Informed Consent: Lessons From Spinal Surgeons – What Not to Do
Ronald Feise, DC
Is it arrogance or carelessness? In either case, medical research reveals that spine surgeons display inappropriate behaviors and actions regarding informed consent. In fact, they are terrible at this critical element of care. Tragically, patients are the ones who suffer unnecessarily due to informed- consent failures by spine surgeons.
Informed Consent Done Wrong: What Spine Surgeons Tend to Do
Over the past two decades, more than 50 percent of malpractice cases that involved spinal surgery cited informed consent as the basis for the lawsuit.1-2 Grauberger and colleagues investigated the reasons behind these informed-consent failures.3 The most common informed-consent allegations were failure to explain the risks and adverse effects of surgery, and failure to explain alternative treatment options.
To examine the current status of this issue, our research team conducted a cross-sectional study. Twenty-five informed-consent documents were assessed. We assumed that if a topic was not mentioned in the written document, it was not included in the informed-consent process.
We found that 100 percent of the forms did discuss some adverse events. But these forms had shortfalls: 24 percent failed to discuss death as a possible adverse event, 52 percent failed to discuss blindness as a possible adverse event, 64 percent failed to discuss re-operation as a possible adverse event, and 52 percent failed to discuss alternative treatments to surgery.
From a patient point of view, all the informed-consent forms should have discussed all these items. Patients would obviously want know about the possibilities of death, blindness and re-operation. Moreover, patients would want to know about alternative treatments to surgery.
Informed Consent Done Right: Six Important Considerations
1. Empower Patients: Informed consent is an ethical and legal necessity in the practice of chiropractic, and it is fundamental to the concept of patient autonomy. Patients must always have access to information that can help them select the best management strategies.
Informed consent has shifted the paradigm from "doctor knows best" to "the patient deserves to know." Patients want to understand their conditions and be involved in the decision process.
Informed-consent discussions must be straightforward. Patients must be told clearly and unequivocally what the harms and benefits are for the treatments you are recommending. A clear explanation alleviates patients' fears and frustrations, thereby making them better treatment partners. Informed consent is fundamental to the doctor-patient interaction and helps form a relationship of trust.
2. Document Disclosure: During the consent process, you should record what information is given and whether it is understood by the patient. The emerging standard of informed consent requires that the patient know what a "prudent person" in the patient's position would want to know, because it is the patient's prerogative – not the physician's – to determine the direction of their care.
3. Create a Best-in-Class Process: Courts and professional ethicists highly recommend a comprehensive disclosure. Disclosure should include information such as the purpose and advantages of the proposed treatment, the material risks of the proposed treatment, and the material harms and benefits of alternatives.
Although your form will be foundational to the informed-consent process, an open dialogue with your patient is vital, so the patient's questions are fully answered.
An informed consent for chiropractors should include information about the following therapies, at a minimum: spinal manipulation, rehabilitation, massage, physical therapies, acupuncture, dry needling, cognitive-behavioral therapy, OTC medications, prescription medications, bed rest, surgery, steroid injections, stem cells and no treatment.4
For each of these interventions, you should provide information about the benefits and harms according to the current scientific literature. It is recommended that each statement be supported by a citation. A best-in-class informed-consent process is foundational to creating trust and credibility with your patient.
4. Avoid the Pitfalls of Unproven Therapies: If you ever consider using a treatment approach that is without scientific support (e.g., only unpublished data or published case series data), you may want to rethink your management strategy. You will not be able to cite scientific research for your claims, and this lack of evidence could invite lawsuits.
5. Update Your Consent Process: To satisfy your ethical and legal obligations, stay abreast of current scientific research and specific disclosure requirements. Update your informed-consent procedures and documents frequently to reflect these changes.
6. Work With Legal Experts: Consult your attorney and insurance company, because the rules vary by state.
References
Epstein NE. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Spine, 2002;27:2425-2430.
Epstein NE. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? J Spinal Disord Tech, 2011;24:15-19.
Grauberger J, Kerezoudis P, Choudhry AJ, et al. Allegations of failure to obtain informed consent in spinal surgery medical malpractice claims. JAMA Surg, 2017;152:e170544.
Cohen MH. Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution. Ann Arbor: University of Michigan Press, 2000.
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