Linguistic Validation: Psychometric equivalence made easy
Due to the new FDA and EMEA guidelines, linguistic validation for Patient Reported Outcomes (PRO) and clinical trials is a discipline where accuracy and thorough processes are key. The old methods of utilizing HRQL measures such as the SF-36, NHP, and EQ-5D have been found to be too generic and therefore inadequate. The interest in how a patient views his or her illness and treatment has increased drastically with non-adherence rates and patient re-admittance steadily climbing. In an effort to increase treatment adherence and drive down re-admittance rates, PROs are key to collecting quality information from patients to better understand their views so they may be addressed. However, often times clinical studies are compiled by non-specialists without a firm understanding of which outcomes should be included and how the data should be measured. Likewise, more often than not PROs are selected in a very late stage making it challenging to allow for appropriate language adaptations to be made. Considering the cost of clinical trials and added benefits of useful data it is imperative to have a skilled specialist ensure the materials are linguistically valid.
CQ fluency’s linguistic validation processes are based on self-correcting iterations that deliver psychometric equivalence. CQ fluency has over 1500 linguists in our global pool with subject matter expertise in Life Sciences who are experts at minimizing linguistic validation iterations.
Simply translating a document is not enough in these cases. The text has to have a meaningful and relevant translation to convey the same message as the original text. In order to ensure that the message has not been “lost in translation” culture plays a pivotal role.
The benefit to you:
- Professionals with deep knowledge of their native cultures and lifestyles, with the ability to immediately relate to forms of expression in patient reported outcomes.
- In-depth experience with technology resources that allow us to provide instruments associated with clinical trials in both printed and e-pro versions.
- First-rate initial translations that are culturally relevant for the target population, fine-tuned until we arrive at the conceptual equivalence necessary for cross-border acceptance of results.
- The experience and flexibility to follow our ISPOR-compliant process.
- Our linguistic validation process guarantees correct terminology and the intricate cultural insights that are critical to comprehension.
- CQ fluency blends this with a full suite of services and capabilities to provide flawless, end-to-end planning, in a unique project team approach accompanied by our trademark CQ care service.
CQ fluency has expert linguists in many therapeutic fields including:
- Cardiology/Vascular Diseases
- Dental and Oral Health
- Genetic Disease
- Healthy Volunteers
- Hepatology (Liver, Pancreatic, Gall Bladder)
- Infections and Infectious Diseases
- Nutrition and Weight Loss
- Orthopedics/Orthopedic Surgery
- Pulmonary/Respiratory Diseases