Validation of the EORTC QLQ-C30 and EORTC QLQ-H&N35 in ...

ORIGINAL ARTICLE 

VALIDATION OF THE EORTC QLQ-C30 AND EORTC 

QLQ-H&N35 IN PATIENTS WITH LARYNGEAL 

CANCER AFTER SURGERY 

Susanne Singer, PhD, 1 Dorit Wollbrück, Dipl-Psych, 1 Cornelia Wulke, MD, 2 Andreas Dietz, MD, 3 

Eckart Klemm, MD, 4 Jens Oeken, MD, 5 Eberhard F. Meister, MD, 6 Hilmar Gudziol, MD, 7 

Julian Bindewald, 1 and Reinhold Schwarz, MD 1 

1 Department of Social Medicine, University of Leipzig, Leipzig, Germany. 

E-mail: susanne.singer@medizin.uni-leipzig.de 

2 Department of Otorhinolaryngology, University of Halle-Wittenberg, Halle, Germany 

3 Department of Otorhinolaryngology, University of Leipzig, Leipzig, Germany 

4 Department of Otorhinolaryngology, Hospital Dresden-Friedrichstadt, Dresden, Germany 

5 Department of Otorhinolaryngology, Clinical Center Chemnitz, Chemnitz, Germany 

6 Department of Otorhinolaryngology, Hospital St. Georg, Leipzig, Germany 

7 Department of Otorhinolaryngology, University of Jena, Jena, Germany 

Accepted 5 June 2008 

Published online 28 October 2008 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hed.20938 

Abstract: Background. The aim of this study was to test the 

validity of the European Organization for Research and Treatment 

of Cancer Quality of Life Questionnaire, Core Module 

(QLQ-C30) and Head and Neck Module (QLQ-H&N35) for 

patients who have undergone surgery due to laryngeal cancer. 

Methods. A total of 323 patients from 6 different centers in 

Germany who had been operated on completed the QLQ-C30 

and the QLQ-H&N35 in addition to being surveyed in a personal 

interview. 

Results. Multitrait scaling analysis confirmed the proposed 

scale structure of both questionnaires. Cronbach’s alpha of the 

QLQ-C30 scales ranged from 0.64 (Cognitive Functioning) to 

0.94 (Global Health Status); the alpha of the QLQ-H&N35 

ranged from 0.55 (Speech) to 0.90 (Sexuality). Known-groups 

comparisons showed multiple differences in sociodemographic 

and clinical variables. 

Conclusion. It can be concluded that the QLQ-H&N35, in 

conjunction with the QLQ-C30, is a reliable instrument that is 

able to differentiate between diverse groups of patients with laryngeal 

cancer after surgery. VC 2008 Wiley Periodicals, Inc. 

Head Neck 31: 64–76, 2009 

Keywords: validation; health-related quality of life; laryngeal 

cancer; EORTC QLQ-H&N35; EORTC QLQ-C30 

Correspondence to: S. Singer 

This work was presented at the Conference of the Multinational Association 

of Supportive Care in Cancer, St. Gallen, Switzerland, 2007. 

Contract grant sponsor: German Federal Ministry of Education and 

Research; contract grant number: 7DZAIQTX; Contract grant sponsor: 

Government of the Federal State of Saxony; contract grant number: 

formel1.57. 

VC 

2008 Wiley Periodicals, Inc. 

The European Organization for Research and 

Treatment of Cancer Quality of Life Core Questionnaire 

(EORTC QLQ-C30) is a cancer-specific 

questionnaire that has often been used for 

patients with head and neck cancer. 1–5 Its psychometric 

characteristics were published for the first 

time in 1992. 6 In that study, the internal consis- 

64 Validation of EORTC QLQ in Patients with Laryngeal Cancer HEAD & NECK—DOI 10.1002/hed January 2009

Table 1. Internal consistency of the EORTC QLQ-H&N35 according to the literature. 

Ref. 7 

(Björdal et al, 1999) 

Cronbach’s alpha 

Ref. 8 (Björdal and de 

Graeff, 2000) 

Ref. 9 

(Sherman et al, 2000) 

Sample N 5 500 N 5 622 N 5 120 

Head and neck tumor patients Head and neck tumor patients Head and neck tumor patients 

with advanced disease 

Countries 

Norway, Sweden, 

The Netherlands 

Norway, Sweden, Finland, UK, 

The Netherlands, Belgium, 

France, Switzerland, Spain, 

Poland, Canada, New Zealand 

Pain in the mouth min. 0.78 0.81 0.88 

Swallowing min. 0.78 0.82 0.92 

Senses 0.10 0.72 0.54 

Speech 0.10–0.87 0.74 0.75 

Social eating 0.82 0.87 0.89 

Social contact 0.79 0.83 0.84 

Sexuality No information 0.95 0.93 

USA 

tency of the QLQ-C30 scales ranged from 0.28 

(Cognitive Functioning scale) to 0.90 (Global 

Health Status) (see Table 1). This was 1 of the first 

publications to take modules specific to head and 

neck cancer into account. 

The first version of the European Organization 

for Research and Treatment of Cancer Quality of 

Life Questionnaire module for patients with head 

and neck cancer (EORTC QLQ-H&N37) was published 

in 1994, 10 revised (EORTC QLQ-H&N35) 

and validated in 1999, 7 and tested in a large field 

study with N 5 622 patients with head and neck 

cancer from 12 different countries. 8 One critique 

that has been made of the development and 

validation of the QLQ-H&N35 is that northern 

European countries were over-represented (Norway, 

36 patients; Sweden, 63 patients; Finland, 63 

patients; UK, 92 patients; The Netherlands, 72 

patients;Belgium,36patients;France,21patients; 

Switzerland, 17 patients; Spain, 64 patients; 

Poland, 51 patients; Canada, 30 patients; New 

Zealand, 27 patients). In addition, independent 

effects of surgery and radiation have not been 

investigated extensively in prior studies. 11 

A study group from the University of Arkansas 

9 demonstrated that the QLQ-H&N35 performs 

well in American patients (55 of them having 

received surgery, 28 surgery and radiation). 

They did not, however, differentiate between surgical 

treatment modalities. The Senses scale 

(Cronbach’s alpha 5 0.54) was the only scale that 

did not have sufficient internal consistency. 

Braz et al 12 investigated Brazilian patients’ 

quality of life after total laryngectomy (N 5 14) 

versus after vertical partial laryngectomy (N 5 

16). They found significant differences on the 

Senses and Social Eating scales, whereby the total 

laryngectomy patients reported more problems 

(Senses: mean 54.8 vs 4.2, p

properties in surgically treated patients. Despite 

this fact, the instrument is already considered a 

gold standard of measurement in the development 

of other questionnaires. 14 Because patients’ and 

doctors’ assessments of health-related quality of 

life often differ, 15,16 it is important that reliable 

ways of measuring quality of life be developed. 

