Persistent disparities between trauma center types in the management of children with high-grade blunt splenic injuries.

BACKGROUND: In the early 2000s, substantial variations were reported in the management of pediatric patients with blunt splenic injury (BSI). The purpose of this study was to assess the recent trends and disparities between different types of trauma centers. We hypothesized that there would be persistent disparities despite decreased trends in the rate of splenectomy. METHODS: This is a retrospective cohort study using the American College of Surgeons Trauma Quality Improvement Program database. We included patients (age ≤18 years) with high-grade BSI (Abbreviated Injury Scale 3-5) between 2014 and 2021. The patients were divided into three groups based on trauma center types (adult trauma centers [ATCs], mixed trauma centers [MTCs], and pediatric trauma centers [PTCs]). The primary outcome was the splenectomy rate. Logistic regression was performed to evaluate the association between trauma center types and clinical outcomes. Additionally, the trends in the rate of splenectomy at ATCs, MTCs, and PTCs were evaluated. RESULTS: A total of 6601 patients with high-grade BSI were included in the analysis. Overall splenectomy rates were 524 (17.5%), 448 (16.3%), and 32 (3.7%) in the ATC, MTC, and PTC groups, respectively. ATCs and MTCs had significantly higher splenectomy rates compared to PTCs (ATCs: OR = 5.72, 95%CI = 3.78-8.67, and p < 0.001 and MTCs: OR = 4.50, 95%CI = 2.97-6.81, and p < 0.001), while decreased trends in the splenectomy rates were observed in ATCs and MTCs (ATCs: OR = 0.92, 95%CI = 0.87-0.97, and p = 0.003 and MTCs: OR = 0.92, 95%CI = 0.87-0.98, and p = 0.013). CONCLUSIONS: This study suggested persistent disparities between different trauma center types in the management of children with high-grade BSI.

Recent Changes in the Management of High-Grade Blunt Pancreatic Injury in Children: A Nationwide Trend Analysis.

BACKGROUND: The optimal management of pediatric patients with high-grade blunt pancreatic injury (BPI) involving the main pancreatic duct remains controversial. This study aimed to assess the nationwide trends in the management of pediatric high-grade BPI at pediatric (PTC), mixed (MTC), and adult trauma centers (ATC). METHODS: This is a retrospective observational study of the National Trauma Data Bank. We included pediatric patients (age ≤16 years) sustaining high-grade BPI (Abbreviated Injury Scale ≥3) from 2011-2021. Patients who did not undergo pancreatic operation were categorized into the non-operative management (NOM) group. Trauma centers were defined as PTC (level I/II pediatric only), MTC (level I/II adult and pediatric), and ATC (level I/II adult only). Primary outcome was the proportion of patients undergoing NOM, and secondary outcomes included the use of endoscopic retrograde cholangiopancreatography (ERCP) and in-hospital mortality. A Cochran-Armitage test was used to analyze the trend. RESULTS: A total of 811 patients were analyzed. The median age was 9 years (interquartile range [IQR]: 6-13), 64% were male, and the median injury severity score was 17 (IQR: 10-25). During the study period, there was a significant upward linear trend in the use of NOM and ERCP among the overall cohort (range 48%-66%; Ptrend =0.033, range 6.1%-19%; Ptrend =0.030, respectively). The significant upward trend for NOM was maintained in the subgroup of patients at PTC and MTC (Ptrend =0.037), while no significant trend was observed at ATC (Ptrend =0.61). There was no significant trend in in-hospital mortality (Ptrend =0.38). CONCLUSION: For the management of pediatric patients with high-grade BPI, this study found a significant trend toward increasing use of NOM and ERCP without mortality deterioration, especially at PTC and MTC.

Association of Contrast Extravasation Grade With Massive Transfusion in Pediatric Blunt Liver and Spleen Injuries: A Multicenter Retrospective Cohort Study.

