[Ethics of (big) data applications in psychiatric practice]. / Ethiek van (big)datatoepassingen in de psychiatrische praktijk.

BACKGROUND: Due to rapid digitalization, an increasing amount of data is available in healthcare settings; big data and artificial intelligence (AI) have also made their appearance. AIM: To provide insight into various ethical dilemmas that need to be considered when applying big data in clinical practice. METHOD: Description and analyses of the ethical aspects associated with the use of clinical data in the context of psychiatric care. RESULTS: Various ethical aspects play a role in four phases; data collection, analysis, dissemination and application of results. In order to use clinical data and AI in a responsible manner, these aspects must be taken into account. CONCLUSION: The use of big data and AI in healthcare should aim to stimulate learning and improving care together with patients and professionals. Big data and AI should not be seen as the holy grail, but as a supporting tool in healthcare - a field in which many of the aspects that play a role in clinical care cannot be converted into measurable data.

Narrative medicine as a medical education tool: A systematic review.

Aim: Narrative medicine has been promoted as an innovative and effective means of stimulating medical students' professional development by teaching them to approach their patients' experiences of illness with more understanding and compassion. This systematic literature review aims to answer the following question: what evidence of effect is available in the literature about models for teaching narrative medicine? Methods: We conducted a narrative review of 36 articles and used the Best Evidence in Medical Education (BEME) Global Scale and Kirkpatrick Scale for strength and importance of evidence to categorize reported assessment strategies and to evaluate the effectiveness of their narrative medicine programs. Results: We found evidence that narrative medicine is an effective pedagogic tool with a clear and replicable structure and methodology. We also determined that a positive impact could be measured when pertaining to participation and modification of attitudes, knowledge, and skills. However, unequivocal evidence of the effect of narrative medicine on students' behavior or ongoing interaction with colleagues and patients is still lacking. Conclusion: While many recent publications describe the goals and virtues of a narrative-based approach, more research is needed to determine whether or not there is an ideological consensus undergirding this approach. In addition, it is still unclear whether the long-term impact of narrative medicine classroom interventions are felt by patients, or whether such interventions positively impact patient care.

Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports.

BACKGROUND: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators encounter during marketing authorization application deliberations, and the incidence of these ethical issues. METHODS: This study used an EMA-provided Excel file that contains all the GCP non-compliance findings from all inspection reports from 2008-2012. There were 112 medicinal products and a total of 288 clinical trial sites. There were a total of 4014 GCP non-compliance findings. The findings that were ethically relevant were extracted using NVivo 10.0 and categories for the ethically relevant findings (ERFs) were created. Note was taken of the incidence of ERFs for each category and the inspectors' gradings of these findings were extracted. This study also looked at the mean and the maximum number of ERFs per grading per medicinal product application, as well as the number of medicinal products with at least one ERF and those with at least major ERFs. RESULTS: With multiple coding, there were 1685 ERFs. ERFs were present in almost all of the medicinal products (97.3%). The majority of ERFs were graded as major. At least major ERFs were present in almost all medicinal products with ERFs. The categories with the highest number of ERFs were protocol issues, patient safety, and professionalism issues. In terms of the density of combined critical and major findings, monitoring and oversight, protocol issues, and respect for persons top the list. This study also showed that, on average, there were 7.54 major and 2.95 critical ERFs per medicinal product application, although ERFs can increase to 30 major and 12 critical. CONCLUSION: Regulators regularly encounter ERFs that at least "might adversely affect the rights, safety or well-being of the subjects". It remains to be explored how regulators respond to these ethical issues.

Publication trends in newspapers and scientific journals for SSRIs and suicidality: a systematic longitudinal study.

Background In the period 2003-2008, the regulatory authorities issued several warnings restricting the use of selective serotonin re-uptake inhibitors (SSRIs) in paediatrics, in reaction to safety concerns regarding the risk of suicidality. In this study, the SSRIs and suicidality controversy serves as a template to analyse the long-term publication trends regarding the benefit/risk profile of medications. The aim is to ascertain differences (in terms of numbers, categories and timing) between negative and positive newspaper and journal articles on SSRIs and suicidality and to ascertain correlations between changes in the reports and regulatory warnings. Methods A systematic review of scientific articles (Embase) and the Netherlands (NL) and the UK newspapers (LexisNexis) was performed between 2000 and 2010. Categorisation was done by 'effect' (related treatment effect), 'type of article' and 'age group'. The articles' positive-to-negative effect ratio was determined. Differences in distribution of effect categories were analysed across sources, type of article and age group using the Mann-Whitney (two subgroups) or Kruskal-Wallis test (three or more). Findings In total, 1141 articles were categorised: 352 scientific, 224 Dutch and 565 British newspaper articles. Scientific articles were predominantly on research and were positive, whereas newspaper articles were negative (ratios=3.50-scientific, 0.69-NL and 0.94-UK; p<0.001). Articles on paediatrics were less positive in scientific journals and more negative in newspapers (ratios=2.29-scientific, 0.26-NL and 0.20-UK; p<0.001), while articles on adults were positive overall (ratios=10.0-scientific, 1.06-NL and 1.70-UK; p<0.001). In addition, negative-effect reporting trends were exacerbated following regulatory warnings and were generally opinion articles, both in scientific journals and in newspapers (2003/2004 and after 2007). Interpretation The authors found a positive publication tendency inherent in journal research articles. This apparent positive publication bias present in scientific journals, however, does not seem to prevent the dissemination of 'bad' news about medications. The negative tendency present in Dutch and British newspapers was perceivable in the paediatrics group and during the warnings, indicating that national news media have informed the public about this international drug safety controversy on time.

The justificatory power of moral experience.

A recurrent issue in the vast amount of literature on reasoning models in ethics is the role and nature of moral intuitions. In this paper, we start from the view that people who work and live in a certain moral practice usually possess specific moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and (modest) theories that grasp a moral experience that generally cannot be found outside the practice. Reflective equilibrium (RE) provides a framework for balancing moral intuitions, ethical principles and general theories. Nevertheless, persisting problems associated with the use of intuitions need to be addressed. One is the objection that moral intuitions lack the credibility necessary to guide moral reasoning. Ethicists have tried to solve this problem by formulating criteria to separate the "bad" intuitions from the "good" ones at the beginning of the reasoning process. We call this the credible input-justified outcome strategy. An example is the appeal to the common morality by Beauchamp and Childress. We think this approach is unsuccessful. As an alternative, we outline the good reasoning-justified outcome strategy. It connects to a variant of RE in which intuitions from different sources are incorporated. We argue that the elements of RE have different levels of justificatory power at the start of reasoning. In our strategy, each element can gain or lose justificatory power when it is tested in a reasoning process that meets several criteria.