Results Of Observational Study Research Articles

Tracheostomy in critically ill patients with SARS 2 COVID-19 infection: a prospective observational multi-center study of short- and long-term outcomes.

BackgroundWe report the characteristics, timing, and factors related to the decision to perform a tracheostomy in patients with confirmed COVID-19 infection admitted to eight Italian intensive care units (ICUs).Materials and methodsProspective observational cohort study of patients with COVID-19 disease on mechanical ventilation. Long-term functional impairment (up to 180 days’ post-hospital discharge) was assessed using the Karnofsky scale. Kaplan–Meier analysis assessed differences in survival and freedom from tracheostomy in relation to ICU stay. Cox regression model was used to assess which variables impacted on tracheostomy as a categorical outcome.ResultsA total of 248 patients were recruited in the eight participating ICUs. Patients undergoing tracheostomy (n = 128) had longer ICU (25 (18–36) vs. 10 (7–16), P = 0.001) and hospital (37 (26.5–50) vs. 19 (8.5–34.5) P = 0.02) stays. ICU and hospital mortality of patients tracheostomized was 34% and 37%, respectively. Cumulative survival Kaplan–Meier analysis documented improved survival rates in patients undergoing tracheostomy (Log-Rank, Mantel–Cox = 4.8, P = 0.028). Median Karnofsky scale values improved over time but were similar between survivors receiving or not receiving tracheostomy. No healthcare worker involved in the tracheostomy procedure developed COVID-19 infection during the study period.ConclusionsPatients with COVID-19 infection who underwent tracheostomy had a better cumulative survival but similar long-term functional outcomes at 30, 60, and 180 days after hospital discharge.

Outcomes and Predictors of Outcome with Cisternostomy in the Management of Traumatic Brain Injury—A Prospective Observational Study at a Tertiary Centre

Abstract Background Traumatic brain injury (TBI) is a major cause of morbidity and mortality in young individuals. Goal of management in TBI patients is mainly focused on the secondary injury. Since the cisterns and the brain communicate, it would be possible to decrease the pressure in both these compartments by opening the cisterns to the atmospheric pressure. Objective To study the outcomes and predictors of outcome with cisternostomy in the management of TBI. Methods A single tertiary care center's prospective observational study of outcomes with cisternostomy with intraoperative intracranial pressure (ICP) monitoring. Patients were evaluated clinically and radiologically with Marshall CT score. They were categorized into mild, moderate, and severe head injury groups based on Glasgow coma scale (GCS) score. Outcomes were evaluated with Glasgow outcome scale (GOS) score. Results A total of 25 patients with TBI were enrolled in this study. They underwent cisternostomy with intraoperative ICP monitoring. They were categorized into 4 groups based on the age. In our study, mortality rate was 32%. As much as 48% had good recovery at 3 months follow-up with GOS 4 and 5. Mean ICP after cisternostomy was 6.36 ± 1.91 mm Hg. In our study, there was decrease in ICP after cisternostomy. Conclusion Age, time interval from trauma to surgery, and ICP showed prognostic importance on outcomes. Cisternostomy can efficiently decrease the ICP in the TBI patients and reduce postoperative complications.

Functional limitations 12 months after SARS-CoV-2 infection correlate with initial disease severity: An observational study of cardiopulmonary exercise capacity testing in COVID-19 convalescents

BackgroundCardiopulmonary Exercise Testing (CPET) provides a comprehensive assessment of pulmonary, cardiovascular and musculosceletal function. Reduced CPET performance could be an indicator for chronic morbidity after COVID-19. MethodsPatients ≥18 years with confirmed PCR positive SARS-CoV-2 infection were offered to participate in a prospective observational study of clinical course and outcomes of COVID-19. 54 patients completed CPET, questionnaires on respiratory quality of life and performed pulmonary function tests 12 months after SARS-CoV-2 infection. ResultsAt 12 months after SARS-CoV-2 infection, 46.3% of participants had a peak performance and 33.3% a peak oxygen uptake of <80% of the predicted values, respectively. Further impairments were observed in diffusion capacity and ventilatory efficiency. Functional limitations were particularly pronounced in patients after invasive mechanical ventilation and extracorporeal membrane oxygenation treatment. Ventilatory capacity was reduced <80% of predicted values in 55.6% of participants, independent from initial clinical severity. Patient reported dyspnea and respiratory quality of life after COVID-19 correlated with CPET performance and parameters of gas exchange. Risk factors for reduced CPET performance 12 months after COVID-19 were prior intensive care treatment (OR 5.58, p = 0.004), SGRQ outcome >25 points (OR 3.48, p = 0.03) and reduced DLCO (OR 3.01, p = 0.054). ConclusionsFunctional limitations causing chronic morbidity in COVID-19 survivors persist over 12 months after SARS-CoV-2 infection. These limitations were particularly seen in parameters of overall performance and gas exchange resulting from muscular deconditioning and lung parenchymal changes. Patient reported reduced respiratory quality of life was a risk factor for adverse CPET performance.

