Translation and cross-cultural adaptation of scales in healthcare: the “why” and the “how”

The number of international clinical trials has increased greatly in recent years, resulting in the need to translate measurement instruments and scales into multiple languages and cultures. But in the end, why is the translation of scales important, and how can it be done correctly?

Scales in the healthcare sector

Scales are evaluation instruments, used increasingly more in the area of health. They can be used to provide information on a patient’s clinical evolution, quality of life and safety, together with clinical decision-making on the treatment best suited to a given health condition.¹

Some examples of scales used in healthcare are:

• The Braden scale, which assesses the patient's degree of risk for developing pressure ulcers;
• The Morse scale, to assess the patient's risk of falling;
• The Ramsay and RASS scales, which assess the level of sedation.²

The assessment normally has a multiple-choice questionnaire with related scoring. The final score will determine the patient’s risk for a given clinical condition.²

The importance of translating healthcare scales

With the rising number of clinical trials, there is also a greater need for various documents or tools in numerous languages, namely medical assessment scales.

Scales used in healthcare are usually developed in English or Japanese-speaking countries¹.

However, they are not only used by people who understand English or Japanese.

Furthermore, for a drug to be approved, medicinal regulatory authorities require the submission of clinical outcome assessments (COAs), including the measurement of patient-reported outcomes (PROs).³

This is a non-clinical method to assess, for example, symptoms experienced by the patient, his/her quality of life and other manifestations of health 4. PROs are used in clinical trials, and differ from other assessment methods since they are based on answers coming directly from the patient, through questionnaires or interviews, without any clinical interpretation by a physician. Healthcare scales are one of the methods used for measuring a PRO.³

For these instruments to be used globally, they must be translated as well as adapted to the culture of their users. Since each culture is different, individuals also express themselves differently, with different ways of reacting to given stimuli. Herein lies the importance of adapting the scale to the clinical practices and actual culture of that country.

The use of poorly translated scales or unvalidated translations may result in misinterpretations, which can even jeopardize patients’ health.¹ Even so, the lack of attention given to the methodology for translating and cross-culturally adapting measurements and scales into other languages is astonishing.

Seven steps for translation, adaptation and cultural validation of metric scales

According to experts, the translation and cultural adaptation of a scale is almost as labour-intensive as the creation of a new one, requiring a well-established and rigorous methodology.

• STEP 1: Translation of the original scale into the desired language by at least two separate translators, preferably certified native speakers;
• STEP 2: Comparison between the two translated versions;
• STEP 3: The translated version is back-translated into the original language by two separate translators with the same qualifications and characteristics as in step 1;
• STEP 4: The two back-translations and the original scale are compared by a multidisciplinary committee;
• STEP 5: Pilot test of the pre-final version with a sample group of participants having the characteristics of the target audience that will use the scale;
• STEP 6: Although rare, when the population is bilingual, a preliminary psychometric test of the translated scale with bilingual individuals is recommended;
• STEP 7: Comprehensive psychometric test of the translated and culturally adapted scale with a sample group of the target population. 5

L10N is a Portuguese company with 20 years of experience offering certified medical and pharmaceutical translation services in 40 languages. These are done by professional translators who specialize in the area of healthcare and are native speakers of the required mother tongue.

References:
1 Pinto, A.L. Tradução e adaptação cultural de escalas. Master’s thesis at the University of Aveiro – Department of Languages and Culture, 2014.
2 Main scales for assessing patients in nursing, Gestão em Saúde, available at  https://gestaoemsaude.net/principais-escalas-de-avaliacao-de-pacientes/ , accessed in November 2021.
3 Clinical Outcome Assessment (COA): Frequently Asked Questions, U.S. Food & Drug, available at https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions, accessed in December 2021.
4 Patient-reported outcomes, EUPATI, available at  https://toolbox.eupati.eu/glossary/resultados-reportados-pelos-doentes/?lang=pt-pt, accessed in December 2021.
5 Sousa, V. D. et al. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. Journal of Evaluation in Clinical Practice, 2010.