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Assessing the quality of the data in a transplant registry: the European Liver Transplant Registry.

The usefulness of a clinical database depends strongly on the quality of the collected data. Data quality assurance should start with deciding in advance the uses to which the database is going to be put, developing an explicitly defined minimum data set, and setting up a user-friendly interface. The quality of the collected data can be assessed by computer validation, during which computerized range and consistency checks are based on information within the database itself. Also, note validation can be used, which implies a comparison of the original database against medical records. A number of related methodological issues are discussed in this article.

Databases, Factual↗

Occupational cancer research in the Nordic countries.

Occupational cancer research in the Nordic countries benefits from certain structural advantages, including the existence of computerized population registries, national cancer registries with high-quality data on cancer incidence, and a personal identification number for each inhabitant. This article outlines the utilization of this research infrastructure in Denmark, Finland, Iceland, Norway, and Sweden, together with research examples from the different countries. Future research on occupational cancer in this region requires that national legislation on electronic handling of sensitive personal information should not be stricter than the European Union Directive on individual protection with regard to personal data. A personal identification number is essential both for keeping up the high quality of data of the registers and for the high quality of the process of linking the different data sources together. Although previous occupational research has focused on male workers, a broader approach is needed in the future, including a study of how cancer risk in women may be affected by occupational activity and the question of possible cancer risk in offspring of men and women exposed to workplace carcinogens.

Adult↗

Measurement of mammography rates for quality improvement.

To determine the best source of high-quality data related to mammography rates, a study was undertaken to compare chart audit and claims data from the Health Care Financing Administration's Ambulatory Quality Improvement Project. Because claims data captured a higher percentage of mammograms than chart audit data in this study, quality improvement projects should consider utilizing claims data only to ascertain mammography rates.

Aged↗

Item response models for longitudinal quality of life data in clinical trials.

Assessment of quality of life is becoming standard in clinical trials. A popular method for measuring quality of life is with instruments which utilize multiple-item subscales, in which each item is scored on a Likert scale. Most statistical methods for the analysis of quality of life data in clinical trials do not explicity consider the properties and psychometric features which were of interest in scale development. In this regard, the measurement and statistical summarization of quality of life data, along with the clinical interpretation, can be somewhat disjoint from the psychometric concerns of the development process. The aim of this paper is to address the complicated issues present in analysing multiple-item ordinal quality of life data in clinical trials while maintaining fidelity to the psychometrical foundations upon which quality of life instruments are built. Accomplishing this will require the development of item response models which recognize the longitudinal aspects of clinical trial designs as well as the potential problem of informatively missing data. A general item response modeling approach is presented for longitudinal multiple-item quality of life data measured on ordinal scales with model components for missing data mechanisms and latent trait regression on treatment indicators and other covariates.

Clinical Trials as Topic↗

Mass data massage: an automated data processing system used for NHEXAS, Arizona. National Human Exposure Assessment Survey.

Data entry and management are critical components of all large survey projects; data quality objectives must be met and data must be quickly and readily accessible. We developed a comprehensive system for data entry and management utilizing scannable forms with bubble fields and handwriting recognition. This 'Mass Data Massage' (MDM) system had three components: (1) form creation and database definition; (2) programming of data dictionaries for documentation and preliminary logic and range checks; and (3) data entry, management and documentation using the 'Mass Data Cleaning Program' (MDCP). Scannable forms were written in Teleform, where the data field definition, variable names and ranges were defined as the form was created. Completed forms were returned from the field, subjected to final field quality control (QC) checks, and transferred to the data management section. They were batched and coded as necessary. Once a batch of data was scanned and visually verified, the operator called up the menu for the MDCP. The MDCP had 31 program modules with 500-1200 lines of code each. The operator could select and run the appropriate dictionary on each data batch 'correcting' apparent errors in responses. This process was iterative until the data batch passed all dictionary checks. Proposed 'changes' were forwarded to the data coordinator (DC) for acceptance or rejection. After all errors had been resolved, each data batch was subjected to a 10% quality assurance (QA) check. The original data batch and associated file of applied changes were archived. Time expenditure using the scanning approach varied with the number of questions and the types of responses (handwritten or bubble fields). One-page forms took 42-60% of the time needed for hand entry; forms longer than 10 pages took 35-38% of the time. Use of faster machines will further speed the process. The main advantage of the system was the reduction of systematic errors. Scanning alone reduced errors found on 995 NHEXAS Baseline Questionnaires. Overall, the dictionary identified 0.55% errors on the scanned forms. Ten percent QC checks, performed on corrected batches ready for appendage to the master database, revealed an overall error rate of 0.02%. Similar checks on a laboratory form scanned from numeric handwriting detected 0.3% errors following dictionary application and 0.2% errors during the 10% QA check. This system was faster, more accurate, and more cost-effective than hand entry of data. A batch of data that took >1 week to process using the hand entry method was processed within 1 day using MDM. Human coding of specific answers and the final verification were the most time-consuming processes.

