Real-World-Data-and-Real-World-Evidence: diferenças entre revisões

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= Real World Data (RWD) and Real World Evidence (RWE) =
= Real World Data (RWD) and Real World Evidence (RWE) =
== 1. Introduction ==
== 1. Introduction ==
=== 1.1 Definition of RWD and RWE ===
According to the [https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence FDA], '''Real World Data (RWD)''' refers to “data relating to patient health status and/or the delivery of health care routinely” (Commissioner O of the. FDA, 2024 <ref name="fda">Commissioner O of the. FDA. FDA; 2024 [cited 2024 Dec 10]. Real-World Evidence. Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence </ref>), derived from various sources such as electronic health records (EHRs), claims and billing data, patient registries, patient-reported data and wearable devices.
=== 1.2 Sources of RWD ===
RWD is derived from diverse and expansive data sources:
{| class="wikitable"
|-
! '''Source Type'''
! '''Description'''
|-
| '''Electronic Health Records (EHRs)'''
| - Provide longitudinal patient data, including diagnoses, medications, and outcomes.
|-
| '''Claims and Biling Data'''
| - Reflect administrative and financial aspects of healthcare utilization.
|-
| '''Patient Registries'''
| - Disease-specific datasets used for long-term monitoring, such as oncology or cardiovascular registries.
|-
| '''Wearable Devices and Mobile Health Apps'''
| - Capture real-time, patient-generated health data, offering continuous insights into lifestyle, activity levels, and biometric trends.
|-
| '''Patient-Reported Outcomes (PROMs)'''
| - Direct feedback from patients on their health status, symptoms, and quality of life. PROMs provide valuable insights into the patient perspective, enabling the assessment of treatment effectiveness and satisfaction in real-world contexts.
|}
=== 1.3 Definition of RWE ===
'''Real World Evidence (RWE)''' refers to evidence derived from the analysis of RWD to generate insights about the usage, safety, and effectiveness of medical products and interventions in real-world settings. It encompasses clinical, operational, and patient-reported outcomes, providing a holistic view of healthcare delivery and its impact on diverse populations. RWE complements data from randomized controlled trials (RCTs) by reflecting the complexities of everyday clinical practice, supporting decision-making for regulators, clinical teams, policymakers, and stakeholders in the healthcare ecosystem. Recent advancements in digital health and big data analytics underscore their transformative potential in contemporary medicine (Magalhães et al., 2022 <ref name="rwe">Magalhães T, Dinis-Oliveira RJ, Taveira-Gomes T. Digital Health and Big Data Analytics: Implications of Real-World Evidence for Clinicians and Policymakers. Int J Environ Res Public Health. 2022 Jul 8;19(14).</ref>).
= References =
<references />

Revisão das 14h19min de 26 de dezembro de 2024

Authors (HEADS-INFORM 2025):

  • Henrique Pereira
  • Olívia Oliveira

Real World Data (RWD) and Real World Evidence (RWE)

1. Introduction

1.1 Definition of RWD and RWE

According to the FDA, Real World Data (RWD) refers to “data relating to patient health status and/or the delivery of health care routinely” (Commissioner O of the. FDA, 2024 [1]), derived from various sources such as electronic health records (EHRs), claims and billing data, patient registries, patient-reported data and wearable devices.

1.2 Sources of RWD

RWD is derived from diverse and expansive data sources:

Source Type Description
Electronic Health Records (EHRs) - Provide longitudinal patient data, including diagnoses, medications, and outcomes.
Claims and Biling Data - Reflect administrative and financial aspects of healthcare utilization.
Patient Registries - Disease-specific datasets used for long-term monitoring, such as oncology or cardiovascular registries.
Wearable Devices and Mobile Health Apps - Capture real-time, patient-generated health data, offering continuous insights into lifestyle, activity levels, and biometric trends.
Patient-Reported Outcomes (PROMs) - Direct feedback from patients on their health status, symptoms, and quality of life. PROMs provide valuable insights into the patient perspective, enabling the assessment of treatment effectiveness and satisfaction in real-world contexts.

1.3 Definition of RWE

Real World Evidence (RWE) refers to evidence derived from the analysis of RWD to generate insights about the usage, safety, and effectiveness of medical products and interventions in real-world settings. It encompasses clinical, operational, and patient-reported outcomes, providing a holistic view of healthcare delivery and its impact on diverse populations. RWE complements data from randomized controlled trials (RCTs) by reflecting the complexities of everyday clinical practice, supporting decision-making for regulators, clinical teams, policymakers, and stakeholders in the healthcare ecosystem. Recent advancements in digital health and big data analytics underscore their transformative potential in contemporary medicine (Magalhães et al., 2022 [2]).

References

  1. ↑ Commissioner O of the. FDA. FDA; 2024 [cited 2024 Dec 10]. Real-World Evidence. Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
  2. ↑ Magalhães T, Dinis-Oliveira RJ, Taveira-Gomes T. Digital Health and Big Data Analytics: Implications of Real-World Evidence for Clinicians and Policymakers. Int J Environ Res Public Health. 2022 Jul 8;19(14).
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