Two-sided Fisher Exact Test Research Articles

The influence of migration on women’s satisfaction during pregnancy and birth: results of a comparative prospective study with the Migrant Friendly Maternity Care Questionnaire (MFMCQ)

Approximately 21% of Germany's inhabitants have been born abroad or are of direct descent of immigrants. A positive birth experience has an effect on a woman's mental health and her future family planning choices. While international studies showed that immigrant women are less satisfied with their birth experience, no such study has been conducted in Germany until now. At our center of tertiary care in Berlin, with approximately 50% immigrants among patients, pregnant women of at least 18years of age were offered participation in this study. A modified version of the Migrant Friendly Maternity Care Questionnaire (MFMCQ) designed by Gagnon et al. in German, English, French, Spanish, Arabic and Turkish was used. We compared non-immigrant women to immigrant women and women with direct descent of immigrants. For certain analysis, the latter two groups were included together under the category "migration background". During the study period, 184 non-immigrant, 214 immigrant women and 62 direct descendants of immigrants were included. The most frequent countries of origin were Syria (19%), Turkey (17%), and Lebanon (9%). We found a slight difference between groups regarding age (non-immigrants: mean 33years versus women with any migration background: mean 31) as well as parity with more non-immigrants delivering their first child. No difference in the satisfaction with care was observed between immigrant and any migration background groups (p ≥ 0.093 in the two-sided Fisher's exact test). At least 75.8% of all participating women reported complete satisfaction with care during labor, birth and after birth. Interestingly, the level of German language proficiency did not influence the immigrant patient's satisfaction with care. The study results show no difference regarding overall satisfaction with care during labor and birth despite a relevant language barrier. We are for the first time providing the MFMCQ in German and Turkish. Further future analyses on the impact of patient expectations on satisfaction with care will be conducted.

Body weight changes in young breast cancer survivors and associated predictors.

11574 Background: Weight gain after cancer diagnosis is common in cancer survivors and has been linked to increased treatment toxicity, poor quality of life, and increased risk of second cancers and overall mortality. Young breast cancer (BC) survivors may be especially susceptible to weight changes given the impact of treatments such as chemotherapy and hormonal therapy on menopausal status. Methods: We identified women with Stage 0-III breast cancer diagnosed at ≤40 years (y) between 2006-2016 from a multi-center prospective cohort study. Clinical data including self-reported pre-diagnosis and follow-up weights were obtained using baseline and follow-up patient surveys. Participants missing baseline weight, pregnant at diagnosis/within 1y of diagnosis or with BC recurrence within 1y were excluded; those pregnant or with BC recurrence between 1-3y from diagnosis were excluded from the 3y analysis. Menopausal status at baseline and treatment-related amenorrhea (TRA) in follow-up were defined by self-reported last menstrual period. Factors associated with weight gain (>5%) were evaluated using univariate two-sided Fisher's exact test. Results: At baseline, 1y and 3y post diagnosis, 956, 899 and 687 women were eligible for analysis respectively. Median age at diagnosis was 37y (17 - 40), 65% received endocrine therapy and 74% chemotherapy. Premenopausal status was verified in 94% at baseline. Mean BMI at baseline was 24.4 (SD 5.3) kg/m2; 20% (187/956) were overweight and 12% (116/956) obese. At 1y and 3y, mean BMI increased modestly to 24.7 (SD 5.6) and 24.9 (SD 5.2), respectively with weight gain (>5%) observed in 18% (164/899) and 13% (87/687) respectively. 37% (300/804) and 32% (196/615) of eligible premenopausal subjects experienced TRA at 1y and 3y, respectively. Receipt of chemotherapy, receipt of endocrine therapy and TRA were not associated with weight gain at any timepoint. Conclusions: In this large prospective cohort of young BC survivors, mean BMI increased only modestly over time. Self-reported weight gain was not associated with treatment and not exacerbated by TRA. Further analysis to understand the effects of physical activity and other predictors of weight gain in this population are ongoing.

Intra-rectal use of epinephrine in radiotherapy of prostate cancer.

Purpose: The aim of the study was to evaluate the feasibility and toxicity of intra-rectal epinephrine during prostatic radiotherapy.Materials and methods: A total of 34 patients with prostate cancer were randomized to receive daily intra-rectal epinephrine (4 mg in 40 mL, n=16) or placebo (40 mL normal saline, n=18) 5 min before daily radiotherapy. Physical examination including systolic blood pressure (SBP) and heart rate (HR) was performed before, 5 min after, and 20 min after intra-rectal use. Toxicities were graded using the Radiation Therapy Oncology Group standard. A two-sided Fisher's exact test was used to compare proportions between groups. A mixed-effects model was used to analyze multiple measurements of SBP and HR. Survival curves were calculated using the Kaplan–Meier method and compared between groups using the log-rank test.Results: All patients completed the protocol treatment and reported no cardiovascular symptoms after intra-rectal administration. There were no differences in SBP and HR between these two groups at any time point (before, 5 min after, and 20 min after epinephrine). At 5 weeks after the start of radiotherapy, the incidence of rectal toxicity≥grade 2 was 27.8% (5/18) for the control group versus 12.5% (2/16) for the epinephrine group, but was not statistically significant (p=0.4). There was no rectal toxicity≥grade 2 in these two groups beyond 2-year follow-up. The 5-year biochemical relapse-free survival was 75.0% and 72.2% for the epinephrine and control group, respectively.Conclusion: Results of this pilot randomized trial have demonstrated that intra-rectal administration of epinephrine is feasible and safe in prostatic radiotherapy. Its radio-protective effect warrants further investigation.

