Reliability and validity of Mandarin (Simplied) version of Head and Neck Cancer-specic Supportive Care Needs (SCNS-HNC) scale

Background To translate the English version of supportive care needs scale of head and neck cancer patients (SCNS-HNC) questionnaire into Mandarin (Simplied), and to test reliability and validity. Methods The With authorization of the English version scale were obtained from Professor Irma M. Verdonck-de Leeuw who worked at VU University Medical Center of Cancer Center Amsterdam (CCA), in the Netherlands. The Mandarin (Simplied) version of the SCNS-HNC scale was developed by translation, back-translation and cultural adaptation. The Mandarin (Simplied) version of Supportive Care Needs Survey Short-Form (SCNS-SF34) and SCNS-HNC scales were used to measure 206 patients with head and neck cancer in a upper rst-class hospital in Chengdu. Among them, 51 patients were re-tested 2 or 3 days after the rst survey. The internal consistency of the scale was evaluated by Cronbach's alpha coecient, the retest reliability of the scale was evaluated by retest correlation coecient r, the structural validity of the scale was evaluated by exploratory factor analysis, and the ceiling and oor effects of the scale were evaluated. Item-domain correlation analysis was used to evaluate the collective validity and differential validity of the scale. Results The Mandarin (Simplied) version of SCNS-HNC had Cronbach's alpha coecients of more than 0.700 (0.737 ≤ 0.962)for the all of the domians. Except for the psychological demand dimension of SCNS-SF34 scale, the retest reliability in other elds was more than 0.8. Three common factors were extracted by exploratory factor analysis, and the cumulative variance contribution rate was 64.39%. The correlation coecient of all items in Mandarin (Simplied) version of SCNS-SF34and SCNS-HNC with their own domians were higher than those with otherdomians. Conclusion The Mandarin (Simplied) of SCNS-HNC demonstrates satisfactory reliability and validity, which is available for measurement of the supportive care needs of Chinese patients with head and neck cancer.


Background
Cancer is one of the leading causes of death worldwide [1], in recent years, the morbidity and mortality of cancer in china are also on the rise [2]. Research shows [3],In addition to medicine, surgery, chemoradiotherapy and other treatment measures, Cancer patients and their families have a need for supportive care in the management of disease symptoms and side effects, and information about medical decisions during illness and treatment, And patients with different types of cancer have different needs for supportive care [4]. According to incomplete statistics, there are more than 900,000 new cases of head and neck cancer (HNC)in the world every year [5], which is the sixth most common cancer in the world today. China has a high incidence of head and neck cancer, with an annual incidence of about 15.34/100,000 [6], accounting for about 10% of all malignant cancers. During treatment, patients with head and neck cancer often face a series of disease-related symptoms such as nasal congestion, voice hoarse, di culty in chewing and other diseases, as well as a variety of treating-related symptoms and functional disorders such as taste loss, oral pain, radioactive mucous/dermatitis, di culty in opening the mouth, di culty in swallowing and so on [7]. At the same time, patients are often faced with a large number of psychosocial problems such as depression [8], stigma [9], economic di culties [10], communication di culties [11], death threats [12], fear of recurrence [13], etc., which seriously affect the quality of life of patients with head and neck cancer. In addition, about 30-50% of HNC patients are associated with varying degrees of malnutrition [14]. At present, there is no special assessment scale for supportive care needs of head and neck cancer patients in China. SCNS -HNC scale (Supportive Care Needs Survey the Head and Neck) is the free university of Amsterdam in the Netherlands medical center Irma m. Verdonck -DE Leeuw professor in 2016, according to the EORTC questionnaire guidelines for patients with Head and Neck cancer Supportive Care Needs scale. The purpose of this study was to Sinicize the scale and evaluate its reliability and validity in Chinese patients with head and neck cancer, so as to provide a tool for evaluating the supportive care needs of Chinese patients with head and neck cancer.

