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Benefit of heparin in central venous and pulmonary artery catheters: a meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the effect of heparin on thrombus formation and infection associated with use of central venous and pulmonary artery catheters. DATA SOURCES: We used MEDLINE, EMBASE, citation review of relevant primary and review articles, personal files, and contact with expert informants. STUDY SELECTION: Fourteen randomized controlled trials evaluating prophylactic doses of heparin or heparin bonding were included. DATA EXTRACTION: In duplicate, independently, we abstracted data on the population, intervention, outcome, and methodologic quality. DATA SYNTHESIS: Prophylactic heparin decreases catheter-related venous thrombosis (relative risk [RR], 0.43; 95% confidence interval [CI], 0.23, 0.78) and bacterial colonization (RR, 0.18; 95% CI, 0.06, 0.60) of central venous catheters and may decrease catheter-related bacteremia (RR, 0.26; 95% CI, 0.07, 1.03). Heparin bonding decreases the risk of pulmonary artery catheter clot formation within 24 h (RR, 0.08; 95% CI, 0.02, 0.37). CONCLUSIONS: Heparin administration effectively reduces thrombus formation and may reduce catheter-related infections in patients who have central venous and pulmonary artery catheters in place. Cost-effectiveness comparisons of unfractionated heparin, low molecular weight heparin, and warfarin are needed.

Adult↗

Completeness and validity of cancer registration in a major public referral hospital in Saudi Arabia.

BACKGROUND: The 1994 Saudi National Cancer Registry (NCR), a population-based registry, showed a crude incidence rate (CIR) of 39/100,000 for all cancers in the Saudi population. The low CIR suggested possible under-reporting, especially during the early years of operation. This study as aimed at estimating the number of missed cases due to under-reporting, and to assess the validity of reported data from a major public referral hospital in Riyadh city. MATERIALS AND METHODS: We compared cancer cases from the three data sources: medical records (MR), which were the original source of NCR cases; pathology reports (PR); and death certificates (DC). We estimated the missing cancer cases using the capture-recapture method with log-linear models of Fienberg to correct for interdependency between the three data sources. To assess the validity of the data, we reabstracted records of about 8% (39/4760 of previously reported cases from the same hospital. RESULTS: A total of 811 cancer cases were reported through the three sources, i.e., MR 611 (75.3%), PR 639 (78.8%) and DC 204 (25.2%). After fitting a series of log-linear models to the three sources of data, the three sources were found to be statistically dependent. Capture-repcapture method indicated that 384 cases were missed, giving an estimation of 1195 cancer cases to be reported. Using these 1195 estimated cases; the estimated ascertainment rates were 51% for medical records, 53% for pathology reports, 17% for death certificates, and 68% for the aggregated registry. In the validity assessment, major disagreement between the abstracted and reabstracted data was found to be highest for stage of disease (44%), followed by histology code and behavior (25.6%). Minor disagreements were most common for date of diagnosis (36%) and grade (36%). Overall, agreements were highest for laterality (95%), followed by primary site codes (90%) and basis of diagnosis (85%). Agreement of tumor description variables (site, histology, behavior, and stage) was 57%. CONCLUSION: Cancer registration will require substantial improvements in both completeness of reporting and data quality at the hospital level. Use of multiple data sources and estimation of missed cases will help ensure completeness of case registration.

Journal Article↗

Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment?

