explaining the risks and benefits - home -...

--- - -~-~ - ---~- - ---

AN UPDATE ONVACCINE SAFETY

Explaining the Risks and Benefitsof Vaccines to Parents 'Doren D. Fredrickson, MD, PhD; Terry C. Davis, PhD; and Joseph A. Bocchini, Jr., MD

A,,' n increasing number of vaccines are

available and recommended for. routine.. . use in children. Pediatricians must keep

up-to-date as new vaccines are added to theschedule and the recommendations for oldervacçines are revised. No vaccine is 100% safe or100% effective. However, the benefits of vaccinesfar outweigh the risks.1 Not only do parents wantand need to know about these vaccines, commu~nication about their risks and benefits is legallymandated and ethically necessary to enable par-ents to make'informed decisions.2

What specific vaccine information needs to becommunicated and who must provide' it areproblematic decisions for many pediatricians tomake. However, neither \ the law nor theAmerican Academy of Pediatrics (AAP) Red Bookis explicit about what must be included in vac-cine commu:ication.3,4 A recent national surveyfound a mismatch among legal mandates forvaccine risk-benefit communication, providers'perceptions of what parents needed to know, andthe actual vaccine risk-benefit communicationpractices of providers.5 The survey also indicatedthat vaccine communication need not be costly intime or effort.

There is no gold standard for vaccine

risk-benefit communication. This article reviewsthe legal requirements, the Red Book recommen-

Dr. Fredrickson is from the Department of 'Preventive Medicine,University of Kansas School of Medicine, Wichita, Kansas. Dr. Davis is lromthe Departments of Pediatrics and Internal Medicine and Dr. Bocchini is lromthe Department of Pediatrics, Louisiana State Universihj Health SciencesCenter-Shreveport, Shreveport, Louisiana. Address reprint requests to TerryC. Davis, PhD, Department of Internal Medicine, LSU Health SciencesCenter-Shreveport, P. O. Box 33932, Shreveport, LA 71130.

This project was partially funded by the Health Resources and ServicesAdministration (HRSA), through Cooperative Agreement #6U76 AlI 00001to the Association of Teachers of Preventive Medicine (ATPM).

400

. EDUGATIONAL OBJEGTIVES .

1. Review the legal requirements for communicat-ing vaccine information to parents during officevisits.

2.Discuss the Red Book recommendations for thecommunication of vaccine information.

3. Review the recent research regarding currentpractice patterns among pediatricians and rec-ommendations from parents surveyed concern-ing communication of vaccine information.

dations, and research findings regarding currentpractice patterns among pediatricians, familyphysicians, and immunization nurses. Recom-mendations from parents across the UnitedStates are also described.

WHAT IS THE LAW?

The National Chidhood Vaccine Injur Act of1986 indicates that "Each health c~re provider whoadmisters a vaccine set forth in the Vaccine InjuryTable shall provide a copy of the current Centers forDisease Control and Prevention (CDC) Vaccine

Inormation Statement (VIS) supplemented with

visual presentations or oral explanations. Suchmaterials shall be provided prior to the admistra-tion of (each) vaccine."3 The law does not specifwhat oral explanation is needed.

WHAT DOES THE AAP RED BOOK RECOMMEND?

The most recent edition of the Red Book rec-

ommends risk-benefit communication as fol-lows:

The. . . parent. . . should be inormed about thebenefits to be derived from the vaccine in pr~-

II1/

r:~

EXPLAINING THE RISKS AND BENEFITS OF VACCINES TO PARENTS

venting disease in individuals and the communi-ty and about the risks of these vaccines.

Questions . should be encouraged so that theinormation is understood. . . . When a parent ini-tiates discussion about a vaccine controversy, thehealth care professional should discuss the spe-cific concerns and provide factual inormation,using language appropriate for parents. . . . Somevaccines may be. acceptable to the resistant par-ent. Their concerns should be addressed in thecontext of this information. . . . Health care pro-fessionals can reinforce important points abouteach vaccine, including vaccine safety, andemphasize the risks encountered by unimmu-nizedchildren. Parents should be advised of

state laws pertaing to school or child care entry,which may require that unimmunzed childrenstay. home from school during outbreaks.i .Documentation of such discussions in thepatient's record may help to reduce any potential

liabilty should a vaccine-preventable disease

occur in the unimmunized patient.4

WHAT ARE PHYSICIANS WHO IMMUNIZE ACTUALLY

DOING?

