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Large Simple Trials and Knowledge Generation in a Learning Health System Workshop Summary (2013) / Chapter Skim
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9 Strategies Going Forward
Pages 59-64

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From page 59...
... Approaches to achieving learning-ready records included enabling all records to collect a minimum data set designed to support maximum improvements in health care and the more widespread use and piloting of minimal data resources already in existence. The identification of such a data set was suggested to be an important first step in this endeavor, which would require the engagement of multiple stakeholders as well as national leadership to consider issues such as balancing the burden of data collection with clinical burdens and work flows.
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From page 60...
... Stating that much of the research currently being conducted does not produce the evidence needed to inform decision making and that many basic effectiveness questions are left unanswered, several participants noted the opportunity to strengthen the evidence base in a way that can inform population-level questions and, ultimately, individual care decisions through the broader use of LSTs. Participants noted that the development of a national capacity to conduct LSTs could be accompanied by an ongoing capacity to elicit, refine, and triage questions to be addressed.
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From page 61...
... Several of the challenges to the broader use of LSTs that workshop participants who spoke highlighted dealt with current reward structures within the research community. A number of speakers and individual discussants pointed to the need for incentives for value rather than incentives for volume of studies (in which volume covers both the number of studies and the amount of data collected)
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From page 62...
... Many participants discussed the need to develop metrics, potentially for use by research funders, to assess the progress of research efforts toward these goals and reward those that make effective use of resources and contribute meaningfully to a useful evidence base for care and decision making. FACILITATIVE OVERSIGHT Much of the discussion around policy challenges to the broader use of LSTs in the United States centered on the need for clear and facilitative oversight.
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From page 63...
... Suggestions on ways to improve informed consent included improving and shortening consent forms, rethinking the requirement for informed consent in situations limited to the use of patient information, and leveraging electronic platform to obtain portable legal consent. Discussions of data sharing and privacy oversight policies followed similar themes.
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From page 64...
... Finally, several individual participants highlighted the need to educate the end users of the evidence produced by approaches like LSTs in an effort to build awareness of the advantages of research and maximize the impact and utility of the results.
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Key Terms

  • individual participants
  • simple trials
  • learning health
  • data sharing
  • informed consent

  • clinical trials
  • patient information
  • minimal data
  • scientific rigor
  • regulated products

  • science stewardship
  • research currently
  • support maximum
  • processes included
  • facilitating learning

  • individual workshop
  • records included
  • effective data
  • discussed included
  • improve informed

  • participants spoke
  • spoke highlighted
  • clinical care
  • minimum data
  • digital health

  • engagement included
  • learning culture
  • conduct lsts
  • clinical burdens
  • health data


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