Arizona↗

Systems of protocol review, quality assurance, and data audit.

The US National Cancer Institute (NCI) is the world's largest sponsor of clinical trials in cancer treatment and biology, and it is responsible for the reliability of data generated by means of its funding. The cooperative groups supported by the NCI consist of main academic institutions and smaller affiliates of these institutions. The size of these groups, their geographical dispersion, and the number of studies accruing patients at any one time make it a challenge to ensure that all requirements of institutional oversight, patient consent, protocol compliance, and data submission and quality are met. Each cooperative group has established various procedures for quality assurance. These include data coordinators at the data management center of the group, study chairs, and statisticians. In addition, each group has a committee of physician-investigators and clinical research associates who make periodic site visits to all member institutions to audit the on-site medical records of a sample of patients entered at that institution. The study records are compared with the medical records for all aspects of protocol management and data generation. In addition, adherence to requirements for consent-form signing and oversight by an institutional review board is assessed. Deviations from the study requirements are evaluated as being minor or major. A written report of the audit result is provided to both the NCI and the relevant administrative components of the cooperative group. The audit process has uncovered rare instances of scientific improprieties in these NCI-funded clinical trials, but more importantly it has educated investigators and support staff to improve adherence to research and data-collection requirements, which has resulted in greater reliability of study results.

Data Collection↗

A public health nursing informatics data-and-practice quality project.

Automation of nursing documentation in client records is one of today's formidable challenges in healthcare settings. Some stakeholders view standardized nursing language as a fundamental component of an automated record, with the end goal of generating valid, reliable data on nursing services and client outcomes. However, few successful applications of standardized nursing language for practice standards and data generation exist in the literature. A joint practice-and-data quality project based on standardized nursing language in an automated platform was undertaken by four local public health departments. Outcomes of this project included articulation of standards for nursing practice and creation and implementation of a sound data quality infrastructure for nursing documentation of client assessments, service delivery information, and client outcomes.

Case Management↗

Stormwater quality models: sensitivity to calibration data.

Stormwater quality modelling is a useful tool in sewer systems management. Available models range from simple to detailed complex ones. The models need local data to be calibrated. In practice, calibration data are rather lacking. Only few measured events are commonly used. In this paper, the effect of the number and the variability of calibration data on models of various levels of complexity are investigated. The study is carried out on "Le Marais" catchment for suspended solids where 40 reliable measured events and good knowledge of the sewer system are available. The method used is based on resampling subsets of measured events among the 40 available ones. Three types of models were calibrated using subsets of events of different sizes and characteristics resampled among the 40 available ones. For each calibration, the model was validated against the remaining events to stand upon the quality of the model. It was found that the models are quite sensitive to calibration data, a problem neglected in practical studies. The use of more complex models does not necessarily improve modelling results since more problems and error sources are to be expected. The findings are specific to "Le Marais" catchment and the models used.

Calibration↗

Relationship between low quality-of-care scores and HMOs' subsequent public disclosure of quality-of-care scores.

