The expert in hemostasis and thrombosis in the Italian health system: role and requirements for a specific clinical and laboratory expertise

Hemorrhagic and thrombotic diseases are highly heterogeneous disorders that may affect a large proportion of the population, as in the case of patients taking antithrombotic drugs. The appropriate management of such conditions requires the availability of specific diagnostic assays, together with knowledge of the possible clinical syndromes and of their appropriate treatment. This can only be achieved through second-level specialized laboratories supervised by trained personnel. Such diagnostic and therapeutic organization is not widely available in Italy except in a very limited number of those large hospitals that are centers of excellence on a national scale. Increasing the availability of such resources would be of great benefit to patients, and could also be cost-effective for the national healthcare system. This document is promoted by the Italian Society for the Study on Hemostasis and Thrombosis (SISET) and by the main Italian scientific societies involved in the field during the years 2011-2012. It aims to identify the level of scientific and professional training required to define a physician as a Hemostasis and Thrombosis Expert, graded according to the levels of skill required for different clinical settings

Center-related determinants of VKA anticoagulation quality: A prospective, multicenter evaluation

Background: Center-specific TTR (c-TTR) is a measure reporting the mean patient TTR within an anticoagulation clinic describing the quality of anticoagulant monitoring offered by that clinic. c-TTR has a considerable between-center variation, but its determinants are poorly understood. Objectives: We aimed at evaluating which clinical, procedural or laboratory factors could be associated with c-TTR variability in a multicenter, observational cross-sectional study over a five-year period. Patients/Methods: Data from 832,204 individual patients followed for VKA therapy in 292 Centers affiliated with the Italian Federation of Anticoagulation Clinics (FCSA) were analyzed. c-TTR was computed based on the TTR of patients followed at each Center, and a mixed linear regression model was used for a predefined set of explanatory variables. Results: The Center next-visit interval ratio (the mean number of days after a visit with an INR outside the therapeutic range, divided by the days after a visit with an INR within the therapeutic range), the Center mean patient INR and the Center laboratory performance at EQA proficiency testing were the only variables that were independently associated with c-TTR (β- coefficients -17.32, 9.67, and -0.11, respectively; r2 = 0.635). Conclusions: These findings suggest that c-TTR associates with proactive strategies aimed at keeping patients very close to their target INR with a prompt re-evaluation of those patients with under- or over-therapeutic INR

Center-Related Determinants of VKA Anticoagulation Quality: A Prospective, Multicenter Evaluation.

Center-specific TTR (c-TTR) is a measure reporting the mean patient TTR within an anticoagulation clinic describing the quality of anticoagulant monitoring offered by that clinic. c-TTR has a considerable between-center variation, but its determinants are poorly understood.We aimed at evaluating which clinical, procedural or laboratory factors could be associated with c-TTR variability in a multicenter, observational cross-sectional study over a five-year period.Data from 832,204 individual patients followed for VKA therapy in 292 Centers affiliated with the Italian Federation of Anticoagulation Clinics (FCSA) were analyzed. c-TTR was computed based on the TTR of patients followed at each Center, and a mixed linear regression model was used for a predefined set of explanatory variables.The Center next-visit interval ratio (the mean number of days after a visit with an INR outside the therapeutic range, divided by the days after a visit with an INR within the therapeutic range), the Center mean patient INR and the Center laboratory performance at EQA proficiency testing were the only variables that were independently associated with c-TTR (β-coefficients -17.32, 9.67, and -0.11, respectively; r2 = 0.635).These findings suggest that c-TTR associates with proactive strategies aimed at keeping patients very close to their target INR with a prompt re-evaluation of those patients with under- or over-therapeutic INR

Boxplot of Center TTR by quintiles of Center mean patient INR, showing an inverse U-shaped relationship between mean patient INR and TTR.

<p>Boxplot of Center TTR by quintiles of Center mean patient INR, showing an inverse U-shaped relationship between mean patient INR and TTR.</p

Characteristics of the patients included during the five years study.

<p>Characteristics of the patients included during the five years study.</p

Relationship between Center TTR and Center Next Visit Interval (NVI) ratio, which is defined as the ratio of days between visits when the INR was below or above range divided by days between visits when the INR was in the therapeutic range.

<p>Relationship between Center TTR and Center Next Visit Interval (NVI) ratio, which is defined as the ratio of days between visits when the INR was below or above range divided by days between visits when the INR was in the therapeutic range.</p

Multivariate analysis of determinants of Center TTR using multilevel mixed regression to adjust for repeated measures for each Center, after backward elimination.

<p>All results are adjusted for study year.</p

Boxplot of Center TTR by study year, showing the overall increase of anticoagulation quality over the years.

<p>Boxplot of Center TTR by study year, showing the overall increase of anticoagulation quality over the years.</p