Skip to main content

The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case

Abstract

Respiratory failure related to COVID-19 may evolve into acute respiratory distress syndrome, which may require invasive treatment. Through the analysis of a concrete clinical case, we want to clarify how to manage patients suffering from serious acute pathologies, which require timely intervention, even invasive, but refuse medical treatment. The Italian law 219/2017 states strongly the freedom of the patient to choose, independently whether to start or stop at any time any type of medical treatment through their informed consent. The law, of course, addresses in several parts the problem of the refusal of the subject to certain choices. The law also provides that if the patient refuses therapies or interventions, putting his life at risk, the doctors need to engage in further communication with the support of other professionals, informing the patient of the consequences, promoting every support action, and involving family members. Judgment on the level of impaired capacity, which makes a patient incompetent to make therapeutic decisions, should ideally reflect the balance between respecting patient autonomy and protecting the patient from the consequences of a wrong decision. For the physicians, it is a matter of balancing the need to save the life of the person, or at least to avoid the establishment of permanent damage, with the subject itself expressly stated, including an explicit refusal to carry out maneuvers or therapies or interventions when it is in danger of life, even if such treatments could save it.

Introduction

The “severe acute respiratory syndrome coronavirus-2” (SARS-CoV-2) is caused by a viral pathogen that in some subjects causes mild diseases, while in others, despite the doses of vaccine administered, there is a progression toward respiratory failure requiring mechanical ventilation [1,2,3]. In the most severe form, respiratory failure related to COVID-19 evolves into acute respiratory distress syndrome (ARDS) [4,5,6,7], which requires invasive treatment. Although the incidence data are limited, in Italy, it has been found that 88% of critical patients need mechanical ventilation [8]. Before undertaking any type of therapy, especially an invasive treatment, by law, the physician must obtain informed consent from the patient [1, 9].

Through the analysis of a concrete clinical case (a patient with acute respiratory failure COVID-19 related that needed mechanical ventilation), we want to clarify how to manage patients suffering from serious acute pathologies, that require timely intervention, even invasive, but refuse medical treatment.

The case

A 63-year-old man with known type 2 diabetes mellitus was admitted to the emergency department (ED) for shortness of breath and oxygen desaturation. He had cough and fever during the week before. Vaccinated against SARS-CoV-2 (two doses: last dose 3 months before admission). At presentation, he had fever (38.0 °C), heart rate was 94 beats per minute, blood pressure 160/80 mmHg, and a respiratory rate of 30 breaths per minute; the oxygen saturation was 78% while breathing ambient air. A reverse-transcriptase-polymerase-chain-reaction assay was positive for SARS-CoV-2 RNA. The patient was admitted to the medical ward and his clinical conditions rapidly worsened. The patient refused non-invasive mechanical ventilation and became progressively more reluctant to comply with the physician’s prescriptions. Despite the need for high flow oxygen to maintain an acceptable O2 saturation, he expressed the will to be discharged. The patient was evaluated by several physicians, including a psychiatric and medical legal counseling, and the risks associated with the refusal of medical care were carefully and repeatedly explained. The patient’s daughter further tried to convince him to accept medical treatment including not invasive ventilation, but the patient signed a voluntary discharge form and left the hospital ward.

The next day, the patient was taken to the ED in critical conditions. He had acute respiratory distress syndrome (ratio of partial pressure arterial oxygen and fraction of inspired oxygen, PaO2/FiO2: 238), acute renal failure (serum creatinine 3.15 mg/dL, Na+ 126 mmol/L, K+ 6.48 mmoL/L) with metabolic acidosis, and severe laboratory alterations (plasma glucose 858 mg/dL, white blood cells count 12,880/mm3, and C-reactive protein 126 mg/L). He was admitted to the COVID-19 semi-intensive-care unit and gave written informed consent to non-invasive mechanical ventilation and medical treatment. The conditions of the patient remained critical for several days. A progressive improvement of respiratory failure and of the metabolic alterations were observed, and after 30 days, it was possible to move the patient to a rehabilitation unit.

Informed consent and refusal of medical treatment

The Charter of Fundamental Rights of the European Union states that “in medicine and biology, in particular, must be respected: the free and informed consent of the person concerned, in accordance with the procedures laid down by law”. It should be stressed that what should become the “Bill of Rights” of the European Union under the Lisbon Treaty has expressly recognized the principle of voluntary treatment, which is based on the recognition of the moral and personal choices. The Charter is used as an interpretative aid by the Court of Justice of the European Union and, according to the Italian Constitutional Court, is “expressive of principles common to European legal systems” [10].