A retrospective analysis of referral patterns to a university oral medicine clinic

The aim of this study was to analyze referral patterns to a university-based oral medicine (OM) clinic and to identify access issues to OM care. A retrospective patient chart review on all OM specialists at the University of Alberta (Edmonton, Alberta, Canada) over a 1-year period was performed. Data collected included patient age and gender, referring clinician training and experience, reason and urgency of referral, provisional and final diagnosis, and the referral times. Proportions for data points were collected by using a 95% Wilson Score confidence interval. Two-sided Fisher's exact tests were performed for significant differences. In total, 924 patients were included. Dentists referred 81.4% of the cases, with the remaining cases referred by physicians. Patients traveled, on average, 55.44 km to the OM clinic, with a mean wait time of 105.5 days. White/red lesions were the most common referral reason (38%), with the tongue (21.8%) being the most common site of concern. There was no significant difference in the accuracy of provisional diagnoses between clinician types. Immune-mediated conditions were the most common final diagnosis. The referral patterns of dental and medical practitioners are similar, with mucosal lesions being the most common referral reason. In our study population, access to care was compromised by wait times and travel distances.

Real-World Outcomes with Bortezomib-Containing Regimens and Lenalidomide Plus Dexamethasone for the Treatment of Transplant Ineligible MM Patients: A Multi-Institutional Report from the National Myeloma Canada Research Network (MCRN) Database

Introduction: Bortezomib-containing regimens (BCRs) have been the standard frontline approach for the treatment of transplant ineligible multiple myeloma (TIMM) patients in Canada for many years. Based on recent randomized clinical trial results lenalidomide and dexamethasone (Ld) has become another provincially funded option in Canada in the same therapeutic space. We aimed to compare the effect of BCRs and Ld for the treatment of TIMM using the newly-formed Myeloma Canada Research Network Multiple Myeloma Database (MCRN-MM-DB) project. This web-based centralized platform can track and characterize real-world outcomes of patients treated at major Canadian institutions and includes both legacy data dating back to 2007 (from 4 centres) as well as ongoing prospective data collection (from 11 centres) analyzed up to 01/07/18. Patients and Methods: The primary objective was to assess the ORR, PFS and OS for TIMM patients treated with CyBorD/CyBorP, Ld, VMP or VD/VP, each given as reported previously but with dose-adjustments at the discretion of the treating physician to maintain patients on therapy. The two-sided Fisher exact test was used to test for differences between categorical variables. Survival curves were constructed according to the Kaplan-Meier method and compared using the log rank test; a p value of <0.05 was considered significant. Results: 842 TIMM patients were evaluated. Clinical characteristics are shown in Table 1. Median OS and PFS for the entire cohort were 54.1 and 20.4 months, respectively. ORR and ≥VGPR better rates were 83% and 52% for the entire cohort. A ≥VGPR rate of 53%, 46%, 56% and 51% were observed for patients treated with CyBorD/P, VMP, Ld and VD/VP, respectively (p=0.3). The median PFS was longer for Ld patients (25 months) compared to CyBorD/CyBorP, VMP and Vd/VP (19.3, 20.5 and 13.7 months, respectively), (p=0.03, Fig 1a); there was no significant difference in PFS between the 2 different alkylating-agent containing regimens when combined with bortezomib + steroids (CyBorD/P vs VMP, p =0.9). Median OS was 51, 59.5, 29.4 and 66.5 months for those patients treated with CyBorD/CyBorP, VMP, VD/VP and Ld, respectively (p=0.07, Fig 1b). When the OS and PFS for CyBorD/P (typically given for a fixed duration of 9 cycles) were compared with Ld in a subset analysis, the p-values were 0.08 and 0.008, respectively. Conclusions: 1) OS was not significantly different in patients treated with either a bortezomib-containing triplet that includes an alkylator + steroid or continuous Ld. 2) The BCR triplets and Ld were more efficacious than the bortezomib + steroid doublet (VD/VP) for both OS and PFS although, the small sample size and adverse factors, such as frailty and comorbidities, may have influenced the findings. 3) The results in the real-world setting, i.e., a median PFS in the range of 1.5-2 years and median OS of 4.5-5.5 years, confirm triplet-based BCRs and Ld as current valid standards of care for frontline therapy in TIMM. 5) This study confirms the utility of a large comprehensive national database to benchmark current results for comparison with newer regimens as they are introduced into the Canadian therapeutic landscape. [Display omitted] DisclosuresArleigh:Celgene: Honoraria; Janssen: Honoraria. Sebag:Janssen Inc.: Membership on an entity's Board of Directors or advisory committees; Amgen Canada: Membership on an entity's Board of Directors or advisory committees; Takeda Canada: Membership on an entity's Board of Directors or advisory committees; Celgene Canada: Membership on an entity's Board of Directors or advisory committees. Leblanc:Celgene Canada: Membership on an entity's Board of Directors or advisory committees; Janssen Inc.: Membership on an entity's Board of Directors or advisory committees; Amgen Canada: Membership on an entity's Board of Directors or advisory committees; Takeda Canada: Membership on an entity's Board of Directors or advisory committees. Louzada:Janssen: Honoraria; Celgene: Honoraria; amgen: Honoraria; pfizer: Honoraria. Venner:Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria; Takeda: Honoraria.

