Reporting Quality of Non-Pharmacological Interventions in Randomized Clinical Trials for Autoimmune Rheumatic Diseases: A Systematic Review

Autori

Scotuzzi Matteo (University of Rome Tor Vergata, Rome, Italy)

Luti Giovanni (University of Rome Tor Vergata, Rome, Italy)

Salamone Chiara (University of Rome Tor Vergata, Rome, Italy)

Gallotti Marco (University of Rome Tor Vergata, Rome, Italy)

De Maio Fernando (University of Rome Tor Vergata, Rome, Italy)

Pellicciari Leonardo (IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy)

Bonetti Francesca (University of Rome Tor Vergata, Rome, Italy)

Background and aims

Autoimmune rheumatic diseases (ARDs) are chronic inflammatory conditions, including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, systemic sclerosis, and psoriatic arthritis. Besides pharmacological treatment, non-pharmacological interventions are crucial but often poorly described in the literature, limiting their reproducibility. This study aimed to evaluate the quality of reporting of non-pharmacological interventions for ARDs using the TIDieR  and CERT checklists.

Methods

A systematic review  was conducted across Medline, CENTRAL, CINAHL, and Web of Science January 2025, using MeSH terms and relevant free-text words. Randomized controlled trials (RCTs) assessing non-pharmacological interventions in adult patients with ARDs were included. Two independent reviewers performed the literature search, screening process, data extrapolation, risk of bias (RoB) assessment (using RoB 2.0) and assessed the quality of experimental and control interventions reporting with TIDieR and CERT checklists. Spearman coefficient correlations (r_s) between TIDieR and CERT scores with Journals’ impact factor and publication year were calculated. Differences between the TIDieR and CERT scores and RoB assessment (i.e., low risk, some concern, high risk) were performed with a chi-squared test.

Results

Twenty-six RCTs were included, (rheumatoid arthritis=14 studies; ankylosing spondylitis=6; systemic sclerosis=4; psoriatic arthritis=2; systemic lupus erythematosus=0). Interventions included exercise, instrumental physiotherapy, balneotherapy and education. Regarding TIDieR, median score was 13.1 points out of 24; the most described items were Item#4 (89.6%), Item#8 (86.8%) and Item#1 (84.9% ); the least described were Item#10 (3.6%), Item#11 (27.4%) and Item#12 (33.0%). Regarding CERT, median total score was 9.9 points out of 19; the most reported items were Item#13 (94.7%), Item#8 (89.5%) and Item#4 (79.0%); the least reported were Item#16a (3.0%), Item#7b (15.8% ) and Item#5 (34.2%). RoB assessment revealed 65% studies with high risk, 27 % with some concern, and 8 % with low risk. Moderate correlation was found between TIDieR and publication year (r_s=0.523), low correlation between the CERT and the publication year (r_s=0.175) and between the TIDieR and CERT and impact factor (r_s=0.074 and 0.205, respectively). No difference was found between TIDieR and CERT and RoB assessment (p>0.05).

Conclusion

The reporting of non-pharmacological interventions in the management of ARDs is inadequate, and clear evidence cannot be determined because of the significant heterogeneity and poor methodological quality. No clear relation was found between the methodological quality and the interventions’ reporting, but it seems that the TIDieR increases as the publication year increases. Future research should focus on improving intervention descriptions and methodological quality.

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