A second authoritative support for the principle of consensus stems from the so-called Oviedo Convention, adopted in the Council of Europe on 4 April 1997 [11]. Article 5 of the Oviedo Convention expressly provides that “an intervention in the field of health can only be carried out after the person concerned has given free and informed consent” [12].

In Italy, Law no. 219 of 22 December 2017 [9], in Article 1, makes informed consent the central, binding, and essential argument, stating that “No medical treatment may be initiated or continued without the free and informed consent of the person concerned, except as expressly required by law”.

One of the key concepts is the affirmation of the indisputable and absolute freedom of the patient to choose, independently whether to start or stop at any time any type of medical treatment through their informed consent.

Informed consent shall be considered valid if information is communicated, for example on the state of health and future prognosis, to a patient of legal age, time, and space-oriented, which has the ability to self-determination and to make a voluntary choice [9].

Already in 2007, the Court of Cassation, with the judgment n. 21,748, stated that “Informed consent is, as a rule, the legitimacy and basis of medical treatment: without informed consent, the intervention of the doctor is, apart from cases of compulsory medical treatment or in which a state of need occurs, certainly illicit, even when it is in the interest of the patient; the practice of free and informed consent represents a form of respect for the freedom of the individual for the pursuit of his best interests. The informed consent has as correlated the faculty, not only to choose between the various possibilities of medical treatment, but (…) also to eventually refuse the therapy and to consciously decide to interrupt it, in all the phases of the life (…)” [13]. Moreover, reference is made to the exception of compulsory medical treatment or to the state of necessity that would make the treatment lawful without consent but, as the rule states, where there is a will (therefore also a refusal), this will must be respected.

Law 219/2017 [9], of course, addresses in several parts the problem of the refusal of the subject to certain choices. In particular, the law (Article 1, paragraph 6) states that “the physician is required to respect the willingness expressed by the patient to refuse medical treatment or to renounce the same and, as a result of this, is free from civil or criminal liability”.

In 2018, the Council of State in the “Request for an opinion on informed consent and advance processing provisions” established that with that legislation “(…) in addition to being informed, the right to refuse, in whole or in part, any diagnostic test or medical treatment (…)” [14].

It is, therefore, to balance the need to save the life of the person, or at least to avoid the establishment of permanent damage, with the subject itself expressly stated, including an explicit refusal to carry out maneuvers or therapies or interventions when it is in danger of life, even if such treatments could save it.

State of necessity

Article 54 of the Penal Code [15] states that “It is not punishable who has committed the fact for having been forced by the need to save himself or others from the present danger of a serious damage to the person, a danger he did not intentionally cause, nor otherwise avoidable, provided that the fact is proportionate to the danger”. In addition, the Code of Medical Deontology, the latest draft of which dates to 2014, Article 36 “Urgency and emergency assistance” states: “The doctor shall ensure the indispensable assistance, in urgency and emergency conditions, in compliance with the will if expressed or considering the statements anticipated treatment if manifested”.

The Law of 22 December 2017, referring to the situation of urgency or emergency, Article 1 paragraph 7 states: “In urgency or emergency situations, the physician and the members of the medical team shall ensure the necessary care, respecting the will of the patient where his clinical condition and circumstances allow it to be received”.

The state of necessity, as a cause of exclusion of the anti-juridical nature of the conduct, exists if the health care provider is faced with the need to save himself or others from the present danger of serious harm to the person, justifying his actions, even in the absence of the consent of the patient and provided that he has not manifested and is knowable an express written dissent (for example with the advance provisions of treatment) to the intervention of the health care professional.

The state of necessity can be expected when this is related to the current assessment of the need to perform interventions that are useful and essential for the patient, according to the best principles of the lex artis: this evaluation allows to consider “covered” the state of need for treatments that, even if not characterized by an absolute clinical emergency, are destined to become such in a very short time, or in the immediate future of the patient, and this makes the doctor’s assessment even more complex, which has to decide whether the intervention can be considered as not delayed.

The question arises as to whether the state of necessity operates as “existent” or “cause of justification”. Such a condition could be to remove the limit of consent, imposing an obligation to take action to protect the health of the patient, obviously not attenuating any unlawful behavior that the physician may have carried out, but by requiring the physician to justify that he had acted in a certain way just having evoked the state of necessity and having to justify it.

It is therefore appropriate to try to define the concept of “urgency” and “emergency” by identifying the differences. If the outcome under discussion is the survival of the patient, that is, immediate interventions are needed to ensure the favorable outcome and the vital signs are altered, it is called emergency. On the other hand, if the intervention must be prompt but not immediate, that is, it must be extendable in time, we speak about urgency. The distinction is inherent in the time needed for action and requires a technical assessment. Therefore, the evaluation of the extreme urgency of the intervention is imposed on the health care, but treatments that are not characterized by an absolute clinical emergency, but can become so in a very short time, can be included in the state of need, in the sense that they are destined to become unavoidable in the immediate future of the patient [16].

