PEDIATRICS Vol. 108 No. 5 November 2001, pp. 1080-1088

Treatment of Febrile Seizures: The Influence of Treatment Efficacy and Side-Effect Profile on Value to Parents

Kevin E. Gordon, MD, MS^*, , Joseph M. Dooley, MB^*, , Peter R. Camfield, MD^*, , Carol S. Camfield, MD^*, , and Judith MacSween, RN^*

From the ^* IWK Health Center,  Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.

	ABSTRACT

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Objectives.  We examined parents' perception of the value of treatments designed to reduce the risk of febrile seizure recurrence.

Study Design.  The families of 42 children with febrile seizures were recruited after pediatric or neuropediatric consultation. A mail questionnaire addressed the family's willingness to pay for a hypothetical treatment for febrile seizures with risk reductions for future febrile seizures of 25%, 50%, 75%, and 100%. The hypothetical clinical scenario was then modified to include the side- effect profiles of either daily phenobarbital or valproic acid, or intermittent diazepam prophylaxis. Covariates included the nature of the child's febrile seizure(s), parents' familiarity with febrile seizures, experiences at the time of febrile seizures or with medication side effects, education and income, and mastery and trait anxiety.

Results.  Thirty-eight parents, representing 22 of 42 families, completed questionnaires. There was a dramatic inflection in parents' willingness to pay for 100% risk reduction as opposed to 75% or lower risk reductions. Introduction of side effects dramatically reduced the value attached to each level of treatment benefit. Nevertheless, a few parents (3/38) would pay "as much as it takes" to be rid of their child's recurrence risk.

Conclusions.  Given the range of value assigned to prophylactic medication for febrile seizures, management strategies for children with febrile seizures must be responsive to the needs and values of individual families.  Key words:  febrile seizures, treatment, willingness to pay, parent attitudes, shared decision-making.

Febrile seizures are emotionally traumatic for parents, as many parents think that their child is dying during the seizure.^1-4 Families may subsequently report persistent fear of fevers and of febrile seizures⁴ with associated altered parental behavior and disruption of family routines.^3-6

Parents and physicians should be reassured by the benign prognosis of febrile seizures. Although 3% to 4% of children have at least 1 febrile seizure,⁷ death caused by a febrile seizure has not been reported. Similarly, the risk of epilepsy is low (2%-4%).⁸ Intelligence and behavior of children with febrile seizures is the same as their unaffected siblings.^9,10

We were interested in parents' perception of the value of treatments designed to reduce the risk of febrile seizure recurrence. We hypothesized that parents of children with febrile seizures who had been seen in consultation by either a pediatrician or pediatric neurologist would be relatively uninterested (low value) in an ideal (free of side effects) prophylactic medication until the efficacy of that medication equaled or exceeded 75%, and that the introduction of side effects would further reduce the perceived value.

We chose a "willingness-to-pay" model for the measurement of health benefits as seen by parents of children who have had febrile seizures. This model takes into account subjective or intangible values associated with health benefit.¹¹

For this study, we used the Popperian philosophy of falsification,¹² where the test of a scientific position is an attempt to refute it, with the finding of one genuine counter-instance serving as a falsification of the original position. To this end, the selected population was not a representative one, but one which might be enriched in individuals who would value the treatment of febrile seizures. In selecting this population, we recognized the risk of being unable to use inferential statistics in providing population-based point estimates.

  Your child has had a febrile seizure and was recently seen by a pediatrician or pediatric neurologist. Your child was examined and you were counseled about febrile seizures.

We would like to find out how you feel about several potential drug treatments in order to prevent recurrent febrile seizures.

In each of the questions that follows we ask about potential medications that prevent febrile seizures. Each medication reduces the chance of recurrent febrile seizures by a variable amount.

For the purposes of these questions, we would ask you to respond as if your child had a 40% (or 4 in 10) chance of having a recurrent febrile seizure, even if you have been told otherwise.

