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Guideline development requires the synthesis of evidence on several treatments of interest, typically by using network meta-analysis (NMA). Because treatment effects may be estimated imprecisely or be based on evidence lacking internal or external validity, guideline developers must assess the robustness of recommendations made on the basis of the NMA to potential limitations in the evidence. Such limitations arise because the observed estimates differ from the true effects of interest, for example, because of study biases, sampling variation, or issues of relevance. The widely used GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework aims to assess the quality of evidence supporting a recommendation by using a structured series of qualitative judgments. This article argues that GRADE approaches proposed for NMA are insufficient for the purposes of guideline development, because the influence of the evidence on the final recommendation is not taken into account. It outlines threshold analysis as an alternative approach, demonstrating the method with 2 examples of clinical guidelines from the National Institute for Health and Care Excellence (NICE) in the United Kingdom. Threshold analysis quantifies precisely how much the evidence could change (for any reason, such as potential biases, or simply sampling variation) before the recommendation changes, and what the revised recommendation would be. If it is judged that the evidence could not plausibly change by more than this amount, then the recommendation is considered robust; otherwise, it is sensitive to plausible changes in the evidence. In this manner, threshold analysis directly informs decision makers and guideline developers of the robustness of treatment recommendations.

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.

Quantitative Results of a National Intervention to Prevent Hospital-Acquired Catheter-Associated Urinary Tract Infection: A Pre–Post Observational Study: Annals of Internal Medicine: Vol 171, No 7_Supplement

Background: Many hospitals struggle to prevent catheter-associated urinary tract infection (CAUTI). Objective: To evaluate the effect of a multimodal initiative on CAUTI in hospitals with high burden of health care–associated infection (HAI). Design: Prospective, national, nonrandomized, clustered, externally facilitated, pre–post observational quality improvement initiative, for 3 cohorts active between November 2016 and May 2018. Setting: Acute care, long-term acute care, and critical access hospitals, including intensive care and non–intensive care wards. Participants: Target hospitals had a high burden of Clostridioides difficile infection plus central line–associated bloodstream infection, CAUTI, or hospital-onset methicillin-resistant Staphylococcus aureus bloodstream infection, defined as cumulative attributable differences above the first tertile in the Targeted Assessment for Prevention (TAP) strategy. Some additional nonrecruited hospitals also joined. Intervention: Multimodal intervention, including Practice Change Assessment tool to identify infection prevention and control (IPC) and HAI prevention gaps; Web-based, on-demand modules involving onboarding, foundational IPC practices, HAI-specific 2-tiered approach to prioritize and implement interventions, and TAP resources; monthly webinars; state partner–led in-person meetings; and feedback. State partners made site visits to at least 50% of their enrolled hospitals, to support self-assessments and coach. Measurements: Rates of CAUTI and urinary catheter device utilization ratio. Results: Of 387 participating hospitals from 23 states and the District of Columbia, 361 provided CAUTI data. Over the study period, the unadjusted CAUTI rate was low and relatively stable, decreasing slightly from 1.12 to 1.04 CAUTIs per 1000 catheter-days. Catheter utilization decreased from 21.46 to 19.83 catheter-days per 100 patient-days from the pre- to the postintervention period. Limitations: The intervention period was brief, with no assessment of fidelity. Baseline CAUTI rates were low. Patient characteristics were not assessed. Conclusion: This multimodal intervention yielded no substantial improvements in CAUTI or urinary catheter utilization. Primary Funding Source: Centers for Disease Control and Prevention.

General and Abdominal Adiposity and Mortality in Mexico City: A Prospective Study of 150 000 Adults: Annals of Internal Medicine: Vol 171, No 6

