A Decision Analysis Approach to the Swine Influenza Vaccination Decision for an Individual Author(s): David L.

Zalkind and Richard H. Shachtman Source: Medical Care, Vol. 18, No. 1 (Jan., 1980), pp. 59-72 Published by: Lippincott Williams & Wilkins Stable URL: http://www.jstor.org/stable/3764381 Accessed: 26/07/2009 04:37
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MEDICAL CARE January 1980, Vol. XVIII, No. 1

A Decision Analysis Approach to the Swine Influenza Vaccination Decision for an Individual

DAVID L. ZALKIND* AND RICHARD H. SHACHTMANf

We present a method to analyze the decision by an individual whether to receive the swine influenza (A/New Jersey) vaccine, including an approach for health care personnel to use in informing an individual about the personal costs, benefits and probabilities, as well as indicated choices of actions, associated with such decisions. This analysis is a prototype for cases where informed consent requirements have prompted increased patient involvement in personal medical decisions. Probabilities and personally assessed values that affect the decision are: reaction to the injection, attack rates, vaccine efficacy, chances for an epidemic and concomitant probabilities of contracting influenza, and mortality. We specify a preference ordering for consequences of receiving the vaccine. The analysis yields a preference ordering for possible actions because relative values reflecting preferences are compared on a fixed consistent scale. The solution exhibited, determined in the fall of 1976, indicates conditions when selection of the action to receive the vaccine is automatic. In cases where the decision is not automatic, an individual needs additional information about the personal value of death (life), relative to other possible outcomes. We previously have developed a noneconomic approach to the determination of the value of death15 and the results, briefly described in this paper, are used to construct a decision region for the choice of receiving the vaccine that depends on both the probability of an epidemic and the value of death. Surprisingly, inclusion of information about the Guillain-Barre syndrome does not necessarily alter the decision to receive the vaccine, even though recognition of the increased incidence of the syndrome caused by the vaccine caused cancellation of the federal program. THE FEDERALLY-SPONSORED swine influenza vaccination campaign that was un* Faculty Fellow, Office of Assistant Secretary for

Planningand Evaluation,U.S. Departmentof Health, Education,and Welfare,Washington,D. C. and Duke University, Durham, North Carolina. i Associate Professor,Director of SENIC Project, in Departmentof Biostatisticsand Curriculum Operations Research and Systems Analysis, University of North Carolina,Chapel Hill, North Carolina. This project was partially supported by Grant # HS-01971-2fromthe NationalCenter for Health Services Research, Health Resources Administration, and Contract# 200-77-0705,Center for Disease Control, Atlanta,Georgia.

expectedly and abruptly aborted highlights the current ethical and legal problems attendant to informed consent by medical patients. There is a need for mechanisms that provide patients with the information and tools to be active decision makers in the medical care process. Decision analysis provides a systematic framework for rational decision making that can be utilized by knowledgeable health care personnel to inform a patient about potential consequences of medical actions, and that can be used with the patient's own values to help make a decision
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that is best for him. In other words, individuals can use the tool of decision analysis, perhaps under the guidance of specially trained health technicians, to educate themselves to make more rational decisions in the face of hard data, soft data, nonexistent data and personal preferences. Equally important, public health analysts can use decision analysis to help determine whether advice about what actions individuals should take is rational from the viewpoint of each individual being advised to take the action. Such an understanding may be of use in devising both one-on-one and mass media educational efforts for preventive health measures. There are at least four different viewpoints for the decision, or four different decisions. The first is the federal government decision of whether to have such a program and, if so, who should fund it. Schoenbaum et al.10 have discussed the first part of this decision from an economic viewpoint. The second is that of a local health administrator who must decide how to pay for the program. We do not consider these problems here. A health professional who must advise individuals whether or not to receive the vaccine has a third viewpoint. The individuals who would receive the vaccine has the fourth viewpoint. For the latter two viewpoints, certain parameters characterizing the individual's values for consequences and probabilities for outcomes may affect the decision. Factors to take into consideration include the probability of an epidemic, reaction to receiving the vaccine, etc. Thus, this article proposes a rational procedure for an individual to follow in deciding whether to obtain a swine influenza vaccination. Many Americans made this decision during the fall of 1976 and similar decisions will be made year after year as new or altered viral to cause national strains threaten epidemics,j for which acceptance of the vaccine is not mandated by law.
t As this is being written, the upcoming example appears to be the "Russian Influenza" (A/USSR).

