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Allocation of Scarce Resources During MCEs

Full Title: Evidence Review on the Allocation of Scarce Resources During Mass Casualty Events (MCEs)

Evidence-based Practice Center Systematic Review Protocol

May 2011

Background
The Key Questions
Analytic Framework
Methods
References
Definitions of Terms

Background

This evidence report will help our Nation prepare for large-scale health emergencies—one of 13 "urgent issues" flagged for immediate attention by the Government Accountability Office (GAO) shortly following the 2008 Presidential election.^1,2 The GAO's concern is based on ample evidence that our Nation's emergency care system, including emergency medical services (EMS), hospital-based emergency departments, and the inpatient wards and intensive care units (ICUs) of many hospitals, are so overburdened that currently, most are ill prepared to cope with a large-scale public health emergency,^3-5 whether the onset is sudden, as is typical of an earthquake or terrorist bombing,⁶ or protracted, as would be likely in case of a major hurricane, flood, infectious disease outbreak,⁷ or bioterrorism attack.⁸

Regardless of the etiology of a major disaster, it can be reasonably foreseen that under current conditions, health care providers and systems will be hard pressed to manage a large-scale surge of victims from a mass casualty event (MCE).⁹ In such incidents, demand for medical care resources is likely to quickly outstrip the capacity of local or even regional health care providers to meet each patient's needs at the level expected of modern health care delivery systems. When normally available resources are clearly insufficient to meet needs, health care providers must be prepared to implement contingency plans to boost delivery of services, and if this is inadequate, to shift rapidly from strategies designed to deliver optimal care to each patient to a modified approach calculated to do the most good for the most people with the resources at hand. The Institute of Medicine (IOM) terms this strategy "crisis standards of care." IOM's definition follows:

"Crisis standards of care" is defined as a substantial change in usual health care operations and the level of care it is possible to deliver, which is made necessary by pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane) disaster. This change in the level of care delivered is justified by specific circumstances and is formally declared by a state government, in recognition that crisis operations will be in effect for a sustained period. The formal declaration that crisis standards of care are in operation enables specific legal/regulatory powers and protections for healthcare providers in the necessary tasks of allocating and using scarce resources and implementing alternative care facility operations.¹⁰

Optimizing resource allocation in an MCE requires a multi-faceted approach that includes strategies to minimize unnecessary demand for health care services, to boost the supply of medical resources for those who need them, and to make difficult resource allocation decisions in crisis care situations. The development and implementation of these strategies requires, in turn, a multi-disciplinary approach that balances multiple considerations, including ethical and legal issues and the special needs of at-risk populations. To be successful, stakeholders from the provider community and the public must be actively engaged in the process of developing and implementing crisis standards of care. One of the first and most critical steps in this process is to systematically review the literature to identify, grade, and summarize relevant evidence regarding how best to approach and manage this process. That is the task we are about to undertake.

Our work will build on previous comprehensive governmental and non-governmental reviews, including important studies performed by the Assistant Secretary for Preparedness and Response (ASPR), a literature review conducted by the Agency for Healthcare Research and Quality (AHRQ) in 2007, a 2008 literature review performed by Koenig and colleagues for the State of California, and a Letter Report on "Crisis Standards of Care" produced by the Institute of Medicine's Forum on Medical and Public Health Preparedness for Catastrophic Events, hereafter referred to as the "IOM Letter Report." These reports provide a strong foundation for our review by creating a conceptual framework for the optimal allocation of scarce resources in MCEs. Our report will build on the framework by identifying existing and proposed allocation strategies, various ways groups have engaged providers and the public, and the key concerns of the public regarding implementation of crisis standards of care. Our report will describe the level of evidence regarding each of these topics. By highlighting the strengths and gaps in the existing evidence base, we hope to inform a research agenda that can quickly improve our Nation's capacity to prepare, respond, and quickly recover from large-scale health emergencies.

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The Key Questions

Key Question 1 (KQ1)

What current or proposed strategies are available to policymakers to optimize the allocation and management of scarce resources during mass casualty events (MCEs)? What outcomes are associated with these strategies? What factors act as facilitators or barriers to the implementation or effectiveness of strategies to optimize the allocation and management of scarce resources in MCEs?

PICOTS Framework for Key Question 1

Population: People who require medical treatment after an MCE. This population will include those who are physically injured and/or ill as a direct or indirect result of the mass casualty event as well as those with unrelated, but urgent, medical needs (e.g., treatment for heart attacks, stroke, kidney failure, or cancer). We will also address behavioral health needs in the setting of MCEs, including acute stress, grief, psychosis, and panic reactions.

