Informed consent in neurosurgery: a systematic review
Nathan A. Shlobin, Mark Sheldon, Sandi Lam
Neurosurgical Focus, 20 August 2020; 49
Open Access
Abstract
Objective
Informed 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.
Methods
A 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.
Results
Of 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.
Conclusion
The 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.
Month: December 2020
Patient Centric Informed Consent in Orthodontic Practice: An Overview
Patient Centric Informed Consent in Orthodontic Practice: An Overview
Research Article
Prateeksha Bora, Poonam Agrawal, Dinesh Kumar Bagga, Madhurima Nanda, Prashant Kumar Shahi
Journal of Critical Reviews, 2020; 7(17) pp 3225-3229
Open Access
Abstract
Informed consent is a fundamental component of good clinical practice and clinical governance. Dental practitioners must be aware of the principal factors that need to be addressed to ensure that consent is valid. Consent, as defined by the Webster’s dictionary, is to give assent or approval. Informed consent is not just a signature on a consent form, it is a process of dialog between the dentist and the patient. It requires a full explanation of the nature, purpose and material risks of the proposed treatment in a language that the patient understands. The patient should have the opportunity to consider the information and ask questions in order to arrive at a balanced judgement of whether to proceed with the proposed treatment. The value of obtaining informed consent is of particular importance in orthodontics. Orthodontic treatment is usually of long duration, involves a number of appointments and is extremely reliant on the patient’s co-operation, in particular with appliance wear and maintenance of good oral hygiene. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment.
Improving informed consent by enhancing the role of nurses
Improving informed consent by enhancing the role of nurses
Research Article
Daniel A Wilkenfeld, Grace Campbell
Nursing Ethics, 28 October 2020
Abstract
From a legal perspective, before a physician engages in a serious medical intervention they must obtain informed consent. In this paper, we argue that there are serious deficits in our processes of obtaining informed consent; it is often seen as just a bureaucratic hurdle, and people agree to interventions without being in an appropriate epistemic state. We explore some possible reasons for this, including ignorance, trust in physicians’ authority, and the minimal time physicians spend with patients. We trace many of these issues to one central cause, which is that in the United States obtaining informed consent is the purview of physicians. We argue that a simple shift in how we obtain informed consent can help to ameliorate these issues. Specifically, we argue that obtaining informed consent should be the responsibility of nurses rather than physicians. While there are several reasons for this, the central ideas are that (1) since nurses are the ones who know the patient, they will be in better position to tell when patients are genuinely informed, and (2) patients will be more comfortable asking questions and admitting ignorance to nurses rather than physicians. While we focus on US law, our conclusions are more broadly applicable.
Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology
Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology
Original Article
Dara Tith, Joong-Sun Lee, Hiroyuki Suzuki, W. M. A. B. Wijesundara, Naoko Taira, Takashi Obi, Nagaaki Ohyamaz
Healthcare Informatics Research, 21 August 2020
Open Access
Abstract
Objectives
Currently, patients’ consent is essential to use their medical records for various purposes; however, most people give their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealing with patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and for healthcare organizations to obtain patient consent efficiently for a variety of purposes.
Methods
We introduce a new e-consent model, which uses a purpose-based access control scheme; it is implemented by a blockchain system using Hyperledger Fabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared among participant organizations. We also created a blockchain chaincode that performs business logic managing patient consent.
Results
We developed a prototype and checked business logics with the chaincode by validating doctors’ data access with purpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grained way of handling medical staff’s access requests with diverse intended purposes for accessing data. In addition, patients can create, update, and withdraw their consents in the blockchain.
Conclusions
Our consent model is a solution for consent management both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides high reliability and availability with transparency and traceability, is expected to be used not only for patient data sharing in hospitals, but also for data donation for biobank research purposes.
Troubleshooting AI and Consent [BOOK CHAPTER]
Troubleshooting AI and Consent [BOOK CHAPTER]
Elizabeth Edenberg, Meg Leta Jones
The Oxford Handbook of Ethics of AI
Oxford University Press, 2020; pp 347-362
Abstract
As a normative concept, consent can perform the “moral magic” of transforming the moral relationship between two parties, rendering permissible otherwise impermissible actions. Yet, as a governance mechanism for achieving ethical data practices, consent has become strained—and AI has played no small part in its contentious state. In this chapter we will describe how consent has become such a controversial component of data protection as artificial intelligence systems have proliferated in our everyday lives, highlighting five distinct issues. We will then lay out what we call consent’s “moral core,” which emphasizes five elements for meaningful consent. We next apply the moral core to AI systems, finding meaningful consent viable within a particular digital landscape. Finally, we discuss the forces driving some commentators away from individual consent and whether meaningful consent has a future in a smart world.
Center for Informed Consent Integrity 