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PubMed1991

The positive known association design: a quality assurance method for occupational health surveillance data.

Quality control must be an integral component of an occupational health surveillance program. The positive known association design offers the occupational health physician a method to test, on a population basis (ie, high periodic medical surveillance examination participation rates by the employees), the quality of periodic medical surveillance data. Several well-established biological associations were evaluated and observed in this study, including a dramatic relation between white blood cell counts and smoking. We highly recommend that the positive known association design be incorporated in the quality assurance procedures of occupational health surveillance programs.

Adult↗

PubMed2005

Validation in pharmaceutical analysis. Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data.

Validation of analytical procedures is a vital aspect not just for regulatory purposes, but also for their efficient and reliable long-term application. In order to address the performance of the analytical procedure adequately, the analyst is responsible to identify the relevant parameters, to design the experimental validation studies accordingly and to define appropriate acceptance criteria. Establishing an acceptable analytical variability for the given application is of central importance as many other acceptance criteria can be derived from such a precision. Acceptable precision ranges for types of control tests and/or analytes can be obtained from validation, but also related activities such as transfer, control charts, or extracted from routine applications such as batch release or stability studies (data mining). Apart from compiling a database for general benchmarking, during such an information-building process, the reliability of the analytical variability of the specific procedure is more and more increased. This is important as a reliable target variability facilitates to detect or investigate atypical or out-of specification behaviour of analytical data in a routine application, thus improving the data quality and reliability. According to the life-cycle concept of validation, measures should be taken to maintain and control the validated status of analytical procedures during long-term routine application, such as monitoring relevant performance parameters (system suitability tests), control charts, etc. If the analytical system is demonstrated to be stable, i.e. under statistical control, a major variability contribution in LC originating from the standard preparation and analysis can be reduced. A concept of quantification by pre-determined calibration parameters instead of the classical approach of simultaneous calibration is described.

Chemistry, Pharmaceutical↗

PubMed2006

[Quality of data transfer in perinatal data -- experience of a centre].

BACKGROUND: A sufficient quality of data transfer from written patient records to electronic data processing is a precondition for a reasonable usage of perinatal data. However the quality of data transfer of the almost 200 characteristics routinely recorded at each delivery is largely unknown. MATERIALS AND METHODS: The quality of data transfer of 33 characteristics in 350 randomly selected singleton deliveries of the women's clinic of the University of Marburg from 2002 and 2003 has been checked by comparing electronically recorded data with the original written documents. RESULTS: The quality of data transfer of the tested characteristics turned out to be heterogeneous. Characteristics necessary to calculate quality indicators show a very high data quality when excluding the characteristic attendance of a paediatrician. The quality of data transfer of characteristics denoting time as well as blood gas analysis are heterogeneous. Characteristics with a low quality of data transfer are associated with ambiguous instructions, the fact that the coding obstetrician is not dealing in the first instance with the item being encoded and the characteristics are of no immediate relevance for delivery, as well as difficult application of the software. CONCLUSION: The quality of data transfer of the characteristics collected in perinatal surveys needs to be validated. The type and amount of data being collected should be reassessed considering improvements of data quality.

Documentation↗

PubMedDate not supplied

The quality management system as a tool for improving stakeholder confidence.

The Corps of Engineers works with local restoration advisory boards (RAB) to exchange information and develop plans for restoration of closed military bases for civilian reuse. Meetings of the RAB to discuss progress in environmental assessment and restoration of former defense sites can be contentious due to the complex technical nature of the information to be shared and the personal stake that the members of the community have in ensuring that contentious areas are restored for safe use. A prime concern of community representatives is often the quality of the data used to make environmental decisions. Laboratory case narratives and data flags may suggest laboratory errors and low data quality to those without an understanding of the information's full meaning. RAB members include representatives from local, state, and tribal governments, the Department of Defense, the Environmental Protection Agency, and the local community. The Corps of Engineers representatives usually include project technical and management personnel, but these individuals may not have sufficient expertise in the project quality assurance components and laboratory data quality procedures to completely satisfy community concerns about data quality. Communication of this information to the RAB by a quality assurance professional could serve to resolve some of the questions members have about the quality of acquired data and proper use of analytical results, and increase community trust that appropriate decisions are made regarding restoration. Details of the effectiveness of including a quality assurance professional in RAB discussions of laboratory data quality and project quality management are provided in this paper.

