Table 2

Selected participant quotations for each theme

ThemeQuotations
Reflecting direct patient relevance and impact
 Survival as the primary goal of dialysisSo many times we’ve done studies and mortality, it seems like it’s always negative trials. Every intervention we have doesn’t actually change the mortality in the end and so, instead of, it just, I don’t know if it’s really something that we should be looking at, at the end of the day. (Canada) 008
There is 13 to 19 per cent 1 year mortality. There are enough events that we should be able to see whether or not a technique that we say is going to have an impact on people’s survival, that it does actually do something. I do think that survival on the technique is an important metric and we must never lose sight that we may do things that will improve or change care, but we have to keep the threshold at which we’re meant to sustain people’s lives and health. So sustaining health and life. Patients should tell us what matters there, but we do need to sustain their lives as well, that’s our responsibility, so we should never shirk reporting death. (UK) 023
 Enabling well-being and functioningI would address it around the concept of rehabilitation and independence. To what extent can a human being undergoing the treatment, address him or herself to a normal life, or close to being a normal life. That’s what quality of life is. You can work, you can get married, have children, have things that people who are healthy, they should never taken them for granted, but almost expect, and are not necessarily going to happen if you’re on haemodialysis. (UK) 019
Most dialysis patients have a generally poor quality of life. And most interventions aren’t specifically geared at that outcome particularly. So would I be keen that it was reported in every trial? Not necessarily, but it is often anyway. Or is often collected, maybe not necessarily reported. (Australia) 044
 Severe consequences of comorbidities and complicationsCardiovascular disease, strokes, heart attacks, peripheral vascular disease, the dialysis patients are in hospital because of those things, that’s what limits what they can do and causes prolonged hospital stay. (USA) 012
Not only mortality but also the cardiovascular events, cerebrovascular accidents, so it’s important for the patients to stay well. It’s invalidating when you have to do an amputation because of calcification or when they are paralysed because of a cerebrovascular accident. (Belgium) 032
Unfortunately many of the symptoms they have can’t be fixed through dialysis because of their comorbidities and in fact dialysis adds to the symptom burden in many of these patients. (Australia) 051
 Indicators of treatment successVascular access, it’s always treated as a peripheral issue but that determines how well you’re dialysing, I think it’s critical. It’s a big hassle when it clots and things like that so, and it’s unattractive. I think it does contribute to quality of life negatively if you don’t have a good working access. (USA) 003
They define the therapy, define the treatment essentially. I can try and understand the treatment better by looking at these outcomes in different ways. (UK) 018
 Universal relevanceSomething that is across all cultures, because you’re talking about different kinds of patients across, some kind of outcome that all of our patients felt very important to them, even if the physicians didn’t. That would be a valuable thing to put in there. And something that could be measured with a fair degree of confidence. (USA) 005
What I would like to see is what matters to the different groups of people, and it may be the travel, and the freedom of travel, is a little nugget that you might dig out of this that you could then take back to policy makers, and patient advocates should be taking back to policy makers. (UK) 019
 Requiring stakeholder consensusIf it’s a consensus set of three outcomes that matches with the patient centred and kind of what we already capture, then I think it’s reasonable. (USA) 001
It should be evolving, periodically we should canvas patients and canvas investigators and see where the overlap is, and prioritise the ones that overlap. (USA) 003
It ensures that regardless of what intervention we’re studying, we’re going to understand how it impacts on what we perceive is important, and there’s consensus around perceiving as being important outcomes. Obviously it’s going to have the consensus around patients, providers, policy makers, thinking it’s important. The benefit of measuring it will outweigh the cost of measuring it, and I think if there’s consensus around that, then that’s going to make the case for the benefits to measure it, you know that we can standardise it reasonably across different places where it’s been measured. (Canada) 007
Amenable and responsive to interventions
 Realistic and possible to intervene onOne of those core outcomes has to do with quality of life otherwise we’re going to be back to the 1980s and 90s where we did those large trials and looked at mortality and morbidity and couldn’t show any difference, and left all the doctors wondering, are we really doing something useful? (USA) 005
You want to be able to intervene, right, so have a targeted intervention that will change that outcome. So those would be the two main things. (Canada) 008
 Differentiating between treatmentsSo depends on how aligned they are towards the intervention that you’re proposing. (USA) 005
