principal that the adult/child is the richest
and most appropriate source for identifying
concepts and areas for measurement.
The HACHQ scientific staff develops new condition-focused measures for research and pharmaceutical company use within observational studies and clinical trials. HACHQ has developed adult and pediatric measures, including surveys related to genetic disorders, enuresis, allergic rhinitis, and attention deficit hyperactivity disorder.
Initiatives such the Patient Reported Outcomes Measurement Information System (PROMIS®) funded by the US National Institutes of Health and the Patient Reported Outcomes Measurement Systems (PROMS) endorsed by the European Agency for the Evaluation of Medicinal Products support the fundamental premise that the health-related quality of life and well-being of patients is a core co-primary endpoint in clinical trials, clinical care, and research.
Survey development is a complex and iterative process.
HACHQ's mixed-method approach is comprised of three essential steps:
- Needs assessment:
Identifying key domains unique to the condition or disease being studied and their impact on everyday life and well-being during in-depth discussions with a sample of adults and/or children. Discussions with clinical experts and a literature search are also used to inform the development of the survey.
An essential element of the HealthActCHQ ethno-grounded approach is to focus on the person's narrative discourse by encouraging each patient to tell their "story" and allowing key words, phrases and concepts to emerge within naturally occurring language.
It is essential that the patient samples are represented across:
- Age - especially in younger populations
- Disease severity
- Subtype - if appropriate
- Onset of disease
- Treatment status
- Identifying key domains unique to the condition or disease being studied and their impact on everyday life and well-being during in-depth discussions with a sample of adults and/or children. Discussions with clinical experts and a literature search are also used to inform the development of the survey.
- Construction and Harmonization:
- Development of the Module - including writing items, selecting the appropriate response options, identifying the general format/layout and length, and obtaining direct adult/child feedback about its ease of completion and readability and conducting formal readability and comprehension evaluations using the Flesch-Kincaid method. Cultural adaptability is also assessed and if possible translations are performed using stringent ISPOR standards. Click here to go to the translation process page.
- Ongoing evaluation:
- Rigorous assessment of the psychometric properties of the module including the distribution of responses, item convergent and discriminant validity, floor and ceiling effects, reliability and validity.