Sound Practices: An Exploratory Study of Building and Monitoring Multiple-Choice Exams at Canadian Undergraduate Medical Education Programs.

PURPOSE: Written examinations such as multiple-choice question (MCQ) exams are a key assessment strategy in health professions education (HPE), frequently used to provide feedback, to determine competency, or for licensure decisions. However, traditional psychometric approaches for monitoring the quality of written exams, defined as items that are discriminant and contribute to increase the overall reliability and validity of the exam scores, usually warrant larger samples than are typically available in HPE contexts. The authors conducted a descriptive exploratory study to document how undergraduate medical education (UME) programs ensure the quality of their written exams, particularly MCQs. METHOD: Using a qualitative descriptive methodology, the authors conducted semistructured interviews with 16 key informants from 10 Canadian UME programs in 2018. Interviews were transcribed, anonymized, coded by the primary investigator, and co-coded by a second team member. Data collection and analysis were conducted iteratively. Research team members engaged in analysis across phases, and consensus was reached on the interpretation of findings via group discussion. RESULTS: Participants focused their answers around MCQ-related practices, reporting using several indicators of quality such as alignment between items and course objectives and psychometric properties (difficulty and discrimination). The authors clustered findings around 5 main themes: processes for creating MCQ exams, processes for building quality MCQ exams, processes for monitoring the quality of MCQ exams, motivation to build quality MCQ exams, and suggestions for improving processes. CONCLUSIONS: Participants reported engaging multiple strategies to ensure the quality of MCQ exams. Assessment quality considerations were integrated throughout the development and validation phases, reflecting recent work regarding validity as a social imperative.

How can controlled human infection models accelerate clinical development and policy pathways for vaccines against Shigella?

Controlled Human Infection Models (CHIMs) now exist for several infectious diseases. CHIMs offer significant insight into disease pathogenesis, as well the potential to rapidly test clinical proof-of-concept of vaccine candidates. The application of CHIMs to identify a correlate of protection that may reduce the sample size of, or obviate the need for clinical efficacy studies to achieve licensure is of considerable interest to vaccine developers and public health stakeholders. This topic was the subject of a workshop at the 2018 Vaccines Against Shigella and ETEC (VASE) conference, in the context of O-antigen-based Shigella vaccines.

The way forward for ETEC controlled human infection models (CHIMs).

In the absence of good animal models, Controlled Human Infection Models (CHIMs) are useful to assess efficacy of new vaccine candidates against Enterotoxic Escherichia coli (ETEC), as well as other preventive or therapeutic interventions. At the 2018 Vaccines Against Shigella and ETEC (VASE) conference, a workshop was held to further review and discuss new challenge model developments and key issues related to further model standardization. During the workshop, invited speakers briefly summarized for attendees recent developments and main agenda issues before workshop participants were divided into four groups for more focused discussions. The main issues discussed were: (1) whether there is a need for more ETEC strains to test a diversity of vaccine candidates, and if so, what criteria/qualities are desirable in strain selection; (2) how ETEC CHIMs could be more standardized to better support ETEC vaccine development; (3) how volunteer selection criteria and screening should be performed, and; (4) how an expanded sample collection schema and collaborative analysis plan may facilitate a more in-depth assessment of the role of antigen-specific humoral and cellular immune responses in ETEC infection, and provide better insights into ETEC pathogenesis and correlates of protection. The workshop concluded that additional challenge strains may need to be developed to better support new vaccines and therapeutics that are advancing in the development pipeline. In this regard, the need for a well characterized ST-only expressing ETEC strain was highlighted as a priority given that promising new heat stable toxoid based vaccine candidates are on the horizon. In addition, further standardization of the ETEC CHIMs was strongly encouraged, noting that it may not be realistic to standardize across all strains. Also, intensified volunteer screening may result in higher attack rates, although more stringent eligibility criteria may contribute to a more limited application of the model and diminish its representativeness. Finally, a sampling schedule and priority list for minimum set of samples was also proposed. Future workshops could be held to further refine standards for ETEC CHIMS and to facilitate more collaborative work on stored sample sets from previous and future ETEC CHIMs to maximize the contribution of these trials to our understanding of ETEC pathogenesis and our development of better prevention and control measures for this important pathogen.

Fortune and hindsight: gene patents' muted effect on medical practice.

Introduction: Physicians have long worried about gene patents' potential to restrict their medical practices. Fortune and hindsight have proven these worries exaggerated both in the UK and elsewhere. Neither current nor future medical practices appear to be impinged by gene patents, although they may be subject to future intellectual property disputes. Sources of data: Qualitative and quantitative (survey) studies of gene patents' effects on medical practice; recent developments in patent law. Areas of agreement: Traditional gene patents do not appear to have restricted medical practice in the UK, although their effect elsewhere has been more nuanced. Areas of controversy: Whether patents will restrict the spread of newer medical technologies is unresolved. Areas timely for developing research: Continuing survey data on practitioners' views concerning patents' role in the distribution of newer technologies would be beneficial.

