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Early diagnosis of persons infected with human immunodeficiency virus (HIV) through diagnostic testing and screening is a critical priority for individual and public health. Emergency departments (EDs) have an important role in this effort. As EDs gain experience in HIV testing, it is increasingly apparent that implementing testing is conceptually and operationally complex. A wide variety of HIV testing practice and research models have emerged, each reflecting adaptations to site-specific factors and the needs of local populations. The diversity and complexity inherent in nascent ED HIV testing practice and research are associated with the risk that findings will not be described according to a common lexicon. This article presents a comprehensive set of terms and definitions that can be used to describe ED-based HIV testing programs, developed by consensus opinion from the inaugural meeting of the National ED HIV Testing Consortium. These definitions are designed to facilitate discussion, increase comparability of future reports, and potentially accelerate wider implementation of ED HIV testing.
The importance of human immunodeficiency virus (HIV) testing in the emergency department (ED) has long been recognized,1 and the Centers for Disease Control and Prevention (CDC) recently charged emergency providers with making HIV testing a “routine” part of clinical emergency medical care.2 Although still in its infancy, ED-based HIV testing has grown beyond the few initial pioneering centers.3–12 Ongoing clinical programs, research studies, and demonstration projects are under way in many EDs, often with funding from a variety of organizations, including health departments, the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), the CDC, and various private foundations. The programmatic details of ED HIV testing are complex and are highly dependent on individual settings. As a result, variations in methods for ED HIV testing are becoming increasingly apparent.7,11,13–24
As ED HIV testing evolves beyond feasibility studies to larger-scale implementation, objective data that allow comparison of research and program experiences are needed. Productive debate and translation of knowledge is enhanced by transparent and consistent use of common terminology that decreases the likelihood of misinterpretation or ambiguity. The existence of terminology ambiguity in relation to ED-based HIV testing is already apparent in the literature,14,17,25 and thus it is timely to develop consensus nomenclature and definitions. In November 2007, an open-invitation panel of experts was convened in part for that purpose.
An organizing committee of emergency researchers with experience in ED-based HIV testing planned a national meeting to systematically discuss key issues related to ED-based HIV testing, including terminology and definitions, guidelines for reporting practices and research findings, ethical and regulatory issues, operational variables, and screening impact. The inaugural conference of the National Emergency Department HIV Testing Consortium convened in Baltimore, Maryland, on November 12, 2007. Invitations to attend the conference were extended to those known by the conference organizers to be involved in existing or planned ED-based HIV testing at academic and community institutions. Attendees were encouraged to further distribute invitations to other potential participants from other institutions. Selected leadership organizations were also asked to send representatives. In total, there were 98 attendees at the conference, and 42 healthcare institutions from around the country were represented. Organizational representatives included those from the Society for Academic Emergency Medicine (SAEM), the American College of Emergency Physicians (ACEP), the HIV Medicine Association (HIVMA), and the CDC, as well as state health departments, advocacy organizations, and foundations.
A primary goal of the conference was to develop consensus definitions that would provide a common lexicon for the reporting of results from ED-based HIV testing research and clinical programs. A related goal was to develop a reporting guideline using these consensus definitions that would further characterize optimal presentation and content when preparing submissions relevant to ED-based HIV testing. Prior to the meeting, the primary authors of this article prepared a set of terms and definitions with an associated draft reporting guideline for ED-based HIV testing efforts, derived from their combined experiences and knowledge of the field. All conference attendees were encouraged to review a discussion guide, the draft definitions, the reporting guideline, and several pertinent manuscripts,2,14,17 which were all distributed 1 month prior to the conference. The discussion guide listed questions that would be posed during the conference and specifically highlighted key areas of likely controversy, where there was known ambiguity and new approaches were being proposed.
Conference attendees were divided into four groups of 20–25 persons. Each group attended a 70-minute discussion session focused on development of consensus definitions and reporting guidelines. Conference organizers formed the groups in advance of the meeting and attempted to diversify the group composition to provide a mixture of persons from different academic, clinical, and institutional backgrounds. Each group session was led by a trained focus-group facilitator, and the session proceedings were recorded by video tape, audio tape, and a scribe. One of four moderators (MSL, CJL, JSH, RER; the primary authors) was present at each of the sessions to answer questions and provide any needed clarification about the definitions, the intent of the project, and the scope of the discussion sessions.
The focus group facilitator used a structured guide to direct discussion. Participants were first asked to initiate the discussion with any points they wanted to raise about content, scope, or consensus process. Following these discussions, the facilitators posed predetermined questions that the moderators believed might be the most controversial or contain areas of ambiguity.
After the consensus conference, the primary authors reviewed all comments recorded by the scribe and facilitator. In addition, the lead author reviewed the session recordings to ensure that the scribe and facilitator records accurately and completely reflected the discussion content. The primary authors then revised the definitions according to input from conference participants. Conference participants were sent electronic copies of the revised definitions for further review using an electronic listserv, in the attempt to not only promote critique, but further public discussion.
After reviewing further critiques and then finalizing the consensus definitions, the first draft of this article was developed by the primary authors and distributed to the larger group of core authors for further revision. Finally, the draft was distributed to all conference participants, including organizational representatives, for final comment to ensure that it ultimately reflected consensus. This article contains the final version of the terms and definitions developed via the consensus process described. A follow-up article utilizing these definitions will serve to provide the detailed consensus guideline for reporting on ED HIV testing.
