MANAGEMENT OF THE QOL DEPARTMENT
The Head of the QOL Department, Dr Andrew Bottomley, undertakes the day-to-day management of the EORTC research program for quality of life assessment. In general, with members of the QOL Department, this involves developing a team-based approach to providing overall advice on the design, conduct and assessment of quality of life within various EORTC co-operative groups.
The Head of the QOL Department aims to ensure the effective development of the QOL Department and provide integrated support and advice for development of the EORTC QOL assessment program. Coordination activities require collaboration with the Quality of Life Group (QLG) and pro-active involvement with all EORTC cooperative groups and other international groups who undertake quality of life assessment.
Presently, over 40 clinical trials are ongoing in the EORTC which have a QOL component. Advice on quality of life assessment to the pharmaceutical industry for clinical trials and educational training is also provided by the Head of the QOL Department.
The QOL Department reviews all new protocols at the EORTC Headquarters and participates in the development of protocols where quality of life is an endpoint, in conjunction with the study coordinator. The statistician also reviews newly developed case report forms (CRF) to ensure standardization of issues relative to collection of QOL data.
Statistical research activities at the QOL Department focus on evaluating and implementing various methods of analyzing, interpreting and reporting QOL data in cancer clinical trials. Analyzing QOL data can be complicated for several reasons e.g. repeated measures are obtained, data may be collected on ordered categorical response scales, the instrument may have multi-dimensional scales and complete data may not be available for all patients. In addition, it could be necessary to integrate QOL with clinical outcomes. The QOL Department has an ongoing interest in all of these areas to establish a standard approach for QOL analysis methodology.
Past projects of the QOL Department have included collaboration with the QLG on production of the reference data manual and a manual of guidelines for assessing quality of life in EORTC clinical trials (see QLG, Manuals). Research projects performed by visiting Fellows have included a Q-Twist analysis in prostate cancer patients and analyses of categorical QOL data where some measurement sequences were incomplete due to a dropout of patients. Recently, new methodology to assess the intercollinearity problem of the various QOL scales and the prognostic value of baseline QOL data has been developed and implemented.
The QOL Department is also responsible for the data management of field studies. (see the list of these studies in QLG Activities: 15861 - 15931 -15941 - 15961 - 15982 - 15001 - 15012 - 15011/30011) which are now completed.
The QOL Department is also responsible for supervising the data management of quality of life evaluations in EORTC studies (N=40) and where possible encourages investigators to adopt a standard approach. To ensure adequate rates of patient accrual, compliance and data quality, there is a continuous need to maintain and improve standard data management strategies.
Contact person: Andrew Bottomley.
DATA REPOSITORY PROJECT
The EORTC QLQ-C30 questionnaire was developed in 1993 as an instrument to assess the quality of life of generic cancer patients. Since then, many other specific questionnaires, called modules, have been developed. The module development process involves four phases, the last one being a large-scale test (field test). Field studies can be conducted inside or outside the EORTC Headquarters. A recent review of the SAC advised the QLG to 1) create a central dataset to store all the data, and 2) develop a standard template and establish guidelines for field studies. To obtain this, the Data Repository project was born.
Francesca Martinelli, a statistician who has been a fellow in the QLD for three years and is consequently familiar with the subject, was appointed to work on the Data Repository project in May 2011.
Since then, a working group including the Head of the QLD, the chair of the QLG and the chair of the Module Development Committee has been set up. The project has been presented to all the QLG members at the QLG meeting in Innsbruck, Austria, in September 2011.
In the future the central dataset will be updated and maintained in order to safely store data and also to give the opportunity to researchers to carry out new research on existing data and enhance the long-term value of the data, according to the data preservation and sharing policy.
Contact person: Francesca Martinelli
The QOL Department is involved in developing QOL sections in all EORTC protocols. On average some six to eight new protocols with QOL are activated each year. This work is conducted in certain cases in collaboration with QLG experts.
Contact person: Andrew Bottomley.
DISSEMINATION OF EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is a copyrighted instrument, which has been translated and validated into more than 90 languages and is used in more than 3,000 studies worldwide. It is supplemented by disease-specific modules e.g. Head & Neck, Lung, Breast, Ovarian, Oesphageal, Gastric, Cervical and Multiple Myeloma. There are also two other stand-alone questionnaires, namely the Patient Satisfaction questionnaire and the Short-form for palliative care patients. New disease-or site- specific modules are under development all the time.
