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Microfiche and automated indexing applications for regulatory submissions to the Food and Drug Administration.

In today's conservative climate, with cost-cutting consciousness, gradual steps should be taken to "marry" micrographics with new technologies. When managers have thorough knowledge and understanding of the regulatory requirements of the federal government, they can proceed to review, analyze and update documentation with indexing and decide the appropriate format of data, as well as the vehicles best suited for the user's needs, integrating micrographics and automated indexing. It is important that industry and regulatory agencies work together. For five years, Merck has been involved in refining microfiche specifications for submissions to various Bureaus at the Food and Drug Administration, originally for the Bureau of Drugs and currently for the Bureau of Foods and the Bureau of Veterinary Medicine. In these pilot projects, Merck has shared its know-how with other pharmaceutical companies in published articles, one-day seminars and several speeches at conferences of national organizations such as the Pharmaceutical Manufacturers Association (PMA) and the Association of Records Managers and Administrators (ARMA). In April 1979, a presentation was made before the Garden State Chapter of the National Micrographics Association (NMA).

Abstracting and Indexing↗

Management of cancer gallbladder found as a surprise on a resected gallbladder specimen.

Carcinoma gallbladder is associated with an overall 5-year survival rate reported less than 5% due to late diagnosis. Advent of ultrasound scanning may help in detecting gallbladder polyps and an early gallbladder cancer. Excellent 5-year survival (up to 100%) has been reported for Stage Ia disease and the survival has significantly improved for Stage Ib, II, and III if appropriate re-operation is carried out soon after the incidental detection of gallbladder cancer. Laparoscopic cholecystectomy (LC) is contraindicated in the presence of gallbladder cancer. It is recommended to excise all laparoscopic port sites, at the time of re-operation. Re-operation for Stage II gallbladder cancer is associated with a 90-100% 3-year survival rate. Patients with Stage III and IV tumors also benefit from an extended cholecystectomy. Patients with bulky primary tumors without lymph node metastases (T4N0) seem to have a better prognosis than those with distant lymph node metastases, and should be treated aggressively. It is advantageous to perform the appropriate extent of surgery for gallbladder cancer at the initial operation. Heightened awareness of the presence of cancer and the knowledge of appropriate management are important. For patients whose cancer is an incidental finding on pathologic review, re-resection is indicated for all disease except Stage Ia. Radiotherapy and chemotherapy have not been found effective as an adjuvant or palliative therapy in gallbladder cancer.

Cholecystectomy↗

Treatment of muscle-invasive bladder cancer: progress and new challenges.

The management of muscle-invasive bladder cancer has evolved over the last 20 years. Radical surgery, while curative for a significant number of patients, is inadequate for a subgroup with aggressive features including, but not limited to, advanced local stage, lymphovascular invasion on transurethral resection specimen, or variant histology such as small cell carcinoma. It is now clear that chemotherapy can improve the outcome for such patients. Combination platinum-based neoadjuvant chemotherapy is associated with a survival advantage of 5-8% at 5 years over local therapy alone. Improvements in surgical technique are also important and need to be further refined. Biologic-based staging and targeted therapies hold promise for the future. The critical issue in multimodal therapy for this very heterogeneous disease is individualized patient selection. In this review, data are presented with emphasis on the practical application of current knowledge to the management of patients with muscle-invasive bladder cancer.

Antineoplastic Agents↗

IMGT, the international ImMunoGeneTics information system: a standardized approach for immunogenetics and immunoinformatics.

