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The development of The Society of Thoracic Surgeons voluntary national database system: genesis, issues, growth, and status.

BACKGROUND: The purpose of this communication is to demonstrate the feasibility of a voluntary national cardiac surgical database. METHODS: The genesis of the Society of Thoracic Surgeons (STS) National Cardiac and General Thoracic Surgery Databases in the interval of 1986 to 1990 is described. The issues facing the Committee in the initial decision making processes are discussed choosing a society-based, in-house activity versus using an outside vendor, private practice needs versus academic ones; open versus closed membership and vendors, risk stratification; data quality; audit; and access to data. RESULTS: In the 6 years of operation the STS cardiac surgical database has grown from 41,000 to 706,000 patients. The number of practice groups, hospitals, and surgeons has increased from 26 to 624, 32 to 750, and 120 to 1850, respectively. All but one state is represented, as are more than 400 teaching hospitals, including 28 Veterans Administration hospitals and 60 university centers. CONCLUSIONS: The STS database system has become firmly established and is a model for other societies and associations. The data placed yearly in the public domain have become a national standard.

Cardiology Service, Hospital↗

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

During the period from January 1979 through January 1981, 155 active participants in the Microbiology Program of the College of American Pathologists Quality Assurance Service (QAS) submitted approximately two million individuals determinations on three quality control reference strains. Of these determinations, 83% were obtained using the standardized disc-diffusion procedure of Bauer and co-workers, and, 6% using the agar overlay modification of Barry and associates. The mean and standard deviation for data obtained using these procedures were similar to those for data collected from the inception of the program in 1974 through December 1978. The number of individual determinations falling above or below existing control limits, however, was significantly less for the present data than for that previously reported. These differences result from a change in computation procedures. In the current report percentages of daily values exceeding the NCCLS limits were calculated using actual counts, whereas in the previous reports these percentages were estimated by accepting an assumption of Gaussian distribution.

Ampicillin↗

The Stanford Microarray Database: data access and quality assessment tools.

The Stanford Microarray Database (SMD; http://genome-www.stanford.edu/microarray/) serves as a microarray research database for Stanford investigators and their collaborators. In addition, SMD functions as a resource for the entire scientific community, by making freely available all of its source code and providing full public access to data published by SMD users, along with many tools to explore and analyze those data. SMD currently provides public access to data from 3500 microarrays, including data from 85 publications, and this total is increasing rapidly. In this article, we describe some of SMD's newer tools for accessing public data, assessing data quality and for data analysis.

Animals↗

A metaanalysis of severe upper gastrointestinal complications of nonsteroidal antiinflammatory drugs.

OBJECTIVE: Prior metaanalyses of the risk of upper gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAID) have focused on the published English language epidemiologic literature and/or only a portion of the relevant evidence, restrictions that are now known to be associated with bias in metaanalysis. We synthesized the published and unpublished evidence to determine the least biased estimates of the risks of perforations, ulcers, and bleeds (PUB) associated with NSAID use from all study designs and all languages. METHODS DATA SOURCES: Using MEDLINE, EMBASE, HEALTHSTAR, and BIOSIS, we searched for English and non-English language studies of NSAID from 1966-1998 reporting primary data on GI complications. We obtained unpublished data from the US Food and Drug Administration (FDA) new drug application (NDA) reviews. NDA were hand searched to identify unpublished studies with inclusion criteria identical to those used for published reports. STUDY SELECTION: Studies had to assess the use of oral NSAID for more than 4 days duration in subjects > 18 years of age and report on the clinically relevant upper GI outcomes of PUB. RESULTS: Two reviewers evaluated 4881 published titles and identified 13 NSAID versus placebo randomized clinical trials and 3 previously unpublished FDA placebo controlled randomized controlled trials, 9 cohort studies, and 23 case control studies sufficiently clinically homogeneous to pool. Two reviewers extracted data about study characteristics and study quality. DATA SYNTHESIS: The majority of clinical trials were of good quality, but observational studies had methodologic limitations. The pooled odds ratio (OR) from 16 NSAID versus placebo clinical trials, comprising 4431 patients, was 5.36 (95% CI: 1.79, 16.1). The pooled relative risk of PUB from 9 cohort studies comprising over 750,000 person-years of exposure was 2.7 (95% CI: 2.1, 3.5). The pooled OR of PUB from 23 case control studies using age and sex matching, representing 25,732 patients, was 3.0 (95% CI: 2.5, 3.7). Data were insufficient to justify subgroup analyses stratified by age, comorbid conditions, drug, or dose. CONCLUSION: These data support an association between the use of NSAID and serious upper GI complications, including estimates from different study designs. Prior pooled estimates about the effect of patient and drug variables on increased risk must be viewed with caution.

