Linguistic Validation of Patient Reported Outcomes

As clinical trial programs have been significantly internationalized and are now conducted in many non-English countries such as India or China, there is an increasing need to translate but also culturally adapt the Patient-Reported Outcomes (PRO) and Quality of Life (QoL) measures. This need is also reinforced by the new guidelines set by the FDA and the EMA regarding the use of Patient-Reported Outcomes.

 

Why choose Novalins for your linguistic validation projects?

In addition to our medical translation and clinical research translation services, Novalins provides full translation and linguistic validation of Patient-Reported Outcomes to pharmaceutical companies from different corners of the globe. We ensure that our customers utilize reliable research instruments for their global clinical trials by linguistically validating and culturally adapting their patient questionnaires.

 

Our Linguistic Validation Team

With a team of over 250 PRO linguistic validators worldwide, Novalins’ Life Sciences Division offers translation and linguistic validation of Patient-Reported Outcomes in over 120 languages to guarantee content validity across the different languages needed by our clients.

Our linguistic validation coordinators and in-country PRO linguistic validators have an average 10 years´ experience in the field of linguistic validation and have participated to a large number of LV procedures, in many therapeutic areas.

They have also gone through certification and training programs such as:

• ISPOR distance learning program;
• MAPI Research Institute trainings;
• EMWA conferences (“Linguistic Validation of the Translation of Patient Reported Outcomes (PRO) Instruments”);
• Online webinars on Linguistic Validation Overview.

Our senior LV coordinators have participated to over 50 linguistic validation procedures in 2011, 2012 and 2013, covering a wide variety of diseases and disorders; while the average of our in-country linguistic validators usually range from 20 to 30 procedures.

Our linguistic validators have established in-country medical contacts in different therapeutic areas, and use those contacts to recruit patients. As most of our LV experts are medical professionals (e.g. medical doctors, clinical psychologists, etc.), they have access to multiple channels, such as hospitals, clinics, patient associations, specialist doctors treating patients with the respective disease(s).

 

Quality Standards

We apply a strict multi-step process compliant with international regulatory authorities such as the reference documents from the FDA (Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims) and ISPOR (International Society for Pharmacoeconomics and Outcomes Research) recommended guidelines, including the preparation phase, translation (forward translations – reconciliation – proofreading – back translation, etc.), harmonization across languages, patients recruitment, cognitive debriefing and final report. See below:

 

1. TRANSLATABILITY REVIEW:

a. Concept Elaboration: The first step of linguistic validation provided by Novalins consists in a Translatability Evaluation of the Patient-Reported Outcomes/Questionnaire (PRO) in order to assess the wording context or possible notions that might appear problematic to the audience that is targeted during translation and adoption process.
b. Instruction Development: Taking into consideration the outcomes of the translatability evaluation process, the following crucial step is the compliance of a meticulous draft instruction as a significant asset for an essential research & data collection. The draft contains the full evidences that the translation groups need to be aware of before proceeding with the translation such as clarification of main concepts, hypotheses, guidelines, complications and uncertainties that might arise. In the meantime, we focus on recruitment procedure for each target country to acquire a copyright permissions for translation.

 

2. TRANSLATION:

a. Forward Translations: We entrust the translation to two different specialized medical translators working independently.
b. Reconciliation: Afterwards, the project manager reconcile the two translated versions by conducting a unified translation by a third specialized translator which undergoes through proofreading, editing and formatting on a later stage.
c. Back Translation: Following the forward translations performed by two independent medical translators and translations reconciliation, a third independent medical translator will be introduced to perform a back translation with no previous knowledge of the original source.
d. Review and Editing: The Project Manager verifies the coherence and correctness of the text and also to recognize possible divergences and discrepancies deriving from the content.
e. Corrected Translation: At this stage a corrected translation is produced which needs to be reviewed by a specialized clinician based in the target country with a considerable experience in the applicable subject matter. The clinical verifies the translation, adopts all the terminology related to symptoms, medical conditions, disorders into a common understanding language used by the patients.

