Leading article
Incidental findings in surgery L. Anderson1 , J. Snelling1,2 and A. van Rij3 1 Bioethics Centre, 2 Faculty of Law, and 3 Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand (e-mail: [email protected])
Published online 23 February 2015 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9719
Introduction
Defining an incidental finding
Occasionally during a surgical procedure a surgeon will discover a further condition not anticipated before surgery1 – 3 . With the patient unconscious, the surgeon now holds critical information that was not available at the time consent was obtained. A surgeon must decide whether to treat the incidental finding (IF) or not. The problem arises because, although treating the IF may be in the patient’s best interest, the patient has not consented. Conversely, delaying intervention to seek consent may not be in the patient’s interest. These situations can generate considerable medicolegal challenges for surgeons. Many surgeons will be wary of acting beyond the scope of the initial consent, owing either to a desire to respect patient autonomy, or to concern regarding the potential for legal proceedings if the patient subsequently objects and the intervention is considered contrary to the patient’s interests. There are currently no specific guidelines to assist surgeons dealing with IFs. The authors have developed a tool that uses a traffic-light framework to guide clinical decisionmaking. The framework identifies the common situations where the surgeon should proceed (‘green light’) or not (‘red light’) in the event of an IF. The ‘orange light’ includes situations where the best course of action is more difficult to determine, and careful structured reflection is required. The authors acknowledge that this framework constitutes a recommendation only and has not been tested clinically.
The authors define an IF as an anomaly or condition not anticipated before surgery and not related to the condition being treated. Where a finding could have been anticipated (and is not an IF as defined here), the patient should be briefed before surgery and specific consent obtained for a possible extended procedure. Although extending any surgery ‘beyond that to which there was consent’4 may lead to a claim against the surgeon5 , if a procedure is considered to fall within the overall nature and purpose for which the patient originally consented, the courts have been reluctant to find against the surgeon6,7 .
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
Broad consent clauses
Some institutions have attempted to pre-empt concerns about IFs by using statements within the consent form. Surgeons may overestimate the legal protection offered by such statements. The courts may consider that an overly permissive clause is too vague to provide legal authorization, particularly if the procedure falls outside of the nature and purpose of the original consented surgery7,8 . Any clause addressing IFs within the consent form will require careful drafting to ensure it does not permit the surgeon free licence to carry out any procedure, nor be so constraining that a surgeon is unable to act in the patient’s interests. Such a clause should encourage dialogue between surgeon and patient, not replace it.
Intraoperative decision-making
On discovering an IF, a surgeon has two options: to deal immediately with the IF or not. In making a decision, the authors suggest the surgeon and team use the traffic-light framework (Fig. 1). According to the framework, as soon as an IF is identified the surgeon and team should take time out to: pause and reflect, consider and discuss, progressing through the traffic-light steps to come to a decision. Discussion within theatre to include all viewpoints (including non-surgical) is suggested, and, where necessary, consultation with surgical colleagues outside theatre. This complex decision-making process must happen in the relatively brief time available. Where there is potential for immediate loss of life, limb or other critical function, or in situations where there is express consent from the patient, it is reasonable for the surgeon to expedite the decision by progressing quickly to the green zone. Here the patient’s immediate survival or loss of critical function is of foremost consideration, and as such specific consent to act is not required and is justified under the legal doctrine of necessity. The red zone indicates where the ethical constraints are obvious, or the impact on the patient so great that further consultation with the patient is necessary before proceeding. This includes non-emergency situations where proceeding will result in the loss of reproductive capacity, or any intervention that will significantly extend recovery time, or will BJS 2015; 102: 433–435
434
1
2
L. Anderson, L. Snelling and A. van Rij
On discovery of an IF
Pause and reflect
Proceed to treat an IF
Follow the Lights
Discuss
Unsure whether to treat an IF
Delay do not immediately treat an IF
Proceed with immediate treatment Weigh up and balance the seven factors of the IF where such action is necessary to Proceed Delay 1. preserve the patient’s life, Many/serious-----------implications for patient associated with delay----------------none/trivial limb, or vital functions there is specific consent for 2. treatment of an IF Low---------------------------------added risk of immediate treatment -------------------------------high 3. Strong-------------------evidence of benefit from immediate treatment--------------------------weak 4. High------------------confident immediate treatment fits with patient views-----------------------low 5. Low--------patient burden associated with immediate treatment (e.g. colostomy)-----------high 6. High-----------confident IF treatment falls within available surgeon’s expertise----------------low 7. High--------------------- resource and access implications for the patient------------------------low
Decide Document the decision Inform the patient
3
Fig. 1
DO NOT proceed with immediate treatment of the IF, if this is not an emergency and the treatment results in a loss of reproductive capacity is associated with significant additional risks to the patient has a significant negative impact on the success of the primary surgery constitutes a major change in the patient’s long-term quality of life requires action beyond the scope of practice of the surgeon cannot be justified by evidencebased practice can be dealt with effectively by non-surgical means would not fit with the patient’s views
Incidental finding (IF) response tool
affect critical body functions (such as colostomy). In these situations the risk–benefit calculation has altered to such a degree that to proceed without consent would be unreasonable. However, by far the most difficult are those findings for which genuine uncertainty exists about the best course of action. Such uncertainty will lead the surgeon and team to the orange zone. Each clinical situation will differ. Consider the example of a 55-year-old woman who consents to cholecystectomy. At surgery a large cystic mass on one ovary is found (for which an oophorectomy is indicated to confirm malignancy). A biopsy is possible, but may have associated risks. The woman has a moderate anaesthetic risk. On one hand, the ovarian pathology may not reach the threshold for immediate intervention. However, given her age and circumstances, and remaining ovary, any potential adverse effects resulting from removal are low.
