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The phase 3 MOMENTUM study (NCT04173494) of the ACVR1/JAK1/JAK2 inhibitor momelotinib (MMB) vs. danazol (DAN) in patients with myelofibrosis (MF) previously treated with a JAK inhibitor (JAKi) met the primary endpoint and all key secondary endpoints at week 24 (W24). We provide updated results from week 48 assessments. Eligible patients had primary or post-ET/ PV MF;DIPSS high, Int-2, or Int-1 risk;Total Symptom Score (TSS) >=10;haemoglobin (Hb) <10 g/dL;platelets >=25 x 109/L;prior JAKi for >=90 days (>=28 days if red blood cell [RBC] transfusions >=4 units in 8 weeks or grade 3/4 thrombocytopenia/anaemia/ hematoma);and palpable spleen >=5 cm. Randomisation was 2:1 to MMB 200 mg/day or DAN 600 mg/day for 24 weeks, followed by open-label (OL) MMB. Week 48 endpoints included durations of response (TSS, transfusion independence [TI], splenic) and overall and leukaemia-free survival (OS, LFS). As of 17 May 2022, 93/130 (72%) MMB -> MMB and 41/65 (63%) DAN -> MMB patients received OL MMB;mean MMB durations were 48 weeks and 24 weeks, respectively. Analyses for W24 responders showed the following: of TSS responders, 31/32 (97%) MMB -> MMB and 6/6 DAN -> MMB patients had TSS < baseline;of TI responders, 36/40 (90%) and 10/13 (77%) had no RBC transfusions or Hb <8 g/dL;and of spleen responders, all patients had splenic volume < baseline. In the OL phase, the most common grade >=3 treatment-emergent adverse events (TEAEs) were thrombocytopenia (MMB -> MMB, 9%;DAN -> MMB, 15%) and anaemia (MMB -> MMB, 9%;DAN -> MMB, 2%). Grade >=3 infections occurred in 19% of MMB -> MMB and 10% of DAN -> MMB patients, including grade >=3 (nonfatal) COVID-19. Peripheral neuropathy (PN) occurred in 2% of patients in each arm, and none discontinued MMB due to PN. TEAEs led to MMB discontinuation in 18% (MMB -> MMB) vs. 10% (DAN -> MMB). A trend towards improved OS up to W24 was previously observed with MMB vs. DAN (hazard ratio [HR], 0.506;p = 0.0719);after all patients crossed over to OL MMB, OS and LFS curves for both arms converged (HR, 0.945, 95% CI, 0.528-1.693;HR, 0.830, 95% CI, 0.473-1.4555). Sixty of 81 (74%) MMB -> MMB and 29 of 43 (67%) DAN -> MMB patients with baseline platelets <=150 x 109/L entered the OL phase. Efficacy and safety results in thrombocytopenic subgroups in the OL period were consistent with the intent-to- treat (ITT) population. OL MMB maintained symptom, TI, and spleen responses with continued good survival and safety in the ITT and low platelet populations. MMB may address an unmet need in anaemic patients with MF.
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Background Surgical strategies to achieve biventricular (BiV) repair in children with borderline left ventricle (LV) continue to evolve. We report our innovative strategy of LV recruitment utilizing systemic to pulmonary artery shunt upsizing along with fenestrated atrial septation (FAS). Case The case is a 22mo old with hypoplastic left heart variant with type A aortic arch interruption and bilateral SVC. The LV, aortic and mitral valve were hypoplastic not meeting criteria for BiV repair. He underwent stage 1 palliation (Norwood with 4mm BTT shunt). Frequent COVID infections and over-circulation led to BiV dysfunction and cardiogenic shock requiring ECMO support for 4 days. At 5 months of age cardiac catheterization (CC) revealed good hemodynamic parameters for a stage 2 Glenn. An MRI also revealed growth of the left ventricle. Decision-making A decision was made to engage in a staged LV recruitment process to achieve BiV repair. We elected to avoid a volume offloading procedure in the form of a Glenn. To optimize continued volume loading on the LV, Stage 2 palliation consisted of upsizing to a 5mm BTT shunt with 4mm FAS. MRI at 22 months showed an LV volume of 60ml/m2 associated with CC hemodynamics showing LA pressure of 13mmHg, and LV end-diastolic pressure of 12mmHg. He underwent BiV repair with takedown of DKS, with primary anastomosis of the aorta and the pulmonary artery to their respective circulations. The postoperative echocardiogram illustrated a gradient of 5mmHg and 3mmHg through the mitral and aortic valve respectively. The pt was placed on a beta blocker and discharged on day 5 following BiV conversion. This strategy provides increased pulmonary blood flow with increased bloodflow across the mitral valve and inflow into the LV. In so doing may enhance the rate of LV growth. Furthermore, this strategy avoids the bidirectional Glenn (BDG), a volume offloading operation. Conclusion Shunt upsizing with FAS is well tolerated. It has the potential advantage for fewer operations to achieve BiV circulation due to rapid LV growth in comparison to other staged LV recruitment strategies involving the BDG.Copyright © 2023 American College of Cardiology Foundation
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Background: Direct viral invasion of the kidney via ACE2 has been hypothesized as a mechanism of AKI in COVID-19 (COVID). The impact of RAASi on the risk of AKI in COVID is not known. We hypothesized that active use of RAASi preceding admission would be associated with a greater proportional risk of AKI in COVID than influenza (flu). Methods: In this retrospective cohort, we compared the AKI incidence by RAASi status in 11,898 hospitalized Veterans with COVID or flu between Oct 1, 2019 and Sept 30, 2020. To control for confounding, propensity score weighting balanced baseline conditions, labs, and co-therapies in 4 exposure groups: RAASi users with COVID, non-users with COVID, RAASi users with flu, and non-users with flu. Weighted logistic regression estimated the main effects of RAASi and COVID, and their interaction. Results: In flu, 7% of RAASi users had a stage 2-3 AKI vs 5% of non-users, a 2% increase (p=0.03). In COVID, 16% of RAASi users had a stage 2-3 AKI vs 12% of nonusers, a 4% increase. While the absolute increase in AKI incidence for RAASi users vs non-users was greater in COVID patients vs flu, the difference was not statistically significant (p=0.66) and the RAASi association was proportionally smaller in COVID (see interaction in Table). Similar absolute differences were observed in stage 1-3 AKI (Table), and the interaction was also not statistically significant (p=0.66). Conclusions: COVID was associated with a greater incidence of AKI than flu. RAASi was associated with an increased incidence of Stage 2-3 AKI in patients with COVID or flu. The proportional effect of RAASi was similar in COVID and flu patients. These findings do not support a disproportionate risk of AKI among RAASi users with COVID.
