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Interlaboratory variability in drug assay: a comparison of quality control data with reanalysis of routine patient samples. II: Digoxin. Clinical Pharmacology and Toxicology Study Group, Italian Society for Clinical Biochemistry.

Fifty-four laboratories providing a serum digoxin monitoring service participated in a 16-month prospective quality control (QC) study that involved (a) determination of spiked QC samples based on a human serum matrix and (b) reanalysis by two to four reference laboratories of patient samples randomly selected among those assayed routinely. Interlaboratory variability on spiked samples was limited, coefficients of variation being usually in the 11-21% range. Correlations between values reported by individual reference laboratories on routine samples were reasonably good irrespective of the techniques used, which were the enzyme-multiplied immunoassay technique (EMIT) or the fluorescence polarization immunoassay (FPIA). When all data were considered, the correlation between the original routine values and reference results (r = 0.93) was comparable to that observed for the other analytes (phenytoin and theophylline) included in the survey. When subsets of results were evaluated according to the technique used, the agreement between routine and reference results was good for samples originally measured by FPIA (r = 0.96), moderate for samples originally measured by non-EMIT/non-FPIA techniques (r = 0.92), and poor for the few samples originally measured by EMIT (r = 0.55). The poor correlation with EMIT results could be ascribed largely to erratic performance of two individual laboratories. It is concluded that interlaboratory variability in routine drug measurements is greater for digoxin than for other analytes such as phenytoin and theophylline, and that the analytical performance of some laboratories is grossly inaccurate.

Digoxin↗

The use of the diary as a data collection technique.

The initiation of a research project requires many decisions, not the least of which is the selection of a method for data collection. This decision is, in large measure, guided by the nature of the research question which generally prescribes the selection of a strategy for data collection from among an array of possible alternatives. This article addresses the use of a diary for data collection. Although diaries have traditionally been used in social science and health research, their use in nursing research is more recent. The article begins with a brief discussion of the rationale for using the diary to gather data in a study of personal and professional caregiving. A brief review of the use of diaries in previous studies follows, along with a description of the use of a diary in the caregiving study and a discussion of the possible threats to high quality data as well as measures used to ensure the collection of high quality data. The article concludes with a discussion of the strengths and weaknesses of the diary and makes recommendations regarding its use in nursing research.

Autobiographies as Topic↗

Strategies for reporting health plan performance information to consumers: evidence from controlled studies.

OBJECTIVE: To assess whether presentation approaches designed to be more meaningful result in greater weighting of quality information in decisions. An emerging body of research indicates that the way information is presented affects how it is interpreted and how it is weighted in decisions. Comparative health plan performance reports are not being used by consumers possibly because the information presented is difficult to use. The next generation of these reports should be designed to support decision making. DESIGN AND STUDY PARTICIPANTS: The study uses a controlled experimental design. Participants (n = 162) were randomly assigned to different conditions and asked to complete tasks related to using quality information and making health plan selections. Dependent variables included the amount of weight given to quality information in choices and decision accuracy. RESULTS: Some presentation approaches make it easier for users to process and integrate quality data into their choices. However, other presentation formats influence consumers' decisions in ways that undermine their self-interest. CONCLUSIONS: Findings indicate that presenting quality data in a more evaluable format increases the weight it carries in consumer decisions. Every change made in the presentation of comparative data has the potential to influence decisions. Those who disseminate information have a responsibility to be aware of how they use that influence and to direct it in productive and defensible ways. The alternative is to manipulate people in ways that are unknown, are not thought out, or are not defensible, but are no less manipulative.

Adult↗

Ground-based air-sampling measurements near the Nevada Test Site after atmospheric nuclear tests.

Historical air-sampling data measured within 320 km (200 mi) of the Nevada Test Site (NTS) have been reviewed for periods following atmospheric nuclear tests, primarily in the 1950s. These data come mostly from high-volume air samplers, with some from cascade-impactor samplers. Measurements considered here are for beta radiation from gross fission products. The resulting air-quality data base is comprised of almost 13,000 samples from 42 sampling locations downwind of the NTS. In order to compile an accurate air-quality data base for use in estimating exposure via inhalation, raw data values were sought where possible, and the required calculations were performed on a computer with state-of-the-art algorithms. The data-processing procedures consisted of (1) entry and error checking of historical data; (2) determination of appropriate background values, air-sampling volumes, and net air concentrations; and (3) calculation of integrated air concentration (C) for each sample (considering fallout arrival times). Comparing C values for collocated high-volume and cascade-impactor samplers during the Upshot-Knothole series showed similar lognormal distributions, but with a geometric mean C for cascade impactors about half that for the high-volume air samplers. Overall, the uncertainty in C values is about a factor of three. In the past, it has been assumed that C could be related to ground deposition by a constant having units of velocity. In our data bases, simultaneous measurements of air concentration and ground deposition at the same locations were not related by a constant; indeed, there was a great amount of scatter. This suggests that the relationship between C and ground deposition in this situation is too complex to be treated adequately by simple approaches.