The aim of this study was to determine 

whether or not the EORTC QLQ-C30 and the 

EORTC QLQ-H&N35 are able to differentiate 

between different treatment modalities (radiation 

vs nonradiation and between different surgery 

methods), tumor sizes (T1–T4), and sociodemographic 

groups (men vs women, age groups) when 

assessing quality of life among laryngeal carcinoma 

patients. Another goal was determining 

how well the scales perform in terms of reliability 

(internal consistency) and construct validity. 

Because psychometric properties of an instrument 

depend on the study population, ie, Cronbach’s 

alpha tends to be higher in heterogeneous 

samples of patients, 7 a more homogeneous population 

was chosen for this study (only patients 

with laryngeal cancer). 

PATIENTS AND METHODS 

Design. In a multicenter study of 6 ear, nose, and 

throat clinics (ENT clinics) in Germany, all 

patients with laryngeal cancer who had undergone 

surgery due to laryngeal cancer and who 

were able to understand and speak German were 

requested to participate both in a personal interview 

and a written survey. The sample was formed 

using information provided by the Leipzig tumor 

registry and the participating study centers. Information 

concerning changed postal addresses of 

potential subjects was provided by the local census 

bureau. The surveys were conducted by the 

staff of the Department of Social Medicine, University 

of Leipzig. Trained psychologists and 

physicians interviewed patients face-to-face in 

their homes. Each participant was informed both 

verbally and in writing about the goals of the 

study, the voluntary nature of his/her participation, 

and the confidentiality of information 

shared. In addition, they were requested to sign 

an official consent form. In the event that a 

patient refused participation, he was informed 

once again about the goals of the study and their 

data protection rights. The study was approved by 

the local Ethics Committee of the University of 

Leipzig and by a review board of scientists convened 

by the German Federal Ministry for Education 

and Investigation. 

A control group was formed using data from a 

previous study done by our department. In that 

study a representative sample of the German 

general population (N 5 2028) completed the 

EORTC QLQ-C30. 17 A sample of persons comparable 

in age and sex distribution with the laryngeal 

cancer study population was filtered from 

that data. 

Assessment Instruments. Health-related quality 

of life was assessed with the EORTC QLQ-C30 

and EORTC QLQ-H&N35. The EORTC QLQ-C30 

is a 30-item self-report instrument, 18 specifically 

developed for patients with cancer and widely 

used in field studies and clinical trials throughout 

the world. Each item has a Likert response scale 

whereby increasing scores indicate increasing 

burden. Scores of the functional and symptom 

scales are constructed by summation, imputation 

of missing values, and transformation. The scales 

computation procedure is described in detail elsewhere. 

19 

The head and neck–specific module EORTC 

QLQ-H&N35 contains 35 items, which can be condensed 

into 7 multi-item and 11 single-item 

scales. Both questionnaires result in scales that 

score from 0 to 100. For the function scales, a score 

of 100 means perfect quality of life, whereas for 

the symptom scales it would indicate heavy burden. 

Patients also completed the Hospital Anxiety 

and Depression Scale (HADS), a questionnaire 

assessing mental distress. 20 Higher scores in the 

HADS indicate more psychological problems. 

Both questionnaires were completed independently 

by the patients. Sociodemographic and 

treatment characteristics were documented by 

the interviewers. 

Sample Characteristics. A total of 652 postal 

addresses of patients with laryngeal cancer were 

obtained. The current whereabouts could not be 

determined for 24 patients (4%), 186 patients 

were deceased (28.5%), and 66 patients refused to 

participate in the study (10%). Four patients 

could not be reached (0.5%). In total, 372 patients 

with laryngeal cancer were interviewed. Complete 

quality of life data sets were obtained from 

323 patients. 

All sociodemographic and clinical characteristics 

are displayed in Table 2. On average, the 

patients’ most recent laryngeal surgery had been 

completed 6 years before they participated in the 

study (range, 9 months to 26 years). Twenty-one 


Table 2. Demographic and clinical characteristics of 

the sample (N 5 323). 

Characteristic No. (%) Mean SD 

Sex 

Male 296 (91.6) 

Female 27 (8.4) 

Age, y 65.1 9.6 

Marital status 

Never married 101 (31.3) 

Married 154 (47.7) 

Separated/divorced 24 (7.4) 

Widowed 34 (10.5) 

Unknown 10 (3.1) 

Occupation 

Employed 25 (7.7) 

Retired 273 (84.5) 

Not employed 14 (4.3) 


Extent of surgery 

Total laryngectomy 181 (56.0) 

Partial laryngectomy 142 (44.0) 

Type of surgery 

Total laryngectomy 181 (56.0) 

CO 2 laser resection 97 (30.0) 

Open partial resection 40 (12.5) 

Other 5 (1.5) 

Time since surgery, y 5.6 4.3 

Radiation 

Irradiated 166 (51.4) 

Not irradiated 138 (42.7) 


Tumour size at time of surgery 

T0 1 (0.3) 

T1 92 (28.5) 

T2 64 (19.8) 

T3 54 (16.7) 

T4 50 (15.5) 

Unknown 62 (19.2) 

Abbreviation: SD, standard deviation. 

Analysis. Analysis was done using the software of 

the Statistical Package for Social Sciences, version 

13. Descriptive analyses of all scales and 

items were performed by describing mean scores 

and standard deviations. The internal consistency 

of the QLQ-C30 and the QLQ-H&N35 scales was 

calculated using Cronbach’s alpha. A value of 

>.70 was considered to be adequate. 

Multi-trait scaling analysis was performed to 

determine whether the structure of the QLQ-C30 

and the QLQ-H&N35 was supported. Any correlation 

of .4 or more (corrected for overlap) between 

an item and its own scale was considered evidence 

of item-convergent validity. 21 These correlation 

coefficients were then compared to the correlation 

of each item with other scales from the respective 

questionnaire in order to determine item-discriminant 

validity, thus QLQ-C30 items were compared 

with QLQ-C30 scales, and QLQ-H&N35 items 

were compared with QLQ-H&N35 scales. If the 

correlation between an item and its own scale was 

higher than its correlation with any other scale, 

this item was considered to be a scaling success. 

Correlations were determined using Pearson’s 

product-moment coefficient. 

The known-groups comparison method was 

used to explore to which extent the QLQ-C30 and 

the QLQ-H&N35 are able to discriminate between 

subgroups of patients differing in types of treatment 

modality received, tumor size, age, and sex. 

Mann–Whitney U tests and Kruskal–Wallis H 

tests for independent samples were performed to 

analyze group differences. 