BACKGROUND: This study aimed to assess whether the grade of contrast extravasation (CE) on CT scans was associated with massive transfusion (MT) requirements in pediatric blunt liver and/or spleen injuries (BLSI). METHODS: This multicenter retrospective cohort study included pediatric patients (≤16 years old) who sustained BLSI between 2008 and 2019. MT was defined as transfusion of all blood products ≥40 mL/kg within the first 24 h of admission. Associations between CE and MT requirements were assessed using multivariate logistic regression analysis with cluster-adjusted robust standard errors to calculate the adjusted odds ratio (AOR). RESULTS: A total of 1407 children (median age: 9 years) from 83 institutions were included in the analysis. Overall, 199 patients (14 %) received MT. CT on admission revealed that 54 patients (3.8 %) had CE within the subcapsular hematoma, 100 patients (7.1 %) had intraparenchymal CE, and 86 patients (6.1 %) had CE into the peritoneal cavity among the overall cohort. Multivariate analysis, adjusted for age, sex, age-adjusted shock index, injury severity, and laboratory and imaging factors, showed that intraparenchymal CE and CE into the peritoneal cavity were significantly associated with the need for MT (AOR: 2.50; 95 % CI, 1.50-4.16 and AOR: 4.98; 95 % CI, 2.75-9.02, respectively both p < 0.001). The latter significant association persisted in the subgroup of patients with spleen and liver injuries. CONCLUSION: Active CE into the free peritoneal cavity on admission CT was independently associated with a greater probability of receiving MT in pediatric BLSI. The CE grade may help clinicians plan blood transfusion strategies. LEVEL OF EVIDENCE: Level 4; Therapeutic/Care management.

Association Between Whole Blood Transfusion and Mortality Among Injured Pediatric Patients.

OBJECTIVE: To assess the association between whole blood (WB) and mortality among injured children who received immediate blood transfusion. BACKGROUND: The use of WB for transfusion therapy in trauma has been revisited, and recent studies have reported an association between WB and improved survival among adults. However, evidence of a similar association lacks in children. METHODS: We performed a retrospective cohort study from the ACS-TQIP between 2020 and 2021. Patients were aged ≤16 years and had immediate blood transfusion within 4 hours of hospital arrival. Survival at 24 hours and 30 days were compared after creating 1:1 propensity-score matched cohorts, matching for demographics, injury type, vital signs on admission, trauma severity scores, hemorrhage control procedures, hospital characteristics, and the need for massive transfusion. RESULTS: A total of 2,729 patients were eligible for analysis. The median age was 14 years (interquartile range: 8-16 y); 1,862 (68.2%) patients were male; and 1,207 (44.2%) patients were White. A total of 319 (11.7%) patients received WB. After a 1:1-ratio propensity score matching, 318 matched pairs were compared. WB transfusion was associated with improved survival at 24 hours, demonstrating a 42% lower risk of mortality (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.34-0.98; P =0.042) Similarly, the survival benefit associated with WB transfusion remained consistent at 30 days (HR, 0.65; 95% CI, 0.46-0.90; P =0.011). CONCLUSIONS: The use of WB was associated with improved survival among injured pediatric patients requiring immediate transfusion.

Detection bias in open-label trials of anticancer drugs: a meta-epidemiological study.

OBJECTIVES: In anticancer clinical trials, particularly open-label trials, central reviewers are recommended to evaluate progression-free survival (PFS) and objective response rate (ORR) to avoid detection bias of local investigators. However, it is not clear whether the bias has been adequately identified, or to what extent it consistently distorts the results. Therefore, the objective of this study was to evaluate the detection bias in oncological open-label trials by confirming whether local investigators overestimate the PFS and ORR compared with the findings of central reviewers. DESIGN: Meta-epidemiological study. DATA SOURCES: MEDLINE via PubMed from 1 January 2010 to 30 June 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Open-label, parallel-group superiority, randomised trials of anticancer drugs that adjudicated PFS or ORR by both central reviewers and local investigators. REVIEW METHODS: We assessed the values for the same outcome (PFS and ORR) adjudicated by both central reviewers and local investigators. A random-effects model was used to estimate the ratio of HR (RHR) for PFS and the ratio of OR (ROR) for ORR between central reviewers and local investigators. An RHR lower than 1 and an ROR higher than 1 indicated an overestimation of the effect estimated by local investigators. RESULTS: We retrieved 1197 records of oncological open-label trials after full-text screening. We identified 171 records (PFS: 149 records, ORR: 136 records) in which both central reviewers and local investigators were used, and included 114 records (PFS: 92 records, ORR: 74 records) for meta-analyses. While the RHR for PFS was 0.95 (95% CI 0.91 to 0.98), the ROR of ORR was 1.00 (95% CI 0.91 to 1.09). The results remained unchanged in the prespecified sensitivity analysis. CONCLUSIONS: This meta-epidemiological study found that overestimation of local investigators has a small impact on evaluating PFS and ORR in oncological open-label trials. However, a limitation of this study is that it did not include data from all trials; hence, the results may not fully evaluate detection bias. The necessity of central reviewers in oncological open-label trials needs to be assessed by further studies that overcome this limitation. TRIAL REGISTRATION NUMBER: CTR-UMIN000044623.

