Surrendering control, or nothing to lose: Parents’ preferences about participation in a randomised trial of childhood strabismus surgery

Abstract

Opposition to surgery and concerns about surrendering control were common obstacles to participation, whereas parents keen for their child to undergo the operation but happy to defer tended to embrace a 'nothing to lose' attitude. Many non-participants would have consented if allowed to choose group, although most of these would have chosen observation. While most parents felt happy with information given and that randomisation was adequately explained, it is of concern that there may be some misunderstanding, which should be addressed in any trial. These findings will inform future trials in childhood exotropia, for example, consideration of preference arms and improving communication. Lessons learnt from the Surgery versus Active Monitoring in Intermittent Exotropia trial could prove valuable to paediatric and surgical trials generally.

Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy)

“…In this embedded study, most of the patients who declined randomisation did so because they had preferences for the surgical method they would be given, which in most cases was the robotic option. The ability of these patients to choose their preferred treatment option in usual care meant that they were unwilling to relinquish control by accepting randomisation and with it the possibility that they might not receive their preferred option, as similarly demonstrated in a feasibility trial of childhood strabismus surgery [ 23 ]. Patient preferences for type of surgery were linked to their understandings of the different risks and benefits attached to each method.…”

“…Following this, a number of patients were explicit about wanting greater input from their consultants when making their treatment decisions [ 23 ]. This preference aligns with research on decision-making preferences in healthcare, which notes that whilst patients welcome the opportunity to participate in decision-making it appears they do not necessarily want to be responsible for decisions, with a sizeable minority to a half preferring passive roles [ 26 – 28 ], compared with a much smaller (and generally better educated, younger) minority who prefer purely autonomous roles [ 27 – 29 ].…”

Paediatric Eye and Vision Research Participation Experiences: A Systematic Review

“…Quality assessments ratings of the two included studies are presented in Additional File 3. Both studies were graded 'good' ('good' range 28-36), with scores of 31 (27) and 35 (26). Despite both studies being 'good', we were conscious of the following limitations when synthesising their ndings.…”

Special considerations in conducting clinical trials of chronic pain management interventions in children and adolescents and their families

“…There has been general reluctance about involving children in trials because of fears of harming children by exposing them to uncertain treatment effects. 9,18,19 A number of strategies may help address concerns about participation in clinical trials including incorporating user-centered design and community-based participatory research approaches that involve patients and other stakeholders in the research process at all levels. This approach can be particularly valuable for addressing disparities in research participation.…”