End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular ...disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin's efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity.
The overall objective of this protocol is to (1) evaluate aspirin's safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin's efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups.
We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed.
The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov.
We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events.
RR1-10.2196/10516.
Background
Hospitalized pediatric hematology‐oncology (PHO) patients have frequent clinical deterioration events (CDE) requiring intensive care unit (ICU) admission, particularly in resource‐limited ...settings. The objective of this study was to describe CDEs in hospitalized PHO patients in Latin America and to identify event‐level and center‐level risk factors for mortality.
Methods
In 2017, the authors implemented a prospective registry of CDEs, defined as unplanned transfers to a higher level of care, use of ICU‐level interventions on the floor, or nonpalliative floor deaths, in 16 PHO centers in 10 countries. PHO hospital admissions and hospital inpatient days were also reported. This study analyzes the first year of registry data (June 2017 to May 2018).
Results
Among 16 centers, 553 CDEs were reported in PHO patients during 11,536 admissions and 119,414 inpatient days (4.63 per 1000 inpatient days). Event mortality was 29% (1.33 per 1000 inpatient days) but ranged widely across centers (11%‐79% or 0.36‐5.80 per 1000 inpatient days). Significant risk factors for event mortality included requiring any ICU‐level intervention on the floor and not being transferred to a higher level of care. Events with organ dysfunction, a higher severity of illness, and a requirement for ICU intervention had higher mortality. In center‐level analysis, hospitals with a higher volume of PHO patients, less floor use of ICU intervention, lower severity of illness on transfer, and lower rates of floor cardiopulmonary arrest had lower event mortality.
Conclusions
Hospitalized PHO patients who experience CDEs in resource‐limited settings frequently require floor‐based ICU interventions and have high mortality. Modifiable hospital practices around the escalation of care for these high‐risk patients may contribute to poor outcomes. Earlier recognition of critical illness and timely ICU transfer may improve survival in hospitalized children with cancer.
In this prospective cohort study of clinical deterioration events among pediatric hematology‐oncology patients in 16 resource‐limited Latin American hospitals, event‐level and center‐level risk factors for mortality are identified. The findings demonstrate that earlier recognition of critical illness and timely intensive care unit transfer may improve survival in hospitalized children with cancer.
Paediatric early warning systems (PEWS) aid in the early identification of clinical deterioration events in children admitted to hospital. We aimed to investigate the effect of PEWS implementation on ...mortality due to clinical deterioration in children with cancer in 32 resource-limited hospitals across Latin America.
Proyecto Escala de Valoración de Alerta Temprana (Proyecto EVAT) is a quality improvement collaborative to implement PEWS in hospitals providing childhood cancer care. In this prospective, multicentre cohort study, centres joining Proyecto EVAT and completing PEWS implementation between April 1, 2017, and May 31, 2021, prospectively tracked clinical deterioration events and monthly inpatient-days in children admitted to hospital with cancer. De-identified registry data reported between April 17, 2017, and Nov 30, 2021, from all hospitals were included in analyses; children with limitations on escalation of care were excluded. The primary outcome was clinical deterioration event mortality. Incidence rate ratios (IRRs) were used to compare clinical deterioration event mortality before and after PEWS implementation; multivariable analyses assessed the correlation between clinical deterioration event mortality and centre characteristics.
Between April 1, 2017, and May 31, 2021, 32 paediatric oncology centres from 11 countries in Latin America successfully implemented PEWS through Proyecto EVAT; these centres documented 2020 clinical deterioration events in 1651 patients over 556 400 inpatient-days. Overall clinical deterioration event mortality was 32·9% (664 of 2020 events). The median age of patients with clinical deterioration events was 8·5 years (IQR 3·9–13·2), and 1095 (54·2%) of 2020 clinical deterioration events were reported in male patients; data on race or ethnicity were not collected. Data were reported per centre for a median of 12 months (IQR 10–13) before PEWS implementation and 18 months (16–18) after PEWS implementation. The mortality rate due to a clinical deterioration event was 1·33 events per 1000 patient-days before PEWS implementation and 1·09 events per 1000 patient-days after PEWS implementation (IRR 0·82 95% CI 0·69–0·97; p=0·021). In the multivariable analysis of centre characteristics, higher clinical deterioration event mortality rates before PEWS implementation (IRR 1·32 95% CI 1·22–1·43; p<0·0001), being a teaching hospital (1·18 1·09–1·27; p<0·0001), not having a separate paediatric haematology-oncology unit (1·38 1·21–1·57; p<0·0001), and having fewer PEWS omissions (0·95 0·92–0·99; p=0·0091) were associated with a greater reduction in clinical deterioration event mortality after PEWS implementation; no association was found with country income level (IRR 0·86 95% CI 0·68–1·09; p=0·22) or clinical deterioration event rates before PEWS implementation (1·04 0·97–1·12; p=0·29).
PEWS implementation was associated with reduced clinical deterioration event mortality in paediatric patients with cancer across 32 resource-limited hospitals in Latin America. These data support the use of PEWS as an effective evidence-based intervention to reduce disparities in global survival for children with cancer.
American Lebanese Syrian Associated Charities, US National Institutes of Health, and Conquer Cancer Foundation.
For the Spanish and Portuguese translations of the abstract see Supplementary Materials section.