Long-Term Follow-up of SWOG S0816: Response-Adapted Therapy for Stage III/IV Hodgkin Lymphoma Demonstrates Limitations of PET-Adapted Approach

Long-Term Follow-up of SWOG S0816: Response-Adapted Therapy for Stage III/IV Hodgkin Lymphoma Demonstrates Limitations of PET-Adapted Approach

Surgical Treatment of Chronic Parotitis.

Introduction chronic parotitis (CP) is a hindering, recurring inflammatory ailment that eventually leads to the destruction of the parotid gland. When conservative measures and sialendoscopy fail, parotidectomy can be indicated. Objective to evaluate the efficacy and safety of parotidectomy as a treatment for CP unresponsive to conservative therapy, and to compare superficial and near-total parotidectomy (SP and NTP). Methods retrospective consecutive case series of patients who underwent parotidectomy for CP between January 1999 and May 2012. The primary outcome variables were recurrence, patient contentment, transient and permanent facial nerve palsy and Frey syndrome. The categorical variables were analyzed using the two-sided Fisher exact test. Alongside, an elaborate review of the current literature was conducted. Results a total of 46 parotidectomies were performed on 37 patients with CP. Near-total parotidectomy was performed in 41 and SP in 5 cases. Eighty-four percent of patients was available for the telephone questionnaire (31 patients, 40 parotidectomies) with a mean follow-up period of 6,2 years. Treatment was successful in 40/46 parotidectomies (87%) and 95% of the patients were content with the result. The incidence of permanent and transient facial nerve palsy was 0 (0%) and 12 (26.1%), respectively. Frey syndrome manifested in 20 (43.5%) patients. Neither this study nor careful review of the current literature resulted in evident difference between SP and NTP regarding the primary outcome variables. Conclusion parotidectomy is a safe and effective treatment for CP in case conservative therapy fails. There is no evidence of a distinct difference between SP and NTP regarding efficiency, facial nerve palsy or Frey syndrome.

Defining polytrauma by abbreviated injury scale ≥ 3 for a least two body regions is insufficient in terms of short-term outcome: A cross-sectional study at a level I trauma center

BackgroundPatients with polytrauma are expected to have a higher risk of mortality than the summation of expected mortality for their individual injuries. This study was designed to investigate the outcome of polytrauma patients, diagnosed by abbreviated injury scale (AIS) ≥ 3 for at least two body regions, at a level I trauma center. MethodsDetailed data of 694 polytrauma patients and 2104 non-polytrauma patients with an overall Injury Severity Score (ISS) ≥ 16 and hospitalized between January 1, 2009, and December 31, 2014 for treatment of all traumatic injuries, were retrieved from the Trauma Registry System. Two-sided Fisher exact or Pearson chi-square tests were used to compare categorical data. The unpaired Student t-test was used to analyze normally distributed continuous data, and the Mann–Whitney U-test was used to compare non-normally distributed data. Propensity-score matching in a 1:1 ratio was performed using NCSS software with logistic regression to evaluate the effect of polytrauma on in-hospital mortality. ResultsThere was no significant difference in short-term mortality between polytrauma and non-polytrauma patients, regardless of whether the comparison was made among the total patients (11.4% vs. 11.0%, respectively; p = 0.795) or among the selected propensity score-matched groups of patients following controlled covariates including sex, age, systolic blood pressure, co-morbidities, Glasgow Coma Scale scores, injury region based on AIS. ConclusionsPolytrauma defined by AIS ≥3 for at least two body regions failed to recognize a significant difference in short-term mortality among trauma patients.

Predictive Value of Schistocytes in Recurrence of Acquired Thrombotic Thrombocytopenic Purpura With Severe ADAMTS13 Deficiency at Discontinuation of Daily Therapeutic Plasma Exchange.

Acquired thrombotic thrombocytopenic purpura (TTP) is characterized by microangiopathic hemolytic anemia, thrombocytopenia, and commonly ADAMTS13 deficiency. Patients with TTP and severe ADAMTS13 deficiency have high risk of disease recurrence, yet the ability to predict which patients will have recurrence remains limited. We assessed whether the presence of persistent schistocytes in TTP patients with severe ADAMTS13 deficiency at the time of daily therapeutic plasma exchange (TPE) discontinuation was predictive of disease recurrence. We retrospectively reviewed the electronic medical records of all patients with a diagnosis of TTP treated with TPE at our university medical center between August 1991 and April 2013. Exacerbation was defined as disease recurrence within 30 days of cessation of daily TPE, and relapse was defined as disease recurrence >30 days after cessation of daily TPE. Comparisons were performed with a two-sided Fisher's exact test or χ2 test. Of the 46 total TTP patients eligible for analysis, nine had residual schistocytosis (20%), four of the nine (44%) had exacerbations, and two of the nine (22%) relapsed. Of the 37 patients without residual schistocytosis, 16 (43%) had exacerbations and 11 (30%) relapsed. There were no statistically significant differences in the exacerbation or relapse rates with or without residual schistocytosis (P = 1.00 and 1.00, respectively). Residual schistocytes after discontinuation of daily TPE were not uncommon. The persistence of schistocytes had poor sensitivity, specificity, and both positive and negative predictive values. After the initial diagnosis of TTP is made, there is no reason to continue documenting the presence or absence of schistocytes.

