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Page 1: BRAZILIAN–PORTUGUESE VALIDATION OF THE ... - … · original article brazilian–portuguese validation of the university of washington quality of life questionnaire for patients

ORIGINAL ARTICLE

BRAZILIAN–PORTUGUESE VALIDATION OF THE UNIVERSITYOF WASHINGTON QUALITY OF LIFE QUESTIONNAIREFOR PATIENTS WITH HEAD AND NECK CANCER

Jose Guilherme Vartanian, MD,1 Andre Lopes Carvalho, MD, PhD,1 Bevan Yueh, MD, MPH,2,3

Cristina Lemos B. Furia, PhD,1 Julia Toyota, RN,1 Jennifer A. McDowell,2

Ernest A. Weymuller Jr, MD,3 Luiz Paulo Kowalski, MD, PhD1

1 Head and Neck Surgery and Otorhinolaryngology Department, Centro de Tratamento e Pesquisa Hospitaldo Cancer A. C. Camargo, Rua Professor Antonio Prudente, 211-01509-900 Sao Paulo, SP, Brazil.E-mail: [email protected] Veterans Affairs Puget Sound Healthcare System, Seattle, Washington3 Department of Otolaryngology-Head and Neck Surgery, University of Washington, Seattle, Washington

Accepted 11 April 2006Published online 5 July 2006 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hed.20464

Abstract: Background. The University of Washington Quality

of Life (UW-QOL) questionnaire is an English-language survey

instrument used worldwide to assess the quality of life of patients

with head and neck cancer. To be used in other cultures, such

instruments require careful translation and psychometric valida-

tion in other languages.

Methods. The translation and cultural adaptation of the

questionnaire were performed following accepted international

guidelines. The psychometric validation was performed on a

consecutive series of patients with at least 1 year of disease-free

survival after treatment for squamous cell carcinoma of the

upper aerodigestive tract, recruited from October 2004 to Janu-

ary 2005 from a tertiary cancer center hospital. Eligible subjects

were invited to complete the Portuguese version of the UW-QOL

questionnaire during routine clinical consultation and complete it

again within 15 days. They also completed a validated Portu-

guese version of the Medical Outcomes Study 36-Item Short-

Form Health Survey (SF-36) and a questionnaire to evaluate anx-

iety and depression symptoms (Hospital Anxiety and Depres-

sion Scale [HADS]).

Results. A Portuguese version of the questionnaire was de-

veloped in iterative fashion. In the psychometric validation proc-

ess, a total of 109 patients were analyzed. Reliability was excel-

lent, including both internal consistency (Cronbach’s alpha [a] of0.744) and test retest reliability (intraclass correlation coefficient

[ICC] of 0.882). Construct validity was supported by statistically

significant relationships between the SF-36 and HAD question-

naires and the translated UW-QOL questionnaire.

Conclusions. The Brazilian–Portuguese version of the UW-

QOL questionnaire appears to be culturally appropriate and

psychometrically valid. This version is a valuable tool to evaluate

accurately the quality of life of Brazilian patients with head and

neck cancer. VVC 2006 Wiley Periodicals, Inc. Head Neck 28:

1115–1121, 2006

Keywords: quality of life; head and neck cancer; questionnaires;

validity; reliability

During the past few years, quality of life (QOL)evaluation has been recognized as an importantoutcome measure in medicine, including oncol-ogy.1,2 These measurements have been made withregularity in the head and neck cancer popula-tion. QOL is important to assess because the mostrecent advances inmanagement can lead to differ-ent physical and/or functional sequelae.3–5 Theanatomic location of head and neck tumors may

Correspondence to: L. P. Kowalski

VVC 2006 Wiley Periodicals, Inc.

