Human Factor Health Data Interoperability.

Comprehensive health data interoperability is recognized as an essential element of high-functioning and accountable health service. Canada is lagging in health data interoperability compared to international comparators, and lacks a comprehensive approach to human factor interoperability, defined as system-level relationships that impact the capacity of health sector stakeholders to adopt harmonized health data standards and technology. Without addressing these system-level relationships, the adoption of harmonized health data standards and technology will be obstructed and Canadians will be underserved. The proposed health data interoperability framework articulates the factors that Canada needs to address to optimize health data design to support quality health programs and services.

Enabling Connected Care with a Person-Centred Data Foundation.

Having the right information at the right time and at the fingertips of the right individuals is not just a necessity for a well-functioning healthcare system but it is also the difference between life and death for Canadians. It is particularly critical to enable improved access to and quality of care for equity-deserving individuals because these data eliminate blind spots for clinicians, policy makers and system planners. The COVID-19 pandemic put a spotlight on the health data challenges that exist across Canada and the tangible impact those have on the healthcare system's ability to meet the needs of underserved populations. It sparked unified urgency at the federal and provincial/territorial levels to build a learning health system powered by connected health data for clinical care, patient access, care organization operations, health system use and population/public health. Person-centric data content standards will lie at the foundation of Canada's learning health system, enabling the creation and exchange of data.

Varying Willingness to Pay Based on Severity of Illness: Impact on Health Technology Assessment Outcomes of Inpatient and Outpatient Drug Therapies in The Netherlands.

OBJECTIVES: Since 2015, Zorginstituut Nederland (ZIN) has linked disease severity ranges of 0.10 to 0.40, 0.41 to 0.70, and 0.71 to 1.00 with willingness-to-pay (WTP) reference values of €20 000, €50 000, and €80 000 per quality-adjusted life year gained, respectively. We sought to review whether these changes have affected ZIN health technology assessment (HTA) outcomes for specialist and outpatient drugs. METHODS: ZIN recommendations for specialist and outpatient drugs published between January 1, 2012, and December 31, 2020, that included a pharmacoeconomic report were reviewed. Data were extracted on disease severity, proportional shortfall calculation, reported WTP reference value, outcomes related to the cost-effectiveness of the product, budget impact, and ZIN's recommendation including rationale for their advice. RESULTS: A total of 51 HTAs were included. Of the 20 HTAs published before June 2015, a total of 9 received positive recommendations, 7 were conditionally reimbursed, and 4 received negative recommendations. None reported WTP reference values. Of the 31 evaluations published after June 2015, a total of 4 products received positive recommendations, 1 was conditionally approved, and 26 received negative recommendations initially. Most products (65%) reported disease severity to be >0.70. CONCLUSIONS: Since 2015, most products have fallen within the highest category of disease severity. Although pre-2015 outcomes were varied, post-2015 products overwhelmingly received negative recommendations, and the proportion of products for which price negotiations were recommended has increased. These differences in outcomes may result from the introduction of an explicit WTP reference value, whether or not in combination with the severity-adjusted ranges, but may also reflect other national policy changes in 2015.

Improving the understanding of how patients with non-dystrophic myotonia are selected for myotonia treatment with mexiletine (NaMuscla): outcomes of treatment impact using a European Delphi panel.

BACKGROUND: Non-dystrophic myotonias (NDMs) comprise muscle chloride and sodium channelopathies due to genetic defects of the CLCN1- and SCN4A-channels. No licensed antimyotonic treatment has been available until approval of mexiletine (NaMuscla®) for adult patients by the EMA in December 2018. This Delphi panel aimed to understand how outcomes of the pivotal phase III Mexiletine study (MYOMEX) translate to real world practice and investigate health resource use, quality of life and the natural history of NDM to support economic modelling and facilitate patient access. METHODS: Nine clinical experts in treating NDM took part in a two-round Delphi panel. Their knowledge of NDM and previous use of mexiletine as an off-label treatment prior to NaMuscla's approval ensured they could provide both qualitative context and quantitative estimates to support economic modelling comparing mexiletine (NaMuscla) to best supportive care. Consensus in four key areas was sought: healthcare resource utilization (HRU), treatment with mexiletine (NaMuscla), patient quality of life (QoL), and the natural history of disease. Concept questions were also asked, considering perceptions on the feasibility of mapping the validated Individualized Neuromuscular Quality of Life (INQoL) instrument to the generic EQ-5D™, and the potential impact on caregiver QoL. RESULTS: Consensus was achieved for key questions including the average long-term dosage of mexiletine (NaMuscla) in practice, the criteria for eligibility of myotonia treatment, the clinical importance of QoL outcomes in MYOMEX, the higher proportion of patients with increased QoL, and the reduction in the need for mental health resources for patients receiving mexiletine (NaMuscla). While consensus was not achieved for other questions, the results demonstrated that most experts felt mexiletine (NaMuscla) reduced the need for HRU and was expected to improve QoL. The QoL mapping exercise suggested that it is feasible to map domains of INQoL to EQ-5D. Points of interest for future research were identified, including that mexiletine (NaMuscla) may slow the annual decrease in QoL of patients over their lifetime, and a significant negative impact on QoL for some caregivers. CONCLUSIONS: This project successfully provided data from an informed group of clinical experts, complementing the currently available clinical trial data for mexiletine (NaMuscla) to support patient access decisions.

