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Study Within A Trial, SWAT, trial methodology, disseminating trial results, public and patient involvement
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Smith V, Gillies K, Corbett G et al. Pictorial enhanced written plus audiovisual information versus standard written information alone for disseminating trial results to trial participants: A Study Within A Trial (SWAT) Protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2026, 9:5 (https://doi.org/10.12688/hrbopenres.14305.1)
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Study Protocol
Pictorial enhanced written plus audiovisual information versus standard written information alone for disseminating trial results to trial participants: A Study Within A Trial (SWAT) Protocol
[version 1; peer review: awaiting peer review]
PUBLISHED 09 Jan 2026
OPEN PEER REVIEW
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This article is included in the HRB-TMRN gateway.
Abstract
Corresponding author:
Valerie Smith
Competing interests:
No competing interests were disclosed.
Grant information:
Health Research Board Trials Methodology Research Network SWAT Awards 2024 [HRB-TMRN-2021-001]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2026 Smith V et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Smith V, Gillies K, Corbett G et al. Pictorial enhanced written plus audiovisual information versus standard written information alone for disseminating trial results to trial participants: A Study Within A Trial (SWAT) Protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2026, 9:5 (https://doi.org/10.12688/hrbopenres.14305.1)
First published: 09 Jan 2026, 9:5 (https://doi.org/10.12688/hrbopenres.14305.1)
Latest published: 09 Jan 2026, 9:5 (https://doi.org/10.12688/hrbopenres.14305.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Introduction
Public and patient involvement (PPI) in research helps ensure that research has relevance for the populations that the research serves1. Research results have the potential to improve patient outcomes, develop new treatments, and prevent disease, but this potential is realised only if research results are communicated effectively to those for whom they apply2. Healthcare researchers have a duty to ensure that the findings from research are easily accessible, transparent and understandable3, so that individuals and wider communities are informed and empowered in healthcare decision-making. Trial participants have repeatedly indicated that they would like to receive the results of the trials that they were enrolled in 4–7, but evidence suggests that trial teams are under performing in this area. In a survey of trial authors (n=1818), 33% indicated that they did not plan to disseminate their results to trial participants, and only 27% had already done so8. Furthermore, in an analysis of 238 participant information leaflets from 178 trials, most (90%) included more than one proposed mode of dissemination that largely targeted healthcare professionals rather than participants9. Reasons for not sharing trial results vary and include time lapses from the point of enrolment to when results become available and a lack of incentive and expectations to do so8. Nonetheless, sharing trial results, it has been argued, is not only an ethical mandate of researchers10, but also shows respect for participants, without whom trial conduct would not be possible3.
Guiding principles related to sharing results with trial participants have been proposed, including proactively offering the results to all trial participants, irrespective of what the results show, and managing participant expectations around when the results will become available3, yet little is known about the most appropriate methods for doing so. Exploratory studies have suggested some promising approaches, for example, a summary leaflet that contains more than generic information11, a leaflet supported with graphs to present findings12, and timely dissemination13. Updating the search used in a previous scoping review of studies on any aspects of disseminating trial results to participants14, identified three randomised studies that evaluated the effectiveness of different methods for sharing trial results with trial participants (Table 1). An additional cross-over trial was identified, albeit in the context of sharing national survey results15. In this cross-over trial, 1236 respondents to a national survey of household units during COVID-19 received a scientific summary of survey results, a lay summary which avoided or explained technical terminology, and a summary with comic illustrations. The results revealed a preference for the comic format (n=716, 57.9%), followed by lay summary (n=321, 26.0%), and scientific summary (n=199, 16.1%). Understanding and enjoyment were also higher with comic and lay summary formats, although no differences between comic and lay summary in understanding and satisfaction were identified. The apparent limited research on methods for disseminating trial results to trial participants specifically highlights the need to expand the methodological evidence base for this essential trial process.
