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Background: Despite the implementation of new regulations to increase organ and tissue donation, few regulations have been evaluated for their effectiveness in achieving this goal. Recently, the province of Quebec (Canada) modified Bill 125 to make notification of all potential donors to donation stakeholders mandatory in clinical settings. The purpose of this study was to evaluate the effectiveness of this new regulation on the potential ocular tissue donor notification rate in clinical settings. Methods: This study used a pre-post design to determine the impact of the new regulation on the ocular tissue donor notification rate. The notification rate of potential ocular tissue donors was measured objectively among 26 departments of five clinical settings over a period of four months, beginning three months after the adoption of the new regulation (post-test measure); the pre-test value consisted in the notification rate during the same four-month period in the previous year. Data were analyzed using generalized estimating equations. Results: The notification rate of ocular tissue donors prior to the change in the regulation (21.0%) did not increase significantly after legislative changes (21.6%) (χ2=0.01, p=0.93). Conclusion: Despite making the notification of potential organ and tissue donors mandatory, the new regulation did not change the notification rate of ocular tissue donors. Policy formulation and policy implementation are two possible reasons for this failure. In particular, it is suggested that working closely with all relevant stakeholders at the time of policy formulation should facilitate implementation strategies.

Evaluating the Effectiveness of an Organ and Tissue Donation Regulation on Ocular Donor Notification Rates in Clinical Settings