A recent national survey of private practiceprimary care pediatricians and family physicianswho provided immunizations found that theyvalued immunization risk-benefit communica-

tion. Providers tended to tell parents what theythought parents needed and wanted to know.5

This generally included practical informationabout common side effects and how to treat them, .when to call the clinc, and the schedule for thenext vaccine. Almost all of the providers (5)7%)

said they believed parents needed information onimmunizations.

However, responses disclosed poor perfor-mance when it came to discussing benefits orsevere risks and in screening for contraindica-

tions. Provider responses also disclosed a gapbetween the legal mandate and actual practice;approximately 40% self-reported they were notgiving the vis with every vaccine dose. Survey

respondents cited/lack of time as the main barrierto risk~benefitcommunication. Providers esti-mated that 4 to 5 minutes were needed to discussimmunizations.

PEDIATRIC ANNALS 30:7/lULY 2001

.'

TABLE 1

Questions That Parents Said TheyWanted Pediatricians to Answer

. What vaccines will my child have?

Why so many?

What diseases do they prevent?

What are the common mild side effects, and how do I. manage them? (detailed)What are the severe risks? (brief) .

What is the overall schedule and when is the n~~t~ac-cine?

WHAT DO PARENTS WANT?

. We studied this issuèby conducting 12 focus

groups among parents in 6 cities.4 Similar toClayton and others, we found that parentsdesired verbal information from their pediatri-cian, even íf they were given the VISs and had lit-tle uncertainty about the vaccines.2,6.8 Parents inour 12 focus groups saw this communication as amatter of respect and trust that they expected

from their pediatrician's staff in general and theirpediatrician in particular.

Pårents were most interested in informationthey deemed relevant and practical (eg, manage-ment of common side effects and what to expectin the immunization schedule) (Table 1). Parentsdesired specific information about what sideeffects to expect, how long such symptoms wouldlast, and whether. the child would miss day care.or they would miss work.

Specific management questions included howto best care for the child after injections (eg, giv-ing acetaminophen or massaging the leg) andunder what conditions to call the pediatrician orreturn to the clinic. Specific information desiredabout the immunization schedule consisted of theoverall schedule and the time to return for thenext vaccine. Parents of all income lèvels wantedto know about risk, but did not require muchdetaiL. Statistical probabilty and rates and num-bers were not helpful to parents with less thanacollege education. An example of a risk statementacceptable to parents was "There is a very smallchance something bad could happen, such as

brain damage."Accurate, timely communication is even more

important because of the issues currently being

II

401

EXPLAINING THE RíSKS AND cBENEIITS OF VACCINES TO PARENTS

TABLE 2

The 8 Cardinal Rules of Vaccine Risk

Communication1 . Involve the parents.

2. Listen nonjudgmentaiiy.. Do not argue with parents.

3. Be empathetic and respectful of parents' need to pro-tect the child.

4. Layer information given.

S. Be honest.

6. Be empathetic.

7. Speak clearly and simply.

8. Check for understanding.

Modifed from Covello and Allen."

raised about vaccine safe~ lack of firsthandexperience with the vaccine-preventable diseases,

i

and the inaccurate information available to par-ents through a variety of sources, including theInternet. 9.13 A recent national telephone survey ofparents found that 25% had important miscon-ceptions about immunizations.14 These miscon-ceptions can arise from a variety of nonscientificsources, such as the media, the Internet, and per-suasive stories from friends and neighbors.

Pediatricians must be aware of the misinforma-tion so that parental concerns can be. adequatelyaddressed in a minimal amount of time.

