Linguistic translation and cultural validation of the COST-FACIT-V2 questionnaire in Odia to measure financial toxicity in India

Linguistic translation and cultural validation of the COST-FACIT-V2 questionnaire in Odia to measure financial toxicity in India | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Short Report Linguistic translation and cultural validation of the COST-FACIT-V2 questionnaire in Odia to measure financial toxicity in India Debasmita Nayak, Isabel Arruda-Caycho, Luca C. Bernardini, Sourajit Parida, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8856042/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Cancer treatment can be associated with numerous direct and indirect financial burdens. These burdens, described as financial toxicity, can often affect care-based decision making of cancer patients. Breast cancer is the leading cause of cancer death of women in India, who often face the detrimental effects of financial toxicity. Measuring financial toxicity can be assessed through the COST-FACIT-V2 questionnaire, yet it is only available in limited languages. This study aimed to translate the widely used COST-FACIT-V2 tool used for assessing financial toxicity in Odia, one of India’s most commonly spoken regional languages. Methods We followed the prescribed linguistic translation guidelines for the 12-item COST-FACIT-V2 developed by the tool developers. This entailed a forward translation and back translation, facilitated by artificial intelligence (AI), confirmed by human validation, and pilot testing with 10 native Odia speakers at a comprehensive cancer center in Odisha, India. Results The AI forward and back translations demonstrated accuracy with human validation. Minor changes were needed to enhance contextual accuracy and consistency with previous FACITtrans key phrases such as “paid work at home”, which were not well understood by the pilot sample group, leading to culturally adapted modifications in the final translated version. Discussion The findings of this paper support the linguistic validity and cultural appropriateness of the Odia COST-FACIT-V2 and highlight the importance of rigorous translation methods to enable equitable measurement of financial toxicity and inform financial protection efforts in diverse cancer care settings. The use of AI represents an important innovation to support translation of standardized tools used in health systems research. Financial Toxicity COST-FACIT-V2 Odia Translation Artificial Intelligence Figures Figure 1 Figure 2 BACKGROUND Cancer treatment can be associated with significant financial burdens stemming from direct treatment costs, medications, travel expenses, caregiving expenses, and variable employment income. 1 , 2 These burdens, often described as financial toxicity in the literature 3 , can create barriers to cancer treatment access and completion, forcing patients and their families to make critical decisions surrounding their care. 2 , 4 – 6 In India, where breast cancer is the leading cause of cancer death in women, 7 there are significant inequities regarding breast cancer treatment plans and access to care. 4 , 8 This is created by inequitable publicly financed healthcare insurance plans where many patients are required to cover their treatment partially or entirely out-of-pocket. 4 , 8 – 10 These out-of-pocket costs have caused one-third of households impacted by a cancer diagnosis to spend more than half of their per-capita annual household expenditure solely on hospitalizations. 11 Coupling these costs with the risk of discontinuing cancer treatment, there is reason to hypothesize that such critical decisions are directly impacting specific health outcomes. 12 , 13 The COmprehensive Score for financial Toxicity – Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2) is a validated and reliable instrument for measuring financial toxicity in cancer populations. 14 Its psychometric properties have been established across multiple English-speaking populations, including in studies conducted in India. 15 – 17 Validated translations are currently available in Hindi and Marathi 17 – 19 , languages spoken by a significant majority of the population. However, India has 22 officially recognized languages, and more than 130 active languages 20 , underscoring the risk of limited linguistic coverage systematically excluding large populations from clinical and health-systems research. Language barriers are a well-documented source of inequitable participation and under-representation in clinical research. 20 – 22 Odia is one of India’s 22 official languages, and the primary language spoken in Odisha, however it is not an available language of the COST-FACIT-V2 questionnaire. 