Portuguese Version of UW-QOL Questionnaire HEAD & NECK—DOI 10.1002/hed December 2006 1115

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influence vital functions such as chewing, swal-lowing, and speech and may also impair cosmeticand psychosocial aspects of patients.6 In this con-text, evaluation of QOL is an important tool forunderstanding the impact of the head and neckcancer and its treatment on the patient’s life. Itcould also be a valuable tool for better planning oftreatment strategies.6–9

Health-related QOL is usually measured byapplication of specific questionnaires. Among allquestionnaires designed to evaluate patients withhead and neck cancer, the University of Washing-ton Quality of Life (UW-QOL) questionnaire10 isone of the most frequently used worldwide. It iswell validated, concise, and easy to complete andinterpret. It has been very suitable for English-speaking populations. To introduce its use in othercultures and countries, it needs to be carefullytranslated and culturally adapted in the new lan-guage, and then psychometrically validated in thenew language, to guarantee its accuracy in thenew population.11,12

The objective of this study was to perform thetranslation and psychometric validation of the UW-QOLquestionnaire into Brazilian–Portuguese.

MATERIALS AND METHODS

The first step was the translation and adaptationof the UW-QOL questionnaire to the Brazilian–Portuguese language.We followed internationallyaccepted guidelines.11,12 Two bicultural expertstranslated the original English version of the UW-QOL questionnaire to Brazilian–Portuguese. Athird bicultural person performed the comparisonof the 2 versions and an iterative consensus wasreached. The consensus version of the Brazilian–Portuguese translation was sent to other 2 addi-tional bicultural experts (at the University ofWashington, Seattle), who performed a similarback-translation process (from Brazilian–Portu-guese to English). This back-translated versionwas then compared with the original English-lan-guage version to ensure that the translationsweresuitable. Discrepancies between the original andback-translated versions were resolved by repeat-ing the process as needed.

The next step was the psychometric validation.We tested the translated version on a consecutiveseries of patients seen in the A. C. Camargo Hospi-tal outpatient clinic betweenOctober 2004 and Jan-uary 2005. Inclusion criteria were adult patientswith squamous cell carcinoma of the upper aerodi-gestive tractwho had 1 year of disease-free survival.Eligible patients were invited to participate in the

study, and participants signed a consent formapproved by the Institutional Ethics Committee.

All participants were asked to complete apacket of self-administered questionnaires duringthe routine outpatient clinic consultation and alsoreceived another UW-QOL questionnaire within 15days, which was returned by mail. The 15-dayinterval was chosen to measure test–retest reli-ability, as enough time had elapsed to preventpatients from remembering their responses to thefirst administration of the scale, but not enoughtime to allow clinicallymeaningful change to occur.We emphasize that no patients in the study under-went treatment in this 15-day interim period. Thepacket included the following questionnaires:Brazilian–Portuguese version of the UW-QOLquestionnaire, the Brazilian–Portuguese validatedform of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36),13 and the HospitalAnxiety andDepression Scale (HADS).14 The chartsof enrolled subjects were reviewed, and demo-graphic, tumor, and treatment datawere collected.

Each domain item on the UW-QOL scale isscored from 0 to 100, with the composite scorebeing the mean of the 12 domains. A higher scoreis indicative of better QOL. Also, 3 separate globalquestions on overall QOL are not used in the com-posite score, and they can be analyzed separately.The HADS is a questionnaire consisting of 14questions designed to evaluate the presence ofanxiety and depression in patients with physicaldiseases. These 14 questions are divided in 2 sub-groups (7 questions to evaluate anxiety and 7 toevaluate depression), each question with scoresvarying from 0 to 3. The sum of each subscaledenotes the category of the patients: 0 to 7, non-cases; 8 to 10, doubtful cases; and 11 to 21 definitecases. In this study, we divided the HADS scoresin 2 categories: patients without depression(‘‘noncases’’) and those who may or definitely havedepression (‘‘doubtful’’ and ‘‘definite’’ cases). TheSF-36 is a multidimensional, 36-item genericinstrument to evaluate QOL. Results may bereported in any of 8 subdomains, or as 2 summaryscores, termed the physical and mental compo-nent summary scales. These 2 component sum-mary scales describe general physical and mentalhealth. They are each scored from 0 to 100; ahigher score is indicative of better QOL, and ascore of 50 represents the normative value in theUS population.

