I’ll be speaking about quality of life measures and their role in clinical care. This is obviously a broad topic. I’m going focus my comments on 2 questions
This a big topic and in 10 minutes I’m not going to give you a complete summary. So instead, I’d like to focus on 2 questions that might be most pertinent to this panel. Why haven’t PRO measures played a bigger role in oncology clinical care to date? What’s happening at the forefront of QOL research to change this?
A little bit of background about my experience in this field. I lead a research team that developed a PRO measured called the BREAST-Q. The BREAST-Q meaures both HRQOL and patient satisfaction in breast surgery. I won’t go into all the details of the development, except to say that this was a project that involved thousands of women over a 5 year period. The measure is now being used extensively in the US and around the world in trials and quality metric programs.
. It was specifically designed for clinical care and as well as for research. Importantly, in the context this panel, we have recently introduce the The BREASTQ electronically into our clincal breast surgery program and as I explore problems and solutions, I’ll reflect on some of our experiences here at MSK.
So going back my first question: In oncology we have a number of well established PRO measures . But to are large extent, these measure and the data they had the impact on every day clinical care that we thought it might. Why is this?
This is an editorial that was written about 10 year ago by Mark Levine and Patty Ganz in JCO. The title is: And the authors state: “ It is disappointing that despite the fact that thousands of patients have been enrolled in clinical trials with an HRQOL component, there are relatively few examples of formal quality of life measurement that have influenced individual patient decision-making or treatment policies” So this where we were 10 years ago – and it is where we’ve been until quite recently.
To understand this problem, we need to understand two perspectives. That of the patient and that of that clinician. Both have different information need and different preferences for how this information is given to them.
Looking first at the patient perspective, this is an article by Michael Brundage who is a medical oncologist who works primarily in prostate. He is also terrific quality of life researcher. I’d like to highlight 2 of his studies The first is a great qualitative study which really honed in on what patients want and how they want it presented. Michael and his team interiewed patients at 3 major cancer center in Canada concluded that Cancer patients do desire HRQOL information. Simple formats depicting scores over time appear to be useful to a majority of patients” So the information is important to them but they want it in a format they can understand.
Specific comments from this study:
Another very recent study in JCO by Claire Synder and Michael Brundage took this a step further. The title is Can PRO measures identify cancer patients’ most bothersome issues? This was a quantitative study in a sample of 130 patients comparing different approaches for interpreting QOL scores. The investigators conclude that: So in additional to change over time, we should look at where a patient in scoring worst at each time point.
I’ll show you a single scale, which is our physical well-being chest and upper body. This scale goes from 0-100 with a higher number meaning better physical well-being. So we are plotting out scores over time. We are also now working to add benchmark means and critical thresholds.
So just to give you a sense of how we’ve tried to learn from this research as we move our own PRO measure the BREAST-Q into clinical care. This is an example of a BREAST-Q patient report in the EMR. You can see we’re focusing on simple graphics and show QOL over time So when I see her at 6 weeks, I’m looking at this report and focusing on the fact that physical well-being is at a low, but when I see her at 6 months, I’m asking about psychosocial well-being which is her lowest score.
So what about the clinician’s perspective. A lot has been written on this as well but I would highlight one particular study that summarizes prevailing attitudes. This study was performed by the ECOG group. 30 academic oncologist from 2 centers participated in structured qualitative interviews
While they indicated that they felt QOL was highly important, they described a number of barriers to it’s use in clinical care. This includes: Skepticism about QOL measurement tech niques Poor quality data and lack of standardization Non-generalizability of the data Lack of time to access QOL data Lack of data relevant to specific populations Unclear estimates of clinically meaningful change This quote summarize their opinions and perhaps your own: Trial reports do not give enough detail. I do not know enough about the (PRO measurement) scales and it is hard to gauge sketchy, patchy information”.
So what about the solutions. What happening at the forefront of QOL research to change this? What are the exciting new approaches?
I’m going to talk about 4 things – but I’m sure there are more that we can consider in our discussion. There is a new emphasis on qualitative research and patient input PRO measure content previously based largely based on ‘expert opinion’ which meant that of clinicians and reseachers If we don’t involve patients in the development of our measures and in our clinical systems, we can’t be sure we are asking the questions that matter most to them, or can we’re providing answers that they can understand and effectively integrate into their decisions.
