TRAUMA: PAST, PRESENT, AND FUTURE
Educational Objectives
| The goal of this program is to improve the practice of evidence-based medicine and trauma care. After hearing
and assimilating this program, the clinician will be better able to:
|
 | 1. Discuss why evidence-based medicine supports a relatively small portion of one’s surgical practice.
|
| 2. Describe ways in which hospitals and surgical societies can promote the adoption of evidence-based
practices among surgeons.
|
| 3. Explain the controversy surrounding the use of factor VIIa in trauma care.
|
| 4. Argue that dedicated trauma centers do save lives.
|
| 5. Define the role of genetic analysis in the management of trauma patients.
|
Faculty Disclosure
In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the
planning committee to disclose relevant financial relationships within the past 12 months that might create any personal
conflicts of interest. Any identified conflicts were resolved to ensure that this educational activity promotes
quality in health care and not a proprietary business or commercial interest. For this program, the faculty and planning
committee reported nothing to disclose.
Acknowledgements
This program was recorded at the 36th Annual Phoenix Surgical Symposium, held in Phoenix, AZ, February 13-16,
2008, and sponsored by Banner Health and the Phoenix Surgical Society. The Audio-Digest Foundation thanks the
speakers and the sponsors for their cooperation in the production of this program.
| SURGICAL EVOLUTION AND EVIDENCE-BASED MEDICINE —Richard P. Billingham, MD, Clinical Professor,
Department of Surgery, University of Washington School of Medicine, Seattle
|
| Hypothetic case: background—71-yr-old man; hypertensive, moderate COPD, and smoker; otherwise active and
healthy; presents with perforated sigmoid diverticulitis; after emergency sigmoid resection and primary anastomosis,
patient develops anastomotic leak; analysis—surgeon A sees as serious error (primary anastomosis should
never be performed in this setting); surgeon B disagrees; claims good evidence for doing anastomosis in unprepared
bowel, even in setting of diverticulitis and peritonitis; always possibility of leak; surgeon C posits that primary
anastomosis appropriate in ideal circumstances, but not in this particular patient; surgeon A replies that in real
world one chooses safest route possible (in this case, Hartmann procedure); systematic review by speaker’s
colleagues—review of multiple studies revealed that Hartmann procedure alone (when looking at series of patients,
not this case in particular) associated with relatively high death rate, Hartmann procedure plus reversal associated
with slightly increased death rate, and primary anastomosis associated with decreased death rate; anastomotic leak
rate nonissue with Hartmann procedure, 4% with Hartmann plus reconstruction, and 14% with primary anastomosis;
incidence of wound infection lowest with primary anastomosis (assuming no leak)
|
| Evidence-based medicine: integrating clinical expertise or professional wisdom with best available external objective
evidence to make decisions about delivering care to individual patient; comparing widely varying therapy
(“conventional wisdom”) to standardized randomized controlled trials (RCTs) to determine which therapy best;
currently, <5% of surgical interventions supported by well-done RCTs; case series and other retrospective studies
comprise ≈85% of published literature on surgical interventions
|
| Care protocols: also known as critical pathways or fast tracks; important to distinguish from care decisions for individual
patients; intended for global application; designed mainly to prevent complications; derived from best
practices; example—routine preoperative care; applied to all patients, with minimal individual variation in patient
response
|
| Clinical decisions: treatment decision based on best evidence, with adjustments made for unique characteristics of
individual patient
|
| Examples of best practices: in-care protocols and pathways; avoidance of routine nasogastric (NG) tubes; reduction
of surgical site infections
|
| Elements of surgical decision making: obedience (uncritical adoption of counsel of teachers and predecessors);
evidence gleaned from trials; experience; inference (application of knowledge to given patient); and
intuition
|
| Sources of evidence: meta-analysis— often, merely shows absence of convincing evidence; may magnify defects
of studies under review; problem that rules of analysis either not followed or not strictly applicable; problems
make meta-analyses difficult to use as gold standard; Cochrane reviews considered gold standard for meta-analyses,
but only 77 reviews have addressed surgical procedures, and of those, only 14 pertain to general or colorectal
surgery; RCTs—difficult when comparing surgical procedures because outcome of one procedure may be
unacceptable (eg, patients cannot be randomized to abdominoperineal resection vs low anterior resection); inclusion
criteria restrictive, with few comorbidities allowed, to ensure parity between groups; also homogeneous
populations enrolled in trials (contrary to real-life practice); conclusion—most clinical decisions based on clinical