BACKGROUND: Studies from the Spanish influenza era reported that transfusion of influenza-convalescent human blood products reduced mortality in patients with influenza complicated by pneumonia. Treatments for H5N1 influenza are unsatisfactory, and convalescent human plasma containing H5N1 antibodies could be an effective therapy during outbreaks and pandemics. PURPOSE: To determine whether transfusion with influenza-convalescent human blood products reduced the risk for death in patients with Spanish influenza pneumonia. DATA SOURCES: Manual search of English-language journals from 1918 to 1925. Citations from retrieved studies were also searched. STUDY SELECTION: Published English-language studies that had at least 10 patients in the treatment group, used convalescent blood products to treat Spanish influenza pneumonia in a hospital setting, and reported on a control or comparison group. DATA EXTRACTION: Two investigators independently extracted data on study characteristics, outcomes, adverse events, and quality. DATA SYNTHESIS: Eight relevant studies involving 1703 patients were found. Treated patients, who were often selected because of more severe illness, were compared with untreated controls with influenza pneumonia in the same hospital or ward. The overall crude case-fatality rate was 16% (54 of 336) among treated patients and 37% (452 of 1219) among controls. The range of absolute risk differences in mortality between the treatment and control groups was 8% to 26% (pooled risk difference, 21% [95% CI, 15% to 27%]). The overall crude case-fatality rate was 19% (28 of 148) among patients who received early treatment (after <4 days of pneumonia complications) and 59% (49 of 83) among patients who received late treatment (after > or =4 days of pneumonia complications). The range of absolute risk differences in mortality between the early treatment group and the late treatment group was 26% to 50% (pooled risk difference, 41% [CI, 29% to 54%]). Adverse effects included chill reactions and possible exacerbations of symptoms in a few patients. LIMITATIONS: Studies were few and had many methodologic limitations. No study was a blinded, randomized, or placebo-controlled trial. Some pertinent studies may have been missed. CONCLUSIONS: Patients with Spanish influenza pneumonia who received influenza-convalescent human blood products may have experienced a clinically important reduction in the risk for death. Convalescent human H5N1 plasma could be an effective, timely, and widely available treatment that should be studied in clinical trials.

Antibodies, Viral↗

[Hepatitis B and C: incidence and regional distribution of hospitalizations in Austria].

UNLABELLED: The aim of this study was to describe the incidence as well as the geographical distribution of hospitalizations due to hepatitis B or C (according to ICD 9) in Austria between 1996 and 1998. The data were taken from the MBDS (Minimum Basic Data Set) which contains medical, demographical and administrative recordings of every in-patient treated in an Austrian hospital. Hepatitis B: The mean value of SHR (standardized hospitalization rate) amounted to 3.2/100.000 for the entire area of Austria. Among all Austrian provinces, Vorarlberg yielded the highest regional value (6.4/100.000), Burgenland the lowest one (1.9/100.000). Considerably high regional values of SHR were found in most districts of Vorarlberg, as well as in Vienna and the eastern districts of Lower Austria. Hepatitis C: The mean value of SHR amounted to 8.4/100.000 for the entire area of Austria. Regional SHR values in Austrian provinces ranged widely from 2.9/100.000 (Burgenland) to 15.1/100.000 (Salzburg), some provinces (Salzburg, Carinthia) showed a marked increase of hospitalizations within the observation period. The highest regional values of SHR were found in and around the districts of Salzburg, Villach, and Klagenfurt. CONCLUSIONS: The differences observed in SHR values of Austrian districts cannot be accounted for by local differences of Hepatitis prevalence alone. They are supposedly also due to local differences of the health care system, as well as the clinical, diagnostical or documentational practices in hospitals in different regions. In order to evaluate MBDS-Data quality, a post-hoc comparison with external data stemming from three Austrian multicenter studies was performed. A remarkable correspondence in geographical distribution of hepatitis C patients was found between the two data sets. This is considered an argument in favour of the validity of MBDS-Data.

Austria↗

Regional trends in crude birth, death, and natural increase rates in Russia and the USSR: 1897-1989.

"This paper establishes and discusses briefly regional patterns and trends in crude birth, death, and natural increase rates in Russia and the USSR from the turn of the century to 1989. The study is based on a comparable regional framework and placed in the context of the demographic transition theory. It discusses sources, collection, and quality of data, as well as necessary estimating procedures. An attempt also is made to examine briefly regional age-standardized rates."

Age Factors↗

Advanced Characterization System Deployments at the Hanford Site.

