User:JamesOAdams/Galen Research

Galen Research was established in 1989 as an independent research company which specializes in developing disease specific patient-reported outcome (PRO) questionnaires. The aim of Galen Research is to “improve the science of health measurement”.

Since its formation in 1989, Galen has developed PRO measures which cover a range of diseases. These questionnaires include the Nottingham Health Profile (NHP), the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and the Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) , among others. These measures have been used in research studies worldwide to determine the effect a given disease has on a patient’s life.

The company is also involved in translation of PRO measures into other languages, writing academic manuscripts, conducting burden of illness studies, the application of Rasch analysis, literature reviews and evaluation of PROs, PRO use training and assistance on clinical trials.

Methodology
According to Galen Research, the development of a new PRO measure involves four stages:


 * Qualitative interviews: Interviews are conducted with a number of patients with a varied representation of age, gender and disease severity. Statements are identified from these interviews which relate to the impact the condition has had on the patients’ lives. These statements are used to create a draft of the measure.


 * Cognitive debriefing: The draft is tested with a new patient sample to confirm the face and content validity, relevance and comprehensiveness.


 * Validation survey: The measure is tested with a validation survey with up to 200 patients, twice in a two week interval. This is used to create the final measure.


 * Data analysis: The psychometric properties of the measure are assessed for test-retest reliability, internal consistency and construct validity. Analyses are performed using Item Response Theory (Rasch) analyses to ensure good scaling properties such as item fit, local item dependence, item-stability and differential item functioning according to age and gender. If the data in the scale corresponds with the Rasch model, the scale is accepted as unidimensional. This means that item scores can be added to give a total score and statistical tests can be applied to trial data.

Philosophy
There are two main schools of thought concerned with assessing quality of life: the health-related quality of life (HRQoL) school and the needs-based quality of life school (NBQoL). HRQoL is interested in assessing the burden a disease has on a patient’s well being over a period of time, which means that it is focused solely on a patient’s health. NBQoL takes the view that quality of life is determined by a patient’s ability to satisfy their needs, and therefore focuses on the disease’s impact on a patient’s ability to meet those needs.

Galen Research utilizes the needs based quality of life model in order to focus more on the patient’s viewpoint of their medical condition and the treatment that they are receiving. Galen measures are patient-based with all items derived from unstructured interviews with patients and do not list typical symptoms or problems associated with the disease in question. This is regarded as the most effective approach by Galen Research because it focuses on the patient’s perception and takes into account that other factors may be affected by health and influence quality of life.

Patient-Reported Outcome (PRO) Measures
Galen Research has developed 31 PRO measures. These measures are:

There are currently three measures in development,. They are focused on the following medical conditions:


 * Dupuytren’s Disease
 * Stretch marks
 * Myelodysplastic syndrome(MDS)

Headquarters
Galen Research is situated in the Manchester Science Park, directly across from the University of Manchester.