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Should This Patient Be Screened for Pancreatic Cancer?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 173, No 11

Because pancreatic cancer is typically advanced at the time of diagnosis, it has a very low 5-year survival rate and may become the second leading cause of cancer death in the United States. A screening program to find early-stage pancreatic cancer is needed but has been challenging to develop because of the lack of an effective screening test. In 2019, the U.S. Preventive Services Task Force performed an evidence review and updated its guidance, confirming its 2004 “D” recommendation against routine screening for average-risk patients. Here, 2 experts review the updated guideline and recent evidence and discuss whether a patient with a family history of pancreatic cancer should undergo screening.

Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder: A Randomized Trial: Annals of Internal Medicine: Vol 174, No 7

Background: Hospitalized patients with comorbid substance use disorders (SUDs) are at high risk for poor outcomes, including readmission and emergency department (ED) use. Objective: To determine whether patient navigation services reduce hospital readmissions. Design: Randomized controlled trial comparing Navigation Services to Avoid Rehospitalization (NavSTAR) versus treatment as usual (TAU). (ClinicalTrials.gov: NCT02599818) Setting: Urban academic hospital in Baltimore, Maryland, with an SUD consultation service. Participants: 400 hospitalized adults with comorbid SUD (opioid, cocaine, or alcohol). Intervention: NavSTAR used proactive case management, advocacy, service linkage, and motivational support to resolve internal and external barriers to care and address SUD, medical, and basic needs for 3 months after discharge. Measurements: Data on inpatient readmissions (primary outcome) and ED visits for 12 months were obtained for all participants via the regional health information exchange. Entry into SUD treatment, substance use, and related outcomes were assessed at 3-, 6-, and 12-month follow-up. Results: Participants had high levels of acute care use: 69% had an inpatient readmission and 79% visited the ED over the 12-month observation period. Event rates per 1000 person-days were 6.05 (NavSTAR) versus 8.13 (TAU) for inpatient admissions (hazard ratio, 0.74 [95% CI, 0.58 to 0.96]; P = 0.020) and 17.66 (NavSTAR) versus 27.85 (TAU) for ED visits (hazard ratio, 0.66 [CI, 0.49 to 0.89]; P = 0.006). Participants in the NavSTAR group were less likely to have an inpatient readmission within 30 days than those receiving TAU (15.5% vs. 30.0%; P < 0.001) and were more likely to enter community SUD treatment after discharge (P = 0.014; treatment entry within 3 months, 50.3% NavSTAR vs. 35.3% TAU). Limitation: Single-site trial, which limits generalizability. Conclusion: Patient navigation reduced inpatient readmissions and ED visits in this clinically challenging sample of hospitalized patients with comorbid SUDs. Primary Funding Source: National Institute on Drug Abuse.

Stepped Exercise Program for Patients With Knee Osteoarthritis: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 174, No 3

Background: Evidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs. Objective: To examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA). Design: Randomized controlled trial. (ClinicalTrials.gov: NCT02653768) Setting: 2 U.S. Department of Veterans Affairs sites. Participants: 345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis. Intervention: Participants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks. Measurements: Primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models. Results: In the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, −10.5 to −3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement. Limitation: Participants were mostly male veterans, and follow-up was limited. Conclusion: Veterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis. Primary Funding Source: Department of Veterans Affairs, Health Services Research and Development Service.

Effects of Intensive Blood Pressure Treatment on Orthostatic Hypotension: A Systematic Review and Individual Participant–based Meta-analysis: Annals of Internal Medicine: Vol 174, No 1

