Background
Methodology
Study design & analysis
Participants
Criterion | % | Rationale |
---|---|---|
Aged 18 years or over; | 0% | The content is not suitable to people under 18; for example, given the program’s focus on daily functioning associated with work, university, parenting, etc. Coupled with consideration of MS demographics, inclusion of persons 17 or under is not warranted. |
Fluent in written and spoken English; | 1.6% | Given the program’s focus on group interaction, fluency in the majority language (i.e. English) is vital for being able to fully participate and engage in the program, as well as avoiding confound. |
Have a diagnosis of multiple sclerosis; | 0% | COB-MS is a Cognitive Occupation-Based program for people with MS and cognitive difficulties; thus, a diagnosis of MS is fundamental. |
Have cognitive difficulties; | 72% | COB-MS is a Cognitive Occupation-Based program for people with MS and cognitive difficulties; thus, having cognitive difficulties is fundamental. |
No neurologic history other than MS (e.g. dementia); | 8.1% | Presence of another neurologic condition could potentially confound the research. |
No history of major depressive disorder, schizophrenia, or bipolar disorder I or II; | 4.8% | Presence of such conditions could potentially confound the research. |
No history of diagnosed substance use or dependence disorder; | 1.6% | Presence of such histories could potentially confound the research. |
Not currently undergoing any other form of cognitive rehabilitation; | 3.2% | An alternative form of cognitive rehabilitation could confound the research. |
Not currently experiencing an active relapse; | 3.2% | Ethically, it would not be appropriate to ask individuals to participate in the program if they were experiencing an active relapse. Moreover, an active relapse could confound the research. |
Are a resident of the Republic of Ireland; | 1.6% | Residency in Ireland is a practical requirement in relation to the feasibility and acceptability of the trial in the context of a country whose healthcare is provided by the Health Service Executive and more specifically, COB-MS delivered through CORU-registered occupational therapists. |
Not living with cognitive impairment that would affect reliable participation or capacity to give informed consent; | 0% | Cognitive impairment to such extent would impede participants’ ability to reliably participate in, engage with and feasibly implement the program, which is fundamental to its design. Moreover, impairment to such extent could confound the research. |
Not incarcerated or institutionalized; and | 3.2% | Incarceration or institutionalisation could prohibit an individual’s ability to participate in and engage with the program. |
Not living with organic brain damage (unrelated to MS). | 1.6% | Presence of such conditions or damage could potentially confound the research. |
Materials
1. Can you tell me how you felt when you were told that you were not eligible to participate in this study? • Prompts: ‘Can you tell me a bit more about each of these feelings’ and ‘Why you felt like that (for each emotion)’ 2. Was the reasoning behind your ineligibility to participate easy for you to understand? • Prompt: If not, get the person to tell you a bit more re this. 3. Were there any eligibility criteria that you thought might be too limiting or unnecessary? • Prompt: ‘Were you concerned that you might not be eligible in advance of being told?’ 4. Can you tell me about any past experiences you might have had in participating in research? • Did you find it a positive or negative experience? • Were you ever deemed ineligible for research before? 5. Has your experience of being ineligible for this study changed your perception or attitude toward research? • Prompt: If yes, ‘how so?’ 6. Do you think you would be willing to participate in research in the future? • Prompt: If no, ‘why not?’ 7. What did you think of the manner in which we advertised the COB-MS study? 8. What did you think of the manner in which we communicated your ineligibility? • ‘What do you think would be the best way to go about this in future research?’ 9. We often find it difficult to recruit people to participate in research studies like this, so what advice would you give as to how we might best do this in the future? • Prompt: Ask them specific unto eligibility (e.g. How can eligibility criteria or programs like this be improved so that they can help recruitment to programs like this?) 10. Finally, we asked you earlier about your feelings regarding being recruited and later determined ineligible to take part in this research. What do you think of the value of making participants feel appreciated in being recruited to a program like this and how do you think that can be best achieved? |
Procedure
Results
Pseudonym | Sex | Residential location | Age | Reason for ineligibility |
---|---|---|---|---|
Amanda | F | Rural | 42 | History of bipolar disorder |
Barbara | F | Suburban | 37 | Currently undergoing other form of cognitive rehabilitation |
Colin | M | Rural | 38 | Institutionalized |
Deborah | F | Urban | 42 | Does not have cognitive difficulties (i.e. per MSNQ) |
Eva | F | Urban | 58 | Two reasons: Ongoing institutionalisation for substance abuse |
Frances | F | Suburban | 59 | Currently experiencing an active relapse |
Grace | F | Suburban | 64 | Neurologic history other than MS (i.e. vascular dementia) |
Harry | M | Urban | 60 | Not a resident of the Republic of Ireland |
Theme 1: Being deemed ineligible is emotion and reaction evoking
Grace also found it disappointing – labelling the emotion as disheartening and deflating:“It was disappointing a bit… here I was trying to be involved with the cognitive study and was told ‘well, thank you for asking’.”