Impact of concurrent treatment with omeprazole on phenylbutazone-induced equine gastric ulcer syndrome (EGUS).

BACKGROUND: Phenylbutazone is commonly prescribed for treatment of various painful or inflammatory disorders in horses, but is associated with gastrointestinal (GI) adverse effects. Anecdotally, many practitioners prescribe omeprazole concurrently with phenylbutazone to reduce development of equine gastric ulcer syndrome (EGUS), but the efficacy and safety of this practice remains unknown. OBJECTIVES: To evaluate the effect of omeprazole on phenylbutazone-induced equine glandular gastric disease (EGGD) and equine squamous gastric disease (ESGD). STUDY DESIGN: Randomised block experimental design. METHODS: Twenty-two horses with EGGD and ESGD scores ≤2 were included. Horses were assigned to treatment groups: phenylbutazone (4.4 mg/kg PO q 12 h; PBZ), phenylbutazone plus omeprazole (4 mg/kg PO q. 24 h; PBZ/OME) or placebo (CON) in a randomised block design based upon initial EGGD score. Horses were treated for up to 14 days. Gastroscopy was performed weekly; CBC and biochemistry were performed at Day 0 and study end. Horses were monitored for signs of colic and/or diarrhoea. RESULTS: EGGD score increased in PBZ (median change 1, inter-quartile range, [IQR], 0-2) compared to PBZ/OME (median change 0, IQR -1 to 0; P = .05). PBZ/OME (6/8) had more intestinal complications than CON (0/6; difference between proportions = 75%; 95% CI, 23%-93%; P = .03). Plasma protein concentrations decreased in PBZ, compared to CON (mean difference between groups, 14 g/L; 95% CI, 1.04-27; P = .03). Five horses were withdrawn from the study due to intestinal complications (n = 3 PBZ/OME and n = 2 PBZ); one horse (PBZ) was withdrawn due to severe grade 4 EGGD. MAIN LIMITATIONS: Small sample size and changes in management for the 2-3 days prior to study initiation; variable treatment duration among groups due to development of complications. CONCLUSIONS: Administration of omeprazole ameliorated PBZ-induced EGGD, but was associated with an increase in intestinal complications. Caution should be exercised when co-prescribing NSAIDs and omeprazole in horses, particularly in association with change in management.

Effects of Epinephrine, Detomidine, and Butorphanol on Assessments of Insulin Sensitivity in Mares.

Sympathoadrenal stimulation may perturb results of endocrine tests performed on fractious horses. Sedation may be beneficial; however, perturbation of results may preclude useful information. Four experiments were designed to 1) determine the effects of epinephrine on insulin response to glucose (IR2G), 2) assess the effects of detomidine (DET), alone or combined with butorphanol (DET/BUT), on IR2G and glucose response to insulin (GR2I), and 3) assess the effects of BUT alone on IR2G. In Experiment 1, mares were administered saline or epinephrine (5 µg/kg BW) immediately before infusion of glucose (100 mg/kg BW). Glucose stimulated (P < .05) insulin release in controls at 5 minutes that persisted through 30 minutes; insulin was suppressed (P < .05) by epinephrine from 5 to 15 minutes, rising gradually through 30 minutes. Experiments 2 (IR2G) and 3 (GR2I) were conducted as triplicated 3 × 3 Latin squares with the following treatments: saline (SAL), DET, and DET/BUT (all administered at .01 mg/kg BW). Glucose stimulated (P < .05) insulin release that persisted through 30 minutes in SAL mares; DET and DET/BUT severely suppressed (P < .0001) the IR2G. Sedation did not affect resting glucose and had inconsistent effects on the GR2I when mares were treated with 50 mIU/kg BW recombinant human insulin. Butorphanol had no effect on IR2G. In conclusion, adrenergic agonists severely suppress the IR2G and cannot be used for sedation for this test. The use of DET did not alter the GR2I, and therefore may be useful for conducting this test in fractious horses.

Outpatient parenteral antimicrobial therapy: updated recommendations from the UK.

