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CHEST publishes select peer-reviewed, accepted manuscripts Online First each week. The media embargo is lifted on the date of Online First publication. Final, edited versions will appear in a numbered issue of CHEST and may contain substantive changes. We encourage readers to check back for the final article. Online First papers are indexed in PubMed and by search engines, but the information, including the final title and author list, may be updated on final publication.

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Christian Sandrock, MD, MPH, FCCP
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No abstract is available for this article
evidence-based medicine  FREE TO VIEW
Michael D. Christian, MD, MSc, FCCP, FRCP(C); Asha V. Devereaux, MD, MPH, FCCP; Jeffrey R. Dichter, MD; Lewis Rubinson, MD, PhD; Niranjan Kissoon, MBBS, FRCP(C), FAAP, FCCM, FACPE on behalf of the Task Force for Mass Critical Care
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  Natural disasters, industrial accidents, terrorism attacks and pandemics all have the capacity to result in large numbers of critically ill or injured patients. This supplement provides suggestions for all of those involved in a disaster or pandemic with multiple critically ill patients including front line clinicians, hospital administrators, professional societies and public health or government officials. In 2008 the American College of Chest Physician’s (ACCP) Task Force on Mass Critical Care published its first series of disaster critical care suggestions. The Task Force for Mass Critical Care was reconvened with expanded scope and expertise to provide an evidence-informed, rigorously developed set of usable recommendations to critical care providers throughout the world. In this iteration we have made a number of attempts to bolster the expertise of the Task Force itself as well as utilized a more rigorous methodology to develop the suggestions.

  Task Force executive committee members identified core topic areas regarding the provision of care to critically ill or injured patients from pandemics or disasters and subsequently assembled an international panel for each identified area. The current Task Force included a total of 100 participants from 9 countries, comprised of clinicians and experts from a wide variety of disciplines. The international disaster medicine experts were brought together to identify key questions (in a PICO-based format) within each of the core topics areas. Comprehensive literature searches were then conducted to identify studies upon which evidence-based recommendations could be made. No studies of sufficient quality were identified. Therefore, the panel developed expert opinion-based suggestions that are presented in this supplement utilizing a modified Delphi process. A total of 315 suggestions were drafted across all topic groups. After two rounds of a Delphi consensus-development process, 267 suggestions were chosen by the panel to include in the document and published in a total of twelve manuscripts comprising the core chapters of this supplement.

  The ultimate aim of the supplement is to expand the focus beyond the walls of intensive care units (ICU) to provide recommendations for the management of all critically ill or injured adults and children resulting from a disaster or pandemic wherever that care may be provided. Considerations for the management of critically ill patients include clinical priorities and logistics (supplies, evacuation, and triage) as well as the key enablers (systems planning, business continuity, legal framework, and ethical considerations) that facilitate the provision of this care. The supplement also aims to illustrate how the concepts of mass critical care are integrated across the spectrum of surge events from conventional through contingency to crisis standards of care.

evidence-based medicine  FREE TO VIEW
Joe Ornelas, MS; Jeffrey R. Dichter, MD; Asha V. Devereaux, MD, MPH, FCCP; Niranjan Kissoon, MBBS; Alicia Livinski, MA, MPH; Michael D. Christian, MD, MSc, FRCPC, FCCP on behalf of the Task Force for Mass Critical Care
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Background:  Natural disasters, industrial accidents, terrorism attacks and pandemics all have the capacity to result in large numbers of critically ill or injured patients. This supplement provides suggestions for all of those involved in a disaster or pandemic with multiple critically ill patients including front line clinicians, hospital administrators, professional societies and public health or government officials. The field of disaster medicine does not have the required body of evidence needed to undergo a traditional guideline development process. In result, consensus statement development methodology was employed to capture the highest caliber expert opinion in a structured, scientific approach.

Methodology:  Task Force executive committee members identified core topic areas regarding the provision of care to critically ill or injured patients from pandemics or disasters and subsequently assembled an international panel for each identified area. International disaster medicine experts were brought together to identify key questions (in a PICO-based format) within each of the core topics areas. A comprehensive literature searches were then conducted to identify studies upon which evidence-based recommendations could be made. No studies of sufficient quality were identified. Therefore, the panel developed expert opinion-based suggestions that are presented in this supplement utilizing a modified Delphi process.

Results:  A total of 315 suggestions were drafted across all topic groups. After two rounds of a Delphi consensus-development process, 267 suggestions were chosen by the panel to include in the document and published in a total of twelve manuscripts comprising the core chapters of this supplement. Drafts manuscripts were prepared by the topic editors and members of the working groups for each of the topics producing a total of eleven papers. Once the preliminary drafts were received, the executive committee (writing committee) then met to review, edit, and promote alignment of all of the primary drafts of the manuscripts prepared by the topic editors and their groups. The topic editors then revised their manuscripts based on the executive committee’s edits and comments. The writing committee subsequently reviewed the updated drafts and prepared the final manuscripts for submission to the GOC. The manuscripts subsequently underwent review by the GOC including external review as well as peer-review for the journal publication. The writing committee received the feedback from the reviewers and modified the manuscripts as required.