Background: Although intensive blood pressure (BP)–lowering treatment reduces risk for cardiovascular disease, there are concerns that it might cause orthostatic hypotension (OH). Purpose: To examine the effects of intensive BP-lowering treatment on OH in hypertensive adults. Data Sources: MEDLINE, EMBASE, and Cochrane CENTRAL from inception through 7 October 2019, without language restrictions. Study Selection: Randomized trials of BP pharmacologic treatment (more intensive BP goal or active agent) that involved more than 500 adults with hypertension or elevated BP and that were 6 months or longer in duration. Trial comparisons were groups assigned to either less intensive BP goals or placebo, and the outcome was measured OH, defined as a decrease of 20 mm Hg or more in systolic BP or 10 mm Hg or more in diastolic BP after changing position from seated to standing. Data Extraction: 2 investigators independently abstracted articles and rated risk of bias. Data Synthesis: 5 trials examined BP treatment goals, and 4 examined active agents versus placebo. Trials examining BP treatment goals included 18 466 participants with 127 882 follow-up visits. Trials were open-label, with minimal heterogeneity of effects across trials. Intensive BP treatment lowered risk for OH (odds ratio, 0.93 [95% CI, 0.86 to 0.99]). Effects did not differ by prerandomization OH (P for interaction = 0.80). In sensitivity analyses that included 4 additional placebo-controlled trials, overall and subgroup findings were unchanged. Limitations: Assessments of OH were done while participants were seated (not supine) and did not include the first minute after standing. Data on falls and syncope were not available. Conclusion: Intensive BP-lowering treatment decreases risk for OH. Orthostatic hypotension, before or in the setting of more intensive BP treatment, should not be viewed as a reason to avoid or de-escalate treatment for hypertension. Primary Funding Source: National Heart, Lung, and Blood Institute, National Institutes of Health. (PROSPERO: CRD42020153753)

Spatial Inequities in COVID-19 Testing, Positivity, Confirmed Cases, and Mortality in 3 U.S. Cities: An Ecological Study: Annals of Internal Medicine: Vol 174, No 7

Background: Preliminary evidence has shown inequities in coronavirus disease 2019 (COVID-19)–related cases and deaths in the United States. Objective: To explore the emergence of spatial inequities in COVID-19 testing, positivity, confirmed cases, and mortality in New York, Philadelphia, and Chicago during the first 6 months of the pandemic. Design: Ecological, observational study at the ZIP code tabulation area (ZCTA) level from March to September 2020. Setting: Chicago, New York, and Philadelphia. Participants: All populated ZCTAs in the 3 cities. Measurements: Outcomes were ZCTA-level COVID-19 testing, positivity, confirmed cases, and mortality cumulatively through the end of September 2020. Predictors were the Centers for Disease Control and Prevention Social Vulnerability Index and its 4 domains, obtained from the 2014–2018 American Community Survey. The spatial autocorrelation of COVID-19 outcomes was examined by using global and local Moran I statistics, and estimated associations were examined by using spatial conditional autoregressive negative binomial models. Results: Spatial clusters of high and low positivity, confirmed cases, and mortality were found, co-located with clusters of low and high social vulnerability in the 3 cities. Evidence was also found for spatial inequities in testing, positivity, confirmed cases, and mortality. Specifically, neighborhoods with higher social vulnerability had lower testing rates and higher positivity ratios, confirmed case rates, and mortality rates. Limitations: The ZCTAs are imperfect and heterogeneous geographic units of analysis. Surveillance data were used, which may be incomplete. Conclusion: Spatial inequities exist in COVID-19 testing, positivity, confirmed cases, and mortality in 3 large U.S. cities. Primary Funding Source: National Institutes of Health.

The Contribution of the Age Distribution of Cases to COVID-19 Case Fatality Across Countries: A Nine-Country Demographic Study: Annals of Internal Medicine: Vol 173, No 9