Presently the QLQ-C30 version 3.0 is the most recent version and should be used for all new studies. Conditions for its use are dependent on whether it will be employed in an academic or commercial setting. For academic settings, there is no charge, although a User Agreement is required for each study (please go to 'Download' to fill in a download request).
For studies carried out on behalf of a commercial sponsor a royalty fee is payable. A royalty fee is required per study. The amount of the fee depends on the number of patients. For further details of the fee structure, please contact Cheryl Whittaker.
The funds that are generated through the copyright arrangement are used exclusively to support the ongoing research of the QLG on the development and refinement of quality of life instruments.
Contact person for academic studies: Justyna Mierzynska
Contact person for commercial studies: Cheryl Whittaker
QUALITY ASSURANCE FOR QUALITY OF LIFE GROUP (QLG) STUDIES
Standards are constantly evolving to improve the conduct of research for QOL studies; there is a call for increased quality assurance in the design, conduct and reporting of QLG studies. Madeline Pe, PhD is hired to support this work. Her task is focused on the projects funded by the QLG (module development, clinical studies and research projects). Working with Francesca Martinelli, they are supporting the QLG to help harmonize the EORTC HQ quality assurance policy with that of the QLG. They are supporting the needs of the QLG Projects and Module Development Committee (PMDC) and Grant research committee (GRC).
Contact person: Madeline Pe
All translations of the core questionnaire (EORTC QLQ - C30) and modules follow the EORTC Translation Procedure, described in detail in the EORTC Translation Manual (EORTC Translation Procedure, Kulis et al., 2016).
All new modules are developed in English, as well as in a number of other European and non-European languages. The translation process in the scope of the module development is described in the Module Development Manual.
All translations are coordinated by the EORTC Translation Unit. Prior consent is required for any translation project. In short, the translation process involves two forward translations into the target languages, which are then reconciled. The reconciled translation is subsequently back translated into English (twice). The back translation report (including the two forward, reconciled and two back translations) is sent for review to the EORTC Translation Unit. Once agreed, the translation is proofread by an independent proofreader. The next stage is the pilot-testing on a group of patients, who comment on the wording and any potential problems. The pilot-testing report is again sent for review to the EORTC Translation Unit. Once all issues have been resolved, the project can be finalized and the new language version is made available for use.
Contact person: Dagmara Kulis
The EORTC Quality of Life Group maintains a database of all its questionnaires, items and their translations. It can be accessed by academic and commercial users on: http://www.eortc.be/itemlibrary Once access has been requested, a user agreement will be prepared for signature.
The Item Library can be used as a reference tool in development of new questionnaires and to create custom-made questionnaires on basis of existing modules and items.
Contact person: Dagmara Kulis
DISSEMINATION OF MANUALS
The QOL Department is responsible for the distribution of the following Manuals:
- Scoring Manual, Reference Values, Guidelines for Developing Questionnaire Modules, Translation Procedure, Guidelines for assessing quality of life in EORTC clinical trials.
A description of the contents of these manuals is given on the QLG website under Manuals
RESEARCH PROJECT: MID
In December 2015 the QLD started a 3-year project on Minimal Important Differences (MID) which aims to provide an evidence-based approach to interprete a clinical meaningful change in HRQOL. The project is funded by the EORTC QLG and makes use of data from published Phase II and III clinical trials conducted by the EORTC HQ, comprising 30 trials, 12 cancer sites and over 10,000 patients in total. The first findings from the MID project were presented at the ISOQOL 23rd Annual Conference in Copenhagen, Denmark (October 2016).
Contact person: Jammbe Musoro
RESEARCH PROJECT: SISAQOL
Clinical research and clinical care move towards a more patient-centred approach in which health-related quality of life (HRQOL) and other patient-reported outcomes (PRO) play a central role. However, diverse ways of analysing PRO and HRQOL endpoints make it difficult to compare results across various cancer clinical trials. To respond to this need, the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium was convened by the EORTC. The goal of the Consortium is to develop recommendations for standardising the analysis and interpretation of quality of life data in cancer randomised trials.
Read more about the Consortium in their published piece in the Lancet Oncology (Personal View): https://www.ncbi.nlm.nih.gov/pubmed/27769798
For more information, please visit: www.eortc.org/sisaqol