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Patient information: Law, ethics and reality
European Annals of Otorhinolaryngology, Head and Neck diseases 132 (2015) 179–180
Available online at
ScienceDirect www.sciencedirect.com
Editorial
Patient information: Law, ethics and reality The otorhinolaryngologist’s obligation to inform the patient before any therapeutic procedure is not a new requirement in France, as this obligation has been part of the contract established, in the eyes of the law, between the doctor and the patient since 1945. This contract protects the otorhinolaryngologist from possible prosecution for “unintentional damages” if the patient is not satisfied with the care provided and seeks compensation in a court of law. The French law of 4 March 2002, called “Patients’ rights and quality of the health system”, specifies that the patient participates in medical decisions concerning him or her and that this participation is documented by obtaining the patient’s “free and informed consent” based on “honest, clear and appropriate information”. [1]. In the eyes of the law, these terms imply that the otorhinolaryngologist cannot hide any information from the patient (“honest”), that the information must be clearly understood by the patient (“clear”) and that it cannot be delivered without a certain degree of discernment and humanism (“appropriate”). In this context, the law requires the otorhinolaryngologist to describe: “the various treatment options, their respective value, their possible degree of urgency, their consequences, normally predictable common or serious risks and predictable consequences in the case of refusal of treatment” [1]. As defined by the consultant Sargos to the Court of Cassation, “normally predictable” risks are “risks likely to have fatal, disabling, or even serious cosmetic consequences in view of their psychological or social repercussions”. Consequently, the less the therapeutic procedure is absolutely necessary, the greater the obligation to provide the patient with adequate information. So-called “comfort” medical or surgical procedures (and otorhinolaryngology comprises a large number of such procedures) therefore imply the need for detailed information. The legislator considers that by respecting the obligation to provide information, the otorhinolaryngologist enables the patient to understand and integrate the proposed treatment, and therefore enables the patient to take a decision in his or her best interests. In the eyes of the law, establishment of such a partnership contributes to good quality medicine in France. Lawyers have amplified the importance of this medical information. The Court of Cassation decision on 25th February 1997 transferred the burden of proof concerning medical information to the otorhinolaryngologist, who, in the event of legal action, must justify that he/she has provided the patient with all of the necessary information to reach a decision [2]. On 3rd June 2010, the same court considered failure to comply with the obligation to inform the patient to be a legal fault that per se generated a specific moral prejudice subject to compensation, even when the procedure concerned did not result in any damages and/or when it can be shown
http://dx.doi.org/10.1016/j.anorl.2015.05.002 1879-7296/© 2015 Elsevier Masson SAS. All rights reserved.
that, if the patient had been correctly informed, he or she would have chosen another option [2]. There is a general consensus in support of this humanistic approach that legislators and lawyers wish to impose on society and our surgical specialty. All of the studies published in the medical literature highlight the desire expressed by the great majority of patients to be informed about the risks involved before undergoing a therapeutic procedure, especially when the risks associated with the procedure are considerable. In 1998 and 2001, two studies published in the English language literature emphasized that information on the risks of treatment was the first point that patients wished to discuss at the preoperative visit [3]. However, this information is not devoid of harmful effects for the patient and for medicine. Scientific studies emphasize the high levels of stress, anxiety and even fear induced by this information. Several studies conducted in France have indicated that 30% to 50% of patients experienced this type of negative reaction [3]. Anxiety can be sufficiently severe for the patient to refuse the proposed procedure. This refusal rate is far from negligible, as it ranges from 10% before endoscopic paranasal sinus surgery, 13.4% before parotid gland surgery, and 14.6% before thyroid surgery [3]. This information on treatment options and/or the surgical risks involved may even sometimes be perceived by the patient as a way for the doctor and/or the healthcare institution to avoid their responsibilities, or even as a defensive attitude by the doctor [3]. The difficulties encountered by otorhinolaryngologists when they are required to inform their patients could possibly lead to the development of a “defensive” approach to our specialty. Over the last ten years, several North American studies have reported that more than 90% of North American surgeons working in specialties with a high legal risk (otorhinolaryngology, ophthalmology, plastic surgery, gynaecology, neurosurgery, etc.) admit to sometimes performing defensive medicine by refusing to perform certain operations that may lead to complications and by avoiding to take care of certain patients presenting complex medical problems and/or perceived as being litigious, resulting in a limitation of access to care for the poorest patients and increased healthcare costs for the community [4–6]. Many articles in the non-scientific press call for French doctors not to follow this North American trend. But is this possible while, the population is ageing, the number of legal actions for inadequate patient information is growing, the number of candidates for complicated specialties (particularly surgical) is decreasing, the number of administrative tasks is increasing with the analysis of the cost of the medical procedure and its level of reimbursement taking precedence to the quality of care delivered?
