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At least 1,171 records · Page 65Linked to original sources

Hand-assisted laparoscopy versus conventional median laparotomy for aortobifemoral bypass for severe aorto-iliac occlusive disease: a prospective randomised study.

OBJECTIVES: To demonstrate that hand-assisted laparoscopy for aortofemoral bypass for severe aorto-iliac occlusive disease reduces morbidity with earlier recovery of bowel function and shorter in-hospital stay. DESIGN: Randomised controlled trial. MATERIALS AND METHODS: Thirty-six consecutive patients with severe aorto-iliac occlusive disease (TASK C/D) without history of major abdominal surgery necessitating an aortobifemoral bypass were randomised between a hand-assisted laparoscopic (HALS) approach and a conventional medial laparotomy. Operative data, early recovery data, quality of life and vascular outcome were analysed. RESULTS: No significant differences in operative data were found. Fluid and solid diet were resumed earlier (28.8 hrs vs. 76.9 hrs; p = 0.016) (45.6 hrs vs. 105.6 hrs; p = 0.02) and in-hospital stay was shorter (7.5 vs. 8.9 days; p = 0.005) in the HALS group. Six weeks post-operatively social functioning measured by the SF-36 survey score was better in patients randomised to HALS (p=0.023). CONCLUSIONS: HALS is a less invasive approach for aortofemoral bypass.

Adult↗

Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research.

BACKGROUND: The Multicentre Project for Tuberculosis Research (MPTR) was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. METHODS: The study was divided in three phases: 1) preliminary phase, 2) field work 3) final phase. Quality control procedures during the three phases are described. RESULTS: Preliminary phase: a) organisation of the research team; b) design of epidemiological tools; training of researchers. Field work: a) data collection; b) data computerisation; c) data transmission; d) data cleaning; e) quality control audits; f) confidentiality. Final phase: a) final data cleaning; b) final analysis. CONCLUSION: The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

Confidentiality↗

RFLP band size standards: cell line K562 values from 1991 to 1997 proficiency studies.

Cell line K562 is the defacto forensic control material for forensic restriction fragment length polymorphism (RFLP) DNA profiling in the U.S. Fifty-one proficiency tests conducted from 1991 through 1997 enable a detailed description of RFLP measurement performance during this period. Sufficient data are available to define reference distributions for all commonly utilized and many less commonly reported genetic loci, for both HaeIII- and HinfI-based RFLP systems. The average measured size of HaeIII locus D1S7 and D5S110 bands has varied slightly over time; while relatively small, these temporal changes add to the overall interlaboratory measurement uncertainty. The characteristic standard deviation for HinfI RFLP system measurements has a nearly identical dependence on expected band size as does the standard deviation for HaeIII measurements. The ellipsoidal distance, K, is suggested for use as an RFLP data quality metric; the critical threshold value that on average excludes 1% of plausibly valid proficiency data for a given polymorphic locus is K1% = 14.2.

DNA Fingerprinting↗

Complementary and alternative therapies for the management of menopause-related symptoms: a systematic evidence review.

BACKGROUND: Nearly half of adults in the United States use complementary and alternative therapies each year for a variety of reasons. These therapies are increasingly popular among women seeking alternatives to treatment with estrogen for managing menopausal symptoms. The objective of this review was to assess the effectiveness of complementary and alternative therapies in the management of menopausal symptoms. DATA SOURCES: MEDLINE, PsychINFO, Cochrane Library database, MANTIS, and AMED. STUDY SELECTION: Full-text, English-language, randomized controlled trials and meta-analyses comparing a complementary or alternative therapy with placebo or control for treatment of menopausal symptoms. DATA EXTRACTION: All eligible trials were reviewed, abstracted into evidence tables, and rated for quality. DATA SYNTHESIS: Seventy randomized controlled trials met inclusion criteria. Forty-eight studies of phytoestrogens and other biologically based agents showed mixed results. Smaller numbers of studies using mind-body, energy, manipulative, and body-based therapies and whole medical systems showed little benefit in treating menopausal symptoms. CONCLUSIONS: Although individual trials suggest benefits from certain therapies, data are insufficient to support the effectiveness of any complementary and alternative therapy in this review for the management of menopausal symptoms. Many of these potential therapies warrant further study in trials with rigorous scientific designs to determine benefit and safety.

Behavior Therapy↗

Recovery of the immune system with antiretroviral therapy: the end of opportunism?

