|Year : 2017 | Volume
| Issue : 2 | Page : 22-25
Quality of life of head-and-neck cancer patients – reliability and effectiveness of the european organization for research and treatment of cancer quality of life questionnaire-30 and European organization for research and treatment of cancer quality of life questionnaire-H and N35 questionnaires in patients in a tertiary care center in India
Vinay V Rao, Sadia M Shaikh, Mahesh Bhat, Anita Aramani, Veronica Lobo
Department of ENT, Father Muller Medical College, Mangalore, Karnataka, India
|Date of Web Publication||26-Sep-2018|
Dr. Vinay V Rao
Department of ENT, Father Muller Medical College, Mangalore - 575 002, Karnataka
Source of Support: None, Conflict of Interest: None
Aims: To test the validation of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQs), the core module QLQ-C30, and the head and neck module QLQ-H and N35 in a tertiary care center. Materials and Methods: Forty head-and-neck cancer patients completed the QLQ-C30 and the QLQ-H and N35 during their treatment. Questionnaires given to them were translated into their regional language Kannada. Evaluation of the responsiveness, reliability, and validity of the questionnaire was undertaken. Results: The data support the reliability of the scales. Validity cannot be assessed. The questionnaire was responsive to change over a period of time; however, the applicability of the European questionnaire in Indian clinical setup is debatable. Summary: This data suggest that the EORTC QLQ-C30 and the QLQ-H and N35 are reliable and responsive when applied to a sample of head-and-neck cancer patients in India. Hence, it can be used as a platform to test validity at a multicentric level. Conclusion: Both the questionnaires are equally effective, the newer one providing more insight however few items maybe irrelevant in Indian context.
Keywords: Effectiveness, quality of life questionnaire, reliability
|How to cite this article:|
Rao VV, Shaikh SM, Bhat M, Aramani A, Lobo V. Quality of life of head-and-neck cancer patients – reliability and effectiveness of the european organization for research and treatment of cancer quality of life questionnaire-30 and European organization for research and treatment of cancer quality of life questionnaire-H and N35 questionnaires in patients in a tertiary care center in India. Ann Indian Acad Otorhinolaryngol Head Neck Surg 2017;1:22-5
|How to cite this URL:|
Rao VV, Shaikh SM, Bhat M, Aramani A, Lobo V. Quality of life of head-and-neck cancer patients – reliability and effectiveness of the european organization for research and treatment of cancer quality of life questionnaire-30 and European organization for research and treatment of cancer quality of life questionnaire-H and N35 questionnaires in patients in a tertiary care center in India. Ann Indian Acad Otorhinolaryngol Head Neck Surg [serial online] 2017 [cited 2019 Jul 19];1:22-5. Available from: http://www.aiaohns.in/text.asp?2017/1/2/22/242232
| Introduction|| |
Head and neck cancers account for 30% of all cancers in males and 13% of cancers in females in developing countries like India as opposed to the West where it accounts for only 5% of all cancers. As the prevalence of head and neck cancers is high in Indian population and it accounts for a major public health problem, therefore, it becomes important to measure the outcomes it has in terms of survival after appropriate treatment and its impact on an individual's quality of life (QOL). To measure this impact European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) was published after analyzing all the psychometric qualities for the first time in 1992. The first version of the EORTC QLQ module for patients with head-and-neck cancer (EORTC QLQ-H and N37) was published in 1994, revised and validated in 1999 as EORTC QLQ-H and N35. The EORTC QLQ-C30 is specifically used in patients with cancer as a core module questionnaire along with EORTC QLQ-H and N35 as a specific module for head-and-neck cancer. These questionnaires that have been developed are culturally very diverse if applied in our country as compared to Western countries. People who suffer from head-and-neck cancers are the ones that belong to low socioeconomic group, therefore, it hinders the usage and application of these questionnaires in India. Core module questionnaire assesses the common symptoms experienced by patients and the specific one assess the problems unique to head-and-neck cancer. Such an approach is used in EORTC questionnaire, which is also the most widely used questionnaire worldwide. The present study is a pilot study which was done to check for the reliability as well as validity of EORTC QLQ-C30 (core questionnaire) and the QLQ-HN35 (head and neck-specific questionnaire).
