Patient Reported Outcome Instruments Creation
PRO instruments provide a means for measuring treatment benefits by capturing concepts related to how a patient feels or functions with respect to his or her health or condition.
Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective and may be used to support claims in approved product labelling.
PRO instruments are included in clinical trials for new medical products for a several reasons:
- Some treatment effects are known only to the patient
- Patients provide a unique perspective on treatment effectiveness
- Formal assessment may be more reliable than informal interview
PRO-Creation™ is a complex process and includes the following steps:
- Identification of concepts and development of conceptual framework
- Identification of concepts and domains that are important to patients
- Determination of intended population and research application
- Hypothesising expected relationships among concepts
- Instrument creation
- Items generation
- Choosing of administration method, recall period, and response scales
- Instrument formatting
- Drafting of procedures for scoring and administration
- Pilot testing of draft instrument
- Refining of instrument and procedures
- Measurement properties assessment
- Assessment of score reliability, validity, and ability to detect change
- Evaluation of administrative and respondent burden
- Finalising of instrument formats, scoring, procedures, and training materials
- Instrument modification
- Changing of concepts measured, populations studied, research application, instrumentation, or method of administration
PRO-Creation™ in Russian or Belarusian languages for Russia or Belarus
In some cases, it is more prudent to create a PRO Instrument in target language rather than to translate and linguistically validate it. As a Medical Linguistics Professional with a 5-year experience in the PRO instruments creation field and 7-year experience in General Medicine, I offer PRO-Creation™ services in Russian and Belarusian languages for use in Russia and Belarus, respectively, in the following medical fields:
- 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 the shortest terms I am able to create PRO Instrument in Russian or Belarusian language for use in Russia and Belarus, respectively, that will be more suitable for the target local audience than validated PRO instruments originally created in English.
PRO-Creation™ in English language for English-speaking countries
My 7-year General Medicine experience and 5-year experience in PRO instruments linguistic validation and creation allows me to create PRO instruments in English language for English-speaking patients in the following medical fields:
- 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 the shortest terms I am able to crate highest accuracy and ultimate understandability PRO instruments in English language for English-speaking countries.
N.B. PRO-Creation™ methodology is based on the “Guidance for industry: patient reported outcomes instruments: use in medical product development to support labelling claims: draft guidance” by the U.S. Department of Health and Human Services FDA Centre for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Centre for Biologics Evaluation and Research and U.S. Department of Health and Human Services FDA Centre for Devices and Radiological Health.