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Vaccine

Information

Pamphlets:

More

Information

Than

Parents

Want?

PEDIATRICS Vol. 95 No. 3 March 1995 331

Thomas M. Fitzgerald, MD, MPH and Deborah E. Glotzer, MD, MPH

ABSTRACT. Objective. To assess the information

needs of parents regarding childhood immunizations,

and their satisfaction with the Vaccine Information

Pamphlets (VIPs).

Research design. Verbally administered,

forced-choice survey of a representative sample.

Setting. Urban teaching hospital-primary care center

(N = 73), neighborhood health center (N = 75), and a

suburban private practice (N = 75).

Participants. Parents or guardians of children

sched-uled for routine checkups, aged 1 month to 18 years,

presenting for routine health care maintenance visits.

Results. Of 227 parents, 223 completed the survey.

Almost all (98%) had prior experience with their

chil-dren’s immunizations, and 7% reported a history of a

“bad” experience. Most parents stated that it was “very

important” to receive information about immunizations

regarding: diseases prevented by the immunizations

(89%); common side effects (91%); serious side effects (89%); contraindications (91%). Eighty percent of parents

indicated they wanted immunization information

dis-cussed with each vaccination. Forty-three percent of the

parents were familiar with the VIPs; of these, 88%

re-ported that the amount of information was “just right,”

and 94% thought the VIPs were helpful. However, 29%

thought the VIPs were either too long, or somewhat too

long.

Conclusions. Parents indicate that they want

informa-tion about many aspects of immunizations, and those

familiar with the VIPs report high levels of satisfaction with the pamphlets. Pediatrics 1995;95:331-334;

immuni-zations, vaccinations, consent, National Childhood

Vaccine Injury Act.

ABBREVIATION. VIP, Vaccine Information Pamphlet.

Immunizations have become one of our most

ef-fective public health instruments.1’2 Although

vacci-nations have proven highly effective, they are not

completely without risk. Vaccines are associated

with both adverse effects and adverse events, and both

are factors in the risk:benefit analysis of

immuniza-tion programs. Adverse effects include local effects

related to injection, and mild systemic effects such as

fever. These effects of vaccinations are often known

before licensure and widespread use. Vaccines are

also associated with rare, temporally related adverse events, which may not become apparent until the

From the Division of General Pediatrics, Department of Pediatrics, Boston City Hospital, Boston University School of Medicine, Boston, MA. Received for publication Mar 14, 1994; accepted Jul 5, 1994.

Reprint requests to (D.E.G.) Department of Pediatrics, Boston City Hospital-lalbot 102, 818 Harrison Avenue, Boston, MA 02118.

PEDIATRICS (ISSN 0031 4005). Copyright © 1995 by the American

Acad-emy of Pediatrics.

vaccine is extensively used. These adverse events are

not thought to be causally related. The vast majority

of children are effectively protected by vaccinations

without long-lasting untoward consequence; very

rarely there may be some children who sustain

injuries following vaccination that may have

life-long sequelae.

In the past, children who had severe reactions

thought possibly attributable to vaccination rarely

had the costs of their long-term care covered by their

health insurance. There was a steadily rising rate of

lawsuits filed between 1978 and 1984, despite a

rel-atively constant distribution of vaccine.3 There were

only 0.06 lawsuits per million doses of vaccine

dis-tributed in 1978, while in 1984 the rate was 4.51

lawsuits per million doses distributed, representing a

75-fold increase.3 While most agreed that injured

vaccine recipients should be financially

compen-sated, the rising cost of vaccine liability was seen as

a threat to future vaccine supply and availability.

Concern over the assurance of a continued

ade-quate vaccine supply prompted interest in a no-fault

approach to vaccine liability. In 1986, Congress

es-tablished the National Vaccine Injury Compensation

Program to provide a mechanism for vaccine

liabil-ity. The compensation program was included in the

legislation of the National Vaccination Program,

which sought to encourage research for safer

vac-cines, establish surveillance of reportable adverse

events, and improve recording and reporting of

information on vaccines.4

As part of the compensation program, Congress

mandated that each child’s legal representative

re-ceive an informational brochure which

communi-cates 10 specific points of information (Table 1). The

Vaccine Information Pamphlets (VIPs) were

devel-oped to communicate these points to the legal

rep-resentative of a child receiving a vaccine. The VIPs

were developed in consultation with The Advisory

Commission on Childhood Vaccines, health care

pro-viders, parent organizations, and the Centers for

Dis-ease Control, as mandated by the legislation.4 The

health care providers’ duty includes providing a

copy of the VIP, or other written document, that

meets the specified information requirements to the

parent or legal representative of a child receiving

immunizations.4

Shortly after their April 1992 introduction, the

vaccine information pamphlets came under severe

criticism, the majority of which came from the

medical community.5 The two major concerns

about the VIPs were that they were too long and

difficult to read in an office visit setting, and that

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TABLE 1. Congressional Vaccine Information Requirements*