Methods Participants
A total of 206 patients with head and neck cancer admitted to a grade a hospital in chengdu from January 2019 to May 2019 were included. Inclusion criteria: residents of mainland China, mainly living in mainland China from birth to participating in this study; The clinicopathologic diagnosis was head and neck carcinoma, including oral, pharynx, larynx, nasal cavity or large salivary adenocarcinoma (with pathological or imaging diagnosis basis); Ability to understand and answer questions; The patient knows the actual condition; Expected survival time ≥3 months; Informed consent to participate in this study voluntarily. Exclusion criteria: patients with cognitive impairment, or mental illness; Patients are participating in other psychology-related clinical trials. All patients signed informed consent.

Instruments
Contacted with Irma m. verdonck-de Leeuw, professor of vrije universitat Amsterdam, the developer of the scale, obtained the English version of the scns-hnc scale and technical supporting documents, and made the scale Chinese through standard translation, back translation, cultural debugging and evaluation procedures.

Translation procedure
The translation and back translation process is divided into the following steps: (1) the forward translation is completed independently by two translators who are native speakers of Chinese . The translation results are named as translation 1 and translation 2 respectively. Translator 1 is a master of medicine who knows relevant medical terms and can be adjusted from the perspective of clinical practice to ensure the medical equivalence with the original scale. Translator 2, a master of English major without medical background, mainly translated from the perspective of language to meet the language habits of the general public. (2) synthesis. A M.d., Ph.D. who was not involved in "forward translation" conducted a comparative analysis of the two translated versions (translation 1 and translation 2); If there are any differences, three people shall discuss and coordinate with each other to form the initial translation version, namely translation 3. The key link in this stage is that the integration of all translation differences is formed through the consensus of three people after discussion, not the compromise of one person to the opinion of the majority. (3) back translation: two translators pro cient in English and Chinese independently back translate translation 3, forming back translation version 1 and back translation version 2. Back translation translator 1 was a master's student, Back translation translator 2 was a doctoral student, and neither of them knew or was informed of the content and purpose of the scale, and neither of them had a medical background. In order to avoid information deviation and at the same time discover the hidden translation differences of the items in translation 3. Finally, a doctor with a master's degree in medicine will compare the translated English version with the original scale, nd out the differences and modify the Chinese version appropriately, and then give it to the translation team for translation, and then compare with the original scale, and repeat until the English version is as similar as possible to the original scale.

Cultural adjustment
According to the characteristics of Chinese culture, some items in the scale are adjusted to t the Chinese cultural background and context, which is called cultural adjustment. Cultural adjustment has the following two aspects: (1) expert consultation, invite 2 chief physicians, deputy chief physicians and deputy chief nurses of head and neck cancer, 1 medical doctor with overseas study experience, 1 professional English teacher, 1 master of psychology, 1 statistical expert and all translators to form the expert committee. Then, according to the habit and context of Chinese culture, the rst draft of SCNS-HNC scale in Chinese is adjusted from four aspects: semantic equivalence, idiom equivalence, empirical equivalence and conceptual equivalence. For example, item 4 "inform nutrition status" was adjusted to "need to know nutrition knowledge", Revised version 1 of the scale in Chinese was formed after adjustment. (2) preliminary investigation. In order to ensure that the language of the scale is easy to understand and accept, 20 head and neck cancer patients whose native language is Chinese are selected from sichuan cancer hospital for preliminary investigation. First, explain the purpose and signi cance of the survey to the patient in detail, and ll in after obtaining the patient's informed consent; After the completion of the scale, each respondent conducted an interview for about 5-10 minutes, asking whether the content of the scale contained any items with vague meaning and di cult to understand. The understanding and feedback of the pre-respondents on the items were recorded, and the revised version 1 of the Chinese scale was revised and proofread according to the questions re ected in the interview. For example, item 9 "neck or shoulder movement disorder" was modi ed to "support needs for shoulder and neck movement di culty" to ensure easy understanding of the scale items, and the Chinese version of the SCNS-HNC scale was nally formed.

Measures
General information questionnaire Self-designed on the basis of literature review, including two parts: (1) demographic sociology data: Age, gender, nationality, education level, marital status, faith, role of caregiver, long-term residence, etc. (2) data of diseases and treatments: Including cancer type, treatment and so on.

