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Uninformed Consent for Children Undergoing Operations

Uninformed Consent for Children Undergoing Operations Abstract Archives of Otolaryngology—Head & Neck Surgery Informed Consent in Pediatric Surgery: Do Parents Understand the Risks? Daniel P. Nadeau, MD; Jeremy N. Rich, MD; Scott E. Brietzke, MD, MPH Objective:  To investigate parental understanding of the risks of pediatric ear, nose, and throat surgery after receiving counseling with and without the use of informational aids. Design:  Prospective, randomized trial. Setting:  Academic tertiary care center. Participants:  Parents of children undergoing ear, nose, and throat surgery. Interventions:  Parents were randomized to receive standard informed consent with or without detailed informational aids. Main Outcome Measures:  Parents completed identical questionnaires testing their general procedure knowledge and their recall of 9 specific surgical risks both immediately after counseling and on the day of surgery. Results:  Thirty-four parents enrolled in and completed the study (18 in the control group and 16 in the test group). The mean time from informed consent to surgery was 6.3 days (range, 1-22 days). Parents in the test group scored significantly higher on identifying the 9 risks on both the preoperative questionnaire (mean score, 6.00 vs 4.44; P = .007, 2-tailed t test) and the postoperative questionnaire (6.25 vs 4.17; P < .001). There was a negative correlation (inverse relationship) between parent education score and risk recall, with parents with lower education levels scoring higher on both the preoperative (Pearson r = –0.36; P = .04) and the postoperative (r = –0.35; P = .04) surveys. The maternal parent recalled risks significantly better than the paternal parent, with surgical risk recall scores of 5.46 out of 9 vs 3.67 out of 9 (P = 2, 2-tailed t test). Conclusions:  Parents of children undergoing ear, nose, and throat surgery recall far less than 100% of counseled risks. The use of detailed surgical risk counseling improves measured parental understanding of surgical risk. Parental educational level and maternal vs paternal parent may affect risk counseling recall. There is virtually universal agreement that patients undergoing operations should be fully informed of the details of the proposed surgical procedures and, especially, the risks associated with those procedures. Ethically, this is easier to reconcile for adults than for children, since parents assess these issues on behalf of their children but do not directly assume the consequences. Since children do not have the legal right to make autonomous decisions regarding proposed surgical procedures, the knowledge bar should be higher for parents making decisions for their children than it would be for parents making equivalent decisions for themselves. In a free society, adults have considerable leeway to decide what they will or will not do. Even behaviors commonly thought of as self-destructive, such as drinking to excess, eating oneself into a state of obesity, or riding motorcycles without wearing a helmet, are tolerated. However, when it comes to caring for children, society demands that a higher degree of responsibility be applied to custodial adults than exists for their own behaviors. Laws enable state agencies to remove children from parents who are not responsibly caring for them. When a parent consents on behalf of his or her child for an operation associated with potential complications, that parent has an extraordinary responsibility to study the procedure, know why it is necessary and, in order to fully protect the child, understand the full range of adverse events and their short- and long-term ramifications. Physicians have an equivalent responsibility to ensure that a child's parents understand these issues. Little is known about how well parents understand the medical details regarding interventions they approve for their children. In an important study recently published in the Archives of Otolaryngology–Head & Neck Surgery, Nadeau and colleagues examined how well parents retain information provided to them about operations to be performed on their children. They studied these data as a function of time and the method by which the information was provided. As expected, when more detailed written information was provided and greater time spent with a family, retention of informed consent information was better. Parents' understanding of their children's operations was about the same before as after the operation. An alarming and disconcerting finding was that no parent could recall all 9 items discussed with him or her before the child's procedure. When provided with a structured interview and written materials, about two-thirds of the information, at best, was retained. Only about 20% of the parents studied were men, who retained a deplorable one-third of the information provided to them. Intriguingly, better retention was achieved by parents with lower levels of education compared with better-educated parents. Perhaps less-educated parents are more cognizant of what they do not know than better-educated ones, causing them to pay more attention, especially when they are called upon to make decisions for the children in their charge. Any physician who has provided informed consent knows this study's results are generalizable to any patient undergoing an intervention. Regardless of how much time we spend and what materials we disseminate in our efforts to educate patients, their retention is poor. We live in an era of unprecedented availability of information. Never before has so much information