'A radical operation' - a thematic analysis of newspaper framing of bariatric surgery in adolescents.

BACKGROUND: Obesity in adolescents is a growing public health issue. Bariatric surgery is an effective, yet controversial treatment option for adolescents. The moral acceptability of this procedure by health-care professionals as well as the general public can be influenced by its portrayal in the news media. Our objective was to analyze how newspaper articles portrayed adolescent bariatric surgery, with attention to the language used and moral arguments made. METHODS: Using an inductive thematic analysis approach, we analyzed 26 UK and 12 US newspaper articles (2014-2022) on adolescent bariatric surgery for implicit or explicit moral evaluations and use of normative language. Coding was performed after immersive reading, assisted by NVivo. Themes were identified and refined iteratively through consecutive auditing cycles to enrich the depth and rigor of our analysis. RESULTS: The major themes identified related to (1) defining the burden of adolescent obesity, (2) sparking moral outrage, (3) sensation-seeking, and (4) raising ethical issues. The articles employed moral language, specifically non-neutral and negative discourse regarding surgery. Blame was attributed to adolescents or their parents. Sensationalist wording often reinforced the normative content, drawing the attention of the reader and contributing to stigmatization of adolescents with severe obesity as lacking will power and being lazy. Further moral issues that stood out were the challenges in obtaining an informed consent, and the unequal access to surgery for socially disadvantaged groups. CONCLUSIONS: Our findings provide insights into how adolescent bariatric surgery is represented in the print news media. Despite frequent citing of experts and studies on the efficacy, safety and unmet need for bariatric surgery, obesity and surgery in adolescents are often stigmatized and sensationalized, with (prospective) patients depicted as looking for an easy way out in the form of a solution brought by others (health systems, society, tax payers). This may increase the stigma surrounding adolescent obesity, and therefore limit the acceptability of specific treatments such as bariatric surgery.

Investigators' sense of failure thwarted transparency in clinical trials discontinued for poor recruitment.

BACKGROUND AND OBJECTIVE: When a randomized clinical trial (RCT) prematurely discontinues, it is essential that stakeholders do the right thing to ensure that lessons can be learnt and trust in clinical research is maintained. There is, however, a lack of evidence exploring this issue. This study aimed to examine clinical trial stakeholders' practices following trial discontinuation due to poor participant recruitment and their views on implications of such discontinuation. METHODS: Individual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n = 39), Germany (n = 9) and Canada (n = 1) between August 2015 and November 2016. RESULTS: After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications. However, barriers continue to undermine transparency regarding trial discontinuation in practice, with it being reported that most investigators of discontinued trials are failing to notify stakeholders or publishing their results. Investigators sense of failure and associated negative emotions were identified as a key reason why investigators are not more transparent following discontinuation. CONCLUSION: The decision to notify stakeholders and publish results of a discontinued clinical trial should not rest solely on individual investigators but come from a systemic approach. However, until health research proactively requires the dissemination of results of all clinical trials, much will rest on individual investigators being motivated to do the right thing. Support programs might be helpful for investigators involved in discontinued trials and promote transparency and learning lessons.

Divergent Views and Experiences Regarding 'Completed Life' and Euthanasia in the Netherlands.

A small proportion of older people in the Netherlands want to end their lives because they feel their lives to be 'completed' and no longer worth living. Currently, there is heated debate over whether or not these people should have the right to euthanasia. Drawing on previous research, we conduct a heuristic analysis of views and experiences of three different 'parties' involved in this debate, namely, the older people, their relatives and friends and medical professionals. The views of these three groups tend to be divergent and conflicting, posing a difficult dilemma to decision-makers.

Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada.

BACKGROUND: Poor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study were to investigate (1) the views of clinical trial stakeholders from three different countries regarding reasons for recruitment failure in RCTs and (2) how these compare and contrast with the causes identified in a previous systematic review of RCT publications. METHODS: From August 2015 to November 2016, we conducted 49 semi-structured interviews with a purposive sample of clinical trial stakeholders. This included investigators based in Germany (n = 9), Switzerland (n = 6) and Canada (n = 1) with personal experience of a discontinued RCT and 33 other stakeholders (e.g., representatives of ethics committees, clinical trial units, pharmaceutical industry) in Switzerland. Individual semi-structured qualitative interviews were conducted and analyzed using thematic analysis. RESULTS: Interviewees identified a total of 29 different reasons for recruitment failure. Overoptimistic recruitment estimates, too narrow eligibility criteria, lack of engagement of recruiters/trial team, lack of competence/training/experience of recruiters, insufficient initial funding, and high burden for trial participants were mentioned most frequently. The interview findings largely confirm the previous systematic review on published reasons for recruitment failure. However, eight new reasons for recruitment failure were identified in the interviews, which led to the checklist of reasons for recruitment failure being revised and a new category describing research environment-related factors being added. CONCLUSIONS: This study highlights the diversity of often interlinked reasons for recruitment failure in RCTs. Integrating the findings of this interview study with a previous systematic review of RCT publications led to a comprehensive, structured checklist of empirically-informed reasons for recruitment failure. The checklist may be useful to guide further research on interventions to improve participant recruitment in RCTs and helpful for trial investigators, research ethics committees, and funding agencies when assessing trial feasibility with respect to recruitment.

