Geriatric Training and the Internal Medicine Residency

American College of Physicians Ethical Guidance for Electronic Patient-Physician Communication: Aligning Expectations

The Crisis in Correctional Health Care: The Impact of the National Drug Control Strategy on Correctional Health Services

Correctional Medicine.

The Acquired Immunodeficiency Syndrome (AIDS) and Infection with the Human Immunodeficiency Virus (HIV)

Utilization Review. Statement of American College of Physicians given before the Advisory Committee on Medicare - Physician Relationships, June 7, 1991.

ACP Comment Letter to Speaker Pelosi Regarding the Release of H.R. 3, the Lower Drug Costs Now Act

Joint Letter Urging Increased Appropriations for Programs in the Depts. of Education, HHS and Labor

ACP Letter to Senate Leadership About Recommendations for the Health, Economic Assistance, Liability Protection and Schools (HEALS) Act

ACP Letter to CMS with Recommendations for Long-term Recovery of Quality Payment Program from COVID-19

Cytokine Inhibition in Patients With Chronic Fatigue Syndrome: A Randomized Trial: Annals of Internal Medicine: Vol 166, No 8

Background: Interleukin-1 (IL-1), an important proinflammatory cytokine, is suspected to play a role in chronic fatigue syndrome (CFS). Objective: To evaluate the effect of subcutaneous anakinra versus placebo on fatigue severity in female patients with CFS. Design: Randomized, placebo-controlled trial from July 2014 to May 2016. Patients, providers, and researchers were blinded to treatment assignment. (ClinicalTrials.gov: NCT02108210) Setting: University hospital in the Netherlands. Patients: 50 women aged 18 to 59 years with CFS and severe fatigue leading to functional impairment. Intervention: Participants were randomly assigned to daily subcutaneous anakinra, 100 mg (n = 25), or placebo (n = 25) for 4 weeks and were followed for an additional 20 weeks after treatment (n = 50). Measurements: The primary outcome was fatigue severity, measured by the Checklist Individual Strength subscale (CIS-fatigue) at 4 weeks. Secondary outcomes were level of impairment, physical and social functioning, psychological distress, and pain severity at 4 and 24 weeks. Results: At 4 weeks, 8% (2 of 25) of anakinra recipients and 20% (5 of 25) of placebo recipients reached a fatigue level within the range reported by healthy persons. There were no clinically important or statistically significant differences between groups in CIS-fatigue score at 4 weeks (mean difference, 1.5 points [95% CI, −4.1 to 7.2 points]) or the end of follow-up. No statistically significant between-group differences were seen for any secondary outcome at 4 weeks or the end of follow-up. One patient in the anakinra group discontinued treatment because of an adverse event. Patients in the anakinra group had more injection site reactions (68% [17 of 25] vs. 4% [1 of 25]). Limitation: Small sample size and wide variability in symptom duration; inclusion was not limited to patients with postinfectious symptoms. Conclusion: Peripheral IL-1 inhibition using anakinra for 4 weeks does not result in a clinically significant reduction in fatigue severity in women with CFS and severe fatigue. Primary Funding Source: Interleukin Foundation and an independent donor who wishes to remain anonymous.

Coverage and Access for Americans With Chronic Disease Under the Affordable Care Act: A Quasi-Experimental Study: Annals of Internal Medicine: Vol 166, No 7

Background: Half of Americans have at least 1 chronic disease. Many in this group, particularly racial/ethnic minorities, lacked insurance coverage and access to care before the Patient Protection and Affordable Care Act (ACA) was enacted. Objective: To determine whether the ACA has had an effect on insurance coverage, access to care, and racial/ethnic disparities among adults with chronic disease. Design: Quasi-experimental policy intervention. Setting: Nationally representative, noninstitutionalized sample in the United States. Patients: 606 277 adults aged 18 to 64 years with a chronic disease. Intervention: Implementation of ACA provisions on 1 January 2014. Measurements: Self-reported insurance coverage, having a checkup, having a personal physician, and not having to forgo a needed physician visit because of cost. Results: After the ACA was implemented, insurance coverage increased by 4.9 percentage points (95% CI, 4.4 to 5.4), not having to forgo a physician visit increased by 2.4 percentage points (CI, 1.9 to 2.9), and having a checkup increased by 2.7 percentage points (CI, 2.2 to 3.4). Having a personal physician did not change (0.3 percentage points [CI, −0.2 to 0.8]). All outcomes varied considerably by state, and coverage increased more in states that expanded Medicaid. Although racial/ethnic minorities had greater improvements in some outcomes, approximately 1 in 5 black and 1 in 3 Hispanic persons with a chronic disease continued to lack coverage and access to care after ACA implementation. Limitation: The study examined data from only the first year of the ACA's major coverage expansion provisions. Conclusion: Although the ACA increased coverage and access for persons with chronic disease, substantial gaps remain, particularly for minorities and those in Medicaid nonexpansion states. Primary Funding Source: None.