Ethical implications of Italian legislation on 'epilepsy and driving'.

The laws concerning driving licences and epilepsy in different countries are very diverse with regard to the criteria for issuance or renewal of licences, and also the methods of evaluating fitness. In 2011, a law was issued in Italy implementing the European directives on driving licences, including provisions for mandatory notification that a driver is epileptic. This was established regardless of the European rules that require compulsory notification only of patients. The Federation of Italian Boards of Physicians has made recommendations against mandated physician reporting, resulting in a current confusion between legal and ethical recommendations to medical doctors. The mandatory notification enacted by Italian law raises ethical concerns about disparities in access to care and possible violations of the right to confidentiality of patient information. Moreover, the law discussed here fails to emphasise the importance of physicians ensuring compliance by the patient, by sharing the correct information about the risks associated with illegal driving and by obtaining information from the patient through regular check-ups. An urgent revision of the law is required to implement the duty of the physician to provide information and to ensure that the rule about mandatory notification should be erased in favour of optional self-reporting by epileptics as the preferred way to notify the licensing authority. The implementation of these measures could correct the dichotomy between the law and the ethical recommendations for medical doctors and protect the rights of people with epilepsy as well as those of any other patients whose pathology or impairment could imply a risk to the community.

Practical legal and ethical considerations for the provision of acute disaster mental health services.

Mental health professionals who provide emergency psychosocial assistance in the immediate aftermath of disasters do so in the midst of crisis and chaos. Common roles undertaken by disaster mental health professionals include treating existing conditions of disaster survivors and providing psychosocial support to front line responders and those acutely affected. Other roles include participating in multidisciplinary health care teams as well as monitoring and supporting team members' mental health. When, in the immediate aftermath of a disaster, mental health professionals provide such assistance, they may take on legal and ethical responsibilities that they are not fully aware of or do not fully comprehend. Unfortunately, not much has been written about these obligations, and professional organizations have provided little guidance. Thus, the purpose of the present article is to outline and discuss an analysis framework and suggest recommendations that mental health professionals can use to help guide their actions during the chaos immediate post disaster.

Open by default: a proposed copyright license and waiver agreement for open access research and data in peer-reviewed journals.

Copyright and licensing of scientific data, internationally, are complex and present legal barriers to data sharing, integration and reuse, and therefore restrict the most efficient transfer and discovery of scientific knowledge. Much data are included within scientific journal articles, their published tables, additional files (supplementary material) and reference lists. However, these data are usually published under licenses which are not appropriate for data. Creative Commons CC0 is an appropriate and increasingly accepted method for dedicating data to the public domain, to enable data reuse with the minimum of restrictions. BioMed Central is committed to working towards implementation of open data-compliant licensing in its publications. Here we detail a protocol for implementing a combined Creative Commons Attribution license (for copyrightable material) and Creative Commons CC0 waiver (for data) agreement for content published in peer-reviewed open access journals. We explain the differences between legal requirements for attribution in copyright, and cultural requirements in scholarship for giving individuals credit for their work through citation. We argue that publishing data in scientific journals under CC0 will have numerous benefits for individuals and society, and yet will have minimal implications for authors and minimal impact on current publishing and research workflows. We provide practical examples and definitions of data types, such as XML and tabular data, and specific secondary use cases for published data, including text mining, reproducible research, and open bibliography. We believe this proposed change to the current copyright and licensing structure in science publishing will help clarify what users - people and machines - of the published literature can do, legally, with journal articles and make research using the published literature more efficient. We further believe this model could be adopted across multiple publishers, and invite comment on this article from all stakeholders in scientific research.

The ethics of live patient use in dental hygiene clinical licensure examinations: a national survey.

A national survey of dental hygienists was conducted to explore ethical issues arising from the use of live patients for dental hygiene clinical licensure examinations. Data were collected regarding respondents' demographics, additional costs they incurred associated with their examination beyond the examination fees, delays in patients' treatment resulting from the examination, unethical candidate and/or patient behaviors they experienced, and provisions they made for patients' follow-up care related to the examination. Five hundred surveys were mailed to dental hygienists from two states in each of the five licensure examination regions. The response rate was 40.6 percent (n=203). Descriptive statistics were used to analyze the data. The results showed that the majority of the respondents spent additional money on examination-related expenses (69.2 percent). Sixty-one percent of the respondents reported paying their patients; however, only 50.5 percent felt such a practice was acceptable. More than half (53.1 percent) reported believing it was appropriate to delay treatment in order to have a patient participate in the examination, although only 16.4 percent reported actually delaying treatment. Informed consent was said to be obtained by 94.9 percent of the respondents. The majority (86.6 percent) said they referred patients for follow-up dental hygiene care. When asked if they felt the examination was an accurate assessment of their clinical skills, 78.7 percent of the respondents agreed that it was.

