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The use of expert consensus opinion as strong evidence in the absence of evidence; is this sound methodology?
A discussion, using the example of the Australian Resuscitation Council (ARC) in the formulation of recommendations and guidelines relating to resuscitation. Author: S. Gould 2016 Aim The purpose of the paper is to discuss the issues resulting from the use and reliance on expert consensus opinion (referred to in Australian Resuscitation Council or ARC literature as Level of Evidence IV or LOE IV). Further this paper will discuss errors in methodology and interpretation that may and do result in, less than ideal, recommendations in resuscitation practice, especially at BLS level; recommendations that are then implemented verbatim by the end-user, in the mistaken belief that they all represent “best-practice”. This can result in a lack of innovation and a stagnancy or degradation in positive outcomes, without appropriate accountability. Background The Australian Resuscitation Council (ARC) is an independent, private, voluntary, non-profit organisation that has representative members from key resuscitation related organisations. These members use a methodology that includes a reliance on Level of Evidence IV – Expert Consensus Opinion (both internally from the International Liaison committee on Resuscitation - ILCOR). While some of this expert opinion in harmonious, some is out of step with current international practice and expert opinion. The constitution of the organisation states that no responsibility is taken for any harm caused by the use of the consensus guidelines and that any recommendation does not mean that any other techniques are ineffective. ARC LOE IV consensus opinion comes from at least two sources derived from international experts and LOE IV based on a re-analysis by local experts based on a local interpretation of the evidence. These two positions may be substantially different and may be contradictory but are presented as being equally rigorous in their position. This raises an important question about the status and methodology in the formulation of a consensus recommendation based on opinion and how two rigorous methodologies can result in differing end-points. For the individual or group seeking the best advice on which to base their guidelines this situation can be confusing, anomalous and illogical. Classes of LOE IV reflect degrees of confidence in the opinion, but all are presented as “best practice”. The methodology relied upon is that LOE IV is ranked by the evidence influence and therefore is of varying veracity. In actuality, the outcome is the same i.e. it is still a somewhat subjective opinion based on a review of selective research, including the decision to include or reject evidence and the personal opinions of those that make up the expert group. Therefore the LOE IV cannot take on the rigour of the considered evidence. In circumstances where the evidence is weaker the subjectivity increases and the associated rigour and veracity decreases. This variation at the end-user/implementer level is not distinguishable and one would naturally assume that all recommendations are equal in rigour. Underlying expert consensus opinion using a specific methodology there must be to innate belief that anyone using the same methodology would arrive at the same recommendation. In a general sense this is what one should expect. Whilst this may be true where there is a wide variety of high level research and evidence, the same cannot be said at the other end of the continuum where evidence is weak or inconclusive and where a range of recommendations may reflect and suitably address the evidence. The assumption that is therefore made is that to reach any other conclusion is not scientific and therefore cannot contain any intrinsic value and therefore cannot and will not be considered. This flaw, based in attitude and belief in infallibility of process/ judgement/ methodology is central to much of the latency in the ARC BLS recommendations. Discussion Much of resuscitation practices (particularly BLS), have very little targeted and definitive research and so recommendations are determined (for the large part) on low, poor, weak or no direct evidence. Rarely is there such overwhelming strong evidence that one approach is clearly to be used at the exclusion of all others. In this vacuum LOE IV (expert consensus opinion) is used as a substitution and/or a subjective opinion of the conflicting evidence. However, an error in methodology occurs when change or alternate opinion is raised, in that those providing the consensus opinion (LOE IV) now consider that in order to alter their position there is a requirement for strong evidence (i.e. higher than LOE IV). This flaw in process now means that LOE IV has been inappropriately elevated in the evidence hierarchy to an unjustified superior position, presumably based on the level of evidence used to influence the opinion. However, even if influenced by higher levels of evidence i.e. based on strong evidence, as LOE IV it still only represents a subjective interpretation, at a point in time, it cannot assume the status of the underlying influence. It also means that the power of veto in consideration of any evidence is apportioned to the creators of the LOE IV (consensus opinion). This does seem on any level to be a significant flaw in the use of research methodology. Expert opinion can in some instances, be based on, the “discussion” section of a research paper rather than originating from the “conclusion” section, however both are not equal as evidence. Long periods between reviews can also confound the ability of opinion to keep pace/ consider the outcomes from changes in practice recommendations. In fact, proof of efficacy in practice is rarely (if ever) considered or studied as part of this methodology as proof and is not considered necessary and until studied at a formal/ high level (e.g. RCT) it is not taken into account. The history of resuscitation practice is littered with techniques based on expert opinion based on “studies” that were obviously ineffective (and sometimes dangerous) long before expert opinion was changed. As one observer rightly pointed out there are no RCT’s to support the use of parachutes when jumping from a plane and therefore we are totally reliant on informal observation to confirm the benefit over not using a parachute. In reality, LOE IV is only a substitute for a collection of other evidence (weak and strong) that can be interpreted and/or result in