All tests were performed 2-tailed and conducted 

at a 5% significance level. 

percent of the patients had been diagnosed with 

Union Internationale Contre le Cancer (UICC) 

stage IV, 16% with stage III, 14% with stage II, 

and 28% with stage I. In 21% of the cases, no 

information about the tumor stage was available. 

Some of the data that are missing were lost in 

the summer of 2002 when an enormous spate 

annihilated many medical records at 1 of the 

study centers (Dresden-Friedrichstadt). 

Forty-eight percent of the study participants 

had blue collars jobs, 36% were company employees, 

5% were civil servants, 9% were freelancers, 

and 2% did not fit into any of these categories. 

The sample selection from the German general 

population study resulted in N 5 508 subjects 

(461 men [91%]; average age, 63.3 years). 

RESULTS 

Internal Consistency. Cronbach’s alpha was calculated 

for all multi-item scales of both questionnaires. 

All coefficients can be found in Tables 3 

and 4. Cronbach’s alpha of the QLQ-C30 scales 

ranged from 0.64 (Cognitive Functioning) to 0.94 

(Global Health Status); the alpha of the QLQ- 

H&N35 ranged from 0.55 (Speech) to 0.90 (Sexuality). 

Additionally, a second analysis was performed 

to find out how the insufficient internal 

consistency of the Speech scale could be improved. 

Results showed that the problematic item was the 

question: ‘‘Have you been hoarse’’ After removal 

of that item, the internal consistency increased 

to 0.80. In laryngectomized patients, Cronbach’s 

alpha of the speech scale was 0.54 (without the 

Validation of EORTC QLQ in Patients with Laryngeal Cancer HEAD & NECK—DOI 10.1002/hed January 2009 67

Table 3. Reliability and construct validity coefficients and descriptive statistics for EORTC QLQ-C30 scales in patients 

with laryngeal cancer after surgery. 

Mean 

SD 

Cronbach’s 

alpha 

Corrected item-total 

correlation* 

Item-other scale 

correlation y 

Scaling 

errors 

Function scores 

Physical functioning 71.4 21.2 0.75 .42–.63 .11–.53 3 (4.0%) 

Role functioning 68.9 32.2 0.88 .79–.79 .21–.60 0 (0.0%) 

Emotional functioning 72.7 25.4 0.85 .64–.76 .16–.68 0 (0.0%) 

Cognitive functioning 83.5 21.3 0.64 .47–.47 .12–.58 3 (10.0%) 

Social functioning 74.8 29.5 0.81 .69–.69 .20–.64 0 (0.0%) 

Global health status 59.4 23.4 0.94 .90–.90 .10–.50 0 (0.0%) 

Symptom scores 

Fatigue 34.5 26.7 0.82 .65–.69 .18–.68 1 (2.2%) 

Nausea and vomiting 5.9 15.3 0.72 .59–.59 .09–.56 0 (0.0%) 

Pain 23.6 28.6 0.84 .72–.72 .21–.58 0 (0.0%) 

Dyspnea 36.8 35.3 n.a. n.a. .12–.59 n.a. 

Insomnia 27.2 34.9 n.a. n.a. .21–.54 n.a. 

Appetite loss 15.9 28.3 n.a. n.a. .18–.50 n.a. 

Constipation 10.4 22.7 n.a. n.a. .02–.32 n.a. 

Diarrhea 10.6 22.5 n.a. n.a. .09–.39 n.a. 

Financial difficulties 30.9 36.1 n.a. n.a. .02–.43 n.a. 

Abbreviations: SD, standard deviation; n.a., not applicable (single-item scale). 

*Item-own scale correlation, corrected for overlap. 

y The opposite value is displayed for negative correlations. 

Hoarseness-item: 0.77), whereas in patients who 

had a partial laryngectomy the alpha was 0.73 

when the hoarseness item was included and 0.81 

when it was not. Another important difference in 

alpha coefficients between the treatment options 

was found on the Senses scale. Although the internal 

consistency was sufficient (0.69) for patients 

who had a partial resection of their larynx, the 

scale did not perform adequately for patients who 

had undergone a total laryngectomy (0.58). Since 

this scale consists of only 2 items, the alpha 

cannot be improved by removing 1 of them. 

Table 4. Reliability and construct validity coefficients and descriptive statistics for the EORTC QLQ-H&N35 scales in patients 

with laryngeal cancer after surgery. 

Mean 

SD 

Cronbach’s 

alpha 

Corrected item-total 

correlation* 

Item-other scale 

correlation y 

Scaling 

errors 

Pain in the mouth 12.6 18.6 0.73 .42–.69 .00–.55 1 (1.4%) 

Swallowing 15.1 23.0 0.81 .53–.78 .02–.73 1 (1.4%) 

Senses 37.1 35.1 0.70 .55–.55 .01–.41 0 (0.0%) 

Speech 31.6 27.0 0.55 .13–.53 .01–.65 13 (24.1%) 

Social eating 14.4 23.5 0.86 .69–.76 .01–.70 0 (0.0%) 

Social contact 10.2 16.0 0.80 .54–.70 .02–.53 0 (0.0%) 

Sexuality 32.9 35.3 0.90 .83–.83 .00–.44 0 (0.0%) 

Problems with teeth 21.8 34.5 n.a. n.a. .05–.42 n.a. 

Problems opening mouth 12.7 26.1 n.a. n.a. .03–.46 n.a. 

Dry mouth 28.3 33.0 n.a. n.a. .02–.56 n.a. 

Sticky saliva 27.4 35.4 n.a. n.a. .04–.56 n.a. 

Coughed 44.2 33.1 n.a. n.a. .04–.43 n.a. 

Felt ill 24.7 32.1 n.a. n.a. .08–.56 n.a. 

Painkillers 22.8 42.0 n.a. n.a. .03–.29 n.a. 

Nutritional supplements 7.1 25.8 n.a. n.a. .01–.25 n.a. 

Feeding tube 7.5 26.3 n.a. n.a. .02–.44 n.a. 

Weight loss 16.7 37.3 n.a. n.a. .08–.34 n.a. 

Weight gain 30.2 46.0 n.a. n.a. .01–.23 n.a. 

Abbreviations: SD, standard deviation; n.a., not applicable (single-item scale). 

*Item-own scale correlation, corrected for overlap. 

y The opposite value is displayed for negative correlations. 


Table 5. Correlations between the EORTC QLQ-H&N35 and the EORTC QLQ-C30 scales. 

