Specific challenges and concerns arise in the developing, testing and use of COAs when the population is one with substantial cognitive, linguistic or physical limitations. Here we discuss whether these concerns are valid and talk through some of the challenges, potential solutions and opportunities, drawing on examples from a number of patient populations including paediatrics, geriatrics, arthritis and psychiatric disorders.
So our title is eCOAs for use in patient populations with substantial physical and cognitive limitations. Chloe and I are doing a bit of a double act. As John said, I’m Katie Garner and I’m the Advisor of Therapeutic Areas at CRF Health.
So we know that eCOA is a widely accepted method of data collection in trials. But we still hear some concerns from clients around challenges for certain populations. And these populations that we hear about fairly regularly are patients with psychiatric disorders, patients with cognitive impairments, patients with dexterity issues, with visual or aural impairment, and also geriatric and paediatric patient populations.
So the way that we’ll tackle this topic is to first look at the challenges in those individual populations and then look at the opportunities and see where we have specific ways that technology can help us overcome some of those challenges. And then we’ll describe some specific solutions. And Chloe will talk about the patient experience, real life patients, how they’ve gotten on with some of these solutions.
Okay, so you’ll have to forgive us, we’re going to keep swapping over throughout it. The first population we’re going to talk about is patients with psychiatric disorders. So there’s a number of preconceptions and misconceptions, perhaps, about patients with psychiatric disorders and their ability to complete eCOA as part of a clinical trial. And the majority of these centre around a familiarity with technology. So it’s been suggested in the literature that people with psychiatric disorders are less digitally proficient than healthy controls or patients with other diseases. Also that they’re less likely to own a mobile device than the general population. In addition, they may have a lower socio-economic status and cognitive difficulties. And these are factors that are both associated with a less frequent use of computers. In addition to that there’s other concerns that arise. So symptoms such as paranoia, for instance, about the purpose of the device, poor attention span, so being distracted easily, not being able to just sit down and complete a number of instruments at one time might interfere with their ability to complete instruments on an eCOA device.
So Chloe mentioned that people with psychiatric disorders can be less digitally proficient. So one way that we can try and tackle that is to provide solutions with large answer buttons. And also, most of these devices have the ability to accept knuckle taps for answers as well. So clear instructions also, and help options, as people are going through an eCOA data collection really help reduce any confusion and reduce any stress and anxiety. And people can be concerned that as they’re going through they might not remember what it is they’re supposed to be doing, but the dynamic nature of technology means they don’t have to remember, they can be prompted as they go through, and that really does reduce anxiety levels. For people that don’t have smartphones or tablet devices, then of course in a trial these are provisioned, so they are given to the patients. And the lack of familiarity if they don’t have one themselves can be overcome by having really good clear training modules on the devices, and of course training provided by the sites as well. And even when bring your own advice gets going as a method of collecting data, there will always be some aspect of provisioning of devices to patients, because patients can’t be accepted onto the trial on the basis of whether or not they have a smartphone or a tablet device. So there’s always going to be some kind of provisioned aspect. And as with any population, any solution could be designed intuitively and the design of that, which Paul will talk about a little bit later, the more intuitive that design is, the easier it is for all populations but especially populations who have anxieties or have less familiarity with IT. Engagement strategies also help to reduce the problem of poor attention span. And I think for psychiatric disorders, those engagement strategies would have to be quite simple, things like feedback messages, positive messages, and reward screens. But you wouldn’t want to go into thinking about a complex strategy, such as donation programs, for that kind of population.
Okay, so just to give a background on where all this information is coming from. So we conduct usability and feasibility testing of devices before they’re implemented within a clinical trial. So this involves us giving the patient the training that they’d have in the trial, and the device that they’d use, and asking them to complete some instruments and then provide us with feedback on any issues they’ve had. And we’ll also observe them using them. Or if the patients in the trial will be taking the device home and completing on a daily basis, we’ll get patients to take it home, say four or five days, complete the instruments on the device, and then come back to us and tell us how it went. And there’s two reasons that we do this. Firstly, we want patients to find these devices not burdensome to use, and easy to complete. So doing this kind of reduces the stress that patients int he trial are going to have in completing the instruments, and it means that they’re not going to be faced with these issues that might prevent them from completing them how we would like. And then also, it alleviates barriers to eCOA completion, so identifying them before you start the trial alleviates any barriers in terms of issues that might present to the patient prior to commencement, so the quality of the data you collect ultimately is better.
