Posted on May 21, 2020 at 5:03 PM
by Jing Wan,Yuqiong Huang, Amaneh Abdel Hafez Aljaafreh, Dandan Dong, Yali Cong , Jun Lin, Hongxiang Chen
COVID-19 is an emerging infectious disease that is extremely contagious and can cause serious consequences and even death. Convalescent plasma, an unregistered therapy, from which the antibodies might suppress the virus, has been proven effective in the treatment of SARS, Ebola and H1N1, without severe adverse events (). It is unclear whether it can play a role or not in the emerging infectious disease COVID-19, but it may be a potential therapy (). According to the guidelines for the diagnosis and treatment of novel coronavirus infection, the use of convalescent plasma is recommended in critically ill patients.
Social media is a dynamic and interactive computer-mediated communication tool that has high penetration rates in the general population in both high-income and middle-income countries (. In health care, social media use allows health information to be shared easily and globally (). To some extent, social media has become an important tool in medicine, and the possible ethical dilemmas in its application has often been discussed (; ; ), but very few cases have shown that it can be used to solve the ethical dilemmas of medicine.
In this blog we share our experience with solving medical ethical dilemmas and legal risks of severe COVID-19. Our experience shows that it is easy to encounter medical ethical dilemmas and legal risks when applying unregistered treatments to critically ill patients. In the context of treating severe COVID-19 with convalescent plasma, we propose a social media-based strategy to address this problem.
Cases of COVID-19
A female patient, 62 years old, who was born in Taiwan and is a Hong Kong resident, currently living in Wuhan. She has a medical history of type 2 diabetes and coronary heart disease and six stent implantation about 6 years ago. Based on the patient’s medical history, auxiliary examination and the guidelines for the diagnosis and treatment of novel coronavirus infection (trial version 5) ), she was diagnosed as a COVID-19 patient with type 2 diabetes, coronary heart disease, fatty liver, and gallbladder stones.
Post hospitalization, the patient quickly progressed to respiratory failure. According to the treatment guidelines, various treatments including non-invasive ventilator-assisted breathing, invasive ventilator-assisted breathing and Extracorporeal Membrane Oxygenation ( ECMO) were done. However, it did not work well. Hence, there was a fierce debate about whether to use convalescent plasma, which is an unregistered treatment in clinical studies. This patient met the inclusion criteria and took part in the clinical study. Consent was given by her son. Several physicians disagreed with the use of convalescent plasma. Since it is an unregistered treatment and the application of convalescent plasma to the patient involved the interests of patients, doctors, hospitals and even medical companies, to implement the clinical research, patient’s families must be fully informed and consent must be obtained. However, the patient’s son was also being treated in the designated hospital due to infection with SARS-CoV-2, and could not sign the informed consent. In addition to its own medical risks, there were also legal risks and ethical dilemmas in adopting this treatment. Other physicians insisted on the use of convalescent plasma because the patient’s condition had deteriorated during the previous conservative treatment, and even the use of ECMO had not alleviated the patient’s condition. This showed that, for this particular patient, all other treatment methods were ineffective. Although convalescent plasma therapy has certain risks, it still has a scope for patients not responding to the treatment plan mentioned above.
Dilemma of principles of clinical ethics and legal risks
Informed consent for medical treatments is an important ethical and legal basis for authorization. The patient’s husband, son and daughter in law all were all being treated in a designated hospital due to their infection with SARS-CoV-2. It was thus impossible for them to sign the informed consent form. It might be debatable that the physician could first call the patient’s families to consult the relatives and obtain an oral consent, then implement the treatment plan based on the choice of patient’s family members, or, regardless of informed consent, directly implement the treatment that the physician thinks is best since according to Chinese law, for emergencies, physician can take emergency treatment measures, do not require informed consent, and must not refuse to provide emergency treatment (). The problem, however, is that convalescent plasma is an unregistered therapy, and the patient who participated in clinical study was not a patient in need of emergency treatment. In this case, the signing of informed consent is not only an ethical need, but also a legal need to fairly deal with the interests of all parties.
The professional use of social media is increasing day by day. In Chinese daily medical activities, many hospitals have established WeChat public accounts, which can be used for registration, payment, and consultation, and many physicians also try to communicate with their patients using WeChat. This leads to the question whether informed consent can be obtained by WeChat.
First, social media used in the medical and health sector has brought a lot of convenience to physicians and patients but also created some new ethical issues. The main ethical issues are the privacy and ownership of patient health data, and the authenticity and openness of what physicians publish (; ). Using WeChat to share the patient’s detailed condition with the patient’s family members respects the right of the patient’s family to know some patient information without violating their right to privacy. At the same time, in order to make the patient’s families fully understand the true situation of patients and make reasonable choices, we will also have to ensure the authenticity of the patient’s information.
Communication between physicians and patients’ families might be more accessible in the form of text, pictures, voice, and video. After family members thoroughly understand the patient’s condition, they can choose appropriate medical strategies in a timely manner. Thus, we can ensure the right of patients’ families to know and choose, and also ensure the interests of patients.
In the case of the 62 year old Taiwanese woman, this form of communication was adopted by the medical team. After using WeChat to efficiently communicate, the patient’s son approved the use convalescent plasma therapy and authorized the clinician to sign the informed consent to ensure that the patient started treatment as soon as possible. Currently, the patient has no need of ECMO, and her condition is gradually stabilizing.
There are no simple answers when dealing with clinical ethic issues and legal risks, in emergency situations. Therefore, here we have outlined a strategy that can be used to guide decision-making and resolve competing perspectives. First, check whether the patient is in an emergency situation. If the patient is not in an emergency situation, treat he/she with common procedures. If the patient does present as an emergency, check whether the patient needs an unregistered/off-label therapy , or whether the patient will join in a clinical study. If the patient can join a clinical study then the next step is to look whether the family members of the patient can go to the hospital to quickly sign an informed consent form. If the patient’s family members can sign the informal consent in time, start treating the patient with common procedures. If the family members cannot sign the informal consent in time then choose an effective social media to communicate with the patient’s family and get authorization, which allows the physician to sign the informed consent form according to the wishes of the patient’s family. While doing this ensures the data is valid and reliable, to verify the identity of the sender of the electronic data, pay attention to maintaining the integrity of electronic data and making it accessible at any time.
COVID-19 is a new type of infectious disease, which progresses rapidly and poses is a risk of death. Convalescent plasma therapy, an unregistered treatment in clinical research, is a promising treatment for severe patients. However, physicians often encounter ethical dilemmas and legal risks in decision-making that make it difficult or impossible include it in the treatment plan. Social media is gradually playing an irreplaceable role in daily life and work, as well as in the medical field. As its use surges in the clinic, clinicians should try to embrace it and use it properly to provide more effective clinical care, including care for patients with COVID-19.
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