Plain language summaries of publications of company-sponsored medical research: what key questions do we need to address?

Figures & data

Figure 1. Study methodology. Abbreviation: PLS, plain language summary.

Figure 2. Expert stakeholders who participated in the study. ^aOne stakeholder accepted the invitation for the project but was not able to complete either survey or participate in the stakeholder discussion sessions. Abbreviations: HCP&CR, healthcare professionals and clinical researchers; M&Soc, media, International Society for Medical Publication Professionals, and the multi-regional clinical trials center; Phar, pharmaceutical industry; P&JE, publishers, journal editors, and National Institutes of Health/National Library of Medicine; PLS, plain language summary; PME, publication/medical education agencies; PP, patient partners.

Table 1. Key information that should be included in a PLS.

Type of information	Important	Consider	Notes
Drug approval status	✓		Broad agreement that some form of acknowledgment is required (e.g. provide the brand name). HCP&CR highlighted that this could raise issues with inconsistency, as approval status varies over time and between locations
What’s known about this therapy to date	✓		Agreement to include from all groups who commented to provide context
Study objective	✓		Agreement to include from all groups who commented
Drug mode of action		✓	Where relevant for context (PP, P&JE), although HCP&CR felt this did not need to be included
Trial design		✓	Short and simple, as design is more for research specialists than patients
Trial patient population	✓		Should be provided for context but should be short (e.g. age of the participants)
Primary/secondary/all endpoints	✓		Primary and key secondary (e.g. patient-reported outcomes and safety) are of particular interest to patients. Some secondary endpoints can be confusing so should be avoided to reduce complexity
What the study adds and if/how it is likely to impact care	✓		Most groups felt it was important to add how the study is likely to impact care, but if a conclusion can't be drawn from the data that should be clearly stated
Context of other studies/competitor studies		✓	Most groups agreed, but Phar noted that there needs to be a careful balance to ensure it is not promotional
Study limitations	✓		Should be noted for transparency and balance but kept simple
What’s being looked at next		✓	Mixed response (P&JE, PME, M&Soc: Yes; Phar, HCP&CR: No; and PP did not comment)
Pronunciation guide		✓	Mixed response (Phar, PME, M&Soc: Yes; PP, HCP&CR: No)
Glossary of terms		✓	Could reduce use of jargon but not needed if lay definitions are used
Thank-you to study participants	✓		Viewed as important by groups who commented and should also be in the main article
Who sponsored the research	✓		Viewed as important by groups who commented but avoid branding/company logos
Who wrote the PLS	✓		Broad agreement, as important for compliance and credibility, although no strong opinion from PP or M&Soc
Has the PLS been reviewed and approved by the manuscript authors?		✓	Will be assumed the summary has been reviewed by authors if the PLS is developed appropriately (some groups only)
Has the PLS been reviewed by patients and/or general public?		✓	Some groups agreed that patient involvement should be clearly stated
Where readers should go for further information		✓	Include relevant links (e.g. www.clinicaltrials.gov, patient group sites) but beware of being promotional. Link to main article is essential
Relevant disclosure statements		✓	Consider including in a PLS
Study dates		✓	Dates study started/closed—important for context, e.g. for ongoing studies
Date PLS was produced		✓	Important to include for future context
Strength of the evidence		✓	Readers may need help to interpret this and understand how strong the evidence is/how reliable it is
Study name/acronym		✓	Consider including in a PLS
Copyright statement		✓	As visual as possible

Abbreviations: HCP&CR, healthcare professionals and clinical researchers; M&Soc, media, International Society for Medical Publication Professionals, and the multi-regional clinical trials center; Phar, pharmaceutical industry; P&JE, publishers, journal editors, and National Institutes of Health/National Library of Medicine; PLS, plain language summary; PME, publication/medical education agencies; PP, patient partners.

Figure 3. Who are the key target audience for PLS? Abbreviations: HCP, healthcare professional; PAG, patient advocacy group; PLS, plain language summary.

Figure 4. Overview of an example content development, review, and approval process for PLS of journal articles developed with medical writing support. Abbreviation: PLS, plain language summary.

Figure 5. Potential approaches to select which publications should include a PLS. Abbreviation: PLS, plain language summary.

Table 2. Opportunities to overcome real or perceived barriers to the uptake of PLS.

Category	Emerging themes	Stakeholder group
		Phar	P&JE	PME	PP	HCP&CR	M&Soc
Why?	Target end users highlight unmet need and advocate for PLS	✓		✓		✓
When?	Clear directive for when publications should have a PLS	✓	✓				✓
	Call on key journals to lead the way by publishing PLS	✓			✓
Who?	PLS stakeholders would benefit from guidance on optimal co-creation	✓		✓
What?	Tools, such as templates, to guide content development	✓					✓
	Industry-recognized guidelines to define and maintain quality	✓	✓	✓		✓	✓
How?	Use specialist PLS writers and/or undertake PLS training for medical writers and researchers (including patients)			✓		✓
	Clarity on optimal format and development process from start to finish	✓	✓
Where?	Optimal dissemination and easy access (including searchable repository)		✓	✓		✓
	Explore use of social media to facilitate dissemination		✓				✓
	Work with patient advocacy groups and charities to expand the reach of PLS			✓	✓

Abbreviations: HCP&CR, healthcare professionals and clinical researchers; M&Soc, media, International Society for Medical Publication Professionals, and the multi-regional clinical trials center; Phar, pharmaceutical industry; P&JE, publishers, journal editors, and National Institutes of Health/National Library of Medicine; PLS, plain language summary; PME, publication/medical education agencies; PP, patient partners.

Data availability statement

The data that support the findings of this study are available from the corresponding author, Dawn Lobban, upon reasonable request.