Risk-of-bias assessment of the randomized clinical trials and systematic reviews on surgical treatments for breast cancer-related lymphedema: A mapping review.

Background: Breast cancer treatment is the principal cause of lymphedema in the upper extremities. Breast cancer-related lymphedema (BCRL) treatments were previously based on conservative therapy; surgical treatments are alternative options that could be highly beneficial, especially for patients who are not responsive to conservative therapy. The main aim of this study was to describe and critically assess the risk of bias of randomized clinical trials (RCTs) and systematic reviews (SRs) on surgical treatment for BCRL.

Methods: We conducted an evidence mapping review according to the methodology proposed by Global Evidence Mapping (GEM). An update was done for our previous systematic search in MEDLINE, EMBASE, CENTRAL (Cochrane), and Epistemonikos from the year 2000 onward. We assessed the risk of bias for the RCTs and SRs using the RoB-2 and ROBIS tools, respectively.

Results: Two surgical RCTs and eight SRs were found among the 47 surgical studies that met the eligibility criteria. The overall risk-of-bias assessments of these studies were rated as some concerns (six outcomes) and high risk (three outcomes) for the measured outcomes among the RCTs and as a high risk of bias (five studies) and low risk (three studies) for the included SRs.

Conclusions: The overall evidence in the literature on surgical treatment for BCRL is low, as there are few published RCTs and SRs, and the risk-of-bias assessment for the majority was rated as high risk of bias or with some concerns. High-quality studies are needed to improve evidence-based decision-making by surgeons and patients.