Grace’s disappointment may stem from the perspective of not fitting in – not being included due to box-ticking. She indicates that she would ‘love’ to only have MS, as if the reasoning behind her ineligibility somehow reflected her own doing, as if she chose to have a comorbidity – which, of course, was not the case. She expressed this in a joking manner, with wry sarcasm. She knows her ineligibility was not her fault; but, nevertheless, she felt left out – another hole she did not fit into.“It’s disheartening to go forward for research and then to be told, ‘Well no, because you don't just have MS’. You know? I'd love to just have MS and nothing else. So, it is disheartening… and it's deflating as well… I just thought, well, maybe something about me can help somebody else and all of a sudden, I wasn't of interest because I didn't just have MS. So yeah, it's a bit… a bit upsetting, you know, to think that that’s another hole I don't fit into…It's not easy having different complaints. There's no point calling them illnesses because I have to live with them so… To put yourself forward and then… it's a bit of a knockback.”
“I suppose I was interested in doing this study, so I was a little disappointed that I wasn't able to do it; but also, on the other side of it I was happy that I wasn't bad enough to do it either, you know? So there was a bit of… different emotions there, I suppose… I suppose it was a bit of a shock that I wasn't eligible, like… and I suppose I wasn't expecting a ‘no’; and yet, it was a very mixed reaction. As I said to you there, like I wasn't expecting it at all. So I was kind of like, ‘oh God, I can't do it now’ and then it was ‘Oh my God, I'm not bad enough to do it now’, so, that’s good! You know? It was a really mixed kind of emotion!”
Though Amanda’s response was interpreted as containing elements of annoyance, indifference and, potentially, some resentment (i.e. in addition to surprise), not all negative responses and reaction manifested in this manner – that is, directed at trial decision-makers. For example, on the other hand, Eva was ‘cross’ with herself, in light of being declared ineligible for reasons of alcoholism. According to Eva:“I have a kind of a ‘I don't care attitude’… I don't care. I said fine…It’s just another little thing to forget about… You shrug it off… [but] I found it a surprise to be honest. I probably… just when I was told that I couldn't partake, I found it a bit confusing because I'm still a person with MS so, it doesn’t really matter what other illness I have; but, I couldn't take part. You know, I just felt that you’re excluded and that’s it and you didn’t fit what they want; so, yeah, I just thought it was a bit ridiculous, to be honest. I wouldn't have taken it as an insult – I would have found it a bit daft from their point of view that they can cut people out just because they suffer from a different illness… So I just found it a bit silly really, from the point of view of the people organizing the survey…That that's how they think. You know, that that I can’t fit in.”
As evidenced from these responses, one common factor that arose within many was the notion of not ‘fitting in’, which may have latently impacted the feeling of disappointment in some participants, despite their positive attitudes towards research (see Theme 5); or even happiness (e.g. Deborah) and relief (e.g. Frances) from being deemed ineligible.“Oh, I knew the minute it mentioned alcohol. But I made a point in saying that I wouldn’t be drinking every day, but I didn't want to give the impression that I've been off it for 20 years. Once I said I'm still active, ‘uh oh’, gone. [laughs] I mean, I didn't sit at home and cry about it or anything. I just, as I say, I was frustrated with myself.”
Theme 2: ‘Doing your bit’: helping others and increasing the value of research
Colin’s quote is interesting to consider because it addresses his emotional reaction of disappointment (as addressed in the first theme), his understanding of the eligibility criteria (see Theme 3 below), as well as his goal of helping others or ‘doing your bit’. Similarly, Grace discusses the concept of helping others in reference to the importance of research and making people aware of the value of participating in research:“I half-thought I wouldn't qualify given me own circumstances anyway; but I said, I can try and help in some fashion, you know?…I suppose I was a bit disappointed because I thought, well, this is an opportunity to try and help… They’re doing their bit, if you get me? I think it should be rewarding, as in a sense of a kind of achievement kinda thing, like ‘yeah, I participated in this study!’ That was how I kind of felt in these other studies I done… when I done my bit, like, if you get me, for the greater good. The way… that's how I feel about it because… like, I really appreciated being on the [specific trial] because I think it's a wonder drug, but it wouldn't be here only for people participating in the trial… Like I find that, you have to give something back to get something better down the road where you might need it.”