judgment, nonrandomized studies, and influence of opinion leaders
|
| Barriers to adoption of evidence-based medicine in surgery: evidence may be unknown or nonexistent; quality of
RCTs may be poor; studies conflict with one another; studies may not apply to situation; fear of criticism should
procedure not go as described in study or paper; fear of lawsuits; inertia; discomfort with deviating from established
protocols; “surgical personality” (supreme confidence in one’s own abilities, less confidence in guidelines
or protocols developed by someone else); apprenticeship system helps perpetuate culture of confidence and individualism;
surgeons most likely to adopt new practices when those practices disseminated during collaborative
face-to-face continuing medical education programs
|
| Example (practice still in use despite extensive evidence of ineffectiveness and possible harm): prophylactic use of
nasogatric (NG) tubes after abdominal surgery; ≥2 meta-analyses show fewer infections and faster return to oral
intake when NG tubes avoided
|
| Evidence-based medicine in treatment decisions: most studies retrospective, not blinded, and have restrictive
inclusion criteria (real-life practices seldom have patients that match exactly); surgeon must make decisions using
judgment, intuition, experience, and evidence
|
| Stricturoplasty vs resection for small-bowel Crohn’s disease: stricturoplasty current standard of care; however,
no RCTs ever performed; even large studies showing relatively high recurrence rates, morbidity, and
need for reoperation thought to compare favorably with resection, based only on level 4 evidence or lower
(case series and poor-quality cohort or case-control studies)
|
| New technology: surgeons more likely to adopt new devices than new care pathways or new treatments; new devices
may enter market with no human data; 501(k) approval requires only animal tests; devices such as lasers and
hemorrhoid staplers widely adopted with little supporting evidence; surgeons expected to collect data after device released;
also, no Food and Drug Administration (FDA) requirements for device training programs (aside from requirement
that training program exists); incumbent on surgeons to educate colleagues; weekend courses alone not
enough to ensure good patient care; surgeons who participate in laboratory courses only have higher complication
rates than those who obtain additional training; major variables determining rate of complications include complexity
of procedure being taught, surgeon’s innate ability, and previous training
|
| Adopting new medications or preventive protocols: each institution should collect data on patient outcomes
and rates at which protocols adopted and share this data with surgeons; academic detailing—refers to visiting individual
clinicians to persuade them to adopt a particular protocol, or having departments or divisions agree on
new protocol collectively; carrot-vs-stick approach—used by Medicare; involves paying bonuses or exacting
penalties to induce physicians to adopt certain protocols (“pay for performance”); surgeons should acknowledge
and apply evidence about treatments (eg, omission of mechanical bowel preparation for colorectal surgery, use of
primary anastomosis for diverticulitis, use of neoadjuvant chemotherapy for T3 or N1 rectal cancer); methods for
disseminating these views include local discussion, group adoption of practices, and monitoring and reporting results
to individual surgeons
|
| Conclusion: protocols for prevention, such as critical pathways, apply to all patients of given class, and should be
pursued aggressively to diminish adverse outcomes; implementation requires local consensus and individual
coaching (adoption hastened by penalties or incentives); scrutinize new devices before adopting them as standard
of care
|
| WHAT’S NEW IN TRAUMA AND CRITICAL CARE —Gregory J. Jurkovich, MD, Professor of Surgery, University
of Washington School of Medicine, and Chief of Trauma Services, Harborview Medical Center, Seattle
|
| Hemorrhage control: mainstay of surgical therapy for traumatic injuries; new developments include chemical adjuncts
to enhance bleeding control (concentrated forms of normal clotting factors), field gauzes, and resurgent
use of tourniquets
|
| Coagulation factor VIIa (recombinant): augments tissue factor-dependent pathways of hemostasis at injury site; activates
and binds platelets; stabilizes clots; contributes to development of “superclots”; requires adequate fibrinogen;
correct temperature necessary for enzymatic reaction; adequate platelets necessary to form stable clot;
controversy—currently approved for treatment of hemophilia, but no adequate prospective RCTs for other applications;
costs ≈$4000 per dose; not approved for trauma care, therefore not covered by insurance (patient or hospital
must bear cost); still, some “intriguing anecdotal evidence” that VIIa enhances clot formation and
“apparently miraculously” stops diffuse coagulopathic bleeding, without thromboembolic complications; currently
used off-label (eg, for cardiac surgery) by some hospitals; trials under way for cardiac surgery and other
applications, including liver resection and head and neck surgery; approved for cessation of intracranial hemorrhage
