ACP Comment Letter on Changes to Office of Management and Budget Guidance Governing Federal Grants and Cooperative Agreements

Joint Letter to EPA Regarding the Affordable Clean Energy Proposed Rule

Joint Letter to EPA Opposing Repeal of the Clean Power Plan

Clinician Perspectives on Caring for Dying Patients During the Pandemic: A Mixed-Methods Study: Annals of Internal Medicine: Vol 174, No 4

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected the hospital experience for patients, visitors, and staff. Objective: To understand clinician perspectives on adaptations to end-of-life care for dying patients and their families during the pandemic. Design: Mixed-methods embedded study. (ClinicalTrials.gov: NCT04602520) Setting: 3 acute care medical units in a tertiary care hospital from 16 March to 1 July 2020. Participants: 45 dying patients, 45 family members, and 45 clinicians. Intervention: During the pandemic, clinicians continued an existing practice of collating personal information about dying patients and “what matters most,” eliciting wishes, and implementing acts of compassion. Measurements: Themes from semistructured clinician interviews that were summarized with representative quotations. Results: Many barriers to end-of-life care arose because of infection control practices that mandated visiting restrictions and personal protective equipment, with attendant practical and psychological consequences. During hospitalization, family visits inside or outside the patient's room were possible for 36 patients (80.0%); 13 patients (28.9%) had virtual visits with a relative or friend. At the time of death, 20 patients (44.4%) had a family member at the bedside. Clinicians endeavored to prevent unmarked deaths by adopting advocacy roles to “fill the gap” of absent family and by initiating new and established ways to connect patients and relatives. Limitation: Absence of clinician symptom or wellness metrics; a single-center design. Conclusion: Clinicians expressed their humanity through several intentional practices to preserve personalized, compassionate end-of-life care for dying hospitalized patients during the SARS-CoV-2 pandemic. Primary Funding Source: Canadian Institutes of Health Research and Canadian Critical Care Trials Group Research Coordinator Fund.

Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 174, No 1

Background: Few studies have examined primary care management for acute sciatica, including referral to physical therapy. Objective: To evaluate whether early referral to physical therapy reduced disability more than usual care (UC) alone for patients with acute sciatica. Design: Randomized controlled clinical trial. (ClinicalTrials.gov: NCT02391350) Setting: 2 health care systems in Salt Lake City, Utah. Patients: 220 adults aged 18 to 60 years with sciatica of less than 90 days' duration who were making an initial primary care consultation. Intervention: All participants received imaging and medication at the discretion of the primary care provider before enrollment. A total of 110 participants randomly assigned to UC were provided 1 session of education, and 110 participants randomly assigned to early physical therapy (EPT) were provided 1 education session and then referred for 4 weeks of physical therapy, including exercise and manual therapy. Measurements: The primary outcome was the Oswestry Disability Index (OSW) score after 6 months. Secondary outcomes were pain intensity, patient-reported treatment success, health care use, and missed workdays. Results: Participants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, −5.4 points [95% CI, −9.4 to −1.3 points]; P = 0.009). The OSW and several secondary outcomes favored EPT after 4 weeks. After 1 year, between-group differences favored EPT for the OSW (relative difference, −4.8 points [CI, −8.9 to −0.7 points]) and back pain intensity (relative difference, −1.0 points [CI, −1.6 to −0.4 points]). The EPT group was more likely to self-report treatment success after 1 year (45.2%) than the UC group (27.6%) (relative risk, 1.6 [CI, 1.1 to 2.4]). There were no significant differences in health care use or missed workdays. Limitation: The patients and providers were unblinded, and specific physical therapy interventions responsible for effects could not be determined. Conclusion: Referral from primary care to physical therapy for recent-onset sciatica improved disability and other outcomes compared with UC. Primary Funding Source: Agency for Healthcare Research and Quality.