Community Participation↗

PubMedDate not supplied

Measuring data abstraction quality in multiresolution visualizations.

Data abstraction techniques are widely used in multiresolution visualization systems to reduce visual clutter and facilitate analysis from overview to detail. However, analysts are usually unaware of how well the abstracted data represent the original dataset, which can impact the reliability of results gleaned from the abstractions. In this paper, we define two data abstraction quality measures for computing the degree to which the abstraction conveys the original dataset: the Histogram Difference Measure and the Nearest Neighbor Measure. They have been integrated within XmdvTool, a public-domain multiresolution visualization system for multivariate data analysis that supports sampling as well as clustering to simplify data. Several interactive operations are provided, including adjusting the data abstraction level, changing selected regions, and setting the acceptable data abstraction quality level. Conducting these operations, analysts can select an optimal data abstraction level. Also, analysts can compare different abstraction methods using the measures to see how well relative data density and outliers are maintained, and then select an abstraction method that meets the requirement of their analytic tasks.

Journal Article↗

PubMed1991

Health care data, the epidemiologist's sand: comments on the quantity and quality of data.

Massive amounts of health care data are currently available for epidemiologic review through improvements in computerization and electronic communication. Multiple abstracts of patient care data are collected, stored, retrieved, and analyzed to study health care practice and outcome. The high level of variation in data from these sources is noted. Examples of these data collections are reviewed and the issues of the quality of these data for research and evaluation are discussed. Increased amounts of poor quality data will not be helpful. Collections from the National Center for Health Statistics and other sources are cited as models for improved standards for quality data banks and registries, including the Centers for Disease Control National Nosocomial Infections Surveillance collection. Throughout, a metaphor relating quality of sand for the production of lens instruments to view scientific change is used.

Data Collection↗

PubMed1995

A national quality improvement effort: cancer registry data.

Cancer registries are sources of epidemiological, patterns-of-care, and outcome data for local, regional, state, and national studies of patients with cancer. Since 1976, these registries have formed a voluntary network of contributors to annual patient care studies under the aegis of the National Cancer Data Committee of the Commission on Cancer. These annual studies provide timely clinical information that is widely disseminated to physicians, allied health personnel, administrators, health care planners, and public and private agencies. The use of the data has grown exponentially and has been the basis for more than 90 publications. Merging this activity with the National Cancer Data Base has further expanded the demand and use of registry data. This study was undertaken to respond to inquiries as to the validity of the data and the qualifications and competency of cancer registrars. It provides the baseline for cancer registry data quality and serves as a quality management tool to identify opportunities to enhance data quality.

Databases, Factual↗

PubMed2001

Interventions for preventing obesity in children.

BACKGROUND: The prevalence of obesity and overweight is increasing world-wide. Obesity in children impacts on their health in both the short and longer term. Obesity prevention strategies are poorly understood. OBJECTIVES: To assess the effectiveness of interventions designed to prevent obesity in childhood. SEARCH STRATEGY: Electronic databases were searched from 1985 to October 1999. SELECTION CRITERIA: Data from RCTs and non-randomised trials with concurrent control group were included. studies with follow up of one year minimum were selected, A priori, this was subsequently amended to include studies with minimum follow up of three months. The possible susceptibility of post hoc questions to bias is addressed. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Seven studies were included, three long-term and four short- term. The studies included were diverse in terms of study design and quality, target population, theoretical underpinning of intervention approach, and outcome measures. As such, it was not possible to combine study findings using statistical methods. REVIEWER'S CONCLUSIONS: The findings of the review suggest that currently there is limited quality data on the effectiveness of obesity prevention programs and as such no generalisable conclusions can be drawn. The need for well-designed studies which examine a range of interventions remains a priority.

Adolescent↗

PubMed1999

Update of the Human MitBASE database.