IMGT, the international ImMunoGeneTics information system http://imgt.cines.fr, was created in 1989 by the Laboratoire d'ImmunoGénétique Moléculaire (LIGM) (Université Montpellier II and CNRS) at Montpellier, France. IMGT is a high quality integrated knowledge resource specialized in immunoglobulins (IG), T cell receptors (TR), major histocompatibility complex (MHC) of human and other vertebrates, and related proteins of the immune system (RPI) of any species which belong to the immunoglobulin superfamily (IgSF) and to the MHC superfamily (MhcSF). IMGT consists of five databases, ten on-line tools and more than 8,000 HTML pages of Web resources. IMGT provides a common access to standardized data from genome, genetics, proteome and three-dimensional structures. The accuracy and the consistency of IMGT data are based on IMGT-ONTOLOGY, a semantic specification of terms to be used in immunogenetics and immunoinformatics. IMGT-ONTOLOGY comprises six main concepts: IDENTIFICATION, CLASSIFICATION, DESCRIPTION, NUMEROTATION, ORIENTATION and OBTENTION. Based on these concepts, the controlled vocabulary and the annotation rules necessary for the immunogenetics data identification, classification, description and numbering and for the management of IMGT knowledge are defined in the IMGT Scientific chart. IMGT is the international reference in immunogenetics and immunoinformatics for medical research (repertoire analysis of the IG antibody sites and of the TR recognition sites in autoimmune and infectious diseases, AIDS, leukemias, lymphomas, myelomas), veterinary research (IG and TR repertoires in farm and wild life species), genome diversity and genome evolution studies of the adaptive immune responses, biotechnology related to antibody engineering (single chain Fragment variable (scFv), phage displays, combinatorial libraries, chimeric, humanized and human antibodies), diagnostics (detection and follow up of residual diseases) and therapeutical approaches (grafts, immunotherapy, vaccinology). IMGT is freely available at http://imgt.cines.fr.

Journal Article↗

The relationship between knowledge and reported behavior in childhood asthma.

Numerous educational interventions have been developed and tested to improve management of childhood asthma. Most programs assume that knowledge about asthma is related to initiating and/or maintaining recommended management behaviors. Although this assumption is widely accepted, some available evidence casts doubt upon its validity. We investigated the relationship between asthma management behaviors and (1) knowledge about asthma, (2) behavioral adjustment, (3) anxiety, and (4) health locus of control. Data were collected on 91 children 7 to 12 years of age with moderately severe asthma. After adjusting for covariates, reported asthma management behavior was significantly related only to knowledge about asthma (p less than .05). The relationship between knowledge and behavior is nonlinear: accurate knowledge is related to engaging in more of the recommended behaviors, but only up to a moderate level of knowledge. Also, the relationship between knowledge and asthma management behavior was especially strong for children who scored lower on behavioral adjustment. These results suggest that children's knowledge about asthma can influence behavior, but only under certain conditions. Educational interventions for children whose knowledge is already adequate may not increase adherence to recommended practices.

Anxiety↗

Strategies for managing group A streptococcal pharyngitis. A survey of board-certified pediatricians.

OBJECTIVE: To assess the management strategies and knowledge of board-certified pediatricians regarding group A beta-hemolytic streptococcal (GABHS) pharyngitis. DESIGN: Survey of 1000 US pediatricians in 1991, chosen randomly from the membership of the American Academy of Pediatrics. The survey included questions related to 2 clinical scenarios, respondent demographics, and knowledge of streptococcal pharyngitis. SUBJECTS: Pediatricians who treated patients with pharyngitis. Of the 690 surveys that were returned, 510 pediatricians treated patients with pharyngitis and were included in the data analysis. DATA ANALYSIS: Data were analyzed using Chi 2 statistics for categorical data and the Student t test for continuous variables. RESULTS: Antigen detection tests (ADTs) were used by 64% of the pediatricians; 85% used throat cultures. Strategies for diagnosing streptococcal pharyngitis were throat culture alone (38%), consider positive ADTs definitive and use throat culture when ADTs are negative (42%), ADT alone (13%), ADT and throat culture for all patients with pharyngitis (5%), and no tests for GABHS performed (2%). Thirty-one percent usually or always treated with antibiotics before test results were available. Only 29% of these "early treaters" always discontinued antibiotics when tests did not confirm the presence of group A streptococci. The drug of choice for treatment was penicillin (73%); another 26% preferred a derivative of penicillin, particularly amoxicillin. Many pediatricians altered their management when a patient had recurrent streptococcal pharyngitis. Nearly half of the respondents would use a different antibiotic than they used for routine acute streptococcal pharyngitis. They most often changed to erythromycin (25%), cefadroxil (23%), or amoxicillin-clavulanate (20%). Follow-up throat culture was obtained by 51% of pediatricians after treatment of recurrent streptococcal pharyngitis. A patient with chronic carriage of GABHS and symptoms of pharyngitis would be treated with an antibiotic by 84%; most (62%) would use a penicillin. Other choices were cephalosporins (19%), erythromycin (12%), clindamycin (3%), or rifampin plus penicillin (3%). Tonsillectomy was recommended for symptomatic carriers by 31% of respondents. Carriers without symptoms were less likely to be treated with antibiotics (23%) or referred for tonsillectomy (21%). CONCLUSIONS: Most surveyed board-certified pediatricians managed acute GABHS pharyngitis appropriately, but 15% to 20% used diagnostic or treatment strategies that are not recommended. There was lack of a consensus about the management of recurrent GABHS pharyngitis and chronic carriage of GABHS.

