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In a prospective test, work-ups rose from 16.6% to 17.2%.","account":"CADx Medical Systems of Laval, Quebec, built Second Look, which digitizes mammogram films and marks possible calcification clusters and masses for a second review. In the ROSE-1M study, 17 institutions supplied 377 cases in which an earlier screening mammogram had been read as normal or benign before cancer was found. Three radiologists reviewed the earlier films blind, and at least one recommended work-up at the later cancer's site in 177 cases. The system marked 62.7% of these cancers. Using the panel's reads as a conservative proxy, FDA reviewers report that the system would have cut false negatives by at least 26.2%. In the prospective ROSE-2 study, 10 experienced mammographers at 5 institutions read 3,946 screening mammograms first alone and then with the marks. Their work-up rate rose from 16.6% to 17.2%. FDA approved the device on 31 January 2002. The 26.2% is an estimate on past films that no radiologist read with the marks, and the prospective study did not count cancers found."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"Second Look"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"FDA concluded that Second Look cut missed cancers on earlier screening mammograms by at least 26.2%, with work-ups rising from 16.6% to 17.2%","headline":"*Second Look* would have cut missed breast cancers by at least a quarter"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["deddceb08562087bd302c3701bc69d1b41efebca631c848107c923405ea723b0"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"CADx Medical Systems of Laval, Quebec, built Second Look, which digitizes mammogram films and marks possible calcification clusters and masses for a second review. In the ROSE-1M study, 17 institutions supplied 377 cases in which an earlier screening mammogram had been read as normal or benign before cancer was found. Three radiologists reviewed the earlier films blind, and at least one recommended work-up at the later cancer's site in 177 cases. The system marked 62.7% of these cancers. Using the panel's reads as a conservative proxy, FDA reviewers report that the system would have cut false negatives by at least 26.2%. In the prospective ROSE-2 study, 10 experienced mammographers at 5 institutions read 3,946 screening mammograms first alone and then with the marks. Their work-up rate rose from 16.6% to 17.2%. FDA approved the device on 31 January 2002. The 26.2% is an estimate on past films that no radiologist read with the marks, and the prospective study did not count cancers found.","replication":{"produced_by":["The system digitized each film with a laser scanner and marked possible calcification clusters with rectangles and possible masses with ellipses.","Radiologists read each case in the usual way before they looked at the printed marks."],"must_hold":["The radiologist completes the initial reading before reviewing the marks.","Work-up decisions rest on review of the mammogram and supporting clinical information."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"715d70f30839038e87da69d988ea82c097a7e8e05de734c0c6d0fbc8c86022d6"}