JAMA surgery最新文献

Importance: Among cancer surgeries, patients requiring open radical cystectomy have the highest risk of red blood cell (RBC) transfusion. Prophylactic tranexamic acid (TXA) reduces blood loss during cardiac and orthopedic surgery, and it is possible that similar effects of TXA would be observed during radical cystectomy.

Objective: To determine whether TXA, administered before incision and for the duration of radical cystectomy, reduced the number of RBC transfusions received by patients up to 30 days after surgery.

Design, setting, and participants: The Tranexamic Acid During Cystectomy Trial (TACT) was a double-blind, placebo-controlled, randomized clinical trial with enrollment between June 2013 and January 2021. This multicenter trial was conducted in 10 academic centers. A consecutive sample of patients was eligible if the patients had a planned open radical cystectomy for the treatment of bladder cancer.

Intervention: Before incision, patients in the intervention arm received a loading dose of intravenous TXA, 10 mg/kg, followed by a maintenance infusion of 5 mg/kg per hour for the duration of the surgery. In the control arm, patients received indistinguishable matching placebo.

Main outcomes and measures: The primary outcome was receipt of RBC transfusion up to 30 days after surgery.

Results: A total of 386 patients were assessed for eligibility, and 33 did not meet eligibility. Of 353 randomized patients (median [IQR] age, 69 [62-75] years; 263 male [74.5%]), 344 were included in the intention-to-treat analysis. RBC transfusion up to 30 days occurred in 64 of 173 patients (37.0%) in the TXA group and 64 of 171 patients (37.4%) in the placebo group (relative risk, 0.99; 95% CI, 0.83-1.18). There were no differences in secondary outcomes among the TXA group vs placebo group including mean (SD) number of RBC units transfused (0.9 [1.5] U vs 1.1 [1.8] U; P = .43), estimated blood loss (927 [733] mL vs 963 [624] mL; P = .52), intraoperative transfusion (28.3% [49 of 173] vs 24.0% [41 of 171]; P = .08), or venous thromboembolic events (3.5% [6 of 173] vs 2.9% [5 of 171]; P = .57). Non-transfusion-related adverse events were similar between groups.

Conclusions and relevance: Results of this randomized clinical trial reveal that TXA did not reduce blood transfusion in patients undergoing open radical cystectomy for bladder cancer. Based on this trial, routine use of TXA during open radical cystectomy is not recommended.

Trial registration: ClinicalTrials.gov Identifier: NCT01869413.

Importance: Health care researchers, professionals, payers, and policymakers are increasingly relying on publicly available composite indices of area-level socioeconomic deprivation to address health equity. Implications of index selection, however, are not well understood.

Objective: To compare the performance of 2 frequently used deprivation indices using policy-relevant outcomes among Medicare beneficiaries undergoing 3 common surgical procedures.

Design, setting, and participants: This cross-sectional study examined outcomes among Medicare beneficiaries (65 to 99 years old) undergoing 1 of 3 common surgical procedures (hip replacement, knee replacement, or coronary artery bypass grafting) between 2016 and 2019. Index discriminative performance was compared for beneficiaries residing in tracts with high- and low-deprivation levels (deciles) according to each index. Analyses were conducted between December 2022 and August 2023.

Main outcomes and measures: Tract-level deprivation was operationalized using 2020 releases of the area deprivation index (ADI) and the social vulnerability index (SVI). Binary outcomes were unplanned surgery, 30-day readmissions, and 30-day mortality. Multivariable logistic regression models, stratified by each index, accounted for beneficiary and hospital characteristics.

Results: A total of 2 433 603 Medicare beneficiaries (mean [SD] age, 73.8 [6.1] years; 1 412 968 female beneficiaries [58.1%]; 24 165 Asian [1.0%], 158 582 Black [6.5%], and 2 182 052 White [89.7%]) were included in analyses. According to both indices, beneficiaries residing in high-deprivation tracts had significantly greater adjusted odds of all outcomes for all procedures when compared with beneficiaries living in low-deprivation tracts. However, compared to ADI, SVI resulted in higher adjusted odds ratios (adjusted odds ratios, 1.17-1.31 for SVI vs 1.09-1.23 for ADI), significantly larger outcome rate differences (outcome rate difference, 0.07%-5.17% for SVI vs outcome rate difference, 0.05%-2.44% for ADI; 95% CIs excluded 0), and greater effect sizes (Cohen d, 0.076-0.546 for SVI vs 0.044-0.304 for ADI) for beneficiaries residing in high- vs low-deprivation tracts.

Conclusions and relevance: In this cross-sectional study of Medicare beneficiaries, SVI had significantly better discriminative performance-stratifying surgical outcomes over a wider range-than ADI for identifying and distinguishing between high- and low-deprivation tracts, as indexed by outcomes for common surgical procedures. Index selection requires careful consideration of index differences, index performance, and contextual factors surrounding use, especially when informing resource allocation and health care payment adjustment models to address health equity.