Guidance, ethics and cocreation for publication summaries

Recommendations and ethical guides set what a plain language summary of a publication should contain and how it is produced with the readers it serves, among them the patients and caregivers who take part as its authors and reviewers.

Guidance and standards

In 2021 there was no requirement to produce or publish a plain language summary alongside a manuscript in a peer-reviewed journal, and no standard guidance on preparing one. ¹ The scarcity and poor visibility of summaries could partly be due to the lack of standardised guidance on their terminology, language and content, guidance the medical writing profession had called for. ² Cochrane Methods in 2013 and the Canadian Frailty Network in 2017 had issued helpful guidance, but even summaries that followed Cochrane's remained highly heterogeneous, with very low adherence to its standards. ¹ Patient Focused Medicines Development and Open Pharma had developed or were developing other guidance and best-practice documents, and the update of Good Publication Practice was expected to include a new section on information for the patient. ¹ Detailed guidance on developing summaries in Good Publication Practice could standardise and improve practice, and the anticipated GPP4 update was expected to include recommendations on them. ³ As more guidance became available, awareness and quality of the summaries were hoped to increase. ¹

Until 2020, a lack of consistent guidance on developing plain language summaries limited their use. ⁴ In response, Open Pharma, a multi-sponsor collaboration of pharmaceutical companies, publishers, patients, editors and other stakeholders, developed recommendations for plain language summaries of peer-reviewed medical journal publications and published them in Current Medical Research & Opinion. ^{4, 5} As a minimum standard, the recommendations call for a plain language summary to be in the style of an abstract, understandable and readable, free of technical jargon, unbiased, non-promotional, peer reviewed and easily accessed. ^{5, 6} In Open Pharma's view, meeting that standard would make medical research easier to engage with for all its intended audiences, from patients, patient advocates and caregivers to healthcare professionals and policymakers. ⁵

The recommendations are a proposed foundational standard rather than a formal guideline. ⁷ They came out of an expert round table and a focused public consultation in 2021 that brought together representatives of medical communications and the pharmaceutical industry. ⁷ Their ten core tenets hold that an accessible, discoverable and inclusive summary should be: ⁷

• Co-developed alongside the main content of the manuscript, in line with the ICMJE authorship criteria.
• User tested, ideally reviewed by a non-expert during development.
• Peer reviewed fully alongside the main content.
• Free to read, alongside the abstract of the scientific publication.
• Tagged with appropriate metadata and keywords, to improve its discoverability in search engines, directories and indexes.
• Written in easily understood, unbiased language, free of expert or technical jargon and accessible to readers whose first language may differ from that of the summary.
• Text-based and concise, at 250 words or fewer, which allows indexing in directories such as PubMed and makes translation straightforward.
• Targeted at a broad, inclusive and non-technical, non-specialist or time-challenged audience.
• Consistent with the overall key points and conclusions of the abstract of the scientific publication.
• Linked explicitly to the citation of the source publication and the relevant clinical trial identifiers, with brief reference to the existing evidence.

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The set, updated in 2022, was published open access under an unrestricted Creative Commons Attribution licence, with a plain language summary, an explanatory author video and an accessible infographic. ⁷ By 25 May 2023 the recommendations article had more than 10,000 views and 8 citations. ⁴ Open Pharma believed the article was contributing to an emerging consensus on best practice among some publishers, to mandatory policies or recommended practices adopted by pharmaceutical companies, and to an update of Good Publication Practice that advises a plain language summary for every clinical research article. ⁴ Industry-wide publication guidance has been updated to recommend adopting plain language summaries. ⁶

Ethical considerations

A plain language summary written without strict regard for ethical principles risks misinforming its readers. ^{8, 9} A summary can contribute to publication bias through an unbalanced choice of the source articles that receive one, data that do not match the source article, unbalanced reporting of efficacy and safety, a missing primary endpoint, or secondary endpoints over- or under-reported. ⁸ Summaries are of value only when facts, numbers and conclusions are conveyed truthfully and objectively, without promotional intent or spin, and when readers can trust that all relevant data, including the uncertainty of the conclusions, have been made available to them. ⁸ So if summaries are to inform patients objectively and be a trustworthy source, their writing needs to rest firmly on a set of ethical principles and a documented institutional framework. ^{8, 9} Patient materials derived from a publication, such as a plain language summary, a video abstract or a graphical abstract, should be balanced: non-promotional, and reflecting only what the journal article or congress presentation includes. ¹⁰

