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A.I. Troost, R. Troost, O.K. Schwenn, S. Kaiser, U. Luka–Krausgrill, N. Pfeiffer, EGPS–Group; Self–reported Patient Compliance within the European Glaucoma Prevention Study . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4506.
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Purpose:The objective of this study was to assess self–reported compliance of patients within the European Glaucoma Prevention Study (EGPS) using an anonymous compliance questionnaire. Additionnaly we wanted to identify factors interfering with compliance. Methods:We developed an compliance questionnaire, which we validated and modified in a previous pilotstudy. It contains 59 questions with the following domains: demographic data, social background, medical history, information about disease, drop application habits, side effects, health behaviour / coping strategies. This questionnaire was handed out and collected anonymously to a subgroup of 370 study patients of the EGPS. Tests of statistical significance were conducted using regression analysis and Receiver Operating Curves (ROC). The effect of different variables was estimated controlling for the influence on compliance. Additionally for the variables with influence on compliance box plots were used to demonstrate the difference between compliant and noncompliant patients. Results:89% of patients returned the questionnaire. In total 67% of all patients reported not to miss eye drops more than once a week. There was no relevant difference between countries (Germany, Belgium, Portugal, Italy). In most cases (78%) the midday dose was missed. 56% of all patients reported side effects due to study medication. Side effect number one was "burning of the eyes", but 95% of all patients with side effects were not or only hardly disturbed in their everyday live. The only factor with reasonable ability to distinguish between compliant and noncompliant patients that might be used to predict whether a patient is compliant or not is "difficulties in applying eye drops". Conclusion:Compliance of the EGPS patients was very good. The main influencing factor was having difficulties in applying eye drops. Strategies to improve compliance could include giving proper instructions for eyedrop applications. Beside the clinical routine compliance data are critically important for a realistic interpretation of the results of clinical trials. To our knowledge this is the first report of self–reported compliance in a randomized, controlled, clinical, multicenter trial.
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