Combined stepladder incision and Sistrunk procedure for en bloc resection of supraclavicular thyroglossal duct cysts.

The accurate diagnosis and therapeutic strategies of thyroglossal duct cysts (TGDCs) are challenging for surgeons if the opening with exudate is far from the hyoid bone. A 7-year-old boy presented with a right supraclavicular mass and persistent pus. Ultrasonography and magnetic resonance imaging revealed the fistula to the hyoid bone. Suspecting a TGDC, we combined the stepladder incision technique and the Sistrunk procedure. The first skin incision cut through the opening in a spindle shape, and the second incision was made in the skin just above the hyoid bone. This combined technique allowed en bloc resection of the TGDC and the hyoid bone to the base of the tongue. Cervical masses are commonly encountered in surgical clinics, and even distant openings off the midline must be considered in the differential diagnosis of TGDCs. This treatment strategy is essential for preventing the recurrence of TGDCs and ensures optimal cosmetic outcomes.

Management of Perforated Sigmoid Colon Cancer in an Incarcerated Inguinal Hernia Using a Combined Abdominal and Inguinal Approach.

The ideal management of perforated colorectal cancer in the hernia sac remains a challenge for general surgeons. We report such a case requiring a combined-incision surgical approach and two-stage operation. A male patient in his 80s presented with fatigue and a bulge in his left groin. Contrast-enhanced CT scan revealed a sigmoid colon perforation within the left inguinal hernia sac. A combination of midline abdominal and inguinal incisions was performed for the iliopubic tract repair and Hartmann procedure. Six months later, the recurrent inguinal hernia was repaired using the Kugel mesh. The treatment strategy for colonic perforation into the inguinal hernia remains nonstandardized, compared to those for nonperforated cases. Combined inguinal and midline abdominal incisions might be necessary for infected lesion removal and colon mesentery resection; using mesh to repair hernia is a rare option. Hernia repair using mesh can be performed in two stages when recurrence occurs.

Proportion attributable to contextual effects in general medicine: a meta-epidemiological study based on Cochrane reviews.

OBJECTIVES: Our objectives were to examine the magnitude of the proportion attributable to contextual effects (PCE), which shows what proportion of the treatment arm response can be achieved by the placebo arm across various interventions, and to examine PCE variability by outcome type and condition. DESIGN: We conducted a meta-epidemiological study. SETTING: We searched the Cochrane Database of Systematic Reviews with the keyword 'placebo' in titles, abstracts and keywords on 1 January 2020. PARTICIPANTS: We included reviews that showed statistically significant beneficial effects of the intervention over placebo for the first primary outcome. MAIN OUTCOME MEASURES: We performed a random-effects meta-analysis to calculate PCEs based on the pooled result of each included review, grouped by outcome type and condition. The PCE quantifies how much of the observed treatment response can be achieved by the contextual effects. PUBLIC AND PATIENT INVOLVEMENT STATEMENT: No patient or member of the public was involved in conducting this research. RESULTS: We included 328 out of 3175 Cochrane systematic reviews. The results of meta-analyses showed that PCEs varied greatly depending on outcome type (I2=98%) or condition (I2=98%), but mostly lie between 0.40 and 0.95. Overall, the PCEs were 0.65 (95% CI 0.59 to 0.72) on average. Subjective outcomes were 0.50 (95% CI 0.41 to 0.59), which was significantly smaller than those of semiobjective (PCE 0.78; 95% CI 0.72 to 0.85) or objective outcomes (PCE 0.94; 95% CI 0.91 to 0.97). CONCLUSIONS: The results suggest that much of the observed benefit is not just due to the specific effect of the interventions. The specific effects of interventions may be larger for subjective outcomes than for objective or semiobjective outcomes. However, PCEs were exceptionally variable. When we evaluate the magnitude of PCEs, we should consider each PCE individually, for each condition, intervention and outcome in its context, to assess the importance of an intervention for each specific clinical setting.

