|LETTER TO THE EDITOR
|Ahead of print
Time to modify informed consent in the COVID-19 era!
Abhity Gulia1, Anju Gupta2, Prateek Sharma3, Nishkarsh Gupta1
1 Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar, Institute Rotary Cancer Hospital, New Delhi, India
2 Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India
3 Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India
|Date of Submission||25-Jun-2020|
|Date of Decision||26-Jun-2020|
|Date of Acceptance||26-Sep-2020|
|Date of Web Publication||27-Jan-2021|
Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar, Institute Rotary Cancer Hospital, New Delhi
Source of Support: None, Conflict of Interest: None
The coronavirus disease 2019 (COVID-19) pandemic has imposed a major burden on the already limited health services across the world. The incubation period varies from 1 to 14 days, but extended up to 24 days has also been reported. The disease presentation is variable ranging from mild to life-threatening illness and has led to an atmosphere of distress and fear.
The routine surgical management of patients has suffered a major setback in this pandemic. A delayed or canceled surgical procedure may inflict substantial harm in up to 50% of patients. Notwithstanding, surgical procedures in COVID-19-positive patients or those becoming positive postoperatively are associated with poor perioperative outcomes due to impaired immunity, thrombocytopenia, venous thromboembolism, increased pulmonary complications, postoperative unmasking of subclinical infection, prolonged intensive care unit (ICU) stay and, increased mortality.
Literature suggests an increased propensity of the elderly patients with concomitant comorbidities to COVID-19 and acute respiratory distress syndrome, thereby leading to higher mortality. Unfortunately, this is the population likely to undergo emergency and time-sensitive surgical procedures during this pandemic.
An informed consent highlighting present condition, patient expectations, and queries regarding the procedure is a norm to ensure patient autonomy.
Due to the pandemic, the majority hospitals are functioning as COVID-19 facilities. Also, besides many healthcare workers (HCWs) may be infected and be an asymptomatic carrier. Hence, written consent regarding the increased risk of iatrogenic COVID-19 infection during the hospital stay and increased perioperative complications should be clearly explained and documented. Also, one needs to document any change in the type of intervention made due to COVID-19. It should also be explained to the patients that a diagnostic test for COVID-19 can sometimes fail to detect the virus, or the patient might contract the infection after the test, leading to potential complications. Additionally, the patient may have acquired asymptomatic infection from the community, and in case the infection becomes overt during the hospital stay, could blame the hospital for the infection transmission. Furthermore, apprehensions about procedure cancellation might lead patients to hide any respiratory symptoms.
In the COVID-19 era, certain changes have been implemented in perioperative care. Though elective otorhinolaryngology and other high-risk surgeries are strongly discouraged in the current scenario, many semi-elective/elective surgeries are gradually being started. To the best of our knowledge, in our institute, and as per our inquiry with colleagues in other hospitals, at present, the only point mentioned in the preoperative consent for elective or emergency surgical procedures is the information regarding mandatory COVID-19 testing for patients along with clinical screening for relatives, and need for doing reverse transcription-polymerase chain reaction preoperatively for the patient and his close relatives. Many of the points pertinent for consent in COVID-19 times are not yet incorporated/thought about in our and other institutes.
For emergency surgeries in COVID-19-positive patients, it is generally mentioned in the consent that the patient stands a heightened risk of complications due to COVID-19 which might lead to increased morbidity, but the same should be incorporated in consent for all patients as COVID-19 may be acquired perioperatively and increase complications, and later lead to medicolegal implications if this was not explained preoperatively. Informed consent before surgery should also include the need for ICU, in case the patient's condition deteriorates in the face of COVID-19 in the postoperative period. All these aspects are not being covered in the present consent forms.
The Ministry of Health and Family Welfare and World Health Organization guidelines for surgery in COVID-19 have covered most areas regarding patient management and consent in patients having COVID-19 infection. But there remains a lacuna regarding the consent modifications needed for elective but urgent surgeries like malignancies in non-COVID patients. It seems important that the consent in the present times should be balanced to provide adequate COVID-19 infection risk information, surgical procedure modifications without scaring those patients away who are in actual need of the surgery.
HCW's burnout and restraints imposed by the personal protective equipment may preclude them from obtaining appropriate consent. However, informed consent is important medicolegally, since negative outcomes of the procedure can be linked to an improper explanation of COVID-19-related issues. Also, alternative ways of obtaining consent like telecommunication and videoconferencing should be considered to reduce patient proximity during the pandemic.
In conclusion, we emphasize the need for modification of informed consent during this pandemic to include the additional risks and possibility of acquiring the infection perioperatively.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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