19 To address this gap, we conducted a translation and validation study of the COST-FACIT-V2 in Odia. Odisha, an eastern Indian state with a population exceeding 40 million, has a predominantly Odia-speaking population and a high reliance on out-of-pocket spending for cancer care, particularly among rural and socioeconomically disadvantaged groups 23 , 24 , making accurate measurement of financial toxicity essential for informing financial protection strategies. METHODS Study Design and Setting This cross-sectional linguistic translation and cultural adaption of the COST-FACIT-V2 questionnaire was undertaken at the Department of Oncology in KIMS Cancer Centre (KCC). KCC is a comprehensive cancer care centre located in Bhubaneswar, Odisha, India, operating within a mixed public–private health system. The centre provides diagnostic, surgical, medical, and radiation oncology services for a broad range of adult cancers and receives referrals from public sector facilities, private providers, and self-referrals across Odisha and neighbouring states. KCC serves approximately 2,000 cancer patients annually, many of whom rely on out-of-pocket payments and/or state and national insurance schemes, underscoring the importance of measuring financial toxicity to inform financial protection strategies for cancer care in this setting. The study was conducted between September 2024 and March 2025. Instrument The COST-FACIT-V2 is a 12-item patient outcome self-report tool that measures financial distress and financial toxicity among adult cancer patients (Fig. 1 ). Responses are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much), with total scores ranging from 0 to 44. All items are based on a 7-day recall period. Translation Process The FACITtrans Team, the translation team for the FACIT Group, provided the guidelines for the translation process (Fig. 2 ) with two approved modifications: the use of AI to support the forward and back translations with manual validation by a human, and the inclusion of both patients and healthcare providers in the pilot testing of conceptual understanding. A revision history was completed to examine and categorize the types of revisions needed during each stage of the translation process. The challenges and solutions encountered during the translation of questionnaire items and pilot testing were documented and presented. Step 1: Forward translation The English version of the COST-FACIT-V2 was first translated into Odia using two different generative AI platforms, ChatGPT-4 and Microsoft Copilot. Each item on the English source was entered individually into the AI engines, which were prompted to “translate from English to Odia” by a research team member. Step 2: Reconciliation Three native Odia speaking authors (DN, SP and SM) made up the linguistic team who reviewed forward translations and reconciled discrepancies. Step 3: Back translation ChatGPT-4 was used to back-translate the reconciled Odia translation into English and reviewed by the same linguistic team. Step 4: FACITtrans analysis The FACITtrans translation manager reviewed all forward-back translations for quality and consistency with terms and phrases used in their existing validated translations, which is referred to as the translation memory bank. Issues identified by the FACITtrans translation manager were resolved by the Odia translators. The FACITtrans translation manager approved the final Odia version of the tool for pilot testing. Step 5: Interview for conceptual understanding The Odia questionnaire was administered to 10 participants recruited from KCC. Both patients and hospital staff were included for participation if they self-identified as fluent Odia speakers. A cognitive interview was conducted to assess participants’ understanding of questionnaire items and terminology, ensuring they accurately understood the intended meaning. Step 6: Review and licensing The FACITtrans team provided final proofing of the translated tool and generated a license for use in research. RESULTS Forward-back translation results The linguistic team reviewed two independent AI-generated forward translations and identified several minor discrepancies requiring revision during reconciliation (Table 1 ). In most instances, the forward translations captured the intended meaning of the English source; however, when neither version fully reflected the semantic or contextual intent of a given term or phrase, the linguistic team selected the most appropriate alternative to ensure conceptual equivalence with the original instrument. Subsequent back translations of the reconciled Odia version demonstrated strong alignment with the English source text, with no substantive discrepancies identified. The FACITtrans analyst and linguistic team jointly reviewed all back translations and confirmed that the reconciled Odia items preserved the original intent, tone, and measurement concepts of the COST-FACIT-V2. Throughout the reconciliation process, the linguistic team worked closely with the FACITtrans analyst to maintain consistency with the FACITtrans translation memory bank. For a limited number of terms (n = 5) the team intentionally deviated from the translation memory bank to improve contextual accuracy or grammatical completeness, especially where direct equivalence risked obscuring meaning for local respondents. To enhance readability and consistency with Odia writing conventions, the team removed all full stops from the translated items. Several recurrent linguistic issues emerged across multiple items (n = 4), most notably, the spelling of the term to denote expenses or costs. The team selected “ଖର୍ଚ୍ଚ” over “ଖର୍ଚ” to better reflect