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The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: tests of data quality, scaling assumptions and score reliability.

OBJECTIVE: To evaluate the psychometric assumptions underlying the construction and scoring of SF-36 scales and summary measures among clinical trial participants with arthritis. METHODS: Cross-sectional SF-36 data from the baseline assessment of adult patients (n = 1,016) participating in four placebo-controlled clinical trials of treatment for arthritis were analyzed with blinding as to treatment. Tests of the completeness of data, scaling assumptions, internal-consistency reliability, and factor structure of SF-36 scales were performed for the combined sample. Eligible participants had at least a 6-month history of moderate to severe osteoarthritis or rheumatoid arthritis of the knee or hip. Participants meeting inclusion criteria had undergone a washout period of 3-14 days before baseline assessment to bring about a flare state in osteoarthritis or rheumatoid arthritis symptoms. Baseline sample sizes for the three osteoarthritis trials were n = 121, n = 341, and n = 187. The baseline sample size for the rheumatoid arthritis trial was n = 367. The average age of participants was 60 years, and the majority were females (72%). Measured were functional health and well-being scales and physical and mental health summary measures from the SF-36 Health Survey acute form. RESULTS: Missing responses ranged from 0.0% to 1.5% across SF-36 items, and scale scores could be computed for 96.8% to 100% of participants across trials. In all four trials, item internal consistency tests were passed (91.4%-97.1%) and item discriminant validity tests were passed (96.9%-100.0%). Across the four trials, internal-consistency reliability coefficients ranged from a low of 0.75 to a high of 0.91 for the eight scales (median = 0.84), exceeding the minimum standards for group comparisons. Ceiling effects were minimal for most scales, and floor effects were noteworthy for the role physical and role emotional scales. Physical and mental health factors identified in previous studies were replicated. CONCLUSION: The SF-36 Health Survey proved to be a psychometrically sound tool for the assessment of the health status of adult participants in clinical trials of arthritis.

Adolescent↗

Case-mix adjustment, claims data quality, and physician profiling.

On the surface, there are many ways in which case mix may be considered, but the key to any successful system often lies below the surface, in the way in which the available data feed the systems, and in the operational environment in which the output is to be used. This article will review terminology used in case-mix adjustment and profiling techniques, highlight some dangerous (and avoidable) data pitfalls, and emphasize reasonable goals that can be achieved through the use of case-mix adjusted profiling.

Data Collection↗

Routine narrative analysis as a screening tool to improve data quality.

AIM: To determine whether narrative information in emergency department surveillance systems can be systematically interrogated to improve our understanding of the causes of injury. METHODS: Screening algorithms for location, intent, and activity were developed from structured analysis of narrative data from 98999 records. The algorithms were then tested on a 50000 record database containing entries in both of the two narrative fields. A proxy gold standard was defined as the total extract using both code and narrative. Sensitivity and specificity of the emergency department coding and narrative algorithms was calculated. RESULTS: The proportion of records carrying an informative emergency department code was higher in records containing narrative-the percentage of causes coded "not know" dropped by 28.3%. The sensitivity of coded data varied from 42% to 98 % and from 33% to 99% for narrative data. Narrative analysis increased the percentage of home injuries identified by 19%, assaults by 26%, and rugby injuries by 137%. CONCLUSIONS: Using a small amount of narrative is a practical and effective means of developing more informative injury causation data in an emergency department based surveillance system. It allows for internal validation of the codes and for the identification of emerging hazards without adding more "tick boxes" or further burdening data entry clerks.

Algorithms↗

Evaluation of data quality in lichen biomonitoring studies: the Italian experience.

A total of 65 operators involved in lichen mapping studies in central and northwestern Italy underwent quality control tests during five lichen biomonitoring workshops organized between 1999 and 2000. The results showed that 75% quantitative accuracy and 90% quantitative precision can be regarded as satisfactory levels for lichen biodiversity data; 65% proved to be sufficient for accuracy of taxonomic identification in the field. Average correct assignment of the interpretative naturality/alteration class was only 48.7%. The results indicated the need for taxonomic training.

Classification↗

Data quality affects meta-analytic conclusions: a response to Miner and Raju (2004) concerning entrepreneurial risk propensity.

J. B. Miner and N. S. Raju (2004) contended that there are additional studies that compare the risk propensity of entrepreneurs and managers, which, when added to the data from W. H. Stewart and P. L. Roth (2001) and meta-analyzed, produce relationships between risk propensity and entrepreneurial status that are substantially weaker than previously believed. This conclusion was evaluated by identifying and examining methodological problems associated with their inclusion of effect sizes (i.e., ds) from studies with variables not relevant to research questions, dependent samples, extraneous variance in outcome variables, and confusion of constructs. When these methodological issues were addressed, a new meta-analysis indicated an overall conclusion consistent with that of Stewart and Roth, but the results varied according to instrumentation, particularly objective instrumentation (observed d = 0.31) versus the Miner Sentence Completion Scale-Form T (observed d = -0.35).

Entrepreneurship↗

Monitoring of IVF birth outcomes in Finland: a data quality study.

