The Golden Hour After Injury Among Civilians Caught in Conflict Zones

ABSTRACTIntroduction:The term “golden hour” describes the first 60 minutes after patients sustain injury. In resource-available settings, rapid transport to trauma centers within this time period is standard-of-care. We compared transport times of injured civilians in modern conflict zones to assess the degree to which injured civilians are transported within the golden hour in these environments.Methods:We evaluated PubMed, Ovid, and Web of Science databases for manuscripts describing transport time after trauma among civilian victims of trauma from January 1990 to November 2017.Results:The initial database search identified 2704 abstracts. Twenty-nine studies met inclusion and exclusion criteria. Conflicts in Yugoslavia/Bosnia/Herzegovina, Syria, Afghanistan, Iraq, Israel, Cambodia, Somalia, Georgia, Lebanon, Nigeria, Democratic Republic of Congo, and Turkey were represented, describing 47 273 patients. Only 7 (24%) manuscripts described transport times under 1 hour. Transport typically required several hours to days.Conclusion:Anticipated transport times have important implications for field triage of injured persons in civilian conflict settings because existing overburdened civilian health care systems may become further overwhelmed if in-hospital health capacity is unable to keep pace with inflow of the severely wounded.

Download Full-text

FOLFOX4/XELOX in stage II–III colon cancer: Efficacy results of the Italian three or six colon adjuvant (TOSCA) trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.3501 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 3501-3501 ◽

Cited By ~ 4

Author(s):

Alberto F. Sobrero ◽

Sara Lonardi ◽

Gerardo Rosati ◽

Maria Di Bartolomeo ◽

Monica Ronzoni ◽

...

Keyword(s):

Colon Cancer ◽

High Risk ◽

Health Care Systems ◽

Standard Of Care ◽

Stage Ii ◽

Phase Iii ◽

Stage Iii ◽

Absolute Difference ◽

Open Label ◽

Care Systems

3501 Background: Six months of oxaliplatin-based treatment has been the standard of care as adjuvant therapy for stage III colon cancer and an accepted option for high-risk stage II. Given the cumulative neurotoxicity associated to oxaliplatin, a shorter duration of therapy, if equally efficacious, would be advantageous for patients and health-care systems. Methods: TOSCA was an open-label, phase III, multicenter, non-inferiority trial randomizing patients with high-risk stage II or stage III radically resected colon cancer to receive 3 months or 6 months of FOLFOX4/XELOX. Primary end-point was relapse-free survival. Results: From June 2007 to March 2013, 3759 patients were accrued from 130 Italian sites, 64% receiving FOLFOX4 and 36% XELOX in either arm. Two thirds were stage III. At the cut-off time for analysis the median time of follow-up was 62 months and 772 relapses or deaths have been observed. The RFS rate at 8 years is 75%. This analysis was done when 82% of the planned number of events was reached, with a power of 72% instead of 80%. The decision to anticipate the analysis was based on the participation to the IDEA joint collaborative analysis of studies sharing this clinical question. The Hazard Ratio of the 3months vs 6 months for relapse/death was 1.14 (95%CI 0.99-1.31, p for non inferiority = 0.253) and the confidence interval crossed the non inferiority limit of 1.20. Conclusions: TOSCA was not able to demonstrate that 3 months of oxaliplatin-based adjuvant treatment is as efficacious as 6 months. Nevertheless , because the absolute difference in RFS between the two treatment durations is small ( less than 3 % at 5 years ), the decision to complete the whole 6-month program should be individualized based on toxicity and patients’ attitude. This study is registered with ClinicalTrials.gov Registration Number: NCT00646607. It was supported by a grant from AIFA (Agenzia Italiana del Farmaco) Grant Code FARM5RWTWZ. Clinical trial information: NCT00646607.

Download Full-text

Adaptive platform trials using multi-arm, multi-stage protocols: getting fast answers in pandemic settings

F1000Research ◽

10.12688/f1000research.26253.1 ◽

2020 ◽

Vol 9 ◽

pp. 1109

Author(s):

Nurulamin M. Noor ◽

Sarah L. Pett ◽

Hanif Esmail ◽

Angela M. Crook ◽

Claire L. Vale ◽

...

