Risk Difference Research Articles

Closed-incision negative-pressure wound therapy after Bascom's cleft lift surgery for pilonidal sinus disease: A randomized study comparing healing.

Despite favourable outcomes in recurrence after off-midline closure techniques in pilonidal surgery, between 18% and 40% of patients suffer from prolonged postoperative wound healing. The aim of this work was to investigate if closed-incision negative-pressure wound therapy (NPWT) promotes wound healing after Bascom's cleft lift (BCL) surgery for complicated pilonidal sinus disease compared with conventional drainage and dressing. Patients were randomized to either NPWT for 4-7 days or loop-vessel drain for 24 h and a dry dressing postoperatively. Healing was evaluated by a wound care nurse blinded for randomization at 2 and 12 weeks postoperatively (primary endpoint). Healing was defined as one or no closing defects of ≤5 mm and with no undermining. Although we had wanted to recruit 200 patients, the study was terminated at 118 patients (NPWT group, n = 60; control group, n = 58) after interim analysis. Patients were comparable by age, sex, body mass index, previous smoking status and indication for BCL surgery. At 2 weeks 12% of patients were healed in both the NPWT and control groups [risk difference = 0.00(95% CI -0.12 to 0.11), p = 1.00]. After 12 weeks, 68% of patients were healed in the NPWT group and 72% in the control group [risk difference = -0.03 (95% CI 0.19 to 0.13), p = 0.82]. There was no significant difference in pain experienced postsurgery. In a symptom-based questionnaire, the control group reported self-esteem to be less affected (p = 0.015). Closed-incision negative-pressure wound therapy did not significantly improve healing after BCL surgery for complicated pilonidal sinus disease.

9221 Reproductive Cancer Risk in Patients Treated with Denosumab Compared with Alendronate: A Population-based Cohort Study

Abstract Disclosure: S.K. Yahyavi: Research Investigator; Self; Principal investigator (PI) on an RCT with denosumab. C. Selmer: None. C. Torp-Pedersen: None. A. Juul: None. M. Blomberg Jensen: Other; Self; Holds two patents on the use of RANKL inhibitors to treat male infertility. BACKGROUND AND OBJECTIVE: Antiresorptive treatment is used in millions of patients with osteoporosis and cancer but during the early studies of denosumab there was a slight increase in ovarian cancer incidence. The aim of this study is to determine the association between use of denosumab and risk of reproductive cancers compared with the use of alendronate in both men and women. Methods: Using a retrospective study design, we combined the Danish registries and identified a population of subjects > 50 years of age. We compared users of Denosumab that had been on alendronate treatment for at least 6 months with a matched population of patients that had been treated for at least 6 months with alendronate alone. Using the L-TMLE method we estimate the risk of reproductive cancers and the risk difference between the groups. Secondary analysis included comparisons with a healthy background population. Results: In the main analysis, a total of 18,162 subjects were included, with 6,054 denosumab users matched 1:2 with 12,108 alendronate users and followed for 3 years. 727 women and 183 men were diagnosed with a reproductive cancer during follow-up. Use of denosumab was not associated with higher risk of reproductive cancer. Compared to alendronate, women who received treatment with denosumab had a 0.06% (95% CI -0.12%; 0.26%) higher risk of a cancer diagnosis after 3 years of treatment. In a model fully adjusted for socioeconomic factors and comorbidities the risk was 0.01% (95% CI -0.35%; 0.37%) higher. The same results were found in men, and when comparing with a healthy background population and sensitivity analysis only using CKD measurements the results were confirmed. Conclusion: When comparing treatments of denosumab and alendronate, this study finds no increased risk of either cancers overall or specific reproductive cancers in men or women. Presentation: 6/3/2024

8384 Reproductive Cancer Risk in Patients Treated with Denosumab Compared with Alendronate: A Population-based Cohort Study

