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PubMedDate not supplied

Multi-institutional studies of the National Cardiovascular Center Ventricular Assist System: use in 92 patients.

A ventricular assist system (VAS) developed at the National Cardiovascular Center (NCVC) and produced by Toyobo Company has been clinically evaluated at 32 institutes. The system consists of a pneumatic and diaphragm-type pump, and a control-drive unit with an automatic bypass flow (BF) control system. The VAS was used in 85 adults and 7 children with acute, severe heart failure. Forty-eight patients were weaned from VAS, and 21 were long-term survivors. Heparin was not used when BF was above 2.0 L/min in an adult sized pump, and 0.8 in a pediatric one. Thrombus formation was noticed in the groove around the valve in eight cases, and in the pump in eight. Pump-originated serious complications were not seen. Hematologic and biochemical findings revealed that the VAS did not directly affect the major organs. The control-drive unit, including the automatic BF control system, functioned accurately, with less manpower, securing reliable control over the circulation. Two major causes of death were irreversible heart failure, and multiple organ failure, which resulted from delayed application. In conclusion, the NCVC-type VAS has been found effective and reliable, less thrombogenic, and requiring less manpower for its clinical use.

Adult↗
PubMed1989

A device for the intraoperative identification of the recurrent laryngeal nerve in piglets.

The recurrent laryngeal nerve (RLN) is one of the most frequently injured nerves in head and neck surgery. Routine identification of the RLN during thyroid surgery has reduced the injury rate from 10% to less than 4%. Difficulty in identification of the RLN contributes to this surgical morbidity. Devices previously used for intraoperative identification of the RLN have failed to achieve the simplicity and reliability necessary for clinical use. This animal study uses a simple double-ballooned endotracheal tube and pressure transducer system, which assists intraoperative RLN identification through nerve stimulation and graphic documentation of vocal fold (VF) motion. Iatrogenic injury is demonstrated by a dampened stimulation-pressure tracing. The RLNs of three piglets were injured and examined, and the degree of injury was correlated with perioperative nerve stimulation patterns. The piglet proved to be an adequate model for laryngeal research. An FDA-approved multi-institutional prospective human study using this system of identification of the RLN is in progress.

Animals↗
PubMed1991

Arterial chemotherapy in the management of colorectal cancer: an overview.

We have discussed the role of arterial therapy in patients with various stages and types of colon cancer. Arterial therapy is probably not useful as an adjuvant therapy for Dukes' C colon cancer. It may, however, play a role among patients with incomplete resection of liver metastases (positive margins). A randomized trial is needed to determine the role of arterial therapy in patients who have undergone complete resection of liver metastasis. Arterial therapy does not seem justified for patients with recurrent pelvic tumors. For nonresectable liver metastases, hepatic arterial therapy induces a higher response rate than does intravenous treatment. It may also improve performance status and offer additional palliation to patients who have failed systemic chemotherapy. are refractory to systemic chemotherapy may be candidates for palliative hepatic arterial chemotherapy even out of the context of a clinical trial. Asymptomatic patients with nonresectable liver metastasis who are refractory to systemic chemotherapy should be enrolled in phase I-II arterial chemotherapy trials designed to identify optimal treatment regimens. Previously untreated asymptomatic patients wishing treatment may be enrolled in a new multi-institutional phase III trial being designed to compare contemporary systemic chemotherapy with less toxic arterial therapy and combined arterial and systemic therapy. Such a new trial will have to avoid any cross-over between arms to determine the true impact of arterial therapy on survival. Regional arterial chemotherapy tries to extract the "extra mile" from marginally active drugs that have a steep dose response curve by increasing tumor drug exposure. Increased drug concentrations in the tumor may be accomplished by means of the blood vessel-to-tumor concentration gradient. The technology to achieve such a gradient has involved percutaneous hepatic arterial catheters, implantable infusion pumps or ports, and external pumps. The most economic hepatic arterial delivery system for protracted arterial FUdR is an infusion pump. Despite good pharmacological rationale, an improved response rate, and good evidence for effective palliation in advanced disease, hepatic arterial therapy has not improved survival when compared with systematic intravenous treatment. Possible explanations include the following: (1) poor study design that allowed patients to cross over between arms: (2) inadequate arterial chemotherapy combination; (3) inadequate arterial chemotherapy schedule; (4) hepatobiliary toxicity levels that required cessation of hepatic arterial therapy and allowed the emergence of resistant tumor clones; and (5) systemic progression of disease. Only time will tell whether improved chemotherapy and the design of a new phase III trial will establish a beneficial role for upfront hepatic arterial therapy in asymptomatic patients with colon cancer metastatic to the liver.