opinion-based implementation strategies. It has little intrinsic merit over any other opinion or approach resulting from a consideration of the available evidence. LOE IV “evidence” is not at this level in all research hierarchies. For example if we look at Joanna Briggs Institute Levels of Evidence, http://joannabriggs.org/assets/docs/approach/JBI-Levels-of- evidence_2014.pdf we see that consensus opinion by a single expert or a group of experts appropriately sits at Level 5 in the hierarchy i.e. the lowest level, sitting behind any other evidence levels. Likewise in the realms of Level 5 evidence it is only the self-assessed status of those who provide the opinion that guides those seeking direction. Regardless of the source of influence of the consensus opinion, it does not change its position in the hierarchy. A confounding issue resulting from this self-assessed “expert” status (used in the formulation of consensus view) is each “expert group” can and does claim its own consensus opinion as an absolute and fundamental truth and tends to defend the ownership of this opinion against any contrary observation or ideas that threaten the authority and status perceived to be ascribed to self-assessed “expert opinion”. This is, of course, is not true of all expert groups, however it is certainly the case in Australia. Although this behaviour can and is frequently denied, actions are a better test of character. The close observer will see as a result, contradictory actions and statements that result from this duplicity of motivation. An example from our ARC example is the organisational slogan “Any attempt at resuscitation is better than no resuscitation”. This statement would appear to encourage an individual (particularly the un-trained bystander) to utilise any means they believe is appropriate in an attempt to save a life i.e. “at least one is trying”. The reality of the meaning of this statement is somewhat different and is clearly demonstrated in defensive actions when alternate recommendations are suggested. The actual meaning is “Any resuscitation that follows the ARC recommendations, including its own expert consensus opinion should be attempted; if unable then no resuscitation is better”. This contradiction in statement vs attitude is only supported by the flawed LOE IV status interpretation which we are discussing in this document. Interestingly, the disclaimer used on each recommendation obviates any responsibility for harm or failure of the recommendations to provide the expected outcome and recognises other methods may be of equal or better efficacy. These two statements are essentially and fundamentally contradictory. The second statement made by the ARC is a disclaimer to the effect that they (the ARC) are not saying that there recommendations are relevant for all circumstances and that individuals should seek “specific advice” in deciding on methods that are applicable to their specific circumstances. Logically, this “specific advice” cannot be from the ARC as it has already (by this statement) referred readers away from the guidelines for advice. Therefore, presumably the statement refers to other sources and/or one’s own review of evidence and recommendations i.e. opinion of relevance. So why do we see such a strong defense of ARC consensus opinion if readers are encouraged to form an opinion independently of the ARC? This statement vs action is also illogical and contradictory in the defense of low level of evidence and demonstrates a misuse of expert opinion. The other weakness of dogma in local, consensus opinion based recommendations is that the individual agenda of those constituting the expert group can more easily become part of the consensus without the need for the same rigour expected of external potential contributors to the collective opinion. Let us review an example that has been in question for more than a decade. The example from ARC literature is contained in Section 4 – Airway, where recommendations are listed for the management of upper airway obstruction (UAO). Of particular interest is the specific management of an upper airway obstruction (UAO) in the conscious patient. Firstly let us paraphrase the consensus opinion of the ARC and compare this with that of ILCOR and the international resuscitation expert community which includes bodies such as the ERC and AHA. 1. ARC – measures for the relief of UAO include firstly back blows and then “chest thrusts” followed by CPR if unconscious. The recommendation excludes the use of abdominal thrusts and refers to a small, single, yet unrelated postmortem study comparing CPR in a supine position with abdominal thrusts in a living patient. 2. The international resuscitation community – measures for the relief of UAO include firstly back blows and then chest and/or abdominal thrusts, followed by CPR if unconscious. Abdominal thrusts are considered to the most effective technique after the failure of back blows. Before examining how consensus opinion can have these fundamental differences it is important to note that “chest thrusts” as mentioned in both consensus statements are not equivalent. The technique described by the international resuscitation community is a modified abdominal thrust method suitable when a patient is too large (including pregnancy) to attempt abdominal thrusts. The technique is performed standing behind and against the back of the patient and using two hands pulling toward the centre of the patient’s chest. This technique, as with abdominal thrusts, is supported by respiratory studies that show pressure changes induced in the airway as a result of utilising this technique. Whereas, the “chest thrusts” as described in ARC literature is a modified, single-handed CPR compression technique, that has no supporting respiratory studies or clinical trials. In terms of our discussion around the use of LOE IV evidence, how did we get to this position that has resulted in a differing recommendation from not only the international resuscitation community, but practice across the world and more importantly after more than a decade no documented cases of success i.e. proof of efficacy. There are several factors that have contributed to this disparate, flawed and unchangeable position. The ability of expert opinion (LOE IV) to be the re-interpreted by other expert opinion without a need for stronger evidence to support a different outcome. A test consensus opinion does not have to achieve. The inappropriate direct substitution of unlike terms (such as “chest thrusts) to support a personal view/ opinion and thus take