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PubMed2006

The efficacy and safety of multivitamin and mineral supplement use to prevent cancer and chronic disease in adults: a systematic review for a National Institutes of Health state-of-the-science conference.

BACKGROUND: Multivitamin and mineral supplements are the most commonly used dietary supplements in the United States. PURPOSE: To synthesize studies on the efficacy and safety of multivitamin/mineral supplement use in primary prevention of cancer and chronic disease in the general population. DATA SOURCES: English-language literature search of the MEDLINE, EMBASE, and Cochrane databases through February 2006 and hand-searching of pertinent journals and articles. STUDY SELECTION: Randomized, controlled trials in adults were reviewed to assess efficacy, and randomized, controlled trials and observational studies in adults or children were reviewed to assess safety. DATA EXTRACTION: Paired reviewers extracted data and independently assessed study quality. DATA SYNTHESIS: 12 articles from 5 randomized, controlled trials that assessed efficacy and 8 articles from 4 randomized, controlled trials and 3 case reports on adverse effects were identified. Study quality was rated fair for the studies on cancer, cardiovascular disease, cataracts, or age-related macular degeneration and poor for the studies on hypertension. In a poorly nourished Chinese population, combined supplementation with beta-carotene, alpha-tocopherol, and selenium reduced the incidence of and mortality rate from gastric cancer and the overall mortality rate from cancer by 13% to 21%. In a French trial, combined supplementation with vitamin C, vitamin E, beta-carotene, selenium, and zinc reduced the rate of cancer by 31% in men but not in women. Multivitamin and mineral supplements had no significant effect on cardiovascular disease or cataracts, except that combined beta-carotene, selenium, alpha-tocopherol, retinol, and zinc supplementation reduced the mortality rate from stroke by 29% in the Linxian study and that a combination of 7 vitamins and minerals stabilized visual acuity loss in a small trial. Combined zinc and antioxidants slowed the progression of advanced age-related macular degeneration in high-risk persons. No consistent adverse effects of multivitamin and mineral supplements were evident. LIMITATIONS: Only randomized, controlled trials were considered for efficacy assessment. Special nutritional needs, such as use of folic acid by pregnant women to prevent birth defects, were not addressed. Findings may not apply to use of commercial multivitamin supplements by the general U.S. population. CONCLUSIONS: Evidence is insufficient to prove the presence or absence of benefits from use of multivitamin and mineral supplements to prevent cancer and chronic disease.

Adult↗

PubMed2004

In-line river monitoring--new challenges and opportunities.

Water management becomes a complex issue when considering the large number of water-rights-of-use like drinking water production, recreation, receiving water, transport on and ecological quality of the water bodies. Recent changes in the legal requirements concerning water management on European scale (EC Water Framework Directive, 2000/60/EC) highlighted the need for appropriate means for monitoring water quality and exchange of water quality data. Indirect measurement of water quality using surrogate parameters (chemical and physical-chemical parameters) can be automated at a high accuracy level. This was shown over the past years by national and international research projects. In 2001 such a research project has started in Austria focusing on the installation and operation of a pilot water quality network, which is suitable for application at several points of interest of water management, i.e. sewer networks, wastewater treatment plants and receiving water bodies. The paper describes the operational problems and experiences of collecting data over a period of one year in the Danube River downstream of Vienna. The sensors are installed in situ, directly in the river, without any bypass system. The first evaluation of the measurements shows that the values are reliable and therefore applicable to further interpretations.

Austria↗

PubMed1980

Quality control of agar diffusion susceptibility tests. Data from the Quality Assurance Service Microbiology Program of the College of American Pathologists.

From 1974 through December 1978, over 180 laboratories participated in the Microbiology Program of the College of American Pathologists Quality Assurance Service (QAS), submitting a total of 2,372,000 individual antibiotic determinations on three quality control reference strains. Of these determinations, 89.5% were obtained by the standard Bauer-Kirby method; 8.4% by the agar overlay modification of Barry and associates. Standard statistical analysis of data obtained using the agar overlay modification has been reported for each antimicrobic/reference strain combination. Comparisons have been made between the QAS data and those data obtained in earlier collaborative studies, which currently serve as precision and accuracy control limits. In many cases QAS data exceed the existing control limits.

Anti-Bacterial Agents↗

PubMed2006

Probabilistic evaluation of ammonia toxicity in Milwaukee's Outer Harbor.

