Translation and validation of the Hungarian Hospital Anxiety and Depression Scale using a large cancer patient sample

Katalin Muszbek1, Anna Szekely2, va Mria Balogh3, Mria Molnr4, Magdolna Rohnszky5, gnes Ruzsa6, Katalin Varga7, Melinda Szllsi1, Piroska Vadsz1
1 2

Hungarian Hospice Foundation, Budapest, Hungary Institute of Psychology, Etvs Lornd University, Budapest, Hungary 3 Oncology Department, Faculty of Medicine, Medical and Health Science Center, University of Debrecen 4 Centre of Oncoradiology, Hospital of Bcs-Kiskun Country, Kecskemt, Hungary 5 Oncology Department, Szent Lszl Hospital, Budapest, Hungary 6 Oncology Department, Zala County Hospital, Zalaegerszeg, Hungary 7 Department of Oncotherapy, University of Szeged, Szeged, Hungary

Corresponding author

Keywords:
Quality of life; Hungarian Hospital Anxiety and Depression Scale (HADS); Cancer patients; Validation study; Self-assessment screening tool

Abstract
Objectives: The Hospital Anxiety and Depression Scale (HADS) is a widely used screening instrument. The purpose of this study was to evaluate reliability and validity of the Hungarian translation. Methods: The English version of the HADS was translated using the 'forward-backward' procedure. The questionnaire was used in a large scale study of 678 Hungarian cancer patients along with other screening measures of psychological state and description of illness. Results: Translated items of the HADS questionnaire showed high internal consistency: Cronbach's alpha values for the subscales were 0.82 (anxiety) and 0.83 (depression). Factor analysis of the Hungarian version yielded an identical two-factor model to the English and German versions. Results of the known groups comparison showed that both subscales of the HADS discriminates well between sub-groups: decreasing performance status and more advanced disease stage showed significantly higher levels of anxiety and depression. Sufficient concurrent validity of the HADS depression subscale was found using the Hungarian version of the Beck Depression Scale (correlation was 0.8, p<0.0001).Conclusions: Based on a detailed analysis of results from a study of over 700 Hungarian cancer patients, we found the translated version of the HADS a reliable and valid self-assessment screening tool in medical practice.

Introduction
The Hospital Anxiety and Depression Scale (HADS) [1], a brief self-report questionnaire was developed by Zigmond and Snaith in 1983 [2] to assess the levels of anxiety and depression among patients in nonpsychiatric hospital clinics. Based on extensive reviews of results from over 700 published studies using this questionnaire Bjelland and colleagues conclude that HADS performs well in assessing the symptom severity and caseness of anxiety disorders and depression in somatic, psychiatric and primary care patients as well as in the general population [3]. The HADS questionnaire has been translated into many languages, and for many of these translations validation studies confirm the internationally applicable nature of this questionnaire (see Hermann, 1997 for an extensive review [4]). Since the brief selfreport scale can be administered to patients in approximately 5-10 minutes, and can be scored in about a minute, it is a useful screening instrument to evaluate dimensional representation of mood. It has been used in many studies investigating the psychological state of cancer patients [5-7], and found to be of vital importance in psycho-oncology. Whereas cancer treatment is developing fast in Hungary, psychooncology is still very much behind. The translated version of HADS could be of great use in initiating general screening procedures for psychological distress.

Methods
All materials used in this study were approved by the Scientific and Research-ethics Committee of the Hungarian Medical Research Council (TUKEB). A detailed description of patient characteristics, procedures and materials can be found on our project website ( http://crl.ucsd.edu/~aszekely/psyoncologyres/ ).
Participants and procedures

745 patients (between the age of 19-76) were recruited randomly from cancer clinics at five regional centers in Hungary. After signing consent forms trained nurses administered the questionnaires to each participant based on a standard protocol. Most patients found the Hungarian version of the HADS acceptable, refusal rate was below 1%. Information about the diagnosis, treatment, and disease stage was assembled from clinicians with approval from the patients.
Materials

The Hungarian translation of the HADS was based on the 'forward-backward' procedure (explained in full detail at out project website). This translation was accepted by the publisher. The ECOG Performance Status has been used to determine measures of daily living abilities of patients. Scales and criteria were adapted from the Eastern Cooperative Oncology Group [8] publicly accessible at: http://www.ecog.org/general/perf_stat.html. Objective performance measures were based on the opinion of clinicians, and in addition subjective performance ratings were also obtained from the patients themselves, based on a simplified version of the performance criteria.
Statistical analysis

