PA to collect data on quality; who's next?
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Data Collection↗
SEARCH · PubMed Health
Results for “data quality”
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[Can data from quality assurance programs such as peri-/neonatal compilations be used for secondary epidemiological studies?].
BACKGROUND: The aim of this study was to explore whether population-based data from a regional quality control program can be utilized to compare the neonatal outcome of small for gestational age (SGA) and appropriate size for gestational age (AGA) new-borns. METHODS: The Center for Quality Management in Health Care maintains perinatal data for almost all births in Lower Saxony (Germany). Neonatal data are collected for all infants admitted to hospital within 10 postnatal days. We evaluated linked perinatal and neonatal datasets of 4126 very low birthweight infants (VLBW; < 1500 g), born in 1991 - 1996. After checking for completeness, representativeness, and validity, exclusion criteria were defined to minimize bias and to yield similar proportions of SGA- and AGA-neonates. Since inclusion of all multiple births would lead to an overestimation of maternal risk factors, one sibling was randomly selected from each set of multiples. Bias arising from not well defined study populations should be shown based on univariable mortality analyses (Kaplan-Meier survival curves). RESULTS: Application of exclusion criteria resulted in a final study population of 1623 independent (disjunctive) new-borns from 25 - 29 weeks gestation, 173 of whom were SGA, 1450 AGA. Kaplan-Meier curves from the initial study population and the well defined study base differed significantly. Trend analysis revealed a significant (p < 0.05) increase in proportions of both VLBW (from 0.95 % in 1991 to 1.11 % in 1996; + 17 %) and SGA infants (from 22.7 % to 27.4 %; + 21 %) within the observational period. A well defined data selection process is necessary if data collected for other purposes are to be used for epidemiological studies. Neglecting this labour-intensive work may be one reason for the varying results on the outcome of SGA and AGA infants.
Bias↗
Value of central analysis of leucocyte depletion quality control data within the National Blood Service, England.
BACKGROUND AND OBJECTIVES: The results of quality monitoring leucocyte counts were analysed nationally for the first 2 years of universal leucocyte depletion (LD), spanning the time-period before and after standardization of the counting and LD methods. The objectives were twofold: first to determine whether the implementation strategy was effective in achieving the LD specification (< 5 x 10(6) leucocytes in 99% of components with 95% statistical confidence); and second, whether quality monitoring was able to detect potential non-conformance. MATERIALS AND METHODS: Residual leucocytes were counted using Beckman Coulter or Becton Dickinson (BD) flow cytometers and reagents. Data were collected into standardized analysis software (NWA Quality Analyst) for local trend analysis and checks for conformance to process specification, and collated centrally. Analysis was performed for six time-periods between January 1999 and March 2001. Specification failures were analysed to determine the likelihood of extreme failure. Statistical process monitoring was adjusted to suit LD processes. RESULTS: Data from red cells in optimal additive solution (OAS), filtered either as whole blood or red cell concentrates, and platelet pools improved significantly over the 2-year period with specification failures falling from 0.35%, 0.48% and 0.56%, respectively, in January-June 1999 to 0.06%, 0.01% and 0.04% in January-March 2001. Specification failures in red cells in OAS LD for the period January-December 2000 showed only 0.02% with a leucocyte count of > 30 x 10(6)/unit. Extreme failures are now very rare. Monitoring methods have been effective in detecting process change and drift. CONCLUSION: LD performance varies between different LD systems, but monitoring has proved sufficiently robust to detect processes that perform poorly. The chosen specification has been both achievable and appropriate to the systems in use. Standardization of the counting method is central to the ability to monitor and analyse results effectively across the whole service.
Blood Banks↗
Transforming data into quality.
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Data Collection↗
Sex genes for genomic analysis in human brain: internal controls for comparison of probe level data extraction.
