Linguistic validation services in the Life Sciences localization industry

by Nicola Kotoulia, Project Coordinator at Commit

Among the multiple specialized localization services available in the Life Sciences sector we also come across those referred to as Cognitive debriefing, Backtranslation & Reconciliation and Readability testing. How familiar are you with these methods? What does each mean, why is it required and what does it entail?

Translation errors can change the meaning of important content in clinical trial settings resulting in medical complications or the rejection of an entire clinical research project. Ambiguity in translated health questionnaires or instruments can mean that items or questions can be interpreted in more than one way, jeopardizing patient safety and clinical trial data integrity. Unclear and hard to use translated drug leaflets mean that users may not be able to take safe and accurate decisions about their medicines.

In order to help avoid such hazards, IRBs, medical ethical committees, regulatory authorities and applicable legislation require that validation methods in accordance with FDA and ISPOR (International Society for Pharmacoeconomics and Outcomes Research) guidelines are put in place for translated documentation, such as Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), Quality of Life (QOL) questionnaires and package leaflets (PL) of medicinal products.

Cognitive debriefing (also known as pilot testing) is a qualitative method for assessing respondents’ interpretation of an assessment, using a small sample of patients. It helps determine if the respondents understand the questionnaire the same as the original would be understood and tests the level of comprehension of a translation by the target audience. The goal is to ensure that data collected from PROs can be comparable across various language groups used during trials. Steps of the process include:

  • Developing a debriefing protocol tailored to the target questionnaires/instruments, subject pool, mode of administration, anticipated problem items etc.
  • Recruiting respondents including in-country professionals experienced in interviewing techniques and patients that match the target population.
  • Conducting the interview (in person or otherwise) during which respondents complete the questionnaire/instrument and answer questions to explain their understanding of each question or item. They restate in their own words what they think each translated item means. This way the interviewer discovers errors and difficulties and locates points that are confusing or misunderstood.
  • Generating a report with demographic and medical details of the interviewees, a detailed account of patients’ understanding of all items, including information about the number of subjects interviewed, their age, time for completing the task and any difficulties that came up. It may also include investigator recommendations or solutions for resolving confusion or difficulties.
  • Review and finalization during which a project manager checks the reports completeness, and ensures that the detected problems are addressed by making revisions as needed for clear, precise and well understood final translations.
  • Creation of summary report where the service provider details the methodology used, as well as the results of the cognitive debriefing.

Backtranslation and reconciliation is a very effective and stringent process that provides additional quality and accuracy assurance for sensitive content, such as Informed Consent Forms (ICFs), questionnaires, surveys and PROs used in clinical trials. It is a process for checking the faithfulness of the target text against the source, focusing mainly on the conceptual and cultural equivalence and less on the linguistic equivalence.

In a back translation, the translated content (forward translation) is translated back into the original language by a separate independent translator. The back translator must be a native speaker of the source language and have excellent command of the target language. He/She should stick more closely to the source that he/she would for a regular translation to accurately reflect the forward translator’s choices, without attempting to explain or clarify confusing statements or to produce a “polished” output.

The next step, “reconciliation”, refers to the process of noting any differences in meaning between the two source versions. The original text is compared to the back translated text and any discrepancies are recorded in a discrepancy report. Discrepancies may be due to ambiguity in the source text, errors introduced by the forward translator, or back translation errors. The reconciler flags issues such as differences in meaning, inconsistent/incorrect terminology, unsuitable register, missing/added information, ambiguities or errors in the backtranslation. Several back and forth between the linguists may be needed to reconcile the versions so that edits and adjustments are made as needed to optimize the final translation.

Readability testing in the fields of pharmaceutics qualifies that the medical information contained in the drug leaflet is usable by potential users of the medication, that is, that they can understand and act upon the information provided. It is a critical step in the process of designing product literature.

Since 2005, manufacturers of medicinal products are legally required to have their patient information leaflets (PILs) readability-tested in order to acquire product approval. According to Directive 2004/27/EC, these leaflets should be “legible, clear and easy to use”, and the manufacturer has to deliver a readability test report to the authorities.

Readability testing may be carried out by the sponsor or CRO, or a language service provider undertaking the localization of the documentation. The process steps can vary, but stages may include:

  • Preparation of the PL, during which the text of the leaflet is carefully edited and checked, spelling and grammatical errors are corrected, and sentences are rephrased to ensure compliance with the appropriate EMA template.
  • Drafting of questionnaires with questions covering the most important details of the product and its use. These questions that must be answered correctly by any user to ensure correct use of the product.
  • Pilot testing for assessing the prototype in terms of clarity, simplicity, safety, non-ambiguity, etc. Results are used to further revise the leaflet.
  • Actual readability testing conducted using subjects of different ages who are native speakers of the language of the leaflet. Participants are interviewed on key questions about the product. They should be able to answer most questions correctly and no question should consistently cause problems. The goal is to achieve a 90% correctness in the responces.
  • Generating reports that detail the test result based on which final edits are made.

The above processes provide an additional safety net for clients in the clinical and pharmaceutical industry helping them meet regulatory requirements and allowing them to focus on their registration and marketing preparation plans.