Interventions: Strategies used by policymakers to optimize resource management. These include actions to reduce or redirect less urgent demand for emergency health care services, to increase the supply of needed medical resources, and when these actions are inadequate, to ethically allocate scarce medical resources in an optimal manner. Specific strategies that will be considered include:

Strategies focused on single or multiple components of the health system, including emergency medical services and dispatch, public health, hospital-based care, renal dialysis, home care, primary care, palliative care, mental health, and provider payment policies.
Actions taken in advance to prepare for large-scale public health events that could trigger a huge surge in demand for medical and health care resources (e.g., stockpiling).
Adaptive strategies that ensure effective incident command, control, intelligence gathering, and communication systems, since these are often necessary channels to implement other strategies that optimally manage and allocate resources.
Actions taken to maximize resources in order to avoid the need to shift to crisis standards of care; for example, actions to substitute, conserve, adapt, and/or reuse critical resources, including reuse of otherwise disposable equipment and supplies, expanding scope of practice laws, and altered approaches that maximize delivery of care.¹⁰
Actions taken to reduce or manage less urgent demand for health care services in order to avoid the need to adopt a crisis standard of care; for example, activating call centers or Web sites that provide information about when and where to seek treatment and how to adequately care for oneself or family members at home.
Strategies for making ethical allocation decisions when critical resources will otherwise be insufficient to meet the population's needs (i.e., "crisis standards of care").

Because the literature on some of these subtopics may be sparse, we may consider examining strategies for optimizing the allocation and management of scarce resources in related contexts such as organ transplantation, rural/remote medicine, and battlefield medicine. We will consult the technical expert panel (TEP) if we foresee having to pursue this course.

Comparators: Where possible, the intervention (use of a strategy) will be compared to no intervention (i.e., no change in the approach to resource allocation or management). We will also consider studies that compare an intervention to one or more alternative interventions.

Outcomes: Combination of:

Process measures (e.g., number of patients treated, amount of resources obtained, ability to maintain conventional standards of care, avoidance of crisis standards of care).
Health outcomes:
- Favorable (e.g., decreased mortality, decreased physical and/or psychological morbidity).
- Unfavorable (e.g., adverse events, such as preventable morbidity and/or mortality).
Other outcomes (e.g., ethical, legal, financial consequences; public perceptions of the intervention, public acceptance of or compliance with the intervention).

Timing: We will confine our review to studies addressing preparedness and response to MCEs. We will consider strategies that address the triggers or timing for returning to normal operations, but we will not examine strategies specifically addressing long-term recovery from MCEs.

Settings: All settings in which patient care might be directed/managed and delivered, including but not limited to pre-hospital triage locations (e.g., on-scene, in transport), emergency department triage and care, inpatient settings (e.g., operating room [OR], intensive care unit [ICU], ward), community health centers, urgent care facilities, long-term care institutions, primary and specialty care practices, skilled nursing facilities, home care agencies, and alternate care facilities.

Key Question 2 (KQ2)

What current or proposed strategies are available to providers to optimize the allocation of scarce resources during mass casualty events (MCEs)? What outcomes are associated with these strategies? What factors are identified as facilitators or barriers to the implementation or effectiveness of strategies to optimize the allocation of scarce resources?

PICOTS Framework for Key Question 2

Population: People who require medical treatment after a mass casualty event. This population will include those who are physically injured and/or ill as a direct or indirect result of the mass casualty event as well as those with unrelated, but urgent, medical needs (e.g., treatment for heart attacks, stroke, kidney failure, or cancer). We will also address behavioral health needs in the setting of MCEs, including acute stress, grief, psychosis and panic reactions.

Interventions: Strategies used by providers to maximize or allocate scarce medical resources. Strategies that will be considered include the following:

Strategies focused on single or multiple components of the health system, including emergency medical services and dispatch, public health, hospital-based care, renal dialysis, home care, primary care, palliative care, mental health, and provider reimbursement.
Actions taken in advance to prepare for large-scale public health events that could trigger a huge surge in demand for medical and health care resources (e.g., training staff, exercising plans, stockpiling critical supplies and equipment).
Adaptive strategies that ensure effective incident command and communication systems, since these are often necessary channels to implement other strategies that optimally manage and allocate resources.
Actions taken to maximize resources in order to avoid the need to adopt a crisis standard of care; for example, actions to substitute, conserve, adapt, and/or reuse critical resources, including reuse of otherwise disposable equipment or supplies, reallocation of staff from non-clinical to clinical functions (i.e., expanding scope of practice), and altered approaches to using staff to deliver care.¹⁰
Actions taken to reduce or manage less urgent demand for health care services in order to avoid the need to adopt a crisis standard of care; for example, activating call centers or Web sites that provide information about when and where to seek treatment and how to adequately care for oneself or family members at home.
Strategies for making allocation decisions when critical resources will otherwise be insufficient to meet the population's needs (i.e., "crisis standards of care").