Background: There is wide variation in coronavirus disease 2019 (COVID-19) case-fatality rates (CFRs) across countries, leading to uncertainty about the true lethality of the disease. A large part of this variation may be due to the ages of individuals who are tested and identified. Objective: To measure the contribution of distortions from the age distributions of confirmed cases to CFRs within and across populations. Design: Cross-sectional demographic study using aggregate data on COVID-19 cases and deaths by age. Setting: Population-based data from China, France, Germany, Italy, the Netherlands, South Korea, Spain, Switzerland, and the United States. Participants: All individuals with confirmed COVID-19, as reported by each country as of 19 April 2020 (n = 1 223 261). Measurements: Age-specific COVID-19 CFRs and age-specific population shares by country. Results: The overall observed CFR varies widely, with the highest rates in Italy (9.3%) and the Netherlands (7.4%) and the lowest rates in South Korea (1.6%) and Germany (0.7%). Adjustment for the age distribution of cases explains 66% of the variation across countries, with a resulting age-standardized median CFR of 1.9%. Among a larger sample of 95 countries, the observed variation in COVID-19 CFRs is 13 times larger than what would be expected on the basis of just differences in the age composition of countries. Limitation: The age-adjusted rates assume that, conditional on age, COVID-19 mortality among diagnosed cases is the same as that among undiagnosed cases and that individuals of all ages are equally susceptible to severe acute respiratory syndrome coronavirus 2 infection. Conclusion: Selective testing and identification of older cases considerably warps estimates of the lethality of COVID-19 within populations and comparisons across countries. Removing age distortions and focusing on differences in age-adjusted case fatality will be essential for accurately comparing countries' performance in caring for patients with COVID-19 and for monitoring the epidemic over time. Primary Funding Source: Alexander von Humboldt Foundation.

Effects of Interleukin-1β Inhibition on Incident Hip and Knee Replacement: Exploratory Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial: Annals of Internal Medicine: Vol 173, No 7

Background: Osteoarthritis is a common inflammatory disorder with no disease-modifying therapies. Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear. Objective: To determine whether IL-1β inhibition with canakinumab reduces incident total hip or knee replacement (THR/TKR). Design: Exploratory analysis of a randomized trial. (ClinicalTrials.gov: NCT01327846) Setting: 1091 clinical sites in 39 countries. Participants: 10 061 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants. Intervention: Random allocation to placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months. Measurements: The primary and secondary outcomes were time to first incident THR/TKR and time to first occurrence of an osteoarthritis-related adverse event (AE). Data were obtained through blinded ascertainment of trial clinical and safety databases. Results: Median follow-up was 3.7 years. For the individual canakinumab dose groups, compared with placebo, hazard ratios (HRs) for incident THR/TKR during follow-up were 0.60 (95% CI, 0.38 to 0.95) for the 50-mg group, 0.53 (CI, 0.33 to 0.84) for the 150-mg group, and 0.60 (CI, 0.38 to 0.93) for the 300-mg group. Thus, in the pooled canakinumab groups, compared with the placebo group, incidence rates for THR/TKR were 0.31 and 0.54 events per 100 person-years (HR, 0.58 [CI, 0.42 to 0.80]; P = 0.001), respectively. The HR for the secondary end point of osteoarthritis-related AEs was 0.73 (CI, 0.61 to 0.87). Similar findings were observed in analyses restricted to participants with a history of osteoarthritis. Limitation: Because the parent trial was not designed to examine the efficacy of IL-1β inhibitors in osteoarthritis, information on structural joint outcomes was not collected. Conclusion: Findings from this exploratory analysis of a randomized controlled trial support further investigation of IL-1β inhibition for treatment of large joint osteoarthritis. Primary Funding Source: Novartis Pharmaceuticals.

Extreme Risk Protection Orders Intended to Prevent Mass Shootings: A Case Series: Annals of Internal Medicine: Vol 171, No 9

