Susan G. Mize

A controlled study of intrathecal antibiotic therapy in gram-negative enteric meningitis of infancy: Report of the Neonatal Meningitis Cooperative Study Group*†

Eighteen institutions collaborated in evaluating the comparative efficacy of combined ampicillin and gentamicin therapy with and without intrathecal administration of gentamicin on the clinical and bacteriologic responses of 117 infants with meningitis caused by gram-negative enteric bacteria. There was a random distribution of patients within the two study groups with regard to age on enrollment, birth weight, sex, race, number of infants greater than 30 days of age, the etiologic agent, and their antimicrobial susceptibilities. There were no statistically significant differences (P greater than 0.05) in mortality, morbidity, or days that cerebrospinal fluid cultures remained positive among the infants in the two treatment groups. The case fatality rate for all patients was 32%; that for full-term infants (18%) was significantly lower (P less than 0.01) than that for low-birth-weight infants (45%) or for the patients greater than 30 days of age (48%). Fifty-one of the 80 (64%) survivors were assessed as normal on follow-up examinations performed up to four years after illness.

An evaluation of the quality of therapeutic studies in perinatal medicine

Treatment methods recommended in respected medical journals may be incorporated rapidly into clinical practice. Adequate evaluation of these methods prior to their recommendation is needed to avoid widespread use of ineffective or hazardous treatment methods, especially if high-risk patients are involved. We conducted a survey to assess the design and performance of published studies of perinatal treatment methods.

Rentran. An on-line computer-based regional kidney transplant matching system.

SUMMARY An interactive on-line computerized renal transplant matching system called RENTRAN which serves the Southwest Kidney Transplant Region is described. The region consists of one transplant center in Arkansas, two in Oklahoma, and six in Texas. The computer used is the DECsystem-10 located in the Medical Computing Resources Center at Dallas. RENTRAN participants have remotely located standard interactive computer terminals and gain access to the computer by dialing over normal telephone lines. Functions provided by RENTRAN include obtaining instructions, performing a donor-recipient match, obtaining a list of potential recipients, making a user comment or adding, updating or deleting a potential recipient record. Either long or short formats for dialog with the computer system are available for inexperienced and experienced users, respectively. In the time period from August 1, 1973, when the system went into production to February 1, 1976, there have been in excess of 232 matches attempted and approximately 142 kidneys have been transplanted according to RENTRAN results. There are about 361 recipients currently on the data base. The system was developed with funds provided by the Texas Regional Medical Program. Expenses of maintaining the system as well as occasional programmed improvements as deemed appropriate by the Southwest Kidney Transplant Region Registry Committee on the basis of user comments are provided through a

696 QUALITY OF PERINATAL THERAPEUTIC STUDIES

25 per year charge to patients for being listed on the data base.

Government regulations and other influences on the medical use of computers.

To assess studies which compare or recommend perinatal methods of treatment or management, all such studies (86) published in 1979 in J. Pediatrics, Pediatrics, Am. J. Ob.Gyn, and Ob.Gyn.were reviewed independently by one of two neonatologists and one of two biostatisticians. A 5 page evaluation form was completed by each reviewer. Items noted by both reviewers included prospective design (48%), predetermined criteria for study completion (3%), adequate number of subjects (15%), adequate description of subjects (39%), clear indications for treatment (47%), use of blinding when feasible (36%), evaluation of treatment hazards (45%), and use of a randomized trial to support treatment recommendations (22%). Both reviewers considered the treatment recommendations fully justified in 10% of articles and partially justified in 69%. An overall score was calculated based on the 34 items considered most important to a well executed study. Despite disagreement on individual items, the total score for important items was highly correlated (r=.99). The mean score for all studies was 16.9 for biostatisticians (SD=6.5) and 17.2 for neonatologists (SD=6.5). The range was 3 to 32. Despite tragic past errors in the use of diethylstilbestrol, oxygen, sulfonamide, and chloramphenicol, poorly designed and executed studies are often the basis for therapeutic recommendations in perinatal medicine.

Impact of government regulations on two management and clinical information systems in a medical school environment.

This paper presents points brought out in a panel discussion held at the 12th Hawaiian International Conference on System Sciences, January 1979. The session was attended by approximately two dozen interested parties from various segments of the academic, government, and health care communities. The broad categories covered include the specific problems of government regulations and their impact on specific clinical information systems installed at The University of Texas Health Science Center at Dallas, opportunities in a regulated environment, problems in a regulated environment, vendor-related issues in the marketing and manufacture of computer-based information systems, rational approaches to government control, and specific issues related to medical computer science.

Regional kidney transplant matching: the RENTRAN interactive approach

Administrative and legal requirements and, in particular, federal and state government health care assistance and social services program regulations all combine to add complexity to the management and operation of ambulatory and inpatient health programs. This paper describes how constantly changing government regulations and differences in interpretations and definitions have been expensive, time-consuming and sometimes detrimental to health care delivery for two large management and clinical computer-based information systems.

Intraventricular gentamicin therapy in gram-negative bacillary meningitis of infancy. Report of the second neonatal meningitis cooperative study group

An interactive on-line computerized renal transplant matching system called RENTRAN which serves the Southwest Kidney Transplant Region is described. The region consists of one transplant center in Arkansas, two in Oklahoma, and six in Texas. The computer used is the DECsystem-10 located in the Medical Computing Resources Center at the University of Texas Health Science Center at Dallas. RENTRAN participants have remotely located standard interactive computer terminals and gain access to the computer by dialing over normal telephone lines. Functions provided by RENTRAN include obtaining instructions, performing a donor-recipient match, obtaining a list of potential recipients, making a user comment or adding, updating or deleting a patient record. Either long or short dialog forms are available for inexperienced and experienced users respectively. In the time period since August 1, 1973 when the system went into production, there have been in excess of 100 matches attempted and approximately 50 kidneys have been transplanted according to RENTRAN results. There are about 350 recipients currently on the data base. The system was developed with funds provided by the Texas Regional Medical Program and operational expenses and enhancements are provided through a

Aid to the evaluation of therapeutic studies.

25 per year potential-recipient patient charge for being listed on the data base.