OCIS: 15 years' experience with patient-centered computing.

In the mid-1970s, the medical and administrative staff of the Oncology Center at Johns Hopkins Hospital recognized a need for a computer-based clinical decision-support system that organized patients' information according to the care continuum, rather than as a series of event-specific data. This is especially important in cancer patients, because of the long periods in which they receive complex medical treatment and the enormous amounts of data generated by extremely ill patients with multiple interrelated diseases. During development of the Oncology Clinical Information System (OCIS), it became apparent that administrative services, research systems, ancillary functions (such as drug and blood product ordering), and financial processes should be integrated with the basic patient-oriented database. With the structured approach used in applications development, new modules were added as the need for additional functions arose. The system has since been moved to a modern network environment with the capacity for client-server processing.

Integrated ambulatory care resource scheduling in oncology.

In a modern managed-care environment, the scheduling of ambulatory care activities must be viewed as a series of closely related activities rather than a group of unique and independent events. These activities must be sequenced in a logical manner, and linked with a variety of information on other clinical, operational, and administrative activities. This article focuses on such an integrated scheduling system which supports the ambulatory care services at the Johns Hopkins Oncology Center.

Chemotherapy and treatment scheduling: the Johns Hopkins Oncology Center Outpatient Department.

The Chemotherapy and Treatment Scheduling System provides integrated appointment and facility scheduling for very complex procedures. It is fully integrated with other scheduling systems at The Johns Hopkins Oncology Center and is supported by the Oncology Clinical Information System (OCIS). It provides a combined visual and textual environment for the scheduling of events that have multiple dimensions and dependencies on other scheduled events. It is also fully integrated with other clinical decision support and ancillary systems within OCIS. The system has resulted in better patient flow through the ambulatory care areas of the Center. Implementing the system required changes in behavior among physicians, staff, and patients. This system provides a working example of building a sophisticated rule-based scheduling system using a relatively simple paradigm. It also is an example of what can be achieved when there is total integration between the operational and clinical components of patient care automation.

Gravimetric measurements of cerebral edema in a rabbit brain tumor model.

The development of tumor-induced cerebral edema was studied in rabbits to establish a data base for future work using this brain tumor model to correlate the degree of edema with other functional and morphological parameters. The VX-2 carcinoma was implanted into the brains of New Zealand White rabbits. Animals were killed 9 and 13 days later, and gravimetric analysis was used to measure the specific gravity of gray and white matter in both the tumor-bearing implanted and contralateral nonimplanted hemispheres. Studies were conducted in untreated tumor-bearing rabbits as well as in those receiving dexamethasone daily for 4 days before death. Tumor tissue and peritumoral gray and white matter and contralateral gray and white matter were analyzed. In all cases, at both 9 and 13 days after tumor cell implantation, tumor tissue exhibited extremely high specific gravity values exceeding the range detectable by the assay procedure. Compared with controls, specific gravity values in tumor-bearing animals generally increased in gray matter and decreased in white matter as a function of tumor growth. This trend was seen in both peritumoral gray and white matter as well as in contralateral gray and white matter areas. However, in most cases, the changes in specific gravity values as compared with controls were not statistically significantly different. The primary exception to this was in peritumoral white matter, in which mean specific gravity values at both 9 and 13 days after implantation were statistically significantly lower than for the corresponding site in control non-tumor-bearing animals.(ABSTRACT TRUNCATED AT 250 WORDS)

Integrated ambulatory care services in oncology.

In today's medical care environment of cost containment and restricted reimbursement, it is important to maximize the use of expensive facility and personnel resources. Concurrently, it is important to provide superior and timely patient services in order to remain competitive in an extremely flexible market. There are many areas in today's larger hospital environments where such ideals can be easily achieved. One of the more obvious areas is the automation of appointment and resource scheduling for ambulatory care services. This article focuses on maximizing the use of available physical and personnel resources in the ambulatory care setting of large and specialty hospitals. The Johns Hopkins Oncology Center's integrated outpatient scheduling and resource management systems are used as examples of what can be achieved. It is hoped that the experiences of the Oncology Center in developing these integrated systems will help others in similar efforts.

The Oncology Clinical Information System.

This presentation provides an overview of the functions of the Oncology Clinical Information System (OCIS) focusing on three new applications. The first part of the presentation will describe the structure of OCIS and show the basic clinical decision-support aspects of the system on-line. The second part of the presentation will provide on-line demonstrations of three new applications: a sophisticated blood products ordering systems, a chemotherapy and treatment scheduling system, and a radiation therapy scheduling system.

