Table 1.

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

	Considerations	Additional prompts	Illustrative quotes
S	Supporting and preparing trial participants to receive results	How will you prepare participants for receiving results? • 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? • What other support is available to them to help understand and process the results?	‘I think it would be a really good idea going forward to, you know, ask patients if they want the results when consenting to the clinical trial, And, again, ask them once they’ve completed the treatment if they’d still like to receive the results.’ HLRNI03: research nurse, large site ‘I think they just wouldn’t care enough to call to opt in, whereas if they really didn’t want the results then I think they’d be more willing to call or take the time out of their day to do that.’ CLTCI04: trial coordinator, large site ‘That was the thing, I think, we were slightly concerned about was, well, what if that raises questions, which again is why we put that you know, compliments slip in… you know, do phone us if you’ve got any issues with it or queries or anything.’ DMRNI02: research nurse, medium site ‘I suppose to some extent, it’s on the research nurses because the two that I saw are really great. I get on really well with them and I don’t feel afraid to ask them any questions. But I think that’s more a personal thing really. It’s quite difficult for somebody if they can’t relate to the people they’re seeing, for whatever reason, obviously the next best option would be to have some paper to take away and read in their own time.’ DMI01: patient, medium site, close relationship to site staff ‘Particularly if sharing the results of the study reawakens emotions that were present initially, at initial diagnosis or initial treatment. Having some ability for that patient to get some additional emotional and psychosocial support is important. But also, if they have questions about the results and for whatever reason they are unable to get appropriate answers from their investigators, being able to go onto patient forums or nurse advisor lines, I think will be important for a proportion of trial participants.’ HLCLI02: oncologist, large site
HO	HOw will the communication tool(s) reach participants?	Which communication mediums are likely to be accessible to your participants? How can you make sure the results are accessible to all your participants? Where will participants receive results? • Will participants prefer to receive results at the clinic, where support may be immediately available, or in the privacy of their own homes, where they can process it in their own time?	‘I know quite a few that wouldn’t bother and don’t like things online anyway… I hate to say it but even my age group don’t like getting things on email. They like it in their hand.’ BMI02: patient, medium site, aged 71 or older ‘I think if the results had been bad (in terms of I would have had to tell them that this treatment arm is better than your treatment arm), I think how they react to that, the clinic isn’t as private as you would want. If I had to tell them to their face I don’t think it would have been as good as me just sending them something on the web page and then putting at the bottom, you know, they needed any further support or whatever they can just call me. Instead of having them be in front of everyone reacting to it, be able to read it on their own time in their own space and react how they would want to react.’ CLTCI04: trial coordinator, large site
W	Who are the trial participants?	What are the demographic characteristics of your trial participants? • What is their: age, socio-economic status, education level, health literacy, computer literacy, access to the internet? How well are your participants likely to be? • How is their health at the time of receiving results? • How was their health and experience of adverse events or side-effects during the trial? What expectations do your participants have around receiving trial results? • What did you put in your Patient Information Sheet about whether/when results would be available? • Do you need to get ethics approval for any changes to how you plan to share results? What will participants want to do with the results? • Will participants want to keep results for future reference? • Will participants want to share results with others?	‘You’ve got to look at the age group of the patient. So everybody is individual, so like, if you are looking at maybe 65 and above, they would mostly prefer written summaries. Whereas the younger group will want the website.’ BMRNI04: research nurse, medium site ‘If there really was a finding that actually, people were living longer and I’d got secondaries or something, yes, I would have liked to have been spoken to about that rather than finding out on the website.’ CLI01: patient, large site ‘I think you’d probably have to be a bit more careful in terms of sharing results with patients who were very unwell and closer to their end of life. Particularly if they’ve reached the point where they are, I suppose, have come to terms with the terminal nature of their illness. Sharing information that might bring back difficult memories at that point, might be more difficult. I think it’s probably still best practice that if we do have that information available and we’re seeing the patient, that we ask them whether they want to know about the outcome of the trial.’ HLCLI02: oncologist, large site ‘I assumed that I would never know the results, that it would be… Well first of all I thought well I’ll probably be dead anyway, but no, I didn’t think they would be available. I thought trials probably went on for much longer, and that they would wait until people died before they assessed it.’ GSI01: patient, small site ‘It’s something that I think is becoming more important. A lot of our patients are becoming more empowered. They’re wanting to seek more information. Treatment of cancer is becoming more complex, often patients will survive for longer and live with their cancer as a chronic illness. Probably there are more trial participants who are keen and interested in finding out the results of studies that they have taken part in, in the past. It is becoming a greater priority for us to engage with them in this setting.’ HLCLI02: oncologist, large site ‘It was easy to read [the printed summary] over a period of time and I could keep a copy without finding a printer.’ BMQ05: patient, medium site
RE	REsults—what do they show?	What do your trial results show? • Will it be seen as good/bad/neutral news by some/all participants? How complex are your results? • Are your trial results complex (e.g. there is important heterogeneity between sub-groups, or do different outcomes go in different directions)? Will the results have implications for the participants’ or their families’ future health or care?	‘I think, when there’s some really good results a doctor always feels that’s what they want to tell their patients. Whereas if there’s a marginal benefit, then you’re likely to not really want to say too much of the results.’ EBLMCLI02: oncologist, large and medium sites ‘If it went into my head that I was going to see more bad news about my participating group I might be less inclined to want to see a written report and just a referral to a website. Because this is almost… When you receive this [printed summary] you have to look at it whereas with the website you may think, oh, I’m not going to bother. You can ignore it more easily if you feel that your group is not going to have any more good news or better results.’ BLI01: patient, large site ‘It would depend if it raised more questions perhaps. So maybe a clinician would have been better suited I suppose, if it was going to have that effect. Maybe the clinician giving a paper and discussing it in clinic maybe better for them than obviously reading it at home on their own.’ GSTCI03: trial coordinator, small site
S	Special considerations	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 efficacy, 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 face-to-face? If face-to-face, was it in person or virtual? • Which organisation or individual was their main point of contact for the trial? • Are the staff members who were their main point of contact still working on the trial? • Does the communication need to be personalised to respect the relationship between site staff and participants? How many participants do sites have? • Will sites with large numbers of participants have sufficient resources to share results individually? Or must other communication approaches be considered?	‘I think they should do them face to face really. I don’t know if that’s… I mean, the thing is, you build up a relationship with your trial nurses because we see them quite regularly or every time we go for a hospital appointment. So, I think it would be really nice if they presented that themselves, obviously backed up with information. I think because you’re feeling vulnerable anyway and I think if you’ve already built up a relationship with people, then it’s easier to talk to them.’ DMI01: patient, medium site, close relationship with site staff ‘The only problem with our site is we recruit so many patients onto our trials, it would be extremely time consuming. Now whether we could, you know, whether the Sponsors could send something out directly to the patients themselves, you know, with an option to receive the results or not. That would probably be a better option, you know, I don’t know. Again, it’s just the volume of patients that we’ve got on trial here. So, it’s a, you know, it’s a lot of information to send out to people, you know, when we’ve got so many patients on trial.’ HLRNI03: research nurse, large site ‘I don’t know, because we are a smaller centre and our numbers don’t tend to be like a big teaching hospital, we have that more personal approach, so we know our patients very well, we know the families very well, so it makes it easier for us in that respect. I’m not saying, if it was a teaching hospital you could follow the same principles, but here, we generally have that closeness.’ CSRNI01: research nurse, small site