Autonomy and dying: Notes about decision-making and "completed life" euthanasia in the Netherlands.

Euthanasia in the Netherlands is based on the notion that the person seeking assistance to die is able to make an autonomous decision. The objective of this study is to explore this notion, in particular, in the case of "tiredness of life." The article is mainly based on two qualitative researches and two selected case histories that provide an in-depth insight into the complex process of (not) reaching a clear decision. We found three obstacles that cast doubt over autonomous decision-making in the face of death: (1) Doctors - not patients - have the final say in "measuring" the "amount" of pain and suffering that entitles a person to be granted euthanasia. (2) Human decisions are always taken in a context of complex circumstances involving relatives, friends, and medical professionals. Decisions may therefore be changed, mitigated, or not taken at all. (3) People lose much of their autonomy when they grow old and fragile, and will be increasingly inclined or forced to leave decisions to others.

Accommodating an Uninvited Guest: Perspectives of Researchers in Switzerland on 'Honorary' Authorship.

The aim of this paper is to analyze the attitudes and reactions of researchers towards an authorship claim made by a researcher in a position of authority who has not made any scientific contribution to a manuscript or helped to write it. This paper draws on semi-structured interviews conducted with 33 researchers at three seniority levels working in biomedicine and the life sciences in Switzerland. This manuscript focuses on the analysis of participants' responses when presented with a vignette describing an authorship assignment dilemma within a research group. The analysis indicates that researchers use a variety of explanations and arguments to justify inclusion of what guidelines would describe as honorary or guest authorship. Fuzzy parameters such as "substantial contribution" lead to varied interpretation and consequently convenient application of authorship guidelines in practice. Factors such as the culture of the research group, the values and practice shaped by the research leaders, the hierarchy and relative (perceived) positions of power within research institutions, and the importance given to publications as the currency for academic success and growth tend to have a strong influence on authorship practice. Unjustified authorship assignment practices can be reduced to some extent by creating empowering research cultures where each researcher irrespective of his/her career stage feels empowered to confidently raise concerns without fearing adverse impact on their professional lives. However, individual researchers and research institutions currently have limited influence on established methods for evaluating academic success, which is primarily based on the number of high impact publications.

How do researchers acquire and develop notions of research integrity? A qualitative study among biomedical researchers in Switzerland.

BACKGROUND: Structured training in research integrity, research ethics and responsible conduct of research is one strategy to reduce research misconduct and strengthen reliability of and trust in scientific evidence. However, how researchers develop their sense of integrity is not fully understood. We examined the factors and circumstances that shape researchers' understanding of research integrity. METHODS: This study draws insights from in-depth, semi-structured interviews with 33 researchers in the life sciences and medicine, representing three seniority levels across five research universities in Switzerland. RESULTS: The results of this study indicate that early education, moral values inculcated by the family and participation in team sports were the earliest influences on notions of honesty, integrity and fairness among researchers. Researchers' personality traits, including degree of ambition and internal moral compass, were perceived as critical in determining the importance they attributed to conducting research with high ethical standards. Positive and negative experiences in early research life also had a significant impact on their views regarding research integrity. Two thirds of the study participants had not received any formal training in research integrity. Their awareness of training opportunities at their institutions was also limited. CONCLUSION: Age-appropriate development of honesty and integrity starts as early as primary education. Research integrity training should be offered from the bachelors level and continue throughout the entire professional life of researchers. Although these courses may not imbue researchers with integrity itself, they are essential to improving the research culture, reinforcing integrity norms, and discouraging researchers who lack personal integrity from engaging in research misconduct.

Is failure to raise concerns about misconduct a breach of integrity? Researchers' reflections on reporting misconduct.