The global organization of the consensus definitions is illustrated in Figure 1, which shows the categorization of key steps in the HIV testing process according to setting, procedures for recruitment and consent, postconsent program methods, and outcome measures. Each of these four content areas is linked to related tables of terminology and corresponding definitions (Tables 1–4). A table defining key summary measures of the testing process is also provided (Table 5). No further text accompanying the definitions is provided, as they are designed to be self-explanatory. Accordingly, detailed review of problems in prior terminology or specific justifications of each new term or definition are not provided in this report. Notably, conference participants consistently expressed the need for clarification of terminology and demonstrated the ability to achieve consensus via discussion
The suggested utility of these terms and definitions is to provide a blueprint for conceptualizing and describing ED-based HIV testing. The framework outlined here should accelerate knowledge translation by providing a common lexicon to facilitate discussion and interpretation of what would otherwise be an ambiguous evidence base. Clarity of discourse should enhance site-specific operational planning as ED HIV testing expands. These definitions are not themselves sufficient to constitute a reporting guideline; the definitions will determine the terminology used in reporting, but do not specify what is reported. Accordingly, an article that fully describes consensus guidelines for ED HIV testing reporting will be developed.
It is important to note that these definitions are not intended as a dictum for ways in which HIV testing should be conducted. No element of this guideline is designed to promote or detract from past, current, or future clinical or operational practice. Some definitions are not likely to be relevant to contemporary or future emergency medicine (EM) practice (i.e., mandatory testing) and are included to clarify alternate terms. Further, future studies or reports of ED HIV testing may not include all or even the majority of elements described herein. Finally, the definitions were not developed with consideration of operational practices specific to postexposure situations and therefore do not necessarily pertain to HIV testing after blood or body fluid exposures.
The definitions are intended to have real or potential utility within the context of EM and may not be completely compatible with other healthcare settings. Where these definitions differ from what has been used previously, changes were deemed necessary to be responsive to the EM context. Despite these caveats, the consensus process included participants from a diversity of public health and healthcare backgrounds, and many of the clarifications contained herein may ultimately prove valuable to those involved with testing in other settings as well.
Several key terms deserve special comment.
By examining the diversity of factors relevant to the operation of ED-based HIV testing programs, the complexity and variability inherent in the process become apparent. The definitions provided in this article reflect consensus opinions provided by a convened group of ED clinicians and researchers, public health officials, HIV medicine clinicians, HIV advocates, and other groups. The purpose of the conceptual framework outlined here is to enhance translation of HIV testing to clinical practice by providing a common lexicon to aid interpretation of these programs and research efforts. A standardized nomenclature with which to describe implementation and research in ED HIV testing should facilitate and accelerate knowledge translation as institutions experiment and report on novel approaches to ED HIV testing.
Dr. Lyons was supported by a mentored, patient-oriented career development award from the National Institute for Allergy and Infectious Diseases (NIAID/NIH) K23 AI068453; Dr. Haukoos was supported by an independent scientist award from the Agency for Health Research and Quality (AHRQ) (K02 HS017526), a cooperative agreement from the Centers for Disease Control (CDC) (U18 PS000314), and an unrestricted grant from Abbott Laboratories; Dr. Merchant was supported by a mentored, patient-oriented career development award from the NIAID/NIH K23 AI060363; Dr. White was supported by a cooperative agreement from the CDC (U18 PS000314); and Dr. Rothman was supported by a grant from the Maryland Department of Health and Mental Hygiene and a cooperative agreement with the CDC through a contract with the Agency for Health Research and Quality.
This first meeting of the National ED HIV Testing Consortium was funded by an unrestricted grant from Gilead Sciences, Inc., with organizational support from the Health Research and Educational Trust (HRET) of the American Hospital Association. The Consortium Conference was held at Johns Hopkins University in Baltimore, Maryland, with the assistance of the Johns Hopkins Department of Emergency Medicine.
The following contributing authors attended the consensus conference and were included in the subsequent processes of manuscript review described herein.
Gretchen Torres, MPP, of HRET, and Samantha Connell and Judy B. Shahan, RN, MBA, of Johns Hopkins University supplied extensive effort for meeting organization and facilitation of post-conference communication. The Center for Prevention, AIDS Administration Maryland Department of Health & Mental Hygiene provided discussion facilitators; Suzanne Kinsky, MPH, was highly instrumental in achieving comprehensive and open discussion during the conference. Chadd Krauss worked as a scribe for the discussion sections and assisted with compiling comments provided by participants. The authors acknowledge the support of the Society for Academic Emergency Medicine (SAEM) and their representative to the National Emergency Department HIV Testing Consortium, Dr. Debra Houry.
The authors additionally acknowledge the following organizations who contributed participants to the Consortium Conference:
American College of Emergency Physicians
Baltimore City Health Department
Centers for Disease Control and Prevention
Colorado Department of Public Health and Environment
Georgia AIDS Coalition
Gilead Sciences, Inc.
HIV Medicine Association
Health Research & Educational Trust, American Hospital Association
Inova Juniper Program
Philadelphia Department of Public Health and Health Federation of Philadelphia
Society for Academic Emergency Medicine
All attendees from the 2007 conference are listed as contributing authors in Appendix A.