Safety relevant knowledge of orally anticoagulated patients without self-monitoring: a baseline survey in primary care.

BACKGROUND: Effective and safe management of oral anticoagulant treatment (OAT) requires a high level of patient knowledge and adherence. The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge. METHODS: This is a baseline survey of a cluster-randomized controlled trial in 22 general practices with an educational intervention for patients or their caregivers. We assessed knowledge about general information on OAT and key facts regarding nutrition, drug-interactions and other safety precautions of 345 patients at baseline. RESULTS: Participants rated their knowledge about OAT as excellent to good (56%), moderate (36%) or poor (8%). However, there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps. Half of the participants (49%) were unaware of dietary recommendations. The majority (80%) did not know which non-prescription analgesic is the safest and 73% indicated they would not inform pharmacists about OAT. Many participants (35-75%) would not recognize important emergency situations. After adjustment in a multivariate analysis, older age and less than 10 years education remained significantly associated with lower overall score, but not with self-rated knowledge. CONCLUSIONS: Patients have relevant knowledge gaps, potentially affecting safe and effective OAT. There is a need to assess patient knowledge and for structured education programs. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586.Universal Trial Number (UTN U1111-1118-3464).

Practice nursed-based, individual and video-assisted patient education in oral anticoagulation--protocol of a cluster-randomized controlled trial.

BACKGROUND: Managing oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only. METHODS AND DESIGN: This trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range. DISCUSSION: This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we expect to discover differences in secondary outcomes, such as the time spent in the therapeutic range. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (German Clinical Trials Register): DRKS00000586Universal Trial Number (UTN U1111-1118-3464).

Effect of interleukin-10 gene polymorphisms on clinical outcome of patients with aggressive non-Hodgkin's lymphoma: an exploratory study.

PURPOSE: Current chemotherapy can achieve high response rates in aggressive non-Hodgkin's lymphoma (NHL), but the factors that influence regression and survival remain unknown. The present exploratory study tested the hypothesis whether interleukin-10 (IL-10) polymorphisms predict clinical outcome, leukocytopenia, or infectivity during therapy. IL-10 was chosen because immune alterations are a major risk factor for NHL, and IL-10 is a cytokine involved in inflammatory processes associated with clinical outcome. EXPERIMENTAL DESIGN: Five hundred patients with aggressive NHL treated with CHOP/CHOEP were analyzed for IL-10 gene polymorphisms, including distal loci -7400InDel, -6752AT (rs6676671), and -6208CG (rs10494879) in comparison with proximal loci -3538AT (rs1800890), -1087AG (rs1800896), and -597AC (rs1800872) according to the incidence and outcome of the lymphoma. RESULTS: No differences in allele frequencies or haplotypes were found comparing a cohort of patients with aggressive NHL/diffuse large B-cell lymphoma with a healthy control group. Patients with aggressive NHL characterized by IL-10(-7400DelDel) had shorter overall survival periods compared with the other genotypes (P = 0.004). The 3-year rate is 43.4% for IL-10(-7400DelDel) and 73.4% for IL-10(-7400InIn) and IL-10(-7400InDel) together. A significant increased risk for event-free survival is found for carriers of the genotype IL-10(-6752TT-6208CC-3538AA) (P = 0.047). Multivariate analysis of IL-10(-7400) gene variation in relation to overall survival adjusted to international prognostic index revealed a relative risk of 1.9 for carriers of IL-10(-7400DelDel) (P = 0.037). No associations were found analyzing diffuse large B-cell lymphoma patients separately. CONCLUSION: Our results indicate that IL-10 gene variations could be associated to the clinical course of aggressive NHL, which points out the importance of host factors and respective genetic elements for treatment response.

Educating orally anticoagulated patients in drug safety: a cluster-randomized study in general practice.

BACKGROUND: Orally anticoagulated patients with insufficient knowledge about their treatment have a higher risk of complications. Standardized patient education could raise their level of knowledge and improve time spent within target INR range. METHODS: This cluster randomized trial included 319 anticoagulated patients drawn from 22 general medical practices. 185 patients received patient education, conducted by practice nurses, consisting of a video, a brochure, and a questionnaire; 134 control patients received only the brochure. The primary endpoint was knowledge about treatment six months after the patient education session. The secondary endpoints were time in the INR (international normalized ratio) target range and complications of anticoagulation. RESULTS: Patients in the intervention and control groups were of comparable mean age (73 vs. 72 years). They answered a comparable number of questions correctly before the intervention (6.8 ± 0.2 vs. 6.7 ± 0.2) but differed significantly on this measure at six months (9.9 ± 0.2 vs. 7.6 ± 0.2, mean difference 2.3 questions, 95% confidence interval [CI] 1.5-3.1, p< 0.001). In the six months prior to the intervention, the INR was in the target range 65 ± 2% vs. 66 ± 3% of the time; in the six months afterward, 71 ± 1% vs. 64 ± 3% of the time (mean difference 7 percentage points, 95% CI -2 to -16 percentage points, p = 0.11). The complication rates were comparable in the two groups (12% vs. 16%, p = 0.30). Patients in the intervention group approved of patient education sessions to a greater extent than control patients (87% vs. 56%). CONCLUSION: Patient education was found to be practical, to improve knowledge relating to patient safety in a durable manner, and to meet with the approval of the patients who received it. There was a statistically non-significant trend toward an improvement of the time spent in the INR target range. In view of the major knowledge deficits of orally anticoagulated patients, standardized patient education ought to be made a part of their routine care.