Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota: A Systematic Review: Annals of Internal Medicine: Vol 169, No 4

Background: Probiotics, prebiotics, and synbiotics are used increasingly, although the safety and potential harms of these interventions are poorly understood. Purpose: To examine how harms-related information is reported in publications of randomized controlled trials (RCTs) of probiotics, prebiotics, and synbiotics. Data Sources: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science (without language restrictions) from 1 January 2015 to 20 March 2018. Study Selection: RCTs assessing the safety or efficacy of at least 1 intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition. Data Extraction: 4 reviewers independently assessed study characteristics, the reporting of harms, and the presentation of safety results. Data Synthesis: Of 384 trials conducted in healthy volunteers (n = 136) or patients with any of several medical conditions (n = 248), 339 (88%) were published in specialty journals. Trials most often evaluated probiotics (n = 265 [69%]). Studies in persons with medical conditions enrolled outpatients (n = 195) and high-risk patients (n = 53). No harms-related data were reported for 106 trials (28%), safety results were not reported for 142 (37%), and the number of serious adverse events (SAEs) per study group was not given for 309 (80%). Of 242 studies mentioning harms-related results, 37% (n = 89) used only generic statements to describe AEs and 16% (n = 38) used inadequate metrics. Overall, 375 trials (98%) did not give a definition for AEs or SAEs, the number of participant withdrawals due to harms, or the number of AEs and SAEs per study group with denominators. Limitation: Journal publication processes may have affected the completeness of reporting; only English-language publications were examined. Conclusion: Harms reporting in published reports of RCTs assessing probiotics, prebiotics, and synbiotics often is lacking or inadequate. We cannot broadly conclude that these interventions are safe without reporting safety data. Primary Funding Source: No specific funding.

Balancing the Benefits and Harms of E-Cigarettes: A National Academies of Science, Engineering, and Medicine Report

Annals for Hospitalists Inpatient Notes - Patient Experience as a Health Care Value Domain in Hospitals

Firearms and Dementia: Clinical Considerations

Persistence and Drivers of High-Cost Status Among Dual-Eligible Medicare and Medicaid Beneficiaries: An Observational Study: Annals of Internal Medicine: Vol 169, No 8

Background: Little is known about the persistence of high-cost status among dual-eligible Medicare and Medicaid beneficiaries, who account for a substantial proportion of expenditures in both programs. Objective: To determine what proportion of this population has persistently high costs. Design: Observational study. Setting: Medicare–Medicaid Linked Enrollee Analytic Data Source data for 2008 to 2010. Participants: 1 928 340 dual-eligible Medicare and Medicaid beneficiaries who were alive all 3 years. Measurements: Medicare and Medicaid payments for these beneficiaries were calculated for each year. Beneficiaries were categorized as high-cost for a given year if their spending was in the top 10% for that year. Differences in spending were then examined for those who were persistently high-cost (all 3 years) versus those who were transiently high-cost (2008 but not 2009 or 2010) and those who were non–high-cost in all 3 years. Results: In the first year, 192 835 patients were high-cost. More than half (54.8%) remained high-cost across all 3 years. These patients were younger than transiently high-cost patients, with fewer medical comorbidities and greater intellectual impairment. Persistently high-cost patients spent $161 224 per year compared with $86 333 per year for transiently high-cost patients and $22 352 per year for non–high-cost patients. Most of the spending among persistently high-cost patients (68.8%) was related to long-term care, and very little (<1%) was related to potentially preventable hospitalizations for ambulatory care–sensitive conditions. Limitation: Potential misclassification of preventable spending and lack of detailed clinical data in administrative claims. Conclusion: A substantial majority of high-cost dual-eligible beneficiaries had persistently high costs over 3 years, with most of the cost related to long-term care and very little related to potentially preventable hospitalizations. Primary Funding Source: Peterson Center on Healthcare.

Shining the LAMP on Efforts to Transform Pain Care in America

Cranial Electrical Stimulation: What Is It, and Should We Use It in Practice?

Should This Patient Receive Hormone Therapy for Her Menopausal Symptoms?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 168, No 3

Hormone therapy (HT) was widely prescribed in the 1980s and 1990s and has been controversial since the initial results of the Women's Health Initiative (WHI) trial in the early 2000s suggested that it increased risk for breast cancer and coronary heart disease and did not prolong life. However, more recent data and reexamination of the WHI results suggest that HT is safe and effective for many women when used around the time of menopause. Two experts debate the 2017 Hormone Therapy Position Statement of The North American Menopause Society, which recommends HT as first-line treatment of vasomotor symptoms, and apply it to the care of Ms. R, a 52-year-old woman with severe hot flashes, sleep disturbance, and irritability.

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.

Prevention of Late-Life Dementia: No Magic Bullet