Administration, Oral↗

Setting thresholds for quality indicators derived from MDS data for nursing home quality improvement reports: an update.

BACKGROUND: Determining meaningful thresholds to reinforce excellent performance and flag potential problem areas in nursing home care is critical for preparing reports for nursing homes to use in their quality improvement programs. This article builds on the work of an earlier panel of experts that set thresholds for quality indicators (QIs) derived from Minimum Data Set (MDS) assessment data. Thresholds were now set for the revised MDS 2.0 two-page quarterly form and Resource Utilization Groups III (RUGS III) quarterly instrument. SETTING THRESHOLDS: In a day-long session in October 1998, panel members individually determined lower (good) and upper (poor) threshold scores for each QI, reviewed statewide distributions of MDS QIs, and completed a follow-up Delphi of the final results. REPORTING MDS QIS FOR QUALITY IMPROVEMENT: The QI reports compiled longitudinal data for all residents in the nursing home during each quarter and cumulatively displayed data for five quarters for each QI. A resident roster was provided to the nursing home so that the quality improvement team could identify the specific residents who developed the problems defined by each QI during the last quarter. Quality improvement teams found the reports helpful and easy to interpret. SUMMARY AND CONCLUSIONS: As promised in an earlier report, to ensure that thresholds reflect current practice, research using experts in a panel to set thresholds was repeated as needed. As the MDS instrument or recommended calculations for the MDS QIs change, thresholds will be reestablished to ensure a fit with the instrument and data.

Activities of Daily Living↗

Cancer incidence in atomic bomb survivors. Part I: Use of the tumor registries in Hiroshima and Nagasaki for incidence studies.

More than 30 years ago, population-based tumor registries were established in Hiroshima and Nagasaki. This report, the first of a series of papers on cancer incidence, describes methodological aspects of the tumor registries and discusses issues of data quality in the context of the Life Span Study (LSS) cohort, the major atomic bomb survivor population. The tumor registries in Hiroshima and Nagasaki are characterized by active case ascertainment based on abstraction of medical records at area hospitals, augmented by tissue registries operational in the area and a number of clinical and pathological programs undertaken over the years among the atomic bomb survivors. Using conventional measures of quality, the Hiroshima and Nagasaki tumor registries have a death certificate-only (DCO) rate of less than 9%, a mortality/incidence (M/I) ratio of about 50%, and a histological verification (HV) rate in excess of 70%, which place these registries among the best in Japan and comparable to many established registries worldwide. All tumor registry data pertaining to the LSS population were assembled, reviewed and handled with special attention given to the quality and uniformity of data based on standardized procedures. Special studies and monitoring programs were also introduced to evaluate the quality of the tumor incidence data in the LSS. Analyses were performed to examine the quality of incidence data overall and across various substrata used for risk assessment such as age, time and radiation dose groups. No significant associations were found between radiation dose and data quality as measured by various indices. These findings warrant the use of the present tumor registry-based data for studies of cancer incidence in the atomic bomb survivors.

Adolescent↗

New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data.

The implementation of quality systems in analytical laboratories has now, in general, been achieved. While this requirement significantly modified the way that the laboratories were run, it has also improved the quality of the results. The key idea is to use analytical procedures which produce results that fulfil the users' needs and actually help when making decisions. This paper presents the implications of quality systems on the conception and development of an analytical procedure. It introduces the concept of the lifecycle of a method as a model that can be used to organize the selection, development, validation and routine application of a method. It underlines the importance of method validation, and presents a recent approach based on the accuracy profile to illustrate how validation must be fully integrated into the basic design of the method. Thanks to the beta-expectation tolerance interval introduced by Mee (Technometrics (1984) 26(3):251-253), it is possible to unambiguously demonstrate the fitness for purpose of a new method. Remembering that it is also a requirement for accredited laboratories to express the measurement uncertainty, the authors show that uncertainty can be easily related to the trueness and precision of the data collected when building the method accuracy profile.

Journal Article↗

Use of emergency departments by Aboriginal and Torres Strait Islander people.