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
A scenario like this is difficult because the threat posed by the IF may be real and significant, but not immediate, whereas the benefits from intervening may be unpredictable or may accrue at a later date. A further operation could be scheduled, but may not be in the patient’s best interest, or expedient. The question for the surgeon is whether to proceed immediately, or postpone to ascertain the patient’s views. Using the traffic-light framework, the authors suggest that the surgical team considers each of the seven factors listed in the orange zone. Each must be considered independently and evaluated on separate sliding analogue scales. The surgical team weighs up each factor, moving towards the green zone if proceeding is more reasonable, or towards the red zone if delay is favoured. The relative weight of each factor will vary with the situation and the particular needs of the
www.bjs.co.uk
patient. Simply adding up the ‘scores’ is not appropriate. The final decision is determined by the global weighing up of this matrix with an outcome that is either red (delay) or green (proceed). After the operation, the framework presupposes documenting the IF, including the rationale for acting (or not), and prompt disclosure to the patient. Conclusion
The occurrence of an IF in the midst of an operation constitutes a significant clinical, ethical and legal challenge. There will be times when surgeons will be genuinely unsure about the right course of action. The use of this tool is premised upon having a good surgeon–patient relationship, and prior knowledge of the patient’s social situation and views. Good preoperative interaction is imperative and, where feasible, the BJS 2015; 102: 433–435
Incidental findings in surgery
potential for IFs should be addressed during the consent process and guidance sought from the patient. Surgeons should not be left isolated in such situations, but supported through a process that promotes sound clinical, legal and ethical decisions. Ultimately, demonstration of a robust, reflective process that includes conscious deliberation and consultation before decision-making is likely to be more favourably received by patients and those subsequently reviewing the decision. Acknowledgements
The authors acknowledge the contributions of N. Pickering, G. Gillett, N. Peart and P. D. G. Skegg to this article.
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
435
Disclosure: The authors declare no conflict of interest. References 1 Gordon P, Nivatvongs S, Smith L. Unexpected intraoperative findings. In Principles and Practice of Surgery for the Colon, Rectum, and Anus. Informa Healthcare: New York, 2007; 1191–1202. 2 Hall J, Stein S. Unexpected intra-operative findings. Surg Clin North Am 2013; 93: 45–59. 3 Timofeev J, Galgano MT, Stoler MH, Lahance JA, Modesitt SC, Jazaeri AA. Appendiceal pathology at the time of oophorectomy for ovarian neoplasms. Obstet Gynecol 2010; 116: 1348–1353. 4 Reibl v Hughes (1980) 2 SCR 880, 890–891.
www.bjs.co.uk
5 O’Connell v Gelb (1988) OJ No 1129. 6 Cowan v Brushett (1990) 69 DLR (4th) 743 [17]; Pridham v Nash (1986) 33 DLR (4th) 304. 7 Snelling J, Anderson L, van Rij A. ‘Incidental findings’ during surgery: a surgical dilemma or the price paid for autonomy? Otago Law Review 2013; 81–106. 8 Hope T, Hope R, Savulescu J, Hendrick J. Medical Ethics and Law: the Core Curriculum (2nd edn). Churchill Livingstone Elsevier: Philadelphia, 2008.
