Why don’t people take part in MS research?

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Randomised control trials (RCT) can be challenging for researchers to recruit for. You need eligible, consenting participants who ideally can be retained throughout the study. It’s essential to have an appropriate sample size to ensure the study’s validity. How can patient and public involvement (PPI) help to improve research recruitment?

In this study, Dwyer et al. (2021) conducted a qualitative study within a trial (SWAT) to interview people on why, after initially expressing interest in participating in a cognitive occupation based RCT (the host trial), they declined to participate.

Interestingly, as part of another SWAT within the host trial, participants were provided with one of two participant information sheets (PIS), one designed by patients and one designed by researchers. You should be able to tell which is which from the images below (Figures 1 & 2). 

Figure 1: Researcher developed PIS
Figure 2: Patient developed PIS

Interestingly, it didn’t seem to matter which PIS the potential participant received, as those who received the patient designed PIS expressed misinterpretation of the information provided and still declined to participate (Figure 3).

Figure 3: Participant characteristics

This study had two phases, where the researchers first analysed the interview data, and the second phase where researchers asked the PPI panel the same questions as the decliners, presented them with the decliners’ comments and asked them to comment and review the findings. This helped to address the study limitations of having a small sample size, short interviews, and to elaborate on the findings.  

The researchers found that the reasons people declined were mostly personal rather than problems with the study intervention. While participants saw the value of MS research, some misunderstood who the study was for, or what it was about. One theme was the idea that “Ignorance is Bliss” where not taking part in research meant people didn’t have to think about their MS and used denial as a coping mechanism. 

The study incorporated PPI input throughout: the development and piloting of the interview guide, developing a patient PIS and getting PPI feedback in the second phase. It would be interesting to know the PPI involvement at the dissemination phase – sharing the study findings with the wider public. 

What would help you to take part in research?

A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial 

Christopher P Dwyer, Anusha Moses, Fionnuala M Rogers, Dympna Casey, Robert Joyce and Sinéad M Hynes 

https://doi.org/10.1177/13591053211037736 Journal of Health Psychology, August 6 2021

Abstract

The current study-within-a-trial explored individuals’ decisions to decline participation in research trialling a chronic illness-focused therapy (i.e. multiple sclerosis). Four themes were identified from seven semi-structured interviews with participation decliners and were confirmed by the host trial’s Patient & Public Involvement (PPI) panel: acknowledgement of the value of research; ‘fit’ of the study; misinterpretation of participant information; and ‘ignorance is bliss’ – discussed in light of theory and research. This study-within-a-trial extends research on trial recruitment and participation decline; while also suggesting that PPI can be utilised in both a practical and impactful manner.

Disclaimer: Please note that the opinions expressed here are those of the author and do not necessarily reflect the position of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust.

Heather Mah is a PhD researcher at the Wolfson Institute of Population Health at Queen Mary University London exploring the experiences of people with MS and healthcare professionals involved with Patient and Public Involvement (PPI).

About the author

Heather Mah

23 comments

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  • Because whenever I ask for the research to put down in writing that I will be handed my data when requested, they come out with all kind of silly excuses (ethics, randomisation, paperwork, authorisation, etc…)

    No one is getting any of my biomarkers until they agree to hand back information. Full stop.

    (p.s. many of those research were ethically comfortable running clinical trials of agent A against placebo just a few years ago – those same people keep refusing my request)

    Can you perhaps come up with an information-sharing protocol to empower MSers to be more involve in research?

    • Very salient points and well made, Tony. Times have changed and clinicians need to take your concerns into account. Pat on the head paternalism should be confined to history.

      • Plenty of typos, but you get my point.
        This request was turned down by one of the largest research centres in Wales just last week!
        Patients should know better! They are more valuable than they think….

  • Regarding drug trials specifically, I and probably many other people find the possibility of being randomized to placebo or to a low-efficacy comparator drug unacceptable. I would rather take my chances with HSCT abroad than risk having my brain destroyed on interferon beta or teriflunomide for three to four years. I understand why researchers do this (results for their new drug look better when put up against low-efficacy comparator, obviously) but I don’t understand why they are still ALLOWED to do this. I believe in cancer research new treatments are not even approved unless they show themselves to be better than the best currently available treatments, MS research should adopt the same paradigm.

      • I always become sceptical of comparisons when they compare with older drugs that openly known to have a lower efficacy. Is that really the best they can do…? Feels insulting to the people who actually live with ms.