Table 1. Randomised studies evaluating the effectiveness of methods for disseminating trial results to trial participants.
| Reference | Aim | Study design | Location | Intervention | Control | Outcomes | Results |
|---|---|---|---|---|---|---|---|
| South 20216 | To test different approaches to sharing trial results | Show RESPECT was a cluster randomised 2 by 2 by 2 factorial trial involving participants of the ICON8 ovarian cancer trial | 43 UK hospitals | Enhanced webpage (n=21) Mailed printed summary (n=22) Invitation to join an email list (n=22) | Basic webpage (n=22) No mailed printed summary (n=21) No invitation to join an email list (n=21) | Satisfaction (primary outcome) | No difference between enhanced versus basic webpages (p=0.235) or email list invitation (p=0.327) Mailed printed summary led to an improvement in satisfaction (p>0.001). |
| Racine 201910 | To investigate methods of disseminating trial findings to participants | Randomised trial involving participants of the Thyroid Hormone Replacement for Subclinical Hypothyroidism (TRUST) trial | Irish TRUST trial sites | PPI group assisted in developing and refining the content of a patient-based results letter (n=38) | Standard results letter (press release) (n=31) | Understanding | 50% of the intervention group and 58% of the control group correctly understood the results of the trial (p=0.504). |
| Mancini 201019 | To assess patients’ uptake and understanding of the results of the trial in which they have participated, and the impact of a letter offering patients the possibility of consulting the trial results on a specific website. | Randomised trial involving women who took part in the FNCLCC-PACS04 cancer trial | 21 specialised centres across France | The Internet group (n=55) received a letter stating that the trial results were available on a password-protected website | The Control group (n=60) received no letter about where results were available | Preference Declared uptake of trial results Understanding | Preference: The internet was described as ‘perfectly suitable’ more often by the Internet Group (43.5% vs 17.6%, p= 0.006). Uptake: Internet group versus Control group (47.1% vs 33.9%; P=0.166) Understanding: Internet versus Control group (18.8% vs 5.6%; P=0.039) |
Aim
To evaluate two methods for sharing trial results with participants of the PREterm birth Prevention with Oral Probiotics (PRE POP) trial through a randomised Study Within A Trial (SWAT).
Methods
The SWAT is registered with the SWAT Repository (https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWATStore/) (ID: SWAT254). Reporting the protocol adheres to the SPIRIT checklist16. The completed checklist is available via the project page on the Open Science Framework (OSF) platform (https://doi.org/10.17605/OSF.IO/S2CKT).
Table 2 summarises the SWAT participants, intervention, control and outcomes (PICO), with expanded details provided below.
Table 2. SWAT PICO.
PRE POP host trial
The host trial is a single-centre, double-blinded (investigator and participant), placebo-controlled randomised trial focused on the prevention of preterm birth17. The trial is registered with the International Clinical Trials Registry (ID: ISRCTN11963471; https://www.isrctn.com/ISRCTN11963471). The sample size for PRE POP is 150 women (75 per treatment group) allowing for 20% attrition during the trial. Consenting Women, who provide written consent to take part in the trial and are assigned to the intervention group take daily oral probiotic supplementation from enrolment to 1 month after birth. Women assigned to the control group take daily oral placebo containing no probiotic. PRE POP outcome measures include the presence of microbes and the characterisation of participant’s vaginal microbiome and gestational age at birth. Study tests (e.g., swabs) and follow-up questionnaires are completed at 12-week intervals during pregnancy, at birth, and 1 month postpartum. Recruitment to the trial began in 2021 and ceased in 2024, with follow-up data collection and analyses continuing through 2025. For this SWAT, the results for PRE POP’s clinical outcome data (e.g., numbers with preterm birth, mean gestational age at birth, etc.,) constitute the SWAT’s results data. These outcomes are chosen as preterm birth prevention was identified as the greatest priority for women within preterm birth research outcomes18.
SWAT design and participants
The SWAT will be a randomised trial with 1:1 participant allocation. Participants of PRE POP, other than those who experienced a perinatal death during PRE POP or a baby who was seriously unwell at birth (as identified by PRE POP investigators), are eligible to take part in the SWAT. Eligible participants will be randomly allocated to the SWAT intervention or control group using computer-generated block randomisation, with block sizes of four and six, subsequently applied to a randomly established list of eligible SWAT participants based on host trial study IDs and stratified by host trial intervention and control group. The SWAT hypothesis will be blinded to SWAT participants and group allocation will be blinded to the SWAT research team including the data analyser. Due to the nature of the intervention, SWAT allocation will be unblinded to a member of the PRE POP research team (gatekeeper) who will distribute the SWAT materials to the participants of PRE POP.