been so readily available to any person who has access to the Internet. As physicians with an ethical responsibility to educate our patients about their health and the full spectrum of risks and benefits associated with any planned intervention, we need to develop Web-based educational tools that enable our patients to study what we propose to do to them. These tools must extend to all medical care, not just surgery. True informed consent is just as serious an issue for the delivery of nonsurgical medical care. For example, when a patient is diagnosed as having isolated calf deep vein thrombosis and we recommend anticoagulation, do most practitioners fully explain the risks of anticoagulation (such as hemorrhagic stroke, retinal bleeding, or lifestyle limitation associated with the anticoagulated state) and fully explain the benefits of treatment? Considering that the evidence for treating isolated calf deep vein thrombosis is weak and most physicians probably are not aware this is so, I suspect true informed consent is rare in clinical practice. The fix is in the Internet. As Nadeau et al point out, health care providers are time limited in their patient interactions and cannot necessarily deliver sufficient information in the time available for the average encounter. Interventions we propose for patients are very personal and, we can assume, highly important to them. Patients are likely to be willing to spend considerable amounts of time investigating the ramifications of a proposed treatment, especially if substantial risk is involved. Our obligation as physicians is to carefully and objectively evaluate the strength of evidence for the treatments we propose and to post this information on free Web sites. Assuming they have access to the Internet, our patients can visit these sites at their leisure so that they can improve their level of health care knowledge. This information should be accompanied by detailed explanations of the downsides of the proposed treatments, expressed in ways patients can fully understand. These materials will never be free from bias, so equivalent information should be provided by experts with known differing biases. In this way, we can ensure that patients are given the chance to assess multiple opinions about these topics and ultimately decide for themselves what to believe and what course of action they should pursue. The study by Nadeau et al demonstrating poor recall belies a significant problem touched on by a recently published article in JAMA.1 O’Brien et al reported findings of a randomized controlled trial comparing aggressive medical therapy with laparoscopic banding procedures in adolescents. Both groups benefitted from their respective interventions but those undergoing laparoscopic banding operations exhibited substantially more weight loss than those treated with medical therapy. Informed consent for these operations was obtained by an assent document signed by the child but the official consent was derived from the child's parents. Putting this information in the context of Nadeau et al's study showing poor retention by parents of the medical details and risks of operations, how should we view, for instance, a parent's consent for bariatric operations that permanently alter a child's gastrointestinal physiology? This is not a small problem, since childhood obesity has become common and bariatric surgery has been advocated as a solution. Owing to the fact that parents' understanding of the informed consent process is limited, as was demonstrated by Nadeau et al, an argument could be made that aggressive, permanent operations such as gastric bypass should not be used to treat childhood obesity unless the parents show complete understanding of the operation and its long-term consequences. At minimum, standards should be developed for the informed consent process to ensure that parents understand what they are allowing to be done to their children. Given the imperfections of the informed consent process, when less permanent alternative treatments exist, such as laparoscopic banding operations for childhood obesity, they should be the preferred treatment for children. Children are a hardy lot. They can tolerate much, such that some disease entities can be temporized until the children have reached adulthood and can decide for themselves what treatments and risks they are willing to accept. Given Nadeau et al's analysis, unless we can develop processes that ensure that parents fully understand what they are getting their children into, we need to exert caution in recommending treatments, deferring major decisions, if at all possible, until the children become adults. Then they can ride a motorcycle without wearing a helmet or get a gastric bypass—it will be their decision. Back to top Article Information Correspondence: Dr Livingston, Division of Gastrointestinal and Endocrine Surgery, Department of Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Room E7-126, Dallas, TX 75390-9156 (edward.livingston@UTSouthwestern.edu). Financial Disclosure: Dr Livingston reports that in 2008 he received honoraria from Allergan Inc and Bayer AG for attending an advisory board meeting. He reports that he has had no direct or indirect financial relationship with these companies before those meetings and has had none since. Funding/Support: This commentary was supported by Hudson-Penn Endowment Funds, Texas Instruments, and grant 5 PL1 DK081183 from the National Institutes of Health. References 1. O’Brien PESawyer SMLaurie C et al. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA 2010;303 (6) 519- 526PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