BACKGROUND: Genomic studies of complex tissues pose unique analytical challenges for assessment of data quality, performance of statistical methods used for data extraction, and detection of differentially expressed genes. Ideally, to assess the accuracy of gene expression analysis methods, one needs a set of genes which are known to be differentially expressed in the samples and which can be used as a "gold standard". We introduce the idea of using sex-chromosome genes as an alternative to spiked-in control genes or simulations for assessment of microarray data and analysis methods. RESULTS: Expression of sex-chromosome genes were used as true internal biological controls to compare alternate probe-level data extraction algorithms (Microarray Suite 5.0 [MAS5.0], Model Based Expression Index [MBEI] and Robust Multi-array Average [RMA]), to assess microarray data quality and to establish some statistical guidelines for analyzing large-scale gene expression. These approaches were implemented on a large new dataset of human brain samples. RMA-generated gene expression values were markedly less variable and more reliable than MAS5.0 and MBEI-derived values. A statistical technique controlling the false discovery rate was applied to adjust for multiple testing, as an alternative to the Bonferroni method, and showed no evidence of false negative results. Fourteen probesets, representing nine Y- and two X-chromosome linked genes, displayed significant sex differences in brain prefrontal cortex gene expression. CONCLUSION: In this study, we have demonstrated the use of sex genes as true biological internal controls for genomic analysis of complex tissues, and suggested analytical guidelines for testing alternate oligonucleotide microarray data extraction protocols and for adjusting multiple statistical analysis of differentially expressed genes. Our results also provided evidence for sex differences in gene expression in the brain prefrontal cortex, supporting the notion of a putative direct role of sex-chromosome genes in differentiation and maintenance of sexual dimorphism of the central nervous system. Importantly, these analytical approaches are applicable to all microarray studies that include male and female human or animal subjects.
Algorithms↗
Incidents/accidents classification and reporting in Statoil.
Based on requirements in the new petroleum regulations from Norwegian Petroleum Directorate (NPD) and the realisation of a need to improve and rationalise the routines for reporting and follow up of incidents, Statoil Exploration & Production Norway (Statoil E&P Norway) has formulated a new strategy and process for handling of incidents/accidents. The following past experiences serve as basis for the changes made to incident reporting in Statoil E&P Norway; too much resources were spent on a comprehensive handling and analysis of a vast amount of incidents with less importance for the safety level, taking the focus away from the more severe and important issues at hand, the assessment of "Risk Factor", i.e. the combination of recurrence frequency and consequence, was difficult to use. The high degree of subjectivity involved in the determination of the "Risk Factor" (in particular the estimation of the recurrence frequency) resulted in poor data quality and lack of consistency in the data material. The new system for categorisation and handling of undesirable incidents was established in January 2002. The intention was to get a higher degree of focus on serious incidents (injuries, damages, loss and near misses), with a thorough handling and follow-up. This is reflected throughout the handling of the serious incidents, all the way from immediate notification of the incident, through investigation and follow-up of corrective and preventive actions. Simultaneously, it was also an objective to rationalise/simplify the handling of less serious incidents. These incidents are, however, subjected to analyses twice a year in order to utilize the learning opportunity that they also provide. A year after the introduction of this new system for categorisation and follow-up of undesirable incidents, Statoil's experiences are predominantly good; the intention to get a higher degree of focus on serious incidents (injuries, damages, loss and near misses), has been met, the data quality for the more serious incidents (5% of the total number of incidents registered) has improved, the improved handling of incidents has contributed to more reliable and accurate HSE indicators at a corporate level, more user friendly codes in place for incident registration (based on MTO methodology), the revised matrix gives distinct criteria with respect to which investigation level to be initiated for a specific incident. All activities related to handling of undesirable incidents have been summarised and illustrated on a two-sided plastic form, incorporating both the categorisation matrix and the activity flowchart (see Figs. 1 and 4).
Accidents, Occupational↗
Public perceptions of air quality and quality of life in urban and suburban areas of London.
