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Parents’

Responses

to Vaccine

Information

Pamphlets

Ellen Wright Clayton, MD, JD’; Gerald B. Hickson, MIY; and Cynthia S. Miller, BS*

ABSTRACT. Objective. To assess parents’ knowledge

and opinions about immunizations and immunization

practices before and after introduction of vaccine

infor-mation pamphlets.

Research design. Telephone questionnaire

adminis-tered to parents whose children received immunizations

in the preceding week.

Setting. Six private pediatric practices in Nashville

area and resident continuity clinic at Vanderbilt

Univer-sity Medical Center.

Participants. Parents whose children were scheduled

to receive immunizations were asked to participate.

In-terviews were completed with 177 parents whose children

received immunizationsbefore and 156 parents after

pam-phiets were introduced. These two groups of parents had

similar demographic characteristics.

Results. Parents who received vaccine information pamphlets learned more about vaccines (2.38 facts/parent after vs 1.18/parent before vaccine information pam-phlets, z = -6.28, P < .0001) and were more eager to obtain immunizations for their children (76% vs 38%, = 47.24,

P < .001). Receipt of pamphlets did not make parents sig-nificantly more likely to report side effects from vaccines

(63% after vs 55% before, NS) but tended to make them

less likely to turn to non health care providers for

infor-mation (58% aftervs 69% before, = 3.73, P = .06). Parents

who received pamphlets, however, said more often that

they received too much information (20% vs 4%, = 14.9,

P < .001).

Conclusions. Vaccine information pamphlets

en-hanced parents’ knowledge and acceptance of

immuni-zations. There is room for further improvement.

Pediatrics 199493:369-372; vaccine information pamphlet, immunization, side effects.

rubella vaccines.2 To address all the mandated issues, each pamphlet is eight pageslong. As a result, parents can

receive

as

many as 24 pages of information

re-garding “routine baby shots” in a single office visit.

Providers may choose not to use Vaccine Information

Pamphlets (VIP), but they must provide written

in-formation that meets the statutory requirements. As

a result, most providers give parents Vii’s.

Before this new requirement came into effect,

pro-viders differed in their approaches to informing

par-ents about ChildhOOd immunizafions. Some simply

talked with parents, whereas others asked parents to

sign brief consent forms developed by the providers or obtained from organizations such as the American Academy of Pediatrics. Still others may not have dis-cussed the information with parents at all.

The introduction of Vii’s raised concerns that their

use would create problems with office flow, deter

par-ents from having their children immunized, erect

bar-riers to access, and undermine parents’ faith in their

providers’ judgmentfr Other physicians argued that the Vii’s were a waste of money because many

par-ents would not read them or would still want to know

what their providers recommended.8’9 In this study,

we tried first to determine whether parents learned

more from the VIPs than from the methods used

pre-viously to educate families about vaccinations. if

par-ents who received Vii’s knew more, we sought to

as-certain whether this augmented knowledge increased

parents’ worries about immunizations and vigilance about possible side effects.

ABBREVIA11ON. VIP, vaccine information pamphlet.

Federallaw now requires that physicians and other child health providers give to parents of children

re-ceiving immunizations standardized information about many aspects of the vaccines and the diseases

they prevent.1 When these requirements were

en-acted, the Secretary of Health and Human Services,

after an extended period of hearing and comment,

developed written materials regarding the polio,

diphtheria-tetanus-pertussis, and

measles-mumps-From the teDiv#{176}-onofGeneral Pediatrics, Department ofPediatrics,

Vander-bilt University School of Medicine, Nashville, TN, and the Vanderbilt

University School of Law, Nashville, TN.

Dr. Qayton is a Qoarles E. Culpeper Foundation Scholar in Medical

Humanities.

Received for publication Apr 30, 1993; accepted Jul 12, 1993.

Reprint requests to (EW.C.) Division of General Pediatrics, TVC 3963,

Nashville, TN 37232-5577.

PEDIATRKS (ISSN 0031 4005). Copyright C 1994 by the American

Acad-emy of Pediatrics.

METHODS

Survey Design and Content

Parents who brought their children to six private pediatric

prac-rices in the greater Nashville, TN area and to a resident continuity

clinic at Vanderbilt University Medical Center for general health maintenance and immunizations were asked to participate. The six practices and the clinic were Selected to reach parents from a representative cross-section of urban and suburban Nashvffle.