standard usage pronunciation and clarity of meaning in Odia. Another challenge was the translation of culturally bounded phrases or expressions without direct Odia equivalents. For example, the phrase “out-of-pocket” medical expenses does not have a literal translation in Odia. Rather than adopting a word -for-word translation, we revised the phrasing to convey the underlying concept of personally bearing medical costs or paying with personal funds . When multiple alternatives were proposed for a given term, the team selected the final wording based on alignment with FACITtrans conventions, as described in the FACITtrans translation memory, or the extent to which the terms accurately conveyed the contextual factors of the English source. For instance, in FT4, the English concept of “choice” refers to the perceived restriction due to the cost of care. To better reflect this meaning, the Odia translation used a term equivalent to “options,” explicitly linked to financial expenditure, preserving the intended measurement construct. Conceptual Understanding Four patients and six healthcare workers participated in the pilot study and cognitive interviews with a mean age of 42.2 [35–56]. The linguistically translated COST-FACIT-V2 was well understood by the majority of the pilot sample. All participants self-reported that they had no difficulty understanding the items. None of the participants reported feeling that any of the translated items were unnatural, irrelevant or offensive. No participants self-reported that they found any of the items difficult to understand. Primary concerns included minor discrepancies in how key terms were translated across items. For example, there was a discrepancy in how the term “money” was translated between items FT1 and FT4, specifically between “ଅର୍ଥ “and “ଟଙ୍କା”. ଟଙ୍କା was chosen as it is the most used and understood by the public in Odisha. “Financial situation” is another term that was translated differently across multiple items [FT6, 10, 11]. The translation for FT6 was revised to ensure consistency without compromising contextual relevance. The concept of "paid work from home", although translated accurately, was not understood by nearly any of the participants, denoting a possible cultural misunderstanding of the concept and a potential lack of relevance for this population. The term remains in the translated version as it is an established item in the validated English source. DISCUSSION This study demonstrates that the Odia translation of the COST-FACIT-V2 achieved strong linguistic and conceptual equivalence with the English source instrument. The forward-back translation and reconciliation process required only minor revisions, primarily to optimize semantic clarity, ensure consistency across items, and adapt culturally specific expressions, such as “out-of-pocket” medical expenses, without altering the underlying measurement constructs. Cognitive interviews with patients and healthcare workers confirmed that the translated items were generally well understood and acceptable, with no reported difficulties in comprehension. These findings support the linguistic validity and cultural appropriateness of the Odia COST-FACIT-V2 and highlight the importance of rigorous translation methods to enable equitable measurement of financial toxicity and inform financial protection efforts in diverse cancer care settings. The use of AI to support study material translation has been an emerging research topic since the development of large language models such as ChatGPT. 25 While the forward and back translations themselves were completed rapidly, the entire process was not significantly accelerated as the AI translations were still embedded on a human-led process that strictly adhered to the COST-FACIT-V2 developer guidelines. Future researchers using AI for similar translation, may not encounter the same time barriers. One limitation with the AI translations was the inconsistent uses of words to translate terms such as “illness” or “money”. Additionally, AI software was unable to recognize cultural differences in semantics such as idioms or concepts such as “paid work from home”. This further emphasises the importance of human pilot testing for effective cultural adaption. This paper is a part of a series of translations working to support a study understanding inequities in breast cancer treatment and care. While the translation process is rigorous and thorough, certain limitations present themselves. During the pilot testing process, only 10 participants were included, and the robustness may have been improved with a larger sample size. Additionally, four of these participants were men which is not reflective of the larger study population, however the COST-FACIT-V2 is neither gender specific, nor specific to breast cancer, thus maintaining validity for general use. However, considering the self-reported nature of the pilot testing, certain biases, including social desirability and recall biases, may have been present. CONCLUSION The Odia translation of the COST-FACIT-V2 has been incorporated into the FACITtrans portfolio of officially validated languages available for future research use. This translation