Acute Disease↗

Determination of the molecular relationship between multiple tumors within one patient is of clinical importance.

PURPOSE: To determine the molecular relationship between multiple tumors within one patient and to evaluate the impact of this knowledge on clinical management. PATIENTS AND METHODS: In 25 consecutive patients with multiple tumors, proven by histology and immunohistochemistry to be identical, molecular aberrations were determined. Each patient had at least one lesion in the lung or head and neck region. Loss of heterozygosity (LOH) and p53 aberration analyses were carried out, and similar aberration profiles suggest clonality and metastasis whereas different profiles suggest independent primary tumors. RESULTS: The molecular determinations indicated that 12 patients had a probable second primary tumor and 10 patients had a metastasis of the first lesion. In three patients, both an independent primary tumor and a metastasis were present. The molecular findings determined the course of additional treatment in all 10 patients with metastases, in all three patients with both a second primary tumor and a metastasis, and in seven of 12 patients with a second primary tumor. CONCLUSION: By comparing DNA alterations of multiple tumors within one patient, the relationship between the tumors can be assessed. This study shows that in 20 of 25 patients, knowledge of the nature of both lesions was essential in clinical decision making. Furthermore, after thorough analysis of the five cases where clinical decision making was not influenced, there was in retrospect no clear indication for LOH or p53 analysis. Because these molecular analyses can be performed on routine specimens, they can be applied in almost all patients.

Adult↗

Therapeutic management of chronic neuropathic pain: an examination of pharmacologic treatment.

Neuropathic pain is defined as pain caused by a lesion in the nervous system and is common in clinical practice. Diagnosis can be difficult. Recommendations for first-line pharmacologic treatments are based on positive results from multiple, randomized, controlled trials, and recommendations for second-line pharmacologic treatments are based on the positive result of a single, randomized, controlled trial or inconsistent results of multiple, randomized, controlled trials. The results of published trials and clinical experience provide the foundation for specific recommendations for first-line treatments, which include gabapentin, 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and tricyclic antidepressants (TCAs). Gabapentin (up to 3,600 mg/day) significantly reduced pain compared with placebo; improvements in sleep, mood, and quality of life were also demonstrated. Adverse effects of gabapentin include somnolence and dizziness, and, less commonly, gastrointestinal symptoms and mild peripheral edema. Thus, monitoring and dosage adjustment are required, without discontinuation of the drug. Gabapentin combined with morphine achieved better analgesia at lower doses of each drug than each drug alone, with only mild adverse effects. The first medication that proved effective for neuropathic pain in placebo-controlled trials was TCAs. Treatment decisions for patients with neuropathic pain can be difficult. Interest in the mechanisms and treatment of chronic neuropathic pain has increased during the past years, resulting in significant treatment advances in the future. In this article all recent knowledge on therapeutic management of chronic neuropathic pain is presented.

Amines↗

Effect of problem-based, self-directed undergraduate education on life-long learning.

OBJECTIVE: To compare how well graduates of a self-directed, problem-based undergraduate curriculum (at McMaster University [MU], Hamilton, Ont.) and those of a traditional curriculum (at the University of Toronto [UT]) who go on to primary care careers keep up to date with current clinical practice guidelines. DESIGN: Analytic survey. Management of hypertension was chosen as an appropriate topic to assess guideline adherence. An updated version of a previously validated questionnaire was mailed to the participants for self-completion. SETTING: Private primary care practices in southern Ontario. PARTICIPANTS: A random sample of 48 MU graduates and 48 UT graduates, stratified for year of graduation (1974 to 1985) and sex, who were in family or general practice in Ontario; 87% of the eligible subjects in each group responded. MAIN OUTCOME MEASURES: Overall and component-specific scores; analysis was blind to study group. RESULTS: The overall mean scores were 56 (68%) of a possible 82 for the MU graduates and 51 (62%) for the UT graduates (difference between the means 5, 95% confidence interval 1.9 to 8.2; p < 0.01). Multivariate linear regression analysis of seven factors that might affect questionnaire scores revealed that only the medical school was statistically significant (p < 0.01). The MU graduates had significantly higher mean scores than the UT graduates for two components of the questionnaire: knowledge of recommended blood pressures for treatment (p < 0.05) and successful approaches to enhance compliance (p < 0.005). The trends were similar for the other components but but were not significant. CONCLUSIONS: The graduates of a problem-based, self-directed undergraduate curriculum are more up to date in knowledge of the management of hypertension than graduates of a traditional curriculum.

