Ethical and legal considerations in non interventional health clinical trials in the French context.

While the development of regulations in the conduct of research in humans, has better allowed risks and associated contraints to be framed, it has also raised further questions. French regulations currently consider that research based on questionnaires or interviews has no impact on the care of patients or on the individual, a view that is too limited and is not shared by the ethics committees charged with the protection of those involved in studies. Any research relating to a person requires his or her active involvement. The intention of the researcher can be perceived by the participant and can therefore affect their responses. Hence, it is important to question the safety of procedures and consider the psychological risks of non-interventional research. Any evaluation process can create a potentially risky situation, not because of the intrinsic qualities of the tools used, but because of the conditions under which they are applied. As members of an ethics committee, our experience has enabled us to observe shortcomings and lack of acknowledgement by study sponsors of issues at stake in the research. This article revisits the foundational texts of the French Jardé law, with which sponsors and investigators in France are required to comply, considers the psychological implications for studies involving questionnaires and/or interviews and ethical questions or dilemmas. Finally, areas for consideration that could improve the framework for non-interventional research are proposed.

The position during urine sample collection from young precontinent children through a bag does not limit contamination rates: Results from a randomized controlled trial: Does infant position influence quality of urine collection?

AIM: Despite its limitation, bag collection is still widely used for a preliminary urine screening test in non-toilet-trained children suspected of febrile urinary tract infection. A previous study conducted by our group raised the hypothesis that the absence of direct contact between urine and the perinea during urine collection could limit urine contamination by perineal flora. The aim of this study was to evaluate the impact of the patient's position during urine collection (upright standing position versus free position) on the rate of contaminated urine samples in non-toilet-trained children with suspected febrile urinary tract infection. METHODS: This prospective, randomized, controlled study took place in seven pediatric emergency departments. Two groups were compared: the intervention group (infants held in an upright standing position during urination) and the control group (free position during urination). RESULTS: Among the 800 pediatric patients randomized to the study, 124 had a urine culture, 60 in the intervention group and 64 in the control group. Among the 124 urine cultures, 12 (9.7%) were contaminated: eight (13.3%) in the intervention group and four (6.3%) in the control group (p = 0.1824). CONCLUSION: The results show that the patient's position does not have a significant impact on the quality of urine samples collected by bag.

Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale.

BACKGROUND: Caregivers encounter difficulties differentiating fear and pain experienced by children and tend to interpret what children may feel, often resulting in inadequate pain management. While many pain self-assessment scales are available, there is no validated self-assessment fear scale for children. METHODS: The aim of this prospective study was to validate, in children aged 4 to 12 years, the psychometric properties of our scale. In a first part, in a school setting, five exercises were given to 484 children in order to validate the expression of fear, grade the intensity of the faces, the ability to discriminate the faces and the equality of the intervals. The scale's reproducibility was studied by assessing the children's fear in everyday situations at two different time points. In a second part, in a hospital setting, the aim was to test the scale's feasibility. Sixty children admitted to one emergency care department self-assessed their fear with the Scary Scale. FINDINGS: The expression of fear was validated by 57.64% (p < 0.0001) of the children in comparison with three other emotions (pain, surprise, sadness).The 7-9 year-olds validated the other properties (gradation, discrimination, equality, reproducibility). The 4-6 year-olds failed to validate the gradation exercise, but succeeded with the others. In the hospital, 95% of children self-assessed their fear using the scale. DISCUSSION: Our self-assessment fear scale was validated in children aged 7-12 years specifically and was readily feasible in the hospital. We recommend its use in that age group in every care situation triggering fear. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02675504.

Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19.

The COVID-19 epidemic has led to the intense mobilization of all health professionals, including those involved in research. From the very beginning, research ethics committees (RECs) have been called upon and mobilized to carry out the scientific and ethical evaluations of research projects to achieve a sound analysis of their risk/benefit balance. The aim of this article is to present an ethical reflection on the challenges and consequences of the fast-track procedure for the evaluation of COVID-19 research projects in the context of a public health emergency. Indeed, a large number of protocols of reduced rigor were hastily prepared without collaboration between researchers and in the absence of national regulation. As a result, a number of ethical dilemmas have emerged concerning the opposing needs of pragmatism imposed by the emergency context and the ethical principles that should govern the conduct of research. Moreover, the dispersion of these individual projects, aggravated by excessive media coverage of specific treatments, has resulted in a weakened impact of the research in the epidemic context. This article provides suggestions for the ethical management of ongoing and upcoming research, giving RECs the opportunity to adapt their evaluations to avoid allowing the pragmatism of the emergency context to subvert the inviolability of the epistemological and ethical principles of research on humans. This reflection may strengthen the ethical basis for the formulation of their decisions.

Parental presence during painful or invasive procedures in neonatology: A survey of healthcare professionals.

BACKGROUND: Newborns in neonatology are exposed to invasive and painful procedures. The absence of parents during procedures revealed significantly high pain scores. OBJECTIVE: The aim of this study was to assess practices regarding the role of parents during painful and invasive procedures. METHODS: This was a prospective, observational, multicenter study in France in which 471 caregivers participated. Professional practices regarding the role of parents during painful procedures on their child were assessed. Univariate and multivariate analyses were performed to identify factors associated with parental presence during painful procedures. RESULTS: Parental presence was most often allowed during capillary blood sampling, nasogastric tube insertions, and vein punctures, whereas it was mostly restricted during central line insertions, extubations, lumbar punctures, and intubations. However, we found discrepancies depending on the type of facility and caregiver seniority. CONCLUSION: An important variability in practices concerning the role of parents during painful and invasive procedures on their child was reported.

