Translation and validation of questionnaires: necessary processes for inflammatory bowel disease studies reliability : European Journal of Gastroenterology & Hepatology

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Translation and validation of questionnaires: necessary processes for inflammatory bowel disease studies reliability

Fousekis, Fotios S.a; Katsanos, Konstantinos H.a; Popovic, Dusan Dj.b,c

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European Journal of Gastroenterology & Hepatology: December 2022 - Volume 34 - Issue 12 - p 1201-1202
doi: 10.1097/MEG.0000000000002465
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Remission of disease activity and improvement of health-related quality of life (HRQoL) of patients with inflammatory bowel disease (IBD) are main goals of IBD management and significant area in medical research. A recent meta-analysis demonstrated that patients with IBD have a poorer HRQoL compared with health individuals, affecting careers, family life and social contribution [1]. Disease activity and course, treatment (efficacy and safety), socioeconomic and psychosocial factors appear to affect the HRQoL of patients with IBD [2]. HRQoL has also been recognized as an important outcome by clinicians, affecting the treatment strategies and health policy. In order to measure this impact and to understand the effect of the treatment on HRQoL of IBD patients, the use of reliable assessment tools is critical.

In this issue, Paupard et al. [3] prospectively investigated the effect of mesalazine on HRQoL of the patients suffering from mild-to-moderate ulcerative colitis (UC); proctitis and proctosigmoiditis, demonstrating that disease activity is proportionally associated with HRQoL in patients receiving mesalazine. In this study, a large majority of UC patients (>80%) used a rectal formulation of mesalazine either or alone or as combined therapy with mesalazine per oral and HRQoL was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The improvement of HRQoL may be associated with the amelioration of symptoms, such as fecal incontinence and urgency, which adversely affect HRQoL. However; as mentioned by the authors, the study presents some limitations, including low population sample and poor adherence to treatment.

The assessment of HRQoL in IBD patients is a complex process because QoL is a subjective feeling of the perception of health and incorporates the patient’s reactions and level of daily functioning in response to their illness. Patient-reported outcomes (PRO) have been used for assessment and monitoring of HRQoL of IBD patients. PRO are information for health status of patients that comes directly from the patient, without the interpretation of the responses by a physician or anyone else. IBD-related PRO or instruments to assess health-related HRQoL have been used as end-point of clinical trials and studies. In this concept, the Food and Drug Administration has developed guidance about the use of PRO measures and their use in medical product development and support drug labeling claims. FDA recommends review of a PRO instrument for validity, reliability, ability to detect change and interpretability [3]. Based on PRO, a large number of IBD-related HRQoL measures have been developed and have been applicate in IBD studies for assessing HRQoL and correlation between disease activity and HRQoL. Each measurement tool covers different dimensions and the final choice depends on the information that is being sought. The individual dimensions (domains) of HRQoL are evaluated based on scoring the answers to certain questions from the questionnaire. One-dimensional disease-specific questionnaires are preferred when the aim of the study is the evaluation of IBD activity. On the other hand, multidimensional disease-specific questionnaires are selected for the impact of IBD on HRQoL [4]. However, reliability and validation of HRQoL instruments should always be proved.

Inflammatory Bowel Disease Questionnaire (IBDQ) and SIBDQ are the most widely used in clinical trials and studies. A recent systematic review of measurement properties of IBD-specific HRQoL instruments concluded that IBDQ has the strongest evidence about reliability, validation and being responsive for adult patients suffering from IBD, followed by the SIBDQ and IMPACT-III [5]. IBDQ was developed in 1989, consisting of 32 items that are divided into four dimensions: emotional function, bowel symptoms, systemic symptoms and social function. IBDQ is mainly an interviewer-administered instrument and every response grades from 1 to 7 and the total score ranges from 32 to 224 with higher scores reflecting better QoL. On the other hand, SIBDQ is a self-administered IBD-specific health-related QoL instrument that has been developed in 1996 by Irvine et al. [6]. It is a shortened version of IBDQ and comprises 10 questions, divided also into four domains: emotional health, bowel symptoms, systemic symptoms and social function [7], being reproducible and responsive to changes in IBD activity. IMPACT-III is a self-administered HRQoL instrument for pediatric patients with IBD, consisting of six domains: bowel symptoms, systemic symptoms, social functioning, body image, treatment and emotional functioning. IMPACT-III appears to have good instrument properties, having been translated in various languages [6].

The aforementioned instruments have been translated and validated in different nationalities and countries. IBDQ has been translated in over 90 languages and has been used as outcome in randomized control trials. Translation and validation of HRQoL measures are always required and should follow methodological concepts in order to ensure the necessary reliability, whereas different methodological approaches have been used in this concept. For initial translating a questionnaire, at least two independent translators should be considered, preferably bilingual translators. After initial translation, backward translation should be performed in order to detect possible misunderstandings. As with initial translation, at least two independent translators, preferably bilingual, are required. Subsequently, an expert constituted committee should produce the prefinal translated version and will resolve any discrepancies. As with a new developed questionnaire, the translated questionnaire should be tested on a small sample and the responders should elaborate each questionnaire item and their response. Thus, translation of questionnaires is a time-consuming process to ensure that translated version is equivalent to the initial questionnaire, whereas knowledge, skills and experience are required [8,9].

Due to differences in culture, language, economy and geographic location, the validation of translated questionnaires is always a necessary step in order to access the suitability of questionnaire’s application in different populations, because the direct translation of questionnaires does not guarantee the reliability and adaption. In the process of validation and transcultural adaptation of the questionnaire, it may happen that the structure of the ‘translated’ questionnaire does not correspond to the original questionnaire. Namely, some questions may belong more to a different domain, than in the original questionnaire. It is possible to form a new domain, which does not exist in the original questionnaire [10]. The arrangement of items by domains is determined by factor analysis, with appropriate internal reliability. Validation is a complex process and requires a representative sample of the target population of interest in order to evaluate the adaption and the cross-cultural validity. The size of sample depends on the psychometric approaches that will be measured. The validation process aims to estimate the internal consistency, the sensitivity and specificity (reliability), stability reliability, homogeneity, dimensionality and model fit, using many statistical approaches, such as Pearson’s correlation analysis and confirmatory factor analysis [11].

Despite of validation of HRQoL measurement instruments, many types of bias may occur, changing the outcomes of studies and should be taken account on evaluation of studies design and interpretation of the results. The reproducibility of HRQoL measurement tools is a common problem, because application of instrument in short repeated intervals may lead to patient memory bias. In addition, response shift is a specific bias of prospective measurement and refers to changes of patient’s self-evaluation over tome, including the recalibration response shift, the reprioritization response shift and the reconceptualization response shift. Recalibration response shift means the different evaluation of response scale among the intervals due to the change of interpretation standards. Reprioritization response shift means that the patient changes the priorities to some dimensions of HRQoL measurement tool in different areas of life, whereas reconceptualization response shift occurs when the patient changes the definition of HRQoL. All three forms of response shift are a result of patient’s adaption to the disease and may make the HRQoL measures less reliable over time [12].

In conclusion, the increase of multicultural societies and the need for cross-cultural research and studies have resulted in the necessity of reliable and cross-validated instruments among diverse cultural segments of the society and populations with different languages. Thus, IBD-related HRQoL instruments require systematic evaluation of their methodological quality and measurement properties in order to achieve reliable systematic assessment of treatment effectiveness.

Acknowledgements

None.

Conflicts of interest

There are no conflicts of interest.

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