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Introduction The effect of COVID-19 pandemic shutdowns on education has been discussed broadly in both the media and among academics, however its true effects on paramedicine students and their ability to attend in-person lectures, skill sessions and clinical placements has not been widely researched. This study aimed to investigate the impact of COVID-19 on a group of paramedicine students at an Australian university. Methods A cross-sectional study using a convenience sample of first and second year paramedicine students was undertaken to explore their perceived experiences of COVID-19 through both qualitative and quantitative responses. Results A total of 83 paramedicine students from Griffith University in Queensland participated in the survey, demonstrating an 84.7% response rate. Of the participants, 78.3% (n=65) disagreed that online workshop sessions were as valuable as face-to-face sessions. Similarly, the majority of participants (61.5%, n=51) disagreed that online lectures and tutorials were as beneficial as in-person equivalents. A further 61.4% (n=51) of students agreed that COVID-19-associated lockdowns had negatively impacted their ability to formulate strong personal relationships that are important for university, however 78.3% of students agreed that communication platforms assisted in maintaining some form of social interaction. Conclusion The results from this study demonstrate that the educational and social impacts of COVID-19 on paramedicine students were highly diverse, and were contingent on several factors including but not limited to: year of study, learning style, previously established social connections and extenuating life circumstances. © 2021, Paramedics Australasia. All rights reserved.
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Purpose: The purpose of this study is to detail the experiences, perspectives and emerging framework for the delivery of library services by member libraries of the College Libraries Information Network (COLINET) at the onset and during the COVID-19 pandemic in Jamaica. Design/methodology/approach: An exploratory sequential mixed approach was used for this study. Qualitative data was collected initially using a semi-structured interview with a virtual focus group comprising seven librarians from the COLINET in Jamaica. Purposive sampling was used to select the participants for the focus group. The second phase of data collection used an online survey through Google Forms to the membership of COLINET;19 of 31 libraries (61.2%) responded to the survey. Findings: The findings reveal the current status of library operation and service delivery at the COLINET member libraries. The impact of COVID-19 on staffing arrangements, support and engagement, library resources and services are seen through the lens of the challenges and opportunities presented by the pandemic. Research limitations/implications: In total, 19 of the 31 libraries in COLINET responded to the survey;therefore, the researchers were unable to get a comprehensive assessment of the impact of COVID-19 on COLINET libraries. Practical implications: This study will assist libraries in their response to COVID-19 and other similar future national public health crises. The findings and recommendations can provide a blueprint for developing policies and procedures for libraries during a national health crisis. Additionally, it will add to the empirical literature on Caribbean libraries. Originality/value: This study is essential for libraries responding to the coronavirus pandemic in Jamaica and the wider Caribbean region. This study examines the response of academic libraries from diverse tertiary institutions;exploring their challenges, solutions and emerging frameworks;making it representative and inclusive for academic libraries. This study advances the limited research that exists with regard to Caribbean libraries and the COVID-19 pandemic. © 2021, Emerald Publishing Limited.
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Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR) are effective in reducing distress among people with physical or mental health problems. However, implementation is limited by variable geographic provision, ability to travel, and the need for remote service delivery during the coronavirus disease 2019 (COVID-19) crisis. Integration with Internet-enabled technologies like videoconferencing potentially enhances access. This article reports a systematic review exploring the feasibility, acceptability, safety, and efficacy of delivering MBCT/MBSR by videoconferencing (MBCT/MBSR-VC). No restrictions were made about population or study design. Eleven online databases were searched and 10 studies met inclusion criteria. Narrative synthesis was used because of study heterogeneity. Articles featured physical health and nonclinical samples, but not mental health. Three studies had moderate-strong methodological quality. Results supported the feasibility and acceptability of MBCT/MBSR-VC. Considerations of safety were largely unreported. MBCT/MBSR-VC demonstrated medium positive effects on mental health outcomes compared with inactive controls (ds = 0.44 -0.71), and little difference compared with active controls like in-person delivery (all confidence intervals crossed zero). Evidence regarding mindfulness or self-compassion as potential mechanisms of action was inconclusive. Future implementation research should target mental health populations using noninferiority designs. Adapting MBCT/MBSR to remote delivery will require development of guidelines and training packages to ensure best practice in this medium and adherence to evidence-based MBCT/MBSR models.
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The COVID-19 pandemic is having a profound effect on the learning of student paramedics. This commentary aims to explores how student paramedics have been affected by COVID-19 and seeks to identify the perceived impact of this experience.