Motivational communication skills to improve motivation and adherence in cardiovascular disease prevention: A narrative review.

Lifestyle optimization is one of the most essential components of cardiovascular disease prevention. Motivational counseling provided by health care professionals could promote lifestyle modification. The purpose of the review is to identify possible evidence-based psychological principles that may be applicable to motivational counseling in the prevention of cardiovascular disease. These motivational communication skills promote behavioral change, improved motivation and adherence to cardiovascular disease prevention. A personal collection of the relevant publications. The review identified and summarized the previous evidence of implementation intentions, mental contrasting, placebo effect and nocebo effects and identity-based regulations in behavior change interventions and proposed their potential application in cardiovascular disease prevention. However, it is challenging to provide real support in sustainable CVD-risk reduction and encourage patients to implement lifestyle changes, while avoiding being unnecessarily judgmental, disrespectful of autonomy, or engaging patients in burdensome efforts that have little or no effect on the long run. Motivational communication skills have a great potential for effectuating sustainable lifestyle changes that reduce CVD-related risks, but it is also surrounded by ethical issues that should be appropriately addressed in practice. It is key to realize that motivational communication is nothing like an algorithm that is likely to bring about sustainable lifestyle change, but a battery of interventions that requires specific expertise and long term joint efforts of patients and their team of caregivers.

The failure of success: four lessons learned in five years of research on research integrity and research assessments.

In the past 5 years, we captured the perspectives from a broad array of research stakeholders to better understand the impact that current approaches to success and research assessment may have on the integrity and the quality of research. Here, we translate our findings in four actions that are urgently needed to foster better research. First, we need to address core research structures to overcome systemic problems of the research enterprise; second, we must realign research assessments to value elements that advance and strengthen science; third, we need to remodel, diversify, and secure research careers; and finally, we need to unite and coordinate efforts for change.

Crowd Funding for Orphan Drugs: The Case of Baby Pia.

Medical crowdfunding is a relatively new strategy to obtain access to orphan drugs. The case of Baby Pia, a Belgian girl with SMA type 1 for whom in 2018 more than $ 2.1 million was raised to get her treated with Zolgensma®, illustrates well the potential power of medical crowdfunding. But apart from the success in raising money, the case is also of particular importance for the ethical issues it brings to the surface as related to justice, equity, power imbalances, responsibility, accountability, indebtedness and privacy.

Neuroblastoma: The basis for cure in limited-resource settings.

BACKGROUND: Neuroblastoma (NB) contributes the most to the mortality of childhood malignancies worldwide. The disease spectrum is heterogenous and the management complex and costly, especially in advanced disease or disease with adverse biology. In low- and middle-income countries (LMICs) the majority of NB presents in advanced stages. Therefore, with limited resources and poor prognosis the treatment of NB is often not a priority. The aim of the study was to evaluate the research activities and perceptions of the management of NB that determine the research and treatment approaches in LMICs. METHODS: Data were sourced from https://www.clinicaltrials.gov/ identifying NB trials open to LMIC. Abstracts on NB research presented at the International Society for Paediatric Oncology (SIOP) Congresses between 2014 and 2020 were evaluated according to income status. An online survey evaluating medical views on NB in LMICs and the effect on the management was conducted. Descriptive analysis was done. Where appropriate categorical association between covariates was assessed using the Pearson chi-square (χ2 ) test or Fishers exact test. RESULTS: There were 15/562 (2.7%) trials open to LMIC. Only six of 138 (4.3%) LMIC participated in NB trials. Of the 688 abstracts presented between 2014 and 2020 at the SIOP International Congress on NB as primary subject, 297 (42.7%) were from LMICs. Only two were from low-income countries (LICs). Sixty-one countries responded to the NB survey. Positive views towards NB management were present when treatment was based on a national protocol, the availability of trimodal or advanced treatment options were present, and when a balance of metastatic or local disease were treated. CONCLUSION: Management of NB in LMICs should include increased advocacy and research as well as implementation of national management strategies.

Advancing science or advancing careers? Researchers' opinions on success indicators.

