RESUMO
The CHARMS (critical appraisal and data extraction for systematic reviews of prediction modelling studies) checklist was created to provide methodological appraisals of predictive models, based on the best available scientific evidence and through systematic reviews. Our purpose is to give a general presentation on how to carry out a CHARMS analysis for prognostic multivariate models, making clear what the steps are and how they are applied individually to the studies included in the systematic review. This tutorial is aimed at providing such a resource. In addition to this explanation, we will apply the method to a real case: predictive models of atrial fibrillation in the community. This methodology could be applied to other predictive models using the steps provided in our review so as to have complete information for each included model and determine whether it can be implemented in daily clinical practice.
Assuntos
Projetos de Pesquisa , Humanos , Prognóstico , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Trastuzumab is a drug used in HER2-positive breast cancer that increases patient survival. Due to cardiotoxicity is the most important side effect of trastuzumab treatment, cardiac monitoring should be a priority. The purpose of this study is to evaluate plasma NT-proBNP level and major cardiovascular risk factors as possible early predictors of trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients. METHODS: We conducted a retrospective observational study involving 66 patients with HER2-positive breast cancer treated with trastuzumab. Left ventricle ejection fraction (LVEF), NT-proBNP values, and the history of cardiovascular risk factors were collected. Cardiotoxicity was diagnosed considering a decrease of the LVEF from baseline or clinical manifestation of congestive heart failure. NT-proBNP cut-off points were considered to establish normal or abnormal values according to patient age. RESULTS: 27.3% of the patients suffered cardiotoxicity during trastuzumab treatment. Most cases were diagnosed due to the appearance of cardiac symptomatology (66.7%). Logistic regression analysis showed a significant association of diabetes mellitus (OR 5.9, 95% CI 1.2-28.5, p = 0.028) and high NT-proBNP levels (OR 22.0, 95% CI 5.7-85.4, p < 0.0001) with the development of trastuzumab-induced cardiotoxicity. CONCLUSION: NT-proBNP levels above the upper limit of the normal range adjusted to age or diabetes mellitus seem to be associated with a higher risk of developing cardiotoxicity. However, some limitations of the present study make necessary further studies aimed to clarify whether NT-proBNP and diabetes-associated markers determinations can be useful in the monitoring of cardiotoxicity risk in breast cancer patients undergoing trastuzumab therapy.