Table 1.

Quotations from workshop discussions to illustrate each theme

Theme	Quotations
Reinforcing the paramount importance of graft outcomes	Prevailing dread of dialysis
	Graft survival is a top ranked issue and of course acute rejection, chronic rejection and graft function, all relate to the fear of graft loss. – H1 Graft failure is the 1 that matters, graft function is a surrogate of graft survival. – H4 When someone says they’re going to give me a kidney, or have a transplant, I didn’t even think about GFRs or anything like that. P4 We don’t want to go back on dialysis again. P8 We thought that the difference between graft loss, and how high patients rated it was almost a reflection of quality of life being important because the difference in quality of life between dialysis and transplant is so great. – TTS Plenary
	Distilling the meaning of graft function
	None of it [graft loss, rejection] is good news. Some of it maybe can be dealt with a little better than others. It’s not over necessarily until it’s over. To me it’s all the same. – P2 What level of GFR change makes you worried. We haven’t really defined those in a patient focussed way in a way that actually reflects the implications of them. H6 What’s the most important, the level or the fact that it remains stable over the years. – H8 Level of the graft, that it’s normal. – P8 (reply)
	Terrifying and ambiguous terminology of rejection
	We throw the words chronic rejection around and there’s not a lot we can do. Maybe patients are hearing those messages more frequently, the futility of treatment, the lack of treatments and lack of things that you can do to intervene and there’s all this uncertainty. How many times do you hear, ‘when’s my graft going to go?’ – H1 When I have graft rejection, if it is not treated, there is no way to treat it, then my final outcome is death. – P7 I’m mystified by chronic graft rejection because that’s not an issue, I’m not sure what it is, maybe it’s conflating graft loss and graft function – H1 Our biological epidemiological understanding of chronic graft rejection is very flimsy compared to almost everything else on this list probably even compared to the patient reported measures. We believed its real but it’s very hard to come to consensus about when it’s there, its severity, and what we know now I think will be very different to what we will know in 5 years, so if I was going to combine something or downgrade something in favour of something else, that would be my choice – H5
Reflecting critical trade-offs	If you’re really interested in side effects, you cut down your doses to nothing, and your long term survival suffers. – H2 Both patients and providers felt that clinical complications of immunosuppression such as infection, cancer and cardiovascular disease were critical to include as core outcomes. – ATC plenary I have taken my immunosuppressant drugs for a long time and I have got a lot of side effects I have got a lot more considerations whether to get my 2nd transplant. - P10
Contextualizing mortality	Inevitability of death
	The doctors are more interested in death, and you really can’t stop death because we’re all eventually going to die at some point, whereas a healthy graft will prevent that day from coming for a very long time, so I don’t really know that death should even be in there because we’re all going to die eventually. – P1 For my partner his attitude is even if his 1st transplant only lasted a year, he would have had a year without dialysis, and he would have lived that long and he will say nobody expected me to live this long. He’s gained something, he sort of cheated death, so if death comes a little bit later it’s a different thing. – C1 Death is not a core issue. As long as I have the organ, I can live quite well, but if my graft is not functioning well, I have to go back to my previous life that is dialysis, but I won’t die. I won’t die because of the loss of my organ. So I would not be afraid of death, but I would be afraid of the loss of my graft and I would have to come back to dialysis. So this is a matter of quality of life. Everyone has to face death, what I would like to have is a good quality of life rather than to face death. – P11
	Preventing premature death
	As a physician what we’re trying to do is to prevent early death, before someone’s time. When we see a patient we transplanted, 3 months later the graft was functioning but the patient died of a heart attack that’s a terrible outcome and that’s what we’re trying to prevent. – H1 As a doctor we have a kind of inherent problem with death. We try to fight death. We are trained to put back life. – H1 There is a slightly unique aspect about the kidney transplant and that is if someone dies be it cardiovascular even immediately after transplant, that’s a kidney that could have gone to somebody else, so it’s not just the patient, we’re also protecting the kidney. – H1 Patients may looking at it in terms of I’m an older individual, if I live 5 years, I’m doing really quite well whereas if I’m 25 and I live 5 years, that’s a poor outcome. It’s not sophisticated enough really as a single endpoint. – H10
	Ensuring safety and quality
