Daphne Christiaens

Ethical considerations of researchers conducting pediatric clinical drug trials: a qualitative survey in two Belgian university children’s hospitals

There is a general consensus about the underlying theoretical ethical principles that ground the practice of pediatric clinical trials: scientific necessity, good risk/benefit ratio, minimized burden, and parental consent/child assent. However, these principles are so broadly construed that it is not always clear how they should be applied in clinical practice. We conducted a qualitative study at Ghent University Hospital and the hospital of the Dutch-speaking university of Brussels on how researchers weigh ethical principles, assess the risk/benefit balance, estimate patient experience, and experience informed consent procedures in pediatric drug studies. Based on our assessment of the burden and risk versus benefit ratio in 62 pediatric drug research protocols, we selected 21 studies for further study to maximize diversity. Twenty-seven researchers (17 physicians, 10 study nurses) completed a qualitative survey about their study. We compared their responses to our assessments. The risk benefit assessment of our participants about their own research projects resembled our assessment almost perfectly. Assessing burden appeared to be more subjective. The researchers were confident in their ability to obtain valid consent. However, we question whether this confidence is warranted.Conclusion: We argue for constant ethical reflexivity in pediatric clinical trials, because broad ethical principles are not always easy to apply to specific situations.What is Known:• Several international guidelines and a large body of scientific literature indicate a broad consensus about the basic ethical framework for pediatric clinical trials, based on risk benefit assessment and respect for autonomy.• Little is known about how researchers implement these broad principles in practice.What is New:• Researchers’ risk/benefit assessments about their own studies resembled the assessment of neutral peers, assessing burden was more subjective.• Researchers were very confident in their ability to obtain valid informed consent.

Nurses’ Sedation Practices During Weaning of Adults From Mechanical Ventilation in an Intensive Care Unit

Background Sedation and analgesia have an important impact on the outcome of patients treated with mechanical ventilation. International guidelines recommend use of sedation protocols to ensure best patient care. Objective To determine the sedation practice of intensive care nurses weaning adults from mechanical ventilation. Methods A cross‐sectional survey with a self‐administered questionnaire was used to determine sedation practices of Flemish critical care nurses during weaning. Consensus on content validity was achieved through a Delphi procedure among experts. Data were collected during the 32nd Annual Congress of the Flemish Society of Critical Care Nurses in Ghent, Belgium, December 2014. Results A total of 342 nurses were included in the study. Of these, 43.7% had a sedation protocol in their unit that was used by 61.8% of the respondents. Sedation protocols were more often available (P < .001) in academic hospitals (72%) than in general hospitals (41.5%). Sedatives were administered via continuous infusion with bolus doses if needed (81%). Level of sedation was assessed every 2 hours (56%), mostly via the Richmond Agitation‐Sedation Scale (59.1%). Daily interruption of sedation was used by 16.5% of respondents. The biggest barriers to daily interruption were patient comfort (49.4%) and fear of respiratory worsening (46.6%). Conclusions A considerable discrepancy exists between international recommendations and actual sedation practices. Standardization of sedation practices across different institutions on a regional and national level may improve the quality of care.