Moreover, the United Sections of the Criminal Court (18/12/2008–21/01/2009 No. 2437) maintained that the profession of doctor is a “public need”, and that is why, this activity does not need to legitimize itself a discriminating typed, such as the patient’s consent to treatment, which excludes the unlawfulness of conduct instrumental to medical treatment, although implemented according to the rules of the art and with favorable outcome for the patient [17]. This rule stresses that the absence of consent, in the absence of explicit refusal, when the intervention has produced a benefit for the patient’s health does not incur the doctor criminal liability.

Application of the standard in clinical practice

The current legislation requires respect for the will of the patient able, but in case of refusal of treatment, the law asks additional attention to the physicians. It is not unusual, in fact, that in the departments of medicine and surgery, including the outpatient area, there are patients whose decision-making capacity can be compromised. Law 219/2017 (Article 1, paragraph 5) provides that if the patient refuses therapies or interventions, putting his life at risk, the doctor engages in further communication with the support of other professionals, informing the patient of the consequences, promoting every support action, and involving family members [9].

Judgment on the level of impaired capacity, which makes a patient incompetent to make therapeutic decisions, should ideally reflect the balance between respecting patient autonomy and protecting the patient from the consequences of a wrong decision [18].

Considering the possibility of fluctuations in the mental state of the patient and thus the level of his capacity, as well as the seriousness of possibly depriving him of the right to make decisions, where possible, it is essential that the assessment is carried out by at least two physicians at different times [19].

Any doctor should be able to assess a patient’s competence, while psychiatric counseling can be useful in particularly complex situations. Between 3 and 25% of requests for psychiatric counseling in hospitals involve questions about the competence of the patient to make decisions about treatment [20, 21].

Whichever approach to evaluation is used, clinicians should first ensure that patients have been provided with information that is relevant to making an informed decision about their treatment. Typically, such communication includes the nature of the patient’s condition, the nature and purpose of the proposed treatment, and the risks and benefits of the proposed treatment and alternative treatments, including the no-treatment option [22].

The expressed will of the subject must be clearly perceptible and there must be no doubt: consequently, even in cases of necessity, if the refusal were clear, the health workers could not intervene, giving precedence to the right to self-determination of the subject over the need to save his life. Once the patient has been warned of the consequences of his choice, the health professionals must nevertheless promote and support any supporting action, avoiding that the refusal of the treatments turns into a potential therapeutic abandonment (Article 2: “principle of not abandon”) [9].

Conclusion

According to the European directives, the Italian law protects the patient’s freedom to choose whether to undergo any type of medical treatment (diagnostic or therapeutic), after having been adequately informed and having given his/her consent. At any time, the “oriented” patient can choose to refuse medical treatment or to suspend it. The only cases in which medical treatment can be carried out without the patient’s consent are compulsory medical treatment or if a state of necessity occurs (urgency or emergency).

In our case, even in the presence of a severe clinical presentation and in consideration of the current legislation, the clinicians have ascertained that the patient was oriented in time and space through the relevant specialist advice. Later, they further explained to the patient the risks associated with the refusal of treatment, trying to convince him through the help of relatives (daughter) and subsequently accepted his explicit refusal to treatment as a valid expression of his decision-making autonomy.

References

  1. Lentz S, Roginski MA, Montrief T, Ramzy M, Gottlieb M, Long B (2020) Initial emergency department mechanical ventilation strategies for COVID-19 hypoxemic respiratory failure and ARDS. Am J Emerg Med 38:2194–2202

    Article  Google Scholar 

  2. Wu Z, McGoogan JM (2020) Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the chinese center for disease control and prevention. JAMA. https://doi.org/10.1001/jama.2020.2648

    Article  PubMed  PubMed Central  Google Scholar 

  3. GuanW-J N-Y, Hu Y, Liang W-H, Ou C-Q, He J-X et al (2020) Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 382:1708–1720. https://doi.org/10.1056/NEJMoa2002032

    Article  Google Scholar 

  4. Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK et al (2020) Covid-19 in critically ill patients in the Seattle region—case series. N Engl J Med. https://doi.org/10.1056/NEJMoa2004500[NEJMoa2004500]

    Article  PubMed  PubMed Central  Google Scholar 

  5. Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M et al (2020) Characteristics and outcomes of 21 critically ill patients with COVID-19 in Washington State. JAMA 323:1612. https://doi.org/10.1001/jama.2020.4326

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  6. Xiong Y, Liu Y, Cao L, Wang D, Guo M, Jiang A et al (2020) Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerg Microbes Infect 9:761–770. https://doi.org/10.1080/22221751.2020.1747363

