Patient Perspectives on Outcome Domains of Medication Adherence Trials in Inflammatory Arthritis: An International OMERACT Focus Group Study

RESULTS

Six focus groups were held (the Netherlands: n = 2; Australia: n = 3; Canada: n = 1), each with 4–10 participants. In total 38 patients participated, with RA (n = 23), AS (n = 11), and PsA (n = 8). Twenty-one (55%) were female and participants had a mean (SD) age of 57.3 (15.0) years. Patient characteristics are shown in Table 1.

Patients discussed 5 types of outcome domains that they considered important when participating in an adherence trial. Some of these outcome domains were related to factors that might support adherence (placed in a category called “adherence-related factors”; e.g., medication knowledge, individualized support). Other outcome domains included improving medication adherence itself, and likely benefits of adherence such as improved pathophysiology (i.e., physical and psychological health), life impact (e.g., ability to work), and economic impact (e.g., productivity loss; Table 2).

We identified 3 overarching themes reflecting the reasons why these outcome domains matter to patients: protecting and enhancing emotional, physical, and social well-being; improving knowledge of and confidence in self-management; and respect and reassurance in care (Figure 1). Below we elaborate on these 3 overarching themes.

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Figure 1.

Schematic presentation of overarching themes reflecting reasons why outcome domains of medication adherence trials matter to patients. In the setting of an adherence trial, patients were most concerned with outcome domains related to their overall well-being. In addition, patients valued improved knowledge and confidence in self-management as well as respect and reassurance in care in relation to participation in adherence trials.

Protecting and enhancing emotional, physical and social well-being.

1. Motivated to maintain function. Patients valued health outcome domains in relation to a medication adherence trial as they felt embarrassed, humiliated, and exhausted with their pain and the lack of physical mobility that their condition caused. They also felt that their cognitive function deteriorated and was somewhat impaired; for instance, they felt depressed due to loss of physical function. Patients emphasized that taking medications could improve these aspects of their mental and physical fitness so that they were able to maintain their social function and ability to work.

· “It physically helps me, obviously, because it reduces my pain, my general well-being, everything. I’m a better person when I take that. My activities are normal like everybody else’s. Mentally as well, I feel like okay, I’m on track.” (F/30s/AS)

· “You have to follow a routine every day or every week or every month, take the medicine to make the goal, to improve your health or pain.” (F/40/AS)

Patients felt vulnerable and feared being dependent on others for care and financial support. Although medication adherence was linked to improved health, patients emphasized that health outcome domains fluctuated, often related to the timing and frequency of medication use, and that other contextual factors aside from their medications also influenced physical and psychological function.

· “Adherence is part of your lifestyle and so, how do you measure somebody’s lifestyle? You’ve got to look at the whole spectrum … You can’t, you can’t just hone in on adherence. You have to look at how was their lifestyle and see if there’s some change that you could ascribe to the intervention that you’re talking about. And that’s fairly tricky.” (F/34/RA)

2. Addressing low morale. Patients wanted an adherence trial to help them feel understood and supported because of the low morale they can experience from their medications. At times, some patients felt their medications were futile and left them depressed and anxious; they therefore lost the motivation and commitment to complete the recommended regime.

· “I think psychological is the biggest block to most people, your situation being one of them … You know I have to take this medication for how long? Am I gonna be on it for life? What’s it gonna do for me?” (F/48/RA)

· “I think the last thing is just ways to overcome any initial negative morale, so if you’ve been taking medication consistently and it doesn’t work, what then?” (M/30/AS)

Patients were not keen to discuss their disease and medications with their relatives for fear of judgment, lack of knowledge, and the absence of acceptance.

3. Balance between medication necessity beliefs and concerns. When participating in an adherence trial, patients wanted assistance with being able to better balance the perceived necessity of taking medication against concerns they had. Concerns related to medication use affected their confidence in therapy. Patients felt that medication adherence was needed to achieve a normal life, but they also expressed negative opinions as medication use induced anxiety about long-term safety and feared addiction to chemical products. Patients indicated that a positive attitude toward medications increased motivation to take them.

· “For me, understanding generally how it works in the body is a good motivating factor ‘cause I would know why I’m taking it and maybe, side effects, risks, expected duration of prescription. Because I was afraid of having to take this the rest of my life, so kind of like a psychological counseling to alleviate concerns with having to take the medication.” (M/76/PsA)

Improving knowledge of and confidence in self-management

1. Desire for knowledge. Patients valued increasing their medication knowledge as a result of participating in an adherence trial. They indicated that sufficient knowledge increased trust and confidence in their medication, enabled them to make deliberate therapy choices, and increased motivation to take medication as prescribed. In terms of being provided information about medications, patients wanted to be given accurate information at the time of diagnosis and regularly throughout the disease process, regarding the expected effectiveness of their medications. They also wanted information on a variety of treatment options to compare and choose from.

· “I’d want to know the benefits of taking the medication … What I mean is, what are the potential things to be aware of that may affect your consistency in how you take medication and ways to manage that?” (M/30/AS) 2.

