Moot Court Cases: Bringing Standards to Life.

Biomedical engineering instructors teach the medical devices design theory and practice following the recommendations derived from the FDA regulations included in 21CFR820 and portraying it as less of a choice but the designer's obligation to uphold laws intended to reduce medical device design risk and protect the general public from defective goods. Although product liability cases are frequently adjudicated in a court of law, many students have only a vague notion of the link between design and product liability issues, and furthermore the important role that standards play in everyday design practice. To give real-life context for the connection between product liability and the benefits of using standards in design, we are aiming to develop moot court case studies that will offer engineering students the opportunity to investigate the viewpoint of various stakeholders and to bring arguments in support of their position. Our work-in-progress is part of a larger effort to reduce the barriers to standards adoption by engineering programs by creating a complete set of educational materials for educators based on specific case studies that foster consideration and use of standards in quality systems (ISO 13485:2016), and cyber-security in medical device design (ISO/IEEE 11073). Materials include lesson plans, content, and homework assignments that will be delivered as videos, tutorials, case study narratives, and Canvas modules. Our preliminary efforts have encouraged continuation of the development of content, though our efforts will benefit from other educator participation - this paper is a "Call to Action" for collaborators.

Effectiveness of a Web-Based Self-Help Program for Suicidal Thinking in an Australian Community Sample: Randomized Controlled Trial.

BACKGROUND: Treatment for suicidality can be delivered online, but evidence for its effectiveness is needed. OBJECTIVE: The goal of our study was to examine the effectiveness of an online self-help intervention for suicidal thinking compared to an attention-matched control program. METHODS: A 2-arm randomized controlled trial was conducted with assessment at postintervention, 6, and, 12 months. Through media and community advertizing, 418 suicidal adults were recruited to an online portal and were delivered the intervention program (Living with Deadly Thoughts) or a control program (Living Well). The primary outcome was severity of suicidal thinking, assessed using the Columbia Suicide Severity Rating Scale. RESULTS: Intention-to-treat analyses showed significant reductions in the severity of suicidal thinking at postintervention, 6, and 12 months. However, no overall group differences were found. CONCLUSIONS: Living with Deadly Thoughts was of no greater effectiveness than the control group. Further investigation into the conditions under which this program may be beneficial is now needed. Limitations of this trial include it being underpowered given the effect size ultimately observed, a high attrition rate, and the inability of determining suicide deaths or of verifying self-reported suicide attempts. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000410752; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=364016 (Archived by WebCite at http://www.webcitation.org/6vK5FvQXy); Universal Trial Number U1111-1141-6595.

e-CBT (myCompass), Antidepressant Medication, and Face-to-Face Psychological Treatment for Depression in Australia: A Cost-Effectiveness Comparison.

BACKGROUND: The economic cost of depression is becoming an ever more important determinant for health policy and decision makers. Internet-based interventions with and without therapist support have been found to be effective options for the treatment of mild to moderate depression. With increasing demands on health resources and shortages of mental health care professionals, the integration of cost-effective treatment options such as Internet-based programs into primary health care could increase efficiency in terms of resource use and costs. OBJECTIVE: Our aim was to evaluate the cost-effectiveness of an Internet-based intervention (myCompass) for the treatment of mild-to-moderate depression compared to treatment as usual and cognitive behavior therapy in a stepped care model. METHODS: A decision model was constructed using a cost utility framework to show both costs and health outcomes. In accordance with current treatment guidelines, a stepped care model included myCompass as the first low-intervention step in care for a proportion of the model cohort, with participants beginning from a low-intensity intervention to increasing levels of treatment. Model parameters were based on data from the recent randomized controlled trial of myCompass, which showed that the intervention reduced symptoms of depression, anxiety, and stress and improved work and social functioning for people with symptoms in the mild-to-moderate range. RESULTS: The average net monetary benefit (NMB) was calculated, identifying myCompass as the strategy with the highest net benefit. The mean incremental NMB per individual for the myCompass group was AUD 1165.88 compared to treatment as usual and AUD 522.58 for the cognitive behavioral therapy model. CONCLUSIONS: Internet-based interventions can provide cost-effective access to treatment when provided as part of a stepped care model. Widespread dissemination of Internet-based programs can potentially reduce demands on primary and tertiary services and reduce unmet need.

