González-Padilla, D.A. (Daniel A.)

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    First-line management of metastatic urothelial cancer: Current and future perspectives after the EV-302 and CcheckMate-901 studies
    (Elsevier, 2023) Barbas-Bernardos, G. (Guillermo); Fata, F.R. (Fernando Ramón) de; Perez-Gracia, J.L. (Jose Luis); Aristu-Mendioroz, J.J. (José Javier); Andrés, G. (Guillermo); Fenor-de-la-Maza, M.D. (Maria Dolores); Gurpide, A. (Alfonso); Villacampa, F. (Felipe); Villacampa, G. (Guillermo); Cambeiro, M. (Mauricio); González-Padilla, D.A. (Daniel A.); Sanz, J. (Julián); Miñana, B. (Bernardino)
    The standard of care for the first-line management of metastatic urothelial carcinoma has been recently challenged, with the combination of pembrolizumab and enfortumab vedotin (P-EV) strongly arising as a practice-changing option from classical platinum-based chemotherapies. With this paradigm shift on the horizon new questions, including the most suitable second line of treatment for these patients, and the role that the molecular characterization of these tumours will have when selecting these therapies will inevitably arise. Furthermore, after the negative results of the Keynote 361 and IMvigor 130 trials, the combination of nivolumab with platinum-based chemotherapy followed by nivolumab maintenance (Nivo GC-Nivo) has also shown positive results when compared with chemotherapy alone. Translational studies at a molecular, cellular, and functional level will be key to better explain these discordant results. In this Current Perspective, we discuss the potential impact of these results in clinical practice and propose specific guidance for prospective translational research.
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    Evaluating the certainty of evidence in evidence-based medicine
    (Elsevier, 2023) Dahm, P. (Philipp); González-Padilla, D.A. (Daniel A.)
    Certainty of evidence (formerly known as quality of evidence) is defined as the extent to which our confidence in an estimate of the effect is correct or our certainty that such estimate supports a particular recommendation for a clinical practice guideline. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) is a structured and reproducible framework for assigning a level of certainty on a per-outcome basis for evidence derived from randomized and nonrandomized studies. The level of certainty starts as high or low and can be increased or decreased after considering several criteria (eg, risk of bias, inconsistency of results, publication bias, dose-response gradient, large magnitude of effect, among others). Here we describe in brief the GRADE process for summarizing and assigning a certainty rating for evidence.