Feasibility of connecting regional research programs to national multisite trials emanating from the CTSA Trial Innovation Network.

A collaborative research model was developed and tested to enable regional healthcare systems to join multisite clinical trials emanating from the Clinical and Translational Science Award (CTSA) Trial Innovation Network (TIN) by the Institute of Translational Health Sciences at the University of Washington and the Northwest Participant and Clinical Interactions (NW PCI) Network. The NW PCI is a collaborative group of regional research programs located at medical centers, healthcare systems, and universities across Washington, Wyoming, Alaska, Montana, and Idaho. This article describes the purpose, development, barriers, and initial experience with feasibility assessment for TIN-supported studies in the NW PCI.

Evidence-based treatment of hyperglycaemia with incretin therapies in patients with type 2 diabetes and advanced chronic kidney disease.

Type 2 diabetes is the leading cause of chronic kidney disease (CKD). The prevalence of CKD is growing in parallel with the rising number of patients with type 2 diabetes globally. At present, the optimal approach to glycaemic control in patients with type 2 diabetes and advanced CKD (categories 4 and 5) remains uncertain, as these patients were largely excluded from clinical trials of glucose-lowering therapies.

The CTSA External Reviewer Exchange Consortium (CEREC): Engagement and efficacy.

Introduction: Many institutions evaluate applications for local seed funding by recruiting peer reviewers from their own institutional community. Smaller institutions, however, often face difficulty locating qualified local reviewers who are not in conflict with the proposal. As a larger pool of reviewers may be accessed through a cross-institutional collaborative process, nine Clinical and Translational Science Award (CTSA) hubs formed a consortium in 2016 to facilitate reviewer exchanges.

: Role and responsibilities of the independent safety officer.

Every research study that includes volunteer participants requires safety assurances in proportion to the risks of the study. Investigator-initiated clinical research can present unique regulatory challenges particularly for studies with a risk profile that warrants more oversight than minimal risk but less than for large, commercial, or high-risk research. The use of an independent safety officer (ISO) offers a middle way of right-sizing oversight to match the risk.

Opportunities for strengthening CTSA evaluation.

The purpose of the article is to describe the progress of the Clinical and Translational Science Award (CTSA) Program to address the evaluation-related recommendations made by the 2013 Institute of Medicine's review of the CTSA Program and guidelines published in CTS Journal the same year (Trochim et al., Clinical and Translational Science 2013; 6(4): 303-309). We utilize data from a 2018 national survey of evaluators administered to all 64 CTSA hubs and a content analysis of the role of evaluation in the CTSA Program Funding Opportunity Announcements to document progress.

Clinician engagement in research as a path toward the learning health system: A regional survey across the northwestern United States.

Introduction:: Increased research engagement of frontline, community-based clinicians could result in greater research relevancy, increased likelihood of implementation into practice, and improved health care for patients. Establishment of learning health systems within health-care organizations may facilitate this process.

Methods:: In 2016, the U.

A Randomized Trial of External Practice Support to Improve Cardiovascular Risk Factors in Primary Care.

Purpose: We conducted a randomized controlled trial to compare the effectiveness of adding various forms of enhanced external support to practice facilitation on primary care practices' clinical quality measure (CQM) performance.

Methods: Primary care practices across Washington, Oregon, and Idaho were eligible if they had fewer than 10 full-time clinicians. Practices were randomized to practice facilitation only, practice facilitation and shared learning, practice facilitation and educational outreach visits, or practice facilitation and both shared learning and educational outreach visits.

Preventing Early Renal Loss in Diabetes (PERL) Study: A Randomized Double-Blinded Trial of Allopurinol-Rationale, Design, and Baseline Data.

Objective: Higher serum uric acid (SUA) is associated with diabetic kidney disease (DKD). Preventing Early Renal Loss in Diabetes (PERL) evaluates whether lowering SUA with allopurinol slows glomerular filtration rate (GFR) loss in people with type 1 diabetes (T1D) and mild to moderate DKD. We present the PERL rationale, design, and baseline characteristics.

Association of Acute Kidney Injury with Cardiovascular Events and Death in Systolic Blood Pressure Intervention Trial.

Rationale And Objective: In the Systolic Blood Pressure Intervention Trial, the possible relationships between acute kidney injury (AKI) and risk of major cardiovascular events and death are not known.

Study Design: Post hoc analysis of a multicenter, randomized, controlled, open-label clinical trial.

Setting And Participants: Hypertensive adults without diabetes who were ≥50 years of age with prior cardiovascular disease, chronic kidney disease (CKD), 10-year Framingham risk score > 15%, or age > 75 years were assigned to a systolic blood pressure target of < 120 mm Hg (intensive) or < 140 mm Hg (standard).

Delay in Treatment After Cancer Diagnosis in Adolescents and Young Adults: Does Facility Transfer Matter?

