Abstract
Clinical practice guidelines aim to improve medical care by clarifying and making useful recommendations to providers. Although providers should account for patients’ unique characteristics when determining a treatment plan, it is generally perceived as good practice to follow guidelines when applicable. This is of interest in malpractice litigation, where it is essential to establish a standard of care to evaluate the performances of providers. Although the opinions of expert witnesses are used to determine standards of care, guidelines are expected to play a leading role. Guidelines alone should not establish a legal standard but may help inform this discussion in the courtroom. Therefore, it is incumbent that excellent, practical, and timely guidelines are continually created and updated in a transparent way. These guidelines must be very clear and underscore the various strengths of recommendation based on the quality of available evidence.
Clinical practice guidelines (CPGs) are “statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.” 1 Early CPGs were based on expert consensus and often fraught with personal bias and conflicts of interest. During the 1980s and 1990s, there was increased emphasis on evidence-based medicine, and the Institute of Medicine identified the scope and purpose of CPGs ( Table 1 ). 2
Institute of Medicine’s Intent of Clinical Practice Guidelines. a
Content excerpted and reprinted with permission from the National Academies Press, copyright 1992, National Academy of Sciences.
In the courtroom, establishing a standard of care is paramount. 3 Since CPGs are designed to assist practitioners in making care decisions, they are of interest in medical malpractice litigation as well. As the number of guidelines increases, it is important that clinicians remain cognizant of them and take into consideration possible conflicts among related CPGs.
Uncertain Authority
Often, the development of CPGs has been decentralized, so it is sometimes uncertain which guideline should be authoritative. 4 For example, national academies, state and federal agencies, hospital systems, health plans, and patient advocacy groups now create guidelines—some are contradictory to one another, and some may have conflicts of interest.4,5 Courts seldom acknowledge the difference between evidence- and consensus-based guidelines 6 and unfortunately tend to lump all guidelines together instead of acknowledging the varying levels of evidence and certainty that each may have. 7 Additionally, physicians may be unaware that certain guidelines even exist. A recent study found that more than half of physicians who did not follow guidelines either were not aware that they existed or were unfamiliar with the specifics within the guidelines 6 —hence, the uncertainty of what constitutes “reasonable standard practice.”
Conflicts of Interest
Guidelines contain potential conflicts of interest that may undermine their authority. Guidelines created by hospitals may be designed to defend against liability while maximizing reimbursements. CPGs created by physicians’ professional societies tend to be highly regarded since their goal is to improve patient care. However, these may become outdated quickly as medicine progresses, and the efforts already invested create a “guideline fatigue” on part of the drafters. They may also contain financial conflicts of interest among the authors of various disciplines or subspecelities. 4
CPGs as a Sword and a Shield
Historically, courts have not relied solely on CPGs, and when they have, they were used conservatively. 7 Guidelines used in conjunction with expert testimony often help a court define the standard of care. 3 Regardless, there have been select cases where CPGs have been introduced into the courtroom and used to both sue and defend physicians. 7 Guidelines may also be used to cross-examine an expert witness to place the testimony into context or even argue for impeachment of the witness. 3
Where guidelines were followed, plaintiffs face a higher burden to prove deviation from accepted practice. When deviating from CPGs, a practitioner may still explicate his or her choice but from a less favorable position. The methods that CPGs are introduced into the courtroom have evolved over the years. Recently, guidelines may be presented as learned treatise, 8 which is authoritative text that is admissible as evidence in support of arguments made in the courtroom.
Several states have even developed projects to utilize CPGs as a ubiquitous defensive shield for providers who follow approved guidelines. Interestingly, most of these experiments have expired, often failing to show meaningful tort, financial, or patient safety benefits. 4
American Academy of Otolaryngology—Head and Neck Surgery Foundation’s Response
Since 1996, the American Academy of Otolaryngology—Head and Neck Surgery Foundation has published 15 CPGs ( Table 2 ) and helped set the standard for creating quality CPGs. An updated manual is available through Otolaryngology–Head and Neck Surgery that describes the principles used to create high-quality, evidence-based, and transparent guidelines. 9 In addition to defining what CPGs are, this manual defines what they are not—specifically, not a legal standard ( Table 3 ). 9 To this end, disclaimers are often placed within CPGs to help clarify their purpose and limitations. For example, the Foundation utilizes specific disclaimers in its CPGs to include the preclusion of establishing a legal standard. This emphasizes that CPGs should assist providers to make educated, evidence-based decisions but should not obstruct an astute clinician from treating individual patients according to their unique needs and goals. Of note, even the most authoritative guidelines with the best evidence cannot usually be introduced as a substitute for expert testimony. 4 Although these types of disclaimers may prevent the individual guideline from being used as a sole source, it is important that providers understand that CPGs may be used in conjunction with other legal treatises and expert testimony to help establish the standard of care in the courtroom. 10 Therefore, it is recommended that clinical discussions incorporate direct reference to existing CPGs when applicable and reasons for deviating when applicable.
AAO-HNSF Clinical Practice Guidelines Stratified by Subspecialty and Publication Year. a
Abbreviation: AAO-HNSF, American Academy of Otolaryngology—Head and Neck Surgery Foundation.
Important Points That Clinical Practice Guidelines Are Not Intended to Be. a
From Rosenfeld et al. 9
Conclusions
Although the opinions of an expert witness are required to determine standards of care, guidelines may play a role as a learned treatise. Providers should account for the unique characteristics of a patient when determining a treatment plan; however, it is also important that providers understand and follow CPGs when applicable. Therefore, it is essential that excellent, practical, and timely CPGs are created and continually updated in an easily accessible and transparent way. These guidelines must be very clear and make the various strengths of recommendation obvious based on the quality of available evidence.
Author Contributions
Disclosures
Footnotes
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.