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PubMed2003

Use of injections in healthcare settings worldwide, 2000: literature review and regional estimates.

OBJECTIVE: To describe injection practices worldwide in terms of frequency and safety. DESIGN: Literature review. The global burden of disease project of the World Health Organization defined 14 regions on the basis of geography and mortality patterns. Data sources included published studies and unpublished WHO reports. Studies were reviewed by using a standardised decision making algorithm to generate region specific estimates. SETTING: Healthcare facilities, both formal and informal. DATA SOURCES: General population and users of healthcare facilities. MAIN OUTCOME MEASURE: Annual number of injections per person and proportion of injections administered with syringes or needles, or both, reused in the absence of sterilisation. RESULTS: The analysis excluded four regions (predominantly affluent, developed nations) where reuse of injection equipment in the absence of sterilisation was assumed to be negligible. In the 10 other regions, the annual ratio of injections per person ranged from 1.7 to 11.3. Of these, the proportion administered with equipment reused in the absence of sterilisation ranged from 1.2% to 75.0%. Reuse was highest in the South East Asia region "D" (seven countries, mostly located in South Asia), the eastern Mediterranean region "D" (nine countries, mostly located in the Middle East crescent), and the western Pacific region "B" (22 countries). No information regarding injection safety was available for Latin America. CONCLUSIONS: Overuse of injections and unsafe practices are still common in developing and transitional countries. An urgent need exists to use injections safely and appropriately, to prevent healthcare associated infections with HIV and other bloodborne pathogens.

Equipment Reuse↗

PubMed2003

Infliximab treatment of rheumatoid arthritis and Crohn's disease.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, safety, and pharmacoeconomic impact of infliximab in the treatment of Crohn's disease (CD) and rheumatoid arthritis (RA). DATA SOURCES: MEDLINE and Pre-MEDLINE (1966-June 2002) and manufacturer prescribing literature were employed to find English-language articles on infliximab. Additional studies and abstracts were identified from the bibliographies of reviewed literature and conference proceedings. STUDY SELECTION/DATA EXTRACTION: All articles identified from data sources were evaluated, and all information deemed relevant was included in this review. Information regarding basic pharmacology was collected from studies in animals. Pharmacokinetic data were collected from human trials. Safety data were extracted from clinical trials and postmarketing surveillance. Priority was given to randomized, double-blind, placebo-controlled studies for the assessment of efficacy. All available economic evaluations were included. DATA SYNTHESIS: Infliximab is a new monoclonal antibody that appears to work by a unique mechanism: inhibiting the action of tumor necrosis factor-alpha (TNF-alpha). Infliximab is administered by intravenous infusion. In clinical trials in CD, infliximab significantly decreased the CD activity index compared with placebo in treatment-resistant disease and significantly reduced the number of draining fistulas in fistulizing disease. In RA, when infliximab was added to methotrexate (MTX), it resulted in a significant improvement in most disease outcome measures when compared with MTX plus placebo. Few major adverse effects were reported in the clinical trials; however, serious adverse events, including malignancy and demyelination, have been reported in postmarketing surveillance. Also, increased susceptibility to infections (including tuberculosis) has been reported. CONCLUSIONS: Infliximab is an effective new agent for the treatment of CD and RA. Its apparent unique mechanism of action makes infliximab an important addition to therapy. Caution should be exercised when considering infliximab for individuals who have chronic or recurrent infections, mild congestive heart failure (New York Heart Association [NYHA] class I/II), nervous system disorders, or live or have lived in an area endemic for histoplasmosis. Infliximab is contraindicated for patients with a clinically important, active infection, moderate to severe congestive heart failure (NYHA class III/IV), or an allergy to mouse proteins or any of the ingredients in infliximab. Further long-term efficacy, safety, and economic data on infliximab are required. Also, for the treatment of RA, the burden of administering infliximab (as a 2-hour supervised infusion) has to be considered when choosing among anti-TNF-alpha medication (as the other 2 approved agents, etanercept and adalimumab, can be self-administered by subcutaneous injection).

Antibodies, Monoclonal↗

PubMed1998

Trends in migration in the UK.

This article presents the latest annual statistics for international migration and for internal population movements in the United Kingdom, and compares them with recent trends. It also aims to give some information on the characteristics of the migrants from the data sources that are available. Measuring migration is not straightforward as there is no compulsory system within the United Kingdom to record movements of the population, either into the country from abroad or within the country. Nevertheless, we can estimate these movements from available data sources and so monitor migration trends and patterns.