Okay, so we conducted a study using tablet devices to administer questions to administer to patients who had schizophrenia. And what we found was that all patients said that they found completing the instruments on the device—and they also went through the training and things like that—they found it a positive experience. They said they found the device easy to use. They found it easy to select responses using the touchscreen. And also they were happy with the time that it took them to complete these instruments. And bearing in mind, they weren’t specifically short—there were three instruments, and some of them were quite substantial. They also said when we asked them that they’d be happy to complete the questionnaires on the devices for multiple time points. And they said they preferred to complete them electronically over paper. And what we found is that really this was in line with what’s in the literature. And that relates to patients with any psychiatric disorder using any sort of technology to fill in questions about their health state.
So you can see we’ve got some quotes form the interviews there. “All you had to do is read it, tap at the bottom,” and it was easier than dealing with a pen and paper, it was just pretty simple and straightforward. However, what we did find is that issues that weren’t reported by patients were observed, either by the interviewers who were observing them and asking questions about using the device or by nurses that were there to help when we were doing them. So we found that patients actually took a lot longer to complete instruments than we would expect in other populations without experience in observing in other populations. We also found that they needed more guidance in terms of using the device and getting to the next question, or if they needed to go back and change an answer they needed help with that.
So you can see there is a quote. “So at first I didn’t realize what the arrow things was on the screen for. then I realized you have to push it to continue.” So that’s something that usually is quite intuitive, oh there’s a big green arrow, I’m going to push it to go to the next page. They needed a bit more help with that. They needed to read the instructions of the items a number of times. And they were often hesitant to commit to a response. So you can see this quote there, “Not that it wasn’t 100% truthful, I just couldn’t make up my mind on the answer.” So we found that they kind of go two questions forward, and then want to go two questions back and just check what they said a couple of question sago, more than we found in other populations.
We also found that patients didn’t appear to use the correct recall period. However, that is by no means specific to this population, nor is it specific to an electronic administration either. Just a note with this one is that these interviews are conducted with patients that have mild and moderate disease. So I think if you’re applying it to patients with severe psychiatric disorders, then you’d probably need to implement a few more of the solutions that we’ve been speaking about.
Okay. So the next population we’re going to touch on is paediatrics. And there’s a number of aspects of paediatric development that can impact the ability of children to complete any sort of instrument, whether that’s on paper or using an eCOA device, so that’s cognitive, linguistic, behavioural development factors. Children tend to have a short attention span, so they get easily distracted when it comes to just sitting and completing a questionnaire. And they can find the measures burdensome to complete. As we know, they much prefer images to graphics and text. And they usually, if they’re completing the questionnaires on a daily basis, they might have difficulty remember to complete them.
In addition, another concern is that children might be embarrassed if they have to complete the instruments daily on the device. So if they’re at school with their friends, and they have to get this strange device out of their bag and start filling in questions, perhaps about the toilet movements and things like that, they can sometimes find it embarrassing, so that’s a concern. And then also, any kind of small, interesting, fun device, they might just see it as a toy, so access to it could need to be monitored.
Short attention span is one of the big challenges with children and a really good engagement strategy can try and get around that by making the experience fun and not a burden. Something as simple as introducing a theme onto a device. Basically pretty in pink or bold and blue, just so that the content hasn’t changed but what the child sees on the screen can make a really big difference. And also some degree of personalization—perhaps hello, Jack—no kind of personalization that would go back into the clinical trial data, but just something that the patient would see on their device. Positive feedback messages. I think we all know how well adults and children respond to a well done and you know, that little bit of pat on the back makes a huge difference to how engaged and motivated people feel. Reward screens, little icons that might appear. So if they have done a certain amount of data collection they will see an interesting picture or a penguin that does a dance, something of that nature, but generally making something fun will make it an engaging thing for children. But you have got to be very careful with is making sure that that engagement is suitable for all the different age groups and all the different genders and isn’t actually a turnoff for older children.
The actual fact that eCOA versus completing paper really helps with that attention span, and that isn’t just true for paediatrics, but that can be true for many different populations.
To combat the problem of children having different developmental challenges and skills, a simple and intuitive design is really important. Something that has perhaps visual response options, so they don’t have to read, they can just automatically pick a picture or a colour for yes and no. Employing skip patterns, which is one of the huge benefits that technology can bring, which automatically takes you to the next question. I don’t know if anybody’s filled in a passport application recently, but those questions where it says, you know, if you’ve answered this, then go to 10, if you’ve answered this, then go to 42. Having technology do that for you is really beneficial, especially for a child who might find it difficult to work out where they need to be next. And having reminders and alarms for children and carers really helps to make sure that, if they’e got a busy day at school or preschool, that the data collection is fitted into their day and it’s not forgotten about. Carer logins can be added if appropriate. And—Chloe talked about discretion—using devices that aren’t too bulky so that children can be discreet. They might not want to be discreet. I know my six-year-old would be the one in the playground making sure that everybody saw what she was doing and she was doing something a bit special. But many children might want to keep what they’re doing to themselves. And privacy is also something that can be very easily controlled by technology, and much easier than with paper. So once a response has been completed, that can be hidden.
