The willingness of patients presenting with advanced glaucoma to participate in a trial comparing primary medical vs primary surgical treatment

Abstract

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 (415 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.

Structural Change Can Be Detected in Advanced-Glaucoma Eyes

“…Descriptive statistics were used to compare demographic characteristics by group (healthy and glaucoma subjects). χ 3 tests were used to compare categorical variables, and t -tests were used to compare continuous variables. Mixed effects models were used to calculate the mean rates of change (slopes) for global cpRNFL thickness, global MRW thickness, and global macular GCIPL thickness loss from baseline.…”

“…An estimated 10% to 39% of patients present with advanced glaucoma (OAG), and many are asymptomatic at the time of diagnosis. 1 – 3 Moreover, as the population ages and life expectancy increases, a larger proportion of patients will develop advanced disease. Advanced-OAG patients are, however, at the highest risk of becoming functionally impaired due to the disease and are the costliest to treat.…”

Factors influencing the enrollment in randomized controlled trials in orthopedics

“…As we hypothesized, patients were less likely to enroll in studies that compared an operative to a non-operative intervention than studies that compared two or more operative interventions, regardless of the country in which the trial was performed. This may be because patients have strong preferences surrounding the irrevocable nature of the decision to undergo surgery and are reluctant to leave this decision to chance [1] , [9] . Alternatively, patients may have a strong preference to undergo a surgical procedure that is the standard of care.…”

“…As suggested by several recent trials that have helped shape treatment recommendations for common orthopedic procedures, RCTs are pivotal for investigating the efficacy of surgical procedures or their components [5] , [6] , [7] . It may be challenging to enroll subjects into RCTs that randomly allocate subjects to different types of procedures, since surgery is irrevocable [8] , [9] . Previous studies have identified a number of reasons why an eligible individual may decline to participate in an RCT, such as a preference for one form of therapy over another, difficulty understanding the concept of an RCT, or discomfort with the idea of being randomized [1] , [10] , [11] , [12] , [13] .…”

Trends in the Retinal Nerve Fiber Layer Thickness Changes with Different Degrees of Visual Field Defects

“…Primary open-angle glaucoma (POAG) is a common clinical eye disease that is irreversible and causes blindness; it is a type of optic neuropathy characterized by the loss of retinal ganglion cells and their axons [1]. An estimated 10% to 39% of patients with POAG present with advanced glaucoma, and many are asymptomatic at the time of diagnosis [2][3][4].…”