advantage of the outcome and reputation of evidence relating to the original technique without the need to support (with evidence) a experimental method. The positioning of LOE IV evidence in an artificially elevated position so that strong evidence is required for change, even though the consensus opinion is based on weak, no or poor evidence or borrows rigour from an unrelated finding. This is true regardless of the source influence. A deliberate dismissal of abdominal thrusts, based on an incomplete consideration of the evidence and a disproportionate emphasis on a misrepresented an “unacceptable risk” (a risk mitigated appropriately and considered against benefit by the international resuscitation community, including ILCOR). The only reason for this position therefore has to come primarily from a personal view of the experts that have contributed to the local expert opinion. The vehement defense against alternative, (but equally or better evidenced) alternative opinions on the basis that LOE IV evidence has a status above its logical and justified level in research methodology. A lack of an experimental framework and associated methodology when recommendations are clearly speculative. What is the result of this difference in consensus opinion? Does it make a difference at the end-user level i.e. to the patient? And what feedback loops are in place to provide proof that one opinion turned out to be better than another? If we review the case of UAO as an example of a divergent view by experts on measures to address the same problem we can see the issues. In Australia an experimental modified chest compression technique and in the rest of the world abdominal thrusts and/or modified abdominal thrust on the chest. Since its inception in 1974 abdominal thrusts in the US have been credited anecdotally by the Washington Post with more than 100,000 saves, whilst in Australia after more than a decade using a different regime there are no documented cases of success. In the recent example in Western Australia a 2 ½ year old child who died after choking on a bubble gum ball he found in his stroller. This was a tragic outcome for the family and those involved and it is uncertain if any measures on the day would have relieved this obstruction. However, what is clear is that in compliance with local expert consensus opinion, 3 separate rescuers (these included a pharmacist, St John Ambulance Volunteers and St Ambulance – State Ambulance) were restricted from using abdominal thrusts and were only able to utilise an experimental technique with little if any supporting evidence (in either clinical trials or field application). The question that should be addressed first is to where in an “all care and no responsibility” methodology does responsibility for review lie. It is doubtful that (unlike an organisation in the general health sector ) that an ARC review (or RCA) of the circumstance has or will take place or seen as necessary in accountability. Differences in recommendations are not restricted to UAO and we see high level guidelines (like BLS Resuscitation) remaining to be focused on a sentimental but uncommon form and cardiac arrest i.e. the hypoxic arrest. This strategic direction, protected by an assumed rigorous methodology, cannot demonstrate improvements in outcome over SCA centered BLS guidelines but cannot be challenged. Finally, there may be another reason why expert opinion can be at odds with “best practice” or other expert opinion and this relates to ideological and political pressures being brought to bear in the process. Political pressure can arise from dependent organisations, which have an interest in resisting change and the associated costs and imposition of implementing change i.e. the opinion to change can be delayed or moderated as a compromise. Ideological pressures can come from an unwillingness to “confuse” a long term message with change. This assumes that the lowest common denominator (e.g. BLS) is incapable of grasping a new focus or deciding between management options in an emergency. Whilst these pressures can be real considerations in recommendation and guideline development they only gain a controlling power at the LOE IV level where they can build legacy characteristics into recommendations and support sub-optimal guidelines. Recommendations The reality in the field of resuscitation is that as we learn more, there will always be better methods being developed than the accepted status quo. They can represent equal levels of opinion and evidence base. The misapplication and defense of any low ranked LOE IV can significantly hamper progress and innovation in guideline development. More significantly it can lead to an unfortunate regression in positive outcomes, when this flawed research methodology is used in resuscitation practice. Recommendation for improvement can be summarised as follows: 1. The adoption of a more appropriate evidence hierarchy system e.g. JBI - Levels of Evidence would more appropriately relegates and classifies consensus opinion. Additionally, nomenclature must clearly differentiate between opinion status and experimental recommendations. 2. Bodies utilising an evidence hierarchy as the basis for any recommendations must exercise appropriate diligence in ensure individual opinion does not unduly affect the consensus view. 3. Ethical and procedural practices need to demonstrate the appropriate and honest representation of research and evidence. The practice of “stolen rigour” used to substitute evidence from unrelated sources must cease immediately, to ensure the maintenance of reputation of expert panels. 4. All consensus opinion based guidelines must be appropriately open to general external scrutiny and peer review and an opportunity for input into development; at any time during the revision cycle. Consultation and comment must represent more than nominal achievements but an important and necessary pathway to excellence. 5. Effective and transparent mechanisms need to be in place to ensure ethical and scientific principles are central to process i.e. that processes are not inappropriately biased toward or away from recommendations for other reasons than a “balance of evidence”. 6. Internal policies that attribute inappropriate status to expert consensus opinion i.e. demand unnecessarily high levels of evidence to affect change; are unscientific and impediments to innovation and improvement. 