There are alWays gaps in our knowledge aboutvaccines. When efficacy trials are performed, welearn about the common sideeffects and risks ofvaccines. Random events associated with a vaccinemay not be identified until the vaccine is given toa much larger number of children. In addition,epidemiologic studies must be completed to dis-tinguish whether the event is truly associated withthat vaccine or has occurred temporally by coinci-dence with the vaccination. When gaps in knowl-edge exist, parents must be made aware of theuncertainty. Our focus groups and the literatureindicate that when uncertainty exists, parents relyon inormation from a trusted physician.2,6,s,15-17

HOW TO COMMUNICATE

Besides the content of communication, the

manner in which a physician çommunicates therisks and benefits of vaccines is also important.The Environmental Protection Agency wroterules for communicating environmental risk to

402

the public, which we have modified for commu-nicating childhood vaccine risk (Table 2).18,19

Parents in the focus groups universallyemphasized the importance of the physician-patient relationship and that the physician was atrusted source of information.5,15 Parents wantedphysicians to know (and respect) that "My childis the most important thing to me." Patents want-ed the highest level health care provider to brieflytell them about the most serious issues, such asrisk. Nurses and other staff were acceptable fordiscussing routine issues such as common sideeffects and scheduling. Interestingly, parents inthe focus groups indicated that they wanted

immunization visits to be timely and efficient justas much as the health care providers did.

Effective Communication In a Busy PracticeMost pediatricians develop brief, informative

messages that are to be repeated on a daily basisto address child health management topics. Thesame can be done for vaccine risk-benefit com-munication. We recommend that pediatricians"layer" vaccine risk-benefit messages by givingsimple information first. Given the opportuni~parents who want more complex, detailed infor-mation wil ask for it. We recommend that eachpediatrician develop a simple, direct messagethat. fits his or her personality, practice, andpatient population. Finally, pediatricians or staffmust check for understanding.20,21

How Much Time to SpendHow much time is enQugh? Only two studies

to date have quantified this for immunization orimmunization risk-benefit communication inpediatric offices. In a time and motion study fromRochester, New York, physicians spent a medianof 1.9 minutes discussing vaccination. Staff inthese practices spent a median of 1.6 minutesadministering vaccines( and a median of 0 min-utes discussing them. However, this shidy didnot indicate the content of vaccine discussions.22

A second time and motion study was conductedin private pediatric and public immunizationclinics in Shreveport, Louisiana. Less than 1minute was spent discussing vaccine risks andbenefits in both public and private clinics (13 sec-onds and 36 seconds, respectively),23 Neither

PEDIATRIC ANNALS 30:711ULY .7001


study assessed parents' understanding of or sat-isfaction with what was discussed

A national survey of physicians and nursesworking in pediatric and family practice officesalso obtained self-report estimates for time spentand time needed.5 When asked how many min-utes on average they currently spend discussingimmunizations with parents, physicians andnurses ~stimated that they spent signficantly lesstime (average 3.5 minutes) than they believed

was actually needed (average 4.5 minutes). Thenational survey results showed that they feelpressured to spend more time than they do. Inany event, the time spent by physicians and nurs-es on risk-benefit communication is brief.

How to Set Up the OffceThe office nursing staff is an underrecognzed

asset that physicians can capitalize on to increas~

compliance with the law while reducing time

demand. 5 Physici~m and nurse respondents to the

national survey were' asked to indicate any staff

(eg,nurses, physicians, or clerks) who gave or dis-cussed imniunization materials. Responses indi-cated that physicians were most likely to discussmaterials but not give them, whereas nurses weremost lik~ly to both give and discuss materials.5

The national survey indicated that office nurs-es felt they had a high investment in immuniza-tion: they had more training in risk-benefit com-munication and desired more trainng than did

physicians, and their role, the content of theirimmunization discussion, and the' amount oftime they spent differed significantly from that ofphysicians.5 Nurse-parent. communication wasan important aspect of immunizations. This wasoften unrecognzed by physicians. Respondents

were asked to rate. how confident they were inknowing what the rest of the clinical team saidwhen discussing the risks and benefits of immu-nization with parents. Health care providers of all

types were only moderately confident.5Thisindi-cates that improvement can occur by organizingand streamlining this communication process.

Immunization Materials Requested by Health CareProviders and What Is Under Development

Health care providers participating in thenational survey were asked what material~

P E D I A TR I CAN N A L S 3 0 : 7 I J U L Y 2 0 0 1

Figure 1. A user-friendly immunization booklet for parents.

would be useful for them and their patients' par-ents. The most commonly requested item was a.pre-immunization booklet for parents (80%). Thesecond most common. request was for screeningsheets about contraindications.5 Foreign languagematerials were requested by many providers andnurses.5 These materials have been developedwith funding from the Health Resources and

Services Administration and under the guidanceof representatives from 15 agencies, including theAAP and others. They are currently undergoingimplementation trials.