Curriculum↗

[PKD: the proliferative kidney disease in fish].

The present study gives an overview about the knowledge and the diagnostic possibilities of the proliferative kidney disease (PKD) in fishes. This disease is responsible for economically significant losses in farmed fish and severe reductions in wild fish populations in Europe and North America. PKD is affecting mainly salmonid species. In Swiss rivers the proliferative kidney disease pictures the highest percentage of diseases among brown trouts. The main symptom of PKD is a massive proliferation of the interstitial kidney tissue which named the disease. Other unspecific symptoms are anemia, ascites, exophthalmus and apathy. The causative agent of the disease is Tetracapsula bryosalmonae (Myxozoa). Many aspects of the life cycle of this parasite remain unclear so far but it is known that the appearance of this parasite is linked to the presence of a range of freshwater bryozoans. PKD appears mostly in summer during high water temperatures (> or = 15 degrees C) and can lead to high mortality rates. A diagnosis can be made by using light-microscopic, lectinimmunhistochemical as well as molecular biological methods. Before we can develop successful management strategies the knowledge gaps in understanding the disease cycle and the exact pathogenesis of PKD need to be closed.

Animals↗

Treatment strategy for patients with unruptured intracranial aneurysms.

The increased sensitivity of neuroimaging techniques has enabled the more frequent diagnosis of unruptured aneurysms. Because the most devastating complication of an unruptured aneurysm is subarachnoid hemorrhage, it has been considered desirable to treat these aneurysms before they rupture. However, the optimal treatment strategy for patients with unruptured aneurysms remains controversial. The management decision requires knowledge of the natural history and an accurate assessment of the risks related to various treatment options. On December 10, 1998 the New England Journal of Medicine published an article by the International Study of Unruptured Intracranial Aneurysms Investigators. The study retrospectively assessed the natural history of unruptured aneurysms in 1449 patients; in addition, treatment-related mortality and morbidity were examined in a prospective cohort of 1172 patients. The major finding was that the rate of rupture for aneurysms smaller than 10 mm in diameter in patients with no history of subarachnoid hemorrhage was 0.05% per year, and that the mortality and morbidity associated with surgery greatly exceeded the risk of rupture in such patients. This report has generated tremendous controversy in the treatment of unruptured aneurysms and has influenced our decision making. The results of this study are critically analyzed and potential flaws presented. To develop recommendations for treatment, the literature was reviewed. The conclusion of this search is that there is insufficient evidence to recommend a standard of management. Therapeutic guidelines are provided, particularly for patients with small incidental aneurysms and no history of subarachnoid hemorrhage.

Aneurysm, Ruptured↗

The impact of nurses' empathic responses on patients' pain management in acute care.

BACKGROUND: Although nurses have the major responsibility for pain management, little is known about nurses' responses to patients in the process of managing acute pain. OBJECTIVE: To examine the relationship between nurses' empathic responses and their patients' pain intensity and analgesic administration after surgery. METHODS: Two hundred twenty-five patients from four cardiovascular units in three university-affiliated hospitals were interviewed on the third day after their initial, uncomplicated coronary artery bypass graft (CABG) surgery about their pain and current pain management. Concurrently, their nurses' (n = 94) empathy and pain knowledge and beliefs were assessed. Patient data were aggregated and linked with the assigned nurse to form 80 nurse-patient pairs. RESULTS: Nurses were moderately empathic, and their responses did not significantly influence their patients' pain intensity or analgesia administered. Patients reported moderate to severe pain but received only 47% of their prescribed analgesia. Patients' perceptions of their nurse's attention to their pain were not positive, and empathy explained only 3% of variance in patients' pain intensity. Deficits in knowledge and misbeliefs about pain management were evident for nurses independent of empathy, and knowledge explained 7% of variance in analgesia administered. Hospital sites varied significantly in analgesic practices and pain inservice education for nurses. CONCLUSIONS: Empathy was not associated with patients' pain intensity or analgesic administration.

