Misrepresented: EBM

The Gist: Evidence based medicine (EBM) is misunderstood; it's not a randomized control trial (RCT) or "the literature." Rather, EBM is the intersection of the best available evidence, clinical expertise, and patient values [1-2]. Avoid BARF (Brainless Application of Research Findings), with tips from Emergency Medicine Cases

We have a cultural problem.  Clinicians are increasingly called upon to practice EBM.  Yet, the term EBM does not sit well on the palate of many physicians.  Conversations involving a mention of EBM have resulted in some of the following refrains...
"See, my patients are different..." 
"We'll never get an RCT on that..." 
"The culture is different here, I don't want to get sued." 
"Patients don't understand, but they do hold the power with satisfaction scores." 
"It's cookbook medicine."
With these words and reactionary body language, the dialogue quickly shuts down - by both parties.  First, this is a shame.  We should learn from one another but there seems to be a "hard stop" between many who champion EBM and those who find EBM off-putting. Second, this is a misunderstanding.  EBM is not an RCT.  In fact, EBM is not the best statistical methods or the rationing of care. EBM is not nihilism.  

EBM is the intersection of the best available evidence, clinical expertise, and patient values:
"the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research" [1].
Why, then, the misunderstanding? 
Here are some thoughts...

Misrepresentation. EBM is often used to refer to literature or studies, rather than to the application of research and evidence to particular patients and situations, using one's clinical experience (example and discussion: "EBM is Crap").  As a result, EBM may be misunderstood as a cost-cutting venture or a cookbook for medicine [3]. I have been complicit in perpetuating this misrepresentation of EBM.   As a novice physician-in-training with limited clinical experience, I draw predominantly upon the literature base.  I have unknowingly quoted the literature, thereby proudly proclaiming my practice of EBM, while unconsciously dismissing the other components of EBM.  
  • A remedy:  Remind ourselves and others that the evidence is part of the trifecta of EBM, along with the patient's values and clinical expertise.  We can be clear in what we mean by EBM and refrain from referring to a body of literature as EBM. 
Zeal. A religiosity exists amongst many champions of EBM, or people who believe they are championing EBM.  We tout our pyramids of evidence and may scoff at a lack of evidence or rigorous trials.  This may be off-putting as not all fields are amenable to RCTs and patient populations vary.  Moreover, there's a human tendency to form a reactionary attitude when someone exerts a strong identity [4].  Hence, EBM zeal may engender an anti-EBM attitude and cause people to be wary of solid practice changing evidence.
  • A remedy:  While championing good research and employing the best available evidence, we can balance our enthusiasm with important caveats and understand the importance for tailored approaches for patients.  Gentle education about EBM rather than diatribes may aid individuals in understanding the values of EBM beyond evidence.
Fear.  People like to be right.  We may reflexively become defensive when we are (possibly) wrong. EBM or "literature" can be used in an antagonizing way and, subconsciously, a way to exert a feeling of superiority.  "You haven't read that study?"
  • A remedy: Understand that unlearning in medicine is difficult.  Aggressive assertions may push people further away.  Think of it as a Kubler-Ross like grief cycle, as explained in this post.  This may help us become more cognitively flexible, understand the reticence of others, and perhaps make our points more effectively.  



Confusion.  Historically, researchers, clinicians, physicians in training, and allied health professionals have limited understanding of fundamental statistics [5,6].  As such, we may not understand what we're reading or how it applies to our patient population.  We may have difficulty understanding why something we believed was proper at one time is no longer the case.  Often, this is because the research was, in fact, initially wrong or misleading [7]. 
  • A remedy: Read.  This podcast proffers tips on getting started; however, even the most seemingly rigorous papers published in high impact journals are subject to bias (publication bias and otherwise), which can be difficult to parse through.  For example, the oseltamivir (tamiflu) recommendations from Cochrane changed after they were allotted access to data, demonstrating the profound impact of publication bias [Jefferson et al].  More on this here.
Time. The number of journal articles needed to read (NNR) to obtain valid and relevant information is typically cited as 20-200, an insurmountable task [8].  The process of trolling through the literature is time consuming and may be overwhelming.  Frustration can turn into apathy, confusion, and mistrust.
There are legitimate issues with EBM.  Evidence is often subject to the biases of industry and legislative bodies.  Guidelines or recommendations billed as "EBM" may be hijacked by individuals with conflicts of interest or other agendas. Further, the grading of evidence isn't always objective or consistent, as seen by the grading of evidence for thromboylitics in acute ischemic stroke listed in the ACEP clinical policy.   In addition, guidelines harness EBM and disseminate the body of evidence to practitioners.  For example, the 2008 AHA/ACC guidelines are based largely on low levels of evidence and expert opinion,  many of whom have financial conflicts of interest.  Only 11% of the recommendations were based on high quality evidence [9].  