Chinese version of Supportive Care Needs Survey Short-Form (Supportive Care Needs Survey Short-Form SCNS-SF34)
SCNS-SF34 is a scale to measure the needs of cancer patients, which can be used to measure the supportive care needs of all cancer patients [15]. SCNS-SF34 contains 34 items on a ve dimensions: physiological and daily life needs (5 items), psychological needs (10 items), sexual needs (3 items), medical system services and information needs (11 items), patient care and support needs (5 items). The time frame for all entries is the past month, using a likert-5 rating of 1 to 5 points: 1 point means no need , because this entry applies to me; 2 points means a need that has occurred but has been met; Three points means I have a small need for help in this area; four points means I have a 50 percent need for help in this area; ve points means I need a lot of help in this area; Calculate the total score of each dimension, Original score according to conversion formula Likert standard total score =(sum of the original scores for all entries in the dimension -m ) ×{100/(m×(k 1)}, Where m is the number of items contained in the dimension, K is the maximum score of each item, namely 5, Likert standard score between 0 and 100 points, The higher the score, the higher the need degree of this dimension [16].

Chinese version of Supportive Care Needs Survey -Head and Neck cancer SCNS-HNC
The Chinese version of SCNS-HNC scale is the head and neck cancer module of supportive care needs of cancer patients, which is used to determine the speci c supportive care needs of patients with head and neck cancer. It should be combined with Chinese SCNS-SF34 scale, To evaluate the general needs of supportive care and the speci c needs of head and neck cancer. The scale consists of 11 items and is divided into 3 areas (head and neck function, nutrition/oral hygiene/head and neck activity, lifestyle). The time frame and scoring method are the same as those of SCNS-SF34.

Other PROMS and clinical measures
All HNC patients also completed the Hospital Anxiety and Depression Scale (HADS ) [17],and the 10-item Social Support Rating Scale (SSRS) [18] .

Data collection
The researcher introduces the purpose, signi cance and notes of the questionnaire to the respondents. After obtaining the consent of the respondents and signing the informed consent form, the researchers distributed the scale.
Respondents ll in the scale by themselves, If the respondents have visual impairment, physical inconvenience, etc., the researcher will provide unguided assistance. 51 cases were selected from the samples and re-measured 2~3 days later to evaluate the reliability of the scale.

Statistical analysis
Excel2010 was used for data entry, and SPSS21.0 software was used for data statistical analysis. Cronbach's alpha coe cient was used to evaluate the internal consistency of the scale, and the Person correlation coe cient measured twice was used to evaluate the reliability of the scale. It is generally believed that Cronbach's alpha coe cient> 0.7, Indicates that the reliability of the scale retest is good. Exploratory factor analysis was used to evaluate The structural validity of The scale. Bartlett's spherical test and KMO(The Kaiser-Mayer-Olkin) test were required for adaptability test before factor analysis. In factor analysis, it is required that the Chi 2 value of Bartlett's spherical test results must be statistically signi cant (P < 0.05). The KMO test is used to investigate the partial correlation between variables, It compares the simple correlation and partial correlation between variables. It is generally believed that KMO statistics >0.5 can be used for factor analysis. Bartlett's spherical test is mainly used to determine the correlation between variables, P < 0.05 can be used for factor analysis. The common factors that can represent the structure of the scale are extracted and the cumulative variance contribution rate of the common factors is obtained. Each common factor is highly correlated with a group of speci c variables. These common factors represent the basic structure of the scale, and the cumulative variance contribution rate re ects the cumulative effectiveness of the common factor to the scale [19]. The common factor can explain more than 40% of the variation, Moreover, each entry has a relatively high load value (≥ 0.4) on the corresponding factor, which is an ideal factor analysis result [20]. Item-domain correlation analysis was used to evaluate the set validity and discriminant validity of the scale, Namely, calculate the correlation coe cient of each item and Pearson of each eld, If the correlation coe cient between each item and the eld is greater than that of other elds, it indicates that the scale has good set validity and discriminant validity. p<0.05 was considered statistically signi cant. Check for Ceiling effects and Floor effects, If more than 50% of the respondents reach the maximum or minimum extremum of each factor, it means that the factor has ceiling effect and oor effect [21].