| Materials And Methods|| |
This prospective longitudinal study was started in November 2016 after obtaining clearance from the institutional ethics committee. Forty patients suffering from head-and-neck cancer visiting the outpatient department of oncology wing of ENT (radiation, medical, and surgical) were included in this study. All of them were thoroughly investigated and disease appropriate treatment plan was drawn. These patients were given EORTC QLQ-C30 and the QLQ-HN35 questionnaires and asked to fill. The questionnaire was translated into Kannada as majority of the patients can read and comprehend it. The same group of patients were followed up posttreatment and asked to fill the same set of questionnaires. A total of 160 questionnaires were filled and analyzed. The questionnaires were checked and corrected for missing values. The relevant clinical details including age, gender, level of education, site, stage of the tumor, and the treatment details were recorded from the hospital case files.
Patients visiting the outpatient department oncology wing of ENT (radiation, medical, and surgical) who were diagnosed with head-and-neck cancer of any subsite or stage with a definitive treatment plan drawn with a curative intent of any modality who were willing to participate in the study were included in the study.
- Patients who are not willing to participate in the study
- Patients in between the treatment course
- Patients who have defaulted the treatment
- Patients with recurrences or relapses
- Patients receiving neoadjuvant treatment
- Patients not available for long-term follow up.
| Results|| |
Forty patients completed the questionnaire before the commencement of treatment and once after completion of treatment giving a total of 160 completed questionnaires. All the patients filled this questionnaire in the translated version. Except for few questions, most of the questions were answered without assistance, brief explanation for the purpose of this study for few was provided.
There were 38 male and 2 female patients. All of them were literate and could comprehend the questionnaires well. Sites of primary tumor have been described in [Table 1]. Out of these, 32 were referred for surgery and 8 for concurrent chemoradiotherapy.
Reliability was measured using Cronbach's alpha coefficient [Table 2] and [Table 3]. Most of the scales in both the questionnaires demonstrated a coefficient of >0.70 which is considered high.
|Table 2: Cronbach's alpha coefficient for quality of life questionnaire-C 30 - test of reliability|
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|Table 3: Cronbach's alpha coefficient for quality of life questionnaire head and neck 35 - test of reliability|
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Cognitive functioning demonstrated a low coefficient in QLQ C-30 pretreatment increased in the posttreatment, but still, it is lower than 0.7, whereas pain scale even though showed a lower coefficient value but posttreatment was lower than the pretreatment, all the other items showed good reliability.
In case of QLQ H and N35 also global and pain scale showed a lower coefficient in both pretreatment and posttreatment where as swallowing scale showed lower coefficient in postscale only and senses problem showed in prescale only.
In EORTC QLQ-C30 internal consistency in cognitive functioning domain demonstrated a low coefficient in QLQ-C30 pretreatment (−0.143), and it increased in the posttreatment (0.484) but still its lower than 0.7 whereas pain scale even though showed a lower coefficient value but pretreatment (0.470) was higher than the posttreatment (0.419). In case of QLQ H and N35 also global and pain scale showed a lower coefficient in both pretreatment (0.244/−0.059) and posttreatment (0.105/0.098) whereas swallowing scale showed lower coefficient in postscale (0.549) only as pretreatment demonstrated a higher coefficient (0.726) and senses problem scale in prescale (−0.118) only as posttreatment, a higher coefficient was seen (0.943). Other values in both questionnaires in all other domains demonstrated a high coefficient value (>0.70). Hence, satisfactory results were achieved.
