BACKGROUND: Biomarker tests are increasingly being offered by laboratories and clinicians as self-pay health services to screen asymptomatic individuals; however, sufficient evidence may not be available to support this practice. We investigated the benefit-harm tradeoffs associated with 11 biomarkers currently offered in Germany as self-pay tests to screen for @entity5 . METHODS: We systematically searched bibliographic databases for health technology assessments, systematic reviews and randomized-controlled trials (RCTs) through September 2015. We included publications that analysed @entity5 screening biomarkers and reported @entity1 -relevant outcomes (mortality, morbidity, quality of life), and potential harms of screening, among asymptomatic individuals in screening and non-screening arms. Language was restricted to English and German. Two reviewers independently screened references; data were extracted and quality of included studies was evaluated by a reviewer and validated by a second reviewer. RESULTS: Six publications of secondary literature and four publications reporting results from two RCTs were included. For 10 @entity5 screening biomarkers, no direct evidence on @entity1 -relevant outcomes was available. Only one trial, which simultaneously assessed @entity5 antigen 125 ( @entity10224 ) and vaginal ultrasound for @entity43 screening, provided the outcome of interest. Screening compared with usual care did not reduce @entity43 mortality. @entity1 harms included overdiagnosis and false-positive results. CONCLUSION: Although @entity43 screening with @entity10224 showed no benefit, false-positive tests, overdiagnosis and overtreatment were reported. Physicians and laboratories should provide @entity1 with comprehensive information about the lack of evidence and potential harms caused by biomarker screening tests offered as a self-pay health service.

Clinical effectiveness of XXXX screening biomarker tests offered as self-pay health service: a systematic review.

@entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity1 :: ('9606', 'Species') :: ['patients', 'patient', 'Patient'] @entity43 :: ('MESH:D010051', 'Disease') :: ['ovarian cancer'] @entity10224 :: ('94025', 'Gene') :: ['CA125']
@entity5 :: (MESH:D009369,Disease) :: ['cancer']