7. The implementation of an experimental framework and methodology to appropriately manage speculative opinion based recommendations. This framework must necessarily include processes for the evaluation of efficacy to inform change, termination or progression. The use of LOE IV rather than an experimental methodology cannot obviate all responsibility. An experimental framework could allow for the appropriate assessment of regimes or procedures that are currently experimental in nature (due to being significantly different to international consensus opinion) and provide a platform for innovation in the area of resuscitation. 8. Expert consensus opinion should be constructed in consultation with a wider and sector specific group rather than cascading down from higher clinical levels under the assumption that there is an innate understanding of lower levels and their specific implementation/ interpretation challenges. This assumes expert status by inference rather than direct and relevant experience. 9. Any defense of consensus opinion should be done through appropriate debate and dialogue. Strategies such as “refusal to engage” and the “discrediting of individuals” are not appropriate strategies in the consideration of research/ evidence and the formulation of widely utilised guidelines and demonstrate a dedication to power rather than outcome. 10. Those assuming responsibility for guideline development (particularly those based on local consensus opinion) must accept some level of responsibility for the monitoring of efficacy, particularly if unwilling to commit to continuous development. Specifically, if an instrument assumes or has claim as “the authority” which results in others being forced into compliance (regardless of methodology or appropriate evidence). 11. There is a need for the broader acceptance of multiple solutions and approaches to guidelines based on common non-specific evidence. Otherwise guidelines and opinion are presumptively rules with some basis in law. Logically, if no responsibility is accepted then there can be no objection to a contrary opinion that relies on the same available evidence. The elevation of LOE IV to evidence requiring an unjustifiable burden of proof would result in in the situation we see in this example. Conclusion Whilst the ARC (using the UK and ILCOR practices in ALS), has structured ALS in Australia to be an effective area of emergency management, the same cannot be said for BLS. The level of immediate care (driven by largely hospital-based clinicians) has been weakened by a flawed methodology and process in the use of its own expert consensus opinion. Unlike in higher levels of care, involving clinical professionals, there is no accountability or meaningful scrutiny for decisions made as a result of expert opinion on BLS. The use of LOE IV should be approached with caution and should be recognised as the lowest form of “evidence” on any hierarchy. There are several pitfalls we see in the methodology when LOE IV – (expert consensus opinion) is used as a substitution for higher levels of evidence, even if influenced in part by stronger evidence. LOE IV cannot be protected by a requirement for higher level of evidence as it is the subjective, momentary interpretation. Protecting this interpretation is weak methodology and impedes innovation and the pursuit of excellence. Ethical and transparent processes must be in place in all considerations of research and evidence, especially when developing widely circulated guidelines. In the absence of proper processes, bias and personal opinion can easily influence group opinion and tends to be self-protective by establishing an unquestionable position. Due to its heavy reliance on LOE IV, the ARC is a good example of the where this methodology can result in sub-optimal guidelines and therefore outcomes in resuscitation. With no accountability for poor methodology and/or the application of the expert opinion and no effective external review together with the assumption of absolute authority in opinion; the example of the ARC demonstrates where evidence methodology can be used as a barrier to genuine consensus and best practice. The question of accountability has still not been resolved and needs to be addressed with a more formal and rigorous approach. Obviating responsibility for outcomes in application at one level is appropriate i.e. as there are no guarantees in any situation that any measure will result in a positive outcome. However, where the recommendation itself is flawed and/or constitutes disparate expert opinion, responsibility must be address, formally acknowledged and be supported by appropriate quality improvement systems to quickly address identified issues.
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Overall, there is not a lot of positives with the new 2016 ARC Guidelines. Some changes, little improvement, the repetition of traditional, out-dated consensus views and the removal of some key procedures based on a narrow, hospital/physician-centric view of the care of casualties i.e. when a casualty ends up in a hospital with a team of clinical staff to care for them, with a list of invasive and definitive procedures to choose from, the care of the first aider can seem irrelevant and not contributing to any positive outcome. There are also some recommendations that have changed based on the notion that first-aiders are incapable of learning a technique properly and so, “the baby is thrown out with the bath water”. Provided in the following, is a summary of the issues with these new guidelines for your consideration. Guideline 3 - Recognition and First Aid Management of the Unconscious Victim The ARC appropriately defines unconsciousness as… “Unconsciousness is a state of unrousable, unresponsiveness, where the person is unaware of their surroundings and no purposeful response can be obtained.” However, the obvious omission here is the absence of “pain” as the ultimate determinate of “response” and therefore consciousness vs unconsciousness. This omission is carried over into the “Head Injury” guideline were assessment of deteriorating consciousness via GCS or AVPU are not supported for the first aider to use “pain” as a determinate (even in suspected cardiac arrest) of unconsciousness. “Pain” as a clinical indicator is safely used everywhere in the management and assessment of casualties and patients, except in these BLS guidelines for first aiders. The ARC continues to rely on the assessment of consciousness as accurately determinable by “gentle shaking of the shoulders and talking to the casualty”, even in determining suspected cardiac arrest. This is neither effective nor clinically sound. Guideline 4 – Airway In this guideline the ARC makes several contradictory and confusing statements that are not supported by evidence and have remained uncorrected. 