Reliability was established by assuring bothinternal consistency (Cronbach’s a) and test–re-test reliability (intraclass correlation coefficient

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[ICC]) at 2 weeks in the absence of interim treat-ment. Internal consistency is considered good if aapproximates 0.70 but does not exceed 0.90,because values of 0.90 imply the presence ofredundant items.15 Test–retest reliability wasmeasured with the ICC, which is more rigorousthan Pearson’s correlation coefficient r because itconsiders not just the strength of the correlationbut also systematic variations.16

There are 3 forms of validity: content, crite-rion, and construct. Content validity was estab-lished with the rigorous approach to item develop-ment in the original form. It is maintained by therigorous process of the translation and back-translation. The criterion validity, which testsscale performance in comparison to a gold stand-ard, is difficult to establish when evaluating QOLscales, mainly in head and neck cancer assess-ment because there is no instrument considered‘‘gold-standard’’ in this population. Construct va-lidity is present if the scale behaves according tohypothesized relationships. We hypothesized thatthe composite score of the UW-QOL should corre-late with general questions about overall QOLand themain component summary scales of the SF-36 questionnaire. We also hypothesized that higherdepression scores and larger tumors would result inworse UW-QOL scores. The Pearson correlationcoefficient andSpearman rho (q) were used to evalu-ate the correlations between continuous and ordinalvariables, respectively. The nonparametric tests ofMann–Whitney or Kruskal–Wallis were used tocomparemeans among the groups studied.

The statistical analysis was performed usingversion 12.0 of the SPSS statistical program(SPSS, Chicago, IL) forWindows.

RESULTS

The first translation of the UW-QOL to Brazilian–Portuguese was successful, without substantialdiscrepancies. A minor difficulty was encounteredin translating the word ‘‘narcotics,’’ which existsin Portuguese but is not currently used in Brazil.We opted to use the expression ‘‘controlledmedica-tion,’’ which is the term more commonly used inBrazil for the designation of such drugs. Afterotherminor adjustments, the back-translation wascompared with the original English version anddid not show any significant content discrepanciesbetween both versions. The final Brazilian–Portu-guese version is contained in the Appendix.

A total of 109 patients were enrolled in the psy-chometric validation process. Most were male

(82.6%) with ages ranging from 34 to 83 years(median, 62 years). The tumor sites were: 37 oralcavity (33.9%), 19 oropharynx (17.4%), 39 larynx(35.8%), 11 hypopharynx (1.1%), and 3 nasopha-rynx (2.8%). The T classifications were as follows:51 (46.8%) T1/T2 and 58 (53.2%) T3/T4. Forty(36.7%) patients had surgery and radiotherapy, 30(27.5%) had surgery alone, 21 (19.3%) had radio-therapy alone, 14 (12.8%) had primary concomi-tant chemoradiation, and 4 (3.7%) had a combina-tion of surgery, radiation, and chemotherapy.

The mean and standard deviation (SD) of theUW-QOL composite score in the test and retestevaluations were 80.2 (SD ¼ 12.6) and 78.9 (SD ¼13.9), respectively.

The translated scale had strong internal consis-tency (Cronbach’s a ¼ 0.744) and excellent test–re-test reliability (ICC¼ 0.880) (raw data inFigure 1).

Construct validity was evaluated based on thehypotheses described. Patients with higher scoreson the depression scale had lower scores on theUW-QOL questionnaire, which showed a statisti-cally significant Spearman’s q correlation of�0.342(p < .001). This association was also significantwith dichotomous categorization of HADS scores asproposed by the authors (p < .001 [Figure 2]). TheUW-QOL composite scores behaved as predictedwhen patients were categorized by T classification,as patients with larger tumors had worse UW-QOLscores (p < .001) (Figure 3). The UW-QOL compos-ite scores also correlated well with global questions

FIGURE 1. Test–retest data of UW-QOL (ICC ¼ 0.880). ICC,

intraclass correlation coefficient.

Portuguese Version of UW-QOL Questionnaire HEAD & NECK—DOI 10.1002/hed December 2006 1117

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(Figure 4). There was also moderately strong con-cordance between the UW-QOL composite scoreand the Physical Component Summary (PCS) andMental Component Summary (MCS) scores of theSF-36 (Table 1).

