Be aware of liability risks if you fail to give high-dose steroids

Treatment is "perceived" standard of care for spinal cord injuries

There is now considerable data indicating that the use of high-dose steroids for spinal cord injuries is not effective and can even be harmful to patients. Despite this, are ED physicians still "obligated" in a legal sense, to administer high-dose steroids to patients with spinal cord injuries?

"The simple answer is yes," says Donald H. Schreiber, MD, associate professor of emergency medicine at Stanford University in Palo Alto, CA. "Steroids are still given, even if they are not effective and despite considerable risk of adverse events — sepsis, pneumonia, and avascular necrosis."

Failing to give them could lead to a malpractice lawsuit if an adverse outcome occurs, and steroid administration "is absolutely still an issue" in ED malpractice litigation, says Schreiber. "The most common malpractice claims are for not giving steroids, giving an incorrect dose, or not giving them within the mandated time frame."

Most ED physicians continue to give steroids because of concerns about medical-legal risk or institutional policy, says Schreiber. In a recent study, although 90.5% of spine surgeons surveyed used a steroid protocol for spinal cord injury patients, only 24.1% used it due to a belief in improved clinical outcomes. The most common justification (38.3%) noted for using steroids was fear of medicolegal issues.1

The same findings would undoubtedly apply to ED physicians, says Schreiber. "Our policy at Stanford is to give steroids because it's the 'perceived' standard of care," he says. "Many people feel that it 'can't hurt.'"

The "standard of care" as a concept is fluid — as more evidence is obtained, evaluated, and critically appraised, practice should change accordingly. "The use of steroids in spinal cord injuries is no different," says Dan Cass, MD, FRCPC, staff ED physician at St. Michael's Hospital in Toronto, Ontario, Canada.

Cass is lead author of the Canadian Association of Emergency Physicians (CAEP) position statement on use of steroids in acute spinal cord injury. (To access the position statement, go to www.caep.ca. Click on "Policies/Guidelines," "Position Statements and Guidelines," and scroll down to "CAEP Position Statement on Steroids in Acute Spinal Cord Injury.")

"The working group of which I was a member critically appraised the evidence and determined that, in our opinion, based on the strength — or lack thereof — of evidence, the use of steroids in spinal cord injury should be a treatment option, not an expected standard of care for every patient," says Cass.2

Cass says he is not aware of any current legal actions related to not giving high-dose steroids to spinal cord injured patients in Canada. However, there have been cases in the past where physicians were sued based on the lack of administration of high-dose steroids.

"This in fact was one of the reasons for the working group examining the evidence in a critical fashion," says Cass.

High risk of complications

Emergency physicians are obligated to treat the patient using therapies based on the best available evidence at the time, says Bryan E. Bledsoe, DO, FACEP, clinical professor of emergency medicine at University of Nevada in Las Vegas.

"Treating the patient to meet the needs of the legal system violates many of the most fundamental tenets of medicine," says Bledsoe. "But spinal cord injuries remain a difficult area."

In the 1980s, the National Institute for Neurological Disorders and Stroke (NINDS) funded several trials evaluating the efficacy of various treatments for spinal cord injury.3,4

"These trials, all conducted by the same lead researcher, resulted in a fax from NINDS to emergency physicians implying that high-dose steroids administered promptly for spinal cord injury would improve neurologic outcome," says Bledsoe.

This was based upon data from the second NINDS trial, and was sent prior to publication of the results in a peer-reviewed journal. "Hospitals and physicians immediately changed their practices and began the administration of high-dose steroids for victims of acute spinal cord injury," says Bledsoe.

However, it soon became clear that there were serious methodological deficiencies in the last two of the three studies. "Despite this, the lead researcher continued to publish the results in varying venues, in various meta-analyses, and even completed a Cochrane Review that seemed to make steroids for spinal cord injury a de facto standard of care," says Bledsoe.5

Meanwhile, other researchers began to detail the complications they were seeing following massive doses of corticosteroids. These included delayed wound healing, an increased infection rate, and hyperglycemia.6,7

The controversy resulted in the publication of position papers by CAEP and the National Association of EMS Physicians,8 which stated that high-dose steroids for acute spinal cord injury is a treatment option only, and not a standard of care.

Subsequent research has confirmed the high incidence of complications following steroid administration, occurring in up to 87% of patients with complete spinal cord injury receiving steroids in one study.9 However, a Japanese study has indicated that there may be some benefit in patients with incomplete cord injuries.10

"Thus, clinical practice should be based upon the evidence available," says Bledsoe.

