Patient-reported outcome measures (PROMs) play a vital role in clinical trials, allowing researchers to assess the impact of diseases or conditions on a patient’s symptoms, mental state, and overall functioning. The data they provide often forms the basis for evaluating treatment efficacy and safety, as well as a patient’s quality of life.
As clinical trials expand globally, it is essential to ensure the accurate translation and cultural adaptation of PRO measures to maintain conceptual equivalence and validity across different languages and cultures. In this article, we will delve into some of the best practices for translating PROMs that can help enhance the validity and reliability of clinical trial outcomes.
1. Early Planning and Strategy Development
By incorporating early planning and a well-defined strategy, you set the foundation for an efficient translation process that captures the intended meanings and concepts of PROMs across all language versions.
• Integration with Trial Design
Consider PROMs as primary or secondary endpoints and determine how they fit into the study objectives. This should involve identifying the specific instruments to be used, as different instruments might require different translation approaches due to their unique constructs.
• Creation of Concept Definition Document and Developer Review
The concept definition document serves as a comprehensive reference guide that defines and explains the conceptual basis for each item or task within the PROM. It outlines the meaning, context, and intent behind each item to avoid misinterpretations during the development or translation process.
The developer’s participation in reviewing the concept definition document is essential for formal approval since they can identify potential issues or discrepancies, such as inaccuracies in concept descriptions or inconsistencies in terminology. Their involvement produces a document that accurately represents the instrument’s core concepts and constructs, thereby enhancing the reliability and validity of assessments in clinical trials, research studies, and more. It also ensures that the document adheres to regulatory requirements and best practices in the field.
• Translatability Assessment
Conducting a translatability assessment will help determine the instrument’s suitability for multilingual clinical studies, in turn helping you achieve conceptual equivalence with the original text and allowing for cross-linguistic data comparison. Consider the linguistic and cultural complexity of the instruments, and whether you require cultural adaptation and cognitive debriefing to ensure accurate interpretation by participants.
• Timeline and Resources
Translation is a time-consuming process and any delays can impact the overall trial timeline. Therefore, make sure to allocate ample time for translation, linguistic validation, and potential revisions. This also involves allocating sufficient budget and resources to the translation process, including the use of qualified translation providers, linguistic validation experts, and cultural adaptation specialists.
• Select a qualified Language Service Provider
Selecting the right provider is fundamental to ensuring that you successfully reach your end goals. Firstly, make sure to choose a professional language service provider experienced in medical and clinical terminology, specifically in PROMs. Ask questions about their translation processes, certifications, references, and anything else you feel is important to consider when making your decision.
• Documentation
Keeping comprehensive documentation of the translation strategy will prove invaluable for regulatory submissions and audits, allowing you to justify the target text and streamline the approval process. Ask your chosen provider to document the rationale behind any translation decisions, provide their qualifications, and keep a record of any discussions relating to linguistic and cultural adaptations.
• Stakeholder Communication
Be prepared to maintain communication with all stakeholders throughout the planning phase, including translators, linguistic validation experts, and regulatory authorities. This helps keep everyone involved on the same page and addresses any potential issues early on.
2. Translation Process
Many regulatory agencies, such as the FDA and EMA, recommend or require the combined use of forward and backward translation to ensure the quality of translated PROMs in clinical trials. Working with your selected translation provider, it is important that you develop a rigorous and systematic process that goes beyond these minimum requirements.
A full translation process should include the following:
• Introduction of the Concept Definition Document to the translation team
Provide the translation team with background information about the research project. Discuss specific concepts, terminology, and contexts that are integral to the research, and include a comprehensive list of key terms, phrases, and concepts that require translation.
• Terminology Management and References
Provide to the linguists any preferred translations or terminology, if available. Offer reference materials or resources that the translation team can consult during the translation process, such as glossaries, style guides, or previously translated materials from similar projects.
• Forward Translation
Two or more translators who are proficient in the source language and native speakers of the target language translate the PRO items. During the translation, they will need to consider cultural nuances and differences when translating the PROMs as certain concepts might not translate directly. If so, cultural adaptations may be needed to maintain the intended meaning and record the participants’ experiences accurately. If during the translation process, they face any challenges, they should document their decisions to provide context for later stages of the translation process.
• Reconciliation
During this step, the team will address any discrepancies between the initial translations. The goal is to reach a consensus and create one final translation that will then be used to perform the back translation.
• Back Translation
A second translator, who is a native speaker of the source language and unaware of the original source document, translates the previously translated items back into the source language.
• Review
The original PRO items and the back-translated items are compared to identify any discrepancies between them. These discrepancies might include differences in wording, meaning, or nuances that could indicate issues in the forward translation. As indicated in the ISPOR guidelines, “it may also be useful to involve the developer to help resolve difficult issues”.
• Harmonisation
Translators, subject matter experts, and in-country clinical experts work together to resolve any discrepancies or differences between all language versions.
• Cognitive Debriefing
Once the translations are delivered, cognitive interviews should be conducted with native speakers of the target language. Participants’ feedback will provide valuable insights into any potential linguistic or cultural discrepancies between the original and translated versions. It will also help with identifying ambiguous phrases, confusing terminology, or concepts that might not directly translate, thus guiding the refinement process.
You may then want to pilot test the translated PROMs with a small sample of the target population. This will help to identify any remaining issues related to wording, clarity, or cultural sensitivity.
• Review of Cognitive Debriefing Results
Like the review of the back translation, this helps identify any changes needed to improve the translations across all languages.
• Proofreading
Before approving the final translation, the document should be proofread to ensure there are no errors that might have been introduced or missed during the previous steps.
• Final Report
All decisions made during the translation process should be documented thoroughly by all parties. These should then be collated into a final report.
3. Continuous Improvement
It is important to acknowledge that the translation process of Patient-Reported Outcome Measures (PROMs) is dynamic and does not end once the final translation is delivered. You should ideally implement regular review cycles for any translated materials, creating a schedule for revisiting and updating content to reflect changes in language usage, terminology, or context.
Continue to benchmark your translation practices against new developments within the industry and regulatory standards, and always seek opportunities to improve based on lessons learned from all projects. Promote the continuous learning and development of all stakeholders, encouraging them to stay updated on language trends, cultural shifts, and best practices in translation.
Practices for Better Outcomes
By implementing the above strategies and maintaining a commitment to quality and continuous improvement, the translation process for PROMs can evolve to better meet the needs of patients, researchers, and healthcare providers. This will ultimately enhance the usefulness and efficacy of PRO instruments in clinical practice and research.
From early planning, collaboration with qualified translation providers and validated translation processes to cultural adaptations, pilot testing and ongoing monitoring, you and your chosen translation provider can ensure that your PROMs are translated accurately. This will help you to capture your patients’ subjective experiences and opinions, leading to reliable research findings and improved patient care.
About Intertranslations
At Intertranslations, we have over 25 years of experience in providing quality translations of clinical research and trials to pharmaceutical, biotech companies, and CROs in the UK and worldwide. Our team of professional translators are native speakers with extensive experience in clinical trial terminology, ensuring accurate and contextually appropriate translations. We prioritise conceptual equivalence, cultural adaptation, and ethical considerations, ensuring the validity and reliability of your clinical trial translations.
Are you in search of a high-quality clinical research translation agency? Discuss your project with one of our clinical translation experts today!
