Making clinical decisions when the stakes are high and the evidence unclear
http://www.100md.com
《英国医生杂志》
1 School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW 2052, Australia, 2 Department of Allergy, Immunology and Infectious Diseases, Children's Hospital at Westmead, Sydney, NSW 2145, Australia, 3 Centre for Values, Ethics and the Law in Medicine, University of Sydney, NSW 2006, Australia
Correspondence to: W Hu, Department of Allergy, Immunology and Infectious Diseases, Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145, Australia wendy.hu@unsw.edu.au
Children with peanut allergy are often provided with adrenaline (epinephrine) in case of a severe reaction. The probability of a life threatening reaction is low, however, and the criteria for provision are controversial. How should the costs and benefits be balanced?
Case study 1
Jarred is 23 months old and attended the same clinic. At 9 months of age, peanut butter touched his face and he developed local urticaria and lip and periorbital swelling without respiratory or systemic symptoms. His parents took him to the local hospital, where he was placed on cardiorespiratory monitors and given two adrenaline injections. He was then seen by a paediatric allergist, who prescribed an adrenaline autoinjector. Since then he has avoided peanuts and has not had further reactions. Peanuts have been removed from the household and the family's diet. After Jarred's enrolment, the childcare centre he attends two days a week completely banned peanuts, nuts, and any foods labelled "may contain nuts."
At this consultation, skin prick tests showed a 9 mm reaction to peanut. Jarred's parents were advised that he should continue to avoid peanuts. Although his mother was informed that the risk of death was extremely low, she wished to continue Jarred's autoinjector prescription: "My biggest fear is that he could be having a reaction and he can't tell us... the autoinjector allows me to feel more in control... it's a safety net so I'm not totally helpless."
Mild reaction to peanut
Credit: P MARAZZI/SPL
The issues
Peanuts are a commonly eaten food and often included in processed and pre-prepared foods. The prevalence of peanut allergy is rising and was estimated at 1.5% in a recent child population study.1 Peanuts have been identified as the most common precipitant for deaths from food induced anaphylaxis in the United Kingdom,2 although not in children under 13 years of age.3 Currently, there is no effective immunotherapeutic or medical treatment, so management strategies rely on avoidance of food allergens and emergency treatment of severe reactions. Analyses of fatal cases have suggested that deaths may be prevented with early administration of adrenaline,2 leading to calls for adrenaline autoinjectors to be widely available to children with food allergies and their carers.4 Although this response seems rational and empirically sound, it camouflages persisting medical, scientific, and ethical uncertainties.5 w2
Medical uncertainties
Although families and the public may wish to hear that there is no risk of childhood anaphylaxis or other feared outcomes such as adverse reactions to measles vaccine, it is not possible to prove a zero risk conclusively.w8 A single case report of fatal anaphylaxis to nut in a 2 year old is sufficient to say that a risk exists.10 Although the probability of death from anaphylaxis in young children is very low, uncertainty about degrees of risk and scientific disagreement over appropriate responses heightens public perceptions of danger.w9
Various sources, including friends and family, mass media, and lobby groups, and the way messages are conveyed can also modify how risks are interpreted.w10 Jarred's emergency treatment at the local hospital is likely to have influenced his parents' perception of the risk of severe reactions. Public perceptions of the risk of childhood anaphylaxis are also increased by the difficulty of controlling exposure to food, the unpredictability of fatal outcomes, and the catastrophic and unjust nature of child deaths. Our reactions reflect fundamental beliefs about societal obligations to protect the vulnerable, and parental responsibilities to nurture and ensure the safety of their children.11 Thus, risk is not a value neutral probability but a socially mediated sense of threat to a cherished section of society. As one prominent UK allergist has stated, "There may be no such thing as a definitely low risk peanut allergic child."w6
Is it better to be safe than sorry?
Childhood peanut allergy presents the possibility of a rare but feared outcome without clear evidence to guide management choices. As a result, a range of clinical decisions could be justified. In such cases, the best response for doctors could be to engage families in a process of negotiation that acknowledges uncertainties, invites and considers all relevant viewpoints, and examines their basis non-judgmentally. Acknowledging uncertainty does not mean that doctors should constantly equivocate; patients may interpret this as meaning "there is nothing to be done" or that "it is simply a matter of chance." When giving advice, doctors might consider the likely effect of different recommendations, possible costs and harms from various interventions, and the values of both the family and the broader community. They should be prepared to explain their reasoning, while recognising that parents and children may value options differently. Whatever is decided, providing information and support, and responding sensitively to parental anxiety remains essential.
This approach to the doctor-patient relationship implies commitment, trust, and open communication. If the preferences of patients and doctors are to be taken into account, practices are likely to vary between individual cases. Doctors may have to accept that in a pluralistic world, there will be varying trade-offs between effective, equitable, or cost efficient goals and between the interests of particular families and of greater society. In situations of uncertainty, clinicians can feel burdened by a perceived need to reconcile competing or incommensurable interests. Beyond finding pragmatic solutions within the clinical setting, the whole responsibility for resolving these interests cannot be shouldered by individual doctors but should be shared by all stakeholders.
