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Evaluation of the efficacy of PREVENIR (PREVention ENvIronment Reproduction) platforms on urinary markers of chemical exposure in pregnant women: protocol for an unblinded randomised clinical trial (PREVENIR-G)

Por: Delva · F. · Sentilhes · L. · Francis-Oliviero · F. · Bessonneau · V. · Sunyach · C. · Audouin · C. · Paris · C. · Haddad · B. · Matrat · M. · Pairon · J.-C. · Belacel · M. · Sitta · R. · Roberts · T. · Bretelle · F. · Garlantezec · R.
Introduction

It has been reported that pregnant women used more cosmetics daily than non-pregnant women. Phenoxyacetic acid is the main metabolite of phenoxyethanol, the most frequent preservative in cosmetics used in Europe, previously associated with reproductive effects (longer time to conception, endocrine disruptors in newborns and poorer verbal comprehension in children). In France, specialised platforms (PREVention ENvIronment Reproduction (PREVENIR)) in university hospital maternity wards are dedicated to evaluating environmental and occupational exposures in patients with pregnancy-related pathologies and supporting targeted prevention efforts. These platforms are composed of occupational health physicians, obstetrician-gynaecologists, midwives, occupational health nurses, and occupational health and environmental engineers. To assess the efficacy of these platforms, we developed a randomised clinical trial, the protocol for which is presented in this paper. The primary objective of the PREVENIR-G Study is to compare the change in urinary phenoxyacetic acid concentrations from baseline to 3 months postintervention between an intervention group and a control group. To date, the intervention has been integrated into routine care in certain facilities; however, its efficacy remains unproven. It is therefore essential to assess the relevance of this intervention, considering both its potential benefits and any adverse effects, such as increased stress or anxiety.

Methods and analysis

This study is an unblinded, randomised clinical superiority trial with two parallel groups (intervention vs no intervention) in four university maternity hospitals in France. We will include 300 pregnant women (aged 18 years or older) who are under 24 weeks of gestation (150 per group) referred to the participating PREVENIR platforms for management. The intervention will consist of clinical prevention management through the PREVENIR platforms, involving a consultation with an environmental health expert for an assessment of environmental and occupational exposures. During the consultation, targeted prevention messages will be provided based on identified exposures. The no intervention comparator will be a waiting-list control group. At the inclusion visit, patients will receive urine collection vials for samples to be collected at baseline and again at 3 months. Urine samples will be collected twice in a single day, on three separate days, during the collection week at home. In the week following the urine collection period, only participants in the intervention group will engage with the PREVENIR platforms. The primary outcome will be the difference in the urinary phenoxyacetic acid concentration between baseline and 3 months postintervention, compared between the intervention and control groups.

Ethics and dissemination

The study has been approved by the hospital ethics committee (CCP Ouest 2, no. 2023-A00941-44). All participants will provide written informed consent. Results will be shared through presentations and publications.

Trial registration number

NCT06642818

Patient perspectives on access to oncology innovations: protocol for a systematic meta-aggregation review

Por: Julliot-Delval · A. · Teixeira · M. · Cartron · E.
Introduction

Healthcare innovation in oncology has accelerated in recent years, with the development of targeted therapies, digital tools and novel care pathways. While these advances promise improved outcomes, concerns remain about unequal access across patient populations. Patient perspectives on access to innovation remain underexplored, yet may offer valuable insights to support more equitable and patient-centred implementation strategies.

Objectives

This meta-aggregation study aims to explore how adult patients with cancer perceive their access to healthcare innovations. A secondary objective is to identify the barriers, facilitators and contextual factors that influence this access, as well as patients’ understandings or definitions of innovation, when available.

Method and analysis

A systematic meta-aggregation review will be conducted according to the Joanna Briggs Institute (JBI) methodology. Full-text, peer-reviewed articles reporting qualitative studies of patients’ experiences with innovations in oncology will be included. Studies will be identified through searches in PubMed, CINAHL, PsycINFO and Cairn.info, with no date restrictions. Articles in English and French will be considered. Two independent reviewers will screen and extract data and assess methodological quality using the JBI checklist. Synthesis will follow the JBI three-phase approach. Confidence in the evidence will be assessed using the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) tool. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 reporting guidelines will be followed.

Ethics and dissemination

Ethical approval is not required for this study, as it is based on previously published data. The findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

PROSPERO registration number

CRD420251046315.

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