Article Text

Protocol
Supporting patient and public partners in writing lay summaries of scientific evidence in healthcare: a scoping review protocol
  1. Sareh Zarshenas1,
  2. JoAnne Mosel2,
  3. Adora Chui3,
  4. Samantha Seaton1,
  5. Hardeep Singh1,
  6. Sandra Moroz2,
  7. Tayaba Khan2,
  8. Heather Colquhoun1
  1. 1Occupational Science and Occupational Therapy Department, University of Toronto, Toronto, Ontario, Canada
  2. 2Strategy for Patient-Oriented Research-Evidence Alliance, Toronto, Ontario, Canada
  3. 3Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Heather Colquhoun; heather.colquhoun{at}utoronto.ca

Abstract

Introduction Despite growing interest among patient and public partners to engage in writing lay summaries, evidence is scarce regarding the availability of resources to support them. This protocol describes the process of conducting a scoping review to: (1) summarise the source, criteria and characteristics, content, format, intended target audience, patient and public involvement in preparing guidance and development processes in the available guidance for writing lay summaries; (2) contextualise the available guidance to the needs/preferences of patient and public partners and (3) create a patient and public partner-informed output to support their engagement in writing lay summaries.

Method and analysis A scoping review with an integrated knowledge translation approach will be used to ensure the collaboration between patient/public partners and researchers in all steps of the review. To meet objective 1, the English language evidence within a healthcare context that provides guidance for writing lay summaries will be searched in peer-reviewed publications and grey literature. All screening and extraction steps will be performed independently by two reviewers. Extracted data will be organised by adapting the European Union’s principles for summaries of clinical trials for laypersons. For objectives 2 and 3, a consultation exercise will be held with patient and public partners to review and contextualise the findings from objective 1. A directed content analysis will be used to organise the data to the needs of the public audience. Output development will follow based on the results.

Ethics and dissemination Ethics approval will be obtained for the consultation exercise. Our target audience will be stakeholders who engage or are interested in writing lay summaries. Our dissemination products will include a manuscript, a lay summary and an output to support patient and public partners with writing lay summaries. Findings will be published in a peer-reviewed journal and presented at relevant conferences.

Open science framework registration osf.io/2dvfg.

  • PUBLIC HEALTH
  • Protocols & guidelines
  • Health policy
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Strengths and limitations of this study

  • This scoping review will be conducted using an integrated knowledge translation approach to ensure our patient and public partners (PPPs) are integral members of the research team and involved in the entirety of the project.

  • The consultation exercise will be conducted as an opportunity for PPPs to contextualise the grey and peer-reviewed literature.

  • A limitation is that only articles in English will be reviewed.

Introduction

Healthcare research systems and agencies are increasingly considering the necessity of patient and public partners’ (PPPs) engagement in the process of knowledge creation and knowledge translation (KT) to ensure that scientific evidence reflects and meets PPPs’ needs.1–4 One of the critical goals of KT is to facilitate the communication of research findings with a public audience.5 6 However, most scientific evidence has targeted specialists and clinical audiences by using scientific jargon, rendering these documents inaccessible to non-specialists, including patients and public audiences.7 8

In response to this demand, ‘lay summary’ or ‘plain language summary’ of research projects has been considered as a viable KT strategy to provide a synopsis of research components to public audiences in a lay format by avoiding the use of jargon and containing the explanations of the technical terms.5 6 8 9 Lay summaries facilitate effective communication of essential information pertaining to a research project (eg, background, objectives, methods, data collection, results, implications and dissemination plan) between researchers and PPPs/other stakeholders.5 Further, lay summaries increase the visibility of research projects by making them more accessible to various audiences and raise their awareness about the most recent health-related evidence.8–10

