Deferred Consent in Emergency Trauma Research: A Qualitative Study Assessing the Healthcare Professional’s Opinions
Injury, 15 August 2024
Zynab Noori, Niek J. Vianen, Esther M.M. Van Lieshout, Erwin J.O. Kompanje, Iscander M. Maissan, Michiel H.J. Verhofstad, Mark G. Van Vledder
Abstract
Introduction
Severely injured patients are often incapacitated to provide informed consent for clinical studies. Deferred consent could facilitate unbiased enrollment in studies involving these patients. Little is known about how healthcare professionals (HCPs) perceive deferred consent and how this impacts patient enrollment. The aim of this study was to identify factors that could influence HCPs decision-making during recruitment of patients for interventional studies in (pre)hospital emergency trauma research.
Methods
This was a qualitative study in which physicians and nurses working in prehospital or in-hospital care were interviewed using a semi-structured interview guide. Interviews were audio-recorded, transcribed, and analyzed according to thematic analysis as described by Braun and Clarke.
Results
Ten semi-structured interviews were conducted with six physicians and four nurses. Eight themes were identified as being relevant consent related factors influencing HCPs’ decision-making during patient recruitment in studies using deferred consent: 1) HCPs’ lack of knowledge; 2) Patients’ and proxies’ inability to be informed; 3) Practical (im)possibilities for informed consent; 4) Nature of intervention; 5) HCPs’ personal beliefs; 6) Importance of emergency care research; 7) HCPs’ trust in legal base; and 8) Communication and collaboration.
Conclusions
Eight consent-related factors influencing HCPs’ decision making were identified. Insufficient knowledge about consent procedures among HCPs leads to significant negative attitudes towards deferred consent.

Follow Informed Patient Consent in Clinical Teaching in Order to Achieve a Truly Patient-Centered Approach
Research Article
Hongnan Ye
Journal of Patient Experience, 14 August 2024
Open Access
Abstract
Patient- and disease-focused clinical teaching is considered the cornerstone of medical education. Current clinical teaching is increasingly taking place in outpatient settings, but this can cause discomfort to patients. Although many professional organizations have developed a set of ethical considerations in response to this issue to use these considerations to guide clinics in their outpatient procedures, these guidelines are not well adhered to in outpatient practice. My experience as an eczema patient in a dermatology outpatient is good evidence of this. In my opinion, there is nothing inherently wrong with the pedagogy of medical students observing clinical interactions in outpatient settings; the real problem lies in not informing the patient of the medical student’s presence or allowing the patient to exercise his or her right of refusal. Therefore, the following recommendations are made: First, academic medical centers should provide regular training to doctors and medical students to ensure that they are fully aware of what is contained in the ethical guidelines established by the professional organizations and that they recognize the importance of adhering to these guidelines in clinical practice. Second, each clinical teaching activity should have the informed consent of the patient and be based on the patient’s wishes. Finally, it is recommended that hospitals establish appropriate evaluation mechanisms to assess doctors’ compliance with the ethical guidelines and provide continuing education and training for doctors and medical students who fail to comply.

Consent for interventions during childbirth: A national population-based study
Clinical Article
Marianne Jacques, Anne Alice Chantry, Anne Evrard, Nathalie Lelong, Camille Le Ray, the ENP2021 Study Group
Gynecology & Obstetrics, 2 August 2024
Open Access
Abstract
Objective
To assess the frequency and determinants of medical interventions during childbirth without women’s consent at the population level.
Methods
The nationwide cross-sectional Enquête Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2-month postpartum follow-up (n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2-month attrition.
Results
Women reporting failure to seek consent were 44.7% (CI: 42.6–47.0) for oxytocin administration, 60.2% (CI: 55.4–65.0) for episiotomy, and 36.6% (CI: 33.3–40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio [aPR] 1.20; 95% CI: 1.06–1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68–0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11–1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13–1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28–1.96).
Conclusion
Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women’s involvement in decision making during childbirth.

Enhancing Patient Understanding of Cardiac Catheterisation Prior to Procedural Consent
J. Reynolds, R. Newcombe, G. Armstrong, S. El-Jack, T. Wijohn
Heart, Lung and Circulation, August 2024
Abstract
Background
People with reduced health literacy are at higher risk of not sufficiently understanding informed consent prior to procedures. Approximately 44% of adults read at or below the age of an average 12-13-year-old, indicating they may struggle to understand basic health information during the consent process. This is magnified in indigenous peoples, older adults and those with English as a second language in both countries.
Methods
We designed a procedural graphic comic booklet to be shared prior to the consent process, aiming to increase understanding in all patient groups. Pilot research on patients’ understanding of basic probability was conducted using non-medical questions confirmed poor understanding of risk. The comic booklet was developed with patient and health literacy group input and subjected to several cycles of feedback to reach the final version utilised in our audit.
Results
We audited patient and staff perceptions of the graphic comic booklet to the commonly used Heart Foundation information booklet. In 15 patients and 12 health-workers, the graphic comic booklet format was felt to be more succinct and understandable and was preferred by the majority of respondents. A small group preferred more detailed information.
Discussion
The use of a graphic comic booklet can therefore be an important educational tool, aiding patient understanding of procedures prior to the consent process. We intend to use it in addition to the current pre-angiography education provided to patients.

Informed consent in neurosurgery – Evaluation of current practice and implementation of future strategies
Francesca Colombo, Ross McLeod, Rohit Ravindranath Nambiar, Helen Maye, Sam Dickens, K Joshi George
Surgical Neurology International, 19 July 2024
Abstract
Background
In recent times, clinical negligence claims against National Health Service hospitals have doubled, with 8% of claims being made due to “failure to warn/informed consent.” This study aimed to assess the current compliance of the neurosurgical division within a large tertiary neuroscience center with the national legal framework and professional guidelines around the issue of surgical consent and to develop strategies to improve the consent process.
Methods
Electronic patient records (EPR) were accessed to collect demographic data and information regarding the surgical procedures. Telephone questionnaires were carried out. Neurosurgical registrars were interviewed. The author met with the trust’s Legal team, the neuropsychology lead, and the trust’s consent lead.
Results
Fifty-eight patients were included in the analysis. Of the respondents to the questionnaire, 98% felt that they were adequately informed during the consent process. When consenting patients, all registrars felt that they explained the reason for the procedure, detailed benefits, and major risks, including uncommon and rare risks. However, 50% admitted to not specifically discussing the postoperative recovery time or alternatives. Only 15% admitted to documenting on the EPR or through a letter to the patient’s General Practitioner.
Conclusion
Informed consent is a delicate moment of communication between a clinician and the patient. Regular training and good communication skills help staff to focus on the most relevant aspects of consent, which should be delivered in an appropriate environment and with family support. Audio-visual aids can support the process but do not replace good communication.