Transition effects from laparocscopic to robotic surgery skills in small cavities.

Conventional laparoscopic surgery (LS) is being challenged by the ever-increasing use of robotic surgery (RS) to perform reconstructive procedures. The purpose of this study was to assess the acquisition of skills in both techniques and the potential transfer of skills from one technique to the other when restricted spaces are involved. A preclinical randomized crossover study design was implemented. Twelve subjects performed two different reproducible drill procedures: "Thread the Ring" (TR) and "Transfer the Plot" (TP). To assess surgical proficiency in confined workspaces, these exercises were performed with LS and RS technology in a pediatric laparoscopic surgery (PLS) simulator. Each performance was recorded and evaluated by two reviewers using objective structured assessment of technical skills (OSATS). The times to complete the TP and the TR procedure were significantly shorter with RS compared to LS (64 s vs. 319 s; p < 0.0001 for both TP and TR). A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006). The percentage improvement was greater overall with LS, meaning a higher number of trials were required to adequately master the procedure. This study demonstrated that RS performed significantly better compared to LS on pediatric simulation devices. A transfer effect was identified from LS to RS exclusively. The learning curves showed that progression was definitely longer with LS. These results, indicate that novice surgeons should be encouraged to persist with learning LS, and they support the use of a pediatric robotic simulation device.

Efficacy of intralesional sodium thiosulfate injections for disabling tumoral calcinosis: Two cases.

INTRODUCTION: Tumoral calcinosis (TC) is a difficult-to-treat complication that can occur during several diseases such as dermatomyositis or genetic hyperphosphatemia. It is a painful and disabling condition that can lead to local complications including joint mobility reduction, cutaneous ulceration and superinfection. For the largest lesions, the treatment relies essentially on surgery. Intravenous sodium thiosulfate (STS) is efficient to treat calciphylaxis in patients undergoing hemodialysis. Local injections of STS seem efficient in superficial calcifications. OBJECTIVE: To report the efficacy and safety of intra-lesional injections of STS in tumoral calcinosis. RESULTS: We report two cases of successful intra-lesional injections of STS. A 44-year-old woman, with a history of dermatomyositis, presenting large subcutaneous calcifications in the right elbow, and a 42-year-old man, with a history of familial tumoral calcinosis, presenting large intramuscular calcifications in the right buttock, received weekly intra-lesional of 1-3g STS injections for 12 and 21 months, respectively. In both cases, the treatment relieved pain and greatly reduced the tumoral calcinosis with a very significant functional improvement without specific adverse effects. In case 1, TC size decreased from 28.7*56.0mm at baseline to 21.5*30.6mm at M12 treatment (59% reduction). In case 2, TC reduced from 167.5*204.3mm at baseline to 86.2*85.2mm at M21 treatment (79% reduction). CONCLUSION: Local injection of STS could be a promising therapeutic strategy for large and deep TC lesions and could therefore be an alternative to surgery.

Prospective evaluation of a cutaneous stimulation technique to induce on-demand urination in non-toilet-trained infants.

CONTEXT: When a urinary tract infection is suspected, it is recommended to capture a midstream sample of urine for analysis, but this strategy is difficult to apply before successful toilet training. A cutaneous stimulation technique has been reported to be effective in provoking micturition in newborns. OBJECTIVE: To evaluate the feasibility and the efficacy of this technique in a population of non-toilet-trained infants. DESIGN AND METHODS: Fifty infants were enrolled in this prospective non-controlled study in three pediatric emergency departments. The bladder was stimulated through suprapubic and paravertebral cutaneous stimulation as previously reported in newborns. The evaluation criterion was the proportion of patients from whom urine had been collected within the first 5min of the procedure. RESULTS: Forty-eight patients (21 boys) were evaluated. The procedure was successful in 27% of the cases overall, but reached 46% for children aged less than 3 months. Elevated weight was associated with failure of the procedure. CONCLUSION: Despite promising results in newborns, the cutaneous stimulation technique to provoke micturition appears to encounter limitations in older children. Nevertheless, the technique is an attractive alternative to urethral catheterization or suprapubic aspiration for infants younger than 3 months.

[Parapneumonic pleural effusion incidence in a French region before and during the antipneumococcal vaccine era]. / Incidence des pleuropneumopathies à pneumocoque en Limousin à l'ère de la vaccination.

BACKGROUND AND AIMS: The aim of the study was to compare the incidence of parapneumonic pleural effusion in the Limousin region of France, based on the comparison of pre- and postvaccination periods. METHODS: Subjects, 0-18-years-old, were retrospectively identified by searching in computerized databases of coded discharge diagnosis for patients with a diagnosis of pleural effusion and/or empyema and/or pulmonary infection in all the pediatric departments in Limousin hospitals. Medical records were reviewed by one of the authors and those with parapneumonic effusion and confirmed or suspected pneumococcal infection were included in the study. Data from the children hospitalized for parapneumonic pleural effusion were collected for two periods: period A, from July 2000 to July 2006, and period B, from July 2006 to July 2009 (before and after the generalization of the antipneumococcal vaccination). The main endpoint was the number of parapneumonic pleural effusion cases in each period in order to calculate the incidence within each period. RESULTS: A total of 35 children were included: nine during period A and 26 during period B. The incidence was 1 per 100,000 children for period A and 5.8 per 100,000 for period B. Bacteriological tests allowed us to serotype eight S. pneumoniae over the two periods. All serotypes were non-vaccine serotypes (1, 3, and 19A). CONCLUSION: This study demonstrates the increase in parapneumonic pleural effusion in the Limousin region.