Human MitBASE is a database collecting human mtDNA variants. This database is part of a greater mitochondrial genome database (MitBASE) funded within the EU Biotech Program. The present paper reports the recent improvements in data structure, data quality and data quantity. As far as the database structure is concerned it is now fully designed and implemented. Based on the previously described structure some changes have been made to optimise both data input and data quality. Cross-references with other bio-databases (EMBL, OMIM, MEDLINE) have been implemented. Human MitBASE data can be queried with the MitBASE Simple Query System (http://www.ebi.ac.uk/htbin/Mitbase/mit base.pl) and with SRS at the EBI under the 'Mutation' section (http://srs.ebi.ac.uk/srs5/). At present the HumanMitBASE node contains approximately 5000 variants related to studies investigating population polymorphisms and pathologies.

Animals↗

PubMed2004

Indicators for hydraulic and pollution retention assessment of stormwater infiltration basins.

Infiltration basins are frequently used for stormwater management even though their long-term evolution is not well understood nor controlled. The two main problems encountered are clogging which compromises the hydraulic capacity of the basin and possible contamination of underlying soil and groundwater. This paper defines a framework for evaluating the hydraulic and pollution retention performance of infiltration basins in the long-term. Sets of context and performance indicators are proposed, along with two complementary modes of evaluation. Context indicators are identified in order to define the clogging and contamination states of the basins. Performance indicators are developed to assess several aspects of basin performance: drainage duration, overflow frequency, predictive life period, particle filtration and pollution trapping. Modes of evaluation include field investigation and long-term simulation modeling. Indicators are tested on five infiltration basins in suburban Lyon (France). Both context indicators and hydraulic performance indicators are reliable and their evaluation is representative of basin behavior. This is not the case for pollution retention performance indicators. Their assessment is difficult because of data quality. Field data has high uncertainties. The model is satisfactory for the hydraulic simulation and the evolution of clogging. Improvements are necessary for pollution flow simulation and the acquisition of better quality data is required.

Conservation of Natural Resources↗

PubMed2005

A microarray study of MPP+-treated PC12 Cells: Mechanisms of toxicity (MOT) analysis using bioinformatics tools.

BACKGROUND: This paper describes a microarray study including data quality control, data analysis and the analysis of the mechanism of toxicity (MOT) induced by 1-methyl-4-phenylpyridinium (MPP+) in a rat adrenal pheochromocytoma cell line (PC12 cells) using bioinformatics tools. MPP+ depletes dopamine content and elicits cell death in PC12 cells. However, the mechanism of MPP+-induced neurotoxicity is still unclear. RESULTS: In this study, Agilent rat oligo 22K microarrays were used to examine alterations in gene expression of PC12 cells after 500 muM MPP+ treatment. Relative gene expression of control and treated cells represented by spot intensities on the array chips was analyzed using bioinformatics tools. Raw data from each array were input into the NCTR ArrayTrack database, and normalized using a Lowess normalization method. Data quality was monitored in ArrayTrack. The means of the averaged log ratio of the paired samples were used to identify the fold changes of gene expression in PC12 cells after MPP+ treatment. Our data showed that 106 genes and ESTs (Expressed Sequence Tags) were changed 2-fold and above with MPP+ treatment; among these, 75 genes had gene symbols and 59 genes had known functions according to the Agilent gene Refguide and ArrayTrack-linked gene library. The mechanism of MPP+-induced toxicity in PC12 cells was analyzed based on their genes functions, biological process, pathways and previous published literatures. CONCLUSION: Multiple pathways were suggested to be involved in the mechanism of MPP+-induced toxicity, including oxidative stress, DNA and protein damage, cell cycling arrest, and apoptosis.

1-Methyl-4-phenylpyridinium↗

PubMed2006

Paper versus computer: feasibility of an electronic medical record in general pediatrics.

