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Education of patients is thought to be key to high-quality oral anticoagulant (OAC) medication management. Theoretically, improving patients' knowledge should improve their self-management skills and adherence. The study's objective was to explore the opinions of healthcare providers and patients on the desired content and format of patient education on OACs, in addition to perceived barriers to high-quality patient education.We applied qualitative descriptive methods in a focus group study on OAC management. Five focus group discussions were conducted in two health regions in Southwestern Ontario from 2017 to 2018 with 19 patients, 7 caregivers and 16 healthcare providers (physicians, nurses and pharmacists). During the focus groups, participants discussed their experiences with OAC education and made suggestions about the content and format for patient education on OACs. Transcripts were analysed using conventional content analysis.We identified the five themes of patient education on OAC management: content of OAC education (rationale, risk and appropriate drug administration methods), the best times for providing OAC education (time of OACs initiation along with continuing education), preferred education delivery strategies (case management targeted patient information summaries from authoritative sources such as Thrombosis Canada and video education), patient and community pharmacist engagement in OAC education, and perceived barriers to optimal patient education (patients depending too much on their healthcare providers for advice, the limited time patients spend with healthcare providers, gaps in clear communication between providers and the lack of a nationally or provincially coordinated OAC management programme).Our findings suggest that patients, caregivers and healthcare providers support the need for education on OACs, including for patients taking DOACs. Specific important content and proper education format are needed. The optimal combination of content, format, duration, timing and sources for OAC education requires further research.

Objective Structured Clinical Examinations (OSCEs) and written tests are commonly used to assess health professional students, but it remains unclear whether the additional human resources and expenses required for OSCEs, both in-person and online, are worthwhile for assessing competencies. This scoping review summarized literature identified by searching MEDLINE and EMBASE comparing 1) OSCEs and written tests and 2) in-person and online OSCEs, for assessing health professional trainees’ competencies. For Q1, 21 studies satisfied inclusion criteria. The most examined health profession was medical trainees (19, 90.5%), the comparison was most frequently OSCEs versus multiple-choice questions (MCQs) (18, 85.7%), and 18 (87.5%) examined the same competency domain. Most (77.5%) total score correlation coefficients between testing methods were weak ( r < 0.40). For Q2, 13 articles were included. In-person and online OSCEs were most used for medical trainees (9, 69.2%), checklists were the most prevalent evaluation scheme (7, 63.6%), and 14/17 overall score comparisons were not statistically significantly different. Generally low correlations exist between MCQ and OSCE scores, providing insufficient evidence as to whether OSCEs provide sufficient value to be worth their additional cost. Online OSCEs may be a viable alternative to in-person OSCEs for certain competencies where technical challenges can be met.

Background Many Canadians face substantial out-of-pocket charges for prescription drugs. Prior work suggests that this causes some patients to not take their medications as prescribed; however, we have little understanding of whether charges for prescription medicines lead patients to forego basic needs or to use more health care services. Our study aimed to quantify the consequences of patient charges for medicines in Canada. Methods As part of the 2016 Canadian Community Health Survey, we designed and fielded cross-sectional questions to 28 091 Canadians regarding prescription drug affordability, consequent use of health care services and trade-offs with other expenditures. We calculated weighted population estimates and proportions, and used logistic regression to determine which patient characteristics were associated with these behaviours. Results Overall, 5.5% (95% confidence interval 5.1%-6.0%) of Canadians reported being unable to afford 1 or more drugs in the prior year, representing 8.2% of those with at least 1 prescription. Drugs for mental health conditions were the most commonly reported drug class for cost-related nonadherence. About 303 000 Canadians had additional doctor visits, about 93 000 sought care in the emergency department, and about 26 000 were admitted to hospital at the population level. Many Canadians forewent basic needs such as food (about 730 000 people), heat (about 238 000) and other health care expenses (about 239 000) because of drug costs. These outcomes were more common among females, younger adults, Aboriginal peoples, those with poorer health status, those lacking drug insurance and those with lower income. Interpretation Out-of-pocket charges for medicines for Canadians are associated with foregoing prescription drugs and other necessities as well as use of additional health care services. Changes to protect vulnerable populations from drug costs might reduce these negative outcomes.