Therapeutic strategies for pseudoaneurysm following blunt liver and spleen injuries: A multicenter cohort study in the pediatric population.

BACKGROUND: Little guidance exists for the treatment of pseudoaneurysm (PA) following pediatric blunt liver and/or spleen injuries (BLSIs). We aimed to describe the incidence of delayed PA development and the subsequent clinical course of PA in pediatric BLSIs. METHODS: This multicenter retrospective cohort study from Japan included pediatric patients (16 years and younger) who sustained BLSIs from 2008 to 2019. The cohort was divided into four groups based on hemostatic intervention within 48 hours of admission, namely, nonoperative management (NOM), NOM with interventional radiology (IR), operative management (OM), and combined IR/OM. Descriptive statistics were used to describe the incidence of delayed PA among the groups and to characterize the clinical course of any PAs. RESULTS: A total of 1,407 children (median age, 9 years) from 83 institutions were included. The overall number (incidence) of cases of delayed PA formation was 80 (5.7%), and the number with delayed PA rupture was 16 cases (1.1%) in the entire cohort. Patients treated with NOM (1,056), NOM with IR (276), OM (53), and combined IR/OM (22) developed 43 (4.1%), 32 (12%), 2 (3.8%), and 3 (14%) delayed PAs, respectively. Among patients who developed any PAs, 39% of patients underwent prophylactic IR for unruptured PA, while 13% required emergency angioembolization for delayed PA rupture, with one ruptured case requiring total splenectomy. At least 45% of patients experienced spontaneous resolution of PA without any interventions. CONCLUSION: Our results suggest that the risk of delayed PA still exists even after acute phase IR as an adjunct to NOM for BLSIs in children, indicating the necessity of a period of further observation. While endovascular interventions are usually successful for PA management, including rupture cases, given the high incidence of spontaneous resolution, the ideal management of PA remains to be investigated in future studies. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Which factors influence the decision to perform Hartmann's reversal in various causative disease situations? A retrospective cohort study between 2006 and 2021.

AIM: Our aim was to investigate the predictive factors for Hartmann's reversal and to describe the differences in the rates and timings of Hartmann's reversal for various causative diseases. METHOD: In this multicentre retrospective cohort study patients who underwent Hartmann's procedure (HP) between 2006 and 2018 were enrolled. To describe the demographic patterns of Hartmann's reversal through to 2021, we analysed the cumulative incidence rate of Hartmann's reversal over time based on the Kaplan-Meier failure estimate. Multivariable Cox proportional hazard analysis was performed with cluster-adjusted robust standard errors to calculate hazard ratios (HRs) for the assessment of variables associated with colostomy reversal. RESULTS: Of 250 patients who underwent the index HP and survived to discharge, 112 (45%) underwent subsequent Hartmann's reversal (36% for malignant and 51% for benign disease). The causative diseases with the highest probability of colostomy reversal were trauma (85%) and diverticular disease (73%). Conversely, colostomy reversal was performed in only 16% for colonic volvulus and 17% for bowel ischaemia. Home discharge after index HP (HR 5.22, 95% CI 3.31-8.23) and a higher body mass index (HR 1.03, 95% CI 1.01-1.04) were associated with a higher probability of Hartmann's reversal, whereas older age, malignant disease and a history of cardiovascular and psychoneurological diseases were independently associated with a lower probability of colostomy reversal. CONCLUSION: The probability and timing of Hartmann's reversal varied considerably with the surgical indications for colostomy creation. Our results could help surgeons counsel patients and their families regarding stoma closure surgery to set realistic expectations.

Intrauterine intestinal volvulus without malrotation presenting neonatal abdominal compartment syndrome.

