Abstract
Head and neck cancer and its treatment had a significant impact on the quality of life. EORTC QLQ-C30 and EORTC QLQ-H&N35 are the two most widely used modules to assess the quality of life among head and neck cancer patients. The aim of the study is to test the reliability and validity of Gujarati version of EORTC QLQ-C30 and QLQ-H&N35module in a clinical setting. Gujarati version of EORTC QLQ-C30 and QLQ-H&N35 was administered to 400 histo-pathologically proven cases of head and neck cancer. For testing the internal consistency (reliability) Cronbach’s alpha coefficient was used. The convergent and discriminant validity were explored by using Spearman’s correlation coefficient test. Factor analysis was performed to obtain information about loading of the items for each scale. All most all scales of EORTC QLQ-C30 and QLQ-H&N35 showed high internal consistency having Cronbach’s alpha coefficient > 0.70. Spearman’s correlation coefficient ranges from −0.45 to 0.95 for EORTC QLQ-C30 and 0.42–0.94 for EORTC QLQ-H&N35 showing moderate to good convergent validity. The magnitude of the correlation of each item with its own scale exceeded the correlation with another scale confirming item discriminant validity. The factor analysis resulted in 7 and 11 different components for measuring quality of life for EORTC QLQ-C30 and QLQ-H&N35 respectively. Based on the results obtained it can be concluded that the Gujarati version of both the modules is a reliable and valid tool for measuring quality of life in head and neck cancer patients in clinical settings.
Keywords: Quality of life, Head and neck cancer, Questionnaire, Validation, Factor analysis
Introduction
India has one of the highest incidences of head and neck cancer (HNC) in the world, which is about 3–7 times more as compared to developed countries [1]. Both HNC and its treatment adversely affect the function, appearance, psychological status and socialization of patients. These have tremendous impact on aspects of daily living such as eating, swallowing, breathing and communication [2]. As a result patients with HNC are the targeted group in terms of specific care and quality of life (QoL) than those of patients diagnosed with other cancers in recent years [3, 4].
Assessment of quality of life is a modular approach which covers thephysical, emotional, functional and social domains for the subjective well being of patients. A general module, which assesses symptoms commonly experienced by cancer patients, is supplemented by a site- or treatment-specific module, which assessesdifficulties unique to that particular typeof cancer or treatment. Literature confirms that general and site-specific measures each contribute important, unique information concerning quality of life [5, 6]. Such an approach is establishedby European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Group.
EORTC has developed a series of questionnaires to assess the QoL of cancer patients. EORTC core questionnaire (QLQ-C30) [7] is used to assess the general well being of the patients. The core instrument is intended to be used in conjunction with site specific modules, to provide more comprehensive assessment of patient’s difficulties. Hence, a site specific EORTC QLQ-H&N35 module was developed for use in patients with HNC [8, 9]. These instruments have been validated in many languages and cultural settings across the globe [4, 7, 10–12].
Through extensive literature review it was revealed that only two studies [13, 14] had validated these instruments in Indian scenario, which shows there is a scarcity of information in this field of research. Keeping this point in view, the study was undertaken with the aim to test the reliability and validity of EORTC QLQ-C30 (core module) and QLQ-H&N35 (head and neck specific module) in context with Gujarati language spoken in western part of India. The validated Gujarati version of these modules, will allow the inclusion of HNC patients of western India into those trials that measure QoL using the EORTC tool.
Materials and Methods
A cross sectional study was conducted among HNC patients attending tertiary cancer centreof western India. Prior to the commencement of the study, the study protocol was submitted to the institutional review board of tertiary cancer centre. The same was reviewed and approval to conduct the study was obtained. The study was conducted in accordance with the Declaration of Helsinki. The purpose of the study was explained to the patients in Gujarati language. Completion of the questionnaire was a condition for entering the study and was regarded as written consent.
Total 400 histo-pathologically proven HNC patients were enrolled having inclusion criteria of: (1) both male and female patients above 18 years of age, (2) Patients having Karnofsky ‘s Performance Status score (KPS) more than 60. Exclusion criteria included (1) refusal to participate, (2) patient above 65 years of age, (3) presence of concurrent secondary malignancy, (4) Patients who were unable to speak and read Gujarati language and (5) survival patients who had completed treatment (in any form) more than 18 months were excluded.