Adolescent↗

PubMed2006

Current status of cetuximab for the treatment of patients with solid tumors.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical evidence, and safety, as well as the potential directions for use, of the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab. DATA SOURCES: A MEDLINE search (1966-December 2005) was conducted using the following terms: cetuximab, Erbitux, C225, epidermal growth factor receptor, and EGFR. Additional information was obtained via meeting abstracts, bibliographies from relevant articles, national guidelines, and the manufacturer. STUDY SELECTION AND DATA EXTRACTION: Preclinical and clinical trials utilizing cetuximab in the treatment of solid tumors were selected from the data sources. All published, randomized clinical trials involving cetuximab in treatment of metastatic colorectal cancer and studies providing a description of the pharmacology, pharmacokinetics, safety, or efficacy were included in this review. DATA SYNTHESIS: Many solid tumors overexpress EGFR, making it an ideal target for anticancer agents. Cetuximab is the only EGFR monoclonal antibody commercially available and is approved for the treatment of EGFR-expressing, metastatic colorectal cancer in patients refractory or intolerant to irinotecan. Data on patients with other solid tumors are encouraging with cetuximab used as monotherapy or in combination with chemotherapy, radiation, or other targeted agents. Common adverse effects include dermatologic and hypersensitivity reactions. CONCLUSIONS: Further clinical data are necessary to clearly define the role of cetuximab in the treatment of patients with solid malignancies, with emphasis on survival and quality-of-life benefits relative to its cost.

Animals↗

PubMed1994

Personality traits are linked to crime among men and women: evidence from a birth cohort.

Is there a relationship between personality and criminal behavior? We addressed this question in a representative birth cohort of 862 male and female 18-year-olds. Personality was assessed with the Multidimensional Personality Questionnaire (MPQ). The MPQ measures 10 relatively independent personality traits and was not designed to identify offenders. Delinquency was assessed via 3 data sources: self-reports, informant reports, and official records. Variable-centered analyses revealed that MPQ scales indexing negative emotionality and behavioral constraint were consistent predictors of delinquency across the 3 data sources. Person-centered analyses revealed that youths abstaining from delinquency were uniquely characterized by low interpersonal potency. Youths involved in extensive delinquency were uniquely characterized by feelings of alienation, lack of social closeness, and risk taking. Advances in understanding criminal behavior can be made through research that places the personality-delinquency link in a developmental context.

Adolescent↗

PubMed2001

A knowledge-based system for patient image pre-fetching in heterogeneous database environments--modeling, design, and evaluation.

When performing primary reading on a newly taken radiological examination, a radiologist often needs to reference relevant prior images of the same patient for confirmation or comparison purposes. Support of such image references is of clinical importance and may have significant effects on radiologists' examination reading efficiency, service quality, and work satisfaction. To effectively support such image reference needs, we proposed and developed a knowledge-based patient image pre-fetching system, addressing several challenging requirements of the application that include representation and learning of image reference heuristics and management of data-intensive knowledge inferencing. Moreover, the system demands an extensible and maintainable architecture design capable of effectively adapting to a dynamic environment characterized by heterogeneous and autonomous data source systems. In this paper, we developed a synthesized object-oriented entity- relationship model, a conceptual model appropriate for representing radiologists' prior image reference heuristics that are heuristic oriented and data intensive. We detailed the system architecture and design of the knowledge-based patient image pre-fetching system. Our architecture design is based on a client-mediator-server framework, capable of coping with a dynamic environment characterized by distributed, heterogeneous, and highly autonomous data source systems. To adapt to changes in radiologists' patient prior image reference heuristics, ID3-based multidecision-tree induction and CN2-based multidecision induction learning techniques were developed and evaluated. Experimentally, we examined effects of the pre-fetching system we created on radiologists' examination readings. Preliminary results show that the knowledge-based patient image pre-fetching system more accurately supports radiologists' patient prior image reference needs than the current practice adopted at the study site and that radiologists may become more efficient, consultatively effective, and better satisfied when supported by the pre-fetching system than when relying on the study site's pre-fetching practice.

Artificial Intelligence↗

PubMed2007

GI Epidemiology: databases for epidemiological studies.

