Giving back to the community: Facilitating ethical research in the trauma setting

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The Helsinki Declaration underpins the ethics of medical research. Yet the minds behind these noble and pivotal codes of conduct could surely have not envisaged the fast pace of cutting-edge emergency care delivered both inside and outside of hospitals in our modern healthcare systems. Furthermore, it fails to address the population-level community consent sometimes required to undertake health service research and evaluations. With community consent information about the study is provided to the local community of potential subject and it is explained that everyone in the community will be considered for participation unless they opt out.

Individualised informed consent which involves a detailed discussion of the risks and benefits of study participation allows for trust and confidence to be established between researchers and subjects and acts as the ultimate legal buffer should expected adverse events occur. But what about time-critical interventions in incapacitated patients? For a while it seemed that emergency care was forever condemned to be backed up by low-quality retrospective data. Ethics committees world-wide have begun to appreciate the need to expand the scope of emergency research to not only improve the quality of care emergency and trauma patients receive, but to also open up study settings that were previously inaccessible to clinical trials such as the pre-hospital environment.

The controversy surrounding community consent is perhaps somewhat overblown, given the history of futile interventions that trauma patients have been subjected to over the years both inside and outside of hospitals. Resuscitative thoracotomy following blunt trauma is still performed despite dismal outcomes overall. How about pneumatic anti-shock trousers, junctional tourniquets or other interventions with limited evidence bases beyond a handful of swine or canine models in controlled settings? Perhaps it’s not so much about the pitfalls of trying to establish a system of community consent, but more a question of why is this such a controversial issue given our history of subjecting incapacitated people to potentially dangerous interventions in their ‘best interests’? This despite there being no guarantee that our interventions aren’t causing more harm than good.

 A pragmatic approach is increasingly being taken to emergency and prehospital research. Much is covered by guidelines similar to the FDAs Exception From Informed Consent Requirements for Emergency Research (EFIC) which states qualifying conditions under which emergency research can take place, namely:

· The human subjects are in a life-threatening situation that necessitates urgent intervention.

· Available treatments are unproven or unsatisfactory.

· Collection of valid scientific evidence is necessary to determine the safety and effectiveness of the intervention.

· Obtaining informed consent is not feasible because the subjects are not able to give their informed consent as a result of their medical condition.

· The intervention must be administered before consent can be obtained from the subject’s legally authorized representative.

· There is no reasonable way to identify prospectively individuals likely to become eligible for participation.

· Participation in the research holds out the prospect of direct benefit to the subjects.

· The clinical investigation could not practicably be carried out without the waiver.

 The Centre for Trauma Sciences (C4TS) at London’s Queen Mary University is well versed in recruiting trauma patients into clinical trials directly from the resus bays of the Royal London Hospital, the busiest trauma centre in Europe. Whether it be observational coagulopathy studies, or a randomised control trial for REBOA consent is simply obtained from a senior member of the ED team who has no direct involvement in the trial and functions as professional legal representative. Written consent from the patient or next of kin is sought as soon after enrolment as appropriate. Most of the interventional studies tick all of the aforementioned EFIC boxes. Following enrolment of over 1800 patients to one particular study over a 10 year period at C4TS, only 5% of patients or relatives subsequently over-ruled the consent of the independent physician. Of course, the inability to reverse the original intervention and its effects potentially opens up the door to legal challenges from the study subject, irrespective of whether their next-of-kin consented on their behalf during their period of incapacitation.

 In the prehospital arena, studies such as the one looking at using whole blood on helicopters clear local ethics boards with similar ease owing to a culture of research and innovation which has been allowed to take root and flourish.  Another approach from the Royal London Hospital has been to display notices in the ED waiting room to inform patients that they may be enrolled into clinical studies and therefore consent is presumed unless patients specifically request opt-outs. Furthermore, trauma systems research into the development of refined triage tools may require cluster randomisation of entire communities and neighbourhoods. Presumed community consent is surely the only way to make all this feasible.

