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Analysis of repeatability in spotted cDNA microarrays.

We report a strategy for analysis of data quality in cDNA microarrays based on the repeatability of repeatedly spotted clones. We describe how repeatability can be used to control data quality by developing adaptive filtering criteria for microarray data containing clones spotted in multiple spots. We have applied the method on five publicly available cDNA microarray data sets and one previously unpublished data set from our own laboratory. The results demonstrate the feasibility of the approach as a foundation for data filtering, and indicate a high degree of variation in data quality, both across the data sets and between arrays within data sets.

Oligonucleotide Array Sequence Analysis↗

Statistical procedures for determination and verification of minimum reporting levels for drinking water methods.

The United States Environmental Protection Agency's Office of Ground Water and Drinking Water has developed a single-laboratory quantitation procedure: the lowest concentration minimum reporting level (LCMRL). The LCMRL is the lowest true concentration for which future recovery is predicted to fall, with high confidence (99%), between 50% and 150%. The procedure takes into account precision and accuracy. Multiple concentration replicates are processed through the entire analytical method and the data are plotted as measured sample concentration (y-axis) versus true concentration (x-axis). If the data support an assumption of constant variance over the concentration range, an ordinary least-squares regression line is drawn; otherwise, a variance-weighted least-squares regression is used. Prediction interval lines of 99% confidence are drawn about the regression. At the points where the prediction interval lines intersect with data quality objective lines of 50% and 150% recovery, lines are dropped to the x-axis. The higher of the two values is the LCMRL. The LCMRL procedure is flexible because the data quality objectives (50-150%) and the prediction interval confidence (99%) can be varied to suit program needs. The LCMRL determination is performed during method development only. A simpler procedure for verification of data quality objectives at a given minimum reporting level (MRL) is also presented. The verification procedure requires a single set of seven samples taken through the entire method procedure. If the calculated prediction interval is contained within data quality recovery limits (50-150%), the laboratory performance at the MRL is verified.

Analysis of Variance↗

ATAC-seq in Emerging Model Organisms: Challenges and Strategies.

The Assay for Transposase-Accessible Chromatin with sequencing (ATAC-seq) is a versatile and widely utilized method for identifying potential regulatory regions, such as promoters and enhancers, within a genome. ATAC-seq has been successfully applied to a wide range of established and emerging model organisms. However, implementing this method in emerging model systems, such as arthropods, can be challenging due to several factors that influence data quality. These factors include the availability of a sufficient amount and quality of tissue or cells, the need for species- and tissue-specific protocol optimization, the completeness and accuracy of the reference genome, and the quality of the genome annotation. In this article, we emphasize the key steps in the ATAC-seq protocol that, based on our experience, have the greatest impact on data quality when adapting this method for emerging model organisms. Specifically, we discuss the importance of nuclei isolation, the incubation conditions of the Tn5 transposase, and PCR amplification of the library. Furthermore, we outline essential quality checkpoints during the bioinformatic analysis of ATAC-seq data to assist in assessing data integrity and consistency. Given that many emerging model organisms may not be readily available in laboratory cultures, we also emphasize the importance of evaluating how different preservation methods affect ATAC-seq data quality. Based on examples in one spider and one ant species, we demonstrate that replication and thorough quality controls at all steps of the protocol and data analysis are essential to assess the usability of ATAC-seq data. Our data highlights the importance of isolating the right number of intact nuclei, as well as ensuring optimal amplification conditions during library preparation to obtain good-quality sequence data for downstream analyses. We recommend using fresh tissue samples if possible because we show that direct cryopreservation of the tissue may affect chromatin integrity. This effect could be avoided or reduced by preserving the homogenate in cell culture medium. Overall, we explain the ATAC-seq protocol and downstream analyses in detail and give step-by-step advice to researchers who are new to the field and want to implement this method. With careful planning and validation, ATAC-seq can reveal the regulatory landscape of a genome and aid in identifying elements that govern gene expression.

Animals↗

Bacteriological assessment of Spoon River water quality.

Data from a study of five stations on the Spoon River, Ill., during June 1971 through May 1973 were analyzed for compliance with Illinois Pollution Control Board's water quality standards of a geometric mean limitation of 200 fecal coliforms per 100 ml. This bacterial limit was achieved about 20% of the time during June 1971 through May 1972, and was never achieved during June 1972 through May 1973. Ratios of fecal coliform to total coliform are presented. By using fecal coliform-to-fecal streptococcus ratios to sort out fecal pollution origins, it was evident that a concern must be expressed not only for municipal wastewater effluents to the receiving stream, but also for nonpoint sources of pollution in assessing the bacterial quality of a stream.