1 “To clear the airway the mouth should be opened and the head turned slightly downwards to allow any obvious foreign material (e.g. food, vomit, blood and secretions) to drain.” This technique 1 is contradictory to 2 below. 1 uses a technique that (as the casualty is supine) will not make a scrap of difference in “clearing the airway”. However the technique in 2 “if the airway is obstructed” is the exception for log rolling a casualty. “The person should not be routinely rolled onto the side to assess airway and breathing—leave them in the position in which they have been found. This has the advantages of simplified teaching, taking less time to perform and avoids movement. 2"The exceptions to this would be where the airway is obstructed with fluid (water or blood) or matter (sand, debris, vomit). Here, the person should be promptly rolled onto their side to clear the airway.” The other continuing error here is that log rolling for “debris” may be of limited value. However, the only fluid that makes a difference to outcome in resuscitation is vomitus in the airway i.e. the only indication to log-roll is therefore vomit. Blood is rarely present in sufficient quantities to create issues, water (salt or fresh) rarely causes significant issues (e.g. delayed pulmonary oedema), and secretions are not a significant issue and like most fluids will disappear across the lung tissue with ventilation. Later in this guideline we come across the statement by the ARC in relation to FBAO in the conscious casualty i.e. “If back blows are unsuccessful the rescuer should perform up to five chest thrusts. To perform chest thrusts, identify the same compression point as for CPR and give up to five chest thrusts. These are similar to chest compressions but sharper and delivered at a slower rate.” In response to this it must be reiterated that the “chest thrust” technique recommended here by the ARC has no clinical evidence, trials, and respiratory studies, nor survivors and is not the “chest thrusts” described in the international literature; or the recommended treatment by ILCOR after the failure of back blows i.e. abdominal thrusts. Guideline 5 - Breathing Here in this guideline there is a mixture of terms. The term “rescue breathing” is used as before, however the proper term for this process is also mentioned i.e. “ventilation”. The term “rescue breathing” is a left-over from the EAR days when the only VENTILATION of a patient was done with one’s mouth. In the “Mouth to Nose” section the ARC has recommended that this technique be used: • “where the rescuer chooses to do so” • “where the person’s jaws are tightly clenched” • “when resuscitating infants and small children” However in practice, this technique (when used in cases of hypoxic arrest) is most useful when:
The fact that “No human studies have addressed the safety, effectiveness, or feasibility of using barrier devices to prevent person-to-rescuer contact during rescuer breathing” does not mean this method should not be preferred over direct contact. The new statement that “ANZCOR suggests that those who are trained and willing to give breaths do so for all persons who are unresponsive and not breathing normally” is not supported by the findings of the 2010 ILCOR in that “In some circumstances the inclusion of ventilations in resuscitation attempts, led to poorer outcomes”. This reduction in poorer outcome was put down to poor technique (poor airway care and hyperventilation – leading to aspiration) and wasting time in SCA where passive ventilation via compressions was considered adequate in BLS for SCA. Guideline 6 - Compressions The assumption made in this guideline is that all cardiac arrests happen with more than one rescuer present, that all rescuers are capable of providing adequate chest compressions using a kneeling technique and that there is only one method of effecting compressions. In reality approximately 46% of the adult population (including health professionals) are able to achieve adequate depth of compression on an adult casualty using the kneeling technique. The statement that “ANZCOR suggests performing chest compressions on the lower half of the sternum. In making this recommendation, we place a high value on consistency with current treatment recommendations in the absence of compelling data suggesting the need to change the recommended approach. Place the heel of their hand in the centre of the chest with the other hand on top.” This statement merely means that the ARC has formed an opinion based on internal consensus rather than evidence contrary to their view. Other techniques, including “pedal compressions” are more effective for rescuers with low strength and/or body mass or those with an injury or disability and who have no assistance available. Pedal compressions are the only method in fact that can maintain depth of compressions after the first few minutes. The next section of the guidelines in relation to depth and rate seems to make little sense and is full of questionable statements that are in opposition to the international evidence and common sense. “The lower half of the sternum should be depressed approximately Œone third of the depth of the chest with each compression. This equates to more than 5cm in adults, approximately Ž5cm in children and 4 cm in infants. ANZCOR places greater importance on adequate compression depth. Although there is some evidence suggesting detriment with compression depths greater than 6cm, the clinical reality of being able to tell the difference between 5 or 6 cm and adjust compressions accordingly is questionable. Inadequate compression depth is definitely associated with poor outcomes. ANZCOR has elected not to put an upper limit on compression depth as the risk of too shallow compressions outweighs the risk of compressions that are too deep. “ The concept of every casualty being compressed approximately 1/3 of the depth of the chest is an ARCism that in the adult casualty is anatomically impossible. The typical chest depth achieved by compressions on an adult is in the order of 20% and so this assertion is incorrect. Additionally, how in practice would a sole rescuer determine a fraction of 1/3 from a position over the casualty?! The measurements used at re-inforce the error of 1/3. The suggested depth on an adult and child here the same (5cm). Whilst 5cm in children and 4 centimetres in infants do represent approximately 1/3 of the chest depth, anatomically the adult approximation must be