This article is part of an occasional series, edited by Michael Parker (michael.parker@ethox.ox.ac.uk) and Julian Savulescu, analysing ethical issues that confront health professionals in daily practice
References w1-12 are on bmj.com
We thank the parents of Dylan and Jarred for contributing their stories to this article.
Contributors and sources: All authors conceived and planned the article, critically reviewed drafts, and approved the final version. WH wrote the first draft, which arose from her research on the handling of risk and uncertainty in clinical and policy decision making, as applied to food anaphylaxis in children. WH wrote the stories using the parents' words. She is the guarantor.
WH was supported by grants from the Australian Allergy Foundation and the National Health and Medical Research Council of Australia ID297112.
Competing interests: AK's superannuation fund owns shares in Commonwealth Serum Laboratories, which distributes adrenaline autoinjectors (EpiPens) in Australia.
References
Grundy J, Matthews S, Bateman B, Dean T, Arshad SH. Rising prevalence of allergy to peanut in children: data from 2 sequential cohorts. J Allergy Clin Immunol 2002;110: 784-9.
Pumphrey RS. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy 2000;30: 1144-50.
Macdougall CF, Cant AJ, Colver AF. How dangerous is food allergy in childhood? The incidence of severe and fatal allergic reactions across the UK and Ireland. Arch Dis Child 2002;86: 236-9.
Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med 1992;327: 380-4.
Warner JO. How dangerous is food allergy in childhood? Pediatr Allergy Immunol 2002;13: 149-50.
Sampson H. Peanut allergy. N Engl J Med 2002;346: 1294-9.
Kemp A. EpiPen epidemic: suggestions for rational prescribing in childhood food allergy. J Pediatr Child Health 2003;39: 372-5.
Clark AT, Ewan PW. Food allergy in childhood: have the dangers been underestimated? Arch Dis Child 2003;88: 79-81.
Gold MS, Sainsbury R. First aid anaphylaxis management in children who were prescribed an epinephrine autoinjector device (EpiPen). J Allergy Clin Immunol 2000;106: 171-6.
Bock SA, Munoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol 2001;107: 191-3.
Jonsen A, Siegler M, Winslade W. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 5th ed. New York: McGraw-Hill, 2002.
Bennett P, Calman K, eds. Risk communication and public health. Oxford: Oxford University Press, 1999.
Munoz-Furlong A. Daily coping strategies for patients and their families. Pediatrics 2003;111: 1654-61.
Avery NJ, King RM, Knight S, Hourihane J O'B. Assessment of quality of life in children with peanut allergy. Pediatr Allergy Immunol 2003;14: 378-82.(Wendy Hu, conjoint lectur)
Correspondence to: W Hu, Department of Allergy, Immunology and Infectious Diseases, Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145, Australia wendy.hu@unsw.edu.au
Children with peanut allergy are often provided with adrenaline (epinephrine) in case of a severe reaction. The probability of a life threatening reaction is low, however, and the criteria for provision are controversial. How should the costs and benefits be balanced?
Case study 1
Jarred is 23 months old and attended the same clinic. At 9 months of age, peanut butter touched his face and he developed local urticaria and lip and periorbital swelling without respiratory or systemic symptoms. His parents took him to the local hospital, where he was placed on cardiorespiratory monitors and given two adrenaline injections. He was then seen by a paediatric allergist, who prescribed an adrenaline autoinjector. Since then he has avoided peanuts and has not had further reactions. Peanuts have been removed from the household and the family's diet. After Jarred's enrolment, the childcare centre he attends two days a week completely banned peanuts, nuts, and any foods labelled "may contain nuts."
At this consultation, skin prick tests showed a 9 mm reaction to peanut. Jarred's parents were advised that he should continue to avoid peanuts. Although his mother was informed that the risk of death was extremely low, she wished to continue Jarred's autoinjector prescription: "My biggest fear is that he could be having a reaction and he can't tell us... the autoinjector allows me to feel more in control... it's a safety net so I'm not totally helpless."
Mild reaction to peanut
Credit: P MARAZZI/SPL
The issues
Peanuts are a commonly eaten food and often included in processed and pre-prepared foods. The prevalence of peanut allergy is rising and was estimated at 1.5% in a recent child population study.1 Peanuts have been identified as the most common precipitant for deaths from food induced anaphylaxis in the United Kingdom,2 although not in children under 13 years of age.3 Currently, there is no effective immunotherapeutic or medical treatment, so management strategies rely on avoidance of food allergens and emergency treatment of severe reactions. Analyses of fatal cases have suggested that deaths may be prevented with early administration of adrenaline,2 leading to calls for adrenaline autoinjectors to be widely available to children with food allergies and their carers.4 Although this response seems rational and empirically sound, it camouflages persisting medical, scientific, and ethical uncertainties.5 w2
Medical uncertainties
Although families and the public may wish to hear that there is no risk of childhood anaphylaxis or other feared outcomes such as adverse reactions to measles vaccine, it is not possible to prove a zero risk conclusively.w8 A single case report of fatal anaphylaxis to nut in a 2 year old is sufficient to say that a risk exists.10 Although the probability of death from anaphylaxis in young children is very low, uncertainty about degrees of risk and scientific disagreement over appropriate responses heightens public perceptions of danger.w9
Various sources, including friends and family, mass media, and lobby groups, and the way messages are conveyed can also modify how risks are interpreted.w10 Jarred's emergency treatment at the local hospital is likely to have influenced his parents' perception of the risk of severe reactions. Public perceptions of the risk of childhood anaphylaxis are also increased by the difficulty of controlling exposure to food, the unpredictability of fatal outcomes, and the catastrophic and unjust nature of child deaths. Our reactions reflect fundamental beliefs about societal obligations to protect the vulnerable, and parental responsibilities to nurture and ensure the safety of their children.11 Thus, risk is not a value neutral probability but a socially mediated sense of threat to a cherished section of society. As one prominent UK allergist has stated, "There may be no such thing as a definitely low risk peanut allergic child."w6
Is it better to be safe than sorry?