Background
Pediatric early warning systems (PEWS) aid in the early identification of deterioration in hospitalized children with cancer; however, they are under‐used in resource‐limited settings. The ...authors use the knowledge‐to‐action framework to describe the implementation strategy for Proyecto Escala de Valoracion de Alerta Temprana (EVAT), a multicenter quality‐improvement collaborative, to scale‐up PEWS in pediatric oncology centers in Latin America.
Methods
Proyecto EVAT mentored participating centers through an adaptable implementation strategy to: (1) monitor clinical deterioration in children with cancer, (2) contextually adapt PEWS, (3) assess barriers to using PEWS, (4) pilot and implement PEWS, (5) monitor the use of PEWS, (6) evaluate outcomes, and (7) sustain PEWS. The implementation outcomes assessed included the quality of PEWS use, the time required for implementation, and global program impact.
Results
From April 2017 to October 2021, 36 diverse Proyecto EVAT hospitals from 13 countries in Latin America collectively managing more than 4100 annual new pediatric cancer diagnoses successfully implemented PEWS. The time to complete all program phases varied among centers, averaging 7 months (range, 3–13 months) from PEWS pilot to implementation completion. All centers ultimately implemented PEWS and maintained high‐quality PEWS use for up to 18 months after implementation. Across the 36 centers, more than 11,100 clinicians were trained in PEWS, and more than 41,000 pediatric hospital admissions had PEWS used in their care.
Conclusions
Evidence‐based interventions like PEWS can be successfully scaled‐up regionally basis using a systematic approach that includes a collaborative network, an adaptable implementation strategy, and regional mentorship. Lessons learned can guide future programs to promote the widespread adoption of effective interventions and reduce global disparities in childhood cancer outcomes.
Lay summary
Pediatric early warning systems (PEWS) are clinical tools used to identify deterioration in hospitalized children with cancer; however, implementation challenges limit their use in resource‐limited settings.
Proyecto EVAT is a multicenter quality‐improvement collaborative to implement PEWS in 36 pediatric oncology centers in Latin America.
This is the first multicenter, multinational study reporting a successful implementation strategy (Proyecto EVAT) to regionally scale‐up PEWS.
The lessons learned from Proyecto EVAT can inform future programs to promote the adoption of clinical interventions to globally improve childhood cancer outcomes.
Précis
Proyecto EVAT is a multicenter, multinational quality‐improvement collaborative that supported successful regional implementation and scale‐up of an evidence‐based intervention—a pediatric early warning system—at 36 pediatric oncology hospitals in Latin America. The knowledge‐to‐action framework was used to explain the project’s implementation strategy and to assess implementation outcomes, including the quality, the time required, and the global impact.
Background
Pediatric early warning systems (PEWS) aid in the early identification of deterioration in hospitalized children with cancer; however, they are under‐used in resource‐limited settings. The ...authors use the knowledge‐to‐action framework to describe the implementation strategy for Proyecto Escala de Valoracion de Alerta Temprana (EVAT), a multicenter quality‐improvement collaborative, to scale‐up PEWS in pediatric oncology centers in Latin America.
Methods
Proyecto EVAT mentored participating centers through an adaptable implementation strategy to: (1) monitor clinical deterioration in children with cancer, (2) contextually adapt PEWS, (3) assess barriers to using PEWS, (4) pilot and implement PEWS, (5) monitor the use of PEWS, (6) evaluate outcomes, and (7) sustain PEWS. The implementation outcomes assessed included the quality of PEWS use, the time required for implementation, and global program impact.
Results
From April 2017 to October 2021, 36 diverse Proyecto EVAT hospitals from 13 countries in Latin America collectively managing more than 4100 annual new pediatric cancer diagnoses successfully implemented PEWS. The time to complete all program phases varied among centers, averaging 7 months (range, 3–13 months) from PEWS pilot to implementation completion. All centers ultimately implemented PEWS and maintained high‐quality PEWS use for up to 18 months after implementation. Across the 36 centers, more than 11,100 clinicians were trained in PEWS, and more than 41,000 pediatric hospital admissions had PEWS used in their care.
Conclusions
Evidence‐based interventions like PEWS can be successfully scaled‐up regionally basis using a systematic approach that includes a collaborative network, an adaptable implementation strategy, and regional mentorship. Lessons learned can guide future programs to promote the widespread adoption of effective interventions and reduce global disparities in childhood cancer outcomes.
Lay summary
Pediatric early warning systems (PEWS) are clinical tools used to identify deterioration in hospitalized children with cancer; however, implementation challenges limit their use in resource‐limited settings.
Proyecto EVAT is a multicenter quality‐improvement collaborative to implement PEWS in 36 pediatric oncology centers in Latin America.
This is the first multicenter, multinational study reporting a successful implementation strategy (Proyecto EVAT) to regionally scale‐up PEWS.
The lessons learned from Proyecto EVAT can inform future programs to promote the adoption of clinical interventions to globally improve childhood cancer outcomes.
Précis
Proyecto EVAT is a multicenter, multinational quality‐improvement collaborative that supported successful regional implementation and scale‐up of an evidence‐based intervention—a pediatric early warning system—at 36 pediatric oncology hospitals in Latin America. The knowledge‐to‐action framework was used to explain the project’s implementation strategy and to assess implementation outcomes, including the quality, the time required, and the global impact.
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