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Barriers to informed consent in obstetric care during childbirth from practitioners perspective: a qualitative study

Por: Abiola · L. · Legendre · G. · Koechlin · A. · Coutellec · L.
Objectives

To explore healthcare professionals’ perspectives and practices regarding informed consent during childbirth, particularly in the context of increased public awareness and discourse surrounding obstetric violence (OV) in France.

Design

A qualitative study based on semistructured interviews and non-participant observations.

Setting

Four maternity units in France, representing a diversity of institutional contexts.

Participants

A purposive sample of 32 participants, including midwives and obstetricians, was recruited across the four sites.

Methods

Data were collected through 32 semistructured interviews and in situ observations in labour and delivery rooms. A thematic analysis was conducted using a phenomenological approach, supported by NVivo software.

Results

Four main themes emerged: (1) relational malaise in the caregiver–patient relationship, reinforced by public discourse on OV, further hindered shared decision-making and open communication. (2) Challenges between caring values and systemic constraints (eg, lack of time, staffing shortages and protocol-driven care) limited professionals’ ability to engage in meaningful informed consent discussions. (3) Safety paradigm in obstetrics: fetal well-being emerged as a central and non-negotiable argument to justify medical interventions during childbirth. (4) Informed consent as a source of tension, where professionals struggled to balance legal and ethical obligations with clinical urgency, often leading to coercive or merely formal consent processes.

Conclusions

Informed consent during childbirth remains a critical and unresolved ethical challenge. This study highlights systemic, relational and emotional barriers that hinder shared decision-making and compromise the core ethical principles of autonomy, beneficence and justice. Addressing these issues requires structural changes, improved working conditions to support individualised care, better training in ethics and communication and greater recognition of the moral distress experienced by healthcare professionals.

Registration number

Registration number 22-219 from CEEI-IRB INSERM (Research Institutional Review Board INSERM, France) (IRB 00003888, IORG 0003254, FWA 00005831).

Conditioned open-label placebos to facilitate opioid reduction in patients with chronic non-cancer pain: study protocol of a randomised controlled trial

Por: Carratta · K. · Bodonyi · K. · Frey Nascimento · A. · Friis · D. · von Känel · R. · Bircher · L. · Koechlin · H. · Bernstein · M. · Streitberger · K. · Arnet · I. · Roth · A. J. · Ronel · J. · Olliges · E. · Locher · C.
Introduction

Chronic non-cancer pain presents a global health problem, with a significant increase in opioid prescriptions over recent decades. However, opioid therapy poses risks of adverse events, overdose and non-medical use. As a result, many patients seek to discontinue or reduce their opioid intake. Strategies for opioid tapering often lack efficacy, prompting the investigation of novel approaches like open-label placebo (OLP), that is, the administration of a placebo with full disclosure that it is a placebo. OLP has shown efficacy in chronic non-cancer pain syndromes and has been suggested as a promising candidate for medication tapering. This study aims to assess whether OLPs can enhance the reduction of daily morphine equivalent dose (MED) in chronic non-cancer pain patients and examines its potential in mitigating opioid withdrawal symptoms.

Methods and analysis

This study is designed as a randomised, controlled, single-centre trial. Participants will be randomised into either an OLP group or a control group. The study duration will span six to nine weeks, during which all participants will aim to reduce their opioid intake. Both groups will monitor their opioid intake daily using a diary app and will receive feedback on their progress of reducing opioids. Additionally, participants in the OLP group will receive OLP tablets for the entire study period. During the first week, the OLP group will undergo a one week learning phase using a classical conditioning paradigm, where each opioid intake is paired with a placebo. In the subsequent five weeks, the OLP group will enter a dose-extension phase in which only the first opioid intake of the day is paired with a placebo, and additional placebos can be taken as desired. At the end of the study, qualitative interviews will be conducted with the first 15 participants in the OLP group. The primary outcome measure is daily opioid intake. Secondary outcomes include opioid withdrawal symptoms, pain severity, disability, anxiety, depression, opioid beliefs, intervention expectancy and qualitative data. Statistical analyses will include analysis of covariance and regression models.

Ethics and dissemination

The ethics committee of the Canton of Zurich, Switzerland, approved the study (SNCTP-nr.: SNCTP000005853/BASEC nr.: 2023–02327).

Participants will be compensated with 100 Swiss Francs for their full participation in the study. Participants who will take part in the qualitative interview will be compensated with additional 15 Swiss Francs.

Trial registration number

This study is registered at clinicaltrials.gov: NCT06350786.

Application of diagnostic criteria in paediatric complex regional pain syndrome: a scoping review protocol

Por: Tham · S. W. · Lee · R. · Rau · L.-M. · Sethna · N. F. · Nylander · E. M. · Fabrizi · L. · Wager · J. · Koechlin · H.
Introduction

There are no validated paediatric-specific diagnostic criteria for complex regional pain syndrome (CRPS). As a result, diagnostic tools developed for adults (eg, Budapest Criteria, Japanese Diagnostic Criteria, Veldman Criteria) are frequently applied in the paediatric population. However, the clinical presentations and trajectories of children can differ from adults. Given that treatment outcomes are linked to early diagnosis and intervention, the lack of paediatric-specific screening or diagnostic tools is an important knowledge gap. We aim to identify the frequency of individual criteria used in diagnosing CRPS in children and adolescents in existing literature, summarise assessment methods used to establish the diagnosis, and provide recommendations for research and clinical application.

Methods

The following databases and platforms will be searched for articles published from 2003 (year the Budapest Criteria was developed) onward: CINAHL, CENTRAL, Embase, Ovid MEDLINE, PubMed, PsycINFO and Web of Science. Our search strategy will use subject headings and text words related to the concepts of CRPS in paediatric populations, with study inclusion criteria from birth up to 18 years old, and a diagnosis of CRPS. Data will be extracted by our multidisciplinary team and findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination

This study does not involve human participants or unpublished data; therefore, approval from a human research ethics committee is not required. The findings of this scoping review will be disseminated through academic conferences and peer-reviewed publications.

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