ranges from 6% to 10% (2–6). The prevalence of OSA ranges from 9% to 38% and is associated with older age, higher body mass index, male sex, and menopause.

Sleep disorders are more prevalent in the populations served by the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) than in the general civilian population. In the RAND report “Sleep in the Military: Promoting Healthy Sleep Among U.S. Servicemembers,” 48.6% of military personnel surveyed had poor sleep quality (Pittsburgh Sleep Quality Index score >5) (7). The prevalence of insomnia symptoms has been reported to be as high as 41% in service members deployed to combat and 25% in noncombatants (8). In a large cohort of soldiers preparing for deployment, 19.9% met criteria for insomnia according to the Insomnia Severity Index (ISI) (8). A more recent study evaluated the incidence of insomnia and OSA in the entire population of U.S. Army soldiers from 1997 to 2011 (9) and showed unprecedented increases in the incidence of both conditions (652% and 600%, respectively) during this period. In military personnel referred for sleep evaluations, sleep-disordered breathing is the most frequently diagnosed disorder, and some studies have found that military personnel have high rates of comorbid insomnia and OSA (10, 11). Further, military personnel with sleep disorders often also have posttraumatic stress disorder (PTSD), symptoms of anxiety and depression, and traumatic brain injury, which can complicate diagnosis and management (11–13).

Sleep disturbances are also common in veterans (14–16). Similar to findings from active-duty service members, the National Veteran Sleep Disorder Study found that the number of veterans diagnosed with sleep disorders increased nearly 6-fold from 2000 to 2010. In this study, 4.5% of veterans were diagnosed with sleep-disordered breathing, and 2.5% were diagnosed with insomnia. However, the actual prevalence of insomnia disorder among veterans is likely to be considerably higher (17) because it is often not documented in the medical record (18, 19). Comorbid PTSD was associated with a 7.6-fold greater risk for OSA and a 6.3-fold greater risk for insomnia (15). Because veterans have high rates of cardiovascular disease and PTSD, and because OSA is more prevalent in patients with these disorders (20), there is likely a large percentage of veterans who have not yet been diagnosed with OSA (21).

Author/s:

Mysliwiec, V., Martin, J.L., Ulmer, J.S., Chowdhuri, S., Brock, M.S., Spevak, C.

Assessment and Management of Patients at Risk for Suicide: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines.

Brian Desmarais — Wed, 28 Aug 2019 19:36:58 +0000

Date Added:

August 28, 2019

Journal/Publication:

Annals of Internal Medicine

Publication Date:

August 27, 2019

URL:

Assessment and Management of Patients at Risk for Suicide: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines.

Format:

Article

DOI (1):

10.7326/M19-0687

Keywords

MeSH

evidence-based practice

DESCRIPTION:

In May 2019, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved an update to the 2013 joint clinical practice guideline for assessing and managing patients who are at risk for suicide. This guideline provides health care providers with a framework by which to screen for, evaluate, treat, and manage the individual needs and preferences of VA and DoD patientswho may be at risk for suicide.

METHODS:

In January 2018, the VA/DoD Evidence-Based Practice Work Group convened to develop a joint VA/DoD guideline including clinical stakeholders and conforming to the National Academy of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel drafted key questions, systematically searched and evaluated the literature through April 2018, created algorithms, and advanced 22 recommendations in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

RECOMMENDATIONS:

This synopsis, which includes 3 clinical practice algorithms, summarizes the key recommendations of the guideline related to screening and evaluation, risk management and treatment, and other management methods. Risk management and treatment recommendations address both pharmacologic and nonpharmacologic approaches for patients with suicidal ideation and behavior. Other management methods address lethal means safety (such as restricting access to firearms, poisons, and medications and installing barriers to prevent jumping from lethal heights) and population health strategies.

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These guidelines produced by the VA apply equally well to all adults. James W. Mold, MD, MPH

Author/s:

Sall, J., Brenner, J., Bell, A.M.M., Colston, M.J.

Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up

Brian Desmarais — Mon, 10 Jun 2019 14:27:35 +0000

Date Added:

June 10, 2019

Journal/Publication:

New England Journal of Medicine

Publication Date:

June 6, 2019

Issue:

Volume:

380

Pages:

2215-2224

URL:

Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1806802.

Keywords

MeSH

glycated hemoglobin a

myocardial infarction

stroke

heart failure

amputation

diabetes mellitus, type 2

Intensive management of glucose levels in patients with Type 2 DM does not extend life. This is not new news, but it is a reminder that the benefit of treatment of Type 2 DM is improved quality of life, primarily fewer symptoms and a reduced risk of future microvascular problems, though those problems are relatively uncommon even without treatment.

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BACKGROUND

We previously reported that a median of 5.6 years of intensive as compared with standard glucose lowering in 1791 military veterans with type 2 diabetes resulted in a risk of major cardiovascular events that was significantly lower (by 17%) after a total of 10 years of combined intervention and observational follow-up. We now report the full 15-year follow-up.

METHODS

We observationally followed enrolled participants (complete cohort) after the conclusion of the original clinical trial by using central databases to identify cardiovascular events, hospitalizations, and deaths. Participants were asked whether they would be willing to provide additional data by means of surveys and chart reviews (survey cohort). The prespecified primary outcome was a composite of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, and death from cardiovascular causes. Death from any cause was a prespecified secondary outcome.

RESULTS

There were 1655 participants in the complete cohort and 1391 in the survey cohort. During the trial (which originally enrolled 1791 participants), the separation of the glycated hemoglobin curves between the intensive-therapy group (892 participants) and the standard-therapy group (899 participants) averaged 1.5 percentage points, and this difference declined to 0.2 to 0.3 percentage points by 3 years after the trial ended. Over a period of 15 years of follow-up (active treatment plus post-trial observation), the risks of major cardiovascular events or death were not lower in the intensive-therapy group than in the standard-therapy group (hazard ratio for primary outcome, 0.91; 95% confidence interval [CI], 0.78 to 1.06; P=0.23; hazard ratio for death, 1.02; 95% CI, 0.88 to 1.18). The risk of major cardiovascular disease outcomes was reduced, however, during an extended interval of separation of the glycated hemoglobin curves (hazard ratio, 0.83; 95% CI, 0.70 to 0.99), but this benefit did not continue after equalization of the glycated hemoglobin levels (hazard ratio, 1.26; 95% CI, 0.90 to 1.75).

CONCLUSIONS

Participants with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had a lower risk of cardiovascular events than those who received standard therapy only during the prolonged period in which the glycated hemoglobin curves were separated. There was no evidence of a legacy effect or a mortality benefit with intensive glucose control. (Funded by the VA Cooperative Studies Program; VADT ClinicalTrials.gov number, NCT00032487.)

Author/s:

Emanuele, N.V., Reaven, P.D., Wiitala, W.L., Bahn, G.D., Reda D.J., McCarren, M., Duckworth, W.C., Hayward, R.A., VADT Investigators