Br Bruc uce e Bar Barnh nhar art MSN t MSN RN RN CE CEP - - PowerPoint PPT Presentation

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

• f 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

• utcome 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

• ne 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

• solve a problem

 Answer a question  T

• sway people (caution!)

 T

• 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

• r 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

• ugh 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

 We’ve come far  It’s not easy  A long way to go  Get involved  Improve your practice  Improve EMS  Stay for Part 2, Implementing Research in

Your Agency

 We’ve come far  It’s not easy  A long way to go  Get involved  Improve your practice  Improve EMS

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