Treatment With Ledipasvir–Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial: Annals of Internal Medicine: Vol 166, No 2

Background: Use of interferon and ribavirin to treat chronic hepatitis C virus (HCV) infection in kidney transplant recipients is limited because of the risk for allograft rejection and poor tolerability. Objective: To evaluate the safety and efficacy of the interferon- and ribavirin-free regimen ledipasvir–sofosbuvir in kidney transplant recipients with chronic genotype 1 or 4 HCV infection. Design: Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT02251717) Setting: 5 sites in Europe. Patients: Treatment-naive or -experienced kidney transplant recipients with chronic genotype 1 or 4 HCV infection, with or without compensated cirrhosis, and with an estimated glomerular filtration rate (eGFR) of 40 mL/min or greater were randomly assigned 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24 weeks. Measurements: The primary end point was sustained virologic response at 12 weeks after therapy ended (SVR12). Results: Among 114 patients, the median age was 53 years, 58% were male, 91% had genotype 1 infection, 69% were treatment naive, and 15% had compensated cirrhosis. The median eGFR was 56 mL/min (range, 35 to 135 mL/min). One hundred percent of patients (57 of 57) treated for 12 weeks (95% CI, 94% to 100%) and 100% of those (57 of 57) treated for 24 weeks (CI, 94% to 100%) achieved SVR12. Serious adverse events were reported in 13 patients (11%). Of these, 3 events—syncope, pulmonary embolism, and serum creatinine increase—in 3 patients were determined to be treatment related. One patient permanently discontinued treatment because of an adverse event (syncope). The most frequent adverse events overall were headache (n = 22 [19%]), asthenia (n = 16 [14%]), and fatigue (n = 11 [10%]). Limitations: The study was open label, no inferential statistics were planned, and only patients with genotype 1 or 4 infection were included. Few patients with HCV genotype 1a and cirrhosis were enrolled. Conclusion: Treatment with ledipasvir–sofosbuvir for 12 or 24 weeks was well-tolerated and seemed to have an acceptable safety profile among kidney transplant recipients with HCV genotype 1 or 4 infection, all of whom achieved SVR12. Primary Funding Source: Gilead Sciences.

Cardiovascular Events Associated With Use of Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia: A Population-Based Cohort Study: Annals of Internal Medicine: Vol 165, No 3

Background: Tyrosine kinase inhibitors (TKIs) have increased survival dramatically for patients with chronic myeloid leukemia (CML), but continuous administration of these drugs may elicit long-term toxicity. Objective: To investigate the incidence of vascular events in patients with CML treated with first- and second-generation TKIs. Design: Retrospective cohort study using nationwide population-based registries. Setting: Sweden. Patients: All patients diagnosed with chronic-phase CML in Sweden from 2002 to 2012 and treated with a TKI, and 5 age- and sex-matched control individuals per patient. Measurements: Relative risks, expressed as incidence rate ratios comparing patients with control individuals, were calculated. Events per 1000 person-years were assessed in interdrug comparisons. Results: 896 patients, 94.4% with documented TKI treatment, were followed for a median of 4.2 years. There were 54 arterial and 20 venous events in the CML cohort, corresponding to relative risks of 1.5 (95% CI, 1.1 to 2.1) and 2.0 (CI, 1.2 to 3.3), respectively. The event rate for myocardial infarction was higher in patients treated with nilotinib or dasatinib (29 and 19 per 1000 person-years, respectively) than in those receiving imatinib (8 per 1000 person-years), although data are limited and the CIs were wide and overlapped. Among 31 patients treated with a TKI who had myocardial infarction, 26 (84%) had at least 1 major cardiac risk factor diagnosed before the event occurred. Limitations: Patients may have been exposed to multiple TKIs. Data on second- and third-generation TKIs were limited. Conclusion: An increased risk for arterial and venous vascular events was seen in patients with CML treated with a TKI. Further study is needed to determine whether the risk for myocardial infarction increases with second-generation drugs. Primary Funding Source: No external funding.

Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial: Annals of Internal Medicine: Vol 165, No 2

Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy for patients with knee osteoarthritis. Design: Randomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985) Setting: An urban tertiary care academic hospital. Patients: 204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). Intervention: Tai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise). Measurements: The primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life. Results: At 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, −10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred. Limitation: Patients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined. Conclusion: Tai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis. Primary Funding Source: National Center for Complementary and Integrative Health of the National Institutes of Health.

Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial: Annals of Internal Medicine: Vol 164, No 7

Background: Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. Objective: To compare the effectiveness and safety of oral prednisolone versus oral indomethacin in patients presenting to emergency departments (EDs) with acute gout. Design: Multicenter, double-blind, randomized equivalence trial. Patients were randomly assigned (1:1 ratio) to receive either indomethacin or prednisolone. (ISRCTN registry number: ISRCTN45724113) Setting: Four EDs in Hong Kong. Participants: 416 patients aged 18 years or older. Measurements: Analgesic effectiveness was defined as changes in pain (at rest or with activity) greater than 13 mm on a 100-mm visual analogue scale. Outcomes were measured during the first 2 hours in the ED and from days 1 to 14. Results: 376 patients completed the study. Equivalent and clinically significant within-group reductions in mean pain score were observed with indomethacin and prednisolone in the ED (approximately 10 mm [rest] and 20 mm [activity]) and from days 1 to 14 (approximately 25 mm [rest] and 45 mm [activity]). No major adverse events occurred during the study. During the ED phase, patients in the indomethacin group had more minor adverse events than those in the prednisolone group (19% vs. 6%; P < 0.001). During days 1 to 14, 37% of patients in each group had minor adverse events. Limitation: Diagnosis of gout was usually based on clinical criteria rather than examination of joint fluid. Conclusion: Oral prednisolone and indomethacin had similar analgesic effectiveness among patients with acute gout. Prednisolone is a safe, effective first-line option for treatment of acute gout. Primary Funding Source: Health and Health Services Research Grant Committee of the Hong Kong Government.

Efficacy of Acupuncture for Chronic Spontaneous Urticaria

Management of Gout

Management of Hyperglycemia in Hospitalized Patients

People with diabetes account for 25% of hospitalizations, or 8 million admissions annually. Poor glycemic control in the hospital is associated with increased morbidity, mortality, length of stay, and readmissions. Key considerations of inpatient diabetes management include initiation of appropriate insulin or medication regimens and frequent dose adjustments based on patient-specific factors. Inpatient diabetes management teams and new technologies are increasingly prevalent and can assist in achieving glycemic targets in the hospital. At discharge, standardized checklists should be used to ensure successful transitions of care.

High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302)

Background: The mRNA platform is under investigation for many vaccines, including HIV-1 vaccines. Objective: To evaluate the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines. Design: Safety analysis of mRNA vaccination in a phase 1, randomized, open-label trial. (ClinicalTrials.gov: NCT05217641) Setting: Ten research sites in the United States. Participants: 108 volunteers aged 18 to 55 years without HIV-1. Intervention: Investigational HIV-1 BG505 MD39.3 trimer mRNA vaccines (gp140 soluble trimer, gp151 membrane-bound trimer, and gp151 CD4KO membrane-bound trimer) at doses of 100 and 250 mcg at 0, 2, and 6 months. Measurements: Solicited and unsolicited adverse reactions and events reported during the 12 months after the first vaccination. Results: Participants (n = 108) were randomly assigned to 6 vaccine groups. Mild to moderate local and systemic solicited events were common. Eighty participants reported 190 unsolicited adverse events (AEs); 30 were considered to be related to a study product. Most (73%) related AEs were mild, and the rest were moderate. Among related AEs, urticaria was reported by 7 of 108 participants (7% [95% CI, 3% to 13%]), 4 of whom had unresolved, intermittent urticaria at 12 months. In post hoc analyses, demographic characteristics, history of allergy or medication use, and COVID-19 were not associated with urticaria. In a comparison of participants with versus without urticaria, 100% (7 of 7; CI, 65% to 100%) versus 37% (37 of 101; CI, 28% to 46%) reported previous Moderna COVID-19 vaccination, 29% (2 of 7; CI, 8% to 64%) versus 76% (77 of 101; CI, 67% to 84%) reported previous Pfizer–BioNTech COVID-19 vaccination, and 0% (0 of 7; CI, 0% to 35%) versus 5% (5 of 101; CI, 2% to 11%) reported no previous mRNA COVID-19 vaccination. Limitations: Lack of a placebo group, open-label study, and post hoc evaluation of urticarial risk. Conclusion: Urticarial reactions associated with experimental HIV-1 mRNA vaccines were observed in this trial. Studies to investigate the mechanism and approaches to mitigate these reactions are underway to further advance HIV-1 vaccine research. Primary Funding Source: National Institutes of Health, National Institute of Allergy and Infectious Diseases.