Relations between physicians and attorneys.
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Health Policy↗
Biomedical subjects
Elliott Foucar
Publications and source records attributed to Elliott Foucar.
An observational examination of the literature in diagnostic anatomic pathology.
Original research published in the medical literature confronts the reader with three very basic and closely linked questions--are the authors' conclusions true in the contextual setting in which the work was performed (internally valid); if so, are the conclusions also applicable in other practice settings (externally valid); and, if the conclusions of the study are bona fide, do they represent an important contribution to medical practice or are they true-but-insignificant? Most publications attempt to convince readers that the researchers' conclusions are both internally valid and important, and occasionally papers also directly address external validity. Developing standardized methods to facilitate the prospective determination of research importance would be useful to both journals and their readers, but has proven difficult. In contrast, the evidence-based medicine (EBM) movement has had more success with understanding and codifying factors thought to promote research validity. Of the many variables that can influence research validity, research design is the one that has received the most attention. The present paper reviews the contributions of EBM to understanding research validity, looking for areas where EBM's body of knowledge is applicable to the anatomic pathology (AP) literature. As part of this project, the authors performed a pilot observational analysis of a representative sample of the current pertinent literature on diagnostic tissue pathology. The results of that review showed that most of the latter publications employ one of the four categories of "observational" research design that have been delineated by the EBM movement, and that the most common of these observational designs is a "cross-sectional" comparison. Pathologists do not presently use the "experimental" research designs so admired by advocates of EBM. Slightly > 50% of AP observational studies employed statistical evaluations to support their final conclusions. Comparison of the current AP literature with a selected group of papers published in 1977 shows a discernible change over that period that has affected not just technological procedures, but also research design and use of statistics. Although we feel that advocates of EBM deserve credit for bringing attention to the close link between research design and research validity, much of the EBM effort has centered on refining "experimental" methodology, and the complexities of observational research have often been treated in an inappropriately dismissive manner. For advocates of EBM, an observational study is what you are relegated to as a second choice when you are unable to do an experimental study. The latter viewpoint may be true for evaluating new chemotherapeutic agents, but is unacceptable to pathologists, whose research advances are currently completely dependent on well-conducted observational research. Rather than succumb to randomization envy and accept EBM's assertion that observational research is second best, the challenge to AP is to develop and adhere to standards for observational research that will allow our patients to benefit from the full potential of this time tested approach to developing valid insights into disease.
Anatomy↗
Evidence-based medicine and tort law.
Recent statutes and legal decisions have been aimed at bettering the quality of tort-law decisions by substantively improving "expert" testimony. However, in analogy to the experience of physicians attempting to upgrade medical practice using the principles of evidence-based medicine, lawyers and the courts have found it much easier to describe ideal science than to actualize it. This is particularly so in a system (the Law) that has traditionally not been very discerning about scientific rigor, and which has established procedural priorities that are often incompatible with strict scientific standards. This overview will examine the American tort system from an evidence-based perspective. We include a discussion of standards that could be used for "outcomes analysis" in the Law; recognition and classification of errors made by the courts themselves; the relationship between medical errors, "negligence," and standard of care; and the problem of reconciling the rights of plaintiffs with medical-scientific facts. We also consider selected impediments to developing a legal system that is capable of consistently reaching evidence-based decisions concerning complex scientific information, including pathologic interpretation of tissue specimens.
Decision Making↗
Classification of error in anatomic pathology: a proposal for an evidence-based standard.
Error in anatomic pathology (EAP) is an appropriate problem to consider using the disease model with which all pathologists are familiar. In analogy to medical diseases, diagnostic errors represent a complex constellation of often-baffling deviations from the "normal" condition. Ideally, one would wish to approach such "diseases of diagnosis" with effective treatments or preventative measures, but interventions in the absence of a clear understanding of pathogenesis are often ineffective or even harmful. Medical therapy has its history of "bleeding and purging," and error-prevention has a history of "blaming and shaming." The urge to take action in dealing with either medical illnesses or diagnostic failings is, of course, admirable. However, the principle of primum non nocere should guide one's action in both circumstances. The first step in using the disease model to address EAP is the development of a valid taxonomy to allow for grouping together of abnormalities that have a similar pathogenesis. It is apparent that disease categories such as "tumor" are not valuable until they are further refined by precise and accurate classification. Likewise, "error" is an impossibly broad concept that must be parsed into meaningful subcategories before it can be understood with sufficient clarity to be prevented. One important EAP subtype that has been particularly difficult to understand and classify is knowledge-based interpretative (KBI) error. Not only is the latter sometimes confused with distinctly different error types such as human lapses, but there is danger of mistaking system-wide problems (eg, imprecise or inaccurate diagnostic criteria) for the KBI errors of individual pathologists. This paper presents a theoretically-sound taxonomic system for classification of error that can be used for evidence-based categorization of individual cases. Any taxonomy of error in medicine must distinguish between the various factors that may produce mistakes, and importantly, whether they are individual, small system (e.g., my histology laboratory), or big system (e.g., published diagnostic criteria). Because no overarching governing agency exists to coordinate this initiative, the recognition of need and effective implementation of EAP counter-measures must emanate from our specialty group itself.