 From spring 2020 UK citizens will have to get used to a similar opt-out principle with regards to organ donation. It would therefore be unsurprising if presumed consent became the default position for a wider scope of emergency clinical trials in years to come.

 

Obi Nnajiuba is a British general surgical resident  with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone.

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If Congress won’t stop the shooter then teachers can Stop The Bleed

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The arrival of the ‘back to school’ season focuses the mind on every parents’ worst nightmare. Since the watershed of the Columbine High School massacre 20 years ago an estimated 228,000 US school children have been exposed to gun violence during school hours. The issues of gun violence in America, and perhaps most sensitively the issue of school shootings remain a permanent fixture of political and social debate.

School are now being designed and built by the same firms that build jails. In addition to existing measures such as emergency drills, remote-controlled building lockdown systems, CCTV and security fencing;  school districts are also investing heavily in on-site armed ‘resource officers’ and mental health personnel. Many have advocated the extra step of arming teachers themselves and although this is already  legal in a number of states, the majority of teachers themselves are opposed to the idea. Just to play devil’s advocate for a moment, if the Geneva Convention allows for medics to use lethal force to defend themselves and their patients, is it too fanciful an idea to expect teachers to be morally bound to use lethal force to protect their children whilst in loco parentis? Just throwing that out there….

New schools such as Fruitport High, Mich. Are being built from the ground up with active shooter frustration in mind. Everything from curved corridors to limit lines of sight to ubiquitous ballistic-grade glass is being fully integrated into building design, fuelling a $2.7 billion school security industry. But should the worst happen and all the expensive security measures fail then the wounded and dying must rely on those in their immediate vicinity to deliver life-saving treatment before medical personnel are able to enter the ‘hot zone’. Teachers now routinely attend Stop The Bleed classes alongside the usual first aid training. In its first 5 years of implementation an estimated 125,000 US teachers received training in life-saving haemorrhage control. Tourniquets and haemostatic dressings are now as much a part of any classroom first aid kit as plasters and antiseptic cream. Some criticism has been levelled at the Department for Homeland Security for funding the program and also rolling it out among the pupils themselves, with accusations of treating the symptoms of gun violence rather than actually pushing for tighter gun controls and tackling the issue at source. One could also make the argument that these skills of emergency haemorrhage control are transferable and equally useful should the teacher or student witness a serious road traffic collision or other non-shooting related traumatic event in their community.

That may be more useful to the students and society than over-zealous active shooter drills that may indeed be causing more harm than good by forcing petrified kids to routinely contemplate their own violent death or filling their heads with far-fetched ‘tactics’ advising them to suppress a gunman by throwing school books or rocks at them.

Obi Nnajiuba is a British surgical resident and current PhD student with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone.

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Trauma Care 2050 Part II: New paradigms in surgery and ICU

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Compared to trauma surgeons of today, the trauma surgeon of 2050 will probably know a great deal more about their patient and what’s going on inside them as they paint their torso with betadine. Injury mechanism and the specific location of bleeding vessels or damaged tissues may be more clearly defined, consigning the ‘exploratory’ element of the laparotomy to the history books. The risk of coagulopathy and multi-organ dysfunction will be known allowing for expedited or prolonged surgical procedures as deemed appropriate. The printing of organs known to be damaged beyond salvage may already be in progress in the lab adjacent the OR. The surgeon may have even been able to use augmented reality to rehearse their approach on that exact patient with their reconstructed images having been fed directly from scanner to surgical VR headset. Senior or specialist advice could be remotely sought from elsewhere with the images being securely transferred to an attending or consultant surgeon outside of trauma centre also utilising VR hardware.