Data Collection
A pretested self-designed proforma was used to collect the demographic details (age, gender, socioeconomic status (SES), residence, marital status, type of family) through personal interview. The SES of the patients was assessed as per the Kuppuswamy's scale [15].The clinical details (stage of cancer, treatment of cancer and KPS) were retrieved from patient medical records. The QoL of patients was assessed by using self-administered questionnaires developed by the European Organization for Research and Treatment of Cancer: General (QLQ-C30) [7] and Head and Neck specific module (QLQ-H&N35) [8]. The Gujarati version of the EORTC QLQ-C30 and QLQ-H&N35 questionnaires is copyrighted instruments. Copies of the questionnaires, scoring instructions, and permission to use them (free of charge for academic users) were obtained from the EORTC Data Centre, Quality of Life Unit, Avenue E Mounier 83 Bte 11,1200 Brussels, Belgium [16].
Instruments to Assess QoL
EORTC QLQ-C30 version3.0 [7] consistsof 30 questions having six multi itemfunctional scales-PF: Physical functioning, SF: Social functioning, EF: Emotional functioning, RF: Role functioning, CF: Cognitive functioning and QL: Global quality of life. 3 multi item symptoms scales—FA: Fatigue, PA: Pain and NV: Nausea and vomiting as well as six are single-item scales (DY: Dyspnoea, SL: Insomnia, AP: Appetite Loss, CO: Constipation, DI: Diarrhoea and FI: Financial Difficulties). Patient respond to items in a four-point Likert scale (measured on a 1–4 interval scale) with response ranging from'not at all' to 'very much' while the 2 items concerning global quality of life are measured on a seven point scale (measured on a 1–7 interval scale) from 'very poor' to 'excellent'.
EORTC QLQ-H&N35 [8] is meant to be used in conjunction with the QLQ-C30 in patients with HNC, irrespective of site, stage and treatment. The 35 questions grouped into 7 multi-item symptoms scales: HNPA: pain, HNSW: swallowing, HNSE: senses, HNSP: speaking, HNSO: social eating, HNSC: social contacts, HNSX: sexuality and 11 single item symptoms scales concerning teeth problems (HNTE), difficulties with opening the mouth (HNOM), dry mouth (HNDR), sticky saliva (HNSS), coughing (HNCO), feeling ill (HNFI), use of pain killers (HNPK), using food supplements (HNNU), feeding tube requirement (HNFE) and losing (HNWL) or gaining weight (HNWG). Similarly, to EORTC QLQ-C30, the first 30 items are scored on a four-point Likert scale (measured on a 1–4 interval scale) with response ranging from 'not at all' to 'very much', whereas the last five items have a dichotomous scale having no/yes format.
Statistical Analysis
Scores for multi-item functional or symptom scales and for single items were calculated by linear transformation of raw scores into a 0–100 score, with 100 representing best global health, functional status, or worst symptoms, depending on the measuring property ofeach multi-item or single-item scale, as described by EORTC scoring manual [17].
Scale Construction
Construct validation was done to evaluates how well an instrument measures the construct it is intended to measure by comparing item-scale and inter-scale correlations by using Spearman ‘s correlation coefficient test. Construct validity was assessed by: (1) Convergent validity and (2) Discriminant validity. Convergent validityindicates the correlation between an item and its own scale. The recommended value for item convergent validity as per EORTC QoL study group items should have moderately high correlation (≥ 0.40) with their own scale [7]. The discriminant validity is a correlation between item with items belonging to any other scale. A high correlation (> 0.70) may indicate that two scales assess the same or highly related constructs [18]. Internal consistency (reliability) estimates of a magnitude of > 0.70 were considered acceptable for group comparisons [19].
Exploratory Factor Analysis
An exploratory factor analysis was performed to obtain information about loadings of the items for each scale. To ascertain the sampling adequacy, Kaiser–Meyer–Olkin measure and Bartlett's test of sphericity were performed. The extraction method used was principal component analysis which extracts the observable variables. The factor that had an eigen values of more than 1 was considered. A varimax rotation method was used to achieve a more understandable structure among factors.
The data were analysed using the Statistical Package for Social Science software (SPSS version 22; IBM). P-value ≤ 0.05 was regarded as significant.
Results
The demographic and clinical characteristics of the patients are shown in Table 1. The age of the patients ranges from 20 to 65 years having mean age of 45.47 ± 10.31 years. Male patients (n = 350, 87.50%) outnumbered their female counterpart. Half of the patients (n = 214, 53.50%) belong to rural community and having lower socio-economic status. Out of 400 patients 340 (85%) had cancer of oral cavity. 199 (49.75%) of patients had reported at the late stage IV of cancer. Patients receiving combined treatment modalities were more than the single modalities treatment.
Table 1.