Abstract Disclosure: S.K. Yahyavi: Research Investigator; Self; Principal investigator (PI) on an RCT with denosumab. C. Selmer: None. C. Torp-Pedersen: None. A. Juul: None. M. Blomberg Jensen: Other; Self; Holds two patents on the use of RANKL inhibitors to treat male infertility. Background and Objective: Antiresorptive treatment is used in millions of patients with osteoporosis and cancer but during the early studies of denosumab there was a slight increase in ovarian cancer incidence. The aim of this study is to determine the association between use of denosumab and risk of reproductive cancers compared with the use of alendronate in both men and women. Methods: Using a retrospective study design, we combined the Danish registries and identified a population of subjects > 50 years of age. We compared users of Denosumab that had been on alendronate treatment for at least 6 months with a matched population of patients that had been treated for at least 6 months with alendronate alone. Using the L-TMLE method we estimate the risk of reproductive cancers and the risk difference between the groups. Secondary analysis included comparisons with a healthy background population. Results: In the main analysis, a total of 18,162 subjects were included, with 6,054 denosumab users matched 1:2 with 12,108 alendronate users and followed for 3 years. 727 women and 183 men were diagnosed with a reproductive cancer during follow-up. Use of denosumab was not associated with higher risk of reproductive cancer. Compared to alendronate, women who received treatment with denosumab had a 0.06% (95% CI -0.12%; 0.26%) higher risk of a cancer diagnosis after 3 years of treatment. In a model fully adjusted for socioeconomic factors and comorbidities the risk was 0.01% (95% CI -0.35%; 0.37%) higher. The same results were found in men, and when comparing with a healthy background population and sensitivity analysis only using CKD measurements the results were confirmed. Conclusion: When comparing treatments of denosumab and alendronate, this study finds no increased risk of either cancers overall or specific reproductive cancers in men or women. Presentation: 6/3/2024

9221 Reproductive Cancer Risk in Patients Treated with Denosumab Compared with Alendronate: A Population-based Cohort Study

Abstract Disclosure: S.K. Yahyavi: Research Investigator; Self; Principal investigator (PI) on an RCT with denosumab. C. Selmer: None. C. Torp-Pedersen: None. A. Juul: None. M. Blomberg Jensen: Other; Self; Holds two patents on the use of RANKL inhibitors to treat male infertility. Background and Objective: Antiresorptive treatment is used in millions of patients with osteoporosis and cancer but during the early studies of denosumab there was a slight increase in ovarian cancer incidence. The aim of this study is to determine the association between use of denosumab and risk of reproductive cancers compared with the use of alendronate in both men and women. Methods: Using a retrospective study design, we combined the Danish registries and identified a population of subjects > 50 years of age. We compared users of Denosumab that had been on alendronate treatment for at least 6 months with a matched population of patients that had been treated for at least 6 months with alendronate alone. Using the L-TMLE method we estimate the risk of reproductive cancers and the risk difference between the groups. Secondary analysis included comparisons with a healthy background population. Results: In the main analysis, a total of 18,162 subjects were included, with 6,054 denosumab users matched 1:2 with 12,108 alendronate users and followed for 3 years. 727 women and 183 men were diagnosed with a reproductive cancer during follow-up. Use of denosumab was not associated with higher risk of reproductive cancer. Compared to alendronate, women who received treatment with denosumab had a 0.06% (95% CI -0.12%; 0.26%) higher risk of a cancer diagnosis after 3 years of treatment. In a model fully adjusted for socioeconomic factors and comorbidities the risk was 0.01% (95% CI -0.35%; 0.37%) higher. The same results were found in men, and when comparing with a healthy background population and sensitivity analysis only using CKD measurements the results were confirmed. Conclusion: When comparing treatments of denosumab and alendronate, this study finds no increased risk of either cancers overall or specific reproductive cancers in men or women. Presentation: 6/3/2024

8384 Reproductive Cancer Risk in Patients Treated with Denosumab Compared with Alendronate: A Population-based Cohort Study