Even today, after a decade of advances in damage-control resuscitation we’ve seen the implications of patients who previously would have died at the roadside surviving to get to the OR and succumbing to multi-organ failure on the ICU in the days that follow. By that same reasoning, further advances in prehospital and ED resuscitation may enable even more patients with significant injury burdens to find their way alive (just about) onto the operating table. This calls for advanced surgical techniques that avoid adding to the physiological stress of the initial injury. Nanotechnology will most likely play a significant role in achieving haemostasis. The use of nanobots as an imaging adjunct in locating bleeding cerebral aneurysms, delivering targeted thrombolysis in atherosclerotic disease and delivering targeted chemotherapy has garnered much interest in recent years. Even at the turn of the 21st century in-depth discussions were taking place about the potential for artificial mechanical platelets (clottocytes) inundated with haemostasis promoting proteins to control haemorrhage. Circulating ‘respirocytes’ may be able to maximise oxygen tissue delivery even in low-flow states. With regard to nerve injuries, advancements in technology have led to the development of devices on the nanoscale which allow manipulation of individual axons.

The greater use of nanotechnology to target hard-to-reach bleeding could facilitate a minimally invasive approach to trauma surgery. Furthermore, the knowledge that these nanobots could be left to quietly go about their business inside the patient could mean shorter times on the operating table, minimising the additional physiological insult of prolonged large-incision surgery. Patients could go to ICU with surgery ongoing inside them. The patient’s ICU journey could become more predictable and manageable with greater knowledge of the expected inflammation response owing to genomic analysis and artificial intelligence.

Patients will have greater control of their long-term rehabilitation with individually customised recovery plans and specialist support, building on existing services such as MyRecovery.AI and AfterTrauma

There is no doubt that the surgeon of the future will need to be ‘multilingual’ in a number of biomedical and allied disciplines, be it genetics, bioengineering, computing or data science. They will need to employ quick thinking and common sense to piece all the various bits of information together. Greater flexibility and multi-disciplinary collaboration throughout medical training will be crucial to this. Technology, however, can never replace the ‘human touch’, especially in a specialty where both patients and relatives will potentially be having the worst day of their entire lives. An in-depth technical and scientific must be coupled the timeless qualities of empathy and compassion.

Obi Nnajiuba is a British surgical resident and current PhD student with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone.

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Trauma Care 2050 Part I: From roadside to ED

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Allow me to paint you a putative vision of trauma care in the year 2050 (assuming civilisation hasn’t been eradicated by climate change by then).

The predicted widespread use of driverless cars may  significantly reduce the trauma burden from road traffic incidents (see June’s article below).  But with the pressures of growing populations, stretched public services and rising social deprivation we can expect interpersonal violence to continue to provide a steady if not increasing flow of trauma cases.

 In the immediate aftermath of a violent or traumatic incident EMS dispatch is automatically triggered by distress signals from the victim’s smart watch-like device. This intelligent wearable tech will detect changes in stress hormones, nociception, significant force vectors and vital signs and relay these along with precise geographical data  to the EMS dispatch HQ.  Existing smart devices such as the Apple Watch Series 4 are already incorporating elements of this with their fall detection technology. First responders will receive all the relevant baseline vital signs and medical history such as anticoagulation status and allergies whilst en-route. Corroborating information garnered from bystander 911 calls will also add to the picture. Upon arrival at the patient’s side the EMS teams will already have an in-depth knowledge of patient physiology, injury pattern and mechanism, thus facilitating rapid triage to an appropriate level of trauma centre.

 Point-of-care genomic testing could feed into predictive models of coagulopathy, transfusion requirement  and subsequent multi-organ dysfunction, further informing the triage decision. Professor Tim Billiar’s group from Pittsburgh are one of several groups looking into the multitude of inflammatory mediators  and their underlying gene expressions that predispose different patients to develop multi-organ dysfunction following trauma. Real-time and predicted physiological data could be fed back to the receiving emergency department allowing them to fine-tune the make-up of the trauma team, prepare blood products and begin the process of creating bed capacity and readying the operating room. On-scene audio-visual feeds from EMS bodycams or overhead drone footage could provide vital information not easily communicated in a standard verbal handover. Police forces around the UK and elsewhere have been using real-time drone footage for a number of years to assist in searches and crowd management operations and we further highlighted the current and future capabilities of medical drones in the March edition of this blog.  Larger drones may even be used to expedite patient transport, especially from remote areas or when road transport would lead to delays.