BACKGROUND: Implementation of electronic medical record systems promises significant advances in patient care, because such systems enhance readability, availability, and data quality. Structured data entry (SDE) applications can prompt for completeness, provide greater accuracy and better ordering for searching and retrieval, and permit validity checks for data quality monitoring, research, and especially decision support. A generic SDE application (OpenSDE) to support documentation of patient history and physical examination findings was developed and tailored for the domain of general pediatrics. OBJECTIVE: To evaluate OpenSDE for its completeness, uniformity of reporting, and usability in general pediatrics. METHODS: Four (trainee) pediatricians documented data for 8 first-visit patients in the traditional, paper-based, medical record and immediately thereafter in OpenSDE (electronic record). The 32 paper records obtained served as the common data source for data entry in OpenSDE by the other 3 physicians (transcribed record). Data entered by 2 experienced users, with all patient information present in the paper record, served as the control record. Data entry times were recorded, and a questionnaire was used to assess users' experiences with OpenSDE. RESULTS: Clinicians documented 44% of all available patient information identically in the paper and electronic records. Twenty-five percent of all patient information was documented only in the paper record, and 31% was present only in the electronic record. Differences were found in patient history and physical examination documentation in the electronic record; more information was missing for patient history (38%) than for physical examination (15%). Furthermore, physical examination contained more additional information (39%) than did patient history (21%). The interobserver agreement of documentation of patient information from the same data source was fair to moderate, with kappa values of 0.39 for patient history and 0.40 for physical examination. Data entry times in OpenSDE decreased from 25 minutes to <15 minutes, indicating a learning effect. The questionnaire revealed a positive attitude toward the use of OpenSDE in daily practice. CONCLUSION: OpenSDE seems to be a promising application for the support of physician data entry in general pediatrics.

Documentation↗

PubMed2005

A generally applicable validation scheme for the assessment of factors involved in reproducibility and quality of DNA-microarray data.

BACKGROUND: In research laboratories using DNA-microarrays, usually a number of researchers perform experiments, each generating possible sources of error. There is a need for a quick and robust method to assess data quality and sources of errors in DNA-microarray experiments. To this end, a novel and cost-effective validation scheme was devised, implemented, and employed. RESULTS: A number of validation experiments were performed on Lactococcus lactis IL1403 amplicon-based DNA-microarrays. Using the validation scheme and ANOVA, the factors contributing to the variance in normalized DNA-microarray data were estimated. Day-to-day as well as experimenter-dependent variances were shown to contribute strongly to the variance, while dye and culturing had a relatively modest contribution to the variance. CONCLUSION: Even in cases where 90% of the data were kept for analysis and the experiments were performed under challenging conditions (e.g. on different days), the CV was at an acceptable 25%. Clustering experiments showed that trends can be reliably detected also from genes with very low expression levels. The validation scheme thus allows determining conditions that could be improved to yield even higher DNA-microarray data quality.

Analysis of Variance↗

PubMed2001

Factors affecting reliability and confidence of DSM-III-R psychosis-related diagnosis.

The relationships between interrater diagnostic reliability, confidence in diagnosis, DSM-III-R criteria ambiguity and case report data quality were examined in 20 case vignettes describing psychosis-related symptomatology. Each of seven diagnosticians made DSM-III-R diagnoses and gave confidence ratings for those diagnoses, as well as ratings on quality of data presented and clarity of diagnostic criteria for each vignette. As hypothesized, confidence ratings significantly predicted interrater diagnostic agreement. Clarity of DSM-III-R criteria positively correlated with both interrater reliability and confidence. Case report data quality correlated with diagnostic confidence but, contrary to the authors' hypothesis, did not correlate with interrater agreement. The authors conclude that confidence ratings may be useful indices of diagnostic reliability among experienced clinicians and suggest that the case report method allows for reliable diagnoses to be made.

Adult↗

PubMedDate not supplied

The effect of the sex of interviewers on the quality of data in a Nigerian family planning questionnaire.

Traditionally, female interviewers have been preferred to men for conducting fertility and family planning surveys. However, in West Africa, evidence for their superiority over male interviewers is mixed. In Nigeria, as part of a four-state pretest of the national family planning questionnaire, an experimental design was incorporated to quantify effects of the sex of the interviewer. In one state, reinterviews were also performed to measure the reliability of responses. In the conservative northern state of Kano, the use of male interviewers was problematic. However, in the other three states, only weak evidence was found to mitigate against the use of male interviewers. In fact, in two states, the proportion of respondents reporting knowledge of several contraceptive methods was significantly higher when male interviewers conducted the survey. Respondents' reports of contraceptive use were very unreliable for interviewers of both sexes.

