Our experts by experience have come together three times so far and our next (virtual) meeting will be held in August 2020. Meetings are loosely structured and involve brief presentations from researchers on proposed research as well as open-ended discussions.

The following document was developed together within this group with those who have lived experience of fibromyalgia who attended three meetings at the Pain Research Institute, University of Liverpool since 2018. Events were facilitated by Dr Andreas Goebel and Dr Charlotte Krahé.

The aim of this document and initial working protocol is to help increase participation and retention (i.e., reduce drop out) in randomised controlled trials (RCTs) recruiting patients with fibromyalgia. Given the disease burden of fibromyalgia as well as known burdens in taking part in randomised controlled trials (RCTs; see Naidoo et al., 2020), discussions at the two initiatives centered around two main themes: 1) identifying barriers to participating in RCTs  and generating possible ways in which to overcome these barriers; 2) identifying factors likely to facilitate participation and engagement with RCTs.
The Capability, Opportunity, Motivation, Behaviour (COM-B) model of behaviour may be well suited to mapping on barriers and facilitators to participating in RCTs (it has been similarly applied elsewhere; McDonagh et al., 2018). This model proposes that behaviour results from the interaction of capability (e.g., knowledge or skills), opportunity (e.g., social or physical) and motivation (e.g., emotions, beliefs, intentions). These factors have been integrated into the Behaviour Change Wheel (Michie, Atkins, & West, 2014; see figure), a ‘tool kit for designing behaviour change interventions’.
We therefore first organised barriers and facilitators to participating in RCTs, as identified during the meetings, within this framework. We then map action points to trial phases in the shape of a preliminary working protocol.

Physical and psychological capability:
Barriers:
•    Fatigue – fatigue can be more debilitating than pain itself and can have a sudden onset (“like flipping a switch”); some members identified fatigue as being always present, while some described it occurring in episodes; some mentioned that pain increases fatigue, rather than fatigue increasing pain
•    Forgetting appointment times
Actions:
•    Acknowledge and name fatigue as an issue when introducing the trial and commitment involved.
•    Be flexible around scheduling and re-scheduling appointments where possible (see also below).
•    Plan a diary with people (map out future appointments) at the initial appointment

  Note: To apply broadly to different RCTs, discussions were held with the following RCT features in mind: 1) RCTs would involve multiple in-person trial visits (likely 4-5 monthly visits) lasting a few hours each time; 2) Participants would not know whether they were receiving active treatment or a placebo

•    Send participants reminders e.g., by text message. Ask participants about preferred means of communication and stick to these means
Facilitators:
•    Knowledge – understanding what trial participation would involve
Actions:
•    Patient advisory group to collaborate on the wording of all study materials to ensure information is easy to understand
o    Make communication very clear – the word “blinding” [to conditions] was misunderstood by patients and highlighted the need for PPI consultation and/or collaboration in drafting all patient communication
•    Host an information session prior to starting the trial. This session could include information on what to expect, any possible side effects (e.g., an elevated risk of getting other infections if in the treatment arm), whether they can continue to take any medication, how to adapt to improvements etc.  
•    Depending on the trial, could recruit patients who have previously taken part in the pain management programme. Completing this programme was seen as helpful in regards learning new skills, such as pacing, which would be relevant in terms of managing changing symptoms during the trial

Physical opportunity:
Barriers:
•    Attending appointments
o    difficulties getting up and out of the house
o    difficulties travelling to appointments
o    difficulties getting time off work to attend appointments
Actions:
•    If conducting interviews only, the whole interview could be done as a phone call / video call so participants could be in setting where they feel most comfortable (and reduces burden of travel etc.)
•    Do not book appointments too early in the day
•    Where possible, be flexible around booking trial appointments so that partners can attend and bring patients to appointments – evenings and weekend would be preferred and would also help with the issue of getting time off work
•    Book appointments closer together – could all be done as an intensive program within a week, perhaps as an inpatient? This would mean taking one week annual leave, rather than spacing out appointments and finding it difficult to get time off work to attend

 