A comparative study was undertaken at two different sites (one urban, one suburban) in Greater London in order to examine whether there was a relationship between publicly available air quality data and the public's perception of air quality. Perceptions of air quality and its role as a potential quality of life indicator was also investigated. A total of 200 people were interviewed in Wood Green and Wimbledon in 1999 and air quality data were obtained simultaneously from the nearest appropriate monitoring station. The study has enabled a comparison between the public's perception of air quality and the actual monitored concentration values. The survey results reveal how seriously the public regards air pollution from road traffic in terms of their quality of life and identifies the attitudes of the public to nuisance from road traffic. The results reveal that the public's perception of air quality is not a reliable indicator of the actual levels of air pollution in their area. The results also revealed that air pollution issues generated as a result of road traffic are of high importance in terms of people's quality of life when compared to other aspects of their quality of life. The study revealed that residents in the urban area (Wood Green) were more disturbed by road traffic than residents in the suburban area (Wimbledon). Out of all the disturbances listed, it was found that residents were more disturbed by vehicle-derived fumes, dust and dirt than other aspects of road traffic related nuisance. The TELETEXT/CEEFAX service on air quality was little used by the public as a means of obtaining information on air pollution.
Adolescent↗
Focus group methodology: explanatory notes for the novice nurse researcher.
Focus group methodology is a qualitative research approach that provides the potential for authentic quality data to be captured by using the candour and spontaneity of participants in an atmosphere of dynamic group interaction. The use of this methodology within nursing research is growing as it provides a qualitative approach that can produce quality data and can be used effectively by both experienced and novice researchers. The purpose of this paper is to provide guidance to the novice nurse researcher who may be considering using this methodology so that appropriate use is promoted and practical advice for its use may generate quality data.
Focus Groups↗
[Evaluation of vital statistics for the study of causes of death in Latin America].
"The present article attempts to take a deeper look at the most relevant aspects of the problems presented by the data on adult mortality and causes of death in Latin America.... Statistical coverage of registered deaths by age and sex is analysed, finding important differences among the countries and higher coverage in the registration of adult deaths than of younger ones.... Data quality on causes of death...showed some improvement during the period studied.... Reference is made to topics related to the analysis of causes of death [that] generally complicate the work, such as the heterogeneity of coverage and data quality at subnational levels, the compatibility among different revisions of the ICD, the use of ill-defined causes and, finally, access and management of basic information." (SUMMARY IN ENG)
Adult↗
Comparison of provision and need for publicly-funded personal health services.
AIM: To determine whether health services have been purchased equitably according to population needs at the territorial local authority (TLA) level. METHODS: The project involved the mapping of different categories of personal health service expenditure onto TLA areas. The measure used to compare provision and need was the ratio of observed to expected expenditure. Need beyond weighted populations by age, sex, and ethnicity or community services card status was measured using standardised mortality ratios. RESULTS: The analysis did not suggest that the inverse care law was operating at the level of TLAs. There was no systematic bias against equity. However there is a good deal of scatter in the plots, some of which will be accounted for by data quality problems, and some of which is possibly due to inequitable purchasing. CONCLUSIONS: The inverse care law does not appear to be operating at the level of TLA. The methods piloted in this study represent a useful way of analysing and presenting information on resource allocation. Deficiencies in data quality limit the strength of conclusions which can be drawn from this project. More specific observations could be made if the methods used here were applied to smaller areas, and data quality issues were addressed.
Financing, Government↗
Comparing indigenous health status across regions: a numerical example of uncertainty.
OBJECTIVE: To illustrate how regional variation in data quality could explain some or all of the apparent regional differences in the health status of Indigenous Australians. METHODS: A series of simple hypothetical numerical examples is provided, with varying assumptions regarding the accuracy of identification of Indigenous deaths. RESULTS: The apparent difference in Indigenous mortality in remote compared with urban areas is of a magnitude that could be explained by relatively modest regional differences in data quality. CONCLUSION AND IMPLICATIONS: Determinations of relative health status within the Indigenous population must take into account the impact of variability in data quality.
Australia↗
QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies.