Childhood peanut allergy presents the possibility of a rare but feared outcome without clear evidence to guide management choices. As a result, a range of clinical decisions could be justified. In such cases, the best response for doctors could be to engage families in a process of negotiation that acknowledges uncertainties, invites and considers all relevant viewpoints, and examines their basis non-judgmentally. Acknowledging uncertainty does not mean that doctors should constantly equivocate; patients may interpret this as meaning "there is nothing to be done" or that "it is simply a matter of chance." When giving advice, doctors might consider the likely effect of different recommendations, possible costs and harms from various interventions, and the values of both the family and the broader community. They should be prepared to explain their reasoning, while recognising that parents and children may value options differently. Whatever is decided, providing information and support, and responding sensitively to parental anxiety remains essential.
This approach to the doctor-patient relationship implies commitment, trust, and open communication. If the preferences of patients and doctors are to be taken into account, practices are likely to vary between individual cases. Doctors may have to accept that in a pluralistic world, there will be varying trade-offs between effective, equitable, or cost efficient goals and between the interests of particular families and of greater society. In situations of uncertainty, clinicians can feel burdened by a perceived need to reconcile competing or incommensurable interests. Beyond finding pragmatic solutions within the clinical setting, the whole responsibility for resolving these interests cannot be shouldered by individual doctors but should be shared by all stakeholders.
This article is part of an occasional series, edited by Michael Parker (michael.parker@ethox.ox.ac.uk) and Julian Savulescu, analysing ethical issues that confront health professionals in daily practice
References w1-12 are on bmj.com
We thank the parents of Dylan and Jarred for contributing their stories to this article.
Contributors and sources: All authors conceived and planned the article, critically reviewed drafts, and approved the final version. WH wrote the first draft, which arose from her research on the handling of risk and uncertainty in clinical and policy decision making, as applied to food anaphylaxis in children. WH wrote the stories using the parents' words. She is the guarantor.
WH was supported by grants from the Australian Allergy Foundation and the National Health and Medical Research Council of Australia ID297112.
Competing interests: AK's superannuation fund owns shares in Commonwealth Serum Laboratories, which distributes adrenaline autoinjectors (EpiPens) in Australia.
References
Grundy J, Matthews S, Bateman B, Dean T, Arshad SH. Rising prevalence of allergy to peanut in children: data from 2 sequential cohorts. J Allergy Clin Immunol 2002;110: 784-9.
Pumphrey RS. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy 2000;30: 1144-50.
Macdougall CF, Cant AJ, Colver AF. How dangerous is food allergy in childhood? The incidence of severe and fatal allergic reactions across the UK and Ireland. Arch Dis Child 2002;86: 236-9.
Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med 1992;327: 380-4.
Warner JO. How dangerous is food allergy in childhood? Pediatr Allergy Immunol 2002;13: 149-50.
Sampson H. Peanut allergy. N Engl J Med 2002;346: 1294-9.
Kemp A. EpiPen epidemic: suggestions for rational prescribing in childhood food allergy. J Pediatr Child Health 2003;39: 372-5.
Clark AT, Ewan PW. Food allergy in childhood: have the dangers been underestimated? Arch Dis Child 2003;88: 79-81.
Gold MS, Sainsbury R. First aid anaphylaxis management in children who were prescribed an epinephrine autoinjector device (EpiPen). J Allergy Clin Immunol 2000;106: 171-6.
Bock SA, Munoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol 2001;107: 191-3.
Jonsen A, Siegler M, Winslade W. Clinical ethics: a practical approach to ethical decisions in clinical medicine. 5th ed. New York: McGraw-Hill, 2002.
Bennett P, Calman K, eds. Risk communication and public health. Oxford: Oxford University Press, 1999.
Munoz-Furlong A. Daily coping strategies for patients and their families. Pediatrics 2003;111: 1654-61.
Avery NJ, King RM, Knight S, Hourihane J O'B. Assessment of quality of life in children with peanut allergy. Pediatr Allergy Immunol 2003;14: 378-82.(Wendy Hu, conjoint lectur)