The impact of DRGs on clinical research centers. A multi-institutional study.
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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↗
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↗
Bone marrow transplantation for diseases of childhood.
Bone marrow transplantation in childhood is an established treatment modality for aplastic anemia, the acute and chronic leukemias, and severe combined immune deficiency. Recently, experience with this treatment has also been favorable with small numbers of children who have Wiskott-Aldrich syndrome, several types of inherited storage diseases, Fanconi's anemia, thalassemia, infantile malignant osteopetrosis, and selected cases of lymphoma and other solid tumors. The psychosocial impact and financial costs of bone marrow transplantation can be substantial. Multi-institutional, prospective, randomized trials that would compare transplantation and conventional therapy are necessary to establish the indications and precise timing for this procedure. Further development of monoclonal antibodies, a better understanding of the histocompatibility antigen systems, and improvement in pretransplantation conditioning regimens should increase the spectrum of effectiveness for bone marrow transplantation in the coming years.
Anemia, Aplastic↗
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↗
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↗
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↗
[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↗
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↗
Predictive testing with the subrenal capsule assay.
Measurement of drug activity as an oncolytic effect, use of the control only to monitor the quality of tissue implanted, and the rapid clearance of necrotic tissue from the subcapsular site, as significant factors incorporated into the design of the assay, have permitted use of a simple tumor size parameter for evaluating drug activity. The simplicity and economy of such a parameter, the predictability and reproducibility of the 6-day assay observed thus far, and evidence that the assay does measure a biological property of the tumor apart from host response, have warranted the continued use of the 6-day time frame and the normal immunocompetent CDF1 mouse as xenograft host. These studies have demonstrated the feasibility of using human tumor explants obtained from a variety of solid human malignancies in a straightforward, short term, in vivo predictive assay system. Preliminary correlations between in vivo (assay) tumor sensitivity and clinical response have given reasonable concurrence. This crucial point will require further study, with larger numbers of patients, under more rigid conditions. Final validation of this, and other, predictive assays will require a prospective, randomized study in large numbers of patients. Our present prospective study is being continued, therefore, with expansion to a multi-institutional design over a broader geographic area.
Altretamine↗
The biology and treatment of superficial bladder cancer.
Management of the superficial bladder cancer patient consists of two complementary but separate therapeutic goals: treatment of the existing tumor(s) and prevention of tumor recurrence. At present, the stage, grade, and multicentricity are the major determinants in the natural and therapeutic history of the disease. Although intravesical instillation of chemotherapeutic agents has been used for greater than 20 years, neither its exact role nor the optimal dose or schedule of administration have been established. To date, no dramatic differences in efficacy between the agents commonly used for intravesical chemotherapy, either as definitive therapy or prophylaxis, have been appreciated. These agents do appear to lower the recurrence rate as well as extend the disease-free interval. Since the most thorough experience is with thiotepa, it is the drug against which other agents should be compared in terms of both efficacy and toxicologic evaluation. Different administration schedules and methodologies need further study, such as the utility of continuous bladder irrigation, the use of sequential chemotherapeutic agents to gain cell synchronization, and the use of multiple drug regimens. Because there are multiple factors that influence the occurrence and recurrence of bladder cancer, combined modality therapy deserves testing. Modes of therapy that could be used together because they act through different mechanisms are intravesical chemotherapy, radioactive needle implants, carcinogen modifiers such as pyridoxine, chemoprotective agents such as retinoic acid, and immune stimulants such as BCG. These studies should be performed in a randomized prospective controlled fashion, which may require cooperative multi-institutional involvement to accrue adequate numbers of patients. At this time there are a number of important questions that remain to be answered concerning the treatment of superficial bladder cancer: (1) does this mode of therapy affect overall survival, (2) does prophylactic intravesical chemotherapy alter the incidence of subsequent muscle invasive disease, (3) does intravesical chemotherapy alter the sites, incidence, or responsiveness to systemic chemotherapy of subsequent metastatic disease, and (4) and what is the optimal timing and duration of prophylactic therapy from a cost-effectiveness standpoint?
Adenocarcinoma↗
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↗
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↗
Chinese medical school exit objectives: a multi-institutional survey of teacher opinion.
This paper describes a collaborative survey of Chinese medical school teacher opinion concerning clinical behaviours and skills that Chinese students should be expected to demonstrate prior to graduation from medical school. Selected teachers from four Chinese medical schools indicated whether each of 77 objectives was: essential for every student to know or demonstrate prior to graduation; useful but not essential; or not applicable to their educational programmes. Results show teachers' expectations regarding some of the behaviours and skills Chinese medical school teachers consider to be important for students to learn. Forty-nine per cent of the exit objectives were regarded as essential by 75% or more of the teachers. The most essential objectives involved performing clinical procedures, collaborating and communicating with health care professionals, conducting organ system examinations, formulating hypotheses and defining problems. Other essential objectives were concerned with communicating with patients and their families, maintaining currency within the discipline, and recognition, evaluation and triage of patients with life-threatening or chronic conditions. Exit objectives related to health promotion and risk assessment were regarded as useful but not essential at the undergraduate level. Implications for Chinese medical education are discussed.