The scientific community has been enthusiastic about DNA microarray technology for pharmacogenomic and toxicogenomic studies in the hope of advancing personalized medicine and drug development. The US Food and Drug Administration has been proactive in promoting the use of pharmacogenomic data in drug development and has issued a draft guidance for the pharmaceutical industry on data submissions. However, many challenges and pitfalls are facing the microarray community and regulatory agencies before microarray data can be reliably applied to support regulatory decision making. Four types of factors (i.e., technical, instrumental, computational and interpretative) affect the outcome of a microarray study, and a major concern about microarray studies has been the lack of reproducibility and accuracy. Intralaboratory data consistency is the foundation of reliable knowledge extraction and meaningful crosslaboratory or crossplatform comparisons; unfortunately, it has not been seriously evaluated and demonstrated in every study. Profound problems in data quality have been observed from analyzing published data sets, and many laboratories have been struggling with technical troubleshooting rather than generating reliable data of scientific significance. The microarray community and regulatory agencies must work together to establish a set of consensus quality assurance and quality control criteria for assessing and ensuring data quality, to identify critical factors affecting data quality, and to optimize and standardize microarray procedures so that biologic interpretation and decision-making are not based on unreliable data. These fundamental issues must be adequately addressed before microarray technology can be transformed from a research tool to clinical practices.
Drug Approval↗
Self-reports of induced abortion: an empathetic setting can improve the quality of data.
OBJECTIVES: This study estimated the proportion of incomplete abortions that are induced in hospital-based settings in Tanzania. METHODS: A cross-sectional questionnaire study was conducted in 2 phases at 3 hospitals in Tanzania. Phase 1 included 302 patients with a diagnosis of incomplete abortion, and phase 2 included 823 such patients. RESULTS: In phase 1, in which cases were classified by clinical criteria and information from the patient, 3.9% to 16.1% of the cases were classified as induced abortion. In phase 2, in which the structured interview was changed to an empathetic dialogue and previously used clinical criteria were omitted, 30.9% to 60.0% of the cases were classified as induced abortion. CONCLUSIONS: An empathetic dialogue improves the quality of data collected among women with induced abortion.
Abortion, Illegal↗
[Quality of data acceptable for perinatal epidemiology surveillance: assessment of the health certificate at birth and the national obstetrics medical file. Study in three Seine-Maritime maternal wards].
Data from several sources could be used for perinatal epidemiology surveillance aimed at an assessment of regional programs such as those proposed by the Superior Committee for Public Health. A retrospective study of 561 births was conducted in three maternity wards in the French Seine Maritime department in order to evaluate the reliability of two data sources: the national obstetrics medical file and the health certificate at birth. The delivery room records were used as the gold standard. The sensitivity of the obstetrics file was better than that of the health certificate. With the obstetrics file, it was possible to identify almost all the vaginal route interventions, almost all the premature births and all the cesareans. With the health certificate, 39-58% of the vaginal route interventions, 61% of the premature births and 61-72% of the cesareans performed in the three wards studied were identified. The quality of data in the obstetrics file appears to be better than that in the health certificate but only concerns 40% of births in the geographical area studied. Inversely, the health certificate is theoretically delivered for all births (actually delivered for 93%). Integrating these two information systems could be an optimum solution.
Bias↗
Using field data analysis for environmental decision making and subsequent remediation at two example sites.
One of the major challenges in remediating contaminated sites is having quick access to quality data on which to base remedial decisions as onsite work progresses. Case studies are presented at two Superfund sites where field screening and field analyses are used to provide these data. Emphasis is placed on the importance of high quality field data, as these data are the basis for remedial decisions prior to receipt of offsite laboratory confirmation. The decision-making processes for remediating contaminated soils and structures are presented in addition to project specifics including data quality objectives, field data collection procedures, quality assurance/quality control procedures, and comparisons of the field data with offsite laboratory results.
Data Collection↗
Automation of matrix-assisted laser desorption/ionization mass spectrometry using fuzzy logic feedback control.