Air Pollutants, Radioactive↗

Factors that influence line managers' perceptions of hospital performance data.

OBJECTIVE: To design and test a model of the factors that influence frontline and midlevel managers' perceptions of usefulness of comparative reports of hospital performance. STUDY SETTING: A total of 344 frontline and midlevel managers with responsibility for stroke and medical cardiac patients in 89 acute care hospitals in the Canadian province of Ontario. STUDY DESIGN: Fifty-nine percent of managers responded to a mail survey regarding managers' familiarity with a comparative report of hospital performance, ratings of the report's data quality, relevance and complexity, improvement culture of the organization, and perceptions of usefulness of the report. EXTRACTION METHODS: Exploratory factor analysis was performed to assess the dimensionality of performance data characteristics and improvement culture. Antecedents of perceived usefulness and the role of improvement culture as a moderator were tested using hierarchical regression analyses. PRINCIPAL FINDINGS: Both data characteristics variables including data quality, relevance, and report complexity, as well as organizational factors including dissemination intensity and improvement culture, explain significant amounts of variance in perceptions of usefulness of comparative reports of hospital performance. The total R2 for the full hierarchical regression model = .691. Improvement culture moderates the relationship between data relevance and perceived usefulness. CONCLUSIONS: Organizations and those who fund and design performance reports need to recognize that both report characteristics and organizational context play an important role in determining line managers' response to and ability to use these types of data.

Adult↗

Following Shipman: a pilot system for monitoring mortality rates in primary care.

As part of the investigations into the crimes of Harold Shipman, it has become clear that there is little monitoring of deaths in general practice. By use of data on annual deaths at family physician and practice level for five English health authorities for 1993-99, we investigate whether cumulative sum charts (a type of statistical process control chart) could be used to create a workable monitoring system. On such charts, thresholds for deaths can be set, which, if crossed, may indicate a potential problem. We chose thresholds based on empirical calculations of the probabilities of false and successful detection after allowing for multiple testing over physicians or practices. We also statistically adjusted the charts for extra-Poisson variation due to unmeasured case mix. Of 1009 family physicians, 33 (including Shipman) crossed the alarm threshold designed to detect a 2 SD increase in standardised mortality, with 97% successful detection and a 5% false-alarm rate. Poor data quality, plus factors such as the proportion of patients treated by these physicians in nursing homes or hospices are likely explanations for most of these additional alarms. If used appropriately, such charts represent a useful tool for monitoring deaths in primary care. However, improvement in data quality is essential.

Data Collection↗

The temperature of flash-cooling has dramatic effects on the diffraction quality of nucleosome crystals.

Nucleosome core-particle crystals are routinely flash-cooled in liquid propane at temperatures of approximately 153 K, followed by transfer into a cold nitrogen-gas stream (approximately 93 K). Analysis of diffraction data from crystals flash-cooled at different temperatures shows that the optimal temperature is approximately 153 K. The data quality worsens, with a concomitant reduction in the diffraction limit, at temperatures both higher and lower than 153 K. With some batches of crystals, significant shrinkage of the unit-cell volume is also observed at temperatures of 138 K and lower. The lattice shrinkage is always restricted to the c axis, concurrent with closer packing of two nucleosomes. Direct plunge-cooling of crystals in liquid nitrogen leads to loss of diffraction quality and resolution limit. Thus, in cases where flash-cooling into liquid nitrogen is detrimental to diffraction, optimizing cooling protocols at higher temperatures using liquid propane or other cryogens with similar properties may lead to dramatically improved results. In a related study, it is shown that a nucleosome crystal transported under 'cryocooled' conditions has higher mosaicity and yields inferior data quality in comparison to a crystal cryocooled at the synchrotron. For fragile crystals, transport in mother liquor and/or cryoprotectant followed by subsequent flash-cooling at the synchrotron may be the best procedure.

Crystallography↗

Methodological issues in interpreting trends in MONICA event rates.