This article describes and discusses the views of researchers on the significance of raising concerns about scientific misconduct in their work environment and the reasons or circumstances that might deter them from doing so. In this exploratory qualitative research study, we conducted in-depth interviews with 33 researchers working in life sciences and medicine. They represent three seniority levels and five universities across Switzerland. A large majority of respondents in this research study argued that failure to raise concerns about scientific misconduct compromises research integrity. This is an encouraging result demonstrating that researchers try to adhere to high ethical standards. However, further interaction with respondents highlighted that this correct ethical assessment does not lead researchers to take the consequent action of raising concerns. The factors that discourage researchers from raising concerns need to be addressed at the level of research groups, institutions, and by setting a positive precedent which helps them to believe in the system's ability to investigate concerns raised in a timely and professional manner. Training of researchers in research integrity related issues will have limited utility unless it is coupled with the creation of research culture where raising concerns is a standard practice of scientific and research activities.

Researchers' interpretations of research integrity: A qualitative study.

Despite increasing interest in integrity issues, relatively few studies have examined researchers' own interpretations of integrity. As part of the Perspectives on Research Integrity in Science and Medicine (PRISM) project, we sought to explore how researchers themselves define research integrity. We conducted 33 semi-structured interviews with clinical and laboratory-based researchers from across Switzerland. Data were transcribed and coded using thematic analysis and illustrative quotes were selected. Researchers defined integrity in terms of honesty, transparency, and objectivity, and generally stressed the importance of sticking to the research question and avoiding bias in data interpretation. Some saw research integrity as being synonymous with scientific integrity, but others regarded research integrity as being a subset of the wider domain of scientific integrity. A few participants equated research integrity with mere absence of misconduct, but the majority of participants regarded integrity as being more than this. Researchers regarded truth as the key aspect of integrity, though they expressed this in different ways and with various emphases on honesty, transparency, and objectivity. Integrity goes beyond avoiding misconduct, and scientific integrity has a wider domain than research integrity.

Insufficient recruitment and premature discontinuation of clinical trials in Switzerland: qualitative study with trialists and other stakeholders.

AIMS OF THE STUDY: Premature discontinuation occurs in about 25% of randomised clinical trials in Switzerland; it mainly affects investigator-initiated trials and is mostly due to problems with recruitment of patients. The aim of this study was to qualitatively investigate reasons for trial discontinuation due to poor patient recruitment and suggestions to address those reasons in the Swiss context. METHODS: We conducted semi-structured interviews with trialists whose trials were discontinued because of recruitment problems, other experienced trialists, and stakeholders in clinical research in Switzerland. Interviews were audio-recorded, transcribed verbatim, and anonymised. We analysed the transcripts using deductive coding and built up themes that were continuously discussed within the research team. RESULTS: Of 65 invited Swiss trialists and stakeholders, 39 (60%) agreed to be interviewed and contributed to this analysis. We identified four main themes of reasons for poor recruitment: (1) Switzerland has a decentralised healthcare system with many small hospitals and few patients per hospital, many research regulations, no standardisation of medical records across hospitals, and a heterogeneous ethics assessment of study protocols. There is little collaboration of different stakeholders in clinical research and a lack of prioritisation of projects. (2) Limited human and financial resources, especially in the academic setting, compromise research questions and size of clinical trials. When funding is used up this typically triggers discontinuation of already delayed clinical trials. (3) Investigators face underdeveloped research networks and a limited collaborative attitude among clinical researchers. They typically embark on clinical studies with a great deal of optimism but insufficient preparation. (4) Swiss patients have universal health coverage and many treatment options. Negative media coverage of clinical research and a lack of accessible information for patients about ongoing clinical studies frequently make participation in clinical trials less attractive. More interactive structures and collaboration across stakeholders were mentioned as potential solutions to tackle the problems. CONCLUSIONS: Recruitment of participants into clinical trials in Switzerland is challenging because of various, often interlinked factors related to the Swiss health system, available funding, investigators, and patients. Common goals and concerted efforts by involved stakeholders appear necessary to achieve improvement.

Generating evidence on a risk-based monitoring approach in the academic setting - lessons learned.

BACKGROUND: In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution. METHODS: We selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01.01.2012 and 31.12.2014. We extracted study characteristics and monitoring information from the CTU Enterprise Resource Management system and from monitoring reports of all selected studies. We summarized the data descriptively. Additionally, we conducted semi-structured interviews with the three current CTU monitors. RESULTS: During the observation period, a total of 214 monitoring visits were conducted in 43 studies resulting in 2961 documented monitoring findings. Our risk-based approach predominantly identified administrative (46.2%) and patient right findings (49.1%). We identified observational study design, high ADAMON risk category, industry sponsorship, the presence of an electronic database, experienced site staff, and inclusion of vulnerable study population to be factors associated with lower numbers of findings. The monitors understand the positive aspects of a risk-based approach but fear missing systematic errors due to the low frequency of visits. CONCLUSIONS: We show that the factors mostly increasing the risk for on-site monitoring findings are underrepresented in the current risk analysis scheme. Our risk-based on-site approach should further be complemented by centralized data checks, allowing monitors to transform their role towards partners for overall trial quality, and success.

Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.

BACKGROUND: Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles. AIM: We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. METHODS: We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. RESULTS: We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. CONCLUSION: We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.

Challenges of clinical translation in nanomedicine: A qualitative study.

Clinical translation of breakthroughs in nanotechnology and nanomedicine is expected to significantly improve diagnostic tools and therapeutic modalities for various diseases. This will not only improve human health and well-being, but is also likely to reduce health care costs in the long run. However, clinical translation is a long, arduous, resource intensive process that requires priority setting, resource mobilization, successful national and international collaboration, and effective coordination between key stakeholders. The aim of this paper is to describe various challenges faced by the stakeholders involved in translational nanomedicine while planning and conducting first in human clinical trials. We draw on insights obtained from 46 in-depth qualitative interviews with key stakeholders from Europe and North America. FROM THE CLINICAL EDITOR: Translational research is a crucial step in bringing basic research into clinical reality. This is particularly important in a new field like nanomedicine. Clinical translation is a long and resource intensive process with difficulties along the way. In this article, the authors looked at the challenges faced by various parties in order to help identify ways to overcome these challenges.

Defining Nano, Nanotechnology and Nanomedicine: Why Should It Matter?

Nanotechnology, which involves manipulation of matter on a 'nano' scale, is considered to be a key enabling technology. Medical applications of nanotechnology (commonly known as nanomedicine) are expected to significantly improve disease diagnostic and therapeutic modalities and subsequently reduce health care costs. However, there is no consensus on the definition of nanotechnology or nanomedicine, and this stems from the underlying debate on defining 'nano'. This paper aims to present the diversity in the definition of nanomedicine and its impact on the translation of basic science research in nanotechnology into clinical applications. We present the insights obtained from exploratory qualitative interviews with 46 stakeholders involved in translational nanomedicine from Europe and North America. The definition of nanomedicine has implications for many aspects of translational research including: fund allocation, patents, drug regulatory review processes and approvals, ethical review processes, clinical trials and public acceptance. Given the interdisciplinary nature of the field and common interest in developing effective clinical applications, it is important to have honest and transparent communication about nanomedicine, its benefits and potential harm. A clear and consistent definition of nanomedicine would significantly facilitate trust among various stakeholders including the general public while minimizing the risk of miscommunication and undue fear of nanotechnology and nanomedicine.

Internet-mediated psychotherapy: Are we ready for the ethical challenges?

Advances in information and communication technology have facilitated the development of online psychotherapy. This form of psychotherapy would provide the developing world with better access to professional mental healthcare services. At the same time, it is prudent to carefully consider the various ethical, legal and regulatory issues involved in online psychotherapy. This paper highlights the major ethical issues involved in the use of online psychotherapy, whether conducted via e-mail, chat rooms or interactive video, and identifies practical solutions for the ethical dilemmas that exist. Many authors and organisations have expressed their opinions on the subject, but no consensus has evolved. The advice offered to psychologists is mostly skewed and the scarcity of literature available to those considering expanding their practice to include online psychotherapy is certainly a source of vexation. While reviewing the existing literature, this paper seeks to describe and discuss the major ethical issues in this area, particularly in India, but many of these issues will be equally applicable to any developing world settings.

Not fit for purpose: the ethical guidelines of the Indian Council of Medical Research.

In 2006, the Indian Council of Medical Research (ICMR) published its 'Ethical guidelines for Biomedical Research on human participants'. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India.

Prioritising Healthcare Workers for Ebola Treatment: Treating Those at Greatest Risk to Confer Greatest Benefit.

The Ebola epidemic in Western Africa has highlighted issues related to weak health systems, the politics of drug and vaccine development and the need for transparent and ethical criteria for use of scarce local and global resources during public health emergency. In this paper we explore two key themes. First, we argue that independent of any use of experimental drugs or vaccine interventions, simultaneous implementation of proven public health principles, community engagement and culturally sensitive communication are critical as these measures represent the most cost-effective and fair utilization of available resources. Second, we attempt to clarify the ethical issues related to use of scarce experimental drugs or vaccines and explore in detail the most critical ethical question related to Ebola drug or vaccine distribution in the current outbreak: who among those infected or at risk should be prioritized to receive any new experimental drugs or vaccines? We conclude that healthcare workers should be prioritised for these experimental interventions, for a variety of reasons.