Timeliness is one of the fundamental yet understudied quality metrics of cancer care. Little is known about cancer treatment delay among adolescent and young adult (AYA) cancer patients. This study assessed cancer treatment delay, with a specific focus on facility transfer and diagnosis/treatment interval.

Serum amyloid A and Janus kinase 2 in a mouse model of diabetic kidney disease.

Background: Serum amyloid A (SAA), a potent inflammatory mediator, and Janus kinase 2 (JAK2), an intracellular signaling kinase, are increased by diabetes. The aims were to elucidate: 1) a JAK2-mediated pathway for increased SAA in the kidneys of diabetic mice; 2) a JAK2-SAA pathway for inflammation in podocytes.

Methods: Akita diabetic mice (129S6) with podocyte JAK2 overexpression and angiotensin II infusion (4 weeks) were given a JAK1,2 inhibitor (LY03103801, 3 mg/kg/day orally for the last two weeks).

Sodium-Glucose Cotransporter 2 Inhibition and Diabetic Kidney Disease.

Diabetic kidney disease (DKD) is now the principal cause of chronic kidney disease leading to end-stage kidney disease worldwide. As a primary contributor to the excess risk of all-cause and cardiovascular death in diabetes, DKD is a major contributor to the progressively expanding global burden of diabetes-associated morbidity and mortality. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a newer class of antihyperglycemic agents that exert glucose-lowering effects via glycosuric actions.

Use of electronic health record data from diverse primary care practices to identify and characterize patients' prescribed common medications.

We use prescription of statin medications and prescription of warfarin to explore the capacity of electronic health record data to (1) describe cohorts of patients prescribed these medications and (2) identify cohorts of patients with evidence of adverse events related to prescription of these medications. This study was conducted in the WWAMI region Practice and Research Network (WPRN)., a network of primary care practices across Washington, Wyoming, Alaska, Montana and Idaho DataQUEST, an electronic data-sharing infrastructure.

Leptin gene variants and colorectal cancer risk: Sex-specific associations.

Background: High levels of serum leptin and low levels of serum adiponectin are strongly correlated with obesity, a well-established risk factor for colorectal cancer (CRC). Growing evidence suggests that dysregulation of leptin and adiponectin levels may play an etiological role in colorectal carcinogenesis. We evaluated 20 candidate variants in 4 genes previously shown to alter serum leptin and adiponectin levels for associations with obesity (BMI>30 kg/m2) and CRC risk.

GLP-1 receptor agonists in diabetic kidney disease: from the patient-side to the bench-side.

Diabetic kidney disease (DKD), one of the most common and severe microvascular complications of diabetes, is the leading cause of chronic kidney disease and end-stage kidney disease worldwide. Since the development of renin-angiotensin system inhibition nearly three decades ago, no new therapeutic agents have received regulatory approval for treatment of DKD. Glucagon-like peptide-1 (GLP-1) receptor agonists, a class of newer antihyperglycemic agents, have shown promise for prevention of DKD onset and progression.

Use of an electronic health record data sharing system for identifying current contraceptive use within the WWAMI region Practice and Research Network.

Objective: To evaluate the ability of electronic health record (EHR) data extracted into a data-sharing system to accurately identify contraceptive use.

Study Design: We compared rates of contraceptive use from electronic extraction of EHR data via a data-sharing system and manual abstraction of the EHR among 142 female patients ages 15-49 years from a family medicine clinic within a primary care practice-based research network (PBRN). Cohen's kappa coefficient measured agreement between electronic extraction and manual abstraction.

Discovery, fine-mapping, and conditional analyses of genetic variants associated with C-reactive protein in multiethnic populations using the Metabochip in the Population Architecture using Genomics and Epidemiology (PAGE) study.

C-reactive protein (CRP) is a circulating biomarker indicative of systemic inflammation. We aimed to evaluate genetic associations with CRP levels among non-European-ancestry populations through discovery, fine-mapping and conditional analyses. A total of 30 503 non-European-ancestry participants from 6 studies participating in the Population Architecture using Genomics and Epidemiology study had serum high-sensitivity CRP measurements and ∼200 000 single nucleotide polymorphisms (SNPs) genotyped on the Metabochip.

SGLT2 Inhibition for the Prevention and Treatment of Diabetic Kidney Disease: A Review.

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease in the United States and the world alike, and there is a great unmet need for treatments to reduce DKD development and progression. Inhibition of sodium/glucose co-transporter 2 (SGLT2) in the proximal tubule of the kidney has emerged as an effective antihyperglycemic treatment, leading to regulatory approval of several first-generation SGLT2 inhibitors for the treatment of type 2 diabetes. In follow-on clinical trials for the cardiovascular safety of the SGLT2 inhibitors, secondary effects to prevent or reduce albuminuria and decline in estimated glomerular filtration rate spurred further investigation into their potential application in DKD.