Demographic and clinical characteristic of head and neck patients
| Variables | Number (n = 400) | Percent (%) |
|---|---|---|
| Mean age (in years) | 45.47 ± 10.31 | |
| Gender | ||
| Male | 350 | 87.50 |
| Female | 50 | 12.50 |
| Location | ||
| Urban | 186 | 46.50 |
| Rural | 214 | 53.50 |
| Marital status | ||
| Unmarried | 35 | 8.75 |
| Married | 357 | 89.25 |
| Divorced/ Widow | 8 | 2.00 |
| Socio-economic status | ||
| Upper | 7 | 1.75 |
| Upper middle | 45 | 11.25 |
| Lower middle | 80 | 20.00 |
| Upper lower | 230 | 57.50 |
| Lower | 38 | 9.50 |
| Stage of cancer | ||
| I | 18 | 4.50 |
| II | 104 | 26.00 |
| III | 79 | 19.75 |
| IV | 199 | 49.75 |
| Karnofsky Performance status | ||
| 60 | 32 | 8.00 |
| 70 | 107 | 26.75 |
| 80 | 163 | 40.75 |
| 90 | 95 | 23.75 |
| 100 | 3 | 0.75 |
| Site of cancer | ||
| Oral cavity | 340 | 85.00 |
| Pharynx/hypopharynx | 26 | 6.50 |
| Larynx | 34 | 8.50 |
| Treatment Modalities | ||
| No treatment (newly diagnosed) | 80 | 20.00 |
| Exclusive surgical | 39 | 9.75 |
| Exclusive radiotherapy | 25 | 6.25 |
| Exclusive chemotherapy | 24 | 6.0 |
| Surgical + Radiotherapy | 92 | 23.00 |
| Surgical + Chemotherapy | 4 | 1.00 |
| Radiotherapy + Chemotherapy | 65 | 16.25 |
| Combination of all | 71 | 17.75 |
Validity and Reliability
Reliability Cronbach's alpha coefficient and mean scores for different scales of EORTC QLQ-C30 and H&N35 is shown in Table 2. The mean functional score ranges from 74.22 ± 20.01 (QL) to 93.49 ± 13.89 (CF) for EORTC QLQ-C30 while for EORTC QLQ-H&N35 the mean symptoms scores ranges from 5.47 ± 15.12 (HNSX) to 30.30 ± 25.88 (HNSO). All the scales for EORTC QLQ-C30 had high reliability (Cronbach’s alpha coefficient > 0.70) expect PF (0.69), FA (0.31) and PA (0.28). For EORTC QLQ-H&N35; HNSP and HNSO had reliability of 0.69 and 0.68 respectively, rest all scales had high reliability (Cronbach’s alpha coefficient > 0.70).
Table 2.
Reliability (Cronbach's alpha coefficient) and mean scores for different scales of EORTC QLQ-C30 and EORTC QLQ-H&N35
| Questionnaires | Reliability (Cronbach's alpha coefficient) | Mean ± SD |
|---|---|---|
| EORTC QLQ-C30 scales | ||
| Physical function (PF) | 0.69 | 88.57 ± 17.02 |
| Role function (RF) | 0.72 | 93.24 ± 13.97 |
| Emotional function (EF) | 0.71 | 82.62 ± 20.30 |
| Cognitive function (CF) | 0.74 | 93.49 ± 13.89 |
| Social function (SF) | 0.76 | 89.70 ± 17.43 |
| Global Health Status (QL) | 0.75 | 74.22 ± 20.01 |
| Fatigue (FA) | 0.31 | 21.99 ± 20.81 |
| Nausea and Vomiting (NV) | 0.78 | 11.21 ± 20.06 |
| Pain (PA) | 0.28 | 14.37 ± 17.99 |
| EORTC QLQ-H&N35 scales | ||
| Pain (HNPA) | 0.73 | 23.91 ± 20.22 |
| Swallowing (HNSW) | 0.71 | 22.51 ± 23.39 |
| Senses (HNSE) | 0.77 | 14.46 ± 21.30 |
| Speech (HNSP) | 0.69 | 20.97 ± 26.00 |
| Social eating (HNSO) | 0.68 | 30.30 ± 25.88 |
| Social contact (HNSC) | 0.71 | 13.39 ± 19.79 |
| Less sexuality (HNSX) | 0.77 | 5.47 ± 15.12 |
Data presented in mean ± standard deviation
The correlations between items and the total score of the scales in the EORTC QLQ-C30 and EORTC QLQ-H&N35 are summarised in Tables 3 and 4 respectively. All item-scale correlation co-efficient for EORTC QLQ-C30 were above 0.40 (−0.45 to 0.95) supporting a moderate to good item convergent validity. Furthermore, item discriminant validity was also confirmed, because the magnitude of the correlation of each item with its own scale exceeded the correlation with another scale. For EORTC QLQ-H&N35 moderate to good item convergent validity as the correlation coefficients between items and its own scale ranges of 0.42–0.94. On the other hand, there were weak correlations between items and other scales conforming item discriminant validity. None of the single item of both questionnaires had a good correlation with the other scales.All the item scale correlations were statistically highly significant having P < 0.001.
