Abstract
Objective
To discuss two alternative approaches for complementing the body of direct evidence
from Randomized Controlled Trials (RCTs) when it is judged insufficient from a guideline
panel making recommendations. The approaches included expanding the evidence's body
to non-randomises studies on the population of interest or to RCTs on indirect populations.
Study Design and Setting
In this report, we adopt the perspective of an evidence review team developing guidelines
following the GRADE approach. Our experience is based on the development of two evidence-based
guidelines promoted by The Italian National Institute of Health (ISS) and focusing
on diagnosis and treatment of Autism Spectrum Disorders (ASD) in children/adolescents
and adults.
Results
We left panel members deciding case by case whether the direct evidence from RCTs
was sufficient or not and indicating which alternative to implement. This strategy
presented unanticipated challenges both from an organizational and methodological
standpoint.
Conclusion
We suggest an early-stage production of a research protocol to define the criteria
for expanding the body of evidence. These criteria should be informed by considerations
around the certainty in the evidence, the clinical applicability of the results, feasibility
and conflict of interest.
Keywords
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Article info
Publication history
Published online: August 21, 2021
Accepted:
August 17,
2021
Received in revised form:
July 30,
2021
Received:
February 21,
2021
Footnotes
Competing interest: None of the authors has competing interest to declare.
Funding: This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Author contribution: All the authors conceived the study and contributed to the data interpretation. Silvia Minozzi and Gian Paolo Morgano drafted the first version of the manuscript. All authors contributed to and approved the final version.
Identification
Copyright
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