Antineoplastic Agents↗
PubMed1991

Three-dimensional photon treatment planning for Hodgkin's disease.

A multi-institutional study was undertaken using computerized planning systems to develop three-dimensional (3-D) radiotherapy plans for Hodgkin's disease (H.D.). Two patients, the first afflicted with bulky stage II disease and another one with early stage I H.D., were studied. Three main categories of plan were produced for each patient: a) a traditional plan which modelled a conventional mantle treatment on the 3-D system, b) a 3-D standard plan where anterior and posterior fields were designed to cover 3-D target volumes, and c) a 3-D unconstrained plan where innovational techniques were employed. Three-dimensional planning provides information about the dose distribution throughout the large volume irradiated in patients with H.D. that is not available with conventional mantle planning. The use of 3-D techniques resulted in improved tumor coverage, but by allowing for uncertainties such as motion, the doses to normal tissues tended to be higher. The use of unorthodox beam arrangements introduced added complexities, and further increased the lung doses. The most even dose distributions were obtained by incorporating compensating filters into anterior fields. Clinicians showed wide variations in their assessment of the plans, possible reasons for which are addressed in this paper. In addition, calculated probabilities from models of tumor control and normal tissue damage are also presented.

Hodgkin Disease↗
PubMed1989

Resection of hepatic metastases from colorectal cancer. Biologic perspective.

During the past decade the results of slightly fewer than 1000 resections of liver metastases from colorectal carcinoma have been analyzed, retrospectively reanalyzed, and reviewed. The following are confirmed conclusions: major liver resection can be performed safely (less than a 5% operative mortality rate); 20% to 25% of these patients are cured; no other regional therapy options have any curative potential. The following caveats are also obvious: most patients who are operated on are not cured; although predictors have been proposed to select patients most likely to benefit from surgery, none is discriminating in and of itself; most therapy questions in this group of patients have not been addressed in any formal way; surgery for isolated regionally recurrent colon and rectum carcinoma remains an important stopgap only until effective systemic therapy is discovered. This review of our own and other single and multi-institutional prospective and retrospective data will be framed by the following questions. (1) Does resection of liver metastases cure patients or simply select those who would have survived in the long-term without any therapy? (2) In the absence of any formalized, properly designed trial, how can one judge the benefit of resection? (3) Why do metastases recur only in the liver? (4) What new therapies should focus on the predominant secondary failure sites in the majority of patients who do not benefit from hepatic metastasis resection?

Colorectal Neoplasms↗
PubMed1992

Multi-institutional privileging: a pilot demonstration project of the United States Navy and the Joint Commission on Accreditation of Healthcare Organizations.

The U.S. Navy and the Joint Commission on Accreditation of Healthcare Organizations have undertaken a 3-year multi-institutional privileging project. The concept involves granting privileges in one Navy facility that are recognized throughout the system during the staff appointment period. It entails: (1) use of specialty-specific standardized privilege lists, (2) designation of one authority at a time to grant the appointment with privileges, (3) use of a single credentials file during the practitioner's career, and (4) medical staff bylaws applicable to the entire system. The concept is potentially useful in other armed services, the Veterans Administration, and some civilian systems.

Hospitals, Military↗
PubMed1986

The changing medical care system: some implications for medical education.

In summary, the medical care system is undergoing the most widespread and significant changes in a generation. Individual hospitals, the basic delivery units of the past, may fast be disappearing as mergers, acquisitions, and a variety of multi-institutional arrangements become the dominant form and as a host of free-standing medical enterprises spread out into the community. Fee-for-service medicine and cost-based hospital reimbursement, each with its service-maximizing incentives, are being replaced--the former by prepaid capitation systems and the latter by discount pricing and all-inclusive admission charges. The hospital, until now a "farmer's market" of diverse programs and activities serving a broad patient population, increasingly has become a provider of intensive services to a narrowing and more ill patient base. The major teaching hospital, formerly a complete educational resource within itself, may soon become simply one of a number of educational settings, all of which are equally essential for providing a total medical education. Finally, after years of change driven by biomedical discoveries and centered in the academic medical centers, there is a new locus of innovation within the delivery system itself, and those in the forefront are not academicians. It is important, therefore, that just as in the past, when the academic medical center took the lead in bringing to the delivery system what it was learning in its laboratories, it must now take what is being learned in the marketplace and bring it back into the classroom.

