Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND).

Evidence derived from existing health-care data, such as administrative claims and electronic health records, can fill evidence gaps in medicine. However, many claim such data cannot be used to estimate causal treatment effects because of the potential for observational study bias; for example, due...

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Publicado en:Journal of the American Medical Informatics Association Vol. 27; no. 8; pp. 1331 - 1338
Autores principales: Schuemie, Martijn J, Ryan, Patrick B, Pratt, Nicole, Chen, RuiJun, You, Seng Chan, Krumholz, Harlan M, Madigan, David, Hripcsak, George, Suchard, Marc A
Formato: research Journal Article
Publicado: Oxford University Press / USA Aug2020
Acceso en línea:Ver este registro en EBSCOhost
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        atl: Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND).
      aug:
        au:
          Schuemie, Martijn J
          Ryan, Patrick B
          Pratt, Nicole
          Chen, RuiJun
          You, Seng Chan
          Krumholz, Harlan M
          Madigan, David
          Hripcsak, George
          Suchard, Marc A
        affil: Epidemiology Analytics , Janssen Research and Development, Titusville, New Jersey, USA
      sug:
        subj:
          Meta Analysis
          Computer Communication Networks
          Hypertension Drug Therapy
          Resource Databases
          Antihypertensive Agents Therapeutic Use
          Antihypertensive Agents Adverse Effects
          Probability
          Data Analysis, Statistical
          Observational Methods
          Treatment Outcomes
          Clinical Trials
          Human
          Confidence Intervals
          Comparative Studies
          Multicenter Studies
          Evaluation Research
          Validation Studies
      ab: Evidence derived from existing health-care data, such as administrative claims and electronic health records, can fill evidence gaps in medicine. However, many claim such data cannot be used to estimate causal treatment effects because of the potential for observational study bias; for example, due to residual confounding. Other concerns include P hacking and publication bias. In response, the Observational Health Data Sciences and Informatics international collaborative launched the Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND) research initiative. Its mission is to generate evidence on the effects of medical interventions using observational health-care databases while addressing the aforementioned concerns by following a recently proposed paradigm. We define 10 principles of LEGEND that enshrine this new paradigm, prescribing the generation and dissemination of evidence on many research questions at once; for example, comparing all treatments for a disease for many outcomes, thus preventing publication bias. These questions are answered using a prespecified and systematic approach, avoiding P hacking. Best-practice statistical methods address measured confounding, and control questions (research questions where the answer is known) quantify potential residual bias. Finally, the evidence is generated in a network of databases to assess consistency by sharing open-source analytics code to enhance transparency and reproducibility, but without sharing patient-level information. Here we detail the LEGEND principles and provide a generic overview of a LEGEND study. Our companion paper highlights an example study on the effects of hypertension treatments, and evaluates the internal and external validity of the evidence we generate.
      pubtype: Academic Journal
      doctype:
        research
        Journal Article
      ougenre: Article
    language: English
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