Water-quality models that are simple yet sound and reliable and that correspond to water-quality criteria that include magnitude, frequency, and duration components are needed. Monte Carlo models are developed on the basis of available flow and water-quality data and a deterministic water-quality model appropriate for the problem at hand and the data available. Monte Carlo models yield time series and probability distributions of constituents of interest in conformance with water-quality criteria. The application of a Monte Carlo model to the probabilistic evaluation of ammonia toxicity in Milwaukee's Outer Harbor is presented here. Under typical operating conditions for the Jones Island Wastewater Treatment Plant, ammonia toxicity was found to not be a problem for the Outer Harbor. The Monte Carlo model then was used to determine effluent limits that would meet the ammonia toxicity criteria.

Ammonia↗

PubMed2004

Assessment of gross motor development in the WHO Multicentre Growth Reference Study.

The objective of the Motor Development Study was to describe the acquisition of selected gross motor milestones among affluent children growing up in different cultural settings. This study was conducted in Ghana, India, Norway, Oman, and the United States as part of the longitudinal component of the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS). Infants were followed from the age of four months until they could walk independently. Six milestones that are fundamental to acquiring self-sufficient erect locomotion and are simple to evaluate were assessed: sitting without support, hands-and-knees crawling, standing with assistance, walking with assistance, standing alone, and walking alone. The information was collected by both the children's caregivers and trained MGRS fieldworkers. The caregivers assessed and recorded the dates when the milestones were achieved for the first time according to established criteria. Using standardized procedures, the fieldworkers independently assessed the motor performance of the children and checked parental recording at home visits. To ensure standardized data collection, the sites conducted regular standardization sessions. Data collection and data quality control took place simultaneously. Data verification and cleaning were performed until all queries had been satisfactorily resolved.

Brazil↗

PubMed1996

Methodological considerations in participant event monitoring of low-base-rate events in health psychology: children's injuries as a model.

The present article outlines the advantages of the participant event monitoring methodology for the investigation of unpredictable, low-base-rate events in children. Several methods for assessing the quality of participant event monitoring data are advanced with a data set showing participant event monitoring of children's minor injuries by 61 children and their mothers. Child-mother correspondence and debriefing data suggest good accuracy for frequency estimates. Home- and laboratory-based simulations illustrate the participant event monitors' accuracy for major details. Traditional measures of data quality show good overall coder and test-retest reliability, and cross-observer reports show acceptable estimates of validity for objective aspects of the events and the expected lower estimates for the more subjective aspects. Conceptual and pragmatic difficulties of the method are considered, and suggestions for future research are advanced.

Accident Prevention↗

PubMedDate not supplied

Practical approaches to minimize problems with missing quality of life data.

Missing information on quality of life (QOL) is a significant problem in many cancer trials particularly for patients with advanced disease, where clinical deterioration may be a reason for not responding to quality of life assessments. Examples from four clinical trials are presented where non-respondents to quality of life assessments have poorer health than respondents. In this context, auxiliary outcome variables, such as health status, may be useful proxies in assessing the impact of missing QOL data on estimated treatment effects. This approach is illustrated in a trial of palliative treatment in advanced cancer. A method for imputation of missing QOL data based on auxiliary outcome variables is also illustrated. However, the most effective method of minimizing the problem of missing data is in designing the trial with preventative strategies in place. Since some missing data due to deteriorating health may still occur, the design should include the collection of auxiliary QOL information. Preventative strategies are illustrated with an ongoing trial in advanced breast cancer.

Breast Neoplasms↗

PubMed2005

Information governance standards for managing e-health information.

Integrity of patient information, from both a quality and a security perspective, is critical to patient care. In the UK, the information governance initiative of the National Health Service (NHS) provides a framework to monitor and control the management of confidential patient data. Information governance standards grew out of the Data Accreditation Programme, first proposed in the 1998 NHS document Information for Health. The Data Accreditation Programme was based on a three-stage assessment of data quality in acute hospitals. Stage one required internal review of policy and procedures for data input into computerized patient administration systems. Stage two involved an external audit to verify compliance with the standards. Stage three mandated audits of data outputs, focusing on clinical coding quality. Before stage three of the programme was fully implemented, the standards were incorporated into the information governance initiative, in which standards were expanded to include primary care and other health-care settings. These standards address many information management issues, including security and data quality, which are key concerns in telemedicine and e-health applications. Compliance is essential for the successful implementation of the NHS Care Records Service, which will allow sharing of electronically stored patient information across the UK.

