Direct Oral Anticoagulants in Cirrhosis Patients Pose Similar Risks of Bleeding When Compared to Traditional Anticoagulation.

BACKGROUND AND AIMS: Direct oral anticoagulants (DOAC) are important new anticoagulant therapies that are not well studied in patients with chronic liver disease. The aim of this study was to compare rates of bleeding in cirrhosis patients treated with DOAC (factor Xa inhibitors: rivaroxaban and apixaban) to those in cirrhosis patients treated with traditional anticoagulation (warfarin and low molecular weight heparin). METHODS: We identified a total of 39 patients with cirrhosis who received anticoagulation therapy over a 3-year period (20 DOAC and 19 traditional anticoagulation) from a research database. Medical records were reviewed to obtain clinical data to compare between the groups. RESULTS: Clinical characteristics between the two groups were similar. There were three documented bleeding events in the traditional anticoagulation group and four bleeding events in the DOAC group (p = 0.9). There were two major bleeding events in the traditional anticoagulation group and one major bleeding event in the DOAC group. There were no documented reports of drug-induced liver injury during this study period. Among all patients, no significant predictors of bleeding were identified using univariate regression and Cox proportional hazard modeling. CONCLUSIONS: This is the first clinical study evaluating the use of DOAC in patients with cirrhosis. DOAC display similar safety characteristics when compared to traditional anticoagulation in patients with cirrhosis and are potentially attractive agents for anticoagulation therapy. Larger studies are now needed to better understand the safety and efficacy of these agents in cirrhosis.

Development of a client-generated health outcome measure for community nursing.

OBJECTIVE: To develop a client-generated outcome measure for use in community nursing. METHOD: Participants for the study were identified from the case load of community health nurses, from a nursing home service and from residents of a retirement village. All participants had a diagnosis of venous leg ulcer (VLU) and/or type 2 diabetes. Preliminary development of the measure involved focus groups of community clients and health professionals, and pilot testing of an existing quality of life (QoL) measure, the Patient-Generated Index. The resulting Client-Generated Index was tested for reliability and validity. RESULTS: The Pearson's correlation coefficient between administration of the CGI at T1 and T2 was 0.526 (n = 51; p = 0.0001). The CGI correlated significantly with four of eight dimensions of the SF-36, and with pain as a clinical marker for VLU r = 0.54 (p = 0.001). Overall, participants with VLU reported a lower QoL (mean CGI score 2.8) compared to those with diabetes (mean CGI score 4.1). CONCLUSIONS: The CGI was developed to measure outcomes in community health settings. Some measures of its reliability and validity are demonstrated and further research is needed to validate the instrument using other client groups. IMPLICATIONS: If routine assessment and evaluation is to contribute to measures of outcome, the instruments need to be concise and acceptable to health care providers. The CGI has all these properties.