Table 3.
Correlations between items and total score of scales ofEORTC QLQ-C30
| Scales | Items | Scales | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PF | RF | EF | CF | SF | FA | NV | PA | QL | ||
| PF | C1 | −0.79b | −0.48b | −0.39b | −0.31b | −0.25b | 0.52b | 0.11a | 0.44b | −0.31b |
| C2 | −0.78b | −0.47b | −0.38b | −0.26b | −0.25b | 0.52b | 0.11a | 0.45b | −0.37b | |
| C3 | −0.49b | −0.32b | −0.28b | −0.18b | −0.09a | 0.34b | 0.03 | 0.29b | −0.19b | |
| C4 | −0.72b | −0.41b | −0.29b | −0.22b | −0.17b | 0.48b | 0.15b | 0.40b | −0.33b | |
| C5 | −0.45b | −0.48b | −0.28b | −0.22b | −0.09 | 0.32b | 0.12a | 0.29b | −0.22b | |
| RF | C6 | −0.54b | −0.91b | −0.35b | −0.24b | −0.23b | 0.39b | 0.07 | 0.42b | −0.30b |
| C7 | −0.46b | −0.78b | −0.29b | −0.20b | −0.21b | 0.38b | 0.08 | 0.31b | −0.27b | |
| EF | C21 | −0.37b | −0.31b | −0.79b | −0.19b | −0.31b | 0.39b | 0.06 | 0.33b | −0.31b |
| C22 | −0.32b | −0.26b | −0.88b | −0.21b | −0.29b | 0.41b | 0.07 | 0.35b | −0.32b | |
| C23 | −0.42b | −0.31b | −0.66b | −0.37b | −0.29b | 0.43b | 0.07 | 0.39b | −0.29b | |
| C24 | −0.31b | −0.27b | −0.80b | −0.24b | −0.27b | 0.36b | 0.03 | 0.33b | −0.23b | |
| CF | C20 | −0.32b | −0.27b | −0.33b | −0.76b | −0.16b | 0.28b | 0.12a | 0.34b | −0.15b |
| C25 | −0.24b | −0.19b | −0.19b | −0.77b | −0.25b | 0.25b | 0.05 | 0.24b | −0.12a | |
| SF | C26 | −0.24b | −0.21b | −0.36b | −0.24b | −0.81b | 0.28b | 0.04 | 0.27b | −0.28b |
| C27 | −0.28b | −0.26b | −0.29b | −0.18b | −0.92b | 0.28b | 0.04 | 0.29b | −0.29b | |
| FA | C10 | −0.41 | −0.29b | −0.36b | −0.21b | −0.24b | 0.71b | 0.15b | 0.39b | −0.31b |
| C12 | −0.49 | −0.32b | −0.42b | −0.23b | −0.25b | 0.86b | 0.17b | 0.48b | −0.45b | |
| C18 | −0.58 | −0.43b | −0.36b | −0.33b | −0.29b | 0.76 b | 0.13a | 0.69b | −0.35b | |
| NV | C14 | −0.14b | −0.09 | −0.12a | −0.08 | −0.08 | 0.24b | 0.92b | 0.16b | −0.21b |
| C15 | −0.07 | 0.004 | 0.01 | −0.10a | 0.09 | 0.10a | 0.81b | 0.11a | −0.11a | |
| PA | C9 | −0.36b | −0.31b | −0.33b | −0.21b | −0.25b | 0.37b | 0.04 | 0.75 b | −0.28b |
| C19 | −0.52b | −0.38b | −0.37b | −0.34b | −0.22b | 0.65b | 0.19b | 0.83 b | −0.33b | |
| QL | C29 | 0.41b | 0.29b | 0.35b | 0.16b | 0.33b | −0.49b | −0.19b | −0.38b | 0.95b |
| C30 | 0.35b | 0.29b | 0.33b | 0.14b | 0.31b | −0.42b | −0.19b | −0.34b | 0.95b | |
| Single items | ||||||||||
| DY | C8 | −0.26b | −0.22b | −0.14b | −0.09 | −0.15b | 0.28b | 0.14b | 0.19b | −0.26b |
| SL | C11 | −0.28b | −0.21b | −0.23b | −0.06 | −0.16b | 0.32b | 0.03 | 0.28b | −0.35b |
| AP | C13 | −0.32b | −0.27b | −0.33b | −0.22b | −0.09 | 0.41b | 0.21b | 0.29b | −0.22b |
| CO | C16 | −0.18b | −0.04 | −0.21b | −0.09 | −0.09 | 0.19b | 0.15b | 0.19b | −0.17b |
| DI | C17 | −0.14b | −0.05 | 0.00 | −0.03 | −0.02 | 0.17b | 0.06 | 0.13b | −0.11a |
| FI | C28 | −0.12a | −0.14b | −0.10a | −0.14b | −0.25b | 0.12a | −0.04 | 0.13b | −0.15b |
aCorrelation: Significant P < 0.05, bCorrelation: significant P < 0.01, Other not significant P > 0.05. Spearman's rho coefficient correlations between items and their own scale are highlighted. Correlation coefficients, higher than 0.4, are underlined
Table 4.