Data analysis was performed using the 11.5 version of SPSS. Cronbach's alpha coefficients for the HADS subscales are provided an estimate of internal consistency reliability of the instrument. Factor analysis was performed using Principal

Component Analysis with Varimax rotation. Validity analysis of known groups comparison [9] tested how well the questionnaire discriminates between sub-groups of patients who differed in clinical status. One-way analysis of variance (ANOVA) for the dependent variables of the HADS scales were carried out using one of the performance status measures or disease stage. The Pearson's correlation coefficient was used to assess concurrent validity of the depression subscale and inter-correlation of anxiety and depression subscales.

Results
Reliability analysis: internal consistency

Item statistics for the two subscales of the Hungarian version are outlined in Table 1. With only one exception (item 11: "I feel restless as if I have to be on the move"), results show very high corrected item-total correlations within the subscales. Internal consistency (as measured by the Cronbach's alpha coefficient) is 0.82 for the anxiety subscale and 0.83 for the depression subscale indicating satisfactory reliability.

Table 1: Item characteristics and reliability of the Hungarian HADS scales

Anxiety subscale (Alpha = 0.82) (N = 666) Mean Std Dev Item 1 1.22 0.81 Item 3 1.23 1.01 Item 5 0.58 0.85 Item 7 1.16 0.82 Item 9 0.70 0.72 Item 11 0.97 1.00 Item 13 0.72 0.82 Depression subscale (Alpha = 0.83) (N = 668) Mean Std Dev Item 2 1.05 0.89 Item 4 0.81 0.81 Item 6 0.79 0.90 Item 8 1.31 0.83 Item 10 0.63 0.87 Item 12 0.87 0.84 Item 14 0.65 0.90

Corrected Item-Total 0.62 0.60 0.65 0.50 0.60 0.33 0.67

Alpha if Item Deleted 0.78 0.79 0.78 0.80 0.79 0.84 0.77

Corrected Item-Total 0.59 0.67 0.61 0.49 0.51 0.65 0.54

Alpha if Item Deleted 0.81 0.79 0.80 0.82 0.82 0.80 0.81

Validity analysis: factorial structure

Based on findings from the extensive review of the different language versions of the HADS questionnaire [4], the two subscales overlap. We also found a relatively high correlation between the two hypothesized subscales: r = 0.67 (p<0.0001). For this reason rotated solution of the factor analysis is reported in Table 2, which yielded identical results with the English and German HADS versions, with one depression and one anxiety factor. Item 7 ("I can sit at ease and feel relaxed") is an Anxiety item in the original English version [2], however, similarly to the latter German, English and Chinese validation studies (see [4]) it loads heavily on the depression factor. These two factors explain 51.4% of the total variance and correlate highly with the corresponding subscales (r = 0.92 for depression and r = 0.88 for anxiety), thus factorial validity of the Hungarian version is sufficient.
Table 2: Factor structure of the Hungarian HADS

Principal component analysis was used with Varimax rotation (N = 678).

Item 4 12 2 7 14 6 8 10 13 5 3 9 1 11 Subscale Depression Depression Depression Anxiety Depression Depression Depression Depression Anxiety Anxiety Anxiety Anxiety Anxiety Anxiety Factor 1 .79 .73 .71 .68 .67 .65 .51 .49 .20 .26 .26 .31 .44 .07 Factor 2 .18 .22 .12 .29 .16 .31 .31 .34 .81 .75 .72 .65 .57 .48

Validity analysis: known groups comparison

Clinical validity was estimated by known-groups comparison using objective and subjective performance status measures (ECOG status) or clinical measures that correspond to disease stages. The HADS subscales of anxiety and depression both discriminated well between subgroups of patients with different levels of performance (daily living abilities). Figure 1 shows the mean level of anxiety and depression scores for each patient group with an objective ECOG status of 0, 1, 2, and 3. Univariate analyses of variance testing between-subjects effects for the HADS subscales were significant: F(3,674) = 13.19 (p<0.0001) for the anxiety, and F(3,674) = 32.18 (p<0.0001) for the depression subscale. Patients with decreasing performance status showed significantly higher levels of anxiety and depression. The respective effect size (Eta squared) was 0.055 for the anxiety subscale, and Post-Hoc tests identified patients with the ECOG status 0; 1-2; and 3 as separate subsets at an alpha=0.05 level. Effect size for the depression subscale was 0.125 for the depression subscale, and Post-Hoc tests identified all four ECOG status group as separate subsets at an alpha=0.05 level. In a subsequent analyses we performed the above univariate tests with the subjective ECOG ratings, and gained even more significant results.