expands the capacity to measure financial toxicity in India and among an Odia-speaking population. While the use of AI in this study accelerated the initial forward and back translation stages, the iterative review and approval process underscored the continued importance of expert linguistic oversight and participant input to ensure conceptual and cultural validity. Cognitive interviewing proved essential in refining the key terms to reflect locally meaningful understanding of money, financial strain and work, concepts that are core to the examining financial toxicity, strengthening the tool’s ability to capture patient-reported financial hardship. By enabling linguistically inclusive measurement, the Odia COST-FACIT-V2 supports more equitable financial protection research and contributes to a broader evidence base that reflects the lived economic experiences of diverse cancer populations. Declarations ETHICAL AND FUNDING DECLARATIONS Human Ethics and Consent to Participate Ethics approval was secured from the Kalinga Institute of Medical Sciences Institutional Ethics Committee [1844/2024], and University of Toronto Research Ethics Board [44562]. Verbal consent was obtained for all participants prior to pilot testing. Research Funding This study received research funding from the Canadian Institutes of Health Research [185706], the Princess Margaret Global Cancer Program, and the Princess Margaret Cancer Foundation. Author Contribution DN: Data Collection, Data Analysis and Interpretation, Visualization, Writing – Original Draft, Writing – Review & EditingIAC: Visualization, Writing – Original Draft, Writing – Review & EditingLCB: Visualization, Writing – Original Draft, Writing – Review & EditingSP: Data Collection, Data Analysis and Interpretation, Visualization, Writing – Review & EditingDR: Conceptualization, Methodology, Writing – Review & EditingSM: Data Collection, Data Analysis and InterpretationBE: Conceptualization, Methodology, Supervision, Data Analysis and Interpretation, Visualization, Writing – Review & EditingAll authors read and approved the final manuscript. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8856042","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Short Report","associatedPublications":[],"authors":[{"id":597800020,"identity":"b6f97062-8e37-4de5-8ef1-e4600f5273e1","order_by":0,"name":"Debasmita Nayak","email":"","orcid":"","institution":"Kalinga Institute of Medical Sciences Cancer Centre","correspondingAuthor":false,"prefix":"","firstName":"Debasmita","middleName":"","lastName":"Nayak","suffix":""},{"id":597800021,"identity":"2ebae935-dd66-43a4-a933-ce3c6018b8e3","order_by":1,"name":"Isabel Arruda-Caycho","email":"","orcid":"","institution":"University of Toronto","correspondingAuthor":false,"prefix":"","firstName":"Isabel","middleName":"","lastName":"Arruda-Caycho","suffix":""},{"id":597800024,"identity":"be552560-8def-409c-b2a3-fbc1579fca22","order_by":2,"name":"Luca C. 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2","display":"","copyAsset":false,"role":"figure","size":273165,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTranslation process of the COST-FACIT-V2 Questionnaire from English to Odia.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"COSTODIAFIGURE2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8856042/v1/c171d28a3a939d62fbcc14d3.jpg"},{"id":104400987,"identity":"cf69bca8-85d9-4afe-927e-56c84facde3c","added_by":"auto","created_at":"2026-03-11 12:11:38","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":978423,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8856042/v1/dcd04281-7cf4-46e3-9c2c-bdd2a2ba67a3.pdf"},{"id":103839288,"identity":"bcc60314-8cf0-49d5-a361-f704bf7a2183","added_by":"auto","created_at":"2026-03-03 14:31:37","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":23811,"visible":true,"origin":"","legend":"","description":"","filename":"COSTODIATABLE1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8856042/v1/2885234e9e493572b28507b6.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Linguistic translation and cultural validation of the COST-FACIT-V2 questionnaire in Odia to measure financial toxicity in India","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eCancer treatment can be associated with significant financial burdens stemming from direct treatment costs, medications, travel expenses, caregiving expenses, and variable employment income.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e These burdens, often described as financial toxicity in the literature\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e, can create barriers to cancer treatment access and completion, forcing patients and their families to make critical decisions surrounding their care.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e In India, where breast cancer is the leading cause of cancer death in women,\u003csup\u003e7\u003c/sup\u003e there are significant inequities regarding breast cancer treatment plans and access to care.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e This is created by inequitable publicly financed healthcare insurance plans where many patients are required to cover their treatment partially or entirely out-of-pocket.