Management Options for an Older Adult With Advanced Chronic Kidney Disease and Dementia: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 173, No 3

About 15% of adults in the United States—37 million persons—have chronic kidney disease (CKD). Chronic kidney disease is divided into 5 groups, ranging from stage 1 to stage 5 CKD, whereas end-stage kidney disease (ESKD) is defined as permanent kidney failure. The treatment options for ESKD are kidney replacement therapy (KRT) and conservative management. The options for KRT include hemodialysis (either in-center or at home), peritoneal dialysis, and kidney transplant. Conservative management, a multidisciplinary model of care for patients with stage 5 CKD who want to avoid dialysis, is guided by patient values, preferences, and goals, with a focus on quality of life and symptom management. In 2015, the Kidney Disease Outcomes Quality Initiative recommended that patients with an estimated glomerular filtration rate below 30 mL/min/1.73 m2 be educated about options for both KRT and conservative management. In 2018, the National Institute for Health and Care Excellence recommended that assessment for KRT or conservative management start at least 1 year before the need for therapy. It also recommended that in choosing a management approach, predicted quality of life, predicted life expectancy, patient preferences, and other patient factors be considered, because little difference in outcomes has been found among options. Here, 2 experts—a nephrologist and a general internist–palliative care physician—reflect on the care of a patient with advanced CKD and mild to moderate dementia. They discuss the management options for patients with advanced CKD, the pros and cons of each method, and how to help a patient choose among the options.

Risk for Subdeltoid Bursitis After Influenza Vaccination: A Population-Based Cohort Study: Annals of Internal Medicine: Vol 173, No 4

Background: Subdeltoid bursitis has been reported as an adverse event after intramuscular vaccination in the deltoid muscle. Most published case reports involved influenza vaccine. Objective: To estimate the risk for subdeltoid bursitis after influenza vaccination. Design: Retrospective cohort study. Setting: The Vaccine Safety Datalink, which contains health encounter data for 10.2 million members of 7 U.S. health care organizations. Patients: Persons who received an inactivated influenza vaccine during the 2016–2017 influenza season. Measurements: Potential incident cases were identified by searching administrative data for persons with a shoulder bursitis diagnostic code within 180 days after receiving an injectable influenza vaccine in the same arm. The date of reported bursitis symptom onset was abstracted from the medical record. A self-controlled risk interval analysis was used to calculate the incidence rate ratio of bursitis in a risk interval of 0 to 2 days after vaccination versus a control interval of 30 to 60 days, which represents the background rate. The attributable risk was also estimated. Results: The cohort included 2 943 493 vaccinated persons. Sixteen cases of symptom onset in the risk interval and 51 cases of symptom onset in the control interval were identified. The median age of persons in the risk interval was 57.5 years (range, 24 to 98 years), and 69% were women. The incidence rate ratio was 3.24 (95% CI, 1.85 to 5.68). The attributable risk was 7.78 (CI, 2.19 to 13.38) additional cases of bursitis per 1 million persons vaccinated. Limitation: The results may not be generalizable to vaccinations done in other types of health care settings. Conclusion: Although an increased risk for bursitis after vaccination was present, the absolute risk was small. Primary Funding Source: Centers for Disease Control and Prevention.

How Would You Treat This Patient With Gallstone Pancreatitis?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 170, No 3

Acute pancreatitis, a common cause of hospitalization in the United States, is often the result of biliary tract disease. In 2016, the American Gastroenterological Association released a guideline that addresses the practical considerations in managing acute pancreatitis within the first 72 hours after the patient presents. The guideline specifically recommends goal-directed hydration therapy, early enteral feeding, judicious use of endoscopic retrograde cholangiopancreatography (ERCP), and gallbladder surgery during the index admission for patients with mild pancreatitis. The authors discuss their approach to these interventions in the context of a patient with recurrent acute pancreatitis who chooses to delay surgery until after hospital discharge. They address hydration and timing of surgery, as well as how they would manage the patient's preferences in the face of existing guidelines.

Annals for Hospitalists Inpatient Notes - Bedrest Is Toxic—Why Mobility Matters in the Hospital

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.