Seventeen community physicians responsible for 140 000 patient visits per year helped with recruitment. The resident continuity clinic accounts for 17 000 patient visits per year. After providers informed parents about immunizations by whatever method was being used in the office at the time, the parents of children receiv-ing immunizations were asked in writing if they would participate in this study and to designate a time for a telephone interview. Recruitment continued in each practice until approximately 25 parents agreed to participate both before and after the VIPs were introduced.

All interviews were performed by one of us (CS.M.) and were

successfully completed with 198 of the 275 (72%) parents asked to participate before the VU’s were introduced and with 177 of the 236 (75%) parents approached after the Vii’s were required. Of the parents approached but not interviewed in each group,

approxi-mately one half initially refused to participate whereas the other

half agreed to take part but refused later or could not be reached

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370 PARENTS RESPOND TO VACCINE INFORMATION

by telephone at a convenient time. Families were called at least 48 hours after the office visit.

Of the parents interviewed, 169 in the first group (85%) and 156 in the second group (88%) said their children received immuniza-lions during their visit. The following analyses evaluate the an-swers of parents whose children received immunizations.

To assess what parents learned about immunizations during the visit, the following open-ended questions were asked: “Based on the information you received during your last visit, tell us the

most important things you learned about baby shots.” and “Was

there anything you learned about immunizations that concerned you?” “If yes, what?” The interviewer was trained not to elaborate on these queries, but to use only the following specific prompts: “Is there anything else you learned?” and “Is there anything else that concerned you?,” respectively. The interviewer took extensive notes about the answers which were then combined for purposes of analysis. We used open-ended questions to assess what parents learned to determine what readily usable knowledge parents ac-quired. Relying on answers to specific questions could be mislead-lag because directed inquiries could trigger recall of information otherwise unaccessible to parents and could lead to guessing.

We asked parents if their children had problems with their most recent immunizations. An affirmative response prompted an

inquiry about specific problems listed in the table of side effects

allegedly caused by the pertussis vaccine cited in the 1991 Amen-can Academy of Pediatrics Report of the Committee on Infectious Diseases: fever, lethargy, fussiness, redness, swelling, vomiting, poor feeding, high pitched cry.’#{176}We used directed inquiries to ensure detection of all instances in which parents perceived

that immunizations had caused problems, even at the risk of

inducing overreporting. We then invited them to mention any other problems.

We also asked their opinions about whether they thought that immunizations were good for children; how they were and should be given information; what role they thought parents should play

in being informed and making decisions about these interven-tions; whether they had learned about immunizations from other sources and if so, what they learned; as well as general demo-graphic information. Finally, parents were asked if they wanted to make any comments about immunizations and the way they are delivered. This study was approved by the Institutional Review Board of Vanderbilt University.

Analytic Methods

Answers to open-ended questions about the facts learned in the physicians’ offices and from other sources were coded by three

independent raters who achieved complete agreement on

appro-priate categorization. Responses to these queries judged by the

raters to be untrue were few and were exduded from the analysis

of facts learned. Comparisons between the responses offered by

parents before and after the use of VIPs were made using

analyses. Means were compared using Mann-Whitney tests.

Miii-tiple regression was fit. These statistical analyses were performed

using SPSS Statistical Analyses.” Binary regression, a special case of the general linear model,’2 was also fit using the software pack-age GLIM because, unlike all the other variables assessed, parental education was coded as a noncontinuous variable.

RESULTS

There were no statistical differences between the

parents interviewed before and after VIPs on any

de-mographic variable measured (Table). As a result of

the study design, we were unable to obtain demo-graphic information about the parents who refused to

participate.

Our first hypothesis was that parents who received

Vii’s would know more about immunizations. The

parents whose visits occurred after introduction of

Vii’s learned more facts about vaccines than did

par-ents whose children were immunized before (2.38

facts learned/parent after Vii’s vs 1.18 before, z =

-6.28, P < .0001). Note that the parents’ patterns of

responses were different before and after the Vii’s

were introduced. The differences between these two

TABLE. Characteristics of R espondents and Th eir Children

Before VIP” After VIP

Women among respon- 98 98

dents, %

Age of respondents, y 29.21 ± 6.4 30.16 ± 6.4

Respondents who worked 56 60

outside home, %

Respondents with high 30 28

school education, %

Respondents with col- 40 46

lege degree, %

No. of sets of shots child 2.64 ± 1.61 3.21 ± 2.21 had received

* VII,, vaccine information pamphlet.

groups of parents was attributable entirely to the

greater knowledge about benefits and minor

reac-lions. Parents who received Vii’s mentioned benefits,

such as the diseases prevented by vaccines, almost

three times as often (1.04 facts learned/parent after vs

0.36 before) and mentioned minor reactions, such as

fever or local sweffing, twice as often (0.78 facts

learned/parent after vs 0.35 before) as parents who

had not received VIPs. Neither group mentioned

ma-jor reactions frequently (0.25 facts learned/parent

after vs 0.23 before).