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e These out-of-pocket costs have caused one-third of households impacted by a cancer diagnosis to spend more than half of their per-capita annual household expenditure solely on hospitalizations.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e Coupling these costs with the risk of discontinuing cancer treatment, there is reason to hypothesize that such critical decisions are directly impacting specific health outcomes.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe COmprehensive Score for financial Toxicity \u0026ndash; Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2) is a validated and reliable instrument for measuring financial toxicity in cancer populations.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e Its psychometric properties have been established across multiple English-speaking populations, including in studies conducted in India.\u003csup\u003e\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e Validated translations are currently available in Hindi and Marathi\u003csup\u003e\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e, languages spoken by a significant majority of the population. However, India has 22 officially recognized languages, and more than 130 active languages\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e, underscoring the risk of limited linguistic coverage systematically excluding large populations from clinical and health-systems research. Language barriers are a well-documented source of inequitable participation and under-representation in clinical research.\u003csup\u003e\u003cspan additionalcitationids=\"CR21\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e Odia is one of India\u0026rsquo;s 22 official languages, and the primary language spoken in Odisha, however it is not an available language of the COST-FACIT-V2 questionnaire.\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eTo address this gap, we conducted a translation and validation study of the COST-FACIT-V2 in Odia. Odisha, an eastern Indian state with a population exceeding 40\u0026nbsp;million, has a predominantly Odia-speaking population and a high reliance on out-of-pocket spending for cancer care, particularly among rural and socioeconomically disadvantaged groups\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e,\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e, making accurate measurement of financial toxicity essential for informing financial protection strategies.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Setting\u003c/h2\u003e \u003cp\u003eThis cross-sectional linguistic translation and cultural adaption of the COST-FACIT-V2 questionnaire was undertaken at the Department of Oncology in KIMS Cancer Centre (KCC). KCC is a comprehensive cancer care centre located in Bhubaneswar, Odisha, India, operating within a mixed public\u0026ndash;private health system. The centre provides diagnostic, surgical, medical, and radiation oncology services for a broad range of adult cancers and receives referrals from public sector facilities, private providers, and self-referrals across Odisha and neighbouring states. KCC serves approximately 2,000 cancer patients annually, many of whom rely on out-of-pocket payments and/or state and national insurance schemes, underscoring the importance of measuring financial toxicity to inform financial protection strategies for cancer care in this setting. The study was conducted between September 2024 and March 2025.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eInstrument\u003c/h3\u003e\n\u003cp\u003eThe COST-FACIT-V2 is a 12-item patient outcome self-report tool that measures financial distress and financial toxicity among adult cancer patients (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Responses are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much), with total scores ranging from 0 to 44. All items are based on a 7-day recall period.\u003c/p\u003e\n\u003ch3\u003eTranslation Process\u003c/h3\u003e\n\u003cp\u003e The FACITtrans Team, the translation team for the FACIT Group, provided the guidelines for the translation process (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) with two approved modifications: the use of AI to support the forward and back translations with manual validation by a human, and the inclusion of both patients and healthcare providers in the pilot testing of conceptual understanding. A revision history was completed to examine and categorize the types of revisions needed during each stage of the translation process. The challenges and solutions encountered during the translation of questionnaire items and pilot testing were documented and presented.\u003c/p\u003e\n\u003ch3\u003eStep 1: Forward translation\u003c/h3\u003e\n\u003cp\u003eThe English version of the COST-FACIT-V2 was first translated into Odia using two different generative AI platforms, ChatGPT-4 and Microsoft Copilot. Each item on the English source was entered individually into the AI engines, which were prompted to \u0026ldquo;translate from English to Odia\u0026rdquo; by a research team member.