Table 1.

Selected quotations from the workshop discussions on the identification and implementation of core outcomes in hemodialysis

Themes	Quotations
Identification
Equitable stakeholder engagement	“It might even be different rankings for different regions. It might be that there’s commonalities between different regions or whatever. I’m not sure one shoe size does fit all broadly.” (health professional)
	“There’s a severe dearth of Asia in this whole thing.” (health professional)
	“Is there symmetry between the stakeholder groups in terms of the impact? Physicians or the health care professionals didn’t change their views [in the Delphi]. I just wondered if there’s a power dynamic going on there? I just wonder if all the stakeholders are influenced more by the health care professionals than the other way around. So is it asymmetrical?” (health professional)
Evolving priorities	“It is best as an ongoing initiative rather than ‘we’re done now, this is the answer.’ Some priorities change over time.” (health professional)
	“This needs to be a breathing initiative…the [priority for outcomes] might be totally different in five years.” (health professional)
Deconstructing language and meaning	“We almost need to deconstruct language. What one person feels when they talk about dialysis adequacy is totally not what the next person feels. We really need to peel off the layers until we understand the core meaning of what it is.” (health professional)
	“Dialysis is the process and adequacy is the overall concept, but there are probably multiple ways to measure that and that’s what we’re hearing.” (health professional)
	“There’s a huge movement, even amongst the health professionals, that dialysis adequacy means much more than the Kt/V. If anything, the patients seem to already know that, but we’re still trying to like figure this out.” (health professional)
	“When your numbers are adequate, your blood is being cleaned, your outcomes are well, then you feel better, you can handle things happening in your life. You can spend more quality time with your family instead of having to take X amount of trips to the emergency room because something has happened, or having those days when you’re so weak you can’t get out of bed. It all comes down to quality of life.” (patient)
	“When I look at dialysis I see in the general that I am at a deficit. My life is not normal. So in essence I’m striving to get that normalcy back into my life so that I can live the quality of life that I see others live and enjoy. So making that difference be understood between what they mean when they say dialysis adequacy and what a patient hears when they hear dialysis adequacy. To me, dialysis adequacy means I have an excellent quality of life even though I am on dialysis.” (patient)
Disentangling interdependency	“The whole point of dialysis is to keep the patient feeling well and feeling better and keeping their normal day-to-day life, it’s all of these other outcomes that contribute to that. So just finding what those four other important things are to measure, that leads to the patient feeling well, right?” (health professional)
	“You start off with fundamentals—whether or not somebody has a fistula or a catheter and whether or not somebody has a measurable lab value or whatever. Then you go to a different group of values like whether someone has an infection or what the quality of life metrics are. Then you end up with the top of the pyramid what really, really matters—getting up in the morning and not feeling wasted, having a good day, knowing that you don’t have to worry about your fistula working. Making sure you’ve got adequate dialysis so you can really live a good life. There’s a pyramid effect and we start with the fundamentals but we end up with what really, really matters to now in patients, any one of those as a human being. What matters and how can we have a good day.” (health professional)
	“Looking at this list of outcomes, it occurs to me some of [these] are like apples and oranges. What you’re really talking about is some things are hard outcomes like the ability to work, or the ability to live, or the ability to not be hospitalized, and some things are surrogate outcomes which may or may not be on the causal pathway to those hard outcomes, and I think health practitioners and patients have a very different perception, just because of knowledge of what things lead to better quality of life. Perhaps a drop in blood pressure is not important if we just asked you, but if you ask us we would say a drop in blood pressure is very important, because we know that that’s going to affect your brain function, your heart function, and ability to function, and so I wonder if some of these things are just a difference in perception, of what leads to what.” (health professional)
	“Let’s say you knew about blood pressure like you know now, because you’re a patient, people have told you that. Let’s say you knew nothing about it, but then once somebody tells you that blood pressure if it’s too high, can lead to a stroke and if it’s too low, it can also lead to a stroke or other harmful things, then would you care about it or would it still not matter if you didn’t have symptoms?” (health professional)
	“So blood pressure is just a number. Are patients always fully informed about the consequences of very high or low blood pressure?” (health professional)
	“Anemia and fatigue may very well be telling you the same thing for example.” (health professional)
	“I’ve got some problems with it really because the outcomes are not mutually exclusive and they may be conflicting. Ability to travel and dialysis free time, they conflict with, say, dialysis adequacy. To categorize them like this is a bit simplistic and may not actually reflect real achievable goals. The other thing is that a lot of the biochemical parameters, which we use as surrogates, may have been used as surrogates for some of these other softer outcomes.” (health professional)
	“A lot of my patients would feel really well if you dialyzed them for eight hours and seven nights and their fatigue would be much lower. But yet that would conflict with the dialysis free time.” (health professional)
Interventional applicability	“In hemodialysis, we have trials that are specifically looking at improving vascular access care. Trials that are looking at reducing cardiovascular morbidity and mortality. Trials that are looking at survival. Trials that are looking at quality of life and symptom control. If the outcomes for one of those are not relevant to some of the other ones, there would be no point in vascular access trial necessarily measuring some of the quality-of-life issues.” (health professional)