Correlations between items and total score of scales of EORTC QLQ−H&N35
| Scales | Items | Scales | ||||||
|---|---|---|---|---|---|---|---|---|
| HNPA | HNSW | HNSE | HNSP | HNSO | HNSC | HNSX | ||
| HNPA | HN1 | 0.68** | 0.12* | 0.02 | 0.09 | 0.09 | 0.11* | 0.04 |
| HN2 | 0.64** | 0.16** | 0.02 | 0.19 | 0.19** | 0.19** | 0.16** | |
| HN3 | 0.59** | 0.31** | 0.26** | 0.24 | 0.24** | 0.15** | −0.03 | |
| HN4 | 0.58** | 0.46** | 0.24** | 0.41 | 0.33** | 0.19** | 0.03 | |
| HNSW | HN5 | 0.40** | 0.71** | 0.16** | 0.39 | 0.34** | 0.26** | 0.13* |
| HN6 | 0.41** | 0.82** | 0.29** | 0.41 | 0.48** | 0.29** | 0.11* | |
| HN7 | 0.36** | 0.91** | 0.28** | 0.48 | 0.56** | 0.33** | 0.13* | |
| HN8 | 0.19** | 0.42** | 0.13** | 0.31 | 0.33** | 0.25** | 0.19** | |
| HNSE | HN13 | 0.06 | 0.17** | 0.46** | 0.17 | 0.14** | 0.17** | 0.06** |
| HN14 | 0.19** | 0.27** | 0.92** | 0.25 | 0.20** | 0.16** | 0.05** | |
| HNSP | HN16 | 0.26** | 0.40** | 0.28** | 0.74** | 0.32** | 0.18** | 0.02 |
| HN23 | 0.32** | 0.36** | 0.18** | 0.82** | 0.49** | 0.48** | 0.25** | |
| HN24 | 0.29** | 0.36** | 0.19** | 0.79** | 0.49** | 0.51** | 0.15** | |
| HNSO | HN19 | 0.38** | 0.50** | 0.23** | 0.48 | 0.87** | 0.38** | 0.17** |
| HN20 | 0.22** | 0.28** | 0.19** | 0.49 | 0.71** | 0.37** | 0.20** | |
| HN21 | 0.27** | 0.37** | 0.19** | 0.47 | 0.85** | 0.45** | 0.13* | |
| HN22 | 0.27** | 0.44** | 0.22** | 0.44 | 0.89** | 0.41** | 0.15** | |
| HNSC | HN18 | 0.12* | 0.09 | 0.11* | 0.22 | 0.29** | 0.64** | 0.23** |
| HN25 | 0.19** | 0.24** | 0.17** | 0.48 | 0.42** | 0.77** | 0.26** | |
| HN26 | 0.22** | 0.31** | 0.17** | 0.50 | 0.45** | 0.82** | 0.29** | |
| HN27 | 0.19** | 0.26** | 0.18** | 0.44 | 0.44** | 0.81** | 0.27** | |
| HN28 | 0.16** | 0.25** | 0.16** | 0.41 | 0.40** | 0.72** | 0.26** | |
| HNSX | HN29 | 0.08 | 0.09 | 0.04 | 0.17 | 0.18** | 0.27** | 0.93** |
| HN30 | 0.05 | 0.12* | 0.06 | 0.18 | 0.20** | 0.29** | 0.94** | |
| Single items | ||||||||
| HNTE | HN9 | 0.23** | 0.02 | 0.07 | 0.05 | 0.14** | 0.11* | 0.13* |
| HNOM | HN10 | 0.24** | 0.09 | 0.12* | 0.16** | 0.31** | 0.30** | 0.11* |
| HNDR | HN11 | 0.25** | 0.28** | 0.37** | 0.26** | 0.31** | 0.18** | 0.002 |
| HNSS | HN12 | 0.34** | 0.39** | 0.37** | 0.29** | 0.31** | 0.16** | 0.02 |
| HNCO | HN15 | 0.17** | 0.33** | 0.14** | 0.34** | 0.22** | 0.13** | 0.00 |
| HNFI | HN17 | 0.38** | 0.32** | 0.17** | 0.38** | 0.28** | 0.35** | 0.13* |
| HNPK | HN31 | 0.16** | 0.09 | 0.01 | 0.05 | 0.04 | 0.04 | −0.19** |
| HNNU | HN32 | 0.04 | 0.08 | 0.01 | 0.09 | 0.05 | 0.07 | 0.19** |
| HNFE | HN33 | 0.07 | −0.07 | 0.006 | 0.28** | 0.37** | 0.32** | 0.13* |
| HNWL | HN34 | 0.25** | 0.30** | 0.22** | 0.29** | 0.28** | 0.22** | 0.003 |
| HNWG | HN35 | −0.09 | −0.05 | 0.04 | −0.03 | −0.05 | 0.07 | 0.05 |
*Correlation: Significant P < 0.05, **Correlation: Significant P < 0.01, other not significant P > 0.05. Spearman's rho coefficient correlations between items and their own scale are highlighted. Correlation coefficients, higher than 0.4, are underlined
