Are we meeting the standards set for informed consent in spinal surgery?

Are we meeting the standards set for informed consent in spinal surgery?
Y Esemen, A Mostofi, D Richardson, EAC Pereira
Annals of Royal College of Surgeons, 29 July 2022
Abstract
Introduction
Informed consent empowers patients to exercise their autonomy and actively participate in their medical care. Guidance published by the British Association of Spine Surgeons (BASS) lists three components of consent: provision of information booklets, patient-centred dialogue and completion of appropriate consent forms. The aim of the study was to review the quality of the spinal surgery consent process against the BASS guidance in a single tertiary neurosurgery centre in London.
Methods
Retrospective review of clinic letters and consent forms was performed for 100 consecutive cases of elective, non-instrumented spinal decompression surgeries performed in 2019. Documentation was graded for inclusion of the intended benefit (improvement of pain/prevention of neurological deterioration), alternative management options (including no treatment), surgical options and risks (infection, bleeding, paralysis, sphincter disturbances, dural tear and recurrence). Provision of supplementary information booklets was recorded. Two-tailed Fisher exact test was used to calculate statistical significance where appropriate.

Results
Documentation of indications and risks of elective spinal surgery, specifically risk of recurrence (62%) and sphincter disturbance (85%), was suboptimal on the consent forms. Documentation of these risks was also poor in clinic letters (<50%). Alternative treatment options were explained in less than half of the clinic letters, and there was no documentation of information booklet provision prior to elective surgeries.
Conclusion
Lack of informed consent plays a major role in medical malpractice claims in spinal surgery. Poor documentation puts the surgeon in a liable position. BASS guidance could be implemented to create a more standardised process of consent in spinal surgery.

“What are my options?”: Physicians as ontological decision architects in surgical informed consent

“What are my options?”: Physicians as ontological decision architects in surgical informed consent
Original Article
Stacy S. Chen, Sunit Das
Bioethics, 1 August 2022
Abstract
The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing of the patient towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship.

 

Consent — Informed Consent and Requirements of Consent

Consent — Informed Consent and Requirements of Consent
Book
Kumari K. Nirmala
Health Laws in India, 2022 [Routledge]
Abstract
    In the medical treatment, the relationship between the doctor and the patient has been in terms of benevolent paternalism. In ancient times, the obligation of the physician was solely in terms of promoting the welfare of the patient, diagnosing the ailment, and prescribing medicine or surgery, but seldom had they thought about patient’s right. But nowadays this locus of the authority in decision making has been shifted from the physician to the patient. A patient will receive all the information that he or she needs in order to make decision as to take treatment or not or a particular operation. There involves the consent of the patient. Consent to treatment is the principle that a person must give permission before they receive any type of medical treatment, test or examination. This must be done on the basis of an explanation by a clinician. Consent from a patient is needed regardless of the procedure, whether it a physical examination, organ donation or something else. The principle of consent is an important part of medical ethics and the international human rights law.

80 The earliest expression of this fundamental principle, based on autonomy, is found in the Nuremberg Code of 1947. The code makes it mandatory to obtain voluntary and informed consent of human subjects. Similarly, the Declaration of Helsinki adopted by the World Medical Association in 1964 emphasizes the importance of obtaining freely given informed consent for medical research by adequately informing the subjects of the aims, methods, anticipated benefits, potential hazards, and discomforts that the study may entail. Several international conventions and declarations have similarly ratified the importance of obtaining consent from patients before testing and treatment.

In India the principle of autonomy is enshrined within Art. 21 of the Indian Constitution, which deals with the right to life and personal liberty. Sec 88 of IPC, provides- Nothing which is not intended to cause death, is an offence to any person for whose benefit it is done in good faith, and who has given a consent. When a tort is committed, meaning that a defendant’s actions interfered with the plaintiff’s person or property, a plaintiff’s consent will excuse the defendant of the wrongdoing.

In the view of the above background, the present chapter proposes to deal briefly with the aspects of laws concerning consent in medical cases, and their implications. The chapter discusses about the capacity to give consent, ‘Real’ consent in the United Kingdom (UK) and as ‘Informed’ consent in the United States (US). To account for the Indian position, unlike in the West, the courts have assigned immense significance to the requirement of informed consent. The Honorable Court has in different cases summarized principles relating to consent and the necessity to enact full-fledged laws so as to adjust to the need of the day.