OBJECTIVE: Clinical care of people infected with human immunodeficiency virus (HIV) has been substantially affected by the introduction of potent antiretroviral therapy. Changes in the immune system after such therapy and the clinical consequences are important issues for clinicians treating patients with HIV. DATA SOURCES: A systematic review of MEDLINE, 1993 to January 1998, of peer-reviewed publications, abstracts from national and international conferences, and product registration information through January 1998. STUDY SELECTION AND DATA EXTRACTION: Criteria used to select studies include relevance to immune reconstitution with potent antiretroviral therapy and having been published in the English language. Assessment of data quality and validity included consideration of venue of the publication and relevance to practice. DATA SYNTHESIS: Suppression of viral replication after administration of potent antiretroviral therapy that includes inhibitors of the HIV-1 protease is associated with quantitative and qualitative changes in the immune system. In patients with relatively advanced disease, there is a first-phase rise (during the initial 3 months) in both naive and memory CD4+ and CD8+ T lymphocytes and B lymphocytes. This is followed by a slower second-phase increase (after 3 months) in cells primarily of the naive CD4+ and CD8+ phenotypes. These quantitative changes are associated with qualitative improvements in host immune responses, best characterized by dramatically reduced risk of opportunistic infection. Restoration of the immune system during the first year of potent antiretroviral therapy is partial at best. CONCLUSIONS: Potent antiretroviral therapy has become the standard of care for people with HIV infection, and its use has led to significant reductions in the incidence of the acquired immunodeficiency syndrome (AIDS) and in mortality from HIV infection. Although incomplete, considerable immune recovery occurs, sufficient, in most cases, to provide adequate protection against most AIDS-associated opportunistic infections.

AIDS-Related Opportunistic Infections↗

Early evaluation of compound QT prolongation effects: a predictive 384-well fluorescence polarization binding assay for measuring hERG blockade.

INTRODUCTION: A large number of drugs from a variety of pharmacological classes have been demonstrated to cause adverse effects on cardiac rhythm, including the life-threatening arrhythmia Torsades de Pointes. These side effects are often associated with prolongation of the QT interval and are mediated via blockade of the human ether-a-go-go related gene (hERG) encoded potassium channel. In order to manage this risk in the pharmaceutical industry it is desirable to evaluate QT prolongation as early as possible in the drug discovery process. METHODS: Here we describe the development of a 384-well fluorescence polarization (FP) binding assay compatible with high-throughput assessment of compound blockade of the hERG channel during the lead optimisation process. To characterise the fluorescent ligand that was developed, competition binding studies, kinetic studies and electrophysiology studies were performed. Furthermore, to validate the assay as a key screening method a series of competition binding studies were performed and correlated with functional data obtained via patch-clamp. RESULTS: Evaluation of the assay indicates that high quality data is obtained (Z'>0.6), that the K(i) values determined are equivalent to more traditional radiometric methods and that it is predictive for functional hERG blockade as assessed by patch clamp. DISCUSSION: Whilst FP assays, utilizing a variety of fluors, have become well established for the evaluation of G-protein-coupled receptor (GPCRs) and kinase ligand interactions, this technique has not been applied widely to the study of ion channels. Therefore, this represents a novel assay format that is amenable to the evaluation of thousands of compounds per day. Whilst other assay formats have proven predictive or high throughput, this assay represents one of few that combines both attributes, moreover it represents the most cost effective assay, making it truly amenable to early assessment of hERG blockade.

Binding, Competitive↗

Putting microarrays in a context: integrated analysis of diverse biological data.

In recent years, multiple types of high-throughput functional genomic data that facilitate rapid functional annotation of sequenced genomes have become available. Gene expression microarrays are the most commonly available source of such data. However, genomic data often sacrifice specificity for scale, yielding very large quantities of relatively lower-quality data than traditional experimental methods. Thus sophisticated analysis methods are necessary to make accurate functional interpretation of these large-scale data sets. This review presents an overview of recently developed methods that integrate the analysis of microarray data with sequence, interaction, localisation and literature data, and further outlines current challenges in the field. The focus of this review is on the use of such methods for gene function prediction, understanding of protein regulation and modelling of biological networks.

Algorithms↗

Quality of life after treatment for pancreatitis.

