The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff

Background Sharing trial results with participants is a moral imperative, but too often does not happen in appropriate ways. Methods We carried out semi-structured interviews with patients (n = 13) and site staff (n = 11), and surveyed 180 patients and 68 site staff who were part of the Show RESPECT study, which tested approaches to sharing results with participants in the context of the ICON8 ovarian cancer trial (ISRCTN10356387). Qualitative and free-text data were analysed thematically, and findings used to develop the SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants. This paper presents the framework, with illustrations drawn from the Show RESPECT study. Results Our adaptable ‘SHOW RESPECT’ framework covers (1) Supporting and preparing trial participants to receive results, (2) HOw will the results reach participants?, (3) Who are the trial participants?, (4) REsults—what do they show?, (5) Special considerations, (6) Provider—who will share results with participants?, (7) Expertise and resources, (8) Communication tools and (9) Timing of sharing results. While the data upon which the framework is based come from a single trial, many of our findings are corroborated by findings from other studies in this area, supporting the transferability of our framework to trials beyond the UK ovarian cancer setting in which our work took place. Conclusions This adaptable ‘SHOW RESPECT’ framework can guide researchers as they plan how to share aggregate trial results with participants. While our data are drawn from a single trial context, the findings from Show RESPECT illustrate how approaches to communication in a specific trial can influence patient and staff experiences of feedback of trial results. The framework generated from these findings can be adapted to fit different trial contexts and used by other researchers to plan the sharing of results with their own participants. Trial registration ISRCTN96189403. Registered on February 26, 2019. Show RESPECT was supported by the Medical Research Council (MC_UU_12023/24 and MC_UU_00004/08) and the NIHR CRN. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-024-08291-7.


Background
Late-phase randomised controlled trials often require hundreds or thousands of participants to detect meaningful differences in outcomes.In order to successfully answer their research questions, trialists must recruit volunteers to take part, often asking participants to accept risk and/or inconvenience, with the aim of improving treatment, care, or prevention of disease for future patients.
Sharing results with trial participants is an ethical imperative (1) and is recommended by authorities that govern the conduct of clinical trials.The World Medical Association's Declaration of Helsinki, which outlines the principles for ethical conduct of medical research involving human participants, states that "all medical research subjects should be given the option of being informed about the general outcome and results of the study" (2).In the UK, the Health Research Authority (HRA) recently published guidance saying that participants have the right to know the ndings of research in which they have taken part, and that sharing results directly with participants can help "build trust, show respect and helps participants feel valued" (3).
There is evidence from a broad array of studies that most participants want to be offered the opportunity to receive trial results, ranging from 88-98% in studies conducted across a range of diseases (cancers, idiopathic scoliosis, internal derangement of the knee, HIV) and geographical settings (including USA, UK, Canada and Uganda) (4)(5)(6)(7)(8).
Despite the moral obligation and clear demand from most participants to receive results, in practice, sharing results often does not happen, or is not done well.The UK HRA research transparency report in 2021 states that "90% of clinical trials have not told participants about ndings" (9).A survey conducted in 2016 of authors of clinical trial results papers published in 2014-15 found that only 27% of respondents reported disseminating results to participants, with only a further 13% planning to do so (10).Even when it does happen, it may not be done in a way that participants can understand.The survey found that 40% of authors who had shared results with participants had shared academic publications, which are not written in a way that is easy for participants to understand (10).Previous studies have reported that many participants struggle to understand trial results which are shared with them.For example, a study within the context of a breast cancer trial found that only 56% of participants said the results letter was easy to understand (11), and a survey of cancer trial participants found fewer than half reported fully understanding the results (7).
Sharing results with participants is a complex issue, with trialists facing considerable challenges including practical (10,(12)(13)(14)(15)(16)(17) and resource barriers (10, 12-15, 18, 19) and concerns about the emotional impact of sharing results (4,7,11,12,14,(19)(20)(21)(22).It is important that it is done well, as there is potential for harm (13,(23)(24)(25).Little work has been done to compare approaches to sharing results with participants.Show RESPECT assessed approaches to sharing results in a cluster randomised factorial trial, comparing an enhanced versus basic webpage; mailed printed summary versus no printed summary; and email list invitation versus no email list invitation, within the context of an ovarian cancer trial (ICON8)(26).A major nding was that the mailed printed summary signi cantly improved patient satisfaction with how results were shared compared to a webpage with or without an email list invitation, without the printed summary(26).It also showed that these approaches were feasible for site staff to implement (27).However, Show RESPECT was carried out within only a single trial, in a particular clinical and geographical setting, with a particular set of results to communicate, so the generalisability of these results is unclear.It is likely that there is no one-size-ts-all approach to sharing results, so it is important that trial teams draw on guidance that offers a sound structure that can be adapted to t the speci c context and requirements of their own trial and trial participants.This paper presents an adaptable framework of factors for trialists to consider when planning how to share results with trial participants, based on and illustrated with qualitative insights from data collected from site staff and patients who took part in the Show RESPECT study.

