Aim: The aim of this study is to examine the attitudes of patients, who presented with advanced glaucoma in at least one eye, to participation in a randomised prospective trial comparing primary medical treatment with primary surgical treatment for advanced glaucoma.
Methods: Patients who had presented with advanced glaucoma (>15 dB loss mean deviation on Humphrey visual field testing) in at least one eye were asked to participate. Five focus groups comprising of 4-8 patients and consisting of 29 patients in total were undertaken. The group interviews were conducted by two experienced qualitative researchers, an ophthalmic clinician was present to clarify technical issues. The focus group discussions were taped and transcribed in full, and analysed through a process of familiarisation, open (inductive) coding, theme generation, theme refinement, and thematic mapping.
Results: Three overarching themes were identified: (1) the extent of patients' knowledge, (2) anxieties about surgery, and (3) concerns about compromised care due to trial involvement; these themes were further classified into eight sub-themes.
Conclusions: Patients' willingness to participate in randomised clinical studies is significantly connected to their level of comprehension and insight about the medical condition, its treatment, and the research process; misunderstandings about any of these aspects may act as a significant barrier to trial recruitment. Recruitment rates for future randomised trials may be enhanced by ensuring that patients have full and accurate information about the treatment alternatives, and that uncertainty exists for best patient outcomes between treatment options, and reassuring potential participants that the research process, in particular randomisation, will not compromise clinical care.