DISCUSSION

QOL evaluation has become an important out-come measure in the head and neck cancer popu-

lation during the past few decades.6,17 This impor-tance is highlighted by the potential impact ofsuch tumors and their treatment on functional,emotional, social, and professional aspects ofaffected individuals.10,18,19

Typically, QOL is measured by the applicationof specific questionnaires. Most instruments havebeen designed in developed and English-speakingcountries.17,20,21 To be of use in other countriesand cultures, these scales require rigorous trans-lation and revalidation.11 The UW-QOL question-naire is a well-validated, concise, and minimallyburdensome scale,17 and also happens to be one ofthe most frequently used head and neck scales inthe world. We have successfully translated andadapted this scale for the Brazilian population.

In addition, we have demonstrated that ourtranslation has excellent reliability and construct

FIGURE 3. Graphic representation of the association between the

UW-QOL composite score and the tumor T classification (p< .001).

FIGURE 4. Graphic representation of the association between

the UW-QOL composite score and the UW-QOL global question

on overall quality of life (p < .001).

Table 1. Correlation between UW-QOL composite score

and the PCS and MCS scores from the Medical

Outcomes Study SF-36.

UW-QOL composite score SF-36 PCS SF-36 MCS

Pearson 0.394 0.358

Sig (1-tailed) <.001 <.001

No. of patients 109 109

Abbreviations: UW-QOL, University of Washington Quality of Life question-naire; PCS, Physical Component Summary; MCS, Mental Component Sum-mary; SF-36, Medical Outcomes Study 36-item Short-Form Health Surveys;Sig, significance.

FIGURE 2. Graphic representation of the association between

the UW-QOL composite score and Hospital Anxiety and

Depression Scale (HADS) grouping score using the Mann–

Whitney U test (p < .001).

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validity. We observed strong correlations betweenthe Brazilian–Portuguese UW-QOL compositescores with T classification, global QOL, andHADS scores. Patients with poor overall QOL andlarger tumors, as well as patients with higherdepressive scores, had lower UW-QOL score, con-firming that the hypothesized variables that couldaffect the QOL were directly related to the UW-QOL scoring.

An important consideration in the applicationof QOL scales is to understand what kind ofchange represents a minimally clinically impor-tant difference.22,23 As yet unpublished data fromthe University of Washington suggest that a 6- to8-point difference in the composite score is therange for a low to a high clinically important dif-ference (B.Y., 2003). Our Brazilian data suggestthat these values may be similar, as we observedstandard deviations on the order of 10 to 12. In T1disease, the mean composite score in the Brazilianpopulation was 88.6 (standard deviation, 9.6). InT2, T3, and T4 disease, the mean scores were 83.4

(10.6), 75.5 (12.5), and 75.2 (13.1), respectively.Therefore, a minimally clinically important differ-ence of 6 to 8 would have an effect size of roughly.5, which is considered an intermediate effect.24

Despite the recognition that disease-specificmeasures differ from general health measures, wefound moderately strong correlations between thephysical and mental component summary scoresof the SF-36 with the translated UW-QOL scale.Nonetheless, a comprehensive evaluation of QOLin patients with head and neck cancer shouldinclude bothmeasures.

In conclusion, the Brazilian–Portuguese ver-sion of the UW-QOL questionnaire appears to beculturally appropriate and psychometrically valid.This version is a valuable tool to accurately evalu-ate the QOL of Brazilian patients with head andneck cancer, and it can be reliably used inBrazil.

Acknowledgments. The authors thanksMrs.RaimundaN.Pereira for her contribution to the de-velopment of the database.

Questionario de qualidade de vida da Universidade de Washington

Este questionario pergunta sobre sua saude e qualidade de vida durante os ultimos sete dias. Por favor responda a todas as

questoes marcando uma alternativa para cada questao.