Bacteriological Techniques↗

Use of risk-adjusted outcome data for quality improvement by public hospitals.

In 1993 the California Office of Statewide Health Planning and Development (OSHPD) began public release of risk-adjusted monitoring of outcomes (RAMO) under the California Hospital Outcomes Project. We studied how 17 acute are public hospitals in California used these RAMO data for quality improvement purposes following their initial distribution, first by analyzing the outcome data for San Francisco General Hospital Medical Center as recommended by OSHPD and, second, by querying the departments at the other 16 public hospitals to determine how their own analyses compared. We found that the hospitals generally did minimal analyses of the OSHPD RAMO data and considered the data of little value to them. Only 3 hospitals initiated quality improvement activities based on their data review. The major reasons given by the hospitals for not using the RAMO data were that their outcomes were adequate, as verified by a comparison of their observed outcomes and those expected after risk-adjustment; that the hospitals had too few patients in the diagnostic categories; that they had too few resources; and that they were not concerned with the data's public release. Other possible explanations were that awareness of the California Hospital Outcomes Project was not widespread at the time of the study, that the RAMO data were not distributed in a way that encouraged their use, and that public hospitals were not inclined to use the outcome data because the project was imposed on them. Whatever the explanation, our study suggests that the California Hospital Outcomes Project has had little effect on quality improvement in public hospitals.

California↗

Use of patient data for quality control.

This article discusses how specific patient data algorithms can be used and optimized for laboratory quality control. These algorithms include delta checks, patient averages, and multivariate checks. With the increasing emphasis on cost containment, the intelligent use of these algorithms should become widespread.

Medical Records↗

Analysis of quality control data of eight modern radiotherapy linear accelerators: the short- and long-term behaviours of the outputs and the reproducibility of quality control measurements.

Quality control (QC) data of radiotherapy linear accelerators, collected by Helsinki University Central Hospital between the years 2000 and 2004, were analysed. The goal was to provide information for the evaluation and elaboration of QC of accelerator outputs and to propose a method for QC data analysis. Short- and long-term drifts in outputs were quantified by fitting empirical mathematical models to the QC measurements. Normally, long-term drifts were well (< or =1%) modelled by either a straight line or a single-exponential function. A drift of 2% occurred in 18 +/- 12 months. The shortest drift times of only 2-3 months were observed for some new accelerators just after the commissioning but they stabilized during the first 2-3 years. The short-term reproducibility and the long-term stability of local constancy checks, carried out with a sealed plane parallel ion chamber, were also estimated by fitting empirical models to the QC measurements. The reproducibility was 0.2-0.5% depending on the positioning practice of a device. Long-term instabilities of about 0.3%/month were observed for some checking devices. The reproducibility of local absorbed dose measurements was estimated to be about 0.5%. The proposed empirical model fitting of QC data facilitates the recognition of erroneous QC measurements and abnormal output behaviour, caused by malfunctions, offering a tool to improve dose control.

Calibration↗

Data-driven quality improvement in the Emergency Department at a level one trauma and tertiary care hospital.

To demonstrate how a comprehensive and internally driven Continuous Quality Improvement (CQI) program was designed and implemented in our Emergency Department (ED) in 1999. This program involved monthly data collection and analysis, data-driven process change, staff education in the core concepts of quality, and data reanalysis. Data components collected during the program included census data, physician profiling, and focused clinical audits. CQI measures collected at the beginning of the program and quarterly included: (1) CQI metric data (turnaround times [TAT] and rates of left against medical advice [AMA] or left without being seen [LWOBS]), (2) rates and nature of patient complaints, and (3) results of patient satisfaction surveys performed by an outside consulting firm contracted by hospital administration. During the 4 years since its implementation the program demonstrated improvement in all measured areas. Despite an increase in patient volume of 32% to nearly 37,000 visits/year, and only minimal staffing adjustments, the mean quarterly TAT decreased from 183 min to 165 min (9.8% decrease), the rate of complaints dropped by 56.1% (2.1 per 1000 patients to 0.92), and patients leaving AMA or LWOBS decreased 66.7% from 2.7% to 0.9%. Overall, 44.8% of ED patients rated their care as "excellent." In summary, we demonstrate how a comprehensive quality improvement program was structured and implemented at a tertiary care center and how such a program demonstrated improvement in specific CQI parameters.

