Reviewed in September 2013
The mission of the EORTC Quality of Life Group (QLG) is to develop measures of patient-reported outcomes in cancer, including health-related quality of life (HRQL), and promote and coordinate studies concerning the quality of life of cancer patients.
- To develop reliable and valid instruments for measuring patient-reported outcomes (PRO) and health-related quality of life (HRQL) of cancer patients participating in international cancer clinical trials and other well-designed research studies.
- To advise the EORTC regarding the assessment of the multidimensional aspects of patients’ HRQL as a measurable outcome of cancer treatment. Where appropriate the QLG will work in collaboration with other EORTC Groups and the EORTC Headquarters/ QL Department to advise and support the design, implementation and analysis of patients’ PRO/ HRQL.
- To conduct research to understand better the effects of cancer and its treatment on the HRQL of diverse populations of patients with cancer and to investigate the possible cross-cultural differences in these effects.
- To conduct basic methodological research in HRQL and PRO assessment.
- To investigate the use of new technologies to administer PRO/ HRQL instruments in clinical trials, research studies and in routine clinical practice.
- To contribute to teaching/training initiatives to promote the EORTC approach to HRQL/PRO measurement through preparation of guidelines, teaching material, oral presentations etc.
- To develop and maintain liaison with other non-EORTC groups conducting quality of life studies in oncology e.g. NCI-Canada Clinical trials group
Membership is open to all professionals with an active interest in quality of life research in oncology. There are 3 categories of members
- Full active members
- Probationary members
- Corresponding members
Full active members – are actively involved in at least one of the Group’s activities such as
a) module development (Phases 1, 2 or 3)
b) field studies
c) other research activities of the QLG
d) providing advice to the EORTC on HRQL assessment
e) serving as an office bearer on one of the Group’s committees
Full members should attend at least two meetings of the QLG over two years.They can attend, vote at the business meetings and receive minutes of the business meetings.Like all others, employees in the EORTC Quality of Life Department can become full members if they fulfill the criteria above, and can thus apply for grants and all other activities.
Probationary members – are individuals seeking to become members of the QLG through active involvement in at least one of its activities. Probationary members must attend a minimum of two meetings during a two year period. By their second attendance probationary members are expected to have identified activities within the Group to which they can contribute. On their third attendance they become full members. Probationary members who are not actively participating after two meetings are discouraged from attending further meetings except in special circumstances. Probationary members have no voting rights and are not allowed to attend the Group’s Business Meeting.
Corresponding Members – include individuals actively supporting the EORTC approach to HRQL assessment but unable to attend, for example because of distance (e.g. NCI – Canada representative) or costs. At the discretion of the Executive Committee individuals interested in the Group’s work but unable to attend meetings may be kept informed of the Group’s work and invited to collaborate e.g. in research, as appropriate.
Officers of the Group
The officers of the Group are the Chairman, Secretary and Treasurer. Each of them is elected to serve for three years and is eligible to stand for reelection (once only) for a further 3 years. In addition there are posts of ‘Chair Elect’ and ‘Past Chair’. Each of these posts is held for one year only. The officers are elected from the Full Members of the Group.
The Group has an Executive Committee which consists of the three officers, a newsletter editor, the chairs of the committees which coordinate the Group’s major activities, a ‘web’ representative and in some years a Chair Elect or Past Chair. The Head of the QoL Department is an ex officio a member of the Executive. There is provision for co-opting members to the Executive for a period limited by the duration of the task for which they were co-opted. By this means retiring officers can be co-opted for a limited period to ensure a smooth handover of tasks and responsibilities to their successors.
In 2010 the Group has 2 permanent committees:
- Module Development Committee
- Translations Committee
These Committees are open to members who are active in these fields of the Group’s work. Each of these committees has a chairman who is a member of the Executive Committee. The Chair of these committees is elected from and by all full members of the Group. Otherwise the structure of these committees is informal.
Officers of the Group and members of the Executive Committee are elected by full members of the Group for a period of three years.
