Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial.

BACKGROUND: Patients with breast cancer encounter difficulties in making surgical treatment decisions. Shared decision-making (SDM) with patient decision aids (PDAs) can minimize patients' decisional conflicts. However, the effect of PDAs in Asia remains inconclusive. This study investigated the effect of SDM assisted by PDAs on the decisional conflict of patients with breast cancer. METHODS: In this two-group, outcome assessor-blind, randomized controlled trial, 151 patients diagnosed as having breast cancer were assigned to the PDA (SDM with PDA) group or the standard (SDM without PDA) group. Demographic and clinical variables were analyzed to identify variables affecting the treatment choice. The patients' decision-making difficulties were evaluated using the four-item SURE scale during preoperative hospitalization, and decisional conflicts were examined using the five-item Decision Regret scale and Hospital Anxiety and Depression Scale (HADS) 1 month after surgery. RESULTS: The choice of breast conservation therapy and mastectomy did not significantly differ between the PDA and standard groups. The PDA group had a higher level of depression after making decisions (P = 0.029) than did the standard group. No significant difference in the total scores of the SURE scale and Decision Regret scale were noted between the groups. CONCLUSION: PDAs did not assist the patients with breast cancer in making breast surgery-related decisions. Clinicians should focus on SDM grounded in evidence-based medicine with care and help patients consider their individual preferences. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03105076; April 7, 2017 ( http://www. CLINICALTRIALS: gov ).

Outcomes of Sentinel Node Biopsy for Women with Breast Cancer After Neoadjuvant Therapy: Systematic Review and Meta-Analysis of Real-World Data.

BACKGROUND: Evidence on the accuracy of sentinel lymph node biopsy (SLNB) after neoadjuvant therapy (NAT) for patients with breast cancer is inconclusive. This study reviewed the real-world data to determine the acceptability of SLNB after NAT. METHODS: The study searched for articles in the PubMed, EMBASE, and Cochrane Library databases. The primary outcomes were the identification rate for sentinel lymph nodes (SLNs) and the false-negative rate (FNR) for SLNB. The study also evaluated the FNR in subgroups defined by tumor stage, nodal stage, hormone receptor status, human epidermal growth factor receptor-2 status, tumor response, mapping technique, and number of SLNs removed. RESULTS: The study retrieved 61 prospective and 18 retrospective studies with 10,680 initially cN± patients. The pooled estimate of the identification rate was 0.906 (95 % confidence interval [CI], 0.891-0.922), and the pooled FNR was 0.118 (95 % CI, 0.103-0.133). In subgroup analysis, the FNR was significantly higher for the patients with estrogen receptor (ER)-negative status and fewer than three SLNs removed. The FNR did not differ significantly between the patients with and those without complete tumor response. Among the patients with initial clinical negative axillary lymph nodes, the incidence of node metastasis was 26.8 % (275/1041) after NAT. CONCLUSION: Real-world evidence indicates that the FNR of SLNB after NAT in breast cancer is 11.8 %, exceeding only slightly the commonly adopted threshold of 10 %. The FNR is significantly higher for patients with ER-negative status and removal of fewer than three SLNs. Using a dual tracer and removing at least three SLNs may increase the accuracy of SLNB after NAT.