Conclusions:  Based on a robust and transparent process, this project utilized rigorous methodology to produce clinically relevant, trustworthy consensus statements, with the aim to provide needed guidance on treatment and procedures for practitioners, hospital administrators, and public health and government officials when addressing the care of critically ill or injured patients in disasters or pandemics.

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John L. Hick, MD; Sharon Einav, MD; Dan Hanfling, MD; Niranjan Kissoon, MBBS; Jeffrey R. Dichter, MD; Asha V. Devereaux, MD, MPH, FCCP; Michael D. Christian, MD, MSc, FRCPC, FCCP on behalf of the Task Force for Mass Critical Care
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Background:  This paper provides consensus suggestions for expanding critical care surge capacity and extension of critical care service capabilities in disaster or pandemics. It focuses on the principles and frameworks for expansion of intensive care services in hospitals in the developed world. A companion paper addresses surge logistics, those elements that provide the capability to deliver mass critical care in disaster events. [See Surge Capacity Logistics article in this supplement]. The suggestions in this chapter are important for all who are involved in large-scale disasters or pandemics with multiple critically ill or injured patients including front line clinicians, hospital administrators, and public health or government officials.

Methods:  The Surge Capacity panel developed 23 key questions focused on the following domains: systems issues; equipment, supplies and pharmaceuticals; staffing; and informatics. Literature searches were conducted to identify evidence on which to base key suggestions. Most reports were small-scale, observational, or used flawed modeling and hence the level of evidence on which to base recommendations was poor, therefore not permitting the development of evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process. Suggestions from the previous task force were also included for validation by the expert panel.

Results:  This paper presents 10 suggestions pertaining to the principles that should guide surge capacity and capability planning for mass critical care including: the role of critical care in disaster planning; the surge continuum; targets of surge response; situational awareness and information sharing; mitigating the impact on critical care; planning for the care of special populations; and service de-escalation (also considered as ”engineered failure”).

Conclusions:  Future reports of critical care surge should emphasize population-based outcomes as well as logistical details. Planning should be based on the projected number of critically ill or injured patients resulting from specific scenarios. This should include consideration of ICU patient care requirements over time and must factor in resource constraints that may limit the ability to provide care. Standard ICU management forms and patient data forms to assess ICU surge capacity impacts should be created and utilized in disaster events.

evidence-based medicine  FREE TO VIEW
Sharon Einav, MD; John L. Hick, MD; Dan Hanfling, MD; Brian L. Erstad, PharmD, FCCM; Eric S. Toner, MD; Richard D. Branson, MSc, RRT; Robert K. Kanter, MD; Niranjan Kissoon, MBBS; Jeffrey R. Dichter, MD; Asha V. Devereaux, MD, MPH, FCCP; Michael D. Christian, MD, MSc, FRCPC, FCCP on behalf of the Task Force for Mass Critical Care
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Introduction:  Successful management of a disaster or pandemic requires implementation of pre-existing plans to minimize loss of life and maintain control. Managing the expected surges in intensive care capacity requires strategic planning from a systems perspective, and includes focused intensive care abilities and requirements as well as all individuals and organizations involved in hospital and regional planning. The suggestions in this chapter are important for all of those involved in a large-scale disaster or pandemic including front line clinicians, hospital administrators, and public health or government officials. Specifically, this paper focuses on surge logistics, those elements that provide the capability to deliver mass critical care.

Methodology:  The Surge Capacity topic panel developed 23 key questions focused on the following domains: systems issues; equipment, supplies and pharmaceuticals; staffing; and informatics. Literature searches were conducted to identify studies upon which evidence-based recommendations could be made. The results were reviewed for relevance to the topic and the articles screened by two topic editors for placement within one of the surge domains noted previously. Most reports were small scale, observational or used flawed modeling and hence the level of evidence on which to base recommendations was poor therefore not permitting the development of evidence based recommendations. The Surge Capacity panel subsequently followed the American College of Chest Physician’s (ACCP) Guidelines Oversight Committee’s methodology to develop expert opinion suggestions utilizing a modified Delphi process.

Results:  This paper presents 22 suggestions pertaining to surge capability mass critical care including: requirements for equipment, supplies and pharmaceuticals, staff preparation and organization, methods of mitigating overwhelming patient loads, the role of deployable critical care services and use of transportation assets to support the surge response.

Conclusions:  Critical care response to a disaster relies careful planning for staff and resource augmentation and involves many agencies. Maximizing use of regional resources including staff, equipment and supplies extends critical care capabilities. Regional coalitions should be established to facilitate agreements, outline operational plans, and coordinate hospital efforts to achieve pre-determined goals. Specialized physician oversight is necessary and if not available on site it may be provided through remote consultation. Triage by experienced providers, reverse triage, and service de-escalation may be used to minimize ICU resource consumption. During temporary loss of infrastructure or overwhelming of hospital resources, deployable critical care services should be considered.

evidence-based medicine  FREE TO VIEW
Mary A. King, MD, MPH, FCCP; Alexander S. Niven, MD, FCCP; William Beninati, MD; Ray Fang, MD; Sharon Einav, MD; Lewis Rubinson, MD, PhD; Niranjan Kissoon, MBBS; Asha V. Devereaux, MD, MPH, FCCP; Michael D. Christian, MD, MSc, FRCPC, FCCP; Colin K. Grissom, MD, FCCP on behalf of the Task Force for Mass Critical Care
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Background:  Despite the high risk for patient harm during unanticipated intensive care unit (ICU) evacuations, critical care providers receive little to no training on how to perform safe and effective ICU evacuations. We reviewed the pertinent published literature and offer suggestions for the critical care provider regarding ICU evacuation. The suggestions in this chapter are important for all who are involved in disasters or pandemics with multiple critically ill or injured patients including front line clinicians, hospital administrators and public health or government officials.