E	Expertise and resources—what expertise and resources do you have access to for sharing results?	What budget do you have for sharing results with participants? • Have you budgeted for costs such as printing and postage, filmmaking and web development? What expertise around developing patient-facing communications tools do you have? • Do you have access to expertise on this within the team, through partners or paying for specialist support? Is this activity seen as a priority for CTU and/or sponsor staff? • Is sharing results with participants incorporated in CTU Standard Operating Procedures and trial protocols? (If not, can it be?) Has sharing results been included in agreements with sites? • Do sites know this is a trial activity they are expected to do (if you are planning for the results to be shared by site staff)?	AMRNI05: ‘If it’s a public post then it can be a bit of an issue for us if postage isn’t supplied because budgets are tight.’ IV: Is there reluctance in your hospital to cover that sort of cost? AMRNI05: ‘Yes. Budgets are very tight.’ (Research nurse, medium site) ‘Although the majority of sites would actively engage, there may be some sites who feel that it’s an optional extra. And they don’t have the staffing, and the information then doesn’t get out to the participants who would actually like to have that information.’ HLCLI02: oncologist, large site
C	Communication tools—which ones will you use?	What will participants want to know? • Can participants who want different levels of information/detail find out what they want to (providing layered information)? 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? • Do you have the experience in design, numeracy and imagery? • Do you have the skills to do this in-house? • Do you have good templates to base it on? • Do you have the budget to pay for a designer? Can you give participants a choice of information products? • Is it feasible for you to provide more than one way for participants to access the results? Which communication tools will you use for sharing results?	‘I like that all of them let you know that if you do need further information, there are plenty of ways of obtaining it. And it’s easy to actually get to the stuff. Sometimes it’s a nightmare for when you go online and you’re trying to find something, you can be half an hour searching your way around trying to get to it. But this is easy to get to everything. Support lines, you can’t ask for more than that, can you really? Loads of different support lines and things you can have another look at.’ BMI01: patient, medium site ‘The rest of it to me as a member of the public, I can’t do anything with that information; it’s not useful to me. But I would have been interested in as you say a headline result.’ BLI01: patient, large site ‘I think the first, I’m not quite sure of the necessity to put all, I don’t know what it means even, under number 1. Study name, it’s quite professionally written from a lay point of view. And all those numbers and letters, goodness knows what that means. ISRCTN:103… You know, for a lay point of view and even from my point of view, I suppose I’m somewhere in between being lay and not lay, it’s gobbledygook really.’ DLI01: patient, large site, retired nurse ‘It’s easy, in little chunks, because if I see messy, great big pieces I don’t really want to be bothered, but if it’s in nice chunks like this, that’s how I like it.’ BMI01: patient, medium site ‘I quite like the fact that it is slightly a larger font size, and I know that my husband would find it easier to read something like this than something with a smaller font.’ CSI01: patient, small site ‘I really like this [Printed Summary]. I think it’s the layout as well … Visually, you can engage someone that’s got an attention span of a two-year-old like me. You can immediately engage someone because of the way something is laid out; they’re more likely to want to read it anyway.’ GMTCI02: trial coordinator, medium site ‘I think it is good to offer variety because different things will suit sort of different people.’ DMRNI02: research nurse, medium site
T	Timing—when should results be communicated?	How urgently do results need to be shared? • Are your results likely to receive media coverage? If so, how can you make sure participants don’t first find out results via the media? • Do your results have implications for the future treatment of your participants? • Are participants still in follow-up? If so, is it feasible to integrate sharing results with routine clinic visits or do they need to reach participants sooner? How certain are you that the results/key messages will not change during the peer review process? • Are you sufficiently confident that your key messages are unlikely to change substantively, to share them with participants prior to publication?	‘If they were to find out that way via press coverage because you haven’t let them know that it’s going to be coming out in the public domain, then that might annoy certain individuals. You probably wouldn’t want to find out, like, put ITV on, the news has come out, and then all of a sudden the paparazzi are there talking about this trial. You’d probably be sitting there thinking, I could’ve done with this information earlier, couldn’t I?… Out of respect for the patient really, you should be telling them as early as possible, I can imagine.’ GMTCI02: trial coordinator, medium site ‘As long as you are confident that is what is going to be written in the journal. You are sending this information to people who participated in the study. I think it’s better to let them know as soon as you are confident about whatever has been outlined. Like, waiting for a year, they might be dead.’ BMRNI04: research nurse, medium site

Template for trial teams is available from https://osf.io/9hwmx/?view_only=1fed4585370e4f0a9d43a79d4940cf97