OBJECTIVE: To accurately evaluate non-ST-elevated acute cardiac syndrome (NSTE-ACS), the quality of high-sensitive cardiac troponin (hs-cTn) assays is of vital importance. The 2020 revision of the NSTE-ACS guideline includes clinical decision-limits (CDL\'s) to both rule-in and rule-out NSTE-ACS for most commercially available platforms, providing both 0/1 h and 0/2 h delta limits. Our study evaluated whether laboratories are able to meet the analytical performance specifications for imprecision (APS) for hs-cTnT.
METHODS: Results from external quality assurance (EQA) in commutable samples were used to evaluate the current and historic performance of analyzers. The performance of analyzers that either passed or failed to comply with 0/1 h-APS were used on a real-world dataset of first hs-cTnT-values to simulate 10.000 samples of t=0, t=1 and t=2 h values with multiple delta\'s for all relevant CDL\'s. We compared the simulated values to the input values to obtain the percentage of aberrant results simulated.
RESULTS: The majority of analyzers complies with APS for rule-in in 2022 (0/1 h: 90.4 % and 0/2 h: 100 %), compliance for the 0/1 h rule-out is still far from optimal (0/1 h: 30.7 %, 0/2 h: 75.4 %), with improving compliance over the past years (rule-in p=<0.0001, rule-out p=0.011, χ2). Whilst 0/1 h-APS-passing analyzers have a minute risk to falsely rule-out patients whom should be ruled-in (0.0001 %), failing performance increases this risk to 2.1 % upon using 0/1 h CDL\'s. Here, adopting 0/2 h CDL\'s is favorable (0.01 %).
CONCLUSIONS: Laboratories that fail to meet hs-cTnT 0/1 h-APS should improve their performance to the required and achievable level. Until performance is reached clinics should adopt the 0/2 h CDL\'s.

In pediatrics, accurate measurement of total serum bilirubin (TSB) is of major importance for reliable diagnosis and appropriate management of neonatal jaundice. However, several studies evidenced poor comparability of results obtained with the different available methods either in central lab or in POCT, on serum, capillary blood or transcutaneous. This situation is partly due to the lack of Reference Materials, especially for high bilirubin concentrations but also on poor communication between central lab and neonatology unit. To progress on these issues, we have compiled some data from CNRHP to propose guidelines for choice, use and management of POCT devices and to help clinical laboratories to achieve a better answer to clinical needs with specific local constraints. The results from several CNRHP studies are presented: traceability to International System of Units, inter-laboratories comparability, POCT vs central labs comparisons with POCT CO-oximeter or photometer, integration of transcutaneous bilirubinometer. We propose, based on an analysis of devices advantages and issues, guidelines to help labs either to improve neonates monitoring in their local context; we distinguished the choices inside laboratory for a better harmonization of results compared to published thresholds and outside lab contexts, to organize a coordinated chain with POCT devices, with capillary and/or transcutaneous approaches.
En néonatalogie, la mesure précise de la bilirubinémie est essentielle pour le diagnostic et le suivi de l’ictère, en regard de seuils consensuels internationaux. Toutefois, une faible comparabilité des résultats est observée entre les laboratoires de biologie médicale (LBM) et avec les dispositifs délocalisés ou transcutanés. Cette situation est en partie due à des défauts de standardisation des méthodes, mais aussi à une coordination insuffisante entre les laboratoires et les unités de soins. L’objectif de ce travail est de progresser dans l’optimisation de la prise en charge des nouveau-nés en proposant des critères de choix et d’articulation des différentes réponses biologiques, EBM, EBMD et TROD, en fonction des besoins cliniques locaux et des moyens disponibles. Les résultats de plusieurs études ciblées sur la bilirubinémie néonatale sont présentés : raccordement au système international, harmonisation interlaboratoires, comparabilité EBMD-CNRHP d’un CO-oxymètre délocalisé en maternité, comparabilité EBMD-CNRHP d’un photomètre délocalisé en maternité, intégration d’un bilirubinomètre transcutané. Nous proposons ensuite, sur la base d’une analyse critique des différents types de dispositifs, des recommandations pour aider les LBM à améliorer la prise en charge des nouveau-nés dans leur contexte local, d’une part sur la mesure de la bilirubinémie néonatale au sein du LBM et d’autre part sur l’organisation d’une chaîne coordonnée EBM – EBMD – TROD en concertation avec les unités de soins.