The way in which we assess researchers has been under the radar in the past few years. Critics argue that current research assessments focus on productivity and that they increase unhealthy pressures on scientists. Yet, the precise ways in which assessments should change is still open for debate. We circulated a survey with Flemish researchers to understand how they work, and how they would rate the relevance of specific indicators used in research assessments. We found that most researchers worked far beyond their expected working schedule. We also found that, although they spent most of their time doing research, respondents wished they could dedicate more time to it and spend less time writing grants and performing other activities such as administrative duties and meetings. When looking at success indicators, we found that indicators related to openness, transparency, quality, and innovation were perceived as highly important in advancing science, but as relatively overlooked in career advancement. Conversely, indicators which denoted of prestige and competition were generally rated as important to career advancement, but irrelevant or even detrimental in advancing science. Open comments from respondents further revealed that, although indicators which indicate openness, transparency, and quality (e.g., publishing open access, publishing negative findings, sharing data, etc.) should ultimately be valued more in research assessments, the resources and support currently in place were insufficient to allow researchers to endorse such practices. In other words, current research assessments are inadequate and ignore practices which are essential in contributing to the advancement of science. Yet, before we change the way in which researchers are being assessed, supporting infrastructures must be put in place to ensure that researchers are able to commit to the activities that may benefit the advancement of science.

Rethinking success, integrity, and culture in research (part 2) - a multi-actor qualitative study on problems of science.

BACKGROUND: Research misconduct and questionable research practices have been the subject of increasing attention in the past few years. But despite the rich body of research available, few empirical works also include the perspectives of non-researcher stakeholders. METHODS: We conducted semi-structured interviews and focus groups with policy makers, funders, institution leaders, editors or publishers, research integrity office members, research integrity community members, laboratory technicians, researchers, research students, and former-researchers who changed career to inquire on the topics of success, integrity, and responsibilities in science. We used the Flemish biomedical landscape as a baseline to be able to grasp the views of interacting and complementary actors in a system setting. RESULTS: Given the breadth of our results, we divided our findings in a two-paper series with the current paper focusing on the problems that affect the integrity and research culture. We first found that different actors have different perspectives on the problems that affect the integrity and culture of research. Problems were either linked to personalities and attitudes, or to the climates in which researchers operate. Elements that were described as essential for success (in the associate paper) were often thought to accentuate the problems of research climates by disrupting research culture and research integrity. Even though all participants agreed that current research climates need to be addressed, participants generally did not feel responsible nor capable of initiating change. Instead, respondents revealed a circle of blame and mistrust between actor groups. CONCLUSIONS: Our findings resonate with recent debates, and extrapolate a few action points which might help advance the discussion. First, the research integrity debate must revisit and tackle the way in which researchers are assessed. Second, approaches to promote better science need to address the impact that research climates have on research integrity and research culture rather than to capitalize on individual researchers' compliance. Finally, inter-actor dialogues and shared decision making must be given priority to ensure that the perspectives of the full research system are captured. Understanding the relations and interdependency between these perspectives is key to be able to address the problems of science. STUDY REGISTRATION: https://osf.io/33v3m.

Rethinking success, integrity, and culture in research (part 1) - a multi-actor qualitative study on success in science.

BACKGROUND: Success shapes the lives and careers of scientists. But success in science is difficult to define, let alone to translate in indicators that can be used for assessment. In the past few years, several groups expressed their dissatisfaction with the indicators currently used for assessing researchers. But given the lack of agreement on what should constitute success in science, most propositions remain unanswered. This paper aims to complement our understanding of success in science and to document areas of tension and conflict in research assessments. METHODS: We conducted semi-structured interviews and focus groups with policy makers, funders, institution leaders, editors or publishers, research integrity office members, research integrity community members, laboratory technicians, researchers, research students, and former-researchers who changed career to inquire on the topics of success, integrity, and responsibilities in science. We used the Flemish biomedical landscape as a baseline to be able to grasp the views of interacting and complementary actors in a system setting. RESULTS: Given the breadth of our results, we divided our findings in a two-paper series, with the current paper focusing on what defines and determines success in science. Respondents depicted success as a multi-factorial, context-dependent, and mutable construct. Success appeared to be an interaction between characteristics from the researcher (Who), research outputs (What), processes (How), and luck. Interviewees noted that current research assessments overvalued outputs but largely ignored the processes deemed essential for research quality and integrity. Interviewees suggested that science needs a diversity of indicators that are transparent, robust, and valid, and that also allow a balanced and diverse view of success; that assessment of scientists should not blindly depend on metrics but also value human input; and that quality should be valued over quantity. CONCLUSIONS: The objective of research assessments may be to encourage good researchers, to benefit society, or simply to advance science. Yet we show that current assessments fall short on each of these objectives. Open and transparent inter-actor dialogue is needed to understand what research assessments aim for and how they can best achieve their objective. STUDY REGISTRATION: osf.io/33v3m.