Hepatitis C virus (HCV) genotype 1 NS5A resistance-associated variants are associated with advanced liver fibrosis independently of HCV-transmission clusters

ObjectivesThe aim of the study was to characterize the differences in the frequencies of NS3 and NS5A resistance-associated variants (RAVs) among Polish therapy-naive genotype 1 (G1) hepatitis C virus (HCV)-monoinfected and human immunodeficiency virus (HIV)/HCV-coinfected patients including clustering patterns and association of RAV frequency with liver fibrosis. MethodsNS3/NS5A RAVs were identified by population sequencing in 387 directly acting antiviral treatment-naive G1-infected individuals (54 with genotype 1a (G1a) and 333 with genotype 1b (G1b)). Liver fibrosis was assessed based on histopathology or ultrasound elastography. Phylogenetic clusters were identified using maximum likelihood models. For statistics, chi-squared or two-sided Fisher's exact tests and multivariate logistic regression models were used, as appropriate. ResultsNS3 RAVs were found in 33.33% (18/54) for G1a and 2.62% (8/297) for G1b whereas NS5A variants were present in 5.55% (3/54) G1a and 9.31% (31/333) G1b sequences. Variations in NS5A 31 and 93 codon positions were found only in G1b (4.2% (14/333) for L31I/F/M and 5.39% (17/333) for Y93H). NS5A RAVs were more frequent among patients with advanced liver fibrosis (17.17% (17/99) for F3–F4 versus 6.94% (17/245) for F0–F2; p 0.004) or liver cirrhosis (20.34% (12/59) for F4 versus 7.72% (22/285) for F0–F3; p 0.003). Liver cirrhosis (F4) was associated with higher odds ratio of the NS5A RAVs among HCV-infected patients (odds ratio 2.34, 95% CI 1.004–5.291; p 0.049). NS5A RAVs were less frequent among sequences forming clusters and pairs (5.16% (8/155) versus 11.21% (26/232); p 0.039). ConclusionsPresence of NS5A RAVs correlated with progression of liver fibrosis and represents de novo selection of variants rather than transmission of drug resistance. Hence, the presence of NS5A RAVs may be a predictor for a long-lasting HCV infection.

Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)

More than 1·8 million new cases of HIV-1 infection were diagnosed worldwide in 2016. No licensed prophylactic HIV-1 vaccine exists. A major limitation to date has been the lack of direct comparability between clinical trials and preclinical studies. We aimed to evaluate mosaic adenovirus serotype 26 (Ad26)-based HIV-1 vaccine candidates in parallel studies in humans and rhesus monkeys to define the optimal vaccine regimen to advance into clinical efficacy trials. We conducted a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial (APPROACH). Participants were recruited from 12 clinics in east Africa, South Africa, Thailand, and the USA. We included healthy, HIV-1-uninfected participants (aged 18-50 years) who were considered at low risk for HIV-1 infection. We randomly assigned participants to one of eight study groups, stratified by region. Participants and investigators were blinded to the treatment allocation throughout the study. We primed participants at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0·5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and gave boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0·5 mL) vectors with or without high-dose (250 μg) or low-dose (50 μg) aluminium adjuvanted clade C Env gp140 protein. Those in the control group received 0·9% saline. All study interventions were administered intramuscularly. Primary endpoints were safety and tolerability of the vaccine regimens and Env-specific binding antibody responses at week 28. Safety and immunogenicity were also assessed at week 52. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. We also did a parallel study in rhesus monkeys (NHP 13-19) to assess the immunogenicity and protective efficacy of these vaccine regimens against a series of six repetitive, heterologous, intrarectal challenges with a rhesus peripheral blood mononuclear cell-derived challenge stock of simian-human immunodeficiency virus (SHIV-SF162P3). The APPROACH trial is registered with ClinicalTrials.gov, number NCT02315703. Between Feb 24, 2015, and Oct 16, 2015, we randomly assigned 393 participants to receive at least one dose of study vaccine or placebo in the APPROACH trial. All vaccine regimens demonstrated favourable safety and tolerability. The most commonly reported solicited local adverse event was mild-to-moderate pain at the injection site (varying from 69% to 88% between the different active groups vs 49% in the placebo group). Five (1%) of 393 participants reported at least one grade 3 adverse event considered related to the vaccines: abdominal pain and diarrhoea (in the same participant), increased aspartate aminotransferase, postural dizziness, back pain, and malaise. The mosaic Ad26/Ad26 plus high-dose gp140 boost vaccine was the most immunogenic in humans; it elicited Env-specific binding antibody responses (100%) and antibody-dependent cellular phagocytosis responses (80%) at week 52, and T-cell responses at week 50 (83%). We also randomly assigned 72 rhesus monkeys to receive one of five different vaccine regimens or placebo in the NHP 13-19 study. Ad26/Ad26 plus gp140 boost induced similar magnitude, durability, and phenotype of immune responses in rhesus monkeys as compared with humans and afforded 67% protection against acquisition of SHIV-SF162P3 infection (two-sided Fisher's exact test p=0·007). Env-specific ELISA and enzyme-linked immunospot assay responses were the principal immune correlates of protection against SHIV challenge in monkeys. The mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine induced comparable and robust immune responses in humans and rhesus monkeys, and it provided significant protection against repetitive heterologous SHIV challenges in rhesus monkeys. This vaccine concept is currently being evaluated in a phase 2b clinical efficacy study in sub-Saharan Africa (NCT03060629). Janssen Vaccines & Prevention BV, National Institutes of Health, Ragon Institute of MGH, MIT and Harvard, Henry M Jackson Foundation for the Advancement of Military Medicine, US Department of Defense, and International AIDS Vaccine Initiative.