The second hypothesis was that receipt of the VIPs

would make parents less enthusiastic about having

their children immuniZed. Quite to the contrary, par-ents who received VIPs were twice as likely as parents

not receiving VIP5 to say that the information made

them want to obtain immunizations for their children

(76% after vs 38% before, = 47.24, P < .0001).

The third hypothesis was that parents who received

VIPs would be more likely to notice side effects from

the vaccines. Instead, we found that parents receiving

Vii’s were not significantly more likely to say that

their children experienced immunization-related

problems than did parents who had not received Vii’s

(63% after vs 55% before, NS). In response to direct

prompting about specific side effects, parents who did not receive VIPs mentioned an average of 1.48

problems per child, whereas parents who did receive

Vii’s mentioned an average of 1.53 problems per

child, numbers that did not differ significantly (z =

-.505, NS)

The fourth hypothesis was that the written

infor-mation would appear so conclusive that physicians

would seem by comparison to be less authoritative

sources of information and guidance. Parents were

asked what role their physicians should play in

pro-viding vaccinations. Whether or not they had re-ceived VIPs, most parents believed that physicians

should be the source of information about

immuni-zations (54% before vs 53% after, NS). This was true

even though most parents in both groups said that

their providers did not talk with them about

immu-nizations (25% before vs 23% after, NS). Physicians

who did talk with parents were almost always

con-sidered highly knowledgeable about vaccinations

(95% before vs 100% after, NS).

At the same time, neither set of parents was willing

to cede all responsibifity to their physicians. Both

groups of parents overwhelmingly agreed with the

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statement, “Physicians know a lot about children’s

health but parents have something to say, too.” (92% before vs 92% after, NS) Even so, few believed that

parents should be able to refuse immunizations for

their children (20% before vs 25% after, NS).

The fifth hypothesis was that parents who learned

more after receiving Vii’s from their physicians

would be less likely to consider other sources of

in-formation as authoritative. This we assessed by

ask-ing parents if they learned anything about

immuni-zations from sources other than their health care

providers. The VIPs influenced where parents

ob-tained information about vaccines. Parents who did not receive VIPs tended to be more likely to cite

in-formation received from nonprovider sources when

compared with parents who had seen the VIPs (69%

before VIPs vs 58% after, = 3.73, P = .06), whether

from friends (25% before vs 16% after, = 3.86, P <

.05),

or from magazines and books (43% before vs 24%

after, 2 = 12.98, P < .005). Some parents mentioned

more than one alternative source.

We hypothesized that parents would dislike the

VIPs. When asked, parents found the VIPs to be no

more helpful or complete than earlier forms of

infor-mation that some practitioners provided. Neither

group was a strong proponent of printed information

(24% before vs 27% after, NS). Parents who received

the Vii’s said more often that they received too much inforn#{176}tation than did parents who obtained informa-tion before the VIPs were introduced (20% too much

after vs 4% before,

x

= 19.44, P < .005).

By contrast, some parents said the VIPs did not con-tam enough information, and many more said they

found the pamphlets to be easy to read and

under-stand, and even to be reassuring. Parents particularly

liked having copies of the Vii’s to take home. Many

said it was nice to have something to show their spouse or to refer to if their infant had problems after

vaccination. Others complained if take-home copies

were not available. Still others specifically asked for

pamphlets about the Haemophilus influenzae and

hepa-titis B vaccines even though federally mandated

in-formational materials have not been developed for

these vaccines.

Finally, to study the contribution that VIPs made to

the amount of information parents learned in their physicians’ offices, we performed both multiple

re-gression and binary analyses, using the number of facts learned as the dependent variable and receipt of

VIPs, parent’s education, whether the parent worked

outside the home, the parent’s age, and the number of

sets of immunizations the child had received as

po-tential independent variables. In earlier analyses, we

had found that the parent’s gender, the parent’s

cur-rent enrollment in school, and the presence or absence

of other children in the home had no correlation with the parent’s knowledge about vaccinations. We found in both analyses that receipt of the VIPs made the most significant contribution to the number of facts learned (P < .001). Other independent but less robust

contributions were made by the parent’s level of

edu-cation (P < .01), which was positively related to

learn-ing, and the number of sets of shots the child had

received (P < .01), which was inversely correlated

with knowledge.

