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Accepted for/Published in: JMIR Medical Informatics

Date Submitted: Feb 28, 2018
Open Peer Review Period: Mar 1, 2018 - Mar 29, 2018
Date Accepted: May 24, 2018
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset

Peddie D, Small SS, Badke K, Bailey C, Balka E, Hohl CM

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset

JMIR Med Inform 2018;6(2):e10248

DOI: 10.2196/10248

PMID: 29954724

PMCID: 6043729

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset

  • David Peddie; 
  • Serena S Small; 
  • Katherin Badke; 
  • Chantelle Bailey; 
  • Ellen Balka; 
  • Corinne M Hohl

ABSTRACT

Background:

Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized.

Objective:

The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety.

Methods:

We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format.

Results:

We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations.

Conclusions:

By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.


 Citation

Please cite as:

Peddie D, Small SS, Badke K, Bailey C, Balka E, Hohl CM

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset

JMIR Med Inform 2018;6(2):e10248

DOI: 10.2196/10248

PMID: 29954724

PMCID: 6043729

Per the author's request the PDF is not available.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.