Truncating mutations of TP53AIP1 gene predispose to cutaneous melanoma.

Genetic predisposition to cutaneous malignant melanoma (CMM) involves highly penetrant predisposing genes and low and intermediate penetrant predisposing alleles. However, the missing heritability in (CMM) is still high. For such and in order to identify new genetic factors for CMM, we conducted an exome sequencing study in high-risk CMM patients. Two rounds of exome sequencing were successively performed in 33 and 27 high-risk patients. We focused on genes carrying rare nonsense, frameshift, and splice variants (allelic frequency <1%) that were present in both series of exomes. An extension study was then conducted in a large cohort (1079 CMM patients and 1230 Caucasian ethnically matched healthy controls), and the inactivating variants frequency was compared between groups using two-sided Fisher exact test. Two TP53AIP1 truncating mutations were identified in four patients: a frameshift c.63_64insG, p.Q22Afs*81 in two patients from the same family and in the proband of a second family; and a nonsense mutation c.95 C > A, p.Ser32Stop in a patient with multiple CMMs. In all patients, TP53AIP1 truncating variants were strongly associated with CMM risk (two-sided Fisher exact test = 0.004, OR = 3.3[1.3-8.5]). Additionally, we showed that TP53AIP1 mRNA was strongly down-regulated throughout different phases of melanoma progression. TP53AIP1 gene is a TP53 target which plays a key role by inducting apoptosis in response to UV-induced DNA damage. Constitutional mutations of TP53AIP1 had previously been involved in susceptibility to prostate cancer. Our results show that constitutional truncating TP53AIP1 mutations predispose to CMM in the French population. Replication studies in other populations should be performed.

Institutional experience with the Zenith Fenestrated aortic stent graft

ObjectiveThe Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, Ind) aortic stent graft system was approved for commercial use by the Food and Drug Administration in April 2012. We report our single-center experience of 100 consecutive patients treated with the ZFEN platform from October 2012 to March 2017. MethodsA retrospective review of our prospectively maintained fenestrated endovascular aneurysm repair (FEVAR) database at a tertiary care academic institution located in the Midwest United States was performed for descriptive analysis. All continuous variables are reported as a mean ± standard deviation and compared using two-sided Student t-tests. Categorical variables were compared using two-sided Fisher exact tests. ResultsAll but one of the procedures were elective in nature. Overall intraoperative characteristics included a mean blood loss (estimated blood loss) of 388 ± 385 mL, fluoroscopy time of 63 ± 30 minutes, radiation dose of 437 ± 272 rad, contrast material volume of 99 ± 36 mL, and operative time of 236 ± 87 minutes. Average number of visceral arteries stented was 2.1 ± 0.5. Technical success was achieved in 98% of the patients. Statistically significant (P < .05) improvement in estimated blood loss (2.1-fold) was observed in the second half of our series. Interestingly, no improvements were made in terms of fluoroscopy time, radiation exposure, contrast material use, or operative time. However, procedural difficulty increased in the last half by number of visceral arteries stented as a surrogate (1.9 vs 2.2; P < .05). Mean length of stay was 3.6 ± 4.3 days. Perioperative mortality at 30 days was 2%. Perioperative morbidity included a 5% incidence of any bowel ischemia, 1% of spinal cord ischemia, 3% of renal failure requiring hemodialysis, 1% of stroke, and 4% of myocardial infarction. Average follow-up was 1.7 ± 1.4 years. Reintervention during the follow-up phase was 20%. Of the 209 visceral arteries stented, we noted 6 instances of stent thrombosis, 6 of kinking or stenosis, and 1 of stent fracture in follow-up. Endoleak, most commonly type II, was present or could not be excluded in 15% of all FEVARs at last available computed tomography angiography. ConclusionsIn our experience, FEVAR with the ZFEN system continues to be safe and effective. There is a significant rate of reintervention observed, and close monitoring is fundamental to maintaining good clinical results.

Same Abbreviated Injury Scale Values May Be Associated with Different Risks to Mortality in Trauma Patients: A Cross-Sectional Retrospective Study Based on the Trauma Registry System in a Level I Trauma Center.