Matrix-assisted laser desorption/ionization (MALDI) mass spectrometry is a sensitive and versatile method for biomolecular analysis which has potential for high-throughput screening in many applications. To obtain mass spectra of optimal quality, however, laser fluence is continuously adjusted during data acquisition to be close to the threshold level of ion production, requiring a skilled operator and several minutes of acquisition time per sample. Using real-time fuzzy logic control of the laser fluence, we here demonstrate that the acquisition of MALDI spectra can be automated without reduction of data quality. The control algorithm evaluates signal intensity and mass resolution of the base peak. It then regulates the laser fluence to keep the ion signal intensity within the dynamic range of the data acquisition hardware while maintaining high mass resolution. This fuzzy logic control system allows unattended data acquisition using either static ion extraction or delayed ion extraction MALDI. Even for difficult samples such as femtomole-level peptide mixtures, no significant reduction in data quality is observed, as compared to manually obtained spectra. Automated analysis of 78 chromatographic fractions with high mass accuracy demonstrates the utility of the method. The control algorithm has been combined with other software modules to completely automate database identification of proteins by their peptide mass maps. The success of fuzzy logic in MALDI automation suggests wider uses of this technique in mass spectrometry.
Automation↗
Reactions to the use of evidence-based performance indicators in primary care: a qualitative study.
OBJECTIVES: To investigate reactions to the use of evidence-based cardiovascular and stroke performance indicators within one primary care group. DESIGN: Qualitative analysis of semi-structured interviews. SETTING: Fifteen practices from a primary care group in southern England. PARTICIPANTS: Fifty two primary health care professionals including 29 general practitioners, 11 practice managers, and 12 practice nurses. MAIN OUTCOME MEASURES: Participants' perceptions towards and actions made in response to these indicators. The barriers and facilitators in using these indicators to change practice. RESULTS: Barriers to the use of the indicators were their data quality and their technical specifications, including definitions of diseases such as heart failure and the threshold for interventions such as blood pressure control. Nevertheless, the indicators were sufficiently credible to prompt most of those in primary care teams to reflect on some aspect of their performance. The most common response was to improve data quality through increased or improved accuracy of recording. There was a lack of a coordinated team approach to decision making. Primary care teams placed little importance on the potential for performance indicators to identify and address inequalities in services between practices. The most common barrier to change was a lack of time and resources to act upon indicators. CONCLUSION: For the effective implementation of national performance indicators there are many barriers to overcome at individual, practice, and primary care group levels. Additional training and resources are required for improvements in data quality and collection, further education of all members of primary care teams, and measures to foster organisational development within practices. Unless these barriers are addressed, performance indicators could initially increase apparent variation between practices.
Adult↗
A Kiswahili version of the SF-36 Health Survey for use in Tanzania: translation and tests of scaling assumptions.
The objective of the study was to translate and adapt the SF-36 Health Survey for use in Tanzania and to test the psychometric properties of the Kiswahili SF-36. A cross-sectional study was conducted as part of a household survey of a representative sample of the adult population of Dar es Salaam, Tanzania. The IQOLA method of forward and backward translation was used to translate the SF-36 into Kiswahili. The translated questionnaire was administered by trained interviewers to 3,802 adults (50% women, mean (SD) age 31 (13) years, 50% married and 60% with primary education). Data quality and psychometric assumptions underlying the scoring of the eight SF-36 scales were evaluated for the entire sample and separately for the least educated subgroup (n = 402), using multitrait scaling analysis. Forward and backward translation procedures resulted in a Kiswahili SF-36 that was considered conceptually equivalent to the US English SF-36. Data quality was excellent: only 1.2% of respondents were excluded because they answered less than half of the items for one or more scales; ninety percent of respondents answered mutually exclusive items consistently. Median item-scale correlations across the eight scales ranged from 0.47 to 0.81 for the entire sample. Median scaling success rates were 100% (range 87.5-100.0). The median internal consistency reliability of the eight scales for the entire sample was 0.81 (range 0.70-0.92). Floor effects were low and ceiling effects were high on five of the eight scales. Results for n = 402 people without formal education did not differ substantially from those of the entire sample. The results of data quality and psychometric tests support the scoring of the eight scales using standard scoring algorithms. The Kiswahili translation of the SF-36 may be useful in estimating the health of people in Dar es Salaam. Evidence for the validity of the SF-36 for use in Tanzania needs to be accumulated.
Activities of Daily Living↗