Methodology:  The Evacuation and Mobilization panel utilized the American College of Chest Physician’s (ACCP) Guidelines Oversight Committee’s methodology to develop 7 key questions for which specific literature searches were then conducted to identify studies upon which evidence-based recommendations could be made. No studies of sufficient quality were identified. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process.

Results:  Based on current best evidence, we provide thirteen suggestions outlining a systematic approach to prepare for and execute an effective ICU evacuation during a disaster. Inter- and intra-hospital collaboration and functional ICU communication are critical for success. Pre-event planning and preparation, are required for a no-notice evacuation. A Critical Care Team Leader must be designated within the Hospital Incident Command System (HICS). A 3-stage ICU evacuation timeline including 1) No Immediate Threat, 2) Evacuation Threat, and 3) Evacuation Implementation should be used. Detailed suggestions on ICU evacuation including: regional planning, evacuation drills, patient transport preparation and equipment, patient prioritization and distribution for evacuation, patient information/tracking, and Federal and international evacuation assistance systems are also provided.

Conclusions:  Successful ICU evacuation during a disaster requires active preparation, participation, communication, and leadership by critical care providers. Critical care providers have a professional obligation to become better educated, prepared, and engaged with the processes of ICU evacuation in order to provide a safe continuum of critical care during a disaster.

evidence-based medicine  FREE TO VIEW
Michael D. Christian, MD, MSc, FRCPC, FCCP; Charles L. Sprung, MD, MCCP; Mary A. King, MD, MPH, FCCP; Jeffrey R. Dichter, MD; Niranjan Kissoon, MBBS; Asha V. Devereaux, MD, MPH, FCCP; Charles D. Gomersall, BSc, MBBS on behalf of the Task Force for Mass Critical Care
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Background:  Disasters and pandemics can result in large numbers of critically ill or injured patients that may overwhelm available resources despite implementing surge response strategies. If this occurs, critical care triage, which includes both prioritizing patients for care and rationing scarce resources, will be required. The suggestions in this chapter are important for all who are involved in large-scale disasters or pandemics with multiple critically ill or injured patients including front line clinicians, hospital administrators and public health or government officials.

Methods:  The triage work group reviewed previous task force suggestions and the literature to identify 17 key questions for which specific literature searches were then conducted to identify studies upon which evidence-based recommendations could be made. No studies of sufficient quality were identified. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process. Suggestions from the previous task force that were not being updated were also included for validation by the expert panel.

Results:  The suggestions from the task force outline the key principles upon which critical care triage should be based as well as a path for the development of the plans, processes, and infrastructure required. This chapter provides eleven suggestions regarding the principles upon which critical care triage should be based and policies to guide critical care triage.

Conclusions:  Ethical and efficient critical care triage is a complex process that requires significant planning and preparation. At present, the prognostic tools required to produce an effective decision support system (triage protocol) as well as the infrastructure, processes, legal protections, and training are largely lacking in most jurisdictions. Therefore, critical care triage should be a last resort after mass critical care surge strategies.

evidence-based medicine  FREE TO VIEW
David J. Dries, MD; Mary Jane Reed, MD, FCCP; Niranjan Kissoon, MBBS; Michael D. Christian, MD, MSc, FRCPC, FCCP; Jeffrey R. Dichter, MD; Asha Devereaux, MD, MPH, FCCP; Jeffrey S. Upperman, MD, FAAP, FACS on behalf of the Task Force for Mass Critical Care
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Background  Past disasters have highlighted the need to prepare for subsets of those critically ill medically fragile patients. These chronic, medically fragile patients require focused disaster planning that will address their medical needs throughout the event in order to prevent clinical deterioration. The suggestions in this chapter are important for all who are involved in large-scale disasters or pandemics with multiple critically ill or injured patients including front line clinicians, hospital administrators and public health or government officials.

Methodology:  Key questions regarding the care of critically ill or injured special populations during disaster or pandemic were identified and subsequently a systematic literature (1985-2013) review was performed. No studies of sufficient quality were identified. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process. The panel did not include pediatrics as a separate special population since pediatrics issues are embedded in each consensus document.

Results:  Fourteen suggestions were formulated regarding the care of the critically ill and injured from special populations during disasters and pandemics. The suggestions cover the following areas: Defining Special Populations for Mass Critical Care, Special Population Planning, Planning for Access to Regionalized Service for Special Populations, Triage and Resource Allocation of Special Populations, Therapeutic Considerations, and Crisis Standards of Care for Special Populations.