1. Dor (marque uma alternativa [X])

100 [ ] Eu nao tenho dor

75 [ ] Ha dor leve nao necessitando de medicacao

50 [ ] Eu tenho dor moderada, requerendo uso de medicacao regularmente

25 [ ] Eu tenho dor severa controlada somente com medicamentos controlados

0 [ ] Eu tenho dor severa, nao controlada por medicacao

2. Aparencia (marque uma alternativa [X])

100 [ ] Nao ha mudanca na minha aparencia

75 [ ] A mudanca na minha aparencia e minima

50 [ ] Minha aparencia me incomoda, mas eu permaneco ativo

25 [ ] Eu me sinto desfigurado significativamente e limito minhas atividades devido a minha aparencia

0 [ ] Eu nao posso estar com outras pessoas devido a minha aparencia

3. Atividade (marque uma alternativa [X])

100 [ ] Eu estou tao ativo quanto sempre estive

75 [ ] Existem vezes em que nao posso manter meu ritmo antigo, mas nao frequentemente

50 [ ] Eu estou frequentemente cansado e tenho diminuido minhas atividades embora eu ainda saia de casa

25 [ ] Eu nao saio de casa porque eu nao tenho forca

0 [ ] Eu geralmente fico na cama ou na cadeira e nao saio de casa

4. Recreacao (marque uma alternativa [X])

100 [ ] Nao ha limitacoes para recreacao em casa ou fora de casa

75 [ ] Ha poucas coisas que eu nao posso fazer, mas eu ainda saio de casa para me divertir

50 [ ] Ha muitas vezes que eu gostaria de sair mais de casa, mas eu nao estou bem para isso

25 [ ] Ha limitacao severa para o que eu posso fazer, geralmente eu fico em casa e assisto TV

0 [ ] Eu nao posso fazer nada agradavel

APPENDIX: BRAZILIAN–PORTUGUESE VERSION OF THE UW-QOL SCALE

Portuguese Version of UW-QOL Questionnaire HEAD & NECK—DOI 10.1002/hed December 2006 1119

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5. Degluticao (marque uma alternativa [X])

100 [ ] Eu posso engolir tao bem como sempre

67 [ ] Eu nao posso engolir algumas comidas solidas

33 [ ] Eu posso engolir somente comidas liquidas

0 [ ] Eu nao posso engolir porque desce errado e me sufoca

6. Mastigacao (marque uma alternativa [X])

100 [ ] Eu posso mastigar tao bem como sempre

50 [ ] Eu posso comer alimentos solidos leves mas nao consigo mastigar algumas comidas

0 [ ] Eu nao posso mastigar nem mesmo alimentos leves

7. Fala (marque uma alternativa [X])

100 [ ] Minha fala e a mesma de sempre

67 [ ] Eu tenho dificuldade para dizer algumas palavras mas eu posso ser entendido mesmo ao telefone

33 [ ] Somente minha familia e amigos podem me entender

0 [ ] Eu nao sou entendido pelos outros

8. Ombro (marque uma alternativa [X])

100 [ ] Eu nao tenho problemas com meu ombro

67 [ ] Meu ombro e endurecido mas isto nao afeta minha atividade ou forca

33 [ ] Dor ou fraqueza em meu ombro me fizeram mudar meu trabalho

0 [ ] Eu nao posso trabalhar devido problemas com meu ombro

9. Paladar (marque uma alternativa [X])

100 [ ] Eu sinto sabor da comida normalmente

67 [ ] Eu sinto o sabor da maioria das comidas normalmente

33 [ ] Eu posso sentir o sabor de algumas comidas

0 [ ] Eu nao sinto o sabor de nenhuma comida

10. Saliva (marque uma alternativa [X])

100 [ ] Minha saliva e de consistencia normal

67 [ ] Eu tenho menos saliva que o normal, mas ainda e o suficiente

33 [ ] Eu tenho muito pouca saliva

0 [ ] Eu nao tenho saliva

11. Humor (marque uma alternativa [X])

100 [ ] Meu humor e excelente e nao foi afetado por causa do meu cancer

75 [ ] Meu humor e geralmente bom e e somente afetado por causa do meu cancer ocasionalmente

50 [ ] Eu nao estou nem com bom humor nem deprimido por causa do meu cancer

25 [ ] Eu estou um pouco deprimido por causda do meu cancer

0 [ ] Eu estou extremamente deprimido por causa do meu cancer

12. Ansiedade (marque uma alternativa [X])

100 [ ] Eu nao estou ansioso por causa do meu cancer

67 [ ] Eu estou um pouco ansioso por causa do meu cancer

33 [ ] Eu estou ansioso por causa do meu cancer

0 [ ] Eu estou muito ansioso por causa do meu cancer

Quais problemas tem sido os mais importantes para voce durante os ultimos 7 dias?