SWAT intervention
The SWAT intervention will be a pictorial enhanced mailed written summary complemented by an animated audiovisual video of the host trial results. The mailed summary format was chosen after considering the findings of previous work which reported that i) receiving trial results by the internet was less preferred than a mailed letter19, ii) satisfaction rates were greater when a mailed printed summary compared to no mailed printed summary was used6, and iii) pictorial information improves comprehension compared to standard written information alone19. The supplementary audiovisual was added following Public and Patient Involvement (PPI) input to offer this format as an adjunct to the intervention. Although not designed to address sensory impairment specifically, the combined format will cater for three of the four key learning styles (Audio, Visual, Read/Write), acknowledging that people absorb information in different ways. The URL link to the audiovisual will be included in the mailed written summary. In this way, we will be able to ascertain how many SWAT intervention participants access this method and whether they considered it a useful adjunct, especially as developing audiovisuals have cost resource implications. The layout and stylistic aspects of the intervention will be informed by guidance20 and co-created with PPI contributors during a half-day workshop.
SWAT control
The SWAT control will be a standard mailed standard written summary report of the host trial results. The written information provided in both the intervention and control summaries will be the same and will undergo PPI review for plain language, however, the control written summary will not be enhanced with pictorial graphics, nor will it contain the URL link to the supplementary audiovisual information. As with the intervention, the layout and stylistic aspects of the control written summary will be informed by guidance18 including EU guidance on ‘Summaries of Clinical Trial Results for Laypersons’21 and co-created with PPI contributors during a half-day workshop.
SWAT outcomes and data collection
To complement previous work that compared methods for sharing trial results with trial participants6,10,19 and to allow for potential future meta-analyses of these data, the primary outcome for this SWAT is
i) Participant satisfaction with the dissemination methods, measured using a 1–5-point Likert scale from 1= very dissatisfied to 5 = very satisfied.
The secondary outcomes are:
ii) Participant satisfaction with the information provided, measured using a 1–5-point Likert scale from 1 = very dissatisfied to 5 = very satisfied.
iii) Participant perception of their understanding of the summary results provided, measured using a 1–5-point Likert scale from 1 = no understanding to 5 = full understanding.
iv) Participant rating of the usefulness of being provided with the results, measured by a 1–5-point Likert scale from 1 = not at all useful to 5 = very useful.
v) Participant rating of the importance of being provided with the results, measured by a 1–5-point Likert scale from 1 = not at all important to 5 = very important.
vi) Participants will be asked if they were glad to receive the results (Yes/No response option) with a free-text-box option to comment/expand on their response.
vii) Participants in the intervention group will also be asked if they accessed the audiovisual link (Yes/No response option).
viii) Participant preferences for how trial results should be shared with participants taking part in future maternity care trials using series of options for different dissemination methods, informed by the literature. Examples may include direct contact (verbally informed), written summary by email, by post, link to trial website, audio, audiovisual, or combinations of these. A free-text option to suggest a method not presented in the list will also be provided.
Participants will be provided with a final free-text response option inviting them to provide further comments or views on sharing trial results. The direct costs incurred by the SWAT will also be reported. Outcomes will be collected via online questionnaires using Google Forms. The link to the questionnaire will be emailed to participants one week after distribution of the SWAT intervention and comparator, with an initial two-week timeframe for return. Two email reminders, in weeks three and four from initial distribution, will be sent to non-responders. Collected data will be entered into SPSS Version 29 in preparation for analysis. Data collection to the SWAT is expected to commence in March 2026.
Data analysis
For the outcomes that use a Likert scale or a yes/no response, descriptive statistics (frequencies and proportions), will be presented. For these outcomes, the numbers of participants who indicate 4 or 5 on each scale in the intervention group, and in the control group, will then be merged and the groups, for each outcome, will be compared using odds ratios and 95% confidence intervals.
If more than 25% of the intervention participants indicate that they did not access the audiovisual information, we will conduct sub-group analyses comparing those who answered i) yes access versus no did not access in the intervention group, ii) yes accessed in the intervention group versus the control group, and iii) no did not access in the intervention group versus the control group.
The number of preferences for each item for how trial results should be shared with participants taking part in future maternity care trials will be counted and arranged in descending order to determine indicators of most often preferred to least often. This will provide a preference-based list for how the results of future maternity care trials should be shared with trial participants. Qualitative data (free-text responses) provided by participants will be analysed using content analysis to determine patterns in the data.
