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To provide the best evidence-based treatment for children, and timely evaluation of innovations, the role of the pediatric surgeon’s participation in randomized controlled trials (RCTs) and prospective comparative studies is required. The ethical considerations of pediatric surgical RCTs pose unique practical difficulties in the design and performance of clinical trials in children. There are several ethical issues unique to pediatric surgical RCTs: diseases with low volume, an inability to conduct Phase 1 and 2 trials, parental emotional involvement, difficulty with recruitment in surgical trials, volume, and modified study design, issues with permission vs. assent and investigator bias. This article reviews the ethical aspects unique to pediatric surgical RCTs and prospective comparative studies.Level of evidence: Level 3.

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

Informed consent in surgical settings requires not only the accurate communication of medical information but also the establishment of trust through empathic engagement. The use of large language models (LLMs) offers a novel opportunity to enhance the informed consent process by combining advanced information retrieval capabilities with simulated emotional responsiveness. However, the ethical implications of simulated empathy raise concerns about patient autonomy, trust and transparency. This paper examines the challenges of surgical informed consent, the potential benefits and limitations of digital tools such as LLMs and the ethical implications of simulated empathy. We distinguish between active empathy, which carries the risk of creating a misleading illusion of emotional connection and passive empathy, which focuses on recognising and signalling patient distress cues, such as fear or uncertainty, rather than attempting to simulate genuine empathy. We argue that LLMs should be limited to the latter, recognising and signalling patient distress cues and alerting healthcare providers to patient anxiety. This approach preserves the authenticity of human empathy while leveraging the analytical strengths of LLMs to assist surgeons in addressing patient concerns. This paper highlights how LLMs can ethically enhance the informed consent process without undermining the relational integrity essential to patient-centred care. By maintaining transparency and respecting the irreplaceable role of human empathy, LLMs can serve as valuable tools to support, rather than replace, the relational trust essential to informed consent.

The integration of artificial intelligence (AI) into surgery raises significant ethical concerns, including the impact on autonomy, human authority and the patient–doctor relationship. This study underscores the need for a multidisciplinary approach to navigate these ethical dilemmas, involving stakeholders from various fields. A comprehensive literature review up to March 2024 was conducted to assess the ethical implications of AI applications in surgery. This included an examination of data privacy, informed consent, algorithmic bias, the role of advanced robotics, and the impact on surgeons’ decision-making. The study also considered the development of autonomous surgical robots and their ethical implications. The review highlights that while AI can enhance surgical precision and improve clinical decision-making, it also poses several ethical challenges. AI’s ability to support decision-making risks undermining surgeons’ autonomy and judgement, raising concerns about over-reliance on technology. Issues such as data privacy, algorithmic bias and equitable access to AI-driven tools were identified as key ethical concerns. Autonomous surgical robots, while promising, introduce complex questions about accountability and liability, particularly when unexpected outcomes occur. Effective integration of AI into surgical practices demands the development of ethical frameworks that respect both the capabilities of AI and the irreplaceable value of human judgement. Balancing technological advancement with ethical integrity is essential to safeguard patient-centred care and ensure equitable access to AI benefits in healthcare.

Background/Objective The act of surgery involves harming vulnerable patients with the intent that the results will improve their health and, ultimately, help the patients. Such activities will inevitably entail moral decisions, yet the ethics of surgery has only recently developed as a field of medical ethics. Within this field, it is striking how few accounts there are of actions within the operating room. The aim of this systematic review was to investigate how much of the scientific publications on surgical ethics focus on what take place inside the operating room and to explore the ethical issues included in the publications that focus on medical ethics in the operating room. Methods We conducted a systematic search of the Medline and Embase databases using a PICO model and the search terms “surgery”, “ethics” and “operating room”. Papers were included if they focused on doctors, entailed activities inside the operating room and contained some ethical analysis. Thematic synthesis was used for data extraction and analysis. Findings Fewer than 2% of the scientific publications on surgical ethics included activities inside the operating room. A total of 108 studies were included in the full-text analysis and reported according to the RESERVE guidelines. Eight content areas covered 2/3 of the included papers: DNR orders in the OR, overlapping surgery, donation of organs, broadcasting live surgery, video recordings in the OR, communication/teamwork, implementing new surgical technology, and denying blood to Jehovah’s Witness. Discussion/Conclusions This systematic review indicates that only a small fraction of scientific publications on the ethics of surgery focus on issues inside the operating room, accentuating the need for further research to close this gap. The ethical issues that repeatedly arose in the included papers included the meaning of patient autonomy inside the operating room, the consequences of technological advances in surgery, the balancing of legitimate interests, the dehumanising potential of the OR, and the strong notion of surgeon responsibility.

