Results 31 to 40 of about 2,671,764 (310)

Asthma control among treated US asthma patients in Practice Fusion’s electronic medical record research database

npj Primary Care Respiratory Medicine, 2023
This study investigated burden of ‘not well-controlled’ asthma, overall and by Global Initiative for Asthma (GINA) Step, among treated asthma patients in Practice Fusion’s research database.
Jonathan Davitte, Bailey DeBarmore, David Hinds, Shiyuan Zhang, Jessica Chao, Leah Sansbury   +5 more
doaj   +1 more source

HARmonized Protocol Template to Enhance Reproducibility (HARPER) of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force

Pharmacoepidemiology and Drug Safety, 2022
Ambiguity in communication of key study parameters limits the utility of real‐world evidence (RWE) studies in healthcare decision‐making. Clear communication about data provenance, design, analysis, and implementation is needed.
Shirley V. Wang, A. Pottegård, William Crown, P. Arlett, D. Ashcroft, Eric I Benchimol, M. Berger, G. Crane, W. Goettsch, Wei Hua, S. Kabadi, D. Kern, X. Kurz, S. Langan, Takahiro Nonaka, L. Orsini, S. Perez‐Gutthann, Simone Pinheiro, N. Pratt, S. Schneeweiss, M. Toussi, Rebecca J Williams   +21 more
semanticscholar   +1 more source

Real-world evidence: the devil is in the detail [PDF]

Diabetologia, 2020
Much has been written about real-world evidence (RWE), a concept that offers an understanding of the effects of healthcare interventions using routine clinical data. The reflection of diverse real-world practices is a double-edged sword that makes RWE attractive but also opens doors to several biases that need to be minimised both in the design and ...
Mugdha, Gokhale, Til, Stürmer, John B, Buse   +2 more
openaire   +2 more sources

Advancing digital health applications: priorities for innovation in real-world evidence generation.

The Lancet Digital Health, 2022
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market.
A. Stern, J. Brönneke, J. Debatin, Julia Hagen, Henrik Matthies, Smit Patel, I. Clay, Bjoern M. Eskofier, A. Herr, Kurt Hoeller, A. Jaksa, D. B. Kramer, Mattias Kyhlstedt, K. Lofgren, N. Mahendraratnam, H. Muehlan, S. Reif, Lars Riedemann, J. Goldsack   +18 more
semanticscholar   +1 more source

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies

British medical journal, 2021
In alignment with the International Council of Harmonization’s strategic goals, a public-private consortium has developed a structured template for planning and reporting on the implementation of real world evidence (RWE) studies of the safety and ...
Shirley V. Wang, Simone P. Pinheiro, Wei Hua, P. Arlett, Y. Uyama, J. Berlin, D. Bartels, K. Kahler, Lily G. Bessette, S. Schneeweiss   +9 more
semanticscholar   +1 more source

Disparities in healthcare providers’ interpretations and implementations of ACIP’s meningococcal vaccine recommendations

Human Vaccines & Immunotherapeutics, 2020
Invasive meningococcal disease (IMD) caused by the bacteria Neisseria meningitidis is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MenACWY and ...
Liping Huang, Amir Goren, Lulu K. Lee, Vicky W. Li, Amanda Dempsey, Amit Srivastava   +5 more
doaj   +1 more source

Strategies to Address Current Challenges in Real-World Evidence Generation in Japan

Drugs - Real World Outcomes, 2023
The generation of real-world evidence (RWE), which describes patient characteristics or treatment patterns using real-world data (RWD), is rapidly growing more popular as a tool for decision-making in Japan.
Thomas Laurent, Dimitra Lambrelli, Ryozo Wakabayashi, Takahiro Hirano, Ryohei Kuwatsuru   +4 more
doaj   +1 more source

The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications

Clinical pharmacology and therapy, 2021
The US Food and Drug Administration (FDA) is open to accepting real‐world evidence (RWE) to support its assessment of medical products. However, RWE stakeholders lack a shared understanding of FDA’s evidentiary expectations for the use of RWE in ...
C. Purpura, E. Garry, N. Honig, A. Case, J. Rassen   +4 more
semanticscholar   +1 more source

Real-World Evidence Analysis of a Hybrid Closed-Loop System

Journal of Diabetes Science and Technology, 2023
Background: We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system. Methods: Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who ...
Heba Alwan, M. Wilinska, Y. Ruan, Julien da Silva, R. Hovorka   +4 more
semanticscholar   +1 more source

The Disruptive Force of Real-World Evidence

Journal of Clinical Medicine, 2023
Evidence-based medicine was in the past primarily based on the (meta-)analysis of randomized clinical trials (RCTs) [...]
openaire   +3 more sources