AMA Journal of Ethics^®

Case

Ms Wannamaker is tired of visiting the emergency department at her community hospital, but on this occasion, her abdominal pain is simply too excruciating to let it go. A working mother of 2, Ms Wannamaker is not apt to let a little stomach pain keep her down. With a sharp wit, she would be quick to tell you about her struggles and accomplishments over her 49 years of life. As Dr. James enters the room, she is happy at the sight of a familiar face and manages to let out a partial smile.

"Hello, Ms Wannamaker. I'm sorry we see each other again under these circumstances. How is your stomach today?"

"It's the same old thing, only worse this time. Still hurts on the right side, right about here," she says, pointing to the right upper quadrant. "And it happened again after I cheated on my diet the other day, you know, at the fast food place."

"How long has the pain been going on?" Dr. James asks.

"About a full day and then some. Plus I feel like I might throw up. Do you think it's related to those gallstones or that colic you talked about last time?"

"It just might be, but let's talk a bit more and then have a look…"

The only abnormal findings in Dr. James's physical examination include a slightly elevated temperature (37.9° C) and pain in the right upper quadrant upon palpation. The relevant blood test results are within normal limits. Dr. James, already aware that Ms Wannamaker's biliary colic might now be acute cholecystitis, orders an ultrasound examination that confirms the diagnosis.

"Ms Wannamaker, I'm sorry to tell you that we'll need to get surgery involved. As I mentioned last time, that gallbladder of yours needs to come out…"

To help his surgery colleagues, Dr. James begins the indicated treatment for acute cholecystitis and preoperative screening, as he often does. He adds an ECG and further blood work (eg, coagulation studies).

Later in the day, Dr. Thorp, the general surgeon, comes to discuss the case with Dr. James and concurs with the diagnosis. Somewhat glibly, Dr. Thorp mentions, "I see you're still ordering those coagulation studies for preoperative screening across the board. You know, we stopped doing that for patients without a suggestive medical history a while ago. For low-risk procedures, it's not worth it. Costs too much and is probably unnecessary."

"I know, I know. But like I said, it would only take 1 adverse event and 1 lawsuit to ruin a career. Someday you'll thank me."

Commentary 2

The exchange between Dr. James and Dr. Thorp highlights a common tension in medicine: how should clinical decisions be made? Dr. James is advocating a defensive strategy, while Dr. Thorp apparently favors adherence to clinical guidelines. Answers to several questions are essential for resolution of this tension. First, what is the basis for the development of the guidelines in question? Second, does adherence to guidelines have any legal effect? Third, does defensive medicine actually protect physicians from liability? Finally, what is the right thing to do?

Clinical guidelines are standardized protocols for evaluation or treatment. They may be very broad or specific to a particular manifestation of an illness, a particular clinical context, or a particular patient population. Ideally, guidelines are based on the best clinical evidence available. There are even guidelines for developing effective and reliable guidelines, emphasizing the importance of evidence in guideline development.¹ Both the Institute of Medicine and the American Medical Association have addressed the issue of quality guidelines as a policy matter.^2,3 Well-developed guidelines reflect the best evidence on the issue and base management or decision recommendations on the probability of generating the best outcome.

As Dr. James notes, some guidelines are developed for cost containment reasons, and other guidelines reflect more of a group consensus on an issue without a formal evidentiary basis. Because guidelines are developed for these disparate purposes, it is important for any clinician to be aware of the purpose and foundation of the guidelines in question. High quality, evidence-based guidelines attempt to distill out those clinical practices that generate the best outcomes; the guidelines attempt to formalize the results of an evidence-based medicine approach which is defined as the "conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients."⁴ Therefore, the crucial initial step in the application of guidelines in clinical practice is to evaluate the guidelines themselves and determine what they will contribute to a particular clinical situation.

Medical Guidelines and the Law

Guidelines do have legal relevance, although this is an area that is still poorly defined and evolving. Few legal cases have actually involved use of guidelines. One search of all published cases in US courts between January 1980 and May 1994 found only 37 cases.⁵ While this seems to indicate that guidelines are not a major influence in legal decisions, evidence indicates that attorneys rely heavily on guidelines in determining whether or not to file suit and whether or not to settle a suit before trial.⁶ In addition, there is some evidence that lawsuits occur more frequently when physicians deviate from clinical protocols or guidelines, and in 79 percent of lawsuits where there was deviation from an existing guideline, that deviation was the main allegation in the lawsuit.⁷

To establish how Dr. James and Dr. Thorp should be using guidelines to direct any aspect of Ms Wannamaker's care, the first issue is the source of the guidelines. There are several sources of guidelines for preoperative evaluation, some based on particular clinical scenarios like cardiac risk, some emphasizing cost control, and others emphasizing the evidence base for deciding which tests improve outcomes. If the guidelines Dr. Thorp is referring to are evidence-based guidelines created to facilitate high quality care, then Dr. James is less likely to be correct in thinking that deviating from them will protect the patient or himself.

After determining whether the guidelines apply to Ms Wannamaker and purport to further goals that Dr. James and Dr. Thorp value, Dr. James should be aware that most of the evidence regarding guidelines indicates that it is legally beneficial to follow guidelines, not deviate from them. Legal literature contains more extensive analysis of how to use guidelines to prove care was poor than how to use them to prove care was competent, but generally it is to the physician's advantage to show compliance with existing guidelines.⁶ This does not mean that guidelines must be followed, and it does not mean that the law expects physicians to use guidelines in the place of clinical judgment. On the rare occasions that guidelines are used in legal situations, however, they are either used to allege negligence because a physician deviated from them, or offered as a defense to suggest that proper care was rendered by a physician because the care was in accordance with guidelines.

Dr. James is practicing defensive medicine by ordering tests that are not clinically indicated and offer no clear benefit to the patient but do offer a potential benefit to the physician if a problem occurs later. Another perspective on defensive medicine is that it does benefit the patient in the rare instance that an unexpected abnormality is detected in time to prevent an injury. Good evidence-based guidelines, however, assess outcomes; therefore, the guidelines should have an inherent determination of the safety or risk of the recommendations. Defensive medicine, practiced solely in the nebulous hope that someday it will save the provider from being sued, costs an estimated $5 billion to $15 billion annually.⁸ When issues of justice in health care are as tangible and serious as they are in theUnited States today, increasing costs for purely hypothetical benefit is difficult to justify.

Guidelines are useful tools for synthesizing a large amount of information and evidence to solve a clinical problem. They promote the laudable goal of incorporating the best possible evidence into patient care decisions. Ultimately, however, patient care decisions should be based on the best interest of the patient, consistent with ethical standards. Evidence is one aspect of determining what is in the patient's best interest. Clinical judgment, technical factors, and the patient's wishes are additional and indispensable considerations. Making medical decisions to further the physician's own interest (protecting him- or herself from future liability) is not appropriate in light of the ethical considerations of beneficence and justice. Making poorly informed decisions in an effort to protect a patient from a rare complication is ethically appropriate but scientifically inadequate. Guidelines, when used properly by clinicians in their proper context and for their proper indications, resolve some of this scientific inadequacy and assist the physician in working with the patient to make the best treatment decisions.