OBJECTIVE: The authors evaluated the morbidity, mortality, and quality of life after pancreatic debridement for necrosis and compared these values to those for quality of life after elective medical and surgical management for chronic pancreatitis. SUMMARY BACKGROUND DATA: Quality of life after pancreatic debridement for necrosis has received little attention. Although quality of life after other pancreatic surgery has been evaluated and is though to be good, management of patients with pancreatic necrosis can be labor intensive and require extraordinary resources. Therefore, further evaluation of the quality of life achieved after treatment is appropriate. METHODS: Forty patients (group 1) underwent operative debridement for necrosis between 1986 and 1994. Medical records of these patients were reviewed for morbidity, mortality, and in-hospital costs. Follow-up of quality of life was assessed by the Short Form-36 Health Survey. Patients in group 2 (n = 89) underwent medical management of chronic pancreatitis. Group 3 included 47 patients who underwent elective operations for ductal abnormalities. The Short Form-36 Health Surveys were administered to all three groups and compared statistically. RESULTS: Mortality and morbidity from pancreatic debridement was 18% and 77%, respectively. Quality-of-life evaluations in groups 1 through 3 and age-matched controls were statistically similar. CONCLUSIONS: Pancreatic debridement for necrosis requires intense application of resources and is associated with a high mortality and morbidity. Long-term follow-up shows good quality of life for patients who survive this morbid disease. This study supports the continued aggressive approach to the management of pancreatic necrosis, given that long-term outcome about quality of life is good.

Chronic Disease↗

Consumer reports in health care: do they make a difference?

The public release of health care-quality data into more formalized consumer health report cards is intended to educate consumers, improve quality of care, and increase competition in the marketplace The purpose of this review is to evaluate the evidence on the impact of consumer report cards on the behavior of consumers, providers, and purchasers. Studies were selected by conducting database searches in Medline and Healthstar to identify papers published since 1995 in peer-review journals pertaining to consumer report cards on health care. The evidence indicates that consumer report cards do not make a difference in decision making, improvement of quality, or competition. The research to date suggests that perhaps we need to rethink the entire endeavor of consumer report cards. Consumers desire information that is provider specific and may be more likely to use information on rates of errors and adverse outcomes. Purchasers may be in a better position to understand and use information about health plan quality to select high-quality plans to offer consumers and to design premium contributions to steer consumers, through price, to the highest-quality plans.

Choice Behavior↗

Is there value in using physician billing claims along with other administrative health care data to document the burden of adolescent injury? An exploratory investigation with comparison to self-reports in Ontario, Canada.

BACKGROUND: Administrative health care databases may be particularly useful for injury surveillance, given that they are population-based, readily available, and relatively complete. Surveillance based on administrative data, though, is often restricted to injuries that result in hospitalization. Adding physician billing data to administrative data-based surveillance efforts may improve comprehensiveness, but the feasibility of such an approach has rarely been examined. It is also not clear how injury surveillance information obtained using administrative health care databases compares with that obtained using self-report surveys. This study explored the value of using physician billing data along with hospitalization data for the surveillance of adolescent injuries in Ontario, Canada. We aimed i) to document the burden of adolescent injury using administrative health care data, focusing on the relative contribution of physician billing information; and ii) to explore data quality issues by directly comparing adolescent injuries identified in administrative and self-report data. METHODS: The sample included adolescents aged 12 to 19 years who participated in the 1996-1997 cross-sectional Ontario Health Survey, and whose survey responses were linked to administrative health care datasets (N = 2067). Descriptive analysis was used to document the burden of injuries as a proportion of all physician care by gender and location of care, and to examine the distribution of both administratively-defined and self-reported activity-limiting injuries according to demographic characteristics. Administratively-defined and self-reported injuries were also directly compared at the individual level. RESULTS: Approximately 10% of physician care for the sample was identified as injury-related. While 18.8% of adolescents had self-reported injury in the previous year, 25.0% had documented administratively-defined injury. The distribution of injuries according to demographic characteristics was similar across data sources, but congruence was low at the individual level. Possible reasons for discrepancies between the data sources included recall errors in the survey data and errors in the physician billing data algorithm. CONCLUSION: If further validated, physician billing data could be used along with hospital inpatient data to make an important and unique contribution to adolescent injury surveillance. The limitations inherent in different datasets highlight the need to continue rely on multiple information sources for complete injury surveillance information.

Activities of Daily Living↗

Principles and practices of neurodevelopmental assessment in children: lessons learned from the Centers for Children's Environmental Health and Disease Prevention Research.