CONTEXT: Public disclosure of quality data on health maintenance organizations (HMOs) might improve public accountability, inform consumer decision making, and promote quality improvement. But, because disclosure is voluntary, some HMOs could subvert these objectives by refusing to release unfavorable data. OBJECTIVE: To determine the association between HMO quality of care and withdrawal from public disclosure of quality-of-care data the subsequent year. DESIGN AND SETTING: Retrospective cohort study of administrative and quality-of-care data on HMOs from the National Committee for Quality Assurance (NCQA) annual Quality Compass databases for 1997, 1998, and 1999, including Health Plan Employer Data and Information Set (HEDIS) quality scores. MAIN OUTCOME MEASURE: One-year rates of HMO withdrawal from public disclosure of HEDIS scores for plans in the highest and lowest tertiles of HEDIS scores, adjusted for method of data collection and plan model type. RESULTS: Of the 329 HMOs that publicly disclosed HEDIS scores in 1997, 161 plans (49%) withdrew from public disclosure in 1998. Of the 292 HMOs that disclosed their scores in 1998 (including 130 newly participating plans), 67 plans (23%) withdrew from public disclosure in 1999. Plans whose scores ranked in the lowest-quality tertile were much more likely than plans ranking in the highest-quality tertile to withdraw from public disclosure in 1998 (odds ratio [OR], 3.6; 95% confidence interval [CI], 2.1-7.0) and 1999 (OR, 5.7; 95% CI, 2.7-17.7). CONCLUSION: Compared with HMOs receiving higher quality-of-care scores, lower-scoring plans are more likely to stop disclosing their quality data. Voluntary reporting of quality data by HMOs is ineffective; selective nondisclosure undermines both informed consumer decision making and public accountability.

Access to Information↗

Data pre-processing in liquid chromatography-mass spectrometry-based proteomics.

MOTIVATION: In a liquid chromatography-mass spectrometry (LC-MS)-based expressional proteomics, multiple samples from different groups are analyzed in parallel. It is necessary to develop a data mining system to perform peak quantification, peak alignment and data quality assurance. RESULTS: We have developed an algorithm for spectrum deconvolution. A two-step alignment algorithm is proposed for recognizing peaks generated by the same peptide but detected in different samples. The quality of LC-MS data is evaluated using statistical tests and alignment quality tests. AVAILABILITY: Xalign software is available upon request from the author.

Algorithms↗

Data reduction from twinned RNA crystals.

Methods were developed to process diffraction data from epitaxically twinned crystals. Four programs for data reduction and two display programs were developed to augment the data-reduction program XDS [Kabsch (1988). J. Appl. Cryst. 21, 916-924]. The programs can be generalized for use with other data-reduction software that provides the user with a list of the reflections used to determine lattice constants and crystal orientation. LATTICE_VIEW generates a PDB file containing 'water molecules' at the reciprocal-space coordinates of the strong spots found in the initial data frames. The PDB file is visualized to identify spots that belong to the same lattice, obtain unit-cell dimensions for a lattice, and assess data quality. VECTOR_MATCH is used to find additional spots belonging to a lattice. ACCOUNT4 determines which spots have been processed by XDS. COMFORT discards reflections that are too close to a reflection in another lattice. The display programs provide useful visual information on the quality of the crystal orientations used. Data with an R(merge) of 7.1% at 2.4 A resolution were obtained from epitaxically twinned crystals of an RNA dodecamer. The data were of sufficient quality to solve the structure with a combination of molecular replacement and single isomorphous replacement methods.

Journal Article↗

Psychotherapy for bulimia nervosa and binging.

