Botulism Questionnaire: A tactical tool for community use in a mass casualty incident
Kelly Burkholder-Allen, Department of Public Health and Disease Prevention, College of Medicine University of Toledo Health Sciences Campus, Mail Stop 1173, 3355 Glendale Ave, Toledo, OH 43614. USA. Email: email@example.com
A botulism-induced mass casualty incident has the potential to severely compromise a community's health-care infrastructure, based upon its lethality, rare occurrence, and duration of symptoms, which require extensive support and care. Although early recognition and treatment with antitoxin or botulism immunoglobulin are essential to the effective management of this type of an incident, the two major challenges in recognition and treatment are the hundreds, if not thousands, of casualties or potential casualties requiring rapid screening and the fact that most clinicians remain ignorant of the management of botulism. The purpose of this article is to present the Botulism Questionnaire, which will assist with the screening of casualties, provide educational and diagnostic cues for clinicians and the lay public, and create a layer of protection for the health-care infrastructure. The applications of this questionnaire in various formats, the numerous points of distribution, and the variety of platforms from which it can be launched will be explored.
CHALLENGES ASSOCIATED WITH BOTULISM
When contemplating the immense time-sensitive challenges that clinicians encounter in the management of a botulism-induced mass casualty incident (MCI), it would be remiss not to mention several crucial facts that would further compound these challenges. Botulinum toxin is the most lethal toxin known to humans (Arnon et al., 2001; Timmons & Carbone, 2005). The natural occurrence of botulism is extremely rare (Stewart, 2001; Horowitz, 2005). Terrorist states and organizations attempting to perpetrate attacks using botulinum toxin to date have been, to our good fortune, unsuccessful (Arnon et al., 2001; Stewart, 2001). Clinicians, and the health-care infrastructure as a whole, have limited awareness and even more limited experience in the recognition and management of casualties of botulism (Pesik et al., 1999; Richards et al., 1999; Rebmann & Mohr, 2008). Also, the lay public has an immediate need for clear, concise, and actionable information that it can process and act upon (Glik et al., 2004; 2007). One answer to these pressing issues was the development of a unique, user-friendly, and zero-cost solution: the Botulism Questionnaire (Appendix I), developed by Rega et al. (2007).
The Botulism Questionnaire offers a user-friendly approach to providing education and enhancing both clinicians' and the lay public's ability to recognize and manage a botulism-induced MCI. The potential number of casualties that could be generated by an intentional contamination of food or beverages with botulinum toxin conceivably could reach the hundreds of thousands (Wein & Liu, 2005). Thus, any tool that offers some screening capability has the potential to minimize the sheer volume of individuals that could present to hospital emergency departments (EDs).
METHODS AND PROCESS
The Botulism Questionnaire was developed to be used as a screening tool by all responders (the lay public, clinicians, and public health officials) in order to recognize and capture the key neurological and other subtle findings that are indicative of botulism. Its intended application is a botulism-induced MCI, which would constitute a high-impact yet seemingly low-probability event.
The Botulism Questionnaire's simple directions and format were designed for capturing self-reported information on the presence or absence of the pre-eminent manifestations that are associated with botulism. It empowers the reporting individual to assist the public health officials and clinicians with expediting the clinical decision-making process. Whether distributed to patients in triage in the ED, physicians' offices, or clinics at registration, published in local newspapers, placed on a “crawler” (the ticker at the bottom of the television screen that is used to convey information while normal programming is underway) on local television media outlets, distributed by faith-based organizations, community-based organizations, schools, or day care centers, or placed on health department websites or social networking sites, this user-friendly template has unlimited points of distribution and unlimited platforms from which it can be launched.
As a template, the Botulism Questionnaire offers flexibility in a time of crisis. It can be customized quickly to better meet the needs of both the health-care infrastructure and the lay public. The questionnaire can be translated rapidly to accommodate language barriers, the font size can be enlarged to improve its readability for the visually impaired, and it even can be digitized for online completion and screening. The possibilities for the points of distribution, formats for delivery, and platforms for launching are only limited by a community's technological capabilities and imagination.