due to aneurysm or wet bleeding; manufacturer has funded one prospective trauma study involving 301 patients;
overall, factor VIIa saved <1 U of blood, despite some “spectacular” salvages; no difference in mortality;
protocol for VIIa use at speaker’s hospital—developed after hospital spent $1.3 million in 3 yr; use must be approved
by attending physician; reasons for use must be documented in patient’s chart; patient cannot be acidotic,
and must have fibrinogen level >80 mg/dL and platelet count >75 x 109 /L
|
| Hemostatic bandage: sponge embedded with hemostatic agent that enhances coagulation, either by creating matrix
on which blood can coagulate or by generating heat; also includes sealant; stuffed into wound; used extensively
by emergency medical services and military
|
| Tourniquets: anecdotal evidence from military use renewing interest; can remain in place for up to 1 hr; “better to
lose the limb than lose the life”
|
| Importance of trauma centers: large study by speaker and colleagues compared outcomes (in patients treated
for moderate to severe injuries) at hospitals with and without level I trauma centers; trauma centers consistently
associated with significantly lower mortality rates in-hospital and at 30, 90, and 365 days after discharge; overall
mortality reduction 25%; impact on younger patients especially pronounced (mortality reduction 53% and 35%
for those with serious and very severe injuries, respectively); no benefit seen for moderately or seriously injured
patients >55 yr of age; based on these findings, treatment at designated trauma centers could save additional
5000 lives/yr; survival among patients with penetrating abdominal trauma plus shock significantly better when
patients treated at high-volume (>600 patients/yr) institutions; no difference if patients not in shock; similar findings
obtained among blunt-trauma patients
|
| Imaging: study now under way using new whole-body computed tomography (CT) scanner that moves across
patient and provides 3-dimensional reconstruction of images
|
| Operating room: damage control still guiding principle; patients often over-resuscitated (given too much saline, resulting
in swelling and high incidence of abdominal compartment syndrome); more urgent use of central venous
pressure (CVP) monitoring in emergency department and tailoring presurgical volume resuscitation to CVP <15
mm Hg recommended, with pressors administered only if patient remains hypotensive; vascular surgery—stents
dominate in emergency as well as elective surgery; speaker’s institution sees 12 to 14 torn aortas per year; all repaired
endovascularly for last 2 yr, regardless of cause; for tears near aortic arch and left subclavian vein, surgeons
place stent across subclavian and perform carotid-subclavian bypass if necessary to reestablish blood flow
|
| Genetics of trauma care: individual variations in response to sepsis suggest possible genetic predisposition to good
or bad outcomes; single nucleotide polymorphisms (SNPs) may have significant impact; example—gene that
codes for tumor necrosis factor (TNF) known to vary among individuals, leading to different forms of TNF; TNF
promoter alters expression of TNF gene; response to certain infectious diseases may be governed by type of TNF
patient makes; knowledge of genotype for particular inflammatory mediator (such as TNF) could help predict
outcome of sepsis or infection, identify high-risk patients, or direct therapy; base change in 308 position on TNF-
α allele increases relative risk for severe sepsis 2.5-fold; gene single best indicator of patient’s risk for sepsis after
infection
|
| New training in trauma care: new paradigm called acute-care surgery proposed by major surgical organizations that
deal with trauma; would consist of training in surgical critical care, emergency general surgery, and trauma surgery
for 2 yr after core training in general surgery; candidate would be certified in all 3 areas; also proposed that
length of core training time be decreased to 2 to 3 yr, with residents then directed to one of 3 tracks (urban, rural,
or subspecialty) for 3 yr to permit earlier specialization
|
Suggested Reading
Boffard KD et al: Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma
patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma 59:8, 2005; Kehlet H et
al: Care after colonic operation—is it evidence-based? J Am Coll Surg 202:45, 2006; MacKenzie EJ et al: A national
evaluation of the effect of trauma-center care on mortality. N Engl J Med 354:366, 2006; Menges T et al: Sepsis
syndrome and death in trauma patients are associated with variations in the gene encoding tumor necrosis factor.
Crit Care Med 36:1456, 2008; Nathens AB et al: Relationship between trauma center volume and outcomes. JAMA
285:1164, 2001; Nelson R et al: Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database
Syst Rev (3):CD004929, 2008; O’Brien MA et al: Educational outreach visits: effects on professional practice
and health care outcomes. Cochrane Database Syst Rev (4):CD000409, 2007; Schroeder TV: Evidence-based medicine
in rapidly changing technologies. Scand J Surg 97:100, 2008; Wang J et al: Commentary: how surgical audits
can be used to promote the update of surgical evidence. ANZ J Surg 78: 437, 2008.
|