Before looking at the trends in coronary event rates and case fatality rates in the WHO MONICA Project, it is necessary to assess the consistency and validity of the data. In the Newcastle MONICA Collaborating Centre, two methods have been used. One involves monitoring data quality by comparisons with external data systems such as hospital discharge data and official mortality records. The other is to examine the internal consistency of MONICA diagnostic findings. For fatal myocardial infarction (MI) or coronary death, there is consistent evidence of a decline, but the MONICA data are not adequate to assess relative changes in sudden compared to non-sudden death rates. For non-fatal definite MI there was an increase early in the study, possibly due to a change in methods, but rates have now stabilized. For non-fatal possible MI there has been a steady increase in rates for events which may be becoming less severe. This is consistent with increasing hospital admissions for subacute ischaemic heart disease (IHD) and angina. This paper exemplifies the importance of maintaining internal and external surveillance of the quality of the data.

Adult↗

Influence of a financial incentive on cognitive services: CARE project design/implementation.

OBJECTIVE: To describe the design and methods of the Washington State Cognitive Activities and Reimbursement Effectiveness (CARE) Project, a demonstration project in which community pharmacies were paid for cognitive services (CS) provided to Medicaid patients, its evaluation objectives, and the extent to which implementation objectives were achieved. DESIGN: Prospective randomized trial. Community pharmacies were allocated to a documentation-and-payment group, documentation-only group, and "silent" control group. CS were reported using a problem-intervention-result classification system embedded within a pseudo-National Drug Code format. Management strategies included use of area coordinators. SETTING: Pharmacies serving ambulatory Medicaid patients in the state of Washington, excluding staff-model health maintenance organization pharmacies and pharmacies predominantly serving long-term-care residents. PARTICIPANTS: 200 community pharmacies (110 treatment; 90 control), with another 100 randomly selected pharmacies as a silent control group. INTERVENTIONS: A modest monthly stipend. The treatment group billed Medicaid for each documented CS associated with a drug therapy-related problem. All participants received training in documentation methods. A unique coding scheme allowed documentation of CS within the constraints of the Medicaid program. Data edit checks and feedback were used to ensure data quality and completeness. Area coordinators were used to facilitate training, compliance with study procedures, and participation. MAIN OUTCOME MEASURES: Participation rates, documentation rates, coding scheme revision, data quality and completeness rates, and effectiveness of area coordinators. RESULTS: Pharmacists documented more than 20,240 CS records. Approximately 89% of records passed edit checks, and 94% did so after modification. Nearly 83% could be linked to a paid drug or CS claim. The coding system was sufficient, with minor modifications, to account for all interventions documented. Area coordinators did not function as expected. CONCLUSION: A system for documentation and payment of pharmacists' CS to Medicaid recipients was implemented successfully and relatively easily in community pharmacies.

Double-Blind Method↗

Stability of mean assay values of magnesium and iron in lyophilized quality control serum: a study based on data from the quality assurance service (QAS) of the College of American Pathologists.

Data from magnesium and iron analyses of pools of lyophilized quality control serum were used to evaluate stability of analyte mean values in the pre-reconstitution period. Information was received from laboratories in Regional Quality Control Programs between 1977 and 1981, using CAP Quality Assurance Service data processing. For magnesium, 28 of 41 (68%) pool-method combinations were stable, 11 (27%) showed decreases, and 2 (5%) showed increases. Decreases averaged 0.008 mg/dL/month (all methods). A pronounced effect of method (automated methylthymol blue) and year correlated with decreases in measurable magnesium. For iron, 45 of 56 (80%) pool-method combinations were stable, 8 (15%) showed decreases, and 3 (5%) showed increases. Decreases averaged 0.349 g/dL (all methods). In most cases, changes in measured concentrations are attributed to methodologic factors, rather than intrinsic changes in analyte concentrations.

Autoanalysis↗

IMGT/LIGM-DB: a systematized approach for ImMunoGeneTics database coherence and data distribution improvement.

IMGT, the international ImMunoGeneTics database (http:(/)/imgt.cnusc.fr:8104), created by Marie-Paule Lefranc, Montpellier, France, is an integrated database specializing in antigen receptors and MHC of all vertebrate species. IMGT includes LIGM-DB, developed for Immunoglobulins and T-cell-receptors. LIGM-DB distributes high quality data with an important increment value added by the LIGM expert annotations. LIGM-DB accurate immunogenetics data is based on the standardization of biological knowledge related to keywords, annotation labels and gene identification. The management of such data resulting from biological research requires an high flexible implementation to quickly reflect up-to-date results, and to integrate new knowledge. We developed a systematized approach and defined LIGM-DB systems which manage and realize the major tasks for the database survey. In this paper, we will focus on the coherence system, which became absolutely crucial to maintain data quality as the database is growing up and as the biological knowledge continues to improve, and on the distribution system which makes LIGM-DB data easy to access, download and reuse. Efforts have been done to improve the data distribution procedures and adapt them to the current bioinformatics needs. Recently, we have developed an API which allows Java programmers to remotely access and integrate LIGM-DB data in other computer environments.