332 VACCINE INFORMATION PAMPHLETS: MORE INFORMATION THAN PARENTS WANT?

1) The frequency, severity, and potential long-term effects of the disease to be prevented by the vaccine;

2) the symptoms or reactions to the vaccine which, if they occur, should be brought to the immediate attention of the health care provider;

3) precautionary measures legal representatives should take to reduce the risk of any major adverse reactions to the vaccine that may occur;

4) early warning signs or symptoms to which legal representation should be alert as possible precursors to such major adverse reactions;

5) a description of the manner in which legal representatives should monitor such major adverse reactions, including a form on which reactions can be recorded to assist legal representatives in reporting information to appropriate

authorities;

6) a specification of when, how, and to whom legal representatives should report any major adverse reaction; 7) the contraindications to (and bases for delay of) the administration of the vaccine,

8) and identification of the groups, categories, of characteristics of potential recipients of the vaccine who may be at significantly higher risk of major adverse reaction to the vaccine than the general population;

9) a summary of:

a) relevant Federal recommendations concerning a complete schedule of childhood immunizations, and b) the availability of the Program, and

10) such other relevant information as may be determined by the secretary.

* (From 42 United States Congress 300aa).

the cost of purchase and/or duplication was

sig-nificant.5 Additionally, concern has been voiced

that the VIPs may present another barrier to the

timely immunization of children.6 There is

consid-erable interest in revising the VIPs such that they

would be shorter, and easier to read.7

To our knowledge, only one organized attempt to

assess the level of parental satisfaction with the

pam-phlets has been undertaken. Woodin et al8 studied

the satisfaction levels of parents in Rochester, NY,

and found generally high levels of satisfaction with

the VIPs. This present study was conducted to

de-termine perceived parental knowledge needs

regard-ing childhood immunizations, and to assess the

ac-ceptance of the VIPs among parents of diverse

socioeconomic and educational backgrounds.

SUBJECTS AND METHODS

Between November 1992 and June 1993, parents or guardians

of patients aged I month to 18 years presenting for routine health care maintenance visits were surveyed. Questionnaires were

ad-ministered Monday through Friday, during both morning and

afternoon sessions, to try to minimize any possible selection bias. Parents of all children presenting for routine health care mainte-nance visits were identified with the assistance of the reception staff, and were considered eligible for study participation. All such parents were approached unless their child was to be seen

immediately by the health care provider. This exception was made to minimize the disruption of office flow.

All eligible parents were approached before seeing the child’s health care provider, and asked to participate in a short, verbally

administered survey. Respondents were not apprised of the

con-tent of the survey until after consent was obtained. The final

sample of survey respondents therefore consisted of all those

eligible, except for those few parents whose children were seen immediately by a health care provider, and those who declined to participate.

Questionnaires were administered at an urban public hospital

pediatric primary care clinic, a neighborhood health center, and a suburban pediatric private practice office in the Boston, MA, area. Respondents were interviewed before receiving immunizations, or receiving information regarding immunizations at that visit. The study was approved by the Institutional Review Board of the

Trustees of Health and Hospitals, City of Boston.

Standard demographic information was collected. Respondents were also questioned about previous experience with children’s

immunizations. Respondents were then asked about their infor-mation needs in an open-ended question: “What information do you want to be given before giving permission for your child to receive their ‘shots’?” A follow-up question was then asked to ascertain which, if any, of their responses was most important.

Four forced-choice questions were subsequently asked inquiring

about the relative importance of information regarding common, and rare, side effects, diseases, and contraindications were asked: for example, “How important is it for you to know about the diseases which the ‘shots’ help prevent?” Respondents were then asked when they would like to receive information about vacci-nations, and whether or not they would like the information repeated with each vaccination. Next, respondents were shown a copy of each of the VIPs, and if they indicated that they were

familiar with the VIPs, they were then asked three forced-choice

questions referring to the pamphlets’ length, helpfulness, and

informational content.

Statistical analysis was performed using the Epilnfo and Met-stat statistical software packages.9.’#{176} Chi-square analysis was

per-formed on categorical data. P values 0.05 were considered statistically significant.

RESULTS

The parents/guardians of 227 children were

ap-proached and asked to participate in the survey.

