During the last decade, our field has seen several recommendation papers, or “white papers” being written, primarily in an attempt to establish certain methods, and ensure a certain degree of reproducibility when using novel MRI methods in clinical practice or as readouts in clinical trials. These “white papers” have either focused on MRI methods (such as the original paper on recommendations when using Arterial Spin Labelling – ASL) [1], or on the use of various MRI methods for a particular organ, such as the collection of papers from the European Cooperation in Science and Technology (COST) Action PARENCHIMA [2]–[6].
These works can play an important role in raising the awareness of upcoming MRI techniques within radiology, and, more importantly, can be used as accepted guidelines for the original equipment manufacturers (OEMs) to implement said technologies following expert opinion. In addition, for all MRI techniques used as outcome measures or biomarkers within clinical trials, a key challenge in their clinical translation is the need to establish solid evidence of their clinical utility with enough rigour to satisfy regulatory bodies (FDA, EMA, etc…). For any MRI-based biomarker, this would mean to establish a clear clinical or biological validation, after the technical and small single-centre proof-of-concept studies usually performed by the ISMRM community. In general, the various stages needed for a biomarker to be accepted have been very clearly established [7], and the requirements for multi-centre clinical trials cannot be avoided. The first step in scaling up the evidence level is the creation of a more harmonised and standardised approach to data collection. It is therefore very important for these papers to have a clear focus, and to ensure that a true consensus can be achieved, as such “white papers” will de facto provide the technical bases used for the establishment of such wider scale clinical trials.
As part of the series of papers coming from the PARENCHIMA COST Action, a methodology paper was established [6], providing a very useful guide on how to write any future “white paper” within our field. In short, the following steps need to be taken:
1. The very first step is to define the remit and aims of the “white paper”, and to stick to it. This aim will need to be solidly established, as the writing of such a paper can be challenging, once many participants are giving their opinion on a topic. Note that in certain cases, some broader, more long terms objectives can also be set, as was the case for the PARENCHIMA COST Action, but this is not always necessary.
2. The resulting recommendations need to follow a series of principles, which, could be:
a. Promoting uptake of a technology
b. Building on the expertise of the core writing group
c. Promoting innovation within the field
d. Serving the context of use (i.e. making sure to focus on a particular topic or organ of interest, and ensuring that the recommendations are specific enough)
3. Formation of the expert panel and establishment of the panel leadership, usually composed of one junior and one senior members, who could become the first and last authors, respectively. This can be tricky, and a limited number of people should be at the heart of the recommendations, as it becomes rapidly impossible to incorporate every possible opinion into such a recommendation paper.
4. Definition of the context of work (which MRI methods / biomarkers are going to be addressed).
5. Systematic review of the literature on a topic, to make sure that the recommendations are not going to be too biased by the panel in charge.
6. Review of all technical protocols used in the literature
7. Establishment of a consensus based on the review of the literature and related protocols. One interesting method to reach a consensus is based on the DELPHI methods [8]. It is an iterative method that determines reliable consensus in practice guidelines on healthcare related matters and on topics where there is little or no definitive evidence and where opinion plays an important role. At each iteration, participants are invited to respond to a survey that will also include an anonymous summary of the previous responses. Discussion in a face-to-face meeting between all respondents usually follows one or several of the rounds until a final consensus can be achieved. In general, a threshold for achieving consensus needs to be established, which, in the case of the PARENCHIMA papers, was set to 75% of the panel members.
8. Reporting of the recommendations in peer-reviewed journals. Authorship is in this case an important point to solve right away, and not everyone within a community can become an author on such a paper. A process of “endorsement” can be used for people to signify their acknowledgment and acceptation of the recommendations. These have all been codified in the meantime, at least within the journals of the ISMRM.
9. Finally, it is important to consider the maintenance of such recommendations and their regular update, which can be done by the same group of people or not.

Acknowledgements

No acknowledgement found.

References

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