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Written risk disclosure in elective neurosurgical consent: A retrospective observational study with descriptive
Muhammad Anas Kamarudin1, Kalai Arasu Muthusamy1, Ronie Romelean Jayapalan2
1Department of Neurosurgery, University Malaya Medical Center, Kuala Lumpur, Malaysia.
Background:
Informed consent is a fundamental ethical and legal requirement in neurosurgical practice, particularly given the high risk of postoperative morbidity and medico-legal litigation. Written documentation of material risk disclosure provides objective evidence that valid consent has been obtained. However, real-world data on neurosurgical consent documentation practices remain limited in Malaysia.
Methods:
A retrospective observational study was conducted at a tertiary referral center, reviewing elective neurosurgical procedures performed in 2022. Electronic medical records and scanned consent forms were analyzed to determine whether material surgical risks were documented during the consent process. Risk documentation was defined as written evidence of disclosed risks recorded on the consent form or in the medical record. Post-operative complications and clinician involvement in consent taking were recorded for descriptive and contextual purposes.
Results:
A total of 283 elective neurosurgical procedures were included. Documented material risks were identified in 260 cases (91.9%). In 23 (8.1%) cases, no written documentation of risk disclosure was found. Postoperative complications occurred in 54 (19.1%) cases. Complications were more frequent in cases without documented risks (30.4%) compared to those with documentation (18.1%), although this difference was not statistically significant. Registrars most frequently documented clinicians involved in explaining risks.
Conclusion:
The most elective neurosurgical procedures in this study were supported by written documentation of material risk disclosure. However, a small but clinically relevant proportion lacked such documentation, representing a potential medico-legal vulnerability. Improving consistency and institutional oversight of consent documentation, particularly in registrar-led consent, may further enhance the consistency, quality, and defensibility of neurosurgical practice.
