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Plain Language Result Summaries

This page is for adult clinical trials, for pediatric clinical trials, please see the CommuniKIDS page.

Plain language summaries provided to participants at the end of a study provide information in easy to understand language help participants learn how they contributed to new knowledge. In some countries, regulations mandate plain language summaries.

“Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%])”. [Sood et al. 2009. Mayo Clinic Proceedings.84(3): 243-247.]

[Getz et al. 2012. Expert Rev. Clin. Pharmacol.5(2): 149-156.]

 

  • Tab IconConsiderations
  • Tab IconResources

Some things to consider when planning and creating a plain-language summary:

Content and Format

  • Use simple headings and non-technical language without jargon and acronyms. This includes using the active voice, simple sentences, and no adverbs.
  • Use graphics, visuals, or videos to make summaries more accessible (e.g., video with closed-captions).
  • Work with patients and/or caregivers to co-develop the template and/or summary. CTO has resources to help you engage patients and caregivers here.
  • Keep as short as possible (1 to 2 pages) while providing all information or consider a short version of the summary and a more in-depth version for those who may wish to learn more.
  • If your organization has a communications group or knowledge translation experts, see if they are available to help your efforts.
  • Ensure that content is in the public domain (i.e. has been published) and can be shared with participants. If the results are from an industry-sponsored trial, ensure the wording has been approved by the sponsor.
  • Ensure the plain language summary is approved by a Research Ethics Board prior to sending it to participants.

Process

  • Some participants may be interested in a scientific publication of the study in which they participated. In the plain language summary, you should ask participants if they wish to receive published results when these become available
  • See if or how web-based platforms such as ClinicalTrials.gov or similar trial listing sites might be appropriate for sharing the summary
  • See if or how other methods of sharing the results, in addition to with participants, are appropriate (e.g. social media, institutional or patient newsletters)
  • Consult a research ethics colleague if you feel advice on timing from their perspective would be helpful.
  • Ensure the process to distribute the plain language summary is approved by a Research Ethics Board

These resources are provided to help with plain language summaries. In addition to the resource name, the organization that developed the resources is listed and a brief description is also provided.

Note: This resource list is not exhaustive and listing a resource does not denote its endorsement or promotion.

Note: The development of CommuniKIDS was funded by a knowledge translation grant from the CHILD-BRIGHT Network to Dr. Nancy Butcher in partnership and supported by Clinical Trials Ontario, the INFORM-RARE Network, and the EnRICH Research Group (Hospital for Sick Children). 

 

 

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