Trial participation as avoidance strategy: a qualitative study

Abstract

BackgroundTrial participation decisions are often influenced by expectations of potential benefit. Attention has focused on trial participation as a means of securing something seen as desirable, such as experimental treatment. In contrast, we consider a case in which one trial arm involved receiving less than usual care. We explore how this influenced participants’ decisions to participate.MethodsSemi‐structured interviews with 29 women participating in a pilot trial comparing invasive urodynamic testing (typically normal care) to basic clinical assessment with non‐invasive tests, prior to surgical treatment for stress urinary incontinence. Analysis was based on the constant comparative method.ResultsInvasive tests were something many were aware of and worried about. Participants understood that trial participation meant they might avoid having these tests, and for about one‐third, this was the primary factor motivating participation. A further third mentioned they were not looking forward to tests (if allocated to them) or were lucky to have missed them (if allocated to basic clinical assessment). None of the women appeared to have discussed their desire to avoid having invasive tests with their clinicians.ConclusionsIn contrast to cases in which trial participation is motivated by the wish to secure an intervention not otherwise available, this study reports the opposite – trial participation as an opportunity to avoid having something regarded as undesirable. The option to decline a particular intervention should always be available, and care must be taken to ensure that potential participants are aware that trial participation is not the only possible means of avoidance.

The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using meta-ethnography

“…Of the 49 potential studies, 23 did not meet the study aims and were excluded. Reasons for excluding the studies included not a surgery/non-surgery comparison ( n = 14) [ 43 – 56 ], conference abstract only ( n = 4) [ 57 – 60 ] and protocol/methods paper ( n = 5) [ 61 – 65 ]. Twenty six studies [ 66 – 91 ] were included in the review.…”

A meta‐synthesis of qualitative studies on stress urinary incontinence in women for the development of a Core Outcome Set: A systematic review

“…Women using Internet‐based information and treatment resources for SUI mentioned that they gained awareness on dealing with the incontinence and learnt about new tools to control SUI (“ And when you know how, then it is easier to do it ”) 32 . In one paper, which analyzed the participation of women with SUI in clinical trials, as an avoidance strategy for invasive testing before surgery for SUI, women put into light the weight of their awareness, as well as the lack of decision‐making power on having urodynamics as part of the preoperative assessment 33 . When asked whether they thought that if they were not part of a trial they would had definitely had to have urodynamics one interviewed patient was convinced she had to do it that way (“ Yes, I would have done ”) 33 …”

“…Six out of seven included articles focused on treatment‐related aspects of SUI, and they were stratified by subthemes as follows: three articles 27,28,30 assessed the expectations of treatments, four articles 27,28,31,32 focused on the choice of treatment for SUI, and one study looked into investigations before treatment 33 …”

“…In the context of SUI onset following childbirth, some women mentioned that it “ would have been better to be prewarned because it came as a shock. Took a while to click on to what was happening (…) only advice is that it would be useful to be alerted to it as a possibility that it can happen .” 31 One study highlighted the views of women participating in a clinical trial on specific investigations such as urodynamics before receiving treatment for SUI 33 …”

“…You don't talk about it with anyone .” 32 Selecting the investigations a patient should undergo before a procedure for SUI should be based on a solid understanding of the implications of each investigation by the patient. Women flagged the fact that they did not have the chance to discuss their desire to avoid invasive testing before surgery for SUI 33 …”