Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial.

OBJECTIVES: To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home. DESIGN: Randomised, parallel design. SETTING: Medical wards at six hospital sites in southern Ontario, Canada. PARTICIPANTS: Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks. INTERVENTIONS: Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care. OUTCOMES MEASURES: Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation. RESULTS: Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)). CONCLUSION: This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial. TRIAL REGISTRATION NUMBER: NCT02777047.

Coordination of Oral Anticoagulant Care at Hospital Discharge (COACHeD): protocol for a pilot randomised controlled trial.

BACKGROUND: Oral anticoagulants (OACs) are commonly prescribed, have well-documented benefits for important clinical outcomes but have serious harms as well. Rates of OAC-related adverse events including thromboembolic and hemorrhagic events are especially high shortly after hospital discharge. Expert OAC management involving virtual care is a research priority given its potential to reach remote communities in a more feasible, timely, and less costly way than in-person care. Our objective is to test whether a focused, expert medication management intervention using a mix of in-person consultation and virtual care follow-up, is feasible and effective in preventing anticoagulation-related adverse events, for patients transitioning from hospital to home. METHODS AND ANALYSIS: A randomized, parallel, multicenter design enrolling consenting adult patients or the caregivers of cognitively impaired patients about to be discharged from medical wards with a discharge prescription for an OAC. The interdisciplinary multimodal intervention is led by a clinical pharmacologist and includes a detailed discharge medication reconciliation and management plan focused on oral anticoagulants at hospital discharge; a circle of care handover and coordination with patient, hospital team and community providers; and early post-discharge follow-up virtual medication check-up visits at 24 h, 1 week, and 1 month. The control group will receive usual care plus encouragement to use the Thrombosis Canada website. The primary feasibility outcomes include recruitment rate, participant retention rates, trial resources management, and the secondary clinical outcomes include adverse anticoagulant safety events composite (AASE), coordination and continuity of care, medication-related problems, quality of life, and healthcare resource utilization. Follow-up is 3 months. DISCUSSION: This pilot RCT tests whether there is sufficient feasibility and merit in coordinating oral anticoagulant care early post-hospital discharge to warrant a full sized RCT. TRIAL REGISTRATION: NCT02777047.

In vitro analysis of the herbal compound Essiac.

BACKGROUND: Despite the recommendation of the Task Force on Alternative Therapies of the Canadian Breast Cancer Research Initiative, little research has been published on the widely used herbal compound Essiac. We aimed to address this deficiency by conducting a series of assays to determine some of the purported activities of Essiac in vitro. MATERIALS AND METHODS: The activity of Essiac was measured using established assays to assess anti-oxidant, fibrinolytic, anti-microbial, anti-inflammatory, immune modulation, cell-specific cytotoxicity, and impact on cytochrome P450 (CYP450) enzyme pathways. RESULTS: Essiac exhibited significant antioxidant activity in the ABTS assay. A 20-fold dilution of Essiac also exhibited significant immunomodulatory effects, specifically through stimulation of granulocyte phagocytosis, increases in CD8+ cell activation, and moderately inhibiting inflammatory pathways. Essiac exhibited significant cell-specific cytotoxicity towards ovarian epithelial carcinoma cells (A2780). Importantly, a 20-fold dilution of Essiac showed significant inhibition of several CYP450 enzymes, most notably CYP1A2 (37%) and CYP2C19 (24%). Essiac demonstrated dose-dependent inhibition of clot fibrinolysis. CONCLUSION: In vitro analysis of Essiac indicates significant antioxidant and immunomodulatory properties, as well as neoplastic cell specific cytotoxicity consistent with the historical properties ascribed to this compound. Importantly, significant CYP450 and fibrinolysis inhibition were also observed. This is the first comprehensive investigation of the in vitro effects of Essiac.

Application of the precautionary principle by senior policy officials: results of a Canadian survey.