Uptake and impact of priority setting exercises in nutrition research publications.

OBJECTIVE: To assess how priority setting exercises for nutrition research are considered in publication. DESIGN: Cross-sectional design. SETTINGS: First, a citation analysis of priority setting exercises found in nutrition research until 2019 was conducted. The reasons for citation were extracted from the text of citing papers and the reasons were defined as: (i) acting on the research questions identified as priorities, (ii) acknowledging the priority setting exercise, (iii) using the same method, or (iv) previous knowledge to support evidence. Second, a survey with authors of the priority setting exercises was done to understand priority setters' perspectives on the impact and satisfaction of their work. PARTICIPANTS: Twenty-one priority setting exercise papers were included. In all, 434 citing papers were found, of which 338 were considered in the citation analysis. A sample of 17 authors representing 13 priority setting exercise papers completed the impact and satisfaction survey. RESULTS: Half of the priority setting exercise papers were published by 2013. After excluding self-citations (n = 60), the priority setting papers had on average 18 citations. Priority setting exercises had a median of 1 (IQR = 0-1) citing manuscript that acted on the recommendations produced from priority setting exercises. Authors of the priority setting exercises expressed a desire for increased uptake of the results of the priority setting exercises by funding agencies. Key barriers for uptake were identified as challenges in involving stakeholders and the general public for participation in the priority setting exercise. CONCLUSIONS: Priority settings exercises are important efforts to guide nutrition research toward effective allocation of resources. However, there seems to be a limited consideration of these priority setting exercises in research papers.

The Impact of Incidental Findings Detected During Brain Imaging on Research Participants of the Rotterdam Study: An Interview Study.

This interview study investigates the short- and long-term implications of incidental findings detected through brain imaging on research participants' lives and their surroundings. For this study, nine participants of the Rotterdam Scan Study with an incidental finding were approached and interviewed. When examining research participants' narratives on the impact of the disclosure of incidental findings, the authors identified five sets of tensions with regard to motivations for and expectations of research participation, preferences regarding disclosure, short- and long-term impacts and impacts on self and others. The paper shows: (1) that the impact of incidental findings may be greater than participants at first let on; (2) incidental findings can have significant effects on participants' social environment; and (3) participants may not feel prepared for disclosure even if incidental findings have been discussed during the informed consent process. The authors call for investigators to be aware of research participants' experiences and these short- and long-term impacts when designing suitable courses of action for the detection and management of incidental findings in research settings.

A Decade of Empirical Research on Research Integrity: What Have We (Not) Looked At?

Research on research integrity has become a field of its own; yet, a comprehensive overview the field is still missing. We systematically searched SCOPUS, Web of Science, and PubMed for relevant articles published between 2005 and 2015. We extracted the topic, methodology, focus, and citations from each articles. From the 986 articles included, only 342 report empirical data. Empirical papers predominantly targeted researchers and students. Although empirical articles questioning causes for misconduct mostly blamed research systems (e.g., pressure, competition) for detrimental research practices, articles proposing approaches to foster integrity focused on researchers' awareness and compliance rather than on system changes. Involving nonresearchers and reconnecting what is known to what is proposed may help research on research integrity move forward.

Ethical Considerations for Movement Mapping to Identify Disease Transmission Hotspots.