INTRODUCTION: Fetal intestinal volvulus without malrotation is extremely rare, and early prenatal diagnosis is challenging because the signs and symptoms are non-specific. However, without proper management, it can cause massive bowel necrosis. PRESENTATION OF CASE: A woman experienced a dilated fetal bowel at 34 weeks of pregnancy and noticed a decrease in fetal movements at 36 weeks; however, she did not visit a hospital. Her newborn developed severe abdominal distension and was diagnosed with neonatal abdominal compartment syndrome with respiratory distress immediately after emergency caesarean section at 36 weeks and 5 days of pregnancy. The neonate underwent emergency exploratory laparotomy. This revealed a volvulus of the small bowel with extensive necrosis and no findings of congenital malrotation. While the patient required massive necrotic bowel resection, 80 cm of the small intestine was preserved. DISCUSSION: Fetal intestinal volvulus without malrotation can cause abdominal compartment syndrome with rapid respiratory distress. Therefore, it should be considered in the differential diagnosis of fetal intestinal dilatation. Volvulus exacerbation risk increases from 30 weeks of pregnancy to late preterm delivery. However, the time lag between the mother's awareness of decreased fetal movement and caesarean section makes early diagnosis challenging, resulting in a life-threatening condition for the neonate. CONCLUSION: When a fetal ultrasound examination shows intestinal dilatation between gestational week 30 and late preterm, the mother must be fully informed about the possibility that the foetus has intestinal volvulus and the potential risk of massive fetal intestinal necrosis.

Inadequate reporting of adjudicators in open-label trials of anticancer drugs between 2017 and 2021: a methodological review.

OBJECTIVES: In open-label trials, the details of the adjudicators are essential to evaluate the risk of detection bias. We aimed to describe how the adjudicators of progression-free survival (PFS) and objective response rate (ORR) have been reported in open-label trials of anticancer drugs. STUDY DESIGN AND SETTING: A literature search was conducted using MEDLINE via PubMed. We included open-label, parallel-group superiority randomized trials that investigated the PFS and ORR of anticancer drugs for solid tumors. After screening based on the titles and abstracts, 200 articles were randomly selected from 2017 to 2021. The researchers independently checked the eligibility and collected the adjudicators' information in the protocol, registry, and original article. RESULTS: One hundred fifty five studies reported the PFS and ORR. Approximately half of the studies did not report adjudicators (47.7% in PFS and 47.6% in ORR) in the published articles. The inconsistency between the protocol/registry and the published article was 31.0% for PFS and 33.5% for ORR. The prespecified outcomes were not reported in 5.2% of the studies evaluating PFS and 4.5% evaluating ORR. CONCLUSION: This methodological review found that adjudicators were poorly and inconsistently reported between the protocol/registry and the final publication in open-label trials of anticancer drugs.

High variability in results and methodological quality among overlapping systematic reviews on the same topics in surgery: a meta-epidemiological study.

BACKGROUND: Redundant publication of systematic reviews and meta-analyses (SRs/MAs) on the same topic presents an increasing burden for clinicians. The aim of this study was to describe variabilities in effect size and methodological quality of overlapping surgery-related SRs/MAs and to investigate factors associated with their postpublication citations. METHODS: PubMed/MEDLINE was searched to identify SRs/MAs of RCTs on thoracoabdominal surgeries published in 2015. Previous SRs/MAs on the same topics published within the preceding 5 years (2011-2015) were identified and 5-year citation counts (through to 2020) were evaluated. Discrepancies in pooled effect sizes and their methodological quality using A Measurement Tool to Assess Systematic Reviews (AMSTAR) among overlapping SRs/MAs were assessed. The SR/MA-level factors associated with 5-year citation counts were explored, using a mixed-effects regression model with a random intercept for surgical topics. RESULTS: A total of 57 surgery-related SRs/MAs (48 topics) published in 2015 were identified, and 146 SRs/MAs had overlapping publications on 29 topics (60.4 per cent of all topics) in the preceding 5 years. There was considerable variability in methodological quality of SRs/MAs and coverage probability for relevant RCTs, resulting in discrepant effect size estimates for the same topic. High quality (AMSTAR score 8-11) was independently associated with higher 5-year citation counts (coefficient = 32.82; 95 per cent c.i. 15.63 to 50.02; P < 0.001). CONCLUSION: Overlapping SRs/MAs with high variability in results and methodological quality were common in surgery. A high-quality SR/MA score was an independent predictor of more frequent citations. Researchers and journal editors should concentrate their efforts on limiting publications to higher-quality reviews.

Laparoscopic subtotal cholecystectomy after percutaneous transhepatic gallbladder drainage for grade II or III acute cholecystitis.