For example, a sturdy, 5 X 7-in "baby shotresource book that can survive a baby bag" hasbeen developed (Fig. 1). The book, written at afourth-grade reading level, notifies parents ofthe risks and benefits of vaccinations and alsoinforms them of how to manage commbn and

403


Based on the "Screening Queslionnaire for Child and Teen lmrnunThis proj~ct \\as supportea by funding tram the HOQ001' to the Association ot Teachers of PrevenUvé Medicine' (

Figure 2. Contraindication screening sheet for child immunizations.

severe side effects. The book also providesinstructions for how to reach the National

Vaccine Inìury Compensation Program and theVaccine Ad verse Event Reporting System.

404 P ED IA T RIC ANN A L S 30: 71J U LY 2001

1"t.

',

a

I~

tI

~¡

l:l

t"i

¡'\

iI'

Il


Figure 3. A poster to prompt vaccine risk-benefit commuriication.

Similarly, a child immunization contraindicationscreening sheet to be co¡npleted by the parenthas been developed (Fig. 2). Finally, a poster list-ing seven questions parents should ask aboutvaccines has b~en created for display in theexaminatiOiiroom to prompt questions and dis-cussiem(Fig. 3).

professional immunization web sites are avail-able that are appropriate for both providers and

TABLE 3

Ways to Involve the Entire Office Staff inVaccine Risk-Benefit Communication

1. Physicians should use up-to-date risk~benefit mes-sages and materials.

2. Office staff should be empowered to use those mes-sages to provide competent risk-benefit communi-

- cation.

3. Vaccine communi9ation tasks should be assigned toimmunization nurses and staff.

4. Nurses and physicians need to develop succinct mes-

sages for parents.

5. Vaccine Information Statements should be provided

before vacciries are administered.

6. Booklets and contraindication screening sheets

should be used to streamline communication.

7. Proper documentation should be obtained.

CONCLUSION

The findings described here imply'that simplesteps can be taken to improve compliance with-out burdenig anyone, by building on the capac-

ity of all members of the immunization team andincorporating practical materials desiglled to'automate the risk-benefit communication pro-cess.

We recommend that the entire office staff func-tion as a team to develop a vaccine risk-benefitcommunication plan that works (Table 3). Several

PEDIATRIC ANNALS 30:7/JULY 2001 405


TABLE 4

Additional Information Resources for Physicians and ParentsImmunization information web sites for physicians

American Academy of Pediatrics

Centers for Disease Control and Prevention, NationalImmunization Program

National Network for Immunization Information

Immunization information web sites for parents

Immunization Action Coalition

Vaccine Education Center

Vaccine Page

.

parents (Table 4). Within the office system, the

immunization nurse may need a stronger voice invaccine risk-benefit communication.\ ,REFERENCES

1. Chen RT, Hibbs B. Vaccine safety: current and future chal-lenges. Pediatr Ann. 1998;27:445-455.

2. Evahs G, Bostrom A, Johnston RB, Fisher BL, Stoto MA,eds. Risk Communication and Vaccination: Summary of aWorkshop: Institute of Medicine. Wasllgton, DC: NationalAcademy Press; 1997.

3. National Childhood Vaccine Injury Act-of 1986, Pub L No.

99-660, 42 USC §300aa-26 (1986).4. American Academy of Pediatrics. Informing patients and

parent~. In: Pickering LK, ed. 2000 Red Book: Report of the

Committee on Infectious Diseases, 25th ed. Elk GroveVilage, IL: American Academy of Pediatrics;' 2000:4.

5. Davis TC, Fredrickson DD, Arnold CL, et al. Childhoodvaccine risk/benefit communication in private practiceoffice settings: a national survey. Pediatrics. 2001;107:e17.

Availableat www.pediá.trics.org/ cgi/ c~ntent/full/l07 /2/e17.