Methods
Show RESPECT was a mixed methods study, comprised of a factorial cluster randomised controlled trial within a trial to assess multiple approaches to communicating trial results, and an embedded explanatory qualitative study.The full protocol for the study is available online(28).Show RESPECT took place within the ICON8 trial.Results from Show RESPECT with regard to participant satisfaction with how the results were shared, and the resources required from sites and the clinical trials unit (CTU) to implement these approaches, have been reported previously(26, 27) and the qualitative results reported in this paper have been published as part of a doctoral thesis (29).This paper reports qualitative results from data collected from trial participants and site staff who had been involved in sharing or receiving results.The Standards for Reporting Qualitative Research checklist for this paper can be found in Additional File 1.

Patient and public involvement
Patient and public involvement (PPI) was integral to the design and conduct of this study, including through discussion groups, a PPI survey, patient representation on the study steering group, and input from patient groups and individuals on the design and content of the interventions, and interpretation of the results.

Context of the ICON8 trial
The ICON8 trial is a phase III non-blinded randomised controlled trial looking at which chemotherapy schedule should be used for women with ovarian cancer (ISRCTN10356387).ICON8 compared threeweekly chemotherapy cycles (the current standard of care), to two different weekly schedules, with either both drugs being given weekly, or paclitaxel given weekly and carboplatin being given once every three weeks.Results from one of the co-primary endpoints, progression-free survival, were published in 2019, showing no difference in progression-free survival between the three arms (30).

Qualitative data collection
The main source of qualitative data for Show RESPECT was semi-structured interviews with ICON8 patients and site staff who had been involved in sharing the ICON8 results with patients.Interviews were conducted either by telephone or face-to-face, in the participant's own home or, for site staff, at the workplace where they conducted the trial.The mode of interview (telephone or face-to-face) was discussed on a telephone call prior to the interview, where time and date of the interview was also arranged, and questions about the study were answered.Interviews were guided by topic guides that were adapted as the study progressed to explore issues that emerged (for example, questions on sharing results with families of deceased participants were added to the topic guides based on issues that were raised by participants in early interviews).Interviews were audio recorded and transcribed.
In addition to the qualitative interviews, qualitative data were collected by free-text questions on the questionnaires that were completed by patients (after receiving results) and site staff (immediately after sharing results, and 2-3 months later).The questionnaires collected data on the views of participants and site staff on how the trial results were shared, including participant satisfaction and comprehension, and site staff views on feasibility, resources required, and acceptability.The free text questions were related to the quantitative questions, allowing the participants to explain why they had selected a certain response option, or raise issues that may be important to them.The topic guide, questionnaires, details of how these were administered, and researcher characteristics and re exivity can be found in our previous publications (26,27,29,31).

Sampling and participants
We used a purposive sampling approach for the semi-structured interviews with both participants and site staff, allowing us to collect data from respondents with a range of characteristics that may be related to their experiences and views on sharing results.For ICON8 patients, this included age, education level, frequency of internet use and reported satisfaction with how the ICON8 results were shared, while for site staff this included their role, number of ICON8 patients at the hospital at which they work.For both groups, we included which interventions their hospital had been randomised to.Invitations to take part in interviews were sent out to ICON8 participants with the Show RESPECT questionnaire, with patients asked to complete a contact details form if they wanted to nd out more about the interviews and to return it alongside their questionnaire.Invitations to site staff were sent by email.Respondents who expressed interest in the interviews and lled one or more gaps in the sampling frame were contacted by telephone with more information about the study.If they were willing to take part, a time and date was arranged for the interview.Interviews were carried out until all the gaps in the sampling frame were lled, or until no more volunteers were available who would ll a gap in the sampling frame.Using the Information Power model (32) to assess the necessary sample size, the study aim was reasonably narrow, focusing on just one aspect of trial experience (receiving or sharing results), although interviews did explore several approaches to results communication.The sample speci city was dense, with all interviewees having highly relevant experiences.As described in the analysis section below, an established model was applied during the analysis.The quality of dialogue in most interviews was strong, with good rapport established between interviewer and interviewee, resulting in a rich dataset.The analysis strategy was cross-case, examining data from different participants for common patterns and ideas.Taken together, these factors suggested that a moderate sample size would provide su cient information power to meet the study aims.