EORTC QLQ-C30 scales 

EORTC QLQ-H&N35 scales 

PF RF EF CF SF QL F NV P Dy In AL Co Di FD 

Pain in the mouth 2.347** 2.395** 2.421** 2.318** 2.362** 2.173** .466** .308** .529** .285** .346** .385** .423** .107 .280** 

Swallowing 2.400** 2.453** 2.415** 2.304** 2.359** 2.238** .455** .286** .463** .268** .309** .334** .278** .109 .232** 

Senses 2.263** 2.297** 2.192** 2.134* 2.314** 2.161** .266** .216** .146** .273** .101 .284** .163** .078 .207** 

Speech 2.309** 2.319** 2.436** 2.325** 2.452** 2.262** .359** .268** .269** .230** .226** .215** .203** .048 .248** 

Social eating 2.402** 2.416** 2.461** 2.348** 2.454** 2.223** .486** .380** .352** .316** .280** .489** .259** .126* .251** 

Social contact 2.481** 2.475** 2.623** 2.455** 2.690** 2.315** .526** .420** .434** .358** .339** .404** .399** .171** .349** 

Sexuality 2.317** 2.351** 2.401** 2.294** 2.440** 2.277** .408** .237** .288** .240** .227** .265** .277** .208** .196** 

Problems with teeth 2.204** 2.258** 2.230** 2.238** 2.270** 2.040 .225** .314** .226** .122* .156** .303** .204** .061 .218** 

Problems opening mouth 2.373** 2.338** 2.289** 2.239** 2.348** 2.152** .306** .253** .354** .236** .133* .246** .305** .131* .265** 

Dry mouth 2.174** 2.211** 2.231** 2.230** 2.200** 2.109 .259** .231** .228** .199** .200** .260** .176** .085 .257** 

Sticky saliva 2.296** 2.341** 2.306** 2.282** 2.359** 2.072 .310** .199** .283** .194** .148** .284** .265** .052 .257** 

Coughed 2.274** 2.318** 2.333** 2.241** 2.301** 2.188** .357** .275** .287** .367** .263** .233** .150** .202** .150** 

Felt ill 2.476** 2.542** 2.548** 2.364** 2.528** 2.405** .623** .459** .533** .389** .453** .385** .283** .273** .290** 

Painkillers 2.230** 2.139* 2.184** 2.141* 2.128* 2.149* .220** .209** .399** .134* .204** .184** .228** .148** .068 

Nutritional supplements 2.127* 2.106 2.129* 2.028 2.092 .015 .129* .116* .123* .140* .072 .186** .173** 2.078 2.026 

Feeding tube 2.190** 2.107 2.153** 2.065 2.189** .001 .094 .076 .150** .061 .059 .100 .172** 2.025 .089 

Weight loss 2.167** 2.146** 2.206** 2.099 2.109 2.064 .144* .247** .115* 2.009 .021 .282** .152** .075 .090 

Weight gain 2.101 2.091 2.017 .011 2.045 2.028 .051 .041 .016 .096 2.083 2.082 2.083 .033 .066 

Abbreviations: PF, physical functioning; RF, role functioning; EF, emotional functioning; CF, cognitive functioning; SF, social functioning; QL, global health status/quality of life; F, fatigue; NV, nausea and 

vomiting; P, pain; Dy, dyspnea; In, insomnia; AL, appetite loss; Co, constipation; Di, diarrhea; FD, financial difficulties. 

Note: Higher scores in the functioning scales (PF to QL) indicate better quality of life, whereas higher scores in the symptoms scales (F to FD) identify more problems. 

*Correlation is significant at the 0.05 level. 

**Correlation is significant at the 0.01 level. 


Table 6. Differences in the EORTC QLQ-C30 and EORTC QLQ-H&N35 scales by sex and age. 

