ERS/ATS Working Group New Lung Function Reference Values:
A United Approach

Statutes

Objective

Establish improved international lung function reference data that:

• encompass all routine clinical lung function tests; including but not limited to spirometry, lung volumes (using both plethysmography and multibreath washout tests) and TL,CO (including matched VA)
• are representative of the population /individuals under study irrespective of age/ethnic group/equipment used
• are based on raw data that have been collected under standardised measurement conditions with documented equipment and software
• are re-modelled using modern sophisticated statistical techniques to allow continuous equations across the entire age range from early childhood to old age.
• allow flexible and appropriate methods of interpretation using upper (or lower limits) of normal, which take into account the variation in between-subject variability according to age and reported lung function parameters, rather than fixed cut–offs
• are clinically useful and can be incorporated into commercially available equipment, with improved methods of reporting to give clear indication of where the subject lies with respect to the normal range and the ability to track changes over time
• can be updated on a regular basis to account for alterations in equipment/software/secular changes/availability of new datasets.

Organisation:

• anyone contributing data to the above end, or involved in the handling and/or analysis of data, or with a general interest in the process, can join the working group by sending an application to become a registered member to the steering committee.
• The working group shall have a steering committee.
• An analytical core team will be formed that forms part of the steering committee.
• The steering committee will communicate with consultants and the membership of the working group and representatives of official bodies.
• The steering committee will seek task force status from the ERS and other societies.
• For the time being communication with members of the working group will be through www.lungfunction.org where progress will be reported and registered members can post relevant messages; reports on analyses in progress will only be accessible to registered members.

• Any person, group or organisation that has collected representative data using modern techniques is welcome to contribute such data for inclusion in the analyses.
• All data must be completely anonymised prior to submission, and be accompanied by information detailed in the data collection template.
• The steering committee will also solicit submission of data from individuals, groups or organisations that are known to have collected representative data on pulmonary function using modern techniques.
• Any person, group or organisation sharing data with the working group will specify in writing whether ethics committees or organisations have given permission for the data to be used in a publication.
• The steering committee will also solicit submission of data from individuals where appropriate.

Data ownership

• The person, group or organisation that has done the data collection will remain the owner of the data, with all rights arising from that, unless agreed otherwise.
• The above implies that under no circumstance will it be possible to publish in any form, or communicate otherwise, results using a data set unless with the agreement of the owner of that data; co-authorship of a publication will automatically imply agreement.
• Under no circumstance will it be allowed for the analytical team to share the data with others, be it within or outside the working group, unless with explicit permission from the owner(s) of the data.
• The owner of the data will be requested to agree with the conditions spelled out in this document, but is free to specify specific conditions that will temporarily or permanently limit the use of the data.
• If these terms and conditions are changed, the owner of the data shall be notified and be asked for agreement to the new terms.

Data management

• The data will be managed by the analytical team.
• Data on unpublished material will be reviewed by the steering committee prior to adding it to the database.
• Depending on the analytical findings, certain data sets may not be included in a publication (clear outliers etc.).
• For safety reasons all data will be available in at least two geographically different sites accessible to two or more members of the analytical team.
• If questions arise about details of a data set, these shall be resolved by contact between the analytical team and the owner of the data.

Publication

• The results of the study/studies will be submitted for publication to a reputable scientific journal. The format of the publication, and the scientific journal chosen, may be dictated by the status of the working group (task force or not).
• Authors and co-authors will be the members of the steering committee, those actively engaged in the analytical process, and persons, groups or organisations that contributed the original raw data sets. Generally there will be one representative per centre/study group who will be nominated by the group as a named author. This individual will communicate with the rest of their study group, and act as lead contact. In the case of several publications that incorporate the same data set, authorship may be changed by mutual agreement.
• The implementation of predicted values for pulmonary function indices, their lower and/or upper limits of normal and the calculation of standardised residuals into software will be facilitated by making such information available in appropriate form. Access to this information will be free, and its use as open source information will be governed by the GNU Free Documentation License and, where appropriate, by the GNU General Public License.