The methodology developed here can be used in several contexts. First, with the aid of an easy-to-use computer package or programmable calculator, a patient in conjunction with medical personnel can use informed consent to its fullest extent. Second, the systematic approach to problem solving inherent in decision analysis makes it an excellent tool for training of health care personnel. We will not review the use of decision analysis in medical care here. The interested reader can find an extensive bibliography in Albert.1 An example of a typical application in the literature is that of Plisken and Beck 7describing how a physician and a patient incorporate some of their subjective feelings and value judgments in a decision analysis model used to determine the treatment of endstage renal failure. An individual is faced with a choicereceive the vaccine, or decline to receive the vaccine. In large part, the consequence of such a choice depends on whether the individual in question is exposed to swine influenza virus, or is never exposed to swine influenza virus. In the terminology of classical statistics, one might say that receiving the vaccine and not being exposed to the virus is a Type I error and that not receiving the vaccine and being exposed to the virus is a Type II error. Although classical statistics develops tradeoffs between probabilities of committing Type I and Type II errors, the methodology of decision analysis, described in this paper, goes further, because it allows the individual decision maker to incorporate his own values (and probabilities) for the potential consequences of his actions and the true state of nature that is unknown at the time the decision is made. For example, at the time the immunization decision is made, the individual does not know whether he will be exposed to the virus. Furthermore, this technique provides the opportunity for the decision maker to explore the sensitivity of his decision to alternative probability estimates and value assessments.

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SWINE FLU VACCINE DECISION

The A/New Jersey? virus is antigenicallyt' similar to both the swine influenza virus and the virus assumed to cause the pandemic# of 1918, for which the death toll was 20 million. Public health officials mounted the swine influenza program because, like the A/Japan ("Asian") influenza of 1957, the A/New Jersey virus represented a radically different strain from recently prevalent strains, and excess mortality during the A/Japan pandemic was the highest of all influenza epidemics in the past 20 years. Also, there was a theory that the next epidemic would come from a swine influenza type virus. We structure the decision tree and indicate parameters for individuals in any age/ sex cohort within the age range 20 to 45. Some of the probabilities used are for the authors' cohort of healthy males in their early thirties. Similar calculations may be made for other age/sex cohorts. We construct the tree in Section 1 and derive probabilities and scale values in Sections 2 and 3, respectively. At the end of Section 3, we enumerate conditions under which the individual can make the vaccination decision without specifying a personal value of death. In Section 4, we report the results of a method we have developed for determining the value of death (or life) to the individual in this context and show how this method may be used to complete the decision. We represent the decision regions graphically. Because the possibility of contracting the Guillain-Barre syndrome was not widely known by the public at the time individual decisions were made to receive the vaccine, we did not include this possi? Hattwicket al.3 contains a description of standardized nomenclature for describing influenza viruses. "An antigen is any substance capable of inducing antibody formation and of reacting specifically in some detectable manner with the antibodies so induced. # A pandemic is a majorepidemic due to a single virus type which sweeps aroundthe world in a short period of time and causes marked increases in mortality.

bility in the main part of the analysis. However, public health officials now recognize that an outbreak of Guillain-Barre syndrome cases might occur with any mass viral immunization program. In Section 5, we modify the decision tree to take the Guillain-Barre syndrome into account. Thus, in the future, a person can include this possible consequence when making a decision. 1. The Basic Decision Tree When the government decided to provide swine influenza vaccine injections to the public free of charge, individuals were faced with the decision of whether to receive it. Although the authors are not experts on swine influenza, we show in this paper how the methodology known as decision analysis can be used as an aid in making the decision. In the age group we consider, it was the belief of experts at the Center for Disease Control (CDC), that the vaccine would be efficacious for at least 1 year and perhaps as long as 2 or 3 years. This period is also a function of the change in the strain of virus to which the individuals are susceptible. Thus it is realistic to fix a 1-year time period for the decision.? The basic data for the decision will be those available in October 1976, when individuals were deciding whether to receive the vaccine. The problem has four basic components: 1. The decision by an individual of whether to receive the vaccine. 2. Values**and probabilities associated with having a reaction to the injection. 3. Value and probabilities associated with contractingswine influenza. 4. Values and probabilities associated with dying as a directresultof having swine influenza.

? The potential additionalbenefit of added protection fromgetting additionalvaccinationin subsequent years is not considered in our analysis because of the 1-yeartime horizon. ** Relative values will be determined on a fixed scale in Section 3.

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.0075

.02

.9925

FIG. 1. Decision tree for individual decision to receive swine influenza shot with probabilities, assuming the epidemic probability is 0.1.