In terms of differentiating between treatments, that’s really important. I was disappointed, so much of the frequent dialysis trials were negative because there wasn’t really either the sufficient separation between the types of treatment or sufficient length of time on treatment, but also the outcomes didn’t really talk to those two different groups in quite the right way. (UK) 026
Reflective of economic burden on healthcare
We consume a ton of resources with vascular access, if we’re smart about who we put them in and can minimise resource consumption, that’s an important goal. (Canada)
The third thing is about expense, how much it’s costing the taxpayer. (UK) 022
It will get more important in the next years as a cost to improve dialysis therapies with the growing amount of patients with more and more costs and more comorbidities, it could also be a very important point to improve that. (Germany) 037
Feasibility of implementation
 Clarity and consistency in definitionWe always think our definition is the best as a researcher. It probably will be difficult to sell to everyone to use just this definition or this standardised outcome, but as long as you use some standardised definitions, and then if you really felt strongly about your own definition that you wanted to use, you can test that too. But it would be really nice to actually have some kind of consistency. At least if we could agree on certain areas, certain outcomes that we could define. (Canada) 008
Fatigue and energy, the problem is, how do you define that, and make sure that definition holds true across all studies and centres? That’s the problem. It’ a combination of outcomes that are important, but also ones that can be defined tightly enough to be meaningful. (UK) 012
At a high level it’s very easy to discuss these things, at a more detailed level it starts to become complicated. Cardiology have been quite good at this much more than cancer have, we need to get more like cardiology trials. They describe something that means something to doctors, professionals, and in the same domain, means something impactful but different to patients. Ideally you need to have something that actually makes sense to patients that makes sense to the public. (UK) 026
 Easily measurableThe challenges will depend on, to some extent, how difficult is it to measure those elements, if the measurement is very hard, it’s going to be more challenging and costly to capture, so, that’s probably going to be the biggest downside, is can you efficiently measure those things in studies? (Canada) 007
Well maybe what the patient’s telling you fatigue/energy is a quite—it’s—also a soft but a relevant end point—how would you measure that energy/fatigue? (Austria) 059
 Requiring minimal resourcesBut if for some reason you don’t have the budget or the time or the resources to do it, I don’t think we should put a black mark on that trial and say, oh that trials not as good as it should be, it doesn’t meet our standards and so there’s going to be some editorial boards that don’t publish a really good study. I doubt that’s going to happen but it’s something that can get out of control here. (USA) 003
If the measurement is very hard, it’s going to be more challenging and costly to capture, so, that’s probably going to be the biggest downside, is can you efficiently measure those things in studies? (Canada) 007
 Creating a culture shiftIt’s a great push, to create a culture is key. You want a real genuine interest in this type of research, and I think you foster that by funding this kind of research, easily done. The next thing you know there’s going to be a plethora of researchers interested in patient centred outcomes if you actually fund it. (USA) 003
It makes sense if this is coordinated with the funding. If there is a call to develop tools to measure the functional independence in dialysis, so if it leads to that for the researchers, it is important. And then I would say that that is used once, validated, and it becomes important for the patients. Because you might understand what kind of interventions can make the functional independence better, maintain better over time. (Canada) 009
It almost requires a shift in mindset of clinicians of what we’re actually trying to achieve when we dialyse people, because clinicians have just been focused on numbers and blood results. (UK) 017
 Aversion to intensifying bureaucracyYou get discouraged, it seems like there’s a bunch of regulations. I value these outcomes, I think they’re important, they’re understudied, we need to change funding mechanisms. We need a revolution, but it’s to compel researchers to include, you must have this assessment tool in your trial, I’m not a big fan of that. Eventually journals will demand it and won’t accept your paper without it, and perhaps there are some mitigating or some issues with administering that tool. I don’t want to burden that investigator. (USA) 003
To mandate things, I’m not a fan of, and you’re not going to get what the desired outcome is, they’re just going to do enough to meet whatever the requirement is, and the heart’s not into it. (USA) 003
 Allowing justifiable exceptionsA trial may not be designed to measure these, but if they still have to report their outcomes, it may not be received as well. (USA) 001
