An article for physicians by physicians
Originally published March 2011 / Revised August 2018
The past decade has witnessed both a proliferation of clinical practice guidelines (CPG) and the increased reference to CPGs in clinical practice. As defined by the Institute of Medicine, CPGs are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances."
Most physicians would agree that a credible CPG, applied appropriately, can improve the quality of clinical care. However, some physicians maintain that simplistic algorithms are not appropriate in complex care situations as they do not recognize the unique needs of a particular patient at a particular time. The CMPA neither creates nor endorses particular CPGs; however, it is frequently called on by its members to address concerns regarding the potential medico-legal implications of CPGs. These concerns include:
- the risk of adherence or non-adherence to a CPG,
- acceptance of a CPG as the standard of care,
- admissibility of a CPG into court, and
- the legal "weight" attached to CPGs.
In legal proceedings, CPGs may be referred to by the defence or by the plaintiff (patient or patient's family) in attempting to establish whether the health care professional acted appropriately. In other circumstances, CPGs might be used as a resource without necessarily being determinative of the standard of care, such as in the following case study.
An older case study
A previously well middle-aged male presents to an emergency department (ED) with a history of brief episodes of chest pain that have resolved. The vital signs and physical examination are normal. The physician, based on the history, feels that further testing in the ED is important. An ECG shows no ischemic changes. A serum cardiac marker test, taken three hours after the episode of chest pain, is normal. The patient is discharged with instructions to take an aspirin a day, follow up with his family physician for an outpatient stress test, and return to the ED if the pain worsens in severity or frequency. The discharge diagnosis is chest pain not yet diagnosed (NYD).
Twenty-four hours after discharge, the patient suffers a cardiac arrest. Resuscitation is unsuccessful. An autopsy shows a 90 per cent occlusion of the cardiac left anterior descending artery without evidence of acute thrombosis and no microscopic evidence of recent infarction. The patient's family initiates a legal action.
At the time of this case, the plaintiff's experts did not acknowledge the existence of any relevant CPG regarding evaluating patients with chest pain. However, these experts stated, based on recent articles and literature, that the standard of care dictated a second cardiac marker test measurement six to 12 hours after the episode of chest pain.
The defence experts disagreed with the plaintiff's experts that paired cardiac marker testing was part of the standard of care at the time this event occurred. One of the defence experts cited a health care agency document on the management of unstable angina as being the most prominent CPG in existence at the time. According to the CPG, the patient would have been stratified into a low risk category for which outpatient testing would have been recommended.
- The defendant physician was found to have met the standard of care for physicians at the time the patient was assessed.
- On the basis of their similar experience working in a community hospital, the testimony of the defence emergency experts was preferred.
- The court acknowledged that immediate incorporation of research findings into clinical practice is not a realistic expectation.
- Although the health agency guideline was acknowledged as being credible, it was not felt to be determinative of the standard of practice at the time. In this case, the test for the standard of care was that of a prudent colleague in a similar practice environment, rather than care as dictated by a guideline.
What can be learned?
- Courts may decide to accept a CPG into evidence in a legal proceeding where an expert gives testimony that it is relevant to the issue before the court. A court will generally not accept a CPG as determinative of a standard of care without expert evidence as to its applicability in the particular case in question.
- Expert evidence may be relied on to determine the degree to which the CPG was disseminated and accepted within the medical community at the time.
- Even an authoritative CPG may not be found to be determinative of a standard of care. In some cases, such as the one above, the standard of care of a "prudent colleague" may hold more weight in court.
- Courts recognize that there may be a lag in time between the publication of research findings and their incorporation into clinical practice. CPGs generally help, but do not guarantee, improved clinical care. Physicians should assess whether a CPG applies to a patient's specific clinical circumstances.
If deviating from an established CPG, documenting your rationale for doing so, as well as any discussions with the patient about such deviation, may assist in your defence should your care come into question in the future.