Okay, so we’ve done a number of studies in paediatrics, and what we’ve found is there’s a definite preference for electronic over paper completion. They find ePRO more engaging. Often they liken it to using a toy or a Nintendo DS or using a smartphone. So you can see, there’s a quote there from a 12-year-old, “I like how simple it was. It reminded me of using a Nintendo DS.” They find the devices easy to use. So this kind of generation, they’ve grown up with technology, they perhaps find it more intuitive to use it than adult populations do. And they don’t really seem to have any issues in navigating the devices. They find reward screens motivating, they find it easy to understand the images that we give them. So as we talked about for instance using size circles as response options instead of using kind of descriptors of the sizes, they found that easy to tell what the circles mean. And in addition, we know that parents and children find it easy to forget to complete these on a daily basis, so using these alarms is really useful to them and they feed that back to us. So, “If I didn't have the alarm, I probably wouldn’t have remembered so it was probably necessary.”
So we’ve also over a number of studies captured the amount of time it takes children to complete instruments on electronic devices. So you can see here, we’ve got four age groups: 6-8 years old, 9-11, 12-14, and 15-17. And you can see that, even though the amount of time it takes to complete these diaries does decrease with age, even for the youngest ones, for the 6-8 year olds, the average time is less than five minutes. And these completions were instruments that were between 30 and 38 items long. So it’s quite a substantial list of questions that they have to answer, and it doesn’t take them long. And actually, when you compare this to adult populations, we find that particularly for the adolescents, say the 12-17 year olds, these averages are a lot less than you would get from a similar number of items with adult populations.
And just a quote there. “So I thought it was simple. It wasn’t a challenge. And it didn’t interfere with our day or anything.” So these are these daily diaries that patients are having to complete, and just to show that the parents don’t find that the get in the way.
Okay, so the next population we’ll be talking about is patients with dexterity issues, so for instance elderly populations, patients with osteoarthritis in the hand, may mean that it’s difficult for them to complete instruments on electronic device, or indeed using traditional pen and paper. They might have difficulties holding the device, particularly if it’s a small device, and selecting responses using the touchscreen. And also long instruments that take them a while if they have to sit for say maybe 10-15 minutes and complete them might actually cause them more pain in their hands or their fingers or their arms.
So dexterity is a limitation that cuts across therapeutic areas. We’ve got diabetes for example, which brings physical challenges of dexterity and also eyesight. But technology for dexterity definitely gives us an opportunity to solve some of these challenges in completing eCOA. There’s no need for a patient to actually hold a pen or a stylus, and they’ve got the knuckle-tap option for responses. Devices don’t have to be held. They can be leaned on something, they can be put flat on a table. And having those large screens which most smartphones have these days means it’s easy for a patient to be able to tap on a response, they’ve got a large screen, large answer button. But perhaps more importantly around the answer button is an even larger response area so that accuracy isn’t really critical. But the shorter completion times compared to paper means that it's more manageable for patients. If they’re uncomfortable, but also if they’re in pain, it’s going to be a much more manageable process for them.
So we conducted a study with patients that had osteoarthritis of the hand, in the dominant hand or in both hands. And what we found is that there was no difference in the self-reported ability to use the device, completion time, or their issues reported, between patients with osteoarthritis in the hand and those with osteoarthritis in other parts of the body or with other health conditions. And again, patients preferred to answer questions on a device than using pen and paper. And they found it easy to navigate the device. So this is in line with work by Nicholas Bellamy and his colleagues and they migrated the WOMAC, which is an instrument used in osteoarthritis, to an electronic form. And they found that there were no differences again in self-reported or measured completion times and ease of device use between patients with osteoarthritis of the hand and patients with osteoarthritis in other areas of the body.
So you can see there’s a couple of quotes there. “It was just simple, it’s like using a phone.” “It was reasonable amount of time, just a few minutes.”
However, what we have found is that patients in this population, if they don’t want to be holding the device because it’s difficult, we ask them to lay it on the table. But they often report a glare from this, and they’ll try and prop it up on anything they can find in the room. So you can see that the interviewer says, “So you’ve propped it up on a water bottle there.” And the patient says, “Yes, just take the glare of the light off it, because the lights sort of distorted it a little.” And this has come up a few times in interviews we’ve conducted where patients are laying this down. So I think what we’ve learned from this is to encourage eCOA developers, but also site staff, to provide options, so say stands or different screens that prevent this glare, because we really don’t want something like a glare getting in the way of how a patient is reading and interpreting instructions and items on the questionnaire.
