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Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis: A Sham-Controlled, Randomized Trial: Annals of Internal Medicine: Vol 177, No 6

Background: No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis. Objective: To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones. Design: 24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781) Setting: Asian Institute of Gastroenterology in India from February 2021 to July 2022. Participants: 106 patients with chronic pancreatitis. Intervention: Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures. Measurements: The primary end point was pain relief on a 0- to 10-point visual analog scale (VAS) at 12 weeks. Secondary outcomes were assessed after 12 and 24 weeks and included 30% pain relief, opioid use, pain-free days, questionaries, and complications to interventions. Results: 52 patients in the ESWL/ERP group and 54 in the sham group were included. At 12 weeks, the ESWL/ERP group showed better pain relief compared with the sham group (mean difference in change, −0.7 [95% CI, −1.3 to 0] on the VAS; P = 0.039). The difference between groups was not sustained at the 24-week follow-up, and no differences were seen for 30% pain relief at 12- or 24-week follow-up. The number of pain-free days was increased (median difference, 16.2 days [CI, 3.9 to 28.5 days]), and the number of days using opioids was reduced (median difference, −5.4 days [CI, −9.9 to −0.9 days]) in the ESWL/ERP group compared with the sham group at 12-week follow-up. Safety outcomes were similar between groups. Limitation: Single-center study and limited duration of follow-up. Conclusion: In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief. Primary Funding Source: Asian Institute of Gastroenterology and Aalborg University Hospital.

Morbidity and Mortality of Hospital-Onset SARS-CoV-2 Infections Due to Omicron Versus Prior Variants: A Propensity-Matched Analysis: Annals of Internal Medicine: Vol 177, No 8

Background: Many hospitals have scaled back measures to prevent nosocomial SARS-CoV-2 infection given large decreases in the morbidity and mortality of SARS-CoV-2 infections for most people. Little is known, however, about the morbidity and mortality of nosocomial SARS-CoV-2 infections for hospitalized patients in the Omicron era. Objective: To estimate the effect of nosocomial SARS-CoV-2 infection on hospitalized patients’ outcomes during the pre-Omicron and Omicron periods. Design: Retrospective matched cohort study. Setting: 5 acute care hospitals in Massachusetts, December 2020 to April 2023. Patients: Adults testing positive for SARS-CoV-2 on or after hospital day 5, after negative SARS-CoV-2 test results on admission and on hospital day 3, were matched to control participants by hospital, service, time period, days since admission, and propensity scores that incorporated demographics, comorbid conditions, vaccination status, primary diagnosis category, vital signs, and laboratory test values. Measurements: Primary outcomes were hospital mortality and time to discharge. Secondary outcomes were intensive care unit (ICU) admission, need for advanced oxygen support, discharge destination, hospital-free days, and 30-day readmissions. Results: There were 274 cases of hospital-onset SARS-CoV-2 infection during the pre-Omicron period and 1037 cases during the Omicron period (0.17 vs. 0.49 cases per 100 admissions). Patients with hospital-onset SARS-CoV-2 infection were older and had more comorbid conditions than those without. During the pre-Omicron period, hospital-onset SARS-CoV-2 infection was associated with increased risk for ICU admission, increased need for high-flow oxygen, longer time to discharge (median difference, 4.7 days [95% CI, 2.9 to 6.6 days]), and higher mortality (risk ratio, 2.0 [CI, 1.1 to 3.8]) versus matched control participants. During the Omicron period, hospital-onset SARS-CoV-2 infection remained associated with increased risk for ICU admission and increased time to discharge (median difference, 4.2 days [CI, 3.6 to 5.0 days]). The association with increased hospital mortality was attenuated but still significant (risk ratio, 1.6 [CI, 1.2 to 2.3]). Limitation: Residual confounding may be present. Conclusion: Hospital-onset SARS-CoV-2 infection during the Omicron period remains associated with increased morbidity and mortality. Primary Funding Source: Harvard Medical School Department of Population Medicine.

Trends in Diet Quality Among U.S. Adults From 1999 to 2020 by Race, Ethnicity, and Socioeconomic Disadvantage

Background: Few data have assessed trends in diet quality among U.S. adults. Objective: To evaluate trends in diet quality by race, ethnicity, and socioeconomic disadvantage. Design: Repeated cross-sectional study. Setting: United States. Participants: Noninstitutionalized adults aged 20 years or older who responded to the 1999–2020 National Health and Nutrition Examination Survey (NHANES). Measurements: The proportion of participants meeting the targets of the validated American Heart Association (AHA) 2020 continuous diet score (based on higher intake of fruits, vegetables, whole grains, fish and shellfish, and nuts, seeds, and legumes and lower intake of sugar-sweetened beverages, processed meat, saturated fat, and sodium) and the Healthy Eating Index (HEI)-2015, and energy-adjusted consumption of their components and other individual food groups and nutrients. Poor diet was defined as less than 40% adherence to the AHA score, intermediate as 40% to 79.9% adherence, and ideal as at least 80% adherence. Results: A total of 51 703 adults were included. From 1999 to 2020, the proportion of U.S. adults with poor diet quality decreased from 48.8% to 37.4% (difference, −11.4 percentage points [95% CI, −16.8 to −5.96 percentage points]), the proportion with intermediate quality increased from 50.6% to 61.1% (difference, 10.5 percentage points [CI, 5.20 to 16.1 percentage points]), and the proportion with ideal quality increased from 0.66% to 1.58% (difference, 0.93 percentage points [CI, 0.35 to 1.51 percentage points]) (P for trend < 0.001 for each). Persistent or worsening disparities in diet quality were observed by age, sex, race and ethnicity, education, income, food security, Supplemental Nutrition Assistance Program participation, and health insurance coverage. For example, the proportion of adults with poor diet quality decreased from 47.9% to 33.0% among those with food security (P for trend < 0.001) but did not change (51.3% to 48.2%) among those experiencing food insecurity (P for trend = 0.140) (P for interaction = 0.001). Findings were similar for HEI-2015. Limitations: Self-reported diet; cross-sectional study design. Conclusion: Diet quality among U.S. adults improved modestly between 1999 and 2020, but the proportion with poor diet quality remains high, and dietary disparities persist or are worsening. Primary Funding Source: National Institutes of Health.