BACKGROUND: Large databases are being increasingly used for examining the epidemiology and outcomes of digestive and liver disorders. The complexity and rigor of the methods used to conduct these studies are often underestimated. AIMS: For the most commonly used databases, we provide a brief description of the contents, highlight strengths and weakness, and provide links for more detailed information. We also present a systematic approach to utilizing large databases for addressing research questions, highlighting commonly encountered study design issues, as well as strategies for resolving these issues. CONCLUSIONS: 1. Research using large databases requires the same essential skills needed to conduct research studies using other data sources. These include a rigorous study design, expertise in analytic methods, and relevant research questions. 2. The completeness and accuracy of information contained in the database must be assessed. Methods for improving the quality and completeness of this information should be considered. 3. Despite similarities among large databases, gaining insight and experience into the structure and content of each database is essential. Key points *Large databases can be a powerful source of information to examine the clinical epidemiology and outcomes of digestive and liver disorders. * Research using large databases requires the same essential skills needed to conduct research studies using other data sources. These include a rigorous study design, expertise in analytic methods, and relevant research questions. * The completeness and accuracy of information contained in the database must be assessed. Methods for improving the quality and completeness of this information should be considered. * Despite similarities among large databases, gaining insight and experience into the structure and content of each database is essential. * Examples of commonly used large databases are presented with a synopsis of information contained in the database, as well as strengths and limitations of using the database for research.

Databases as Topic↗

PubMedDate not supplied

Understanding the scientific issues embedded in the generic drug approval process.

OBJECTIVE: To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Drug Approval↗

PubMed2004

Nonestrogen treatment modalities for vasomotor symptoms associated with menopause.

OBJECTIVE: To systematically review the literature regarding the efficacy and safety of nonestrogen treatments for menopause-associated vasomotor symptoms not due to cancer or chemotherapy. DATA SOURCES: Pertinent literature and clinical studies were identified by searching MEDLINE (1966-February 2004) and EMBASE (1959-February 2004) using the key search terms vasomotor symptoms, hot flashes, and menopause. Bibliographies of relevant articles were reviewed for additional references. STUDY SELECTION AND DATA EXTRACTION: English-language articles reporting efficacy and safety of nonestrogen treatment modalities for perimenopausal and postmenopausal vasomotor symptoms were evaluated. All articles identified from the data sources were evaluated, and all information deemed relevant was included. Emphasis was placed on randomized, double-blind, placebo-controlled clinical trials, as these provide the best efficacy and safety data. Studies evaluating treatment of vasomotor symptoms from other causes, such as cancer or chemotherapy, were excluded. DATA SYNTHESIS: Prescription medications reviewed for efficacy and safety in postmenopausal vasomotor symptoms include clonidine hydrochloride, danazol, gabapentin, methyldopa, mirtazapine, progestins, propranolol hydrochloride, selective serotonin-reuptake inhibitors (SSRIs), and venlafaxine. Nonprescription therapies reviewed include black cohosh, dong quai, evening primrose oil, physical activity, phytoestrogens, and red clover. CONCLUSIONS: According to this systematic literature review, postmenopausal vasomotor treatments that have been shown to be safe and effective in short-term use include black cohosh, exercise, gabapentin, medroxyprogesterone acetate, SSRIs (ie, paroxetine hydrochloride), and soy protein. Initial, small reports are suggestive for efficacy in menopausal vasomotor symptoms with megestrol acetate and venlafaxine.

Exercise Therapy↗

PubMed1997

Evaluation of prenatal care information on birth certificates.

Misclassification frequently leads to bias in epidemiological studies, and causes concern for perinatal epidemiologists interested in using birth certificates as a data source. We used a maximum likelihood method to estimate the classification probabilities (conditional probabilities that indicate the probability of classification in a particular category, given the person's true category) of two data sources for a three-category outcome of prenatal care. The probability that women receiving adequate or inadequate care were correctly classified was estimated to be greater than 90%. The probability was much lower (< 35%) that women receiving intermediate care were correctly classified. The misclassification women from the intermediate category resulted in poor predictive values (< 70%) of women classified as receiving either adequate or inadequate care. Because of these findings, we combined the adequate and intermediate categories to form a two-category classification system. This revision resulted in higher positive predictive values (> 90%) with only a slightly lower classification probability (> 85%) for the combined category. We conclude that the degree of accuracy for a two-category classification of prenatal care based upon birth certificate information is acceptable, but we question the accuracy of indices of prenatal care with more than two categories.

Birth Certificates↗

PubMed2006

Record linkage and capture-recapture estimates for underreporting of human leptospirosis in a Brazilian health district.

Record linkage and capture-recapture models were used to estimate the number of cases of human leptospirosis in the health district of Santa Maria, RS in southern Brazil. Twelve months of laboratory, hospital and epidemiological surveillance data were matched by name, age, residence and the month of diagnosis. Only laboratory-confirmed cases were considered. The record linkage revealed more than 20 times more cases than the official estimate for the health district, indicating a leptospirosis epidemic, with an annual incidence of more than 3 per 1,000 inhabitants and a case fatality of 0.37%. Severe cases were predominantly found through hospital records, overlapping to some extent with the epidemiological surveillance data, whereas less severe cases were found almost exclusively through laboratory logs. Different combinations of data sources influenced the detection rate for low versus high severity cases. Based on log-linear capture-recapture models, stratified by case severity and taking into account possible dependencies between the data sources, an insignificant number of cases were missed by all sources.