OBJECTIVES: The review aims to evaluate the psychotherapeutic treatments for those with binge eating syndromes, that have been tested in randomised controlled trials. Specifically, cognitive-behavioural(CBT) therapy is compared with waiting list or a non-treatment group, any other psychotherapy, CBT in a "pure self-help" form and CBT augmented by exposure and response therapy. As well, the reveiw aims to evaluate the evidence for the efficacy of other psychotherapies when compared to a no treatment control group and to evaluate the evidence for the efficacy of other psychotherapies when compared to a 'placebo' therapy. SEARCH STRATEGY: Handsearch of The International Journal of Eating Disorders since its first issue; database searches of MEDLINE, EXTRAMED, EMBASE, PSYCHLIT, CURRENT CONTENTS, LILACS, SCISEARCH, The Cochrane Collaboration Controlled Trials Register and the Cochrane Depression, Anxiety and Neurosis Group Database of Trials; citation list searching and personal approaches to authors communication are used. SELECTION CRITERIA: All studies that have tested any form of psychotherapy for adult patients with non-purging bulimia nervosa, binge eating disorder and/or EDNOS of a bulimic type, and which have applied a randomised controlled and standardized outcome methodology, are sought for the purpose of this review. DATA COLLECTION AND ANALYSIS: Data are entered into a spreadsheet programme, and into the REVMAN analysis program. Relative risk analyses are conducted of binary outcome data. The relative risk analysis is used rather than the odds ratio as the outcome measures proposed are not measuring a rare event (such as death) and the total number of studies is small. Standardized mean difference analyses are conducted of continuous variable outcome data, as the continuous outcome measures are not consistent across studies. Sensitivity analyses are conducted of a number of measures of trial quality. Data were not reported in such a way to do subgroup analyses, but the effect of treatment on depressive symptoms, psychosocial and/or interpersonal functioning, general psychiatric symptoms and weight is examined where possible. Chi-square tests for homogeneity are done, @ 5% level of significance, using a fixed effects model. Funnel plots to evaluate presence of publication bias are completed and available in a text file upon request. MAIN RESULTS: To date, 1360 trials have been generated by searching and 58 trials have been evaluated in detail. Because of a relatively high number of exclusions (n=12) the trial inclusion criteria were broadened to include those with non-blinded outcome assessment, providing 20 trials for analyses. Because of incomplete published and available data, at best up to 10 studies had data available for any single analysis. The maximum number of total patients included in a single analysis is 396. The majority of studies (18) evaluate patients with bulimia nervosa of a purging type. CBT is superior to waiting list controls with respect to abstinence from binge eating (RR 0.64 CI.53-.78). CBT is not superior to other psychotherapies with respect to abstinence from binge eating (RR.79, CI.54-1.17). CBT in a full or less intensive form is not significantly superior to CBT in a pure self-help form. Augmentation of CBT with exposure therapy is not more effective than CBT alone. NonCBT-psychotherapies also have significantly greater abstinence rates in comparisons with wait-list controls, but there is a paucity of such studies (RR 0.67, CI.56-.81, n=3 studies). Funnel plots suggest a bias towards publication of positive outcome studies only. REVIEWER'S CONCLUSIONS: There is small body of evidence for the efficacy of cognitive-behaviour therapy in bulimia nervosa and similar syndromes, but the quality of trials is very variable (e.g. the majority, 12, are not blinded) and sample sizes are often very small. More trials are needed, particularly for binge eating disorder and other EDNOS syndromes, and evalu

Adult↗

Automatic scoring and quality assessment using accuracy bounds for FP-TDI SNP genotyping data.

BACKGROUND: Human diversity, namely single nucleotide polymorphisms (SNPs), is becoming a focus of biomedical research. Despite the binary nature of SNP determination, the majority of genotyping assay data need a critical evaluation for genotype calling. We applied statistical models to improve the automated analysis of 2-dimensional SNP data. METHODS: We derived several quantities in the framework of Gaussian mixture models that provide figures of merit to objectively measure the data quality. The accuracy of individual observations is scored as the probability of belonging to a certain genotype cluster, while the assay quality is measured by the overlap between the genotype clusters. RESULTS: The approach was extensively tested with a dataset of 438 nonredundant SNP assays comprising >150,000 datapoints. The performance of our automatic scoring method was compared with manual assignments. The agreement for the overall assay quality is remarkably good, and individual observations were scored differently by man and machine in 2.6% of cases, when applying stringent probability threshold values. CONCLUSION: Our definition of bounds for the accuracy for complete assays in terms of misclassification probabilities goes beyond other proposed analysis methods. We expect the scoring method to minimise human intervention and provide a more objective error estimate in genotype calling.

Algorithms↗

Review: occupational risks for voice problems.

