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Disclosure without or with reservation? Contemplating the development of persistent postsurgical pain due to nocebo effect
Accepted Manuscript Disclosure Without or With Reservation? Contemplating the Development of Persistent Post-surgical Pain Due to Nocebo Effect Xiulu Ruan, MD, Adjunct Clinical Associate Professor of Anesthesia, Alan David Kaye, MD, Ph.D., Professor and Chairman of Anesthesia PII:
S0002-9610(16)30304-X
DOI:
10.1016/j.amjsurg.2016.04.013
Reference:
AJS 11967
To appear in:
The American Journal of Surgery
Received Date: 16 March 2016 Revised Date:
30 March 2016
Accepted Date: 4 April 2016
Please cite this article as: Ruan X, Kaye AD, Disclosure Without or With Reservation? Contemplating the Development of Persistent Post-surgical Pain Due to Nocebo Effect, The American Journal of Surgery (2016), doi: 10.1016/j.amjsurg.2016.04.013. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
RI PT
Disclosure Without or With Reservation? Contemplating the Development of Persistent Post-surgical Pain Due to Nocebo Effect
Xiulu Ruan, MD, Adjunct Clinical Associate Professor of Anesthesia (corresponding author)
M AN U
1542 Tulane Ave. New Orleans, LA 70112
SC
Dept. of Anesthesiology, Louisiana State University Health Science Center
Alan David Kaye, MD, Ph.D., Professor and Chairman of Anesthesia Dept. of Anesthesiology, Louisiana State University Health Science Center
TE D
1542 Tulane Ave. New Orleans, LA 70112
Chronic pain after surgery became recognized as a significant problem in 1992 1. It remained
EP
largely a neglected issue until 2001, when Macrae published a review article in the British Journal of Anesthesia 1.The incidence of chronic pain after major surgery is estimated to lie
AC C
between 20% and 50% 2, and the overall estimated incidence of severely disabling pain after surgery is in the range of 2–10% 3.
Macrae noted that, in a survey of surgical textbooks, the general topic of chronic pain after surgeries, such as mastectomy, thoracotomy or hernia repair, was either mentioned briefly or ignored all together. When one looks at the whole spectrum of the syndromes of chronic pain after surgery, it seems unlikely that the cause of the pain is related to something that the surgeon
ACCEPTED MANUSCRIPT
has done wrong. It seems more likely that this is the inevitable result of surgery in a certain percentage of patients 1.
RI PT
Simanski and colleagues 4 investigated the incidence of chronic postsurgical pain (CPSP) in a general population. They found 14.8% of patients had CPSP, and by surgical discipline, 28% were general, 15% vascular, and 57% trauma/orthopedic surgery. Most often cited pain sites
SC
were joint (49.4%), incisional/scar (37.7%), and nerve pain (33.7%). Further, there was a high CPSP rate after 2 years both generally and particularly in orthopedic/trauma (57%) patients.
M AN U
In a large survey (N=12,981), Johansen et al. 5 found that of the individuals with chronic pain (N=3352), 6.2% indicated surgery as a cause, although only 0.5% indicated surgery as the only cause. They also found that most cases of persistent post-surgical pain are coexistent with other chronic pain.
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In 2007, Aroori and Spence 6 reported that 9% of patients suffered chronic severe pain following inguinal hernia repair. They discussed that all patients undergoing inguinal hernia repair, irrespective of type, should be informed about the risk of severe and chronic groin pain following
EP
a hernia repair. This should be clearly recorded on the consent form 6.
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Nocebo effect occurs when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation 7. Nocebo effects are the direct result of the psychosocial context or therapeutic environment on a patient’s mind, brain, and body, involving multiple factors, such as verbal suggestions and past experience 8. The consideration of nocebo effects in the context of patient-clinician communication and disclosure before surgeries may be valuable in both minimizing the nocebo component of a given therapy and improving surgical outcomes.
ACCEPTED MANUSCRIPT
Informed consent is the process by which a person authorizes medical treatment after discussing with clinicians the nature, indications, benefits, and risks of treatment 9. In the case of any
RI PT
surgical procedure, the likelihood of the development of chronic post-surgical pain should be disclosed, presumably.
SC
The principle of informed consent obligates physicians to explain possible side effects before performing surgeries. One of the primary missions of physicians, dating back to Hippocrates, is
M AN U
the principle of nonmaleficence, Primum non nocere: “Above all do no harm.” At the same time, the pinnacle of modern bioethics is informed consent, respect for person, and transparency 10. In the meantime, the honest disclosure may itself induce adverse effects through expectancy mechanisms, i.e., nocebo effects, such as persistent post-surgical pain, contradicting the principle
TE D
of nonmaleficence.
This dilemma can be quite malignant, since it involves a direct causality of harm by the caregiver
EP
that is unparalleled by other potential harmful effects of information disclosure 7. The physician risks creating harm by merely mentioning its potentiality. Moreover, this harm can be
AC C
biologically real and cannot be dismissed as ‘merely psychological’. When the harmfulness of the nocebo effect may outweigh the good in proper disclosure of medical information to the patient, is it ethical to suspend the duty to inform the patient? Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event can actually increase side effects 10.