So, while EBM has imperfections in concept, representation, and implementation, the model incorporates the primary things we, as providers, care about - the evidence, the patient, and clinical experience.  Let's understand what EBM means and apply the term and principles appropriately.

References:
1. Sackett DL, Rosenberg WM, Gray JAM, et al. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71–72. 
2. Greenhalgh T, Howick J, Maskrey N. Evidence based medicine: a movement in crisis? BMJ 2014;348:g3725
3. Straus SE, McAlister FA. Evidence-based medicine: a commentary on common criticisms. CMAJ. 2000;163(7):837–41. 
4.  Maalouf A.  In the Name of Identity: Violence and the Need to Belong. New York: Penguin Books, 2000.
5.  Windish D, Huot S, Green M. Medicine residents’ understanding of the biostatistics and results in the medical literature. Jama. 2007;298(9). 
6.  Mavros MN, Alexiou VG, Vardakas KZ, Falagas ME. Understanding of statistical terms routinely used in meta-analyses: an international survey among researchers. PLoS One. 2013;8(1):e47229. 
7.Ioannidis JP a. How many contemporary medical practices are worse than doing nothing or doing less? Mayo Clin Proc. 2013;88(8):779–81.
8. McKibbon KA, Wilczynski NL, Haynes RB. What do evidence-based secondary journals tell us about the publication of clinically important articles in primary care journals? BMC Med. 2004;2:33. 
9.  Tricoci P1, Allen JM, Kramer JM, et al.  Scientific evidence underlying the ACC/AHA clinical practice guidelinesJAMA. 2009 Feb 25;301(8):831-41.

SBO Ultrasound

The GistAs mentioned in this post, the operating characteristics of historical and physical features are suboptimal in small bowel obstruction (SBO).  Bedside ultrasound has better operating characteristics and is one of the easier scans to perform and read.  Assuming others like to make their lives easier, I gave a talk on this; but professionals have created a tutorial at The Ultrasound Podcast tutorial.

I delivered a quick talk at the Controversies and Consensus in Emergency Medicine Conference on ultrasound for SBO, a modality that I've found great utility for in my developing practice. As a believer in Free Open Access Medical education (FOAM) and with hopes that, as a novice I might receive some constructive criticism to help me become better, I have posted the recording.



A Few Tidbits (some redundancy from prior post): 
Time.  Ultrasound for SBO is quick and easy and can be performed in conjunction with the history and physical exam in appropriate patients.  This may alleviate the time to definitive diagnosis (say CT or surgical evaluation), treatment, and/or disposition.*  Furthermore, sometimes we see things we don't expect on ultrasound.  Familiarity with US findings of SBO may make sense of dilated loops of bowel or altered peristalsis encountered during a gallbladder or aorta scan for abdominal pain.  Conversely, there are times when SBO may be suspected and a quick ultrasound may reveal an alternative diagnosis that may grossly change management (examples in talk).

X-rays are out for SBO.  Bedside ultrasound has better operating characteristics than plain films with fewer instances of equivocal results.  Sometimes plain films are crucial to evaluate for pneumoperitoneum but most patients with abdominal pain don't fall in this category.  Indeed, The American College of Radiology conclusion on plain films in suspected SBO
"In light of these inconsistent results, it is reasonable to expect that abdominal radiographs will not be definitive in many patients with a suspected SBO. It could prolong the evaluation period and add radiation exposure while often not obviating the need for additional examinations, particularly CT" [5].
Limitations.
  • Ileus vs. SBO - while US beats plain films with regard to percentage of ambiguous scans, ultrasounds can be equivocal as well.
  • Cause of obstruction/Transition point not well elucidated.  In patients with recurrent SBO from malignancy or adhesions and this may be less important to the managing team and surgeons often stop ordering CT scans if the presentation is consistent with prior presentations. 
  • Consultant access to images obtained at the bedside.
Note:  I have not included surgical consultants requiring a CT scan as part of the limitations.  The surgical literature recognizes the capacity of US to diagnose SBO, although this is not yet widely adopted [6].  However, despite common assumptions, surgeons don't require a CT scan for every recurrent SBO.  As a result, sometimes a positive ultrasound, followed by plain film, may be enough in these patients who will undergo conservative management.  Have a chat with each consultant, they're not always as inflexible as we make them out to be. 

