Cadth 2015 d6 scop jacqueline
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This document discusses levels of evidence for clinical practice guidelines, from systematic reviews to expert opinion. It outlines classes of recommendations from Class I, where there is evidence a procedure is effective, to Class III, where there is evidence a procedure is not effective or may be harmful. The document presents three case studies to demonstrate how this framework can be applied.
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Cadth 2015 d6 scop jacqueline
- 3. It all started with Aspirin….
- 4. The Provincial Emergency Services Practice Committee
- 5. What is the (clinical) problem we are trying to address?
- 6. Levels of Evidence 1A Systematic Review of Randomized Controlled Trials 1B RCTs with Narrow Confidence Intervals 1C All or None Case Series 2A Systematic Review Cohort Studies 2B Cohort Study / Low Quality RCT 3A Outcomes Research 3B Case-controlled Study 4 Case Series, Poor Cohort Case Controlled 5 Expert Opinion
- 7. Determine the Class of Evidence (adopted from the ACC/AHA Clinical Practice Guidelines) Class of Recommendation Class I conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective Class II conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness / efficacy of a procedure or treatment Class IIa weight of evidence/opinion is in favor of usefulness/efficacy Class IIb usefulness/efficacy is less well established by evidence/opinion Class III conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective and in some cases may be harmful
- 10. Case Study One
- 11. Case Study Two
- 12. Case Study Three
- 15. Saskatchewan College of Paramedics
Editor's Notes
- Good morning and welcome…
- Let’s start with a bit of perspective… In the late 1980’s: paramedic practice was governed by The Ambulance Act and Regulations; Paramedics were registered by the Ministry of Health Scope of practice and protocols were blended Regional medical advisors had oversight into paramedical practice In 2008, we transitioned to The Paramedics Act This was due in large part, to a push from profession to become self-regulated The practice of paramedicine evolved; With the increased impact to public; need for self regulation It became evident that it was important to engage an expert body of knowledge to make decisions surrounding scope and protocols With the 2008 Proclamation of The Paramedics Act Removing paramedics from The Ambulance Act – no longer just about transportation – clinical treatment needs were changing Drove out need for a more evidence-based approach to deciding what to do and what was off limits Formation of the College Initial licencing of members Evidence based approach adopted (vs. historic anecdotal approach)
- Protocols vs Scope - so what is the difference?? This all started many years ago… “First aiders” were able to provide aspirin to patients Paramedics could not because ASA was not an approved drug in the protocols The system for making changes to practice (aka protocols) at the time, was less formalized and as such, the ambulance services needed to convince other stakeholder groups that this was a good idea before a change could be introduced. Keep in mind that at that time, ambulance services were more specific to transport than treatment. This forced the question: What do we actually want our ambulance services to do? Protocols were driven by operational need; scope of practice was not independent of protocols Often physicians made decisions while not working in an EMS environment Pretty quickly, it became evident that a move to province wide standardization was going to be important As the system required paramedics to provide more advanced treatment, educational requirements also moved forward…often lagging behind system needs. It became evident that there was a need for a more evidence-based (vs. operational and anecdotal) process for advancement of these changes – which would allow for planning with respect to training and implementation
- With the introduction of The Paramedics Act, CPSS oversight was introduced; PESPC was created to provide recommendations to CPSS PESPC became the vetting body for changes to scope as well as protocols Information coming to PESPC had to be based on evidence and best practice; anecdotal information was still considered, however evidence needed to support changes We have continued to operate under a blended model – protocols and scope of practice embedded within one document
- When creating patient care guidelines, it is important to be consistent in order to achieve consensus. The following steps should be used when presenting changes to the existing protocols: Start with the patient. A clinical problem / question arising from the care of the patient. P (Patient or Problem) – describe the group of patients and their most important characteristics. I (Intervention) – what do you want; what factors will influence your decision C (Comparison) – what other options exist? O (Outcomes) – what outcome are you seeking> Then – lit review followed by…evidence evaluation, consultation, protocols impacted, training, impact, and merit vs criteria
- Evaluate and Assess the Evidence It is imperative that an explicit approach is utilized so that it is easily understood, and subsequently ensures that members make well-informed decisions when providing patient care. There are numerous methods available to us for evaluating levels of evidence and the strength of the recommendations. Each has their own strengths, and shortcomings.
