Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors

Should We Screen for Coronary Heart Disease in Asymptomatic Persons?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 164, No 7

In March 2015, the American College of Physicians (ACP) released a clinical guideline on the value of screening for coronary heart disease (CHD) in asymptomatic persons. The guideline authors found that results of screening studies are unlikely to change patient management or the intensity of risk factor reduction strategies. Most events occur in patients who are at low to intermediate risk for CHD; and in low-risk asymptomatic patients, percutaneous coronary intervention in “screen-positive” patients does not improve outcomes and creates unnecessary risks. As a result, the ACP recommended against screening for asymptomatic patients who are at low risk for CHD. Instead, it recommended a focus on proven strategies, such as treatment of hypertension and hypercholesterolemia, to reduce risk in appropriately selected asymptomatic persons. Two discussants weigh the evidence for and against screening for CHD in asymptomatic patients with varying degrees of risk and provide recommendations for a specific patient who is uncertain whether to proceed to screening.

Yes, You Can: Physicians, Patients, and Firearms

Physicians have unique opportunities to help prevent firearm violence. Concern has developed that federal and state laws or regulations prohibit physicians from asking or counseling patients about firearms and disclosing patient information about firearms to others, even when threats to health and safety may be involved. This is not the case. In this article, the authors explain the statutes in question, emphasizing that physicians may ask about firearms (with rare exceptions), may counsel about firearms as they do about other health matters, and may disclose information to third parties when necessary. The authors then review circumstances under which questions about firearms might be most appropriate if they are not asked routinely. Such circumstances include instances when the patient provides information or exhibits behavior suggesting an acutely increased risk for violence, whether to himself or others, or when the patient possesses other individual-level risk factors for violence, such as alcohol abuse. The article summarizes the literature on current physician practices in asking and counseling about firearms, which are done far less commonly than recommended. Barriers to engaging in those practices, the effectiveness of clinical efforts to prevent firearm-related injuries, and what patients think about such efforts and physicians who engage in them are discussed. Proceeding from the limited available evidence, the authors make specific recommendations on how physicians might counsel their patients to reduce their risk for firearm-related death or serious injury. Finally, the authors review the circumstances under which disclosure of patient information about firearms to third parties is supported by regulations implementing the Health Insurance Portability and Accountability Act.

Should Patients Have Periodic Health Examinations?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 164, No 3

Physicians and patients have come to expect that periodic health examinations (PHEs) are a standard part of comprehensive ongoing medical care. However, considerable research has not demonstrated a substantial benefit of the PHE. Given this lack of benefit and the high total cost of PHE to the health care system, the American Board of Internal Medicine (ABIM) Foundation and the Society of General Internal Medicine (SGIM) have identified “routine health checks in asymptomatic patients” as something of low value that physicians and patients should question, as a part of the Choosing Wisely campaign. Two discussants review the debate about PHE and consider the value of PHE for a healthy 70-year-old woman who appreciates seeing her physician annually.

Suicide Rates and Methods in Active Duty Military Personnel, 2005 to 2011: A Cohort Study: Annals of Internal Medicine: Vol 165, No 3

Background: Suicide prevention programs have become ubiquitous among military units; identifying temporal trends and nonclinical factors associated with the chosen suicide methods may help improve suicide prevention strategies. Objective: To calculate suicide rates of active duty military personnel and identify those who are at risk for firearm-specific suicide. Design: Retrospective cohort study. Setting: Military units in the United States. Patients: All active duty enlisted U.S. military personnel from 2005 to 2011. Measurements: Suicide rates per 100 000 were calculated for each branch. Adjusted odds ratios for firearm-specific suicide were calculated with 95% CIs. Results: 1455 military personnel committed suicide from 2005 to 2011. From 2006 to 2011, the rates were highest among army personnel (19.13 to 29.44 cases per 100 000). Among suicides with a known cause of death, 62% were attributed to firearms. The results of this study also suggest that among army personnel or marines who committed suicide, those with infantry or special operations job classifications were more likely than those in noninfantry positions to use a firearm. Limitations: Results are generalizable only to enlisted personnel and reflect only stateside suicides. Data regarding previous psychiatric illness, deployment history, and firearms ownership were lacking. Conclusion: These results may help inform policymakers and advisors about differences in risks of suicide and violent suicide among the armed services and may help guide efforts to prevent self-harm within the military. Primary Funding Source: None.

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.

Association Between Patient-Centered Medical Homes and Adherence to Chronic Disease Medications: A Cohort Study: Annals of Internal Medicine: Vol 166, No 2