 With significant life-threatening injuries identified prior to arrival, a targeted primary survey will facilitate rapid transfer of the patient to the imaging suite where static anatomical displays will be augmented with dynamic organ functional imaging to provide unprecedented cellular-level detail of organ dysfunction and hone in on specific bleeding points and the best surgical targets for haemostasis. Ultra-high-resolution 3D images of the scan will quickly be distributed amongst the surgical team to start planning their approach as well as providing a basic blueprint for the dimensions of any replacement organs that may need to be bioprinted at a later date. Recent breakthroughs in bioengineering allowing the printing of intricate vascular tissue beds herald the way for the  rapid mass production of organs on-demand and without the often-tricky issue of having to approach recently bereaved relatives to seek permission to harvest the organs of their loved one.

 In the next article we look at the crossover of advanced imaging into the operating room of 2050 where nanotechnology complements surgical hands and the continuum of care through ICU to rehabilitation is tailored to specific patient needs.

 Obi Nnajiuba is a British surgical resident and current PhD student with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone.

@drnnajiuba

Driverless cars and the journey to unintended consequences

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Tomorrow’s World is very much the here and now. As the technologies of childhood dreams continue to develop at a rate of knots, careful consideration must be given to the potential implications of exciting new innovations. This is especially true for the world of automated, driverless or self-driving vehicles. Not only are millions of taxi and delivery drivers about to be made redundant but we should expect to see both positive and negative implications for the healthcare sector.

The first thing worth noting is that there are different levels of automation ranging from your standard driver assistance aids such as forward collision warning and emergency braking (Level 0), adaptive cruise control and lane assist (Level 2) up to near full automation (Level 4). Lower level automation is widely incorporated into most modern cars and has significantly reduced the rate of rear-end frontal impacts

The benefits of removing humans from the driving equation altogether are obvious. Human error is a factor in 90% of vehicle collisions with a significant chunk of that down to people driving while under the influence of alcohol or drugs. Driverless cars allow the users all the benefits of owning a vehicle, with the addition of not having to worry about parking, or watching how much you drink on a night out and also allows for greater productivity during the 200 hours per year the average person spends commuting. Replacing millions of private gas-guzzling vehicles with a smaller pool of shared cleaner or electric vehicles also has positive environmental implications. The state of Arizona is one of several locations throughout the US and Canada that have been used as a testing hub for companies like Waymo, Tesla and Uber. Waymo (the offspring of Google’s automated vehicle program) hit the 10 million mile mark in October 2018, however despite this the long-term data required to make sensible safety comparisons between conventional and automated vehicles is lacking. Cars driven under traditional human control are currently involved in approximately 1.18 fatalities for every 100 million miles. It’s worth noting that there are still over 37000 road traffic deaths on US roads  each year, including around 6000 pedestrians. To date there have been 5 recorded self-driving car fatalities. Four of those killed were Tesla test drivers in the US and China and perhaps most tragically one involved a pedestrian struck by an Uber vehicle (with a human backup driver on board) in March 2018. It was later found that the car’s sensors had detected the victim but the emergency braking had been disabled owing to previous passenger complaints about the jerkiness of the ride. Until driverless cars clock up hundreds of millions of miles however, it’s difficult to draw any solid conclusions from a handful of tragic cases.

 It is projected that a 10% penetration of the vehicle market by driverless cars would result in a 4% reduction in the annual vehicle collision burden and that a 90% market share would result in almost 80% of vehicle collisions being avoided each year. Globally, 10 million lives per decade could be saved thanks to driverless cars. That’s awesome. But will such a reduction in work load make some trauma centers and their staff equally as redundant as the truck drivers? Will it provide governments with an excuse to cut back on health spending? Will we see a sharp downfall in the supply of organs for donation? Around 20% of organ transplants come from road fatalities. Or will a new source of death and disability arise, that, much like the impact of ride-hailing apps, we cannot even conceptualize at this point?