Abstract Disclosure: S.K. Yahyavi: Research Investigator; Self; Principal investigator (PI) on an RCT with denosumab. C. Selmer: None. C. Torp-Pedersen: None. A. Juul: None. M. Blomberg Jensen: Other; Self; Holds two patents on the use of RANKL inhibitors to treat male infertility. BACKGROUND AND OBJECTIVE: Antiresorptive treatment is used in millions of patients with osteoporosis and cancer but during the early studies of denosumab there was a slight increase in ovarian cancer incidence. The aim of this study is to determine the association between use of denosumab and risk of reproductive cancers compared with the use of alendronate in both men and women. Methods: Using a retrospective study design, we combined the Danish registries and identified a population of subjects > 50 years of age. We compared users of Denosumab that had been on alendronate treatment for at least 6 months with a matched population of patients that had been treated for at least 6 months with alendronate alone. Using the L-TMLE method we estimate the risk of reproductive cancers and the risk difference between the groups. Secondary analysis included comparisons with a healthy background population. Results: In the main analysis, a total of 18,162 subjects were included, with 6,054 denosumab users matched 1:2 with 12,108 alendronate users and followed for 3 years. 727 women and 183 men were diagnosed with a reproductive cancer during follow-up. Use of denosumab was not associated with higher risk of reproductive cancer. Compared to alendronate, women who received treatment with denosumab had a 0.06% (95% CI -0.12%; 0.26%) higher risk of a cancer diagnosis after 3 years of treatment. In a model fully adjusted for socioeconomic factors and comorbidities the risk was 0.01% (95% CI -0.35%; 0.37%) higher. The same results were found in men, and when comparing with a healthy background population and sensitivity analysis only using CKD measurements the results were confirmed. Conclusion: When comparing treatments of denosumab and alendronate, this study finds no increased risk of either cancers overall or specific reproductive cancers in men or women. Presentation: 6/3/2024

7555 Gender-Related Differences in Outcomes of Patients With Diabetic Ketoacidosis: An Analysis of the National Readmission Database

Abstract Disclosure: E. Ahsan: None. C. Lesniak: None. M. Akula: None. K. Hu: None. K. Chalasani: None. R. Ong: None. S. Holland: None. M. Hossain: None. J. Cheng: None. J. Heaton: None. Introduction: Diabetic ketoacidosis (DKA), one of the most serious complications of diabetes, is a significant cause of morbidity and mortality. Hospitalizations for DKA have increased significantly over the past two decades. Despite this, there is a notable absence of data on gender-related variations in the clinical characteristics and outcomes of individuals hospitalized with DKA. Understanding these distinctions is crucial for optimizing disease prevention and care. Thus, the primary aim of this study was to explore whether gender influences the outcomes of DKA. Methodology: We analyzed the National Readmissions Database (NRD) from 2016 to 2020 by evaluating patients admitted with a primary diagnosis of DKA without coma. Patients were included if they were at least 18 years old and admitted between January and November. Patients meeting inclusion criteria were stratified by sex. The groups were assessed for 30-day readmissions, all causes of mortality, length of stay, and total cost. Descriptive statistics, Cox proportional hazards, and adjusted Wald tests were used to compare the groups. Results: Between 2016 and 2020, 642,431 patients met the inclusion criteria with a median age of 44, of which 46.5% were female and 53.5% were male. Early readmission occurred in 33,639.20 females and 31,101.92 males. Cox regression analysis showed a significant difference in readmission risk for female patients than males (HR 1.20, 95% CI 1.17-1.22, P = <0.001). The length of stay was higher in male patients than in female patients (adjusted Wald test, P =<0.001). Inpatient mortality was higher in females than in males (Cox regression analysis, P = 0.009). Total cost was higher in males compared to females (adjusted Wald test, P = <0.001). Conclusion: Regrettably, the majority of studies on diabetic ketoacidosis (DKA) have not given due attention to gender differences. Our study, however, reveals statistically significant variations in in-hospital mortality and 30-day readmission rates between men and women hospitalized with DKA, with women exhibiting higher rates than men. Additionally, the length of stay and total cost were found to be higher for men. To comprehend the underlying reasons for these distinctions, further investigations are warranted. Early introduction and intensification of insulin therapy may prove beneficial for this patient group in mitigating the risk of DKA and other complications associated with diabetes mellitus. Presentation: 6/2/2024

Haemophilia testing of young girls in Canada: Describing the current recommendations for factor level and genetic testing and the experiences of Canadian parents.

It is widely acknowledged that haemophilia affects women and girls, yet current testing recommendations for factor level and genetic testing vary and do not universally incorporate updated research. Canadian parents have expressed frustration at inconsistent recommendations and reported instances where delayed testing led to missed diagnosis and preventable bleeding. Study aim was to explore and describe the practice of haemophilia-related testing of young girls in Canada. A mixed methods study was carried out with two populations: (1) Nurses working in haemophilia care completed a survey regarding the current testing recommendations of their Haemophilia Treatment Centre (HTC), (2) Parents of obligate or potential haemophilia carriers completed a structured interview with questions about their family experience of haemophilia and testing decisions for daughters. Twenty-six survey responses were received and showed wide variation in the usual recommendations of Canadian HTCs. Different factor level testing recommendations may be given to obligate and potential carriers despite no difference in bleeding risk. Only a minority of HTCs currently recommend an early baseline factor level (<10 years) to obligate carriers (27%) or potential carriers (15%). For genetic testing of potential carriers, 70% of HTC would approve a family request for genetic testing of a minor with specific conditions. The majority of parents interviewed felt dissatisfied with their testing experience (58%) and highlighted many issues related to delayed testing recommendations. Updated, nationally affirmed testing recommendations are needed that align with research on bleeding in women and girls affected by haemophilia.