Ambulatory Care↗
PubMed1988

Primary central nervous system germ cell tumors. Effect of histologic confirmation on radiotherapy.

Primary malignant intracranial germ cell tumors are rare lesions responsible for only 0.5% of all central nervous system (CNS) malignancy. With stereotactic localization these lesions can be safely biopsied, and histologic confirmation will affect the ultimate prognosis. This report is a multi-institutional retrospective analysis of 33 patients diagnosed with a primary CNS germ cell tumor. Tumors in 14 patients (42%) were histologically confirmed (13 germinoma and one embryonal cell carcinoma); 19 patients were treated with a presumptive diagnosis. All patients were irradiated with a dose range of 3950 cGy to 6000 cGy to the primary lesions. Eight patients received craniospinal irradiation, and 25 patients were locally treated. The 5-year actuarial survival for the entire population was 64%. The survival rate in patients with histologic confirmation was 79% versus 53% in the unbiopsied population. Radiation doses greater than 5000 cGy, radiotherapy volume, and age were prognostic factors in determining survival.

Age Factors↗
PubMed1978

Health care delivery: strength in numbers.

The number and types of multi-institutional arrangements among health care facilities are on the increase, and the days of the completely autonomous, independent hospital are coming to a close. Although by themselves hospital systems are no panacea in dealing with the challenges facing hospitals today, many such arrangements offer more opportunities than problems in coping with the rapid changes currently facing the health care industry. The pros and cons of seven arrangements are discussed in detail.

Area Health Education Centers↗
PubMed1991

Hematoporphyrin photodynamic therapy: is there truly a future in head and neck oncology? Reflections on a 5-year experience.

Photodynamic therapy, which consists of the selective destruction of tumors using a combination of a photosensitizer administered systemically (dihematoporphyrin ether) and an argon dye-pumped laser, has provoked profound interest amongst oncologists and has particularly titillated head and neck oncologists with its potential. Unfortunately, no multi-institutional trials for head and neck tumors have been introduced, and the literature is replete with anecdotal reports from individual researchers on the management of advanced cancers for palliation, superficial early cancers, and field cancerization of the mucosa ("condemned mucosa"). A personal 5-year experience with 41 head and neck cancers was reviewed, as was the current literature. An attempt was made to place in perspective the true role and future direction of this technology.

Carcinoma, Squamous Cell↗
PubMed1986

The immunohistochemical application of three anti-GFAP monoclonal antibodies to formalin-fixed, paraffin-embedded, normal and neoplastic brain tissues.

The intermediate filament, glial fibrillary acidic protein (GFAP) has proven to be an important glial marker in diagnostic neuropathology. We report the histochemical application of three monoclonal antibodies (Mab) produced in this laboratory, 1B4, 2E1, and 4A11, which are monospecific to GFAP by radioimmunoassay, immunoblot electrophoresis, and immunoperoxidase histochemistry. The goal of this study was to compare the specificity and sensitivity of these Mab to GFAP on surgical brain biopsy specimens which had been routinely processed for diagnostic neuropathology with that of a high titer, highly specific, reference polyvalent anti-GFAP antiserum. The Mab stained astrocytes specifically in normal brain. When combined in a "cocktail" preparation, the quality of the immunoperoxidase detection of GFAP by these Mab closely approached that of the reference serum in 71 intracranial and intraspinal neoplasms. As these three Mab represent a continuous supply of a well defined, monospecific reagent, the monoclonal "cocktail" represents a standard reagent for large multi-institutional studies and for studies extending over a period of time.

Antibodies, Monoclonal↗
PubMed1989

Systemic therapy of head and neck cancer: most effective agents, areas of promise.

The management of squamous cell cancer of the head and neck is a challenging problem. However, "induction" chemotherapy administered prior to surgery and radiation therapy in newly diagnosed patients is showing encouraging results for the preservation of organ function and is the focus of multi-institutional trials. Concurrent chemotherapy and radiation therapy is another approach with promise for unresectable disease. Recent studies combining cisplatin with radiation therapy have reported minimal enhancement of mucocutaneous toxicity and promising survival data. Other strategies which are just beginning to receive attention in clinical research trials include adjuvant chemotherapy in the disease-free patient and biologic response modifiers.

Antineoplastic Agents↗
PubMed1992

Multi-institutional approach to regionalization of pediatric critical care. Seven year experience.