 We’ve yet to see how these vehicles function outside of their carefully selected test locations. Adverse weather conditions, roadworks and the subtle non-verbal social interactions that are integral to communicating your intentions (and frustrations) to other road users may prove tricky nuts to crack and it may be some time before fully automated cars are let loose on the streets of the world. However, the healthcare sector may find itself having to quickly adapt to the unforeseen second-order effects of this new technology.

Obi Nnajiuba is a British surgical resident and current PhD student with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone

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Don't Hire A Dud!

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There are 4 red flags you need to be on the lookout for

Recruiting the right acute care surgeon for your trauma center is a difficult challenge. The key is to find a candidate with the right mix of clinical abilities and interpersonal skills. And while certain characteristics are desirable in a trauma surgeon, other traits are indicators to proceed with caution.

 Following are four red flags to watch for when assessing physician candidates for your trauma medical staff:

 1. Not board certified within five years. Failure to pass board exams within a few years of graduation could indicate fundamental problems in clinical skill, cause major problems with medical staff credentialing, and actually lead to increased malpractice premiums. Focus on finding a board-certified  general surgeon with trauma experience and, ideally, added qualifications in surgical critical care. An acceptable alternative is a new physician who is making strong progress toward board certification.

 2. Multiple residency programs. Working in three different residency programs to finish a five-year training course may indicate issues. The physician may lack focus, or they may have trouble getting along with colleagues. Look for candidates who are able to “bloom where they are planted.” One positive sign: The candidate was chosen to do a fellowship at the same program where they did their general surgery.

 3. Multiple divergent fellowships. Training in several unrelated specialties could indicate that the physician has had trouble securing a job. The candidate may have jumped from a transplant fellowship to a surgical endoscopy fellowship before entering training for acute care surgery. However, there are several fellowship which are complementary, such as critical care and burns, or trauma and critical care.

 4. Vague evaluations. Strong evaluations include examples of a candidate's outcomes, practice style and interactions with others. Vague evaluations with few details and just a few adjectives may indicate that evaluators are reluctant to talk substance. Even less talented surgeons should be able to find three evaluators who have something good to say, so vague comments could indicate real problems with the candidate.

 Would you like to learn more strategies for identifying the strongest physician candidates for your trauma program? Just contact us!

Massive transfusion confusion: Changing practices causing new problems requiring simple solutions

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The recorded history of trauma resuscitation probably begins in 18th century London, where in 1774 a 3-year-old girl by the name of Catherine Sophie Greenhill was witnessed to have fallen from an upper storey window onto the cobbled streets below. A volunteer from the newly formed Humane Society arrived and applied an electrical current to her chest from a portable electrostatic generator, reviving the clinically dead child. Fast forward to the battlefields of France during the First World War and French physicians note that treatment administered within the first hour of injury resulted in improved mortality . The data would later inform R Adams Cowley’s Golden Hour concept. Dr Cannon observed during the same conflict evidence of poor outcomes in shock following intravenous fluid resuscitation in the absence of surgical haemorrhage control, however the benefits of permissive hypotension would be largely forgotten for the next three quarters of a century. The British (in their infinite British wisdom) started resuscitating with whole blood during World War 2, whilst their slightly slower American counterparts began by using plasma only, before noticing the inferior survival outcomes on the battlefields of North Africa and changing their protocols to include blood transfusion. Liberal approaches to blood transfusion in the civilian setting continued in the post-war years until the discovery of blood-borne viruses and the increased costs associated with screening prompted more conservative transfusion policies.

In modern day trauma resuscitation, major haemorrhage protocols are ubiquitous and we know that compliance improves outcomes.  The debate in recent years has been more of a philosophical and tinkering nature. What constitutes a massive transfusion? Is it 4 units of blood and/or FFP within 2 hours? 10 units in 24 hours? Does it really matter? Should we be giving extra cryoprecipitate earlier on? Should it be guided by viscoelastometry TEG or ROTEM depending on which side of the Atlantic you’re on) and should it be 1:1:1 or 1:1:2? We’ve also seen the inevitable encroachment of machine-learning algorithms and Bayesian prediction tools. 