Comparative Effectiveness and Safety of Atorvastatin Versus Rosuvastatin: A Multi-database Cohort Study: Annals of Internal Medicine: Vol 177, No 12

Background: Rosuvastatin and atorvastatin are the most widely prescribed moderate- to high-intensity statins. However, evidence on their efficacy and safety during actual use is limited. Objective: To compare the real-world effectiveness and safety of rosuvastatin and atorvastatin. Design: Active comparator cohort study using target trial emulation. Setting: The China Renal Data System (CRDS) and UK Biobank (UKB) databases. Participants: Adults newly prescribed rosuvastatin or atorvastatin. Measurements: The primary outcome was all-cause mortality. Cox proportional hazards regressions were used after 1:1 multilevel propensity score matching. Results: Among the 285 680 eligible participants in both databases, 6-year all-cause mortality was lower for rosuvastatin than for atorvastatin (2.57 vs. 2.83 per 100 person-years in the CRDS database and 0.66 vs. 0.90 per 100 person-years in the UKB database), with differences in cumulative incidence of −1.03% (95% CI, −1.44% to −0.46%) in the CRDS database and −1.38% (CI, −2.50% to −0.21%) in the UKB database. For secondary outcomes in both databases, rosuvastatin conferred lower risks for major adverse cardiovascular events and major adverse liver outcomes. In the UKB database, the risk for development of type 2 diabetes mellitus was higher with rosuvastatin, and the 2 medications carried similar risks for development of chronic kidney disease and other statin-related adverse effects. Limitation: Possible residual confounding. Conclusion: This study found differences in risks for some important outcomes associated with rosuvastatin and atorvastatin. The differences were relatively small, and many did not meet traditional standards for statistical significance. Further research is needed to understand whether these findings can be used with confidence in clinical practice. Primary Funding Source: National Key R&D Program of China and National Natural Science Foundation of China.

A Blueprint for U.S. Health Insurance Reform

The current U.S. health insurance “system” was not deliberately planned and constructed but has emerged piecemeal over the past half-century through a series of incremental and haphazard reforms. That policy history also reveals a clear but unfulfilled societal commitment to providing access to essential health care regardless of resources. To fulfill this obligation, the solution proposed in this article has 2 key elements: 1) universal coverage that is automatic, free, and basic, and 2) the option to buy supplemental coverage in a well-designed market. Such a system could, if desired, be created without raising taxes and without disrupting or changing the delivery of medical care.

Epidemiology of Homebound Population Among Beneficiaries of a Large National Medicare Advantage Plan

Background: Interest in home-based care is increasing among Medicare Advantage (MA) plans. The epidemiology of homebound MA beneficiaries is unknown. Objective: To determine the prevalence, characteristics, predictors, health service use, and mortality outcomes of homebound beneficiaries of a large national MA plan. Design: Cross-sectional. Setting: National MA plan. Participants: Humana MA beneficiaries in 2022 (n = 2 435 519). Measurements: Homebound status was assessed via in-home assessment using previously defined categories: homebound (never or rarely left home in the past month), semihomebound (left home with assistance, had difficulty, or needed help leaving home), and not homebound. Demographic, clinical, health service use, and mortality outcomes were compared by homebound status. Results: In 2022, the overall prevalence of homebound beneficiaries was 22.0% (8.4% of beneficiaries were homebound, and 13.6% were semihomebound). In adjusted models, female sex (odds ratio [OR], 1.36 [95% CI, 1.35 to 1.37), low-income status or dual eligibility for Medicare and Medicaid (OR, 1.56 [CI, 1.55 to 1.57]), dementia (OR, 2.36 [CI, 2.33 to 2.39]), and moderate to severe frailty (OR, 4.32 [CI, 4.19 to 4.45]) were predictive of homebound status. In multivariable logistic regression, homebound status was associated with increased odds of any emergency department visit (OR, 1.14 [ CI, 1.14 to 1.15]), any inpatient hospital admission (OR, 1.44 [CI, 1.42 to 1.46]), any skilled-nursing facility admission (OR, 2.18 [CI, 2.13 to 2.23]), and death (OR, 2.55 [CI, 2.52 to 2.58]). Limitation: The study period overlapped the tail end of the COVID-19 pandemic, and data were derived from a single national MA plan, which limits generalizability. Conclusion: Overall homebound prevalence in a national MA plan was 22.0% and was independently associated with increased health service use and mortality. Study findings can inform strategic initiatives to identify and manage care for homebound beneficiaries. Primary Funding Source: Humana, under a collaborative research agreement with Johns Hopkins University.