Adolescent↗

PubMed2002

Effects of anonymity, gender, and erotophilia on the quality of data obtained from self-reports of socially sensitive behaviors.

This study examined the effects of anonymity, gender, and erotophilia on the quality of self-reports of socially sensitive health-related behaviors. A sample of 155 male and 203 female undergraduate students was randomly assigned to an anonymous and a confidential (i.e., nonanonymous) assessment condition. Gender, erotophilia, self-reports (of substance use, sexual behaviors, illegal activity), and perceived item threat were assessed by questionnaire. Data quality was strongly affected by experimental condition and gender. Thus, terminations were more frequent in the confidential condition and among women. In the confidential condition, women were significantly more likely to "prefer not to respond" to sensitive items compared to men. Both female gender and confidential condition were associated with lower frequency reports of sensitive health behaviors, and greater perceived threat of the assessment questions. Self-reported engagement in sensitive behaviors was positively related to both perceived question threat and erotophilia. Path analyses suggest that question threat mediates the effects of anonymity manipulations and gender on data quality (item refusal, termination), and that erotophilia mediates the effects of gender on incidence and frequency self-reports. The results indicate that anonymous assessments as well as male gender are associated with better data quality.

Adult↗

PubMed2003

Systematic review of scope and quality of electronic patient record data in primary care.

OBJECTIVE: To systematically review measures of data quality in electronic patient records (EPRs) in primary care. DESIGN: Systematic review of English language publications, 1980-2001. DATA SOURCES: Bibliographic searches of medical databases, specialist medical informatics databases, conference proceedings, and institutional contacts. STUDY SELECTION: Studies selected according to a predefined framework for categorising review papers. DATA EXTRACTION: Reference standards and measurements used to judge quality. RESULTS: Bibliographic searches identified 4589 publications. After primary exclusions 174 articles were classified, 52 of which met the inclusion criteria for review. Selected studies were primarily descriptive surveys. Variability in methods prevented meta-analysis of results. Forty eight publications were concerned with diagnostic data, 37 studies measured data quality, and 15 scoped EPR quality. Reliability of data was assessed with rate comparison. Measures of sensitivity were highly dependent on the element of EPR data being investigated, while the positive predictive value was consistently high, indicating good validity. Prescribing data were generally of better quality than diagnostic or lifestyle data. CONCLUSION: The lack of standardised methods for assessment of quality of data in electronic patient records makes it difficult to compare results between studies. Studies should present data quality measures with clear numerators, denominators, and confidence intervals. Ambiguous terms such as "accuracy" should be avoided unless precisely defined.

Ambulatory Care Information Systems↗

PubMed1999

Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires.

PURPOSE: To evaluate alternative automated methods of collecting data on quality of life (QOL) in cancer patients. After initial evaluation of a range of technologies, we compared computer touch-screen questionnaires with paper questionnaires scanned by optical reading systems in terms of patients' acceptance, data quality, and reliability. PATIENTS AND METHODS: In a randomized cross-over trial, 149 cancer patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 2.0 (EORTC QLQ-C30), and the Hospital Anxiety and Depression Scale (HADS) on paper and on a touch screen. In a further test-retest study, 81 patients completed the electronic version of the questionnaires twice, with a time interval of 3 hours between questionnaires. RESULTS: Fifty-two percent of the patients preferred the touch screen to paper; 24% had no preference. The quality of the data collected with the touch-screen system was good, with no missed responses. At the group level, the differences between scores obtained with the two modes of administration of the instruments were small, suggesting equivalence for most of the QOL scales, with the possible exception of the emotional, fatigue, and nausea/vomiting scales and the appetite item, where patients tended to give more positive responses on the touch screen. At the individual patient level, the agreement was good, with a kappa coefficient from 0.57 to 0.77 and percent global agreement from 61% to 97%. The electronic questionnaire had good test-retest reliability, with correlation coefficients between the two administrations from 0.78 to 0.95, kappa coefficients of agreement from 0.55 to 0.90, and percent global agreement from 56% to 100%. CONCLUSION: Computer touch-screen QOL questionnaires were well accepted by cancer patients, with good data quality and reliability.

Adult↗