China↗
Graduate medical education into the 1990's. A call for debate.
The authors have reviewed the present system of graduate medical education, including independent, affiliated, and integrated residency training programs. Advantages and disadvantages are considered in light of recent changes in health-care delivery systems. Structure, historical development, present status, and limitations of the programs are discussed. Personnel resources of the residency program are classified as United States citizens and non-citizens, American medical school graduates, United States citizen graduates of foreign medical schools, and alien foreign medical school graduates, and their different educational backgrounds are compared. Financial aspects of these programs are considered, and the need to increase university control over residency programs, especially in multi-institutional affiliated residency training programs is discussed. The authors recommend upgrading the status of residents from that of student to that of full-fledged medical doctor with concomitant authority and responsibility.
Education, Medical, Graduate↗
Continuous-infusion diaziquone in acute myeloid leukemia: a Southeastern Cancer Study Group trial.
Diaziquone (AZQ) is a synthetic quinone with considerable activity against L1210 leukemia and potent myelosuppressive activity in man. To test the efficacy and toxicity of AZQ administered by continuous infusion, a phase II multi-institutional trial was undertaken by the Southeastern Cancer Study Group. Eligible adults with acute myeloid leukemia (AML) received AZQ at a dose of 28 mg/m2 daily by continuous infusion for 5 days. Patients failing to achieve complete remission received a second course utilizing the same dose and schedule. Of 25 evaluable patients with relapsed or refractory AML, three achieved complete response (12%) and two achieved partial response (8%). All patients experienced marked myelosuppression. Severe or life-threatening infection was observed in 15 (56%) patients. Clinical or postmortem evidence of central nervous system hemorrhage was encountered in three (12%) patients with severe refractory thrombocytopenia. Minimal nonhematologic toxicity was observed, suggesting that further studies of this agent in combination regimens and possibly for marrow transplantation preparation in patients with acute leukemia are warranted.
Adult↗
Role of calcium antagonists in cerebral arterial spasm.
Spasm of the large cerebral arteries at the base of the brain causes delayed ischemic neurologic deficits in approximately 30% of patients after a subarachnoid hemorrhage from an intracranial aneurysm. In vitro chamber studies have shown that both dog and human large cerebral artery segments contract to a variety of vasoactive agents, and the dog and human segments are remarkedly similar in their responses. The source of calcium necessary to initiate contraction was found to be extracellular for large cerebral arteries. In contrast, systemic arteries such as the femoral artery use a bound intracellular pool of calcium for contraction. The calcium antagonists nifedipine and nimodipine were found to selectively inhibit the contractions of large cerebral arteries but not the femoral artery. In vivo experiments demonstrated that both nifedipine and nimodipine, given sublingually, would prevent and reverse cerebral arterial spasm in the dog after a subarachnoid hemorrhage. Nimodipine was found to be more potent, both in the chamber and in the live dog experiments. Nimodipine significantly decreased the occurrence of severe neurologic deficits from spasm alone in a multi-institutional, prospective, double-blind, randomized, placebo-controlled trial.
Animals↗
High Prevalence of Potential Molecular Therapeutic Targets in Poorly Differentiated Thyroid Carcinoma.
Poorly differentiated thyroid carcinoma (PDTC) is a rare thyroid cancer with aggressive clinical course and peculiar clinical/pathological characteristics but lacking effective therapeutic options, when surgery is not curative. We aimed at the molecular characterization of PDTC with a specific focus on the identification of potential therapeutic targets. A series of PDTC cases was selected from a multi-institutional network. Fifty-nine samples underwent wide targeted DNA and RNA next-generation sequencing (NGS) testing and immunohistochemical analysis for mismatch repair (MMR) proteins. Gene fusion analysis was enriched by 25 additional samples. Prevalence of MMR protein loss was 11.9%. The most prevalent mutations were in NRAS (25%) and TP53 (25%), mutually exclusive. TERT promoter (TERTp) mutations were detected in 19.6% of cases (10/51). NRAS-mutated cases were enriched for mutations in genes belonging to the same pathway. TP53-mutated samples lacked TERTp co-mutations, but were associated with mutations in PTEN and in genes related to MMR system and/or loss of MMR proteins. TERTp mutations were the most prevalent alterations (28%, 7/25) in a third group that lacked NRAS or TP53 mutations. Four cases harbored gene fusions, including two cases harboring the TBL1XR1::PIK3CA fusion that has never been reported in thyroid cancer, so far. In conclusion, PDTC may be genomically segregated in subgroups with specific molecular characteristics. Overall, targetable gene fusions have a prevalence of 9% (4/42). Moreover, 47% of cases are potential candidates for individualized target therapies since they harbor mutations in genes coding for potentially targetable molecules and/or have defects in the MMR system.
Humans↗