ObjectivesDuring the COVID-19 pandemic, healthcare professionals were faced with prioritisation dilemmas due to limited surgical capacity. While the views of healthcare professionals on fair allocation have been given considerable attention, the views of patients have been overlooked. To address this imbalance, our study aimed to identify which ethical principles are most supported by patients regarding the fair allocation of surgical resources.DesignA Q-methodology study was conducted. Participants ranked ordered 20 statements covering different viewpoints on fair allocation according to their point of view, followed by an interview. Principal component analysis followed by varimax rotation was used to identify subgroups who broadly agreed in terms of their rankings.SettingThe setting of this study was in the Netherlands.Participants16 patient representatives were purposively sampled.ResultsTwo perspectives were identified, both of which supported utilitarianism. In perspective 1, labelled as ‘clinical needs and outcomes’, resource allocation should aim to maximise the health gains based on individual patient characteristics. In perspective 2, labelled as ‘population outcomes and contribution to society’, allocation should maximise health gains as with perspective 1, but this should also consider societal gains.ConclusionsThere was a broad agreement among patient representatives that utilitarianism should be the guiding ethical principle for fair allocation of scarce surgical resources. The insights gained from this study should be integrated into policymaking and prioritisation strategies in future healthcare crises.

Background The informed consent process is a mandatory requirement for surgical procedures that enables patients to exercise autonomy and make informed decisions concerning their medical care, fully aware of the consequences. However, emerging evidence suggests inconsistent adherence to this requirement. Aim This study investigated patients’ and next-of-kins perspectives and experiences of the informed consent process following the completion of a surgical procedure. Methods Using a qualitative approach, patients and next-of-kins who had consented or offered proxy consent on behalf of a patient to undergo surgical procedures at a teaching hospital’s surgical departments in Ghana were purposively recruited. We audio-recorded and transcribed 30 semi-structured interviews with 15 patients and 15 next-of-kins. Two members of the team conducted an independent thematic analysis of the data, guided by Braun and Clarke’s six-step approach. Results The data analysis generated four key themes related to the context, key elements, influencing factors, perceptions, and experiences of the informed consent process. The informed consent process took place in varied hospital settings, largely in the presence of next-of-kins and typically facilitated by a team of medical professionals, under private conditions where possible. Family opinion, doctors’ paternalism and trust in the doctor’s expertise seemed to be major factors that influenced the decision-making process. However, when conflicts emerged, the patient’s choice and best interest remained paramount in the final decision. The consent process often involved discussions regarding the medical condition, treatment options, and potential risks; participant experiences of these deliberations showed variability. Issues of time constraints, poor doctor-client communication, and language barriers often complicated the informed consent experience. Conclusion Patient experiences of the informed consent process varied, which points to the importance of standardized guidelines and a more patient-centered approach. This approach should encourage continued collaboration and effective communication between medical professionals and patients/next-of-kins, while upholding the patient’s right to make an informed surgical decision.

Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: (1) the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; (2) clinically important research question; (3) the risk to patients is minimised and reasonable; (4) there is uncertainty about treatment allocation rather than deception; (5) there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and (6) ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool. Placebo-controlled trials in surgery will most often be justified when surgery is performed to improve function or relieve symptoms and when objective outcomes are not available, while the risk of mortality or significant morbidity is low. In line with medical placebo-controlled trials, the surgical trial (1) should be sufficiently powered and (2) standardised so that its results are valid, (3) consent should be valid, (4) the standard treatment or rescue medication should be provided if possible, and (5) after the trial, the patients should be told which treatment they received and there should be provision for post-trial care if the study may result in long-term negative effects. We comment and contrast our guidelines with those of the American Medical Association.