19.  Trait anxiety using the State-Trait Anxiety Inventory.¹³

20.  Who filled out this survey? (Circle number)
1  Mother
2  Father
3  Other    Specify 
21.  How much time does it take to drive from your home to the nearest emergency room/emergency care centre? (Circle number)
1  Less than 5 minutes
2  5 to 10 minutes
3  10 to 20 minutes
4  20 to 30 minutes
5  More than 30 minutes
22.  What is your highest completed schooling? (Circle number)
1  No formal education
2  Some grade school
3  Completed grade school
4  Some high school
5  Completed high school
6  Graduate education diploma (GED)
7  Some college
8  Completed college
23.  What is your combined family income? (Circle number)
1  Under $20,000
2  $20,000-$39,999
3  $40,000-$59,999
4  $60,000-$79,999
5  $80,000-$99,999
6  Over $100,000
24.  What is your current occupation? (Circle number)
1  At home
2  Unemployed
3  Employed    Specify 
Thank you very much for your time and effort. Please return your completed questionnaire in the enclosed envelope.

	MATERIALS

Study Design

Families of children with febrile seizures were recruited after pediatric or neuropediatric consultation for their child with febrile seizures. Families lived in many communities within eastern Canada. An introductory letter was provided and consent to be contacted by the study nurse was obtained by the consultant physician. After confirming the families' interest in participating in this study, a mail questionnaire was forwarded and completed >4 weeks after the initial consultation.

The questionnaire addressed the family's willingness to pay for a hypothetical treatment for febrile seizures with relative risk reductions for future febrile seizures of 25%, 50%, 75%, and 100%. For each alternative, parents assigned a Canadian dollar value. For the purposes of the study, parents were asked to consider the recurrence risk for future febrile seizures as "40% (or 4/10)," even if they had been otherwise informed. The parents were then asked to answer a series of questions about a hypothetical drug to prevent febrile seizure recurrences (Fig 1). Initially, the medication was presented without side effects and then was modified to include the side effect profiles of daily phenobarbital, then intermittent diazepam prophylaxis, and then daily valproic acid. The presented side-effect profiles were as follows: phenobarbital: irritability and personality change 10% to 20%, sleep disturbance 10% to 20%, and some degree of reduced concentration and memory in most children; valproate: stomach upset 10%, exceedingly rare reports of death (estimated as 1 in 10 000); intermittent diazepam: unsteadiness 30%, lethargy 30%, irritability 25%. The drugs were not named, but the type of preparation and dosing intervals were provided.

View larger version (24K): [in this window] [in a new window]   Fig. 1.   Willingness-to-pay question.

Additional information sought in the questionnaire included the following: the nature of the child's febrile seizure(s), familiarity with febrile seizures, experiences at the time of febrile seizures or with medication side effects, education, and income. We also assessed trait anxiety using the State-Trait Anxiety Inventory¹³ and mastery.¹⁴ The only information requested about the initial consultation was an estimate of the recurrence risk that had been provided by the consultant. Febrile seizures were considered atypical if they had been prolonged (>15 minutes), recurrent (within 24 hours), or focal.

Statistical Analysis

Data manipulation and processing was performed using Epi Info version 6.04b (Centers for Disease Control and Prevention, Atlanta, GA)¹⁵ and Systat version 7.0 (SPSS Inc, Chicago, IL).¹⁶ For 2 parent families, the correlation between parent's answers was modest (r_s = 0.255); as a result, all questionnaires were considered independently. The willingness-to-pay data were presented graphically along with nonparametric summary statistics. For the hypothetical drug with no side effects and 100% risk reduction, 3 parents replied "as much as it takes" or "anything"; for these parents $250 was entered, as this amount exceeded all other answers. To determine whether the willingness to pay for treatment benefit was associated with any potentially predictive factors, parents were arbitrarily divided into 2 equal groupsthose unwilling to pay for a 75% reduction in seizure risk, and those willing to do so.

The Research Ethics Board of the IWK Health Center approved this study.

	RESULTS

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Questionnaires were received from 22 of 42 initially enrolled families.

There were 16 two-parent families and 6 single parent families (all female), comprising 38 questionnaires from 22 mothers and 16 fathers. Most (15/22) had been seen outside our health center. The children had a median age of 22 months (range: 10-40 months), with 14/22 experiencing 2 or more febrile seizures, and 15/22 having atypical febrile seizures. The last seizure was at least 4 weeks previously for 20/22, whereas 18 children had experienced a febrile seizure within the past 6 months. Two families had rectal benzodiazepine available for administration at the time of a febrile seizure. Data were missing for 4/38 willingness-to-pay question sequences and from 5/38 for family income. The responses were otherwise virtually complete.