New psychometric methods. Over the past years, the science of pyschometrics has really evovled. New approaches to questionnaire development like Rasch and IRT allow us to develop measure that provide interval level measurement – not just ordinal. What does this mean? When we take someone temperature, we get interval measurement. Not only do we know that 104 is great than 99 (that’s the ordinal part) but also know that every degree point change is the same along the thermometer. There is fix distance between the degree points on a thermometer. And as clinician, this is what I want. I want a fixed interal level ruler that I can understand. This is also what patients want because it transposed very easily into simple graphics This is what Rasch developed measures can provide. So Rasch allow us to develop measures that are more clinically meaningful -- so they are not just research tools. Finally, Rasch developed measure are designed for computer adaptive testing. Because the questions span a interval level continuum, a patient can start by answering a single question in the middle of the scale and based on how they answer, they are directly electronically to the next more appropriate question. So they answer 4-5 questions, rather than 20. But we get just as much information.
On to solution 3. Going back to the ECOG study, clinicians want rigorous HRQOL data which hasn’t always been available. We are now seeing standard set for collection and reporting of HRQOL data and I think this will go a long way towards improve the quality of our information and the confidence with which we can speak to patients. Fabio Efficace is a quality of life researcher in Rome. Several years ago, he wrote this systematic review of QOL in prostate cancer and based on this, he went on to develop the Efficace criteria for evaluation of HRQOL data in clinical trials. This has been a major contribution to the field.
Finally, solution 4 relates to electronic capture of PRO data Patients increasingly want to give and receive information electronically and we now have the Technology to support this and in so doing decrease clinic burden New Rasch PRO measures designed for computer adaptive testing
The field to QOL research in rising to meet these needs and as exciting new solutions are we are seeing:
So as example --- this is our BREAST-Q scale Sat with Breast. It was Rasch developed and the questions span a continuum.. What you see is a number of item that address all different aspect of a woman’s satisfaction with her breasts, so not just how they look but also how they feel. And these items are extend on a continue. At one end, we ask her how she feels she looks clothed and one the other, unclothed. Really, any reconstruction can look good clothed but only a really superior outcomes will satisfy a patient when she is naked in front of a mirror. The patient’s responses to these items are then summed and transformed into a 0-100 score, where a higher number means greater satisfaction.
What you see is a number of item that address all different aspect of a woman’s satisfaction with her breasts, so not just how they look but also how they feel. And these items are extend on a continue. At one end, we ask her how she feels she looks clothed and one the other, unclothed. Really, any reconstruction can look good clothed but only a really superior outcomes will satisfy a patient when she is naked in front of a mirror. The patient’s responses to these items are then summed and transformed into a 0-100 score, where a higher number means greater satisfaction.
And these items are extend on a continue. At one end, we ask her how she feels she looks clothed and one the other, unclothed. Really, any reconstruction can look good clothed but only a really superior outcomes will satisfy a patient when she is naked in front of a mirror. The patient’s responses to these items are then summed and transformed into a 0-100 score, where a higher number means greater satisfaction.
Taking this a step further into clinical care – my Rasch Ruler extend from 0-100
Let imagine patient presents having already had a mastecotomy. She score 10 on my BREAST-Q. So clinically what I know this means is that she looks OK in clothes – which you do pretty much with a prosthesis.
So she undergoes an implant reconstruction and I can move her pretty reliably to hear – wear bras fit better and she can wear a bathsuit. She has an implant reconstuction and get to here. And before we finalize her reconsturction I can talk to her about the fact that if choose a saline implant, she’ll like move up 5 points compared to silicone.This can help guide her decision and it’s based on data from patient’s like herself that have been involved in BREAST-Q cohort studies.
So now she shows up 5 year later and the implants don’t look so good. And this is pretty predictable based on BREAST-Q data that we have. Patient satsifaction with the results on implant recosntruction declines over time.
So we discuss options and then I can also use BREAST data to help her understand where she can expect to get to if we now do a TRAM flap or autologous reconstruction. We have the potential to move all the way to the end of the ruler and she can expect to maintain this level of satisfaction in the longterm. So Rasch gives me a ruler that I and my patients can understand and that is useful clinically.
Quality of Life Measures and their Role in Cancer Care Andrea Pusic MD MHS FRCSC
Why haven’t PRO measures played a bigger role in cancer care to date?
“ It is disappointing that despite the fact that thousands of patients have been enrolled in clinical trials with an HRQOL component, there are relatively few examples of formal quality of life measurement that have influenced individual patient decision-making or treatment policies” Mark Levine, Patricia Ganz
Annotated descriptions of the graph increase understanding
QOL scores needed to be given in context over time
“ When I see the graph, then I read the text, the graph makes sense.” “ There is too much in your head already. The simpler the better” “ I don’t think this is helpful at the time of diagnosis, but instead when you’ve calmed down and are looking for information.”
The Patient Perspective “ Absolute scores identify patients' most bothersome quality-of-life issues …These results support the use of PROs in clinical practice.” Claire Snyer, Michael Brundage