Translation of Supportive Care Needs Survey Short Form 34 (SCNS-SF34) into Nepali Language with Cultural Validation

Purpose Supportive Care Needs Survey (SCNS) is one of the strongest and complete tools to assess the perceived supportive care needs of cancer patients. SCNS –SF34 has been translated into various other culture based languages, validated and established its psychometric properties. Till now no Nepali version, so we planned to assess the linguistic and cultural validity of Nepali version of the SCNS-SF34 in Nepali population. quality of life among cervical cancer patients.


Introduction
Globally cancer is the second leading cause of deaths and 9.6 million people died of cancer in 2018 of which 70% were from middle and low-income countries. The main causes of deaths due to cancer worldwide were highest for lung cancer, followed by colorectal cancer, stomach cancer, liver cancer and Brief description of the SCNS-SF34 instrument SCNS-SF 34 is identi ed as a valid and reliable assessment instrument for identifying the supportive care needs by means of self-reporting questionnaire regarding patients' perceived supportive care needs [21] . It consists of 34 items along with 5 domains (psychological needs (10 items), healthcare system and information needs (11 items), physical and daily living needs (5 items), patient care and support needs (5 items) and sexuality needs (3 items). Patients report the current need and extent of support for help in the previous month as a result of having cancer (1-no need, not applicable; 2-no need, satis ed; 3-low need; 4-moderate need; 5-high need). A high score in the tool indicates that perceived supportive care need is high level [19].

Translation and adaptation process
Translation of original English version SCNS-SF 34 was translated in the Nepali Language by following Beaton's guideline. This guideline has the following 7 stages of translation.
Beaton's guideline was used in the study in Italy for Translation of Supportive Care Needs Survey Short Form 34 (SCNS-SF34) into Italian and cultural validation study [22].
Stage (1): translation into the target language (Translation from English to Nepali): Independent forward translations of the original SCNS-SF34 was done by two native Nepali (T1 and T2). The rst forward translation was done by a medical oncologist with long-experienced in oncology health care and clinical research. The second translation was done by a non-clinician specialized in translation and communication and in the translation of instruments and different contents for patient and caregiver education in general and special.
Stage (2): Synthesis of the forward translations (Make one compile document from two forward translated documents): The two forward translated documents were made into one by the main researcher and also kept the written record of the main difference between two translations.

Stage (3): Backward translations (Nepali to English):
The new one combined version of the forward translated document was then backward translated by two independent native English speakers (a bilingual English teacher and a bilingual translator experience in scienti c writing). The backward translated version (B1 and B2) were again made in one form with the written records of main differences in B1 and B2 by the main researcher. With the help and coordination of a third native bilingual (English, Nepali) speaker, Item equivalence(similarity) of the synthesized backward translated version was then assessed by comparing it with the original SCNS-SF34 English version.
Stage (4): consensus conference (Make preliminary Nepali) version of the SCNS-SF34 questionnaire): A consensus conference was done by the team of medical oncologist, nurse working in the oncology area, psychiatric nurse, research nurse, statistician, bilingual translators, patient representative and main researcher by means of discussion (on translated and synthesized documents and keynotes on difference found during translation), meeting and email. The linguistics similarities of the two synthesized translations (forward into Nepali and backward into English) were carefully analyzed by the research team and chose the proper, simple and easily understandable terms to use in the preliminary Nepali version.
At the end, a decision was reached on the de nitive format of the initial Nepali version of the SCNS-SF34 questionnaire and all the initial documents were shared with the research team. were informed about the purpose of the study and written informed consent from each respondent. The pretest study was carried out from 1 st February 2020 to April 30 th 2020 in and an outpatient department of the selected hospital. Pretest respondents included 34 cervical cancers patients' representative of the target population of the questionnaire, cervical cancer, female patients >18 years of age with any stage or treatment setting, and from a variety of socioeconomic characteristics.