A multi-institutional, pediatric intensive care program initiated in Jacksonville, Florida, is a systematic approach to critical care which avoids costly duplication and provides efficient clinical services and an academic fellowship program. A total of 6,876 consecutive admissions to the two units over a seven-year period are discussed and compared to national data. A coordinated system may provide a model for other communities; however, the ability to expand services in a market where public and private third party funding is being reduced may become a problem.

Adolescent↗
PubMed1987

[Biological characteristics and prognosis of childhood malignant lymphoma].

The biological characteristics and prognosis of childhood malignant lymphoma were reviewed. A national survey of 568 cases of childhood malignant lymphoma in Japan revealed that 505 cases (88.9%) were non-Hodgkin's lymphoma (NHL), and 63 cases (11.1%) were Hodgkin's lymphoma (HL). The biological characteristics of NHL in Japan were a male predominance, an average age of 7.8 years, and frequent occurrence in the head and neck (38.2%). Histopathologically, only 3.2% of NHL was nodular type and 96.8% was diffuse type (lymphoblastic 28.4%, histiocytic 19.5%, medium-size cell 18.6%, Burkitt's 14.6%, and miscellaneous 15.8%.) The characteristics of the 63 cases of HL were a male predominance, an average age of 9.3 years, 73% of primary lesions in the cervical nodes, and 46.6% of mixed cellularity type. The survival rate at 7 years estimated by the Kaplan -Meier method was 41.1% for patients with NHL, and 84.9% for patients with HL. Leukemic conversion and CNS involvement occurred in 27.9% and 22.9% of patients with NHL, respectively. The current multi-institutional treatment study for NHL conducted by the Children's Cancer and Leukemia Study Group (CCLSG) has improved the prognosis of childhood NHL to an 84.6% induction rate with initial therapy and a relapse-free survival rate of 55.6% at four years. The most important principle for the management of childhood malignant lymphoma is the recognition of the systemic nature of the disease.

Adolescent↗
PubMed1992

Hypothermia in the sepsis syndrome and clinical outcome. The Methylprednisolone Severe Sepsis Study Group.

OBJECTIVE: To evaluate the consequences of clinical hypothermia associated with sepsis syndrome and septic shock. DESIGN: Analysis of data from a multi-institutional, randomized, placebo-controlled, prospective study with predetermined end-point analysis of development of shock, recovery from shock, hospital length of stay, and death. SETTING: Multi-institutional medical and surgical ICUs. PATIENTS: Patients meeting predetermined criteria for severe sepsis syndrome. INTERVENTIONS: Appropriate sepsis and shock care with 50% of patients receiving methylprednisolone and 50% receiving placebo. MEASUREMENTS AND MAIN RESULTS: The occurrence rate of hypothermia (< 35.5 degrees C) is 9% in this population. When compared with febrile patients, hypothermic patients had a higher frequency of central nervous system dysfunction (88% vs. 60%), increased serum bilirubin concentration (35% vs. 15%), prolonged prothrombin times (50% vs. 23%), shock (94% vs. 61%), failure to recover from shock (66% vs. 26%), and death (62% vs. 26%). The hypothermic patients were also more likely to be classified as having a rapidly or ultimately fatal disease upon study admission. CONCLUSIONS: This prospective study confirms that hypothermia associated with sepsis syndrome has a significant relationship to outcome manifest by increased frequency of shock and death from shock. This finding is in sharp contrast to the protective effects of induced hypothermia in septic animals and perhaps man.

Adolescent↗
PubMed1992

The impact of PACS on research and education.

Picture Archiving and Communication Systems (PACS) are rapidly evolving and the total digital radiology department may be a reality within the next decade. PACS can have a major impact on the educational and research responsibilities of a medical institution. The possibility of correlating real patient data with existing radiological teaching files opens up numerous possibilities. Multi-institutional research can be strengthened by employing the PACS as the means to the end. This paper discusses the representative examples of how teaching and research can be enhanced with PACS and the technical requirements to achieve the inter-connectivity.

Education, Medical↗
PubMed1991

A model for multidisciplinary data collection for cervical metastasis.

A system for multidisciplinary data collection for metastatic neck disease is discussed. Information from 87 neck dissections and 3218 lymph nodes is reported to illustrate the strength of the model. Clinical (endoscopic) assessment under general anesthesia, surgical assessment during the neck dissection, and radiographic (computed tomographic scan) assessment were compared with the pathological evaluation. All disciplines stratified the necks by region and node size. This model provides an effective stratagem for multi-institutional studies.

Data Collection↗