12340 Cardiovascular Risks With Testosterone Replacement Therapy In Patients With Type 2 Diabetes Mellitus

Abstract Disclosure: A. Gupta: None. M. Nassar: None. H. Ghanim: None. Background: Concerns have been raised about testosterone replacement therapy (TRT) in hypogonadism patients, particularly regarding cardiovascular disease (CVD) risk. Despite some studies showing TRT's non-inferiority to placebo in men at high CVD risk, its impact on patients with type 2 diabetes mellitus (T2DM) remains uncertain. This study examines the incidence of cardiovascular events in patients with T2DM on TRT, with a focus on the first four years of treatment. Methods: Utilizing the TriNetX electronic health records network, this retrospective cohort study targeted patients with T2DM with testosterone levels &amp;lt;300 ng/dl or diagnosed hypogonadism. Patients were divided into two main groups based on their CVD history and TRT status. We conducted a comparative analysis between each cohort and a control group of patients who did not get testosterone replacement therapy (TRT). Matching for age, HbA1C, and BMI created balanced cohorts for comparison: 39,589 in each of the non-CVD event cohorts and 16,065 in each of the CVD event cohorts. Results: In patients without prior CVD, TRT significantly reduced the risk of acute myocardial infarction (MI) (risk ratio: 0.765, p &amp;lt;0.0001), with no significant difference in cerebral infarction risk. Conversely, TRT increased the risk of acute MI (risk ratio: 1.164, p &amp;lt; 0.0001) and cerebral infarction (risk ratio: 1.177, p &amp;lt; 0.0001) in patients with a history of CVD.Discussion: TRT may decrease acute MI risk in patients with T2DM without prior CVD but elevate acute MI and stroke risks in those with a CVD history. These findings suggest the need for cautious TRT consideration in patients with T2DM with differing cardiovascular histories. Conclusion: This analysis reveals that TRT is associated with a decreased risk of acute myocardial infarction in patients with T2DM without a history of CVD, suggesting a potential protective effect in this subgroup. However, TRT increases the risk of both myocardial infarction and stroke in patients with a prior history of CVD, indicating the need for careful patient selection and monitoring. These findings highlight the significance of personalized evaluation in the administration of TRT, particularly in patients with T2DM who have different cardiovascular backgrounds, to balance benefits against potential risks. Presentation: 6/2/2024

Perceived discrimination and refraining from seeking physician’s care in Sweden: an intersectional analysis of individual heterogeneity and discriminatory accuracy (AIHDA)

BackgroundDiscrimination may further impede access to medical care for individuals in socially disadvantaged positions. Sociodemographic information and perceived discrimination intersect and define multiple contexts or strata that condition the risk of refraining from seeking physician’s care. By applying analysis of individual heterogeneity and discriminatory accuracy (AIHDA) we aimed to improve the mapping of risk by considering both strata average risk differences and the accuracy of such strata risks for distinguishing between individuals who did or did not refrain from seeking physician’s care.MethodsWe analysed nine annual National Public Health Surveys (2004, 2007–2014) in Sweden including 73,815 participants. We investigated the risk of refraining from seeking physician’s care across 64 intersectional strata defined by sex, education, age, country of birth, and perceived discrimination. We calculated strata-specific prevalences and prevalence ratios (PR) with 95% confidence intervals (CI), and the area under the receiver operating characteristic curve (AUC) to evaluate the discriminatory accuracy (DA).ResultsDiscriminated foreign-born women aged 35–49 with a low educational level show a six times higher risk (PR = 6.07, 95% CI 5.05–7.30) than non-discriminated native men with a high educational level aged 35–49. However, the DA of the intersectional strata was small (AUC = 0.64). Overall, discrimination increased the absolute risk of refraining from seeking physician’s care, over and above age, sex, and educational level.ConclusionsAIHDA disclosed complex intersectional inequalities in the average risk of refraining from seeking physician’s care. This risk was rather high in some strata, which is relevant from an individual perspective. However, from a population perspective, the low DA of the intersectional strata suggests that potential interventions to reduce such inequalities should be universal but tailored to the specific contextual characteristics of the strata. Discrimination impairs access to healthcare.