BACKGROUND: Severe adhesions and fibrosis between the posterior wall of the gallbladder and liver bed often render total cholecystectomy after percutaneous transhepatic gallbladder drainage (PTGBD) difficult, leading to high open conversion rates. Since the publication of Tokyo Guidelines 2018 (TG18), our policy has shifted from open conversion to subtotal cholecystectomy (SC) when total laparoscopic cholecystectomy for difficult cases of cholecystitis is not feasible. Recently, SC has been frequently applied as bailout surgery for complicated cholecystitis. Nonetheless, the efficacy and validity of laparoscopic SC after PTGBD remain unclear. This study aimed to evaluate the safety and feasibility of laparoscopic SC after PTGBD for grade II or III acute cholecystitis (AC) by comparing two periods of altered surgical strategies. METHODS: This retrospective cohort study was conducted between January 2013 and December 2020. A total of 44 eligible patients with grade II or III AC were divided according to the time of cholecystitis onset into the pre-TG18 group (2013-2017, n = 17) and post-TG18 group (2018-2020, n = 27). Patients' background demographics, surgical method, surgical results, and postoperative complications were compared. RESULTS: The interval between PTGBD and surgery was significantly longer in the post-TG18 group than in the pre-TG18 group (15 [interquartile range: 9-42] days vs. 8 [4-11] days; P = 0.010). The frequency of laparoscopic cholecystectomy significantly increased from 52.9% in the pre-TG18 group to 88.9% in the post-TG18 group (P = 0.007), whereas the frequency of SC was 23.5% and 40.7%, respectively, which showed no statistically significant difference (P = 0.241). However, the rate of laparoscopic SC significantly increased from 0 to 90.9% among 15 SC cases, whereas the rate of open SC significantly plummeted from 100 to 9.1% (P = 0.001). Significant differences in the operative time, amount of intraoperative bleeding, and incidence of postoperative complications (wound infection and subhepatic abscess) were not observed. Mortality, bile leakage, and bile duct injury did not occur in either group. CONCLUSIONS: For grade II or III AC after PTGBD, aggressive adoption of SC increased the completion rate of laparoscopic surgery. Laparoscopic SC is a safe and feasible treatment option.

Determining the optimal surgical timing of fulminant Clostridium difficile colitis by using four objective factors and computed tomography findings: A case report.

INTRODUCTION AND IMPORTANCE: Clostridium difficile colitis is increasingly seen in everyday clinical situations, and most cases are treated with antibiotics. Fulminant C. difficile colitis (FCDC) is rare; however, it is extremely virulent, and understanding its appropriate surgical treatment is critical. The surgical timing is controversial because of the lack of concrete decision-making factors. We report a case of FCDC with a favourable outcome, which was achieved by using four objective factors and computed tomography (CT) findings. CASE PRESENTATION: A patient with head trauma developed pneumonia at 2 days post-admission. He was prescribed with antibiotics. Fever and leucocytosis persisted on hospital day 10. Clostridium was detected in the stool on day 12, and metronidazole was administered. His condition did not improve; thus, he was started on vancomycin on day 14. The marked deterioration in the four laboratory parameters (white blood cell, albumin [Alb], creatinine, and body temperature) on day 15 and CT findings contributed to the decision to perform emergency subtotal colectomy and ileostomy. His condition improved dramatically postoperatively. CLINICAL DISCUSSION: Many factors of FCDC are already suggested for surgical intervention in the guidelines; however, they are often seen at the late stage of FCDC. Early detection of FCDC is the key to favourable surgical outcome. Following the trend of these objective factors guides in making appropriate surgical decisions. CONCLUSION: Focusing on the four objective factors and CT findings of FCDC could help surgeons detect FCDC at an early stage and decide the optimal surgical timing.

The use of warm fresh whole blood transfusion in the austere setting: A civilian trauma experience.

