Research team description
In this study, the research team of following professional members were involved: medical oncologist, nurse working in the oncology area, psychiatric nurse, research nurse, statistician, bilingual translators, patient representative, method expert (project leader), English language, and Nepali language expert. Patient representatives were also involved in the process of a consensus conference.
Brief description of the SCNS-SF34 instrument
SCNS-SF 34 is identified 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, satisfied; 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 first 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 scientific 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 definitive format of the initial Nepali version of the SCNS-SF34 questionnaire and all the initial documents were shared with the research team.
Methods
Participants and recruitment
Ethical approval was taken from the School of Nursing and Health, Zhengzhou University, Henan, China (ZZU IRB 2019-028), Nepal Health Research Council, Nepal (Ref. No 1706). Formal permission was taken from Bhaktapur Cancer Hospital (BCH), Bhaktapur, Nepal and Bisweswar Prasad Koirala Memorial Cancer Hospital(BPKMCH), Bharatpur, Chitwan, Nepal cancer Hospital & Research center; Harisiddhi, National Hospital &Cancer center; Jawalakhel, Kathmandu Cancer Center; Tathali, Nepal. Participants were informed about the purpose of the study and written informed consent from each respondent. The pretest study was carried out from 1st February 2020 to April 30th 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 figured 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 coefficients (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, difficulty 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 findings 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 five 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 confirmed after evaluating the inter-item correlation The reliability was evaluated by using Cronbach’s αcoefficient. 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 significant at the 0.01 level (2-tailed) (Refer to Table 2).