Principles and practices of pediatric neurotoxicology are reviewed here with the purpose of guiding the design and execution of the planned National Children's Study. The developing human central nervous system is the target organ most vulnerable to environmental chemicals. An investigation of the effects of environmental exposures on child development is a complex endeavor that requires consideration of numerous critical factors pertinent to a study's concept, design, and execution. These include the timing of neurodevelopmental assessment, matters of biologic plausibility, site, child and population factors, data quality assurance and control, the selection of appropriate domains and measures of neurobehavior, and data safety and monitoring. Here we summarize instruments for the assessment of the neonate, infant, and child that are being employed in the Centers for Children's Environmental Health and Disease Prevention Research, sponsored by the National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency, discuss neural and neurobiologic measures of development, and consider the promises of gene-environment studies. The vulnerability of the human central nervous system to environmental chemicals has been well established, but the contribution these exposures may make to problems such as attention deficit disorder, conduct problems, pervasive developmental disorder, or autism spectrum disorder remain uncertain. Large-scale studies such as the National Children's Study may provide some important clues. The human neurodevelopmental phenotype will be most clearly represented in models that include environmental chemical exposures, the social milieu, and complex human genetic characteristics that we are just beginning to understand.

Central Nervous System↗

A partnership study of PCBs and the health of Mohawk youth: lessons from our past and guidelines for our future.

This paper describes a research partnership between the people of Akwesasne and researchers from the State University of New York at Albany for the study of polychlorinated biphenyls and the health of Mohawk youth. The study is distinctive because its goals have been set by the scientists and the community members and is being conducted jointly by these groups. The research partnership recognizes the history of relationships between native and nonnative peoples, particularly scientists, and seeks not only to fulfill certain scientific goals but to further community ones as well. The relationship is based on three principles: mutual respect, mutual equity, and mutual empowerment. These principles guided every aspect of the research process. The project goals were determined jointly to maximize data quality and minimize the intrusion of research activities into the lives of community members. Data collection is performed by research assistants who received extensive and ongoing training in data collection methods, and who are members of the community. Feedback procedures were designed by community members and scientists jointly to maximize understanding. Feedback regarding individuals' pollutant levels and assessments of growth and development are provided to each individual. Information about community pollutant levels are provided to the community. Hypothesis testing is carried out by research scientists, and the results presented first at a community meeting. Research conducted in this way--as a partnership--requires more communication, discussion, and travel, but the result is mutual satisfaction and growth.

Community Participation↗

State, hospitals join up for outcomes data.

In Rhode Island, the hospitals are leading the charge. Suggest to hospitals that they should provide the public with quality data on outcomes, and many balk at the idea. Suggest that a state should adopt a requirement that they do so, and you might expect a full-fledged effort to thwart the legislation. But in Rhode Island, the hospitals not only welcomed the idea, they helped draft the legislation.

Benchmarking↗

HIV-1 protease inhibitors. A review for clinicians.

OBJECTIVE: The clinical care of people infected with human immunodeficiency virus (HIV) has been substantially affected by the introduction of HIV-specific protease inhibitors (PIs). The 4 PIs available are saquinavir mesylate, ritonavir, indinavir sulfate, and nelfinavir mesylate. Comparison studies have not been reported; therefore, an assessment of the available data to aid clinicians and patients in choosing appropriate treatment will be presented. DATA SOURCES: A systematic review of peer-reviewed publications, abstracts from national and international conferences, and product registration information through September 1996. STUDY SELECTION AND DATA EXTRACTION: Criteria used to select studies include their relevance to PIs, having been published in the English language, and pertinence for clinicians. Data quality and validity included the venue of the publication and relevance to clinical care. DATA SYNTHESIS: Oral adminstration of ritonavir, indinavir, or nelfinavir generates sustainable drug serum levels to effectively inhibit the protease enzyme; however, saquinavir may not generate sustained levels necessary to inhibit the protease enzyme. Patients treated with ritonavir, indinavir, or nelfinavir experience similar reductions in viral load and increases in CD4+ lymphocytes; smaller effects occur among those treated with saquinavir. Two randomized placebo-controlled studies conducted among patients with severe immune system suppression and substantial zidovudine treatment experience demonstrated reduced HIV disease progression and reduced mortality with PI treatment. Genotypic resistance to PIs occurs; the clinical relevance of resistance is unclear. The costs of these agents including required monitoring impose new and substantial costs. CONCLUSIONS: The PIs have emerged as critical drugs for people with HIV infection. Optimal use involves combination with reverse transcriptase inhibitors. Resistance develops to each agent, and cross-resistance is likely. These agents must be used at full doses with attention to ensuring patient compliance. The expense of these agents may be offset by forestalling disease progression and death and returning people to productive life. Selecting the initial PI must be individualized, and factors to consider include proven activity, possible toxicities, dosing regimens, drug interactions, and costs.

