Delineation and agreement of FET PET biological volumes in glioblastoma: results of the nuclear medicine credentialing program from the prospective, multi-centre trial evaluating FET PET In Glioblastoma (FIG) study-TROG 18.06.

PURPOSE: The O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET in Glioblastoma (FIG) trial is an Australian prospective, multi-centre study evaluating FET PET for glioblastoma patient management. FET PET imaging timepoints are pre-chemoradiotherapy (FET1), 1-month post-chemoradiotherapy (FET2), and at suspected progression (FET3). Before participant recruitment, site nuclear medicine physicians (NMPs) underwent credentialing of FET PET delineation and image interpretation. METHODS: Sites were required to complete contouring and dynamic analysis by ≥ 2 NMPs on benchmarking cases (n = 6) assessing biological tumour volume (BTV) delineation (3 × FET1) and image interpretation (3 × FET3). Data was reviewed by experts and violations noted. BTV definition includes tumour-to-background ratio (TBR) threshold of 1.6 with crescent-shaped background contour in the contralateral normal brain. Recurrence/pseudoprogression interpretation (FET3) required assessment of maximum TBR (TBRmax), dynamic analysis (time activity curve [TAC] type, time to peak), and qualitative assessment. Intraclass correlation coefficient (ICC) assessed volume agreement, coefficient of variation (CoV) compared maximum/mean TBR (TBRmax/TBRmean) across cases, and pairwise analysis assessed spatial (Dice similarity coefficient [DSC]) and boundary agreement (Hausdorff distance [HD], mean absolute surface distance [MASD]). RESULTS: Data was accrued from 21 NMPs (10 centres, n ≥ 2 each) and 20 underwent review. The initial pass rate was 93/119 (78.2%) and 27/30 requested resubmissions were completed. Violations were found in 25/72 (34.7%; 13/12 minor/major) of FET1 and 22/74 (29.7%; 14/8 minor/major) of FET3 reports. The primary reasons for resubmission were as follows: BTV over-contour (15/30, 50.0%), background placement (8/30, 26.7%), TAC classification (9/30, 30.0%), and image interpretation (7/30, 23.3%). CoV median and range for BTV, TBRmax, and TBRmean were 21.53% (12.00-30.10%), 5.89% (5.01-6.68%), and 5.01% (3.37-6.34%), respectively. BTV agreement was moderate to excellent (ICC = 0.82; 95% CI, 0.63-0.97) with good spatial (DSC = 0.84 ± 0.09) and boundary (HD = 15.78 ± 8.30 mm; MASD = 1.47 ± 1.36 mm) agreement. CONCLUSION: The FIG study credentialing program has increased expertise across study sites. TBRmax and TBRmean were robust, with considerable variability in BTV delineation and image interpretation observed.

Evaluation of Cangrelor Use After Percutaneous Coronary Intervention in Patients With Mechanical Circulatory Support.

OBJECTIVES: To describe cangrelor use in patients on concurrent mechanical circulatory support who underwent postpercutaneous coronary intervention. DESIGN: A single-center, retrospective, cohort study. SETTING: At a quaternary teaching hospital. PARTICIPANTS: Included patients were ≥18 years old, admitted to the intensive care unit, underwent percutaneous coronary intervention with stent placement, initiated on mechanical circulatory support, and received cangrelor in the postpercutaneous coronary intervention period. INTERVENTIONS: Retrospectively analyzed cangrelor use in patients on mechanical circulatory support. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of thrombosis and bleeding events during cangrelor administration. Additional outcomes included initial cangrelor dose, number of cangrelor dose adjustments per patient, survival from mechanical circulatory support, and mortality within 30 days. Overall, 19 patients were included in this study. In total, 14 patients (74%) experienced a bleeding event; however, 93% were classified as a minor bleed. There was 1 major bleeding event. There were no thrombotic events observed during cangrelor administration. The median initial cangrelor dose was 0.5 µg/kg/min. There were 10 patients who underwent dose adjustment, with the majority being dose reductions based on antiplatelet monitoring (VerifyNow assay). Survival from mechanical circulatory support occurred in 17 patients (89%), and 30-day mortality occurred in 8 patients (42%). CONCLUSIONS: For patients receiving cangrelor as a bridge to oral P2Y12 inhibitor therapy on mechanical circulatory support, the authors observed a low rate of major bleeding and no episodes of thrombosis. Lower starting doses appear feasible with no observed increased risk of thrombotic complications. Future studies are needed to confirm these observations.

Evaluation of Continuous Inhaled Epoprostenol in the Treatment of Acute Respiratory Distress Syndrome, Including Patients With SARS-CoV-2 Infection.