Only approximately five of the otherwise eligible

parents were unable to participate, because their

children were seen immediately. Two-hundred

and twenty-five parents (99%) consented to

partic-ipate, and 223 surveys were completed. Selected

demographic information for respondents is

pre-sented in Table 2. The median age of the index

child was 15.5 months. In general, parents who

completed the questionnaire in the private practice

reported higher levels of income, and reported

completing more formal education than the

respondents in the other practice sites.

Almost all (98%) of the respondents reported that

they had prior experience with childhood

immuni-zations with the index child. Two-thirds of the

respondents reported having prior vaccination

experience with siblings.

Almost all respondents reported that they were

familiar with immunizations: 43% reported being

“very familiar,” 51 % reported being “somewhat

fa-miliar,” 5% reported being “not at all familiar,” and

1 % were unable to give an opinion. Only 7% of

respondents reported a “bad” immunization

experi-ence with one of their children, and 6% reported

knowing someone whose child had a “bad”

experi-ence with immunizations.

Forty-three percent of the respondents reported

being familiar with the VIPs. Of this group, 88%

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TABLE 2. Selected Demographics of Respondents by Primary Care Site

ARTICLES 333

Urban Public Hospital

(N = 75)

Neighborhood Health Center

(N = 75)

Suburban Private Practice

(N = 75)

Race (% Black) 60% 11% 0%

Marital Status (% married) 33% 69% 80%

Income (% <$25 000/yr) 92% 57% 13%

Education (%) not graduated from 25% 11% 1%

high school)

Insurance (% Medicaid) 75% 32% 11%

P < .05 by Chi-square for all comparisons.

reported the amount of information in them as “just

right,” while the remainder reported the information

as “too much” (9%), or “too little” (3%). Ninety-four

percent reported that the pamphlets were helpful,

while 3% found them somewhat helpful, and 3% did

not

find

them helpful. When asked if they found the

pamphlets too lengthy, 71% reported no, 18%

re-ported yes, and I I % reported somewhat. These

sat-isfaction ratings for the VIPs did not significantly

differ by primary care site.

There were varied responses to the open-ended

question: “What information do you want to be

given before giving permission for your child to

receive their ‘shots’?” The majority of respondents

(157 of 225, 69%) indicated that they would like

information about side effects. Other frequent

re-sponses included: purpose of vaccines (91 /225, 40%),

and safety/risk of vaccination (40/225, 17%). Of the

120 respondents who considered one of these issues

most important, 59 felt that side effects were most

important, while 37, and 24 felt that purpose, and

safety, respectively, were most important.

The vast majority of the respondents at all three

sites reported that it was “very important” to receive

information regarding: the diseases for which the

immunizations are given, the common side effects,

the rare, serious side effects, and the

contraindica-tions to vaccination. These results, presented in Table

3, yielded no significant differences among sites.

When asked to select which visit was the best time

to receive the information about the vaccinations,

46% of the respondents chose the visit before the first

immunization visit, 31 % chose the visit in which the

immunizations would be given, and 22% selected the

child’s first visit to the doctor. The majority of the

respondents, 80%, felt that the vaccine information

should be repeated each and every

time

an

immuni-zation is given.

DISCUSSION

Many providers have seen the introduction of the

VIPs as another obstacle in the quest to provide

efficient and proper health care. There can be no

doubt that the VIPs introduce new requirements to

an increasingly cumbersome office practice.

How-ever, the notion that the VIPs are poorly received by

parents is not supported by our results. In fact, most

parents considered the informational objectives

con-tamed in the VIPs as very important.

Although there were high levels of reported

satis-faction with the VIPs, only 43% of the sample

re-ported being familiar with the pamphlets. This may

be the result of the family not having received the

pamphlet, or it could be possible that they received

the pamphlets, and were unable, or unwilling to

familiarize themselves with them. Since the median

age of the respondent’s index child was 15.5 months,

it is likely that a large percentage of the children had

not presented for an immunization since

introduc-tion of the VIPs. The median age of the index child of

those parents reporting familiarity with the VIPs was

9.4 months, while the median age for those reporting

no familiarity was 19 months.

We wanted to sample parents from diverse

socio-economic, and educational backgrounds to allow the

greatest external validity. Our sampling method

in-volved approaching all parents presenting for their

child’s regular health care maintenance visit. Only a

small fraction (<3%) of the eligible parents were

un-able to be approached for study recruitment due to

the logistical concerns outlined in the methods

section. Of the 227 parents approached, 225

con-sented to participate. Questionnaires were

adminis-tered during both morning and afternoon sessions,

Monday through Friday. We believe, therefore, that

the study population was representative of the

pop-ulation seeking routine health care maintenance at

the sites surveyed.