	Death is also a safety issue for us when we look at new drugs. – H1 Regulators tend to be very cognisant of safety issues but the patients and the physicians are telling us that the most important things are retaining a graft, so if there’s a drug that’s being reviewed for approval, and it has some safety issues, that needs to be balanced against the potential for that drug to prolong graft function versus some risk of death. – ATC Plenary I was a little stunned that death wasn’t at the top. As transplanters, death is very important. Any death within a year at my institution requires a formal debriefing and conversation as to what happened. H11
Imperative to capture patient-reported outcomes	Making patient priorities explicit
	If you have a functioning graft you generally have a good quality of life, that’s generally true but not always true and that would completely be glossed over, things like side effects of drugs, so, I’m sort of a bit uncomfortable with saying oh that’s covered by graft function. – H5 The kidney patient doesn’t wake up every morning and worry about whether their graft is going to fail. They wake up worried about, annoyed that they can’t screw the lid back on the tacrolimus top after they’ve taken it because of the tremor. So really important to consider patient reported outcome measures. – ATC plenary I work at this grocery store and I’m always getting germs, pink eye, they just don’t understand the aspect of suppressed immune systems, they think it’s a joke. The social aspect of it is totally missing, they give you the kidney they say go for it, and then you gain 50 pounds because of your prednisone, your appetite comes back up and nobody ever told me, if you have a transplant, I mean I felt great but 50 pounds, 30 years later its diabetes, cataracts, and the long term side effects of all the drugs, and cataracts and crystals with the cyclosporine, so as you say quality of life,. – P5 In our country (Korea), quality of life will be 1 of the main issue to understand the success of a graft, especially if you are doing living kidney transplant, quality of life is very important for us. – H11
	External mandates
	What I get from discussions with the FDA is that it is very important to have patient-reported outcomes. How the patient feels, functions, and survives. Actually in some of the other areas like HIV, aspects such as feels, functions and survives, or medication nonadherence in some of these trials, is used to enrich the trials.– H8 So CMS in the US just released a new criteria as a part of QAPI? They’re requiring centres to look at quality of life, so they want centres to capture that and have that as a part of 1 of the metrics that they will evaluate you on so when they come and do your site visits. Transplant centres. they’re beginning to realise this as they get their QAPI surveys, there’s going to be a lot of interest in trying to figure out how do we do that so I, there will be a lot of buy in to try to figure out what that means. - H4 [In the US we have] the quality assessment program improvement, a requirement from our regulatory agencies to make sure we’re constantly assessing our transplant centres outcomes in different ways and they have very recently put a new emphasis on the patient side of things, with a focus on trying to understand how transplant patients quality of life after the transplant has it improved, are we making a difference, are we doing things like we said we should so that’s a new thing. – H4 In ANZDATA, we are interested in recording it for every patient but the problem is there’s so many ways you can record it and no one really agrees on it and most of them would not be practical to do in that many people every year but if something kind of came out of SONG-HD or PD or Transplant, this is what we recommend, we would pilot it. – H5
	Life participation
	The ability to work and quality of life are 2 different things I suppose. For me the ability to work is that I am able to work and I can find a job if I want to and I physically I have the capacity, ability to work. But quality of life is something different. I have the ability to work but that doesn’t mean that I really need to work or financially, I want to work. Because some patients want early retirement to enjoy life more. – P10 Some people work to pay bills and some people work because it’s what they want to do. It’s essential to keep people motivated by giving them something, to have a sense of purpose in their lives, whether or not they are being paid for it. – P1 You’re talking about the ability to live your life. – C1 I can only say quality of life is important and I can remember it was worse before the transplant. I couldn’t walk any distance, I couldn’t breathe, and since I’ve received a kidney, I’m now walking miles, and just as much as I could do, to live life is very important to me. – P2 I think of what he wants to do with his life which is why I ranked ability to work very high. You want to have the ability to do something, not necessarily paid work, it could be volunteer work, or family, something that makes you feel fulfilled, and then also gives you a reason for overcoming the challenges you need to overcome when you’re having a transplant. – C3 When I see my patients back on annual visits a good question just in the back of my mind, are you doing everything that you want to do. – H7 Going back to work is not my utmost priority, my priority is to enjoy life. – P10 Maybe it’s as simple as asking patients whether, how well they are able to participate in the life that they want to lead because it’s going to be different for different people. – H9
