Digital Health and Big Data Analytics: Implications of Real-World Evidence for Clinicians and Policymakers

Autores da FMUP

• Ricardo Jorge Dinis Oliveira

  Autor

• Tiago Salgado De Magalhães Taveira Gomes

  Autor

Participantes de fora da FMUP

• Magalh?es, T.

Unidades de investigação

• Ciências da Saúde Pública e Forenses, e Educação Médica

• Medicina da Comunidade, Informação e Decisão em Saúde

Abstract

Real world data (RWD) and real-world evidence (RWE) plays an increasingly important role in clinical research since scientific knowledge is obtained during routine clinical large-scale practice and not experimentally as occurs in the highly controlled traditional clinical trials. Particularly, the electronic health records (EHRs) are a relevant source of data. Nevertheless, there are also significant challenges in the correct use and interpretation of EHRs data, such as bias, heterogeneity of the population, and missing or non-standardized data formats. Despite the RWD and RWE recognized difficulties, these are easily outweighed by the benefits of ensuring the efficacy, safety, and cost-effectiveness in complement to the gold standards of the randomized controlled trial (RCT), namely by providing a complete picture regarding factors and variables that can guide robust clinical decisions. Their relevance can be even further evident as healthcare units develop more accurate EHRs always in the respect for the privacy of patient data. This editorial is an overview of the RWD and RWE major aspects of the state of the art and supports the Special Issue on Digital Health and Big Data Analytics: Implications of Real-World Evidence for Clinicians and Policymakers aimed to explore all the potential and the utility of RWD and RWE in offering insights on diseases in a broad spectrum.

Keywords

• real-world evidence; real-world data; big data; digital health; healthcare