Abstract
Informed consent has become a challenging issue when surgery at the time of novel corona virus disease 2019 (COVID-19) is to be performed, in view of increased risk of the need of intensive care unit (ICU) in the post-operative period and the associated high mortality if a patient exhibits COVID-19 symptoms in the post-operative period. We have devised a new informed consent format for all patients undergoing surgery incorporating a few points specific for the disease.
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Introduction
Informed consent for surgery, which is a critical component of surgical practice, has become a challenging issue in the time of COVID-19 infection. There are few specific requirements which need to be discussed pre-op during this pandemic with the patient and the relatives, in order to avoid any unnecessary medicolegal issues. We have devised the first pro forma of informed consent of such patients undergoing surgical intervention.
Informed Consent During COVID-19
On March 11, 2020, the World Health Organization (WHO) declared the novel corona virus disease 2019 (COVID-19) a global pandemic, which classifies the outbreak as an international emergency. In a retrospective cohort study of 34 operative patients with confirmed COVID-19, 44.1% of patients required ICU care in the post-operative period and mortality rate was 20.5% [1]. Therefore, it is very important to devise a separate informed consent for operative patients during COVID-19, taking all the risk under consideration. We are reporting the first ever informed consent pro forma especially designed for COVID-19 patients undergoing surgery.
Consent Form
Discussion
The Canadian Medical Protective Association reports that over a recent 5-year period, 65% of medicolegal cases involving informed consent were surgical and only 21% of these cases were decided in favour of the surgeon [2]. It is mandatory that prior to obtaining consent for the proposed surgery, the surgeon must provide the patient with detailed information about the nature of the surgery, the expected benefits, alternate treatments and the consequence of not having the surgery [3].
In a country like India, the need for ICU in the post-op period must be discussed with the patient’s relative as it involves an increased financial burden. There are also concerns about the lack of pre-op COVID testing in India due to paucity of commercial testing kits. A normal patient may develop or contract corona virus infection in the peri- or post-operative period which should be again documented in the consent form. Hence, a detailed modified consent form was designed exclusively for all patients who require surgery during this pandemic.
References
Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z (2020) Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine 21:100331. https://doi.org/10.1016/j.eclinm.2020.100331
Hanson M, Pitt D (2017) Informed consent for surgery: risk discussion and documentation. Can J Surg 60:69–70
Canadian Medical Protective Association. Risk Fact Sheet CMPA. [accessed 2016 Mar. 1]. Available: www.cmpa-acpm.ca/documents/10179/300031190/informed_consent-e.pdf
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