Figure 1: Decreasing performance is characterized by higher levels of anxiety and depression

Mean values of HADS anxiety and depression raw scores ( standard error of mean) are presented according to the ECOG level of performance as rated by the clinician from 0-3 (from best to worst).

14

Mean raw score for HADS subscales

Anxiety
12

Depression

10

0 (N=149)

1 (N=375)

2 (N=127)

3 (N=27)

Ecog status

Known groups comparison using disease stage (local or metastatic) aimed to test how well the questionnaire discriminates between sub-groups of patients who differ in their clinical status. The mean level of anxiety and depression scores for the local and the metastatic patient groups is outlined in Figure 2. Univariate analyses of variance testing between-subjects effects for the HADS subscales were significant: F(1,676) = 6.8 (p<0.009) for the anxiety, and F(3,676) = 22.15 (p<0.0001) for the depression subscale. Patients with a more severe disease stage have show significantly higher levels of anxiety and depression, as measured by the HADS questionnaire. The respective effect size (Eta squared) was 0.01 for the anxiety subscale, and 0.32 for the depression subscale.

Figure 2: Higher levels of anxiety and depression is present in patients with more advanced disease stage

Mean values of HADS anxiety and depression raw scores ( standard error of mean) are presented according to the disease stage (local metastatic).

Mean raw score for HADS subscales

8 7 6 5 4 3 2 1 0

Anxiety

Depression

Local (N=329)

Metastatic (N=349)

Disease stage
Concurrent validity of the HADS depression scale

The HADS questionnaire and the Beck depression scale was administered to a group of 64 Hungarian cancer patients from two of the regional centers to assess concurrent validity of the HADS depression subscale. The two measures showed a large and significant correlation (r = 0.78, p<0.0001), thus concurrent validity of the depression subscale is confirmed.

Discussion
A large scale validation study of 678 cancer patients was conducted to test reliability and validity of the Hungarian version of the HADS. Patients were randomly recruited from five regional cancer clinics in Hungary to assure a representative sample from the country's cancer population. Reliability analysis showed sufficient internal consistency for the subscales. Item total correlations were generally high, except for item 11, which proved to be a weaker item in other international validation studies as well, e.g. [10]. We agree, that this item carries cross-cultural difficulties, proper translation of this item caused many debates in our team. Factorial validity confirmed the two-factor model of the original English version [2], these two factors explain 51.4% of the total variance and correlate highly with the corresponding subscales. Similarly to the German, English and Chinese validation studies [4] item 7 (from the anxiety subscale) showed unexpected loadings on the

depression factor. Clinical validity was estimated by known-groups comparison using objective and subjective performance status measures and disease stage. The subscales of anxiety and depression both discriminated well between sub-groups: decreasing performance status and more advanced disease stage showed significantly higher levels of anxiety and depression. Concurrent validity of the HADS depression scale was tested using the Beck Depression Scale. Results indicate high correlation between the two scales. Similarly to prior results inter-correlation between the anxiety and the depression subscales was found this study as well, which is probably due to real coincidence of anxious and depressed symptoms and not to shortage of the instrument, as noted by Hermann [4]. In conclusion, the present study indicates that the Hungarian version of the HADS is a reliable and valid measure of anxiety and depression. This brief and simple tool could contribute enormously to psycho-oncology and patient care in cancer clinics as part of a general screening procedure for psychological distress. Intercultural adaptation of the instrument enables cross-cultural evaluation of quality of life in cancer patients.

Acknowledgements
The HADS is under copyright and may not be reproduced without the permission of the publisher: NferNelson, The Chiswick Centre, 414 Chiswick High Road, London, W4 5TF, U.K. http://www.nfer-nelson.co.uk . The study was carried out in the framework of the Psycho-Oncology Program supported by the Bristol - Myers Squibb Foundation.

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