Traditional public health methods for detecting infectious disease transmission, such as contact tracing and molecular epidemiology, are time-consuming and costly. Information and communication technologies, such as global positioning systems, smartphones, and mobile phones, offer opportunities for novel approaches to identifying transmission hotspots. However, mapping the movements of potentially infected persons comes with ethical challenges. During an interdisciplinary meeting of researchers, ethicists, data security specialists, information and communication technology experts, epidemiologists, microbiologists, and others, we arrived at suggestions to mitigate the ethical concerns of movement mapping. These suggestions include a template Data Protection Impact Assessment that follows European Union General Data Protection Regulations.

Quality of medicines in resource-limited settings: need for ethical guidance.

The quality of medicines is generally adequately assured by manufacturers and regulatory authorities for well-resourced settings, while the implementation of existing quality standards is challenged in many low- and middle-income countries. This situation of multiple pharmaceutical standards raises the question whether it could ever be ethically justified to compromise on the quality assurance of medicines depending on what individuals, communities, or societies can afford. In this paper, we contend that ethically, any unjustified exceptions to medicines' quality assurance represents a violation of the principles of beneficence and non-maleficence. Exceptions are only acceptable in exceptional and temporary circumstances, if based on a meaningful quality risk assessment, guided by a rigorous ethical framework built on the principles of independence, technical competence, transparency, and accountability. We also discuss how such exceptional and temporary circumstances should be defined/justified. Finally, we propose that empirical bioethics should acknowledge the existence of these dilemmas in public health, and help to build a normative approach to dealing with them. Ideally, an international group of experts in quality assurance/regulatory affairs and health ethicists should be set up to take up this topic and formulate a Guide to Ethical Principles of Quality Assurance of Medical Products.

Perspective: Consideration of Values When Setting Priorities in Nutrition Research: Guidance for Transparency.

Nutrition research can guide interventions to tackle the burden of diet-related diseases. Setting priorities in nutrition research, however, requires the engagement of various stakeholders with diverse insights. Consideration of what matters most in research from a scientific, social, and ethical perspective is therefore not an automatic process. Systematic ways to explicitly define and consider relevant values are largely lacking. Here, we review existing nutrition research priority-setting exercises, analyze how values are reported, and provide guidance for transparent consideration of values while setting priorities in nutrition research. Of the 27 (n = 22 peer-reviewed manuscripts and 5 grey literature documents) studies reviewed, 40.7% used a combination of different methods, 59.3% described the represented stakeholders, and 49.1% reported on follow-up activities. All priority-setting exercises were led by research groups based in high-income countries. Via an iterative qualitative content analysis, reported values were identified (n = 22 manuscripts). Three clusters of values (i.e., those related to impact, feasibility, and accountability) were identified. These values were organized in a tool to help those involved in setting research priorities systematically consider and report values. The tool was finalized through an online consultation with 7 international stakeholders. The value-oriented tool for priority setting in nutrition research identifies and presents values that are already implicitly and explicitly represented in priority-setting exercises. It provides guidance to enable explicit deliberation on research priorities from an ethical perspective. In addition, it can serve as a reporting tool to document how value-laden choices are made during priority setting and help foster the accountability of stakeholders involved.

Ethical framework for the detection, management and communication of incidental findings in imaging studies, building on an interview study of researchers' practices and perspectives.

BACKGROUND: As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers' practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of incidental findings in imaging research. METHODS: We conducted an interview study with a purposive sample of researchers (n = 20) at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium (n = 14). RESULTS: Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. CONCLUSION: We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers' moral obligations and the principle of reciprocity.

Barriers in the Uptake and Delivery of Preconception Care: Exploring the Views of Care Providers.

Objectives To examine health care professionals' views of their role and responsibilities in providing preconception care and identify barriers that affect the delivery and uptake of preconception care. Methods Twenty health care professionals who provide preconception care on a regular basis were interviewed using semi-structured interviews. Results We interviewed twelve community midwives, three General Practitioners, three obstetricians, one cardiologist specialized in congenital heart diseases and one gastroenterologist.We identified four barriers affecting the uptake and delivery of preconception care (PCC): (1) lack of a comprehensive preconception care program; (2) limited awareness of most future parents about the benefits of preconception care, hesitance of GP's about the necessity and effectiveness of PCC; (3) poor coordination and organization of preconception care; (4) conflicting views of health care professionals on pregnancy, reproductive autonomy of patients and professional responsibility. Conclusion We have identified four barriers in the uptake and delivery of preconception care. Our findings support the timely implementation of a comprehensive program of PCC (already advocated by the Health Council of the Netherlands) and increasing awareness and knowledge of PCC from care providers and future parents. We emphasize the need for further research on how organizational barriers lead to suboptimal PCC and how interdisciplinary collaboration and referral can lead to optimally tailored intervention approaches.

