PEDIATRICS Vol. 120 No. 2 August 2007, pp. 453-455 (doi:10.1542/10.1542/peds.2007-0951)
LETTER TO THE EDITOR |
The Importance of Disclaimers: Distinction Between Optimal Care and Standard of Care
Eric Joel Slosberg, MD, FAAPProMed
Richland, MI 49083
C. Giles Smith, Jr, Esquire
Private Attorney and Counselor
Kalamazoo, MI 49008
To the Editor.—
As a practicing pediatrician who occasionally does medical expert witness work and a malpractice defense attorney, we applaud the carefully worded and prominent disclaimer found in the clinical practice guideline published recently in Pediatrics by the American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis.1 The subcommittee states: "This clinical practice guideline is not intended as a sole source of guidance in the management of children with bronchiolitis. Rather, it is intended to assist clinicians in decision-making. It is not intended to replace clinical judgment or establish a protocol for the care of all children with this condition. These recommendations may not provide the only appropriate approach to the management of children with bronchiolitis."1
Previous guidelines and "best practices" have not always been so carefully worded. The lay public, practicing physicians, academics, the press, and the legal profession have all been guilty, at times, of blurring the important distinction between optimal care and standard of care. Lack of attention to this kind of detail all too often leads to misunderstandings and the initiation of malpractice actions.
"Optimal care," although always the goal of medical practitioners, has never accurately meant the same thing as the phrase "standard of care." "Standard of care" is a technical legal term, as well as a general medical term, that is much used but too-little understood. The context, legal and medical, in which the phrase usually arises is possible malpractice situations in which the physician's duty to provide legally adequate care to the patient may have been "breached," resulting in injury to the patient. In such cases, the duty is said to have been failed when the physician breached the standard of care.
The standard of care has been defined in the common law and state statutes in various ways. In Michigan, for example, the standard of care is stated as the burden of proof in malpractice litigation that a plaintiff must meet:
The defendant, if a specialist, failed to provide the recognized standard of practice or care within that specialty as reasonably applied in light of the facilities available in the community or other facilities reasonably available under the circumstances, and as a proximate result of the defendant failing to provide that standard, the plaintiff suffered an injury. (Michigan statute MCL 600.2912a[1][b]; italics for emphasis were added).
Other common definitions refer to the level of care expected of the physician or specialist of "reasonable" or "ordinary" care and that of the "reasonably prudent" physician of similar education, training, and experience as that of the physician who is claimed to have committed malpractice. The standard, regardless of how worded, is universally that which existed at the time that the care at issue was rendered.
Regardless of the phraseology of the standard of reasonable care, the specific parameters of the medical issue are usually framed by the opinions of expert witnesses retained by the respective parties in the litigation. (The validity and integrity of expert testimony are broad subjects, which are well beyond the scope of this letter.) Unfortunately, expert witnesses themselves all too often fall into the trap of citing medical publications and optimal-care guidelines as evidence of the standard of care not being met. The written "authority" may be in the form of case reports, experimental treatment, early studies, treatments or techniques that have not become widely understood, accepted, or used within the specialty or may even have been published after the date of the care at issue. None of these are proper citations of the reasonable, or standard, care in effect at the pertinent time.
A concrete example of the problem of assuming optimal care to be the standard of care may be found in published guidelines for the diagnosis and treatment of Kawasaki disease, which contain a range of disclaimers or none at all.2–5 Witt et al pointed out that "prompt diagnosis is critically important, because the incidence of coronary artery abnormalities (CAA) can be reduced from 20% to 25% to <5% by early treatment with intravenous immune globulin (IVIG)."6 Although treatment with IVIG before the often-recommended 10-day cutoff may represent optimal care, it is frequently not possible to come to the diagnosis of Kawasaki disease and initiate treatment within this time frame.
In fact, Witt et al6 found that the mean time to initiation of IVIG therapy was 11.8 ± 5.8 days in patients who met American Heart Association criteria for the diagnosis of Kawasaki disease and 12.8 ± 8.5 days to initiation of IVIG in patients who did not meet American Heart Association criteria (atypical Kawasaki disease). Anderson et al reported that "[m]ost pediatric providers in Colorado are familiar with Kawasaki Syndrome (KS). However, in a recent outbreak, 30% of cases were diagnosed after illness day 10."7
If recommendations, guidelines, or best practices that advocate the initiation of IVIG therapy in Kawasaki disease before the 10th day of illness are interpreted as the standard of care, then malpractice actions might be initiated for all patients who develop coronary artery aneurysms when a delay in diagnosis is perceived. In theory, this would be true even in those cases in which the patient does not present, or perhaps is not referred, until late in the time parameter of the recommended, optimal care.
We encourage the American Academy of Pediatrics to continue in its efforts as an advocate for the continuous improvement of the medical care of children while recognizing that optimal care is not always possible in an imperfect world. The absence of optimal care is not necessarily a violation of the standard of care. We believe that medical societies, journals, and individual authors should use careful language so that guidelines and recommendations cannot be misconstrued as the standard of care.
REFERENCES
- American Academy of Pediatrics, Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis.
Pediatrics. 2006;118
:1774
–1793
[Abstract/Free Full Text] - Newburger JW, Takahashi M, Gerber MA, et al. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association.
Circulation. 2004;110
:2747
–2771
[Abstract/Free Full Text] - Maconochie IK. Best practices: Kawasaki disease. Arch Dis Child Educ Pract Ed. 2004;89 :e3 –e8
- Brogan PA, Bose A, Burgner D, et al. Kawasaki disease: an evidence based approach to diagnosis, treatment, and proposals for future research.
Arch Dis Child. 2002;86
:286
–290
[Abstract/Free Full Text] - Han RK, Sinclair B, Newman A, et al. Recognition and management of Kawasaki disease.
CMAJ. 2000;162
:807
–812
[Abstract/Free Full Text] - Witt MT, Minich LL, Bohnsack JF, Young PC. Kawasaki disease: more patients are being diagnosed who do not meet American Heart Association criteria. Pediatrics. 1999;104(1) . Available at: www.pediatrics.org/cgi/content/full/104/1/e10
- Anderson MS, Todd JK, Glod MP. Delayed diagnosis of Kawasaki syndrome: an analysis of the problem. Pediatrics. 2005;115 (4). Available at: www.pediatrics.org/cgi/content/full/115/4/e428
PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics
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