BACKGROUND: The collection of information on infertility treatments is important for the surveillance of potential health consequences and to monitor service provision. STUDY DESIGN: We compared the coverage and outcomes of IVF children reported in aggregated IVF statistics, the Medical Birth Register (subsequently: MBR) and research data based on reimbursements for IVF treatments in Finland in 1996-1998. RESULTS: The number of newborns were nearly equal in the three data sources (N = 4331-4384), but the linkage between the MBR and the research data revealed that almost 40% of the reported IVF children were not the same individuals. The perinatal outcomes in the three data sources were similar, excluding the much lower incidence of major congenital anomalies in the IVF statistics (157/10 000 newborns) compared to other sources (409-422/10 000 newborns). CONCLUSION: The differences in perinatal outcomes in the three data sets were in general minor, which suggests that the observed non-recording in the MBR is most likely unbiased.

Adult↗

Multiple observers, humidity, and choice of precision statistics: factors influencing craniometric data quality.

This study investigates three topics: (1) interobserver measurement error in craniometry, (2) the effects of humidity on craniometric measurements, and (3) the current status of estimators of measurement precision in craniometry and anthropometry. The results of the three-observer error analysis based on 24 linear measurements taken on 47 crania indicate that minor idiosyncratic variations in measurement technique can lead to high levels of statistical discrimination among the data produced by the different observers. The results of the humidity experiment substantiate the contention that increasing levels of relative humidity are associated with cranial expansion. The results of the comparison of 11 univariate precision estimators suggest that the combination of percentage agreement, the mean absolute difference, and Fisher's nonparametric sign test can give an instructive picture of the frequency, magnitude, and directionality of measurement imprecision. Information on the comparability of technique and measurement precision can then be used in the variable selection process prior to the application of multivariate statistical procedures to strengthen the substantive interpretation of craniometric data.

Analysis of Variance↗

Development of standards and data quality control.

Health care expenses represent 6 to 10% of the Gross National Product in most European countries. This budget exceeds by far those devoted to Defence or Education. The rising cost of health care concerns all governments. In each country of the European Community, measures were and will further be taken in order to increase efficiency in the delivery of health care. Recent advances in information technology offer new opportunities to collect, process and exchange data to document health practices. In Belgium the Ministry of Public Health collects uniform medical summaries for all acute care hospital inpatients, while detailed health care activities are documented for each patient through a very precise billing system. The use of Minimal Clinical Data and Minimal Nursing Data Sets in hospitals became mandatory four years ago. The fundaments for any data collection is reliability, no matter what the preconceived aim was.

Belgium↗

The Psychiatric Out-Patient Experiences Questionnaire (POPEQ): data quality, reliability and validity in patients attending 90 Norwegian clinics.

The aim of this study was to develop and evaluate the Psychiatric Out-Patient Experiences Questionnaire (POPEQ). The instrument was developed following a literature review, patient interviews and pre-testing of questionnaire items. The POPEQ was administered as part of a postal survey of 15,422 adult outpatients attending Norwegian clinics; 6677 (43.3%) patients responded to the questionnaire. Items had low levels of missing data. Factor analysis showed that 11 widely applicable items contribute to a measure of overall experiences. Sub-dimensions include clinician interaction (six items) information (two items) and outcomes (three items). Item-total correlations ranged from 0.5 to 0.8. Cronbach's alpha and test-retest reliability estimates exceeded the criterion of 0.7; the majority were over 0.8 and total scores over 0.9. Construct validity was supported by the results of 128 tests. The POPEQ includes important aspects of patient experience for psychiatric outpatients and has excellent evidence for reliability and construct validity. The instrument is recommended for the measurement of psychiatric outpatient experiences.

Adult↗

Data-quality issues and alternative variable-screening methods in a questionnaire-based study on subclinical Salmonella enterica infection in Danish pig herds.

Our aim was to determine risk factors for subclinical Salmonella enterica infection in Danish finishing-pig herds. In this paper, the evaluation, combining and initial reduction of variables is presented, along with assessment of the hypotheses in the preliminary statistical testing. The first group of herds was selected at random with no former knowledge of S. enterica infection. Both the herd prevalence and the within-herd prevalence among these herds turned out to be low; hence, some additional herds were selected from The Danish Salmonella Control program, based on their high seroprevalence. This resulted in a hybrid case-"control" design of the study and therefore, five different methods of categorising the data were used to ensure that variables were not wrongfully excluded as a result of using an improper design. Our questionnaire focused on management, infection-limiting precautions and feed and feeding procedures. To establish the prevalence of S. enterica infection within herds at the time of the visit, 50 blood samples from each herd were collected and serologically examined. The reliability of each variable from the questionnaire was assessed and it was decided which variables should be selected, disregarded, combined with other variables and/or recoded. In the simple statistical testing (2x2 tables, cut-off: P=0.25) herds were defined as subclinically S. enterica infected if the within-herd proportion of individual pigs with OD%>10 was more than 20%. The results included questionnaires from 96 randomly selected and 39 high-seroprevalence herds and 6814 blood samples. The initial 95 variables originally included in the questionnaires were reduced to 21 by critical check, combination, recoding and preliminary screening. We failed to demonstrate "herd size" as a risk factor for subclinical S. enterica infection in pig herds.

Analysis of Variance↗