Taking control with accurate medication use. Patients strongly preferred to make their own decisions and therefore wanted an adherence trial to help them take better control of their disease, especially when it came to medications.

· “The intervention could help me walk through a solution of how do I stay on track with my medications and keep my disease under control while I keep going through, you know, what I do in life.” (F/48/RA)

Patients acknowledged that long-term medication use is challenging, and they struggled to fit it into daily life. Patients valued the feeling that the medication was the best possible that would make them believe they were getting maximum benefits. Patients admitted to being less adherent with medications and blood test monitoring due to forgetfulness and/or busy lifestyles and were willing to get help to take their medications as prescribed. Patients wanted to be aware of what could affect medication adherence and the options to manage difficulties with adherence.

· “The question I think that a lot of patients have is if you miss a dose or if you stop taking it, like how quickly after that would you feel the effects of not taking it ….” (M/40/AS)

If patients were not adhering to their medications, they felt it would be important to know why this was occurring. Some patients experienced their overall well-being improving when they were nonadherent with their medications, thereby questioning the need for therapy, whereas others felt their disease progressing, emphasizing the need of being adherent.

· “My results are better without them, in some respects, when I’ve been a bit sloppy with my medications. Which is quite strange, because then you start questioning are my medications really working? And then you start thinking well, what if I didn’t need to take this or that?” (M/50/RA)

3. Equipped to minimize the risk of harms. Patients felt it was empowering to better understand unintended effects (e.g., side effects) of their medications in the setting of an adherence trial as this could affect their medication-taking behavior. They wanted to know short- and long-term side effects with regard to likelihoods and severity, as well as how to identify side effects.

· “My experience with RA is I’ve had more problems from side effects than I have from the disease itself.” (F/50/RA)

· “It would be good to know more about the likelihood of those things happening and how would you spot that? So yes, lymphoma is a risk, what are the signs of lymphoma? Because when it was happening to me, I didn’t even connect it with the medication.” (F/50/RA)

Patients preferred to know the actions that they need to take in the case of side effects, for example, by taking medications at night. Knowing about side effects could increase anxiety for some patients, and some preferred the option of not receiving information about possible side effects.

· “I just disregard [the potential side effects of medications] because I think I’ll probably get them anyway, so I’d rather not know.” (F/70/RA)

Respect and reassurance in care

1. Value in care. Patients valued HCP support to address adherence-related factors as part of an adherence intervention. They wanted their opinions to be acknowledged and felt ignored when objective tests conflicted with their subjective experiences.

· “One of the negative things would be judgment. When you have those times where you go, ‘it’s not working, I’m not right.’ And they’ll say, ‘but your blood looks good,’ and you go, ‘but I’m telling you, it’s not right.’ I guess you just want it to be a safe place where you can say, ‘yeah, I’ve had it, I don’t want to do injections anymore. When can I stop?’” (F/40/RA)

They wanted to feel able to ask questions, and to feel safe when disclosing nonadherence to their HCPs.

· “I hid from my doctor and the medications for like 6 months because I was scared of them. But it was really important to me when I came back to my doctor with the tail between my legs, and like ‘I’m sorry’ that I was met without judgment for doing that.” (F/56/RA)

2. Sensitivity to individual goals. When discussing outcome domains that were important to them, patients felt that HCPs were often focused on numbers, laboratory values, pain, and inflammation, which were not the most important things to patients. Fatigue was an example of something that influences daily function but was not addressed by their HCP.

· “Just communication with nurses would be sufficient for me when I feel bad … At one point I knew it was because of the medication while they said you can do whatever you want. But I’m not going, I know my own body. I said it is because of that. It felt undermining when they said it isn’t.” (F/67/RA)

Patients wanted their HCPs to enable them to achieve their unique role in society, and to understand individual goals, social expectations, and employment needs. In the setting of an adherence trial, patients wanted the adherence intervention to help them achieve goals that were important to them, and also for the intervention to be relevant and tailored to their individual issues. They indicated that the support one person needed could be very different from another individual (e.g., needing reminders, a phone contact for advice or injection support) and could change over time.

· “You also want to be able to achieve, just in general, your lifestyle goals because everyone’s different in terms of what they want to be able to do in their own life.” (M/30/AS)

3. Access in time of need. HCP and family support was an important outcome of an adherence trial to patients so they could access assistance in times of need, eliminating delays in care from someone with the knowledge and skills to offer the appropriate support. Patients felt secure having someone to call between appointments for medication advice when required, and for emotional support during difficulties with their medications.

· “I think the relationship is super important and when I was first diagnosed … Having that person there … knowing that there was somebody at the clinic that you could ask. Right, I think that’s important.” (M/40/AS)

4. Fears related to being in an adherence trial. Patients discussed potential disadvantages of participating in an adherence trial. Some patients feared acknowledging medication nonadherence in a trial might adversely influence their access to treatment outside the trial. They wanted to be able to have access to adherence interventions when required, at convenient times and places.