OBJECTIVE: To review published Australian literature about ED care of Aboriginal and Torres Strait Islander peoples. METHOD: Six databases were searched electronically for articles about ED use by Indigenous people in Australia. This strategy was complemented by manual searches of two websites, Emergency Medicine (1994-2004) and three bibliographies. RESULTS: Aboriginal and Torres Strait Islander peoples attend EDs about twice as often as other Australians. The waiting times of Indigenous patients are similar to, or slightly shorter than, those of non-Indigenous patients. However, more Indigenous than other patients choose to walk out before being seen, indicating possibly greater Indigenous dissatisfaction with ED care. CONCLUSIONS: Further conclusions of the present literature review were limited by contradictory results in the few studies of reasonable quality and by general concerns about data quality, especially the poor (but slowly improving) identification of Indigenous people in routine ED data sets. Closer collaboration between ED staff and Indigenous hospital liaison staff, combined with regular monitoring of routinely-collected ED data, have the potential to improve Indigenous ED care and so contribute to improvements in Indigenous health.

Australia↗

Daily mortality in the Philadelphia metropolitan area and size-classified particulate matter.

Time-series of daily mortality data from May 1992 to September 1995 for various portions of the seven-county Philadelphia, PA, metropolitan area were analyzed in relation to weather and a variety of ambient air quality parameters. The air quality data included measurements of size-classified PM, SO4(2-), and H+ that had been collected by the Harvard School of Public Health, as well as routine air pollution monitoring data. Because the various pollutants of interest were measured at different locations within the metropolitan area, it was necessary to test for spatial sensitivity by comparing results for different combinations of locations. Estimates are presented for single pollutants and for multiple-pollutant models, including gaseous pollutants and mutually exclusive components of PM (PM2.5 and coarse particles, SO4(2-) and non-SO4(2-) portions of total suspended particulate [TSP] and PM10), measured on the day of death and the previous day. We concluded that associations between air quality and mortality were not limited to data collected in the same part of the metropolitan area; that is, mortality for one part may be associated with air quality data from another, not necessarily neighboring, part. Significant associations were found for a wide variety of gaseous and particulate pollutants, especially for peak O3. Using joint regressions on peak O3 with various other pollutants, we found that the combined responses were insensitive to the specific other pollutant selected. We saw no systematic differences according to particle size or chemistry. In general, the associations between daily mortality and air pollution depended on the pollutant or the PM metric, the type of collection filter used, and the location of sampling. Although peak O3 seemed to exhibit the most consistent mortality responses, this finding should be confirmed by analyzing separate seasons and other time periods.

Adolescent↗

Health care provider quality improvement organization Medicare data-sharing: a diabetes quality improvement initiative.

BACKGROUND: This paper describes a collaborative Medicare claims data linkage and sharing effort between the Baylor Health Care System (BHCS) and Texas Medical Foundation (TMF, the Texas Quality Improvement Organization) designed to assess the effect of three quality improvement interventions on care delivered to elderly patients with diabetes. The randomized controlled trial is being conducted among a network of primary care physician practices owned by BHCS and focuses on measures of care process and outcome. METHODS: Cohort definition and baseline measurement took place between January 1 and December 31, 2000. BHCS administrative data and TMF-supplied Medicare enrollment data were used to define the January 1, 2001 prevalence cohort of Medicare diabetic beneficiaries meeting study inclusion criteria. A total of 22 practices (with 92 physicians and 2,158 patients) were randomized to one of three interventions, each of which involved performance measurement feedback on three claims-based measures of care process. Physician profiles, generated by TMF using Medicare utilization files, were reported to study physicians via academic detailing sessions with a BHCS physician educator. RESULTS: The January 1 - December 31, 2000 baseline Medicare claims for the January 1, 2001 prevalence cohort were provided to HTPN by TMF in October 2001, representing a ten-month lag in the ability of Quality Improvement Organizations to provide Part B data relative to a specific episode of care time frame. Overall baseline rates for the claims-based process measures were: annual HbA1c testing (86.1%), annual eye examination (60.8%), and annual lipid profile (72.5%). As anticipated, medical-record based rates of annual eye examination were significantly underrepresented. Agreement between claims-based and medical record-based measures was very close for annual HbA1c and annual lipid profile. CONCLUSIONS: The use of Medicare claims data, through collaboration with a QIO, can help health care providers overcome a significant barrier associated with quality improvement initiatives. Limitations associated with the use of Medicare claims can impact implementation of intervention strategies, but do not prevent them from being a practical tool for improving care.

Aged↗

Promoting the use of environmental data collected by concerned citizens through information and communication technologies.

