EULAR: Synovial tissue research should include biopsy details
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Biopsy details, including the operator’s training and any intra-articular steroids used prior to the procedure, should be reported in every study involving synovial tissue, according to new EULAR points to consider.
“The introduction of ultrasound guidance has enabled the development of minimally invasive biopsies allowing for an exponential interest for such procedures,” Aurelie Najm, MD, PhD, of the University of Glasgow College of Medical Veterinary and Life Sciences, told Healio.
“While more and more centers perform synovial biopsies, the way in which research results are reported in terms of biopsy procedure, tissue handling, quality check and experimental data remains highly variable,” Najm added. “This variation threatens the progress of our rapidly expanding field.”
To meet the need for uniformity in reporting and data analysis in synovial tissue research, Najm and colleagues assembled a task force of 25 members including 19 rheumatologists, one translational immunologist, two pathologists, one allied health professional and two patient representatives. The group developed research questions to help formulate the points to consider at a meeting in December 2020. In addition, Najm and colleagues performed a systemic literature review of papers relating to synovial tissue biopsy procedures.
The literature review included data on the procedures, their tolerability, outcomes, tissue handling, randomization, quality control and tissue outcomes. The task force held a second virtual meeting in May 2021, where they presented data from the literature review. The group formulated three overarching principles and nine points to consider. The manuscript was approved by every member of the task force and verified by the EULAR Executive Committee.
The overarching principles focus on biopsy conditions, tolerability and imaging options. They follow:
Single and sequential synovial biopsies, performed in aseptic conditions, are safe, well tolerated and can be conducted for both clinical and research purposes;
Synovial biopsies, whether conducted for clinical or research purposes, should be guided by imaging techniques, with arthroscopy and ultrasonography being the preferred guidance techniques; and
Ultrasound or arthroscopy can be used to guide the synovia biopsies without impacting the tolerability of the procedure or the minimal required tissue for meaningful analysis.
The nine points to consider include a focus on comprehensive reporting of the details of biopsies in every study, full study design definitions, the use of conventional disease activity measures, the use of clinical and contemporary imaging characteristics to evaluate generalization feasibility, and making full details and analysis available, according to the authors. They include:
Details of the biopsy procedures — including exclusion criteria, targeted joints, use of intra-articular steroids during or 4 weeks prior to the procedure, technique used, adverse events, machine/probe for ultrasound-guided procedures and arthroscopic equipment, and the operator’s experience — should be reported in the study;
Methods and results of the tissue quality assessment should be reported;
Methods of extraction and quantification should be defined in the study, and purity, quantity and quality of DNA/RNA should be reported;
Overarching clinical study design, including participants’ disease characteristics and treatments, must be defined in the study, to examine the generalizability and validity of the outcome; and
Tissue handling and processing methods must be reported, including numbers and size of fragments allocated randomly to each analytic, to ensure reproducibility.
“In this EULAR endorsed work, we propose a set of recommendations, created by a group of experts in the field — for clinicians, scientists, reviewers, editors and policymakers, among others — on minimal reporting requirements in synovial tissue research,” Najm said. “We believe this initiative will enable the field to progress in a robust and transparent manner over the coming years.”
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