.025

NO SHOT

.975

The decision problem is represented in the decision tree of Figure 1. The square, called the decision node, represents the human decision of whether or not to receive the vaccine. The circles, called the chance nodes, represent chance events (nature's decisions). There are nine different consequences represented in the tree, labeled "A" through "I." For example, "A" represents the human choice to receive the vaccine, followed by a reaction to the vaccine, followed by contracting swine influenza, followed by dying as a direct result of swine influenza. Consequence "B" is the same as "A" except that the decision maker does not die as a result of getting swine influenza (a rather important differ62

ence). Note that consequence "B" does not preclude the possibility of the decision maker dying from something else during the upcoming year. Similarly, we can see that consequence "C" involves taking the vaccine and not getting swine influenza; thus we do not have to consider dying as a result of getting swine influenza. We interpret the other consequences in a similar manner. In order to analyze the decision tree we must assign probabilities to the branches emanating from each chance node (the circles representing nature's decisions) and assign a personal value to each consequence. These are explained in Section 3. The methodology of decision analysis pre-

Vol. XVIII, No. 1 scribes that we make the choice of Shot (receiving the vaccine) versus No Shot (not receiving the vaccine) that yields the highest expected value. t f We use information available from CDC to determine some of the appropriate probabilities and values. When "objective" probabilities and values are unavailable, decision analysis relies on the use of subjective or personal judgments of the decision maker. Of course, the decision maker may wish to rely heavily on "expert" opinion. The probabilities and values we use were valid as of October 1976 for healthy males in their early thirties. t We assume that only the monovalent shot (providing protection against one strain of influenza} is available to us. 2. Probabilities Although as many as 50 per cent of vaccine recipients might get sore arms, the swine influenza vaccination field trials indicated that only slightly more than 2 per cent of those getting the vaccine would suffer some other kind of side effect. These additional reactions might include fever, headache or malaise ranging from mild to severe, usually lasting no longer than one day. Moreover, any type of foreign protein injected, ingested or inhaled into the body could produce an anaphylactic?? reaction which could be dangerous, even fatal. However, prior to the vaccination program, experts believed the chances of death from anaphylaxis would be quite small; in fact,
ff For our purposes, expected value is the same as weighted average. The weights are calculated from the probabilities we assign to potential consequences. The quantities to be "averaged" are the scale values we will assign to the consequences. t t It is straightforward to substitute values for individuals in other groups. Any conclusions drawn are only for individuals not allergic to eggs, with no current respiratory problems or other current medical contraindications. We do not consider the problem for ages younger than 25 or older than 45, although the approach would be the same. ?? Anaphylaxis is an exaggerated reaction of an organism to a foreign protein or other substance to which it has previously become sensitized.

SWINE FLU VACCINE DECISION

CDC was unaware of any such case occurring during the field trials or program through October 1976. (See, however, Section 5 for a discussion of the effect of the Guillain-Barre syndrome.) In this paper we use 0.02 for the probability of a reaction for our cohort. The probability of suffering from influenza is, of course, dependent on whether an individual receives the vaccine. Other factors affecting this probability are the probability of an epidemic and the attack rate for our cohort if there is an epidemic. A typical expert estimate for an epidemic, as of August 1976, was 0.1.6 Using the information in Schoenbaum et al.,10 as well as CDC expert opinion, the assumption is made that if there is an epidemic the attack rate will be 25 per cent for those not protected from the disease. That is, if an individual does not receive the vaccine and there is an epidemic, he has a 0.25 probability of contracting influenza. If there is no epidemic, the probability of contracting swine influenza is assumed to be negligible. Thus, if the individual does not receive the vaccine, the probability of his contracting influenza is the probability of an epidemic times the attack rate: (0.1) (0.25) = 0.025. (Later in the article we will consider a range of values for the probability of an epidemic, since as of late October 1976, the lack of new cases caused most individuals to estimate a much lower probability of an epidemic occurring. We analyze the decision using a range of epidemic probability from 0.01 to 0.1.) We assume, based on expert advice, the vaccine has 70 per cent efficacy for the cohort under consideration. That is, if an individual chooses to get the shot, the probability of his contracting influenza is reduced by a factor of 0.7. Thus, assuming that an epidemic occurs with probability 0.1, if he takes the shot his probability of contracting swine influenza is (0.3) (0.025) = 0.0075. Our assumptions also rely on expert judgment that there is no significant 63

