DISCUSSION
Guidelines are intended to review systematically the available evidence,
rate its validity, and distill the findings into easy to understand
recommendations that practitioners can follow. Many different
methodologies have been developed for this
purpose21,174,175 The GRADE method (Grading of
Recommendations Assessment, Development and
Evaluation)175, has been recently adopted by a number
of professional organizations for the development of guidelines, but we
did not choose it because it relies heavily on RCTs and systematic
observational studies that are not available in the literature on
EA-TEF.
We developed our recommendations on the basis of the Rand
Appropriateness Method24–26, offered certain
important advantages for the type of evidence we had available such as:
a) the responders do not have to accept positions they do not agree
with, in order to reach a consensus; b) disagreements are not
suppressed, thus reflecting more accurately the uncertainties and
variability that exist in the actual clinical practice; c) each item is
rated by all responders, and their responses carry the same weight (thus
preventing a single issue (or a single person) from dominating the
process; d) the anonymity of the responses allows the participants to
express their opinions more freely; and e) it provides timely feedback
by communicating the results of each round to the responders, allowing
them to compare their responses to others and potentially adjust them.
Our recommendations were based on the strength of the agreement among
the RCWG members. Thus, Level A recommendations refer to unanimous
adoption of specific interventions and care practices. Level B & C
recommendations reflect both the lack of evidence and actual
controversies on a specific topic, as well as the different areas of
expertise, skill mix, resource availability and hospital culture among
the RCWG’s representative institutions. This differs from other
consensus based methods that assign different weight on the evidence
depending on the design of the study, its size, the type of analysis
etc.)176.
As diagnostic methods improve and therapeutic interventions become more
precise, it is likely that many of the current recommendations will have
to be revised. In the meantime, the document provides a common approach
for the evaluation and management of these complex patients at levels
that can be provided by most practitioners and institutions. It may also
serve as the basis for multicenter collaborations that will eventually
provide a higher level of evidence.
ACKNOWLEDGMENTS
The authors would like to acknowledge the contribution of Dr. Michael
Rutter and Dr. Marlene Soma for their input in the development of the
original statements. We would also like to thank Drs. Frederic Gottrand,
Christophe Faure, Luigi dall’ Oglio, and Usha Krishnan for their
critical review of the manuscript.