Compliance with ethical principles matters particularly for a plain language summary, because its readers are likely to lack the expertise to detect methodological flaws, and so form a vulnerable group that needs protecting from the harm of misinformation. ¹¹ Scientists are trained to present research in a structured way, but that common format is alien to most patients and nonexperts. ¹¹ So authors, editors and publishers are obliged to minimise the potential for misunderstanding of the results a summary presents. ¹¹

The "How-To" Guide on plain language summaries of peer-reviewed publications was developed by Patient Focused Medicines Development (PFMD), a collaboration of health stakeholders, among them publishers, patient organisations and pharmaceutical companies, that aims to facilitate patient engagement across the medicine development lifecycle. ⁸ PFMD recognised the need for practical guidance that would ensure both ethical considerations and the early involvement of patients. ⁸ An international working group, whose members needed experience of patient engagement or expertise in writing summaries, developed it through rounds of cocreation, two public consultations, internal review and a final external review. ^{8, 12} The first consultation covered content, and the second usability and user experience. ¹² Feedback from each step refined the draft, which was then validated through further consultation. ¹² Patient representatives, industry members, publishers, researchers, medical communications agencies and public officials in research bodies gave input. ⁸ The guide is a standalone, practical, ready-to-use tool to support multistakeholder cocreation of summaries. ⁸ It contains selected resources for developing summaries, complementary tools and good-practice examples, and it is available on PFMD's PE Management Suite, a central repository that gives open access to all PFMD tools. ¹³

The guide's 15 ethical considerations, which support the obligation to minimise misunderstanding, recommend that a writer: ¹¹

• Make every statement objective and aligned with the data in the publication, and give no data beyond the article's.
• Apply health literacy and numeracy principles in writing and design.
• Choose neutral and factual words, and avoid superlatives, emotional words and phrases, and metaphors.
• Keep the summary free of any commercial bias; it must be strictly nonpromotional.
• In a summary of a clinical trial publication, present efficacy and safety data in balance.
• Describe the primary objective of the research.
• Describe and explain the results of the primary endpoint when the publication reports them.
• Optionally include results of key secondary endpoints that were prespecified, statistically powered and analysed, and are of particular relevance to patients.
• Mention the important limitations of the research.
• Provide translations for patients whose native language is not English that reflect the content faithfully, are mindful of cultural differences and are ideally reviewed by members of the target audience for each language.
• Make the summary inclusive of all genders, nationalities and ethnicities.
• Have the summary reviewed by members of the public or by patients or patient representatives, ideally with the condition studied.
• Have the lead author of the article approve it, as a minimum, and give every author of the article the chance to review and comment on it.
• Disclose the authors of the summary, the funding of the research and the funding of the summary.
• Link to the scientific publication.

^{14, 15}

A consistent policy for developing and publishing summaries is essential for sponsors and journals alike. ¹¹ To prevent publication bias, the policy should set transparent, prospective and objective criteria for choosing which publications get a summary and for deciding how and when it is published. ¹¹ A sponsor might, for example, commit to a summary for every phase 3 trial, whatever its outcome. ¹¹ A summary of a single trial needs a disclaimer on the limitations and generalisability of its results. ¹¹

As more and more journals offer the opportunity for a summary, the field of plain language summary writing is evolving. ⁹ The content guidance that collaborative networks such as Cochrane and Open Pharma have published applies to all summaries, but it does not state ethical considerations explicitly and offers no method for cocreation with the target audience. ^{8, 9} Both still set requirements in line with the PFMD guide: Cochrane treats consistency with the source, reporting of the primary outcome and balanced reporting of efficacy and safety as mandatory, and Open Pharma asks for nonpromotional, unbiased summaries linked to the source. ⁹ The January 2022 version of the Cochrane guidance is substantially less explicit about the ethics of content than its predecessor. ⁹ In a modified Delphi study, stakeholders rated including the primary endpoint results and the study's limitations as important, but left approval of the summary by the authors of the source article as only to be considered. ⁹ The authors of the PFMD guide hold that it is the first to require compliance with a set of ethical considerations more explicitly. ¹³