Nominations must be proposed and seconded by full members. Nominees must have indicated their willingness to accept the office before the nomination is formally submitted. Offices to be filled are announced at Group meetings and the call for nominations appears in the Minutes sent to all active members. Nominations received are announced via e-mail to all members in advance of the next meeting. In the case of one nomination, this is ratified by the members present at the Business meeting. When more than one nomination is received elections are held via an electronic ballot prior to the Group meeting. Announcement of the electronic ballot is made 1 month in advance. The ballot is open for 14 days, and automated reminders will be sent. The electronic ballot is valid if more than 50% of the full members vote and the elected officer must have majority of the votes (at least 50% plus 1). Election results are announced at the Business meeting which ratifies the post. In the case of electronic vote being a tie (i.e. exactly 50/50 split), the members present at the Business meeting will vote again and the select the candidate with simple majority.
Officers and members of the Executive may stand for re-election for a second time but the office will be advertised as vacant and in the event of other nominations being received, an election will be held.
The Group holds at least two meetings per year to which all members are invited. Currently the EORTC hold a meeting in Brussels in the spring of every second year and all groups are invited to attend (EGAM). Other meetings are generally hosted by group members in their home city. Members are required to register their intention to attend the meeting in advance by notifying the secretary.
The meetings have 6 parts:
a) Closed meeting of the Group’s Executive Committee
b) QoL Department Update
c) Parallel sessions for scientific meetings of working parties for the group’s current studies. It is at the discretion of the study coordinator whether the meetings are open or closed for others to attend. New probationary members are asked to contact the study coordinator in advance expressing their interest.
d) Module Development Committee – open meeting
e) Plenary session – open meeting. Working groups report on their scientific progress and external speakers are invited to present.
f) Business meeting – full members only.
- Apologies for absence
- Minutes of the last meeting
- Matters arising
- Chairman’s Report
- Secretary’s Reports
- Treasurer’s Report
- Date of next meeting
The Executive Committee principally communicate electronically and by regular conference call between Group meetings. Exceptionally additional meetings of the Executive Committee or Scientific Working groups will be held between the main Group meetings. Proceedings are reported to the Business or Plenary session of the next Group Meeting.
Protocol Writing and Design
Module Development – The Module Development Committee (MDC) coordinates the process of module development within the QLG by reviewing proposals for modules and by being available for advice throughout the module development process. Module development should follow the published procedural guidelines. The MDC is responsible for development and update of the guidelines.
Protocols for large scale studies (field studies) to confirm the psychometric properties of the modules are prepared by representatives of the working group which has been responsible for developing the module. The field studies may be conducted through the EORTC Headquarters, in studies coordinated outside of EORTC Headquarters or by using the module in EORTC or other clinical trials. A detailed protocol is required to specify the study aims and procedures for field testing. The protocol is peer reviewed either during the process of grant applications, by the Module Development Committee and by EORTC PRC when the study is conducted through EORTC HQ and QL Department. The study coordinator is responsible for ensuring strict following of ethical guidelines, research governance, quality assurance, data management and statistical analysis procedures and their rigorous documentation.
Other QLG Studies – For other studies, members have the opportunity to present outline proposals to meetings of the Group. Where these meet the scientific priorities of the Group and attract Group support a working group will be formed to develop more detailed proposals for discussion at a subsequent Group meeting. The working group is then responsible for identifying a protocol writing committee and presenting work in progress to Group members for comment during the bi-annual meetings. It is the responsibility of the study coordinator to ensure adequate communication between the protocol writing committee and other relevant members of the Group and when relevant, the EORTC QL Department at all times.
For field studies conducted through the EORTC Headquarters the respective SOPs and working procedures and instructions will apply for quality assurance.
For studies conducted outside the EORTC Headquarters, the respective SOPs and working procedures and instructions developed by the Data Repository officer will apply for quality assurance.
Quality assurance during module development is provided by the peer review procedures of the Module Development Committee (see Protocol Writing and Design – Module Development). The EORTC QLG produces a number of ‘blue books’ with guidelines and advice for using QLG instruments. These can be downloaded from the group’s website.
