Why do we need modules?
While the EORTC QLQ-C30 is an important tool for assessing the generic aspects of QOL, it has limitations and therefore a modular approach was adopted for disease-specific treatment measurements. An essential aspect of the “modular” approach to QOL assessment adopted by the EORTC QLG (Quality of Life Group) is the development of modules specific to tumour site, treatment modality, or a QOL dimension, to be administered in addition to the core questionnaire (EORTC QLQ-C30). The modules, like the core questionnaire, are designed for use in cancer clinical trials.
Since individual members or subgroups of the QLG are involved in module development, guidelines are needed and these have been developed to standardize the module development process. This ensures uniformly high quality across modules.
Phases of development
The development process is divided into four phases. Phase I and II modules are in an early stage of development. From completed Phase III onwards, modules are available for use. Modules that have completed Phase III are available for general use but, although they have been carefully developed and tested for acceptability with patients, they have not undergone psychometric testing in a large international group of patients. Modules that have completed Phase IV are fully validated.
For more information, please see our Guidelines for Developing Questionnaire Modules.
When a module has completed Phase IV successfully and has received formal approval is considered to be “Phase IV completed” or “validated”.
A validated module should consist of a single version of the questionnaire itself (in English) with all official translations and a scoring/interpretation guideline. In most circumstances, the conclusion of a module development process is represented by the acceptance (or in press/on-line) of a peer reviewed publication in an international journal reporting Phase IV.
Phase III Completed
A module which has completed Phase III as described in the Guidelines for Developing Questionnaire Modules, i.e. which has completed the pre-testing process and that has received the formal approval of the Phase III report, is described as “completed Phase III”.
Such modules may be used in clinical trials under certain conditions which are detailed on the QLG website. Although they have been carefully developed and tested for acceptability with patients, they have not undergone psychometric testing in a large international group of patients. Therefore the suggested subscales for those modules are hypothetical and may change after psychometric analysis.
A module which has completed Phase III and is undergoing validation testing may be described as “in Phase IV testing”.
The term “module that has completed Phase I” describes modules for which a list of QoL issues has been generated.
A module will be considered to have “completed Phase II” once the list of QoL issues has been converted into a set of items and a preliminary version of the questionnaire is available and has been approved for pre-testing in Phase III.