Sex 

Men Women 75 y 

N 5 296 N 5 27 N 5 19 N 5 125 N 5 113 N 5 58 

Mean SD Mean SD p Mean SD Mean SD Mean SD Mean SD p 

EORTC QLQ-C30 

PF 71.2 20.9 73.6 24.6 .35 70.5 19.0 72.1 19.2 70.9 24.2 71.3 20.8 .96 

RF 68.5 32.4 73.5 30.4 .54 63.0 30.5 63.2 32.5 72.9 31.7 72.7 33.0 .04 

EF 72.4 25.5 76.9 23.9 .37 60.5 24.7 69.7 26.0 73.3 26.2 82.5 19.4 .00 

EF 83.0 21.5 89.5 18.6 .08 78.1 20.1 84.3 20.1 85.1 22.4 80.7 21.6 .09 

SF 74.1 29.6 81.5 27.9 .18 70.2 28.6 70.9 30.6 77.7 30.4 79.3 24.2 .07 

QL 58.8 23.2 65.7 25.1 .18 58.8 18.8 57.8 23.3 60.0 26.1 61.2 20.5 .67 

Fa 35.2 26.8 26.8 25.1 .08 44.4 24.0 36.4 26.2 33.2 28.5 29.0 24.4 .06 

NV 6.0 14.9 4.3 19.4 .14 2.6 8.4 7.3 18.1 6.3 15.8 2.9 7.7 .50 

Pa 24.0 28.5 18.5 29.7 .18 29.8 31.2 26.4 29.8 22.9 29.2 17.2 23.6 .18 

Dy 37.5 35.4 29.6 33.8 .27 47.4 35.7 38.1 35.8 36.9 35.7 30.5 32.6 .30 

In 26.0 34.2 40.7 39.6 .06 25.9 33.4 33.3 37.4 25.0 34.2 20.1 30.6 .13 

AL 15.4 27.6 21.0 36.0 .64 14.0 23.1 18.1 28.9 13.9 28.8 15.5 28.8 .39 

Co 10.9 23.3 4.9 15.2 .20 0.0 0.0 8.8 20.4 10.8 23.0 14.4 26.6 .09 

Di 10.4 21.9 12.4 28.0 .87 10.5 22.4 12.5 23.8 9.2 20.1 9.8 25.0 .54 

FD 32.1 36.3 18.5 31.1 .05 66.7 29.4 40.8 37.8 23.1 33.3 12.6 23.2 .00 

EORTC QLQ-H&N35 

hnpa 12.6 18.2 12.5 22.4 .51 14.5 20.4 13.7 17.9 13.7 20.6 7.3 14.7 .08 

hnsw 14.5 21.7 20.9 33.7 .83 19.3 28.9 18.5 22.7 12.7 21.6 10.4 21.6 .01 

hnse 37.9 35.2 28.6 33.3 .17 47.4 34.4 39.7 33.5 38.1 35.3 27.3 37.0 .03 

hnsp 32.0 26.6 27.2 31.3 .19 32.7 22.4 32.8 27.6 32.2 28.7 26.2 23.7 .52 

hnso 14.6 23.9 11.7 18.1 .71 19.7 27.4 17.7 25.8 11.6 21.5 11.2 20.6 .08 

hnsc 10.2 15.8 10.2 18.6 .71 10.0 10.4 13.4 18.1 9.2 15.7 4.8 10.7 .01 

hnsx 33.0 35.0 31.9 38.7 .79 25.4 30.6 32.1 34.9 33.2 35.4 36.4 37.9 .78 

hnte 22.0 34.7 19.1 33.3 .72 26.3 37.8 28.8 38.5 17.7 31.7 13.5 25.9 .03 

hnop 12.9 25.9 10.7 28.8 .33 19.3 30.1 15.9 28.8 11.4 24.8 7.6 20.9 .10 

hndm 28.3 33.0 28.6 33.6 .94 29.8 33.1 34.7 35.1 24.0 32.2 22.6 27.0 .06 

hnss 28.7 35.6 14.3 30.7 .02 35.1 36.0 29.9 35.5 26.7 36.1 23.6 34.9 .36 

hnco 44.1 32.8 45.2 36.5 .90 56.1 25.0 48.5 33.2 41.1 34.5 38.5 31.1 .07 

hnfi 25.0 32.3 21.4 30.4 .63 28.1 29.9 31.0 36.6 20.0 30.4 20.7 24.0 .08 

hnpk 23.0 42.1 21.4 41.8 .85 10.5 31.5 25.2 43.6 23.4 42.5 23.7 42.9 .58 

hnns 7.5 26.4 3.6 18.9 .44 10.5 31.5 7.9 27.1 7.2 26.0 5.2 22.3 .86 

hnft 6.5 24.7 17.9 39.0 .03 10.5 31.5 8.8 28.4 6.3 24.4 3.4 18.4 .54 

hnwl 17.9 38.4 3.6 18.9 .05 10.5 31.5 18.1 38.7 14.4 35.3 20.3 40.6 .64 

hnwg 30.1 45.9 32.1 47.6 .82 31.6 47.8 38.6 48.9 27.9 45.1 13.6 34.5 .01 

Abbreviations: SD, standard deviation; PF, physical functioning; RF, role functioning; EF, emotional functioning; CF, cognitive functioning; SF, social 

functioning; QL, global health status/quality of life; F, fatigue; NV, nausea and vomiting; P, pain; Dy, dyspnea; In, insomnia; AL, appetite loss; Co, constipation; 

Di, diarrhea; FD, financial difficulties; hnpa, pain in the mouth; hnsw, swallowing; hnse, senses; hnso, social eating; hnsc, social contact; 

hnsx, sexuality; hnte, problems with teeth; hnop, problems opening mouth; hndm, dry mouth; hnss, sticky saliva; hnco, coughed; hnfi, felt ill; hnpk, 

painkillers; hnns, nutritional supplements; hnft, feeding tube; hnwl, weight loss; hnwg, weight gain. 

Note: p denotes significance level. 

Age 

Scale Structure. Multitrait scaling analysis confirmed 

the proposed scale structure of both questionnaires. 

In the EORTC QLQ-C30, only 1 scale 

did not perform well, namely the Cognitive Functioning 

scale (10% scaling errors). The problematic 

item of the Cognitive Functioning scale was 

the question: ‘‘Have you had difficulty in concentrating 

on things like reading a newspaper or 

watching television’’ something which is moderately 

correlated with Emotional Functioning 

(.60), Social Functioning (.50), and Pain (.50). In 

the EORTC QLQ-H&N35, the performance of the 

Speech scale was not satisfactory (24% scaling 

errors). Occurrences of scaling errors affiliated 

with the Speech scale were due to the fact that the 

Hoarseness item is barely associated with the 

scale itself (.13). Moreover, all 3 items correlate 

with the Social Contact scale (.18–.65). All other 

scales showed a high level of convergent validity 

(see Tables 3 and 4). 

Discriminant Validity. Two hundred thirty-three 

(86.3%) of the possible absolute correlations (the 

opposite value were mentioned for negative corre- 


Table 7. Differences in the EORTC QLQ-C30 and EORTC QLQ-H&N35 scales by treatment. 