From the correlation matrix for EORTC QLQ-C30 (Table 3), the items of PF scales have moderate correlation with RF, FA and PA. Similar type of correlation was observed for items of RF scale with PF and PA. Items of EF scale had moderate correlation with PF and FA. The items of FA scale shows correlation with PA, RF, EFand QL scale. Similarly, moderate correlation (Table 4) was observed for the theoretically related scales for QLQ-H&N 35: HNSP with HNSC, HNSW with HNSO and HNSC with HNSO. However, no scale showed a high correlation (> 0.70) with the other scales, which means that none of the scales measured the same construct. In order to study whether these different scales with moderate correlation can be kept within the same construct factor analysis was employed.
Exploratory Factor Analysis
The sample was adequate for factor analysis as there was significantly (P < 0.001) high value of Kaiser–Meyer–Olkin test (0.88) and (0.83) for both EORTC QLQ-C30 and EORTC QLQ-H&N35 respectively. Principal component analysis extracted seven factors with eigen values ranging from 8.74 to 1.07 for EORTC QLQ-C30 with total cumulative variance of 58.97%; while 11 factors were extracted for EORTC QLQ-H&N35 with eigen values ranging from 8.09 to1.01 with total cumulative variance of 68.33%.The factor loadings with their related items for EORTC QLQ-C30 and EORTC QLQ-H&N35 are presented in Tables 5 and 6 respectively. The naming of the newly extracted factors has been made based on the clinical judgments, referring the literatures, and also the underlying theoretical views that run through the items.
Table 5.
Factor loadings for items of EORTC QLQ-C30
| Factors | Questions | Items | Factor Loadings |
|---|---|---|---|
| Factor 1: Physical well-being (9 items) | Trouble doing strenuous activities | C1 | 0.60 |
| Trouble taking a long walk | C2 | 0.63 | |
| Trouble taking a short walk | C3 | 0.65 | |
| Stay in bed or a chair | C4 | 0.62 | |
| Need help with eating, dressing, washing yourself or using the toilet | C5 | 0.74 | |
| Limited in doing either your work or otherdaily activities | C6 | 0.76 | |
| Limited in pursuing your hobbies | C7 | 0.74 | |
| Did you need rest? | C10 | 0.36 | |
| Have you lacked appetite? | C13 | 0.38 | |
| Factor 2: Emotional well-being (4 items) | Did you feel tense? | C21 | 0.79 |
| Did you worry? | C22 | 0.82 | |
| Did you feel irritable? | C23 | 0.48 | |
| Did you feel depressed? | C24 | 0.84 | |
| Factor 3: General well-being (5 items) | Were you short of breath? | C8 | 0.29 |
| Have you had trouble sleeping? | C11 | 0.58 | |
| Have you felt weak? | C12 | 0.47 | |
| Overall health | C29 | −0.82 | |
| Overall QoL | C30 | −0.83 | |
| Factor 4: Socio-economic well being (3 items) | Interfered with your family life? | C26 | 0.75 |
| Interfered with your social activities? | C27 | 0.76 | |
| Caused you financial difficulties? | C28 | 0.59 | |
| Factor 5: Personal activities (3 items) | Have you had diarrhea? | C17 | 0.68 |
| Were you tired? | C18 | 0.55 | |
| Did pain interfere with you daily activities? | C19 | 0.56 | |
| Factor 6: Problems related with nausea and vomiting (2 items) | Have you felt nauseated? | C14 | 0.86 |
| Have you vomited? | C15 | 0.82 | |
| Factor 7: Cognitive well-being(4 items) | Have you had pain? | C9 | 0.39 |
| Have you been constipated? | C16 | 0.69 | |
| Difficulty in concentrating | C20 | 0.41 | |
| Difficulty remembering things? | C25 | 0.48 |
Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization, Rotation converged in 9 iterations
Table 6.