Impact of Primary Care Intensive Management on High-Risk Veterans' Costs and Utilization: A Randomized Quality Improvement Trial: Annals of Internal Medicine: Vol 168, No 12

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: Primary care models that offer comprehensive, accessible care to all patients may provide insufficient resources to meet the needs of patients with complex conditions who have the greatest risk for hospitalization. Objective: To assess whether augmenting usual primary care with team-based intensive management lowers utilization and costs for high-risk patients. Design: Randomized quality improvement trial. (ClinicalTrials.gov: NCT03100526) Setting: 5 U.S. Department of Veterans Affairs (VA) medical centers. Patients: Primary care patients at high risk for hospitalization who had a recent acute care episode. Intervention: Locally tailored intensive management programs providing care coordination, goals assessment, health coaching, medication reconciliation, and home visits through an interdisciplinary team, including a physician or nurse practitioner, a nurse, and psychosocial experts. Measurements: Utilization and costs (including intensive management program expenses) 12 months before and after randomization. Results: 2210 patients were randomly assigned, 1105 to intensive management and 1105 to usual care. Patients had a mean age of 63 years and an average of 7 chronic conditions; 90% were men. Of the patients assigned to intensive management, 487 (44%) received intensive outpatient care (that is, ≥3 encounters in person or by telephone) and 204 (18%) received limited intervention. From the pre- to postrandomization periods, mean inpatient costs decreased more for the intensive management than the usual care group (−$2164 [95% CI, −$7916 to $3587]). Outpatient costs increased more for the intensive management than the usual care group ($2636 [CI, $524 to $4748]), driven by greater use of primary care, home care, telephone care, and telehealth. Mean total costs were similar in the 2 groups before and after randomization. Limitations: Sites took up to several months to contact eligible patients, limiting the time between treatment and outcome assessment. Only VA costs were assessed. Conclusion: High-risk patients with access to an intensive management program received more outpatient care with no increase in total costs. Primary Funding Source: Veterans Health Administration Primary Care Services.

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)

Intermediate Diabetes Outcomes in Patients Managed by Physicians, Nurse Practitioners, or Physician Assistants: A Cohort Study: Annals of Internal Medicine: Vol 169, No 12

Background: Primary care provided by nurse practitioners (NPs) and physician assistants (PAs) has been proposed as a solution to expected workforce shortages. Objective: To examine potential differences in intermediate diabetes outcomes among patients of physician, NP, and PA primary care providers (PCPs). Design: Cohort study using data from the U.S. Department of Veterans Affairs (VA) electronic health record. Setting: 568 VA primary care facilities. Patients: 368 481 adult patients with diabetes treated pharmaceutically. Measurements: The relationship between the profession of the PCP (the provider the patient visited most often in 2012) and both continuous and dichotomous control of hemoglobin A1c (HbA1c), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) was examined on the basis of the mean of measurements in 2013. Inverse probability of PCP type was used to balance cohort characteristics. Hierarchical linear mixed models and logistic regression models were used to analyze continuous and dichotomous outcomes, respectively. Results: The PCPs were physicians (n = 3487), NPs (n = 1445), and PAs (n = 443) for 74.9%, 18.2%, and 6.9% of patients, respectively. The difference in HbA1c values compared with physicians was −0.05% (95% CI, −0.07% to −0.02%) for NPs and 0.01% (CI, −0.02% to 0.04%) for PAs. For SBP, the difference was −0.08 mm Hg (CI, −0.34 to 0.18 mm Hg) for NPs and 0.02 mm Hg (CI, −0.42 to 0.38 mm Hg) for PAs. For LDL-C, the difference was 0.01 mmol/L (CI, 0.00 to 0.03 mmol/L) (0.57 mg/dL [CI, 0.03 to 1.11 mg/dL]) for NPs and 0.03 mmol/L (CI, 0.01 to 0.05 mmol/L) (1.08 mg/dL [CI, 0.25 to 1.91 mg/dL]) for PAs. None of these differences were clinically significant. Limitation: Most VA patients are men who receive treatment in a staff-model health care system. Conclusion: No clinically significant variation was found among the 3 PCP types with regard to diabetes outcomes, suggesting that similar chronic illness outcomes may be achieved by physicians, NPs, and PAs. Primary Funding Source: VA Health Services Research and Development.