Brazil↗

PubMedDate not supplied

Potential reduction in mortality rates using an intensivist model to manage intensive care units.

CONTEXT: Because of evidence suggesting that outcomes are better in "intensivist-model" intensive care units (ICUs), the Leapfrog Group's hospital safety standards propose that ICUs be managed by critical care physicians (intensivists) who work exclusively in the ICU. COUNT: Number of lives saved annually in the United States. CALCULATION: Lives saved = (number of ICU admissions x in-hospital mortality rate of ICU patients) x reduction in mortality rates associated with the intensivist model. DATA SOURCE: Reduction in mortality rate associated with intensivist-model ICUs was determined by performing a structured literature review from 1986 to the present using MEDLINE. Other variables were estimated from various data sources. RESULTS: In the nine studies that met our selection criteria, relative reductions in mortality rates associated with intensivist-model ICUs ranged from 15% to 60%. On the basis of the most conservative estimate of effectiveness (15% reduction), full implementation of intensivist-model ICUs would save approximately 53,850 lives each year in the United States. CAUTIONS: Given the large number of ICU patients and their high baseline risks, even modest reductions in mortality rates would save many lives. Because of potential constraints related to the workforce and other resources, the feasibility of fully implementing intensivist-model ICUs nationwide is uncertain.

Health Services Research↗

PubMed2004

Bio-ALIRT biosurveillance detection algorithm evaluation.

INTRODUCTION: Early detection of disease outbreaks by a medical biosurveillance system relies on two major components: 1) the contribution of early and reliable data sources and 2) the sensitivity, specificity, and timeliness of biosurveillance detection algorithms. This paper describes an effort to assess leading detection algorithms by arranging a common challenge problem and providing a common data set. OBJECTIVES: The objectives of this study were to determine whether automated detection algorithms can reliably and quickly identify the onset of natural disease outbreaks that are surrogates for possible terrorist pathogen releases, and do so at acceptable false-alert rates (e.g., once every 2-6 weeks). METHODS: Historic de-identified data were obtained from five metropolitan areas over 23 months; these data included International Classification of Diseases, Ninth Revision (ICD-9) codes related to respiratory and gastrointestinal illness syndromes. An outbreak detection group identified and labeled two natural disease outbreaks in these data and provided them to analysts for training of detection algorithms. All outbreaks in the remaining test data were identified but not revealed to the detection groups until after their analyses. The algorithms established a probability of outbreak for each day's counts. The probability of outbreak was assessed as an "actual" alert for different false-alert rates. RESULTS: The best algorithms were able to detect all of the outbreaks at false-alert rates of one every 2-6 weeks. They were often able to detect for the same day human investigators had identified as the true start of the outbreak. CONCLUSIONS: Because minimal data exists for an actual biologic attack, determining how quickly an algorithm might detect such an attack is difficult. However, application of these algorithms in combination with other data-analysis methods to historic outbreak data indicates that biosurveillance techniques for analyzing syndrome counts can rapidly detect seasonal respiratory and gastrointestinal illness outbreaks. Further research is needed to assess the value of electronic data sources for predictive detection. In addition, simulations need to be developed and implemented to better characterize the size and type of biologic attack that can be detected by current methods by challenging them under different projected operational conditions.

Algorithms↗

PubMed1991

Child pedestrian injury: a population-based collision and injury severity profile.

Linked multiple data sources were analyzed to provide a population-based collision and injury severity profile among pedestrians under 20 years of age struck by a motor vehicle during 1986-1987 in Hartford, Connecticut. Data sources included police accident reports, medical examiner records, and hospital charts. There were 234 motor vehicle-pedestrian collisions reported to the police in the study period. Of these, 213 were Hartford residents resulting in an annual age-specific pedestrian collision rate of 22.8 per 10,000 persons. A spot map of collision location reveals several well-defined geographic areas, which includes nearly half (45%) of the motor vehicle-pedestrian collisions. We reviewed 143 of 192 medical charts (75%) and 6 medical examiner records. The case fatality rate was 4.2% and the mean Injury Severity Score was 4.4. These findings will be useful for designing, implementing, and evaluating a targeted child pedestrian safety program.

Accidents, Traffic↗

PubMedDate not supplied

Overview of oral modified-release opioid products for the management of chronic pain.