The medical translators assigned to each translation step of a Linguistic Validation project respond to our minim selection criteria, i.e. minimum 8 years’ experience in medical and pharmaceutical translation, native speaker of the target language with perfect command of the source language, and in-country resident of the target country with good knowledge of the local culture. Additional they are required to have proven experience translating PROs.

Usually, our medical translators have a scientific background to M.S., PhD or MD level and work in the medical sector, therefore they have a strong network of specialists in different therapeutic areas.

 

3. HARMONIZATION:

Another substantial step in the linguistic validation process is the harmonization between all translations to make sure every potential alteration among any content value is successfully diagnosed and set. This step ensures a consistency between all language translations.

 

4. COGNITIVE DEBRIEFING:

Cognitive Debriefing on the other hand guarantees a full matching between the culture component and the context in the validated material appropriate for the target population. Novalins mobilizes professional medical teams with a deep background in the field, conducting cognitive debriefing interviews. Generally each team is composed by specialized psychologists, psychiatrists or social workers experienced in interviewing methods.

Our in-country linguistic validators first recruit 5 to 10 patients, diverse in terms of age, location and educational background depending on the project requirements or client’s instructions. Depending on the project requirements, our in-country linguistic validators conduct the interview either on the phone or face to face. They go through the questionnaire with the patients, discussing in details all items to make sure that each item is clearly understood. The patient is then asked to convey the meaning of each item in their own words, in the way they perceive the meaning. They are also asked how they would word the item/if they would apply any change. The interviewer asks additional questions if necessary in order to further clarify particular key concepts or issues, asks for examples, etc. The answers and remarks are recorded in the debriefing grids and then compiled in a report, as required. Depending on the results of the interviews, the instruments may be updated accordingly. Therefore, once the interviews are concluded a detailed report is originated.

Our interviewers receive written guidelines based on the client’s instructions and project requirements and after acquainting themselves with the LV project, a discussion is held to make sure everything is clear. The interviewers share any questions or doubts they may have and the process is further discussed. If any additional questions arise during this phase, they are promptly clarified. All interviewers have strong experience in linguistic validation therefore the training phase is mostly intended to ensure that they understand the project-specific instructions.

 

5. FINALIZATION:

The final step resides in the internal review of the report form the Project Manager. After carefully checking if the requirements are met, the project coordinator finalizes the translation. In the major cases, a proofreading round is required, and the databases are updated. In the end, the customer receives an ultimate report detailing Novalins’ Linguistic Validation process.

Disease areas in which we have conducted Linguistic Validation projects

Our Linguistic Validation specialists have conducted projects in a large number of therapeutic and disease areas, including but not limited to:

Therapeutic areas:
Cardiology, CNS, dermatology, endocrinology, female reproductive health, gastroenterology, general health, general QoL, gynecology, hematology, infections, inflammatory, metabolic, musculoskeletal, neurology, oncology, orthopedics, pediatrics, psychiatry, pulmonology, respiratory, or urology.

Disease areas:
Alzheimer’s disease, Ankylosing Spondylitis disease, anxiety, arthritis, back pain, atopic dermatitis, binge eating disorder, buying disorder, chemotherapy treatment, Chron’s disease/ulcerative colitis, compulsive disorders, compulsive sexual behavior, COPD, depression, diabetes, diabetic foot ulcer, dyspnea, endometriosis, epilepsy, erectile dysfunction, esclerodermia, functional dyspepsia, gambling disorder, GERD, haemophilia, heart failure, HIV, impulsive disorders, irritable Bowel syndrome, lung cancer, lymphocytic leukemia, menstruation, mental retardation, multiple sclerosis, neurological fatigue, otitis media, overactive bladder, pain symptoms, Parkinson’s disease, pelvic floor disorders, pulmonary hypertension, psoriasis, psychotic disorders, rheumatoid arthritis, schizophrenia, sexual dysfunction, sleep disorders, suicidality, type I and type II diabetes, urinary tract infection, uterine fibroids, or Von Willebrand disease.

On top of our Translation & Linguistic Validation of PROs service, we also offer the following:

• Medical Writing
• Medical Translation
• Readability Testing of the PIL
• Regulatory and Quality Compliance Support
• Clinical Data Management

 


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