BJS 2015; 102: 433–435
Incidental findings in surgery L. Anderson1 , J. Snelling1,2 and A. van Rij3 1 Bioethics Centre, 2 Faculty of Law, and 3 Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand (e-mail: [email protected])
Published online 23 February 2015 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9719
Introduction
Defining an incidental finding
Occasionally during a surgical procedure a surgeon will discover a further condition not anticipated before surgery1 – 3 . With the patient unconscious, the surgeon now holds critical information that was not available at the time consent was obtained. A surgeon must decide whether to treat the incidental finding (IF) or not. The problem arises because, although treating the IF may be in the patient’s best interest, the patient has not consented. Conversely, delaying intervention to seek consent may not be in the patient’s interest. These situations can generate considerable medicolegal challenges for surgeons. Many surgeons will be wary of acting beyond the scope of the initial consent, owing either to a desire to respect patient autonomy, or to concern regarding the potential for legal proceedings if the patient subsequently objects and the intervention is considered contrary to the patient’s interests. There are currently no specific guidelines to assist surgeons dealing with IFs. The authors have developed a tool that uses a traffic-light framework to guide clinical decisionmaking. The framework identifies the common situations where the surgeon should proceed (‘green light’) or not (‘red light’) in the event of an IF. The ‘orange light’ includes situations where the best course of action is more difficult to determine, and careful structured reflection is required. The authors acknowledge that this framework constitutes a recommendation only and has not been tested clinically.
The authors define an IF as an anomaly or condition not anticipated before surgery and not related to the condition being treated. Where a finding could have been anticipated (and is not an IF as defined here), the patient should be briefed before surgery and specific consent obtained for a possible extended procedure. Although extending any surgery ‘beyond that to which there was consent’4 may lead to a claim against the surgeon5 , if a procedure is considered to fall within the overall nature and purpose for which the patient originally consented, the courts have been reluctant to find against the surgeon6,7 .
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
Broad consent clauses
Some institutions have attempted to pre-empt concerns about IFs by using statements within the consent form. Surgeons may overestimate the legal protection offered by such statements. The courts may consider that an overly permissive clause is too vague to provide legal authorization, particularly if the procedure falls outside of the nature and purpose of the original consented surgery7,8 . Any clause addressing IFs within the consent form will require careful drafting to ensure it does not permit the surgeon free licence to carry out any procedure, nor be so constraining that a surgeon is unable to act in the patient’s interests. Such a clause should encourage dialogue between surgeon and patient, not replace it.
Intraoperative decision-making
On discovering an IF, a surgeon has two options: to deal immediately with the IF or not. In making a decision, the authors suggest the surgeon and team use the traffic-light framework (Fig. 1). According to the framework, as soon as an IF is identified the surgeon and team should take time out to: pause and reflect, consider and discuss, progressing through the traffic-light steps to come to a decision. Discussion within theatre to include all viewpoints (including non-surgical) is suggested, and, where necessary, consultation with surgical colleagues outside theatre. This complex decision-making process must happen in the relatively brief time available. Where there is potential for immediate loss of life, limb or other critical function, or in situations where there is express consent from the patient, it is reasonable for the surgeon to expedite the decision by progressing quickly to the green zone. Here the patient’s immediate survival or loss of critical function is of foremost consideration, and as such specific consent to act is not required and is justified under the legal doctrine of necessity. The red zone indicates where the ethical constraints are obvious, or the impact on the patient so great that further consultation with the patient is necessary before proceeding. This includes non-emergency situations where proceeding will result in the loss of reproductive capacity, or any intervention that will significantly extend recovery time, or will BJS 2015; 102: 433–435
434
1
2
L. Anderson, L. Snelling and A. van Rij
On discovery of an IF
Pause and reflect
Proceed to treat an IF
Follow the Lights
Discuss
Unsure whether to treat an IF
Delay do not immediately treat an IF
Proceed with immediate treatment Weigh up and balance the seven factors of the IF where such action is necessary to Proceed Delay 1. preserve the patient’s life, Many/serious-----------implications for patient associated with delay----------------none/trivial limb, or vital functions there is specific consent for 2. treatment of an IF Low---------------------------------added risk of immediate treatment -------------------------------high 3. Strong-------------------evidence of benefit from immediate treatment--------------------------weak 4. High------------------confident immediate treatment fits with patient views-----------------------low 5. Low--------patient burden associated with immediate treatment (e.g. colostomy)-----------high 6. High-----------confident IF treatment falls within available surgeon’s expertise----------------low 7. High--------------------- resource and access implications for the patient------------------------low
Decide Document the decision Inform the patient
3
Fig. 1
DO NOT proceed with immediate treatment of the IF, if this is not an emergency and the treatment results in a loss of reproductive capacity is associated with significant additional risks to the patient has a significant negative impact on the success of the primary surgery constitutes a major change in the patient’s long-term quality of life requires action beyond the scope of practice of the surgeon cannot be justified by evidencebased practice can be dealt with effectively by non-surgical means would not fit with the patient’s views
Incidental finding (IF) response tool
affect critical body functions (such as colostomy). In these situations the risk–benefit calculation has altered to such a degree that to proceed without consent would be unreasonable. However, by far the most difficult are those findings for which genuine uncertainty exists about the best course of action. Such uncertainty will lead the surgeon and team to the orange zone. Each clinical situation will differ. Consider the example of a 55-year-old woman who consents to cholecystectomy. At surgery a large cystic mass on one ovary is found (for which an oophorectomy is indicated to confirm malignancy). A biopsy is possible, but may have associated risks. The woman has a moderate anaesthetic risk. On one hand, the ovarian pathology may not reach the threshold for immediate intervention. However, given her age and circumstances, and remaining ovary, any potential adverse effects resulting from removal are low.