Animals↗

Challenges in surveillance of dementias in New York State.

Prevalence of dementia is expected to increase three- to four-fold in the next 50 years. In 1986, New York State established the Alzheimer's Disease and Other Dementias Registry, one of a few such registries in the United States. We identify surveillance challenges within the Registry. Data quality--specifically, the attributes of completeness and accuracy--is the primary challenge to the New York State dementias registry. Completeness may be undermined when hospitals and nursing homes fail to report data, and hospital charts do not record dementia diagnoses. Failure to record diagnoses may occur because of diagnosis uncertainty, perceived stigma, clinical attention on the primary reason for hospitalization, and financial disincentives. Dementia is well recorded in nursing home data because care planning requires frequent resident evaluations. The accuracy of recording specific forms of dementia is limited because coding terminology has not kept pace with physicians' perspectives on dementias. Hospitals and nursing homes document dementia and comorbidities more effectively among frail individuals and those with advanced dementias than among individuals who appear to be relatively healthy. One way to overcome challenges of data quality is to form partnerships with organizations that have expertise in managing medical records and coding dementias. As medical advances make early diagnoses more possible outside the hospital or nursing home setting, we will need to redesign the current surveillance system to capture this additional dementia data and ensure a representative system.

Aged↗

How useful are hospital morbidity data for monitoring conditions occurring in the perinatal period?

BACKGROUND: There is currently no published information on the full range of morbid conditions affecting mothers and newborns in Australia. Hospital morbidity data collections are a possible source of this information, but have not been widely utilised due to concerns about data quality. AIMS: To assess the accuracy and reliability of perinatal morbidity reporting to the New South Wales Inpatient Statistics Collection (NSW ISC). METHODS: A sample of 1000 records relating to 500 mothers and 500 newborns were randomly selected from the NSW ISC for the financial year 1999-2000 and compared with information obtained from medical records. Sensitivities and specificities were calculated for conditions of clinical relevance. RESULTS: There was a wide range of sensitivities among the 41 conditions selected, indicating a variable level of under-enumeration. Only 17 (41%) had a sensitivity of 80% or more. Sensitivities were more than 95% for gestational diabetes, prolonged pregnancy, perineal laceration, single live birth, low birth weight, and intracranial haemorrhage. However, numbers are small and confidence intervals wide for some of these conditions. Specificities were generally high. Neonatal conditions tended to be more accurately reported than maternal conditions. The pattern of results was similar to that reported for state perinatal data collections. CONCLUSIONS: While hospital administrative data are readily available, data quality is a valid concern. However, if the data are viewed critically and information on accuracy is available, they can be a useful resource for monitoring the health of mothers and babies.

Data Collection↗

Applying an evidence-based approach to the management of patients with ocular hypertension: evaluating and synthesizing published evidence.

PURPOSE: The use of evidence-based medicine in managing patients with ocular hypertension has been constrained by the limited availability of high-quality data from controlled clinical trials and by limited formal training of clinicians in evaluating published evidence. This article will provide strategies and techniques to evaluate critically the quality of published research, synthesize the findings, and integrate published evidence in the care of patients with ocular hypertension. DESIGN: Review of the published literature and consensus of a panel of experts. METHODS: The published literature on evidence-based medicine was reviewed. Strategies and techniques in evaluating the quality of evidence and how to integrate evidence into the practice setting using the following three major questions were discussed by a panel of experts: Are the results of the study valid? What are the results? Do the study outcomes apply to individual patient care? RESULTS: Approaches to assessing study validity and the importance of considering the size of the treatment effect and precision of the effect size were detailed. The importance of using the "number-needed-to-treat" as a tool for translating results of clinical trials to individual patient care and the "number-needed-to-harm" as a method of comparing the potential benefit and harm of a given therapy was acknowledged. CONCLUSION: As the volume of high-quality data increases, the information provided herein may help ophthalmologists apply evidence-based medicine techniques as they seek to optimize the care of individual patients with ocular hypertension.

Evidence-Based Medicine↗