The fate and future of patents on human genes and genetic diagnostic methods.

Since the 1970s, patents on human genes and genetic diagnostic methods have been granted under the assumption that they stimulate the development of diagnostic methods and therapeutic products. However, the principles and practices of patenting vary between jurisdictions. Do patent holders, researchers, clinicians and patients really benefit from this heterogeneous patent system? We discuss the problems that result from the current system and suggest how they might be solved by altering the way in which patents are granted and/or licensed.

Psychiatric disability and the practising lawyer in Australia.

In recent years there has been significant recognition given to the extent of mental illness, particularly depression, in the legal profession. At the same time, international trends suggest that as more students with disabilities are given support to make it through school, more will become law students and enter the legal profession. International studies have already shown that law students and members of the legal profession exhibit higher levels of psychological distress and depression than do community members of a similar age and sex. In light of rights such as those in the Convention on the Rights of Persons with Disabilities for individuals with disabilities to pursue their chosen profession, this article examines whether people with mental illnesses should be admitted to or remain in the legal profession, the obligations on legal practitioners to report mental illness in other lawyers, and the types of matters brought before disciplinary bodies where mental health issues are raised.

Thoughts on legal and ethical concepts on the professional development of Ayurveda in the U.S.

The following is a transcript of a talk given by Wynn Werner, who is a board member of the National Ayurvedic Medical Association (NAMA) and member of the NAMA standards committee, at the NAMA conference in April 2010. In this talk, Werner discusses the legal and licensing challenges facing Ayurvedic practitioners in the United States. IAYT finds the work of NAMA on the issue of professional development to be both educational and thought-provoking for our own field's parallel process. We present this transcript to contribute to the conversation within the yoga therapy community.

The social disutility of software ownership.

Software ownership allows the owner to restrict the distribution of software and to prevent others from reading the software's source code and building upon it. However, free software is released to users under software licenses that give them the right to read the source code, modify it, reuse it, and distribute the software to others. Proponents of free software such as Richard M. Stallman and Eben Moglen argue that the social disutility of software ownership is a sufficient justification for prohibiting it. This social disutility includes the social instability of disregarding laws and agreements covering software use and distribution, inequality of software access, and the inability to help others by sharing software with them. Here I consider these and other social disutility claims against withholding specific software rights from users, in particular, the rights to read the source code, duplicate, distribute, modify, imitate, and reuse portions of the software within new programs. I find that generally while withholding these rights from software users does cause some degree of social disutility, only the rights to duplicate, modify and imitate cannot legitimately be denied to users on this basis. The social disutility of withholding the rights to distribute the software, read its source code and reuse portions of it in new programs is insufficient to prohibit software owners from denying them to users. A compromise between the software owner and user can minimise the social disutility of withholding these particular rights from users. However, the social disutility caused by software patents is sufficient for rejecting such patents as they restrict the methods of reducing social disutility possible with other forms of software ownership.

Impact of gene patents and licensing practices on access to genetic testing for Alzheimer disease.

Genetic testing for Alzheimer disease includes genotyping for apolipoprotein E, for late-onset Alzheimer disease, and three rare autosomal dominant, early-onset forms of Alzheimer disease associated with different genes (APP, PSEN1, and PSEN2). According to researchers, patents have not impeded research in the field, nor were patents an important consideration in the quest for the genetic risk factors. Athena Diagnostics holds exclusive licenses from Duke University for three "method" patents covering apolipoprotein E genetic testing. Athena offers tests for apolipoprotein E and genes associated with early-onset, autosomal-dominant Alzheimer disease. One of those presenilin genes is patented and exclusively licensed to Athena; the other presenilin gene was patented but the patent was allowed to lapse; and one (amyloid precursor protein) is patented as a research tool. Direct-to-consumer testing is available for some Alzheimer disease-related genes, apparently without a license. Athena Diagnostics consolidated its position in the market for Alzheimer disease genetic testing by collecting exclusive rights to patents arising from university research. Duke University also used its licenses to Athena to enforce adherence to clinical guidelines, including elimination of the service from Smart Genetics, which was offering direct-to-consumer risk assessment based on apolipoprotein E genotyping.