Patient Safety in the Office-Based Practice Setting

The Oversight of Medical Care: A Proposal for Reform

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

Medicare Managed Care: How to Ensure Quality

Managed Care: ACP Policy Compendium

Improved Availability of Comparative Effectiveness Information

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.

Home Health Care

Health Care Needs of Inmates of Correctional Institutions.

Acquired Immunodeficiency Syndrome

The U.S. Environmental Protection Agency's Proposed Transparency Rule Threatens Health

Pitfalls and Potential in Medicare's Move Toward Outpatient Care Episodes

Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 170, No 5

Background: Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences. Objective: To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control. Design: Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061) Setting: 13 medical and surgical ICUs at 5 hospitals. Participants: Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses. Intervention: A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting. Measurements: The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician–surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation. Results: The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, −1.7 percentage points [95% CI, −8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ. Limitation: Contamination among clinicians could have biased results toward the null hypothesis. Conclusion: A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making. Primary Funding Source: National Institutes of Health.

Characteristics of High Cardiovascular Risk in 1.7 Million Chinese Adults

Background: As cardiovascular risk increases in China, interest in strategies to mitigate it is growing. However, national information about the prevalence and treatment of high cardiovascular disease (CVD) risk is limited. Objective: To assess the prevalence and treatment of high CVD risk as well as variations in risk across population subgroups. Design: National project of CVD screening and management. Setting: 141 county-level regions in all 31 provinces of China. Participants: Local residents aged 35 to 75 years. Measurements: Rates of high CVD risk were assessed both in the overall study population and by age, sex, body mass index, geographic region, and socioeconomic status. Multivariable mixed models were fitted to assess the associations between individual characteristics and high CVD risk. Statin and aspirin use was evaluated among persons at high risk for CVD. Results: Among 1 680 126 participants, 9.5% (95% CI, 9.5% to 9.6%) had high risk for CVD. Mixed models identified persons who were of Han ethnicity, had medical insurance, were currently using alcohol, or were obese as more likely to be at high risk for CVD. Of those with high CVD risk, only 0.6% (CI, 0.5% to 0.6%) and 2.4% (CI, 2.3% to 2.5%) reported using statins and aspirin, respectively. Among persons with high CVD risk and hypertension, 31.8% were receiving antihypertensive medications. Limitation: Samples were not nationally representative. Conclusion: Of the 1.7 million participants, 1 in 10 had a high risk for CVD; among those at high risk, fewer than 3% were receiving statins or aspirin. An immense opportunity exists for risk mitigation in this substantial population. Primary Funding Source: Ministry of Finance and National Health Commission, China.

Cost-Effectiveness of Alirocumab: A Just-in-Time Analysis Based on the ODYSSEY Outcomes Trial: Annals of Internal Medicine: Vol 170, No 4

Background: The ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial included participants with a recent acute coronary syndrome. Compared with participants receiving statins alone, those receiving a statin plus alirocumab had lower rates of a composite outcome including myocardial infarction (MI), stroke, and death. Objective: To determine the cost-effectiveness of alirocumab in these circumstances. Design: Decision analysis using the Cardiovascular Disease Policy Model. Data Sources: Data sources representative of the United States combined with data from the ODYSSEY Outcomes trial. Target Population: U.S. adults with a recent first MI and a baseline low-density lipoprotein cholesterol level of 1.81 mmol/L (70 mg/dL) or greater. Time Horizon: Lifetime. Perspective: U.S. health system. Intervention: Alirocumab or ezetimibe added to statin therapy. Outcome Measures: Incremental cost-effectiveness ratio in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained. Results of Base-Case Analysis: Compared with a statin alone, the addition of ezetimibe cost $81 000 (95% uncertainty interval [UI], $51 000 to $215 000) per QALY. Compared with a statin alone, the addition of alirocumab cost $308 000 (UI, $197 000 to $678 000) per QALY. Compared with the combination of statin and ezetimibe, replacing ezetimibe with alirocumab cost $997 000 (UI, $254 000 to dominated) per QALY. Results of Sensitivity Analysis: The price of alirocumab would have to decrease from its original cost of $14 560 to $1974 annually to be cost-effective relative to ezetimibe. Limitation: Effectiveness estimates were based on a single randomized trial with a median follow-up of 2.8 years and should not be extrapolated to patients with stable coronary heart disease. Conclusion: The price of alirocumab would have to be reduced considerably to be cost-effective. Because substantial reductions already have occurred, we believe that timely, independent cost-effectiveness analyses can inform clinical and policy discussions of new drugs as they enter the market. Primary Funding Source: University of California, San Francisco, and Institute for Clinical and Economic Review.

The Next Stage of Buprenorphine Care for Opioid Use Disorder

Buprenorphine has been used internationally for the treatment of opioid use disorder (OUD) since the 1990s and has been available in the United States for more than a decade. Initial practice recommendations were intentionally conservative, were based on expert opinion, and were influenced by methadone regulations. Since 2003, the American crisis of OUD has dramatically worsened, and much related empirical research has been undertaken. The findings in several important areas conflict with initial clinical practice that is still prevalent. This article reviews research findings in the following 7 areas: location of buprenorphine induction, combining buprenorphine with a benzodiazepine, relapse during buprenorphine treatment, requirements for counseling, uses of drug testing, use of other substances during buprenorphine treatment, and duration of buprenorphine treatment. For each area, evidence for needed updates and modifications in practice is provided. These modifications will facilitate more successful, evidence-based treatment and care for patients with OUD.

Cost-of-Care Conversations During Clinical Visits in Federally Qualified Health Centers: An Observational Study: Annals of Internal Medicine: Vol 170, No 9_Supplement

Background: The Centers for Disease Control and Prevention estimates that 10% of the U.S. population delays or avoids health care because of cost concerns. It is unknown whether and how cost-of-care conversations occur in primary encounters, especially settings that provide care to vulnerable patients. Objective: To describe cost-of-care conversations with financially vulnerable (<400% federal poverty level) adult patients during clinical encounters. Design: Five observers shadowed a convenience sample of patients during encounters and then interviewed patients and clinicians after the encounter. Setting: Federally Qualified Health Centers in Texas (n = 2) and Pennsylvania (n = 2). Participants: A convenience sample of 67 adult patients seeking chronic disease management or prenatal care from 9 clinicians (5 medical doctors, 2 physician assistants, and 2 nurse practitioners). Measurements: Self-reported characteristics of patients, and frequency and characteristics of interviewer-observed cost-of-care conversations. Results: Because of missing responses from patient and clinician interviews, data are reported for 67 consenting patients. During 46.3% of encounters, some discussion of costs of care was observed. Discussion of indirect costs (lost work time or transportation) was observed in only 2.9% of encounters. In only 11.9% of encounters did the physician discuss costs of care. When costs were discussed, the conversation was not organized and did not take place in conjunction with the discussion of the treatment plan. Limitations: This exploratory work involved a small convenience sample, and generalizability to other settings is uncertain. Missing data prohibited meaningful analysis of patient and clinician interview data. Conclusion: In the 4 federally funded health centers studied, cost-of-care conversations occurred in a minority of clinical visits, discussions were unorganized, and indirect costs of care were rarely addressed. Whether more frequent discussion of the costs of care improves patient adherence and outcomes requires further study. Primary Funding Source: Robert Wood Johnson Foundation.

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.

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.

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