The massive dose of steroids used in the NINDS protocol has numerous documented adverse effects, says Bledsoe. "These primarily are infection, severe pneumonia and sepsis, delayed wound healing, and hyperglycemia," he says. "The length of hospital stay is longer for patients who receive steroids — 44.4 versus 27.7 days in one study. Fatal complications have been reported."11

The prevailing national standard of care for acute spinal cord injury is primarily emergent medical stabilization followed by appropriate surgical stabilization, says Bledsoe.

It is Bledsoe's opinion that "the use of high-dose steroids probably should only be considered in patients with incomplete lesions who do not have confounding medical or surgical conditions that would be adversely affected by steroids," he adds.

Regardless, complications from high-dose steroid administration have a high incidence and must be anticipated. "The decision to administer steroids to the victim of an acute spinal cord injury should be made only following consultation from the neurosurgeon who will be subsequently managing the patient," says Bledsoe.

The devastating impact of a spinal cord injury is a factor in the outcome of ED malpractice litigation. "Most juries will feel sorry for a spinal cord injury victim and rule based upon emotion and not the evidence," says Bledsoe. "This is complicated by the fact that the science in this area is quite complex and quite controversial."

The 2007 spinal injury of Buffalo Bills football player Kevin Everett was closely followed by the public, notes Bledsoe. Three components of Everett's treatment have been the source of considerable discussion in the media: Care on the field by emergency medical services and trainers, induction of hypothermia, and administration of high-dose steroids.

Everett reportedly had an incomplete lesion at the C4 level. "His recovery appears to be better than typically seen — although the reason remains unclear," says Bledsoe. "However, media coverage of the event may put undue pressure on emergency physicians to use empiric steroids when confronted with an acute spinal cord injury."

ED medical directors should proactively meet with neurosurgical staff and plan an evidence-based treatment strategy/clinical pathway for these devastating injuries, advises Bledsoe. "Multidisciplinary clinical pathways applied routinely to appropriate patients indicate a local standard and can aid in risk management," he says.

References

1. Eck JC, Nachtigall D, Humphreys SC, et al. Questionnaire survey of spine surgeons on the use of methylprednisolone for acute spinal cord injury. Spine 2006;31:E250-E253.

2. Canadian Association of Emergency Physicians. CAEP Position Statement: Steroids in acute spinal cord injury. Can J Emerg Med 2003;5(1).

3. Bracken MB, Collins WF, Freeman DF, et al. Efficacy of methylprednisolone in acute spinal cord injury. JAMA 1984; 251:45-52.

4. Bracken MB, Shephard MJ, Collins WF, et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the Second National Acute Spinal Cord Injury Study. N Engl J Med 1990; 322:1405-1411.

5. Bracken MB. Pharmacological interventions for acute spinal cord injury. Cochrane Database Syst Rev 2000;(2):CD001046.

6. Coleman WP, Benzel E, Cahill DW, et al. A critical appraisal of the reporting of the National Acute Spinal Cord Injury Studies (II and III) of methylprednisolone in acute spinal cord injury. J Spinal Disord 2000;13:185-199.

7. Nesathurai S. Steroids and spinal cord injury: revisiting the NASCIS 2 and NASCIS 3 trials. J Trauma 1998;45:1088-1093.

8. Bledsoe BE, Wesley AK, Salomone JP, et al. High-dose steroids for acute spinal cord injury in emergency medical services. Prehosp Emerg Care 2004;8:313-316.

9. Lee HC, Cho DY, Lee WY, et al. Pitfalls in the treatment of acute cervical spinal cord injury using high-dose methylprednisolone: a retrospective audit of 111 patients. Surg Neurol 2007;68(Suppl 1):S37-S41.

10. Tsutsumi S, Ueta T, Shiba K, et al. Effects of the Second National Acute Spinal Cord Injury Study of high-dose methylprednisolone therapy on acute cervical spinal cord injury—results in spinal injuries center. Spine 2006;31:2992-2996.

11. Galandiuk S, Raque G, Appel S, et al. The two-edged sword of large-dose steroids for spinal cord trauma. Ann Surg 1993;218:419-425.

Sources

For more information, contact:

  • Bryan E. Bledsoe, DO, FACEP, Clinical Professor, Emergency Medicine, University of Nevada, Las Vegas, 4505 S. Maryland Pkwy., Las Vegas, NV 89154. E-mail: bbledsoe@earthlink.net
  • Daniel Cass, MD, Chief, Emergency Medicine, St. Michael's Hospital, 30 Bond St., Toronto ON M5B 1W8. E-mail: cassd@smh.toronto.on.ca
  • Donald H. Schreiber, MD, Associate Research Director, Division of Emergency Medicine, Stanford University, 701 Welch Road, Bldg. C, Palo Alto, CA 94304-5777. Phone: (650) 723-6576. Fax: (650) 723- 0121. E-mail: donalds@stanford.edu