Volume 195 - Issue 6
Clinical practice guidelines: the need for greater transparency in formulating recommendations
Author: Robert F W Moulds
Med J Aust 2011; 195 (6): 324-325. || doi: 10.5694/mja11.10875
Published online: 19 September 2011
Published online: 19 September 2011
To the Editor: Scott and Guyatt are absolutely correct that as much transparency as possible is required in the process by which any clinical guidelines are formulated.1 I also agree that this must include careful management of conflicts of interest, particularly in the selection of the members of the expert panels required to formulate guidelines and in the functioning of those panels.1
However, transparency does not necessarily require adopting the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system or any other hierarchical system for formulating guidelines, nor does it necessarily require seeking formal feedback from external stakeholders.
The GRADE system, like most hierarchical systems, assumes there is at least some evidence in the literature that addresses the relevant clinical problem — thus, it gives its lowest grade to observational studies with a very uncertain estimate of effect. But, often, practitioners most want help with the complex and multifaceted clinical problems on which there are not even formal observational studies. The GRADE system would presumably put these problems in the category of “You’re on your own, chaps, and don’t expect us to help you”.
Recommendations on the problems that are most vexing to practitioners will be mainly (and inevitably) based on clinical experience and circumstantial evidence — in other words, expert opinion. Most practitioners looking for guidance will be well aware that such recommendations are likely to be based on expert opinion rather than excellent formal evidence. When deciding whether or not to trust the recommendations, they will be much more concerned that any conflicts of interest for the experts making the recommendations have been recognised and appropriately redressed, rather than that the level of evidence has been rigorously graded.
Seeking formal feedback from stakeholders is also a separate issue from transparency. Potential users should be well represented on any writing panel, and their feedback is obviously essential — there is no point in producing guidelines that don’t address the problems that the potential users are facing. However, many stakeholders — for example, the pharmaceutical industry — will have much more serious conflicts of interest than do the members of the expert panel, and these can be impossible to deal with. Of course, feedback should be sought where appropriate, but to make it an absolute requirement under the guise of transparency seems nonsensical.
It is clearly essential that users of clinical guidelines must be able to have confidence that they have been developed as rigorously as possible, but an excessively doctrinaire approach to their development will almost certainly lead to a decline in usefulness without a counterbalancing increase in trustworthiness.
Competing interests
Robert Moulds is the medical advisor (part-time) to Therapeutic Guidelines Ltd, an independent, not-for-profit company that publishes clinical practice guidelines for use in Australian health care institutions and general practices.
References
- Scott IA, Guyatt GH. Clinical practice guidelines: the need for greater transparency in formulating recommendations. Med J Aust 2011; 195: 29-33. <eMJA full text>