  • I browse the recruiting trials from time to time but haven’t found anything I feel I am eligible for, besides I would need an open mri scanner and won’t risk another LP without a radiographer so I imagine I would be rejected anyway. I have registered with the brain bank but would like to contribute to something before I die.

  • I participated in a Phase 4 safety study, and was dismayed to find that the trial design was structured to ignore my side effects. (Constipation that started after each infusion and lasted progressively longer after each, but was gone by the time I filled out study surveys before my next infusion 6 months later that only asked about the last 3 weeks). Even the trial investigator trivialized my finding because constipation is a known side effect of MS. I’d had MS for 8 years at that point, and my only constipation issues following infusions of that drug…much stronger correlation to the drug than my MS.

    That experience makes me skeptical of trials. I would do one that didn’t have much of a chance of harming me (ie, adding a new exercise or dietary regimen), but I wouldn’t do one that risked me having to be on a lower efficacy drug to juice some pharmaco’s results.

  • So far wasn’t eligible for anything remotely reasonable.

    Personally mainly interested in drug trials and then only if
    a) the control is a sane medication (IOW, one of the mabs or Cladribine)
    b) the drug itself has a sane story / MoA

    Finally not sure if I would consent to another LP.

  • Maybe the better MS therapy’s get, the less people see the need or want to take a risk.

    Any unknown effects may not be worth the risk to some people

  • I was initially excited to be a participant in the TREAT-MS study (escalation vs. high efficacy). Figured it was relatively safe since all of the DMTs were already approved and no placebo. I felt good about participating, since it would provide data to future pwms so they could make more informed DMT decisions, which is a scary and overwhelming experience (particularly on top of just being diagnosed with an incurable disease). Plus I would get more of my neurologist’s time and attention. Win-Win.

    However, when speaking with my doctor about my DMT symptoms and infusion reactions, he dismissed them and said to me that “we need to consider the integrity of the trial”……..“those are not standard side effects”…..blah blah blah. I withdrew, switched neurologists, and changed my DMT, which the trial doctor wanted me to continue taking despite my adverse reactions. Subsequently, I found out the next infusion probably would have killed me, fun times!! I was still left with constant nausea, sporadic anaphylaxis, and mild anemia. Do not even get me started on the issue of all the “speaking fees” the trail doctor was receiving from the drug manufacturer of the DMT he wanted me to continue taking.

    So I guess my point is….the patient and their safety should be the priority, not the integrity of the trial. A little compassion, trust, and more ethical neurologists would be a good start at recruiting more participants. Or to be honest, just in general.

  • I suspect one reason why it may be difficult to recruit people to take part in MS research is the number of false dawns. I’ve lost track of the number of failed remyelination trials. Hundreds if not thousands of MSers who participated and gave up their time for nothing.

    Another reason is that MS is still a mystery – no one knows what kicks it off and drives it. So many research projects look a bit hit and hope ie let’s inject people with worms, let’s try a double dose of Copaxone, let’s try giving Vit d supplements, let’s give women with MS oestrogen supplementation…. MS was four disease then one; it was an inflammatory disease, but now is considered and inflammatory + neuro-degenerative disease; it is a disease where inflammatory cells from the periphery invade the CNS or is the real MS smouldering MS in the CNS?

    Until the MS “experts” understand the disease better and come up with plausible treatment strategies, I suspect many MSers will remain reluctant to participate in MS research.

  • My age ALWAYS precedes me. I too refused to go on a Rebif trial in 2005 in France because I thought I would have to travel out of area (3hr train journey). I also applied to be on a REC. Was invited to observe. My former GP, a good friend stood referee + another excellent referee. She (GP) was disbelieving and incensed when I never heard from them again, as she knows my level of commitment to research.

  • I would love to take part in a trial but I’d say am picky so am not really interested in trying out vitamins, exercise or anything too dangerous. Wouldn’t mind taking TAF.

  • LP and standard MRI, are reasons why I would decline participating in a trial.

    But an open and upright MRI scanner, then I would be more interested.

  • Re. Sharing study finding with the public..

    I’ve been involved as a patient with three studies. At the signing up end I state yes I want to know the study outcomes and please keep me informed when it is published.

    I have never been contacted with details of the published or unpublished results! It’s been six years Even one study I emailed the staff member conducting the research and he just ghosted my email!

    Unfortunately this has put me off participating in studies and the benefits of participation would need to be worth it for me in future.

    • Patients have said they don’t often get informed about outcomes or publications, or acknowledged in publications for studies they have contributed to, which is something researchers need to get better at!

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