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
A scenario like this is difficult because the threat posed by the IF may be real and significant, but not immediate, whereas the benefits from intervening may be unpredictable or may accrue at a later date. A further operation could be scheduled, but may not be in the patient’s best interest, or expedient. The question for the surgeon is whether to proceed immediately, or postpone to ascertain the patient’s views. Using the traffic-light framework, the authors suggest that the surgical team considers each of the seven factors listed in the orange zone. Each must be considered independently and evaluated on separate sliding analogue scales. The surgical team weighs up each factor, moving towards the green zone if proceeding is more reasonable, or towards the red zone if delay is favoured. The relative weight of each factor will vary with the situation and the particular needs of the
www.bjs.co.uk
patient. Simply adding up the ‘scores’ is not appropriate. The final decision is determined by the global weighing up of this matrix with an outcome that is either red (delay) or green (proceed). After the operation, the framework presupposes documenting the IF, including the rationale for acting (or not), and prompt disclosure to the patient. Conclusion
The occurrence of an IF in the midst of an operation constitutes a significant clinical, ethical and legal challenge. There will be times when surgeons will be genuinely unsure about the right course of action. The use of this tool is premised upon having a good surgeon–patient relationship, and prior knowledge of the patient’s social situation and views. Good preoperative interaction is imperative and, where feasible, the BJS 2015; 102: 433–435
Incidental findings in surgery
potential for IFs should be addressed during the consent process and guidance sought from the patient. Surgeons should not be left isolated in such situations, but supported through a process that promotes sound clinical, legal and ethical decisions. Ultimately, demonstration of a robust, reflective process that includes conscious deliberation and consultation before decision-making is likely to be more favourably received by patients and those subsequently reviewing the decision. Acknowledgements
The authors acknowledge the contributions of N. Pickering, G. Gillett, N. Peart and P. D. G. Skegg to this article.
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
435
Disclosure: The authors declare no conflict of interest. References 1 Gordon P, Nivatvongs S, Smith L. Unexpected intraoperative findings. In Principles and Practice of Surgery for the Colon, Rectum, and Anus. Informa Healthcare: New York, 2007; 1191–1202. 2 Hall J, Stein S. Unexpected intra-operative findings. Surg Clin North Am 2013; 93: 45–59. 3 Timofeev J, Galgano MT, Stoler MH, Lahance JA, Modesitt SC, Jazaeri AA. Appendiceal pathology at the time of oophorectomy for ovarian neoplasms. Obstet Gynecol 2010; 116: 1348–1353. 4 Reibl v Hughes (1980) 2 SCR 880, 890–891.
www.bjs.co.uk
5 O’Connell v Gelb (1988) OJ No 1129. 6 Cowan v Brushett (1990) 69 DLR (4th) 743 [17]; Pridham v Nash (1986) 33 DLR (4th) 304. 7 Snelling J, Anderson L, van Rij A. ‘Incidental findings’ during surgery: a surgical dilemma or the price paid for autonomy? Otago Law Review 2013; 81–106. 8 Hope T, Hope R, Savulescu J, Hendrick J. Medical Ethics and Law: the Core Curriculum (2nd edn). Churchill Livingstone Elsevier: Philadelphia, 2008.
BJS 2015; 102: 433–435
![[Incidental findings in internal medicine].](/assets/img/hold.png)
