Informed consent in neurosurgery: a systematic review

Abstract

OBJECTIVEInformed consent has served as a main principle of medical ethics and laws in the United States. The 1986 American Association of Neurological Surgeons Code of Ethics implied medicolegal liability for the failure to obtain informed consent without providing practical guidance regarding the application of informed consent to individual patient encounters in a medicolegal environment. Here, the authors aimed to identify baseline patient recall after discussions with neurosurgeons and their capacity to provide informed consent, describe the effects of interventions to improve patient comprehension, and elucidate the role of informed consent in malpractice litigation in neurosurgery. Their findings may guide neurosurgeons in discussions to properly inform patients and reduce the risk of litigation.METHODSA systematic review was conducted to explore informed consent within neurosurgery and its application to medicolegal liability using the PubMed, Embase, and Scopus databases. Titles and abstracts from articles identified in the search were read and selected for full-text review. Studies meeting prespecified inclusion criteria were reviewed in full and analyzed for study design, aim, population, interventions, and outcomes.RESULTSOf 1428 resultant articles, 21 were included in the review. Baseline patient recall was low, particularly for risks and alternatives of treatments, and even decreased over time. Cognitive impairment was noted as a factor limiting the ability to provide informed consent. Interventions incorporating a combination of modalities in informed consent discussions, a specialized consent form with points for neurosurgeons to check off upon discussion, interactive websites, question prompt lists, and illustrations were found to be effective in improving patient knowledge. Lack of informed consent was a common factor for malpractice litigation. Spine surgery was particularly prone to costly lawsuits. Payments were generally greater for plaintiff verdicts than for settlements.CONCLUSIONSThe application of informed consent to patient encounters is an important facet of clinical practice. Neurosurgeons have a duty to provide patients with all pertinent information to allow them to make decisions about their care. The authors examined baseline patient comprehension and capacity, interventions to improve informed consent, and malpractice litigation; it appears that determining the proper capacity to provide informed consent and considering informed consent as a process that depends on the setting are important. There is room to improve the informed consent process centered on baseline patient health literacy and understanding as well as clear communication using multiple modalities.

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

“…Better models for empowering parents and obtaining informed consent in LMIC needs to be carefully addressed in future trials. Innovative approaches using infographics and videos to communicate different aspects of trial may improve participant understanding and reduce anxiety, 29 30 and such techniques may facilitate better informed consent in LMICs. Involving parents and family members in the design of studies would help in understanding their perspectives and addressing their priorities.…”

Spine surgery and fat embolism syndrome. Defining the boundaries of medical accountability by hospital autopsy

“…Neurosurgery is amongst the medical specialties subject to the highest number of claims with an average payout of $440.000 [3]. In particular medical malpractice litigation in neurosurgery is associated with spinal procedures, as six out of the seven most claimed pathologies involved the spinal column [4,5]. In most cases, malpractice claims are motivated by three main factors: ascertaining the facts that led to a negative outcome in order to understand what happened, securing financial compensation and defining the alleged responsibility of the physician or the system.…”

“…In most cases, malpractice claims are motivated by three main factors: ascertaining the facts that led to a negative outcome in order to understand what happened, securing financial compensation and defining the alleged responsibility of the physician or the system. Curiously, even when poor outcome, poor performance or supposed negligence during procedure were supporting the claims, a bad physician-patient relationship represents the first risk factor of claims, no matter the outcome [4]. In a recent review about informed consent in neurosurgery, it emerged that the lack of informed consent is the basis for a large portion of malpractice.…”

Ethical Considerations in the Implantation of Neuromodulatory Devices

“…This must be conducted longitudinally throughout the timeline of care in order to maintain informed consent. 110 Providers should also identify strategies to improve patient counseling.…”

“…While these studies occur, novel NDs may be used under certain controlled conditions to promote informed consent. 110 First, clinicians must have reason to believe that the device will provide therapeutic benefit based on the pathology and function of the device. Second, only well-selected patients, namely those who have not benefited from medical therapy, traditional surgery, or current NDs or who do not qualify for such treatments, must be offered the novel ND, preferably within the context of a well-designed controlled trial with appropriate scientific and ethical guardrails.…”