The VIPs were developed in concert with parent

groups, and were designed to be written at an eighth

grade reading level. However, there is evidence that

the VIPs require a reading capability which is

con-siderably higher than eighth grade norms.11 There

are currently no published data on the

comprehen-TABLE 3. Reported Importance of Immunization Information by Primary Car e Site

Percentage reporting Urban Public Neighborhood Health Suburban Private

information as Hospital Center Practice

very important (N = 73) (N = 75) (N = 75)

Diseases against which vaccinations protect 96% 87% 85%

Common side effects 91% 89% 93%

Rare side effects 93% 86% 88%

Contraindications to vaccination 87% 93% 88%

P > .05 by Chi-square for all comparisons.

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334 VACCINE INFORMATION PAMPHLETS: MORE INFORMATION THAN PARENTS WANT? sion, and retention of the information in the VIPs by

parents. We did not assess if parents would find

shorter, simpler versions of the VIPs equally accept-able.

Our

data did show that parents were generally satisfied with the present VIPs, and that they

consid-ered the following information needs very

impor-tant: diseases prevented by the immunizations, com-mon, and rare side effects, and contraindications.

The VIPs are one informational source that can be used to educate and inform parents about childhood

immunizations. There are elements of the VIPs, and

their informational objectives, that serve both

parents’ and providers’ needs. So, although it may

appear that the needs of parents and the needs of

providers regarding the dissemination of vaccine in-formation may be dissimilar, it is more likely that

their needs are complementary. The VIPs in their

present form, however, may not be the best vehicle for that purpose.

Our research suggests that parents have varied

informational needs, with respect to content,

amount, and timing of dissemination. It may be im-possible to develop a single information source that will address the needs of every parent. Further re-search on how best to revise the VIPs is needed, as well as investigation of the effectiveness and accep-tance of nonwritten media to convey vaccine

infor-mation. Revisions can be made to the VIPs which

address both provider and parent needs.

ACKNOWLEDGMENTS

This research was supported in part by grants from the Health Resources and Services Administration, Faculty Development in

General Pediatrics (D28PE51008) and Residency Training in

Gen-eral Pediatrics (D28PE11122).

Thanks to the health care providers, staff, and families of Bos-ton City Hospital, Neponset Health Center, and Quincy Pediatrics Associates for their kind participation and support.

REFERENCES

1. Orenstein WA, Bernier RH: Pediatric vaccinations: update 1990 surveil-lance. Pediatr Clin North Am. 1990;37:709-731

2. Centers for Disease Control. Progress toward elimination of Haemophi-lus influenzae type b disease among infants and children-United States,

1987-1993. MMWR. 1994;43:144-148

3. Hinman AR: DIP vaccine litigation. Am JDis Child. 1986;140:528-530 4. The National Childhood Vaccine Injury Act of 1986. 42 USC 300aa

5. Goldsmith MF; Vaccine Information Pamphlets here, but some physi-cians react strongly. JAMA. 1992;267:2005-2007

6. Crozier K: VIPs: just another barrier to vaccination? Infect Dis Child.

1993;6:12

7. Marwick C. Congress to simplify those complex, anxiety-provoking immunization booklets. JAMA. 1992;268:3413

8. Woodin KA, Rodewald LE, Humiston SC, Carges MS. Schaffer SJ,

Szilagyi PG. Physician and parent opinions of Vaccine Information Pamphlets. Am IDis Child. 1993;147:439 (Abstract)

9. Dean AG, Dean JA, Burton AH, Dicker RC. Epilnfo, Version 5: a word-processing, database, and statistics program for epidemiology on

micro-computers. USD, Incorporated, Stone Mountain, GA, 1990

10. Suskm D, Super DM. Metstat. Cleveland, OH. Version 2.01. Copyright

1990

11. Kaplan JM, Melman SI, Caloustian JA, Weinberger JA, Smith J. Readability of the revised Childhood Immunization Consent State-ments. Am JDis Child. 1993;147:456 (Abstract).

The most important scientific revolutions have as their only common feature, the

dethronement of human arrogance from one pedestal after another of previous

convictions about our own cosmic importance.

Sigmund Freud

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1995;95;331

Pediatrics

Thomas M. Fitzgerald and Deborah E. Glotzer

Vaccine Information Pamphlets: More Information Than Parents Want?

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1995;95;331

Pediatrics

Thomas M. Fitzgerald and Deborah E. Glotzer

Vaccine Information Pamphlets: More Information Than Parents Want?

http://pediatrics.aappublications.org/content/95/3/331

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 © 1995 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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