Quality Evaluation Of Diagnostic Accuracy Of Contrast-Enhanced Ultrasonography In Breast Cancer

ObjectiveTo outline the STARD and QUADAS-2criterion lists and to discuss the methodological and reporting quality of recently published diagnostic accuracy studies on CEUS for breast cancer.MethodsA systematic review of the CBM,CNKI,WANFANGdata,and CQVIP was performed by using a validated strategy. Reviewer extracted datas on study characteristics and used STARD (STAndards for the Reporting of Diagnostic accuracy studies) and QUADAS-2(Quality Asseeement of Diagnostic Accuracy Studies) to evaluate the quality of reporting and methods.ResultsA total of20studies were included. The overall quality of reporting of methods was poor. In terms of quality of reporting,14STARD indicators were reported in less than50%of the studies:participant sampling method(0%), Describe the reference standard and its rationale(0%), number of eligible patients who did not participate in the study and whether a flow diagram is recommended(0%), adverse effects of the diagnostic tests(0%), description of the team executing the test and management of indeterminate/outlier results(0%), statistical methods to calculate diagnostic accuracy and uncertainty/precision(0%), distribution of severity of disease/other diagnoses (5%), estimates of diagnostic accuracy between subgroups(5%), methods for calculation and estimates of reproducibility (10%), time interval from the index tests to the reference standard, and any treatment administered between (10%), data collection method (15%), the inclusion and exclusion criteria (30%), participant recruitment method (40%), blinding of the test readers (45%)According to QUADAS-2criterion, in the domain of Reference Standard, all included studies had a low risk of bias and concerns about applicability. All included studies had a low risk of bias in the domain of Flow and Timing.Eighteen of20included studies had a high risk of bias and two studies had a low risk of bias; Seventeen of20included studies had a high risk of concerns about applicability,but one study was judged low risk and two studies had a unclear risk of concerns about applicability, in the domain of Patient Selection.Nineteen of20included studies had a high risk of bias and one study had a low risk of bias; eleven of20included studies had a high risk of concerns about applicability,but nine studies had a unclear risk of concerns about applicability, in the domain of Index Test.ConclusionRecently published diagnostic accuracy studies on CEUS for breast cancer have low quality and are poorly reported. Most studies were a high risk of bias and concerns about applicability. Recently CEUS for breast cancer is not recommended in the diagnosis of breast tumors in daily clinical practice, but can aid in distinguishing lesions of BI-RADS category4.