| PET/CT in cancer: Methodological considerations for comparative diagnostic phase II studies with paired binary data. | |
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MedLine Citation:
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PMID: 19057803 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: When the combined diagnostic imaging technique PET/CT is considered promising with respect to diagnosis/staging of a certain cancer type, a systematic investigation by means of clinical diagnostic studies in the target population is necessary to evaluate the usefulness of PET/CT compared to the current standard. It is often difficult to decide in advance whether it is appropriate to plan a superiority or non-inferiority study. We propose a statistical analysis strategy which is flexible enough to cope with both aims alike. METHODS: In opposition to clinical studies on drugs, each patient can be subjected to both PET/CT and the current standard, leading to paired observations of binary data (e.g., cancer = yes/no, stage = 0/1+). The analysis strategy focuses on point estimates and confidence intervals for the difference (or relative increase) in accuracy measures. RESULTS: Formulas for approximate 95% confidence intervals for the differences in sensitivity, specificity, positive and negative predictive values between PET/CT and the standard procedures are given, respectively. The strategy can also be applied if results obtained with a golden standard are not available in patients in whom both PET/CT and the standard procedure gave negative results. Sample sizes can and should be determined in an adaptive manner. CONCLUSIONS: Diagnostic studies to assess the merit of PET/CT in the diagnostic work-up of cancer patients can and should start with phase II studies focusing on 95% confidence intervals for differences in diagnostic measures. Even if the gold standard procedure is incomplete, the statistical analysis strategy given here may still be applicable. |
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Authors:
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O Gerke; W Vach; P F Høilund-Carlsen |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Methods of information in medicine Volume: 47 ISSN: 0026-1270 ISO Abbreviation: Methods Inf Med Publication Date: 2008 |
Date Detail:
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Created Date: 2008-12-05 Completed Date: 2009-02-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0210453 Medline TA: Methods Inf Med Country: Germany |
Other Details:
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Languages: eng Pagination: 470-9 Citation Subset: IM |
Affiliation:
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Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark. oke@stat.sdu.dk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Data Interpretation, Statistical Feasibility Studies Humans Neoplasms / diagnosis*, physiopathology Positron-Emission Tomography* Predictive Value of Tests Sample Size Sensitivity and Specificity Tomography, X-Ray Computed* |
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