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chance of death from the shot itself, and that a reaction to the shot will not affect its efficacy; see, however, Section 5. We next assess the probability of dying from swine influenza. If the individual does not get the shot and eventually contracts influenza, expert opinion is that the probability of dying is about 0.0005 for our cohort (which is between 0.004 for the 1918-19 pandemic and 0.00014 for the 1968 "Hong Kong" influenza). Experts believe the shot will reduce the severity of a case if contracted and will reduce the probability of dying from influenza by about 70 per cent. Hence, the probability that an individual dies from influenza, given that he received the vaccine but contracts it anyway, is 0.00015. (It is straightforward to test the sensitivity of our decision to this assumption.) The probabilities discussed above appear on the tree in Figure 1 for an epidemic probability of 0.1. Values The consequences of the decision tree of Figure 1 naturally cluster in three groups according to relative "value" to the individual. These clusters are: no influenza (consequences C, F and I), influenza but not death from it (consequences B, E and H) and death from influenza (consequences A, D and G). A reasonable preference ordering for the consequences that do not involve death is, from best to worst, I, F, C, E, H, B. For purposes of computathese consetion and interpretation quences will be assigned values from 0.0 to 1.0. In the first group assign a value of 1.0 to I, since it is the best consequence. Assign (somewhat arbitrarily) slightly lower personal values for F and C, namely 0.98 and 0.90 respectively."" (Because the decision
1Itl has been suggested that we are ignoring a moral It .obligation to contribute to "herd immunity" by gettingthe shot and shouldn't rate consequence I as high. Also, we are not taking potential medical care costs or lost personal income into account in our analysis here. For our current purposes, we are just considering our attitudes about our own health and mortality. These other factors can be taken into account.

will be found to be sensitive to the value assigned to F, and F may plausibly have a value as high as I, i.e. 1.0, we will subsequently solve the decision tree using values for F from 0.98 to 1.0.) In the second group of consequences, we believe B should be assigned the value 0.0 since it is the worst consequence. For the other consequences in this group we decided that values of 0.2 and 0.1 for E and H, respectively, would be appropriatefor the authorsas decision makers. This judgment is based on the supposition, supported by expert opinion, that even though the shot would not prevent us from contracting influenza, it would enable us to have a milder case than we would have had otherwise. We tested the sensitivity of our decision to ranges aroundthe above values of E and H and found that the decision is relatively insensitive to changes of these values. In the third group, the consequences involve dying during the upcoming year as a result of contracting swine influenza. As we have discussed,15we assume it is not consequential to differentiate values among them and so assign a value of -X to each of the consequences A, D and G. The value -X is a large negative number reflecting the individual's value of death and is a point on a scale which includes the values for consequence I (assigned a value of 1.0) and consequence B (assigned a value of 0.0). The decision tree now looks like Figure 2. The (conditional) probabilities in the righthand column are calculated by multiplying the probabilities along the path leading to each consequence. For example, the probability of consequence A, given that an individual gets the shot, is written as P(A/shot)and is calculated as: P(A/Shot) = P(Reaction/Shot)
x P(Influenza/Shot, Reaction) x P(Death/Shot, Reaction, Influenza)

= (0.02) (0.0075) (0.00015) =
0.0000000225 = 2.25 x 10-8.

Vol. XVIII, No. 1

SWINE FLU VACCINE DECISION
Consequence ,Qwell?i FnO II E0.00I Value -X Probability 2.250 x 10'8 1.500 x 10'4

-

C

0.90

1.985 x 10'2

AIFLUE

D

-x

1.103 x 10-6

FltQIATIFL E0.20

7.349 x 10'3

FIG. 2. Swine influenza decision tree with probabilities and values, asthe epidemic suming probability is 0.1.

F 0.98

9.727 x 101

DEAT -X FROM FLUH INFLUENZA ;K'ASf IglU 0.10

1.250 x 10'5 2.4" x 10-2

I

1.00

9.750 x 1'1

At this point decision analysis calls for evaluating the tree by the method known as "averaging out and folding back."8'11'13 E(S) and E(NS) denote the expected values associated with getting the shot and with not getting the shot, respectively. Assuming an epidemic probability of 0.1, these values are: E(S) = (-X) (2.25 x 10-8) + (.0) (1.5 x 10-4) + (0.9) (1.985 x 10-2) + (-X) (1.103 x 10-6) + (0.2) (7.349 x 10-3) + (0.98) (0.97265) = (1.125 x 10-6) (-X) + 0.97253 and E(NS) = (-X)(1.25 x 10-5) + (0.1) (2.496
x 10-2) + (1.0) (0.975) = (1.25 x 10-5)(-X) + 0.9775.