Extent of surgery 

Radiation 

Time since surgery 

TL PL R NR 5 y >5 y 

N 5 181 N 5 142 N 5 166 N 5 138 N 5 161 N 5 140 

Mean SD Mean SD p Mean SD Mean SD p Mean SD Mean SD p 


PF 68.2 20.3 75.5 21.7 .00 67.0 20.4 76.8 21.0 .00 70.4 21.8 72.6 20.3 .46 

RF 64.4 32.3 74.5 31.4 .00 62.3 33.0 75.8 30.4 .00 67.8 32.7 69.6 31.8 .65 

EF 71.3 25.4 74.5 25.3 .19 69.5 26.0 76.5 24.4 .01 72.9 25.7 72.3 25.8 .80 

EF 85.5 20.2 81.1 22.6 .05 81.8 22.5 85.3 19.9 .19 83.0 22.2 84.7 19.6 .72 

SF 71.2 29.9 79.4 28.3 .01 68.5 31.8 82.8 24.7 .00 74.2 29.9 75.7 28.8 .65 

QL 59.3 22.5 59.4 24.5 .95 58.6 22.4 60.0 25.0 .58 58.3 24.4 59.6 22.6 .50 

Fa 36.7 25.8 31.6 27.5 .04 39.7 27.1 28.5 25.4 .00 36.0 27.9 32.2 25.8 .28 

NV 7.5 16.0 3.9 14.1 .00 6.5 16.2 5.1 14.5 .25 4.3 12.4 7.5 18.4 .15 

Pa 24.8 28.6 22.1 28.6 .30 26.4 29.9 19.0 26.3 .02 23.3 31.1 22.6 25.8 .47 

Dy 40.9 35.3 31.7 34.7 .02 41.2 36.7 30.9 32.1 .02 37.9 35.1 35.7 35.5 .56 

In 29.1 35.1 24.8 34.6 .20 30.7 37.5 23.2 32.4 .10 27.0 35.4 27.6 34.8 .80 

AL 19.5 30.2 11.3 25.1 .00 21.9 31.9 8.7 21.8 .00 15.3 28.4 15.5 28.1 .87 

Co 12.1 25.2 8.2 19.1 .21 12.3 24.8 6.3 16.4 .04 8.5 20.2 10.1 22.3 .58 

Di 10.6 21.6 10.6 23.6 .62 8.6 19.0 12.9 26.0 .32 10.1 21.7 11.5 23.6 .67 

FD 34.1 36.6 26.9 35.1 .06 35.8 38.0 24.6 32.7 .01 36.7 38.0 24.3 32.3 .01 


hnpa 14.7 20.1 9.9 16.2 .02 17.3 21.1 6.1 11.8 .00 14.1 20.0 9.9 16.5 .03 

hnsw 15.6 23.0 14.4 23.1 .39 19.5 25.1 9.1 17.5 .00 18.0 25.0 11.2 19.2 .01 

hnse 56.5 30.5 12.9 23.5 .00 51.6 34.0 18.2 26.8 .00 37.1 36.2 38.2 34.0 .69 

hnsp 32.2 27.5 30.8 26.5 .70 33.4 28.8 28.7 24.6 .24 34.3 26.9 28.2 27.2 .03 

hnso 17.7 23.4 10.3 23.0 .00 21.4 27.2 5.6 14.1 .00 17.8 26.2 10.4 19.9 .01 

hnsc 12.2 16.5 7.7 15.0 .00 12.2 17.2 7.3 13.1 .02 10.8 16.6 9.1 15.1 .35 

hnsx 37.5 35.6 27.3 34.2 .01 37.4 36.9 26.6 32.8 .01 32.6 35.8 32.3 33.8 .84 

hnte 25.2 36.5 17.5 31.6 .04 26.9 37.9 14.3 27.0 .00 20.4 33.3 21.5 34.8 .90 

hnop 15.7 28.2 8.9 22.8 .01 19.9 30.9 3.9 14.0 .00 15.4 28.6 9.8 22.9 .09 

hndm 24.1 31.1 33.6 34.5 .01 38.4 35.4 16.1 23.9 .00 31.3 34.2 23.7 30.2 .06 

hnss 29.3 35.6 25.1 35.1 .22 40.2 38.7 11.6 23.5 .00 31.3 37.6 22.1 31.0 .05 

hnco 49.7 32.6 37.3 32.5 .00 51.1 32.6 36.2 31.6 .00 44.2 34.2 44.0 32.7 .99 

hnfi 28.6 33.4 19.8 29.9 .01 29.3 34.4 19.5 28.8 .01 24.4 33.1 24.9 31.9 .76 

hnpk 22.2 41.7 23.6 42.6 .77 24.9 43.3 20.4 40.5 .36 21.6 41.3 24.1 42.9 .60 

hnns 6.7 25.1 7.6 26.7 .76 7.7 26.7 6.6 25.0 .72 8.7 28.3 5.7 23.3 .32 

hnft 6.7 25.1 8.4 27.8 .58 11.2 31.7 2.2 14.8 .00 10.0 30.1 3.6 18.6 .03 

hnwl 20.0 40.1 12.5 33.2 .07 23.7 42.6 8.0 27.3 .00 20.4 40.4 12.8 33.5 .08 

hnwg 35.0 47.8 24.3 43.0 .04 31.4 46.5 27.7 44.9 .49 28.4 45.2 32.6 47.1 .43 

Abbreviations: SD, standard deviation; TL, total laryngectomy; PL, partial laryngectomy; R, radiation therapy; NR, no radiation therapy; PF, physical 

functioning; RF, role functioning; EF, emotional functioning; CF, cognitive functioning; SF, social functioning; QL, global health status/quality of life; F, fatigue, 

NV, nausea and vomiting; P, pain; Dy, dyspnea; In, insomnia; AL, appetite loss; Co, constipation; Di, diarrhea; FD, financial difficulties; hnpa, 

pain in the mouth; hnsw, swallowing; hnse, senses; hnso, social eating; hnsc, social contact; hnsx, sexuality; hnte, problems with teeth; hnop, problems 

opening mouth; hndm, dry mouth; hnss, sticky saliva; hnco, coughed; hnfi, felt ill; hnpk, painkillers; hnns, nutritional supplements; hnft, feeding tube; 

hnwl, weight loss; hnwg, weight gain. 


lations) between the head and neck cancer module 

QLQ-H&N35 and the core questionnaire QLQ- 

C30 were weak (r < .40), 34 (12.6%) were moderate 

(r 5 .40–.60), and 3 (1.1%) were strong (r > 

.60). Strong correlations were evident between 

the Social Contact scale of the QLQ-H&N35 and 

the Social Functioning as well as the Emotional 

Functioning scale of the QLQ-C30. Another 

strong correlation was found between the Felt Ill 

scale of the QLQ-H&N35 and the Fatigue scale of 

the QLQ-C30 (for details see Table 5). 

Correlations between the QLQ-C30 and the 

HADS anxiety subscale ranged from .16 (Constipation) 

to .68 (Emotional Functioning) and were, 

on average, .37. The associations with the depression 

subscale ranged from to .12 (Diarrhea) to .62 

(Social Functioning), and the average was .40. 

Fifteen correlations (50%) were weak, 13 (43.3%) 

were moderate, and 2 (6.7%) were strong. 

The maximum correlation between the QLQ- 

H&N35 scales and the HADS anxiety score was 

found to be .49 (Social Contact), the minimum 


Table 8. Differences in the EORTC QLQ-C30 and EORTC QLQ-H&N35 scales by tumor size. 