BACKGROUND: Hemostatic resuscitation strategy using blood components with a balanced ratio is adopted in the civilian trauma setting. However, there is usually limited availability of blood components in the austere setting. Warm fresh whole blood (WFWB) has been used for trauma patients with life-threatening hemorrhage necessitating massive transfusions in the Okinawa Islands, Japan. The purpose of this study was to evaluate the safety and feasibility of WFWB use in the austere civilian trauma setting. METHODS: We conducted a retrospective cohort study between January 1999 and June 2019, including trauma patients who received WFWB within 24 hours of admission. Immediately after WFWB was collected from blood donors, the sample was typed and screened for transmissible infectious diseases. Approximately half of the study population received irradiated WFWB to prevent graft versus host disease. We evaluated the incidence of transfusion-associated adverse events. Transfusion requirements and patient outcomes were compared between early and late WFWB use. RESULTS: A total of 28 patients from three civilian institutions were eligible. Of those, 93% sustained blunt trauma. The median Injury Severity Score was 37 (interquartile range, 32-49). All patients required operative hemostatic intervention, and half of the patients required both operative and endovascular hemostatic interventions. Patients received a median of 1,800 mL WFWB transfusions from seven volunteer blood donors. None of our subjects developed hemolytic reactions, transmissible infectious diseases, or graft versus host disease. Early WFWB use (within 4 hours of admission) was associated with a significant reduction in platelet transfusion requirement compared with the late WFWB group in univariate analysis (16 units vs. 47 units, p = 0.002). CONCLUSION: Warm fresh whole blood use is safe and feasible in an austere civilian trauma setting. Prospective studies with larger cohorts are necessary to determine whether early WFWB use will affect patient outcomes, transfusion requirement, and treatment cost. LEVEL OF EVIDENCE: Therapeutic, Level IV.

Association between contrast extravasation on computed tomography scans and pseudoaneurysm formation in pediatric blunt splenic and hepatic injury: A multi-institutional observational study.

PURPOSE: We aimed to examine the association between contrast extravasation (CE) on initial computed tomography (CT) scan and pseudoaneurysm (PSA) development in pediatric blunt splenic and/or liver injury. METHODS: We conducted a multi-institutional retrospective study in cases of blunt splenic and/or hepatic injury who underwent an initial attempt of nonoperative management. A logistic regression model was used to compare PSA formation and CE on initial CT scan, and the area under the receiver operating characteristic curve (AUC) with and without CE was used to assess the predictive performance of CE for PSA formation. RESULTS: Of 236 cases enrolled from 10 institutions, PSA formation was observed in 17 (7.2%). Multivariate analysis showed a significant association between CE on initial CT scan and increased incidence of PSA formation (odds ratio, 4.96; 95% confidence interval, 1.37-18.0). There was no statistically significant association between the grade of injury and PSA formation. The AUC improved from 0.75 (0.64-0.87) to 0.80 (0.70-0.91) with CE. CONCLUSION: Active CE on initial CT scan was an independent predictor of PSA formation. Selective use of follow-up CT in children who showed CE on initial CT may provide early identification of PSA formation, regardless of injury grade. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology: A Systematic Review and Quantitative Analysis.

Importance: Progression-free survival (PFS) has become a commonly used outcome to assess the efficacy of new cancer drugs. However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit. Objective: To evaluate the association between PFS and health-related quality of life (HRQoL) in oncology through a systematic review and quantitative analysis of published randomized clinical trials. Eligible trials addressed oral, intravenous, intraperitoneal, or intrapleural chemotherapy or biological treatments, and reported PFS or health-related quality of life. Data Sources: For this systematic review and quantitative analysis of randomized clinical trials of patients with cancer, we searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 2000, through May 4, 2016. Study Selection: Paired reviewers independently screened citations, extracted data, and assessed risk of bias of included studies. Data Extraction and Synthesis: We examined the association of difference in median PFS duration (in months) between treatment groups with difference in global, physical, and emotional HRQoL scores between groups (standardized to a range of 0-100, with higher scores representing better HRQoL) using weighted simple regressions. Main Outcome and Measure: The association between PFS duration and HRQoL. Results: Of 35 960 records screened, 52 articles reporting on 38 randomized clinical trials involving 13 979 patients across 12 cancer types using 6 different HRQoL instruments were included. The mean (SD) difference in median PFS between the intervention and the control arms was 1.91 (3.35) months. The mean (SD) differences in change of HRQoL adjusted to per-month values were -0.39 (3.59) for the global domain, 0.26 (5.56) for the physical domain, and 1.08 (3.49) for the emotional domain. The slope of the association between the difference in median PFS and the difference in change for global HRQoL (n = 30 trials) was 0.12 (95% CI, -0.27 to 0.52); for physical HRQoL (n = 20 trials) it was -0.20 (95% CI, -0.62 to 0.23); and for emotional HRQoL (n = 13 trials) it was 0.78 (95% CI, -0.05 to 1.60). Conclusions and Relevance: We failed to find a significant association between PFS and HRQoL in cancer clinical trials. These findings raise questions regarding the assumption that interventions prolonging PFS also improve HRQoL in patients with cancer. Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure HRQoL directly and accurately, ensuring adequate duration and follow-up.