Public participation within environmental monitoring may contribute to increasing the knowledge on the state of the environment at the same time it promotes citizens' involvement in environmental protection. However, the use of voluntary collected data is limited due to a lack of confidence in data collection procedures. Additionally, data quality is often unknown and the data are usually dispersed and non-structured. Information and communication technologies (ICT) may promote the use of voluntary collected data through the development of a collaborative system that incorporates tools and methodologies to facilitate data collection, access and validation. Furthermore, the use of ICT may promote public involvement within environmental monitoring, since it facilitates communication among all the stakeholders. This paper analyses the role of ICT in developing a system for environmental collaborative monitoring intending to promote the use of volunteer collected data. It starts by analysing the role of volunteers within environmental monitoring and continues analysing the potential of ICT to take advantage of the benefits of using data collected by citizens. A collaborative system that allows the public to express its knowledge on the state of the environment is described. Special emphasis is given to tools that explore non-traditional types of environmental data such as images, sounds and videos in association with spatial information. To illustrate the above mentioned concepts, a case study for beach quality monitoring developed within the Senses@Watch project, is described.

Communication↗

Surgical interventions for treating distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To determine when, and if so what type of, surgical intervention is the most appropriate treatment for fractures of the distal radius in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group's specialised register, Cochrane Controlled Trials Register (The Cochrane Library Issue 4, 2000), MEDLINE, EMBASE, CINAHL, the National Research Register (Issues 2 to 4, 2000) and bibliographies of trial reports. The full search was concluded in December 2000. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials involving skeletally mature patients with a fracture of the distal radius, which compared surgical treatment with conservative treatment, different types of surgical intervention or the duration of immobilisation after surgery. The main categories of surgical intervention were external fixation, percutaneous pinning, open reduction and internal fixation, and the insertion of bone scaffolding materials. DATA COLLECTION AND ANALYSIS: All trials, meeting the selection criteria, were independently assessed by both reviewers for methodological quality. Data were extracted for anatomical, functional and clinical outcomes (including complications). The trials were grouped into categories relating to the main comparisons and types of surgical intervention. Despite clear heterogeneity in the characteristics of comparable trials, pooling of data was undertaken where possible and appropriate. MAIN RESULTS: Forty four trials, examining 23 treatment comparisons, met the inclusion criteria of this review. These involved a total of 3193 mainly female and older patients with generally displaced, often comminuted and potentially or evidently unstable fractures. Half of the trials compared surgery with plaster cast immobilisation. Summarising the outcomes was hampered by the variation between the studies in participant characteristics, interventions, quality of trial methodology and reporting, and methods of outcome measurement. Surgical methods were usually associated with better anatomical appearance after fracture healing, but there was inadequate evidence to confirm that these had resulted in better functional and clinical outcomes for the patients. REVIEWER'S CONCLUSIONS: The 44 randomised trials do not provide robust evidence for most of the decisions necessary in the management of these fractures. Although, in particular, there is some evidence to support the use of external fixation or percutaneous pinning, their precise role and methods are not established. It is also unclear whether surgical intervention of most fracture types will produce consistently better long-term outcomes. There is a need for good quality evidence for the surgical management of these fractures.

Adult↗

A quality study of a computerized medical birth registry.

Processed by a computerized medical birth registry system, the birth records of 20,103 deliveries, from February 1992 to February 1993, were digitized with medium registry. From January 1, to February 28, 1993, the original records (n = 2,840 cases) of all 10 collaborative hospitals were requested for assessment of the data quality. Thirty-six items were scored, data of poor quality was found in 8 items; acceptable quality in 4 items; and good quality in 28 items. The feasibility of data transfer by floppy disc and per modem was evaluated. This registry system had shortened data processing time effectively and improved mutual feedback between data center and delivery units. Errors resulting from technical faults originating in preparation of the data for computerizing at hospital level could be effectively reduced. The validity of diagnosis remained as the major source of errors.

Birth Certificates↗

Development and implementation of a high-quality clinical database: the Australian and New Zealand Intensive Care Society Adult Patient Database.