Qualitative analysis
We used a re exive thematic analysis approach (33), with a critical realist stance (taking the ontological position that an external reality exists that is independent of our beliefs and understanding, but that our knowledge of that external reality is in uenced by our historical, social and cultural situation (34)), to analyse the data.The rst stage was familiarization with the data, which included reading the transcripts while listening to the audio recordings of the interviews.AS coded transcripts using a combination of inductive codes (creating labels for sections of data that evoke important features of the data that might be relevant to the research question (35)) and deductive codes (labels applied to sections of data based on a priori concepts in the topic guide and research questions), within the software Atlas.tiversion 8.4.Sections of the data were given as many codes as were appropriate to cover the content of the section.Initial codes were then grouped into potential themes and sub-themes, which were discussed with staff from the ICON8 and Show RESPECT trial management teams.At this stage, we identi ed that the Information Seeking and Communication Model (ISCM)(36, 37) tted the data well as a framework for high-level categorisation and conceptualization, so we mapped our potential themes, sub-themes and codes using concepts from the model.The model covers the perspective of both the Information User (trial participants) and Information Provider (site staff), incorporating: Once coding of all the interview transcripts was complete, we then coded the free-text responses from the questionnaires using the same coding scheme as the interview data, with additional codes added where necessary.As analysis progressed, we re ned codes, themes, and sub-themes, creating network diagrams to explore linkages between codes within each candidate theme and sub-theme.AS read and compared quotations linked to all the codes within the network to check for consistency of meaning for each code and created links between related codes (such as one code being associated with another, being an example of something described by another, higher-level code, or being the opposite of or contradicting another code).Where a theme or sub-theme included data from both site staff and patients, we looked at the quotations by type of respondent, to see how their perspectives compared.
Participant checking (returning data or results to participants for checking) did not take place, but a patient and public involvement discussion group and discussion groups with site staff were held to re ect on the preliminary ndings and interpretation.

