Table 2-1Examples of initially ambiguous claims that were clarified through the process of topic development

Full-Field Digital MammographyHER2PET
General topicFFDM to replace SFM in breast cancer screening (Figure 2-3)HER2 gene amplication assay as add-on to HER2 protein expression assay (Figure 2-4)PET as triage for breast biopsy (Figure 2-5)
Initial ambiguous claimFFDM may be a useful alternative to SFM in screening for breast cancer.HER2 gene amplification and protein expression assays may complement each other as means of selecting patients for targeted therapy.PET may play an adjunctive role to breast examination and mammography in detecting breast cancer and selecting patients for biopsy.
Key concerns suggested by PICOTS, analytic framework, and decision treeKey statistics: sensitivity, diagnostic yield, recall rate; similar types of management decisions and outcomes for index and comparator test- and-treat strategiesKey statistics: proportion of individuals with intermediate/equivocal HER2 protein expression results who have HER2 gene amplification; key outcomes are related to effectiveness of HER2- targeted therapy in this subgroup.Key statistics: negative predictive value; key outcomes to be contrasted were benefits of avoiding biopsy versus harms of delaying initiation of treatment for undetected tumors.
Refined claimIn screening for breast cancer, interpretation of FFDM and SFM would be similar, leading to similar management decisions and outcomes; FFDM may have a similar recall rate and diagnostic yield at least as high as SFM; FFDM images may be more expensive, but easier to manipulate and store.Among individuals with localized breast cancer, some may have equivocal results for HER2 protein overexpression but have positive HER2 gene amplification, identifying them as patients who may benefit from HER2-targeted therapy but otherwise would have been missed.Among patients with a palpable breast mass or suspicious mammogram, if FDG PET is performed before biopsy, those with negative scans may avoid the adverse events of biopsy with potentially negligible risk of delayed treatment for undetected tumor.
ReferenceBlue Cross and Blue Shield Association Technology Evaluation Center, 200215Seidenfeld et al., 200816Samson et al., 200217

FDG = fluorodeoxyglucose; FFDM = full-field digital mammography; HER2 = human epidermal growth factor receptor 2; PET = positron emission tomography; PICOTS = Patient population, Intervention, Comparator, Outcomes, Timing, Setting; SFM = screen-film mammography

From: Chapter 2, Developing the Topic and Structuring Systematic Reviews of Medical Tests: Utility of PICOTS, Analytic Frameworks, Decision Trees, and Other Frameworks

Cover of Methods Guide for Medical Test Reviews
Methods Guide for Medical Test Reviews [Internet].
Chang SM, Matchar DB, Smetana GW, et al., editors.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.