OBJECTIVE: To describe the development of a binational intensive care database. SETTING: One hundred thirty-eight intensive care units (ICUs) in Australia and New Zealand. METHODS: A structure was developed to enable ICUs to submit data for central and local analysis. Reports were developed to allow comparison with similar ICU types and against published mortality prediction models. The database was evaluated according to (a) the criteria of the Directory of Clinical Databases (DoCDat) and (b) a proposed framework for data quality assurance in medical registries. RESULTS: Between January 1987 and December 2003, 444,147 data sets were collected from 121 (72.5%) of 167 Australian and 10 (37.0%) of 27 New Zealand ICUs. Data sets from more than 60000 ICU admissions were submitted in 2003. Overall hospital mortality was 14.5%. The mean quality level achieved according to DoCDat criteria was high as was performance against a proposed framework for data quality. The provision of no-cost software has been vitally important to the success of the database. CONCLUSION: A high-quality ICU database has successfully been implemented in Australia and New Zealand and is now used as a routine quality assurance and peer review tool. Similar developments may be both possible and desirable in other countries.

APACHE↗

Improving coded data entry by an electronic patient record system.

Data are presented on the use of a browsing and encoding utility to improve coded data entry for an electronic patient record system. Traditional and computerized discharge summaries were compared: during three phases of coding ICD-9 diagnoses phase I, no coding; phase II, manual coding, and phase III, computerized semiautomatic coding. Our data indicate that (1) only 50% of all diagnoses in a discharge summary are encoded manually; (2) using a computerized browsing and encoding utility this percentage may increase by 64%; (3) when forced to encode manually, users may "shift" as much as 84% of relevant diagnoses from the appropriate coding section to other sections thereby "bypassing" the need to encode, this was reduced by up to 41% with the computerized approach, and (4) computerized encoding can improve completeness of data encoding, from 46 to 100%. We conclude that the use of a computerized browsing and encoding tool can increase data quality and the percentage of documented data. Mechanisms bypassing the need to code can be avoided.

Data Collection↗

[Experience in the use of data of air quality monitoring networks].

An evaluation of environmental data for use in epidemiologic studies has been made, based on the experience of air pollution monitoring networks management. Univocal criteria are necessary for networks project and their management to have comparable data, underlining the importance of Quality Insurance Control Laboratories. Data elaborations to verify the Air Quality Standards observance are often not sufficient for exposure assessment. Some methods to explain to general populations environmental phenomena are shown from an experience carried out recently in Reggio Emilia and Milan. Finally, it is emphasised the importance to establish a cooperation between air pollution network managers and the data users to understand the representativeness and the correct use of data from monitoring systems.

Air↗

Evaluation of a computerized field data collection system for health surveys.

A customized field data collection system (FDCS) has been developed for a hand-held computer to collect and check questionnaire data. The data quality, preparation time, and user acceptability of the system were evaluated during a malaria morbidity survey in Bakau, the Gambia. Eight field-workers collected data with either the FDCS or on paper questionnaire forms in alternate weeks over a 6-week period. Significantly fewer item errors occurred with the FDCS, and by the end of the survey period interview times were significantly less with the FDCS than with the paper and pencil questionnaire. Advanced appropriate technology may have a useful role in providing accurate and rapid information, particularly in overcoming bottlenecks in data processing, and in obviating the need for costly expertise and equipment. In developing countries this could help to improve the quality of data on health care.

Data Collection↗

Ambient air quality for the territory of the Czech Republic in 1996-1999 expressed by three essential factors.

A new method for spatial interpretation and visualisation of measured air quality data developed and introduced in 1998 is used for ambient air quality assessment in the Czech Republic. The data from a countrywide air quality monitoring network is collated into the least possible number of factors describing the overall air quality in 1996-1999. The factors identified as 'ambient air pollution', 'ground-level ozone' and 'wet atmospheric deposition' represent three different aspects of ambient air quality and their impact on receptors' evaluation. The monitoring stations are classified for each factor using five categories clearly distinguishing the sites over the Czech Republic territory within the 'best-worst' scale range. The results are presented in maps with spot symbols produced in Arc/View system. The problem areas within the country are identified clearly for each factor. The air quality picture differs considerably for the respective factors within one calendar year. Categorisation of each factor for the entire period under review, however, remains strikingly similar, indicating that in spite of partial improvement and some decreases in air pollutant concentration, the problem areas have remained more or less the same for each factor. Comparison of all three factors shows that the southern part of the country is in a certain simplification very clean as to the 'ambient air pollution' and 'wet atmospheric deposition' factors, while it is impacted as to the 'ground-level ozone' factor. In contrast, the northern part of the country impacted as to the 'ambient air pollution' along with the 'wet atmospheric deposition' and 'ground-level ozone' factors at the higher elevations.

Air Pollutants↗