Overview:
Those generating clinical practice guidelines typically pursue two general goals: 1.) to improve the quality of care provided; and 2.) to provide a defense against claims.
We shall examine the efficacy of CPGs in achieving these objectives. What will emerge from that examination is evidence that CPGs seldom meet the IOM’s criteria for trustworthiness. Often, for example, committees authorized to generate CPGs lack a data scientist or a patient or patient representative. CPGs are often either too vague to be meaningful or too detailed to permit general application.
Frequently, they are written in language that seems to ignore the nearly infinite variability of human biology as well as the central importance of clinical judgment, as if the authors thought one size really does fit all. While some CPGs reflect a deep command of the literature of double-blinded, randomized, controlled clinical trials, many are merely consensus documents with no basis in evidence apart from the collective experience of the authors. There may not even be agreement on what 'evidence-based' means. CPGs are generated by a wide variety of organizations, including many that enjoy great respect and prestige, but guidelines themselves are very often inconsistent, leaving the reader in a quandary about which learned society's wisdom to rely on and which to reject.
Seldom do the authors indicate in any quantitative or even semi-quantitative fashion the strength of any given piece of advice; too often, there is no discussion of the risks or the benefits of the path recommended. Hardly ever are dissenting views of the minority disclosed. Given the time needed: to convene the expert authors, virtually or in person; for their review of the literature; for their internal debates; for the drafting itself; and the lag between submission and publication, CPGs are routinely obsolete at publication. Years may go by before they are updated. Rarely if ever do the originators of CPGs identify their funding sources, so the reader is unable to judge whether or to what extent the funder may have had some influence on the finished product.
Most CPGs make no effort to identify conflicts of interest; in fact, there is rather persuasive evidence that bias creeps into a discouragingly high fraction of the total. On top of all that, the extent to which practitioners actually consult guidelines in daily practice is modest at best.
I contend, therefore, that CPGs are poorly designed to achieve either of their objectives, never mind both.
Why should you Attend:
The United States is the litigation capital of the known universe. In tort claims, such as medical malpractice and product liability, the party claiming injury, the plaintiff, must show that the conduct of the defendant not only caused the injury complained of, but that it was culpable in some way. Against professionals, the claim is that the conduct breached the standard of care: that the professional's actions failed to reflect the degree of skill and diligence one expects from 'reasonably prudent' practitioners of like kind in similar circumstances.
In products claims, the allegation is that the drug or device was 'unreasonably dangerous' in its design, or in its manufacture, or both, and/or that the defendant failed to issue adequate warnings. To prove such contentions, the plaintiff needs to establish some sort of yardstick to assess the conduct criticized, and prove that, tested against that yardstick, the conduct fell short. Traditionally, the yardstick was created through the testimony of experts accepted as such by the court. Such experts, like all witnesses, are subject to cross-examination, the process the law provides to unmask bias, ignorance of facts, insufficient qualifications, and other shortcomings that may tend to justify a measure of skepticism in the expert’s testimony.
Suppose, however, that in addition to the testimony of an expert, the proponent of a given allegation can adduce clinical practice guidelines or similar documents, or their content, to support his claims? Such guidelines bear the seal of approval of learned societies, and purport to be accurate, current, objective, reliable guides to the conduct the law expects of defendants. Now the advocate has a new, more powerful weapon, sometimes beyond the reach of cross-examination, and quite possibly seen by the jurors as substantially unimpeachable. I claim that guidelines such as these, far from being a nearly infallible guide to the Truth, are in fact so problem-ridden as to justify their exclusion from trial.
Areas Covered in the Session:
Those generating clinical practice guidelines typically pursue two general goals: 1.) to improve the quality of care provided; and 2.) to provide a defense against claims.
We shall examine the efficacy of CPGs in achieving these objectives. What will emerge from that examination is evidence that CPGs seldom meet the IOM’s criteria for trustworthiness. Often, for example, committees authorized to generate CPGs lack a data scientist or a patient or patient representative. CPGs are often either too vague to be meaningful or too detailed to permit general application.