Specificity to transplantation	I’ve got a bit of a problem with an outcome of transplantation that you can treat with antidepressants. – H4 I wasn’t sure whether people were ranking by some combination of seriousness and attributable risk or both. For example skin cancer, I don’t think of it as a likely sequelae of organ transplantation if it were common then I would be inclined to rate if very seriously. I wondered the extreme for example, if shark attack was on there, it would clearly be devastating but not because you’re at an increased risk. – H5
Feasibility and pragmatism	Achievability of long-term impacts
	We’re seeing an increase in trying to get better grafts and get better initial functioning in the hope that will lead to better outcomes. If you’re going to ask the surgeon please give us cancer, cardiovascular disease 5 years out, we’re going to get a lot of papers that won’t be able to comply with what the core outcomes. I’m not saying that they’re not important, I wonder whether there should be a difference between the type of trial or the type of study and the necessity of which kind of outcomes need to go in there. – H2 Pharma was saying you don’t have an outcome in a year that we can measure, we’re not really going to invest in drug development in that field so if the goal is clinical trials, how are we going to use this to build into clinical trials? Death is very rare in the 1st year, it’s really 1%, 2%, graft loss is 2% in a year, so things like graft function is something that people are looking at within a 1 to 2 year window of measure as a way of getting sufficient differentiating that you would actually have a sample size that is feasible. – H10 In the UK, we are moving towards a situation where quite a few trials are being funded by the government so there’s no longer the necessity for them to be short term outcomes and there’s the requirement increasingly for the trials to be linked to the national registry so for example, death, cancer rates, can be followed for 5 to 10 years in a cohort that had been intervened or randomised in 1 way. We need to change the focus on how we think about trials, away from short term 6 months, 12 month outcomes, to something we are building, which has a large population that we have enrolled and we have got 5–10 year follow up but it means it takes a long time to answer the question and obviously things change over time, but certainly that’s the way that the national institute of funding is working now so 1 of the issues is not just about the outcome you measure but the duration of time of the trial and how you might measure those outcomes, instead of the traditional way of having just a CRF or eCRF and it might be that you pool the data from different registries. We have the advantages as in Canada we have a national database of everything so you can pool it and link 1 thing to another, but I think there should, that should be 1 way of going. – H10 Belatacept can be an example where they had to go out to 5 years, follow up and continued follow up in order to get to a result that is looking interesting to people so therefore industry will fund longer term studies if that’s the way they’re going to get their product marketed so therefore we should be trying to encourage industry not to just fund things just for 3, 6 to 12 months, we should, maybe partnership with NIH in the States, or NIHR in the UK for example, would mean that you could persuade them to fund things for longer and get longer term outcome measures as well. – H10
	Responsiveness to interventions
	But if you’re looking at literature from the past 20 to 40 years, about 95% of the trials will be drug trials, very limited proportion of trials would be surgical trials, so those are underrepresented and in those trials we should define short term outcomes like delayed graft function, function of the kidney, needing dialysis within the hospital stay, technical graft failures, and much less about what is kidney function a few years down the road because as a surgeon we don’t have that, we can’t wait that long to decide on whether a technique is correct or not. I do not doubt the importance of outcomes that are here they are all important in any study, probably should in an ideal world probably be reporting all of them and follow patients for 10 years and then decide whether or not. In reality the time isn’t there so may main question is if there is a ranking order, should all of these core outcomes be a necessity or should it be, a necessity to report the top 3 or the top 4, I don’t know. – H2 Skin cancer in a preservation of organs study is not going to be meaningful. – H6
Recognizing gradients of severity	Infection is rated high but can they define infections because a urinary tract infection is 1 problem, but, devastating CMV is another. – H7 Disease caused by viruses, bacteria, parasites, it’s a very wide definition. – H7 If you’ve got a colon cancer, that’s a bigger deal than skin cancer. – H11

H, health professional, P, patient, C, caregivers, number indicated is Group ID (1 – 6 Boston, 7–11 Hong Kong), plenary, quotation was from the full group discussion at the respective workshop