The inadequacies of community consultation in emergency medicine research: a proposal for revising the rule

The inadequacies of community consultation in emergency medicine research: a proposal for revising the rule

730 Correspondence [2] Trinquart L, Ray P, Riou B, Teixeira A. Natriuretic peptide testing in EDs for managing acute dyspnea: a meta-analysis. Am J ...

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Correspondence

[2] Trinquart L, Ray P, Riou B, Teixeira A. Natriuretic peptide testing in EDs for managing acute dyspnea: a meta-analysis. Am J Emerg Med 2011;29: 757–67. [3] Golcuk Y, Golcuk B, Velibey Y, Oray D, Atilla OD, Colak A, et al. Predictive cutoff point of admission N-terminal pro-B-type natriuretic peptide testing in the ED for prognosis of patients with acute heart failure. Am J Emerg Med 2013;31: 1191–5.

Compensatory “eryhtrocytosis” in cyanotic heart disease

To the Editor, We read with great pleasure the work by Wu and Tseng [1]. Indeed, the clinical presentation of pulmonary embolism (PE) can mimic as hypercyanotic crisis or Tet spells in a patient with tetralogy of Fallot. Furthermore, the presence of telltale sign of Tet spells, that is, profound hypoxia and cyanosis in patients with tetralogy of Fallot, decreases the clinical suspicion of PE. The authors maintained a commendable degree of clinical suspicion; however, we would like to highlight an additional important consideration in this case. The authors use the term compensated polycythemia, referring to an outcome in patients with cyanotic congenital heart disease causing an increase in blood viscosity and thromboembolic events. “Polycythemia” refers to increase in more than 1 cell lines in bone marrow. As a matter of fact, hypoxia in cyanotic congenital heart disease is a trigger for “erythrocytosis,” that is, proliferation of red blood cell lines and thereby increased red cell mass [2,3]. Therefore, we recommend using the term compensatory erythrocytosis instead of compensated polycythemia. The Wells score is truly not validated in cyanotic heart disease. Nevertheless, one must remember that these patients have a slightly higher risk than general population for the development of PE given their underlying hyperviscosity [4]. Thus, a clinical suspicion for PE is perhaps very reasonable if there is no clinical improvement with the conventional therapy for Tet spells.

Vinod K. Chaubey, MD Department of Medicine, Saint Vincent Hospital University of Massachusetts Medical School, Worcester, MA Corresponding author. 123 Summer St, Worcester, MA 01604 Tel.: +1 508 363 5000; fax: +1 508 363 9798 E-mail address: [email protected] Lovely Chhabra, MD Department of Cardiovascular Medicine, Hartford Hospital University of Connecticut School of Medicine, Hartford, CT

http://dx.doi.org/10.1016/j.ajem.2015.02.053

References [1] Wu IL, Tseng JC. Pulmonary embolism in a patient of tetralogy of Fallot: a diagnostic challenge. Am J Emerg Med 2014. http://dx.doi.org/10.1016/j.ajem.2014.12.061 [pii: S0735-6757(14)00982-6]. [2] Perloff JK, Marelli AJ, Miner PD. Risk of stroke in adults with cyanotic congenital heart disease. Circulation 1993;87:1954–9. [3] Lee FS. Genetic causes of erythrocytosis and the oxygen-sensing pathway. Blood Rev 2008;22(6):321–32. [4] Wolf SJ, McCubbin TR, Feldhaus KM, Faragher JP, Adcock DM. Prospective validation of Wells Criteria in the evaluation of patients with suspected pulmonary embolism. Ann Emerg Med 2004;44(5):503–10.

The inadequacies of community consultation in emergency medicine research: a proposal for revising the rule To the Editor, The 21 Code of Federal Regulations §50.24 is a federal regulation that permits an institutional review board (IRB) to issue a waiver of informed consent [1]. Before a waiver is granted to an investigator, an IRB may require him or her to consult a community located in the area where study subjects will be drawn. This requirement is known as community consultation (CC). Yet, many investigators find it difficult to satisfy the CC requirement because there is no clear definition of this process [2-7]. One alternative is a less centralized active process that the United States Congress uses that is known as fire-alarm oversight, a term created by McCubbins and Schwartz [8]. Fire-alarm oversight begins with a congressperson establishing an informal procedure that will enable an individual and interest group to examine the decisions of an administrative agency [8]. For example, an individual may contact a congressperson by notifying their local congressional office or attending a town hall meeting. When an individual alerts a congressperson of an administrative problem, it is referred to as activating the alarm [8]. Conversely, when a congressperson creates a way for constituents to contact him or her, such as at a town hall meeting, it is referred to as creating an alarm box [8]. Just as congressional leaders can create an alarm box, investigators have the capability of performing a similar task. For instance, Northfield Laboratories Incorporated, a clinical research sponsor, and investigators at Duke University, have created quasi fire-alarm boxes to satisfy the CC requirement [9,10]. Northfield used booths at community events and shopping malls. By contrast, investigators at Duke University used a Rotary Club, shopping mall, and a baseball game. Therefore, it is evident that Northfield and investigators at Duke University have proven that they are capable of creating a fire-alarm box, which will enable them to engage in fire-alarm oversight. As such, other investigators should be able to proceed in a similar manner. For the most part, there are many benefits in an investigator to engage in fire-alarm oversight. First, an investigator enhances his or her ability to search for concerns from community members regarding their study [11]. For example, investigators at San Francisco General Hospital found that Latinos who arrived to an emergency department were reluctant to participate in a clinical study because of fear of discovery of their immigration status, which may result in deportation [12]. Under fire-alarm oversight, these very same individuals would activate the alarm box to notify the investigator of these concerns. Second, an investigator is able to improve his or her ability to monitor public sentiment. Typically, fire-alarm oversight relies on community members rather than an investigator for surveillance of public sentiment [8]. As such, an investigator no longer has to solicit concerns from community members [5,6]. Instead, an investigator's involvement (in partnership with an IRB) begins when the alarm is activated (see Figure). But, selecting which alarms to respond will be the most challenging for an investigator. For instance, if majority of the alarms that are activated is from large well-organized groups, an investigator will devote most of his or her attention to these concerns. The downside is that if an individual who has other concerns about the study may not sound the alarm loud enough to get the attention of the investigator. In fact, members of Congress have found that well-organized groups get most of their attention at the expense of an individual [8]. However, congressional leaders have resolved this problem by devising ways to work one-on-one with their constituents, such as casework [8]. Casework describes the method in which a congressperson acts as an advocate and responds to constituents who request assistance, for instance, tracking misdirected benefits payment [8,13].