Comparators: Where possible, the intervention (use of a strategy) will be compared to no intervention (i.e., no change in the approach to resource allocation or management), and when specified, to one or more alternative interventions.

Outcomes: Combination of:

Process measures (e.g., number of patients treated, amount of resources obtained, ability to maintain conventional standards of care, avoidance of crisis standards of care).
Health outcomes:
- Favorable (e.g., decreased mortality, decreased physical and/or psychological morbidity).
- Unfavorable (e.g., adverse events such as preventable morbidity and/or mortality).
Other outcomes (e.g., ethical, legal, financial consequences, public perceptions of the intervention, public acceptance of or compliance with the intervention).

Timing: We will confine our review to studies addressing preparedness and response to mass casualty events. We will consider strategies that address the triggers or timing for returning to normal operations, but we will not examine strategies specifically addressing long-term recovery from MCEs.

Settings: All settings in which patient care might be delivered, including but not limited to pre-hospital triage locations (e.g., on-scene, in transport), emergency department triage and care, inpatient settings (e.g., OR, ICU, ward), community health centers, urgent care facilities, long-term care institutions, primary and specialty care practices, skilled nursing facilities, home care agencies, and alternate care facilities.

Key Question 3 (KQ3)

What are the public's key perceptions and concerns (e.g., values, equity, transparency, communication, and public input) regarding the development and implementation of strategies to allocate and manage scarce resources during both actual and potential mass casualty events (MCEs)?

PICOTS Framework for Key Question 3

Population: The general public, with special attention paid to members of vulnerable populations, including for example, children and elders, individuals in minority groups, and individuals with special medical needs.

Interventions: Not applicable. This key question focuses on public opinions, perceptions, values, and norms regarding the development and implementation of strategies to allocate and manage scarce medical resources in a MCE.

Comparators: Studies may compare outcomes from a single setting when conventional standards of care are in effect, versus outcomes under constrained or crisis care standards. In addition, studies may compare outcomes of the same resource allocation strategy among individuals or communities with different characteristics, or they may compare outcomes of distinct resource allocation strategies in communities with similar characteristics.

Outcomes: Public opinions and/or perceptions of key issues related to the allocation and management of scarce medical resources in MCEs, including but not limited to: values, priorities, preferred methods of communication, and ethics.

Settings: No exclusions.

Key Question 4 (KQ4)

What current and proposed strategies are available to engage providers in discussions regarding the development and implementation of strategies to allocate and manage scarce resources both in planning for and during an MCE? What outcomes are associated with these strategies? What factors are identified as facilitators or barriers to engaging providers in these discussions?

PICOTS Framework for Key Question 4

Population: Health care providers, including executive and administrative personnel, chief medical officers, and other health care providers who lead health care facilities and associations, regardless of race, gender, ethnicity, religion, sexual orientation, or disability.

Interventions: Strategies for engaging providers in discussions regarding the allocation and management of scarce resources. Strategies for engaging providers include a wide range of activities intended to:

Contact and connect with providers (e.g., face-to-face, electronically, through provider associations).
Educate providers on key issues that need to be addressed (e.g., through continuing medical education (CME) activities and conferences).
Elicit dialog and discussion with and among providers (e.g., through workshops and tabletop exercises on medical decision making during "crisis care" situations, discussion groups).
Encourage provider participation in collaborative activities (e.g., CME credits).

Comparators: Where possible, the intervention will be compared to usual practice (i.e., without the provider engagement). Studies may also compare provider outcomes (including knowledge, attitudes, and self-reported or observed behavior) over time (e.g., before and after an intervention), as well as the impact of provider engagement upon collaborative efforts at the local/regional, state, and national levels. Additional information will also be included that compares interventions according to the experience and "readiness" of the provider audience characteristics.

Outcomes: Combination of:

Process outcomes (e.g., number of providers reached, provider satisfaction with the process).
Provider outcomes (e.g., changes in knowledge, attitudes and self-reported or observed behavior).
Local/regional, state, national outcomes (e.g., increased provider participation in Multi-Agency Coordination [MAC] groups).

Timing: No restrictions on timing.

Settings: We will confine our review to studies addressing preparedness and response to MCEs. We will consider strategies that address the triggers or timing for returning to normal operations, but we will not examine strategies specifically addressing long-term recovery from MCEs.