Preventing postoperative acute bleeding of the upper part of the gastrointestinal tract.

Two hundred and ninety-eight critically ill patients at risk for the development of postoperative stress ulcers and bleeding were randomized into three groups. The first group comprised 85 patients who received meciadanol, a new bioflavonoid, 500 milligrams every six hours through a nasograstric tube; the second group comprised 100 patients who received sucralfate (crushed tablets), 1,000 milligrams every six hours through a nasogastric tube, and the third group comprised 113 patients who received an antacid (Maalox [magnesium aluminum hydroxide gel]) through a nasogastric tube at an initial dose of 15 milliliters every hour. The gastric pH was measured hourly and titrated to a pH greater than or equal to 4.0 in patients in the group receiving the antacid. The gastric pH was measured every two hours in the other two groups. Bleeding in the upper part of the gastrointestinal tract was determined visually (frank blood in gastric contents) or by guaiac testing. Bleeding occurred in seven patients receiving meciadanol, nine receiving sucralfate and six receiving the antacid. The difference in rates of bleeding was not statistically significant. Correlation between the severity of illness index and the development of bleeding was poor, at least in the low and intermediate index range. In contrast, there was a strong correlation between the age of the patient and the development of bleeding. Only one patient younger than 50 years had bleeding develop. Apparently, meciadanol exerts its action by a mechanism other than pH control. It may, therefore, fill an important gap in the ability to prevent postoperative stress ulcers and bleeding.

An efficient method for psychosocial screening of cancer patients.

In high-volume outpatient areas, using Weisman and Worden's Omega instruments for psychosocial screening of cancer patients is not feasible. This study of 30 newly diagnosed patients compared the accuracy of the Omega instruments and the Brief Symptom Inventory (BSI) in identifying patients with high levels of distress at the time of diagnosis as well as in predicting future distress. A significant level of agreement was found between the BSI and the Omega instruments. Both instruments correctly identified the future distress of 16 of 19 patients (84.2%), but the BSI screens patients in one-fourth the time and at one-third the cost. These results support our decision to employ the BSI as a screening tool in an outpatient setting.

Clinical and pathological associations with allelic loss in colorectal carcinoma [corrected].

Clinical and pathological associations with molecular genetic alterations were studied in colorectal carcinomas from 83 patients. Fractional allelic loss, a measure of allelic deletions throughout the genome, and allelic deletions of specific chromosomal arms (the short arm of 17 and long arm of 18) each provided independent prognostic information by multivariate analysis when considered individually with Dukes' classification. Distant metastasis was significantly associated with high fractional allelic loss and with deletions of 17p and 18q. Mutations of ras proto-oncogenes and deletions of 5q had no prognostic importance. Statistically significant associations were also found between allelic losses and a family history of cancer, left-sided tumor location, and absence of extracellular tumor mucin. Allelic deletion analysis thus identified subsets of colorectal carcinoma with increased predilection for distant metastasis and cancer-related death. Further studies may define a subset of genetic alterations that can be used clinically to help assess prognosis.

In vivo cell growth and pharmacologic determinants of clinical response in acute myelogenous leukemia.

A predictable increase in the proliferative rate of malignant cells remaining after initial cytoreduction in vivo forms the rationale for timed sequential therapy (TST) with 1-B-D-arabinofuranosylcytosine (ara-C) for adult acute myelogenous leukemia (AML). The relationship between in vivo leukemic cell growth, intracellular ara-C metabolism, and clinical response to ara-C-containing TST was evaluated by comparing AML marrow cell growth kinetic and biochemical pharmacologic determinants obtained before therapy (day 0) and at the predicted peak of in vivo postdrug residual tumor proliferation (day 8). Serial measurements of DNA synthesis and net intracellular ara-C metabolism demonstrated marked increases in both determinants in day 8 residual tumor when compared with the pretreatment cells for newly diagnosed adults achieving complete remission but not for TST-refractory patients. The interrelationship of AML cell proliferation and biochemical pharmacology together quantitate cytotoxicity measured by both achievement and duration of remission and serve to predict eventual clinical outcome in response to TST with ara-C where both growth and favorable pharmacokinetics are intrinsic to the success of the drug schedule.

Large acinar atypical hyperplasia and carcinoma of the prostate.