Frequently, they are written in language that seems to ignore the nearly infinite variability of human biology as well as the central importance of clinical judgment, as if the authors thought one size really does fit all. While some CPGs reflect a deep command of the literature of double-blinded, randomized, controlled clinical trials, many are merely consensus documents with no basis in evidence apart from the collective experience of the authors. There may not even be agreement on what 'evidence-based' means. CPGs are generated by a wide variety of organizations, including many that enjoy great respect and prestige, but guidelines themselves are very often inconsistent, leaving the reader in a quandary about which learned society's wisdom to rely on and which to reject.
Seldom do the authors indicate in any quantitative or even semi-quantitative fashion the strength of any given piece of advice; too often, there is no discussion of the risks or the benefits of the path recommended. Hardly ever are dissenting views of the minority disclosed. Given the time needed: to convene the expert authors, virtually or in person; for their review of the literature; for their internal debates; for the drafting itself; and the lag between submission and publication, CPGs are routinely obsolete at publication. Years may go by before they are updated. Rarely if ever do the originators of CPGs identify their funding sources, so the reader is unable to judge whether or to what extent the funder may have had some influence on the finished product.
Most CPGs make no effort to identify conflicts of interest; in fact, there is rather persuasive evidence that bias creeps into a discouragingly high fraction of the total. On top of all that, the extent to which practitioners actually consult guidelines in daily practice is modest at best.
I contend, therefore, that CPGs are poorly designed to achieve either of their objectives, never mind both.
Why should you Attend:
The United States is the litigation capital of the known universe. In tort claims, such as medical malpractice and product liability, the party claiming injury, the plaintiff, must show that the conduct of the defendant not only caused the injury complained of, but that it was culpable in some way. Against professionals, the claim is that the conduct breached the standard of care: that the professional's actions failed to reflect the degree of skill and diligence one expects from 'reasonably prudent' practitioners of like kind in similar circumstances.
In products claims, the allegation is that the drug or device was 'unreasonably dangerous' in its design, or in its manufacture, or both, and/or that the defendant failed to issue adequate warnings. To prove such contentions, the plaintiff needs to establish some sort of yardstick to assess the conduct criticized, and prove that, tested against that yardstick, the conduct fell short. Traditionally, the yardstick was created through the testimony of experts accepted as such by the court. Such experts, like all witnesses, are subject to cross-examination, the process the law provides to unmask bias, ignorance of facts, insufficient qualifications, and other shortcomings that may tend to justify a measure of skepticism in the expert’s testimony.
Suppose, however, that in addition to the testimony of an expert, the proponent of a given allegation can adduce clinical practice guidelines or similar documents, or their content, to support his claims? Such guidelines bear the seal of approval of learned societies, and purport to be accurate, current, objective, reliable guides to the conduct the law expects of defendants. Now the advocate has a new, more powerful weapon, sometimes beyond the reach of cross-examination, and quite possibly seen by the jurors as substantially unimpeachable. I claim that guidelines such as these, far from being a nearly infallible guide to the Truth, are in fact so problem-ridden as to justify their exclusion from trial.
Areas Covered in the Session:
- CPGs defined
- The uses to which they are put in litigation
- The reliability criteria of the Institute of Medicine and the extent to which CPGs satisfy those criteria
- Sources of CPGs
- The level of detail in CPGs
- The time lag in publication and the obsolescence problem
- The inflexibility of CPGs and the evidentiary consequences
- The problem of conflicts of interest
- The problem of bias
- The extent to which practitioners heed CPGs and the legal significance of their reluctance
Who Should Attend
- Health care professionals
- Health care institutions
- Health care professional societies
- Risk managers
- Liability insurers
- Defense counsel
- Anyone who writes or reads clinical practice guidelines
