All Clinical Practice Guidelines Are Not Created Equal
By Brendan Faulkner, Esq. and Mike A. D'Amico, Esq
The standard of care pertinent to a medical malpractice claim in Connecticut is defined by Conn. Gen. Stat. 52-184(c) as a breach of the prevailing professional standard of care-that level of care, skill and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.
There is an inherent tension in the language of the statute. "Prevailing" in its everyday usage means common, frequent, or widespread. However what is a popular practice among a group of healthcare providers may not be "reasonably prudent." For example, the prevailing practice among interventional radiologists in 2004 when implanting a hemodialysis catheter was apparently to throw away the instructions for use at the time of the surgery (thus preventing important safety warnings from getting to patients and other healthcare providers who will be using the catheter). Query whether this is reasonably prudent.
Physicians and other healthcare providers are expected to adhere to certain standards of treatment in their medical practices. Often these standards are encapsulated in clinical practice guidelines, which the Institute of Medicine defines as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Clinical practice guidelines are admissible as some evidence of the standard of care, i.e. what reasonable prudence would require.
Clinical practice guidelines have proliferated rapidly and are now used by many organizations involved in healthcare, including the federal government (i.e. the Agency for Healthcare Research and Quality which has a searchable database at www.guidelines.gov,and Centers for Medicare and Medicaid Services), state governments, and peer-review organizations.
Many times, as a condition of privileges, a hospital's credentialing file for a doctor will contain an agreement by the doctor to abide by hospital and medical staff policies and procedures, which are often derived from national consensus standards. By analogy, a violation of a workplace's safety rules may be admissible as some evidence of negligence. See Masceola v. Wise, Smith & Co., 120 Conn. 699, 701 (1935); see also Van Steensburg v. Lawrence & Memorial Hospitals, 194 Conn. 500, 506 (1984); Boone v. William W. Backus Hosp., 2003 Conn. Super. LEXIS 2705, *16-17 (Sept. 24, 2003) (Corradino, J.).
When a provider departs from a clinical practice guideline and harm results, the failure to follow a clinically appropriate guideline may be some evidence that there was a deviation from the applicable standard of care.
Clinical practice guidelines and hospital guidelines may be admitted in a variety of ways as some evidence of the standard of care. At times, clinical practice guidelines are admitted under 8-3(8) of the Code of Evidence, which provides that a statement in a learned treatise is admissible to support an expert witness's opinion. Historically, the expert would have had to recognize the treatise as "authoritative" within the field. The Code provides that the witness recognize that the text is "a standard authority in the field." In Pestey v. Cushman, 259 Conn. 345 (2002), for example, testimony that a handbook was a standard reference in the expert's profession was a sufficient foundation for admissibility.
Among the goals of clinical guidelines are to standardize medical care, to improve patient safety, and to reduce risk. It has been demonstrated repeatedly that the use of these types of guidelines by healthcare providers is an effective way of achieving these objectives. Though clinical practice guidelines originated as a means of improving the quality of care, that purpose has been subverted by practice guidelines promulgated by special societies and insurance carriers which conflict with unbiased evidence-based standards and were created to meet the needs of the drafting organization (such as protection from malpractice claims, so called "litigation science"). This has complicated the task facing courts when parties seek to introduce clinical practice guidelines as evidence of the standard of care in medical malpractice cases.
When faced with the question of admissibility of suspect guidelines, courts should exercise their discretion in judging the quality, relevance, and reliability of clinical practice guidelines, rejecting those they find to be biased or lacking scientific integrity. When it comes to the type of clinical practice guidelines generated for use in the defense of malpractice claims, trial courts should allow for interlocutory voir dire of the expert on the issue of whether the guideline is in fact "standard" if offered under the learned treatise exception to the hearsay rule.
The most widely accepted modern medical guidelines are based on an examination by experts from across various specialties of current evidence within the paradigm of evidence-based medicine. They typically identify, summarize and evaluate the highest quality evidence and most current data about prevention, diagnosis, prognosis, therapy (including dosage of medications), risk/benefit and cost-effectiveness. Expert committees sift through the scientific literature for clinicians and offer coherently sequenced recommendations based on the best available evidence aimed at everyday decision-making situations.
"Excellence in clinical practice guidelines requires both systematic evidence-linked construction and a representative and inclusive multidisciplinary writing panel of recognized subject matter experts." Defining Excellence in Evidence-Based Medicine Clinical Practice Guidelines, Linkskey, Mark E., Clinical Neurosurgery 57 (2010). Without both of those features present and uncompromised, a panel drafting a clinical practice guideline runs high risks of bias and a low-quality result.
In deciding whether to admit a clinical practice guideline as a learned treatise, courts should consider factors that can detract from the reliability of a guideline and undermine a claim that it is a standard authority in the field. In O'Brien v. Angley, 407 N.E.2d 490 (Ohio 1980), for example, the court declined to allow an editorial from the Journal of the American Medical Association stating that "[t]he best medicine often requires that a physician depart from packaged insert recommendations" because the editorial was written with litigation concerns in mind, taking it outside of the realm of impartial learned treatises. In Meschino v. N.Am. Drager, Inc., 841 F.2d 429 (1st Cir. 1988), an insurance carrier's risk management guidelines signed by a medical malpractice defendant were not admissible because they were created "by a private insurance company as part of an insurance contract and did not reflect a generally recognized standard of care within the medical profession." Similarly, in Tavares v. New York City Health and Hospitals Corp., 2003 NY Misc LEXIS 1217 (Sup. Ct. Kings County 2003), the court rejected the defense's attempt to preclude plaintiff's experts' opinions alleging that they were medically unsound. The defense relied on a guideline-like bulletin published by the American College of Obstetricians and Gynecologists. After a detailed analysis, the court determined that the literature espoused by the defense was unreliable, and therefore denied the motion to preclude.
The bottom-line is that all clinical practice guidelines are not created equal, and some are not worthy of admission into evidence.