Tumor size at the time of the surgery 

T1 T2 T3 T4 

N 5 92 N 5 64 N 5 54 N 5 50 

Mean SD Mean SD Mean SD Mean SD p 


PF 81.2 19.3 67.1 19.0 66.8 20.9 69.5 21.4 .00 

RF 80.3 28.6 63.3 33.4 63.0 33.6 66.3 32.3 .00 

EF 77.9 24.0 70.7 25.9 69.9 27.7 70.0 23.6 .08 

EF 83.3 19.6 79.7 23.8 86.1 20.7 85.5 21.6 .19 

SF 84.8 22.4 72.4 32.3 69.1 33.6 69.1 29.1 .00 

QL 61.3 25.3 57.0 24.2 59.2 20.8 57.9 25.7 .72 

Fa 26.5 24.1 37.8 28.0 38.5 27.9 38.2 26.8 .01 

NV 2.0 7.3 7.8 20.8 7.4 17.0 4.6 10.8 .05 

Pa 18.8 24.1 22.1 31.2 25.3 28.7 26.2 28.0 .32 

Dy 26.8 30.2 39.1 36.4 46.3 36.9 39.7 38.5 .01 

In 19.6 30.5 31.7 37.6 29.0 38.3 27.0 35.9 .23 

AL 7.2 20.3 17.2 30.3 18.5 28.7 19.9 27.5 .00 

Co 5.9 16.2 8.3 18.8 8.6 19.6 12.1 23.5 .35 

Di 9.9 24.1 13.5 24.3 13.0 25.4 7.1 18.3 .24 

FD 19.5 30.1 35.4 37.0 40.1 36.8 38.3 39.9 .00 


hnpa 7.7 13.5 11.8 16.0 15.7 19.5 14.5 18.0 .02 

hnsw 8.7 16.2 17.8 23.0 14.3 22.0 20.0 24.4 .00 

hnse 11.9 23.9 34.1 33.1 46.5 29.1 55.2 33.3 .00 

hnsp 29.2 23.5 29.6 28.5 27.8 28.6 39.0 27.5 .10 

hnso 4.3 10.7 15.9 29.2 18.1 21.7 24.3 26.8 .00 

hnsc 4.8 10.1 12.3 16.5 10.4 16.8 14.0 15.8 .00 

hnsx 24.2 32.5 32.0 34.4 43.7 38.1 44.8 36.9 .00 

hnte 13.5 26.0 21.4 33.3 28.9 38.7 25.8 38.6 .07 

hnop 5.4 17.2 14.1 27.1 12.6 22.9 21.5 31.1 .00 

hndm 23.3 29.0 37.5 36.4 33.3 34.0 25.8 30.4 .07 

hnss 13.6 25.6 34.9 37.1 37.2 38.3 34.1 37.7 .00 

hnco 31.9 30.1 49.0 32.0 50.9 31.8 51.1 34.5 .00 

hnfi 17.4 27.1 27.1 35.1 27.7 33.8 28.9 34.5 .14 

hnpk 20.7 40.7 21.2 41.2 24.1 43.2 31.9 47.1 .48 

hnns 4.3 20.5 9.1 29.0 1.9 13.7 8.5 28.2 .29 

hnft 2.2 14.7 10.6 31.0 3.8 19.4 17.0 38.0 .01 

hnwl 7.6 26.7 25.8 44.1 13.0 33.9 23.4 42.8 .01 

hnwg 26.1 44.2 28.8 45.6 37.0 48.7 31.9 47.1 .56 

Abbreviations: SD, standard deviation; PF, physical functioning; RF, role functioning; EF, emotional functioning; CF, cognitive functioning; SF, social 

functioning; QL, global health status/quality of life; F, fatigue; NV, nausea and vomiting; P, pain; Dy, dyspnea; In, insomnia; AL, appetite loss; Co, constipation; 

Di, diarrhea; FD, financial difficulties; hnpa, pain in the mouth; hnsw, swallowing; hnse, senses; hnso, social eating; hnsc, social contact; 

hnsx, sexuality; hnte, problems with teeth; hnop, problems opening mouth; hndm, dry mouth; hnss, sticky saliva; hnco, coughed; hnfi, felt ill; hnpk, 

painkillers; hnns, nutritional supplements; hnft, feeding tube; hnwl, weight loss; hnwg, weight gain. 


correlation was .03 (Feeding tube), and the average 

correlation was .22. The QLQ-H&N35 scales 

and HADS depression subscale correlated the 

most at the Social Contact scale (.54) and the least 

at the Weight Gain scale (.05). 

In the majority of the cases (83.3%), there was 

either a weak correlation or none at all between 

the QLQ-H&N35 scales and the Hospital Anxiety 

and Depression subscales. Six (16.7%) of the correlations 

were moderate, and none were strong. 

Known-group comparisons showed multiple 

differences in sociodemographic and clinical variables 

(see Tables 6–8). Both questionnaires discriminated 

well between patients with small tumors 

versus patients with advanced tumors. Eleven of 

18 QLQ-H&N35 and 8 of 15 QLQ-C30 scales indicated 

significant differences. Regarding the type 

of the treatment (partial vs total laryngectomy 

and radiation vs no radiation), the QLQ-H&N35 

performed better than the QLQ-C30 in discriminating 

between various patient groups. Seven of 

the QLQ-C30 and 11 of the QLQ-H&N35 scales 

differentiated significantly between partial 

and total laryngectomy, as did 10 (QLQ-C30) and 


Table 9. Differences in the EORTC QLQ-C30 between patients with laryngeal cancer and the German general population, matched 

by sex and age. 

Patients 

General Population 

N 5 323 N 5 508 

Mean SD Mean SD 

p 

diff 

Physical functioning 71.4 21.2 86.5 19.4 .00 15.0 

Role functioning 68.9 32.2 84.3 26.1 .00 15.4 

Emotional functioning 72.7 25.4 79.9 19.9 .00 7.2 

Cognitive functioning 83.5 21.3 88.8 18.3 .00 5.3 

Social functioning 74.8 29.5 87.9 21.9 .00 13.1 

Global health status 59.4 23.4 66.6 22.1 .00 7.2 

Fatigue 34.5 26.7 20.1 23.7 .00 14.4 

Nausea and vomiting 5.9 15.3 2.4 8.4 .00 3.5 

Pain 23.6 28.6 20.7 28.1 .15 2.9 

Dyspnea 36.8 35.3 12.2 23.9 .00 24.6 

Insomnia 27.2 34.9 19.7 29.1 .00 7.5 

Appetite loss 15.9 28.3 5.9 16.2 .00 10.0 

Constipation 10.4 22.7 4.2 14.9 .00 6.2 

Diarrhea 10.6 22.5 2.6 10.0 .00 8.0 

Financial difficulties 30.9 36.1 8.5 21.9 .00 22.4 

Abbreviations: SD, standard deviation; diff, difference between means (>10 5 clinically significant, indicated by bold numbers). 


14 (QLQ-H&N35), respectively, between radiation 

therapy versus no radiation. Interestingly, the 

Speech scale showed no significant differences 

between surgical treatment groups. 

The adjustment to and the recovery from the 

disease (time elapsed since surgery) resulted in 

only 1 difference in the QLQ-C30 and 6 statistically 

significant differences in the QLQ-H&N35. 

The QLQ-H&N35 indicated differences between 

age and sex more clearly than the QLQ-C30 

though, all in all, these sociodemographic variables 

did not appear to considerably influence 

patients’ overall quality of life (QLQ-C30: differences 

in 3 and 0 scales; QLQ-H&N35: 5 and 3 

scales, respectively). 

Fourteen QLQ-30 scales showed statistically 

significant differences between the German general 

population and patients with laryngeal cancer. 

Seven of them (Physical Functioning, Role 

Functioning, Social Functioning, Fatigue, Dyspnea, 

Appetite Loss, Financial Difficulties) were, 

with more than a 10-point difference, also of definitive 

clinical importance. 22 Details are listed in 

Table 9. 

DISCUSSION 

This investigation examined the reliability and 

validity of the recently developed EORTC QLQ- 

H&N35 and the EORTC QLQ-C30 for patients 

who have undergone surgery due to laryngeal 

cancer. Results indicate that both questionnaires 

perform well in terms of internal consistency and 

construct validity. In this study, the Speech and 

the Cognitive Functioning scale showed to be 

problematic. The latter scale has performed 

unsatisfactorily in other populations as well. 18 It 

seems that concentration problems are more a 

matter of emotional well-being than mental 

performance. 