wrong or a 3 year old has the same chest depth as a 40 year old. At the ARC acknowledges the 6cm depth (used in the UK and Europe for some time), it suggested that a rationale for not increasing their recommendation (which we have established is wrong) is that the new depth would be impossible to estimate. As stated 1/3 in adults is not only wrong anatomically, but is impossible also to determine by the sole rescuer. The risk to casualties in of too shallow compressions is vastly understated. Except in the very old and frail, the main failure of adequate compressions comes from too shallow compressions rather than too deep compressions. This is not therefore a rationale for not applying an upper limit. Later in the revision, the statement on rate below is inserted into the new guidelines: “ANZCOR acknowledges that compression rates will vary between and within providers and survival rates are optimised at compressions rates of 100-120 compressions per minute. There is some evidence that compressions rates less than 100 or greater than 140 compressions per minute are associated with lower rates of survival.” Here again we see an acknowledgement that international practice has evidence of improved outcomes with a faster rate, but the ARC fails to provide clear guidance around an optimum value i.e. 120 /min. An aspirational goal would have been helpful here as an appropriate benchmark. Later in the guideline the ARC makes another interesting statement in relation to CPR feedback devices (presumably including those within AED’s) that is contradictory to its own methodology: “There is no high level evidence that the use of CPR feedback devices during real time CPR improves survival or return of spontaneous circulation. CPR prompt / feedback devices may be considered for clinical use to provide data as part of an overall strategy to improve quality of CPR at a systems level. ANZCOR places a higher value on resource allocation and cost effectiveness than widespread implementation of a technology with uncertain effectiveness during real time CPR. We acknowledge that data provided by CPR feedback devices may benefit other victims as part of a broader quality improvement system.” The absence of “high level evidence” in relation to recommendations made by the ARC is not a pre-requisite for exclusion. There are many techniques recommended by the ARC that are made on low, no or very poor levels of evidence. Feedback devices, especially when used by individuals with little or no real exposure to resuscitation, just make good sense. The question to the ARC from the statement above is if “CPR prompt / feedback devices may be considered for clinical use to provide data as part of an overall strategy to improve quality of CPR at a systems level.” what is the difference for improving systems at the first responder level? The data is real time and does not need clinical/ academic review to prompt immediate improvement. Lastly in this guideline is a welcome but again contradictory statement: “Rib fractures and other injuries are common but acceptable consequences of CPR given the alternative of death. CPR should be initiated for presumed cardiac arrest without concerns of harm to patients not in cardiac arrest. In making this recommendation, ANZCOR places a higher value on the survival benefit of CPR initiated by laypersons for patients in cardiac arrest against the low risk of injury in patients not in cardiac arrest.” Whilst this statement is absolutely true and refreshing, the theory is not universally applied to examples such as FBAO when the consequence of non-relief is death. Guideline 7 – External Automated Defibrillation in BLS This guideline sets out the recommendations in relation to the use of AEDs, however the there is a lack of detail in the following leading to an obvious interpretation by some who read and implement this guideline. “If the AED does not have a paediatric mode or paediatric pads then it is reasonable to proceed with standard adult AED pads.” This would suggest that it is acceptable to not purchase a defibrillator with a paediatric switch or purchase paediatric pads, because adult pads can be routinely substituted. The recommendation should read “In cases of emergency, where the AED available is not fitted with a paediatric switch or paediatric pads, the adult pads can be used. The substitution of adult pads for paediatric pads is not a recommended strategy for the management of casualties in cardiac arrest. ANZCOR recommends that the type of defibrillator available and the pads stored in the machine should reflect the risk associated with the AED’s location and intended use.” 9.1.1 – Principle of Controlling Bleeding for First Aiders. This guideline’s recommendation changes are a little puzzling. Whilst there may be no evidence that elevation of a bleeding part will control severe bleeding, it is extremely doubtful that there is no evidence that as a self-care measure, for instance, in the management of minor bleeding that this technique is effective. This is also true for pressure points. “There is no evidence that elevation of a bleeding part aids control of bleeding and there is the potential to cause more pain or injury.” Certainly in the face of severe or life-threatening haemorrhage, elevation may have little use, however the “potential to cause more pain and injury” is far more from tourniquets and the like, so this rationale is not particularly valid. This guideline change assumes that all bleeding is haemorrhagic and severe. 9.1.4 Head Injury The head injury guideline unfortunately makes no distinction between, for example, a facial laceration/bruise and a head (brain injury). The notion that all casualties with wounds to the face or head have a “brain injury” and need to be “assessed” in hospital is not supported by the evidence and is totally unworkable (particularly in sports). This would mean, for example, the first time a boxer was hit in the first seconds of the first round he/she needs to be taken to hospital. “A brain injury should be suspected if the victim has a reported or witnessed injury, has signs of injury to the head or face such as bruises or bleeding, or is found in a confused or unconscious state. A victim may have a brain injury without external signs of injury to the head or face. Serious problems may not be obvious for several hours after the initial injury.” Undetected brain injuries are not common and can occur even after assessment in a hospital. It would be expected that considering the resource implications of such a recommendation, this would be supported by a high level of evidence. Whilst the Glasgow Coma Score is not well understood or implemented by first aiders (particularly when faced with a young child or mute), and should not be used as an absolute determinate of head injury; surely any altered LOC at or after an injury (or a high risk event), is a stronger indication of concern requiring hospitalisation. There is also no mention in this guideline of the higher likelihood of a neck injury with brain injury. 