The impact of medical research is usually judged on the basis of citations in the serial literature. A better test of its utility is through its contribution to clinical practice guidelines (CPGs) on how to prevent, diagnose, and treat illness. This study aimed to compare the parameters of lung cancer research papers with those cited as references in lung cancer CPGs from 16 countries, and the Cochrane Collaboration. These comparisons were mainly based on bibliographic data compiled from the Web of Science (WoS).
We examined 7357 references (of which 4491 were unique) cited in a total of 77 lung cancer CPGs, and compared them with 73,214 lung cancer papers published in the WoS between 2004 and 2018.
References used by lung CPGs were much more clinical than the overall body of research papers on this cancer, and their authors predominantly came from smaller northern European countries. However, the leading institutions whose papers were cited the most on these CPGs were from the USA, notably the MD Anderson Cancer Center in Texas, the Memorial Sloan Kettering Cancer Center, New York, and the Mayo Clinic in Rochester, Minnesota. The types of research cited by the CPGs were primarily clinical trials, as well as three treatment modalities (chemotherapy, radiotherapy and surgery). Genetics, palliative care and quality of life were largely neglected. The median time gap between papers cited on a lung CPG and its publication was 3.5 years longer than for WoS citations.
Analysis of the references on CPGs allows an alternative means of research evaluation, and one that may be more appropriate for clinical research than citations in academic journals. Own-country references show the direct contribution of research to a country\'s health care, and other-country references show the esteem in which this research has been held internationally.

The SFBC-CNBH-CNRHP \"Neonatal bilirubin\" working group performed a biological and clinical study on bilirubin use in neonates for reliable diagnosis and appropriate management of neonatal jaundice. A brief report of a national survey on analytical and biological practices in France is shown. The guidelines of the French Society of Neonatology (SFN) founded the decision of phototherapy set up upon an accurate lab measurement of total serum bilirubin. An abacus is proposed with defined thresholds, as a function of neonate lifetime in hours. However, several studies evidenced poor comparability of results obtained with the different available methods. This situation is partly due to the lack of reference materials, especially for high bilirubin concentrations. Clinical consequences might be observed. We present in this paper the results of a national harmonization study to progress on this issue. Beyond the analytical aspects, the clinical consequences of harmonization defects were investigated. Finally, guidelines for clinical laboratories are proposed, to be locally adapted.

Knowing the extent to which a clinical trial\'s findings translate into clinical practice can be challenging. One practical approach to estimating a trial\'s influence on clinical practice can be achieved by assessing how the trial informed relevant clinical practice guidelines (CPGs). Accordingly, the objectives of this study were to provide an overview of all the clinical trials involving the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) that aimed at informing or resulted in informing the management of high blood pressure and to identify and describe the extent to which these trials informed CPGs for the management of high blood pressure. A total of 26 clinical trials involving the VA CSP were identified. Using bibliographic information, 21 CPGs for the management of hypertension representing over 40 years of treatment recommendations from eight collectives were evaluated to determine how they were informed by trials involving the VA CSP. From 1977 to 2018, 13 of the 26 trials (50.0%) were found to have informed 19 of the 21 CPGs (90.5%) a total of 54 times (mean = 2.6 trial citations per CPG, SD ± 1.8). Clinical trials involving the VA CSP have informed a sizeable proportion of CPGs for the management of high blood pressure over the past 40 years. Because of this impact on the CPGs, these trials are also likely to have had at least moderate influence on clinical practice.