FDA Draft Guidance for Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet: Comments by the Society for the Study of Celiac Disease

In light of the commentary published in Gastroenterology by Goldkind et al,1 we would like to present the comments offered by the Society for the Study of Celiac Disease (SSCD) to the US Food and Drug Administration (FDA) regarding its draft guidance for developing drugs for adjunctive treatment to a gluten-free diet.

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Luglio 2022

Perceptions and expectations of parents regarding their position in a French NICU: quantitative and qualitative approaches

Objectives
To assess perceptions, expectations, and concerns of parents of preterm infants regarding their position during hospital admission in the neonatal intensive care unit.

Design
Data were analysed from two studies, using complementary methods (quantitative and qualitative). Study I surveyed parents via a questionnaire, and study II was a reanalysis of interviews with fathers, collected in a previous study.

Setting
Neonatology department in a French tertiary care university hospital that promotes the Newborn Individualised Care and Assessment Program (NIDCAP).

Participants
In both studies, participants had a premature child admitted for any level of care in the neonatal intensive care unit.

Results
For study I, about half (33) of eligible families participated in the questionnaire survey, and for study II, we reanalysed interviews with 20 fathers. In both analyses, parents were satisfied overall with their involvement in the care of their child. In both studies, however, they expressed that they had expected to be better informed about their child’s condition and more involved in medical decision-making. Parents also reported relational issues with some healthcare practitioners who made them feel judged, unheard or not competent to discuss their child’s case. These concerns were not reported for NIDCAP staff. Respondents in both studies also described insufficient contact with physicians and an inability to obtain rest in the room with their child.

Conclusion
Provision of training to healthcare practitioners regarding information that parents request and doing so respectfully might be keys to fulfilling parent-reported needs. Such improvements could facilitate parental empowerment and involvement.

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Luglio 2022

Mental health and working constraints of first-year PhD students in health and science in a French university: a cross-sectional study in the context of occupational health monitoring

Objectives
To assess the mental health and working constraints perception of first-year PhD in France.

Design
It is a cross-sectional study.

Setting
The study was conducted by the team of the Lyon 1 University’s Occupational Health and Medical Service for Staff, from October 2019 to February 2020. First-year PhD students employed by the university were seen during the routine occupational health medical check-up.

Participants
A total of 161 PhD students in science from the 2019 intake were included in the study (participation rate 98%).

Outcome measures
Data were collected using a self-questionnaire on psychosocial constraints at work (Job Content Questionnaire), the quality of the professional relationship with the supervisor (Advisory Working Alliance Inventory, Student perspective (AWAI-S)), medical conditions, anxiety (Generalized Anxiety Disorder-7) and depressive symptoms (Patient Health Questionnaire-9).

Results
A total of 161 PhD students from the 2019 intake were included in the study (participation rate 98%). Most of the PhD students reported high psychological demands (58%), high decision latitude (53%), high social support (55%) and good professional relationships with their supervisor (mean of global score of AWAI-S=114.5). However, 34% showed signs of at least mild depression, 19% showed signs of anxiety and 20% were referred to a mental health professional after the survey. Bivariate analyses showed that history of psychiatric disorders, their relationship with their supervisor, having complementary teaching activities and stressful working conditions contributed to anxiety and depression.

Conclusions
Even in the first year of their PhD, some students had mental health issues. It seems relevant to generalise the medical follow-up of all PhD students as soon as they enter the doctoral programme in order to detect and treat their health problems and psychological disorders at an early stage.

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Giugno 2022

Building a practice-based research network for healthcare integration: a protocol paper for a mixed-method project

Introduction
Practice-based research networks (PBRNs) are sustained collaborations between healthcare professionals, researchers and members of the community that develop, conduct and report on research relevant to local needs. While PBRNs have traditionally been focused towards primary care practices and their patients, there has been increasing interest in how they may help facilitate healthcare integration. Yet, little is known on the ways in which PBRNs can best integrate with the broader healthcare system, in particular Advanced Health Research and Translation Centres. The overall project aim is to build a sustainable collaboration between a PBRN and an Advanced Health Research and Translation Centre to generate a research platform suitable for planning, undertaking and translating research to improve care across the healthcare continuum.

Methods and analysis
We will use a developmental evaluation design. Our iterative approach will be informed by a programme logic model and consists of: preparation work (pre-implementation assessment, literature review, community and stakeholder engagement), adaptation and building for a sustainable collaboration (strategy for recruitment and sustainment of members) and planning for network action (designing and implementing priority initiatives, monitoring and follow-up).

Ethics and dissemination
This project was approved by the Monash Health ethics committee (ERM Reference Number: 76281; Monash Health Ref: RES-21-0000-392L) and the Monash University Human Research ethics committee (Reference Number: 29786). Dissemination will take place via various channels, including relevant national and international committees and conferences, peer-reviewed journals and social media. Continuous dissemination to and communication with all participants in this project as well as other relevant stakeholders will help strengthen and sustain the network.

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Giugno 2022