This is equivalent to (1.25 x 10-6)(-X) + 0.97253 > (1.25 x 10-5)(-X) + 0.9775, which reduces to approximately X > 437. Thus the decision depends on the numerical value a person assigns to X. Before further specification of X, we point out two possible conclusions not requiring specification of X: 1) If the value 1.0 was assigned to consequence F, the expected value of getting
the shot is E(S) = 1.125 x 10-6 (-X) +

0.99198 and the expected value of not getting the shot is E(NS) = 1.25 x 10-5(-X) + 0.9775. For all negative values of -X, E(S) > E(NS) and the individual should decide to get the shot, since the expected value for this action is always greater than that for not getting the shot.## There are other
## E(S) > E(NS) if and only if 1.1375 x 10-5(X) 3 (0.9775 - 0.99198). But the right hand side of the last inequality is negative and admissible values of X are non-negative. Hence the inequality is true for any admissible value assigned to X.

A rational decision maker would choose to receive the vaccine if and only if E(S) is greater than (or, perhaps, equal to) E(NS).

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0.995

0.990

0.985

e= Prob(Epidemic) r = Prob(Reoction) f =V(F) =Value assigned to consequence F

abilities of dying from swine influenza, depending on whether or not the shot is taken. Thus, one can see that receiving the vaccine reduces the (subjective) probability of dying from the swine influenza from about 12.5 out of a million to slightly more than one out of a million. (Naturally, these figures would be altered if we had used different probabilities in the decision tree.) Some decision makers may wish to stop at this point. They may feel that consideration of the relative probabilities of death is sufficient for making the decision (with other potential consequences taken into account in some "intuitive" manner). However, we believe that a more thorough analysis including a personal estimation of the value of X should be carried out. 4. Personal Value of Death (or Life) We have presented15 the derivation of a personal value of life relative to other values in the swine influenza vaccination decision tree (see Figure 2) using the tree structure presented here. A brief description of the approach used follows. Using a simplifying assumption, the derived value of X depends on only two parameters-s, the probability of death for the cohort under investigation during the upcoming year in the absence of a swine influenza epidemic, and p, a fractional reduction of s, more fully described below. Given these two parameters, the value of X is derived as
X = (1/s - l)/p = (1 - s)/ps.

0.980

0 .02 .04 .06 .08 .10 .12 .14 .16 FIG. 3. Decision regions for automatic choice of receiving the vaccine (not requiring specification of value of death).

values of F for which this conclusion also holds. Figure 3 shows regions of values for F and for the personal probability of having a reaction (possibly different from 0.021?) where the choice of the shot does not depend on X. These regions are bounded by lines that depend on the subjective probability estimate for an epidemic actually occurring during the coming year. Using the notation e = probability of an epidemic, r = probability of a reaction and f = value assigned to consequence F, the decision is automatic for any pair of values (r, f) falling in a shaded region above the curve corresponding to a given epidemic probability, e. If the individual's values do not fall into one of these automatic decision regions, he should continue the analysis. 2) One can observe that the sum of the coefficients of -X in the expressions for E(S) and E(NS), respectively, are the probT? Some individuals assess their personal probability of a reaction, r, to be much higher than the field trials indicated.

Note that X does not depend on any consequence values or other probabilities used in the original tree (i.e. reaction, epidemic, attack rate, efficacy of vaccine or dying from swine influenza). Values of s are available from the National Center for Health Statistics12 for most cohorts which would be analyzed, since s is an overall probability of dying during the upcoming year, assuming no special risk such as contraction of swine influenza.

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Vol. XVIII, No. 1 Death from s - t Take TA

SWINE FLU VACCINE DECISION

ing year

with reaction to TA

1 - s +

Life, upcomingyear
r

with reaction to TA

s / Don't Take TA

with no reaction to TA

1 - s

Life, upcomingyear
--

with no reaction to TA
FIG. 4.

Decision tree used to derive the reduction probabilityt.

Briefly, the death rate reduction factor p is derived in the following way: Let t = ps, so that s - t = s(l - p) is the (reduced) probability of dying resulting from using a special therapeutic agent (TA) which enhances one's chances of living during the coming year. However, TA also has a negative effect: taking it will definitely make one temporarily ill with the same reaction as one might get from the swine influenza shot, including any immediate reaction such as a temporary malaise plus an illness with symptoms that mimic swine influenza symptoms. The interpretation oft is that it is a decrement in the probability of death that is sufficient to induce one to take a TA. This situation is represented by the decision tree in Figure 4. Each individual decision maker must find a probability decrement t sufficiently large so that he is indifferent between tak-