Adult↗

[Knowledge and skills of newly graduated nurses].

Nursing education was recently reformed in Finland. By now nurses who have graduated from the new programmes have already entered nursing practice. The purpose of this study is to describe the following two aspects: 1) How do the newly graduated nurses assess their own skills and knowledge on completion of their nursing studies and what is their assessment four months later? 2) What skills and knowledge did the nurse managers expect the nurses to have and what, in fact, did they discover when the new nurses began their work in practice? The data were collected by questionnaires, measuring the competencies of professional nurse (Clayton 1983) from a sample (N = 30), which consisted of registered nurses (response rate was 67%), specialized in medical-surgical nursing, and their nurse managers. The nurses had graduated from two different colleges of nursing. Data were analysed by the means and differences of the means. On completion of their studies the nurses felt that their best skills and knowledge were related to the hygienic care of the patient, while their weakest area was in implementing specialized care. In their assessment made four months after graduation the nurses felt that in terms of the different areas of nursing practice their skills and knowledge had improved to some degree. The nurse managers, on the other hand, expected the newly graduated nurses to have better skills and knowledge than what was actually discovered. Furthermore, the nurse managers were clearly more critical in their assessment than the nurses themselves.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Competence↗

Risk in numbers--difficulties in the transformation of genetic knowledge from research to people--the case of hereditary cancer.

Difficulties in communicating diagnostic information are exacerbated when the 'diagnosis' is a 'genetic risk' for cancer. The risk estimation demanded in this situation differs from other types of probability estimations. Observations of participants in 45 consultation sessions between physicians and potential patients were conducted at a clinic for hereditary cancer to explore the communication of genetic information. Thirty-three sessions were audiotaped, transcribed verbatim and analyzed, along with notes from the other sessions. A dominant theme was found to be numerical discussion of risk. Further analysis resulted in the description of problems for practitioners in the process of translating scientific knowledge into clinical management. Problems in providing information include unclear aims of the consultation sessions, mixing various types of background information and probabilities, recognizing how low the predictive values are, and difficulties in communicating the relationship between probability and conclusions. Problems in communicating information about the genetic risk for cancer are of at least two types: dilemmas arising from uncertainties implicit in the nature of the information itself and difficulties in communicating information in a manner that those concerned can interpret. These issues need clarification, so that information with far-reaching consequences can be made as clear and comprehensible as possible for those involved.

Adult↗

Managing obesity: a survey of attitudes and practices among Israeli primary care physicians.

OBJECTIVES: To document and assess Israeli family physicians' (FPs) knowledge, attitudes and practices regarding the management of overweight and obesity. METHODS: Anonymous questionnaires were completed by 510 family physicians (82% compliance rate). The questionnaires were distributed in various continuous medical education sites of FPs in Israel. The measures included attitudes to and resources of knowledge on weight management, views regarding the prescription of drugs, approaches to and strategies recommended for weight loss. RESULTS: In all, 73% of FPs viewed weight management as important and reported that they often treated cases of overweight and obesity, including for patients without concomitant risk factors. The medical advice most frequently offered is: increase physical activity, decrease number of total calories (eat less) and consultation with a dietitian (95, 81 and 58% respectively). However, most responders (72%) believed that they had limited efficacy in treating obesity and considered themselves not well prepared by medical school to treat overweight patients. Some 60% reported feeling that they have insufficient knowledge regarding nutritional issues. Regarding pharmacotherapy for treating obesity, only 66% knew the drugs' prescription indications. However, the vast majority (87%) knew about the gradual increase of weight after stopping drug treatment. CONCLUSIONS: Knowledge gaps and ambivalent attitudes toward obesity management were found. More education focusing on obesity, from medical school to post-graduate learning, seems warranted based on these findings.

Adult↗

Improved perinatal mortality rates in 1001 patients with severe pre-eclampsia.