Though use of the controversial precautionary principle in risk management has increasingly been recommended as a guide for the construction of public policy in Canada and elsewhere, there are few data available characterizing its use in risk management by senior public policymakers. Using established survey methodology we sought to investigate the perceptions and terms of application of the precautionary principle in this important subset of individuals. A total of 240 surveys were sent out to seven departments or agencies in the Canadian government. The overall survey response rate was 26.6%, and our findings need to be interpreted in the context of possible responder bias. Of respondents, the overwhelming majority perceived the precautionary principle and the management of risk as complementary, and endorsed a role for the precautionary principle as a general guideline for all risk management decisions. However, 25% of respondents responded that the lack of clarity of the definition of the principle was a limitation to its effective use. The majority of respondents viewed their own level of understanding of the precautionary principle as moderate. Risk managers appeared to favor an interpretation of the precautionary principle that was based on the seriousness and irreversibility of the threat of damage, and did not endorse as strongly the need for cost effectiveness in the measures taken as a precaution against such threats. In contrast with its perceived role as a general guideline, the application of the precautionary principle by respondents was highly variable, with >60% of respondents reporting using the precautionary principle in one-quarter or less of all risk management decisions. Several factors influenced whether the precautionary principle was applied with the perceived seriousness of the threat being considered the most influential factor. The overwhelming majority of risk managers felt that "preponderance of evidence" was the level of evidence required for precautionary action to be instituted against a serious negative event. Overall, the majority of respondents viewed the precautionary principle as having a significant and positive impact on risk management decisions. Importantly, respondents endorsed a net result of more good than harm to society when the precautionary principle was applied to the management of risk.

An in vivo analysis of the herbal compound essiac.

BACKGROUND: Essiac is a herbal compound that has been in common use with cancer patients in North America for over 80 years. Despite its relatively widespread use, there are no peer-reviewed published reports of in vivo studies regarding the use of this compound. MATERIALS AND METHODS: Essiac was administered orally to test animals prior to all experiments. Standard assays to test protection from ethanol-induced gastric ulceration and carbon tetrachloride-induced hepatic injury were performed on Wistar rats. Assays of postglucose-load serum glucose and cellular and humoral immune modulation were conducted on ICR and BALB/C mice, respectively. RESULTS: Essiac demonstrated a modest gastric protective effect via reduction of ethanol-induced gastric ulceration. However, Essiac did not demonstrate significant hepatoprotective, hypoglycemic or immunomodulatory properties. CONCLUSION: Essiac, administered in established in vivo experimental models, did not significantly demonstrate its purported physiological modifying effects.

Impact of African herbal medicines on antiretroviral metabolism.

We examined the effects of two African herbal medicines recommended for HIV/AIDS patients on antiretroviral metabolism. Extracts from Hypoxis and Sutherlandia showed significant effects on cytochrome P450 3A4 metabolism and activated the pregnane X receptor approximately twofold. P-glycoprotein expression was inhibited, with Hypoxis showing 42-51% and Sutherlandia showing 19-31% of activity compared with verapamil. Initiating policies to provide herbal medicines with antiretroviral agents may put patients at risk of treatment failure, viral resistance or drug toxicity.

Knowledge of safety and herb-drug interations amongst HIV+ individuals: a focus group study.

OBJECTIVE: To determine how HIV+ individuals access safety and knowledge of drug interactions related to complementary and alternative medicine (CAM). METHODS: We conducted two separate focus group sessions with HIV+ users of complementary therapies. A total of 8 men participated at an urban health centre. Focus group sessions were audio taped and transcribed verbatim. Analysis was conducted independently and in duplicate, using thematic analysis. RESULTS: All focus group participants described their use of CAM as very important for their health maintenance, giving them a feeling of empowerment in their health care. Potential side effects and safety issues were indicated as major concerns for treatment decisions, but the participant's knowledge of safety issues involved in CAM care for HIV+ patients was limited. The sources used by the participants to gather information regarding safety and interactions with medications were varied but included: their CAM providers, their physicians, books, resources from AIDS Service Organizations, the internet and health food stores. Participants acknowledged that appraising the quality of such information is difficult. CONCLUSIONS: The participants in this study had a strong trust in CAM and used a wide variety of sources to gather information on CAM safety, though their knowledge base was poor. As the use of CAM grows, further research on how to disseminate reliable information on safety and efficacy to this potentially vulnerable population is required.