Keyword(s):

Global Health ◽

International Collaboration ◽

Health Care Systems ◽

Standard Of Care ◽

Therapeutic Agents ◽

Effective Interventions ◽

Multi Stage ◽

Large Numbers ◽

Care Systems

Global health pandemics, such as coronavirus disease 2019 (COVID-19), require efficient and well-conducted trials to determine effective interventions, such as treatments and vaccinations. Early work focused on rapid sequencing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), subsequent in-vitro and in-silico work, along with greater understanding of the different clinical phases of the infection, have helped identify a catalogue of potential therapeutic agents requiring assessment. In a pandemic, there is a need to quickly identify efficacious treatments, and reject those that are non-beneficial or even harmful, using randomised clinical trials. Whilst each potential treatment could be investigated across multiple, separate, competing two-arm trials, this is a very inefficient process. Despite the very large numbers of interventional trials for COVID-19, the vast majority have not used efficient trial designs. Well conducted, adaptive platform trials utilising a multi-arm multi-stage (MAMS) approach provide a solution to overcome limitations of traditional designs. The multi-arm element allows multiple different treatments to be investigated simultaneously against a shared, standard-of-care control arm. The multi-stage element uses interim analyses to assess accumulating data from the trial and ensure that only treatments showing promise continue to recruitment during the next stage of the trial. The ability to test many treatments at once and drop insufficiently active interventions significantly speeds up the rate at which answers can be achieved. This article provides an overview of the benefits of MAMS designs and successes of trials, which have used this approach to COVID-19. We also discuss international collaboration between trial teams, including prospective agreement to synthesise trial results, and identify the most effective interventions. We believe that international collaboration will help provide faster answers for patients, clinicians, and health care systems around the world, including for future waves of COVID-19, and enable preparedness for future global health pandemics.

Download Full-text

Ethical issues in pragmatic trials of “standard-of-care” interventions in learning health care systems

Learning Health Systems ◽

10.1002/lrh2.10045 ◽

2018 ◽

Vol 2 (1) ◽

pp. e10045 ◽

Cited By ~ 4

Author(s):

Scott Y.H. Kim

Keyword(s):

Health Care ◽

Ethical Issues ◽

Health Care Systems ◽

Standard Of Care ◽

Pragmatic Trials ◽

Care Systems

Download Full-text

Should critically ill patients with COVID-19 be managed in high-volume ICUs?

Critical Care and Resuscitation ◽

10.51893/2020.4.l1 ◽

2020 ◽

Vol 23 (4) ◽

pp. 394-396

Author(s):

Mahesh Ramanan ◽

◽

Aidan Burrell ◽

Andrew Udy ◽

◽

...

Keyword(s):

Health Care ◽

Intensive Care ◽

Regional Variation ◽

Health Care Systems ◽

Standard Of Care ◽

High Volume ◽

Case Volume ◽

Care Systems ◽

Volume Outcome ◽

Maximal Capacity

To the Editor: The coronavirus disease 2019 (COVID-19) pandemic has resulted in 38 394 169 cases and 1 089 047 deaths worldwide as of 15 October 2020, although to date, Australia has been relatively spared, with only 11 441 cases and 118deaths. Globally, health care systems and intensive care units (ICUs) have been under immense pressure and wide regional variation in mortality has been observed, both between and within countries. It has been suggested that a higher ICU case volume of COVID-19 may be associated with increased mortality, although this has not yet been systematically investigated. Intuitively, a negative volume–outcome association is plausible under pandemic conditions, as a stretched system running above maximal capacity may not be able to deliver its usual standard of care.

Download Full-text

Outpatient neurosurgery in neuro-oncology

Neurosurgical FOCUS ◽

10.3171/2018.3.focus1831 ◽

2018 ◽

Vol 44 (6) ◽

pp. E19 ◽

Cited By ~ 3

Author(s):

Miguel Marigil ◽

Mark Bernstein

Keyword(s):

Brain Tumor ◽

Health Care Systems ◽

Standard Of Care ◽

Tumor Surgery ◽

Brain Tumor Surgery ◽

Progressive Development ◽

Care Systems ◽

Clinical Benefits ◽

Modern Application ◽

Medicolegal Issues

Technological breakthroughs along with modern application of awake craniotomy and new neuroanesthesia protocols have led to a progressive development in outpatient brain tumor surgery and improved surgical outcomes. As a result, outpatient neurosurgery has become a standard of care at the authors’ center due to its clinical benefits and impact on patient recovery and overall satisfaction. On the other hand, the financial savings derived from its application is also another favorable factor exerting influence on patients, health care systems, and society.Although validated several years ago and with recent data supporting its application, outpatient brain tumor surgery has not gained the traction that it deserves, based on scientific skepticism and perceived potential for medicolegal issues. The goal of this review, based on the available literature and the senior author’s experience in outpatient brain tumor surgery, was to evaluate the most important aspects regarding indications, clinical outcomes, economic burden, and patient perceptions.