Outpatient parenteral antimicrobial therapy (OPAT) offers safe, effective and patient-centred care for adults and children. The OPAT UK good practice recommendations for adults and children have recently been updated through a process of literature review, expert consensus and extensive stakeholder consultation. Here we discuss the key changes in the updated recommendations in the context of recent developments, including novel antimicrobial agents and delivery devices, the place of oral antimicrobials as an alternative to intravenous therapy, new OPAT service models and the broader antimicrobial stewardship agenda.

Incorporating medical leadership into undergraduate curricula: a proposal for a spiral curriculum.

PURPOSE: There is increasing recognition of the importance of incorporating medical leadership training into undergraduate medical curricula and this is now advocated by the General Medical Council (GMC) and supported through the development of the Undergraduate Medical Leadership Competency Framework (MLCF). However to date, few medical schools have done so in a systematic way and training/experience in medical leadership at undergraduate level is sporadic and often based on local enthusiasm. The purpose of this paper is to outline a theoretical curriculum to stimulate and support medical leadership development at undergraduate level. DESIGN/METHODOLOGY/APPROACH: This study describes a theoretical framework for incorporation of medical leadership training into undergraduate curricula using a spiral curriculum approach, linked to competences outlined in the Undergraduate Medical Leadership Competency Framework. The curriculum includes core training in medical leadership for all students within each year group with additional tiers of learning for students with a particular interest. FINDINGS: This curriculum includes theoretical and practical learning opportunities and it is designed to be deliverable within the existing teaching and National Health Service (NHS) structures. The engagement with local NHS organisations offers opportunities to broaden the university teaching faculty and also to streamline medical leadership development across undergraduate and postgraduate medical education. ORIGINALITY/VALUE: This theoretical curriculum is generic and therefore adaptable to a variety of undergraduate medical courses. The combination of theoretical and practical learning opportunities within a leadership spiral curriculum is a novel and systematic approach to undergraduate medical leadership development.

Updated good practice recommendations for outpatient parenteral antimicrobial therapy (OPAT) in adults and children in the UK.

UK good practice recommendations for outpatient parenteral antimicrobial therapy (OPAT) were published in 2012 and 2015 for adult and paediatric patients, respectively. Here we update the initial good practice recommendations in a combined document based on a further review of the OPAT literature and an extensive consultation process. As with the previous good practice recommendations, these updated recommendations are intended to provide pragmatic guidance for new and established OPAT services across a range of settings and to act as a set of quality indicators for service evaluation and quality improvement.

Heroin-associated anthrax with minimal morbidity.

In 2010, during an outbreak of anthrax affecting people who inject drugs, a heroin user aged 37 years presented with soft tissue infection. He subsequently was found to have anthrax. We describe his management and the difficulty in distinguishing anthrax from non-anthrax lesions. His full recovery, despite an overall mortality of 30% for injectional anthrax, demonstrates that some heroin-related anthrax cases can be managed predominately with oral antibiotics and minimal surgical intervention.

Assessment and management of active and latent TB.

More than 25% of the world population has been infected with tuberculosis (TB), however only 10% of those infected will ever develop active disease. Clinically significant disease occurs through progression of primary infection or through later reactivation of latent TB infection (LTBI); this is most likely to occur in the first few years following infection, although late reactivation can occur several decades later, particularly in individuals who become immunosuppressed. Risk of TB acquisition is increased in people who have come to the UK from high incidence countries or who are born in the UK but come from high-risk ethnic minority groups. In 2015, 73% of those diagnosed with active TB were born outside the UK. Other risk groups include those who are homeless, in prison or who misuse drugs or alcohol. Once infected people who are immunosuppressed are at greater risk of progression to active disease. Infants below the age of 12 months can develop rapidly progressive and potentially fatal infection. Initial clinical assessment with chest radiography and the collection of three deep respiratory samples for smear microscopy and culture remain the standard of care. The management of active TB has not changed significantly over many years. The most significant changes in the 2016 NICE guidance relate to screening for LTBI in individuals who are contacts of a patient with active TB, or who are recent entrants to the UK from a high incidence country. NICE recommends that only contacts of patients with active pulmonary or laryngeal TB be screened.

Implementing Guidelines: The Cost and Clinical Impact of Anticoagulants in the UK Atrial Fibrillation Population.

BACKGROUND: Updated treatment guidelines for atrial fibrillation (AF) have been released by the National Institute for Health and Care Excellence (NICE) in the UK, and highlight a current shortfall in the prescription of anticoagulants to patients with AF for stroke prevention. OBJECTIVE: To design a budget impact model as a planning tool for UK Clinical Commissioning Groups (CCGs) looking to budget for greater use of anticoagulants in the AF population. METHODS: An Excel® model was developed to estimate the five-year impact of gradually treating all eligible patients with AF who are currently not being prescribed anticoagulants, both in terms of the effect on key clinical outcomes (strokes, major bleeds and mortality) and the associated financial impact. RESULTS: For a population of 251,693 (average CCG size) with an estimated 2626 prevalent patients and an additional 546 incident cases annually, the model estimated that increasing the proportion of the eligible AF patient population receiving anticoagulation by a fraction would require an additional budget of GBP139,961 in Year 1 to treat an additional 314 patients. This would rise to GBP1,004,900 in Year 5 to treat an additional 2242 patients, with all eligible patients treated by this year. The price year was 2014. Over the 5-year timeframe, this could lead to the prevention of 24 strokes and 29 deaths, with an increase of 31 major bleeds. CONCLUSIONS: The clinical benefits of appropriate anticoagulation are widely recognised; however, full implementation can be difficult and costly. Therefore, the development of models can support the planning process by facilitating discussion among stakeholders on how best they can reach full implementation. The model is flexible and can be adapted to suit different payers.

