Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis

Importance Carotid endarterectomy (CEA) among asymptomatic patients involves a trade-off between a higher short-term perioperative risk in exchange for a lower long-term risk of stroke. The clinical benefit observed in randomized clinical trials (RCTs) may not extend to real-world practice. Objective To examine whether early intervention (CEA) was superior to initial medical therapy in real-world practice in preventing fatal and nonfatal strokes among patients with asymptomatic carotid stenosis. Design, Setting, and Participants This comparative effectiveness study was conducted from August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs. Data analyzed were those of veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009. Patients without a carotid imaging report, those with carotid stenosis of less than 50% or hemodynamically insignificant stenosis, and those with a history of stroke or transient ischemic attack in the 6 months before index imaging were excluded. A cohort of patients who received initial medical therapy and a cohort of similar patients who received CEA were constructed and followed up for 5 years. The target trial method was used to compute weighted Kaplan-Meier curves and estimate the risk of fatal and nonfatal strokes in each cohort in the pragmatic sample across 5 years of follow-up. This analysis was repeated after restricting the sample to patients who met RCT inclusion criteria. Cumulative incidence functions for fatal and nonfatal strokes were estimated, accounting for nonstroke deaths as competing risks in both the pragmatic and RCT-like samples. Exposures Receipt of CEA vs initial medical therapy. Main Outcomes and Measures Fatal and nonfatal strokes. Results Of the total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received initial medical therapy within 1 year after the index carotid imaging. The observed rate of stroke or death (perioperative complications) within 30 days in the CEA cohort was 2.5% (95% CI, 2.0%-3.1%). The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, −2.3%; 95% CI, −4.0% to −0.3%). In an analysis that incorporated the competing risk of death, the risk difference between the 2 cohorts was lower and not statistically significant (risk difference, −0.8%; 95% CI, −2.1% to 0.5%). Among patients who met RCT inclusion criteria, the 5-year risk of fatal and nonfatal strokes was 5.5% (95% CI, 4.5%-6.5%) among patients randomized to CEA and was 7.6% (95% CI, 5.7%-9.5%) among those randomized to initial medical therapy (risk difference, −2.1%; 95% CI, −4.4% to −0.2%). Accounting for competing risks resulted in a risk difference of −0.9% (95% CI, −2.9% to 0.7%) that was not statistically significant. Conclusions and Relevance This study found that the absolute reduction in the risk of fatal and nonfatal strokes associated with early CEA was less than half the risk difference in trials from 20 years ago and was no longer statistically significant when the competing risk of nonstroke deaths was accounted for in the analysis. Given the nonnegligible perioperative 30-day risks and the improvements in stroke prevention, medical therapy may be an acceptable therapeutic strategy

Outreach invitations for FIT and colonoscopy improve colorectal cancer screening rates: A randomized controlled trial in a safety-net health system.

BACKGROUND: The effectiveness of colorectal cancer (CRC) screening is limited by underuse, particularly among underserved populations. Among a racially diverse and socioeconomically disadvantaged cohort of patients, the authors compared the effectiveness of fecal immunochemical test (FIT) outreach and colonoscopy outreach to increase screening participation rates, compared with usual visit-based care. METHODS: Patients aged 50 to 64 years who were not up-to-date with CRC screening but used primary care services in a large safety-net health system were randomly assigned to mailed FIT outreach (2400 patients), mailed colonoscopy outreach (2400 patients), or usual care with opportunistic visit-based screening (1199 patients). Patients who did not respond to outreach invitations within 2 weeks received follow-up telephone reminders. The primary outcome was CRC screening completion within 12 months after randomization. RESULTS: Baseline patient characteristics across the 3 groups were similar. Using intention-to-screen analysis, screening participation rates were higher for FIT outreach (58.8%) and colonoscopy outreach (42.4%) than usual care (29.6%) (P <.001 for both). Screening participation with FIT outreach was higher than that for colonoscopy outreach (P <.001). Among responders, FIT outreach had a higher percentage of patients who responded before reminders (59.0% vs 29.7%; P <.001). Nearly one-half of patients in the colonoscopy outreach group crossed over to complete FIT via usual care, whereas <5% of patients in the FIT outreach group underwent usual-care colonoscopy. CONCLUSIONS: Mailed outreach invitations appear to significantly increase CRC screening rates among underserved populations. In the current study, FIT-based outreach was found to be more effective than colonoscopy-based outreach to increase 1-time screening participation. Studies with longer follow-up are needed to compare the effectiveness of outreach strategies for promoting completion of the entire screening process

