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Why Should Anyone Share? Is It Possible to Design Ethical and Effective Evaluation Systems to Capture Unpublished Evaluation Data?. S. Snyder, L.A . Fabian 1 , C. Layfield 1 , J. Derzon 1 , A. Alford 1 1 Battelle, Health and Analytics, USA. DISCUSSION. INTRODUCTION. FINDINGS.

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Why Should Anyone Share? Is It Possible to Design Ethical and Effective Evaluation Systems to Capture Unpublished Evaluation Data?

S. Snyder, L.A. Fabian1, C. Layfield1, J. Derzon1, A. Alford1

1Battelle, Health and Analytics, USA

DISCUSSION

INTRODUCTION

FINDINGS

Systematic Evidence Reports

Issues in accessing unpublished data

Publications

Benefits of Unpublished data

  • Patient Specimen Identification– Barcoding
    • Barcoding systems and point-of-care test barcoding had positive effects in all studies analyzed (Snyder et al, 2012a)
  • Blood Culture Contamination
    • Reduced blood culture contamination with venipuncture and phlebotomy teams (Snyder et al, 2012a)
  • Critical Value Test Result Reporting
    • Call centers can improve timeliness of critical value reporting in patient care settings (Liebow et al, 2012)
  • Hemolyzed Blood Samples
    • Straight needle venipuncture instead of intravenous access is effective for reducing hemolysis in emergency departments (Heyer et al, 2012)

Ethical

  • Theoretically provide evaluators with vetted evidence, but
  • Often limited, possibly biased, often not timely, and generally estimates efficacy, not effectiveness
  • Wealth of Evidence
  • Remains unpublished for varied reasons, including bias (Hopewell, 2007)
  • Often little published evidence to address specialized or specific research questions (Alford & Derzon, 2012)
  • Access to unpublished data can build the knowledge base – especially for effectiveness
  • Easer access with electronic databases
  • Sensitive data need to be protected
  • Ensure appropriate approvals before releasing
    • Contact your Institutional Review Board
  • Consider any caveats to the data (was there a reason it wasn’t published?)

What about the missing parts?

Unpublished Evaluation Data

Economical

  • Is it possible to ethically collect and represent unpublished data?
  • When would an independent evaluator or practitioner release primary data to a third party?
  • Maintaining and archiving data can incur additional project costs
  • Consider the usefulness of the data before it’s collected
  • Have a plan to mine the data

Experiences with the LMBP project

Project Example

  • Reviewed and ranked unpublished data via the same format as published data
    • Study Quality
    • Practice Quality
    • Measure Quality
    • Results Quality
    • Total Quality rating
      • Poor, fair, good
    • Effect size rating
    • Overall consistency
    • Overall strength of body of evidence
      • Excluded, moderate, substantial
  • Presented unpublished data as distinct from published data to maintain transparency within the user community
  • Unpublished data had similar inconsistencies in quality as published data
  • Difficult to fully determine how much of unpublished data actually obtained out of what was truly available
    • Consider layered decision tree to initiate contact
      • Published authors to colleagues to graduate students

CDC-Laboratory Medicine Best Practices Initiative ( LMBP™)

Pending Systematic Evidence Topics

CONCLUSION

  • Biomarkers and Risk of Cardiovascular Disease
  • Red Blood Cell (RBC) Transfusion Utilization
  • Routine Use of Coagulation Testing
  • Summaries of these articles are available online at: https://www.futurelabmedicine.org/our_findings/

Will you share your unpublished data?

Approach

  • Develops evidence-based quality improvement best practice recommendations focusing on the pre- and post-analytic testing stages
    • Depends on active participation from the field to increase data and analysis related to healthcare quality outcomes
    • Uses “A-6” systematic steps (Christenson, et al. 2011)
  • Paperless technologies and cloud storage may provide new opportunities for disseminating data and findings in less traditional ways
  • Be vigilant for new opportunities to use data to translate into uses for practice
  • In the era of big data and improved electronic records systems, there are opportunities to collect and use unpublished data to draw conclusions and improve the evidence available for decision making.

METHODS

Gathering Unpublished Data

Multiple Methods

ACKNOWLEDGEMENTS

  • Word of mouth
  • Posters and presentations at conferences
  • Referrals from expert panels
  • Ongoing website solicitation, e.g.,
    • https://www.futurelabmedicine.org/get_involved/data_submission/
  • The LMBP™ A6 method was developed under CDC contract # W911NF-07-D-0001/DO 1016/TCN 10226.
  • The findings and conclusions are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (CDC/ATSDR).