Conclusions:  The chronically ill, technologically dependent and complex critically ill patients present a unique challenge to preparing and implementing mass critical care. There are, however, unique opportunities to engage patients, primary physicians, advocacy groups, and professional organizations to lessen the impact of disaster on these special populations.

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Jeffrey R. Dichter, MD; Robert K. Kanter, MD; David J. Dries, MD; Valerie A. Luyckx, MD; Matthew L. Lim, MD; John Wilgis, MD; Michael R. Anderson, MD; Babak Sarani, MD; Nathaniel Hupert, MD; Ryan Mutter, PhD; Asha V. Devereaux, MD, MPH, FCCP; Michael D. Christian, MD, MSc, FRCPC, FCCP; Niranjan Kissoon, MBBS on behalf of the Task Force for Mass Critical Care
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Background:  Systems level planning involves uniting hospitals and health systems, local/regional government agencies, emergency medical services, and other health care entities involved in coordinating and enabling care in a major disaster. We reviewed the literature and sought expert opinions concerning systems level planning and engagement for mass critical care due to disasters or pandemics and offer suggestions for systems planning, coordination, communication, and response. The suggestions in this chapter are important for all of those involved in a disaster or pandemic with multiple critically ill or injured patients including front line clinicians, hospital administrators, and public health or government officials.

Methodology:  The ACCP consensus statement development process was followed in developing suggestions. Task force members met in person to develop 9 key questions thought to be most relevant for systems planning, coordination, and communication. A systematic literature review was then performed for relevant articles and documents, reports, and other publications reported since 1993. No studies of sufficient quality were identified upon which to make evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process.

Results:  Suggestions were developed and grouped according to the following thematic elements: 1) National government support of healthcare coalitions/Regional Health Authorities; 2) Teamwork within healthcare coalitions and Regional Health Authorities; 3) Systems level communication; 4) System level surge capacity and capability; 5) Pediatric patients and special populations; 6). Healthcare coalitions, Regional Health Authorities and networks: 7). Models of advanced regional care systems: and 8) The use of simulation for preparedness and planning.

Conclusions:  Systems level planning is essential to provide care for large numbers of critically ill patients due to disaster or pandemic. It also entails a departure from the routine, independent system and involves all levels from healthcare institutions to regional health authorities. National government support is critical, as are robust communication systems and advanced planning supported by realistic exercises.

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Pritish K. Tosh, MD; Henry Feldman, MD; Michael D. Christian, MD, MSc, FRCPC, FCCP; Asha V. Devereaux, MD, MPH, FCCP; Niranjan Kissoon, MBBS; Jeffrey R. Dichter, MD on behalf of the Task Force for Mass Critical Care
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Background:  During disasters supply chain vulnerabilities such as power, transportation and communication may affect the delivery of medications and medical supplies, and hamper the ability to deliver critical care services. Disasters also have the potential to disrupt information technology (IT) in healthcare systems, resulting in interruptions in patient care, particularly critical care, and other healthcare business functions. The suggestions in this chapter are important for all of those involved in a large scale disaster or pandemic with multiple critically ill or injured patients including front line clinicians, hospital administrators, and public health or government officials.

Methodology:  The Business and Continuity of Operations Panel followed the American College of Chest Physicians’ (ACCP) Guidelines Oversight Committee’s methodology in developing key questions regarding medication and supply shortages, and the impact disasters may have on healthcare IT. Task force members met in person to develop the13 key questions felt to be most relevant for Business and Continuity of Operations. A systematic literature review was then performed for relevant articles and documents, reports, and grey literature reported since 2007. No studies of sufficient quality were identified upon which to make evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process.

Results:  Eighteen suggestions addressing mitigation strategies for suppy chain vulnerabilities including medications and IT were generated. Suggestions offered to hospitals and health system leadership regarding medication and supply shortages include: 1) purchase of key medications and supplies from more than one supplier, 2) substituted medications or supplies should ideally be similar to those already used by an institution’s providers, 3) inventories should be tracked electronically to monitor medication/supply levels, 4) consider higher inventories of medications and supplies known or projected to be in short supply 5) institute alternate use protocols when a (potential) shortage is identified, and 6) support government and non-governmental organizations in efforts to address supply chain vulnerability. Healthcare IT can be damaged in a disaster, and hospitals and health system leadership should have plans for urgently reestablishing local area networks. Planning should include utilizing portable technology, plans for providing power, maintenance of a patient database that can accompany each patient, and protection of patient privacy. Additionally, long-term planning should include prioritizing servers and memory disk drives, and possibly increasing inventory of critical IT supplies, in preparedness planning.

