Few ACR-, EULAR-endorsed guidelines backed up by head-to-head randomized clinical trials
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Fewer than one in six guidelines put forth by the American College of Rheumatology and EULAR are backed up by head-to-head, randomized clinical trials, according to data published in ACR Open Rheumatology.
“This study was brought about by noticing a decline in comparative efficacy research being conducted in rheumatology,” Katie Henry, BS, a medical student at the Medical College of Wisconsin, told Healio. “This sparked a curiosity if this decline has impacted how clinical practice guideline recommendations are informed.”
To investigate the level at which randomized clinical trials (RCTs) inform the guidelines put forth by the ACR and EULAR, Henry and colleagues conducted searches of the ACR and EULAR official websites. The searches were conducted on June 12, 2021, and guidelines were included in the analysis if they were published between Jan. 1, 2017, and June 12, 2021.
The researchers excluded published guidelines if a more recent version had since been published, or if they did not use the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system, for ACR, or the Oxford Centre for Evidence based Medicine Standards (OCEBM) system, for EULAR. The researchers also conducted a literature review to catch any guidelines that were not published on the ACR or EULAR websites.
A single researcher extracted data from each included guideline, including the PubMed identifier, title, disease state, endorsement and year of publication. Cited references were searched for RCTs, which were classified as head-to-head if they compared at least two different therapies. Included study designs were categorized into groups including conventional synthetic disease-modifying antirheumatic drugs, biologic and targeted DMARDs, NSAIDs, urate-lowering therapy and “other” vs. placebo or head-to-head, the researchers wrote.
Recommendations were extracted and included in the analysis if they included a level of evidence. Two reviewers independently assessed whether each recommendation was informed by a RCT.
The analysis included 15 ACR- and nine EULAR-endorsed guidelines, which together cited 609 RCTs and offered 481 recommendations. Among the referenced RCTs, 70.1% investigated biologic and synthetic targeted DMARDs, while just 28% employed a head-to-head design. According to the researchers, 2.8% and 28.9% of recommendations achieved a high level of evidence using the GRADE assessment or OCEBM methodology, respectively. Overall, the level of evidence was higher for recommendations informed by RCTs (P < .001) and head-to-head studies (P = .008).
“The main takeaway for rheumatologists is to understand that many guideline recommendations are not informed by comparative efficacy research, and that we should strive to encourage more comparative efficacy research in order to make more informed clinical decisions,” Henry said.
According to Susan M. Goodman, MD, who serves as the chair of the ACR guideline subcommittee, the findings presented are not surprising.
“We have not done the same analysis as the authors did, so we cannot comment on the percentage of RCTs in ACR guidelines,” Goodman said. “However, we agree that the number of RCTs available to us to use in guidelines is lower than we would like.”
“We would love to have more high-quality RCTs to include in our guideline work,” Goodman added. “However, our aim in these guidelines is to provide recommendations based on the best available evidence synthesized through a consensus process, while meeting the need of addressing common clinical dilemmas where the evidence is sparse.”
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