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Analytic Framework

Figure 1 depicts the analytic framework for the evidence review. Starting at the center of the figure, our framework reflects the two key objectives of strategies employed by policymakers and providers to ensure that patients receive the best care possible, under prevailing circumstances of an MCE. The first tier of strategies is focused on maximizing resource delivery in order to maintain, as much as possible, conventional standards of care. Many of these "resource maximization" strategies are aimed at assuring preparedness and anticipating exceptional resource needs in order to forestall serious shortages. If these measures are inadequate, health care providers and facilities may begin operating at "contingency capacity" (excessive but manageable) with the goal of forestalling or avoiding "crisis capacity" (extremely excessive and unmanageable under normal standards of care).

A second tier of strategies involves allocating and managing critically short resources in a manner designed to maximize outcomes for the population rather than for every individual patient. These strategies are typically employed in crisis conditions once efforts to maximize available resources have reached their limit. During a prolonged event, the health care system may shift in and out of "crisis care" over time as the event evolves. Thus, multiple strategies may be sequentially employed during an MCE depending on its rate of onset, magnitude, available resources, and capacity of the medical care system.

Our proposed framework distinguishes strategies that have been implemented and formally evaluated by policymakers and/or providers in actual MCEs from those that have been devised and perhaps tested in simulated circumstances, but never used in actual crisis conditions. Because large-scale MCEs are uncommon in the United States, field-validated strategies are likely to be rare. Therefore our systematic review will encompass both sets of strategies. Key Questions 1 and 2 focus on strategies developed or implemented by policymakers and providers, respectively. Question 3 focuses on public perceptions and concerns. Question 4 focuses on strategies designed to engage providers in developing and implementing strategies for allocating and managing scarce medical resources in an MCE.

Although the ultimate goal of resource maximization and allocation strategies in MCEs is to maximize health outcomes in the affected population, measuring these outcomes and attributing them to the medical care received poses significant challenges. Thus, our framework emphasizes the need to consider multiple measures of process and outcomes. Process measures (including numbers of patients treated, avoidance of crisis standards of care, and the effectiveness of resource deployment during the MCE), are likely to be the easiest to measure, but they may not adequately capture the impact of an actual or proposed strategy on population health outcomes. These include, but are not limited to: rates of survival and notable adverse events such as preventable morbidity and/or mortality. Other outcomes used to assess the effectiveness of strategies include ethical outcomes (e.g., perception of fairness and stewardship), legal outcomes (e.g., legal protections secured, or, conversely, lawsuits filed), and financial outcomes. We expect that process measures and non-health related outcomes will be commonly encountered in our review.

We conceptualize the outcomes of each strategy as having a feedback loop that may help policymakers and providers refine the strategy or develop new ones. Outcomes, especially adverse outcomes, are likely to influence public opinion of a strategy. Key Question 3 is crafted to address the public's key themes and concerns.

In ideal circumstances, strategies to maximize and allocate scarce resources are developed through collaborative processes undertaken within individual organizations, regional initiatives, or through statewide or national planning efforts. Large-scale provider-oriented collaboratives, in particular, may produce strategies that are relevant to bedside care and also acceptable to the public and policymakers. Key Question 4 is focused on identifying effective provider engagement initiatives.

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Methods

A. Criteria for Inclusion/Exclusion of Studies in the Review

General:
- Include peer-reviewed journal articles and grey literature (e.g. documents retrieved via LexisNexis, Internet, Web sites, etc.), State and Federal government reports, State and Federal plans, peer-reviewed reports/papers by nongovernmental organizations , policy and procedure documents, and specialty societies' clinical care guidelines.
- Include studies from both U.S. and international sources.
- Include English- and non-English-language publications.
- Exclude studies published prior to 1990.
- Exclude publications that only present conceptual frameworks.
- Include the following:
  - Randomized controlled trials.
  - Quasi-experimental evaluation design with data from real event(s).
  - Quasi-experimental evaluation design with data from a drill, exercise, or simulation.
  - Recommended strategies developed through a rigorous qualitative process.
- Primary attention will be paid to studies that consider such strategies in the context of an MCE. However, recognizing that the number of high-quality studies in this area may be small, studies that address the allocation of scarce medical resources in other relevant related contexts (e.g., organ transplantation, battlefield medicine, allocation of vaccine when the supply is limited) may also be included. A determination whether to expand the search to include other contexts will be made once all abstracts have been screened and the number of potential articles for inclusion has been established. If the set of included abstracts is too small to likely yield a reasonable set of high-quality studies, the search will be expanded.
Key Question 1:
- Include studies that describe the processes and/or outcomes (actual or expected) of strategies used by policymakers, or studies that result from the strategic direction provided by policymakers to maximize and allocate scarce resources during an MCE.
- Please go to the definitions section for detailed descriptions of policymakers, scarce resources, and MCEs.
Key Question 2:
- Include studies that describe the processes and/or outcomes (actual or expected) of strategies used by providers to maximize or allocate scarce resources during an MCE.
- Please see the definitions section for detailed descriptions of providers, scarce resources, and MCEs.
Key Question 3:
- Include studies that describe, from a systematic data collection effort, public opinion regarding the implementation of strategies for allocating scarce resources in an MCE.
- Studies can consider the general population or sub-populations of interest such as minority groups and other at-risk populations.
Key Question 4:
- Include studies that describe processes and outcomes of strategies used to engage providers in discussions regarding the allocation of scarce resources; for example, the strategy of eliciting dialog through workshops and tabletop exercises on medical decisionmaking during "crisis care" situations.
- Please see the definitions section for detailed description of providers.