Results characteristicsof participants
In this study, a total of 210 questionnaires were distributed, and 206 questionnaires were effectively recovered, with an effective recovery rate of 98.0%. Among the 206 patients, 125 were male and 81 were female. The mean age was 47.29±12.678 years (age range 16~77 years). General information and clinical information of the patients are shown in table 1 The reliability The reliability of the scale was investigated from two aspects: internal reliability and retest reliability. According to the analysis, Cronbach's alpha coe cient ranges from 0.737 to 0.962 in each eld of the scale in this study, the correlation coe cient of the retest was greater than 0.8 except for the psychological dimension was 0.674.

Validity
The structural validity and discriminant validity of the scale were evaluated from ceiling effect, exploratory factor analysis and item-domain correlation analysis.
Ceiling oor effect and exploratory factor analysis Exploratory factor analysis showed that Bartlett's spherical test difference was statistically signi cant (Chi 2 =1051.123, P < 0.0001), the KMO value is 0.759, indicating that the data is suitable for factor analysis.

item -domain correlation analysis
According to the results of item-domain correlation analysis, the correlation coe cient between each item and its domain is relatively high, while the correlation between each item and other domains is signi cantly lower than that of this domain, as shown in table 4.

Correlation analysis of structural domain between SCNS-SF34 and SCNS-HNC scale
Except that the correlation coe cient r of medical system services and information demand and nutrition/oral health/shoulder and neck activity was 0.542, the correlation of structural domain between SCNS-HNC and SCNS-SF34 was relatively low (r < 0.5). The structure domain of SCNS-HNC is positively correlated with that of SCNS-SF34, as shown in table 5.

Clinical validity
The Mann-Whitney U test was used to compare the mean scores of each domain between the two age groups (292 cases <65 and 101 cases ≥65, Rual and city/town). No signi cant differences were found regarding age or region as shown in Table 6. except for the lifestyle dimension, which is not statistically signi cant, all others domains of the SCNS-SF34-C (Mandarin) mostly had signi cant correlations with the HADS. And there were some signi cant weak correlations between the SSRS and the psychological, patient care and support domains of the SCN-SF34.

Discussion
The necessity and signi cance of introducing SCNS-HNC scale China is a large country in the incidence of head and neck cancer, and head and neck cancer anatomically includes the head, face, ear, nose, throat, mouth, thyroid and other parts(from skull base to supraclavicular, excluding cervical vertebra) 22[25], The head have the eyes, ears, nose, tongue, throat and other important organs; In addition, the head and face have a great impact on the appearance and image of patients [23]. Although the survival rate of patients with head and neck cancer has increased gradually with the improvement of medical technology. However, due to the anatomic characteristics of head and neck cancer and the way of disease treatment, patients with head and neck cancer still face many di culties and problems in the treatment and rehabilitation period, and need the support and

Conclusion
To sum up, the Chinese version of the SCNS-HNC scale was Sinicized in this study, and the reliability and validity of the Chinese version were tested. The results showed that the Chinese version of the SCNS-HNC scale had good reliability and validity. The Chinese version of SCNS-HNC scale is concise and clear, easy to understand and to be accepted by patients, which can be used to investigate the supportive care needs of Chinese patients with head and neck cancer, and provide basis for medical staff to timely understand patients' needs and adopt targeted medical care support. Although this study followed the principle that the sample size was 5 to 10 times of the number of items, but as a result of this research limitations in patients with a tumor hospital in chengdu in sichuan province, and using the convenience sampling method, may affect the representation of the survey population, Therefore, it is suggested that follow-up studies should expand the sample and scope, adopt more reasonable sampling methods, and further verify and develop Chinese version of SCNS-HNC scale.

Declarations
Ethics approval and consent to participate This study was approved by the Sichuan Cancer Hospital Ethics Committee and the project number was IIT2019007.

Consent for publication
Not applicable.

Availability of data and materials
The datasets generated and/or analysed during the current study are not publicly available due individual pricacy but are available from the corresponding author on reasonable request.

Competing interests
The authors declare that they have no con ict of interest.