Patient Reported Outcome Instruments Linguistic Validation for Belarus

PRO instruments are included in the majority of global clinical trials and other research studies throughout the world. This means that they are need to be translated into other languages from single original language and the data obtained from each country using these translated instruments is often pooled or aggregated and analysed and reported as a single data set. The quality of the data derived from those translated instruments relies on the accuracy of the translation. Prompt linguistic validation of PRO instruments allows for faster introducing of drug products to new markets and saves a company’s financial resources.

As a professional Medical Linguist with more than a 5-year experience in the field, I validated dozens of questionnaires covering concepts as varied as Quality of Life, ADL, Goal Attainment, Symptoms, Disease Control, Satisfaction and Adherence and offer linguistic validation services in English to Russian and English to Belarusian language pairs for the PRO instruments for use in Belarus:

  • PRO Instruments
  • ePRO Instruments
  • Quality of Life Questionnaires
  • Rating Scales
  • Cognitive Battery Tests

Steps of PRO-LiV™

Linguistic validation process is based on the standard ISPOR methodology and best-in-class translation process. Adapting English language PRO instruments for use in global research studies is a complex and challenging process and normally includes the following steps:

  • Preparation
  • Forward Translation
  • Reconciliation
  • Back Translation
  • Back Translation Review
  • Harmonization
  • Cognitive Debriefing
  • Review of cognitive debriefing results
  • Finalisation
  • Proofreading
  • Final Report

All these steps are crucial in the linguistic validation process and require involvement of different professional linguists native in target language and fluent in the source one.

As a professional Medical Linguist, I am able to perform all of the tasks either by myself of with the involvement of other highly professional Medical Linguists with both Medical Degree and Degree in Translation and Interpretation.

Areas of expertise

Provision of PRO instruments linguistic validation services from English to Russian for Belarus and Russian and from English to Belarusian for Belarus in the following areas:

  • Allergology
  • Cardiology
  • Congenital/Hereditary Diseases
  • Endocrinology
  • Gastroenterology
  • Infectious diseases
  • Neurology
  • Nutrition
  • Oncology
  • Ophthalmology
  • Orthopaedics
  • Psychiatry and Psychology
  • Respiratory diseases
  • Rheumatology
  • Sexual Functioning
  • Urology
  • and more…

In-country Consulting

PRO instruments linguistic validation always requires in-country consulting by a native speaker of the target language, fluent in the source language, who should reside in the target country. He or she should come from a medical background and have experience in translating/managing the translation of PRO instruments. As a professional Medical Linguist who fulfils all of the above criteria, I offer In-country Consulting services for adapting PRO instruments for use in Belarus.

Cognitive Debriefing

Cognitive Debriefing is one of the most important steps in PRO instruments linguistic validation and involves testing the instrument on a small group of relevant patients or lay people in order to test alternative wording and to check understandability, interpretation, and cultural relevance of the translation.

Normally the newly translated PRO instruments should be tested for cognitive equivalence on a group of 5 to 8 respondents in the target country. Respondents should be native speakers of the target language who adequately represent the target population (sex, age, education, diagnosis).

As a medical doctor I am able to recruit any needed number of patients for cognitive debriefing with almost any medical condition from outpatient and inpatient medical facilities within the shortest period of time.

My having a 5-year experience in conducting cognitive debriefing and a direct access to healthcare facilities allows the following:

  • Recruitment of any number of respondents with any medical condition within the shortest period of time
  • Highest quality and accurate cognitive debriefing
  • Accurate and reliable reporting