Allied health growth: what we do not measure we cannot manage.

BACKGROUND: Data describing the Australian allied health workforce is inadequate and so insufficient for workforce planning. National health policy reform requires that health-care models take into account future workforce requirements, the distribution and work contexts of existing practitioners, training needs, workforce roles and scope of practice. Good information on this workforce is essential for managing services as demands increase, accountability of practitioners, measurement of outcomes and benchmarking against other jurisdictions. A comprehensive data set is essential to underpin policy and planning to meet future health workforce needs. DISCUSSION: Some data on allied health professions is managed by the Australian Health Practitioner Regulation Agency; however, there is limited information regarding several core allied health professions. A global registration and accreditation scheme recognizing all allied health professions might provide safeguards and credibility for professionals and their clients. Arguments are presented about inconsistencies and voids in the available information about allied health services. Remedying these information deficits is essential to underpin policy and planning for future health workforce needs. We make the case for a comprehensive national data set based on a broad and inclusive sampling process across the allied health population.

The use of complementary and alternative medicine in adults with depressive disorders. A critical integrative review.

BACKGROUND: Depression has been identified as one of the most frequent indications for CAM use and is a strong predictor of CAM use. The present article provides a critical review of CAM use for depressive disorders including bipolar depression by addressing prevalence of CAM use and CAM users׳ characteristics, motivation, decision-making and communication with healthcare providers. METHODS: A comprehensive search of 2003-2014 international literature in the Medline, CINAHL, AMED, and SCOPUS databases was conducted. The search was confined to peer-reviewed articles published in English with abstracts and reporting new empirical research findings regarding CAM use and depressive disorders. RESULTS: A considerable level of CAM use was observed among both general and clinical populations of people suffering from depressive disorders, many of whom use CAM concurrently with their conventional medicine. In particular, high rates of CAM use were found among those with bipolar disorder, an illness known to cause substantial impairments in health-related quality of life. Concomitant prescription medication use ranged from 0.52% to as high as 100%. LIMITATIONS: Study design such as the inclusion of bipolar and depression in the same diagnostic category hamper the differentiation and attribution of CAM usage for symptoms. CONCLUSION: Findings of our review show that enduring impairments in function and persistence of symptoms (as reflected by increased CAM use proportional to severity of illness and comorbidity) are the impetus for sufferers of depressive illness to seek out CAM. The psychosocial factors associated with CAM use in depressive illnesses and severe mental illness are yet to be established. Subsequent research amongst those with depressive disorders would be informative in clarifying the range of motivations associated with mental illness.

Reducing suicidal thoughts in the Australian general population through web-based self-help: study protocol for a randomized controlled trial.

BACKGROUND: Suicidal thoughts are common in the general population, causing significant disability. However, a substantial number of people struggling with suicidality do not access appropriate services. Online self-help may help overcome barriers to help-seeking. This study aims to examine the effectiveness of an online self-help program targeted at reducing suicidal thoughts compared with an attention-matched control condition in the Australian adult population. This trial is based on a Dutch self-help program, which was found to be effective in reducing suicidal thoughts. METHODS/DESIGN: A total of 570 community-dwelling adults (18 to 65 years old) with suicidal thoughts will be recruited via various media and randomly assigned to the 6-week online program aimed at reducing suicidal thoughts or a 6-week attention-matched control program. Primary outcome measure is the severity of suicidal thoughts. Secondary outcome measures include suicide plans, capacity to cope with suicidal thoughts, reasons for living, symptoms of depression, hopelessness, anxiety/worry, rumination, panic, perceived burdensomeness and thwarted belongingness, acquired capability, alcohol consumption, insomnia, and various cost-effectiveness measures. DISCUSSION: Although the original Dutch trial found web-based self-help to be effective in reducing suicidal thoughts, randomized controlled trials (RCT) of online programs for suicidal thoughts are rare. The present study extends previous research by running the first English language RCT of this sort. As a result of the original study, the current RCT includes refinements to the design, including greater levels of participant anonymity and longer follow-up periods. Limitations of this trial include the potential for high drop-out and the inability to ascertain whether any suicides occur during the study. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000410752 (15 April 2013). Universal Trial Number (UTN): U1111-1141-6595 (15 April 2013).