Likewise, Frances, Harry and Barbara all addressed helping others as a reason for initially wanting to get involved. For example, according to Barbara:“You're putting yourself forward in the hope that it will help somebody else. That’s the way I would look at research; like if they can find something in me, you know? When I die I want my brain to go to… some kind of research about brain disease, in the hope that it would help somebody else… if you can learn one thing from one patient, that’ll help towards the future… Do people realize why research is done? Do they see the benefit in… it's a bit like being an organ donor and some people don't see the value in it. Yeah, so maybe to hit – not their conscience, but… just to make them realize that it's for the benefit of others that, you know, it may help them.”
Overall, the theme of ‘doing your bit’ addresses some important characteristics of wanting to help others. There was an element of obligation felt in some cases, such as in Barbara’s response, in terms of feeling like she should ‘make the effort’. The concept of feeling like one ‘should’ help might be explained in terms of genuine altruism, given that these individuals have the shared experience of living with MS; thus, knowing from their own lives that any form of help might be useful to others. It might also be explained in terms of the opposite – that there is a self-preservation-like function to helping, in that if one ‘does their bit’ now, they might experience some benefit later. For example, as Colin indicated – ‘you have to give something back to get something better down the road where you might need it’. Similarly, it may just be a combination of both with respect to helping for altruistic reasons, but also gaining from that act of helping – be it from gaining something later, as suggested in the last example, or simply enjoying the feeling that one has contributed in some kind of meaningful, purposeful manner, as suggested by Grace.“For people with MS… any kind of research into how things could be improved for people's lives is useful and I feel like I should make the effort to try and give any kind of insight that I might have that would help.”
Theme 3: Communication of ineligibility: understanding, clarity and phone calls
Understanding of ineligibility and related criteria
Likewise, Colin stated:“Yeah, it's easy to understand. Like if you're looking for something specific, then you're looking for something specific. You just ‘muddied the waters by making it too wide’, you know, because if you were to do research on me for MS and then something pops up when you turn around, ‘Well, I've never heard of that thing and MS before’ and suddenly think no, because that's got nothing to do with that MS. No, it was easy to understand.”
Both Colin and Grace exhibited understanding of the rationale for eligibility criteria and their potential impact on the research. However, it also implies that they understand that the intervention (potentially) on offer is part of a research study and that for the intervention to be evaluated properly – for future use – specific guidelines must be followed. With that, consistent with the following sub-theme, it is also suggested that perhaps greater clarity is necessary for conveying the importance of such guidelines.“In order for the trial to be effective, I suppose that you have to be able to tick off these boxes, like there's no point being wishy washy about it… for this trial to be accurate you have to be x, y and z and I thought it’s reasonable to have an effective trial that you have to tick all these boxes… I didn't find that it was… umm, ‘Oh, this is very tough to take’, you know, for the qualifying criteria. It's more realistic. … Like, for talk’s sake, if I qualified, is that not going to put your test results skew-ways? Because it's not actually… my symptoms are MS-related, so is that going to put the whole… the results off if you broaden the scope that I could qualify? So, you have to take that into consideration to get an accurate result.”
The need for clarity
Even in a situation where happiness was part of the reaction to being deemed ineligible, greater clarity was still desired:“You folks know exactly what you're looking for, but I kind of wish I knew more… and if the answer was the same, fine; but, it just felt like it would have been nice to have one bit of discussion about why it didn't work out… Sort of you know, like when you break up, they say ‘it's really not you, it's me’. You know? I had no idea what the difficulty was.”
“Let them know why they’re not eligible, you know? I mean, I was fine to know, ‘OK, you're not too bad for this’, you know, I'm not needed for this – which is fine. That was great, but, another way of looking at it is, ‘well, why wasn't I?’ and ‘what was the reasoning behind me not being able to do this?’… I probably would have liked to have known more about it… I didn't think loads about it, now, don't get me wrong, I wasn't bad about it or anything… So that wasn't a problem, but just to know the reason behind why I wasn't eligible, I suppose.” - Deborah
Positive impact of a phone call
Likewise:“She was so nice on the phone… She explained everything in detail and then just went through all the questions and I answered as best I could… I was happy that I was told straight away, as well. There was no messing about… it was done perfectly on the phone.”