Direct oral anticoagulants (DOACs) have expanded the armamentarium for antithrombotic therapy. Although DOAC-related major bleeding was associated with favorable outcomes compared with warfarin in clinical trials, warfarin effects were reversed in 40% of cases, raising concerns about the generalizability of this finding.Consecutive patients ≥ 66 years presented to five tertiary care hospitals across three cities in Ontario, Canada from October 2010 to March 2015 with diagnoses that included hemorrhage. Charts were screened for association with DOAC or warfarin use; eligible cases were abstracted and linked to administrative databases.Among 19,061 records screened, 2,002 (460 receiving DOAC, 1,542 receiving warfarin) were eligible. Reversal agents (72.9% vitamin K, 40.7% prothrombin complex concentrates) were frequently used in warfarin bleeding events. Red blood cell transfusions occurred more often in DOAC bleeding events than in warfarin events (52.0% vs 39.5%; adjusted relative risk [aRR], 1.32; 95% CI, 1.19-2.47). However, units of blood products transfused were not different between the two groups. Thirty-four DOAC cases (7.4%) received activated prothrombin complex concentrates or recombinant factor VIIa. In-hospital mortality was lower following DOAC bleeding events (9.8% vs 15.2%; aRR, 0.66; 95% CI, 0.49-0.89), although differences in 30-day mortality did not reach statistical significance (12.6% vs 16.3%; aRR, 0.79; 95% CI, 0.61-1.03).In this unselected cohort of patients with oral anticoagulant-related hemorrhage with high rates of warfarin reversal, in-hospital mortality was lower among DOAC-associated bleeding events. These findings support the safety of DOACs in routine care and present useful baseline measures for evaluations of DOAC-specific reversal agents.

Clinical decision support (CDS) for atrial fibrillation is expected to ease the implementation of often-complex guidelines for atrial fibrillation and anticoagulation. Most clinical decision support systems (CDSS) for anticoagulation are stand-alone systems that do not integrate with electronic medical records (EMR). We have developed an architecture that consists of a computerized CDS that can integrate with multiple EMRs and multiple patient health records (PHRs). The design process revealed some significant issues that were resolved through systematic business/clinical analysis and creative clinical design in the diagnostic and treatment domains. Key issues identified and resolved include: 1) how to correctly allocate existing patients into various CDSS states (e.g., MAINTENANCE, HOLD, DISCONTINUE, etc), 2) identify when a patient becomes eligible for CDSS guidance over time, 3) how the CDSS maintains information about the patient's anticoagulation state and 4) how to transform vague human-readable concepts to explicit computable concepts. The management of anticoagulation for atrial fibrillation is no easy task and we believe our architecture will improve patient care at all levels and ultimately better balance the reduction of stroke risk while minimizing harms from major bleeding. In addition, the architecture presented is scalable to other treatment guidelines and is scalable to multiple EMRs and PHRs, making it suitable for use in a platform approach.

The objective of the report was to review the evidence on the impact of health information technology (IT) on all phases of the medication management process (prescribing and ordering, order communication, dispensing, administration and monitoring as well as education and reconciliation), to identify the gaps in the literature and to make recommendations for future research.We searched peer-reviewed electronic databases, grey literature, and performed hand searches. Databases searched included MEDLINE®, Embase, CINAHL (Cumulated Index to Nursing and Allied Health Literature), Cochrane Database of Systematic Reviews, International Pharmaceutical Abstracts, Compendex, Inspec (which includes IEEE Xplore), Library and Information Science Abstracts, E-Prints in Library and Information Science, PsycINFO, Sociological Abstracts, and Business Source Complete. Grey literature searching involved Internet searching, reviewing relevant Web sites, and searching electronic databases of grey literatures. AHRQ also provided all references in their e-Prescribing, bar coding, and CPOE knowledge libraries.Paired reviewers looked at citations to identify studies on a range of health IT used to assist in the medication management process (MMIT) during multiple levels of screening (titles and abstracts, full text and final review for assignment of questions and data abstrction). Randomized controlled trials and cohort, case-control, and case series studies were independently assessed for quality. All data were abstracted by one reviewer and examined by one of two different reviewers with content and methods expertise.40,582 articles were retrieved. After duplicates were removed, 32,785 articles were screened at the title and abstract phase. 4,578 full text articles were assessed and 789 articles were included in the final report. Of these, 361 met only content criteria and were listed without further abstraction. The final report included data from 428 articles across the seven key questions. Study quality varied according to phase of medication management. Substantially more studies, and studies with stronger comparative methods, evaluated prescribing and monitoring. Clinical decision support systems (CDSS) and computerized provider order entry (CPOE) systems were studied more than any other application of MMIT. Physicians were more often the subject of evaluation than other participants. Other health care professionals, patients, and families are important but not studied as thoroughly as physicians. These nonphysicians groups often value different aspects of MMIT, have diverse needs, and use systems differently. Hospitals and ambulatory clinics were well-represented in the literature with less emphasis placed on long-term care facilities, communities, homes, and nonhospital pharmacies. Most studies evaluated changes in process and outcomes of use, usability, and knowledge, skills, and attitudes. Most showed moderate to substantial improvement with implementation of MMIT. Economics studies and those with clinical outcomes were less frequently studied. Those articles that did address economics and clinical outcomes often showed equivocal findings on the effectiveness and cost-effectiveness of MMIT systems. Qualitative studies provided evidence of strong perceptions, both positive and negative, of the effects of MMIT and unintended consequences. We found little data on the effects of forms of medications, conformity, standards, and open source status. Much descriptive literature discusses implementation issues but little strong evidence exists. Interest is strong in MMIT and more groups and institutions will implement systems in the next decades, especially with the Federal Government's push toward more health IT to support better and more cost-effective health care.MMIT is well-studied, although on closer examination of the literature the evidence is not uniform across phases of medication management, groups of people involved, or types of MMIT. MMIT holds the promise of improved processes; clinical and economics studies and the understanding of sustainability issues are lacking.

