Revised: Statement of Principles on the Role of Governments in Regulating the Patient-Physician Relationship

The Oversight of Medical Care: A Proposal for Reform

Nutrition

National Immigration Policy and Access to Healthcare

Meeting the Health Care Needs of Elderly Veterans and the Role of the VA in the US Health Care System

Medical Savings Accounts

Medical Savings Account

Medicaid and Healthcare Reform

Impact of the Clinical Laboratory Improvements Amendments on Physicians, Medicare Choices Demonstration Project and Resource-Based Practice Expense Project. Statement to the Practicing Physician Advisory Council.

Health Planning

Caring for Those Who Serve: Potential Implications of the Veterans Affairs Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018

Association Between Publication Characteristics and Treatment Effect Estimates: A Meta-epidemiologic Study: Annals of Internal Medicine: Vol 169, No 6

Background: Evidence about the effect on meta-analysis results of including unpublished trials or those published in languages other than English is unclear or discordant. Purpose: To compare treatment effects between published and unpublished randomized controlled trials (RCTs) and between trials published in English and other languages using a meta-epidemiologic approach. Data Sources: Cochrane reviews published between March 2011 and January 2017 and trial references cited in the reviews. Study Selection: RCTs included in meta-analyses of 3 or more trials with a binary efficacy outcome. Data Extraction: Trial characteristics were extracted by original review authors. A single reviewer assessed publication status and language, with quality assurance by another investigator. Data Synthesis: Among 5659 RCTs included in 698 meta-analyses, 5303 (93.7%) were published in journal articles and 356 (6.3%) were unpublished. Of journal articles, 92.6% (4910 of 5303) were published in English and 7.4% (393 of 5303) in another language. Treatment effects were larger in published than unpublished trials (combined ratio of odds ratios [ROR] for 174 meta-analyses, 0.90 [95% CI, 0.82 to 0.98]; I 2 = 19.3%; τ2 = 0.0492). Treatment effects were also larger for trials published in a language other than English than in English (combined ROR for 147 meta-analyses, 0.86 [CI, 0.78 to 0.95]; I 2 = 0%; τ2 = 0.0000). Limitation: Reliance on the primary reference cited by review authors as the record of interest. Conclusion: In meta-analyses, treatment effects were larger in published than unpublished trials and, for published trials, in those published in a language other than English than in English. Primary Funding Source: Cochrane France.

Effectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study

Background: CT-P13 is a biosimilar of the reference product (RP) infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of Crohn disease (CD) on that basis, without specific studies examining its effects in CD. Objective: To compare the effectiveness and safety of CT-P13 and RP in infliximab-naive patients with CD. Design: Comparative equivalence cohort study. Setting: Système National des Données de Santé (SNDS), a French nationwide health administrative database (1 March 2015 to 30 June 2017). Patients: 5050 infliximab-naive patients with CD who were older than 15 years, had started treatment with RP (n = 2551) or CT-P13 (n = 2499), and had no other indications for infliximab. Measurements: The primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy. Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus RP in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25). Results: Overall, 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively). In multivariable analysis of the primary outcome, CT-P13 was equivalent to RP (HR, 0.92 [95% CI, 0.85 to 0.99]). No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]). Limitation: The SNDS does not contain all relevant clinical data (for example, disease activity). Conclusion: This analysis of real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD. No difference was observed for safety outcomes. Primary Funding Source: Caisse Nationale de l'Assurance Maladie.

Annals for Hospitalists Inpatient Notes - Medical Uncertainty as a Driver of Resource Use—Examining the “Gray Zones” of Clinical Care

What Should Be the Target Blood Pressure for This Older Patient With Hypertension?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 169, No 3

Hypertension is prevalent and the most important risk factor for cardiovascular disease. Controversy exists regarding the optimum threshold above which to begin antihypertensive therapy and the optimum target blood pressure once medication is begun. This controversy is particularly true for older patients, who may be more likely to benefit from treatment because of their higher risk for cardiovascular events, but may also be more at risk for adverse effects of treatment. Two guidelines published in 2017 address this issue. The American College of Physicians/American Academy of Family Physicians guideline recommends initiating antihypertensive therapy for older patients (aged 60 years or older) if systolic blood pressure is 150 mm Hg or higher and to treat to the same target. They recommend a lower threshold for starting treatment and a lower target systolic blood pressure (140 mm Hg) for patients with cerebrovascular disease and potentially those at high risk for cardiovascular events. The American College of Cardiology/American Heart Association guideline, which is based primarily on SPRINT (Systolic Blood Pressure Intervention Trial), advises a target systolic blood pressure of 130 mm Hg for community-dwelling ambulatory patients aged 65 years or older. This article presents the case of a 79-year-old man who is contemplating antihypertensive therapy. Two experts discuss the optimal approach for the patient and suggest how to apply the 2 guidelines to his care.

Reassessment of Risk for Stroke During Follow-up of Patients With Atrial Fibrillation

Pregabalin and the Risk for Opioid-Related Death: A Nested Case–Control Study

How Would You Manage This Patient With Osteoporosis?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 168, No 11

Osteoporosis is a skeletal disorder characterized by reduced bone strength that increases the risk for fracture. Approximately 10 million men and women in the United States have osteoporosis, and more than 2 million osteoporosis-related fractures occur annually. In 2016, the American Association of Clinical Endocrinologists issued the “Clinical Practice Guideline for the Diagnosis and Treatment of Postmenopausal Osteoporosis,” and in 2017, the American College of Physicians issued the guideline “Treatment of Low Bone Density or Osteoporosis to Prevent Fracture in Men and Women.” Both guidelines agree that patients diagnosed with osteoporosis should be treated with an antiresorptive agent, such as alendronate, that has been shown to reduce hip and vertebral fractures. However, there is no consensus on how long patients with osteoporosis should be treated and whether bone density should be monitored during and after the treatment period. In this Beyond the Guidelines, 2 experts discuss management of osteoporosis in general and for a specific patient, the role of bone density monitoring during and after a 5-year course of alendronate, and treatment recommendations for a patient whose bone density decreases during or after a 5-year course of alendronate.

To a Patient

Should This Patient Receive Prophylactic Medication to Prevent Delirium?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 168, No 7

In 2015, the American Geriatrics Society released recommendations for prevention and management of postoperative delirium, based on a systematic literature review and evaluation of nonpharmacologic and pharmacologic approaches by an expert panel. The guidelines recommend an interdisciplinary focus on nonpharmacologic measures (reorientation, medication management, early mobility, nutrition, and gastointestinal motility) for prevention and consideration of this strategy for acute management. They also recommend optimizing nonopioid medication as a means to manage pain and avoiding benzodiazepines other than to treat substance withdrawal. The authors concluded that evidence to recommend antipsychotics for prevention of delirium is insufficient but that these drugs may be considered for short-term treatment in the setting of imminent harm to the patient or caregivers or severe distress due to agitation. Patients should be given the lowest possible dose for the shortest duration when other nonpharmacologic measures have failed. In this Beyond the Guidelines, a psychiatrist and a geriatrician debate whether Mr. W, a 79-year-old man at high risk for postoperative delirium, should receive prophylactic antipsychotics with his next surgery. They review risk factors, appropriate evaluation, and potential benefits and harms of the various medications often used in this setting.