Computer-Based Patient Records

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Association of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto

I am an internist and have been in solo private practice since 1981. Before I opened my own practice, I was full-time faculty at the University of Arizona College of Medicine and a staff physician at the Veterans Administration Medical Center in Tucson.

While employed there, I participated in the first (and as far as I know the only) controlled study on the use of practice guidelines by physician extenders, employing checklists designed for computerized data entry. This is the type of research in which the computerized patient record might be used.

I am the editor of the first edition of The Art and Science of Bedside Diagnosis by Joseph D. Sapira, a textbook of clinical examination that is rather widely used by medical students. Record-keeping and the diagnostic thought process are integral parts of this book.

The introduction of computer-based medical records with a standard, mandatory format would be a truly radical change in American medical practice. Before recommending or helping to implement such a change, this Committee has the responsibility to ask: what is the evidence that such a change would be safe and effective? To ask this question implies that we should consider not just how the computerized medical record should be implemented, but whether it should be implemented, especially on a compulsory basis.

As you know, a new drug may not be marketed in the United States without approval by the Food and Drug Administration. Obtaining such approval requires more than a quarter of a billion dollars worth of research to establish safety and effectiveness. A truckload of data must be submitted for careful scrutiny, presumably by expert advisors who do not have a financial conflict of interest. This process is mandated despite the fact that a new drug can harm only those patients who actually take it, and delayed approval can result in uncounted loss of lives that might have been saved by timely use of the drug.

Forced standardization and computerization of medical records will affect everyone who provides or receives medical care. Surely such a change should be no less carefully researched than new drugs or medical devices.

1. Computerized clinical records and practice guidelines have not been adequately tested.

2. Purported benefits of computerized patient records are based on assumptions that are not plausible on the basis of clinical experience.

3. Special interests will gain a huge financial windfall from the imposition of computerized record keeping, data gathering, and practice guidelines.

4. Forced computerization of the medical record and the gathering of large patient data bases will have adverse consequences. It will violate constitutional rights, destroy the patient-physician relationship, impede scientific progress, drive independent practitioners out of the medical field, and seriously degrade physicians' ability to provide good medical care.

1. Computerized clinical records and practice guidelines have not been adequately tested.

In the 1970s, the late Dr. Louis Kettel, who later became Dean of the University of Arizona College of Medicine, saw the trend toward practice guidelines and computerized patient records. He thought that such an important development ought to be researched. Thus, he designed a study of our ambulatory care department before and after the introduction of evidence- based, computerized algorithms or "guidelines," to see the effect on the cost and quality of patient care, improvements in which are two of the stated purposes of the computerized patient record.

The protocols that we used were written at Dartmouth and Stanford under the direction of Dr. Harold C. Sox, Jr., a collaborator in our study, who is now President of the American College of Physicians-American Society of Internal Medicine, director of the Robert Wood Johnson Foundation Generalist Physician Initiative, and an editor of Scientific American Medicine.

The results of the study, portrayed in the most positive light possible, were decidedly equivocal. No salutary effects were definitely attributable to the evidence-based guidelines, data collection devices, or computerized monitoring of the process of care. There was a decrease in the number of diagnostic tests ordered (for both appropriate and inappropriate tests), but this could be explained by other factors: the nurse practitioners were being followed around by a research assistant armed with a stopwatch, every chart was closely monitored, and they knew they were supposed to order fewer tests. The study also showed some potential hazards: inaccurate or even dishonest record- keeping, and the denial of beneficial care in order to avoid receiving a dreaded "error statement."

A majority of Americans may say that they favor a computerized medical record linked to a nationwide, government-controlled data base if it will improve their treatment, especially in an emergency, or lead to advances in science and medicine, or lead to better quality assurance.

In a true emergency, review of the old medical record is one of the last things a good physician does. First, he takes care of the ABCs: airway, breathing, circulation. Next, he obtains the history of what recently happened (which will not be in the chart!), probably while simultaneously examining the patient. He is also ordering tests to evaluate the patient's current status. Last week's EKG, chest x-ray, or blood sugar doesn't matter nearly as much as today's. Much of the information in the chart will be irrelevant; some will have become instantly out-dated; some may give the physician a false sense of security. (For every medical disaster, there is always a first time.) Some items of past history are crucial: serious allergies, for example. Those should be on a Medic-Alert bracelet, not on a card lost at the accident scene or somewhere in cyberspace.

