CLOVER (CLOstridium difficile Vaccine Efficacy tRial) Study: A Phase 3, Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection.

Background: Clostridioides difficile infection (CDI) causes substantial mortality and healthcare burden. We assessed the detoxified toxin-A/B PF-06425090 vaccine for primary CDI prevention.

Methods: This phase 3 observer-blinded study randomized (1:1) ≥50-year-olds at increased CDI risk (N = 17 535) to receive 3 PF-06425090 or placebo doses (0, 1, and 6 months).

Classification Accuracy and Description of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in an Integrated Health Care System, 2006-2017.

Introduction: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic illness characterized by marked functional limitations and fatigue. Electronic health records can be used to estimate incidence of ME/CFS but may have limitations.

Methods: The authors used International Classification of Diseases (ICD) diagnosis codes to identify all presumptive cases of ME/CFS among 9- to 39-year-olds from 2006 to 2017.

Cardiovascular and mortality benefits of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide 1 receptor agonists as third-step glucose-lowering medicine in patients with type 2 diabetes: a retrospective cohort analysis.

Introduction: Studies have found that sodium-glucose cotransporter 2 inhibitors (SGLT2) and glucagon-like peptide 1 receptor agonists (GLP1) have cardiovascular benefits for patients with type 2 diabetes (DM2) and atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or heart failure (HF). The literature does not provide evidence specifically for patients with these conditions who are adding one of these medicines to two glucose-lowering medications (ie, as "third-step" therapy). We explored the effects of different third-step medications on cardiovascular outcomes in patients with diabetes and these comorbid conditions.

ORCA, a values-based decision aid for selecting additional findings from genomic sequencing in adults: Efficacy results from a randomized trial.

Purpose: Individuals having genomic sequencing can choose to be notified about pathogenic variants in genes unrelated to the testing indication. A decision aid can facilitate weighing one's values before making a choice about these additional results.

Methods: We conducted a randomized trial (N = 231) comparing informed values-choice congruence among adults at risk for a hereditary cancer syndrome who viewed either the Optional Results Choice Aid (ORCA) or web-based additional findings information alone.

COVID-19 Vaccination and Non-COVID-19 Mortality Risk - Seven Integrated Health Care Organizations, United States, December 14, 2020-July 31, 2021.

By September 21, 2021, an estimated 182 million persons in the United States were fully vaccinated against COVID-19.* Clinical trials indicate that Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Johnson & Johnson; Ad.26.

Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations.

Advances in the application of genomic technologies in clinical care have the potential to increase existing healthcare disparities. Studies have consistently shown that only a fraction of eligible patients with a family history of cancer receive recommended cancer genetic counseling and subsequent genetic testing. Care delivery models using pre-test and post-test counseling are not scalable, which contributes to barriers in accessing genetics services.

A decision aid for additional findings in genomic sequencing: Development and pilot testing.

Objective: To describe the development of a web-based, patient-facing decision aid to support patients and research participants to make an informed, values-based decision about whether to receive additional results from genomic sequencing.

Methods: We developed the decision aid following the multi-step process described in the International Patient Decision Aids Standards. This utilized literature review, focus groups, and alpha testing with research participants undergoing clinical genomic sequencing.

Pneumococcal Conjugate Vaccine Safety in Elderly Adults.

Background: The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged ≥65 years. The study examines adults ≥65 years for risk of adverse events (AEs) requiring medical attention following vaccination with PCV13 as compared with vaccination with PPSV23, a long-standing vaccine with a satisfactory safety profile.

Methods: The cohort study included 6 Vaccine Safety Datalink sites.

Balancing Adherence and Expense: The Cost-Effectiveness of Two-Sample vs One-Sample Fecal Immunochemical Test.

Colorectal cancer (CRC) causes more than 50,000 deaths each year in the United States but early detection through screening yields survival gains; those diagnosed with early stage disease have a 5-year survival greater than 90%, compared to 12% for those diagnosed with late stage disease. Using data from a large integrated health system, this study evaluates the cost-effectiveness of fecal immunochemical testing (FIT), a common CRC screening tool. A probabilistic decision-analytic model was used to examine the costs and outcomes of positive test results from a 1-FIT regimen compared with a 2-FIT regimen.