Conclusions:  The provision of care to critically ill or injured during a disaster or pandemic is dependent on key processes such as the supply chain and infrastructure such as IT systems. Hospitals and health systems will help minimize the impact of medication and supply shortages with a focused strategy using the steps suggested. IT preparedness for maintaining local area networks, functioning clinical information systems, and adequate server and memory storage capacity will greatly enhance preparedness for hospital and health system clinical and business operations.

evidence-based medicine  FREE TO VIEW
Asha V. Devereaux, MD, MPH, FCCP; Pritish K. Tosh, MD; John L. Hick, MD; Dan Hanfling, MD; James Geiling, MD, MPH, FCCP; Mary Jane Reed, MD, FCCP; Timothy M. Uyeki, MD, MPH, MPP; Umair A. Shah, MD, MPH; Daniel B. Fagbuyi, MD; Peter Skippen, MBBS, FRCPC; Jeffrey R. Dichter, MD; Niranjan Kissoon, MBBS; Michael D. Christian, MD, MSc, FRCPC, FCCP; Jeffrey S. Upperman, MD, FAAP, FACS on behalf of the Task Force for Mass Critical Care
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Background:  Engagement and education of Intensive Care Unit (ICU) clinicians in disaster preparedness is fragmented by time constraints, institutional barriers and frequently occurs during a disaster.1 We reviewed the existing literature from 2007 to April 2013 and expert opinions concerning clinician engagement and education for critical care during a disaster or pandemic and offer suggestions for integrating ICU clinicians into planning and response. The suggestions in this chapter are important for all of those involved in a large-scale disaster or pandemic with multiple critically ill or injured patients including front line clinicians, hospital administrators, and public health or government officials.

Methodology:  A systematic literature review was performed and suggestions were formulated according to the American College of Chest Physicians’ Consensus Statement development methodology. We assessed articles, documents, reports, and grey literature reported since 2007. Following expert-informed sorting and review of the literature, key priority areas and questions were developed. No studies of sufficient quality were identified upon which to make evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process.

Results:  Twenty-three suggestions were formulated based on literature-informed consensus opinion. These suggestions are grouped according to the following thematic elements: 1. Situational awareness, 2. Clinician roles and responsibilities, 3. Education, and 4. Community engagement. Together these four elements are considered to form the basis for effective ICU clinician engagement for mass critical care.

Conclusions:  The optimal engagement of the ICU clinical team in caring for large numbers of critically ill patients due to a disaster or pandemic will require a departure from the routine independent systems operating in hospitals routinely. An effective response will require robust information systems, coordination between clinicians, hospitals, and governmental organizations, pre-event engagement of relevant stakeholders, and standardized core competencies for the education and training of critical care clinicians.

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Brooke Courtney, JD, MPH; James G. Hodge, Jr., JD, LLM; Eric S. Toner, MD; Beth E. Roxland, JD, M.Bioethics; Matthew S. Penn, JD, MLIS; Asha V. Devereaux, MD, MPH, FCCP; Jeffrey R. Dichter; MD; Niranjan Kissoon, MBBS; Michael D. Christian, MD, MSc, FRCPC, FCCP; Tia Powell, MD on behalf of the Task Force for Mass Critical Care
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Introduction:  Significant legal challenges arise when health care resources become scarce and population-based approaches to care are implemented during severe disasters and pandemics. Recent emergencies highlight the serious legal, economic, and health impacts that can be associated with responding in austere conditions and the critical importance of comprehensive, collaborative health response system planning. This article discusses legal suggestions developed by the American College of Chest Physicians (ACCP) Task Force for Mass Critical Care (MCC) to support planning and response efforts for mass casualty incidents involving critically ill or injured patients. The suggestions in this chapter are important for all of those involved in a disaster or pandemic with multiple critically ill or injured patients including front line clinicians, hospital administrators and public health or government officials.

Methodology:  Following the ACCP Guidelines Oversight Committee’s methodology, the Legal Panel developed 35 key questions for which specific literature searches were then conducted. The literature in this field is not suitable upon which to make evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process resulting in seven (7) final suggestions.

Results:  Acceptance is widespread for the health care community’s duty to appropriately plan for and respond to severe disasters and pandemics. Hospitals, public health entities and clincicians have an obligation to develop comprehensive, vetted plans for mass casualty incidents involving critically ill or injured patients. Such plans should address processes for evacuation and limited appeals and reviews of care decisions. To legitimize responses, deter independent actions, and trigger liability protections, MCC plans should be formally activated when facilities and practitioners shift to providing MCC. Adherence to official MCC plans should contribute to protecting hospitals and practitioners, who act in good faith, from liability. Finally, to address anticipated staffing shortages during severe and prolonged disasters and pandemics, governments should develop approaches to formally expand the availability of qualified health care workers, such as through using official foreign medical teams.

Conclusions:  As a fundamental element of health care and public health emergency planning and preparedness, the law underlies critical aspects of disaster and pandemic responses. Effective responses require comprehensive advance planning efforts that include assessments of complex legal issues and authorities. Recent disasters have shown that while law is a critical response tool, it can also be used to hold health care stakeholders that fail to appropriately plan for or respond to disasters and pandemics accountable for resulting patient or staff harm. Claims of liability from harms allegedly suffered during disasters and pandemics cannot be avoided altogether. However, appropriate planning and legal protections can help to facilitate sound, consistent decision-making and support response participation among health care entities and practitioners.