\u003c/p\u003e\n\u003ch3\u003eStep 2: Reconciliation\u003c/h3\u003e\n\u003cp\u003eThree native Odia speaking authors (DN, SP and SM) made up the linguistic team who reviewed forward translations and reconciled discrepancies.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStep 3: Back translation\u003c/h2\u003e \u003cp\u003eChatGPT-4 was used to back-translate the reconciled Odia translation into English and reviewed by the same linguistic team.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStep 4: FACITtrans analysis\u003c/h3\u003e\n\u003cp\u003eThe FACITtrans translation manager reviewed all forward-back translations for quality and consistency with terms and phrases used in their existing validated translations, which is referred to as the translation memory bank. Issues identified by the FACITtrans translation manager were resolved by the Odia translators. The FACITtrans translation manager approved the final Odia version of the tool for pilot testing.\u003c/p\u003e\n\u003ch3\u003eStep 5: Interview for conceptual understanding\u003c/h3\u003e\n\u003cp\u003eThe Odia questionnaire was administered to 10 participants recruited from KCC. Both patients and hospital staff were included for participation if they self-identified as fluent Odia speakers. A cognitive interview was conducted to assess participants\u0026rsquo; understanding of questionnaire items and terminology, ensuring they accurately understood the intended meaning.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStep 6: Review and licensing\u003c/h2\u003e \u003cp\u003eThe FACITtrans team provided final proofing of the translated tool and generated a license for use in research.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eForward-back translation results\u003c/h2\u003e \u003cp\u003eThe linguistic team reviewed two independent AI-generated forward translations and identified several minor discrepancies requiring revision during reconciliation (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). In most instances, the forward translations captured the intended meaning of the English source; however, when neither version fully reflected the semantic or contextual intent of a given term or phrase, the linguistic team selected the most appropriate alternative to ensure conceptual equivalence with the original instrument. Subsequent back translations of the reconciled Odia version demonstrated strong alignment with the English source text, with no substantive discrepancies identified. The FACITtrans analyst and linguistic team jointly reviewed all back translations and confirmed that the reconciled Odia items preserved the original intent, tone, and measurement concepts of the COST-FACIT-V2.\u003c/p\u003e \u003cp\u003eThroughout the reconciliation process, the linguistic team worked closely with the FACITtrans analyst to maintain consistency with the FACITtrans translation memory bank. For a limited number of terms (n\u0026thinsp;=\u0026thinsp;5) the team intentionally deviated from the translation memory bank to improve contextual accuracy or grammatical completeness, especially where direct equivalence risked obscuring meaning for local respondents. To enhance readability and consistency with Odia writing conventions, the team removed all full stops from the translated items.\u003c/p\u003e \u003cp\u003eSeveral recurrent linguistic issues emerged across multiple items (n\u0026thinsp;=\u0026thinsp;4), most notably, the spelling of the term to denote expenses or costs. The team selected \u0026ldquo;ଖର୍ଚ୍ଚ\u0026rdquo; over \u0026ldquo;ଖର୍ଚ\u0026rdquo; to better reflect standard usage pronunciation and clarity of meaning in Odia. Another challenge was the translation of culturally bounded phrases or expressions without direct Odia equivalents. For example, the phrase \u0026ldquo;out-of-pocket\u0026rdquo; medical expenses does not have a literal translation in Odia. Rather than adopting a word -for-word translation, we revised the phrasing to convey the underlying concept of \u003cem\u003epersonally bearing medical costs\u003c/em\u003e or paying with \u003cem\u003epersonal funds\u003c/em\u003e.\u003c/p\u003e \u003cp\u003eWhen multiple alternatives were proposed for a given term, the team selected the final wording based on alignment with FACITtrans conventions, as described in the FACITtrans translation memory, or the extent to which the terms accurately conveyed the contextual factors of the English source. For instance, in FT4, the English concept of \u0026ldquo;choice\u0026rdquo; refers to the perceived restriction due to the cost of care. To better reflect this meaning, the Odia translation used a term equivalent to \u0026ldquo;options,\u0026rdquo; explicitly linked to financial expenditure, preserving the intended measurement construct.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eConceptual Understanding\u003c/h2\u003e \u003cp\u003eFour patients and six healthcare workers participated in the pilot study and cognitive interviews with a mean age of 42.2 [35\u0026ndash;56]. The linguistically translated COST-FACIT-V2 was well understood by the majority of the pilot sample. All participants self-reported that they had no difficulty understanding the items. None of the participants reported feeling that any of the translated items were unnatural, irrelevant or offensive.