Background: Despite the widespread adoption of patient-centered medical homes into primary care practice, the evidence supporting their effect on health care outcomes has come primarily from geographically localized and well-integrated health systems. Objective: To assess the association between medication adherence and medical homes in a national patient and provider population, given the strong ties between adherence to chronic disease medications and health care quality and spending. Design: Retrospective cohort study. Setting: Claims from a large national health insurer. Patients: Patients initiating therapy with common medications for chronic diseases (diabetes, hypertension, and hyperlipidemia) between 2011 and 2013. Measurements: Medication adherence in the 12 months after treatment initiation was compared among patients cared for by providers practicing in National Committee for Quality Assurance–recognized patient-centered medical homes and propensity score–matched control practices in the same Primary Care Service Areas. Linear mixed models were used to examine the association between medical homes and adherence. Results: Of 313 765 patients meeting study criteria, 18 611 (5.9%) received care in patient-centered medical homes. Mean rates of adherence were 64% among medical home patients and 59% among control patients. Among 4660 matched control and medical home practices, medication adherence was significantly higher in medical homes (2.2% [95% CI, 1.5% to 2.9%]). The association between medical homes and better adherence did not differ significantly by disease state (diabetes, 3.0% [CI, 1.5% to 4.6%]; hypertension, 3.2% [CI, 2.2% to 4.2%]; hyperlipidemia, 1.5% [CI, 0.6% to 2.5%]). Limitation: Clinical outcomes related to medication adherence were not assessed. Conclusion: Receipt of care in a patient-centered medical home is associated with better adherence, a vital measure of health care quality, among patients initiating treatment with medications for common high-cost chronic diseases. Primary Funding Source: CVS Health.

Transmission of Neurodegenerative Disorders Through Blood Transfusion: A Cohort Study: Annals of Internal Medicine: Vol 165, No 5

Background: The aggregation of misfolded proteins in the brain occurs in several neurodegenerative disorders. Aberrant protein aggregation is inducible in rodents and primates by intracerebral inoculation. Possible transfusion transmission of neurodegenerative diseases has important public health implications. Objective: To investigate possible transfusion transmission of neurodegenerative disorders. Design: Retrospective cohort study. Setting: Nationwide registers of transfusions in Sweden and Denmark. Participants: 1 465 845 patients who received transfusions between 1968 and 2012. Measurements: Multivariable Cox regression models were used to estimate hazard ratios for dementia of any type, Alzheimer disease, and Parkinson disease in patients receiving blood transfusions from donors who were later diagnosed with any of these diseases versus patients who received blood from healthy donors. Whether excess occurrence of neurodegenerative disease occurred among recipients of blood from a subset of donors was also investigated. As a positive control, transmission of chronic hepatitis before and after implementation of hepatitis C virus screening was assessed. Results: Among included patients, 2.9% received a transfusion from a donor diagnosed with one of the studied neurodegenerative diseases. No evidence of transmission of any of these diseases was found, regardless of approach. The hazard ratio for dementia in recipients of blood from donors with dementia versus recipients of blood from healthy donors was 1.04 (95% CI, 0.99 to 1.09). Corresponding estimates for Alzheimer disease and Parkinson disease were 0.99 (CI, 0.85 to 1.15) and 0.94 (CI, 0.78 to 1.14), respectively. Hepatitis transmission was detected before but not after implementation of hepatitis C virus screening. Limitation: Observational study design, underascertainment of the outcome, and possible insufficient statistical power. Conclusion: The data provide no evidence for the transmission of neurodegenerative diseases and suggest that if transmission does occur, it is rare. Primary Funding Source: Swedish Research Council, Swedish Heart-Lung Foundation, Swedish Society for Medical Research, and Danish Council for Independent Research.

Network Meta-analysis for Clinical Practice Guidelines: A Case Study on First-Line Medical Therapies for Primary Open-Angle Glaucoma

Background: Network meta-analysis compares multiple treatment options for the same condition and may be useful for developing clinical practice guidelines. Purpose: To compare treatment recommendations for first-line medical therapy for primary open angle-glaucoma (POAG) from major updates of American Academy of Ophthalmology (AAO) guidelines with the evidence available at the time, using network meta-analysis. Data Sources: MEDLINE, Embase, and the Cochrane Library were searched on 11 March 2014 for randomized, controlled trials (RCTs) of glaucoma monotherapies compared with placebo, vehicle, or no treatment or other monotherapies. The AAO Web site was searched in August 2014 to identify AAO POAG guidelines. Study Selection: Eligible RCTs were selected by 2 independent reviewers, and guidelines were selected by 1 person. Data Extraction: One person abstracted recommendations from guidelines and a second person verified. Two people independently abstracted data from included RCTs. Data Synthesis: Guidelines were grouped together on the basis of literature search dates, and RCTs that existed at 1991, 1995, 1999, 2004, and 2009 were analyzed. The outcome of interest was intraocular pressure (IOP) at 3 months. Only the latest guideline made a specific recommendation: prostaglandins. Network meta-analyses showed that all treatments were superior to placebo in decreasing IOP at 3 months. The mean reductions (95% credible intervals [CrIs]) for the highest-ranking class compared with placebo were as follows: 1991: β-blockers, 4.01 (CrI, 0.48 to 7.43); 1995: α2-adrenergic agonists, 5.64 (CrI, 1.73 to 9.50); 1999: prostaglandins, 5.43 (CrI, 3.38 to 7.38); 2004: prostaglandins, 4.75 (CrI, 3.11 to 6.44); 2009: prostaglandins, 4.58 (CrI, 2.94 to 6.24). Limitation: When comparisons are informed by a small number of studies, the treatment effects and rankings may not be stable. Conclusion: For timely recommendations when multiple treatment options are available, guidelines developers should consider network meta-analysis. Primary Funding Source: National Eye Institute, National Institutes of Health.

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