ing TA and not taking TA. If t = 0, one clearly would not take TA. Ift is very close to s, the authors believe most people in their cohort would choose to take TA. Hence, somewhere between 0 and s there exists a t for which the decision maker is indifferent between the two possible actions. In 15 we derive a value for X as a function of s and t, namely X = (1 - s)/t. Since it may be easier for an individual to think about a reduction in the probability of death as a proportional factor rather than a difference we write t = ps and ask the decision maker to make a personal estimate for p rather than directly for t. Then the expression for X becomes X = (1/s1)/p. For the authors' cohort at the time the decision was made, s = .002 and X = (1/s l)/p = 499/p. In Section 3 we found that the shot should be taken for X > 437 when 67

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the probability of an epidemic is 0.1. Since for p < 1 we have X > 499, it is clear that the "correct" decision is to get the vaccination. We can also resolve the decision problem assuming that the probability of an epidemic is only 0.01. The numerical values for the probabilities of the various consequences are given in Table 1. For the values in Table 1, we can calculate that x 10-7 (-X) + E(S) = 1.1255 and .97780828, .997749875. E(NS) = 1.25 x 10-6(-X)+ From these figures we see that the shot should be taken if X > 17,532, which is < equivalent to 499/p > 17,532 or p in this case, an indi0.02846. Therefore, vidual following the expected value model should receive the vaccination if the proportional reduction in the probability of death which is sufficient to induce him to take action TA is only about 3 per cent. The values of the proportional reduction p sufficient to imply that action TA should be taken are shown in Figure 5 for varying (subjective or objective) probabilities e for the occurrence of an epidemic. The swine influenza vaccine should be taken for any point (e,p) in the shaded region. For example, if one believes that the probability of an epidemic is less than 0.02 and if one requires a reduction proportion for death during the upcoming year of at least 0.25 to induce him to take action TA, then he should choose not to take the swine influenza vaccination.

It can be seen in Figure 5 that for the consequence values on the right hand side of Figure 2, the vaccine should be taken by the individual for any personal probability estimate for an epidemic greater than 9.7 per cent, regardless of the reduction proportion value. 5. The Guillain-Barre Syndrome The Guillain-Barre Syndrome (GBS) is a neurologic disease which may be induced by the introduction of foreign matter into the body, for example, by a swine influenza vaccination. Possible outcomes for a victim of GBS include death, permanent disabling paralysis, temporary disabling paralysis or other less severe permanent or temporary effects. Intensive respiratory care may be required for the paralysis outcomes. Before October 1976, most individuals facing the vaccination decision would not have been aware of the additional risks due to GBS. We indicate a modification of the decision tree of Figure 1 which reflects GBS outcomes. Attached to the ends of each of the consequences labeled B, C, E and F in Figure 1 are the additional branches shown in Figure 6. We will analyze the personal cost for these branch modifications using information about probabilities and types of health outcomes provided by CDC.6 By mid-January 1977, CDC gave an estimate of about 10 out of a million for the

TABLE 1. Values and Probabilities for Decision Tree Consequences for an Epidemic Probability of 0.01 Receive Vaccination Consequence A B C D E F Value -X 0.0 0.9 -X 0.2 0.98 Probability 2.25 x x 1.5 1.9985 x 1.103 x 7.349 x 9.7926 x 10-9 10-5 10-2 10-7 10-4 10-1 Consequence G H I Decline Vaccination Value -X 0.1 1.0 Probability 1.25 x 10-6 2.4988 x 10-3 9.975 x 10-'

68

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SWINE FLU VACCINE DECISION )
[

augmented attack rate of GBS during the first few weeks after receiving the swine influenza vaccine. The mortality rate for those contracting the GBS in our cohort is approximately 0.05. Precise estimates for the probabilities of other outcomes are not available; hence, we proceed with the analysis below using both relatively high probabilities and highly negative personal values (approaching that for death) as well as nominal estimates for the severe outcomes. This provides a risk averse analysis, i.e. fairly conservative with respect to the GBS, for individuals specifically wanting to take into account the potential iathe of receiving effect trogenic* vaccine. f We can estimate the values for the consequences of the branches of Figure 6 by first finding the expected value for the set of branches using the above probabilities and then adding this value to the values already computed for branches B, C, E and F, respectively, in our basic tree in Figure 2. The hypothesis that these values can be summed is fairly innocuous, since it is based on the assumption that the occurrence of influenza, GBS and other reaction outcomes are independent events and that the probability associated with non-GBS outcomes when the shot is taken is of the order of 10 -6, which is much larger than the probability of dying from GBS induced by the shot. Although the GBS could occur for branches A and D representing death from influenza following vaccination, the probability of such an event is of the order of 10-11. Hence, corresponding values are insignificant relative to all other outcome values. Moreover, we will show the ultimate decision about taking the vaccine to be rather insensitive to the values assigned
* An iatrogenic effect is an abnormal state or condition produced by a physician, other health care provider or intervention in a patient by inadvertent or erroneous treatment. f It is taken as given that a person has not contracted GBS unless there is physiological muscle involvement, e.g. at least some temporary paralysis.

