In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”5 This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”5
There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”5 Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.6 However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,7 which runs counter to the standardized approach typically espoused by guidelines.
Dr. Samer El-Dika
A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.8 This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.
So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.9 The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.
Conclusions
Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.