Developing the framework
Based on our ndings around the factors that in uenced the experience of patients and site staff around receiving/sharing trial results, and discussions of those ndings and their implications with key stakeholders (including trialists, site staff, trial participants, research funders and others) we developed an adaptable framework of factors that we believe trial teams should consider when planning how to share results with trial participants.Additional File 2 shows how the framework items relate to the qualitative themes, sub-themes, and high-level codes from Show RESPECT.• What did your Patient Information Sheet say about how and when results will be shared?
• How will you inform participants that the results are available?
Will you use an opt-in or opt-out approach?
• Are most of your participants likely to want to know the results (if so, an opt-out approach may be best)?
• How and when will you give participants the choice of whether to receive results?
How will you provide support to patients who have additional questions or concerns about the results?
• Are participants still in follow-up?Can they still access support from their research nurse/doctor?Have things happened over the course of the trial that need to be taken into account?For example: • Were there changes to the trial over the course of the trial that need to be explained?
• Are there results from other trials that need to be taken into account when communicating the results of this trial?
• Has the trial closed early for e cacy, for safety or for accrual issues?
• Has the trial received negative publicity?"I was [surprised] actually because I thought that the reason this was being done was because the Japanese women had found it easier and had found it better to have a more gentle approach.And I saw from this that it wasn't only the UK, there were other hospitals throughout the world, so it might be something to do with the Japanese diet or their way of life, their whatever, it could be a lot of environmental factors.So, yes, it did surprise me."CLI01 -patient, large site P Provider -who will provide the results to participants?
How close are relationships between site staff and participants likely to be?
• How long were participants in the trial for?
• Was follow-up done faceto-face?If face-to-face, was it in person or virtual?
• Which organisation or individual was their main What language will your participants understand?
• In what languages was the Patient Information Sheet available?
• Do you know how to write in plain language?
• How will you get feedback from PPI contributors about your draft results summaries?
How will you make your information product accessible, welcoming, and easy to follow and use?Consideration needs to be given to supporting and preparing participants to receive trial results.This includes what participants are told when they join the trial, and immediately before receiving the trial results.It also includes how participants will be able to access support around dealing with the emotional aspects of processing the trial results, and nding answers to questions they have about the results and their implications.Patients in ICON8 differed in the extent to which they felt comfortable asking site staff for more information or clari cation, and their con dence in searching for health information from other sources, such as online.Some patients were part of local support groups for people with cancer, whereas others felt they received su cient support from family and friends.Still other patients were neither linked to support groups, nor had family or friends they could talk to about their cancer.In this context, both patients and site staff felt that links to further information and support might be useful for some patients (even if not themselves), particularly those with less access to support with processing the results.
Thought also needs to be given to how the communication tool(s) will reach participants, and the accessibility needs of your patient population.Alongside the question of how the results will reach participants is the question of where.Receiving results in the clinic may make support and clari cation more easily available but provides less privacy and time for processing the results than patients receiving them at home.
Participant characteristics may affect the appropriateness of different communication approaches.The people taking part in the ICON8 trial were women with an average age of 67 by the time results were available.Four in ten of them used the internet and email less than daily(26).In this context, printed summaries were viewed as being easy to access for all participants (including older participants and those who are not con dent computer users).Other patient characteristics that may affect results communication include education level and health literacy.Non-written forms of communication (such as videos) may be useful for those who do not like to read.Consideration should also be given to what participants are likely to want to do with the results.Many patient interviewees kept folders with all the information they received about the ICON8 trial, to allow them to refer to it for future reference.Printed summaries of the results facilitated this, while email or webpages required printing.Printed summaries also made it easier to share results with others, such as family and friends.
The nature of the trial and its results also affects how results should be shared.ICON8 found no difference between the different chemotherapy schedules tested.In some ways, this made it easier for some patients to receive the results, as although they were disappointed that the trial did not nd an improvement in treatment of ovarian cancer, no one was allocated to an inferior arm.The approaches used to share results in Show RESPECT were felt to be appropriate in this context.If the results had been different, with a clear difference between the arms, some patients and site staff felt that there may have been a need to communicate results to people in the group that had done less well overall in a more personal way.This may be less important in trials for less severe conditions than ovarian cancer, where participants have less riding on the results.Similarly, if the results are complex, they may need personal discussion to help patients to understand.There may be special considerations of things that have happened over the course of the trial that need be taken into account when communicating results.For example, in ICON8, some patients wanted explanations on why the ICON8 results differed from those of previous similar trials in different settings.Patient and Public Involvement in the design of tools and processes is essential.
Communication of results takes place within the context of relationships that have developed over the course of the trial between patients and site staff.Participants in ICON8 have been in follow-up for ve to eight years, with regular clinic visits during that time.At sites where participants were seen by the same site staff each time, many developed close relationships, almost friendships.Where this was the case, site staff felt uncomfortable sharing the results without some degree of personalisation, so some added personalised cover notes, or called participants to let them know the study results were about to be disseminated.Communication of trial results should consider the strength of relationships developed between site staff and patients, for example, allowing a degree of personalisation of how the results are shared where these relationships are close.Some staff at the largest sites did not know participants so well and felt uncomfortable telephoning patients out of the blue.There may be less need for personalisation in trials with shorter follow-up, or with follow-up that does not involve face-to-face visits with consistent staff over time, or when results come from staff other than those who had developed relationships with participants.
When considering the expertise and resources needed for sharing results with participants, thought needs to be given to the skills, staff time, and budget needed for the development of the information product (e.g.writing the content in plain language, patient and public involvement, scienti c review to ensure the summary is accurate, and technical skills required for the chosen communications tools); distribution of the results (e.g.site staff time for posting information, costs of distribution [e.g.printing, postage]) and supporting participants and dealing with queries.Our previous report describes the resources required from sites and the clinical trials unit for sharing the results in the ways tested in Show RESPECT (27).Budget or staff time limitations may rule out certain approaches to sharing results, if they have not been included as part of the initial budget for and funding of the trial.
Choice of communication tools will be in uenced by the factors described above.Patient and public involvement is important in helping to make these decisions.In addition to deciding what type of communication tool(s) to use, consideration needs to be given to the content of that tool.It should include the language(s) used and the appropriate reading level for the target audience (if a written tool is used).It should also include consideration of how to make the information attractive and easy to use (which may require input from design specialists).It may be appropriate to offer participants a choice of communication tools, possibly with different levels and forms of information.
The nal factor for consideration is timing -when should the results be communicated to participants?
This will depend on the point at which the research team are con dent that the messages for participants are unlikely to change, and whether (and when) the results are likely to receive media or social media attention, to avoid participants nding out the results from others before hearing from the trial team.It should take into account when results will be released to other audiences (e.g. via conferences, peer-reviewed publications and public trial databases and registries), and associated embargoes and deadlines (such as the European Medicines Authority requirement to post a summary of results within a certain time period from the end of the trial).
Practical examples of the application of the framework to two very different trials can be found in Additional File 4: the ICON8 ovarian cancer trial in which Show RESPECT was conducted, and the CHAPAS-4 (ISRCTN 22964075) paediatric HIV treatment trial, which was conducted in Uganda, Zambia, and Zimbabwe.