The Botulism Questionnaire is organized with an initial patient information section for capturing the responders' identification and demographic information. A brief set of instructions informs the responders that their answers will assist the clinician in rapidly determining who could have botulism. This is followed by a “call to action” to be customized prior to distribution. This section instructs the responders to “notify” or “seek” immediate attention if they report “yes” to any of the document's questions. Using a left-to-right approach, the remainder of the document will be reviewed. The general section, on the upper left corner of the template, prompts the responders to reveal any generalized weakness that might be present. The throat section provides a prompt for reporting a sore or hoarse throat. The stomach/gastrointestinal section, opposite the general section, located on the upper left side, prompts the responders to reveal the following stomach-related or gastrointestinal symptoms: nausea, vomiting, abdominal cramping, and diarrhea, which is the typical prodrome associated with food-borne botulism and which usually precedes the bulbar palsy. The lungs section provides prompts for revealing and reporting shortness of breath, a key aspect as suffocation is a lethal hallmark if not promptly recognized and addressed. The neurological section prompts the responders to report difficulty in using their hands, walking, and standing. The eyes and mouth sections focus on the paresis or paralysis of the cranial nerves specifically, another hallmark of botulism. The eyes section provides prompts for the reporting of blurred vision, droopy eyelids, and/or difficulty with vision. The mouth section prompts the responders to reveal deficits in their ability to open their mouth, chew, difficulties with swallowing and speaking, slurred speech, and issues with drooling.
The fact that the Infant Questionnaire is contained within a separate section within the Botulism Questionnaire is significant in that the manifestations are not well known. The symptoms that manifest in infant botulism are subtle and their recognition is dependent upon the observations by astute parents and caregivers. The Infant Questionnaire is age-specific and its distinct placement was intended to prompt the responding parent or adult caregiver to capture the key findings that are consistent with infant botulism: floppiness, a weak cry, constipation, poor head control, vomiting, diarrhea, an absence of facial expression, drooling, feeding problems, and listlessness.
The content validity was measured by using the content validity ratio (CVR) (Lawshe, 1975). Five physicians that are board-certified in emergency medicine, with an average experience of 25 years, independently reviewed the Botulism Questionnaire's items (Rega P. P., 2009, pers. comm.). In each case, the reviewer indicated that the questions included were “essential”. For five panelists, the CVR must equal or exceed 0.99 to be statistically significant at the P ≤ 0.05 level. Using the formula, CVR = (nessential − N/2)/N/2, a CVR of 1.0 resulted, so the questionnaire was considered to be valid.
A botulism-induced MCI is a community-wide incident that requires a community-wide response. The Botulism Questionnaire serves both the public and the medical infrastructure. It empowers the lay public by providing botulism education, a format for identifying the presence or absence of symptoms and subtle findings consistent with botulism, and a “call to action”. For the clinician, it provides a screening tool with self-reported findings to aid in the triage of a botulism-induced MCI; for public health officials, valuable information is provided that could be of assistance with an epidemiological investigation.
A botulism-induced MCI, for all intents and purposes, is a low-probability but high-impact event. Yet, a large-scale poisoning, whether naturally occurring or intentionally perpetrated, has the potential to yield thousands, if not hundreds of thousands, of casualties. Though there has been no successful perpetration of such an event to date, the threat remains. Although it is not stable in its crude form and is susceptible to light, heat, and air movement, requiring refinement and stabilization for an aerosolized dissemination, the botulinum toxin can be used in an act of biological terrorism, for which plans must be made.
Planning for a low-probability but high-impact event provides the health-care infrastructure with a catch-22 situation. The resources expended in the preparation and planning for a botulism-induced MCI most likely will never be called into action, yet the absence of planning for a Category A biological agent could be viewed as negligent. The Botulism Questionnaire, the initial template in the Botulism Tool Kit, offers a no-cost option that has the potential to make a big impact in the response to a botulism-induced MCI.
The Botulism Questionnaire is a screening tool to be used by responders at every level: the lay public, clinicians, and public health officials. Its use will strengthen the health-care infrastructure at a time when it could be compromised easily. Hopefully, the health-care infrastructure will experience a lesser degree of degradation, owing to the fact that clinicians and the lay public alike receive education and cues that lead to more rapid recognition and clinical decision-making.
The authors would like to acknowledge the following physicians for their evaluation of the Botulism Questionnaire: David Lindstrom, MD, Jay Ryno, DO, Michael Guinness, MD, S. Newton, MD, and Jeff Hugus, MD.