A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network-based learning healthcare system.

The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient pop...

Descripción completa

Detalles Bibliográficos
Publicado en:Wound Repair & Regeneration Vol. 25; no. 3; pp. 354 - 366
Autores principales: Serena, Thomas E., Fife, Caroline E., Eckert, Kristen A., Yaakov, Raphael A., Carter, Marissa J.
Formato: pictorial tables/charts Journal Article
Publicado: Wiley-Blackwell May/Jun2017
Acceso en línea:Ver este registro en EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=124751640&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 124751640
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        10671927
        DPV
      jtl: Wound Repair & Regeneration
      issn: 10671927
      maglogo: Y
    pubinfo:
      dt: May/Jun2017
      vid: 25
      iid: 3
      pid: 480
      pub: Wiley-Blackwell
      place: Malden, Massachusetts
    artinfo:
      ui:
        124751640
        124751640
        124751640
        10.1111/wrr.12538
        124751640
      ppf: 354
      ppct: 12
      formats:
        fmt:
          – @attributes:
              type: T
          – @attributes:
              type: P
      tig:
        atl: A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network-based learning healthcare system.
      aug:
        au:
          Serena, Thomas E.
          Fife, Caroline E.
          Eckert, Kristen A.
          Yaakov, Raphael A.
          Carter, Marissa J.
        affil: SerenaGroup®, Cambridge Massachusetts
      sug:
        subj:
          Wound Care
          Clinical Research
          Consortia
          Electronic Health Records
          Quality Improvement
          Health Care Delivery
          Health Information Systems
      ab: The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regulatory decision making. As the healthcare system transitions from volume- to value-based care, there is a growing need to harness the power of real-world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network-based learning healthcare system by a for-profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real-world data within a purpose-built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose-built electronic health record and the 21 wound-specific quality measures help to standardize the potential sources of bias in real-world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit-Based Incentive Payment System.
      pubtype: Academic Journal
      doctype:
        pictorial
        tables/charts
        Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N