Marque [X] em ate 3 alternativas

[ ] Dor [ ] Degluticao [ ] Paladar

[ ] Aparencia [ ] Mastigacao [ ] Saliva

[ ] Atividade [ ] Fala [ ] Humor

[ ] Recreacao [ ] Ombro [ ] Ansiedade

Questoes gerais

Comparado com o mes antes de voce desenvolver o cancer, como voce classificaria sua qualidade de vida relacionada a saude

(marque uma alternativa: [X])

[ ] Muito melhor

[ ] Um pouco melhor

[ ] Mais ou menos o mesmo

[ ] Um pouco pior

[ ] Muito pior

1120 Portuguese Version of UW-QOL Questionnaire HEAD & NECK—DOI 10.1002/hed December 2006

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8. Allal AS, Nicoucar K, Mach N, Dulguerov P. Quality oflife in patients with oropharynx carcinomas: assessmentafter accelerated radiotherapy with or without chemo-therapy versus radical surgery and postoperative radio-therapy. Head Neck 2003;25:833–884.

9. Hanna E, Sherman A, Cash D, et al. Quality of life forpatients following total laryngectomy vs chemoradiationfor laryngeal preservation. Arch Otolaryngol Head NeckSurg 2004;130:875–879.

10. Rogers SN, Gwanne S, Lowe D, et al. The addition ofmood and anxiety domains to the University of Washing-ton Quality of Life scale. Head Neck 2002;24:521–529.

11. Guillemin F, Bombardier C, Beaton D. Cross-cultural ad-aptation of health-related quality of life measures: litera-ture review and proposed guidelines. J Clin Epidemiol1993;46:1417–1432.

12. Beaton DE, Bombardier C, Guillemin F, Ferraz MB.Guidelines for the process of cross-cultural adaptation ofself-report measures. Spine 2000;25:3186–3191.

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valid quality of life outcome measure. Rev Bras Reumatol1999;39:143–115.

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15. Streiner DL, Norman GR. Health measurement scales: apractical guide to their development and use. 2nd ed.Oxford, UK: Oxford University Press; 1989.

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18. Taylor JC, Terrell JE, Ronis DL, et al. Disability inpatients with head and neck cancer. Arch OtolaryngolHead Neck Surg 2004;130:764–769.

19. Vartanian JG, Carvalho Al, Toyota J, et al. Socioeco-nomic effects and risk factors for disability in long-termsurvivors of head and neck cancer. Arch OtolaryngolHead Neck Surg 2006;132:32–35.

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Em geral, voce poderia dizer que sua qualidade de vida relacionada a saude nos ultimos 7 dias tem sido: (marque uma alternativa

[X])

[ ] Excelente

[ ] Muito boa

[ ] Boa

[ ] Media

[ ] Ruim

[ ] Muito ruim

De um modo geral a qualidade de vida inclui nao somente saude fisica e mental, mas tambem muitos outros fatores, tais como

familia, amigos, espiritualidade, atividades de lazer pessoal que sao importantes para sua satisfacao com a vida. Considerando

tudo em sua vida que contribui para seu bem-estar pessoal, classifique a sua qualidade de vida emgeral durante os ultimos 7 dias.

(marque uma alternativa: [X])

[ ] Excelente

[ ] Muito boa

[ ] Boa

[ ] Media

[ ] Ruim

[ ] Muito ruim

Por favor descreva quaisquer outros problemas (medicos ou nao medicos) que sao importantes para sua qualidade de vida e que

nao tenham sido adequadamente mencionados pelas nossas perguntas (voce pode anexar folhas adicionais se necessario).

Portuguese Version of UW-QOL Questionnaire HEAD & NECK—DOI 10.1002/hed December 2006 1121