Taken to task: what is and is not an appropriate response to an ERS guidelines task force?

The European Respiratory Society (ERS) management group have discussed the worrying recent trend for outside interference by a small number of pharmaceutical and other companies in the Society's processes for generating, publishing, disseminating and/or implementing clinical practice guidelines. Recently, some companies have targeted their unwanted attentions very aggressively on particular individuals who are chairs or members of task forces developing guidelines. This is unacceptable, and the purpose of this manuscript is to remind all concerned of our guideline procedures, the proper way of responding and expressing comments, and how the Society will regard any future attempts to manipulate outcomes.

Clinical practice guidelines are generated by the Society only after a rigorous process. The task force proposal has to be approved by the ERS Science Council and Executive Committee, who also have to approve the chairs and task force members individually. Importantly, conflict of interest statements of all task force members are reported in a fully transparent manner and are managed appropriately. The actual process of generating the guideline is carefully monitored by independent methodologists, and recommendations for clinical practice are generated in accord with the pre-specified evidence-based methodology (using the GRADE approach [1]). Our guidelines meet most of the standards for trustworthy guidelines as described by the Institute of Medicine and fulfil the requirements for inclusion in the National Guideline Clearinghouse [2, 3]. The document is then externally and internally peer reviewed, endorsed by the ERS Science Council, and finally has to be endorsed by the ERS Executive Committee. These steps involve far more extensive scrutiny than that accorded to most scientific reports. The end product, the clinical practice guideline, as clearly stated, is a manuscript containing a set of recommendations, not prescriptive commands, and every physician is at liberty to apply them or not to an individual patient, taking into account what is in the best interests of that patient. To be specific, we state “The guidelines published by the European Respiratory Society (ERS) incorporate data obtained from a comprehensive and systematic literature review of the most recent studies available at the time. Health professionals are encouraged to take the guidelines into account in their clinical practice. However, the recommendations issued by this guideline may not be appropriate for use in all situations. It is the individual responsibility of health professionals to consult other sources of relevant information, to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and the patient's caregiver where appropriate and/or necessary, and to verify rules and regulations applicable to drugs and devices at the time of prescription.” They are thus advisory, not mandatory, nor is there any intention that they should be mandatory. There can of course always be room for divergent opinions about a clinical practice guideline, as with any document, and the way these are addressed should be in the correspondence columns of the journal, under the control of the editors, with the right of reply for the original authors. What is not acceptable is any interference with these processes before publication, or threats and attacks on individual task force members during development of the guideline or after its publication. Indeed, for this reason all task force proceedings are confidential, and members sign a confidentiality agreement, and it is therefore wrong for there to be any discussions with outside parties. We consider that these are an attack on the independence and integrity of the document and on the whole Society, which we take very seriously.

The ERS management group were very clear that a clinical practice guideline belongs to the Society as a whole, and an attack on the guideline or its task force members will be considered as an attack on the whole Society, and a robust defence of individual task force members will be mounted. Any interference with our processes will be publicised and reported to the regulatory bodies, and will have repercussions for participation in future ERS Congresses. The vast majority of commercial interests have been respectful of our guidelines and their processes and will not regard this annotation as at all controversial; for those very few of whom this cannot be said, their activities will be dealt with most seriously. We are sure other scientific Societies producing guidelines will want to endorse our approach.

Disclosures