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  7. Ziehr DR, Alladina J, Petri CR, Maley JH, Moskowitz A, Medoff BD et al (2020) Respiratory pathophysiology of mechanically ventilated patients with COVID-19: a cohort study. Am J Respir Crit Care Med. https://doi.org/10.1164/rccm.202004-1163LE[rccm.202004-1163LE]

    Article  PubMed  PubMed Central  Google Scholar 

  8. Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A et al (2020) Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region. Italy JAMA 323:1574. https://doi.org/10.1001/jama.2020.5394

    CAS  Article  PubMed  Google Scholar 

  9. Legge 22 dicembre 2017, n. 219. Norme in materia di consenso informato e di disposizioni anticipate di trattamento. (18G00006) (GU Serie Generale n. 12 del 16–01–2018). https://www.gazzettaufficiale.it/eli/id/2018/1/16/18G00006/sg

  10. Italian Constitutional Court (2006) Judgment n. 135 of 2002, confirmed by judgment n. 394 of 2006

  11. Council of Europe (1997) Convention for the Protection of Human Rights and Dignity of the Human Being against the Applications of Biology and Medicine: Convention on Human Rights and Biomedicine. ETS No. 164 - Oviedo, 4.IV.1997. https://www.coe.int/en/web/conventions/-/council-of-europe-convention-for-the-protection-of-human-rights-and-dignity-of-the-human-being-with-regard-to-the-application-of-biology-and-medicin-2. Accessed 29 June 2022

  12. Vallini A (2003) Il valore del rifiuto alle cure «non confermabile» dal paziente alla luce della Convezione di Oviedo sui diritti umani e la biomedicina. Dir pubbl 185–217. http://hdl.handle.net/11568/883303. Accessed 29 June 2022

  13. Corte di Cassazione (2007) Judgment of 16 Oct 2007, n. 21748. https://www.biodiritto.org/ocmultibinary/download/2445/23238/9/a8c03fe6f441a32ecb6b9cfba437915c.pdf/file/21748_2007_Cass.pdf

  14. Consiglio di Stato ( 2018) Adunanza della Commissione speciale del 18 luglio 2018. Richiesta di parere in materia di consenso informato e di disposizioni anticipate di trattamento. https://www.panoramasanita.it/wp-content/uploads/2018/07/dat-consiglio-di-stato.pdf. Accessed 29 June 2022

  15. Codice Penale. Libro primo - Dei reati in generale; Titolo III - Del reato; Capo I - Del reato consumato e tentato; Articolo 54 - Stato di necessità (R.D. 19 ottobre 1930, n. 1398). https://www.brocardi.it/codice-penale/libro-primo/titolo-iii/capo-i/art54.html. Accessed 29 June 2022

  16. Cacace S, Conti A, Delbon P (2019) La volontà e la scienza—relazione di cura e disposizioni anticipate di trattamento. G. Giappichelli Editore, Torino, pp 225–231

    Google Scholar 

  17. Corte di Cassazione (2008) Sezioni Unite Penali, 21 gennaio 2009 (Ud. 18 Nov 2008), n. 2437. https://www.ambientediritto.it/sentenze/2009/Cassazione/Cassazione_2009_n._2437.htm

  18. Kim SYH (2006) When does decisional impairment become decisional incompetence? Ethical and methodological issues in capacity research in schizophrenia. Schizophr Bull 32:92–97

    Article  Google Scholar 

  19. Applebaum PS (2007) Assessment of patients’ competence to consent to treatment. N Engl J Med 357(1834):1840

    Google Scholar 

  20. Farnsworth MG (1990) Competency evaluations in a general hospital. Psychosomatics 31:60–66

    CAS  Article  Google Scholar 

  21. Jourdan JB, Glickman L (1991) Reasons for requests for evaluation of competency in a municipal general hospital. Psychosomatics 32:413–416

    CAS  Article  Google Scholar 

  22. Berg JW, Appelbaum PS, Lidz CW, Parker L (2001) Informed consent: legal theory and clinical practice, 2nd edn. Oxford University Press, New York

    Google Scholar 

Download references

Funding

The authors report that there was no funding source for the work that resulted in the article or the preparation of the article.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Maria Lorenza Muiesan.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

There is no informed consent, because there were not any human participants.

Human and animal rights statement

There is no research involving human participants and/or animals.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Maghin, F., Salvetti, M., Muiesan, M.L. et al. The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case. Intern Emerg Med (2022). https://doi.org/10.1007/s11739-022-03046-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s11739-022-03046-1

Keywords

  • COVID-19
  • Mechanical ventilation
  • Informed consent
  • State of necessity
  • Refusal of medical treatment