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

IMPORTANCE: Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results. OBJECTIVE: Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings. INTERVENTIONS: Random assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach. MAIN OUTCOMES AND MEASURES: Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation). RESULTS: All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P < .001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P < .001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P < .08 and P < .13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P < .001 for both comparisons). There were no screening-related harms in any groups. CONCLUSIONS AND RELEVANCE: Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01710215

Comparative Effectiveness of Carotid Endarterectomy vs Initial Medical Therapy in Patients With Asymptomatic Carotid Stenosis

Importance Carotid endarterectomy (CEA) among asymptomatic patients involves a trade-off between a higher short-term perioperative risk in exchange for a lower long-term risk of stroke. The clinical benefit observed in randomized clinical trials (RCTs) may not extend to real-world practice. Objective To examine whether early intervention (CEA) was superior to initial medical therapy in real-world practice in preventing fatal and nonfatal strokes among patients with asymptomatic carotid stenosis. Design, Setting, and Participants This comparative effectiveness study was conducted from August 28, 2018, to March 2, 2020, using the Corporate Data Warehouse, Suicide Data Repository, and other databases of the US Department of Veterans Affairs. Data analyzed were those of veterans of the US Armed Forces aged 65 years or older who received carotid imaging between January 1, 2005, and December 31, 2009. Patients without a carotid imaging report, those with carotid stenosis of less than 50% or hemodynamically insignificant stenosis, and those with a history of stroke or transient ischemic attack in the 6 months before index imaging were excluded. A cohort of patients who received initial medical therapy and a cohort of similar patients who received CEA were constructed and followed up for 5 years. The target trial method was used to compute weighted Kaplan-Meier curves and estimate the risk of fatal and nonfatal strokes in each cohort in the pragmatic sample across 5 years of follow-up. This analysis was repeated after restricting the sample to patients who met RCT inclusion criteria. Cumulative incidence functions for fatal and nonfatal strokes were estimated, accounting for nonstroke deaths as competing risks in both the pragmatic and RCT-like samples. Exposures Receipt of CEA vs initial medical therapy. Main Outcomes and Measures Fatal and nonfatal strokes. Results Of the total 5221 patients, 2712 (51.9%; mean [SD] age, 73.6 [6.0] years; 2678 men [98.8%]) received CEA and 2509 (48.1%; mean [SD] age, 73.6 [6.0] years; 2479 men [98.8%]) received initial medical therapy within 1 year after the index carotid imaging. The observed rate of stroke or death (perioperative complications) within 30 days in the CEA cohort was 2.5% (95% CI, 2.0%-3.1%). The 5-year risk of fatal and nonfatal strokes was lower among patients randomized to CEA compared with patients randomized to initial medical therapy (5.6% vs 7.8%; risk difference, −2.3%; 95% CI, −4.0% to −0.3%). In an analysis that incorporated the competing risk of death, the risk difference between the 2 cohorts was lower and not statistically significant (risk difference, −0.8%; 95% CI, −2.1% to 0.5%). Among patients who met RCT inclusion criteria, the 5-year risk of fatal and nonfatal strokes was 5.5% (95% CI, 4.5%-6.5%) among patients randomized to CEA and was 7.6% (95% CI, 5.7%-9.5%) among those randomized to initial medical therapy (risk difference, −2.1%; 95% CI, −4.4% to −0.2%). Accounting for competing risks resulted in a risk difference of −0.9% (95% CI, −2.9% to 0.7%) that was not statistically significant. Conclusions and Relevance This study found that the absolute reduction in the risk of fatal and nonfatal strokes associated with early CEA was less than half the risk difference in trials from 20 years ago and was no longer statistically significant when the competing risk of nonstroke deaths was accounted for in the analysis. Given the nonnegligible perioperative 30-day risks and the improvements in stroke prevention, medical therapy may be an acceptable therapeutic strategy

