Multiphase Research to Develop a Self-report Measure of the Preparedness for Self-Monitoring and Self-Management of Oral Anticoagulation in Adults (The PERSONAE Project)

Scientific Rationale / Background

In every situation where the direct oral anticoagulants are not safe (e.g., adults with multiple morbidities), optimal anticoagulation with warfarin or other vitamin K antagonists (VKAs) like acenocoumarol or phenprocoumon could potentially prevent more than half of the strokes associated with atrial fibrillation and heart valve replacements with a relatively low risk of major bleeding complications. Globally, the proportion of patients taking oral anticoagulants has been rising. For instance, roughly 2 out of 100 Italians are taking oral anticoagulants (both direct and indirect drugs). As a result, regular monitoring of prothrombin time and dose adjustment by a specialized hospital service, primary care physician, registered nurse, nurse practitioner, or pharmacist is necessary for people in treatment with VKAs.

People using long-term oral anticoagulation could currently use point-of-care testing equipment (POCT) to keep track of their blood clotting time, which is represented by the international normalized ratio (INR). Patients who self-test have two options: they can self-manage (change their medication dosage following a predetermined dose-INR schedule) or self-monitor (contact a clinic and ask for the proper dose adjustment). According to several published studies and systematic reviews, these approaches to monitoring anticoagulant medication were found to be as good as or better than routine monitoring by the traditional physician-managed approach.

The quality of anticoagulation control is traditionally expressed by the time in the therapeutic range (%TTR). More time spent by patients within the therapeutic range (higher %TTR) leads to a decline in thromboembolic events with no corresponding rise in risks. In this context, CoaguChek XS and other coagulometers are presently recommended for patients with atrial fibrillation and heart valve disease by the National Institute for Health and Care Excellence (NICE) advice in the UK (NICE diagnostics guidance [DG14]). Similar recommendations are available worldwide, which were triggered by the COVID-19 pandemic.

Although self-monitoring and self-management (self-testing approaches) are supported by a good level of evidence showing their effectiveness and cost-effectiveness, the last Cochrane review on this topic concluded that future research should examine the factors defining the preparedness of people's decisions for self-testing (or not) and should take into account consumer knowledge of self-management, factors that lead people to seek medical attention and detailed medical information (health literacy), self-efficacy or self-confidence in one's ability to self-manage, and perceived or actual support. Assessing the preparedness for self-management and self-monitoring is highly strategic to tailoring the healthcare delivery, boosting its efficiency, and supporting an adequate educational preparation of suitable patients for self-testing. Highlighting the preparedness for self-management and self-monitoring could also be a strategy to boost the need for adopting self-testing approaches in those countries, such as Italy, where the rate of adoption of this approach is undermined by several organizational and professional barriers, such as the costs of POCT and the unjustified fears of losing a direct control on how patients manage their treatment.