A randomised controlled trial of written information: the effect on parental non-concordance with occlusion therapy

Background/aims: It is well documented that non-concordance with occlusion therapy is both substantial and a major factor leading to treatment failure. Parental understanding in previous work has been found to be poor in key areas such as the critical period and effect of age on prognosis. Research in other areas of medicine has shown that the level of understanding can have a direct effect on the level of concordance. The aims of this study were to assess the ability of educational material in the form of a leaflet, to improve parental understanding of amblyopia and occlusion, and subsequently increase concordance. Methods: Parents of children aged between 1 and 7 years receiving a minimum of 1 hour of occlusion for amblyopia were recruited. A randomised controlled trial was undertaken where, on inclusion, the patients were randomised into a leaflet group, whose parents were issued with written educational material, and a control group whose parents did not receive the written information. Patients were paired and matched for age (<2 years difference) and amount of prescribed occlusion (no more than 1 hour difference). Concordance was monitored by a parental diary and knowledge and parental reasons for non-concordance were assessed by a questionnaire. Concordance was analysed by means of a concordance index and by calculating the proportion of non-concordant parents by setting a threshold of concordance at 80%. Results: Parental knowledge was significantly greater in the leaflet group (88% had complete knowledge) compared to the control group (49% had complete knowledge) (p <0.001). There were also differences between the groups in the area of the treatment regimen, with errors only occurring in the control group (three patients occluded the incorrect eye), but this did not reach statistical significance. Concordance was significantly greater in the leaflet group (mean concordance index 0.85) compared to the non-leaflet group mean concordance index (0.71) (p <0.001). Comparison of the proportion of non-concordant parents was also statistically different (p <0.005) at 0.23 (95% CI 0.13 to 0.35) for the leaflet group compared to 0.54 (95% CI 0.41 to 0.67) for the control group. Conclusion: A large proportion of patients would benefit by increasing parental knowledge in key areas such as the critical period importance of occlusion, and potential negative consequences of not treating amblyopia. Written information is a simple, inexpensive, easy to implement, yet effective method of improving parental understanding and subsequent concordance.