Background: Some reports suggest that body mass index (BMI) is not strongly associated with mortality in Hispanic populations. Objective: To assess the causal relevance of adiposity to mortality in Mexican adults, avoiding reverse causality biases. Design: Prospective study. Setting: 2 Mexico City districts. Participants: 159 755 adults aged 35 years and older at recruitment, followed for up to 14 years. Participants with a hemoglobin A1c level of 7% or greater, diabetes, or other chronic diseases were excluded. Measurements: BMI, waist-to-hip ratio, waist circumference, and cause-specific mortality. Cox regression, adjusted for confounders, yielded mortality hazard ratios (HRs) after at least 5 years of follow-up and before age 75 years. Results: Among 115 400 participants aged 35 to <75 years at recruitment, mean BMI was 28.0 kg/m2 (SD, 4.1 kg/m2) in men and 29.6 kg/m2 (SD, 5.1 kg/m2) in women. The association of BMI at recruitment with all-cause mortality was J-shaped, with the minimum at 25 to <27.5 kg/m2. Above 25 kg/m2, each 5-kg/m2 increase in BMI was associated with a 30% increase in all-cause mortality (HR, 1.30 [95% CI, 1.24 to 1.36]). This association was stronger at ages 40 to <60 years (HR, 1.40 [CI, 1.30 to 1.49]) than at ages 60 to <75 years (HR, 1.24 [CI, 1.17 to 1.31]) but was not materially affected by sex, smoking, or other confounders. The associations of mortality with BMI and waist-to-hip ratio were similarly strong, and each was weakened only slightly by adjustment for the other. Waist circumference was strongly related to mortality and remained so even after adjustment for BMI and hip circumference. Limitation: Analyses were limited to mortality. Conclusion: General, and particularly abdominal, adiposity were strongly associated with mortality in this Mexican population. Primary Funding Source: Mexican Health Ministry, Mexican National Council of Science and Technology, Wellcome Trust, Medical Research Council, and Kidney Research UK.

Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study: Annals of Internal Medicine: Vol 170, No 11

Background: Pulmonary embolism (PE) is associated with increased risk for ischemic stroke, but the underlying mechanism remains unclear. The authors hypothesized that paradoxical embolism through patent foramen ovale (PFO) should be the main mechanism. Objective: To determine the frequency of recent ischemic stroke in patients with symptomatic PE according to whether PFO was detected. Design: Prospective cohort study with masked assessment of stroke outcomes. (ClinicalTrials.gov: NCT01216423) Setting: 4 French hospital centers. Participants: 361 consecutive patients with symptomatic acute PE from 13 November 2009 through 21 December 2015. Intervention: Systematic contrast transthoracic echocardiography (TTE) and cerebral magnetic resonance imaging (MRI) within 7 days after enrollment. Measurements: Recent symptomatic or silent ischemic stroke was diagnosed on the basis of clinical examination and cerebral MRI showing a hypersignal on the trace diffusion-weighted image with reduction or pseudonormalization of apparent diffusion coefficient. Results: Contrast TTE was conclusive in 324 of 361 patients and showed PFO in 43 patients (13%). The median age was 66 years (interquartile range, 54 to 77 years). In total, 51% of patients (145/284) had associated deep venous thrombosis, 91% (279/306) had cardiovascular risk factors, and 10% (16/151) presented with arrhythmia (no difference between PFO and non-PFO groups). Cerebral MRI was conclusive in 315 patients. Recent ischemic stroke was more frequent in the PFO group than in the non-PFO group (9 of 42 patients [21.4%] vs. 15 of 273 patients [5.5%]; difference in proportions, 15.9 percentage points [95% CI, 4.7 to 30.7 percentage points]). Limitation: Because of inconclusive contrast TTE or MRI, 46 patients were excluded from analysis. Conclusion: Frequency of recent ischemic stroke in patients with symptomatic PE was higher in patients with PFO than in those without PFO. This finding supports the hypothesis that paradoxical embolism is an important mechanism of ischemic stroke in patients with PFO. Primary Funding Source: French Ministry of Health.

Qualitative Assessment of a State Partner–Facilitated Health Care–Associated Infection Prevention National Collaborative

Background: The Centers for Disease Control and Prevention (CDC) funded a 3-year national collaborative focused on facilitating relationships between health care–associated infection (HAI) prevention stakeholders within states and improving HAI prevention activities within hospitals. This program—STRIVE (States Targeting Reduction in Infections via Engagement)—targeted hospitals with elevated rates of common HAIs. Objective: To use qualitative methods to better understand STRIVE's effect on state partner relationships and HAI prevention efforts by hospitals. Design: Qualitative case study, by U.S. state. Setting: 7 of 22 eligible STRIVE state partnerships. Participants: Representatives from state hospital associations, state health departments, and other participating organizations (for example, Quality Innovation Networks–Quality Improvement Organizations), referred to as “state partners.” Measurements: Phone interviews (n = 17) with each organization were conducted, recorded, and transcribed. Results: State partners reported that relationships with each other and with participating hospitals improved through STRIVE participation. The partners saw improvements in hospital-level HAI prevention activities, such as improved auditing and feedback practices and inclusion of environmental services in prevention efforts; however, some noted those improvements may not be reflected in HAI rates. Many partners outlined plans to sustain their partner relationships by working on future state-level initiatives, such as opioid abuse prevention and antimicrobial stewardship. Limitation: Only 7 participating states were included; direct feedback from participating hospitals was not available. Conclusion: Although there were no substantial changes in aggregate HAI rates, STRIVE achieved its goal of improving state partner relationships and coordination. This improved collaboration may lead to a more streamlined response to future HAI outbreaks and public health emergencies. Primary Funding Source: Centers for Disease Control and Prevention.