*NCT02190981 pending with LOS as secondary outcome


References:
1.  Carpenter CR, Pines JM. The end of X-rays for suspected small bowel obstruction? Using evidence-based diagnostics to inform best practices in emergency medicine. Acad. Emerg. Med. 2013;20(6):618–20.
2.  Taylor MR, Lalani N. Adult small bowel obstruction. Acad. Emerg. Med. 2013;20(6):528–44.
3. Böhner H, Yang Q, Franke C, Verreet PR, Ohmann C. Simple data from history and physical examination help to exclude bowel obstruction and to avoid radiographic studies in patients with acute abdominal pain. Eur. J. Surg. 1998;164(10):777–84. 
4. Jang TB, Schindler D, Kaji AH.  Bedside ultrasonography for the detection of small bowel obstruction in the emergency department. Emerg Med J. 2011 Aug;28(8):676-8.
5. Katz DS, Baker ME, Rosen MP, Lalani T, et al, Expert Panel on Gastrointestinal Imaging. ACR Appropriateness Criteria® suspected small-bowel obstruction. Reston (VA): American College of Radiology (ACR); 2013. 10 p.
6.  
Maung AA, Johnson DC, Piper GL et al. Evaluation and Management of Small-Bowel Obstruction.  J Trauma. 73(5):S362-S369, November 2012

Euboxia – Not Necessary (Or Necessarily Normal)

The Gist:  In medicine, we historically strive towards achieving values that fall within a reference range, or are normal, a phrase coined "euboxia" [1].  Targeting treatments to normalize values may not result in patient-oriented benefit and may cause harm.  We must also consider that normal values may not necessarily be normal for our patients.  Data fatigue, the exposure to copious data, may lead to ignoring values that are not flagged as abnormal, regardless of the appropriateness for a patient.
"'Euboxia' (from the Greek 'eu' meaning good, normal or happy, and 'box' from the tradition of writing physiological variables in boxes) is a colloquial word used in many North American and other hospitals to describe the state of apparent perfection aimed at by residents by the time they present their patients on morning rounds" - MC Meade [2].
Euboxia Is Not Always Necessary
Chris Nickson's Free Open Access Medical education (FOAM) post on Euboxia highlights some of the pitfalls with this obsession with normalcy. He also delivered a talk Euboxia and (ab)Normality at SMACC Gold which will hopefully be available on the SMACC podcast in the near future. A few examples include:
  • Hemoglobin transfusion trigger in anemia - Studies such as TRICC, CRIT, SOAP, and TRISS demonstrate that transfusion targets of more "normal" hemoglobin levels is not advantageous and may incur increased risks.  As such, transfusion triggers, in the absence of active myocardial ischemia, have moved to <7 g/dL while uptake of this trigger remains low in some communities [4]. 
  • Oxygen saturation in COPD - Unless patients are under duress, guidelines suggest patients with COPD have oxygen saturations targeted to 88-92% rather than the 98-100% more often associated with perfection [5]
  • Blood gas and saturations in ARDS - Guidelines for ventilation in patients with ARDS aim to protect the lungs using low tidal volumes and plateau pressures at the expense of allowing a pH of 7.20, permissive hypercapnia, and lower oxygen saturations of 88-95% (paO2 55-80 mmHg).  Correction of these lab abnormalities may come at the cost of additional lung damage by means of higher pressures or volumes and are thus discouraged [6].
Euboxia Is Not Necessarily Normal
Euboxia, however, may fool also practitioners into a false sense of security.  Failure to truly see a value that appears normal and isn't flagged, red, or outside of the box may be problematic. A few examples:

Normotension - Hypotension typically refers to systolic blood pressure <90 mmHg or a drop in systolic blood pressure >40 mmHg.  The latter part of this definition is often unable to be determined (due to lack of information) or forgotten.  The trauma literature seems to have solidified around the notion that the widely accepted definition of hypotension does not apply to many trauma patients, particularly those > 65 years old, and that 110 mmHg is probably a better cutoff [9-12].  While these recommendations have been out since 2011,  90 mmHg remains the common cut point for hypotension.
  • The CDC triage guidelines/"National Trauma Triage Protocol" have suggested <110 mmHg as the new hypotension guideline in patients > 65 years of age as multiple registry studies have demonstrated that an SBP <110 mmHg is associated with increased mortality and has an improved AUC compared with other blood pressure cut offs [9]. 
    • An abstract presented at AAST in 2014 found that patients >65 y/o with an SBP 90-109 mmHg had an odds of mortality of 9.7 (95% CI 8.7-10.8, p<0.01).  This survey study found improved, but terrible sensitivity for Trauma Center Need (ISS>15, ICU admit, urgent OR, or ED death) with the higher SBP cut-off [10].
Normal White Blood Cell Count (WBC) - Leukocytosis is often used as a predictor of infection/inflammation and historically loved by surgical services, yet the operating characteristics don't perform that well.  During a lecture as a medical student Dr. Sean Fox (PEM Morsels) shared the following perspective on the WBC, "WBC is the last bastion of the intellectually destitute."
I soon discovered that the sensitivity and specificity of leukocytosis, or the absence thereof, wasn't helpful in many situations.
  • In acute cholecystitis, for example, the WBC proves unhelpful as demonstrated by the following operating characteristics for leukocytosis: +LR 1.5; -LR 0.6; Sensitivity 63%; Specificity 57% [13].  Thus, a normal WBC does not help rule out acute cholecystitis.  Similarly, a normal WBC does not exclude acute appendicitis, although values <8 (a normal value) may have some utility in this regard according to Bundy et al.  
Normal Potassium in DKA - The reference range for potassium runs approximately 3.5-5 mEq/L.  Patients presenting in DKA may have low normal potassium concentrations but have severe total body potassium deficits.  As a result, professional societies recommend withholding insulin if a patient has a potassium <3.5 and supplementing potassium even when values are well within the upper "normal" limit of 4-5 mEq/L [14].  Despite these teachings and nearly habitual practice, without mindful attention to the potassium the "normal" lab value could easily be ignored. 