Okay, so the final population we’ll be talking about is geriatrics. And again here, the main concerns are around familiarity with technology, whether that’s computers or touchscreen devices. And often in older patients this is driven by fear of using technology and a fear of these devices that they haven’t used before. In addition, the older generations are more likely to have problems with vision, problems with dexterity, as we’ve just discussed. And they also might have difficulty recalling over longer periods of time. They’re more likely to have concomitant diseases, but also mobility issues which may mean that they have difficulty getting to sites to complete assessments on a regular basis.
So for poor eyesight we have the ability of our technology to adjust the brightness on a screen, but also to adjust the font size. The instructions and reminders mean that if not just recall is a problem but the anxiety associated with remembering what to do next, that can interfere with remembering what to do next, that can all be reduced with the instructions and reminders but also the training. And I think that’s really where eCOA comes into its own because it’s dynamic, it can help the patient. We talked about solutions for poor dexterity, with there being no need to hold a pen or a stylus. But some patients, maybe geriatric patients, might feel more comfortable holding a stylus. So that always is an option if that’s something that patients want to do. Knuckle taps, resting the device on an object, and using large screens and answer buttons and large response areas. And also the shorter completion times don’t just help with poor dexterity but they help with fatigue as well.
Geriatric patients can be less mobile, and that can have an impact in two ways. It can mean that it’s more difficult for them to complete information in their own home, but perhaps more of an issue could be the fact that they’re less mobile outside of the home as well. So any ways that we can find for patients to complete data remotely and reduce the need for them to attend site is going to be helpful. There’s getting around the home and there’s actually leaving the home, using public transport, relying on family members to transport them places. So mobile data is going to become more and more important, I think, as the population ages.
We talked about how elderly populations might feel less familiar with the mobile technology, and also that they might not have them themselves. So devices will always be provisioned if necessary, and the training that the patient goes through will help overcome any familiarity issues. And our experience really has been that it’s an initial unfamiliarity, it’s not an ongoing problem that the elderly populations have interacting with technology. And as with any population, the intuitive and well designed screen, that’s got to be good for anybody, but especially somebody who isn’t familiar with using technology.
Okay, so our experience with older populations. So again, we’ve done a lot of studies with older patients. And as Katie said, so in our experience, they take a little longer to get used to the device. They maybe need a bit more training. But once they get going, we found that there’s no difference in their ability to complete eCOA on a device and the ability of other age groups. In addition, when they’re taking the devices home to complete them there’s no difference in the issues that they report experiencing at home compared to other age groups and patients with different conditions. They find the devices easy to use and easy to navigate, and this is regardless of whether they’ve got experience or not.
So if you can see on these quotes here, I’ve put where the patients have said they’ve got no touchscreen experience. Because when we do these studies, we’ll always make an effort to A, recruit a certain number of patients who have no familiarity with any sort of computer technology, so whether that be desktop, laptop, or touch screens, and then also patients who may have a desktop or a laptop at home but actually they’ve never used a tablet or a touchscreen phone. And as you can see, there’s some quotes there. So, I liked it, it was simple it was easy, so that’s someone with no touchscreen experience. A lot of the feedback we get is like, well I can do it and I don’t know what I’m doing, then surely anybody can do it. And there at the top, so “even for me who doesn’t know computer anything, after I got going, I thought it was pretty simple.”
So despite us finding this with the patients that don’t have experience, what we do find is it’s actually quite hard to find the patients that don’t have any touchscreen experience and don’t have any computer experience, because a lot of the patients do have experience of using these devices, even if they don’t own one themselves. Maybe family members or friends have them, and they’ve used those.
And recent reports have actually found that 74% of patients aged over 65 in the US own a mobile device. And in the UK, patients between 65 and 74, 82% own a mobile device. So it’s actually quite surprising that the patients do kind of know what to do and they’re used to these kind of devices.
And I’m sure that a lot of you have seen this before, about compliance and ePRO completion times. But we actually found that elderly patients are the second most compliant population when it comes to taking the devices home and completing them on a daily basis. So beaten only by caregivers of infants, and I think it’s quite self explanatory why they’re so compliant. The elderly population are very compliant, and they’re happy to do it.
So just one conclusion slide. While we know there are challenges associated with eCOA in certain populations, we know that there are solutions that can be implemented to help patients. And eCOA provides opportunities to help engage patients, because of its dynamic nature. Usability studies allow for identification and, importantly, any resolution of problems specific to that population. And that eliminates any barriers. And feedback from patients with psychiatric disorders, from children, patients with dexterity issues, and the elderly show that if correct modifications are made, then these patients find devices easy to use, prefer them to paper, and are compliant with completing them at home.
Okay, that’s us. I hope it wasn’t too distracting, the way we were moving around and swapping over. And I’ll hand you back over to John.
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