Download Full-text

Adaptive platform trials using multi-arm, multi-stage protocols: getting fast answers in pandemic settings

F1000Research ◽

10.12688/f1000research.26253.2 ◽

2020 ◽

Vol 9 ◽

pp. 1109

Author(s):

Nurulamin M. Noor ◽

Sarah L. Pett ◽

Hanif Esmail ◽

Angela M. Crook ◽

Claire L. Vale ◽

...

Keyword(s):

Global Health ◽

International Collaboration ◽

Health Care Systems ◽

Standard Of Care ◽

Therapeutic Agents ◽

Effective Interventions ◽

Multi Stage ◽

Large Numbers ◽

Care Systems

Global health pandemics, such as coronavirus disease 2019 (COVID-19), require efficient and well-conducted trials to determine effective interventions, such as treatments and vaccinations. Early work focused on rapid sequencing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), subsequent in-vitro and in-silico work, along with greater understanding of the different clinical phases of the infection, have helped identify a catalogue of potential therapeutic agents requiring assessment. In a pandemic, there is a need to quickly identify efficacious treatments, and reject those that are non-beneficial or even harmful, using randomised clinical trials. Whilst each potential treatment could be investigated across multiple, separate, competing two-arm trials, this is a very inefficient process. Despite the very large numbers of interventional trials for COVID-19, the vast majority have not used efficient trial designs. Well conducted, adaptive platform trials utilising a multi-arm multi-stage (MAMS) approach provide a solution to overcome limitations of traditional designs. The multi-arm element allows multiple different treatments to be investigated simultaneously against a shared, standard-of-care control arm. The multi-stage element uses interim analyses to assess accumulating data from the trial and ensure that only treatments showing promise continue to recruitment during the next stage of the trial. The ability to test many treatments at once and drop insufficiently active interventions significantly speeds up the rate at which answers can be achieved. This article provides an overview of the benefits of MAMS designs and successes of trials, which have used this approach to COVID-19. We also discuss international collaboration between trial teams, including prospective agreement to synthesise trial results, and identify the most effective interventions. We believe that international collaboration will help provide faster answers for patients, clinicians, and health care systems around the world, including for each further wave of COVID-19, and enable preparedness for future global health pandemics.

Download Full-text

The Excess Costs of Dementia: A Systematic Review and Meta-Analysis

Journal of Alzheimer s Disease ◽

10.3233/jad-210174 ◽

2021 ◽

pp. 1-22

Author(s):

Nadine Sontheimer ◽

Alexander Konnopka ◽

Hans-Helmut König

Keyword(s):

Health Care Systems ◽

Meta Analysis ◽

Global Scale ◽

Cochrane Library ◽

Nursing Facilities ◽

Policy Makers ◽

Time Period ◽

Excess Costs ◽

Care Systems ◽

Cost Studies

Background: Dementia is one of the costliest diseases for health care systems with growing importance for policy makers. Objective: The aim of this study is to systematically review the current literature of excess cost studies for dementia and to analyze excess costs in a meta-analysis. Methods: A systematic literature search was conducted in PubMed, EconLit, NHS-EED, and Cochrane Library. 22 studies were included and assigned to one of three subgroups according to the time period that they analyzed during disease progression: the time of diagnosis, the time between diagnosis and death, and the time prior to death. Excess costs were analyzed using the ratio of means (ROM) and meta-analysis was performed by pooling ROMs in a random effects model. Results: Total costs were significantly higher for demented persons compared to non-demented persons at the time of diagnosis (ROM: 2.08 [1.71, 2.54], p < 0.00001, I 2 = 98%) and in the time period between diagnosis and death (ROM: 2.19 [1.97, 2.44], p < 0.00001, I 2 = 100%). The ROM was highest for professional home care (ROM: 4.96 [2.62, 9.40], p < 0.0001, I 2 = 88%) and for nursing facilities (ROM: 4.02 [2.53, 6.40], p < 0.00001, I 2 = 100%) for the time period between diagnosis and death. Conclusion: This meta-analysis is the first to assess excess costs of dementia by the ROM method on a global scale. We conclude that our findings demonstrate that costs of dementia constitute a substantial economic burden.

Download Full-text