Step-sections of 429 whole prostate glands were studied. Large acinar atypical hyperplasia was graded as mild, moderate, and severe based on the degree of cellular anaplasia. The relationship between atypical hyperplasia and prostatic carcinoma was investigated. There was a strong association between prevalence and grade of atypical hyperplasia and prostatic carcinoma in patients up to 60 years old. Beyond the age of 60 no association was detected. In the younger age groups (36 to 60 years) atypical hyperplasia was found in 86.8% of prostates with carcinoma, but only in 37.9% of benign glands. Corresponding figures for the over-60 age group were 68.8% and 65.1%, respectively. A biologic explanation of the association between atypical hyperplasia and carcinoma in the younger age groups has been proposed. It was suggested that these men with atypical hyperplasia, particularly with severe atypical hyperplasia, have a greater risk for developing prostatic carcinoma.

The effects of distance from primary treatment centers on survival among patients with multiple myeloma.

Twenty-one comprehensive cancer centers participated in a national reporting system of common data items, recording information on all patients seen between 1977 and 1982. There were 240,531 patients who had data abstracted. This report describes 1,479 patients with multiple myeloma. Parameters that may effect the type of treatment given during the initial episode of therapy in the center and the effect of these characteristics on survival were studied. In the univariate analysis, age, treatment, and distance traveled to the center were statistically associated with survival. In a multivariate analysis adjusting for potentially confounding covariates, blacks survive better than whites and the effects of sex and socioeconomic status (SES) on survival approach significance. Survival consistently improved with increasing distance traveled to treatment centers. This may be a serious confounding variable in assessing the results by both single and multiinstitution clinical trials.

Clonidine for anticipatory nausea and vomiting: a pilot study examining dose-toxicity relationships and potential for further study.

In preparation for studies of noradrenergic activity in anticipatory nausea and vomiting, we performed an open-dose study of clonidine to examine dose-toxicity relationships and indications of antiemetic activity. Nine patients, three each at 0.1, 0.2, and 0.4 mg/day, received clonidine twice a day for 5 days before chemotherapy. Unwanted effects, principally blood pressure reduction, dry mouth, and sedation, accumulated between 4 and 5 micrograms/kg/day. Four of eight evaluable patients had no anticipatory symptoms on clonidine. It is concluded that clonidine, at a dose of 4 micrograms/kg/day, might safely probe the role of noradrenergic activity in anticipatory nausea and vomiting.

The role of diet in prostate cancer.

This is a one-to-one, age- and race-matched case-control study involving 55 histologically confirmed black prostate cancer patients and 55 controls who were seen at three major hospitals in Washington, DC from 1982 to 1984. Personal interviews were conducted to obtain the number of times food items of specified serving size were consumed per week by cases and controls; the subjects were grouped according to the age periods 30-49 and 50 years and older. We then calculated the average daily consumption of each of 18 nutrients per 1,000 calories. There was a significant negative association between linoleic acid (p less than 0.04) for the 50 years and older group, thiamin (p less than 0.05) for those 30-49 years old, riboflavin (p less than 0.03) for the 50 and older group, and iron (p less than 0.05) for those 30-49 years old. The results of this study suggest that the intake of thiamin and iron (in subjects 30-49 years old), linoleic acid and riboflavin (in subjects 50 years and over) could be protective because control subjects consumed more of these nutrients than did the cases.

Blood flow to experimental renal tumors.

Radiolabeled microsphere techniques were used to measure renal blood flow (RBF) in rabbit kidneys with 14- to 16-day-old experimentally induced renal tumors. VX-2 carcinoma cells (25 microliters) harvested from carrier animal intramuscular tumors were injected supraselectively into an intralobar artery using fluoroscopically guided transcatheter techniques. Within 2 to 3 weeks, all animals developed localized 10 to 25 mm diameter renal tumors. Renal blood flow was calculated after left ventricular injection of 113Sn-labeled 15 mu diameter microspheres. Blood flow (ml/minute) in tumor-bearing kidneys (26.91 +/- 1.86) was significantly lower (P = less than .05) than in normal controls (49.79 +/- 7.71). The tumor-bearing kidneys were also significantly larger (15.21 +/- 1.27 gm) than control animal kidneys (10.89 +/- 0.071 gm). Analysis of the tumor kidneys showed flow (ml/minute/g) in the tumor-containing sections (1.82 +/- 0.15) and in the actual tumor tissue (0.62 +/- 0.07) to be significantly lower (P = less than .05) than (1) in the nontumor portions of the same kidneys (2.58 +/- 0.28), and (2) in the tumor animals' contralateral nontumor-bearing kidneys (3.22 +/- 0.16), and (3) in normal control animal kidneys (4.54 +/- 0.29). The reduced flow in tumor-bearing kidneys was not an artifact due to arteriovenous shunting, as demonstrated by 99mTc-microsphere studies in four additional tumor-bearing animals. This study has shown that blood flow to the tumor is extremely low compared with nontumor-containing ipsilateral, contralateral, and normal control renal tissue. These results provide important information relative to possible experimental therapeutic research involving embolization or pharmacologic manipulation of the blood supply to potentiate intra-arterial chemotherapy.