B. Searching for the Evidence: Literature Search Strategies for Identification of Relevant Studies to Answer the Key Questions

Our search strategy will leverage existing reviews of the literature, including but not limited to those included in the Institute of Medicine's Letter Report and Summary on Crisis Standards of Care^10-11 and AHRQ/ASPR's Community Planning Guide on Providing Mass Medical Care with Scarce Resources.¹² These existing reviews will help identify relevant medical care resource management and allocation strategies in existence at the time these documents were published, and summary information on the relevant outcomes of these strategies. Building on this work will help us focus our search. Depending on the yield of historical and more recent studies from the abstract screening process, we may extend our search beyond MCEs to related contexts such as resource allocation decisions in organ transplantation, remote or austere conditions (e.g., post-conflict, post-disaster, or war zones), and shortages of vaccines. Once abstract screening is complete we will decide, based on past experience, whether the set of potential studies for inclusion is likely to yield a reasonable set of high-quality studies to be reviewed. If the decision is not clear, we will seek input from the technical expert panel (TEP) about whether to expand the search to other contexts. If appropriate, we will formally amend the protocol.

Our literature search will be comprised of four parts: (1) a formal search using multiple research databases, (2) a scan of the "grey" literature, (3) a review of current State plans, and (4) consultation with our TEP for any additional sources. We will consult with an expert librarian at the National Institutes of Health (NIH) who has conducted literature searches in this area on behalf of the Assistant Secretary for Preparedness and Response (ASPR). We will work closely with a team of research librarians to develop and refine our overall search strategy and algorithms to search each research database.

Due to the cross-disciplinary nature of this topic, our formal literature search will use research databases beyond those covering the biomedical literature. We will consider the following databases: MEDLINE®, Scopus, EMBASE, CINAHL, Global Health, Web of Science®, and the Cochrane Database of Systematic Reviews. We will also search online library catalogs such as the National Library of Medicine's LocatorPlus to identify relevant books. We will finalize the set of databases to be searched through consultation with our TEP. We will construct search algorithms for each database, execute the search, download the results into individual EndNote® libraries, combine the libraries resulting from each search, and delete duplicate references. We will also conduct "forward searches" of key references using the Web of Science database.

Our search of the grey literature will include a search of the New York Academy of Medicine's Grey Literature Report, which will help identify reports from research and advocacy organizations, including peer-reviewed reports. For information relating to public opinion on allocation strategies, we will search Lexis-Nexis. We will compile a list of key Web sites, including U.S. and international agencies, such as the Department of Health and Human Services, the Centers for Disease Control and Prevention, the Veterans' Health Administration (VHA), and the U.K.'s National Institute for Health and Clinical Excellence (NICE) for additional information on resource allocation strategies used by policymakers or health care providers. We will also search for relevant peer reviewed reports/papers from non-governmental organizations such as Trust for America's Health. In addition, the TEP has identified a number of relevant studies that we will seek to obtain.

We will then review the set of State plans provided to us by our Federal partners. As needed, we will conduct Web searches to obtain additional State plans. In some cases, we may contact State health department personnel via coordination with ASPR Regional Emergency Coordinators to gather additional plans for review.

C. Data Abstraction and Data Management

Selecting studies for inclusion in the evidence review

First, one researcher will conduct a title screen and eliminate citations that are clearly unrelated to the topic. Two researchers will then independently review all abstracts and make a determination on whether each should be included or excluded according to specific criteria for each key question. When there is disagreement between the reviewers about whether an abstract should be included or excluded a third researcher will be asked to review the abstract and reconcile the difference.

At the full-text review stage, two researchers will independently review the articles and make a determination as to whether the article should be included for data abstraction. When there is disagreement between the reviewers about whether a study should be included or excluded a third researcher will be asked to review the article and resolve the difference. We will maintain an electronic file of excluded studies with the reason(s) for exclusion.