evidence-based medicine  FREE TO VIEW
Lee Daugherty Biddison, MD, MPH; Kenneth A. Berkowitz, MD, FCCP; Brooke Courtney, JD, MPH; Marla J. De Jong, PhD, RN, Colonel; Asha V. Devereaux, MD, MPH, FCCP; Niranjan Kissoon, MBBS; Beth Roxland, JD, MBE; Charles L. Sprung, MD, MCCP; Jeffrey R. Dichter, MD; Michael D. Christian, MD, MSc, FRCPC, FCCP; Tia Powell, MD on behalf of the Task Force for Mass Critical Care
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Background:  Mass critical care (MCC) entails time-sensitive decisions and changes in the standard of care that it is possible to deliver. These circumstances increase provider uncertainty as well as patients’ vulnerability and may therefore jeopardize disciplined, ethical decision-making. Planning for disasters and pandemics should incorporate ethics guidance to support providers who may otherwise make ad hoc patient care decisions that overstep ethical boundaries. This manuscript provides consensus-developed suggestions about ethical challenges in caring for the critically ill or injured during pandemics or disasters. The suggestions in this chapter are important for all of those involved in any disaster or pandemic with multiple critically ill or injured patients including front line clinicians, hospital administrators, and public health or government officials.

Methodology:  We adapted the American College of Chest Physician’s (ACCP) Guidelines Oversight Committee’s methodology to develop suggestions. Twenty-four key questions were developed, and literature searches were conducted to identify evidence for suggestions. The detailed literature reviews produced 144 articles. Based on their expertise within this domain, panel members also supplemented the literature search with governmental publications, interdisciplinary workgroup consensus documents, and other information not retrieved through PubMed. The literature in this field is not suitable upon which to make evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions utilizing a modified Delphi process.

Results:  We report the suggestions which focus on five essential domains: triage and allocation; ethical concerns of patients and families, ethical responsibilities to providers; conduct of research; and international concerns.

Conclusions:  Ethics issues permeate virtually all aspects of disaster and pandemic response. We have addressed some of the most pressing issues, focusing on five essential domains: triage and allocation; ethical concerns of patients and families, ethical responsibilities to providers; conduct of research; and international concerns. Our suggestions reflect the consensus of the Task Force. We recognize, however, that some suggestions, including those related to end-of-life care, may be controversial. We highlight the need for additional research and dialogue in articulating values to guide healthcare decisions during disasters.

evidence-based medicine  FREE TO VIEW
James Geiling, MD, MPH, FCCP; Frederick M. Burkle, Jr., MD, MPH; Dennis Amundson, DO, MS, FCCP; Guillermo Dominguez-Cherit, MD; Charles D. Gomersall, BSc, MBBS; Matthew L. Lim, MD; Valerie A. Luyckx, MD; Babak Sarani, MD; Timothy M. Uyeki, MD, MPH, MPP; T. Eoin West, MD, MPH, FCCP; Michael D. Christian, MD, MSc, FRCPC, FCCP; Asha Devereaux, MD, MPH, FCCP; Jeffrey R. Dichter, MD; Niranjan Kissoon, MBBS on behalf of the Task Force for Mass Critical Care
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Background:  Planning for mass critical care in resource poor or constrained settings (developing or undeveloped countries) has been largely ignored despite their large populations that are prone to suffer disproportionately from natural disasters. Addressing mass critical care in these settings has the potential to help vast numbers of people and also to inform planning for better-resourced areas.

Methodology:  The Resource Poor Settings panel developed 5 key question domains; defining the term resource poor and using the traditional phases of disaster (mitigation/preparedness/response/recovery), literature searches were conducted to identify evidence on which to answer the key questions in these areas. Given a lack of data upon which to develop evidenced-based recommendations, expert-opinion suggestions were developed and consensus was achieved using a modified Delphi process.

Results:  The 5 key questions were then separated as follows: definition, infrastructure and capacity building, resources, response, and reconstitution/recovery of host nation critical care capabilities and research. Addressing these questions led the panel to offer 33 suggestions. Due to the large number of suggestions the results have been separated into two sections, part I: Infrastructure/Capacity in this manuscript, and part II, Response/Recovery/Research in the accompanying manuscript.

Conclusions:  Lack of, or presence of, rudimentary Intensive Care Unit resources and limited capacity to enhance services further challenge resource poor and constrained settings. Hence, capacity building entails preventative strategies and strengthening of primary health services. Assistance from other countries and organizations is needed to mount a surge response. Moreover, planning should include when to disengage and how the host nation can provide capacity beyond the mass casualty care event.

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James Geiling, MD, MPH, FCCP; Frederick M. Burkle, Jr., MD, MPH; T. Eoin West, MD, MPH, FCCP; Timothy M. Uyeki, MD, MPH, MPP; Dennis Amundson, DO, MS, FCCP; Guillermo Dominguez-Cherit, MD; Charles D. Gomersall, BSc, MBBS; Matthew L. Lim, MD; Valerie A. Luyckx, MD; Babak Sarani, MD; Michael D. Christian, MD, MSc, FRCPC, FCCP; Asha Devereaux, MD, MPH, FCCP; Jeffrey R. Dichter, MD; Niranjan Kissoon, MBBS on behalf of the Task Force for Mass Critical Care
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Background:  Planning for mass critical care in resource poor and constrained settings (developing or underdeveloped countries) has been largely ignored despite large densely crowded populations who are prone to suffer disproportionately from natural disasters. As a result, disaster response has been sub-optimal and in many instances hampered by lack of planning, education and training, information, and communication.