A Tiered Approach for Preventing Catheter-Associated Urinary Tract Infection

Access to Office-Based Buprenorphine Treatment in Areas With High Rates of Opioid-Related Mortality: An Audit Study: Annals of Internal Medicine: Vol 171, No 1

Background: Improving access to treatment for opioid use disorder is a national priority, but little is known about the barriers encountered by patients seeking buprenorphine–naloxone (“buprenorphine”) treatment. Objective: To assess real-world access to buprenorphine treatment for uninsured or Medicaid-covered patients reporting current heroin use. Design: Audit survey (“secret shopper” study). Setting: 6 U.S. jurisdictions with a high burden of opioid-related mortality (Massachusetts, Maryland, New Hampshire, West Virginia, Ohio, and the District of Columbia). Participants: From July to November 2018, callers contacted 546 publicly listed buprenorphine prescribers twice, posing as uninsured or Medicaid-covered patients seeking buprenorphine treatment. Measurements: Rates of new appointments offered, whether buprenorphine prescription was possible at the first visit, and wait times. Results: Among 1092 contacts with 546 clinicians, schedulers were reached for 849 calls (78% response rate). Clinicians offered new appointments to 54% of Medicaid contacts and 62% of uninsured–self-pay contacts, whereas 27% of Medicaid and 41% of uninsured–self-pay contacts were offered an appointment with the possibility of buprenorphine prescription at the first visit. The median wait time to the first appointment was 6 days (interquartile range [IQR], 2 to 10 days) for Medicaid contacts and 5 days (IQR, 1 to 9 days) for uninsured–self-pay contacts. These wait times were similar regardless of clinician type or payer status. The median wait time from first contact to possible buprenorphine induction was 8 days (IQR, 4 to 15 days) for Medicaid and 7 days (IQR, 3 to 14 days) for uninsured–self-pay contacts. Limitation: The survey sample included only publicly listed buprenorphine prescribers. Conclusion: Many buprenorphine prescribers did not offer new appointments or rapid buprenorphine access to callers reporting active heroin use, particularly those with Medicaid coverage. Nevertheless, wait times were not long, implying that opportunities may exist to increase access by using the existing prescriber workforce. Primary Funding Source: National Institute on Drug Abuse.

Improving the Patient Protection and Affordable Care Act's Insurance Coverage Provisions: A Position Paper From the American College of Physicians

The coverage reforms of the Patient Protection and Affordable Care Act have fundamentally changed the U.S. health care system. The law's health insurance regulations, which include protections for persons with preexisting conditions, have made health insurance more accessible. The premium tax credit and cost-sharing subsidies have made nongroup coverage more affordable. The essential health benefit package and coverage for preventive services without cost sharing have made insurance more comprehensive. Perhaps most important, the Medicaid expansion extended coverage to millions of low-income adults. Despite these gains, more needs to be done to bring the United States closer to achieving universal coverage. In this position paper, the American College of Physicians recommends action to enhance and expand eligibility for health insurance financial subsidies; stabilize health insurance marketplaces; provide sustained funding for outreach, education, and enrollment assistance activities; test and implement a mechanism to encourage enrollment; expand Medicaid in all states; and establish a public insurance option to increase competition.

The Development of Clinical Guidelines and Guidance Statements by the Clinical Guidelines Committee of the American College of Physicians: Update of Methods

The American College of Physicians (ACP) was one of the first organizations in the United States to develop evidence-based clinical guidelines and has been developing guidelines since 1981. ACP's Clinical Guidelines Committee (CGC), in collaboration with staff from the Clinical Policy department, develops clinical guidelines and guidance statements and continues to refine and enhance its methodology. This article presents an update of the CGC's 2010 paper outlining policies, methods, and presentation format of ACP's clinical guidelines and guidance statements. Updated methods include more stringent policies about disclosure of interests and conflict management; inclusion of public perspective; full adoption of GRADE (Grading of Recommendations Assessment, Development and Evaluation) methods; more standardized reporting formats that consider value of care, patient comorbid conditions, patient values and preferences, and costs; and further clarification of guidance statement methods.

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