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. Co-ordination activities require collaboration with the Quality of Life Group (QLG) and pro-active involvement with all EORTC co-operative 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 pharmaceutical industry for clinical trials and educational training is also provided by the Head of the QOL Department.
Statistical research
The QOL Department reviews all new protocols at the EORTC Data Center and participates in the development of protocols where quality of life is an endpoint, in conjunction with the study co-ordinator. 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. Contact person: Corneel Coens.
Data management
The QOL Department was 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 also is 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.
Protocols
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 81 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 module. There are also two other stand alone questionnaires, namely the Patient Satisfaction questionnaire and the Short-form for palliative care patients, which are distributed from the Data Center. Other disease specific modules are under development but not yet validated.
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, but a User's agreement is required for each study (please go to 'Downloads' 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 Sarah Williams.
The funds that are generated through the copyright arrangement are used exclusively to support the on-going research of the QLG on the development and refinement of quality of life instruments.
A specimen of the QLQ-C30 is available here. For further information contact Rossella Guzzo (for academic studies) and Sarah Williams (for commercial studies).
Translations
The QLQ-C30 and some disease specific modules are presently being translated into several different languages. This is done according to strict guidelines (see QLG, Manuals). Briefly, the process involves two forward translations (from English into language X) and two backward translations (from language X into English). A co-ordinator (a native speaker of language X) is appointed to ensure that the procedure is adhered to, and to also make a final judgement, when necessary, if translations should differ. Please contact the Translation Team Leader for more information.
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. All may be obtained from Rossella Guzzo.
- The QLG has developed an interactive CD ROM which may also be obtained from Rossella Guzzo.
A description of the contents of these manuals is given on the website of the QLG, Manuals.
Research Project: PROBEThe EORTC Quality of Life Department, established for over 15 years, is one of the major European cancer research organizations, was recently awarded a major grant to undertake detailed analysis of clinical trial data, including research training and fellowships. With access to and generating high-quality data related to the psychosocial and HRQOL functioning of European cancer patients, the PROBE project aims to use EORTC data and the clinical network formulate better patient care. PROBE will shed light on many critical topics as yet unclear resulting in a significant impact on future psychosocial care. Eventually, PROBE will influence clinicians, policy makers, healthcare providers and services. |