Effect of antenatal Chlamydia trachomatis and Neisseria gonorrhoeae screening on postdelivery prevalence and vertical transmission in Gaborone, Botswana: findings from an exploratory study

ObjectivesChlamydia trachomatis and Neisseria gonorrhoeae are common sexually transmitted infections (STIs). Untreated infection in pregnancy can result in adverse neonatal outcomes, including vertical transmission. Screening for these infections is not...

Analysis of Mpox by Occupation and Industry in Seven U.S. Jurisdictions, May 2022-March 2023.

During responses to outbreaks, the collection and analysis of data on employed case patients' industry and occupation are necessary to better understand the relationship between work and health outcomes. The occurrence of mpox by occupation and industry has not previously been assessed in the context of the 2022 outbreak. We analyzed employment data from 2548 mpox cases reported to the U.S. Centers for Disease Control and Prevention from surveillance systems in seven U.S. jurisdictions and population-based reference data on employment patterns from the U.S. Bureau of Labor Statistics to describe the differential proportionate distribution of cases across occupation and industry groups using the proportionate morbidity ratio. In gender-specific analyses, we found that men employed in certain occupations and industries had a higher relative risk of mpox than others. While occupational transmission cannot be ruled out, it is more likely that individuals with personal and behavioral risk factors for mpox were more likely to work in these occupations and industries. This analysis provides an example of collecting and analyzing occupation and industry data in case reports to understand possible differences in risk by occupation and industry in infectious disease outbreak investigation and help inform resource allocation, messaging, and response.

Cystine urolithiasis-free duration after first occurrence and treatment is longer for castrated dogs than for sexually intact male dogs.

To evaluate outcome in 60 dogs with cystine urolithiasis treated with surgical removal with and without castration and postoperative therapeutic diet to determine frequency of recurrence and urolith-free duration. Patient records were reviewed for dogs with documented cystine urolithiasis from September 2010 to December 2020. Medical records, client interviews, and referring veterinarians were contacted to document the absence of clinical signs associated with subsequent urolith formation and to evaluate risk factors for urolith reoccurrence. 80 patients were identified with cystine uroliths, with 60 qualifying for inclusion in the study. Seven dogs were neutered prior to surgery, and 25 dogs were neutered at the time of the first surgery. Recurrence occurred in 20 dogs; 17 of those patients were intact (85%) at the time of recurrent urinary signs. Of the 20 dogs with recurrence, 50% (10 of 20) were being treated with dietary modifications. The risk of recurrence among neutered pets was 23% versus 47% for intact pets, but this difference was not statistically significant; however, neutered pets had a longer urolithiasis-free duration. There was no statistically significant difference in risk of recurrence and urolith-free duration between pets with and without therapeutic diet management, (30% vs 32.5%) respectively. Multivariant analysis showed no significant interaction between surgical intervention with therapeutic diet, with nonsignificant hazard ratios (HRs) for neuter status (HR = 0.503), diet (HR = 1.056), and their interaction (HR = 4.32 to 9). Sexually intact (vs castrated) male dogs should be monitored more closely for recurrence of surgical cystine urolithiasis.

Environmental Exposures and Cancer Risk: A Comprehensive Review

Environmental exposure is increasingly recognized as a significant cancer risk factor. This comprehensive review aims to provide an overview of current knowledge regarding the relationship between several environmental factors and the development of cancer. The complicated interactions between genetic predispositions and environmental factors in the etiology of cancer are highlighted in this study by looking at both known and newly discovered environmental carcinogens. The review covers a broad spectrum of environmental exposures, including occupational risks, dietary and physical activity habits, and toxins in the air and water. It also explores the molecular processes by which these exposures cause cancer, with particular attention to pathways including DNA damage, oxidative stress, and epigenetic changes. This review also discusses the differences in cancer risk associated with environmental exposures among various populations, highlighting the necessity of focused preventative and therapeutic measures. The results highlight how crucial it is to implement public health programs and regulatory regulations targeted at lowering environmental carcinogen levels and lessening their influence on the incidence of cancer. Considering an emphasis on developing precision medicine techniques and enhancing environmental health equality, future research directions are suggested further to clarify the complex links between the environment and cancer.