It also has to come with the proviso that, there are certain types of things that maybe we shouldn’t do in every single trial, but you should always consider in every single trial and how you capture them, like the patient experience. It may not be that those patient reported outcomes should be captured in every single one, it’s that you should capture patient reported outcomes in every single trial. That’s a philosophical stand I guess. (Canada) 010
Authoritative inducement and directive
 Endorsement for legitimacyYou must have these core outcomes and assessment tools, you can have endorsed assessment tools. (USA) 003
 Necessity of buy in from dialysis providersIf you come up with a bunch of core outcomes that industry says we cannot deliver these, you might as well go home, they have the ability to block anything that they do not like. (USA) 005
So would it be possible that the dialysis industry would strongly object to something that the patients and the physicians really want? That would be terrible publicity for them, and ultimately, they’re all beholden to their shareholders and their boards that keep them floating. (USA) 005
 Incentivising uptakeIf you tie payment to these patient centred outcomes, in a perfect world, that would be fantastic, I would endorse it 100 per cent. But I just know there are some situations for units small enough where a couple of patients can interfere with those outcomes, and they can hurt the unit. What you can have is, keep the payments the same and instead of penalising, incentivise those units that are exemplary. (USA) 003
How would you commission for these outcomes? And that means you have to measure them. And it means you have to measure them relatively easily to be measured, and they have to be, we’re not talking about, safety is part of a quality outcome, but we’re really talking about things that are responsive as well. So diabetes is the place to look to because you could easily, and people have said we’re going to commission for these outcomes … we would commission around blindness and amputation, and renal failure and hospitalisation, and vascular utilisation. (UK) 016
I would commission for how much travel in the population have done. So I would put inducements in to support travel for people on haemodialysis, things like that. (UK) 016
Instituting patient-centredness
 Explicitly addressing patient-important outcomesThe most obvious reason to have a set of core outcomes is that we should enforce or at least try to provide care to all of our patients such that all of these core outcomes are met. I’m glad that somebody’s going to do trials about them, but more importantly, I want our patients to realise, or notice that, we are listening to what they think is important to them, and we’re tailoring our treatment to provide it appropriately. (USA) 005
We need things from trials that then translate into routine practice that people can think about when they’re seeing patients in the clinic, and help patients then target those sort of outcomes that are beneficial to them rather than beneficial on a bit of paper or a spreadsheet. (UK) 026
 Reciprocating trial participationBecause patients give us their time and effort to participate in the trial, they need to get something out of that, that is valuable to them. So that’s absolutely fantastic that somebody is coming up with a list of core group of values or outcomes that will come out of a trial. (USA) 005
 Improving comparability of interventions for decision-makingSo we can all speak the same language, so that when we’re going to do a study, we can actually know, it’s better to compare the different studies and their findings then, right, because half the time it’s, well this group over here looked at a slightly different definition, so really how do we put them all together and come up with a final decision on, is this important or not, or does this change their mortality or not, so I think that’s great to standardise outcomes. (Canada) 008
It’s a great idea because it’s very difficult to compare across trials, centres, networks. We tend to focus on these things because they are easy to measure. (UK) 017
 Driving quality improvementDefinitely could be used for programs to look at their own, not as an official research, but a quality improvement kind of thing, how is our program doing, so you could borrow some of those outcomes and be tracking them in your program. (Canada) 008
It also sets up hypotheses that can then be tested in a quality improvement.(UK) 016
 Compelling a focus on quality of lifeThere are a lot of providers who see their patients like cattle, a way of making money. They don’t really care, it’s a sort of billing code, that’s what patients represent. I don’t know if you can force them to sit down and think about these issues. Once a year they have to take the KDQOL. Have it be a part of the formal assessment, including the nephrologist. When patients a platform for expressing these concerns, then even the greedy nephrologist, he’s going to say, ‘ok, I gotta address these issues, you don’t just ignore patients, they’re just going to fire you and go to another nephrologist’. That would be one easy way of instituting these patient centred outcomes. (USA) 003
We need things from trials that then translate into routine practice that people can think about when they’re seeing patients in the clinic, and help patients then target those sorts of outcomes that are beneficial to them rather than beneficial on a bit of paper or a spread sheet. (UK) 026
  • Quotations tagged by country only to maintain anonymity.

  • KDQOL, Kidney Disease Quality of Life measure.