The use of premedication to prevent acute transfusion reactions has been estimated to occur in 50% to 80% of transfusions. While this practice has some biologic rationale, few clinical studies have been performed to assess the efficacy of this practice, and the methodologic quality of these studies is variable. The primary objective of this study was to describe current practices regarding transfusion premedication to prevent febrile nonhemolytic transfusion reactions, mild allergic transfusion reactions, and transfusion-associated circulatory overload.We conducted an observational retrospective chart review of a stratified random sample of 324 transfusions that took place over a 6-month period. Data were abstracted from medical records and then scanned into a database for analysis. We calculated inter- and intraobserver agreement on key abstracted data to estimate assessment error. A two-phase adjudication process was used to determine whether or not medications given before the time of each transfusion were intended as premedications.Of the transfusions sampled, 1.6% (95% confidence interval, 0.4-3.9) were associated with premedication medications to prevent an acute transfusion reaction. Inter- and intraobserver reliability in the abstraction of key data points was good. Good agreement in adjudicator classification of outcomes was achieved only when adjudicators were provided with patient source documents.Premedication use was infrequent and much less common than previously reported. Improved methods of capturing transfusion premedication, which likely require prospective assessments, are needed for future research studies.

E-health interventions require rigorous evaluation, preferably within a randomized trial. Health technology assessment and complex intervention methodologies exist, but are often not used in health informatics research. We propose a framework of methodologic issues which should be considered for every e-health intervention.

The issue of therapeutic equivalence has been a source of controversy in Canada since the approval of generic warfarin products in 2000.We surveyed Ontario patients and physicians on perceptions of generic warfarin and brand substitution.Self-administered questionnaires employed 7.0-point Likert scales of agreement. Patient participants were drawn from a thromboembolism clinic in Hamilton, Ontario. Physician participants were from a random sample of 375 Ontario family physicians, internists, cardiologists and hematologists.Eighty-one patients responded: 52% female, mean age 63.4 years and 63% brand-name warfarin users. Overall, 33% of respondents agreed or strongly agreed that they would feel comfortable taking generic warfarin. However, seventeen percent agreed or strongly agreed that generic warfarin was neither as safe nor as effective as brand-name warfarin, with this view more common amongst patients taking brand-name than those taking generic warfarin. One hundred and ten (29.3%) physicians returned the survey--29% females, mean age 45.3 years, 22% family physicians. Forty-four percent agreed or strongly agreed that they would rather prescribe brand-name than generic warfarin for patients starting warfarin therapy, while 40.7% agreed or strongly agreed that they would not feel comfortable switching from brand-name to generic warfarin. However, only 19.4% of physicians who had switched patients from brand-name to generic warfarin actually reported difficulties in managing the switch.While most patients and physicians appear to have accepted the principle of therapeutic equivalence of generic and brand-name warfarin, a sizable minority has concerns that could influence prescribing and compliance.