The Advanced Characterization System (ACS) uses readily available commercial radiation Environmental Restoration Contractor (ERC) detection and measurement equipment in a complementary staged system to locate and identity contamination in structures, systems and land area at Hanford's Environmental Restoration Contractor work sites. Large structures, such as former plutonium production reactors and separations facilities, are thoroughly and comprehensively characterized, not only for decontamination and decommissioning (D&D), but also for disposal and/or release. The ACS uses gamma-ray imaging instruments, in situ gamma spectrometry and large-area data-logging contamination survey meters to generate sufficient quality data to make operational and release decisions. The system is also used to safely characterize in-place systems without violating any containment and to localize activity in unusual situations.

Journal Article↗

Advanced characterization system deployments at the hanford site.

The Advanced Characterization System (ACS) uses readily available commercial radiation Environmental Restoration Contractor (ERC) detection and measurement equipment in a complementary staged system to locate and identity contamination in structures, systems and land area at Hanford's Environmental Restoration Contractor work sites. Large structures, such as former plutonium production reactors and separations facilities, are thoroughly and comprehensively characterized, not only for decontamination and decommissioning (D&D), but also for disposal and/or release. The ACS uses gamma-ray imaging instruments, in situ gamma spectrometry and large-area data-logging contamination survey meters to generate sufficient quality data to make operational and release decisions. The system is also used to safely characterize in-place systems without violating any containment and to localize activity in unusual situations.

Decontamination↗

National public health surveillance in China: implications for public health in China and the United States.

STUDY OBJECTIVE: Throughout the world, political developments have brought new demands to communities to prevent and intervene in the incidence of infectious and noninfectious conditions. Historically, these developments have required new and more effective public health surveillance activities. This report describes public health surveillance practice in the People's Republic of China, making comparisons with selected aspects of surveillance in the United States with respect to collection, analysis, dissemination, and use of data. MAIN RESULTS: In both the People's Republic of China and the United States, political change has affected health, and multiple surveillance system are used in public health practice. Surveillance of acute infectious diseases based on the reporting of legally notifiable diseases and the use of vital records for surveillance have the longest established history in both countries. In both countries, data from the surveillance systems have been used to affect public health policy. CONCLUSIONS: In comparing surveillance practices in these countries, we find similarities in conditions reported and in the dissemination of the data. At the same time, legal, social, cultural, and economic differences between the nations have affected the practice of surveillance in analysis and evaluation. We make explicit recommendations for improvement and evaluation of systems in both countries, including sentinel surveillance system and data quality measures in China and computer networking and data analysis in the United States.

Centers for Disease Control and Prevention, U.S.↗

Validation of 1989 Tennessee birth certificates using maternal and newborn hospital records.

In 1989, the state of Tennessee adopted a new birth certificate which incorporates changes recommended by the National Center for Health Statistics in the revised US Standard Certificate of Live Birth. The data now being collected are intended to provide improved information for understanding maternal and infant health issues. To assess data quality, the authors compared information reported on the 1989 Tennessee birth certificates with the same data obtained from an ongoing case-control study in which the delivery hospital medical records of mothers and infants were reviewed by trained nurse abstractors using a structured data collection instrument. Cases (n = 1,016) were all infants born in Tennessee in 1989 with birth weights less than 1,500 g or other infants who died during the first 28 days of life. The infants were identified from linked birth-death certificate files. Control infants (n = 634) were randomly selected from the noncase population. The most reliable information obtained from birth certificates was descriptive demographic data and birth weight. The quality of information obtained from the new birth certificate checkboxes varied. Routine medical procedures were better reported on the birth certificates than relatively uncommon conditions and occurrences, even serious ones. Caution is needed in using birth certificate data for assessment of maternal medical risk factors, complications of labor and delivery, abnormal conditions of the newborn, and congenital anomalies, since sensitivity is low.

Birth Certificates↗

A review of software for data management, design and analysis of clinical trials.