Economic evaluation of St. John's wort (Hypericum perforatum) for the treatment of mild to moderate depression.

BACKGROUND: The burden of rising health care expenditures has created a demand for information regarding the clinical and economic outcomes associated with Complementary and Alternative Medicines. Clinical controlled trials have found St. John's wort to be as effective as antidepressants in the treatment of mild to moderate depression. The objective of this study was to develop a model to assess the cost-effectiveness of St. John's wort based on this evidence. METHODS: A Markov model was constructed to estimate health and economic impacts of St. John's wort versus antidepressants. Outcomes were treatment costs, quality-adjusted life years (QALYs) and Net Monetary Benefits (NMB). Probabilistic analyses were conducted on key model parameters. RESULTS: The average NMB across 5000 simulations identified St. John's wort as the strategy with the highest net benefit. The total cost savings for SJW were $359.66 and $202.56 per individual for venlafaxine and sertraline respectively, with a gain of 0.08 to 0.12 QALYs over the 72 weeks of the model. LIMITATIONS: A lack of direct comparative clinical trial data comparing SJW to venlafaxine and limited data with sertraline as a comparator was a major limitation. CONCLUSIONS: In this model, St. John's wort was shown to be a cost-effective alternative to generic antidepressants. Patients are more likely to receive treatment for a duration consistent with professional guidelines for treatment of major depression due to reduced incidence of adverse effects, improving outcomes. This represents an important option in the treatment of Major Depressive Disorder.

Potential of St John's Wort for the treatment of depression: the economic perspective.

The burden of rising health care expenditures has created a demand for information regarding the clinical and economic outcomes associated with complementary and alternative medicines. Meta-analyses of randomized controlled trials have found Hypericum perforatum preparations to be superior to placebo and similarly effective as standard antidepressants in the acute treatment of mild to moderate depression. A clear advantage over antidepressants has been demonstrated in terms of the reduced frequency of adverse effects and lower treatment withdrawal rates, low rates of side effects and good compliance, key variables affecting the cost-effectiveness of a given form of therapy. The most important risk associated with use is potential interactions with other drugs, but this may be mitigated by using extracts with low hyperforin content. As the indirect costs of depression are greater than five times direct treatment costs, given the rising cost of pharmaceutical antidepressants, the comparatively low cost of Hypericum perforatum extract makes it worthy of consideration in the economic evaluation of mild to moderate depression treatments.

The use of economic evaluation in CAM: an introductory framework.

BACKGROUND: For CAM to feature prominently in health care decision-making there is a need to expand the evidence-base and to further incorporate economic evaluation into research priorities.In a world of scarce health care resources and an emphasis on efficiency and clinical efficacy, CAM, as indeed do all other treatments, requires rigorous evaluation to be considered in budget decision-making. METHODS: Economic evaluation provides the tools to measure the costs and health consequences of CAM interventions and thereby inform decision making. This article offers CAM researchers an introductory framework for understanding, undertaking and disseminating economic evaluation. The types of economic evaluation available for the study of CAM are discussed, and decision modelling is introduced as a method for economic evaluation with much potential for use in CAM. Two types of decision models are introduced, decision trees and Markov models, along with a worked example of how each method is used to examine costs and health consequences. This is followed by a discussion of how this information is used by decision makers. CONCLUSIONS: Undoubtedly, economic evaluation methods form an important part of health care decision making. Without formal training it can seem a daunting task to consider economic evaluation, however, multidisciplinary teams provide an opportunity for health economists, CAM practitioners and other interested researchers, to work together to further develop the economic evaluation of CAM.