RESUMO
Resumen Todo acto quirúrgico implica un traumatismo directo al organismo, porque expone moléculas que normalmente no se encuentran en el medio extracelular, a las cuales el sistema inmune puede reconocer, e iniciará una respuesta inflamatoria aguda, con la consecuente producción de proteínas mensajeras llamadas citocinas proinflamatorias. Éstas se encargan de generar cambios en el tejido conectivo y el sistema vascular, lo que origina una vasodilatación que ocasiona la salida de líquido al espacio extracelular, lo que permitirá llegar al sitio de la lesión a los leucocitos y proteínas efectoras solubles, con el fin de responder al estímulo agresor mediante mecanismos innatos y adaptativos. Una vez que el estímulo agresor ha sido controlado, la respuesta fisiológica normal llevará a la producción de mediadores antiinflamatorios que permitan realizar una adecuada reparación tisular para llevar a los tejidos lesionados por el proceso quirúrgico a su estado normal.
Abstract Every surgical procedure results in a direct trauma to the organism because of an exposure to molecules that are not normally found in the extracellular environment, yet they can be recognized by the immune system and initiate an acute inflammatory response resulting in the production of messenger proteins called pro-inflammatory cytokines. This will produce changes in the connective and vascular tissues, leading to vasodilation and afterwards, the reléase of fluid into the extracellular space, allowing leukocytes and the soluble effector proteins to reach the injury in order to respond to the aggressor's stimulus with innate and adaptive mechanisms. Once the aggressor's stimulus has been controlled, the normal physiological response will lead to the production of anti-inflammatory mediators that will allow an adequate tissue repair. In this way, the injured tissues by the surgical lesion will return to its normal state.
RESUMO
BACKGROUND: The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. PURPOSE: Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. METHODS AND RESULTS: We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. CONCLUSION: This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.
