The cost benefit of electronic patient referrals in Denmark: summary report.
This summary report is written by ACCA and MedCom in collaboration with the European Commission Information Society Directorate-General.
Cost-Benefit Analysis↗
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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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A cohort study of summary reports of controlled trials.
Substantial numbers of clinical trials continue to be reported only in summary reports that present insufficient methodological details to permit informed judgments about the likely validity of the conclusions. Using a cohort of 176 controlled trials reported in summary form, we tested the hypotheses that they would be more likely to be followed by full reports if, on the basis of the information provided in the summary report, (1) the trial was judged to be methodologically sound, (2) the results favored the test treatment, and (3) the sample size was relatively large. The results of univariate and multivariate analyses provided support for only the third of these hypotheses. Investigators, as well as those who fund and sanction the conduct of clinical research, should make greater efforts to ensure that clinical trials are reported properly.
Clinical Trials as Topic↗
Development of an automatic medical summary report system.
We developed a medical summary report system. In this system, each department can specify the predetermined conditions for issuing the summary report. The summary is made through a hierarchical database in the integrated hospital information system according to the predetermined conditions. The summary automatically issued after reception of the outpatient, or also issued by on-line summary report program with the patient number if requested by doctors. The report is sent to the proper consulting room from the reception desk using an air-shooter. The report contains the patient information such as a patient name, age, sex, birthday, a clinic name, a chart number, a patient number, diagnoses and examinations. The doctors can refer to the points of the clinical history of the patient in his own and other departments, and make a correct diagnoses and avoid the overlaps of the examinations and medications. This system has contributed to the quality-up of the patient care by availability of patient information even in other departments without the medical chart.
Hospital Information Systems↗
American National Standard for nonautomated sphygmomanometers. Summary report.
The Association for the Advancement of Medical Instrumentation develops voluntary standards for medical devices so that manufacturers might provide information on their product and basic safety and performance criteria that should be considered in qualifying the instrument for clinical use. American National Standards are generated through a consensus process by committees of experts in research, development, and design from user, industry, and government communities. Draft standards are made available for public review and become American National Standards after review by the American National Standards Institute. This report is a summary of the American National Standard that establishes both the safety and performance requirements of pneumatic and other nonautomated sphygmomanometers (especially mercury gravity and aneroid sphygmomanometers) used in the indirect measurement of blood pressure. This standard was developed by a consensus panel from academia, industry, and government; it updates the previous standard approved by the American National Standards Institute in 1986. This summary report does not cover all of the provisions of the revised 1994 American National Standard, thus users, researchers, and instrument designers should refer to the standard for detailed requirements.
Blood Pressure Determination↗
Pediatric transplantation of the kidney, liver and heart: summary report.
The following is a summary report of an extensive review of the literature from 1966 to 2001 on growth and development in children receiving kidney, liver and heart transplants. The literature was assessed for relevancy to current clinical practice and for reliability and generalizability of the inferences based on the study design, controls, sample size, age distribution, confounding factors, use of standardized instruments, and consistency with other findings. While studies on growth are included in the review, the main emphasis is on research in cognitive and psychosocial development since these areas have been far less thoroughly studied and contain various methodological deficiencies. On the basis of the literature review both general methodological recommendations and specific recommendations for future research studies are made. Access to the full is provided on the World Wide Web at http://light.emmes.com/pedstransplantation/.
Child↗
Guidelines for the design and analysis of studies on nonsyndromic cleft lip and cleft palate in humans: summary report from a Workshop of the International Consortium for Oral Clefts Genetics.
OBJECTIVE: The members of the International Consortium for Oral Clefts Genetics recognize the need for collaboration between researchers involved in etiologic studies of nonsyndromic cleft lip and palate and cleft palate. To address this need, the consortium established four working subcommittees: diagnostic and phenotypic assessment, molecular genetic studies, epidemiologic data collection and analysis, and genetic data collection and analysis. These subcommittees were charged with the development of guidelines for data collection and analysis that would facilitate both a priori and a posteriori comparisons and pooling of data from multiple centers. This report presents summary statements of the four subcommittees.
Cleft Lip↗
An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics.