Urgent, individualized interventions to reduce firearm access, such as extreme risk protection orders (ERPOs, colloquially known as “red flag” orders), provide a rapid, focused response when risk for imminent firearm violence is high. Studies to date suggest such interventions are most commonly used to prevent suicide and are effective. Authorizing legislation has often been enacted after public mass shootings but, to our knowledge, there have been only 2 reported cases of ERPO use in efforts to prevent mass shootings. California enacted the nation's first ERPO statute, which took effect in January 2016. The authors are evaluating that statute's implementation and effectiveness and are seeking to obtain court records for all 414 cases occurring in 2016 to 2018. Based on 159 records received thus far, this article presents an aggregate summary and individual histories for a preliminary series of 21 cases in which ERPOs were used in efforts to prevent mass shootings. Most subjects were male and non-Hispanic white; the mean age was 35 years. Most subjects made explicit threats and owned firearms. Four cases arose primarily in relation to medical or mental health conditions, and such conditions were noted in 4 others. Fifty-two firearms were recovered. As of early August 2019, none of the threatened shootings had occurred, and no other homicides or suicides by persons subject to the orders were identified. It is impossible to know whether violence would have occurred had ERPOs not been issued, and the authors make no claim of a causal relationship. Nonetheless, the cases suggest that this urgent, individualized intervention can play a role in efforts to prevent mass shootings, in health care settings and elsewhere. Further evaluation would be helpful.

Health-Related Values and Preferences Regarding Meat Consumption: A Mixed-Methods Systematic Review: Annals of Internal Medicine: Vol 171, No 10

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: A person's meat consumption is often determined by their values and preferences. Purpose: To identify and evaluate evidence addressing health-related values and preferences regarding meat consumption. Data Sources: MEDLINE, EMBASE, Web of Science, Centre for Agriculture and Biosciences Abstracts, International System for Agricultural Science and Technology, and Food Science and Technology Abstracts were searched from inception to July 2018 without language restrictions. Study Selection: Pairs of reviewers independently screened search results and included quantitative and qualitative studies reporting adults' health-related values and preferences regarding meat consumption. Data Extraction: Pairs of reviewers independently extracted data and assessed risk of bias. Data Synthesis: Data were synthesized into narrative form, and summaries were tabulated and certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Of 19 172 initial citations, 41 quantitative studies (38 addressed reasons for meat consumption and 5 addressed willingness to reduce meat consumption) and 13 qualitative studies (10 addressed reasons for meat consumption and 4 addressed willingness to reduce meat consumption) were eligible for inclusion. Thirteen studies reported that omnivores enjoy eating meat, 18 reported that these persons consider meat an essential component of a healthy diet, and 7 reported that they believe they lack the skills needed to prepare satisfactory meals without meat. Omnivores are generally unwilling to change their meat consumption. The certainty of evidence was low for both “reasons for meat consumption” and “willingness to reduce meat consumption in the face of undesirable health effects.” Limitation: Limited generalizability of findings to lower-income countries, low-certainty evidence for willingness to reduce meat consumption, and limited applicability to specific types of meat (red and processed meat). Conclusion: Low-certainty evidence suggests that omnivores are attached to meat and are unwilling to change this behavior when faced with potentially undesirable health effects. Primary Funding Source: None. (PROSPERO: CRD42018088854)

To What Target Hemoglobin A1c Level Would You Treat This Patient With Type 2 Diabetes?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 171, No 7

In the United States, 9.4% of all adults—and 25% of those older than 65 years—have diabetes. Diabetes is the leading cause of blindness and end-stage renal disease and contributes to both microvascular and macrovascular complications. The management of patients with type 2 diabetes (T2D) is a common and important activity in primary care internal medicine practice. Measurement of hemoglobin A1c (HbA1c) provides an estimate of mean blood sugar levels and glycemic control. The optimal HbA1c target level among various persons with T2D is a subject of controversy. Guidelines regarding HbA1c targets have yielded differing recommendations. In 2018, the American College of Physicians (ACP) published a guideline on HbA1c targets for nonpregnant adults with T2D. In addition to a recommendation to individualize HbA1c target levels, the ACP proposed a level between 7% and 8% for most patients. The ACP also advised deintensification of therapy for patients who have an HbA1c level lower than 6.5% and avoidance of HbA1c-targeted treatment for patients with a life expectancy of less than 10 years. This guidance contrasts with a recommendation from the American Diabetes Association to aim for HbA1c levels less than 7% for many nonpregnant adults and to consider a target of 6.5% if it can be achieved safely. Here, 2 experts, a diabetologist and a general internist, discuss how to apply the divergent guideline recommendations to a patient with long-standing T2D and a current HbA1c level of 7.8%.

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