Measuring states of pathological (un)consciousness: research dimensions, clinical applications, and ethics.

Consciousness is a multidimensional construct with no widely accepted definition. Especially in pathological conditions, it is less clear what exactly is meant by (un)consciousness, how it can be reliably observed or measured. Here, we aim at (i) bringing together state of the art approaches to classification of single patients suffering from disorders of consciousness by means of motor-independent assessment of consciousness states with electrophysiology and functional neuroimaging, (ii) showing how each proposed metric translates into clinical practice and (iii) raising a discussion on the ethical aspects of consciousness measurements. We realize that when dealing with patients some issues commonly pertain to each methodology discussed here, such as the overall clinical condition, clinical heterogeneity, and diagnostic uncertainty. When predicting patients' diagnosis, though, each method adopts a different approach to determine (a) a "gold standard" of the benchmark population upon which the metric is computed and (b) the generalization and replicability in the attempt to avoid overfitting. From an applied ethics perspective, the focus is, hence, on knowing what one is measuring and on the validity of measurements. We conclude that, when searching for consciousness in pathological conditions, confident diagnosis can be based on the use of probabilistic predictions as well as on accumulative evidence stemming from multiple non-overlapping assessments with different modalities. A framework which will regulate the application order of these techniques (balancing their availability, sensitivity, and specificity, based on underlying clinical assumptions about a patient's conscious state), is expected to ameliorate clinical management and further inform on the critical patterns of (un)consciousness.

Content Analysis of Informed Consent for Whole Genome Sequencing Offered by Direct-to-Consumer Genetic Testing Companies.

Whole exome sequencing (WES) and whole genome sequencing (WGS) have become increasingly available in the research and clinical settings and are now also being offered by direct-to-consumer (DTC) genetic testing (GT) companies. This offer can be perceived as amplifying the already identified concerns regarding adequacy of informed consent (IC) for both WES/WGS and the DTC GT context. We performed a qualitative content analysis of Websites of four companies offering WES/WGS DTC regarding the following elements of IC: pre-test counseling, benefits and risks, and incidental findings (IFs). The analysis revealed concerns, including the potential lack of pre-test counseling in three of the companies studied, missing relevant information in the risks and benefits sections, and potentially misleading information for consumers. Regarding IFs, only one company, which provides opportunistic screening, provides basic information about their management. In conclusion, some of the information (and related practices) present on the companies' Web pages salient to the consent process are not adequate in reference to recommendations for IC for WGS or WES in the clinical context. Requisite resources should be allocated to ensure that commercial companies are offering high-throughput sequencing under responsible conditions, including an adequate consent process.

Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority.

Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of whether, to satisfy the ethical and legal norms of consent for research, participants in pediatric studies who attain the age of majority after their parents or guardians enrolled them in a study should be "recontacted" to obtain their consent to remain in the study. Using three different contexts (longitudinal studies, clinical trials, and newborn screening), we argue that distinctions should be made between the risks and benefits involved in recontacting for consent before determining the potential duties of researchers. An obligation to recontact should always be balanced with the feasibility and cost of such efforts in each particular research context and with consideration for the existence or lack of an ongoing relationship with the participant.

Risks in a Trial of an Innovative Treatment of Duchenne Muscular Dystrophy.

Studies of innovative therapies for muscular dystrophy raise unique ethical issues. The disease is currently untreatable and relentlessly progressive. A number of potentially efficacious treatments are being developed, but like all treatments, they may have unforeseen adverse effects. Nevertheless, patients and families, facing a bleak future, may be willing to take the gamble and try the treatments. Many doctors are eager to study them. But should institutional review boards approve them? This article discusses these issues and recounts the ways that one such study elicited different responses from different institutional review boards.