Original articleDeterminants of informed consent in a cataract surgery clinical trial: why patients participate
Section snippets
Methods
Respondents were sampled consecutively among patients who were approached to participate in a prospective cataract clinical study titled A Randomised, Single Centre Study of the Equivalence of Two Intraocular Lenses Used in Cataract Surgery at the Royal Victorian Eye and Ear Hospital in Melbourne, Australia, between January 2008 and June 2009. The Human Research Ethics Committee of the hospital approved the study. Intention to participate in the cataract clinical trial was determined after
Results
Over the course of study, 40 patients were asked to participate. All 40 patients agreed to participate and were interviewed by questionnaire. Of these 40 patients, 20 (50%) consented to enter the randomized controlled clinical trial assessing IOLs, and 20 (50%) declined. There were no statistically significant differences between the 2 groups in terms of age, sex, level of education, or annual income (Table 1).
Of those who did not consent, 14 (74%) reported that they had completed primary or
Discussion
In our study, the expected comforts and discomforts of participating in the trial differed significantly between consenting and nonconsenting patients. The factors that were independently associated with patients' consent were the amount of time required and the burden imposed on daily life resulting from participation in the trial. Demographic variables did not have any significant impact on a patients' decisions to accept or decline entry into the trial. Most patients who entered the trial
Disclosure
The authors have no proprietary or commercial interest in any materials discussed in this article.
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