Confidentiality↗

PubMed2002

[Risk and prevention of lesions of the lingual nerve in wisdom tooth osteotomy. Analysis of the literature and faculty opinion in maxillofacial surgery in German-speaking countries].

BACKGROUND: Disturbance of lingual nerve function is one of the relevant complications after surgical removal of lower third molars. In the literature, however, protective measures against this complication are not unanimously recommended. In order to find out the current opinion in terms of the state of the art in this field, a questionnaire was sent to the heads of 39 University Departments for Oral and Maxillofacial Surgery in Germany, Austria, and Switzerland. All of them responded. TECHNICAL FINDINGS: In 54% of the departments, a periosteal elevator or similar instrument is recommended for the protection of the lingual nerve in every instance, whereas in 8% of the departments this is not recommended. In the remaining departments, the decision about protective measures is made according to the individual anatomical situation. STATISTICS AND DISCUSSION: The literature review revealed insufficient data quality for a sound data-based decision on whether and when to use an instrument to protect the lingual nerve. In any case, the statistical risk of a temporary disturbance of the lingual nerve seems to be higher with use of the lingual split (0.5%-19.8%) than with the lateral osteomtomy technique (0%-1.9%). In contrast to widespread opinion, even in anatomically difficult cases, there seems to be no statistical advantage of the standardized use of a protective instrument either in respect to temporary or permanent nerve damage. Yet, a slight increase of temporary lesions seems to be documented when the instrument is used. According to the current literature data, the subperiosteal insertion of an instrument to protect the lingual nerve cannot be considered an essential standard procedure in each case.

Attitude of Health Personnel↗

PubMed2005

Tissues from population-based cancer registries: a novel approach to increasing research potential.

Population-based cancer registries, such as those included in the Surveillance, Epidemiology, and End-Results (SEER) Program, offer tremendous research potential beyond traditional surveillance activities. We describe the expansion of SEER registries to gather formalin-fixed, paraffin-embedded tissue from cancer patients on a population basis. Population-based tissue banks have the advantage of providing an unbiased sampling frame for evaluating the public health impact of genes or protein targets that may be used for therapeutic or diagnostic purposes in defined communities. Such repositories provide a unique resource for testing new molecular classification schemes for cancer, validating new biologic markers of malignancy, prognosis and progression, assessing therapeutic targets, and measuring allele frequencies of cancer-associated genetic polymorphisms or germline mutations in representative samples. The assembly of tissue microarrays will allow for the use of rapid, large-scale protein-expression profiling of tumor samples while limiting depletion of this valuable resource. Access to biologic specimens through SEER registries will provide researchers with demographic, clinical, and risk factor information on cancer patients with assured data quality and completeness. Clinical outcome data, such as disease-free survival, can be correlated with previously validated prognostic markers. Furthermore, the anonymity of the study subject can be protected through rigorous standards of confidentiality. SEER-based tissue resources represent a step forward in true, population-based tissue repositories of tumors from US patients and may serve as a foundation for molecular epidemiology studies of cancer in this country.

Biomarkers, Tumor↗

PubMed1998

Health registers as a feasible means of measuring health status in childhood--a 7-year follow-up of the 1987 Finnish birth cohort.

Follow-up studies on health have usually been based on ad hoc cohort studies in which detailed information is collected specifically for research purposes on a certain group of people. The increasing collection of routine health data provides an alternative method of gathering follow-up data. In this study, the feasibility of using routinely collected health-register data and data linkages to follow up children's health was investigated. Five nationwide registers, 18 regional registers of intellectually disabled children and school administration data in one county were found to be of use for our follow-up and were combined with the 1987 Finnish Medical Birth Register (n = 60,254 births). In the follow-up, 62 children were untraced (0.1%), 327 were stillborn (0.5%), 440 died after birth (0.7%) and 287 emigrated (0.5%) before the age of 7 years. The cumulative incidences for all diseases (8.9% of all children living in Finland at the age of 7 years), for diabetes (3.0/1000), for epilepsy (6.8/1000) and for asthma (34.2/1000) correspond to the estimates of other studies, but our estimate for intellectual disabilities (18.0/1000, of whom 18% were reported to have an IQ of 70 or less) seems to be an underestimate. Our data collection did not provide reliable information on institutionalised children or children taken into care. Data collection conducted by using health registers is a feasible method, and it saves both time and financial resources compared with cohort studies. Potential problems with data linkage studies are variation in the content of data and in data quality of different registers and data protection issues.