The Abbreviated Injury Scale (AIS) measures injury severity of a trauma patient with a numeric method for ranking anatomy-based specific injuries. The summation of the squares of the three most severe injuries in the AIS of six predefined body regions comprises the Injury Severity Score (ISS). It assumes that the mortality of a given AIS value is similar across all body regions. However, such an assumption is less explored in the literature. In this study, we aimed to compare the mortality rates of the patients with the same AIS value in different injured body regions in a level I trauma center. Hospitalized adult trauma patients with isolated serious to critical injury (AIS of 3 to 5) between 1 January 2009, and 31 December 2016, from the Trauma Registry System in a level I trauma center were grouped according to the injured body regions (including, the head/neck, thorax, abdomen, or extremities) and were exclusively compared according to their AIS stratum. Categorical data were compared using the two-sided Fisher exact or Pearson chi-square tests. ANOVA with Games-Howell post hoc test was performed to assess the differences in continuous data of the patients with injury in different body regions. The primary outcome of the study was in-hospital mortality. The adjusted odds ratios (AORs) were estimated using a stepwise selection of a multivariable regression model adjusted by controlling the confounding variables such as sex, age, comorbidities, and ISS. Survival curves were estimated with the Kaplan–Meier approach with a corresponding log-rank test. The patients with AIS of 5 for abdomen injury and those with AIS of 3 for extremity injury had a significantly lower odds of adjusted mortality (adjusted odds ratio (AOR) 0.1, 95% confidence interval (CI) 0.01–0.39, p = 0.004 and AOR 0.3, 95% CI 0.15–0.51, p < 0.001, respectively) than that of the patients with head/neck injury. However, the patients with AIS of 4 for extremity injury demonstrated significantly higher odds of adjusted mortality (AOR 8.4, 95% CI 2.84–25.07, p < 0.001) than the patients with head/neck injury. This study found that the risks to mortality in the patients with a given AIS value of serious to critical injury in different injured body regions were not the same, even after controlling for confounding variables such as sex, age, comorbidities, and ISS.

Effect of Age on Glasgow Coma Scale in Patients with Moderate and Severe Traumatic Brain Injury: An Approach with Propensity Score-Matched Population.

Background: The most widely used methods of describing traumatic brain injury (TBI) are the Glasgow Coma Scale (GCS) and the Abbreviated Injury Scale (AIS). Recent evidence suggests that presenting GCS in older patients may be higher than that in younger patients for an equivalent anatomical severity of TBI. This study aimed to assess these observations with a propensity-score matching approach using the data from Trauma Registry System in a Level I trauma center. Methods: We included all adult patients (aged ≥20 years old) with moderate to severe TBI from 1 January 2009 to 31 December 2016. Patients were categorized into elderly (aged ≥65 years) and young adults (aged 20–64 years). The severity of TBI was defined by an AIS score in the head (AIS 3‒4 and 5 indicate moderate and severe TBI, respectively). We examined the differences in the GCS scores by age at each head AIS score. Unpaired Student’s t- and Mann–Whitney U-tests were used to analyze normally and non-normally distributed continuous data, respectively. Categorical data were compared using either the Pearson chi-square or two-sided Fisher’s exact tests. Matched patient populations were allocated in a 1:1 ratio according to the propensity scores calculated using NCSS software with the following covariates: sex, pre-existing chronic obstructive pulmonary disease, systolic blood pressure, hemoglobin, sodium, glucose, and alcohol level. Logistic regression was used to evaluate the effects of age on the GCS score in each head AIS stratum. Results: The study population included 2081 adult patients with moderate to severe TBI. These patients were categorized into elderly (n = 847) and young adults (n = 1234): each was exclusively further divided into three groups of patients with head AIS of 3, 4, or 5. In the 162 well-balanced pairs of TBI patients with head AIS of 3, the elderly demonstrated a significantly higher GCS score than the young adults (14.1 ± 2.2 vs. 13.1 ± 3.3, respectively; p = 0.002). In the 362 well-balanced pairs of TBI patients with head AIS of 4, the elderly showed a significantly higher GCS score than the young adults (13.1 ± 3.3 vs. 12.2 ± 3.8, respectively; p = 0.002). In the 89 well-balance pairs of TBI patients with head AIS of 5, no significant differences were observed for the GCS scores. Conclusions: This study demonstrated that elderly patients with moderate TBI present higher GCS score than younger patients. This study underscores the importance of determining of TBI severity in this group of elderly patients based on the GCS score alone. A lower threshold of GCS cutoff should be adopted in the management of the elderly patients with TBI.

Analysis of the MELD Score Impact in the Outcome of Endovascular Portal Vein Reconstruction

IntroductionEndovascular therapy represents a less invasive alternative to open surgery for reconstruction of the portal vein (PV) and the spleno-mesenteric venous confluence to treat Portal hypertension. The objective of this study is to determine if the Model for End-Stage Liver Disease (MELD) score is a useful method to evaluate the risk of morbidity and mortality during endovascular approaches. Material and methodsPatients that underwent endovascular reconstruction of the PV or spleno-mesenteric confluence were identified retrospectively. Data were collected from November 2011 to August 2016. The MELD score was calculated using international normalized ratio, serum billirubin and creatinine. Patients were grouped into moderate (≤15) and high (> 15) MELD. Associations of the MELD score on the postprocedural morbidity, mortality and vessels patency were assessed by two-sided Fisher's exact test. ResultsSeventeen patients were identified; MELD score distribution was: ≤ 15 in 10 patients (59%) and > 15 in 7 (41%). Even distribution of severe PV thrombosis was treated in both groups, performing predominately jugular access in the high MELD score group (OR 0.10; 95%; CI 0.014-0.89; p = 0.052) in contrast to a percutaneous transhepatic access in the moderate MELD score group. Analysis comparing moderate and high MELD scores was not able to demonstrate differences in mortality, morbidity or patency rates. ConclusionMELD score did not prove to be a useful method to evaluate risk of morbidity and mortality; however a high score should not contraindicate endovascular approaches. In our experience a high technical success, good patency rates and low complication rates were observed.

