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 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 development process for any EORTC questionnaire follows a standard procedure and is closely monitored. This ensures high quality across modules.

Phases of development

The development process is divided into four phases. Modules in Phase I and II are in an early stage of development. From the completion of Phase III onwards, modules are available for use. However, even though 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, they should be used with some caution and bearing in mind that the development has not been finalised. Modules that have completed Phase IV are considered fully validated.

For more information, please see our Module Development Guidelines here.

Validated

When a module has successfully completed Phase IV and has received formal approval from the QLG, it is considered to be “validated”.

Most of the time, the results of Phase IV are presented in a peer-reviewed publication in an international journal.

Completed Phase III

As described in the Module Development Guidelines, a “Phase III completed module” has completed the pre-testing process, and a Phase III report has been submitted and approved.

Such modules may be used in clinical trials under certain conditions which you can find here. 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.

In principle, the module developers should have the right to publish their data first. Please see our Module Development Guidelines here for more details.

A module which has completed Phase III and is undergoing validation testing may be described as “Phase IV – in development”.

A module which has completed Phase IV and is waiting for formal approval may be described as “Phase IV – completed”.

Terms and conditions of use modules under development can be found here.

In Phase I/II/III

As modules “in development” we mean any questionnaire that has not completed Phase III yet.

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 provisional version of the questionnaire is available and has been approved for pre-testing in Phase III.

If a module is “in Phase III”, the provisional questionnaire is undergoing testing to confirm comprehensibility and come up with a scale structure. Once Phase III has been completed and any changes to the questionnaire, resulting from the results of Phase III have been made, it becomes available for use. See paragraph “Phase III Completed” above for more details.