The cost-effectiveness of diagnostic cardiac imaging for stable coronary artery disease.

Early and accurate diagnosis of stable coronary artery disease (CAD) is crucial to reduce morbidity, mortality and healthcare costs. This critical appraisal of health-economic literature concerning non-invasive diagnostic cardiac imaging aims to summarize current approaches to economic evaluation of diagnostic cardiac imaging and associated procedural risks, inform cardiologists how to use economic analyses for decision-making, highlight areas where new information could strengthen the economic evaluation and shed light on cost-effective approaches to diagnose stable CAD. Economic analysis can support cardiologists' decision-making. Current economic evidence in the field does not provide sufficient information to guide the choice among different imaging modalities or strategies for each patient. Available economic analyses suggest that computed tomography coronary angiography (CTCA) is a cost-effective approach to rule out CAD prior to invasive coronary angiography in patients with low to intermediate pre-test probability of disease and that stress imaging modalities may be cost-effective at variable pre-test probabilities.

Spontaneous methicillin-sensitive Staphylococcus aureus spondylodiscitis-Short course antibiotic therapy may be adequate: Evidence from a single centre cohort.

Spontaneous methicillin-sensitive Staphylococcus aureus spondylodiscitis is increasing in prevalence and there appears to be little consensus on the optimum management of this condition. This paper analyses antimicrobial therapy and associated outcomes over a seven-year period at a large UK hospital trust. A retrospective search strategy identified 55 patients; notes were available for 39. Patients were treated with a median 12 weeks of antibiotics (IQR 7), with 6 weeks intravenous (IQR 3) and 9 weeks oral therapy (IQR 6). 23 different treatment regimens were utilised. 33/36 (92%) patients for whom outcomes were available were cured or improved at latest follow-up. This study reports a wide variation in antibiotic prescribing at a single centre. Outcomes were generally positive regardless of total duration of therapy and proportion of intravenous therapy. These findings highlight the need for multi-centre prospective randomised controlled trials to determine the most clinically effective and low-risk treatment strategy.

Patient retention of training in self-administration of intravenous antibiotic therapy in an outpatient parenteral antibiotic therapy service.

AIMS AND OBJECTIVES: To assess patient retention of initial training on completion of self-administration of a prolonged course of intravenous therapy. BACKGROUND: Outpatient parenteral antibiotic therapy is being used increasingly in the UK, and patients requiring prolonged antibiotic courses may be trained to self-administer therapy. DESIGN: Prospective clinical evaluation. METHODS: Patients self-administering parenteral antibiotic therapy through the Sheffield outpatient parenteral antibiotic therapy service were assessed when nearing completion of therapy for correct technique in five key areas of proficiency using a scoring system. RESULTS: Twenty-nine patients and nine carers were reassessed, at a median interval of 35 days after completion of the initial training package. Of these, 35 of 38 were fully competent in all areas. Three patients showed incomplete retention of their initial training. All made errors relating to use of sterile technique. CONCLUSIONS: Overall retention of training was excellent, and this supports earlier reports that patient-administered outpatient parenteral antibiotic therapy is as safe as nurse-administered therapy. However, this study highlighted a small number of patients or carers who were not fully competent at maintaining sterile technique, and as a result, the protocol for training patients has been altered. RELEVANCE TO CLINICAL PRACTICE: In this study, we assess patients' ability to maintain safe self-administration of therapy over a period of time. Patients are increasingly involved and engaged in their own health care, and this study provides a novel approach to assessing their competence in practical procedures.

Managing and monitoring tuberculosis using web-based tools in combination with traditional approaches.

Tuberculosis (TB) remains a global health emergency. Ongoing challenges include the coordination of national and international control programs, high levels of drug resistance in many parts of the world, and availability of accurate and rapid diagnostic tests. The increasing availability and reliability of Internet access throughout both affluent and resource-limited countries brings new opportunities to improve TB management and control through the integration of web-based technologies with traditional approaches. In this review, we explore current and potential future use of web-based tools in the areas of TB diagnosis, treatment, epidemiology, service monitoring, and teaching and training.