Anti-HIV Agents↗

A microprocessor-based system for measurement of gas exchange.

The basic physical measurements for determining gas exchange are difficult to make accurately even in a well-equipped, human-performance laboratory with experienced personnel. A fully automated system has been developed to achieve the accuracy of standard laboratory measurements. The application of this instrument extends from critical care to stress-testing. Real-time, multitasking software integrates the data collected from several transducers and analyzers and calculates up to several dozen physiological variables, which are range-checked for reasonableness. The operator is provided with user-friendly means to tailor the data-reporting and- collection functions of the system to his own needs and requirements. Because the instrument is controlled by software, the functions of calibration, measurement, timing, reporting, plotting, and data quality assurance are highly cost-effective. Extensive use of formal test procedures permits verifying all systems and data reliability; it also assures meeting the desired specifications. The ease of operation and high-quality results inherent in this system make it unsurpassed in gas-exchange measurements.

Computers↗

Application of multicriteria decision making methods to air quality in the microenvironments of residential houses in Brisbane, Australia.

This paper reports the first application of the multicriteria decision making methods, PROMETHEE and GAIA, to indoor and outdoor air quality data. Fourteen residential houses in a suburb of Brisbane, Australia were investigated for 21 air quality-influencing criteria, which included the characteristics of the houses as well as the concentrations of volatile organic compounds, fungi, bacteria, submicrometer, and supermicrometer particles in their indoor and outdoor air samples. Ranking information necessary to select one house in preference to all others and to assess the parameters influencing the differentiation of the houses was found with the aid of PROMETHEE and GAIA. There was no correlation between the rank order of each house and the health complaints of its occupants. Patterns in GAIA plots show that indoor air quality in these houses is strongly dependent on the characteristics of the houses (construction material, distance of the house from a major road, and the presence of an in-built garage). Marked similarities were observed in the patterns obtained when GAIA and factor analysis were applied to the data. This underscores the potential of PROMETHEE and GAIA to provide information that can assist source apportionment and elucidation of effective remedial measures for indoor air pollution.

Air Pollution, Indoor↗

Data reliability and structure in the Swedish National Cataract Register.

PURPOSE: A Swedish National Cataract Register was instituted in 1992, monitoring nearly all cataract operations in Sweden, and since its inception comprising about 95% of all operations. Data from a total of approximately 290 000 operations have been collected during 1992-1998. Data quality is an important factor, and we have therefore assessed the various types and frequencies of data entry errors in the material. METHODS: The medical records for all operations in five selected participating clinics were retrieved for a set month. Each data transfer step from the record to the final data base was monitored for a total of 574 operations. A total of 10 variables were recorded for each operation. RESULTS: Significant sources of error were absent in most variables. However, possibly important errors appeared in three: "date entering waiting list", "preoperative best corrected visual acuity in the operated eye", or "visual acuity in the fellow eye". There were also noteworthy variations between the five clinics, different for different parameters. Errors were predominantly prone to appear at the very first step of registration. In most cases this was due to deviations from the data collection instructions. CONCLUSIONS: The reliability is good for most values entered into the register, but it is important to ensure that data definitions are exact and adhered to. Repeated information to the involved persons on how to fill in the forms appears to be a requisite for maintaining good input quality.

Cataract↗

Emergency protocols in prehospital emergency medicine in Slovenia.

Emergency medicine is a branch of medicine in which prompt and accurate information is of crucial importance, because a patient's survival and the final outcome of a treatment very often depends on it. Therefore the standardization of prehospital emergency service administration with uniform documentation, methods of annotation of technical data as well as uniform gathering and data analysis are necessary. Wanting to process a fair amount of data and specially to disburden personnel, a need for computer aided processing is evident. Application that was developed in strong collaboration with EMS project team and information science engineers definitely improves data quality. Firstly when team members, especially physicians, are constrained to fulfill paper forms and secondly when data are entered into the computer, because all inconsistencies are being reconsidered and corrected if necessary. The developed application also gave the opportunity to the emergency team for prompt and accurate information.

Data Collection↗