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Editorial / European Annals of Otorhinolaryngology, Head and Neck diseases 132 (2015) 179–180
Jacqueline de Romilly, in 2001, declared “There is an art of speaking, which does not consist of lies or flattery, but which serves the truth. There is a way of presenting, explaining and discussing the truth, which is the very extension of the most rigorous knowledge, and this is particularly true for medicine, a science of man that must comprise knowledge of human nature” [3]. Although this capacity appears to be essentially a talent and an art, the growing importance of patient information over recent years must encourage us to assiduously teach these techniques to our students, but also to have these techniques constantly in mind in our everyday practice. Effective information also requires revalorisation of French and philosophy in the scientific sections of our high schools, which now provide the very great majority of our future doctors. Finally, we must continuously inform our patients and society in general about the concept that information on the risks of treatment constitutes a guarantee not only of the otorhinolaryngologist’s rigorous approach and skill, but also his/her honesty. Disclosure of interest The author declares that he has no conflicts of interest concerning this article.
References [1] Loi no 2002-203 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé. JO Rep Fr 2002:4118–58. [2] www.legifrance.gouv.fr [3] Laccourreye O, Cauchois R, Werner A. Analyse des facteurs qui influent sur la mémorisation et l’interprétation par le malade de l’information concernant les risques de la thyroidectomie. Bull Acad Natl Med 2008;192:27–34. [4] Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA 2005;293:2609–17. [5] Nahey BV, Babu MA, Smith TR. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Plos One 2012;7(6):e39237, http://dx.doi.org/ 10.1371/journal.pone.0039237 [Epub 2012 Jun 22]. [6] Sathiyakumar V, et al. The prevalence and costs of defensive medicine among orthopaedic trauma surgeons: a national survey study. J Orthop Trauma 2013;27:592–7.
Ollivier Laccourreye Service d’oto-rhino-laryngologie et de chirurgie cervico-faciale, HEGP, université Paris Descartes Sorbonne Paris Cité, AP–HP, 20-40, rue Leblanc, 75015 Paris, France E-mail address: [email protected]
Available online at
ScienceDirect www.sciencedirect.com
Editorial
Patient information: Law, ethics and reality The otorhinolaryngologist’s obligation to inform the patient before any therapeutic procedure is not a new requirement in France, as this obligation has been part of the contract established, in the eyes of the law, between the doctor and the patient since 1945. This contract protects the otorhinolaryngologist from possible prosecution for “unintentional damages” if the patient is not satisfied with the care provided and seeks compensation in a court of law. The French law of 4 March 2002, called “Patients’ rights and quality of the health system”, specifies that the patient participates in medical decisions concerning him or her and that this participation is documented by obtaining the patient’s “free and informed consent” based on “honest, clear and appropriate information”. [1]. In the eyes of the law, these terms imply that the otorhinolaryngologist cannot hide any information from the patient (“honest”), that the information must be clearly understood by the patient (“clear”) and that it cannot be delivered without a certain degree of discernment and humanism (“appropriate”). In this context, the law requires the otorhinolaryngologist to describe: “the various treatment options, their respective value, their possible degree of urgency, their consequences, normally predictable common or serious risks and predictable consequences in the case of refusal of treatment” [1]. As defined by the consultant Sargos to the Court of Cassation, “normally predictable” risks are “risks likely to have fatal, disabling, or even serious cosmetic consequences in view of their psychological or social repercussions”. Consequently, the less the therapeutic procedure is absolutely necessary, the greater the obligation to provide the patient with adequate information. So-called “comfort” medical or surgical procedures (and otorhinolaryngology comprises a large number of such procedures) therefore imply the need for detailed information. The legislator considers that by respecting the obligation to provide information, the otorhinolaryngologist enables the patient to understand and integrate the proposed treatment, and therefore enables the patient to take a decision in his or her best interests. In the eyes of the law, establishment of such a partnership contributes to good quality medicine in France. Lawyers have amplified the importance of this medical information. The Court of Cassation decision on 25th February 1997 transferred the burden of proof concerning medical information to the otorhinolaryngologist, who, in the event of legal action, must justify that he/she has provided the patient with all of the necessary information to reach a decision [2]. On 3rd June 2010, the same court considered failure to comply with the obligation to inform the patient to be a legal fault that per se generated a specific moral prejudice subject to compensation, even when the procedure concerned did not result in any damages and/or when it can be shown
http://dx.doi.org/10.1016/j.anorl.2015.05.002 1879-7296/© 2015 Elsevier Masson SAS. All rights reserved.