Ethical issues in the SWAT
Ethical approval for the host trial is granted by the Research Ethics Committee of the host trial site (EC37 2020). This includes approval (Amendment 1 March 2023) to obtain feedback from involved participants on trial processes, i.e., from trial screening processes through to trial methods, dissemination and directions for future research. The SWAT, which falls under the trial process of dissemination, will adhere to the ethical principles of autonomy, respect for person, beneficence, and maleficence. Participation will be voluntary and oral consent is implied by returning SWAT data collection forms. This approach to consent was chosen as it provides a robust method for obtaining affirmative agreement as well as adhering to the General Data Protection Regulation maintaining of participant anonymity. Participants, at the time of intervention and control distribution, will be informed that a link to access the questionnaire for feedback will be sent via email one-week after the summary results are mailed to them. Participants will be informed that they can request a hard copy by post if they prefer.
All study information will be stored in accordance with the General Data Protection Regulations (https://gdpr-info.eu/). Online submitted questionnaires will be accessible to the research lead only, and the SPSS file will be password protected on a password protected computer housed in a locked workplace office. Returned hard copy questionnaires (if any), which will be anonymous (i.e., no identifying information is collected on these), will be securely stored by the lead investigator in a locked press in a locked workplace office. Once all data have been entered into the SPSS file and cross-checked for accuracy, any hard copy data collection forms will be securely destroyed (shredded) by the lead investigator. The SPSS file will be permanently deleted by the lead investigator once the SWAT is completed and reported (published).
Although not anticipated there is a potential for participants to become upset on reading the results. Participants will be offered the opportunity to contact the PRE POP lead investigators and advice/support will be offered. Confidentiality will be maintained throughout, and results will be presented in an aggregated form only.
Public and Patient Involvement (PPI)
PPI is centrally embedded in the host trial research centre’s research on preterm birth prevention18. PPI is equally embedded in this SWAT from the outset through co-researcher involvement of a PPI contributor and University lead for PPI Ignite. PPI Ignite offers a suite of resources to support PPI in research which the SWAT team will draw on. Further PPI is planned through a half-day workshop where the intervention and control materials will be discussed and co-designed, drawing on the recommendations of the RECAP project20, as well as focusing on the concepts of content (information that should be included) and format (presentation and stylistics aspects). Three to four PPI contributors (women and/or their partners who have taken part in maternity trials previously) will be invited to attend the workshop, with members of the project team, to finalise the SWAT intervention and control materials.
Dissemination and knowledge transfer plan
The dissemination and knowledge transfer plan will use recognised knowledge exchange and implementation programmes and toolkits. The Health Services Executive ‘Knowledge Translation, Dissemination, and Impact: A Practical Guide for Researchers’22, for example, contains tools and templates to help researchers plan, share and use their research findings, and this document has already been consulted in planning the SWAT. The toolkit sets out eight key stages, within which guidance points are offered when planning knowledge translation (KT) activity.
The target audiences for this SWAT include researchers engaged in participant enrolled trial research, researchers of populations of pregnant women, national and international PPI organisations and networks, research funders, Directors of International Clinical Trial Networks, Centres and Hubs and Directors of Trial Methodology research centres and initiatives. Members of the project team will also responsibly circulate the project results to their networks and contacts of relevance. A multi-method approach to dissemination of the SWAT results will be used to ensure widespread dissemination. Current proposed methods include:
- Journal publication with an open access Journal strategically chosen for having methodological and topic-specific relevance in disseminating to the target audiences. Reporting the SWAT in a journal will adhere to the SWAT reporting guideline23.
- Presentations at research conferences (i.e., the International Clinical Trials Methodology Conference 2026), clinical symposium events (e.g., the Research and Innovation Symposium Exhibition, National Maternity Hospital, 2026) and dedicated national and international PPI platforms (e.g., PPI Ignite).
- Relevant national and international trial research methodology platforms.
We will also consider the use of social media platforms, podcasts, newsletters and research briefs, and innovation in these methods, for disseminating the results to the relevant audiences.
Conclusion
The conduct and findings of this SWAT will add to the evidence base on trial processes. The findings will be informative for those intending to share trial results with trial participants in currently ongoing or future trials. The findings will also contribute to any future systematic review that is designed to evaluate methods for disseminating trial results to trial participants.
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Smith V, Gillies K, Corbett G et al. Pictorial enhanced written plus audiovisual information versus standard written information alone for disseminating trial results to trial participants: A Study Within A Trial (SWAT) Protocol [version 1; peer review: awaiting peer review]. HRB Open Res 2026, 9:5 (https://doi.org/10.12688/hrbopenres.14305.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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