Academic Medical Centers↗

[Can we rely on Norwegian surgery data? A quality control at central and local hospitals of the procedure codes used in the survey on organization of gastrointestinal cancer surgery].

The nation-wide register of hospital discharges in Norway includes ICD-9 and national procedure codes. Hospitals were asked to check five surgical procedures listed in the register against the primary data sources. 649 discharges were controlled. The response rate was 68%. The results indicate that the quality of the data in the register varies for the different procedures. For procedures with high volume (resection of rectum), the error in the register is 3%. This is the same as reported from other Nordic countries. The proportion of errors in the register was high in hospitals with only one registered procedure code. The quality of data can to some extent be checked on the basis of DRG coding (DRG group 468/477). Quality control of register data is required when the number in DRG 468/477 is high in the nation-wide register or when the number of specific procedures in hospitals is low.

Databases, Factual↗

Evaluation of surgical services in a large university-affiliated VA hospital: use of an in-house-generated quality assurance data base.

In this era of occurrence screening, increased documentation of surgical resident supervision, and overall efforts to alter quality of patient care through increased documentation, an in-house quality assurance data base can greatly facilitate these activities. To establish a data base, 6241 operative procedures over a 15-month interval were logged into a StatView II Database using the patient's name and record number, diagnosis, and operative information available from the standard operation report worksheet. Additional information, including the name of the supervising staff and level of supervision, had also been recorded concurrently on this form. Each month, after this demographic information has been entered into the data base for each surgical service, it is reviewed, ensuring 100% surveillance of all cases. The subsequent morbidity and mortality (M & M) information is then added to the data base. Using the contingency table option of the StatView II Database, quarterly and annual reviews have been done to study individual services, types of cases, staff attending, individual supervision, levels of staff involvement, and incidence of complications. Our Surgical Service has reported an overall morbidity of 306 cases (4.9%) and mortality of 71 (1.14%). Average numerically coded levels of resident supervision have been compiled with regard to individual services and staff surgeons. This data base has proved helpful in the recredentialling process of our surgical staff, resident logs, identification of necessary reviews of certain case types, and formation of a computerized operative log.

Computers↗

Quality improvement data analysis of a mass casualty event.

Trauma auditing is important for monitoring the process of trauma care and outcome prediction. This pilot study was conducted to evaluate quality improvement (QI) data following a mass casualty event and discuss its impact on the trauma care process and outcome. A pre-designed trauma quality improvement data set was used for all 103 injured patients admitted to Asir Central Hospital, Saudi Arabia, who were involved in a single motor vehicle crash. Most of the trauma management variations from norms occurred during the initial assessment and resuscitation phase of care, and these had the greatest impact on morbidity and mortality. Trauma management variations throughout all phases of care were associated with 10% and 9% incidence of preventable morbidity and mortality, respectively. Efforts including rigorous educational programs should be made to stress the initial assessment and resuscitation phase of care. Successful regionalized trauma care systems involving quality improvement programs report significant reduction in morbidity and mortality rates from trauma.

Accidents, Traffic↗

Are outcome data regarding the survivors of neonatal care available from routine sources?

AIM: To determine whether existing information and surveillance systems can be used to provide follow up data on groups of infants at increased risk of disability--for example, the survivors of neonatal intensive care. METHODS: A survey was made of maternity, neonatal, and community child health information systems and surveillance programmes in the Trent Regional Health Authority. Children known to have received neonatal intensive care in Trent between 1 August 1992 and 31 July 1993, and a random sample of normal children in two health districts (data quality check) were included. A data linkage study was made to determine whether follow up information about a random sample of infants, known to be at increased risk of poor outcome, could be identified on community child health databases. Two widely accepted datasets (birth and 2 years) were used as standards for this exercise. The quality of data was audited. RESULTS: All clinical items of the birth minimum dataset were routinely recorded by at least one agency in each health district in Trent. Of the descriptive items, only the mother's age on leaving full time education was not collected. At 2 years, all clinical items were collected as part of the routine surveillance programme, but data were recorded using a system which severely limited interpretation. Data quality, in terms of the number of errors introduced at data entry, was very good with only 1.1% of the check items (4/368) incorrectly recorded. Only two districts had organised electronic transfer of data between maternity, neonatal, and community child health systems. The mother's NHS number, although available, was not routinely recorded by any system. The NHS number of the infant was routinely collected by six out of 12 community paediatric services. Data linkage was attempted in six districts with appropriate community child health databases. Just over 70% of the intensive care sample was successfully linked with follow up information on child health systems. CONCLUSIONS: The existing programmes for routine child surveillance could provide outcome data for high risk groups of infants, such as the survivors of neonatal intensive care. However, the present coding system used for data entry is inadequate. Furthermore, rates of identification, without the use of a unique identifier (NHS number) for each subject, are currently insufficient for monitoring health status in later life.