Adolescent↗

PubMed2003

Development of a food composition database for the estimation of dietary intakes of glucosinolates, the biologically active constituents of cruciferous vegetables.

Evidence indicates that cruciferous vegetables are protective against a range of cancers with glucosinolates and their breakdown products considered the biologically active constituents. To date, epidemiological studies have not investigated the intakes of these constituents due to a lack of food composition databases. The aim of the present study was to develop a database for the glucosinolate content of cruciferous vegetables that can be used to quantify dietary exposure for use in epidemiological studies of diet-disease relationships. Published food composition data sources for the glucosinolate content of cruciferous vegetables were identified and assessed for data quality using established criteria. Adequate data for the total glucosinolate content were available from eighteen published studies providing 140 estimates for forty-two items. The highest glucosinolate values were for cress (389 mg/100 g) while the lowest values were for Pe-tsai chinese cabbage (20 mg/100 g). There is considerable variation in the values reported for the same vegetable by different studies, with a median difference between the minimum and maximum values of 5.8-fold. Limited analysis of cooked cruciferous vegetables has been conducted; however, the available data show that average losses during cooking are approximately 36 %. This is the first attempt to collate the available literature on the glucosinolate content of cruciferous vegetables. These data will allow quantification of intakes of the glucosinolates, which can be used in epidemiological studies to investigate the role of cruciferous vegetables in cancer aetiology and prevention.

Brassicaceae↗

PubMed2006

Adverse outcomes in surgical patients: implementation of a nationwide reporting system.

PROBLEM: Lack of comparable data on adverse outcomes in hospitalised surgical patients. DESIGN: A Plan-Do-Study-Act (PDSA) cycle to implement and evaluate nationwide uniform reporting of adverse outcomes in surgical patients. Evaluation was done within the Reach Efficacy-Adoption Implementation Maintenance (RE-AIM) framework. SETTING: All 109 surgical departments in The Netherlands. KEY MEASURES FOR IMPROVEMENT: Increase in the number of departments implementing the reporting system and exporting data to the national database. STRATEGIES FOR CHANGE: The intervention included (1) a coordinator who could mediate in case of problems; (2) participation of an opinion leader; (3) a predefined plan of action communicated to all departments (including feedback of results during implementation); (4) connection with existing hospital databases; (5) provision of software and a helpdesk; and (6) an instrument based on nationwide standards. EFFECTS OF CHANGE: Implementation increased from 18% to 34% in 1.5 years. The main reason for not implementing the system was that the Information Computer Technology (ICT) department did not link data with the hospital information system (lack of time, finances, low priority). Only 5% of the departments exported data to the national database. Export of data was hindered mainly by slow implementation of the reporting system (so that departments did not have data to export) and by concerns regarding data quality and public availability of data from individual hospitals. LESSONS LEARNED: Hospitals need incentives to realise implementation. Important factors are financial support, sufficient manpower, adequate ICT linkage of data, and clarity with respect to public availability of data.

Benchmarking↗

PubMed2000

The role of population pharmacokinetics in drug development in light of the Food and Drug Administration's 'Guidance for Industry: population pharmacokinetics'.

Population pharmacokinetics (PPK) has evolved from a discipline primarily applied to therapeutic drug monitoring to one that plays a significant role in clinical pharmacology in general and drug development in particular. In February 1999 the US Food and Drug Administration issued a 'Guidance for Industry: Population Pharmacokinetics' that sets out the mechanisms and philosophy of PPK and outlines its role in drug development. The application of PPK to the drug development process plays an important role in the efficient development of safe and effective drugs. PPK knowledge is essential for mapping the response surface, explaining subgroup differences, developing and evaluating competing dose administration strategies, and as an aid in designing future studies. The mapping of the response surface is done to maximise the benefit-risk ratio, so that the impact of the input profile and dose magnitude on beneficial and harmful pharmacological effects can be understood and applied to individual patients. PPK combined with simulation methods provides a tool for estimating the expected range of concentrations from competing dose administration strategies. Once extracted, this knowledge can be applied to labelling or used to assess various future study designs. PPK should be implemented across all phases of drug development. For preclinical studies, PPK can be applied to allometric scaling and toxicokinetic analyses, and is useful for determining 'first time in man' doses and explaining toxicological results. Phase I studies provide initial understanding of the structural model and the effect of possible covariates, and may later be used to evaluate PPK differences between patients and healthy individuals. Phase II studies provide the greatest opportunity to map the response surface. With these PPK models it is possible to gain an improved understanding of the role of the dose on the response surface and of the range of expected responses. In phase III and IV studies, PPK is implemented to further refine the PPK model and to explain unexpected responses. Planning for the implementation of PPK across all phases of drug development is necessary, as well as planning for individual PPK studies. Planning should include: defining important questions, identifying covariates and drug-drug interactions that need to be investigated, and identifying the applications and intended use of the model(s). The plan for each project must have a strategy for data management, data collection, data quality assurance, staff training for data collection, data analysis and model validation.