Leaving all that aside, for the busy ED nurse or physician in the organised chaos of the civilian or battlefield trauma bay, the only thing that really matters is effectively keeping track of what products went in to the patient and when. The trauma team is often compared to a Formula 1 pit stop team. Everyone playing their minor role and doing it well in order to contribute to the overall slickness of the operation. Inevitably in the heat of battle some elements get overlooked. In my experience this normally becomes apparent during the clean-up and documentation when the question of “how much blood did we give?” gets asked. The number of empty bags on the floor almost never corresponds with the amount that was prescribed.

What is needed is a stand-alone system which incorporates the speed and simplicity of pen and paper, that provides real-time relevant information to all relevant parties and that does not require any significant IT infrastructural overhaul or change to institutional clinical processes to implement. A simple scorekeeper that performs a simple task well and can seamlessly fit in to any major haemorrhage scenario be it in the trauma bay, on the labour ward or even in the elective operating theatre. As we continue to develop ever more intelligent and complex approaches to trauma resuscitation the logistics of implementing effective strategies remains a challenge.  We leave room for mistakes to happen and mistakes in medicine cost lives and money. Perhaps it’s time to apply a simple solution.

Obi Nnajiuba is a British surgical resident and current PhD student with a specialist interest in trauma, acute care, prehospital care, triage, mass casualty events and trauma systems. His postgraduate qualifications include an MSc in Trauma Sciences and membership of the Royal College of Surgeons of England. He is also a registered Motorsport UK physician, providing trackside advanced trauma care to competitors at world famous motor-racing circuits such as Brands Hatch, Goodwood and Silverstone.

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How Can You Weed Out Surgeons That Will Cause Your Program Trouble in The Long Run? (It's easier than you think)

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When considering a trauma physician candidate, you need to understand how he or she will function on the job. The gold standard is personal experience—hiring one of your program's residents or a physician you have worked with in the past. But absent firsthand experience, the next best way to assess a candidate is to conduct an oral examination based on trauma team scenarios:

Clinical scenarios. Ask the candidate to tell you what they do when they suspect a hemothorax that may require operative exploration. What factors do they consider? What is their philosophy for resuscitative thoracotomy? How do they decide when to leave a colostomy versus primary anastomosis? Ask about the grey, or controversial, areas in clinical management. Even if you do not agree with the candidate’s perspective, you will very quickly see whether they are dogmatic about their views and how they respond to disagreement.

Non-clinical scenarios. It is also important to understand how a candidate deals with the many management headaches and organizational challenges that surround trauma care. How would the candidate handle a disagreement with the ICU charge nurse over clinical management? What would they do if they felt that referrals were not being distributed fairly? How would they react if the ER was consistently “dumping” intoxicated patients on their service?

 

What's The Most Important Factor That No One Thinks About When Trying To Recruit A Trauma Surgeon?

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If you said money, you would be close, but not right. After a certain amount of salary, it is the little things that make a difference.

What you need to do is limit additional duties

Make your opportunity more attractive is to set clear limits on physician duties. For example:

Non-call clinical care. You can limit non-call duties by hiring physician assistants and/or nurse practitioners to see patients in clinic for follow-up appointments. Mid-level providers can also be assigned to take care of patients post-op.

Paperwork. No trauma physician wants to sit up at night doing paperwork. That is why 24/7 support from either a physician assistant or resident is a very attractive recruiting incentive. The PA or resident handles the paperwork so the physician can focus on caring for patients.

Semi-elective surgery. Develop a rational policy for determining when trauma surgeons will and will not be called in for semi-elective procedures. Let physician candidates know that they will not be handed a gallbladder surgery just because they happen to be on call.

Performance improvement responsibilities. Create guidelines that spell out the expected physician contribution to PI activities. Let candidates know they will not be required to review two dozen charts for every PI meeting.

What good is a strong salary, if you are too stressed out to enjoy it?

For more tips, please download our free e-book by clicking here.