Clinical validity-known-group comparisons
Both the questionnaires with respect to pretreatment and posttreatment values show statistically significant difference in all domains as all the P < 0.001 [Table 4] and [Table 5].
|Table 4: Test for validity between pre- and post-treatment scores in European Organization for Research and Treatment of Cancer quality of life questionnaire 30|
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|Table 5: Test for validity between pre- and post-treatment scores in European Organization for Research and Treatment of Cancer quality of life questionnaire head and neck 35|
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| Discussion|| |
Head and neck has a complex anatomical structure and poses a challenge to a surgeon while managing any pathology affecting it. Cancer of this region is quite prevalent in this part of the continent and numerous studies have been published from various tertiary care centers, enough has been told about its pathophysiology and control. In these past two decades or so equal importance has been given to facial esthetics, organ preservation and QOL along with treatment outcome because of which QOL issues have become an integral part of disease management. By far, oral cavity is the most common site as seen in our study as well. Surgical management of head-and-neck tumors can cause varying degrees of defects structurally as well as cause functional disability which affects the overall well-being, self-esteem, and social integration of the patient. In addition, treatment of head-and-neck tumors can induce added mutilation, thereby worsening the QOL. These questionnaires provide an opportunity to have more elaborate discussion with the patient giving more insight about the mental and social impact it has on an individual which was noticed by Chaukar et al., we too observed similar usefulness of the questionnaire hence, QOL is an important end-point in evaluating treatment results and mental and social well-being of head-and-neck cancer patients. Different QLQ scales are available which can be used, but we chose an established core scale with a disease-specific scale to improve the outcome as mentioned by Tamburini. He also pointed out the applicability of a test in terms of validity, reliability, coverage, and responsiveness.
The QLQ 30 and QLQ H and N35 have 30 and 35 questions, respectively, the former being a core questionnaire and the latter being a head and neck-specific questionnaire. The questions were broadly grouped as global, functional, and symptoms which were well balanced. In both the questionnaires, all the items showed acceptable reliability except for cognitive and pain items in QLQ 30 and pain along with global and senses items in QLQ H and N 35. There was no statistically significant difference in interpretation between the scales as similar items were showing poor reliability with no association with other items. Most of the items showed high pretreatment reliability and prospectively the scores improved in most of the cases, similar trend was reported by Mario et al. and Braam et al. with slight contradiction with Bansal et al. where he showed positive correlation with worsening functions and increasing symptoms.
This study was not designed to assess the QOL-based on the tumor stage but however when looked closely we found that patients with early-stage tumors performed better than those with advanced stage tumors in QOL questionnaires. As there were too many confounding factors to comment upon the stage-specific QOL which we felt was a shortcoming in our study, perhaps a large volume stage-specific QOL study can be done.
With respect to validity of these questionnaires, it can be stated that these questionnaires are not valid but are reliable, this could be because the sample size taken for this study was inadequate according to Kaiser–Meyer–Olkin measures of sample of adequacy.
Certain questions included in the QLQ H and N35 were not very appropriate for Indian population. Patients could not comprehend the association of questions based on sexual activity as it is either considered inappropriate to discuss or for someone with such an overwhelming disease in terms of financial burden and loss of productivity its impractical for him to associate his QOL with his sexual life, hence we did not find its appropriateness in our setting, similar comments were found in Chaukar et al.'s study.
A very important property of QOL tools for it to be used in a trial is that it should be responsive to changes in the health status of the patient. In this study, there was a statistically significant difference in all the various domains as expected. Posttreatment patients had a significantly worse score in most of the scales in comparison to patients before treatment. But based on the above results, it can be concluded that the newer scale does not replace the older one. Hence, this study could be taken as a pilot study, and using the same two questionnaires, we can conduct a multicentric study across Karnataka with a bigger sample size from all over the state for better randomization. Therefore, this study can serve as a template to effectively test the validity of these questionnaires.
| Conclusion|| |
These questionnaires help the clinician to gather disease-specific QOL data which otherwise is often missed. Both QOL questionnaires are highly reliable however validity warrants a much bigger study. The items included are all relevant except for few which may vary based on cultural differences. Core questionnaires should be combined with site-specific questionnaires for better QOL outcome. This study can act as a template for testing effective validity in the future.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]