1.0 0.9 -

(0.097,l) I0

0.80.7-

...

NO SHOT

0.60.5 0.4 -

0.30.29*.

0r

i?

SHOT

0.1tJ -i I - YI -t-' I -tI , -SI

i.

. -

I

'Y` -I

" '' - - L '' "1

P _-

0

01 .02 .03 .04 .05 .06 .07 .08 .09

.10

FIG. 5. Decision region for choice of receiving the swine influenza shot given epidemic probabilities and reduction proportions.

to consequences of these branches. For this reason, we have not further disaggregated paralysis outcomes. We give "reasonable" upper and lower bounds for values of the branches of Figure 6 as well as probabilities of each consequence conditional on the fact that we have already reached the end of the corresponding branches in Figure 2. The value involving ranges for consequences paralysis were determined by considering typical decision analysis "lottery" questions involving the outcomes. Using Figure 7 we assessed a value for temporary paralysis by considering sequential choices between contracting swine influenza for certain and a hypothetical lottery between the status quo and temporary paralysis where the probabilities q and 1 q, respectively, of the latter two outcomes were varied until a range was established. From Figure 7, we see that 0 = q(l.0)+ (1- g)(k), or k = -q/(l - q). The authors feel that their probability q is between 0.5 and 0.95 implying that k is 69

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MEDICAL CARE

Value Bounds Severe Moderate Probability 3
1 - 10-5

0

0.99999

IS -2X

--X
-.5X

5 x 10
1.5 x 10'6

-19 PARALYSIS TEMPORARY
FIG. 6.

-1

8 x 10

Additional branches for Guillain-Barr6 syndrome with associated probabilities and ranges of values.

between -1.0 and -19.0. This procedure is a standard one for assessing subjective values for decision analysis. Thus, the expected value to be added to branches B, C, E and F of Figure 2 is between 3.5 x 10-6 (-X) - 1.52 x 10-4 and 1.25 x 10-6 ( -X) - 8.0 x 10-6, where ( -X) is the personal value of death. Returning to the calculation in Section 4, we see that in the case of the severe value estimates, the value to which X must be compared becomes 650 and in the case of the moderate value estimates, the comparable value is 492. We recall that the previous value was 437. The reason that this difference is relatively small is that relative to other outcomes the probability of actually contracting GBS and suffering a severe outcome is quite small.t The decision here remains automatic since X = 499/p > 492 for p < 1; that is, take the shot. For X = 499/p > 650, p < 0.767; although the decision is not automatic, we believe that if a proportional reduction of three-fourths in the probability of death
t In fact, in the past the probability of getting GBS from a "typical" influenza vaccine (other than for swine influenza) was thought to be negligible and had never been a serious consideration in the decision of whether or not to take such vaccines.

during the upcoming year could be obtained by taking TA, most people would do so. Therefore, following the line of reasoning in this paper, we believe that most people should take the swine influenza vaccination. Hence, rather surprisingly, for the authors' cohort, probabilities and values, analysis of the tree augmented with GBS branches indicates no change in the decision. That is, if the original decision were clearly in favor of getting the shot and if there had been no concomitant drop in the subjective estimates for the occurrence of a swine influenza epidemic about the same time that the increased incidence of GBS was being recognized, the individual's decision to get the shot might not have changed. 6. Summary and Conclusions We have illustrated that the systematic methodology of decision analysis can be applied to problems viewed in a distinctly non-economic manner-in this case, the personal decision based on potential health consequences of whether to get an influenza vaccination. It was shown that once the problem was formulated, the

70

Vol. XVIII, No. 1

SWINE FLU VACCINE DECISION

Swine Influenza for sure after and getting reaction

taking shots 0.0

()~~~~~~~~~~~,

,

1.0

versus

FIG. 7. Lottery to determine value range for temporary paralysis.

Status
q

1.0

1 -q Temporary Paralysis k

k = value assigned

to temporary paralysis.

