Br Bruc uce e Bar Barnh nhar art MSN t MSN RN RN CE CEP
Employed by The University of Arizona’s Arizona Emergency Medicine Research Center, Phoenix AZ. No relevant financial or nonfinancial relationships to disclose. The opinions expressed are mine alone and not necessarily representative of the opinion of my employer, ITLS or any others.
Describe EMS research past and present Explain the basic ethical framework of research List three types of EMS research List basic strengths and weaknesses of research List three challenges to high quality EMS research Differentiate research and QI Link research to prehospital care practice
Research is a: Voyage of discovery Method for critical thinking Act of inquisitiveness Systematic search to gain new knowledge Different way of thinking Researchers are often insatiably curious Great researchers are passionate Movement from the known to the unknown We all do research…most of us don’t write it up
Any type of effort to create “generalizable knowledge” from 911 call to hospital arrival May extend beyond EMS interval: Preventive (before illness or injury — e.g. helmets) After arrival at hospital (e.g. seizure followup) Up to or after discharge (e.g. reducing readmissions)
Prospective ( If they do this …) Randomized Controlled Clinical Trial (RAMPART) Exception from Informed Consent (EFIC) Retrospective ( When they did that …) NEMSIS Standardized PCR Data Collection Trauma Registries Before/After Comparison EPIC TBI Project CARES/SHARE cardiac arrest database Telephone Assisted CPR project Others
Single Site Multicenter Statewide EFIC (Exception from Informed Consent) Others
Examples of how we used to do it : The Golden Hour Waddell’s Triad
…“There is a golden hour between life and death. If you are critically injured you have less than 60 minutes to survive. You might not die right then; it may be three days or two weeks later — but something has happened in your body that is irreparable.” R. Adams Cowley
The Golden Hour — Real or Myth? “Little scientific evidence” found in literature review Lerner, 2001 “No association between EMS intervals and mortality among injured patients with physiologic abnormality in the field.” Newgard, 2010 …The concept…was instrumental in the formation of emergency medical services (EMS) systems and the design of trauma systems worldwide, despite a paucity of supporting evidence. Zane, 2010
Newgard, 2010
It is possible that other factors….precluded our ability to show such an association. Although it is likely that minutes do affect outcome for certain severely injured individuals, demonstrating this relationship.…has generally produced inconclusive results. Although a cornerstone of trauma systems, the “golden hour” premise has proven challenging to consistently demonstrate across larger samples of trauma patients and specific EMS intervals. Because more rigorous study designs (ie, randomized controlled trials or quasi-experimental designs) are generally not practical, feasible, or ethical for addressing this study question, adequately testing the hypothesis that shorter intervals improve outcomes may not be possible. Newgard, 2010
Conclusion: “Although lights-and-sirens transport and running red lights are embedded in EMS culture, risks to EMS personnel and to the public of rapid EMS response are not inconsequential, especially given the lack of evidence that taking such risks improves patient outcomes .” Zane, 2010
Injury Pattern evidenced by: Injury about the knee (….) • Injuries to the hip or pelvis • Craniocerebral injury Waddell, 1971 • …a triad of injuries associated with pedestrian/motor vehicle collision (MVC), including trauma to the head, abdomen, and lower extremities. Orsborn, 2010
Waddell reported on10 patients, all adults, only one death Using minimal references: One study describing 5 patients with LE trauma One study describing injuries in 200 car/pedestrian deaths, 23 pediatric (age<15), no patterns discussed
Waddell, 1971
This “classic” injury pattern rarely occurs, but is still being taught. “Although the concept of Waddell's triad is logical…the incidence of this predictable injury pattern is low .” Orsborn, 1999 “All components of the triad are present in no more than about 3% of cases” Baren, Pediatric Emergency Medicine, 2007
However, part of Waddell’s theory is important: Easy to miss occult injuries in car/pedestrian accidents. “Of the 10 patients reviewed….six had one or more injuries overlooked on initial assessment” Waddell, 1971 But the Triad itself rarely occurs
Routine Hyperventilation in TBI Rotating Tourniquets Procardia, aminophylline, etc
An evolving struggle to understand, measure, and improve care in the prehospital environment
Face a challenge T o solve a problem Answer a question T o sway people (caution!) T o seek to understand Intellectual joy Because I have to (to get a degree) Others?
Basic science Lab Chemicals, cells, pipettes, cultures Mice, rats, etc. Typically preliminary Goal is to understand basics of Interaction of molecules Genetic basis behind disease Find possible solutions ▪ Early drug development
T esting on people (human subjects) Applying lab research Conducted in clinical setting (EMS, ED, other) Use experimental tools, drugs, etc Typically later in development Goal is to understand effectiveness of Treatments Drugs Preventative measures
Qualitative research Quantitative research Translational research Evidence based guidelines QI vs Research Research Protocol Exception from Informed Consent (EFIC)
Qualitative: Perceptions, feelings, surveys Quantitative: Facts, structured, data
From lab to clinical research to community care
Care protocols derived from current medical literature Produced through research Challenging to create for EMS Examples: Spinal Motion Restriction Treatment of Prolonged Seizures Brain Trauma Foundation Prehospital TBI Guide
Quality Improvement — Evaluating and learning from experience Data guided In a particular setting or agency May not apply to any other setting or agency Part of ongoing care Process can be adapted as necessary Should not put patients at risk GOAL: Improve a process, program or system
Research — Systematic investigation “Generalizable Knowledge”(useful in many settings) Requires rigid protocol May put patients at risk Requires consent (Usually….) Some type of innovation or validation Requires ethical oversight (IRB) Tightly monitored GOAL: Answer a question
Set of boundaries (controls), limiting variables or possibilities Arbitrary “box” Strict “recipe” to test a thought or idea Systematic Replicable (same results) Self-Correcting (DSMB) Supervised (IRB)
Individual (maybe) Society as a whole (if proven successful) Advances human knowledge Synthesizes new knowledge Transfers findings to new areas Chemotherapy “dose” vs. EMS “dose” Others?
Idea is created Protocol is developed to test the idea IRB reviews research plan and consent forms Staff is trained Trial starts Subjects are screened and enrolled Investigator reports any problems to IRB DSMB reviews data for safety IRB reviews trial at least yearly for safety
Not Always Further research expands understanding of past research Assumptions (box) may have been wrong Group tested might not have been representative Plavix Other factors may have been in play Progesterone for TBI (ProTECT) Other care improvements may overshadow intervention Albumin in Acute Stroke (ALIAS)
Direct harm Coercion Vulnerable populations Errors can cause incorrect outcomes 25-38% of BMJ & Nature papers had statistical errors* 4% of those misrepresented findings as significant* Deliberate fraud Ethical lapses Tuskeegee Study Lack of adequate informed consent *The Economist, 5 June 2004, p 70-71
Belmont Report (1979) Respect people Do no harm Maximize benefits Justice- Be fair (do unto others…) IRBs are charged with protection of Human Subjects
T ough to do randomized clinical trials Time needed to get consent Uncontrolled environment Urgency of immediate care Inability to confirm diagnosis Subject density — potential enrollments spread out geographically EFIC creates possibilities and challenges
Exception from Informed Consent (EFIC) Retrospective Review/Databases/“Big Data” Data Collection (machine, vehicle, monitors, etc) Animal Studies
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