Data collection forms

We will develop a data collection form to capture the necessary data elements needed to answer all of the study's key questions. Data elements will include: study design, geographic location, practice setting characteristics, details of the strategy (including the development process and specific protocols), outcomes reported, and unintended consequences.

Data quality control

The data collection form will be pilot tested on a sample of articles to assess appropriateness and consistency of use. The data collection form will be revised as needed based on the pilot test. When the data collection form has been finalized, two researchers will independently review each article and abstract the needed data. The data will then be entered into a database to manage and organize the information. When there is a difference in the data abstracted between the two reviewers, a third researcher will be asked to review the article and resolve any differences.

Topic leads will periodically conduct random audits of the abstraction process to ensure the accuracy of coding.

D. Assessment of Methodological Quality of Individual Studies

Because few if any studies of this topic are likely to be randomized controlled trials, conventional techniques used in the biomedical literature to evaluate the quality of studies within the broader category, such as the Jadad¹³ scale, will not be useful. Given the diversity in methodologies and outcomes we are likely to encounter, we will require a more generic quality rating system. We evaluated existing rubrics, such as the Substance Abuse and Mental Health Services Administration's (SAMHSA's) National Registry of Evidence-based Programs and Practices (NREPP) for use in this systematic review. The NREPP approach uses 6 criteria to assess study quality: (1) reliability of measures, (2) validity of measures, (3) intervention fidelity, (4) missing data and attrition, (5) potential confounding variables, and (6) appropriateness of the analysis. Where necessary, we have modified the rating system so that it is more responsive to the studies we are likely to include in our review. For example, we anticipate that very few studies will report reliability coefficients for each outcome. In these cases, we will therefore assess reliability through a qualitative assessment of the data sources and the data collection techniques used in each study. In addition, we expect that some studies may only report qualitative data on the allocation strategy and associated outcomes. In these cases, we will use methods described by Lincoln and Guba¹⁴ to appraise the quality of qualitative research studies. Studies are assessed on whether they are credible (i.e., level of confidence in the "truth" of the findings), transferable (i.e., extent to which findings have applicability in other contexts), dependable (i.e., extent to which findings are consistent and could be repeated), and confirmable (i.e, degree of neutrality or the extent to which the findings of a study are shaped by the respondents and not researcher bias, motivation, or interest). Within each assessment category we will employ techniques outlined by Lincoln and Guba¹⁴ to establish that the assessment criteria are met (e.g., use of triangulation to establish credibility).

Because many studies included in our review may report effectiveness outcomes using both quantitative and qualitative data, we will merge domains from both the NREPP and from Lincoln and Guba.

E. Data Synthesis

We will develop flow diagrams of our literature search following established EPC protocols, including specifying the number of studies eliminated at each stage. We will construct data tables containing key variables and a narrative review of our findings. Because of the diversity of studies addressing any one key question, we will organize the studies into categories and synthesize the evidence within each category. A priori, we have identified four broad categories, which we reviewed with the TEP. These include (1) strategies to manage or reduce less urgent demand for health care services, (2) strategies to maximize use of existing resources, (3) strategies to augment resources, and (4) strategies for ethical decisionmaking regarding the allocation (or reallocation) of scarce medical resources. The set of categories will be expanded to be more specific as needed to best organize the evidence to be presented in the report. Within each category, the evidence regarding the impact of the strategy on health outcomes (e.g., reduced mortality and/or morbidity, adverse events) will be given the highest priority. Where there is no evidence regarding the impact of the strategy on health outcomes, we will present evidence of the impact on process measures.

Although we will attempt to conduct meta-analyses if and when possible, our working assumption is that the evidence will not be amenable to this approach due to the diversity of strategies considered, the qualitative nature of the methods used, and the wide range of potential outcomes we will likely encounter. We will highlight differences in outcomes across patient subgroups to the extent these data are reported in individual studies. After finishing our review, we will draw conclusions where clear evidence exists. Where the evidence is not clear (e.g., results from included studies are conflicting), we will summarize the strength of the evidence and highlight where additional research would be beneficial.

F. Grading the Evidence for Each Key Question

We believe the approach for grading the strength of evidence outlined in the Methods Guide for Effectiveness and Comparative Effectiveness Reviews will be appropriate for this review.¹⁴ This approach requires assessment in four domains: risk of bias, consistency, directness, and precision. Risk of bias refers to the internal validity of each study and relies heavily on study design and the aggregate quality of the included studies. Scores in this domain will be denoted as high, medium, or low. Consistency is a measure of the extent to which effect sizes for the set of studies are similar in size and direction. After assessing this domain the EPC will designate the evidence as consistent or inconsistent. Directness refers to the degree to which the strategies have an impact on health outcomes rather than intermediate outcomes. In this domain the evidence is deemed either direct or indirect. Finally, precision refers to the level of certainty surrounding the set of effect estimates. For this domain, the evidence will be rated as precise or imprecise. After making assessments in the four domains, the strength of the evidence will be graded, using the four point scale (i.e., high, moderate, low, or insufficient), for the selected strategy categories and outcomes within each key question.