In clinical trials, subjects are usually entered one at a time, and their responses to treatment monitored sequentially. Regular monitoring of trial progress in the early stages is crucial for accurate reporting of the final results. This paper discusses in detail the principles of quality data management in clinical trials, with specific reference to three clinical data management systems namely, CLINTRIAL, ORACLE CLINICAL and MACRO. All three systems have the essential features for monitoring and processing quality clinical trials data. In terms of functionality, there appears to be no significant advantage of one system over the other. However, to reap the full benefits of sophisticated systems such as these, a good support network and comprehensive training programmes are essential since their day-to-day use demands a high level of technical competence. Basic considerations pertinent to the success of a clinical trial involve not only logistics and data management. Issues relating to the study design are also of primary concern. In this respect, we briefly describe some sample size packages, NQUERY, PEST, POWER, POWER AND PRECISION and SAMPSIZE. Finally, a brief comparison is made with regards to some distinct features of three commonly used statistical packages, namely SPSS, SAS and STATA.

Clinical Trials as Topic↗

A novel method for patch-clamp automation.

An increasing demand of the pharmaceutical industry for automated electrophysiological stations for ion channel drug discovery has recently resulted in the development of several commercial platforms for secondary and safety screening of ion channel modulators. These commercial systems have demonstrated an enhanced throughput, however, often at the expense of some quality-sensitive aspects of traditional patch-clamp recordings. To improve data quality and content, we have developed a patch-clamp robot that fully automates manual patch-clamp recordings, including patch pipette handling, gigaseal formation, obtaining whole-cell or perforated-cell configuration, drug application, and data acquisition. Utilization of glass micropipettes results in high-quality electrophysiological recordings with an overall success rate of about 30% in perforated-cell mode. A fast drug application system with low volume requirements (1-1.5 ml) allows the study of ligand-gated ion channels on a millisecond scale. As proof-of-concept, we present two assays developed for voltage-gated human ether-a-go-go-related and ligand-gated alpha(7) nicotinic receptor ion channels. The system throughput was a single concentration-response curve every 30-40 min or 12-17 6-point concentration-response curves daily, representing a significant improvement of typical manual patch-clamp throughput. This system represents an efficient method for patch-clamp automation without the need for a complex and expensive electrophysiological set-up for cell visualization.

Animals↗

The California Clinical Data Project: a case study in the adoption of clinical data standards for quality improvement.

The California Clinical Data Project is a statewide initiative to remove barriers to the widespread and effective use of information technology to improve chronic disease care. The project is a case study in the development and widespread adoption of clinical data standards by varied and often competing stakeholders. As an initial step, the project defined precise data standards for the batch reporting of pharmacy claims data and laboratory results data. These uniform standards facilitate the flow of existing electronic clinical information into disease registries and electronic health record systems. Pharmacy and lab results data now are being exchanged electronically with this standard among the largest health plans, medical groups, and clinical laboratories participating in California's pay-for-performance programs. Lessons from this project may apply to the development and adoption of data standards for other states and locales and for the emerging national health information infrastructure.

California↗

Selection models and pattern-mixture models to analyse longitudinal quality of life data subject to drop-out.

Longitudinally observed quality of life data with large amounts of drop-out are analysed. First we used the selection modelling framework, frequently used with incomplete studies. An alternative method consists of using pattern-mixture models. These are also straightforward to implement, but result in a different set of parameters for the measurement and drop-out mechanisms. Since selection models and pattern-mixture models are based upon different factorizations of the joint distribution of measurement and drop-out mechanisms, comparing both models concerning, for example, treatment effect, is a useful form of a sensitivity analysis.

Aged↗

Comparison of immunoassays for tumor markers CA 19-9, CA 15-3 and CA 125: data from an international quality assessment scheme.