DISCUSSION

Effect of VIPs on Parental Knowledge, Views About

Immunizations, and Relationships With Physicians

The Vii’s were beneficial to parents from a wide array of educational levels, socioeconomic strata, and pediatric practices. Our strongest observation was

that parents who received the VIPs knew more about

the benefits and minor side effects of immunizations.

Because parents did not talk with their providers

more frequently after the VIPs came into use, the

greater knowledge of these parents probably resulted

from reading the pamphlets.

By contrast, both sets of parents said very little

about the risk of major reactions. In fact, worries

about major side effects comprised only 12% of the

comments made by parents who received Vii’s as compared with 25% of the facts recited by parents

who had not received the Vii’s. This lack of concern

may be the result of denial, ofnews about serious risks

being lost in the large amount of information pro-vided, or, one hopes, of parents’ understanding that these sequelae are very rare. One cannot argue,

how-ever, that the parents who received Vii’s were not

exposed to the information, because the pamphlets

describe the major side effects in great detail.

In addition, fears that the introduction of the Vii’s

would make vaccines less desirable to parents seem

to be unwarranted. Far from scaring people away,

parents who received the Vii’s became more adamant

about obtaining immunizations. There also was no

evidence that parents became “hypervigilant” in

watching for and reporting side effects of vaccines

after receiving the VIPs, giving little reason to fear

that parents would refuse later shots. All this bodes

well for current efforts by pediatricians and the public

health sector to boost the immunization status of

chil-dren <2 years of age in the United States.’3’14

The availabifity of Vii’s did not undermine

pa-tients’ high esteem of their physicians’ knowledge

and role in making decisions about their children’s

health care. If anything, the Vii’s seemed to fortify the

position of physicians as providers of information

be-cause receipt of the VIPs tended to make it less likely

that parents recalled learning about immunizations

from non-health care providers. It was as if the

au-thority of the VIPs displaced other immunization

in-formation from parents’ minds. This is remarkable

given the prevalence of other “knowledges” that

corn-pete with pediatricians’ advice,’5 as well as the flood

of information asserting that vaccinations pose

unac-ceptable dangers.16’8

What Parents Thought About the VIPs and Their Suggestions for Improvement

Parents did not speak with one voice when asked

what they thought about the VIPs. To be sure, 20% of the parents who received Vii’s said they received too much information. On a more anecdotal level, some parents said that they found the information to be scary or that other mothers would be frightened, a

finding of concern even if slightly at odds with the

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372 PAREN1S RESPOND TO VACCINE INFORMATION

high level of parental enthusiasm for immunizations after the VIPs were introduced. Other parents, how-ever, praised and found reassurance in the VIPs.

Some explicitly asked for similar information about

the newer immunizations now in use.

Given the length of the Vii’s, it is hardly surprising

that many parents said it was hard to read all the

information during the visit at which immunizations

were to be administered initially. Many parents thought this problem could be surmounted by giving

the VIPs at an earlier child care visit, after delivery, or

during prenatal care. Moreover, despite receiving the

Vii’s in the middle of a busy office visit, the fact that

parents whose children had previously received few or no shots were likely to learn more about

immuni-zations suggests that the first presentation of this

in-formation may be the most important. Although this

conclusion is hardly surprising because parents are

more likely to pay attention to interventions their chil-dren receive for the first time, it confirms the need to

make the first presentation of the information truly

successful. Parents’ requests that they have the

op-portunity to read the Vii’s in an unhurried (and

un-harried) setting are particularly compelling.

This study does have some limitations. The respon-dents all saw pediatricians in the greater Nashville area, a large urban area in the southeastern United

States. Yet subjects were recruited from a diverse

group of practices, which from prior research we

know are composed of children whose parents have

widely differing educational and socioeconomic backgrounds.’9 In addition, the interviewer was aware of the hypotheses of this study at the time she

spoke with the parents. Although this awareness

could create bias, some hypotheses were strongly

re-jected whereas others were confirmed, suggesting that there was no systematic bias in the results. Looking to the Future

On balance, when viewed from the parents’

per-spective, the VIPs are a marked success. Physicians and the public health sector should find much

en-couragement in these findings. Providers should

re-alize, however, that giving out pamphlets does not

obviate the need to talk with parents about

immuni-zations. Practitioners also would be well advised to

give parents the Vii’s some time before the 2-month visit.

