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October 2003

How Laboratory Test Analysis Alters the Course of Life
The Importance of a Medical Detective Mindset to Achieve an Early Diagnosis, Proper Evaluation and Successful Treatment
By Stephen B. Strum, M.D., Medical Oncologist Specializing in Prostate Cancer

Editor’s Note: While this article may be somewhat technical for the average reader, it contains innovative, life-saving medical concepts that should be shared with your doctor. For this reason, we are publishing it in an attempt to improve the way that medicine is practiced. Ideally, doctors will integrate these critical procedures into their practice and “you as patients will be better served.”

In today’s world of major scientific breakthroughs we are often left wondering why high-tech achievements are not incorporated into the everyday care of the patient. So called translational medicine—that is supposed to bring to the bedside that which we have learned at the bench (research laboratory)—is just not happening. Added to this is the medical profession’s failure to use the tools currently available to almost every practitioner. Therefore, as patients and consumers within the health industry, our protest should be not only that we are not benefiting in a timely fashion from the new advances in medicine made in the research laboratory, but also that given the proverbial tool bag of medical resources presently available, alas, many of these tools are not used at all.

The following article presents to the reader concepts that are critical to our lives. Although the main focus is on laboratory testing, the same principles apply exactly to radiology and pathology, as well as to the findings of the history and physical examination. We have had the tools to employ concepts to prevent illness, to diagnose disease earlier and to achieve better treatment outcomes for many years, but they are not as widely nor as universally used as they should be. The tools described here are not expensive and are not elusive to the empowered patient and the caring and conscientious physician.

I. Biologic Indicators, Medical Profiling and Concordance.
When it comes to an appraisal of our health status, we routinely rely on biologic indicators. Such indicators are “biologic LEDs”—just like the “light emitting diode” readout indicators on your automobile’s dashboard. These biologic markers are called biomarkers because they relate information about life forms. They represent biofeedback from a myriad of mind-body interactions. When a physician evaluates a patient, he takes a history and performs a physical examination. These are inputs into the medical detective (MD) framework that a true physician uses as part of his mode of operation (MO or modus operandi). Beyond the history and physical, a physician samples the patient’s biology by ordering the appropriate laboratory, radiology and/or pathology examinations. He obtains a profile that more comprehensively relates the status of a particular tissue, organ or system within the body. This is medical profiling, and at its best it facilitates early diagnosis and timely treatment. A good detective, however, does not rely only on one piece of circumstantial evidence to solve the mystery. He obtains corroborative evidence to confirm and support his initial premises. Similarly, medical profiling at an optimal level involves additional studies that either confirm or refute the significance of the initial observation. If two or more findings point to the same conclusion, a condition known as concordance is met. Concordant findings increase the statistical significance in the course of diagnosis, staging of disease, prognosis and outcome of treatment.[1-3] Figure 1 attempts to depict the steps involved in this initial data acquisition and processing (IDAP).

Figure 1: Initial Data Acquisition and Processing (IDAP): The Importance of Medical Profiling and Concordance.
Medical investigation at its highest level involves obtaining biologic inputs from the various systems of the human mind and body. These biologic inputs are used to create a medical profile. The accuracy of such an investigation increases if additional evidence indicates that there is agreement or concordance with the initial observation. Example: A 65-year-old man with a history of diabetes in his family complains of frequent urination. His urinalysis reveals the presence of protein and glucose. A fasting blood sugar is obtained and is 150. A glycohemoglobin (hemoglobin A1C) level is drawn and is elevated at 7.9. The patient is diagnosed with diabetes mellitus and an appropriate treatment strategy ensues. Here, initial inputs of information led to a tentative diagnosis of diabetes and additional test results were concordant with this diagnosis.

II. Validation, Response Parameters and Stratification
An important aspect of accurate data analysis is the quality of the data obtained. There may be significant variability in the accuracy of the biologic inputs we obtain. A biologic indicator is only good if it reflects the true status of the patient. The old saying is “garbage in equals garbage out.” This is somewhat blunt but it does find its reality in the variable skills involved in medical evaluation that lead to issues of false positive or false negative findings. This can relate to variations in proficiency of a laboratory or radiology imaging center or to the skill of a medical examiner or a pathologist interpreting a biopsy or surgical specimen. To minimize this pitfall within the methodology of medical profiling, a simple measure known as validation should be used. Validation results in a higher level of confidence that the finding or diagnosis being made is a correct one. For example, repeating an abnormal laboratory or radiology finding or obtaining a second pathology opinion from a recognized expert involves validation.

Once we have obtained validated biologic inputs, and hopefully have substantiated their importance through the concept of concordance, we now have a high-level medical profile not only to diagnose an illness earlier, but also to optimize a treatment strategy. If we have come this far as a “medical Columbo” then the use of response parameters logically follows. Response parameters are the gauges we use to determine objectively if the selected therapy is achieving its goal. For example, on a very elementary level, if within the process of medical profiling we determine that a patient has obesity and diabetes, we should at least select the response parameters of body weight, blood sugar and hemoglobin A1c to follow up on the condition of the patient in order to ascertain whether our therapy is effective. It is amazing to see how many patients with medical problems such as obesity and diabetes do not have these issues addressed despite having been placed on a formal medical therapy. Many of these same patients do not have the desired therapeutic response and continue to suffer the consequences of these medical conditions. To add insult to injury, many may also experience adverse effects that lead to morbidity and mortality. In a study reported in 1998, adverse drug reactions in the United States in 1994 were among the top ten leading causes of death, accounting for 106,000 fatalities,* not to mention an additional 2,216,000 serious adverse drug reactions.†[4] Thus, not only do we need to recognize the value of biologic indicators and of medical profiling and its subtleties, but also to acknowledge that we must use biologic endpoints to objectively grade our treatments. The proof of the pudding is in the eating.

* 95% confidence interval 76,000-137,000
† 95% confidence interval 172,000-2,711,000

In its highest form, medical profiling also invokes the process called stratification. In this course of action, we first obtain the patient’s biologic data via the processes of profiling, concordance and validation. Then, a determination is made to place the patient into high, intermediate or low risk categories involving organ systems vital to health. These include the cardiovascular, pulmonary, hepato-biliary, renal, gastrointestinal, male or female genitourinary, nervous system, skeletal system, endocrine, immune and cutaneous systems. This concept may be applied to situations that involve family history and the risk of a specific illness. It also should be used in situations where a diagnosis has been established and a grading of the apparent severity of the illness, i.e., stratification, has relevance to the nature of the treatment, its prognosis and its outcome.

Organization: What a Concept!
After 40 years in medicine involving consultation with thousands of patients from all over the United States and abroad, it is evident to me that we are not employing the above concepts. This is blatantly the case when it comes to utilizing the wealth of resources coming from the laboratory. Within the context of laboratory testing, a lab result is not just a report that is added to a manila folder that relates “normal” versus “abnormal.” Rather, it is a biologic indicator that reflects the status of our health in a dynamic fashion.

Unfortunately, what most often happens when lab tests are ordered is that the reports are put into the doctor’s inbox along with a morass of other paperwork. The doctor “eyeballs” the reports, looking to spot what might represent any abnormal finding. Often, the physician has not initialed the report to acknowledge that he has reviewed it and ideally that he has given more than a glancing thought to it. The report is then filed in the patient’s chart. Too often the “medical record” is a manila folder with assorted test results and other documents thrown together. There is no organization of data by category (i.e., laboratory, radiology, cardiology, pathology, consultations, office visits, correspondence and even routine physical exam assessments like weight and blood pressure) or by chronology, with sorting of oldest to newest data within the above categories.