Data collection
For cultural adaptation (an expert panel and pre testing) was done. Experts reviewed the items of the Nepali version and compared it to the original version. They were doctor, nurse and educationist who were involved in treatment, management, education and research of cancer patient in Nepal (Oncologist, Nurse study and working in Oncology, Ph.D. nurse, Different level hospital nursing administrator, professor working in research and nursing education).
For the content validity index (CVI), experts needed to rate each item of the instrument concerning semantic/ idiomatic, cultural and conceptual aspects [23,24] based on scoring technique Davis (1992) Data were collected from 10 experts for the assessment of content validity by using 4 points Likert scale, expert opinions on content validity were taken and the content validity index (CVI) was gured in terms of item level and scale level. the content validity test was carried out with the help of Davis (1992) technique that grades experts' opinion in a four -choice criteria: 1=not relevant, 2=somewhat relevant, 3=quite relevant, 4=highly relevant. The CVI is found out by dividing the number of the experts that mark the choices and with the total number of the experts and subtracting 1. Instead of comparing this value with a statistical scale, the 0.80 value is accepted as the criterion for scale level and more than 0.70 is accepted as the criterion for item level content validity index [25].
For the assessment of the clarity of the questionnaire, 15 patients were interviewed on the developed questionnaire by means of Likert scale and comments. The test-retest method was carried out among 50 respondents for the assessment of reliability. Test-retest reliability was analyzed using intra-class correlation coe cients (ICC). An ICC value of 0.70 or above was considered satisfactory [26]. Pretesting done among 34 respondents (10% of sample size=340) for the assessment Reliability and construct validity. After completing the self-administered questionnaires by the respondents, the respondents were again asked about each item, how they thought about the question, di culty level, understanding level, easily understandable words/phrase, replacement of words/ phrase, offensive or aggressive words. They had been encouraged to give comments in any section of the questionnaire to make it suitable in Final Nepali version.

Stage (5): pretest patient survey
Pre-testing was carried out among 34 (10% of sample size) respondents. The Demographic ndings were as follows:

Demographics Characteristics of Respondents
Among 34 respondents, most of the respondents 35.3% of the respondents were above 60 years, and 29.4% of the respondents were between 46-55 years. Regarding educational status most of the respondents 64.7% were illiterate. Among them70.6% were married ,55.9% of the respondents were in II stage of cervical cancer disease. Regarding treatment modalities, majority of the respondents, 67.6%, were on Radiation +Chemotherapy therapy (Refer to Table 1).

Reliability of tool
For the assessment of reliability of tool, 34 respondents were included to get the response on ve point Likert of questionnaire. Scale Mean, Scale Variance, Total Correlation and Cronbach's Alpha were calculated. The item-wise Cronbach's Alpha is more than 0.7 and average Cronbach's Alpha is 0.902. The reliability was con rmed after evaluating the inter-item correlation The reliability was evaluated by using Cronbach's αcoe cient. Item wise Cronbach's Alpha was found more than 0.7 and scale Cronbach's Alpha was found 0.902(Refer to Table 2).

Validity of Instrument
For the assessment of the content validity of the questionnaire, 10 experts were consulted. They were doctor, nurse and educationist who were involved in treatment, management, education and research of cancer patient in Nepal (Oncologist, Nurse study and working in Oncology, Ph.D. nurse, Different level hospital nursing administrator, professor working in research and nursing education).
Item level (I-CVI) and Scale level (S-CVI) content validity index was assessed. I-CVI was found more than 0.78 semantic/ idiomatic, cultural and conceptual aspects and S-CVA/Ave was found,89.00% (0.89) 91.88 % (0.91) 90.00%(0.90) in semantic/ idiomatic, cultural and conceptual aspects respectively. CVR was calculated by using the formula CVR = [ (E-(N/2))/ (N/2)] where E indicates the number of experts who rated the objects as essential and N indicated total number of experts. CVR can measure between -1.0 and 1.0. The closer to 1.0 the CVR is, the more essential the object is considered to be. The results show that CVR was found 0.9 to 1 (Refer to Table 3).

Clarity Assessment
For the assessment of the clarity of the questionnaire, 15 patients were interviewed on the developed questionnaire by means of Likert scale and comments.
The item-wise clarity of the questionnaire and average clarity of the questionnaire was assessed. The average clarity of questionnaire was 91.29 % (Refer to Table 3).

Analysis of test-retest Method for reliability
The test retest method was carried out among 50 respondents. The retest was carried out after 3 weeks of completion of teat assessment. The mean score (3.0518 & 3.1176) and standard deviation (0.57585 &0.56590) in test and retest were found respectively. The correlation is signi cant at the 0.01 level (2tailed) (Refer to Table 2).

Instructions and response scale
The majority of patients agreed that the instruction section was clear and understandable.
Majority of patients said that the instruction of the alternatives of the level of needs (1,2,3, 4,5) Must include in the questionnaire section not only in the example section -Half of the patients suggested substituting the example of a perceived need in the instruction section with one relating to a physical need (pain) because patients in a cancer setting would relate more easily to it and would better understand how to complete the questionnaire.
Item clarity, comprehensiveness, and signi cance Study participants considered all item clear and comprehensible.
More simple Nepali words were choose as suggested by participants in item no2,3,7 9,10, 12,18,19,21,22,23,24,25,27 and 30 than the preliminary Nepali version Item importance All of the study participants rated the importance of each item as ≥3 on a ve-point Likert scale, and more than 80 % evaluated each one as ≥4.

