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At least 595 records · Page 33Linked to original sources

Relative sensitivity to change of the erythrocyte sedimentation rate and serum C-reactive protein concentration in rheumatoid arthritis.

OBJECTIVE: To compare the sensitivity to change of the erythrocyte sedimentation rate (ESR) and serum C-reactive protein (CRP) concentration used as measures of rheumatoid arthritis (RA) activity. METHODS: A literature search was conducted to identify all clinical trials and observational studies of disease-modifying medications and corticosteroids in RA that reported results for both ESR and CRP before treatment and 4 weeks to 24 weeks after treatment in the same patients. For each test, effect sizes were computed as the change in the test with treatment divided by the pretreatment standard deviation. A pooled analysis was performed on the paired differences in effect sizes for ESR and CRP within each study. RESULTS: One hundred twenty-three studies with 184 active treatment arms were identified that included measurements of both ESR and CRP. Sixty-three studies with 90 active treatment arms provided sufficient data to permit calculation of effect sizes, and were included in the analysis. In the 36 treatment arms that reported results at 12 weeks, the ESR was more sensitive to change than the CRP, with a paired difference in effect sizes of 0.09 units (95% confidence interval 0.03, 0.15; p = 0.005). In the 76 treatment arms that reported results at 24 weeks, the ESR was also more sensitive to change than the CRP, with a paired difference in effect sizes of 0.11 units (95% CI 0.05, 0.17; p = 0.0004). CONCLUSION: In these studies of disease-modifying medications in RA, the ESR was more sensitive to change than the CRP at 12 weeks and 24 weeks of treatment. Few studies examined changes in these measures at times earlier than 12 weeks.

Arthritis, Rheumatoid↗

Informatics tools to improve clinical research.

During the conduct of complex clinical trials, there are numerous sources and types of data collection and project coordination problems. Methods and approaches to address the conduct of a trial vary in both the cost and time to perform and the potential benefit. Informatics tools can help trial coordinators and investigators ensure the collection of high quality research data during all phases of a clinical trial.

Clinical Trials as Topic↗

Quality management tools: facilitating clinical research data integrity by utilizing specialized reports with electronic case report forms.

Data collected throughout the course of a clinical research trial must be reviewed for accuracy and completeness continually. The Oracle Clinical (OC) data management application utilized to capture clinical data facilitates data integrity through pre-programmed validations, edit and range checks, and discrepancy management modules. These functions were not enough. Coupled with the use of specially created reports in Oracle Discoverer and Integrated Review, both ad-hoc query and reporting tools, research staff have enhanced their ability to clean, analyze and report more accurate data captured within and among Case Report Forms (eCRFs) by individual study or across multiple studies.

Biomedical Research↗

The morbidity and mortality conference: a prolegomenon on its role as an anesthesia risk-management tool.

Although the morbidity and mortality conference (MMC) is an essential component of any anesthesia risk-management program, it has not undergone systematic analysis. All MMC narratives detailing the proceedings at two university centers from June 1988 to June 1990 were examined by content analysis and the unique perspectives of MMC participants were captured. The majority of MMC events were of an educational or informational nature; 32% dealt with patient complications, and 14% involved incidents that could have led to detrimental outcomes. Participant beliefs were ultimately organized into categories describing "the lived experience" of the MMC. These included (1) disclosure of knowledge, (2) correspondence of relationship, (3) teaching conformity to rule, (4) developing a sense of aplomb, (5) preparation for litigation, (6) the ceremony, (7) a quality-assurance mechanism, (8) a personal lambaste function, and (9) an instrument of punitive retribution. The MMC appeared improperly named; "case conference" or "clinical teaching conference" may serve as a more accurate rubric. The MMC played a variety of cognitive and affective roles. Recognition of the nature of the teaching and learning associated with the MMC will allow risk managers to utilize it optimally in achieving envisioned objectives that enhance patient outcomes.

Anesthesiology↗

[Data input management in clinical trial].

Data management in the clinical trial is not always processed adequately in Japan. Data management largely depends on the doctor who is in charge of the study. For the effective data processing to the computer, careful attentions should be paid to the proper selection of data-items and quantity, design of data format, coding of data to the format, and the procedure of data input into the computer. These procedures are mainly owed to data managers and computer engineers in the large clinical trials of western countries. Establishing local and central data center and identify of the data manager in our country are urgent for effective implementation of multiinstitutional clinical trial.

Clinical Trials as Topic↗