Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.

RATIONALE AND OBJECTIVE: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease. STUDY DESIGN: Multicenter, pragmatic, randomized controlled clinical trial. SETTING AND PARTICIPANTS: 6650 individuals with African ancestry and hypertension from 13 health systems. INTERVENTION: APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. OUTCOMES: Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months. RESULTS: To date, the trial has enrolled 3423 participants. CONCLUSIONS: The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record. TRIAL REGISTRATION: ClinicalTrials.govNCT04191824.

Low ERCP Volume Is Associated with More Industry Representative Interactions but Similar Training of Nurses.

BACKGROUND: Data on ERCP nurses and associate (ERCP-NA) training and comfort are lacking. Healthcare industry representative (HCIR) influence may be greater in low-volume units (LVUs) due to decreased procedure and device familiarity. AIM: The aim of this study was to compare ERCP-NA training, safety, and HCIR relationships between LVU and high-volume unit (HVU) ERCP facilities. METHODS: We conducted an electronic survey of all Society of Gastroenterology Nurses and Associates (SGNA) members assessing: (1) demographics and procedure volume, (2) ERCP training and radiation safety, and (3) HCIR interactions. Responses were stratified by ERCP volume. RESULTS: Among 832 SGNA member respondents (median age 55), 615 (74%) worked as an ERCP-NA; 41% derived from LVUs. The majority of ERCP-NAs, irrespective of unit volume, had observed <50 ERCPs before starting. Except for lead glasses, the majority (>80%) adhered to basic radiation safety, irrespective of unit volume. LVUs were more likely than HVU ERCP-NAs to agree that HCIRs were requested for intra-procedure assistance (24 vs. 19%, p = 0.008), asked for input on the next choice of device (22 vs. 15%, p = 0.01), and assist in device usage (27 vs. 22%, p = 0.04). Irrespective of volume, 30% agreed that they were more likely to utilize a company's devices if that HCIR was present. CONCLUSIONS: ERCP-NA training before independent participation in ERCP is suboptimal. HCIRs are frequently requested for assistance during ERCPs, especially in LVUs. HCIR impact on ERCP outcomes and device utilization and whether enhanced ERCP-NA training will impact the role of HCIR, require further study.