Social opportunity:
Facilitators:
•    Social support from friends and family including help with motivation to attend appointments
Actions:
•    Implementing a buddy scheme e.g., could be husband – just someone to motivate to attend the sessions (not everyone felt they would need this)
•    Being able to bring a friend / partner to appointments so as not to be bored during the 2-3 hour sessions
Automatic and reflective motivation:
Barriers:
•    Placebo ‘dread’: patients mentioned they might feel “humiliated” if they felt better after placebo treatment; this phenomenon similar to that mentioned in Naidoo et al. (2020; see Figure 2 – “embarrassed to benefit from placebo”)
•    Worry that if treatment does not work, nothing will work
Actions:
•    Carefully develop wording around the sham arm of the trial
•    Could include a little vignette on placebo effects and what placebo means, including e.g., ‘good run’, natural fluctuation…
•    At debrief
o    Reassure participants that they still have fibromyalgia, even if they showed improvements in the placebo arm
o    Tell participants in treatment arm (especially if they felt that treatment did not work) that different treatments work for different people – contextualise results
o    Give participants the choice about whether to find out if they were in treatment or placebo arm
o    Offering the active treatment to participants who were in the sham arm. This might not be feasible or practicable given the amount of time that would be required (essentially the same time commitment again – 8 sessions in 4 weeks); be up front with participants about this

Facilitators:
•    Thinking about reasons for taking part in the research
Actions:
•    Ask participants on initial contact what they hope to gain from taking part in the trial; could highlight that some participants do so to get answers, some to help advance science, and help participants to elucidate own reasons for participating (contextualise it by explaining random allocation etc. and that participants themselves may not personally benefit from taking part)

Preliminary protocol
Action points ordered in temporal sequence:
1)    Preparing study materials (e.g., advert, information sheet, consent form):
a.    Involve patient advisory group in collaborating on the wording of all study materials to ensure information is easy to understand
b.    Acknowledge and name fatigue as an issue when introducing the trial and commitment involved.
c.    Carefully develop wording around the sham arm of the trial
2)    Recruiting participants:
a.    Host an information session prior to starting the trial. This session could include information on what to expect, any possible side effects (e.g., an elevated risk of getting other infections if in the treatment arm), whether they can continue to take any medication, how to adapt to improvements etc.  
b.    Ask participants on initial contact what they hope to gain from taking part in the trial; could highlight that some participants do so to get answers, some to help advance science, and help participants to elucidate own reasons for participating (contextualise it by explaining random allocation etc. and that participants themselves may not personally benefit from taking part)
3)    Initial study appointment:
a.    Do not book appointment too early in the day
b.    Plan a diary with people to map out future appointments (Book appointments closer together – could all be done as an intensive program within a week, perhaps as an inpatient? This would mean taking one week annual leave, rather than spacing out appointments and finding it difficult to get time off work to attend)
c.    Implement a buddy scheme if desired e.g., could be husband – just someone to motivate to attend the sessions (not everyone felt they would need this)
4)    Subsequent study appointments:
a.    Be flexible around scheduling and re-scheduling appointments where possible
b.    Do not book appointment too early in the day
c.    Send participants reminders e.g., by text message. Ask participants about preferred means of communication and stick to these means
d.    Where possible, be flexible around booking trial appointments so that partners can attend and bring patients to appointments – evenings and weekend would be preferred and would also help with the issue of getting time off work
5)    Debrief:
a.    Reassure participants that they still have fibromyalgia, even if they showed improvements in the placebo arm
b.    Tell participants in treatment arm (especially if they felt that treatment did not work) that different treatments work for different people – contextualise results
c.    Give participants the choice about whether to find out if they were in treatment or placebo arm
d.    Offering the active treatment to participants who were in the sham arm. This might not be feasible or practicable given the amount of time that would be required (essentially the same time commitment again – 8 sessions in 4 weeks); be up front with participants about this

References
McDonagh, L. K., Saunders, J. M., Cassell, J., Curtis, T., Bastaki, H., Hartney, T., & Rait, G. (2018). Application of the COM-B model to barriers and facilitators to chlamydia testing in general practice for young people and primary care practitioners: a systematic review. Implementation Science, 13(1), 130. doi:10.1186/s13012-018-0821-y
Michie, S., Atkins, L., & West, R. (2014). The behaviour change wheel: a guide to designing interventions. UK: Silverback Publishing.
Naidoo, N., Nguyen, V. T., Ravaud, P., Young, B., Amiel, P., Schanté, D., . . . Boutron, I. (2020). The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Medicine, 18(1), 6. doi:10.1186/s12916-019-1476-5