Pan-African analysis identifies genetic differences in prostate cancer risk.

Pan-African analysis identifies genetic differences in prostate cancer risk.

A randomized controlled non-inferiority trial of placebo versus macrolide antibiotics for Mycoplasma pneumoniae infection in children with community-acquired pneumonia: trial protocol for the MYTHIC Study

BackgroundMycoplasma pneumoniae is a major cause of community-acquired pneumonia (CAP) in school-aged children. Macrolides are the first-line treatment for this infection. However, it is unclear whether macrolides are effective in treating M. pneumoniae CAP, mainly due to limitations in microbiological diagnosis of previous studies. The extensive global use of macrolides has led to increasing antimicrobial resistance. The overall objective of this trial is to produce efficacy data for macrolide treatment in children with M. pneumoniae CAP.MethodsThe MYTHIC Study is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial in 13 Swiss pediatric centers. Previously healthy ambulatory and hospitalized children aged 3–17 years with clinically diagnosed CAP will be screened with a sensitive and commercially available M. pneumoniae-specific IgM lateral flow assay from capillary blood. Mycoplasma pneumoniae infection in screened patients will be verified retrospectively by respiratory PCR (reference test) and IgM antibody-secreting cell enzyme-linked immunospot (ELISpot) assay (confirmatory test for distinguishing between carriage and infection). Patients will be randomized 1:1 to receive a 5-day treatment of macrolides (azithromycin) or placebo. The co-primary endpoints are (1) time to normalization of all vital signs, including body temperature, respiratory rate, heart rate, and saturation of peripheral oxygen (efficacy), and (2) CAP-related change in patient care status (i.e., admission, re-admission, or intensive care unit transfer) within 28 days (safety). Secondary outcomes include adverse events (AEs), as well as antimicrobial and anti-inflammatory effects. For both co-primary endpoints, we aim to show non-inferiority of placebo compared to macrolide treatment. We expect no macrolide effect (hazard ratio of 1, absolute risk difference of 0) and set the corresponding non-inferiority margins to 0.7 and −7.5%. The “at least one” success criterion is used to handle multiplicity with the two co-primary endpoints. With a power of 80% to reject at least one null hypothesis at a one-sided significance level of 1.25%, 376 patients will be required.DiscussionThis trial will produce efficacy data for macrolide treatment in children with M. pneumoniae CAP that might help to reduce the prescription of antibiotics and therefore contribute to the global efforts toward reducing antimicrobial resistance.Trial registrationClinicalTrials.gov, NCT06325293. Registered on 24 April 2024

Effect of perioperative erythropoietin on postoperative morbidity and mortality after cardiac surgery: a meta-analysis of randomized controlled trials

ObjectiveCardiac surgery is known to have high rates of perioperative red blood cell (RBC) transfusions which are associated with increased postoperative mortality and morbidity. Perioperative erythropoietin (EPO) has been suggested to lower perioperative RBC transfusions, and the effect on postoperative morbidity or mortality is unknown. MethodsThe registered study protocol is available on PROSPERO (CRD42022314538). We searched the Pubmed, EMbase, and Cochrane CENTRAL databases for randomized controlled trials (RCT) of EPO in cardiac surgery. Outcomes were short-term mortality, acute kidney injury (AKI), re-operation, cerebrovascular accident (CVA), perioperative myocardial infarction (MI), infectious complications, and RBC transfusions. RCT studies of perioperative EPO that reported at least one prespecified outcome of interest were included. ResultsA total of 21 RCT’s (n = 2,763 patients) were included. Mortality analysis included 17 studies (EPO 1,272 patients, control 1,235) and showed no significant difference (risk difference (RD) 0.0004, 95%CI: −0.016, 0.009). EPO did not reduce the incidence of AKI (RD −0.006, 95% CI: −0.038, 0.026) and reoperation (RD 0.001, 95% CI: −0.013, 0.015). The incidence of CVA (RD −0.004, 95% CI: −0.015, 0.007) and perioperative MI (RD −0.008, 95% CI: −0.021, 0.005) was similar between the groups. ConclusionsAlthough EPO had been proven to reduce perioperative RBC transfusions, we did not find that it reduces the incidence of postoperative short-term mortality, AKI, and reoperation. The study results support that perioperative EPO is also safe, with no rise in thrombotic events, including CVA and perioperative MI.