Methodology:  The Resource Poor Settings panel developed 5 key question domains; defining the term resource poor, and using the traditional phases of the disaster cycle (mitigation/preparedness/response/recovery) literature searches were conducted to identify evidence to answer the key questions in these areas. Given a lack of data on which to develop evidenced-based recommendations, expert-opinion suggestions were developed and consensus was achieved using a modified Delphi process.

Results:  The 5 key questions were as follows: definition, capacity building and mitigation, what resources can we bring to bear to assist/surge, response, and reconstitution and recovery of host nation critical care capabilities. Addressing these led the panel to offer 33 suggestions. Due to the large number of suggestions the results have been separated into two sections, Part I: Infrastructure/Capacity in the accompanying manuscript, and Part II: Response/Recovery/Research in this manuscript.

Conclusions:  A lack of rudimentary Intensive Care Unit resources and capacity to enhance services plagues resource poor or constrained settings. Capacity building therefore entails preventative strategies and strengthening of primary health services. Assistance from other countries and organizations is often needed to mount a surge response. Moreover, the disengagement of these responding groups and host country recovery require active planning. Future improvements in all phases require active research activities.

evidence-based medicine  FREE TO VIEW
Sandra Zelman Lewis, PhD; Rebecca L. Diekemper, MPH; Cynthia T. French, PhD, MS, ANP-BC; Philip M. Gold, MD, FCCP; Richard S. Irwin, MD, Master FCCP on behalf of the CHEST Expert Cough Panel

Background:  This series of guidance documents on Cough, which will be published over time, is a hybrid of two processes: (1) evidence-based guidelines and (2) trustworthy consensus statements based on a robust and transparent process.

Methods:  The CHEST Guidelines Oversight Committee selected a non-conflicted Panel Chair and jointly assembled an international panel of experts in each clinical area with few, if any, conflicts of interest. PICO-based (population, intervention, comparator, outcome) key questions and parameters of eligibility were developed for each clinical topic to inform the comprehensive literature search. Existing guidelines, systematic reviews, and primary studies were assessed for relevance and quality. Data elements were extracted into evidence tables and synthesized to provide summary statistics. These, in turn, are presented to support the evidence-based graded recommendations. A highly structured consensus-based Delphi approach was employed to provide expert advice on all guidance statements. Transparency of process was documented.

Results:  Evidence-based guideline recommendations and consensus-based suggestions were carefully crafted to provide direction to healthcare providers and investigators who treat and/or study patients with cough. Manuscripts and tables summarize the evidence in each clinical area supporting the recommendations and suggestions.

Conclusions:  The resulting guidance statements are based on a rigorous methodology and transparency of process. The recommendations and suggestions provided meet almost all of the guidelines for trustworthiness developed by The Institute of Medicine and can be applied with confidence by physicians, nurses, other healthcare providers, investigators and patients.

original research 
Margarita Oks, MD; Krystal L. Cleven, MD; Jose Cardenas-Garcia, MD; Jennifer Ann Schaub, MD; Seth Koenig, MD, FCCP; Rubin I. Cohen, MD, FCCP; Paul H. Mayo, MD, FCCP; Mangala Narasimhan, DO, FCCP
Topics: ,

Background:  Point of care ultrasonography performed by frontline intensivists offers the possibility of reducing the use of traditional imaging in the medical intensive care unit (MICU). We compared the use of traditional radiographic studies between two MICU’s; one where point of care ultrasonography is used as a primary imaging modality to another where it is only used for procedure guidance.

Methods:  This was a retrospective 3 month chart review comparing the utilization of chest radiographs (CXR), computerized tomographic scans (CT) (chest and abdomen/pelvis), trans-thoracic echocardiography (TTE) performed by the cardiology service, and deep vein thrombosis (DVT) ultrasonography studies performed by the radiology service between two MICU’s of similar size, acuity and staffing levels.

Results:  Total number of admissions, patient demographics, and acuity of disease were similar between both MICU’s. Comparing the non-point of care ultrasonography MICU with the point of care ultrasonography MICU, there were 3.75±4.6 versus 0.82±1.85 (p<0.0001) CXR per patient; 0.10±0.31 versus 0.04±0.20 (p=0.0007) chest CT scans per patient; 0.17±0.44 versus 0.05±0.24 (p<0.0001) abdomen/pelvis CT scans per patient; 0.20±0.47 versus 0.02±0.14 (p<0.0001) radiology performed DVT studies per patient; and 0.18±0.40 versus 0.07±0.26 (p<0.0001) cardiology performed TTE per patient, respectively.

Conclusion:  The use of point of care ultrasonography in an MICU is associated with a significant reduction in the number of imaging studies performed by the radiology and cardiology services.

original research 
Giovanni Zagli, MD, PhD; Morena Cozzolino, MD; Alessandro Terreni, BSc; Tiziana Biagioli, BSc, PhD; Anna Lucia Caldini, BSc; Adriano Peris, MD
Topics: ,

Background  To facilitate the clinical diagnosis of ventilator-associated pneumonia (VAP) in the Intensive Care Unit (ICU), the clinical pulmonary infection score (CPIS) has been proposed, which, however, has shown a low diagnostic performance in subsequent studies. Here we propose a new score based on procalcitonin and chest echography with the aim of improving VAP diagnosis: the CEPPIS (Chest Echography and Procalcitonin Pulmonary Infection Score).

