Theme 3: offsetting participant burden with the understanding of trial needs
dyslexia, pain, acne, ’
MINOR, ACNE
Study participants reported an’ overwhelmingly positive experience and trust in the research staff, which often led them to overlook minor inconveniences. However, when asked directly about certain aspects of the trial, and more broadly, what could be done to improve their experience there were several suggestions. This third theme explores how trials may be improved from participants' experiences.Some participants described the ‘massive booklet about the study’ (the participant information sheet) they received as part of the introduction to the trial as ‘intense’ and ‘complicated’ which caused them to delay reading it. However, all appeared to understand the purpose of the information sheet. One participant with dyslexia showed consideration for those who may have additional learning needs or were slightly less confident when accessing and understanding the information in the written information sheets.The information sheet..was quite wordy! For people that maybe have additional learning needs, they may have benefitted from maybe bigger text, or different colour text on different coloured background, but that's just me putting a dyslexic mind to it. Emily, age 26It was the combination of the written information and clear explanation with research staff that enabled participants to understand different components of the trial, including randomisation, trial tasks and the possibility of receiving a placebo.When asked about their feelings regarding the possibility of being randomised to placebo, most hoped they were on the active drug but also that they ‘knew exactly what they were signing up for’. Despite the potential disappointment of receiving the placebo, participants felt it was important that they were contributing to finding better treatments for women with acne.I was on the placebo then I still would have taken part in something that ultimately will help people with acne, so yes, I wasn’t upset about being on the placebo either because it’s gone a long way, I hope, to help the medication being more available for other women with acne. Emily, age 26One participant, who believed she was receiving the placebo because the drug she received did not match descriptions of Spironolactone on the internet, committed to the trial for 6 weeks before leaving because she felt it was not a good use of personal time. This individual was subsequently prescribed Spironolactone and found the treatment effective by 3 months.I’ve been dealing with this for the past two to three years now; you get to a point where unfortunately I just didn’t feel that I had that time to spare. As much as I’d like to help medical research, it had gone on long enough for me and I needed a solution by that time. Liz, age 36When asked about the questionnaires, the belief in the research team led many to feel that the volume of data being collected and the questions themselves, although an inconvenience, must be needed and generally accepted as being ‘part and parcel’ of the study.I mean one thing that was a bit of a pain with it, but, again, it’s one of those things where like it’s part of the process and it has to be done, was that one of the questions felt quite redundant and repetitive. Natalie, age 27On reflection, participants felt they could have provided more accurate questionnaire answers to reflect any change if they were able to keep their completed questionnaires.It was quite difficult when I didn’t have my previous set of answers to actually even remember where, on this arbitrary scale, I had placed myself. I was giving a number, but I was like, ‘Is that higher or lower than the number I gave last time?’ because I want it to be lower or I want it to be higher. Shok, age 24Last, although accepted as a consequence of participating in the trial, on-site visits to provide blood samples and collect research drugs from the pharmacy brought up frustrations around hospital parking and the long period such appointments took.to have my bloods taken at phlebotomy took 40 minutes extra out of the appointment time. Linda, age 32The parking at the hospital’s not easy! It’s quite expensive. It was a little bit challenging getting an appointment around work. Kat, age 30