Expert Stakeholder Group Research Articles

Data dialogues: critical connections for designing and implementing future nanomaterial research

Individuals and organizations in the engineered nanomaterial (ENM) community have increasingly recognized two related but distinct concerns: (1) Discordant data due to differences in experimental design (e.g., material characteristics, experimental model, and exposure concentration) or reporting (e.g., dose metric and material characterization details), and (2) a lack of data to inform decisions about ENM environmental, health, and safety (EHS). As one way to help address these issues, this Commentary discusses the important role of “data dialogues” or structured discussions between ENM researchers in EHS fields (e.g., toxicology, exposure science, and industrial hygiene) and decision makers who use the data researchers’ collect. The importance of these structured discussions is examined here in the context of barriers, solutions, and incentives: barriers to developing research relevant for human and ecological risk assessments; potential solutions to overcome such barriers; and incentives to help implement these or other solutions. These barriers, solutions, and incentives were identified by a group of expert stakeholders and ENM community members at the December 2013 Society for Risk Analysis panel discussion on research needed to support decision making for multiwalled carbon nanotubes. Key topics discussed by experts and ENM community members include: (1) The value of researchers collaborating with EHS decision makers (e.g., risk analysts, product developers, and regulators) to design research that can inform ENM EHS-related decisions (e.g., occupational exposure limits and product safety determinations), (2) the importance of funding incentives for such collaborative research, (3) the need to improve mechanisms for data sharing within and between sectors (e.g., academia, government, and industry), and (4) the critical need to educate the “next generation” of nanotechnology researchers in EHS topics (e.g., risk assessment, risk management). In presenting these outcomes, this Commentary is not intended to conclude the conversation that took place in December 2013 but rather to support a broader dialogue that helps ensure important risk assessment questions are answered for ENMs.

A risk-based regulatory framework for health IT: recommendations of the FDASIA working group.

The Secretary of Health and Human Services (HHS) acting through the Food and Drug Administration (FDA), and in collaboration with the Federal Communications Commission (FCC) and Office of the National Coordinator for Health IT (ONC) was tasked with delivering a report on an appropriate, risk-based regulatory framework for health information technology (IT). An expert stakeholder group was established under the auspices of the Health IT Policy Committee to help provide input into the development of this framework, including how healthcare IT systems could be stratified in terms of risk and recommendations about how the regulatory requirements currently in place should be adapted. In this paper, we summarize the public deliberations and final public report of the expert stakeholder group, and conclude with key suggestions intended to address the charge to recommend the features of a risk-based regulatory framework that promote innovation, protect patient safety, and avoid regulatory duplication.

Survey of European clinical geneticists on awareness, experiences and attitudes towards direct-to-consumer genetic testing

BackgroundThe advent of direct-to-consumer (DTC) genetic testing (GT) has sparked a number of debates regarding the scientific validity of tests, their broad health and ethical implications for society as well as their legal status. To date, relatively few empirical studies have been published regarding this phenomenon. We conducted a survey of European clinical geneticists to gauge their awareness of, experiences with, and attitudes towards DTC GT.MethodsWe invited 300 clinical geneticists from 28 European countries to complete an online questionnaire. Statistical analyses of closed-ended questions were performed using the STATISTICA software package. Answers to open-ended questions were analysed for recurring themes.ResultsOne hundred and thirty-one clinical geneticists answered our survey (response rate, 44%). Eighty-six percent (110/128) of respondents were aware of DTC GT, and over one-third had been contacted by at least one patient regarding these services. The majority (84%) of respondents did not agree with telephone medical supervision outside of an established doctor-patient relationship. The majority of clinical geneticists also found it unacceptable to provide non-face-to-face medical supervision for: (i) a presymptomatic test for a condition with very high penetrance; (ii) a predictive test for a condition that has a 'medium' penetrance of 50% to 60%; and (iii) carrier testing. For conditions that are neither treatable nor preventable and for disorders with serious health consequences, clinical geneticists were almost unanimous in expressing the unacceptability of offering such genetic tests outside of the traditional healthcare setting, without an established physician-patient relationship and without face-to-face medical supervision.ConclusionA high percentage of European clinical geneticists are aware of DTC GT and the majority do not agree with the model of provision used by many commercial companies for certain severe or actionable health conditions. Despite this disagreement with the DTC model of provision, >85% of respondents said that they would offer genetic counselling to patients who asked for a consultation after having undergone DTC genetic testing. The understanding of the views and opinions of this expert stakeholder group should be considered in the attempts to shape responsible policy and guidelines for these services.