For a hypothetical prophylactic treatment without side effects (Fig 2), 11/34 parents would pay for a 25% reduction, 16/34 for a 50% reduction, 17/34 for a 75% reduction, and 28/34 for a 100% reduction. The interquartile dollar ranges for reported willingness to pay for various risk reductions was as follows: 25%: $0-20/month, 50%: $0-25/month, 75%: $0-30/month, and 100%: $25-100/month. There was a dramatic inflection in parents' willingness to pay for 100% risk reduction as opposed to 75% or lower risk reductions. Three parents from 2 families were prepared to pay "as much as it takes" or "anything" to obtain no risk of seizure recurrence.

View larger version (22K): [in this window] [in a new window]   Fig. 2.   Symmetric dot density of value assigned (in Canadian dollars) to a hypothetical prophylactic drug without side effects for febrile seizures for various risk reductions. The number in brackets at the baseline is the number answering $0.

Introduction of side effects dramatically reduced the value attached to each level of treatment benefit, with most parents electing not to value reductions in seizure recurrence risk in the face of the side effect profiles of daily phenobarbital, intermittent diazepam, and daily valproate (Fig 3). Only 7 parents were willing to assign any value for treatment benefit in the face of potential side effects, assigning low values (<$50). The only exception was 1 parent who valued intermittent diazepam at $200 but only if it was associated with 100% risk reduction. For the remaining 6 parents, 1 parent valued all 3 medications, 4 valued both daily phenobarbital and intermittent diazepam, and 1 valued daily valproate only.

View larger version (20K): [in this window] [in a new window]   Fig. 3.   Symmetric dot density of value assigned to a hypothetical prophylactic drug for febrile seizures, but with the side effects of daily phenobarbital (circles), intermittent diazepam (diamonds), and daily valproic acid (triangles) for various risk reductions. Each symbol represents 1 parent's response. The remaining parents assigned a $0 value in the context of potential adverse effects.

Two factors discriminated parents willing to pay for 75% seizure risk reductions from those unwilling to pay. Parents who had worried that their child might die during a seizure were more likely to be willing to pay for this level of treatment benefit (P = .04, Fisher exact test). All parents who were willing to pay reported this fear, whereas 12/17 unwilling to pay had similar concerns. Parents of children whose febrile seizures were atypical were much more likely to pay for a 75% or greater seizure risk reduction (odds ratio = 11.2, 95% confidence interval: 1.2, 105, P = .02, Fisher exact test). Virtually all children of parents willing to pay had experienced an atypical febrile seizure (16/17). Familiarity with febrile seizures through a known family history, experiences with medication side effects, parental education and income, and parental mastery and trait anxiety did not discriminate between these 2 groups.

	DISCUSSION

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We were able to show that parents of children with febrile seizures who had been seen in consultation by either a pediatrician or pediatric neurologist more highly valued side-effect-free prophylaxis for recurrent febrile seizures when the efficacy equaled or exceeded 75%. The values assigned to the treatment were considerably reduced once side effects were introduced. Not surprisingly, parents who had reported ever having worried that their child might die during a seizure were more likely to place higher values on treatment, as were parents of children with atypical febrile seizures. A few parents were willing to pay "as much as it takes" to avoid a recurrent febrile seizure.

Parents understood the theoretical construct that the assigned numbers of dollars reflects the perceived relative value of the associated therapy. Only 4 of 38 parents did not complete the willingness-to-pay questions. All answers from the other parents showed a nonlinear increase in perceived value as the magnitude of the treatment benefit increased, with a subsequent fall in value after the introduction of side effects. Shuper et al¹⁷ found that about half of their parents preferred that their children with febrile seizures be treated, provided that the treatment was free of side effects. We assessed parent's views more than a month after a pediatric or neuropediatric consultation for febrile seizures, with the hope of accurately reflecting the parents' views rather than the opinions of their physicians.