Cocreation with the target audience

Cocreation is a key ethical consideration. ⁸ Preparing a summary with members of its target audience expresses respect for that audience and for potential and enrolled research participants, and aims at an optimal outcome for the adequacy of its content and presentation. ^{8, 16} The guide's authors hold that its method ensures adequate representation of the target population. ¹⁶ In current practice, however, patient involvement is often confined to the late stages of development, such as review. ⁸

The guide breaks the work into seven steps that serve maximum audience focus and full cocreation with members of the target audience: ¹⁷

1. Have a rationale and scope. The criteria for choosing the source publication must be clear before writing starts, set through a transparent process such as an organisation-wide standard operating procedure, so that providing summaries selectively does not create publication bias. Reasons for a summary can be the impact of the data, the uniqueness of the scientific approach or the needs of a particular audience.
2. Identify the target audience before writing starts. The choice affects the resources cocreation needs and determines the administrative and operational complexity of the writing.
3. Consider dissemination to the target audience. Free access is important to optimise distribution. The method of dissemination influences how far the data of the source article are aggregated and summarised: a summary in the same journal issue as its manuscript can leave some details to the source. Some journals may allow supplementary material, such as additional infographics.
4. Identify the key stakeholders for cocreation before writing; a broad range that includes patients and caregivers is desirable. Check whether the cocreators reach the target audience or need new relationships, and consider resourcing, such as contracting, payment and technical infrastructure, and any legal requirements, so that the relationships can be kept up throughout.
5. Write the summary. Set up an appropriate infrastructure, agree roles and interaction, and decide the literacy level, the structure and the use of visuals or infographics for the target audience. Review of the draft by a member of the target audience is highly recommended, and the summary must reference or link to the source article.
6. Disseminate it. Once published, it may be shared in print, in online repositories or on relevant websites, through channels chosen by the audience's preference. Use of social media depends on legal restrictions in some countries and on the compliance rules of large organisations.
7. Track success. Ways to monitor its impact should be developed, to gauge future efforts. The metrics available depend on where the summary is hosted: views and downloads, the attention the summary or its source article receives on social media and in commentaries, and whether patient organisations and healthcare providers in the disease area share it.

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Patients as authors and reviewers

Patient involvement helps build trust. ^{18, 19} Including patients and caregivers as authors adds unique insights and establishes trust with audiences, who may be encouraged to engage with a publication that includes a representative of their community. ¹⁸ It may also increase a summary's reach and engagement: of 72 summaries Future Science Group published between August 2020 and February 2023, the 10 with a patient or caregiver author had on average higher downloads and Altmetric scores. ¹⁸ It is essential that authorship criteria are followed when the summaries are created. ¹⁸

A patient perspective section lets patients and caregivers share their experience rather than only facts and statistics, which can help foster trust in medical information and raise awareness of the patient voice. ¹⁹ Summaries with such a section had higher downloads and Altmetric scores than those without. ¹⁹ The summaries are tools that can help empower people to draw their own conclusions about their own or someone else's care plan. ¹⁹ Because experiences and outcomes differ, a perspective section should aim to empower readers to learn about the condition and treatment options rather than offer conclusions about individual treatment outcomes. ¹⁹

Peer review by patients gives insight into what matters to the patient community while making sure the content is clear and the language suits a non-specialist. ¹⁹ Involving patients in review is a vital step for establishing trust in the content, and it shows a publisher's commitment to patient-centred publications. ¹⁹ Publishers may offer patient reviewers guidance on the purpose and process of peer review and on submitting a review through electronic systems, and may recognise their reviews, for example through Publons. ¹⁹ Whether to pay patient reviewers is an ethical question for publishers. ¹⁹ Paying traditional peer reviewers is debated because it can introduce a conflict of interest. ¹⁹ Patients, however, are often outside the publication pipeline and give time from their daily lives, and paying them widens and diversifies the pool of reviewers by removing cost as a barrier. ¹⁹