Bias↗
Diagnostic precision and accuracy in interpretation of specimens from cancer screening programs.
Few areas in modern medicine provide a better example of evidence-based data than the anatomic pathologists' classification of fully developed malignancies. Beginning with the Papanicolaou (Pap) smear, morphologic tools also were applied to specimens obtained in cancer screening programs directed at large, asymptomatic patient populations. The Papanicolaou test was quickly responsible for a reduction in the incidence of invasive squamous cell carcinoma of the cervix, proving the concept that screening could interdict the development of advanced malignancy. Other screening programs followed the Papanicolaou test initiative, producing a revolutionary change in the specimens submitted to pathologists. Cancer screening generates specimens containing morphologic deviations from normal that are thought to put currently healthy patients at risk of future malignancy. However, translating morphologic findings in such samples into risk estimates raises a number of statistical and ethical problems. When diagnostic thresholds are set to favor specificity, unwanted false-negative results accrue. Conversely, aiming at sensitivity over specificity is associated with biologically false-positive results, which are likewise undesirable. Pathologists interpreting these specimens find themselves facing a screening paradox. These screening programs attempt to discover the very earliest changes of neoplastic transformation, but these same earliest changes are inherently the most difficult to identify with precision and accuracy. This paper discusses these challenges.
Data Interpretation, Statistical↗
Pathology expert witness testimony and pathology practice: a tale of 2 standards.
CONTEXT: Pathologists work in an environment in which, to the extent possible, diagnostic decisions are based on scientific principles. It can therefore be a rather shocking experience when a pathologist finds one of his or her diagnostic decisions being evaluated by a legal system developed and controlled by lawyers and judges rather than by scientists or pathologists. This experience can be even more troubling when a key participant in the proceedings is a fellow pathologist guiding a jury toward an unfamiliar interpretation of the pathology standard of care. OBJECTIVE: To provide the interested pathologist with the background information necessary to (1) understand the role of expert testimony in malpractice litigation and (2) understand why there can be a gap between expert opinions expressed in court and expert opinions expressed in a medical care context. DATA SOURCES: Medical literature review supplemented by review of subspecialty position papers, selected articles from newspapers and magazines, and legal decisions. The medical literature review was limited to articles published in English and was based largely on articles retrieved using the MeSH terms expert testimony/legislation & jurisprudence, and pathology/legislation & jurisprudence. CONCLUSIONS: Medical error has become an increasingly important topic for pathologists, and although errors or allegations of error are evaluated in many ways, the evaluation with the most impact on the individual pathologist is a malpractice case. During the last decade physicians have increasingly become aware of the critical role played by expert testimony in malpractice litigation. Some physicians have asserted that providing expert testimony is the practice of medicine, and that it is unacceptable for juries to be presented with expert testimony that incorrectly describes medical practice standards. However, this opinion has been vigorously opposed by attorneys who feel that juries are best able to come to a correct conclusion if they base their deliberations on a broad spectrum of opinion. Gaining an increased role in the oversight of expert testimony would allow physicians to establish a closer alignment between opinions expressed in court testimony and opinions expressed in clinical practice. However, despite some physician success in inserting themselves into the oversight process, both physicians and physician organizations attempting to take action against misleading expert testimony continue to be vulnerable to legal attack.
Defensive Medicine↗
Diagnostic certainty is sometimes certainly an error.
We evaluated a low-density lipoprotein (LDL) subfraction separation method using polyacrylamide tube gel electrophoresis (PTGE) and compared it with the reference method, polyacrylamide gradient gel electrophoresis (PGGE-REF). Excellent intra-assay and interassay coefficients of variation were obtained (<4%) for PTGE. For 102 subjects, LDL subclasses correlated most significantly with triglyceride (TG) level, high-density lipoprotein (HDL) cholesterol level, total cholesterol/HDL cholesterol ratio, and non-HDL cholesterol level (P < .05). The distribution of large LDL (76%) was predominant for subjects with low TG levels (< 150 mg/dL [1.69 mmol/L]), while distribution of small LDL (79%) was predominant for subjects with high TG levels (>200 mg/dL [2.26 mmol/L]). Excellent agreement between the methods was observed (weighted kappa = 0.78). Of 51 samples classified as small, dense LDL by PGGE-REF, none were misclassified as lage LDL and 4 as intermediate LDL by PTGE (92% concordance); of 44 samples classified as small and 7 as intermediate by PTGE (77% concordance). The PTGE method is precise and compares favorably with PGGE-REF. It has the advantage of being simple, less expensive, and more suitable for use in the clinical laboratory.
Diagnostic Errors↗
How much oversight is necessary to protect human subjects?
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Ethics Committees, Research↗