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J. Wilmarth, T. Gardner; Willingness of Patients With Chronic Eye Disease to Participate in Clinical Trials . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1956.
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Purpose: Lack of adequate recruitment to clinical trials may cause trials to be delayed or abandoned. The purpose of this study was to determine the percentage of patients with chronic eye disease willing to participate in a clinical trial and to examine factors significant to a patient’s decision regarding participation in a clinical trial. Methods: A cross–sectional study was survey was performed with patients (n=150) visiting the Penn State Ophthalmology clinic. Those with chronic eye disease were asked to complete a questionnaire of 20 questions during their office visit. Patients were considered to have chronic eye disease, if their condition caused them noticeable vision loss, discomfort, or required ongoing medical treatment without expectation of returning to normal. Willingness to participate in an ophthalmic clinical trial was the outcome variable and was assessed with one yes or no answer. Possible predictor variables include awareness and knowledge of clinical trials, concern about treatment side–effects or receiving placebo, level of perceived visual impairment, satisfaction with current treatment, level of family support, recommendation by a physician, current physical condition, financial factors, transportation, and patient demographics. Questions were yes/no answers or were rated on a Likert scale. Each factor was assessed individually with a chi–square or Wilcoxon test. A logistic regression model was developed for multivariate analysis. Results: 73% (95%CI: 65–81) of patients with chronic eye disease were willing to participate in a clinical trial. Univariate analysis revealed: the potential to improve their eyesight and the eyesight of others, as well as their physicians’ recommendation as important reasons for deciding to participate in a clinical trial. Lack of interest and negative views of clinical research were significant reasons patients may not participate. Multivariate analysis determined that the potential to improve one’s own vision and the vision of others, as well as views on clinical research were significant in the decision to participate. Conclusions: A high percentage of patients with chronic eye disease report a willingness to participate in an ophthalmic clinical trial. Understanding the factors that motivate or inhibit patients may lead to means to increase patient recruitment into clinical trials.
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