"best" personal decision might be evident without having to make value judgments about conceptually difficult-to-measure outcomes, such as death. Furthermore, we used a (derived) personal non-economic value of the decision maker's own life in making a decision where recognition of the appropriate choice without knowledge of such a value was not automatic. One rather unexpected result is that the inclusion of the possibility of contracting the Guillain-Barre Syndrome, a pos sibility that effectively ended the massive federal swine influenza vaccination program, was unlikely to alter the personal decision about getting the vaccine. Public health authorities have been concerned with "high-risk groups" when considering influenza immunization policy and programs. In general, high-risk groups have been characterized by age, respiratory ailments and certain chronic diseases.2, 4-6,9 In the case of swine influenza,

no specific identification of high risk was made.6 However, for individuals who ordinarily would receive influenza vaccine, a bivalent vaccine (including A/New Jersey) to was recommended. Accordingly, employ our methodology to such cohorts, one would alter the probabilities of morbidity and mortality in the decision tree and perform sensitivity analyses. Clearly, such individuals may also reflect their attitudes about consequences by adjusting the corresponding values in the tree. Currently, HEW officials are revaluating federal policy on influenza immunization. There is an ensuing controversy on the key cost-effectiveness issue, which involves the estimation of excess morbidity and mortality from influenza viruses with and without consideration of high risk.2,4-6,9 Regardless of the outcome of federal discussions, including, possibly, revised estimates of risks and benefits, our analysis remains appropriate for individuals faced 71

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with the decision of using available vaccines. A relatively inexpensive package could be developed which would allow a paraprofessional, working with a patient in any risk group, to use personal values in evaluating the decision. The authors hope that this paper will contribute toward making informed consent by patients about medical care more prevalent as they become intelligent participants in decisions about their own health care. References
1. Albert D. Decision theory in medicine: a review and critique. Milbank Mem Fund Q 1978;56(3). 2. Gregg B, Bergman J, O'Brien RJ, Millar JD. Influenza-related mortality. JAMA 1978;239. 3. Hattwick MAW, O'Brien RJ, Hoke CH, Dowdle WR. Pandemic influenza, the swine influenza virus and the national influenza immunization program. Center for Disease Control, DHEW, 1976. 4. Housworth J, Langmuir AD. Excess mortality from epidemic influenza, 1957-1966, Am J Epidemiol 1974;100. 5. -, Spoon MM. The age distribution of excess mortality during A2 Hong Kong Influenza epidemics compared with earlier A2 outbreaks. Am J Epidemiol 1971;94.

6. O'Brien RJ, Schoenberger L, Bregman DJ, Goodman, R. Center for Disease Control, DHEW,
personal communications, 1976 and 1978. 7. Pliskin JS, Beck CH. Decision analysis in individual clinical decision making: a real-world application in treatment of renal disease. Methods Inf Med 1976;15(1):43. 8. Raiffa H. Decision analysis: introductory lectures on choices under uncertainty. Reading, Mass.: Addison Wesley Co., 1968. 9. Sabin AB. Mortality from pneumonia and risk conditions during influenza morbidity during nonepidemic years. 1977;237(26). 10. Schoenbaum S, McNeil BJ, Kavet J. The swine-influenza decision. New Engl J Med 1976;295(14). 11. Shachtman RH, Blau RA. A syllabus for decision analysis. Chapel Hill: University of North Carolina, 1974. 12. Vital Statistics of the United States, Vol. 11, Section 5. Rockville, MD: National Center for Health Statistics, 1976. 13. Zalkind DL, Shachtman RH. An introduction to decision analysis for health professionals. Unpublished manuscript, presented at the American Public Health Association Meeting, Miami, Florida, November, 1976. 14. , Shachtman RH. The swine flu vaccination decision for an individual. Presented at the American Public Health Association Meeting, Miami, Florida, November, 1976. 15. , Shachtman RH. A non-economic personal value of life.

Call for Abstracts American Public Health Association
108th Annual Meeting The Medical Care Section of the American Public Health Association is calling for abstracts of studies ready to report by summer 1980. The papers selected will be presented at the 108th Annual Meeting, to be held October 19-23, 1980, in Detroit. Abstracts must use the standard form appearing in the January through March 1980 issues of The Nation's Health or available from the contact below. All submissions to the Medical Care Section must be postmarked no later than March 15, 1980. Please submit abstracts to Lyman Dennis, Ph.D. Vice President Medicus Systems Corporation
7315 Wisconsin Avenue

Washington, D. C. 20014 Authors of selected abstracts will be asked to submit a 3-5 page draft later in the spring. Final selections will be made from these drafts. 72

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