Two programs to reduce expenditures for common gastrointestinal drugs were introduced simultaneously by British Columbia (BC) Pharmacare in 1995. Reference-based pricing restricted reimbursement for all histamine-2 receptor antagonists (H2RAs) to the cost of the least expensive H2RA available, generic cimetidine. Special authority restricted reimbursement for proton pump inhibitors (PPIs) to patients who met certain eligibility criteria. We evaluated the effect of reference-based pricing for H2RAs and special authority for PPIs on dispensing and reimbursement for senior citizen beneficiaries of BC Pharmacare.Itemized monthly claims data for upper gastrointestinal drugs were obtained from BC Pharmacare for all beneficiaries 65 years of age or older. Periods before and after implementation of reference-based pricing and special authority were compared with respect to defined daily doses dispensed per 100,000 beneficiaries, BC Pharmacare reimbursement per 100,000 beneficiaries, BC Pharmacare reimbursement per defined daily dose and beneficiary contributions per defined daily dose. We used regression models to project forward trends in expenditures observed before implementation of the new policies and hence to estimate accrued cost savings.Before reference-based pricing and special authority, the numbers of defined daily doses that were dispensed and total BC Pharmacare reimbursements for H2RAs appeared to be declining gradually, whereas those for PPIs were rising. With reference-based pricing, the monthly defined daily dose of cimetidine dispensed increased more than 4-fold, to 116,257 per 100,000 beneficiaries, while those of other restricted H2RAs decreased by more than half, to 50,927 per 100,000 beneficiaries. Special authority immediately reduced the dispensed volumes of PPIs by one-fourth, but growth in volume then appeared to resume at its previous rate. The estimated annualized cost savings achieved by reference-based pricing and special authority were $1.8 million to $3.2 million for H2RAs (depending on the estimation method used) and $5.5 million for PPIs. However, beneficiary contributions for H2RAs increased from negligible amounts to approximately 16% of total drug expenditures.Reference-based pricing and special authority appear to have been successful in altering prescribing habits and reducing provincial expenditures for upper gastrointestinal drugs, but they have increased the financial burden on senior citizen beneficiaries.

Objective: We estimate the effects of Reference Pricing, a drug cost control policy introduced by the BC Ministry of Health Pharmacare program in 1995, on its program expenditures for seniors, out of pocket costs paid by its senior beneficiaries, indicators of beneficiary health status and attendant Ministry of Health expenditures on physicians and hospitals services. Rationale: Reference pricing (RP) limits the reimbursement of a group of drugs with similar therapeutic effect but different active ingredients to a fixed "reference price". The setting of the reference price varies by jurisdiction but typically is based on an average of the lowest cost "reference standard" drugs within the group. Critics of RP contend that the partially subsidized and fully subsidized (reference standard) drugs are not therapeutically interchangeable, and therefore patient health will be compromised and use of other non-pharmacologic health services may increase as a result, thus partially or wholly offsetting any potential cost savings from the policy. Findings: The application of RP to 3 groups of cardiac drugs produced annualized savings to Pharmacare of about $7.7 million, or 3.6% of the $213.7 million that Pharmacare spent on drugs for seniors (not including dispensing fees) in 1997. The additional costs for physician consultations were modest, around $500,000 in the subsample of seniors we studied, from the introduction of the RP plans to March 1998, although the costs could be greater, perhaps up to twice this amount, if we accounted for all seniors exposed to the RP over the same period. We found no effects of RP on mortality, or premature admission to a longterm care facility. Seniors using the nitrate drugs for angina that were no longer fully subsidized when RP was introduced faced a higher probability in the short run of using medicines to deal with acute exacerbations of angina and in the longer run having bypass surgery or other revascularization procedures. No long run effects of morbidity were observed for the application of RP to two different types of anti-hypertensive medications, although there was a short run increase in the rate of revascularizations among those taking 1 type of anti-hypertensive: the ACE inhibitors. The results of these morbidity models should be seen as tentative, until these results can be replicated using alternative estimation strategies. Conclusions: The introduction of RP can indeed reduce Ministry of Health drug expenditures. The effects of RP on patient morbidity remain to be fully investigated before definitive policy recommendations can be offered.

(see QSEP 369 for abstract)

(see SEDAP 70 for abstract)