9.1.6 Spinal Injury Of the guideline changes, the changes to this guideline are obviously the recommendation of hospital-based trauma physicians with little appreciation for the circumstances and challenges faced by first-aiders. There is also a failure in this guideline to take the opportunity to improve the techniques and methods of spinal care pre-hospital and provide what is actually missing from the SR Cervical collar debate, standards for proper training in the effective application of collars and improved methods. The statement in the new guidelines below appears to be little more than an opinion based on, at best, anecdotal evidence of the authors. “The use of SR (cervical collars) by first aid providers is not recommended.” Although this is listed as a weak recommendation with low quality evidence. The evidences used by the ARC are: Hauswald M, Hsu M, Stockoff C: Maximizing Comfort and Minimizing Ischemia: A Comparison of Four methods of Spinal Immobilization. Pre-hospital Emergency Care. 2000; 4: 250-252 - which concluded that SR cervical collar application in the pre-hospital setting is prudent and the primary source of morbidity was the transport of victims on hard backboards. It also suggested that additional padding could vastly improve comfort and fitting issues. Some unsupported discussion/speculation in the research has also been used by the ARC as evidence. Hood N, Considine J: Spinal Immobilisation in Pre-hospital and Emergency Care: A Systematic Review of the Literature. Australasian Emergency Nursing Journal 2015; 18(3):118-137 - which found that there was a balance of fair and poor (no good studies with good quality evidence) studies for and against pre-hospital spinal immobilisation. "There are no published high-level studies that assess the efficacy of spinal immobilisation in the pre-hospital and emergency care settings. Almost all of the current evidence related to spinal immobilisation is extrapolated data, mostly from healthy volunteers. There were no studies that showed spinal immobilisation improved neurological outcomes as all studies using neurological outcome as an endpoint were neutral due to high mortality rates from other causes (mostly gunshot wounds)...Protocols that recommend application of spinal immobilisation should consider the risk vs benefits. Prospective studies of patients at risk of, or with actual spinal injuries, are needed using real pre-hospital or clinical environments." It also reinforced that the Canadian C-Spine Rule has 100% sensitivity and 42.5% specificity which should be considered as an indicator for cervical spine immobilisation in the pre-hospital setting (see also Nexus). Hauswald M, Ong G, Tandberg D, Omar Z: Out-of-hospital Spinal immobilization: Its Effect on Neurologic Injury. Academic Emergency Medicine. 1998; vol5, 3: 214-219 - which did not show a causation, was a relatively small sample and acknowledged that the observation that the non-immobilised group had less neurological injury could have been related to a difference in other more serious associated injuries (which was not part of the research corrections in data). Zideman, D. A., Singletary, E. M., De Buck, E.,et al. (2015). Part 9: First aid: 2015 International Consensus on First Aid Science with Treatment Recommendations. Resuscitation, 95, e225. - which acknowledged that "more evidence is needed on manual stabilization (using hands/knees to restrict motion), trauma patients in the pre-hospital setting, high-risk versus low-risk patients, other forms of physical cervical spinal stabilization, and implementation and education. A review of the adverse effects as a consequence of application of a cervical collar could be interesting in the future." Although not recommending SR cervical collars in first aid, this was based on poor training and the risk criteria used in determining the need for a cervical collar; two elements that could be addressed directly. The application of SR Cervical Collars is an interim emergency measure until more effective means are available. The suggestion that all the first aider needs to do is to have someone stabilise the head during treatment and transport, again neglects to recognise that the movement, extrication and transport of casualties is often required to meet emergency services or remove them from danger and that not all first aiders will have a team around them (as in an ED) to be able to sacrifice one person to “look after the stabilisation of the head and neck”. The rationale that unnecessary movement is caused by the “sizing and fitting of collars” and that other complications “may” occur (including increased intra-cranial pressure) just means that some direction may be helpful for the proper training in the safe fitting and sizing of collars (a task that many clinicians do not understand well). This is another example of “the baby out with the bath water”. The other missed opportunity in this guideline is a recommendation around head immobilisation boards with specific padding, as a preferred adjunct rather than the reliance on cervical collars. 9.2.3 Shock The definition and management of shock by the first aider has always created much confusion in the non-clinical individual. For the most part, without a clear understanding, shock is assumed by the first aider in every emergency and is confused frequently with “emotional distress”. What are lacking in this guideline are changes to clarify the position and assist in determining likelihood and more specific deferential diagnosis. “For individuals with shock who are in the supine position and with no evidence of trauma, the use of PLR (passive leg raise) may provide a transient (less than 7 minutes) improvement.” “The clinical significance of this transient improvement is uncertain; however, no study reported adverse effects due to PLR. Because improvement with PLR is brief and its clinical significance uncertain, ANZCOR recommends the supine position without passive leg raising for victims of shock” The new statements above in the guideline fail to recognise 4 essential factors in the first aid management of patients.
