Translation and Linguistic Validation of BIS (Body Image Scale) for Breast Cancer Patients in India

Treatment for breast cancer involves multidisciplinary care. Management algorithms include surgery, chemotherapy, radiation therapy, targeted therapy, and endocrine therapy. Adjuvant radiotherapy following breast-conserving surgery is the current standard of care for early-stage breast cancers, as the survival and local control rates have been shown to be equal to mastectomy [1, 2]. With the improvement in the efficacy of the neoadjuvant therapies for locally advanced breast cancer, higher response rates are achieved that confer an excellent opportunity for breast conservation. Hence, more and more women are now undergoing breast conservation [3, 4].

Breast cancer has implications beyond the physical disease and the aftermath of treatment complications often leads to considerable psychological and emotional distress. The treatment, even if it is lifesaving, often creates morbidity of its own. Cosmetic outcome is considered one of the paramount endpoints to measure the success of breast conservation. To achieve an optimal cosmetic outcome, oncoplastic breast surgery (OPBS) is being increasingly adopted. Improved surgical techniques in the form of OPBS provide superior cosmetic outcomes as compared to traditional breast conservation surgery while offering comparable oncological safety. It allows for excision of larger volumes of breast tissue and extends the option of breast conservation to more patients with larger tumors, multifocal disease, and extensive intra-ductal component [5].

For anyone having battled and survived cancer, quality of life (QOL) post-treatment becomes extremely important. Assessing the quality of life in patients and cancer survivors was earlier restricted to research settings. However, recently, it is slowly seen moving to routine clinical practice and is commonly referred to as “patient-reported outcomes (PRO)”. These are defined as any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else. PROMs (patient-reported outcomes measures) are instruments that are used to measure the PROs and are most often self-report questionnaires [6].

A number of PROMs have been developed and validated for English-speaking populations [7]. However, their utility in non-English-speaking countries is limited. Hence, attempts are commonly made to validate such patient-reported outcome instruments to other languages to increase their applicability [8,9,10].

For this purpose, an instrument has to be systematically translated into a native language. Such a translation must be comparable to the original, accurate in collecting the intended data, easy to understand to a generic reader, and, most importantly, respect the cultural differences that come naturally as the geographical location of the target population changes. There are various factors that must be considered in such translations, including the cultural differences between the concerned populations, lifestyle, and acceptable social practices [11, 12].

Such a cross-cultural, language translation is a complicated process. It is possible that in-spite of having the same meaning, changing of context changes the implication of a word in one language, not in another. For example, the Hindi word “takleef” (तकलीफ़) is commonly used for discomfort related to a physical activity or an emotionally distressing situation; however, in English, the word “discomfort,” which is a literal translation of the word “takleef” usually corresponds to mostly physical discomfort.

The need for appropriately translated and validated PROMs is ever-increasing now with multinational clinical trials in place. Especially for breast cancer, the treatment modalities are rapidly changing, with universal implications, generating a need for PROMs in various regional languages. There is an obvious need for outcome-measuring instruments that are uniform and applicable in various cultural settings by virtue of their translation. To address this requirement, Beaton et al. have published guidelines for the process of cross-cultural adaptation of self-report measures [13]. EORTC and MAPI guidelines are also available for standardized translations of various questionnaires and PROMs [14, 15].

Body image scale (BIS) is a type of PROM questionnaire which assesses the changes in the body image of a patient diagnosed with cancer, on a 4-point scale that ranges from “not at all” to “very much.” It was constructed in collaboration with EORTC and tested on British cancer patients. The scale showed high reliability (Cronbach’s alpha 0.93) and good clinical validity [16].

BIS has been translated into various languages. Shunmugasundaram et al. translated and validated BIS in three Indian languages (Hindi, Tamil, and Telugu) and validated in head and neck cancer patients [17, 18]. The current study was carried out to translate the BIS in Hindi and Marathi, to be later validated in a large cohort of breast cancer patients.

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