In all clinical encounters, routine or emergency, all good physicians interview and examine the patient first-hand. Even if the medical record contains every pertinent item of history (impossible), and even if all the information is correct (extremely unlikely), the history in the chart is of no operational significance by itself. Only information that is in the physician's awareness is of immediate clinical value for the patient. The computerized record can be more of a hindrance than a help in retrieving the needed information. The pertinent data can be buried in irrelevancies, contaminated with errors and bias, and organized in a way that is not appropriate for the clinical situation or the individual physician's approach to clinical problem- solving.

As to advances in research, there is no reason to believe that having every patient's clinical record on-line will lead to scientific advances. Those who promote this belief tend to speak in generalities rather than formulating specific hypotheses subject to testing. The pitfalls in research based on clinical records are summarized in the accompanying article from the Medical Sentinel. Briefly, there is the GIGO problem: garbage in, garbage out.

Data now present in the clinical record are of highly variable quality. For clinical findings that have been subjected to study, interobserver agreement may be not much better than expected by chance alone; and most clinical findings have not even been scrutinized in this way. Data entered because required on a checklist are likely to be of much less value than items entered because a clinician believes them to be relevant, important, and reliable. Data entered in order to justify payment may be colored by financial incentives. Information that a patient knows will be in a government or insurance-company data base may be both inaccurate and incomplete because of (often well- founded) patient distrust.

Many institutions now engage in "continuous quality improvement," using extensive record review. While better compliance with stated objectives can be achieved, it is not clear that any measurable benefit accrues to patients. A survey of Arizona physicians, contemporaneous with CQI, showed that a striking 63% of physicians believe that overall quality of medical care in Arizona is deteriorating. One problem with CQI is that compliance is not the proper endpoint. The goal should be to make the correct diagnosis and provide the optimum treatment for an individual. Measuring quality in these terms requires a gold standard (autopsy, surgical pathology, actual consultation with a recognized expert who personally sees the patient, etc.), not just a "criterion."

3. Special interests will gain a huge financial windfall from the imposition of computerized record keeping, data gathering, and practice guidelines.

It is highly ironic that just as Microsoft is being prosecuted for antitrust violations in marketing products that customers choose to buy, the government is considering actions that are likely to grant monopoly privileges to insiders, drafting standards for materials that physicians will be compelled to buy and use.

One group that stands to profit handsomely from health information systems is the American Medical Association, which views itself as the "acknowledged leader in ... setting standards for medical ethics, practice, and education." About two-thirds of the AMA's more than $200 million in annual revenue results from business activities mostly derived from its perceived authoritative position in such areas. The AMA was a strong supporter of legislation in the past Congress to mandate extensive data collection from all health plans, not just the managed care plans accused of certain abusive practices. It was also an advocate for federal legislation to establish a corporate right of ownership over medical databases, by virtue of the "Collections of Information Antipiracy Act."

The AMA already has a substantial financial interest in licensing data. In 1997, the AMA reaped $10 million in profits, from $11 million in revenue, in matching physician prescribing data to its Physician Masterfile.

According to its 1999 Strategic Plan, the AMA "will design and implement compelling strategies that position the AMA to make appropriate contributions in each of these standard-setting arenas [of computerized patient records and health care electronic commerce]."

From its own publications, it appears that the AMA wants to control the standards and the dissemination of information-for profit.

4. Forced computerization of the medical record and the gathering of large patient data bases will have serious adverse consequences. It will violate constitutional rights, destroy the patient-physician relationship, impede scientific progress, drive independent practitioners out of the medical field, and seriously degrade physicians' ability to provide good medical care.

The drive for gathering all patient records into a national computer data base is widely recognized to conflict with patient confidentiality. Therefore, numerous acts have been introduced into Congress, which attempt to establish procedures governing the use of information for which disclosure is now either prohibited or practically impossible-all in the name of "protecting" privacy. A disturbing feature of such legislation is the inclusion of loopholes and exemptions that permit the use of patients as experimental subjects without their consent, and circumventing Fourth Amendment protections against unreasonable searches and seizures.