Data collected in the 1993 and 1994 cycles of an international external quality assessment (EQA) program and in a national multicenter collaborative study were cumulatively analyzed to evaluate the standardization of the methods currently in use for the assay of mucinous tumor markers CA 19-9, CA 15-3 and CA 125. On average the between-laboratory variability was 15.2 and 16.0 CV% for CA 15-3 and CA 125 respectively; the between-laboratory variability found for CA 19-9 was markedly worse (mean 28.3 CV%). The variability component attributable to systematic differences between different methods/kits was relatively small for CA 15-3 and CA 125 (18% and 24% of the total variability) but markedly larger for CA 19-9 (48% of the total variability). The agreement of CA 19-9 results worsened in the last few years when new nonisotopic techniques became available. The precision of the methods/kits most used in the survey ranged from 9.9 to 13.3 CV% for CA 125 and from 11.6 to 13.9 CV% for CA 15-3. For these two tumor markers the precision of the traditional IRMAs does not appear different from that of the new fully automated nonisotopic techniques. The precision of CA 19-9 methods was on average worse (from 11.7 to 19.6 CV%) although two automated systems exhibited a precision better than that of IRMAs. In conclusion, the results of this study indicate that CA 15-3 and CA 125 are satisfactorily assayed whereas CA 19-9 assay appears affected by larger differences between methods and by poorer precision of laboratories and kits.

Antigens, Tumor-Associated, Carbohydrate↗

Epidemiology of constipation in North America: a systematic review.

OBJECTIVE: The aim of this study was to systematically review the published literature regarding prevalence, risk factors, incidence, natural history, and the effect on quality of life of constipation in North America. METHODS: A computer-assisted search of MEDLINE, EMBASE, and Current Contents databases was performed independently by two investigators. Study selection criteria included the following: (1) North American population-based sample of adults with constipation; (2) publication in full manuscript form in English; and (3) report on the prevalence, incidence, and natural history of constipation or impact of constipation on quality of life. Eligible articles were reviewed in a duplicate, independent manner. Data extracted were compiled in tables and presented in descriptive form. RESULTS: The estimates of the prevalence of constipation in North America ranged from 1.9% to 27.2%, with most estimates from 12% to 19%. Prevalence estimates by gender support a female-to-male ratio of 2.2:1. Constipation appears to increase with increasing age, particularly after age 65. No true population-based incidence studies or natural history studies were identified. In one cohort, 89% of patients with constipation still reported constipation at 14.7 months follow-up. From limited data, quality of life appears to be diminished by constipation, but the clinical significance of this is unclear. CONCLUSIONS: Constipation is very common, as approximately 63 million people in North America meet the Rome II criteria for constipation. Minimal data are available regarding incidence, natural history, and quality of life in patients with constipation. Effort should be expended toward the study of these topics, particularly in the elderly, who are disproportionately affected by this condition.

Constipation↗

The quality of histopathology data in a computerised cancer registration system: implications for future audit of care.

Electronic linkage between pathology data sources and other information systems has not realised its full potential benefits due to the poor quality of histopathology coding. This study showed that 38% of a sample of 158 pathology reports were coded accurately. Of the incorrectly coded reports, 25% had the potential to distort published cancer incidence figures. The incidence figures of the most common cancers are less likely to be affected by coding errors. Areas in which all errors, both topographical and morphological, could have significant impact include examining resource allocation at directorate level and adjusting outcome indicators for casemix. This study concludes that electronic linkage between histopathology systems and cancer registries is not sufficient to improve the quality of registration data. As cancer registries become more dependent on computerised information provided through hospital information systems, registries need to be aware of poor quality data and put in place appropriate quality assurance measures specifically tailored to support electronic cancer registration. Purchasers and providers need to be aware that incomparable datasets could be produced if other bodies use computerised pathology datasets without first validating the data.

England↗

Use of insurance claims data in measuring quality of care.

This article discusses data that might be used for measuring quality of care, for health care administrative purposes, and for tracking the use of technologies. The advantages and limitations of administrative data banks for research purposes and some process-of-care and outcome analysis are noted. Three important obstacles to their use--reliability of diagnosis and service information, unique patient identifiers, and provider identifiers--are discussed briefly.

Health Services Research↗