BACKGROUND: Recent years have seen the introduction of many antidepressants and antipsychotics. Typically, efficacy of these agents is based on published positive clinical trials; however, the Food and Drug Administration (FDA) compiles summary reports of all pivotal randomized clinical trials, which are available for public review under the Freedom of Information Act. They are rarely accessed but may have public health utility. Thus, we assessed these reports to evaluate if the clinical data can be used for comparing psychotropics. METHODS: We examined FDA summary reports of 58 pivotal trials from 10 antidepressants and 7 pivotal trials from three antipsychotics approved in the United States between 1985 and 1998. We evaluated each FDA report based on criteria derived from the recently revised Consolidated Standards of Reporting Trials (CONSORT standards) proposed by the Journal of the American Medical Association to improve randomized clinical trial reports. RESULTS: Overall, the FDA reports of antidepressant and antipsychotic trials adequately met 38.1% of the CONSORT criteria. Among the antidepressant reports, 36.7% adequately met CONSORT criteria compared with 49.0% among the antipsychotic reports. The proportions meeting CONSORT criteria have increased over the past 15 years; 21.0% for those approved between 1985 and 1989, 37.8% for those between 1990 and 1994, and 40.5% for those between 1995 and 1998. CONCLUSIONS: The large and inclusive public domain FDA summary reports may provide balanced efficacy clinical trial data. With minor changes in the preparation of reporting by using CONSORT or similar guidelines, the data would be even more valuable.
Antidepressive Agents↗
Center for Devices and Radiological Health Problem Reporting Program for Radiation Therapy Devices (summary reports received from January 1991 to June 1991).
Explore the source record for details and available documents.
Equipment Safety↗
NTP summary report on the metabolism, disposition, and toxicity of 1,4-butanediol (CAS No. 110-63-4).
1,4-Butanediol is an industrial chemical used in the manufacture of other organic chemicals. It was nominated by the National Cancer Institute and selected for evaluation by the NTP because of high production volume, the potential for worker exposure, the lack of adequate toxicological characterization, and the lack of evaluation for carcinogenic potential. As documented in the scientific literature, 1,4-butanediol is rapidly absorbed and metabolized to gamma-hydroxybutyric acid in animals and humans. A metabolism and disposition study conducted in F344/N rats by the NTP confirmed the rapid and extensive conversion of 1-[14C]-1,4-butanediol to 14CO2. Because of this rapid and extensive conversion, the toxicological profile of 1,4-butanediol reflects that of gamma-hydroxybutyric acid. gamma-Hydroxybutyric acid is a naturally occurring chemical found in the brain and peripheral tissues which is converted to succinate and processed through the tricarboxylic acid cycle. Although the function of gamma-hydroxybutyric acid in peripheral tissues is unknown, in the brain and neuronal tissue it is thought to function as a neuromodulator. gamma-Hydroxybutyric acid readily crosses the blood-brain barrier, and oral, intraperitoneal, or intravenous administration elicits characteristic neuropharmacologic responses. These same responses are observed after administration of 1,4-butanediol. The lactone of gamma-hydroxybutyric acid, gamma-butyrolactone, is also rapidly converted to gamma-hydroxybutyric acid by enzymes in the blood and liver of animals and humans. gamma-Butyrolactone was previously evaluated by the NTP in 14-day and 13-week toxicology studies and 2-year toxicology and carcinogenesis studies in F344/N rats and B6C3F1 mice. No organ-specific toxicity occurred in the toxicology studies. In the carcinogenesis studies, an equivocal response occurred in male mice, based on a marginal increase in the incidence of pheochromocytomas of the renal medulla. Because of the rapid and extensive conversion of gamma-butyrolactone to gamma-hydroxybutyric acid, the evaluation of gamma-butyrolactone was in fact an evaluation of gamma-hydroxybutyric acid. This summary report presents a review of the current literature which documents that both 1,4-butanediol and gamma-butyrolactone are rapidly metabolized to gamma-hydroxybutyric acid, and the pharmacologic and toxicologic responses to these chemicals are due to their metabolic conversion to gamma-hydroxybutyric acid. Because the toxicity and carcinogenicity of gamma-hydroxybutyric acid was fully evaluated in the NTP studies of gamma-butyrolactone, and a lack of organ-specific toxicity or carcinogenic potential was demonstrated, it is concluded that there is a high likelihood that 1,4-butanediol would be negative in a similar set of studies. For these reasons, it is the opinion of the NTP that 1,4-butanediol should be considered not carcinogenic in animals and no further evaluation of 1,4-butanediol is needed at this time.
Animals↗
Summary report of a symposium: genes and gene delivery for diseases of alcoholism.
This article represents a summary of a symposium on genes and gene delivery for diseases of alcoholism that was held at the University of North Carolina, Chapel Hill, on May 7-10, 2001. The purpose of the meeting was to examine two key technologies: gene chip-microarrays and gene delivery. Three main pathologies associated with alcoholism--addiction, liver disease, and birth defects--were discussed. This summary of the meeting is grouped into sections on the brain, liver, and fetus.
Abnormalities, Drug-Induced↗
National outcomes management survey: summary report.
Spurred by national trends towards accountability and outcomes management, behavioral healthcare organizations are increasingly focused on efforts to develop and implement outcomes research strategies. CentraLink, in cooperation with the Institute for Behavioral Healthcare, developed a survey designed to reflect and summarize current outcomes efforts in early 1994. This column provides a brief summary of several salient features reported by organizations responding to that survey.