White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system

ObjectiveTo convene a group of expert stakeholders to develop recommendations for standardizing systems for the implementation of risk evaluation and mitigation strategies (REMS). Data sourcesOn July 15, 2009, the American Pharmacists Association convened an expert panel of stakeholders to explore standardized solutions to REMS development and implementation. Meeting participants included pharmacists from various practice settings, physicians, researchers, patient advocates, and a nursing delegate, and the meeting was observed by a U.S. Food and Drug Administration representative. The stakeholders’ recommendations were combined with themes arising from discussion of their experiences with existing REMS, and a review of the literature on REMS and risk management was performed by the author. SummaryA systematic, standardized REMS process that balances the need to control the risks of medications with the need to minimize the impact on patient access is required. A standardized REMS system could address various aspects of development and implementation, including the creation of specific REMS “levels,” centralized systems for data management and program structure, public education, individualized patient education, provider education, access to medications, pilot testing, outcomes monitoring, and quality of care. ConclusionSeveral strategies to streamline the development and implementation of a REMS system are feasible. Incorporating such strategies is necessary to manage the rapidly growing number of individual and diverse REMS programs that patients and health care providers must navigate. Furthermore, a standardized REMS system could be used to improve quality of care and support patient education and empowerment.

Rasch scaling procedures for informing development of a valid Fetal Surveillance Education Program multiple-choice assessment

BackgroundIt is widely recognised that deficiencies in fetal surveillance practice continue to contribute significantly to the burden of adverse outcomes. This has prompted the development of evidence-based clinical practice guidelines by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and an associated Fetal Surveillance Education Program to deliver the associated learning. This article describes initial steps in the validation of a corresponding multiple-choice assessment of the relevant educational outcomes through a combination of item response modelling and expert judgement.MethodsThe Rasch item response model was employed for item and test analysis and to empirically derive the substantive interpretation of the assessment variable. This interpretation was then compared to the hierarchy of competencies specified a priori by a team of eight subject-matter experts. Classical Test Theory analyses were also conducted.ResultsA high level of agreement between the hypothesised and derived variable provided evidence of construct validity. Item and test indices from Rasch analysis and Classical Test Theory analysis suggested that the current test form was of moderate quality. However, the analyses made clear the required steps for establishing a valid assessment of sufficient psychometric quality. These steps included: increasing the number of items from 40 to 50 in the first instance, reviewing ineffective items, targeting new items to specific content and difficulty gaps, and formalising the assessment blueprint in light of empirical information relating item structure to item difficulty.ConclusionThe application of the Rasch model for criterion-referenced assessment validation with an expert stakeholder group is herein described. Recommendations for subsequent item and test construction are also outlined in this article.

Deliberations of an Advisory Committee regarding priorities, sources, and methods for collecting animal antimicrobial use data in the United States

This paper describes the methodological options for food animal antimicrobial use data collection in the United States, including data priorities, methods, and limitations that were identified by a diverse group of expert stakeholders. Four major categories of antimicrobial use data were identified based on the source of information and its proximity to actual use: end-user data, prescription data, manufacturing data, and distribution data. Criteria were developed to aid in evaluating the overall utility of each methodological option, and an attempt was made to develop a qualitative, composite “overall usefulness” score for each option. Concensus was not reached on option scores, therefore, the experts individually rated six methodological options relative to the evaluation criteria, and provided comments and rationale for each response. The responses serve as a microcosm of the issues and stakeholder perspective: most relevant to animal antimicrobial use data collection in the United States.

Risk of fatal pulmonary embolism in patients with treated venos thromboembolism

Currently, no standardized classification criteria exist for cutaneous lupus erythematosus. With increased interest in studying cutaneous lupus erythematosus, specifically discoid lupus erythematosus, it is our aim to apply previously adopted methods from rheumatology to dermatologic diseases to develop feasible, validated, and standardized classification criteria useful in both academic and community practice. Here we report the progress to date to define discoid lupus erythematosus using clinical, histopathologic, and serologic features by means of a Delphi method—using a series of iterative questionnaires sent to expert stakeholders. We present specific updates from the World Congress of Dermatology 2015 meeting, at which a nominal group of expert stakeholders met to discuss the results of round 1 of the Delphi process to further clarify and harmonize specific classification items for inclusion into round 2.