OBJECTIVE: To evaluate pharmaceutical and pharmacotherapeutic differences in oral opioid modified-release products used in the management of chronic pain. DATA SOURCES: Searches of MEDLINE (1966-May 2006) and an extensive review of peer reviewed journals were conducted using the key search terms opioid, morphine, hydromorphone, and oxycodone. Supplemental information was gathered through the American Pain Society, and limited but relevant information was obtained from manufacturers' labeling. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated. Information deemed relevant was included for this review if it introduced new or well supported concepts or clarified clinical practice issues. DATA SYNTHESIS: The recognition and treatment of pain has become a major focus of healthcare professionals. The Joint Commission on Accreditation of Healthcare Organizations mandates compliance with recommended standards, outcome measures, and other initiatives. A general review of pain management and pharmacokinetic parameters are included. CONCLUSIONS: Oral modified-release products have enabled patients to better maintain pain control due to convenient dosing intervals and sustained blood concentrations. The differences between available oral modified-release products are half-life, cost, and formulation (excipients and drug-release properties).

Administration, Oral↗

PubMed2001

Herbal medicines and perioperative care.

CONTEXT: Widespread use of herbal medications among the presurgical population may have a negative impact on perioperative patient care. OBJECTIVES: To review the literature on commonly used herbal medications in the context of the perioperative period and provide rational strategies for managing their preoperative use. DATA SOURCES: The MEDLINE and Cochrane Collaboration databases were searched for articles published between January 1966 and December 2000 using the search terms herbal medicine, phytotherapy, and alternative medicine and the names of the 16 most commonly used herbal medications. Additional data sources were obtained from manual searches of recent journal articles and textbooks. STUDY SELECTION: We selected studies, case reports, and reviews addressing the safety and pharmacology of 8 commonly used herbal medications for which safety information pertinent to the perioperative period was available. DATA EXTRACTION: We extracted safety, pharmacodynamic, and pharmacokinetic information from the selected literature and reached consensus about any discrepancies. DATA SYNTHESIS: Echinacea, ephedra, garlic, ginkgo, ginseng, kava, St John's wort, and valerian are commonly used herbal medications that may pose a concern during the perioperative period. Complications can arise from these herbs' direct and pharmacodynamic or pharmacokinetic effects. Direct effects include bleeding from garlic, ginkgo, and ginseng; cardiovascular instability from ephedra; and hypoglycemia from ginseng. Pharmacodynamic herb-drug interactions include potentiation of the sedative effect of anesthetics by kava and valerian. Pharmacokinetic herb-drug interactions include increased metabolism of many drugs used in the perioperative period by St John's wort. CONCLUSIONS: During the preoperative evaluation, physicians should explicitly elicit and document a history of herbal medication use. Physicians should be familiar with the potential perioperative effects of the commonly used herbal medications to prevent, recognize, and treat potentially serious problems associated with their use and discontinuation.

Dietary Supplements↗

PubMed2003

How useful are unpublished data from the Food and Drug Administration in meta-analysis?

The goals of this systematic review and meta-analysis were to ascertain whether studies of nonsteroidal anti-inflammatory drugs (NSAIDs) summarized in the FDA reviews are ultimately published, to compare the methodologic and population characteristics of studies summarized in the FDA reviews with those reported in peer reviewed literature, and to compare the pooled relative risk of dyspepsia from NSAIDs in each data source. Summary measures of risk difference were calculated with a random effects model; meta-regression was used to assess the effect of study covariates. Among 37 studies described in the FDA reviews, one was published. Sample size, gender distribution, indication for drug use, and methodologic quality did not vary significantly between the published and FDA data. The pooled risk ratio for dyspepsia obtained using published data (1.21) or FDA data (1.07) did not differ significantly or practically. Data from FDA reviews may be a viable data source for systematic reviews and meta-analyses but only after being subjected to the same methodologic scrutiny as published data.

Adult↗

PubMed2004

Bioinformatics integration and agent technology.

Vast amounts of life sciences data are scattered around the world in the form of a variety of heterogeneous data sources. The need to be able to co-relate relevant information is fundamental to increase the overall knowledge and understanding of a specific subject. Bioinformaticians aspire to find ways to integrate biological data sources for this purpose and system integration is a very important research topic. The purpose of this paper is to provide an overview of important integration issues that should be considered when designing a bioinformatics integration system. The currently prevailing approach for integration is presented with examples of bioinformatics information systems together with their main characteristics. Here, we introduce agent technology and we argue why it provides an appropriate solution for designing bioinformatics integration systems.

Algorithms↗