Summary of key ndings
We propose several considerations when planning how to share results with participants in clinical trials.This includes how participants will be prepared and supported when receiving results and how the communication tool(s) will reach participants.Participant-related factors, such as demographics, education-levels, and computer literacy, alongside their health and expectations around receiving results, must also be considered.The trial results themselves (whether they will be considered as good, bad, or neutral news by some or all participants, and their complexity) also need to be taken into account.Trials with more complex or potentially upsetting results (e.g.where the participants allocated to an arm did less well than participants allocated to other arms, or where one sub-group did less well than others) may need to offer participants additional support, for example through sharing results face-to-face or in individual video calls, or offering follow-up appointments or phone calls with doctors or research nurses if results are shared via written summaries.Trial results communication must also consider whether participants have developed relationships with site staff over the course of their participation, and how and from whom they are used to receiving communication about the trial.It may be appropriate to re ect this in some way, for example through allowing personalisation or one-to-one communication.The expertise and resources available to trial teams to communicate trial results is an important factor when deciding how this is done.Any communication tools used must re ect what the participants are likely to want to know and be understandable (using appropriate language(s) and reading levels) and accessible to the intended audience.It may be appropriate to provide a choice of tools, as different participants are likely to have different preferences and needs.The timing of when results are shared also needs to be carefully considered, avoiding participants nding out results from other sources prior to being informed by the trial team, if possible.Considering these factors, and involving patients and the public, can help develop communication tools and processes that are appropriate to the trial context, population, and messages.

Strengths of this study
A key strength of this study is its triangulation of qualitative data from both site staff and ICON8 trial participants, giving us insight into the views of those who are responsible for sharing results, alongside those who have experienced receiving trial results.Many of the site staff who took part in Show RESPECT worked across many trials and were able to draw on their experience from other studies in addition to Show RESPECT.The qualitative data provide a rich understanding of the perspectives of ICON8 trial participants and site staff on the experience of receiving or sharing trial results.We applied an established theoretical model (the Information Seeking and Communication Model (37,39)), increasing our 'information power' (32).The Information Seeking and Communication Model was developed based on a review of existing models from the eld of Library Information Science and communication studies, and incorporates many of the insights from these models (39).It has been used empirically in research into healthcare communication, both by the original authors (37) and others (40)(41)(42).Applying it to our research helped us to ground our conclusions in the context of existing knowledge about the process of information seeking and communication.