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Figure. Process of obtaining approval from IRB for clinical studies needing to satisfy CC requirement.

Comparatively, there is evidence that an investigator can work one-on-one with study subjects whom she or he intends to enroll. At Virginia Commonwealth University, investigators were able to enroll and train key community members in order for them to become part of their study team [6]. Later, these trained community members were successful in identifying relevant groups and creating suitable outreach activities. This in turn allowed the investigators to satisfy the CC requirement. Conceivably, other investigators should consider this approach to work with individuals who belong to a disorganized group. As a final point, fire-alarm oversight has worked in other fields, such as public policy [14,15]. For instance, in Pennsylvania, the state legislature successfully used fire-alarm oversight to monitor public sentiment for administrative decisions issued by the state board of education [14]. Perhaps, investigators who engage in fire-alarm oversight will also accomplish a similar success. In the end, fire-alarm oversight would significantly assist in the achievement of 21 Code of Federal Regulations §50.24 goal to properly monitor public sentiment of a clinical investigation. Acknowledgments The author would like to thank the faculty of UCSF/UC Hastings Consortium on Law, Science & Health Policy, his research mentor Dr. Robert Rodriguez at San Francisco General Hospital, and his mother, G.R. Johnson for her valuable comments. Jonathan R. Fortman, MSL UCSF/UC Hastings Consortium on Law, Science & Health Policy Corresponding author. UCSF/UC Hastings Consortium on Law, Science & Health Policy 200 McAllister San Francisco CA 94102 E-mail address: [email protected] http://dx.doi.org/10.1016/j.ajem.2015.02.044

References [1] Department of Health and Human Services. Federal policy for the protection of human subjects, common rule. http://www.hhs.gov/ohrp/humansubjects/commonrule/index. html. [Accessed on Jan 15, 2015]. [2] Adams JG, Wegener J. Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Ann Emerg Med 1999;33(2):218–23. [3] Morrison CA, Horwitz IB, Carrik MM. Ethical and legal issues in emergency research: barriers to conducting prospective randomized trials in an emergency setting. J Surg Res 2009;157(1):115–22. [4] Nelson MJ, Deiorio NM, Schmidt TA, Zive DM, Griffiths D, Newgard CD. Why persons chose to opt out of an exception from informed consent cardiac arrest trial. Resuscitation 2013;84(6):825–30. [5] Kremers MS, Whisnant DR, Lowder LS, GreggLast L. Initial experience using the food and drug administration guidelines for emergency research without consent. Ann Emerg Med 1999;33(2):224–9. [6] Ramsey CA, Quearry B, Ripley E. Community consultation and public disclosure: preliminary results from a new model. Acad Emerg Med 2011;18(7): 733–40. [7] Ernst AA, Fish S. Exception from informed consent: viewpoint of institutional review boards—balancing risks to subjects, community consultation, and future directions. Acad Emerg Med 2005;12(11):1050–5. [8] McCubbins MD, Schwartz T. Congressional oversight overlooked: police patrols versus fire alarms. Am J Polit Sci 1984;28(1):165–79. [9] Northfield Labs, Inc.. Docket No. 2006D-0331: guidance for institutional review boards, clinical investigations, and sponsors, exception from informed consent requirements for emergency research, Document No. EC62. Available at http:// www.fda.gov/ohrms/dockets/dockets/06d0331/06D-0331-EC62-Attach-1.pdf. [Accessed on Jan 15, 2015]. [10] Holloway KF. Accidental communities: race, emergency medicine, and the problem of polyheme. Am J Bioeth 2006;6(3):7–17. [11] Lupia A, McCubbins MD. Learning from oversight: fire alarms and police patrols reconstructed. J Law Econ Org 1994;10(1):96–125. [12] Maldonado CZ, Rodriguez RM, Torres JR, Flores YS, Lovato LM. Fear of discovery among Latino immigrants presenting to the emergency department. Acad Emerg Med 2013;20(2):155–61. [13] Petersen RE. Casework in a congressional office: background, rules, laws, and resources. https://www.fas.org/sgp/crs/misc/RL33209.pdf. [Accessed on Jan 15, 2015]. [14] Wohlstetter P. The politics of legislative evaluations: benefits to “fire-alarm” oversight. http://files.eric.ed.gov/fulltext/ED339079.pdf. [Accessed on Jan 15, 2015]. [15] Oleszek WJ. Congressional oversight: an overview. https://www.fas.org/sgp/crs/ misc/R41079.pdf. [Accessed on Jan 30, 2015].