197 Summary and discussion To secure authorization for this pilot study, we adhered to stringent and rigorous regulatory protocols, culminating in approval from our Medical Ethics Committee (MEC). The study was subjected to extensive monitoring, and a Data Safety Monitoring Board (DSMB) was instituted. Inclusion criteria were meticulously formulated to enlist only those patients with an extended illness duration (exceeding 10 years) who had exhausted all conventional treatment avenues and for whom the potential benefits of recovering from AN would be substantial. To mitigate both medical and psychological risks, our patient cohort underwent rigorous pre-inclusion screening, facilitated by a comprehensive study protocol designed to enact safeguards. Throughout the study, the physical and psychological well-being of the participants was carefully monitored via weekly consultations with our nurse practitioner and consulting psychiatrist. In the perioperative phase or in instances of significant adverse events, patients were admitted to our Medical Psychiatric Unit (MPU) for more intensive evaluation and care. Unlike psychiatric conditions such as OCD, the symptoms of AN are often ego-syntonic, meaning patients may perceive these symptoms as integral to their identity. Moreover, a lack of insight into, or trivialization of, the physical implications of the disorder is a characteristic feature among AN patients. These factors raise complex ethical issues regarding patient autonomy and the capacity for informed consent. Although cognitive impairments can occur in AN patients due to prolonged malnutrition, their intellectual capabilities are generally preserved. However, their specific decision-making competence concerning their disorder may be compromised by their perception of the eating disorder as part of their identity, as well as by dysfunctional beliefs surrounding body weight, shape, and behaviors associated with AN. Given that all conventional treatment avenues have typically been exhausted for these patients, the allure of a novel, experimental intervention like deep brain stimulation (DBS) and the hope for a positive outcome may exert a disproportionate influence on their decision to participate in the study. The unique opportunity to partake in the inaugural DBS trial for AN in the Netherlands - especially when only a handful of similar initiatives exist globally - may further skew consent. Patients may be inclined to overestimate the benefits and underestimate the risks, influenced both by hope and a sense of being ‘special’ or pioneering. These aspects, being important a-specific therapeutic factors, may also affect the clinical course and outcome of the study. To address these ethical complexities, Park et al. (2017) have developed “The Oxford Neuroethics Gold Standard Framework for DBS in AN,” aimed at guiding ethics committees and researchers in ensuring ethically robust conduct of such studies (16).
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