title: The willingness of patients presenting with advanced glaucoma to participate in a trial comparing primary medical vs primary surgical treatment.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK. paul.leighton@nottingham.ac.uk
authors.forename: P
authors.initials: P
authors.lastname: Leighton
authors.forename: A J
authors.initials: AJ
authors.lastname: Lonsdale
authors.forename: J
authors.initials: J
authors.lastname: Tildsley
authors.forename: A J
authors.initials: AJ
authors.lastname: King
mesh_terms: D001007:Anxiety / Q000523:psychology; D001294:Attitude to Health; D005239:Fear; D005260:Female; D017144:Focus Groups; D005901:Glaucoma / Q000523:psychology / Q000628:therapy*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D013508:Ophthalmologic Surgical Procedures / Q000523:psychology; D010358:Patient Participation / Q000523:psychology*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic
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