ACCEPTED MANUSCRIPT
Wells and colleagues advocate that the conflict between the informed consent and nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white “truth”10. They believe informing a patient about side effects is not a mere presentation of
RI PT
“facts” but an important component of the art of medicine and requires the practitioner’s clinical judgment. They have proposed a pragmatic approach for providers to minimize nocebo
responses while still maintaining patient autonomy through “contextualized informed consent,” ,
SC
an ethical procedure in which the disclosed information is tailored in a way that reduces
M AN U
expectancy induced side effects while still respecting patient autonomy and truth-telling 10.
We wonder, if we could better achieve this delicate balance of minimizing nocebo effect, while protecting a patient’s autonomy by integrating a pre-surgical stratification process into the informed consent. We propose that for surgeries which serve as lifesaving or for major
TE D
functional restoration, such as tumor removal, trauma surgical intervention, organ transplant, etc., where postsurgical pain is of less concern comparatively, disclosure of the likelihood of CPSP in a balanced manner may be warranted. However, for surgeries which are solely for the purpose of
EP
pain relief, such as various surgical interventional procedures to treat pain, disclosure of CPSP
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may be given with reservation or probably withheld.
External Funding: None.
ACCEPTED MANUSCRIPT
RI PT
Conflict of Interest: None.
References:
6. 7. 8. 9.
10.
SC
M AN U
5.
TE D
4.
EP
3.
Macrae W. Chronic pain after surgery. British Journal of Anaesthesia. 2001;87(1):88-98. Schug SA, Pogatzki-Zahn EM. Chronic pain after surgery or injury. Pain Clinical Updates. 2011;19(1):1-4. Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. The Lancet. 2006;367(9522):1618-1625. Simanski CJ, Althaus A, Hoederath S, et al. Incidence of chronic postsurgical pain (CPSP) after general surgery. Pain Medicine. 2014;15(7):1222-1229. Johansen A, Schirmer H, Stubhaug A, Nielsen CS. Persistent post-surgical pain and experimental pain sensitivity in the Tromsø study: Comorbid pain matters. PAIN®. 2014;155(2):341-348. Aroori S, Spence RA. Chronic pain after hernia surgery–an informed consent issue. The Ulster medical journal. 2007;76(3):136. Cohen S. The nocebo effect of informed consent. Bioethics. 2014;28(3):147-154. Colloca L, Finniss D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. Jama. 2012;307(6):567-568. Everett CR, Novoseletsky D, Cole S, Frank J, Remillard C, Patel RK. Informed consent in interventional spine procedures: how much do patients understand. Pain Physician. 2005;8(3):251-255. Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. The American Journal of Bioethics. 2012;12(3):22-29.
AC C
1. 2.
S0002-9610(16)30304-X
DOI:
10.1016/j.amjsurg.2016.04.013
Reference:
AJS 11967
To appear in:
The American Journal of Surgery
Received Date: 16 March 2016 Revised Date:
30 March 2016
Accepted Date: 4 April 2016
Please cite this article as: Ruan X, Kaye AD, Disclosure Without or With Reservation? Contemplating the Development of Persistent Post-surgical Pain Due to Nocebo Effect, The American Journal of Surgery (2016), doi: 10.1016/j.amjsurg.2016.04.013. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
RI PT
Disclosure Without or With Reservation? Contemplating the Development of Persistent Post-surgical Pain Due to Nocebo Effect
Xiulu Ruan, MD, Adjunct Clinical Associate Professor of Anesthesia (corresponding author)
M AN U
1542 Tulane Ave. New Orleans, LA 70112
SC
Dept. of Anesthesiology, Louisiana State University Health Science Center
Alan David Kaye, MD, Ph.D., Professor and Chairman of Anesthesia Dept. of Anesthesiology, Louisiana State University Health Science Center
TE D
1542 Tulane Ave. New Orleans, LA 70112
Chronic pain after surgery became recognized as a significant problem in 1992 1. It remained
EP
largely a neglected issue until 2001, when Macrae published a review article in the British Journal of Anesthesia 1.The incidence of chronic pain after major surgery is estimated to lie
AC C
between 20% and 50% 2, and the overall estimated incidence of severely disabling pain after surgery is in the range of 2–10% 3.
Macrae noted that, in a survey of surgical textbooks, the general topic of chronic pain after surgeries, such as mastectomy, thoracotomy or hernia repair, was either mentioned briefly or ignored all together. When one looks at the whole spectrum of the syndromes of chronic pain after surgery, it seems unlikely that the cause of the pain is related to something that the surgeon
ACCEPTED MANUSCRIPT
has done wrong. It seems more likely that this is the inevitable result of surgery in a certain percentage of patients 1.
RI PT
Simanski and colleagues 4 investigated the incidence of chronic postsurgical pain (CPSP) in a general population. They found 14.8% of patients had CPSP, and by surgical discipline, 28% were general, 15% vascular, and 57% trauma/orthopedic surgery. Most often cited pain sites
SC
were joint (49.4%), incisional/scar (37.7%), and nerve pain (33.7%). Further, there was a high CPSP rate after 2 years both generally and particularly in orthopedic/trauma (57%) patients.