BACKGROUND: Acute respiratory distress syndrome (ARDS) management is primarily supportive. Pulmonary vasodilators, such as inhaled epoprostenol (iEPO), have been shown to improve PaO2:FiO2 (PF) and are used as adjunctive therapy. OBJECTIVE: To identify the positive response rate and variables associated with response to iEPO in adults with ARDS. A positive response to iEPO was defined as a 10% improvement in PF within 6 hours. METHODS: This retrospective study included adults with ARDS treated with iEPO. The primary endpoint was the variables associated with a positive response to iEPO. Secondary endpoints were positive response rate and the change in PF and SpO2:FiO2 within 6 hours. Statistical analysis included multivariable regression. RESULTS: Three hundred thirty-one patients were included. As baseline PF increased, the odds of responding to iEPO decreased (odds ratio [OR], 0.752, 95% CI, 0.69-0.819, p < 0.001). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related ARDS (OR 0.478, 95% CI, 0.281-0.814, p = 0.007) was associated with decreased odds of a positive response to iEPO. The total population had a 68.3% positive response rate to iEPO. SARS-CoV-2-related ARDS and non-SARS-CoV-2-related ARDS had a 59.5% and 72.7% positive response rate, respectively. iEPO significantly improved PF (71 vs 95, P < 0.001) in the whole population. CONCLUSION AND RELEVANCE: iEPO was associated with a positive effect in a majority of moderate-to-severe ARDS patients, including patients with SARS-CoV-2-related ARDS. Lower baseline PF and non-SARS-CoV-2-related ARDS were significantly associated with a positive response to iEPO. The ability to predict which patients will respond to iEPO can facilitate better utilization.

Angiotensin II in Patients With Shock on Mechanical Circulatory Support: A Single-Center Retrospective Case Series.

OBJECTIVES: To describe angiotensin II (ANGII) use in patients on mechanical circulatory support (MCS). To evaluate the efficacy and safety of ANGII in patients with shock on MCS. DESIGN: Retrospective cohort study. SETTING: A single-center, quaternary care academic medical center. PARTICIPANTS: The study comprised critically ill patients on MCS. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Fourteen patients were included in this retrospective analysis. The median age was 54 years (44.8, 68.3) and 78.6% were men. Six patients were receiving venoarterial extracorporeal membrane oxygenation support, 4 patients were receiving venovenous extracorporeal membrane oxygenation support, and 4 patients were on left ventricular assist devices. Five patients (36%) achieved hemodynamic response to ANGII at 3 hours, defined as a mean arterial pressure (MAP) of ≥65 mmHg or a 10-mmHg increase in MAP with a decrease or no change in total vasopressor dose. Overall, the median MAP increased from 61 mmHg (51, 73) at baseline to 66 mmHg (58, 71) at 3 hours, and the median norepinephrine dose decreased from 0.45 µg/kg/min (0.28, 0.6) at baseline to 0.2 µg/kg/min (0.18, 0.32) at 3 hours. The in-hospital mortality rate was 78.6%. Two patients experienced severe adverse drug events and 1 patient had a sentinel thrombotic event. CONCLUSIONS: This study suggested that ANGII may provide a salvage treatment option in patients on MCS with refractory vasodilatory shock. There are several safety considerations with the use of ANGII in these patients. Prospective randomized controlled trials are needed to evaluate the safety and efficacy of ANGII in patients on MCS.

Best Practices for Developing Specialty Nursing Scope and Standards of Practice.

Nursing specialization involves focusing on nursing practice in an identified specific area within the entire field of professional nursing. A defined specialty scope of practice statement and standards of professional practice, with accompanying competencies, are unique to each nursing specialty. These documents help assure continued understanding and recognition of nursing's diverse professional contributions. The purpose of this article is to demystify the process for specialty nurses who are creating or revising their specialty nursing scope and standards of practice. We provide best practices for the developmental process based on our recently published scope and standards of specialty nursing practice. The conclusion provides strategies to disseminate scope and standards documents to appropriate stakeholders.

The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity.

OBJECTIVE: To investigate the effect of nutrient stimulation of gut hormones by oligofructose supplementation on appetite, energy intake (EI), body weight (BW) and adiposity in overweight and obese volunteers. METHODS: In a parallel, single-blind and placebo-controlled study, 22 healthy overweight and obese volunteers were randomly allocated to receive 30 g day(-1) oligofructose or cellulose for 6 weeks following a 2-week run-in. Subjective appetite and side effect scores, breath hydrogen, serum short chain fatty acids (SCFAs), plasma gut hormones, glucose and insulin concentrations, EI, BW and adiposity were quantified at baseline and post-supplementation. RESULTS: Oligofructose increased breath hydrogen (P < 0.0001), late acetate concentrations (P = 0.024), tended to increase total area under the curve (tAUC)420 mins peptide YY (PYY) (P = 0.056) and reduced tAUC450 mins hunger (P = 0.034) and motivation to eat (P = 0.013) when compared with cellulose. However, there was no significant difference between the groups in other parameters although within group analyses showed an increase in glucagon-like peptide 1 (GLP-1) (P = 0.006) in the cellulose group and a decrease in EI during ad libitum meal in both groups. CONCLUSIONS: Oligofructose increased plasma PYY concentrations and suppressed appetite, while cellulose increased GLP-1 concentrations. EI decreased in both groups. However, these positive effects did not translate into changes in BW or adiposity.