G. Assessing Applicability

The applicability of studies refers to the extent to which the effects observed in published studies are likely to reflect the expected results when a specific intervention is applied to the population of interest under "real world" conditions. The PICOTS framework is a useful way to organize factors that may affect the applicability of studies. A priori, we have identified a number of factors that may affect the applicability of studies that will be included in the review. First, in the area of study population, we expect that many studies will evaluate the use of allocation strategies in a particular geographic area and that therefore the effects may be specific to the demographic composition of that area. The setting of the studies may also limit applicability. For instance, the organizational structure of and level of coordination across emergency response organizations in a community could modify the effect of the strategy on the outcomes of interest. In particular, studies describing resource allocation strategies used during MCEs in other countries may not be generalizable to domestic MCEs. It is also possible that the same strategy would have different effects depending on whether a disaster declaration was made. In some cases the data on effects of the intervention may be from exercises, drills, or simulations. To the extent that these differ from actual disasters, it may be difficult to apply the results more generally. Similarly, the type of disaster (e.g., pandemic influenza, chemical attack) for which the strategy was used could modify the effect on the outcomes of interest.

To facilitate our assessment of the applicability of the studies included in the review, we will extract data, where available, on the factors that we have identified a priori as most likely to affect applicability—demographics of study population, organizational structure for emergency response in a community, whether a disaster declaration was made, whether the data are from a drill, exercise, simulation, or real event, and the type of disaster.

Once the data have been extracted, we will assess the applicability of each study. We will then consider and summarize the applicability of the body of evidence using the individual dimensions of the PICOTS framework.

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References

1. U.S. Government Accountability Office (GAO) Web site: Strengthening Preparedness for Large Scale Public Health Emergencies. Available at at http://www.gao.gov/highrisk/risks/national-challenges-public-health/. Accessed Oct. 8, 2010.

2. U.S. Government Accountability Office (GAO), Emergency Preparedness: States are Planning for Medical Surge, but Could Benefit from Shared Guidance for Allocating Scarce Medical Resources, GAO-08-668, Washington, D.C., June 2008.

3. Institute of Medicine Committee on the Future of Emergency Care in the U.S. Health System. Hospital Based Emergency Care: At the Breaking Point. Washington D.C. The National Academies Press, 2006.

4. Institute of Medicine Committee on the Future of Emergency Care in the U.S. Health System. Emergency Medical Services: At the Crossroads. Washington, D.C. The National Academies Press, 2006.

5. Institute of Medicine Committee on the Future of Emergency Care in the U.S. Health System. Pediatric Emergency Care: Growing Pains. Washington, D.C. The National Academies Press, 2006.

6. National Center for Injury Prevention and Control. In a Moment's Notice. Surge Capacity for Terrorist Bombings. Atlanta (GA): Centers for Disease Control and Prevention, 2007.

7. Centers for Disease Control and Prevention. FluSurge. Available at http://www.cdc.gov/flu/flusurge.htm. Accessed April 19, 2011.

8. Kaji AH, Koenig KL, Lewis RJ. Current hospital preparedness. JAMA 2007;298(18):2188-90.

9. Salinsky E. Strong as the Weakest Link: Medical Response to a Catastrophic Event. National Health Policy Forum Background Paper, No. 65. August 8, 2008.

10. IOM (Institute of Medicine). Guidance for establishing crisis standards of care for use in disaster situations: A letter report. Washington, DC: The National Academies Press, 2009.

11. IOM (Institute of Medicine). Crisis standards of care: Summary of a workshop series. Washington, DC: The National Academies Press, 2010.

12. Phillips SJ, Knebel A, eds. Providing Mass Medical Care with Scarce Resources: A Community Planning Guide. Prepared by Health Systems Research, Inc., under contract No. 290-04-0010. AHRQ Publication No. 07-0001. Rockville, MD: Agency for Healthcare Research and Quality, 2006.

13. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17(1):1-12.

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15. Owens DK, Lohr KN, Atkins D, Treadwell JR, Reston JT, Bass EB, Chang S, Helfand M. AHRQ series paper 5: Grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health Care Program. J Clin Epidemiol 2010 May;63(5):513-23.

16. National Health Security Strategy of the United States of America. Washington, DC: U.S. Department of Health and Human Services, 2009.

17. Agency for Healthcare Research and Quality. Altered Standards of Care in Mass Casualty Events: Bioterrorism and Other Public Health Emergencies. AHRQ Publication No. 05-0043, Apr 2005.

