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In this paper the role of validity and reliability in the development of physical employment standards (PESs) and the consideration of these factors in determining the final pass/fail criteria for a PES and ultimately the legal defensibility of a PES is examined. Particular attention is paid to the use of subject-matter experts, the levels of evidence used in the establishment of the minimum acceptable pace/intensity for the completion of critical tasks, and the considerations needed in physical test selection. [ABSTRACT FROM AUTHOR]

Context and Aims: Breast cancer prognosis and predictive biomarkers development would allow sparing some patients from chemotherapy or identifying patients for whom chemotherapy would be indicated. In this context, in 2009, the French National Cancer Institute, a National Health and Science Agency dedicated to cancer, in collaboration with the « Société française de sénologie et de pathologie mammaire » published a report on the assessment of the prognostic and the predictive clinical validity of tissular biomarkers, uPA/PAI-1, Oncotype DX™ and MammaPrint ®, in breast cancer management. They concluded that only the uPA/PAI-1 prognosis value reached the highest level of evidence (LOE I according to Hayes 1998 classification). In 2012, it was decided to update this report since new data have emerged and because information disparities among clinicians have been identified. This article aims to present the main conclusions together with the levels of evidence associated with those conclusions. Methods: The updating process was based on literature published since 2009 appraisal and on multidisciplinary and independent experts' opinion. The levels of evidence (LOE) used are those of the classification defined by Simon in 2009 (updated Hayes 1998 classification): LOE IA and LOE IB: high level of evidence; LOE IIB and LOE IIC: intermediate level of evidence; LOE IIIC and LOE IV-VD: low level of evidence. Conclusions: Among patients without lymph-node involvement, uPA/PAI-1, invasion process biomarkers, reach the highest level of evidence for 10 years recurrence free survival prognosis (LOE IA according to Simon). The predictive value to anthracyclins chemotherapy remains to be confirmed. No data were identified on uPA/PAI-1 medico-economic value. Oncotype DX™ and MammaPrint® prognosis and predictive value do not reach the LOE I level. This updating' process confirms the 2009 levels of evidence for all the three biomarkers prognosis value. Besides, concerning Oncotype DX™ and MammaPrint®, new data do not allow to conclude neither to their complementary clinical information to other clinicopathological existing biomarkers nor to a favorable cost-efficiency ratio in therapeutic decision making and this because of the methodological weakness and uncertainty that are identified in the selected studies. Practically, beyond the prognosis and predictive biomarkers validity, the clinical utility of a new biomarker for chemotherapy indication depends on its clinical added information with regard to validated biomarkers (HR, HER2 and Ki67) and to clinicopathological parameters. Since they are the sole validated biomarkers of the invasion process, uPA/PAI-1 could complete clinical information of other clinicopathological factors and consequently could confer an added clinical value. However, data concerning the impact of this information on chemotherapy clinical indication are lacking. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to report the updating process of the CCAFU evidence-based Clinical Practice Guideline (CPG), on urinary and genital tracts management, which was edited in 2013. Updating of CPG is a continuous process based on systematic search of the scientific literature aiming to identify clinical questions to be updated. The CPGs were defined following the RPC methodology based on evidence synthesis and explicit and transparent experts'opinion and on the ADAPTE methodology when good quality guidelines were available. In summary, a literature search was performed in Medline® database and on EBM web sites, using a defined search strategy, to identify all available publications published since 2013 related to the specific topic. Papers were then selected and classified according to predefined selection criteria. Subsequently, critical appraisal of the new data were done and recommandations and their levels of evidence were updated according to the new conclusions and to the CCAFU members'opinion. This project results of a collaborative work with members from the CCAFU committee and other learned societies (urologists, oncologists, radiotherapists, radiologists, pathologists,…). The document was reviewed by independent experts and their comments were incorporated in the final version. These updated guidelines will be submitted to French cancer institute (INCa) for quality approbation and labelling after a national peer-reviewing process according to the AGREE grid. Implementation of the recommendations, their dissemination to practitioners, and assessment of their impact on clinical practice as well as their future actualisation (every 1 to 3 years) are all objectives that have to be achieved. © 2016 Elsevier Masson SAS. All rights reserved., (© 2016 Elsevier Masson SAS. Tous droits réservés.)

Context and Aims: Breast cancer prognosis and predictive biomarkers development would allow sparing some patients from chemotherapy or identifying patients for whom chemotherapy would be indicated. In this context, in 2009, the French National Cancer Institute, a National Health and Science Agency dedicated to cancer, in collaboration with the French society of senology and breast pathology (SFSPM) published a report on the assessment of the prognostic and the predictive clinical validity of tissular biomarkers, uPA/PAI-1, Oncotype DX™ and MammaPrint(®), in breast cancer management. They concluded that only the uPA/PAI-1 prognosis value reached the highest level of evidence (LOE I according to Hayes 1998 classification). In 2012, it was decided to update this report since new data have emerged and because information disparities among clinicians have been identified. This article aims to present the main conclusions together with the levels of evidence associated with those conclusions., Methods: The updating process was based on literature published since 2009 appraisal and on multidisciplinary and independent experts' opinion. The levels of evidence (LOE) used are those of the classification defined by Simon in 2009 (updated Hayes 1998 classification): LOE IA and LOE IB: high level of evidence; LOE IIB and LOE IIC: intermediate level of evidence; LOE IIIC and LOE IV-VD: low level of evidence., Conclusions: Among patients without lymph-node involvement, uPA/PAI-1, invasion process biomarkers, reach the highest level of evidence for 10 years recurrence free survival prognosis (LOE IA according to Simon). The predictive value to anthracyclins chemotherapy remains to be confirmed. Oncotype DX™ and MammaPrint(®) prognosis and predictive value do not reach the LOE I level. This updating' process confirms the 2009 levels of evidence for all the three biomarkers prognosis value. Besides, concerning Oncotype DX™ and MammaPrint(®), new data do not allow to conclude neither to their complementary clinical information to other clinicopathological existing biomarkers nor to a favorable cost-efficiency ratio in therapeutic decision making and this because of the methodological weakness and uncertainty that are identified in the selected studies. Practically, beyond the prognosis and predictive biomarkers validity, the clinical utility of a new biomarker for chemotherapy indication depends on its clinical added information with regard to validated biomarkers (HR, HER2 and Ki67) and to clinicopathological parameters. Since they are the sole validated biomarkers of the invasion process, uPA/PAI-1 could complete clinical information of other clinicopathological factors and consequently could confer an added clinical value. However, data concerning the impact of this information on chemotherapy clinical indication are lacking., (Copyright © 2014. Published by Elsevier Masson SAS.)

Introduction: The objective of the 2013 recommendations performed by the different committees of CCAFU is to improve the management of urological cancers regarding diagnosis, clinical assessment and treatments in men and women., Material and Methods: 2010 clinical guidelines were updated based on international AUA and EAU guidelines and on systematic literature search performed by each sub-Committee in Medline and PubMed databases to evaluate references, levels of evidence and grade of recommendation., Results: CCAFU clinical guidelines reply to the main clinical questions on management of urological cancers., Conclusion: French clinical guidelines are updated every three years by CCAFU in accordance with the main international guidelines in onco-urology., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)