Thursday, March 17, 2011

Patient Informed Consent in Pain Care: Neglected?

Briefly NotedThe pain management field has been so focused on concerns about medication misuse and abuse, that there has been little discussion of a most critical element in the treatment process — patient informed consent, whether for pharmacologic or nondrug therapy. A recent commentary in JAMA highlights the importance of this often-neglected component of proper patient care.

Writing in the March 16, 2011 edition of the Journal of the American Medical Association (JAMA), Yael Schenker, MD, and Alan Meisel, JD, from the University of Pittsburgh, state that “Informed consent is a fundamental tenet of the U.S. health care system, rooted in the ethical principles of respect for patient autonomy and enhanced patient well-being. As famously stated in a pivotal court case, ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body’” [Schenker and Meisel, 2011].

Generally, this means that all patients should be able to participate in decisions about their medical care, weighing the pros and cons of a recommended intervention or treatment — understanding the risks, benefits, and alternatives — to ensure that the care they receive reflects their goals, preferences, and values. While Schenker and Meisel were not specifically critiquing the pain management field in their article, they observe overall that “the current reality of informed consent for medical and surgical interventions often falls far short of stated goals.”

In the pain field, there has been great concern about the appropriateness and safety of long-term opioid analgesic therapy, yet most discussions appear to skirt around issues of informed patient consent. Rather, the emphasis has been on “Opioid Treatment Agreements” [discussed in UPDATE here], including urine drug testing, or UDT [UPDATE here], as prerequisites for treatment. These approaches primarily focus on enforcing patient adherence to the prescribed medication regimen, and questions have been raised about their usefulness for improving patient care or safety — patient informed consent is rarely mentioned as a specific component of the therapeutic process.

Most Opioid Treatment Agreements, as they are currently constructed, do not address the risks and benefits of the specifically prescribed opioid medication, which would comprise informed consent. Rather, such Agreements involve a laundry list of rules and obligations recited to a patient who has already committed to the therapy, followed by the requisite signatures on a form. Schenker and Meisel observe that, in such cases, it is not surprising that patient comprehension is often poor and patients often have mistaken beliefs about the benefits and risk of the therapy.

There have been no studies [that we know of] investigating the extent of adequate informed consent being imparted to patients by their pain-care providers, whether for interventional or pharmacologic therapies. However, as Schenker and Meisel argue, “Without a basic understanding of risks, benefits, and alternatives, patients cannot meaningfully participate in decision making (although providing such information does not guarantee that patients will understand the information, use it, and use it wisely).” They also concede that the process of obtaining informed consent takes up valuable time and in some cases does little to promote patient autonomy or well-being. This has incurred cynicism among some healthcare providers and patients who view informed consent as a legal nuisance without true meaning.

The authors provide several recommendations for improving the patient informed consent process…
  1. More is not always better. Providing extensive information — whether verbally or in consent forms — does not ensure that it will be read or understood, and may in fact create confusion. The challenge of informed consent is to condense and simplifying complex medical information in a manner that is meaningful to patients.

  2. Timing is everything. The consent process often occurs just before the intervention or therapy is about to commence. In the case of pain management, patients are already psychologically committed to doing something to help relieve their suffering; they may feel pressure to sign the consent form because the clinician is waiting and ready to start therapy. Patients need appropriate time to decide, assuming alternative approaches were addressed; otherwise, informed consent becomes merely a formality, or “little more than a medical Miranda warning.”

  3. Strategies that do not involve physician time are needed to improve informed consent. Schenker and Meisel note that “there is no legal requirement that information be given and consent obtained by a physician.” Physician-led informed consent discussions can be ill-timed, rushed, or ineffective, which is not surprising when considering the pressures of busy clinical practices. While the patient-practitioner relationship is important, other ways of educating patients and gathering informed consent may be more suitable, such as the tutelage of a nurse or other educated healthcare professional, or interactive computer-based patient-education programs.
COMMENT: It is essential in pain management that informed consent be viewed as a mandatory component of the patient education and decision-making process, and not just a formality or way to avoid legal liability. In the case of opioids, the best use of Opioid Treatment Agreements and UDT are as clinical tools for providing better ongoing patient care and safety after the treatment decision has been made, they do not substitute for prior informed consent. It seems plausible that elements of the Opioid Treatment Agreement might be incorporated into the informed consent process; however, we have not seen good examples of this being done in clinical practice. Meanwhile, it is important that pain care providers clearly understand differences between the Agreements and informed consent, and recognize that informed consent has foremost priority.

REFERENCE: Schenker Y, Meisel A. Informed Consent in Clinical Care Practical Considerations in the Effort to Achieve Ethical Goals. JAMA. 2011;305(11):1130-1131 [abstract here].