that, if the patient had been correctly informed, he or she would have chosen another option [2]. There is a general consensus in support of this humanistic approach that legislators and lawyers wish to impose on society and our surgical specialty. All of the studies published in the medical literature highlight the desire expressed by the great majority of patients to be informed about the risks involved before undergoing a therapeutic procedure, especially when the risks associated with the procedure are considerable. In 1998 and 2001, two studies published in the English language literature emphasized that information on the risks of treatment was the first point that patients wished to discuss at the preoperative visit [3]. However, this information is not devoid of harmful effects for the patient and for medicine. Scientific studies emphasize the high levels of stress, anxiety and even fear induced by this information. Several studies conducted in France have indicated that 30% to 50% of patients experienced this type of negative reaction [3]. Anxiety can be sufficiently severe for the patient to refuse the proposed procedure. This refusal rate is far from negligible, as it ranges from 10% before endoscopic paranasal sinus surgery, 13.4% before parotid gland surgery, and 14.6% before thyroid surgery [3]. This information on treatment options and/or the surgical risks involved may even sometimes be perceived by the patient as a way for the doctor and/or the healthcare institution to avoid their responsibilities, or even as a defensive attitude by the doctor [3]. The difficulties encountered by otorhinolaryngologists when they are required to inform their patients could possibly lead to the development of a “defensive” approach to our specialty. Over the last ten years, several North American studies have reported that more than 90% of North American surgeons working in specialties with a high legal risk (otorhinolaryngology, ophthalmology, plastic surgery, gynaecology, neurosurgery, etc.) admit to sometimes performing defensive medicine by refusing to perform certain operations that may lead to complications and by avoiding to take care of certain patients presenting complex medical problems and/or perceived as being litigious, resulting in a limitation of access to care for the poorest patients and increased healthcare costs for the community [4–6]. Many articles in the non-scientific press call for French doctors not to follow this North American trend. But is this possible while, the population is ageing, the number of legal actions for inadequate patient information is growing, the number of candidates for complicated specialties (particularly surgical) is decreasing, the number of administrative tasks is increasing with the analysis of the cost of the medical procedure and its level of reimbursement taking precedence to the quality of care delivered?
180
Editorial / European Annals of Otorhinolaryngology, Head and Neck diseases 132 (2015) 179–180
Jacqueline de Romilly, in 2001, declared “There is an art of speaking, which does not consist of lies or flattery, but which serves the truth. There is a way of presenting, explaining and discussing the truth, which is the very extension of the most rigorous knowledge, and this is particularly true for medicine, a science of man that must comprise knowledge of human nature” [3]. Although this capacity appears to be essentially a talent and an art, the growing importance of patient information over recent years must encourage us to assiduously teach these techniques to our students, but also to have these techniques constantly in mind in our everyday practice. Effective information also requires revalorisation of French and philosophy in the scientific sections of our high schools, which now provide the very great majority of our future doctors. Finally, we must continuously inform our patients and society in general about the concept that information on the risks of treatment constitutes a guarantee not only of the otorhinolaryngologist’s rigorous approach and skill, but also his/her honesty. Disclosure of interest The author declares that he has no conflicts of interest concerning this article.
References [1] Loi no 2002-203 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé. JO Rep Fr 2002:4118–58. [2] www.legifrance.gouv.fr [3] Laccourreye O, Cauchois R, Werner A. Analyse des facteurs qui influent sur la mémorisation et l’interprétation par le malade de l’information concernant les risques de la thyroidectomie. Bull Acad Natl Med 2008;192:27–34. [4] Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA 2005;293:2609–17. [5] Nahey BV, Babu MA, Smith TR. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Plos One 2012;7(6):e39237, http://dx.doi.org/ 10.1371/journal.pone.0039237 [Epub 2012 Jun 22]. [6] Sathiyakumar V, et al. The prevalence and costs of defensive medicine among orthopaedic trauma surgeons: a national survey study. J Orthop Trauma 2013;27:592–7.
Ollivier Laccourreye Service d’oto-rhino-laryngologie et de chirurgie cervico-faciale, HEGP, université Paris Descartes Sorbonne Paris Cité, AP–HP, 20-40, rue Leblanc, 75015 Paris, France E-mail address: [email protected]