Child Health Services↗

A pilot study on the quality of data management in a cancer clinical trial.

Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the processed data revealed that the median rate of errors was 13% for the 12 data managers. The error rate differed among the types of trial forms. The factors causing these errors were mistakes in interpretation, documentation, and coding. The level of experience of the data managers proved to be an important factor. It became clear that the documentation in the medical record was inadequate. We conclude that data managers as well as physicians involved in cancer clinical trials need specific training and that the quality of data management in cancer clinical trials is an important issue for further investigation.

Clinical Trials as Topic↗

Women's health in mid-life: life course social roles and agency as quality.

Data from a prospective British birth cohort study showed that women who were childless, lone mothers or full-time homemakers between the ages of 26 and 53 were more likely to report poor health at age 54 than women who occupied multiple roles between these ages. To explain this finding we developed and tested a theory of role quality based on the concept of agency by drawing on Giddens' theory of structuration and Doyal and Gough's theory of human needs. According to our theory, the patriarchal structuration (drawing on Giddens' term) of work and family roles provides both limitation and opportunity for the expression of agency. Doyal and Gough's theory of human needs was then used to identify the restriction of agency as a possible influence on health. This theory of role quality was operationalised using a measure of work (paid and unpaid) quality at age 36 and a measure of work and family stress between ages 48 and 54. The relatively poor subjective health in mid-life of lone mothers was explained by work and family stress and adult social class. In contrast, the poor health in mid-life of long-term homemakers and childless women was less easily explained. Homemaker's excess risk of reporting poor health at age 54 remained strong and significant even after adjusting for role quality and socioeconomic indicators, and childless women were at an increased risk of reporting poor health despite the social advantage inherent in attaining educational qualifications and occupying professional or managerial occupations. This study highlights the need to develop measures of role quality specifically designed to capture agency aspects of social roles.

Adult↗

HLA-B27 expression by flow cytometry: an analysis of 7 years quality assurance data.

The Royal College of Pathologists of Australasia Quality Assurance Programs Pty. Ltd. has been monitoring HLA-B27 assignment by flow cytometry for 7 years as part of the Immunology Program. Here we present data that demonstrates a gradual improvement in reports of false positive and negative results. Many participating laboratories demonstrate an ability to assign HLA-B27 status correctly by flow cytometric means. This ability appears to be independent of reagent and methodology. However a small number of laboratories produce consistently unacceptable results that suggest poor quality assurance practice.

Flow Cytometry↗

Trends in the quality of data from 5168 oligonucleotide microarrays from a single facility.

Improvements in the quality of gene expression data were investigated based on a database consisting of 5168 oligonucleotide microarrays collected over 3 years. The database includes diverse treatments of human and mouse samples collected from multiple laboratories. The array designs and algorithms used to capture the data have also changed over the 3 years of data collection. All hybridizations and labeling were conducted in the Hartwell Center for Bioinformatics and Biotechnology at St. Jude's Children's Research Hospital. Quality metrics for each human and mouse array were collected and analyzed. Statistical tests, such as ANOVA and linear regression, were applied to test for the effects of array design, algorithm, and time. The quality metrics tested were average background, actin 3'/5' ratio, Bio B signal, percent present, and scale factor. ANOVA results indicate that both recent algorithms and chip designs significantly correlate with improvements in Bio B, scale factor, percent present, and average background. Significant quality improvements correlated with new chip designs, algorithms, and their interaction. In addition, within one chip type analyzed by the same algorithm significant improving trends were still observed. Scale factor, percent present, and average background significantly improved over time for U133A arrays analyzed by the Affymetrix MicroArray Suite 5.0 algorithm according to linear regression. Proportionally fewer outlier arrays (those with less than 25% present calls) were seen over time. Also, high throughput periods did not increase the proportion of outliers, indicating that laboratory monitoring of quality is successfully preventing failures.

Actins↗