9.2.5 First Aid for Asthma The new revision for the management of asthma has not corrected a significant failing of the old guideline; in that there is still no trigger for calling an Ambulance without first giving the “up to 6 puffs and wait 4-6 minutes then give another 4-6 puffs”. A casualty in extremis, who is hyper-inflated, will receive no benefit from inhaled broncho-dilators or the accumulated wait time of more than 6 minutes. There is also no acknowledgement of techniques such as “sustained lateral expiratory chest thrusts” in the management of severe asthma. This technique, in the absence of adrenaline, can mean the difference between a dead asthmatic and a treatable one. This technique has good evidence and has been re-instated in all Ambulance protocols. See Allan, J., Williams, B., & Fallows, B. (2007). Investigating the Benefits of Out-of-Hospital External Chest Compression. Australasian Journal of Paramedicine, 5(3). Retrieved from http://ro.ecu.edu.au/jephc/vol5/iss3/2 10.4 Use of Oxygen in Emergencies The changes to use of oxygen in emergencies have changed significantly after the research done by the UK Anaesthetics Society several years ago. Australia is now playing a bit of catch up regarding the use of oxygen. Unfortunately, there are some disparities and anomalies in the guidelines between the recommendations for ALS vs BLS. Whilst the ARC is aware of these anomalies, no changes have been made to address these issues. For example, the guideline states: “When bag-valve-mask oxygen resuscitation is used by trained but occasional operators, a minimum of two trained rescuers are required to provide ventilation for a non-breathing victim.” However many ALS operators would be considered “occasional” and there is no stipulation that they “are required” to use two operators. Surely the standard should be competence in one person ventilation (after all first aiders do not travel in groups for the most part) and on failure of this, then two-person (if available) delivery. Conclusion In reviewing the summary of changes in the 2016 ANZCOR Guidelines, it is apparent to ARAN that they have fallen short of their potential to promote improvement in casualty outcomes and better equip first aiders to provide effective, evidenced-based foundations to their care. The individual guidelines are inconsistent and contradictory in both terminology and the use of evidence on which is based recommendations and consensus view. It is apparent that many authors have controlled the review of individual sections, without a consistent approach to the purpose, implications and evidence required to inform consensus view over scientific literature and clinical findings. This misuse of evidence-based review leads to therapeutic nihilism (the belief that there is no objective basis for truth) in the absence of evidence from randomized trials. Historically, highlighting issues such as these to the ARC and/or the submission of constructive, evidenced suggestions are met with silence. This is followed by complete dismissal (without explanation, discussion or the provision of counter evidence). This must suggest that to the observer, that the methodology of review and evidence used by the ARC is flawed, partisan and conceited. This unfortunately means that there is no current, effective means of influencing change in the ARC published guidelines in Australia regardless of one’s evidence and/or clinical standing (outside of its internal structure) and thus no peer review. ARAN suggests that individuals (both clinical and non-clinical) closely review the new ANZCOR guidelines for themselves to determine their consistency and efficacy and then independently decide if the ARC Guidelines (opinions as published) are suitable and relevant for their individual situation. The Dichotomy in the Australian Resuscitation Council With a catchphrase of “Any attempt at resuscitation is better than no attempt” but aims and objectives that seek to control standardisation in Australia and New Zealand; how committed is the Australian Resuscitation Council to better outcomes as opposed to control over resuscitation practice and teaching? This dichotomy has perhaps hamstrung improvements in OHCA outcomes in Australia for years and seen us languishing behind the rest of the world. The fundamental belief that must be assumed, (in order to enable these opposing concepts to co-exist), is that the ARC guidelines and consensus opinion is unquestionably “right”, at all times. It is quite evident that the stated aim in regard to “uniformity and standardisation” is the overriding philosophy, the driver of actions and that any notion of “any resuscitation attempt be better than none” only (and will forever only) refer to attempts that are made in conforming to ARC sanctioned, standardised recommendations. “Aim: Foster and co-ordinate the practice and teaching of resuscitation promote uniformity and standardisation of resuscitation; act as a voluntary co-ordinating body” – ANZCOR Aims and Objectives. In order to claim this infallibility, the ARC uses its objectives to give the appearance that its consensus opinion is the only correct interpretation of current research and evidence, restricts any input into resuscitation practice to the members of its own organisation, prosecutes (with apparent impunity) any view or solution that has not originated from its own deliberations and then the ARC fails to exercise due diligence to ensure recommendations are show the expected efficacy when applied i.e. there is a lack of accountability despite a demand for conformity. This methodology may be acceptable in a non-scientific environment but merely acts as a handbrake on genuine improvements in survival. That aside, if this methodology was effective at achieving best practice and results, this would be in evidence in outcome data, however this is not the case in Australia where the things measured don’t show a significant improvement over other approaches and those things not measured we will never know if recommendations result in help or harm. How are the objectives used and misused to promote conformity and standardisation over ultimate improvement.
Develops and publishes Guidelines- this is a fundamental role of any resuscitation body. In reality, guidelines cannot be current at all times (unless they are constantly reviewed). Whilst a single set of guidelines may simplify practice, the assumption that must be made is that this solitary is both applicable in all circumstances and is an accurate distillation of international consensus and more importantly, evidence. With no review of outcomes from recommendations and no accountability for sub-standard recommendations; one guideline is in fact as good as any other guideline. However, one only has to produce an alternative guideline to experience the veracity in which the ARC defends its own guidelines as the only interpretation of evidence and international consensus with only its own consensus as the proof. While the defence may be the reliance on ILCOR recommendations, the ARC has demonstrated on more than one occasion that it is willing to go against international recommendations if its own local consensus has another opinion.
There are no less than nine areas where the ARC can improve its structure and practices to realise the spirit of its aims and objectives rather than what it has become:
As consumers of the guidelines and consensus opinions of the ARC (as Government and industry are also); we should demand that changes are made to the organisation if it is to continue to claim to be the “authority” on resuscitation practice in Australia and New Zealand. This includes meaningful and significant changes to governance structures, processes and focus. Resuscitation outcomes are the concern of many individuals and organisations across the community, health and government. No one group has a monopoly on evidence, ideas and best practice. Particularly in Australia, where government (State and Federal) have no interest in improving OHCA survival rates outside their statutory obligations in the provision of ambulance and hospital services; it is incumbent on voluntary, not-for-profit organisations and individuals to all work toward the common goal of improving survival rates. Critical Review ARC Document – A Guide to AEDs July 2017 Although somewhat belated, it is good to see the ARC releasing a statement on this topic. Although this is not an original work (by its own admission), much has been written on this topic overseas and in Australia although the ARC has chosen in this case not to utilise or acknowledge any of the good work already done here (including the books such as “Back in a Heart Beat”, a National AED Standard and various other publications.).
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