Following the increase of calls to provide lay summaries of research, knowledge brokers such as medical journals/publishers, associations and agencies have made many efforts to generate lay summary guidelines and make findings available to lay audiences.5 6 8 9 11 12 For instance, the European parliament and the council of the European Union (EU) released some regulations regarding clinical trials on medicinal products in 2014 that requires all sponsors to submit a lay summary of the clinical trials’ results.11 Following this movement, the ‘Good Lay Summary Practice’ guidance was developed to provide recommendations on preparing, writing and disseminating lay summaries for clinical trials.12 Also, Taylor and Francis Publisher Group in 2021 provided authors with instructions regarding writing an English lay summary.13 The Cochrane lay summaries manual (2022) is another well-studied resource that provides authors with standards to write a lay summary that captures pertinent information of intervention reviews for PPPs.14 Consistent with this trend, agencies such as the Canadian Frailty Network15 and Multiple Sclerosis Society of Canada16 also published a set of guidelines to write lay summaries to communicate research projects to a general audience.15 16 However, these resources are very dispersed and varied regarding linguistic qualities, format, general content and presentation of results.15–17 Further, they are primarily developed for researchers or unspecified audiences and are often presented in grey literature rather than empirical studies.13–15 18

With rising awareness about the value of employing the patient-centred approach in the KT process, PPPs have expressed a growing desire to play an active role in creating all forms of scientific evidence.1 3 8 However, information about the contribution of PPPs regarding their roles and related tasks in the writing of publications including lay summaries is undetermined.3 8 19 For instance, in a systematic review study by Arnstein et al, they investigated patients’ involvement in preparing peer-reviewed publications and results summaries in health research.19 However, they limited their search to clinical trial studies and ended up with nine publications in which none of them focused on preparing result summaries.19 In another rapid review on the PPPs’ authorship in knowledge synthesis by Ellis et al, they concluded that the roles of patient partners as co-authors of publications are not well defined, and information is very sparse regarding their contributions in specific tasks during the writing of systematic and scoping reviews.20

These findings point to the need for resources that target patients and the public audience regarding their roles and contribution in writing scientific evidence, including lay summaries. Further, to encourage, empower and support PPPs to successfully write lay summaries, guidance tailored to their needs is crucial since they vary in skill and ability levels (eg, knowledge, interest, reading level).5 10 Applying an integrated KT (iKT) approach is an effective strategy to facilitate PPPs’ engagement in all stages of a research project.3 iKT is a transdisciplinary and inclusive KT approach.3 21 The key principle of iKT is engaging knowledge users as equal partners alongside researchers to make findings more relevant and useful to end users.3 21

The overarching goals of our study are to optimise the involvement of patients and the public in the writing of lay summaries of scientific evidence and improve an integral aspect of KT, which is science communication between various stakeholders. To meet these goals, we will conduct a scoping review with a consultation exercise employing iKT principles to obtain comprehensive insight into the available evidence and resources for writing lay summaries and develop an output that will support patients and public partners in writing lay summaries of scientific evidence.

Our specific objectives are to:

  1. Summarise the source (eg, publication details), criteria (eg, writing style), characteristics (eg, text length), content (ie, main elements such as research objectives), format (eg, template), intended target audience (eg, patient partner, researcher), patient and public involvement in preparing guidance and development processes (eg, actions, procedures, training, roles and tasks) in the available guidance for writing lay summaries.

  2. Contextualise the summary of guidance to meet the needs and preferences of PPPs.

  3. Develop a PPPs-informed output to support them in writing lay summaries.

Our research questions are as follows:

  1. What guidance for writing lay summaries is available by considering the source, the criteria, characteristics, content, structure, intended target audience and patient/public partners involvement in the guidance development? (Refers to objective 1)

  2. How can this guidance be contextualised to meet the needs and preferences of PPPs? (Refers to objective 2)

  3. What type of output can be used to disseminate this guidance? (Refers to objective 3)

Methods

Study design

Our scoping review with the consultation exercise will follow the methodological guidance outlined in the Joanna Briggs Institute, methodological guidance for the conduct of scoping reviews.22 This review will comply with reporting guidance to conduct scoping reviews (ie, Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews—PRISMA-ScR) (online supplemental file 1).23 Further, this review’s search strategy will be peer-reviewed using the Peer Review of Electronic Search Strategies (PRESS) criteria.24 This protocol is registered on Open Science Framework.25