Effect of data censoring on thoracic injury risk curves

Objective The first objective was to evaluate the effect of using less censored (i.e., exact and interval-censored) data on thoracic injury risk curves and the resulting injury probabilities. The second objective was to generate new injury risk curves to predict Abbreviated Injury Scale (AIS) 3+ rib fractures based on chest deflection. Methods Two data sets consisting of postmortem human surrogate (PMHS) tests with multipoint chest deflection measurements were compiled: A less censored data set consisting of exact and interval-censored data and a doubly censored data set consisting of left- and right-censored data. Chest deflection data from both data sets were processed in a consistent manner to calculate the maximum deflections at different locations across the chest. Survival analysis methods were used to generate nonparametric and parametric injury risk curves for serious skeletal injury. The total sample sizes and proportions of less censored data used to generate the risk curves were varied for each curve to evaluate the effects of sample size and less censored data on risk curve shape and predicted injury thresholds. Results Increasing the proportion of less censored data resulted in steeper injury risk curves and a higher predicted risk for a given amount of deflection. Differences in injury risk were more pronounced in the upper half of the injury risk curves. Introducing less censored data also produced narrower confidence intervals. At a total sample size of 79, increasing the percentage of less censored data from 0 to 30 had minimal effect on the shape of the risk curve. Conclusions Doubly censored chest deflection data have historically been used to generate thoracic injury risk curves for frontal motor vehicle crash events. This study found that incorporating less censored data into thoracic injury risk curves meaningfully affected the shape of the injury risk curves and their resulting injury risk predictions. All of the injury risk curves generated in the study predicted a lower threshold for serious rib fracture injury compared to previously developed injury risks curves that are currently in use in the field. Based on the results of this study, adding less censored data to injury risk curves should be strongly considered to improve thoracic injury risk curve prediction and confidence, especially for smaller sample sizes.

Carcinogenic risks of inorganic arsenic in white rice in Asia

This study estimated the incremental lifetime cancer risk (ILCR) of inorganic arsenic (iAs) from white rice ingestion in eight countries (China, Korea, Pakistan, Saudi Arabia, Thailand, Vietnam, Bangladesh, and Cambodia) in Asia by using data collected from published literature (n = 4857). ILCR of iAs exposure from white rice ingestion substantially varied with region, ranging from 0.37 to 13.46 per 10000 people, with an average of 6.12 per 10000 people. Bangladesh had the highest ILCR, followed by Cambodia, Vietnam, Thailand, China, Korea, Saudi Arabia, and Pakistan. Carcinogenic risks of iAs exposure from white rice ingestion in China, Korea, Thailand, Vietnam, Bangladesh, and Cambodia are at an unacceptable level (more than 1 per 10000 people). Linear regression analysis indicated that ingestion rate and inorganic arsenic content were the critical factors determining regional differences in carcinogenic risk of iAs exposure from white rice ingestion in Asia.

A-017 Clinical Performance Evaluation of the Atellica IM High-Sensitivity Troponin I Assay to Aid in Risk Stratification for All-Cause Mortality and Major Adverse Cardiac Events