18. Phillips SJ, Knebel A, Johnson K, eds. Mass Medical Care With Scarce Resources: The Essentials. AHRQ Publication No. 09-0016. Rockville, MD: Agency for Healthcare Research and Quality, 2009.

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Definitions of Terms

1. Mass casualty event (MCE): A natural (e.g., earthquake, pandemic) or man-made (e.g., detonation of a nuclear device, conventional explosive, bioterror attack) incident that suddenly or progressively generates large numbers of injured and/or ill people who require medical and/or mental health care. The magnitude of this increase in demand for medical care resources has the potential to outstrip the ability of local or regional public health and health care delivery systems to deliver medical care services consistent with established standards of care.

2. Scarce resources: Medical care resources that are likely to be scarce in a crisis care environment, including: physical items (e.g., medical supplies, drugs, beds, equipment), services (e.g., medical treatments, nursing care, palliative care), and health care personnel (e.g., physicians, nurses, psychologists, laboratory technicians, other essential workers).

3. Policymakers: Government officials and agencies at the Federal, State, regional, and local level that have authority to develop and enforce policies and protocols that drive decisionmaking, for example:

Federal departments and agencies (e.g., HHS, DHS, DoD).
State and local public health officials.
State governing officials (e.g., governor, State legislature).
Local governing officials (e.g., mayor, city council, county supervisors).
State and local emergency management officials.
Tribal officials.
International health officials (e.g., WHO, PAHO).

4. Providers: Individuals who may provide healthcare services during an MCE, for example:

Licensed individuals such as physicians, nurses, social workers, pharmacists, paramedics.
Health care organizations such as health maintenance organizations (HMO), private practices, home care agencies, community health centers, emergency medical services organizations, non-governmental organizations.
Health care facilities/institutions such as acute care hospitals, skilled nursing facilities, long-term care institutions, psychiatric care facilities .
Health responder teams for catastrophic events (e.g. international, NGOs, military).
Volunteers.

5. Public: All community members and individuals not addressed as policymakers or health care providers, regardless of gender, race, ethnicity, sexual orientation, age, disability, setting, health status, or other defining characteristic.

6. Provider engagement: A wide range of activities intended to:

Contact and connect with providers.
Elicit dialog and discussion with and among providers.
Encourage provider participation in collaborative activities.

7. Crisis standards of care: A substantial change in usual health care operations and the level of care it is possible to deliver, which is made necessary by a disaster that is pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane). This change in the level of care delivered is justified by specific circumstances and is formally declared by a state government, in recognition that crisis operations will be in effect for a sustained period. The formal declaration that crisis standards of care are in operation enables specific legal/regulatory powers and protections for health care providers in the necessary tasks of allocating and using scarce resources and implementing alternative care facility operations.

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Note: The following protocol elements are standard procedures for all protocols.

Review of Key Questions

For all EPC reviews, key questions were reviewed and refined as needed by the EPC with input from the Technical Expert Panel (TEP) to assure that the questions are specific and explicit about what information is being reviewed.

Technical Experts

Technical Experts comprise a multi-disciplinary group of clinical, content, and methodologic experts who provide input in defining populations, interventions, comparisons, or outcomes as well as identifying particular studies or databases to search. They are selected to provide broad expertise and perspectives specific to the topic under development. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, study questions, design, and/or methodological approaches do not necessarily represent the views of individual technical and content experts. Technical Experts provide information to the EPC to identify literature search strategies and recommend approaches to specific issues as requested by the EPC. Technical Experts do not participate in analysis of any kind nor do they contribute to the writing of the report. They have not reviewed the report except as given the opportunity to do so through the public review mechanism.

Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Individuals are invited to serve as Technical Experts because of their unique clinical or content expertise, and those who present with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified.

Peer Reviewers

Peer reviewers are invited to provide written comments on the draft report based on their clinical, content, or methodologic expertise. Peer review comments on the preliminary draft of the report are considered by the EPC in preparation of the final draft of the report. Peer reviewers do not participate in writing or editing of the final report or other products. The synthesis of the scientific literature presented in the final report does not necessarily represent the views of individual reviewers. The dispositions of the peer review comments are documented and will, for CERs and Technical briefs, be published three months after the publication of the Evidence report.

Potential Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Invited Peer Reviewers may not have any financial conflict of interest greater than $10,000. Peer reviewers who disclose potential business or professional conflicts of interest may submit comments on draft reports through the public comment mechanism.

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Current as of May 2011

Internet Citation:

Allocation of Scarce Resources During Mass Casualty Events (MCEs), Review Protocol. May 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/tp/scarcerestp.htm