A Rapid Outcomes Ascertainment System Improves the Quality of Prognostic and Pharmacogenetic Outcomes from Observational Studies
| Autor: | Frances A. Shepherd, David C. Christiani, Panos Fidias, Geoffrey Liu, John C. Wain, Rebecca S. Heist, Wei Zhou, Ariela L. Marshall, Li Su, David P. Miller, Penelope A. Bradbury, Sohee Park, Lecia V. Sequist, Matthew H. Kulke, Jennifer S. Temel, Thomas J. Lynch |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Lung Neoplasms Epidemiology Pilot Projects Clinical Trials Phase II as Topic Surveys and Questionnaires Outcome Assessment Health Care medicine Humans Response rate (survey) Data collection business.industry Quality control Prognosis Surgery Survival Rate Clinical trial Exact test Clinical Trials Phase III as Topic Oncology Pharmacogenetics Case-Control Studies Data quality Emergency medicine Feasibility Studies Female Observational study business Quality assurance Algorithms |
| Zdroj: | Cancer Epidemiology, Biomarkers & Prevention. 17:204-211 |
| ISSN: | 1538-7755 1055-9965 |
| Popis: | Purpose: Case-control and observational studies are popular choices for evaluating molecular prognostic/pharmacogenetic outcomes, but data quality is rarely tested. Using clinical trial and epidemiologic methods, we assessed the quality of prognostic and outcomes data obtainable from a large case-control study of lung cancer. Methods: We developed an explicit algorithm (set of standard operating procedures forming a rapid outcomes ascertainment system) that encompassed multiple tests of quality assurance, and quality of data for a range of prognostic and outcomes variables, in several cancers, across several centers and two countries were assessed. Based on these assessments, the algorithm was revised and physicians' clinical practice changed. We reevaluated the quality of outcomes after these revisions. Results: Development of an algorithm with internal quality controls showed specific patterns of data collection errors, which were fixable. Although the major discrepancy rate in retrospective data collection was low (0.6%) when compared with external validated sources, complete data were found in Conclusions: Observational studies can be a useful source for studying molecular prognostic and pharmacogenetic outcomes. A rapid outcomes ascertainment system with strict ongoing quality control measures is an excellent means of monitoring key variables. (Cancer Epidemiol Biomarkers Prev 2008;17(1):204–11) |
| Databáze: | OpenAIRE |
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