\u003c/p\u003e \u003cp\u003eNo participants self-reported that they found any of the items difficult to understand. Primary concerns included minor discrepancies in how key terms were translated across items. For example, there was a discrepancy in how the term \u0026ldquo;money\u0026rdquo; was translated between items FT1 and FT4, specifically between \u0026ldquo;ଅର୍ଥ \u0026ldquo;and \u0026ldquo;ଟଙ୍କା\u0026rdquo;. ଟଙ୍କା was chosen as it is the most used and understood by the public in Odisha. \u0026ldquo;Financial situation\u0026rdquo; is another term that was translated differently across multiple items [FT6, 10, 11]. The translation for FT6 was revised to ensure consistency without compromising contextual relevance.\u003c/p\u003e \u003cp\u003eThe concept of \"paid work from home\", although translated accurately, was not understood by nearly any of the participants, denoting a possible cultural misunderstanding of the concept and a potential lack of relevance for this population. The term remains in the translated version as it is an established item in the validated English source.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study demonstrates that the Odia translation of the COST-FACIT-V2 achieved strong linguistic and conceptual equivalence with the English source instrument. The forward-back translation and reconciliation process required only minor revisions, primarily to optimize semantic clarity, ensure consistency across items, and adapt culturally specific expressions, such as \u0026ldquo;out-of-pocket\u0026rdquo; medical expenses, without altering the underlying measurement constructs. Cognitive interviews with patients and healthcare workers confirmed that the translated items were generally well understood and acceptable, with no reported difficulties in comprehension. These findings support the linguistic validity and cultural appropriateness of the Odia COST-FACIT-V2 and highlight the importance of rigorous translation methods to enable equitable measurement of financial toxicity and inform financial protection efforts in diverse cancer care settings.\u003c/p\u003e \u003cp\u003eThe use of AI to support study material translation has been an emerging research topic since the development of large language models such as ChatGPT.\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e While the forward and back translations themselves were completed rapidly, the entire process was not significantly accelerated as the AI translations were still embedded on a human-led process that strictly adhered to the COST-FACIT-V2 developer guidelines. Future researchers using AI for similar translation, may not encounter the same time barriers. One limitation with the AI translations was the inconsistent uses of words to translate terms such as \u0026ldquo;illness\u0026rdquo; or \u0026ldquo;money\u0026rdquo;. Additionally, AI software was unable to recognize cultural differences in semantics such as idioms or concepts such as \u0026ldquo;paid work from home\u0026rdquo;. This further emphasises the importance of human pilot testing for effective cultural adaption.\u003c/p\u003e \u003cp\u003e This paper is a part of a series of translations working to support a study understanding inequities in breast cancer treatment and care. While the translation process is rigorous and thorough, certain limitations present themselves. During the pilot testing process, only 10 participants were included, and the robustness may have been improved with a larger sample size. Additionally, four of these participants were men which is not reflective of the larger study population, however the COST-FACIT-V2 is neither gender specific, nor specific to breast cancer, thus maintaining validity for general use. However, considering the self-reported nature of the pilot testing, certain biases, including social desirability and recall biases, may have been present.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe Odia translation of the COST-FACIT-V2 has been incorporated into the FACITtrans portfolio of officially validated languages available for future research use. This translation expands the capacity to measure financial toxicity in India and among an Odia-speaking population. While the use of AI in this study accelerated the initial forward and back translation stages, the iterative review and approval process underscored the continued importance of expert linguistic oversight and participant input to ensure conceptual and cultural validity. Cognitive interviewing proved essential in refining the key terms to reflect locally meaningful understanding of money, financial strain and work, concepts that are core to the examining financial toxicity, strengthening the tool\u0026rsquo;s ability to capture patient-reported financial hardship. By enabling linguistically inclusive measurement, the Odia COST-FACIT-V2 supports more equitable financial protection research and contributes to a broader evidence base that reflects the lived economic experiences of diverse cancer populations.