Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Informatics External Quality Assurance (IEQA) Down Under: evaluation of a pilot implementation

External quality assurance (EQA) provides ongoing evaluation to verify that laboratory medicine results conform to quality standards expected for patient care. While attention has focused predominantly on test accuracy, the diagnostic phases, consisting of pre- and post-laboratory phases of testing, have thus far lagged in the development of an appropriate diagnostic-phase EQA program. One of the challenges faced by Australian EQA has been a lack of standardisation or harmonisation resulting from variations in reporting between different laboratory medicine providers. This may introduce interpretation errors and misunderstanding of results by clinicians, resulting in a threat to patient safety. While initiatives such as the Australian Pathology Information, Terminology and Units Standardisation (PITUS) program have produced Standards for Pathology Informatics in Australia (SPIA), conformity to these requires regular monitoring to maintain integrity of data between sending (laboratory medicine providers) and receiving (physicians, MyHealth Record, registries) organisations\u27 systems. The PITUS 16 Informatics EQA (IEQA) Project together with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) has created a system to perform quality assurance on the electronic laboratory message when the laboratory sends a result back to the EQA provider. The purpose of this study was to perform a small scale pilot implementation of an IEQA protocol, which was performed to test the suitability of the system to check compliance of existing Health Level-7 (HL7 v2.4) reporting standards localised and constrained by the RCPA SPIA. Here, we present key milestones from the implementation, including: (1) software development, (2) installation, and verification of the system and communication services, (3) implementation of the IEQA program and compliance testing of the received HL7 v2.4 report messages, (4) compilation of a draft Informatics Program Survey Report for each laboratory and (5) review consisting of presentation of a report showing the compliance checking tool to each participating laboratory

Examining the educational value of a CanMEDS roles framework in pediatric morbidity and mortality rounds

Abstract Background In order to determine whether the CanMEDS roles could be helpful in solidifying knowledge during clinical training, we examined quality of care issues identified during morbidity and mortality (M&M) rounds. Methods During the M&M rounds, following the case presentation, there was a pause and attendees were asked to identify quality of care issues that were present in the case. The attendees were assigned to a CanMEDS prompted group or non-prompted group. Following the rounds, the issues were identified, coded according to CanMEDS role, and compared between groups. Results A total of 111 individuals identified a total of 350 issues; 57 individuals were in the CanMEDS-prompted group and 54 were in the unprompted group. The mean number of issues identified was significantly higher in the CanMEDS-prompted group compared to the unprompted group (3.7 versus 2.6, p = 0.039). There were significantly more issues raised in the prompted group for the roles of communicator, collaborator, scholar and professional. Conclusions Using CanMEDS roles as prompts, attendees at M&M rounds identify more quality of care issues than if not given a prompt. Use of the CanMEDS framework may assist learners to consolidate the linkage between expected training objectives and the complexities of clinical practice

The “Minimum Information about an ENvironmental Sequence” (MIENS) specification

We present the Genomic Standards Consortium’s (GSC) “Minimum Information about an ENvironmental Sequence” (MIENS) standard for describing marker genes. Adoption of MIENS will enhance our ability to analyze natural genetic diversity across the Tree of Life as it is currently being documented by massive DNA sequencing efforts from myriad ecosystems in our ever-changing biospher

Accommodating Pharmacy Students With Physical Disabilities During the Experiential Learning Curricula.

Accommodating pharmacy students with physical disabilities during the experiential learning portion of the Doctor of Pharmacy (PharmD) curriculum can present unique challenges for pharmacy schools. The available literature regarding accommodations for pharmacy students in the experiential learning environment is sparse, leaving programs with little guidance. This commentary from the Big Ten Academic Alliance calls on the Academy to create a community of shared resources and best practice examples and offers practical suggestions for accommodating pharmacy students with mobility, vision, and auditory disabilities during introductory pharmacy practice experiences (IPPEs) and advanced pharmacy practice experiences (APPEs)

Efficacy of prednisolone for Bell palsy in children:a randomized, double-blind, placebo-controlled, multicenter trial

Background and Objectives: Corticosteroids are used to treat the early stages of idiopathic facial paralysis (Bell palsy) in children, but their effectiveness is uncertain. We set out to determine whether prednisolone improves the proportion of children with Bell palsy with complete recovery at 1 month. Methods: We conducted a double-blind, placebo-controlled, randomized trial of prednisolone in children presenting to emergency departments with Bell palsy. Patients aged 6 months to younger than 18 years were recruited within 72 hours after the symptom onset and were randomly assigned to receive 10 days of treatment with oral prednisolone (approximately 1 mg/kg) or placebo. The primary outcome was complete recovery of facial function at 1 month rated on the House-Brackmann scale. Secondary outcomes included facial function, adverse events, and pain up to 6 months. Target recruitment was n = 540 (270 per group). Results: Between October 13, 2015, and August 23, 2020, 187 children were randomized (94 to prednisolone and 93 to placebo) and included in the intention-to-treat analysis. At 1 month, the proportions of patients who had recovered facial function were 49% (n = 43/87) in the prednisolone group compared with 57% (n = 50/87) in the placebo group (risk difference −8.1%, 95% CI −22.8 to 6.7; adjusted odds ratio [aOR] 0.7, 95% CI 0.4 to 1.3). At 3 months, these proportions were 90% (n = 71/79) for the prednisolone group vs 85% (n = 72/85) for the placebo group (risk difference 5.2%, 95% CI −5.0 to 15.3; aOR 1.2, 95% CI 0.4 to 3.0) and, at 6 months, 99% (n = 77/78) and 93% (n = 76/82), respectively (risk difference 6.0%, 95% CI −0.1 to 12.2; aOR 3.0, 95% CI 0.5 to 17.7). There were no serious adverse events and little evidence for group differences in secondary outcomes. Discussion: In children with Bell palsy, the vast majority recover without treatment. This study, although underpowered, does not provide evidence that early treatment with prednisolone improves complete recovery