ASH 2015

Children most at risk of over-reporting adherence to at-home chemotherapy regimen

Dr Wendy Landier - University of Alabama at Birmingham, Birmingham, USA

You are looking basically at adherence and specifically here in the case of acute lymphoblastic lymphoma. Why was adherence so important in this particular disease?

In children with acute lymphoblastic leukaemia adherence to oral chemotherapy during the maintenance phase, which is the final two years of therapy, has been shown to be associated… low adherence is associated with an increased risk of relapse.

What did you do in the study looking at adherence?

In this study we focussed on whether or not what patients told us, the self-report, matched what we were monitoring electronically by giving them special bottles with the oral chemotherapy that had a cap on the top of the bottle that measured every time the bottle was opened, the date and time was recorded.

They were supposed to take their medicine every day, what in fact did you find were the differences between what they said they were doing? And of course they were children, weren’t they, so it was sometimes their parents.

Sometimes their parents. Up to age 12 the parents were reporting on behalf of the children and over age 12 the children reported on their own behalf. What we found was that 24% of the children or the parents on their behalf over-reported. So compared to what electronically was monitored they over-reported the chemotherapy intake by five or more days in over half of the study months.

I suppose they were basically trying to tell the doctor what they thought the doctor wanted to hear – yes I took my medicine.

Well one would think that and one would think that might be happening in the clinic. On this particular study the doctors weren’t involved. So this study had a research assistant that came and assessed the intake of oral 6MP and this was all done on a written questionnaire that was never shown to the child’s doctor.

Just how bad was the over-reporting? Was it by a huge amount?

We found that 24% of the cases were by this five or more days in a one month period. So we considered that to be a significant amount, yes.

And what would have been the clinical impact of that in acute lymphoblastic leukaemia?

The impact of this particular study is looking at can we rely on self-report in the clinic, is that a reliable report of what’s really happening at home and is that a reliable report of that chemotherapy really getting into that child. We’re finding that we think it has to be used with caution because we found that in many cases it’s not reliable.

Can doctors identify which patients are most at risk of over-reporting like this?

In this study we found that there were several things that pointed to patients that were more likely to be at risk. So we found that in families that had lower paternal education, so the father’s education level was less than a college education. We found that in families that were Hispanic or African-American or Asian there was more of a tendency than in the non-Hispanic white families. And we found that especially in the non-adherent patients, so there was almost 8½ times the risk of over-reporting in the non-adherent patients compared to the adherent patients.

So what do you advise doctors and medical teams to be doing about this?

I think it brings an opportunity for us to explore what is a better way to be able to identify patients who are not taking their medicines. It’s very easy for any of us who are prescribed a medication to think we’re doing better with it than we are. I think that the patients who were involved in this study, many of them were probably not intentionally over-reporting, they simply thought that they had taken that medicine and they were reporting that. I think that commonly can be happening in a clinical setting where people, yes, think that they are taking their medicine as it’s prescribed when in fact they aren’t.

Psychologically it’s quite difficult to take a medicine regularly. What are the tricks in packaging and in the way you take your medicine, the actual behaviour, that could help ensure greater adherence, do you think?

We are looking into that now in a clinical trial that is on-going in children with leukaemia. What we are looking at is education, so understanding the importance of taking the medicine, understanding why it’s important to continue that two years on-going even after achieving remission. And we are also looking at an intervention where what we found from that study was that patients when they were asked why they hadn’t taken their medicine told us overwhelmingly it’s because they forgot. It’s not because of side effects, it’s not because they couldn’t get the medicine from the pharmacy or logistically otherwise, it’s because they forgot. So the intervention is looking at a text messaging reminder that comes every night when their medicine is due. It’s also looking at partnering each parent and child so that the parent oversees the administration of the medication to the child, even if the child is in their teen years, to make sure that that actually is consumed by the child every night as it’s prescribed.

What are the challenges and potentially confusing factors in all of this?

I think that when patients come to the clinic and they are asked, did you take your medicine? Most patients are answering yes, I have taken my medicine. Sometimes there is an element of just wanting to please the healthcare provider, wanting to do what’s socially acceptable, but also, and I think this study points out, because we have patients in this study who were electronically monitored and knew they were being monitored and knew it was being recorded by the special track cap the date and time that they were taking their pills, and yet still over-reported. So I think that that points to the likelihood that there’s an over-estimation on the part of many of us, maybe all but 12% of us that we found in the study, only 12% were perfect reporters, that we over-estimate perhaps how well we’re doing with our oral medications.

So the big thing is to be aware of this?

I think to be aware of this, to understand how difficult it is. I think it’s under-estimated by healthcare providers how difficult it is to take medication on a regular basis and perhaps it’s under-estimated a bit by patients and families as well and they think they’re perhaps doing better than they are.