M AN U
In a large survey (N=12,981), Johansen et al. 5 found that of the individuals with chronic pain (N=3352), 6.2% indicated surgery as a cause, although only 0.5% indicated surgery as the only cause. They also found that most cases of persistent post-surgical pain are coexistent with other chronic pain.
TE D
In 2007, Aroori and Spence 6 reported that 9% of patients suffered chronic severe pain following inguinal hernia repair. They discussed that all patients undergoing inguinal hernia repair, irrespective of type, should be informed about the risk of severe and chronic groin pain following
EP
a hernia repair. This should be clearly recorded on the consent form 6.
AC C
Nocebo effect occurs when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation 7. Nocebo effects are the direct result of the psychosocial context or therapeutic environment on a patient’s mind, brain, and body, involving multiple factors, such as verbal suggestions and past experience 8. The consideration of nocebo effects in the context of patient-clinician communication and disclosure before surgeries may be valuable in both minimizing the nocebo component of a given therapy and improving surgical outcomes.
ACCEPTED MANUSCRIPT
Informed consent is the process by which a person authorizes medical treatment after discussing with clinicians the nature, indications, benefits, and risks of treatment 9. In the case of any
RI PT
surgical procedure, the likelihood of the development of chronic post-surgical pain should be disclosed, presumably.
SC
The principle of informed consent obligates physicians to explain possible side effects before performing surgeries. One of the primary missions of physicians, dating back to Hippocrates, is
M AN U
the principle of nonmaleficence, Primum non nocere: “Above all do no harm.” At the same time, the pinnacle of modern bioethics is informed consent, respect for person, and transparency 10. In the meantime, the honest disclosure may itself induce adverse effects through expectancy mechanisms, i.e., nocebo effects, such as persistent post-surgical pain, contradicting the principle
TE D
of nonmaleficence.
This dilemma can be quite malignant, since it involves a direct causality of harm by the caregiver
EP
that is unparalleled by other potential harmful effects of information disclosure 7. The physician risks creating harm by merely mentioning its potentiality. Moreover, this harm can be
AC C
biologically real and cannot be dismissed as ‘merely psychological’. When the harmfulness of the nocebo effect may outweigh the good in proper disclosure of medical information to the patient, is it ethical to suspend the duty to inform the patient? Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event can actually increase side effects 10.
ACCEPTED MANUSCRIPT
Wells and colleagues advocate that the conflict between the informed consent and nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white “truth”10. They believe informing a patient about side effects is not a mere presentation of
RI PT
“facts” but an important component of the art of medicine and requires the practitioner’s clinical judgment. They have proposed a pragmatic approach for providers to minimize nocebo
responses while still maintaining patient autonomy through “contextualized informed consent,” ,
SC
an ethical procedure in which the disclosed information is tailored in a way that reduces
M AN U
expectancy induced side effects while still respecting patient autonomy and truth-telling 10.
We wonder, if we could better achieve this delicate balance of minimizing nocebo effect, while protecting a patient’s autonomy by integrating a pre-surgical stratification process into the informed consent. We propose that for surgeries which serve as lifesaving or for major
TE D
functional restoration, such as tumor removal, trauma surgical intervention, organ transplant, etc., where postsurgical pain is of less concern comparatively, disclosure of the likelihood of CPSP in a balanced manner may be warranted. However, for surgeries which are solely for the purpose of
EP
pain relief, such as various surgical interventional procedures to treat pain, disclosure of CPSP
AC C
may be given with reservation or probably withheld.
External Funding: None.
ACCEPTED MANUSCRIPT
RI PT
Conflict of Interest: None.
References:
6. 7. 8. 9.
10.
SC
M AN U
5.
TE D
4.
EP
3.
Macrae W. Chronic pain after surgery. British Journal of Anaesthesia. 2001;87(1):88-98. Schug SA, Pogatzki-Zahn EM. Chronic pain after surgery or injury. Pain Clinical Updates. 2011;19(1):1-4. Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. The Lancet. 2006;367(9522):1618-1625. Simanski CJ, Althaus A, Hoederath S, et al. Incidence of chronic postsurgical pain (CPSP) after general surgery. Pain Medicine. 2014;15(7):1222-1229. Johansen A, Schirmer H, Stubhaug A, Nielsen CS. Persistent post-surgical pain and experimental pain sensitivity in the Tromsø study: Comorbid pain matters. PAIN®. 2014;155(2):341-348. Aroori S, Spence RA. Chronic pain after hernia surgery–an informed consent issue. The Ulster medical journal. 2007;76(3):136. Cohen S. The nocebo effect of informed consent. Bioethics. 2014;28(3):147-154. Colloca L, Finniss D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. Jama. 2012;307(6):567-568. Everett CR, Novoseletsky D, Cole S, Frank J, Remillard C, Patel RK. Informed consent in interventional spine procedures: how much do patients understand. Pain Physician. 2005;8(3):251-255. Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. The American Journal of Bioethics. 2012;12(3):22-29.
AC C
1. 2.