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eETHICAL AND FUNDING DECLARATIONS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHuman Ethics and Consent to Participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval was secured from the Kalinga Institute of Medical Sciences Institutional Ethics Committee [1844/2024], and University of Toronto Research Ethics Board [44562]. Verbal consent was obtained for all participants prior to pilot testing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResearch Funding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study received research funding from the Canadian Institutes of Health Research [185706], the Princess Margaret Global Cancer Program, and the Princess Margaret Cancer Foundation.\u0026nbsp;\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eDN: Data Collection, Data Analysis and Interpretation, Visualization, Writing \u0026ndash; Original Draft, Writing \u0026ndash; Review \u0026amp; EditingIAC: Visualization, Writing \u0026ndash; Original Draft, Writing \u0026ndash; Review \u0026amp; EditingLCB: Visualization, Writing \u0026ndash; Original Draft, Writing \u0026ndash; Review \u0026amp; EditingSP: Data Collection, Data Analysis and Interpretation, Visualization, Writing \u0026ndash; Review \u0026amp; EditingDR: Conceptualization, Methodology, Writing \u0026ndash; Review \u0026amp; EditingSM: Data Collection, Data Analysis and InterpretationBE: Conceptualization, Methodology, Supervision, Data Analysis and Interpretation, Visualization, Writing \u0026ndash; Review \u0026amp; EditingAll authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eDonkor A, Atuwo-Ampoh VD, Yakanu F et al (2022) Financial toxicity of cancer care in low- and middle-income countries: a systematic review and meta-analysis. 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Quantifying the performance of large language models in the translation of patient-reported outcome measures (PROMs). J Patient Rep Outcomes 9:94. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s41687-025-00926-w\u003c/span\u003e\u003cspan address=\"10.1186/s41687-025-00926-w\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Financial Toxicity, COST-FACIT-V2, Odia, Translation, Artificial Intelligence","lastPublishedDoi":"10.21203/rs.3.rs-8856042/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8856042/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCancer treatment can be associated with numerous direct and indirect financial burdens. These burdens, described as financial toxicity, can often affect care-based decision making of cancer patients. Breast cancer is the leading cause of cancer death of women in India, who often face the detrimental effects of financial toxicity. Measuring financial toxicity can be assessed through the COST-FACIT-V2 questionnaire, yet it is only available in limited languages. This study aimed to translate the widely used COST-FACIT-V2 tool used for assessing financial toxicity in Odia, one of India\u0026rsquo;s most commonly spoken regional languages.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003e We followed the prescribed linguistic translation guidelines for the 12-item COST-FACIT-V2 developed by the tool developers. This entailed a forward translation and back translation, facilitated by artificial intelligence (AI), confirmed by human validation, and pilot testing with 10 native Odia speakers at a comprehensive cancer center in Odisha, India.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe AI forward and back translations demonstrated accuracy with human validation. Minor changes were needed to enhance contextual accuracy and consistency with previous FACITtrans key phrases such as \u0026ldquo;paid work at home\u0026rdquo;, which were not well understood by the pilot sample group, leading to culturally adapted modifications in the final translated version.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003e The findings of this paper support the linguistic validity and cultural appropriateness of the Odia COST-FACIT-V2 and highlight the importance of rigorous translation methods to enable equitable measurement of financial toxicity and inform financial protection efforts in diverse cancer care settings. The use of AI represents an important innovation to support translation of standardized tools used in health systems research.\u003c/p\u003e","manuscriptTitle":"Linguistic translation and cultural validation of the COST-FACIT-V2 questionnaire in Odia to measure financial toxicity in India","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-03 14:31:32","doi":"10.21203/rs.3.rs-8856042/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"86a64608-b3be-43bb-97d3-219322dbdb46","owner":[],"postedDate":"March 3rd, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Revision requested","date":"2026-05-05T21:00:53+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-05T05:29:24+00:00","index":15,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-05T21:08:46+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-03 14:31:32","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8856042","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8856042","identity":"rs-8856042","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}