GR are recognised as international leaders in the development and application of PRO measures. We are able to provide clear and effective training in the selection and use of such measures. 

Training areas include:

  • Theoretical background of PRO’s: PRO covers many different types of outcome from symptoms and activity limitations through to quality of life. Selecting a measure that has the appropriate theoretical or conceptual framework while often overlooked is crucial to good measurement. The FDA recommends that all PROs suitable for making labelling claims should be based on a clear conceptual framework [1]. Often the conceptual framework of a PRO is unclearly defined by authors who, also, fail to understand the different types of outcome. Galen is able to provide informed training on theoretical aspects of health outcome measurement.
  • Assessing classic psychometric properties of PROs: An understanding of the required psychometric properties (such as reliability, validity and responsiveness) is essential for selecting the most appropriate tool for use in a clinical trial or study. Authors claim that any value they obtain indicates satisfactory measurement – but this is rarely the case.
  • The use of Item Response Theory (IRT): IRT, and in particular Rasch analysis, is now recognised as being essential to PRO measure development and application. Consequently, whether or not a PRO fits the Rasch model is crucial to whether or not data collected with the measure are meaningful. IRT is important for assessing the unidimensionality of scales (whether it is justifiable to add together a set of items) and assessing their measurement properties. It is sobering to realise that few of the PRO measures available produce data that fit the Rasch model. Galen were foremost in the application of Rasch analysis in PRO measure development. We provide training on the application of IRT and assessment of the results in health outcomes research.
  • Interpreting PRO data: GR provide training on how to understand and interpret PRO scores. We also provide advice on how to assess the minimal important difference (MID) of PRO’s and use this information in trial analyses.

Training can be tailored to suite your company’s specific needs. For more information contact Galen Research.


  1. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Reserach (CBER), Center for Devices and Radiological Health (CDRH): Guidance for industry: Patient-Reported outcome measures: use in medical product development to support labeling claims; 2009.