Referral bias for children with febrile seizures has been demonstrated¹⁸ and is evident within our population as nearly 70% had previously had atypical febrile seizures. Furthermore, as our response rate is low, there has been additional self-selection of our respondents. A review of abstract reported response rates to mail-out willingness-to-pay questionnaires in the past 5 years shows a mean response rate of 48% (range: 34%-69%),^19-22 suggesting that our response rate is not unusual for this study design. Although educational programs for parents^23,24 have been demonstrated to significantly improve information about febrile seizures and their prognosis,²⁵ they had more limited impact on parental anxiety and fears.^4,26 This is consistent with our findings that familiarity with febrile seizures did not influence parental responses. It is therefore difficult to ascertain what impact a consultation with a specialist has on parents of children with febrile seizures.

By finding 3 parents from 2 families who highly value the treatment of febrile seizures, we can refute the position that all parents are uninterested in the treatment of febrile seizures after pediatric or neuropediatric consultation. Although Popper¹² provides the philosophy necessary for this conclusion to be drawn, the selection involved in our population of respondents does not allow any estimation of the prevalence of parents such as these within the general population of parents of children with febrile seizures.

Currently, there are strongly held beliefs both for^27,28 and against^29,30 the use of prophylactic medication for febrile seizures. The recent practice parameter of the American Academy of Pediatrics has recommended against either continuous or intermittent anticonvulsant therapy for children with 1 or more simple febrile seizures.³¹ Ultimately, recommendations for such treatment hinge on the issue of prevention of parental anxiety and family disruption, among other issues.^32,33 One of the most cited reasons for physicians initiating medication management is parental anxiety.^34,35 Despite this, no trials have demonstrated that anxiety is reduced by pharmaceutical intervention, or whether such an intervention may be trading the fear of febrile seizures for the fear of medication side effects.

The strict application of clinical practice guidelines enforces a "one size fits all" philosophy, and ignores the needs of individual patients and families. Appropriate therapy should address family preferences, values, and expectations within a shared decision-making environment. The decision to institute anticonvulsant therapy after a febrile seizure ultimately rests with the parents.³⁶

After either pediatric or neuropediatric consultation for their children with febrile seizures, most parents are either not interested in preventative therapies, or are interested in therapies that are more efficacious and have fewer potential adverse effects than currently available options. Despite this, there are a few parents who would pay "as much as it takes" to avoid a recurrent febrile seizure. There may be a role for prophylactic medication for their children when its use has been shown to be of benefit to these families. Treatment of children with febrile seizures must be tailored to the needs of individual families.

From the Section of Pediatric Neurology

that a new drug to prevent febrile seizures has recently been introduced. This drug does not have any side effects. It is available both as syrup and pills, which have to be taken twice daily. Unfortunately, it is not covered by any drug plan that you may have.

Knowing all that you do about febrile seizures, how much would you be willing to pay (each month) for this medication:

If, while taking the medication, the chance of a recurrent seizure is: 3 in 10?      $ 
2 in 10?      $ 
1 in 10?      $ 
No chance      $ 

that a new drug to prevent febrile seizures has recently been introduced. Its side effects include irritability and personality change in 10-20% of children who take it, sleep disturbance in 10-20%, and some degree of reduced concentration and memory in most children. It is available both as syrup and pills, which have to be taken once daily. Unfortunately, it is not covered by any drug plan that you may have.

Knowing all that you do about febrile seizures, how much would you be willing to pay (each month) for this medication:

If, while taking the medication, the chance of a recurrent seizure is: 3 in 10?      $ 
2 in 10?      $ 
1 in 10?      $ 
No chance      $ 

that a new drug to prevent febrile seizures has recently been introduced. Its side effects include unsteadiness in 30% of children who take it, lethargy in 30%, and irritability in 25%. It is available as pills, which only have to be taken every 8 hours during fever, until the fever has cleared for 24 hours. Unfortunately, it is not covered by any drug plan that you may have.

Knowing all that you do about febrile seizures, how much would you be willing to pay (each month) for this medication:

If, while taking the medication, the chance of a recurrent seizure is: 3 in 10?      $ 
2 in 10?      $ 
1 in 10?      $ 
No chance      $ 

that a new drug to prevent febrile seizures has recently been introduced. Its side effects include stomach upset in 10% of children who take it. There have been some rare reports of death related to taking this medication but these are exceedingly rare (estimated as 1 in 10,000). It is available both as syrup and pills, which have to be taken twice daily. Unfortunately, it is not covered by any drug plan that you may have.