Normal Lactate - Lactate is beloved in Emergency Department (ED) care and it's well accepted that elevated lactate values predict mortality.  Yet, normal lactate levels may be falsely reassuring.  Lactate has been used as screening test in mesenteric ischemia as small, early reports yielded a sensitivity of 100% [15].  More recent analysis, however, show that the +LR 1.7 (1.4–2.1), -LR 0.2 (0–2.9) for L-lactate.  The -LR for lactate crosses 1.0, demonstrating that a normal lactate is not useful in crossing mesenteric ischemia off the list [16].  While we may cognitively understand this notion, in practice I think we quite often feel reassured by normal lactates (or reassure the admitting teams).

What to do?
Data overload and obsession may engender a sort of "data fatigue."  It is difficult to notice abnormalcy in data that may appear, for most individuals, normal.  This may be particularly arduous in a sea of numbers.  Furthermore, our attention is typically drawn to the red or flagged "abnormal" numbers.  This is not to suggest that we should agonize over every value and cannot trust anything "normal."  Rather, it seems that the signal in medicine is that tests and parameters are only as good as the context of the patient and the provider interpreting them. Here's what I'm trying, to combat my own data fatigue and subconscious euboxic thinking:
  • Think about a patient's clinical context, which requires mindfulness in the fast pace and overwhelming environment we call an ED.
  • Order a test?  Review the results (really), paying attention and process the results in the context of the patient.
  • If possible and appropriate, prevent data overload and data fatigue by ordering tests that will add value to the care of the patient.
References:
1.  Reade MC. The pursuit of oxygen euboxia. Anaesth Intensive Care. 2013;41(4):453–5.
2.  Reade MC. Should we question if something works just because we don’t know how it works? Crit Care Resusc. 2009;11(4):235–6. 
3. Nickson CN.  Don't Put Your Patient In A Box.  Life in the Fast Lane. 
4. Carson JL, Grossman BJ, Kleinman S et al.  Red blood cell transfusion: a clinical practice guideline from the AABB.*Ann Intern Med. 2012 Jul 3;157(1):49-58.
5. Abdo WF, Heunks LM. Oxygen-induced hypercapnia in COPD: myths and facts. Crit Care. 2012 Oct 29;16(5):323. 
7. Putensen C, Theuerkauf N, Zinserling J et al. Meta-analysis: ventilation strategies and outcomes of the acute respiratory distress syndrome and acute lung injury. Ann Intern Med. 2009 Oct 20;151(8):566-76.
10. Brown JB, Gestring ML, Forsythe RM et al. Systolic Blood PRessure Criteria in the National Trauma Triage Protocol for Geriatric Trauma: 110 is the new 90.  Oral Abstracts, AAST July 2014.
11. Eastridge BJ, Salinas J, McManus JG, et al. Hypotension begins at 110 mm Hg: redefining “hypotension” with data. J Trauma. 2007;63(2):291–7; discussion 297–9.
12. Oyetunji TA, Chang DC, Crompton JG, et al. Redefining hypotension in the elderly: normotension is not reassuringArch Surg. 2011;146(7):865–9.
13. Trowbridge RL, Rutkowski NK, Shojania KG. Does This Patient Have Acute Cholecystitis? JAMA. 2003;289(1):80–86.
14. Kitabchi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglycemic crises in adult patients with diabetes. Diabetes Care. 2009;32(7):1335–43. 
15. Lange H, Jäckel R. Usefulness of plasma lactate concentration in the diagnosis of acute abdominal disease. Eur J Surg. 1994;160(6-7):381.
16.  Cohn B.  Does This Patient Have Acute Mesenteric Ischemia?  Ann Emerg Med. 2014 Jan 30