Tailored information increases patient/physician discussion of colon cancer risk and testing: The Cancer Risk Intake System trial

Assess whether receipt of tailored printouts generated by the Cancer Risk Intake System (CRIS) – a touch-screen computer program that collects data from patients and generates printouts for patients and physicians – results in more reported patient-provider discussions about colorectal cancer (CRC) risk and screening than receipt of non-tailored information.Cluster-randomized trial, randomized by physician, with data collected via CRIS prior to visit and 2-week follow-up telephone survey among 623 patients.Patients aged 25–75 with upcoming primary-care visits and eligible for, but currently non-adherent to CRC screening guidelines.Patient-reported discussions with providers about CRC risk and testing.Tailored recipients were more likely to report patient-physician discussions about personal and familial risk, stool testing, and colonoscopy (all p < 0.05). Tailored recipients were more likely to report discussions of: chances of getting cancer (+10%); family history (+15%); stool testing (+9%); and colonoscopy (+8%) (all p < 0.05).CRIS is a promising strategy for facilitating discussions about testing in primary-care settings. Keywords: Colorectal neoplasms, Mass screening, Physician-patient relations, Health behavior, Tailorin

Experimental approach and initial forest response to a simulated ice storm experiment in a northern hardwood forest.

Ice storms are a type of extreme winter weather event common to north temperate and boreal forests worldwide. Recent climate modelling studies suggest that these storms may become more frequent and severe under a changing climate. Compared to other types of storm events, relatively little is known about the direct and indirect impacts of these storms on forests, as naturally occurring ice storms are inherently difficult to study. Here we describe a novel experimental approach used to create a suite of ice storms in a mature hardwood forest in New Hampshire, USA. The experiment included five ice storm intensities (0, 6.4, 12.7 and 19.1 mm radial ice accretion) applied in a single year, and one ice storm intensity (12.7 mm) applied in two consecutive years. Results demonstrate the feasibility of this approach for creating experimental ice storms, quantify the increase in fine and coarse woody debris mass and nutrients transferred from the forest canopy to the soil under the different icing conditions, and show an increase in the damage to the forest canopy with increasing icing that evolves over time. In this forest, little damage occurred below 6.4 mm radial ice accretion, moderate damage occurred with up to 12.7 mm of accretion, and significant branch breakage and canopy damage occurred with 19.1 mm of ice. The icing in consecutive years demonstrated an interactive effect of ice storm frequency and severity such that some branches damaged in the first year of icing appeared to remain in the canopy and then fall to the ground in the second year of icing. These results have implications for National Weather Service ice storm warning levels, as they provide a quantitative assessment of ice-load related inputs of forest debris that will be useful to municipalities creating response plans for current and future ice storms

Barriers to Implementing Registered Nurse–Driven Clinical Decision Support for Antibiotic Stewardship: Retrospective Case Study