The Vii’s need to be improved. Some parents feel

overwhelmed with information. Particular attention

must be devoted to informing parents who have less

education because they still know less about

immu-nizations than do other parents. In addition, VIPs

con-tam contestable information as new studies question

whether some of the sequelae commonly ascribed to

vaccines are caused by their administration.#{176} Yet as efforts are made to revise and shorten the Vu’s,2’ it is

critical that the gains in the parents’ eyes are not lost in the process.

ACKNOWLEDGMENTS

We would like to thank Drs Nancy Beveridge, Janet Blackwell, Eric Chazen, John Fields, Ralph Greenbaum, James Henderson, Mary Keown, Leonard Koenig, Brian Leeper, William Long, Susan

McGrew, David Moroney, Charles Moss, William Slonecker,

David Thombs, William Wadlington, and Arville Wheeler, their nurses, and Dr Rachel Mace, Director, and the nurses at the

Vanderbilt University Pediatric Continuity Clinic for recruiting

parents from their practices to participate in this study, and cape-daily the parents who answered our questions.

REFERENCES

1. 42 USC §300aa-26 (1992)

2. 56 Federal Register 51798-51818 (Oct 15, 1991); codified at 42 FR §110.101-110.103

3. Holt VL, Marcuse EK, Coombs J.Pediatricians’ immunization consent practices in Washington state. AJDC. 1987;141:734-735

4. BlaCk RL. Vaccine pamphlets undermine immunization efforts. AAP

News. October 1992:12

5. McCormally T. Are the new CDC brochures on immunizations really a good idea? PedIatT News. 19922&3,17

6. Kusumoto WI. Immunizafionbmchures will impede access. AAP News.

April 1992:20

7.

Sedlis MM. Pamphlet mandate impedes access. AAP News. August

19928

8. Shea DW. President asks agency to reconsiderbrochure law. AAP News.

April 1992:4

9. Garry T. Vii’s proving not to be very important. Pediatr Management. August 1992A3

10. Committee on Infectious Diseases, American Academy of Pediatrics. Report of the Committee on Infections Diseases. Elk Grove Village:

Amen-can Academy of Pediatrics; 1991

11. SPSS Reference Guide. Chicago, IL: SPS5, mc; 1990

12. MCCUIIagh P, Nelder JA. Generalizd Linear Models. 2nd ed. London

Chapman and Hall; 1989

13. Cutts FF, Zell ER, Mason D, Bernier RH, Thni EF, Orenstein WA. Mom-toting progress toward US preschool immunization goals. JAMA. 1992;

267:1952-1955

14. Hinman AR. What will it take to fully protect all American children

with vaccines? AJDC. 1991;145559-562

15. Hickson GB, Jayton EW. Are you and your waiting room’s televised

“expert” saying the same thing? Clin Pediatr. 199332:1fl-174

16. Coulter HL, Fisher BL DPT: A Shot in the Dark New Yoric Harcourt

Brace Jovanovich; 1985

17. DPT: Vaccine Roulette. NBC Television Stations Division, NBC, mc, Lea

Thompson, NewsCenter Four; April 19, 1982

18. Leviton R. A shot in the dark. Yoga J.June 199259-61,110-118,128

19. Hickson GB, Altemeier WA, OConsor S. Concerns of mothers seeking

care in private pediatric offices: opportunities for expanding services. Pediatrics. 1983;72:619-624

20. Committee to Review the Adverse Consequences of PertUssis and

Ru-bells Vaccines. institute of Medidne. Adverse Effects of Pertussis and

Rubella Vaccines. Washington, DC: National Academy Press; 1991

21. Tate L Academy works to reach vaccine law compromise. AAP News.

July 19922,18

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(5)

1994;93;369

Pediatrics

Ellen Wright Clayton, Gerald B. Hickson and Cynthia S. Miller

Parents' Responses to Vaccine Information Pamphlets

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1994;93;369

Pediatrics

Ellen Wright Clayton, Gerald B. Hickson and Cynthia S. Miller

Parents' Responses to Vaccine Information Pamphlets

http://pediatrics.aappublications.org/content/93/3/369

the World Wide Web at:

The online version of this article, along with updated information and services, is located on

American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 1994 by the

been published continuously since 1948. Pediatrics is owned, published, and trademarked by the

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has

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