Higher Mortality in Trauma Patients Is Associated with Stress-Induced Hyperglycemia, but Not Diabetic Hyperglycemia: A Cross-Sectional Analysis Based on a Propensity-Score Matching Approach.

Background: Stress-induced hyperglycemia (SIH) is a form of hyperglycemia secondary to stress and commonly occurs in patients with trauma. Trauma patients with SIH have been reported to have an increased risk of mortality. However, information regarding whether these trauma patients with SIH represent a distinct group with differential outcomes when compared to those with diabetic hyperglycemia (DH) remains limited. Methods: Diabetes mellitus (DM) was determined by patient history and/or admission glycated hemoglobin (HbA1c) ≥6.5%. Non-diabetic normoglycemia (NDN) was determined by a serum glucose level <200 mg/dL in the patients without DM. Diabetic normoglycemia (DN) was determined by a serum glucose level <200 mg/dL in the patients with DM. DH and SIH was diagnosed by a serum glucose level ≥200 mg/dL in the patients with and without DM, respectively. Detailed data of these four groups of hospitalized patients, which included NDN (n = 7806), DN (n = 950), SIH (n = 493), and DH (n = 897), were retrieved from the Trauma Registry System at a level I trauma center between 1 January 2009 and 31 December 2015. Patients with incomplete registered data were excluded. Categorical data were compared with Pearson chi-square tests or two-sided Fisher exact tests. The unpaired Student’s t-test and the Mann–Whitney U-test were used to analyze normally distributed continuous data and non-normally distributed data, respectively. Propensity-score-matched cohorts in a 1:1 ratio were allocated using NCSS software with logistic regression to evaluate the effect of SIH and DH on the outcomes of patients. Results: The SIH (median [interquartile range: Q1–Q3], 13 [9–24]) demonstrated a significantly higher Injury Severity Score (ISS) than NDN (9 [4–10]), DN (9 [4–9]), and DH (9 [5–13]). SIH and DH had a 12.3-fold (95% confidence interval [CI] 9.31–16.14; p < 0.001) and 2.4-fold (95% CI 1.71–3.45; p < 0.001) higher odds of mortality, respectively, when compared to NDN. However, in the selected propensity-score-matched patient population, SIH had a 3.0-fold higher odd ratio of mortality (95% CI 1.96–4.49; p < 0.001) than NDN, but DH did not have a significantly higher mortality (odds ratio 1.2, 95% CI 0.99–1.38; p = 0.065). In addition, SIH had 2.4-fold higher odds of mortality (95% CI 1.46–4.04; p = 0.001) than DH. These results suggest that the characteristics and injury severity of the trauma patients contributed to the higher mortality of these patients with hyperglycemia upon admission, and that the pathophysiological effect of SIH was different from that of DH. Conclusions: Although there were worse mortality outcomes among trauma patients presenting with hyperglycemia, this effect was only seen in patients with SIH, but not DH when controlling for age, sex, pre-existed co-morbidities, and ISS.

Effects of Patients’ Affect on Adverse Procedural Events during Image-Guided Interventions

PurposeTo assess how a patient’s affect on presentation relates to the likelihood of adverse events during their subsequent interventional image-guided procedures. Materials and MethodsA secondary analysis was performed of an existing dataset from a clinical trial with 230 patients who underwent percutaneous peripheral vascular and renal interventions and who had completed the positive affect (PA) negative affect (NA) schedule (PANAS) before their procedures. Summary PANAS scores were split over the median and used to classify the participants into those with high vs low PA and high vs low NA. Associations between affect and the absence or presence of adverse medical events were examined by two-sided Fisher exact tests. ResultsPatients with high baseline NA were significantly more likely to have adverse events during their procedures than those with low baseline NA (18% vs 8%; P = .030). High baseline PA was not associated with a significantly higher frequency of subsequent adverse events compared with low PA (15% vs 9%; P = .23). Patients with high NA requested and received significantly more sedative and opioid agents than those with low NA (2.0 vs 1.0 units requested [P = .0009]; 3.0 vs 1.0 units received [P = .0004]). PA levels did not affect medication use. ConclusionsHigh NA, but not PA, was associated with an increased likelihood of adverse events. Improving patients’ NA before procedures seems a more suitable target than attempting to boost PA to improve the procedural experience.

Polytrauma Defined by the New Berlin Definition: A Validation Test Based on Propensity-Score Matching Approach.