	“The end points are going to have to reflect what your drug or device is targeting. We’re going towards cluster randomized trials. The challenge is going to be to create this pre-specified data set or a set of data fields on the dialysis unit that we always collect that potentially in the future will work for a new device for vascular access that maybe comes out. Because depending on your product or your device, your things you’re going to want to collect even in a pragmatic trial are going to be very different.” (health professional)
	“I have no objection whatsoever that we do need to measure patient-centric outcomes and I do it in all my trials. What I worry about is people are going to be very prescriptive about what I have to measure and how I measure it. Rather than allowing me to weigh up what I think is the best mechanism.” (health professional)
Procedural efficiency	“That’s the beauty about the process. We have this smorgasbord of different outcomes but at the end of the day we can’t measure everything. It’s a matter of focus, it’s a matter of efficiency and this process really helps us. On one hand, of course focus on what was ranked extremely highly. Also, there’s a good list of outcomes that people have considered that really are not important and just getting that noise out of the entire system I think is already a good contribution.” (health professional)
Implementation
Feasibility of outcome measures	“If you just distill this patient experience down to no more than five scales, one might be on vascular access, one might be in terms of dialysis adequacy or something. Patients would all opt in and not be opposed to responding to four or five questions.” (health professional)
	“The dialysis adequacy what we measure and how we measure it before you can implement something is probably your crawl before you can walk.” (health professional)
	“You have to think about it from a perspective of designing the trial and that everything that I measure is going to cost time and money and it will detract from my ability to do other things in the trial.” (health professional)
	“Some of us would be concerned that if it was regulated, that we had to have these outcomes, that it might increase the cost of the study beyond what we could do. So we’ve got to be a bit careful about being too prescriptive about what’s collected.” (health professional)
Propagating and patient-centered paradigm	“The other thing in terms of translation was just as a physician seeing the disparity between where certain items fall is eye opening for me. That is informing physicians about these, even just this process could be very useful for individual patients and physician relationships.” (health professional)
	“We should have the end point be patient driven. Death of course is always an end point but before there’s also quality of life that is critical. I would rather be healthy and alive than anything but I’d rather be feeling good while I’m alive.” (patient)
	“It’s a trial that’s being conducted in dialysis units. It’s a large trial. The outcomes that they’re looking at don’t include, I think, patient-centered outcomes. It would be nice if they did, so that you would have a better idea of what longer dialysis means to people, hundreds of thousands of people.” (health professional)
	“This lecture at this table really impressed me and I believe some things that I said made a difference to doctors and patients. Pretty much I feel there is more discussion down the road, more seminars like this and more knowledge to learn from both sides. I would like to add education for the doctors, the clinicians, the people working with the patients. A term may mean one thing to you but to the patient every term basically boils down to quality of life. When I wake up in the morning do I feel good enough to be able to spend time with my family, to be able to travel the way I’d like to, to be able to go to work if I want to, to be able to do the hobbies that I enjoy doing.” (patient)
	“That’s a major point because we get labs every month of course. We get them passed out and there are patients that crumple them up, some of them fold them up put them in a bag whatever because they’re looking at these numbers and they don’t know what they mean. So it’s so important to translate it from the numbers to something that even the newest guy who’s a patient can wrap their head around it and understand.” (health professional)
	“Patient-centered outcomes is more and more relevant to them today than ever. They’re also willing to start thinking about trade-offs from let’s say mortality goes up a little bit, the quality of life improves significantly.” (health professional)
	“There may be trial end points that the FDA tell us that we have to use. We would also like some end points in there that have some key relevance to the patients. Now there may be secondary end points but at least we’re collecting the vital information to assess those end points.” (health professional)
Contextualizing translation of outcomes	“It’s different the context in which you’re asking that question, one is are you planning clinical trials with these outcomes or you’re measuring those as a measure of qualitative care that can pay for performance schemes that have cropped up all over the world. The scope of that is going to vary based upon the context in which you’re asking, and are variable across the health care systems.” (health professional)
	“There are two different issues though. One is clinical studies and how you standardize those. But the other is actually the carrot to get people to practice and treat people in certain ways, the incentives that are out there.” (health professional)
	“Is that really what the goal is though, is to drive the research agenda by choosing which outcomes are important? Or is it to ensure that whatever the research agenda is, is that the outcomes that are in it are reasonably standardized across different trials with similar goals?” (health professional)
	“Doesn’t it stifle innovation and interest in new things? If you concentrate the funders on four things that just means that we’re going to be investigating those four things. It removes any chance of anything novel and new coming into the market and changing the paradigm.” (health professional)

FDA, Food and Drug Administration