Factor loadings for items of EORTC QLQ-H&N35
| Factors | Questions | Items | Factor Loadings |
|---|---|---|---|
| Factor 1: Problems in having social contact (4 items) | Trouble having social contact with your family? | HN25 | 0.84 |
| Trouble having social contact with friends? | HN26 | 0.89 | |
| Trouble going out in public? | HN27 | 0.87 | |
| Trouble having physical contact with family or friends? | HN28 | 0.86 | |
| Factor 2: Problems while eating (5 items) | Problems swallowing solid food? | HN7 | 0.53 |
| Have you had trouble eating? | HN19 | 0.74 | |
| Trouble eating in front of your family? | HN20 | 0.63 | |
| Trouble eating in front of other people? | HN21 | 0.72 | |
| Trouble enjoying your meals? | HN22 | 0.77 | |
| Factor 3: Problems in throat (7 items) | Have you had a painful throat? | HN4 | 0.72 |
| Have you had problems swallowing liquids? | HN5 | 0.69 | |
| Problems swallowing pureed food? | HN6 | 0.54 | |
| Have you choked when swallowing? | HN8 | 0.52 | |
| Have you coughed? | HN15 | 0.66 | |
| Have you been hoarse? | HN16 | 0.62 | |
| Have you felt ill? | HN17 | 0.42 | |
| Factor 4: Post RT complications(4 items) | Have you had a dry mouth? | HN11 | 0.70 |
| Have you had sticky saliva? | HN12 | 0.65 | |
| Problems with your sense of smell? | HN13 | 0.35 | |
| Problems with your sense of taste? | HN14 | 0.71 | |
| Factor 5: Oral pain (3items) | Have you had pain in your mouth? | HN1 | 0.84 |
| Have you had pain in your jaw? | HN2 | 0.77 | |
| Have you had problems with your teeth? | HN9 | 0.51 | |
| Factor 6: Problems while talking (2 items) | Have you had trouble talking to other people? | HN23 | 0.82 |
| Have you had trouble talking on the telephone? | HN24 | 0.82 | |
| Factor 7: Less sexuality (2 items) | Have you felt less interest in sex? | HN29 | 0.89 |
| Have you felt less sexual enjoyment? | HN30 | 0.88 | |
| Factor 8: Weight (3 items) | Have you used pain-killers? | HN31 | 0.58 |
| Have you lost weight? | HN34 | 0.68 | |
| Have you gained weight? | HN35 | −0.74 | |
| Factor 9: Post-surgical complications (2 items) | Problems opening your mouth wide? | HN10 | 0.45 |
| Has your appearance bothered you? | HN18 | 0.73 | |
| Factor 10: Mucositis and nutritional supplements (2 items) | Have you had soreness in your mouth? | HN3 | −0.41 |
| Have you taken any nutritional supplements | HN32 | 0.76 | |
| Factor 11: Need for feeding tube(1 item) | Have you used a feeding tube? | HN33 | 0.94 |
Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization, Rotation converged in 7 iterations
Discussion
QoL have now become a vital part of health outcomes appraisal and an effective means to cover personal and psycho-social context of patients. There arises a necessity to complement classical oncologic outcomes with the use of measures of patients’ perception on disease impact and treatment consequences [11]. Validation of EORTC QLQ-C30 and QLQ-H&N35 questionnaires had been done across the global [4, 20–22] however till date no validation has been performed in Gujarati language. Hence, this is the first preliminary report aiming to validate Gujarati version of EORTC QLQ-C30 and QLQ-H&N35 among HNC patients in Western part of India.
The items-scale and between-scales correlations showed a high convergent and discriminant validity, as the scales met all of the recommended standards. This was in line with other validation studies [4, 8, 9, 23, 24]. There was a significant correlationbetween scales which investigate related parameters.
The internal consistency was very high for EORTC QLQ-C30, as six of the nine scales conformed reliability having Cronbach's alpha coefficient greater than 0.70, with the exception of the physical functioning, fatigue and pain (0.69, 0.31 and 0.28 respectively). A similar Cronbach's alpha value of 0.68 for PF scale has already been documented in the original paper presenting the EORTC questionnaire [7]. The relatively poor performance of these three scales can be justified in light of the nature of some of the items which composethe scale, exploring the limitations encountered by patients in their basic daily activities [25]. In accordance with the previous studies [17, 23, 26] the internal consistency of each scale of EORTC QLQ-H&N35 was high, except for the speech and social eating scale (0.69 and 0.68 respectively), which indicates a low congruence between the items of the two scales. The low alpha coefficient for speech scale was also reported in other studies [9, 18, 23, 24]. Correlations among the scales varied, indicating a good deal of overlap among different dimensions of quality of life, but most of the associationswere moderate. Hence, factor analysis was performed to determine whether these different scales with moderate correlation can be kept within the same construct.