At the same time, there is pressure to document more personal and family history in the medical record. Whether initially intended or not, the medical record could become a tool for oppressive agencies engaged in fishing expeditions for "undesirable" persons (homosexuals, persons with mental disturbances, smokers, drinkers, gun owners, religious fundamentalists, etc.). The new E&M Documentation Guidelines proposed by the AMA show the general trend. Such searches could be vastly facilitated by networked computers using standardized data. Thus far, protections against such use have not even been proposed.

Some physicians have noted that patients are already withholding information because they fear that once in the medical record, disclosures that were once confidential could find their way to employers, ex-spouses, blackmailers, or just aggressive marketers of prostate aids and remedies for impotence. If physicians cannot obtain complete information about their patients, they are hindered in making the correct diagnosis and advising the best treatment.

History has shown that scientific progress is made only in an atmosphere of free inquiry. If physicians fear that an adverse economic profile, or a history of "noncompliance" with favored treatment, will imperil their ability to practice, innovation will cease. Every patient will, in fact, become a potential threat or adversary.

The computerized medical record will be very expensive to implement, to the disadvantage of small practices. In fact, the overhead is likely to be unaffordable for many. It will certainly increase the cost of care, and decrease access to care. As the AMA Strategic Plan notes: "Electronic sophistication is now a fundamental requirement of a medical practice of any kind." Independent practice "will likely not be the dominant mode of practice" in the future. Many more physicians will be employees of large institutions. These prophecies may well be self-fulfilling. In fact, electronic sophistication is a requirement only if the government mandates it.

One of the most serious problems with the computerized record is that it can stand in the way of medical reasoning. The electronic checklist might be suitable for the medical student, who is just learning to take a history and perform a physical examination. But to the sophisticated clinician, constraining the record into a computer straitjacket is not just a thief of time. It alters and impairs the entire diagnostic process. The good clinician's interview and examination is a complex, highly individualized process of hypothesis testing. It is interactive and iterative. Every patient, every clinician, every problem is unique; yet there are patterns, and the clinical expert is highly skilled at pattern recognition. The computerized checklist has both too much and too little: too many irrelevancies, too few special questions or tests for the unusual diagnosis or presentation. Attempts to computerize the clinical process demonstrate very clearly the difference between a human being and a V-8 engine.

Another serious problem is that in any human endeavor, one gets more of what one measures. If physicians are being judged by the percentage of patients who have C-sections, or blood transfusions, or aspirin after a heart attack, or a beta blocker in the intensive care unit, he will be treating the patient with one eye on his own clinical profile. This leads to another potential source of corruption. While the FDA forbids speakers to mention off-label uses of drugs, or physicians to accept gifts that might influence their judgment, no one is scrutinizing the ones who are writing the protocols for measuring "quality."

The purported benefits of mandated computerized records are based on untested and implausible assumptions.

Computer technology is undoubtedly useful in many aspects of medical care. When patients and physicians benefit from such technology, it has been voluntarily purchased by them. Mandatory standards and compulsory usage are likely to be of benefit only to vendors such as the AMA, insurers attempting to improve their underwriting, marketing agents, government oversight agencies, and agencies that intend to control and redistribute resources. Quality will be assured only if quality means compliance.

Patient privacy is widely recognized to be an issue. However, some believe that "the real issue is not security, per se, but data control" (Moran, 1998). And data control brings vast profit-or in some instances (e.g. the East German Stasi), just immense power.

The end result of mandatory computerization could be what Dr. Herbert Fred called "elephant medicine": "In elephant medicine, each doctor, like a circus elephant, metaphorically wraps his trunk around the tail of the elephant in front of him, all marching in a line, looking neither left nor right, exactly in the trail of the first elephant" (Sapira 1993).

Moran DW: Health information policy: on preparing for the next war. Health Affairs 17:9-22, 1998.

Orient JM: Practice guidelines and outcomes research (part II): scientific pitfalls. Medical Sentinel 3:10-13, 1996.

Orient JM, Kettel LJ, Sox HC, Jr., Sox CH, Berggren HJ, Woods AH, Brown BW, Lebowitz M: The effect of algorithms on the cost and quality of patient care. Medical Care 21:157-167, 1983.

Sapira JD: The Art and Science of Bedside Diagnosis. Ed. by Jane M. Orient, Baltimore-Munich, Urban & Schwarzenberg, 1990.