Correction to: Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data.

The article Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data, written by Mark C. Hornbrook, Ran Goshen, Eran Choman, Maureen O'Keeffe-Rosetti, Yaron Kinar, Elizabeth G. Liles, and Kristal C.

Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data.

Background: Machine learning tools identify patients with blood counts indicating greater likelihood of colorectal cancer and warranting colonoscopy referral.

Aims: To validate a machine learning colorectal cancer detection model on a US community-based insured adult population.

Methods: Eligible colorectal cancer cases (439 females, 461 males) with complete blood counts before diagnosis were identified from Kaiser Permanente Northwest Region's Tumor Registry.

Implementation challenges and successes of a population-based colorectal cancer screening program: a qualitative study of stakeholder perspectives.

Background: Few studies describe system-level challenges or facilitators to implementing population-based colorectal cancer (CRC) screening outreach programs. Our qualitative study explored viewpoints of multilevel stakeholders before, during, and after implementation of a centralized outreach program. Program implementation was part of a broader quality-improvement initiative.

Participant uptake of the fecal immunochemical test decreases with the two-sample regimen compared with one-sample FIT.

Background: Fecal immunochemical tests (FITs) are recommended to screen average-risk adults for colorectal cancer (CRC). Little research has examined whether a two-sample FIT affects participant uptake, compared with a one-sample FIT. Examining participant uptake is important, as evidence suggests that a two-sample FIT may increase the sensitivity to detect CRC.

Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis.

Background: Performance characteristics of fecal immunochemical tests (FITs) to screen for colorectal cancer (CRC) have been inconsistent.

Purpose: To synthesize data about the diagnostic accuracy of FITs for CRC and identify factors affecting its performance characteristics.

Data Sources: Online databases, including MEDLINE and EMBASE, and bibliographies of included studies from 1996 to 2013.

More comprehensive discussion of CRC screening associated with higher screening.

Objectives: Examine association of comprehensiveness of colorectal cancer (CRC) screening discussion by primary care physicians (PCPs) with completion of CRC screening.

Study Design: Observational study in Kaiser Permanente Northwest, a group-model health maintenance organization.

Methods: A total of 883 participants overdue for CRC screening received an automated telephone call (ATC) between April and June 2009 encouraging CRC screening.

Automated telephone calls to enhance colorectal cancer screening: economic analysis.

Objectives: To estimate the cost-effectiveness of an automated telephone intervention for colorectal cancer screening from a managed care perspective, using data from a pragmatic randomized controlled trial.

Methods: Intervention patients received calls for fecal occult blood testing (FOBT) screening. We searched patients' electronic medical records for any screening (defined as FOBT, flexible sigmoidoscopy, double-contrast barium enema, or colonoscopy) during follow-up.

Change to FIT increased CRC screening rates: evaluation of a US screening outreach program.

Objectives: To compare completion rates of colorectal cancer screening tests within a health maintenance organization before and after widespread adoption of the fecal immunochemical test (FIT).

Study Design: Retrospective cohort study.

Methods: Using electronic medical records of 113,901 patients eligible for colorectal cancer screening, we examined test completion during 2 successive time periods among those who received an automated screening outreach call.

Primary care colorectal cancer screening recommendation patterns: associated factors and screening outcomes.

Background: The relationship of a primary care provider's (PCP's) colorectal cancer (CRC) screening strategies to completion of screening is poorly understood.

Objective: To describe PCP test recommendation patterns and associated factors and their relationship to patient test completion.

Design: This cross-sectional study used a PCP survey, in-depth PCP interviews, and electronic medical records.

Automated telephone calls improved completion of fecal occult blood testing.

Background: Although colorectal cancer (CRC) prognosis is improved by early diagnosis, screening rates remain low.

Objective: To determine the effect of an automated telephone intervention on completion of fecal occult blood testing (FOBT).

Research Design: In this randomized controlled trial conducted at Kaiser Permanente Northwest, a not-for-profit health maintenance organization, 5905 eligible patients aged 51 to 80, at average risk for CRC and due for CRC screening, were randomly assigned to an automated telephone intervention (n = 2943) or usual care (UC; n = 2962).