OBJECTIVE: To ascertain the change in perinatal mortality (PNM) rate over a period of 10 years in 1001 patients with severe pre-eclampsia. METHODS: Patients with severe pre-eclampsia before a gestational age of 34 weeks were managed expectantly. Initial treatment consisted of the administration of magnesium sulphate to prevent convulsions and dihydralazine to reduce blood pressure. Methyldopa alone or in combination with other oral antihypertensive drugs was started soon after admission. In order to prevent fetal death from abruptio placentae, the fetal heart rate was monitored at least four times per day. Patients were delivered either at 34 weeks' gestation or when fetal or maternal indications for immediate delivery were present. The 10-year study was divided into four successive time periods and the PNM rate was calculated separately for each of these time periods. RESULTS: Perinatal survival was low if patients were delivered before or at 26 weeks' gestation but improved rapidly if delivered thereafter. There were only 33 intrauterine deaths of babies who weighed 1000 g or more. The majority of these deaths were due to abruptio placentae which had occurred prior to admission to hospital. The PNM rate for babies of 1000 g or more decreased from 61 in the first time phase and 83 in the second to 19 in the last. The overall PNM rate during the 10-year study was 62. CONCLUSION: Improved knowledge about the management of patients with severe pre-eclampsia in early pregnancy resulted in a decline in the PNM rate. Although the exact cause of this reduction towards the end of the study is not known, several factors probably played a role. They are expectant management with a little gain in the gestational age, better fetal monitoring before and during labour, earlier detection of fetal distress, earlier referral to the tertiary hospital and improved neonatal care.

Blood Pressure↗

Risk factors for infection in patients with traumatic lacerations.

BACKGROUND: Most of our knowledge of laceration management comes from studies in animal models or patients with closure of sterile postoperative surgical incisions. Traumatic laceration management has not been well studied. OBJECTIVE: To determine which characteristics of traumatic lacerations were associated with the development of wound infection. METHODS: A cross-sectional study of consecutive patients with traumatic lacerations repaired over a four-year period was conducted. Structured closed-question data sheets were prospectively completed at the time of laceration repair and suture removal. Infection was determined at the time of suture removal. Multivariate modeling was used to determine the adjusted odds ratio (OR) of infection. RESULTS: Five thousand five hundred twenty-one patients were enrolled; 195 patients developed an infection (3.5%). An increased likelihood of wound infection was associated with age (adjusted OR per year, 1.01; 95% CI = 1.0 to 1.02); history of diabetes mellitus (adjusted OR 6.7; 95% CI = 1.7 to 26.4); laceration width (adjusted OR 1.05 per mm; 95% CI = 1.02 to 1.08); and presence of foreign body (adjusted OR 2.6; 95% CI = 1.3 to 5.2). Laceration location on the head/neck was associated with a decreased risk of infection (adjusted OR 0.28; 95% CI = 0.18 to 0.45). CONCLUSIONS: Both patient and wound characteristics of traumatic lacerations have an influence on the likelihood of infection. This knowledge may be valuable for determining whether various methods of wound cleansing, debridement, and repair can improve the outcome of patients with traumatic lacerations.

Adolescent↗

Using computer software to improve group decision-making.

This article provides a review of some of the work done in the area of knowledge-based systems for strategic planning. Since 1985, with the founding of the Center for Knowledge-based Systems for Business Management, the project has focused on developing knowledge-based systems (KBS) based on these models. In addition, the project also involves developing a variety of computer and non-computer methods and techniques for assisting both technical and non-technical managers and individuals to do decision modelling and KBS development. This paper presents a summary of one segment of the project: a description of integrative groupware useful in strategic planning. The work described here is part of an ongoing research project. As part of this project, for example, over 200 non-technical and technical business managers, most of them working full-time during the project, developed over 160 KBS prototype systems in conjunction with MBA course in strategic planning and management decision making. Based on replies to a survey of this test group, 28 per cent of the survey respondents reported their KBS were used at work, 21 per cent reportedly received promotions, pay rises or new jobs based on their KBS development work, and 12 per cent reported their work led to participation in other KBS development projects at work. All but two of the survey respondents reported that their work on the KBS development project led to a substantial increase in their job knowledge or performance.

Artificial Intelligence↗