Patient and public involvement

The iKT approach will be employed through all objectives of this study. The embedded interdisciplinary concept of iKT and its key principles regarding equitable involvement of stakeholders in the research projects will allow us to ensure the engagement of the main knowledge users (ie, PPPs) across all steps of this project, such as identifying priorities regarding lay summaries writing and developing questions/objectives, data collection, interpretation of findings, contextualising the guidance and developing the final output.21 For this purpose, we will use suggested potential contributions of patients in the iKT process by Banner et al, with the focus on knowledge inquiry, knowledge synthesis and knowledge output as the main components of knowledge creation as follows3:

  • Knowledge inquiry

    • Identification of patient experiences, needs, priorities and values.

    • Conceptualisation of the research problem from a patient perspective.

    • Co-creation of responsive research questions.

    • Potential to contribute to the collection, analysis and interpretation of primary research data with the appropriate skill set (eg, patient partners that have participated in research training).

  • Knowledge synthesis

    • Identification of patient experiences, needs, priorities and values.

    • Facilitating opportunities for the co-creation of responsive questions for knowledge synthesis activities.

    • Potential to participate in the collection, analysis and interpretation of research literature from a patient perspective.

    • Identification of relevant literature or resources for inclusion in the knowledge synthesis, such as grey literature and patient education resources.

  • Knowledge outputs

    • Identification of patient experiences, needs, priorities and values to inform the development and testing of outputs.

    • Participations in the co-creation of knowledge outputs.

This project is co-led by a patient partner (JM) and a researcher (HC). The team includes two additional PPPs (SM; TK), two researchers (SZ, HS), one postdoctoral fellow (AC), one PhD student (SS) and a research assistant. This project was initiated by our patient partner co-lead (JM) through a submission to the Strategy for Patient-Oriented Research (SPOR) Evidence Alliance in response to an identified gap in the dissemination of scientific evidence. The SPOR Evidence Alliance is a pan-Canadian research initiative designed to promote evidence-informed health policy and practice changes and values the importance of patient and public identified priorities in forming the health research design and ultimately informing changes in the health system to address patients’ needs.26 27 Our two additional PPPs (SM; TK) are members of the SPOR Evidence Alliance and have a strong interest in improving guidance for the writing of lay summaries. All patient partners have provided input into the protocol development via team meetings and participated in ideas for the grey literature search. As the project continues, they will support planning the consultation exercise, decisions for output development, publication through authorship and the co-production of a lay summary. All these processes will be performed through consensus decision-making among all team members.

Also, to report PPPs’ engagement in this study, we will use the Guidance for Reporting Involvement of Patients and the Public form (GRIPP2).28

Eligibility criteria

Population

For the scoping review, objective 1, the population of interest will be any healthcare audience of lay summaries guidance (eg, PPPs, researchers). For the consultation exercise (objectives 2&3), a minimum of five patient/public partner participants will be the population focus to contextualise the guidance and develop our output. These participants will be recruited via a purposeful sampling approach and will be enrolled if they are: (1) medically stable adults and have been living in the community for at least 2 years, (2) interested in the concept of the lay summary or have previously collaborated on research studies as a patient or public partner and (3) fluent in English. We will aim to sample with a range of ethnocultural backgrounds, indigenous status, geographic location, ability/disability. There is no limitation regarding types of health conditions.

Concept(s)

The first concept is PPPs. According to the Canadian Institutes of Health Research’s (CIHR) SPOR, the term patient is ‘overarching and is inclusive of individuals with personal experience of a health issue and informal caregivers, including family and friends’.2 Also, CIHR defines public or citizen as ‘any interested representatives of the general public, consumers of health services, patients, caregivers, advocates and representatives from affected community and voluntary health organisations’.29 The second concept is lay summary. The National Institute for Health Research identifies a lay summary as ‘a summary of a research project or a research proposal that has been written for members of the public, rather than researchers or professionals. It should be written in plain English, avoid the use of jargon and explain any technical terms that have to be included’.30

Context

This scoping review study will focus on the field of healthcare in any human condition and will not be limited to specific settings. Further, the consultation exercise will be held online.