Item acceptability
All of the study participants easily accept all the item All of the patients positively commented on that item 14 (feelings about death and dying) although it was a distressing concept but inquiry about that feeling is essential to make the patient more comfortable.
All of the participants felt that items although 15 (change in sexual desires) and 16 (change in sexual relations) were embarrassing but need to explore the particular problem because it is hidden cultural problem in Nepal All of the participants wanted to aid nance-related problem, problem-related to caretaker, problems during the hospital stay.

Construct validity of the preliminary Nepali version
The construct validity of the preliminary Nepali version was assessed by calculating Cronbach's alpha, item wise Cronbach's Alpha is more than 0.7 and average Cronbach's Alpha is 0.902. These ndings are alike with original SCNS-SF34 validation studies and other studies SCNS-SF34 translated into other languages.

Modi ed phrases
After nishing the pretesting study, Consensus conference meeting was done with the team of medical oncologist, nurse working in the oncology area, psychiatric nurse, research nurse, statistician, bilingual translators, patient representative and main researcher through discussion (on translated and synthesized documents and keynotes on difference found during translation), meeting and email. The team members agree with to change the simple Nepali language in the instruction section and other item section. (Majority of patients said that the instruction of the alternatives of the level of needs (1,2,3,4,5) Must include in the questionnaire section not only in the example section. Half of the patients suggested substituting the example of a perceived need in the instruction section with one relating to a physical need (pain) because patients in a cancer setting would relate more easily to it and would better understand how to complete the questionnaire). More simple Nepali words were chosen as suggested by participants in item no 2,3,7, 9,10, 12, 18,19, 25, 27and 30 than the preliminary Nepali version. At the end of this meeting the nalized Nepali version of the SCNS-34 SF was approved. The questionnaire items modi ed in the nal version concerning to the preliminary version used in the pretest study were presented in the table (Refer to Table 4).

Discussion
According to this study, I-CVI is found more than 0.78 and Scale level content validity index (S-CVI) is found 0.91. Content validity Ratio (CVR) was found at 0.9 to 1. The item-wise Cronbach's Alpha is found more than 0.7 and average Cronbach's Alpha is found 0.902. correlation is signi cant at the 0.01 level (2tailed). The average clarity of the questionnaire is found 91.29 %. Construct validity (0.902) of the preliminary Nepali version is found alike with original SCNS-SF34 validation studies and other studies SCNS-SF34 translated into other languages. These ndings are similar with the study "Translation of Supportive Care Needs Survey Short Form 34 (SCNS-SF34) into Italian and cultural validation study" carried out among cancer patient found that Italian questionnaire maintained the construct validity of the original version and was easy to understand and use. The construct validity, evaluated by calculating Cronbach's alpha, was 0.924 [22]. These ndings are also in line with the study "An Adaptation of the Short-Form Supportive Care Needs Survey Questionnaire (SCNS-SF 34) to Turkish among breast cancer patient found that the content validity index of the scale was calculated as 0.83. The Cronbach α coe cient is 0.93. [25]. These ndings are supported by the study "Supportive care needs and quality of life of patients with gynecological cancer undergoing therapy in Indonesia used the tool SCNS-SF 34 and found that it had a validity score of validity 0.302-0.792 and a reliability score of 0.933 [27]. These ndings are also supported by the study "Un-met Supportive Care Needs of Iranian Breast Cancer Patients" found that internal reliability coe cients (Cronbach Alpha) of the translated questionnaire was substantial, greater than 0.90 [28].
Our research is further completed on validation of the questionnaire on a larger sample of the target population in different cancer-speci c hospital in Nepal. In particular, we also aim to prospectively assess the supportive care needs of cervical cancer patients along with its associated factors.  No 1706) approved the study proposal. Formal permission was granted from the setting of the study and informed consent was taken from participants before the data collection. Formal permission was granted from setting of the study and informed consent was taken from participants before the data collection.

Consent for publication
Informed consent for publication was taken from all participants included in the study, Nepal Health Research Council, Nepal and School of Nursing and Health, Zhengzhou University, Henan China.

Availability of Data and Material
The primary data are stored safely and con dently by the authors and agree to review the primary data upon the request of the journal.

Competing interests
All the authors declared that they have no competing interests for the declarations of this manuscript.

Funding
No funding was received for conducting this study.  The frequency (n) and proportion (%) were used for the analysis of participant's demographic characteristics Item wise Cronbach's Alpha more than 0.7 was accepted.
** sig at 0.01 level I-CVI and S-CVI was assessed. I-CVI more than 0.7 and S-CVA more than 0.8 was accepted.