The purpose of this paper is to provide a cohesive review of the literature regarding the functional consequences of voice problems and occupational risk factors for them. The salient points are as follows. According to conservative estimates, approximately 28,000,000 workers in the US experience daily voice problems. Many people who experience voice problems perceive them to have a negative impact on their work and their quality of life. Estimates based on empirical data suggest that, considering only lost work days and treatment expenses, the societal cost of voice problems in teachers alone may be of the order of about $2.5 billion annually in the US. In fact, across several countries, "teacher" consistently emerges as the common occupation most likely to seek otorhinolaryngological (ORL) evaluation for a voice problem. Other occupational categories likely to seek ORL examination for a voice problem are singer, counselor/social worker, lawyer, and clergy. Finally, US Census data indicate that keyboard operators may be at special risk for voice problems because of a near-epidemic growth of repetitive strain injury (RSI), which can adversely affect the voice especially when speech recognition software is implemented. This paper discusses frequency data, quality of life data, and treatment considerations for these voice-related occupational issues.

Adult↗

Quality control of agar diffusion susceptibility tests: data from the Quality Assurance Service Microbiology program of the College of American Pathologists.

Over a 12-month period, between July 1981 and June 1982, 115 active participants in the Microbiology program of the College of American Pathologists Quality Assurance Service (QAS) submitted a total of 555,619 individual determinations on three quality control reference strains using the NCCLS standardized disc diffusion procedure. Data is presented for those antimicrobic agent/reference strain combinations for which NCCLS control limits have been changed since the last report of QAS microbiology data or that continue to show discrepancies with current NCCLS individual daily test control guidelines. Data for Escherichia coli versus cefoxitin, doxycycline, and nalidixic acid and for Staphylococcus aureus versus cefoxitin, nafcillin, and oxacillin show good compliance with the new NCCLS guidelines and distributions that are all approximately Gaussian. Significant discrepancies were noted for six combinations; cefamandole, cephalothin, neomycin, and nitrofurantoin versus E. coli and amikacin and clindamycin versus S. aureus. Of these discrepancies, only neomycin/E. coli and amikacin/S. aureus can be accounted for by a subpopulation of laboratories, which, when removed, corrects the data.

Amikacin↗

The methodical collection of ear surgery data as a basis for quality control.

Data relating to daily clinical practice were collected in an otologic database. Over a period of 3 years, information was gathered about 1,000 ear operations. This led to the following conclusions: the collection of data is difficult; the selection of data and the moment it should be fed into the systems are very important; there is a risk of using too many items and therefore reducing surgeon compliance. On the other hand, too few items result in irrelevant overviews. The collection of ear surgery data makes it easier to understand positive and negative outcomes.

Adult↗

Quality assurance and data feedback.

Health care quality measurement and improvement are vital concerns of all health care managers. Data feedback is an emerging body of literature delineating principles designed to improve physician interest and cooperation in utilization of peer review activities.

Feedback↗

Antibiotics for acute asthma.

BACKGROUND: Antibiotics are often prescribed to patients who are admitted to hospital with acute asthma. Their exacerbation is often precipitated by a viral upper respiratory infection (URTI), but in some instances antibiotics are prescribed in spite of questionable efficacy. A lack of strong evidence either to support or to refute the use of treatments in acute asthma leaves room for discussion and debate as to how effective antibiotics are in an acute setting. This review assesses what evidence is available. OBJECTIVES: To determine the efficacy of antibiotics prescribed in the treatment of acute asthma SEARCH STRATEGY: Electronic databases (MEDLINE, EMBASE and CINAHL) were searched to identify all possible randomised control trials. SELECTION CRITERIA: Only RCTs or quasi RCTs were eligible for inclusion. Studies were included if patients were treated for acute asthma in the ED or its equivalent with antibiotics or placebo. Two reviewers independently assessed articles for potential relevance, final inclusion, and methodological quality. DATA COLLECTION AND ANALYSIS: Two reviewers completed trial quality assessment and data extraction independently. MAIN RESULTS: From 128 potential studies, two trials were identified for inclusion in the review. Both trials reported numbers of exacerbations and not patient numbers due to re admissions over the course of the trials. The total number of patients in this review was 97, but values were recorded for 115 exacerbations. REVIEWER'S CONCLUSIONS: The role of antibiotics in the treatment of acute asthma is difficult to assess from the current literature. Recommendations regarding antibiotic use in acute asthma will remain consensus driven until more research is conducted which includes larger numbers of patients.

Acute Disease↗