Limitations of this study
Show RESPECT was carried out within the context of a single trial, a limitation of this study, raising questions about the transferability of the ndings to trials with different patient populations, diseases, results scenarios, and settings.We acknowledge this possibility and emphasize that in this paper we focus on exploring factors that trialists should consider when preparing to share results with participants, rather than recommending that the approach that worked best within Show RESPECT should be used in trials with very different contexts or patient populations.We further acknowledge that we were not able to take account of ethnicity of respondents, nor on factors such as socio-economic background, as these data were not collected for this study.Very few of our patient participants reported having a rst language other than English, but patient participants did report widely varying education levels.Many of our ndings align with ndings from the RECAP study (43,44) Our ndings around giving participants a choice over whether to receive the results or not reinforces previous recommendations that a two-stage approach should be used, offering results and then providing them, rather than simply distributing results to all participants (45).Choosing not to access results was, for some patients, a way of protecting themselves from potentially nding out that they missed out on the better treatment.This concept of people choosing what information to engage with or not as a protective mechanism is similar to ndings from the BRACELET study, where some bereaved parents of babies who died while participating in a trial for very high-risk neonates advised that communication from the trial should be managed in a way that would suit any parents who felt that they might be upsetting for themselves or their partner(46).
Only by providing information in a way that is understandable to the intended audience can we meet the objectives of sharing research results.Care needs to be taken when preparing results summaries, to ensure they are comprehensible for participants.Previous research has found that much written information about clinical trials exceeds the average reading age (47).The UK National Health Service Digital Service Manual style guide states that they aim for a reading age of 9-11 years old where possible(48).Arti cial Intelligence can be used to help researchers produce plain language summaries, but these will still require review from both investigators and patient representatives to ensure the content is correct and appropriate for the intended audience.

Further research
Further research involving participants and site staff receiving and sharing trial results in trials with different patient populations, trial characteristics, and results scenarios would be valuable for exploring the transferability of our ndings to other contexts.Research is also needed to address how demographic factors such as geographical location, socio-economic status, ethnicity, and different levels of language pro ciency in uence how results should be shared with participants.

Conclusion
To ensure that trials meet their moral obligations to participants to share trial results, trialists must consider how results should be shared with participants from the planning stage of trials, to ensure that adequate resources are budgeted for and included in agreements with sites.Relevant information about how results will be shared should be included in the Patient Information Sheet.When deciding how to share results with participants, trialists should consider the following factors: how to support and prepare participants to receive results, including whether to use an opt-in or opt-out approach and who will be available to answer participant questions; how the results will reach participants; the characteristics and expectations of participants in relation to the results; what the results show and how they are likely to be perceived by participants; special considerations; who will provide the results to participants; the expertise and resources available for sharing results; the communication tool(s) to be used; and the timing of results communication.Patient and public involvement is essential for planning how to share results with participants, identifying the outcomes and study results that are important and relevant to participants, and developing the content of results summaries to ensure they are written in a clear and sensitive manner.

Abbreviations
context in which the Information User and Information Provider are operating what the Information User does to process that information the outcomes from receiving that information.

Table 1
Char27)eristics of qualitative interviewees(26,27) Had not found out the results prior to interview Reported satisfaction with how the results were shared (from quantitative questionnaire) Very unsatis ed, quite unsatis ed or neither satis ed nor unsatis ed Quite satis ed or very satis ed

Table 1 :
Characteristics of qualitative intervieweesAdaptable framework of factors to consider when planning how to share results with trial participantsThe adaptable framework of factors trialists should consider when planning how to share results with trial participants, is shown in Table2, with illustrative quotes from the Show RESPECT data.An editable template with the adaptable framework can be found online(38).The framework covers supporting and preparing participants to receive results; how the communications tools will reach participants; who the trial participants are; what the results show; special considerations; who will provide results to participants; the expertise and resources the trial team have access to for sharing results; which

Table 2
Factors to consider when planning how to share results with trial participants, with illustrative quotes from the Show RESPECT study

Table 2 :
Factors to consider when planning how to share results with trial participants, with illustrative quotes from the Show RESPECT study "It's easy, in little chunks, because if I see messy, great big pieces I don't really Note: Template for trial teams is available from https://osf.io/9hwmx/?view_only=1fed4585370e4f0a9d43a79d4940cf97 Note: Template for trial teams is available from https://osf.io/9hwmx/?view_only=1fed4585370e4f0a9d43a79d4940cf97 , supporting the transferability of our framework to trials beyond the UK ovarian cancer setting in which our work took place.The applicability of our framework to very different trials is illustrated by the example of the CHAPAS-4 trial, shown in Additional File 4.Our results in the context of what was already knownOur adaptable framework of factors to consider when planning how to share results is similar to guidance released by the UK Health Research Authority in 2023(3), after the Show RESPECT patient results had been published.These similarities are unsurprising, given that the results of Show RESPECT helped inform this guidance, and several authors of this paper were involved in developing them.The This is a list of supplementary les associated with this preprint.Click to download.