Responses suggest that the personal connection facilitated by a phone call allows individuals to hear notification of their ineligibility in a more ‘human’ kind of situation. It also provides a chance for individuals to ask questions and gain answers in the immediate, as opposed to waiting on an email or some other form of correspondence. Furthermore, it facilitates an opportunity for researchers to more clearly explain both the rationale for why an individual was ineligible for participation and why such eligibility criteria are important – as suggested in the previous subtheme.“I thought that it was fine because there was no kinda messing or anything… Whatever way you communicated initially, you should communicate back the same way… Like if you if you were talking on the phone and then you sent me an email later about that kind of thing – well look, I just talked to you there on the phone, why didn’t you ring me back and tell me? If you begin with the email that’s fine, but once you’ve made the phone call… it’s more of a personal connection. I know it’s professional, but still it’s more of a personal connection…. A lot of [people with MS] will be living alone or they might have carers; and one phone call could make their day – might be the only contact they had all day with anybody… So, just the fact that you made the effort to tell them ‘thank you for trying. Thank you for applying’.” – Eva
Theme 4: Appreciation for those who express interest
Likewise, according to Colin:“It’d be lovely to find out what the research garnered and the information found out is or what other people have with their MS – what they suffer or what they have, so it would be good to learn the findings or the conclusion of the research, even if it's just even a simple email to all the participants you know, give us a bit of closure and to give us the findings. It would be great… We'd like to know the results because a lot of surveys just do that email of ‘Thank you very much’ and all of that, but you never hear what exactly was achieved.” – Amanda
Second, the individual will feel appreciation if they feel valued. According to Barbara:“I did often wonder, how did that fare out? What were the results? …That would be kind of interesting, that it was actually worthwhile… like, ‘our story is complete now. These were our findings’, rather than maybe stumbling across it on the [MS society] website… So, in reality, people can say thank you and all that, but at the end of the day, you'd rather actually rather see the impact it's actually had.”
Similarly, Grace reinforces this sentiment through emphasising the importance of saying ‘thank you’:“I think everybody always likes to feel valued, don't they? Like personally, I have like a high regard for just basic… like good etiquette. Saying ‘thank you’ means a lot to me… I just personally think it's important to always be appreciative of things so… Just as long as people are thanked for their input, that’s just really valuable.”
On the other hand, if appreciation is not felt, there could be negative consequences for research in the future, for example, Grace warns:“If you do something, it's only manners to say ‘thank you’ for doing that. Thank you for giving your time… a simple email saying ‘thank you for putting yourself forward and we wish you well’ or whatever. It doesn’t have to be flowers and roses – just a very simple ‘thank you’”.
“Someone could very easily say, ‘well, that's the last time I put myself forward’… It doesn't have to… just a very simple thank you and hope that in the future that if anything would come forward… that they would still consider it, because, you know, you may have lost several people through this, who just say, ‘well, never again am I putting myself forward’, because it's not an easy thing to do either… So, yeah, just acknowledge all the people that have come forward… you may need them again”.
Theme 5: Subsequent perceptions and attitudes towards research
Amanda’s response possibly suggests some resentment to being deemed ineligible – veiled by the notion of ‘moving along with life’; perhaps in the sense, that though she was disappointed, upset and even concerned about implications for her ineligibility for future research, she would cope with this and move on with her life, even if she does not totally accept it.“I suppose [being deemed ineligible has changed my attitude] a little, really. I've been mindful of the fact that they mightn’t want me again … So, yeah, that does concern me… I mightn’t be eligible and if I'm not, fair enough, and move along with life.”
Similarly, Barbara sees the value of research and likewise, the value of being a part of it:“I do believe it's brilliant what you’re doing and I believe if it's not for me, someone else has that place, you know what I mean? Someone else gets that place, so I do believe it's very good to be doing research; so, just ‘cause it wasn’t an issue for me at the time, it doesn't mean it mightn’t be in future, so I'd have no problem doing it again.”
Harry also sees the value of research and participation, as well as the powerful impact they can have:“I think it's a valuable piece of work and I would be delighted to be able to give anything that would offer some valuable information or research material… it wouldn't make me not want to engage in something like this again, you know? I'd still be as… even after this – if something else came up that I could offer something to, I would absolutely be happy to get involved.”
Overall, perspectives regarding research and getting involved in the future were all positive, consistent with Theme 2’s concept of ‘doing your bit’, in that interviewees showed appreciation for the value of research. Such value meant a variety of things to each individual, ranging from the potential to help at least one other individual, to helping make a contribution to the community of people living with MS, to helping contribute to the field as a whole. Despite being deemed ineligible for this particular research and, thus, not being able to contribute, their perception of research’s value remained.“Actually, [being deemed ineligible for this trial] makes me a little more resolute to be involved – not in a pushy way like, ‘let me in’, but not necessarily… if it doesn't fit, that's fine, but I'm still here. I still have MS and if I can help I will; and I think that's sort of the modus operandi for many people with MS that – they want to do something… being a part of this will change and improve the cognitive treatment and discussion and understanding for medical professionals as well as the people who have MS, their supportive community, their network, all of those things. And to do that as a layperson, without a medical degree or anything like that, I think it's huge. I think it's very powerful to be told this, that's what you're doing.”