The factors analysis for EORTC QLQ-C30 showed that all the items of PF and RF scale were loaded on first factor. This result was consistent with studies conducted elsewhere [13, 27, 28]. Hence, according to Luo [27] and Guzelant [28] suggest that the items related to physical and role functioning should be clubbed together and considered in only one scale. This factor describes the functioning of all forms. This factor includes the items related to physical activities on the daily basis hence; it was named as "physical well being." The items of emotional functioning were loaded in the second factor, thus the second factor addressed the "emotional well being" of the cancer patients. The items related to weakness and insomnia with overall general health was loaded in the third factor so this factor was named as "general well being." The items relating to social functioning scale as well as single item scale of financial difficulties were loaded on the fourth factorand so named as "socio-economic well being." The fifth factor was named as "personal activities" as it includes single item symptoms scale related to diarrhoea, tiredness and interference with daily activities. The items of nausea and vomiting scale were loaded together with the single item symptom scale on sixth factor hence, it was named as "problems related to nausea and vomiting". The items of cognitive functioning scale and single items scale for pain and constipation were loaded on the seventh factor so named as "cognitive well being."
For EORTC QLQ-H&N35, the first factor was named as "problem in having social contact" as it loads all items of social contacts. All the items related to social eating and one item:"have you had problems swallowing solid food?" were loaded onsecond factor and therefore it was named as "problems while eating." Items related to: "have you had painful throat?", "have you had problems in swallowing liquid and pureed food?", "choking when swallowing", "cough and hoarseness of voice" were together loaded on third factor. All the items were having common characteristic related to throat hence; it was termed as "problems in throat." Items related to dry mouth, sticky saliva and senses were loaded on fourth factor. These symptoms were the common complications associated with radiotherapy [29, 30]. So, this factor was named as "post RT complications." Fifth factor loads items related to pain in mouth, jaw and teeth hence, the name was given as "oral pain." The sixth factor load the items related to speech problems hence, it was named as "problems while speaking." Seventh factor includes items related with problems while having sex so named as "less sexuality." Single items related to weight gain and weight loss with use of pain killers were loaded in eighth factor therefore the name given was "issues related weight." Problems in wide opening mouth and appearance were mostly associated as one of the complications following surgery (mandibulectomy, commando operation); so the ninth factor was considered as "post surgical complications." The tenth and eleventh factors were named as "mucositis and nutritional supplements" and "need for feeding tube" respectively. Even though the items were few in factor 10th and 11th, they are powerful to contribute common and unique variance to the factor structure and were thus included in the result.
The HNC patients enrolled in this study were from only one institute. This is considered as one of the limitation of this work.Further assessment of QoL should be performed multi centric to confirm the generalizability of the result. This study has not explored comparison with demographic or clinical variables. This will be the subject of a separate paper.
Conclusion
The Gujarati version of both the modules is a reliable and valid tool for measuring QoL in HNC patients. Because of brevity and ease of administrationof EORTC QLQ-C30 and QLQ-H&N35, it can be recommended to implement these modules into general clinical practice to assess QoL in HNC patients.
Acknowledgements
Not applicable.
Authors' Contributions
Sujal Parkar has contributed in the study conception, design of the work, data acquisition and data interpretation, revision of the work, and final approval of the version. Abhishek Sharma has contributed in the data acquisition and interpretation, revision of the work, and final approval of the version for publication. Mihir Shah has contributed in the study design, drafting of the work, and final approval of the manuscript. All authors have read and approved the manuscript and are accountable for all aspects of the work.
Funding
There is no source for funding of this study as this study was self funded.
Compliance with Ethical Standards
Conflict of interest
The authors declare that they have no conflict of interest.
Availability of Data and Materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Code Availability
Statistical Package for Social Science software (SPSS; version 19).
Consent to Participate
Informed written consent was obtained from participants.
Consent for Publication
The participant has consented to the submission of manuscript to the journal.
Ethics Approval
The study was approved by Ethics committee of Ahmedabad Dental College and Hospital, Gujarat, India approval letter no: ADC/EC/13/108 and Institutional review board of Gujarat Cancer Research Institute, Gujarat, India letter no: GCRI/ SNS/1417.
Footnotes
Publisher's Note
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.