Uninformed Consent for Children Undergoing Operations

Archives of Surgery , Volume 145 (8) – Aug 1, 2010

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Publisher
American Medical Association
Copyright
Copyright © 2010 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.2010.133
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Abstract

Abstract Archives of Otolaryngology—Head & Neck Surgery Informed Consent in Pediatric Surgery: Do Parents Understand the Risks? Daniel P. Nadeau, MD; Jeremy N. Rich, MD; Scott E. Brietzke, MD, MPH Objective:  To investigate parental understanding of the risks of pediatric ear, nose, and throat surgery after receiving counseling with and without the use of informational aids. Design:  Prospective, randomized trial. Setting:  Academic tertiary care center. Participants:  Parents of children undergoing ear, nose, and throat surgery. Interventions:  Parents were randomized to receive standard informed consent with or without detailed informational aids. Main Outcome Measures:  Parents completed identical questionnaires testing their general procedure knowledge and their recall of 9 specific surgical risks both immediately after counseling and on the day of surgery. Results:  Thirty-four parents enrolled in and completed the study (18 in the control group and 16 in the test group). The mean time from informed consent to surgery was 6.3 days (range, 1-22 days). Parents in the test group scored significantly higher on identifying the 9 risks on both the preoperative questionnaire (mean score, 6.00 vs 4.44; P = .007, 2-tailed t test) and the postoperative questionnaire (6.25 vs 4.17; P < .001). There was a negative correlation (inverse relationship) between parent education score and risk recall, with parents with lower education levels scoring higher on both the preoperative (Pearson r = –0.36; P = .04) and the postoperative (r = –0.35; P = .04) surveys. The maternal parent recalled risks significantly better than the paternal parent, with surgical risk recall scores of 5.46 out of 9 vs 3.67 out of 9 (P = 2, 2-tailed t test). Conclusions:  Parents of children undergoing ear, nose, and throat surgery recall far less than 100% of counseled risks. The use of detailed surgical risk counseling improves measured parental understanding of surgical risk. Parental educational level and maternal vs paternal parent may affect risk counseling recall. There is virtually universal agreement that patients undergoing operations should be fully informed of the details of the proposed surgical procedures and, especially, the risks associated with those procedures. Ethically, this is easier to reconcile for adults than for children, since parents assess these issues on behalf of their children but do not directly assume the consequences. Since children do not have the legal right to make autonomous decisions regarding proposed surgical procedures, the knowledge bar should be higher for parents making decisions for their children than it would be for parents making equivalent decisions for themselves. In a free society, adults have considerable leeway to decide what they will or will not do. Even behaviors commonly thought of as self-destructive, such as drinking to excess, eating oneself into a state of obesity, or riding motorcycles without wearing a helmet, are tolerated. However, when it comes to caring for children, society demands that a higher degree of responsibility be applied to custodial adults than exists for their own behaviors. Laws enable state agencies to remove children from parents who are not responsibly caring for them. When a parent consents on behalf of his or her child for an operation associated with potential complications, that parent has an extraordinary responsibility to study the procedure, know why it is necessary and, in order to fully protect the child, understand the full range of adverse events and their short- and long-term ramifications. Physicians have an equivalent responsibility to ensure that a child's parents understand these issues. Little is known about how well parents understand the medical details regarding interventions they approve for their children. In an important study recently published in the Archives of Otolaryngology–Head & Neck Surgery, Nadeau and colleagues examined how well parents retain information provided to them about operations to be performed on their children. They studied these data as a function of time and the method by which the information was provided. As expected, when more detailed written information was provided and greater time spent with a family, retention of informed consent information was better. Parents' understanding of their children's operations was about the same before as after the operation. An alarming and disconcerting finding was that no parent could recall all 9 items discussed with him or her before the child's procedure. When provided with a structured interview and written materials, about two-thirds of the information, at best, was retained. Only about 20% of the parents studied were men, who retained a deplorable one-third of the information provided to them. Intriguingly, better retention was achieved by parents with lower levels of education compared with better-educated parents. Perhaps less-educated parents are more cognizant of what they do not know than better-educated ones, causing them to pay more attention, especially when they are called upon to make decisions for the children in their charge. Any physician who has provided informed consent knows this study's results are generalizable to any patient undergoing an intervention. Regardless of how much time we spend and what materials we disseminate in our efforts to educate patients, their retention is poor. We live in an era of unprecedented