Publication policy for all EORTC QLG studies should be specified in advance and included in the protocol for each study. Authors will usually include at least the study coordinator, members of the protocol writing committee and major contributors to study recruitment, statistical analysis and reporting. Authorship implies involvement throughout the research process and individual clinicians contributing patients to QLG studies are acknowledged but are not automatically co-authors. Specific details of authorship and the publication policy will vary from study to study.
The study coordinator is the final arbiter of the timing of presentation and the publication of results. Prior to submission of manuscripts they should be submitted to the QLG Executive Committee for comments and approval. When manuscripts are approved for submission a copy is sent to the EORTC QL Department and EORTC Headquarters. Publication should be “on behalf of the EORTC Quality of Life Group”.
Where a member of the QLG has been responsible for liaising with other EORTC Group(s) in protocol writing for QL assessment in an EORTC clinical trial or other well-designed research study, they should agree in advance whether they will be involved in the processes of data analysis, interpretation and reporting. It is usually expected that they will be a co-author on the final publication.
Organisation of Financial Support
The Group currently draws no financial support from the EORTC Treasury. At present funding is derived from the pharmaceutical industry and interest from deposits. Other opportunities may be expected to arise in the future (such as income from software for electronic/phone administration of EORTC instruments).
Commercial users of the EORTC QLQ-C30 are required to pay a fee for the use of the EORTC QLQ-C30. The level and nature of this fee are determined by the Executive Committee. Currently there is no fee for pharmaceutical users for use of modules. The EORTC QLQ-C30 and modules are available in numerous languages and provided the translation has already been pilot tested and validated there is no extra fee for each translation used. However, pharmaceutical users requiring new translations are required to pay the costs of acquiring the translation plus an additional management fee to cover the administrative costs of coordinating the translation and subsequent review of the pilot study and translation reports. Payment is not required for academic use of the EORTC QLQ-C30 or modules in existing languages.
The Group supports the costs of a number of administrative staff in the QL Department. The EORTC Headquarters supports the expenses of QL Department staff of attending QL Group meetings. An educational grant is made available each year to the Translation Team leader in the QL Department to attend external scientific meetings and present QLG work.
Full members can apply in advance to the Executive Committee for partial financial support to attend meetings of other EORTC Groups provided attendance is linked to an activity involving HRQL.
Full members of the Group are given the opportunity to respond to calls for funding from the Group to support scientific projects in line with the Group’s aims and priorities. Financial limits are set on these grant applications. Such applications are reviewed by at least two independent peer reviewers (QLG members or external as appropriate to the project) and at least one member of the Executive. A decision is made by the entire voting members of the Executive as to whether funding should be approved. This process is co-ordinated by the Past Chair starting in the year after they leave office or by another member appointed by the Executive. Financial support is provided to the grant coordinator to cover secretarial services. The grant coordinator is not considered a member of the Executive Committee and whilst they can make recommendations to the Executive they do not have voting rights. Full reports of these decisions are presented to the subsequent Business meeting of the QLG for ratification.
The financial management of QLG accounts, as for all EORTC groups, is performed by the EORTC Headquarters Finance Department. The Treasurer presents accounts to the Group at each Business Meeting.
Relations with EORTC HQ and Quality of Life Department
The QLG cooperates closely with the personnel in the QL Department in administrative, scientific and business activities.
Staff at the QL Department administer pharmaceutical contracts and user agreements for academic users. They also maintain the EORTC Quality of Life website and support the production of the EORTC QLG Newsletter and distribution of QLG related educational/support materials. A translation Team Leader and Translation Officers work closely with the Translation Committee Chair on the Executive committee to maintain high standards of translation for the EORTC QLQ-C30 and modules. Staff at the QL Department also maintain the Item Bank.
The coordinator of the QoL Department is ex officio a member of the QLG Executive. The coordinator of the QoL Department and the Chair of the QLG are in regular contact.
Alterations to the Statutes
Any alterations to these statutes shall be presented to all full members. Such changes will be circulated 21 days in advance of the next business meeting so that they can be discussed and if necessary amended at the meeting. Alterations /amendments of the Statutes must be approved by at least two thirds of those present at the meeting.