The poor performance of the Speech scale, 

however, appears to be limited to patients with laryngeal 

cancer and has not been found in those 

with other types of head and neck cancer. 7–9 This 

fact is easy to explain: the Hoarseness item 

decreases the internal consistency considerably. 

Patients who have undergone a total laryngectomy 

are inevitably never hoarse because they do 

not have a larynx. At least in the German language, 

the word ‘‘hoarse’’ is only applicable if the 

speaker has a laryngeal voice. An artificial larynx 

always has the same somewhat mechanical sound 

and the tracheoesophageal voice would never 

be described as sounding hoarse. In our study, 

laryngectomized patients, understandably, even 

reacted angrily sometimes when asked if they are 

ever hoarse. One possible solution for this problem 

would be removing this item when investigating 

laryngectomies, thus making it possible to avoid 

asking ‘‘stupid questions.’’ Another possibility 

would be to substitute the ‘‘hoarseness’’ question 

with another item asking about the patient’s level 


of satisfaction with the sound of the (a)laryngeal 

voice. This would be a more general wording and 

could still cover the quality of life domain the 

authors of the QLQ-H&N35 presumably would 

have liked to assess. Evidently, this would result 

in a new version of the questionnaire, and therefore, 

the validating process needed to start again. 

Additionally, the EORTC quality of life group usually 

avoids using items asking about patients’ feelings 

of dissatisfaction with a particular symptom. 

They prefer to ask about the occurrence of symptoms 

rather their impact. The style of the QLQ- 

H&N35 would, therefore, lose some of its coherence. 

Still, we think that a discussion about this 

problem, hopefully resulting in a more generally 

usable version of the item, would be worthwhile. 

As the related literature indicates that the 

Senses scale has a low level of internal consistency, 

7–9 we also conducted a separate analysis of 

this scale for patients after total versus after partial 

laryngectomy despite the fact that the alpha 

in the overall sample was satisfactory. Indeed, we 

found that the alpha of this scale was very low for 

patients who had undergone a total laryngectomy. 

We would, therefore, recommend handling these 

items not as a scale but rather as single items. 

Correlations of the QLQ-H&N35 with the 

QLQ-C30 and the HADS were mainly weak, indicating 

that despite shared variance with the other 

questionnaires, the head and neck module contributes 

distinctive information, a result that is in 

accordance with Sherman et al. 9 Considerable 

overlap was found between the Emotional and 

Social Functioning, Insomnia, Social Contact, and 

Feeling ill scales on the one hand and both subscales 

(anxiety and depression) of the HADS on 

the other hand, all together creating strong evidence 

of convergent validity. 

As shown in other studies, 2 the QLQ-H&N35 

performed slightly better in discriminating 

between patient groups than did the QLQ-C30. 

Both questionnaires, however, contributed distinctive 

information and should be used together, 

as it was intended by the group who developed the 

questionnaires. 8,23 

We could show that the QLQ-H&N35 is able to 

distinguish significantly between different surgical 

treatments in terms of resulting pain in the 

mouth, problems with senses, social eating, social 

contact, sexuality, problems with teeth, difficulties 

in opening the mouth, xerostomia, feeling ill, 

and weight gain. Interestingly, the scores of the 

Speech scale in the laryngetomized group were 

not distinct from those of the partially resected 

patients, even though relevant differences here 

might be expected, because the quality of the postoperative 

voice is considerably better when the 

larynx can be preserved. 24–26 This counterintuitive 

result could be an effect of the questionnaire 

performing poorly, or more likely, of differing 

expectations on the part of the patients. 27 It might 

be possible that the EORTC H&N35 module is, in 

its present version, not sensitive to differences in 

speech difficulties, and additional symptom scales 

must be administered. 28 On the other hand, for 

economic and practical reasons it would be useful 

to administer 1 single questionnaire. Therefore, 

we would prefer using a revised EORTC head and 

neck module in our studies that includes additional 

sensitive items, for example ‘‘communicating 

in noisy environments.’’ In our view, it 

would be a good task for a consensus group, representing 

healthcare professionals from different 

disciplines, to develop appropriate items and to 

decide whether additional scales or an update of 

the H&N35 are preferable. 

In that consensus group, it would also be useful 

to develop additional items covering typical 

side effects of new treatment strategies such as 

chemoradiation or antibody therapy. These issues 

are not covered by the H&N35 module because it 

was developed before those treatments were common 

in patients with head and neck cancer. 

Regarding radiation therapy side effects, 

according to our data as well as others’, 29 the 

H&N35 seems to be very sensitive, indicating 

excellent discriminant validity in this respect. 

Stoeckli et al 30 do have results that differ from 

these; however, it is presumable that their data 

could not reach statistical significance levels 

because of the sample size—only 16 of their study 

participants had been irradiated. 

Both questionnaires, the QLQ-C30 and the 

QLQ-H&N35, showed little differences between 

men and women, which is useful to know for further 

studies. As laryngeal cancer is rarer in 

women than in men, 31 it is often difficult to balance 

study designs regarding sex effects. 

Although it is known that women are more likely 

to report health complaints, 17 especially anxiety 

symptoms, 32 this was not the case in our study. 

Elderly patients reported significantly fewer 

emotional, role, and financial difficulties, and 

even fewer health-related symptoms such as difficulties 

with senses and dry mouth, an effect that 

is fairly common in other cancer groups 33 but not 

in patients with head and neck cancer. 11 Interestingly, 

in a general population survey done with 


the QLQ-C30, older people generally reported 

more problems. 17 

When compared with the matched data from 

the German general population, our study participants 

reported more not only statistically but also 

clinically relevant problems. 22 Taking into 

account that the time since operation was, on average, 

6 years, we should conclude that even years 

after initial treatment individuals are still undergoing 

significant difficulties, warranting a reconsideration 

of continued rehabilitation and management 

of their health-related complaints. It 

would be useful to conduct a similar comparison 

study with the EORTC QLQ-H&N35. 

To summarize, it can be concluded that the 

QLQ-H&N35, in conjunction with the QLQ-C30, 

is a valuable and reliable instrument that is able 

to differentiate between diverse groups of patients 

with laryngeal cancer regarding treatment modality 

(surgery, radiation), tumor size, time 

elapsed since surgery, and age. 

Acknowledgments. The authors thank the 

following investigators who recruited and/or 

interviewed the patients: R. Täschner, U. Kienast, 

E. Herrmann, A. Meyer, H. Danker, N. Seidel, J. 

Dudda, S. Klötzner, S. Schmidt, and S. Fleischmann. 

F. Mädler and W. Kubitza (The German 

Association of Post-Laryngeal Cancer Surgery 

Patients) also gave us valuable support. Many 

thanks are extended to all patients who were willing 

to participate in our study. Two anonymous 

reviewers gave valuable advice for the improvement 

of earlier versions of the manuscript. 

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