availability of information. Never before has so much information been so readily available to any person who has access to the Internet. As physicians with an ethical responsibility to educate our patients about their health and the full spectrum of risks and benefits associated with any planned intervention, we need to develop Web-based educational tools that enable our patients to study what we propose to do to them. These tools must extend to all medical care, not just surgery. True informed consent is just as serious an issue for the delivery of nonsurgical medical care. For example, when a patient is diagnosed as having isolated calf deep vein thrombosis and we recommend anticoagulation, do most practitioners fully explain the risks of anticoagulation (such as hemorrhagic stroke, retinal bleeding, or lifestyle limitation associated with the anticoagulated state) and fully explain the benefits of treatment? Considering that the evidence for treating isolated calf deep vein thrombosis is weak and most physicians probably are not aware this is so, I suspect true informed consent is rare in clinical practice. The fix is in the Internet. As Nadeau et al point out, health care providers are time limited in their patient interactions and cannot necessarily deliver sufficient information in the time available for the average encounter. Interventions we propose for patients are very personal and, we can assume, highly important to them. Patients are likely to be willing to spend considerable amounts of time investigating the ramifications of a proposed treatment, especially if substantial risk is involved. Our obligation as physicians is to carefully and objectively evaluate the strength of evidence for the treatments we propose and to post this information on free Web sites. Assuming they have access to the Internet, our patients can visit these sites at their leisure so that they can improve their level of health care knowledge. This information should be accompanied by detailed explanations of the downsides of the proposed treatments, expressed in ways patients can fully understand. These materials will never be free from bias, so equivalent information should be provided by experts with known differing biases. In this way, we can ensure that patients are given the chance to assess multiple opinions about these topics and ultimately decide for themselves what to believe and what course of action they should pursue. The study by Nadeau et al demonstrating poor recall belies a significant problem touched on by a recently published article in JAMA.1 O’Brien et al reported findings of a randomized controlled trial comparing aggressive medical therapy with laparoscopic banding procedures in adolescents. Both groups benefitted from their respective interventions but those undergoing laparoscopic banding operations exhibited substantially more weight loss than those treated with medical therapy. Informed consent for these operations was obtained by an assent document signed by the child but the official consent was derived from the child's parents. Putting this information in the context of Nadeau et al's study showing poor retention by parents of the medical details and risks of operations, how should we view, for instance, a parent's consent for bariatric operations that permanently alter a child's gastrointestinal physiology? This is not a small problem, since childhood obesity has become common and bariatric surgery has been advocated as a solution. Owing to the fact that parents' understanding of the informed consent process is limited, as was demonstrated by Nadeau et al, an argument could be made that aggressive, permanent operations such as gastric bypass should not be used to treat childhood obesity unless the parents show complete understanding of the operation and its long-term consequences. At minimum, standards should be developed for the informed consent process to ensure that parents understand what they are allowing to be done to their children. Given the imperfections of the informed consent process, when less permanent alternative treatments exist, such as laparoscopic banding operations for childhood obesity, they should be the preferred treatment for children. Children are a hardy lot. They can tolerate much, such that some disease entities can be temporized until the children have reached adulthood and can decide for themselves what treatments and risks they are willing to accept. Given Nadeau et al's analysis, unless we can develop processes that ensure that parents fully understand what they are getting their children into, we need to exert caution in recommending treatments, deferring major decisions, if at all possible, until the children become adults. Then they can ride a motorcycle without wearing a helmet or get a gastric bypass—it will be their decision. Back to top Article Information Correspondence: Dr Livingston, Division of Gastrointestinal and Endocrine Surgery, Department of Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Room E7-126, Dallas, TX 75390-9156 (edward.livingston@UTSouthwestern.edu). Financial Disclosure: Dr Livingston reports that in 2008 he received honoraria from Allergan Inc and Bayer AG for attending an advisory board meeting. He reports that he has had no direct or indirect financial relationship with these companies before those meetings and has had none since. Funding/Support: This commentary was supported by Hudson-Penn Endowment Funds, Texas Instruments, and grant 5 PL1 DK081183 from the National Institutes of Health. References 1. O’Brien PESawyer SMLaurie C et al. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA 2010;303 (6) 519- 526PubMedGoogle ScholarCrossref

Journal

Archives of SurgeryAmerican Medical Association

Published: Aug 1, 2010

References