6. Clayton EW, Hickson GB, Miler CS. Parents' responses tovaccine information pamphlets. Pediatrics. 1994;93:369c372.

7. Ball LK, Evans G, Bostrom A. Risky business: challengesin vaccine risk communication. Pediatrics. 1998;101:453-

458.8. Fulgiti VA. Informed consent in írrunization practice.

In: Fulginiti VA, ed. Immunization in Clinical Practice.Philadelphia: J. B. Lippincott; 1982:29-47.

9. Evans G. Pediatricians must use official Vaccine. Inormation Statements. AAP News. AprIl2000;14:7.

10. Ratzan Sc. 21st century communication age. Journal ofHealth Communication. 2000;2:101-103. EditoriaL.

11. Evans G. Vaccine liabilty and safety revisited. ArchPediatr Adolesc Med. 1998;152:7-10.

406

ww.aap.org/new/immpublic.htmwww.cdc.gov/nip/vacsafe

ww.immunizationinfo.org

ww.immunize.orgww.vaccine.chop.eduwww.vaccines.org

12. Zimmerman RK,Schlesselman Ji' Mieczkowski TA,Medsger AR, Raymund M. Physician concerns about vac-cine adverse effects and potential litigation. Arch PediatrAdolesc Med. 1998;152:12-19.

13. Freed GL, Katz SL, Clark SJ. Safety of vaccinations: MissAmerica, the media, and public health. JAMA.1996;276:1869-1872

14. Gellin BG, Maibach E, Marcuse EK. Do parents under-stand immunizations? A national telephone survey.Pediatrics. 2000;106:1097-1102.

15. Cross JT, Davis TC, Arnold C, et al. Physicians are fromPluto, nurses are from Jupiter, and parents are fromMercury: focus group interviews on immunization prac-tices. J Investig Med. 1999;47:112a.

16. Fulginiti VA. Patient education for immunizations.Pediatrics. 1984;74(suppl):961-963.

17. Zimmerman RK, Kimmel SR, Trauth JM. An update onvaccine safety. Am Fam Physician. 1996;54:185-193.

18. Covello VT, Allen FH. Seven Cardinal Rules of RiskCommunication. Washington, DC: U.S. Environmental

Protection Agency; April 1988. OPA-87-020.

19. Page D, Eason P, HumistonS, Barkèr W. Notes from theAssociation of Teachers of Preventive Medicine: vaccine

risk/benefit communication project. Am J Prev Med.2000;18:176-177.

20. Davis TC, Wiliams MV, Branch WT, Green KW.Explainng ilness to patients with limited literacy. In:Whaley BB, ed. Explaining Ilness. Mahwah, NJ: LawrenceErlbaum Associates; 2000:123-146.

21. Cohen-Cole SA, Bird J. Why "three" functions? In: Cohen-Cole SA, ed. The Medical Interview: The Three-Function

Approach. St. Louis, MO: Mosby; 1991:21-27.22. LeBaron CW, Rodewald L, Humiston S. How much time

is spent on well-child care and vaccinations? Arch Pediatr

Adolesc Med. 1999;153:1154-1159.23. Sugar M, Davis TC, Arnold CL, Bocchini JA. Childhood

vaccine risk/benefit communication: public health clincvs. private pediatric office. J Investig Med. 2001;49:136A.

PEDIATRIC ANNALS 30:7/JULY 2001

'Q'~~¡r . 0;UQVJ ..

~':5S §.0 Q

"0

--==-=----r.'rLtf

;:,.,l~~

fL~\ZI-"'eu

....

Journal Title: Pediatric Annals

Volume: 30Issue: 7

Month/Year: 2001Pages: 400-406

Article Author: Fredrickson D. D., Davis T. C.

Article Title: Explaining the risks and benefits

of vaccines to parents.

Imprint:

C J-OP

00\24

COfYb \ \

60000

Call #:

OlA/V) ) P (c f\ ttrc

(P~~' $1 ~G5

Location:

Item #:

CUSTOMER HAS REQUESTED:

Kristen York (kgately)1200 N. Phillips Ave.Suite 12400Oklahoma City, OK 73104

RECEIVEDJuN 03 2011

~

\\f'

\

'- ,''''''''''.

'\.\ .".-

'"'\-:.

/'\,

\

explaining the risks and benefits - home -...

Documents