Abstract Background Cardiac troponin I (cTnI) is the only troponin isoform present in the myocardium, where it binds to actin and inhibits actin and myosin interaction. Upon myocardial injury, cTnI is released into circulation and serial measurements can be used to aid in the diagnosis of acute myocardial infarction (AMI). In addition, in patients presenting with signs and symptoms of acute coronary syndrome (ACS), elevated cTnI levels provide useful prognostic information relative to short and long-term risk of all-cause mortality (ACM) and major adverse cardiac events (MACE). The objective of this study was to evaluate the clinical performance of the Atellica® IM TNIH assay to aid in risk stratification for ACM/MACE*. Methods Patients from 29 emergency departments (ED) across the United States presenting with signs and symptoms suggestive of ACS were followed for 30-, 90-, and 365-day progression to ACM/MACE (consisting of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization). At each timepoint, the risk (cumulative incidence) and hazard ratios were calculated for populations with baseline cTnI levels ≤ or &amp;gt; the 99th percentile value. Kaplan-Meier curves were generated to display the absolute risk (cumulative incidence) of ACM/MACE outcomes. Analyses were performed for all enrolled patients (entire population) and separately for the entire population excluding those with an adjudicated AMI at presentation. Analyses were performed separately for both serum and plasma (lithium heparin) sample types. Results For the Entire Population cohort, the binary baseline TNIH result (TNIH &amp;gt; overall 99th percentile or ≤ overall 99th percentile) was significantly associated with 30-, 90-, and 365-day cumulative ACM/MACE (p-value&amp;lt;0.0125) for both plasma and serum samples. For plasma samples, risk difference increased from 6.27% at day 30 to 19.62% at day 365. For serum samples, risk difference increased from 6.24% at day 30 to 18.71% at day 365. Cox proportional hazard regression analysis compared the TNIH 99th percentile groups in their hazard of experiencing an ACM/MACE event in the 30-, 90-, and 365-days post ED presentation. For plasma samples, the hazard of ACM/MACE for subjects with cTnI values above the TNIH 99th percentile was relatively constant at each follow-up interval as more than double the rate of subjects below the 99th percentile; hazard ratios ranged between 2.81 (p-value&amp;lt;0.0001) and 3.49-fold (p-value&amp;lt;0.0001) for the three follow up visits. For serum samples, the hazard ratios were between 2.69 (p-value&amp;lt;0.0001) and 3.28-fold (p-value&amp;lt;0.0001) for the three follow up visits. Similar results were obtained for the Entire Population Excluding Subjects with Adjudicated AMI During Initial Presentation cohort. Conclusions The Atellica IM TNIH assay can be used in the detection of myocardial injury and can aid in risk stratification for 30-, 90-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). *This prognostic claim is not available in the United States.

Development and validation of a risk prediction model for acute care use among patients with advanced cancer on clinical trials.

277 Background: Patients with advanced cancer on clinical trials are at high risk for unplanned Emergency Room visits (ER_visits) and hospital stays (HS). Identifying patients at highest risk could inform personalized intervention strategies. Methods: The data were from the SWOG Cancer Research Network. Medicare claims data were linked to data from advanced cancer clinical trials. The occurrence of any HS or ER visit within 1 year after enrollment was the primary endpoint. Patients must have had 6 months of continuous Medicare claims prior to registration to determine comorbid conditions prior to treatment, and 12 months of claims after registration (or until death) to detect outcomes. We examined 23 sociodemographic (age, sex, race, ethnicity, insurance status), geographic (rural or urban, area-level deprivation), clinical (disease severity, performance status), treatment (line of therapy, therapy type), and individual comorbidity factors to establish a predictive risk model. Model derivation was conducted in a 60% random sample and tested in the remaining 40%. Best subset selection with logistic regression was used with iterative application of 3-, 4-, and 5-fold cross validation repeated 10 times. Results: Among N=1397 total patients from 6 trials (lung, 3; prostate, 2; pancreas, 1), 33.9% were 75+ years, 20.3% were female, and 8.2% were Black. The overall proportion of patients with ≥1 HS/ER visit was 68.8%. In the training set (n=839), a best 5-variable risk was identified with adverse risk factors including cancer type (prostate vs other), performance status (PS; 0 vs. &gt;=1), coronary artery disease (CAD; yes vs. no), hypertension (yes vs. no), and liver disease (yes vs. no). As cancer type was a study-level variable, we derived a risk model using PS, CAD, hypertension, and liver disease and adjusted for cancer type. There were no differences in adverse risk between those in with and without prostate cancer (interaction p-value=.44), justifying combining across cancer types. In the training set, patients with ≥2 risk factors (high risk; n=303, 36.1%) vs. 0/1 risk factor (low risk; n=536, 63.9%) had nearly a 3-fold increased odds of experiencing HS/ER visit (82.2% vs. 59.1%, OR=2.85, 95% CI, 2.01-4.03, p&lt;.001). Results were successfully validated in the test set (OR=1.93, p=.002). In all patients, those in the highest risk quartile (3/4 factors) vs the lowest risk (0 factors) had nearly a fourfold increased odds of HS/ER visits (OR=3.92, 95% CI, 2.25-6.83, p&lt;.001). Conclusions: Rates of HS_ER visits were high within the first year after enrolling on a trial for advanced cancer. We derived and validated a risk model that delineated strong differences in risk. With expansion of eligibility to include patients with more comorbid conditions, personalized interventions aimed at preventing acute care use could decrease the cost and improve the quality of cancer care.