Data Collection↗
A systematic review of newer pharmacotherapies for depression in adults: evidence report summary.
BACKGROUND: Depressive disorders are persistent, recurring illnesses that cause great suffering for patients and their families. PURPOSE: To evaluate the benefits and adverse effects of newer pharmacotherapies and herbal treatments for depressive disorders in adults and adolescents. DATA SOURCES: English-language and non-English-language literature from 1980 to January 1998 was identified from a specialized registry of controlled trials, meta-analyses, and experts. STUDY SELECTION: Randomized trials evaluating newer antidepressants (such as serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and St. John's wort) that reported clinical outcomes were selected. DATA EXTRACTION: Two persons independently abstracted data that were then synthesized descriptively; some data were pooled by using a random-effects model. DATA SYNTHESIS: Of 315 eligible trials, most evaluated antidepressants in adults with major depression, were conducted among outpatients, and examined acute-phase treatment. Newer antidepressants were more effective than placebo for major depression (relative benefit, 1.6 [95% CI, 1.5 to 1.7]) and dysthymia (relative benefit, 1.7 [CI, 1.3 to 2.3]). They were effective among older adults and primary care patients. Efficacy did not differ among newer agents or between newer and older agents. Hypericum (St. John's wort) was more effective than placebo for mild to moderate depression (risk ratio, 1.9 [CI, 1.2 to 2.8]), but publication bias may have inflated the estimate of benefit. Newer and older antidepressants did not differ for overall discontinuation rates, but side effect profiles varied significantly. Data were insufficient for determining the efficacy of newer antidepressants for subsyndromal depression, depression with coexisting medical or psychiatric illness, or depression in adolescents. CONCLUSIONS: Newer antidepressants are clearly effective in treating depressive disorders in diverse settings. Because of similar efficacy, both newer and older antidepressants should be considered when making treatment decisions. Better information is urgently needed on the efficacy of newer antidepressants in patients with nonmajor depression and in special populations, including adolescents.
Age Factors↗
Regulation of oxidative metabolism and blood flow in skeletal muscle. Summary report of the first ACSM Basic Science Specialty Conference, Indianapolis, IN, September 28-30, 1995.
The first ACSM Basic Science Specialty Conference was held in Indianapolis, September 28-30, 1995. The topic was integration among cellular metabolism, blood flow regulation, and O2 supply during exercise, principally in skeletal muscle. The structure of the meeting was uniquely designed to emphasize free discussion among the 102 registrants; thus, this unique program design does not lend itself to a conventional collection of written symposium proceedings. On the other hand, the College, editor-in-chief Peter B. Raven, and the meeting organizers felt that a summary of the meeting's major points was important to compile and distribute to members via Medicine and Science in Sports and Exercise. Therefore, the organizing committee present a summary of the major issues discussed.
Endothelium, Vascular↗
[Clinical practice guideline: 2003 update of Standards, Options et Recommendations for first line palliative chemotherapy in patients with metastatic colorectal cancer (summary report)].
CONTEXT: The "Standards, Options and Recommendations" (SOR) project, which started in 1993, is a collaboration between the Federation of French Cancer Centres (FNCLCC), the 20 French Regional Cancer Centres, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. OBJECTIVES: To update clinical practice guidelines for first line palliative chemotherapy in patients with metastatic colorectal cancer previously validated in 1995, then updated in 1997 and published again in 1998. These recommendations do not cover second line treatment. METHODS: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts who define the CPGs according to the definitions of the Standards, Options and Recommendations project. Once the guidelines have been developed, they are reviewed by independent reviewers. RESULTS: This article is a summary version of the updated clinical practice guidelines with algorithms. The main questions addressed by the expert group in this update concerned (1) Which patients should be treated? (2) What is the best treatment duration? (3) Which treatment should be administered? The new data identified concerning which patients to treat and the duration of treatment were consistent with the data presented in the initial report and did not modify the original recommendations from 1997. The new data available represent stronger evidence than those in the original report (Two good-quality meta-analyses published since 1997). A new guideline concerning patients who are 75 years old or more has been added. Concerning, the new evidence identified has modified the guidelines for the therapeutic schema to adopt from 1997. These modifications concern irinotecan, oxaliplatin, oral fluoropyrimidines and methotrexate. Treatment with irinotecan or oxaliplatin associated with continuous 5FU infusion, modulated with folinic acid (LV5FU2-like) has become a standard. The use of oral fluoropyrimidines has become an option for patients who refuse hospitalisation or treatment by infusion. The use of methotrexate combined with 5FU is no longer recommended.
Antimetabolites, Antineoplastic↗
[Clinical practice guidelines: Standards, Options and Recommendations for first line medical treatment of patients with ovarian neoplasms (summary report)].