- Determine the Class of Evidence (adopted from the ACC/AHA Clinical Practice Guidelines)
- Heavy lifting…
- We had success…and less success
- PICO: Patient – Patients presenting with ST segment elevation myocardial infarction Intervention – Anticoagulant/Antiplatelet regime, prehospital administration of thrombolytic (TNK/tPA), direct transport of patient to catheterization lab for Percutaneous Coronary Intervention (PCI) Comparison – Status quo (transport to nearest hospital then to terteriary centre for PCI), transmit 12/15 lead ECG to ER physician or cardiologist Outcome – decrease call to needle/balloon time, improve patient outcome of patients experiencing STEMI Rate the quality of the evidence and strength of the recommendations: Evidence was reviewed by PESPC and CPSS Consultation/Training/Impact/Merit: Consultation: Process fell short. In this instance despite being the protocol being approved, provincial implementation has been delayed upon learning that representation from the Saskatchewan Cardiosciences Council (Cardiologists) did not express support for the initiative during the consultation process at a council meeting in 2011 when the Provincial EMS STEMI plan was presented to council by the Ministry of Health. As a result, the PEPSC did not want to proceed until the concerns from the cardiologists were addressed. Training: minimal Impact: Who needs to verify the 12/15 ECG lead? If physician or cardiologist how does it get transmitted? Merit: The desirable effects outweigh the undesirable effects. Put the patient at the centre of care. ISSUE: Protocol still not implemented…
- PICO: Patient: Demonstrating any two of… Oral temp >38 degrees or <36 degrees Celsius Heart rate >90 Respirations >20/min Plus one of… BP<90 SPO2 <90% Mottled skin Altered mental status; Restlessness or anxiety Immunocompromised Secondary Criterion… Administering broad spectrum antibiotic is no > 45 minutes after recognition of severe sepsis / septic shock. Intervention: Prehospital administration of broad spectrum antibiotic, prehospital administration of vasopressor to restore hemodynamic stability Comparison: Status quo … oxygen, fluid therapy, antipyretic. Incorporate point of care testing to draw cultures prior to broad spectrum antibiotic administration. Outcome: decrease morality and improve outcomes for patients experiencing severe sepsis/ septic shock. Rate the quality of the evidence and strength of the recommendations: Evidence was reviewed by PESPC and CPSS. Consultation/Training/Impact/Merit: Consultation: Process fell short. In this instance the protocol was approved and implementation was rolled out provincially. Soon after rollout, two separate health regions brought concerns forward from Intensivists in their respective areas. Specifically the concerns were administering a broad spectrum antibiotic prior to drawing cultures, as well as administering a vasopressor through a peripheral line versus the recommended central line. In this case, there was an assumption that individuals representing the regions on PESPC had consulted with experts in their region and that there were no concerns with the protocol. As a result of the issues brought forward, the MOH and SCoP met to discuss whether or not the concerns were valid enough to retract the protocol. The evidence was again reviewed, and it was determined that the desirable effect of the implementing the protocol outweigh the undesirable effects. Training: minimal Impact: Administering broad spectrum antibiotic prior to drawing a culture significantly limits the ability to identify the source of the infection. Administering vasopressor through a peripheral line has an increased risk of extravasation causing tissue necrosis. Severe sepsis / septic shock is a major health care problem affecting millions world wide each year, killing 1 in 4 people. As with cardiac arrest, myocardial infarctions, strokes and trauma, the speed and appropriateness of therapy affect mortality and patient outcome. Merit: The desirable effects outweigh the undesirable effects. Delays in antibiotic therapy is associated with increased mortality. Delays in administering vasopressors when treating hemodynamically unstable patients is associated with increased mortality. Research supports the administration of vasopressors peripherally until a central line can be established. ISSUE: Needed to better define severe sepsis / septic shock criteria. Needed to add more clarity to time frame (delay of > 45 minutes). Protocol was sound. Some systems have implemented the protocol, others have chosen not to despite the evidence.
- PICO: Patient: Patients experiencing trauma spinal injuries requiring spinal motion restriction. Intervention – Use a stretcher to provide spinal motion restriction to patients experiencing a traumatic spinal injury and limit the use and length of time a patient is secured to a spineboard. Comparison – Status quo … continue using spineboards. Outcome – to mitigate the risks associated with traditional practice of securing patients to a spineboard who have sustained or suspected of having a traumatic spinal injury. Rate the quality of the evidence and strength of the recommendations: Evidence was reviewed by PESPC and CPSS. NO RESEARCH HAS SHOWN THAT USE OF BACKBOARDS IMPROVE PATIENT OUTCOMES. Consultation/Training/Impact/Merit: Consultation: Extensive consultation was conducted. Consultation included Medical Director for the Regina Qu’Appelle Health Region Trauma Program, who in turn sought input from his colleagues. The spinal surgeons group from the Saskatoon Health Region reviewed the proposal and provided feedback. A position statement from the National Association of EMS Physicians (NAESMP) and the American College of Surgeons Committee on Trauma (ACSCT) was considered. Letters were sent out relevant health care professional regulators in Saskatchewan (CPSS, SRNA, SALPN, SAMRT etc.) advising of the changes and asking for feedback in advance of implementation. Employer groups and training agencies were also sent communication advising of the changes and asking for feedback. In this instance the protocol was approved and implementation was rolled out provincially only after the consultation and communication had been completed. Training: Heavy focus education, understanding what the evidence is saying. Impact: Using a spineboard to provide spinal motion restriction (SMR) increases scene time, mortality, and requires additional resources. Healthy subjects left on spineboards develop pain in the neck, back of the head, shoulder blades and lower back. areas are at risk of pressure necrosis. Conscious victims may attempt to move around in an effort to improve comfort, potentially worsening their injury. Physicians potentially order unnecessary radiological procedures based on the presence of pain. Paralyzed or unconscious victims are at higher risks of development of pressure necrosis due to their lack of pain sensation. Strapping has been shown to restrict breathing and should be loosened if compromising the victim. Merit: Spinal motion restriction using a spineboard does not improve patient outcome when compared to providing SMR with an just a stretcher. Miniscule potential benefit does not outweigh the risk of airway compromise, difficult intubations, loss of ability to conduct on going assessments when using a backboard. SMR using a stretcher is as effective as using a longboard. The desirable effects outweigh the undesirable effects. ISSUE: A major paradigm shift in the way spinal injuries are managed. Implementation has been relatively seamless. Expected changes to be extremely controversial but it has been a non issue. Consultation and communication was paramount prior to implementation.
- When evidence is not enough… Impact analysis Assessment of merit against criteria Evidence should guide decision-making versus driving policy development Evidence alone is only information; only when it is contextualized does it become valuable Needs to be integrated with the clinical findings; environmental factors; etc…
- We’d be lying if we didn’t say that some of these things took years Operational need often drove out important changes Barriers always crop up
- Section 23 (Practice) implications: Oversight by the CPSS – gave us an opportunity to re-examine our approach to protocols PESPC was created Section 23 changes to come…