Animals↗

PubMedDate not supplied

AHIMA provides testimony on coding/classification issues pertaining to HIPAA (Health Insurance Portability and Accountability Act of 1996) implementation.

In summary, AHIMA has identified the following key issues: Uniformity and consistency must be required of all health-care organization, payers, and other data users. A central authority, comprised of representatives from the public and private sector, should be created to ensure compliance with and enforcement of coding system rules and official coding guidelines. A realistic implementation plan for the introduction of any new coding system, including migration to a single procedural classification system, must be established. Since data quality is based on the data source, clinical vocabulary, and classification system, it is important not to focus on only one component. A standard data set must be established. It is important to maintain data comparability with other nations in order to conduct global research studies. AHIMA has had a long-standing relationship working with the department on coding and classification issues and is committed to providing assistance to carry out out the requirements of the law.

Abstracting and Indexing↗

PubMed1999

[Value of German Hospital Diagnosis Statistics in epidemiology-- an analysis with subarachnoid hemorrhage as an example].

Due to the Hospital Statistics Regulations of the 10th April 1990, the German Hospital Diagnosis Statistics were introduced in 1993 with the intention to serve as a database of health care decisions. This purpose requires a high-quality collection of epidemiologically relevant data. From 1993 to 1996 we analysed the datasets obtainable for subarachnoid haemorrhage which is coded with ICD 430. A subset concerning the data of 1996 and the Saarland region was compared to the data of the Saarland medical school at Homburg/Saar. Cases treated in the neurosurgical department were critically reviewed. About 20% of the cases coded with ICD 430 showed no subarachnoid haemorrhage. On the other hand, again about 20% of subarachnoid haemorrhage cases were not coded with ICD 430. The statistics comprise duplicates due to transfers between hospitals. The calculation of incidence is not possible because new bleeding cases cannot be outlined. In the present form the German Hospital Diagnosis Statistics are not suitable as a reliable base of health care decisions. This is partly caused by the inadequacy of the ICD-classification but, also, by the criteria for collecting data. We propose several modifications which can improve data quality in order to meet the intended requirements.

Databases, Factual↗

PubMed2001

[Using discharge abstracts as a tool to assess a regional perinatal network].

To assess the regional perinatal network of Burgundy (20 obstetrical units; 18,000 births/year), discharge abstracts are collected for all mothers and all neonates. Discharge abstracts are expanded with some additional data. According to the French law, data are rendered anonymous in each hospital before their transmission to the teaching hospital for statistical analysis. The linkage of all anonymous information concerning a patient is obtained. Moreover, this specific procedure allows the linkage of data concerning each mother and her corresponding neonate. This study shows that after an expanded data quality control, the linkage between data of the mothers and their infants is obtained in 99.8% of births.

Adult↗

PubMedDate not supplied

Infant mortality trends and differentials in Nepal.

Infant mortality trends and differentials are estimated from the 1981 Nepal Contraceptive Prevalence Survey (NCPS) and compared with similar estimates from the 1976 Nepal Fertility Survey (NFS) and the 1981 Census of Nepal. The analysis indicates that infant mortality rates derived directly from the NFS maternity histories are the most accurate. Infant mortality rates derived directly from the NCPS maternity histories are severely underestimated and yield a strongly biased trend that is the reverse of the true downward trend. Indirect estimates of infant mortality trends derived from child survivorship data do not result in a consistent pattern. Infant mortality differentials, when expressed in relative rather than absolute terms, are generally consistent with findings from earlier studies. Possible reasons for data quality differences among the three data sources are discussed.

Actuarial Analysis↗