CONTEXT: The "Standards, Options and Recommendations" (SOR) project, which started in 1993, is a collaboration between the French Federation of Cancer Centers (FNCLCC), the 20 French Regional Cancer Centers, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. OBJECTIVE: To update clinical practice guidelines for first line medical treatment of patients with ovarian neoplasms in collaboration with the French Society for Gynaecologica Oncology. METHODS: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts. The CPGs are defined following the definitions of the Standards, Options and Recommendations project. Once the guideline has been developed, the document is submitted for review by independent reviewers. RESULTS: This article is a summary version of the full document presenting the clinical practice guidelines with algorithms. After surgery, most patients with ovarian neoplasms need adjuvant medical treatment. These guidelines concern the initial medical treatment (chemotherapy, hormone treatment and immunotherapy) and potential consolidation treatment. To complete the indications, two alternative treatment strategies are taken into account: no treatment and radiotherapy. This updated version concerns the indications and the modalities of chemotherapy. The main modifications are: 1) first-line chemotherapy for ovarian neoplasm can be taxane-platinum or carboplatine alone; 2) poly-chemotherapy is no longer a standard; 3) for early stages, except for stage IA grade I non-clear-cell tumours, adjuvant chemotherapy should be preferred to no treatment; 4) chemotherapy is standard for all stage III tumours, irrespective of the surgical result; 5) for stage IA G2-3 to IIA tumours, complete surgical staging and determination of the histological grade are standards.
Antineoplastic Agents↗
[2003 clinical practice guideline: Standards, Options and Recommendations for pain assessment in adult and children with cancer (summary report)].
CONTEXT: The "Standards, Options and Recommendations" (SOR) project, which started in 1993, is a collaboration between the French Federation of Cancer Centers (FNCLCC), the 20 French Regional Cancer Centers, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. OBJECTIVE: To update clinical practice guidelines for the assessment of pain in adult or children with cancer in collaboration with the French society for pain study and treatment. METHOD: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts who define the CPGs according to the definitions of the Standards, Options and Recommendations project. Once the guideline has been defined, the document is submitted for review by independent reviewers. RESULTS: This article is a summary version of the full document presenting the clinical practice guidelines with algorithms. The main recommendations concern the means used to evaluate pain and its consequences and their use in specific cases (acute or chronic pain, patients able to communicate or not, children under or over 6 years old). Others recommendations were also established concerning the evaluation ofpsychological, social and family context, the evaluation of pain in hospital or at home, in terminal phase patients and for the establishment of a therapeutic strategy and follow-up of patient with pain.
Age Factors↗
[Clinical practice guideline: 2005 update of recommendations for the management of patients with cutaneous melanoma without distant metastases (summary report)].
CONTEXT: The National French federation of comprehensive cancer centres (FNCLCC) and the French society of dermatology (SFD) initiated together the update of clinical practice guideline for the management of patients with cutaneous melanoma in collaboration with the French national cancer institute and with specialists from French public universities, general hospitals and private clinics. This work is based on the methodology developed in the "Standards, Options and Recommendations" (SOR) project. OBJECTIVES: To update SOR guidelines for the management of patients with cutaneous melanoma previously validated in 1998 and French melanoma consensus conference published by SFD and ANAES in 1995. METHODS: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts who define the CPGs according to the definitions of the Standards, Options and Recommendations project. Once the guidelines have been developed, they are reviewed by independent reviewers. RESULTS: This article is a summary version of the updated clinical practice guidelines with algorithms. The main questions addressed by the expert group in this update concerned (1) The new AJCC-UICC classification (2) Excision margins (3) Sentinel node biopsy (4) Adjuvant treatments (5) Initial staging and follow up of operated patients.
Algorithms↗
[2003 Update of Standards, Options and Recommendations for management of patients with salivary gland malignant tumors (excluding lymphoma, sarcoma and melanoma) (summary report)].
CONTEXT: The "Standards, Options and Recommendations" (SOR) project, which started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French Regional Cancer Centers, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. OBJECTIVES: To update clinical practice guidelines for the management of patients with salivary gland malignant tumors previously validated in 1997. These recommendations cover diagnosis, classification, treatment and follow-up of patients with these tumors. METHODS: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts who define the CPG s according to the definitions of the Standards, Options and Recommendations project. Once the guidelines has been defined, the document is submitted for review by independent reviewers. RESULTS: This article is a summary version of the full document presenting the updated clinical practice guidelines with algorithms. The main questions addressed by the expert group in this update concern the place of fine needle aspiration biopsy in preoperative diagnosis, the place of cervical lymph node area surgical treatment, the place of postoperative irradiation and neutron therapy in the treatment of unresectable tumors and also the place of medical imaging, especially RMI, for the diagnosis of these tumors.
Antineoplastic Agents↗