Type of studies

We will include any English language resources/evidence in the field of healthcare that outlines guidelines, instruction, templates, recommendations or strategies to create a lay summary of conducted studies. No limits on the type of health condition or publication year will be employed. As we are primarily interested in the writing process of lay summaries, we will exclude any guidance or support for writing full manuscripts and studies that examine health literacy or explore how to increase PPPs’ understanding of research. Further, conference abstracts, books and book chapters will be excluded from this study as they may not be comprehensive in their guidance (conference abstracts) or may be potentially outdated or hardly available (books).

Sources of data, search strategies and data collection

A comprehensive research strategy for this scoping review was designed by SZ in collaboration with members of the research team (HC), PPPs and an information specialist at the University of Toronto. The search strategy was validated by another information expert at the SPOR Evidence Alliance using PRESS. We will use three search strategies to extract the relevant literature. First, eight databases including, Ovid MEDLINE, Scopus, Embase, Cochrane libraries, CINAHL, PsycINFO, ERIC and PubMed will be searched electronically (online supplemental file 2-Ovid-Medline search strategy example).

Second, we will search grey literature to ensure the retrieval of relevant health documents on the topic in governmental and non-governmental agencies, organisations and community associations.

For searching grey literature, we will (1) use The Canadian Agency for Drugs and Technologies in Health guidance for searching health-related grey literature31, (2) search for relevant documents on the first 10 pages of google and (3) ask research team members for suggested resources. We will limit the grey literature research to English language countries including Canada, USA, UK and Australia. Finally, we will supplement our research by hand-searching the reference lists of selected articles to distinguish related documents that may have been missed in the above search strategies.

Data screening

All retrieved articles from databases will be combined, and duplicates will be removed using Endnote software or COVIDENCE. Titles and abstracts of the remaining articles will be screened by two independent reviewers (SZ and a research assistant), and then the same reviewers will check the full text of selected evidence to ensure they meet the eligibility criteria. Any discrepancies will be resolved by consensus or involvement of a third reviewer.

We expect diverse and heterogenous guidance for the writing of lay summaries and anticipate the need for iteration and piloting of our extraction guide. Once we draft our full guide, we will undertake multiple pilots of 5% of articles at a time to ensure consistency and clarity of the guide. We expect to stop piloting when the percent agreement is >80% across reviewers. Members of the research team, including PPPs, will be invited to participate in pilot screening and will be received training in advance.

Data extraction

Two reviewers will independently extract data from each included study/guidance using a data abstraction form via Microsoft Excel spreadsheets. Also, we will conduct a pilot on 5% of screened articles to ensure the accuracy of the data abstraction form.

The extraction variables for objective 1

  • For the source, we will extract publication details (eg, year, journal as appropriate, country of the first author, whether peer-reviewed or grey literature source, government agency, health condition group agency, other). Then, we will check whether the developed guidance was evaluated and if so, we will extract information on study design, methods and outcomes.

  • For extracting data on criteria and characteristics, we will adapt ‘the European Union’s principles for summaries of clinical trials for laypersons’.32. These principles include the following seven criteria: general principles, health literacy principles and writing style, readability and use of plain language, numeracy, visual, language and others. Each criterion consists of components, called characteristics (ie, visual criterion=8 characteristics). While the principles are comprehensive, there is some overlap of characteristics and thus, we plan to adapt the principles as needed to reduce this redundancy.

  • For the content, we will extract data on recommendations for what lay summaries should include (eg, what question the researchers are asking, why the findings matter).

  • In terms of format, we will extract data on the structure of the suggested guidance (eg, template, checklist).

  • Information on the target audience will be extracted as PPPs, researchers, policymakers, funders, unspecified, a combination of audiences, others.

  • Further, we will extract data regarding PPPs’ involvement in creating the guidance (yes/no).

  • Finally, for the development process, we will focus on the steps of creating guidance such as preparations, training for PPPs, processes, participants’ roles and time duration.

