Participant Experience Toolkit

Plain Language Result Summaries

Plain language summaries provided to participants at the end of a study provide information in easy-to-understand language and help participants learn how they contributed to new knowledge. In a study on patients’ attitudes and preferences about clinical trial participation, Sood et al. found that 91% of patients wanted to be informed of research findings, and 68% said they would not participate in future trials if not informed. In fact, some countries have regulations requiring plain language summaries be made available.

0 %

of participants wanted to know trial results*

0 %

would not participate in future trials if not informed of trial results*

*Sood et al. 2009. Mayo Clinic Proceedings.84(3): 243-247

This page has information on creating plain language summaries for both adult and pediatric trial participants. Recognizing that each audience has unique needs, we’ve developed separate considerations and resources for each group.

Adult Clinical Trials

Content & 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.
  • 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
Plain Language Result Summaries Template

Clinical Trials Ontario and Clinical Trials BC have developed a template with helpful instructions and suggested wording which is intended to be “plug and play” and easily branded by your organization.

Additional Resources

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

Pediatric Clinical Trials

CommuniKIDS

CommuniKIDS, a freely accessible template, takes its inspiration from CTO’s Plain Language Results Summary template, and was developed to support researchers in sharing pediatric clinical trial results back to participating youth and/or their families.

The editable CommuniKIDS template comes with instructions in the template and a separate “tip sheet” which provides additional guidance on how to use the template. We have also compiled completed examples of the CommuniKIDS template and resources that may be beneficial to you (see the tabs below).

Development of CommuniKIDS

Our project team consisted of a diverse group of pediatric researchers, healthcare professionals, and patient/public engagement partners that worked directly with Canadian youth and parents through virtual workshops to adapt the CTO template to meet the needs of sharing pediatric research results to youth and their families. To learn more about how CommuniKIDS was developed watch the video below.

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 (The Hospital for Sick Children). For more information about this project and how CommuniKIDS was developed, read Youth & Family Involvement in the Development of a Plain Language Trial Results Communication Tool: CommuniKIDS.

Tip Sheets
The CommuniKIDS template

The template is intended to be “plug and play” and can be easily branded by your organization.

Example Template

A populated CommuniKIDS template that was created by the CommuniKIDS team and developed with permission of the study team.

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