AIDS Treatment News #165, December 18, 1992
John S. James

In addition to its use in daily clinic management, the system supports research in several ways. It keeps almost all patient data in a compatible, computerized form, so that records can be combined from different practices and clinics for retrospective studies. It enables physicians with large HIV practices to quickly check all of their patients' records to test hypotheses as they come up -- usually prohibitively difficult with the usual paper-based medical records. And it greatly reduces the work of identifying patients within a practice who are eligible for a prospective clinical trial.

Medsys has been tested in daily use in the practice of Larry Bruni, M.D., for about two years. Dr. Bruni, the leader in the development of Medsys, has a large HIV practice, currently over 1300 patients, in Washington, D. C. (An interview with Dr. Bruni on treatment strategies appeared in AIDS TREATMENT NEWS #124, April 5, 1991.)

This article will outline some of the highlights of the system, the computer environment in which it runs, and the business and practical arrangements to install it for community-based research, or for use in other clinics. The next step for interested medical professionals is to talk to persons who have used Medsys, or to see a demonstration, which provides a better feel for the system than a printed article can, and a better sense of its potential uses and importance.

System Overview

Medsys runs on a local area network of DOS (IBM-compatible) computers. As many terminals as needed can be connected; they can be in patient examining rooms if desired, in physicians' private offices, where blood is drawn for laboratory tests, and in the reception or accounting areas. (Passwords can prevent administrative employees from viewing patients' medical data.) In addition, physicians can access the system by telephone from home or while traveling, using portable computers, giving them complete access to patient records in an emergency, even during nights or weekends when no one is in the office.

To use Medsys, physicians or staff at any available terminal can select a patient by typing a few letters of his or her name, or by using a patient identification number if available. The patient's name, address, demographics, and insurance information appears, and menus guide the user to appropriate parts of the electronic chart, including laboratory tests, radiology, pathology, problem list (of all current and resolved medical conditions diagnosed), medication list, and physical exam information. Data can be added or changed, and a patients' medical history can be displayed immediately, in various tabular or graphic forms, either on the screen or on paper.

Many clinical laboratories now transmit results automatically by telephone to the offices of the physicians who ordered the tests. Usually the results are printed on paper as they come in, but with Medsys they go directly into the database as well; no retyping is required. (A person must intervene, however, before the data goes into the patients' charts. Since there can be incompatibilities or errors, such as slight differences in the spelling of a patients' name by the physicians' office vs. the laboratory, or notes to the physician from the laboratory, human examination is required to assure accuracy. It takes only a few minutes a day to post the labs in Dr. Bruni's 1300-patient practice.)

Laboratory tests include chemistry panels, drug levels, endocrinology, hematology, immunology, microbiology, p24 antigen and antibody, serology, T-cell subsets, and urinalysis. Some of these categories (such as chemistry and microbiology) have submenus which are selected for display or editing of the data.

Normal ranges for the same test (e.g. T-helper count) often differ between laboratories. Medsys records the normal values for each test used in the clinic or physicians' practice, and marks high or low patient laboratory results to call attention to them. New tests or new laboratories can be added, or existing values changed, by the physician's staff when necessary.

Patients' records also include the pharmacy at which they usually fill prescriptions, and formatting information for specimen labels, which are printed as needed by Medsys.

The problem list is kept by ICD-9 codes (International Classification of Diseases). The ICD-9 directory is included in Medsys, so users can search it for keywords and do not need to have the printed volume available to look up the codes.

Usually data is entered by selection from lists (of diseases, medications, tests, findings, etc.), instead of by typing in text. This system saves time, avoids spelling errors or incompatible synonyms, and facilitates research by helping to make the computerized data compatible between different physicians' practices.

When the physician decides on tests, specimen labels are automatically printed at the appropriate departments. The system also computes the bill for the visit, which is usually ready by the time the patient gets to the front desk. Not everything in the database is patient information. Other sections record consultants, pharmacies, hospitals (which works like "consultants," except that it also has menu choices for departments and staff, including the best persons and phone numbers to call during any shift), vendors, drugs and companies, services, and friends. Another section keeps the appointments and other schedule information for physicians and staff.

Research and expanded-access protocols can also be entered into the system.

For research use, data can be transmitted (by telephone if desired) without patient identifiers to other sites, to be combined for community-based research. Also, an interface between Medsys and SAS (a standard statistical analysis software package) is now being developed.

Business Arrangements

Medsys was created by the National Community Research Initiative (NCRI), a nonprofit organization. Medical Office Management Systems (MOMS), a for-profit corporation, sells Medsys commercially. MOMS owns Medsys, while NCRI has an unlimited license for HIV research. MOMS is also customizing Medsys for oncology and cardiology, which requires adding additional laboratory tests, and other minor modifications.

MOMS sells Medsys for $25,000, which includes installation and training; there is also a $2500 per year maintenance fee. This does not include the cost of the computers; usually these are ordered in advance, before the MOMS staff travels to the site for installation.

NCRI is providing Medsys free (except for the cost of computers and the maintenance fee) to HIV practices and clinics which support community-based research and agree to certain restrictions -- the main one being not to provide data collected through this software to third parties without the permission of NCRI.

MOMS is working with Curaflex, headquartered in Ontario, California, to set up a national network of community-based research sites which use the Medsys software. The (anonymous) patient information from all these sites will be combined to quickly identify patients eligible for new clinical trials. Later, data from the trials will be sent to a biostatistical center for analysis. Such a system has considerable commercial potential, since the FDA is moving toward earlier approval of drugs for life-threatening conditions, while requiring that more research be done in postmarketing studies. Community-based trials, which are conducted through physicians' offices, are ideal for such studies, since the drugs are already in standard use and available by prescription. Software such as Medsys should enable pharmaceutical companies to get answers faster and less expensively, when the FDA asks for particular information.

Technical

For those interested in the system internals, Medsys is programmed in Foxpro, a commercially available database language, and uses the SQL query language. The software is table-driven and easy to modify, which allowed its rapid evolution in Dr. Bruni's practice; when he wanted a change, the programmer could quickly provide it.

Recommended equipment for running Medsys is a 486 computer (it can run on a 386); a mouse is optional. Medmodem*, the part of Medsys which controls the modem (for receiving laboratory test results, allowing remote access to patients' records by the physician, and sharing research data) can use a 286.

The computers are connected with a Novell local area network.

Comment

Before publishing AIDS TREATMENT NEWS, this writer developed computer software, and was particularly interested in making it easy to learn and use. In this respect Medsys has done very well. Medical staffs are already oriented to the system before training begins, because they are familiar with its elements -- the individual patients in the practice, clinical and laboratory findings, medications, prescriptions, pharmacies and other vendors, specialists and consultants, calendars and appointments, etc. At every point the screen shows what the user's options are, so it is seldom necessary to consult the manual.

And with proper hardware the system is fast, usually responding immediately to user choices, even with 1300 patients in the database in the practice where we saw the software demonstrated. The benefit is not only in saving staff time, but also in allowing people to work at their own rhythms, instead of having to change to accommodate the computer.

We believe this system can contribute significantly to the computerization of medical records, which would greatly facilitate both retrospective and prospective community-based research.

For More Information

For more information about the Medsys system, contact Peter H. Anestos, President, NCRI, Suite 201, 801 Pennsylvania Ave., S.E., Washington, DC 20003-2167, phone 800/466-0854.

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