Academic journal article Applied Health Economics and Health Policy

Organization and Estimated Patient-Borne Costs of Oral Anticoagulation Therapy in Italy: Results from a Survey

Academic journal article Applied Health Economics and Health Policy

Organization and Estimated Patient-Borne Costs of Oral Anticoagulation Therapy in Italy: Results from a Survey

Article excerpt


Oral anticoagulation therapy (OAT) is the mainstay in the prevention and treatment of several conditions caused by, or at elevated risk of, thrombosis. The effectiveness of the OAT regimen, i.e. its ability to maintain the international normalized ratio (INR) within a pre-specified range, has to be periodically monitored, and adjusted as necessary, in order to offer the best possible benefit : risk ratio (decreased risk of unwanted clotting vs increased risk of bleeding complications).

The management of the OAT patient population, 600 000-1 000 000 patients in Italy,[1-2] poses organizational challenges that can be approached with different modalities.

In Italy, different organizational models coexist, and a large proportion of OAT patients are managed using a traditional, clinic-based strategy. However, the availability of near-patient devices allows patients to monitor their clotting time themselves and deliver results to a physician, or even decide on treatment adjustments themselves (patient self-testing and patient self-management, sometimes collectively referred to as patient self-monitoring strategies). Patient self-monitoring strategies have been shown to be clinically at least equivalent[3] and economically superior[4-8] to clinic-based strategies in several studies. These results are interesting and promising but cannot be directly transferred to the Italian setting, because of both methodological issues (e.g. patient selection in clinical trials) and organizational differences. Moreover, adaptations of existing pharmacoeconomic modelling studies are also hampered by the substantial lack of knowledge on the current patterns of OAT management and their respective costs.[9] Thus, the aim of this study was to collect patient-level information from Italian patients regarding current OAT management strategies, associated costs, self-reported satisfaction with current management and preference for potential alternatives. This paper focuses on organizational and cost issues; preferences will be reported in a separate paper.


The Instrument

The study was conducted in July to November 2008 by means of a questionnaire developed ad hoc and administered to patients face-to-face by volunteers of the main Italian OAT patients association (Associazione Italiana Pazienti Anticoagulati [AIPA]). The only inclusion criterion was current OAT, regardless of the underlying condition, age, sex and duration of therapy. In July 2008, the questionnaires were sent out to all AIPA centres throughout Italy, which were instructed to administer them to all consenting patients.

The questionnaire was composed of an introductory section exploring general characteristics (age, sex, employment, association with AIPA) and 19 further questions, divided into three broad domains. These three domains were OAT regimen (underlying diagnosis, anticoagulant drug, target INR, duration); organization and logistics of OAT management (location and technique of blood sample collection, modality of results delivery, time/location concomitance of specimen collection and OAT adjustment, monitoring frequency, ranges of distances covered and times dedicated for monitoring and adjustment, working time loss ranges for the patient and their companion/caregiver, and other costs related to OAT monitoring); and personal judgement of current and alternative OAT management options. The questionnaire was completely anonymous; participation in the survey was voluntary and not remunerated.


Returned questionnaires were collected, checked for the inclusion criterion (current OAT) and tabulated in a spreadsheet. Inconsistent (e.g. monitoring and adjustment in the same facility but different distances) and/or contradictory (e.g. retired patient claiming time off work) data were discarded.

For each item explored, descriptive statistics were calculated and presented in the form of a distribution among available options for categorical variables and as the mean ± SD for continuous variables. …

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