Knowing all that you do about febrile seizures, how much would you be willing to pay (each month) for this medication:

If, while taking the medication, the chance of a recurrent seizure is: 3 in 10?      $ 
2 in 10?      $ 
1 in 10?      $ 
No chance      $ 

Now we would like to ask you to give us some information about your child and his/her febrile seizures. This is so that we can examine your answers to the previous questions more thoroughly.  1.  How many febrile seizures has your child had? (Circle number) 1  One
2  Two
3  Three-five
4  Six-ten
5  Over ten
 2.  Have you seen your child having a febrile seizure? (Circle number)
1  No
2  Yes
 3.  Have any of your child's seizures lasted longer than 15 minutes? (Circle number)
1  No
2  Yes
 4.  Have any of your child's seizures involved just one side of his/her body? (Circle number)
1  No
2  Yes
 5.  Has your child ever had 2 or more seizures within 24 hours? (Circle number)
1  No
2  Yes
 6.  When was your child's last seizure? (Circle number)
1  Less than 2 weeks ago
2  2-4 weeks ago
3  5-8 weeks ago
4  3-4 months ago
5  4-6 months ago
6  7-12 months ago
7  Over 12 months ago
 7.  What chances were you given that your child would have another febrile seizure? (Circle number)
 1  Never (0%)
 2  About 1 in 10 (10%)
 3  About 2 in 10 (20%)
 4  About 3 in 10 (30%)
 5  About 4 in 10 (40%)
 6  About 5 in 10 (50%)
 7  About 6 in 10 (60%)
 8  About 7 in 10 (70%)
 9  About 8 in 10 (80%)
10  There will be more (100%)
11  Unsure
 8.  Is there anyone else in your family who has had febrile seizures? (Circle number)
1  No
2  Yes, child's brother or sister
3  Yes, child's father or mother
4  Yes, other relative
5  I don't know
 9.  Is there anyone else in your family who has or has had seizures? (Circle number)
1  No
2  Yes, child's brother or sister
3  Yes, child's father or mother
4  Yes, other relative
5  I don't know
10.  At the present time, is your child receiving medication to prevent febrile seizures? (Circle number)
1  No  if no, go to Question 11
2  Yes
At the present time, what medication is your child receiving? (Circle number(s))
1.  Phenobarbital
2.  Valium (Diazepam), rectally with seizure
3.  Valium (Diazepam), by mouth with fever
4.  Ativan (Lorazepam), rectally with seizure
5.  Ativan SL (Lorazepam), by mouth with seizure
6.  Depakene, Epival (Valproic acid)
7.  Other, please specify 
11.  What is your child's date of birth? (Fill in)
 /  / 
DayMonthYear 12.  Compared with other children the same age, do you consider your child to be: (Circle number)
1  Average or brighter than average
2  Slower than average

Because the original series of questions concerned medication use, next we would like to examine some issues about prescription medications within your home. 13.  Has anyone within your family experienced any serious side effects after taking prescribed medications? (Circle number)
1  No
2  Yes
14.  Are the costs of your family's medication needs covered to some degree by a drug plan or social assistance/disability)? (Circle number)
1  No
2  Yes
3  Partially

Because febrile seizures are very anxiety-provoking, we would like to ask you a series of questions that deal with anxiety because of febrile seizures, and your underlying level of anxiety. 15.  Do your child's febrile seizures frighten you? (Circle number)
1  No
2  Yes
3  Sometimes
16.  Does the possibility that your child might have a febrile seizure frighten you more than an actual seizure? (Circle number)
1  No
2  Yes 17.  Have you ever worried that your child might die during a seizure? (Circle number)
1  No
2  Yes
18.  The next set of statements describe how people sometimes feel about their lives. How strongly do you agree or disagree that:

Strongly Agree Agree Disagree Strongly Disagree There is really no way I can solve some of the problems I have Sometimes I feel that I'm being pushed around in life I have little control over things that happen to me I can do almost anything I set my mind to I often feel helpless in dealing with the problems of life What happens to me in the future mostly depends on me There is little I can do to change many of the important things in my life

	APPENDIX

	FOOTNOTES

Received for publication Nov 21, 2000; accepted Apr 18, 2001.

Address correspondence to Kevin E. Gordon, MD, MS, Department of Pediatrics, IWK Health Center, Box 3070, Halifax, Nova Scotia, Canada B3J 3G9. E-mail: kegor{at}is.dal.ca

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