Methods  This is a retrospective pilot study in which patients admitted to the ICU of the Emergency Department (Careggi University Hospital, Florence, Italy) from Jan 2009 to Dec 2011 were considered. Patients were retrospectively divided into a microbiologically-confirmed VAP group or a control group, based on diagnosis of VAP and positivity of tracheal aspirate culture.

Results  A total of 221 patients were included, 113 in the microbiologically-confirmed VAP group and 108 in the control group. A CEPPIS score of >5 retrospectively fixed resulted to be significantly better in predicting VAP (OR 23.78, sensitivity 80.5%, specificity 85.2%) than CPIS >6 (OR 3.309, sensitivity 39.8%, specificity 83.3%). The AUC-ROC analysis also showed a significantly higher diagnostic value for CEPPIS >5 than CPIS >6 (AUC 0.829 vs 0.616, respectively; P < 0.0001).

Conclusions  In our pilot, exploratory analysis, CEPPIS had an acceptable and promising level of prediction effectiveness in VAP diagnosis. Prospective validation is needed to confirm the potential value of this score to facilitate VAP diagnosis.

original research 
Harold R. Collard, MD; Kevin K. Brown, MD; Fernando J. Martinez, MD; Ganesh Raghu, MD; Rhonda S. Roberts, MSPH; Kevin J. Anstrom, PhD for the IPFnet investigators
Topics: ,

Background:  The feasibility of an interventional clinical trial in idiopathic pulmonary fibrosis (IPF) using death and hospitalization as primary endpoints is an area of uncertainty. This manuscript aims to illustrate the impact of cohort enrichment and study duration on sample size requirements for IPF clinical trials in which death alone or death plus hospitalization serve as the primary endpoint, using data from a large well-characterized clinical trial population.

Methods:  Event rate estimates for death and hospitalization were determined from patients enrolled into the NIH-sponsored idiopathic pulmonary fibrosis clinical research network clinical trials. Standard sample size formulae were applied to estimate the total sample size required for varying gender, age, and pulmonary function (GAP) stage-based cohorts.

Results:  Risk estimates for death and hospitalization in the clinical trial cohort were substantially lower than published. An IPF trial with death as its primary endpoint, enrolling GAP stage 1 and 2 subjects over one year with a minimum follow-up of 1 year, would require an estimated 7986 subjects to achieve 90% power for a hazard ratio of 0.70. Alternatively, an IPF trial with death plus hospitalization as its primary endpoint, enrolling GAP stage 2 and 3 subjects over two years with a minimum follow-up of 1 year, would require an estimated 794 subjects for the same power and hazard ratio.

Conclusion:  Study design decisions, in particular cohort enrichment strategies, have a substantial impact on sample size requirements for IPF clinical trials using time to event primary endpoints such as death and death plus hospitalization.

original research 
Benoit Bataille, (MD); Beatrice Riu, (MD); Fabrice Ferre, (MD); Pierre Etienne Moussot, (MD); Arnaud Mari, (MD); Elodie Brunel, (MD); Jean Ruiz, (MD); Michel Mora, (MD); Olivier Fourcade, (MD, PhD); Michele Genestal, (MD); Stein Silva, (MD, PhD)
Topics: , , ,

Background.  (It has been suggested that the complementary use of echocardiography could improve the diagnostic accuracy of lung ultasonography (LUS) in acute respiratory failure (ARF) patients. Nevertheless, the additional diagnostic value of echocardiographic data when coupled to LUS is still debated in this setting. The aim of the current study was to compare the diagnostic accuracy of LUS and an integrative cardiopulmonary ultrasound approach (TUS) in patients with ARF.

Methods.  We prospectively recruited patients consecutively admitted for ARF in ICU (University Teaching Hospital) over a 12-month period. Inclusion criteria were age at least 18 years and the presence of criteria of severe ARF justifying ICU admission. We compared both LUS and TUS approaches and the final diagnosis determined by the panel of experts using machine-learning methods to improve the accuracy of the final diagnostic classifiers.

Results.  One hundred thirty-six patients were included (age 68 ± 15 yr; sex ratio 1). A 3 dimensional PLS-mod (partial least square and multinomial logistic regressions) was developed and subsequently tested using an independent sample of patients. Overall, the diagnostic accuracy of TUS was significantly greater compared to LUS (p < 0.05; learning and test sample). Comparisons between ROC curves shown that TUS significantly improve the diagnosis of cardiogenic edema (p < 0.001; learning and test samples), pneumonia (p < 0.001; learning and test samples) and pulmonary embolism (p <0.001; learning sample).

Conclusion.  This study demonstrated for the first time a significantly better performance of TUS compared to LUS in the diagnosis of ARF. The value of TUS approach was particularly important to disambiguate cases of hemodynamic pulmonary edema and pneumonia. We suggest that the patient’s bedside use of artificial intelligence methods in this setting, could pave the way for the development of new clinically relevant integrative diagnostic models.

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  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543