Tastes associated with parenteral chemotherapy for breast cancer.

We employed a structured interview to retrospectively study tastes and vomiting associated with the parenteral components of cyclophosphamide, methotrexate, and 5-FU in 45 patients with stage II-IV breast cancer. Sixteen patients (36%) reported tastes which generally occurred in each cycle within 30 minutes of parenteral drug administration, lasted less than or equal to 1 hour, and were bitter. Five patients recalled that tastes seemed to produce vomiting. Tasting was significantly associated with postchemotherapy (P less than 0.01) but not anticipatory vomiting. Employing logistic regression techniques, tasting did not significantly improve prediction of anticipatory vomiting by postchemotherapy vomiting. Tastes may be produced by the action of plasma or salivary cyclophosphamide, methotrexate, and 5-FU on taste buds. While tastes might cause some vomiting, they are not necessary for it. Because this was a retrospective study with a small sample, these findings require confirmation.

Nutrition and prostate cancer: a case-control study.

This one-to-one, age- and race-matched case-control study involved 181 histologically confirmed black prostate cancer patients and 181 controls seen at three major hospitals in Washington, DC, during the period 1979-1982. Personal interviews were conducted to obtain the number of times food items of specified serving size were consumed per week by cases and controls during the age periods 30-49 and 50 years and older. Then the average daily consumption of each of 18 nutrients per 1,000 calories was calculated. There was risk enhancement associated with increased intake of proteins, total fat, saturated fat, oleic acid, and vitamin A during the age period 30-49 years. The association was highly significant for vitamin A and approached statistical significance for the other four nutrients. A hypothesis based on disturbance of the zinc-retinol binding protein-vitamin A axis was put forward to explain the relative risk enhancement effect of vitamin A on prostate cancer.

United States cancer reporting laws: structure and utility.

Authorities in 52 United States jurisdictions were contacted to determine the existence and structure of cancer reporting laws and registration systems. Of the 52 US reporting areas examined; 30 (58 per cent) had a law requiring cancer reporting; 36 (69 per cent) of the reporting areas had at least one centralized cancer registry covering a geographically defined population. Among the 30 areas with cancer reporting laws, 26 had population-based registries; of the 22 areas with no cancer reporting law, 10 had a population-based registry. Among the 30 areas with cancer reporting laws, 12 required one reporting source (hospital, physician, laboratory), 11 required two reporting sources, four required three reporting sources, two areas gave the health department the authority to designate reporting sources, and one did not specify any reporting source. While 11 of the laws provided legal protection for both the data provider and the cancer patient, eight did not specify any such legal protection. While 13 laws made provisions for research uses of cancer reporting data, 17 did not do so. None of the laws had ever been legally tested at or beyond the State Appellate Court level.

Double-blind multiple-dose crossover study of the antiemetic effect of intramuscular levonantradol compared to prochlorperazine.

Twenty cancer patients who received chemotherapy were entered into a double-blind crossover design antiemetic study comparing 1 mg levonantradol, an investigational synthetic cannabinoid, to 10 mg prochlorperazine. Sixteen patients completed the crossover. For each antiemetic course, four doses of each study medication were given intramuscularly 2 hours before chemotherapy and then 2, 6, and 10 hours after chemotherapy administration. There were no statistical differences in patients' responses to levonantradol and prochlorperazine. The frequency of side effects was greater with levonantradol than with prochlorperazine. The most common side effect of levonantradol were somnolence, dry mouth, dizziness, tachycardia, postural hypotension, and blurred vision, while those for prochlorperazine were somnolence, dry mouth, and tachycardia.