Objective 2

The consultation exercise will be held online via a secure University of Toronto Zoom account. We will use Zoom since we will recruit pan-Canadian participants. This strategy will be safer and result in greater ability to recruit in the event of further pandemic measures. For this purpose, we will use the Nominal Group Technique (NGT) to collect data via two online groups with 5–7 PPPs in each, in total approximately 10–14 participants.33 Using NGT, we will empower participants to have their voices heard and share their opinions with other members. This technique includes four steps: generation ideas, round robin, clarification and voting (ranking or rating). Following these steps, the results of synthesis from objectives 1 will be presented to the participants and input will be sought related to three general areas: which of the guidance is most/least helpful, what is missing from the guidance and how should we package this guidance to optimise its use to PPPs. Then, all shared ideas will be discussed to ensure PPPs’ understanding and enable them to make an informed decision in the voting step. Finally, PPPs will be asked to rank their top preferences regarding the three aforementioned areas using a rank sheet. Participants will be provided with the guide in advance of sessions. Also, sessions will be audio/video recorded for further analysis.

Data analysis

Descriptive quantitative statistics will be used for many variables. Extracted data on criteria and characteristics will be analysed using the adapted the EU principles. Using this strategy, we will be able to determine what proportion of documents/studies recommend each principle and will rank order in terms of the most recommended. Data on the content, development process and format of lay summaries will be analysed inductively. For the consultation exercise, data will be organised and analysed deductively using a consensus-driven discussion and a directed content analysis of the discussion using Miles et al, approach.34 Decisions on the resulting outputs of the project (objective 3) will be determined based on the final analysis of the consultation exercise with input from the PPPs on the research team.

Presentation of results

Results of the search strategy and selection process will be described in the PRISMA flow diagram.23 Further, all descriptive quantitative findings will be organised and reported in tables using either the EU principles or the inductive analyses. Qualitative findings will be presented as thematic or content-based summaries. Results of GRIPP2 will be reported narratively.

Ethics and dissemination

For the scoping review, we will review pre-existing published articles, and therefore, ethical permissions will not be required. Regarding the consultation exercise, Research Ethics Board approval will be sought through the University of Toronto. Also, all participants will be required to provide informed consent to participate in the consultation exercise.

Our target audiences include any PPPs who engage in the writing of lay summaries and any researchers/other who collaborate with the PPPs to write lay summaries of scientific evidence. Our dissemination products will include a manuscript and a lay summary. We will also publish the review in a peer-reviewed journal and present the findings at national and international related conferences that focus on PPPs and/or KT. We hope that our consultation exercise will result in an output to support PPPs in writing a lay summary. Regarding the eventual type and form of the output, we will remain open to including the insights and input from a sample of PPPs who will be involved in our consultation exercise to decide on various types of potential products such as an infographic, a checklist or set of short engaging videos or whiteboard videos or recommendations. It should be noted that the lay summary of this protocol manuscript is available in online supplemental file 3.

Conclusion

This scoping review with a consultation exercise will provide stakeholders with comprehensive information regarding the content and characteristics of lay summaries and support PPPs in the process of writing lay summary. Further, the inclusion of PPPs on the research team and the consultation exercise will help to ensure that their perspectives are included in the review itself and the resulting knowledge products. This review could support increased involvement of PPPs in writing lay summaries and potentially the quality of summaries available.

Ethics statements

Patient consent for publication

Acknowledgments

We recognise the collaboration of our patients and public partners who have engaged in the process of developing this protocol. Also, we gratefully acknowledge the contribution of Ms Erica Lenton, information specialist at the University of Toronto for her invaluable advise in designing the search strategy.

References

Supplementary materials

Footnotes

  • Contributors This project was initiated by a query submitted to the evidence alliance team by a co-lead patient partner, JM. This study was co-led by JM, the patient partner and HC, the principal investigator of this project. SZ drafted the protocol and designed the search strategy in consultation with an information expert from the University of Toronto. Researchers including HS, AC and SS and all patient partners including JM, SM, TK were involved in the review and refinement of the protocol. All authors read and approved the final protocol manuscript.

  • Funding This project was supported by the Operating grant: SPOR – Guidelines and Systematic Reviews: The Evidence Alliance, grant number (154442).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.