Background: Polytrauma patients are expected to have a higher risk of mortality than that obtained by the summation of expected mortality owing to their individual injuries. This study was designed to investigate the outcome of patients with polytrauma, which was defined using the new Berlin definition, as cases with an Abbreviated Injury Scale (AIS) ≥ 3 for two or more different body regions and one or more additional variables from five physiologic parameters (hypotension [systolic blood pressure ≤ 90 mmHg], unconsciousness [Glasgow Coma Scale score ≤ 8], acidosis [base excess ≤ −6.0], coagulopathy [partial thromboplastin time ≥ 40 s or international normalized ratio ≥ 1.4], and age [≥70 years]). Methods: We retrieved detailed data on 369 polytrauma patients and 1260 non-polytrauma patients with an overall Injury Severity Score (ISS) ≥ 18 who were hospitalized between 1 January 2009 and 31 December 2015 for the treatment of all traumatic injuries, from the Trauma Registry System at a level I trauma center. Patients with burn injury or incomplete registered data were excluded. Categorical data were compared with two-sided Fisher exact or Pearson chi-square tests. The unpaired Student t-test and the Mann–Whitney U-test was used to analyze normally distributed continuous data and non-normally distributed data, respectively. Propensity-score matched cohort in a 1:1 ratio was allocated using the NCSS software with logistic regression to evaluate the effect of polytrauma on patient outcomes. Results: The polytrauma patients had a significantly higher ISS than non-polytrauma patients (median (interquartile range Q1–Q3), 29 (22–36) vs. 24 (20–25), respectively; p < 0.001). Polytrauma patients had a 1.9-fold higher odds of mortality than non-polytrauma patients (95% CI 1.38–2.49; p < 0.001). Compared to non-polytrauma patients, polytrauma patients had a substantially longer hospital length of stay (LOS). In addition, a higher proportion of polytrauma patients were admitted to the intensive care unit (ICU), spent longer LOS in the ICU, and had significantly higher total medical expenses. Among 201 selected propensity score-matched pairs of polytrauma and non-polytrauma patients who showed no significant difference in sex, age, co-morbidity, AIS ≥ 3, and Injury Severity Score (ISS), the polytrauma patients had a significantly higher mortality rate (OR 17.5, 95% CI 4.21–72.76; p < 0.001), and a higher proportion of patients admitted to the ICU (84.1% vs. 74.1%, respectively; p = 0.013) with longer stays in the ICU (10.3 days vs. 7.5 days, respectively; p = 0.003). The total medical expenses for polytrauma patients were 35.1% higher than those of non-polytrauma patients. However, there was no significant difference in the LOS between polytrauma and non-polytrauma patients (21.1 days vs. 19.8 days, respectively; p = 0.399). Conclusions: The findings of this propensity-score matching study suggest that the new Berlin definition of polytrauma is feasible and applicable for trauma patients.

The protective effect of helmet use in motorcycle and bicycle accidents: a propensity score\u2013matched study based on a trauma registry system

BackgroundTransportation by motorcycle and bicycle has become popular in Taiwan, this study was designed to investigate the protective effect of helmet use during motorcycle and bicycle accidents by using a propensity score–matched study based on trauma registry system data.MethodsData of adult patients hospitalized for motorcycle or bicycle accidents between January 1, 2009 and December 31, 2015 were retrieved from the Trauma Registry System. These included 7735 motorcyclists with helmet use, 863 motorcyclists without helmet use, 76 bicyclists with helmet use, and 647 bicyclists without helmet use. The primary outcome measurement was in-hospital mortality. Secondary outcomes were the hospital length of stay (LOS), intensive care unit (ICU) admission rate, and ICU LOS. Normally distributed continuous data were analyzed by the unpaired Student t-test, and non-normally distributed data were compared using the Mann–Whitney U-test. Two-sided Fisher exact or Pearson chi-square tests were used to compare categorical data. Propensity score matching (1:1 ratio using optimal method with a 0.2 caliper width) was performed using NCSS software, adjusting for the following covariates: sex, age, and comorbidities. Further logistic regression was used to evaluate the effect of helmet use on mortality rates of motorcyclists and bicyclists, respectively.ResultsThe mortality rate for motorcyclists with helmet use (1.1%) was significantly lower than for motorcyclists without helmet use (4.2%; odds ratio [OR] 0.2; 95% confidence interval [CI]: 0.17–0.37; p < 0.001). Among bicyclists, there was no significant difference in mortality rates between the patients with helmet use (5.3%) and those without helmet use (3.7%; OR 1.4; 95% CI: 0.49–4.27; p = 0.524). After propensity-score matching for covariates, including sex, age, and comorbidities, 856 well-balanced pairs of motorcyclists and 76 pairs of bicyclists were identified for outcome comparison, showing that helmet use among motorcyclists was associated with lower mortality rates (OR 0.2; 95% CI: 0.09–0.44; p < 0.001). In contrast, helmet use among bicyclists was not associated with a decrease in mortality (OR 1.3; 95% CI: 0.30–5.96; p = 0.706). The hospital LOS was also significantly shorter for motorcyclists with helmet use than for those without (9.5 days vs. 12.0 days, respectively, p < 0.001) although for bicyclists, helmet use was not associated with hospital LOS. Fewer motorcyclists with helmet use were admitted to the ICU, regardless of the severity of injury; however, no significant difference of ICU admission rates was found between bicyclists with and without helmets.ConclusionsMotorcycle helmets provide protection to adult motorcyclists involved in traffic accidents and their use is associated with a decrease in mortality rates and the risk of head injuries. However, no such protective effect of helmet use was observed for bicyclists involved in collisions.