Linguistic Validation
of Questionnaires

Since 1987

We are experts in the translation and linguistic validation of questionnaires used to collect data to evaluate health outcomes.  We work for pharmaceutical, biotech, medical device companies and research groups throughout the world.  Our team understands the importance of patient-centered communications and the necessity of equivalence in order to pool data for a single statistical analysis.

EXPERIENCE

We have conducted linguistic validations in more than 90 languages in all therapeutic areas since 1987. See the diseases and health issues where we have worked.

QUALITY AND SERVICE

Our certified translators are professionals who are experienced in translating health outcomes measures. A select group of these linguists have been trained to interview individuals with health problems.

FAST AND FLEXIBLE

We are able to complete a full translation and linguistic validation of most PRO instruments in three weeks, anywhere in the world.

Why You Can Trust Health Outcomes Group

Our Values

We value integrity, honesty and time.  Our linguistic validation professionals respect the culture and unique concerns of each individual.  We are always at your service as we are in charge of ensuring the quality of your data.

We formed a team of devoted experts with a rich experience in linguistics and health outcomes. We put a great emphasis on health outcomes, because in today’s rapidly-changing environment, medical professionals, ordinary people, companies and governments require assistance in understanding the benefits and risks of medical treatments. Our experience and our values allow us to be confident and stand by our work.

Health Outcomes Group was established in 1987 by David Himmelberger.  During his experiences at Stanford University School of Medicine he foresaw the need to have objective information on which to make treatment decisions, especially for chronic diseases where there were no cures and patients were unlikely to die prematurely.

We are the only consultancy that focuses solely on evaluating health outcomes in the context of multinational clinical trials.  We have proved our competence and have many satisfied clients. We have expanded our services to create patient-centered content to educate patients, and to provide translation and linguistic validation services for medical devices and digital apps.

We provide high quality linguistic validation services worldwide.

WHAT IS LINGUISTIC VALIDATION

Linguistic validation is a process that establishes objective evidence that ensures that the outcomes being evaluated by individuals in the target audience are functionally equivalent to those in the source.

BENEFITS OF LINGUISTIC VALIDATION

  • Uses the natural language of patients
  • Lessens the patient burden
  • Decreases patient dropouts
  • Reduces the sample size

BENEFITS OF LINGUISTIC VALIDATION

  • Training for study coordinator at study site
  • Increases credibility among local clinicians
  • Improves recruitment of patients
  • Decreases costs

Our Linguistic Validation Services

Translation

We provide patient-centered translations for clinical trials and for educational purposes. These are always tailored to the target audience.

Linguistic Validation

We insure our linguistically validated translations meet the standards required by the FDA, EMA and other regulatory authorities.

Consultation

We provide guidance on which outcomes are most meaningful and the best instruments to use. We can also assist in working with developers.

Defining the Performance Characteristics

We can provide you with data to establish how the translated questionnaire works. This information is useful to plan and to design an efficient clinical trial.

Working with the Developer of the Questionnaire

Most questionnaires are protected by copyright. Some developers have special requirements to translate and to use their questionnaire. We can help with this.

Medical Devices and Digital Apps

We provide translation and linguistic validation services to establish that the user information for your medical device or digital app is well understood by lay individuals.

Linguistic validation in Jönköping, Sweden

Interesting Projects

Obscured vision
Real Problem
Macular degeneration - The real problem for individuals with macular degeneration is their inability to see contiguous areas clearly. People with this condition have blind spots where the field of vision is obscured. The current test of Distance Visual Acuity does not adequately evaluate the problem of obscured vision. We developed two new tests, Near Vision Visual Acuity and Reading Speed that are more meaningful outcomes measures for people with macular degeneration. These new tests were implemented in 21 languages.
Near Vision Visual Acuity and Reading Speed
Burden of Pain from Herpes Zoster
Burden of Pain
Herpes Zoster - We conducted a pilot study to confirm that an outcomes questionnaire that had been developed for cancer patients was acceptable to use in a large phase III clinical trial for patients with herpes zoster. We gathered data on the performance characteristics of three potential outcomes, pain, lesion size and post herpetic neuralgia. These data were used to create the study design for the very large phase II clinical trial with about 40,000 individuals. The results of our work demonstrated that the measures were easy to use and efficient.
Use of an Existing Questionnaire in a New Patient Population
Linguistic validation with children with severe asthma
Comfort and Security
Pediatric asthma - To facilitate interviewing children 6 - 12 years of age who were hospitalized with asthma we built a bond and gained the confidence of the child via a comforting hedgehog. The interviews were conducted by special linguists who were sensitive to children hospitalized with severe asthma. Our linguists used creative graphics and games that helped the child feel at ease during the interviews.
Gaining the Confidence of Young Children

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