BackgroundUp to 50% of antibiotic prescriptions for upper respiratory infections (URIs) are inappropriate. Clinical decision support (CDS) systems to mitigate unnecessary antibiotic prescriptions have been implemented into electronic health records, but their use by providers has been limited. ObjectiveAs a delegation protocol, we adapted a validated electronic health record–integrated clinical prediction rule (iCPR) CDS-based intervention for registered nurses (RNs), consisting of triage to identify patients with low-acuity URI followed by CDS-guided RN visits. It was implemented in February 2022 as a randomized controlled stepped-wedge trial in 43 primary and urgent care practices within 4 academic health systems in New York, Wisconsin, and Utah. While issues were pragmatically addressed as they arose, a systematic assessment of the barriers to implementation is needed to better understand and address these barriers. MethodsWe performed a retrospective case study, collecting quantitative and qualitative data regarding clinical workflows and triage-template use from expert interviews, study surveys, routine check-ins with practice personnel, and chart reviews over the first year of implementation of the iCPR intervention. Guided by the updated CFIR (Consolidated Framework for Implementation Research), we characterized the initial barriers to implementing a URI iCPR intervention for RNs in ambulatory care. CFIR constructs were coded as missing, neutral, weak, or strong implementation factors. ResultsBarriers were identified within all implementation domains. The strongest barriers were found in the outer setting, with those factors trickling down to impact the inner setting. Local conditions driven by COVID-19 served as one of the strongest barriers, impacting attitudes among practice staff and ultimately contributing to a work infrastructure characterized by staff changes, RN shortages and turnover, and competing responsibilities. Policies and laws regarding scope of practice of RNs varied by state and institutional application of those laws, with some allowing more clinical autonomy for RNs. This necessitated different study procedures at each study site to meet practice requirements, increasing innovation complexity. Similarly, institutional policies led to varying levels of compatibility with existing triage, rooming, and documentation workflows. These workflow conflicts were compounded by limited available resources, as well as an implementation climate of optional participation, few participation incentives, and thus low relative priority compared to other clinical duties. ConclusionsBoth between and within health care systems, significant variability existed in workflows for patient intake and triage. Even in a relatively straightforward clinical workflow, workflow and cultural differences appreciably impacted intervention adoption. Takeaways from this study can be applied to other RN delegation protocol implementations of new and innovative CDS tools within existing workflows to support integration and improve uptake. When implementing a system-wide clinical care intervention, considerations must be made for variability in culture and workflows at the state, health system, practice, and individual levels. Trial RegistrationClinicalTrials.gov NCT04255303; https://clinicaltrials.gov/ct2/show/NCT0425530

Clinical and Sociobehavioral Prediction Model of 30-Day Hospital Readmissions Among People With HIV and Substance Use Disorder: Beyond Electronic Health Record Data

Under the Affordable Care Act, hospitals receive reduced reimbursements for excessive 30-day readmissions. However, the Centers for Medicare and Medicaid Services does not consider social and behavioral variables in expected readmission rate calculations, which may unfairly penalize systems caring for socially disadvantaged patients, including patients with HIV. Randomized controlled trial of patient navigation with or without financial incentives in HIV-positive substance users recruited from the inpatient setting at 11 US hospitals. External validation of an existing 30-day readmission prediction model, using variables available in the electronic health record (EHR-only model), in a new multicenter cohort of HIV-positive substance users was assessed by C-statistic and Hosmer-Lemeshow testing. A second model evaluated sociobehavioral factors in improving the prediction model (EHR-plus model) using multivariable regression and C-statistic with cross-validation. The mean age of the cohort was 44.1 years, and participants were predominantly males (67.4%), non-white (88.0%), and poor (62.8%, <$20,000/year). Overall, 17.5% individuals had a hospital readmission within 30 days of initial hospital discharge. The EHR-only model resulted in a C-statistic of 0.65 (95% confidence interval: 0.60 to 0.70). Inclusion of additional sociobehavioral variables, food insecurity and readiness for substance use treatment, in the EHR-plus model resulted in a C-statistic of 0.74 (0.71 after cross-validation, 95% confidence interval: 0.64 to 0.77). Incorporation of detailed social and behavioral variables substantially improved the performance of a 30-day readmission prediction model for hospitalized HIV-positive substance users. Our findings highlight the importance of social determinants in readmission risk and the need to ask about, adjust for, and address them