An observational study of treatment and outcomes of patients admitted in a dedicated Covid hospital in central India during second wave of Covid -19 pandemic

The peak of second wave of corona virus disease in India was from mid March to mid May 2021 which was lethal. The present study was carried out with the objectives to find the characteristics, clinical presentation of patients and to co-relate these features with treatment outcomes - mortality and adverse effects. This is an observational study carried out in patients admitted in a Dedicated COVID Hospital (DCH) with severe symptoms of COVID-19 with or without undergoing lab test for diagnosis. The patients were prospectively evaluated for demographics, clinical course, treatment offered and outcomes during a period from 15 April to 19 May 2021. Patients in age group of 45-61 years were most affected. Men were affected more as compared to women. All patients were offered treatment protocol as per updated National guidelines. Primary outcomes in terms of In- hospital mortality was 24.13% The In- hospital mortality was significantly more in patents above the age of 45 years as compared to patients below 45 years and also in patients with co-morbidity than in patients without it. The biomarkers of patients who died were found to be on higher side. Secondary outcomes –death post discharge was 8.04% and 2.29% of patients developed mucormycosis. All the admitted patients had severe symptoms irrespective of confirmatory diagnosis and High –resolution computed tomography (HRCT) scores. All of them required mechanical ventilation, injection Remdisivir, injectable antibiotics, anti-coagulants, injection Methyl Prednisolone. Inspite of this management the In-hospital mortality was 24.13%.

Análisis de supervivencia en pacientes con micosis fungoide foliculotropa de un centro latinoamericano

IntroductionFolliculotropic mycosis fungoides is a variant that has poor prognosis and a variable clinical presentation. Concerns have been expressed that the current TNMB staging of this tumor may not be useful. A recently developed classification system based on clinical and histologic variables classifies this tumor as early or advanced, a distinction found to correlate with prognosis. The aim of this study was to compare survival in FMF in Colombia between patients with early versus advanced tumors. Material and methodsRetrospective, observational study of clinical course and outcomes in patients with FMF treated at the National Cancer Institute of Colombia between 2008 and 2020. Survival was compared between early and advanced disease. ResultsTwenty-one patients (11 with early FMF and 10 with advanced FMF) were studied. Seven patients, all with advanced disease, died. Survival at 5 years was 62% overall and 40% for patients with advanced FMF. No differences were observed when survival was analyzed according to TNMB stage. ConclusionsTNMB staging is not useful in FMF. The new classification system based on clinicopathologic features appears to provide reliable information for assessing prognosis and guiding treatment decisions.

Observational Study of Early Outcomes in Single-Vessel and Multiple-Vessel Renal Allograft.

IntroductionEnd-stage renal disease (ESRD) is a global problem with a similar worldwide need for renal replacement therapy. However, the availability of transplant organs remains a challenge. Therefore, we conducted this study to measure early outcomes (up to one month) of renal allograft functions after renal transplant by assessing graft vascularity. We also measured the changes in serum creatinine and hemoglobin levels in single- and multiple-vessel renal allograft recipients.MethodsWe conducted an observational study of 108 renal allograft patients for two years. The study included all renal allograft recipients during the study period. The study excluded patients with a history of renal transplant, patients on antithrombotic therapy, a donor with previous surgery of graft kidney, and patients with anatomic abnormalities. Eighty-five patients were in the single-vessel group, and 23 were in the multiple-vessel group. Donors and recipients received standard pretransplant workup, including donor CT angiography and human leukocyte antigen crossmatching. We performed laparoscopic donor nephrectomies for all participants and perfused all renal arteries separately with Renograph solution (Claris Lifesciences, North Brunswick, NJ). A renal transplant was done in the right or left iliac fossa, noting warm and cold ischemia times. In single-vessel recipients, we anastomosed the renal artery to the external iliac artery (EIA), the renal vein to the external iliac vein (EIV), and the ureter to the bladder via a modified Lich-Gregoir technique. In multiple-vessel recipients, we performed bench anastomosis to make a single vessel, or we anastomosed vessels separately to the EIA, EIV, or the inferior epigastric artery for patients with a second small renal artery. We measured postoperative serum creatinine and hemoglobin levels for one month. In addition, we assessed graft vascularity with ultrasound-guided (USG) Doppler in the first postoperative week. We used IBM SPSS Statistics for Windows, version 21.0. (IBM Corp., Armonk, NY) for all data analyses.ResultsWarm ischemia time (WIT) was longer in multiple-vessel patients than in single-vessel patients, but the difference was insignificant (p=0.054). Cold ischemia time (CIT) was significantly longer in the multiple-vessel group than in the single-vessel group (p=0.048). We found no significant difference in serum creatinine or hemoglobin levels between groups during the study period. Perigraft collection occurred in three single-vessel patients and decreased vascularity in two multiple-vessel patients, according to USG Doppler.ConclusionsWe conducted this study to measure early outcomes of renal allograft functions after renal transplant by assessing graft vascularity, serum creatinine, and hemoglobin levels in single- and multiple-vessel renal allograft patients. According to our results, renal transplantation is not inferior in multiple-vessel allograft patients. We found no significant difference in serum creatinine levels one month postoperatively. Using multiple-vessel donors helps increase the limited donor pool, which is ultimately better for managing ESRD patients.

Comparative effectiveness of biologics in clinical practice: week 12 primary outcomes from an international observational psoriasis study of health outcomes (PSoHO).

Clinical trials study treatment outcomes under stringent conditions, capturing incompletely the heterogeneity of patient populations and treatment complexities encountered in real-world practice. To compare the effectiveness of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis. The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year observational cohort study in adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. Primary study endpoint is the proportion of patients achieving 90% improvement in Psoriasis Area and Severity Index (PASI 90) and/or static Physician Global Assessment (sPGA) 0/1 at Week 12 (W12) in the anti-IL-17A cohort (ixekizumab [IXE], secukinumab) vs. all other approved biologics. Secondary outcomes include the proportion of patients who achieve PASI 75/90/100, absolute PASI scores ≤5, ≤2 and ≤1, Dermatology Life Quality Index (DLQI) score of 0/1 at W12 between the two cohorts and among the individual biologics. Comparative effectiveness analyses were conducted using Frequentist Model Averaging (FMA), a novel causal inference machine learning approach. Missing data for binary outcomes were imputed as non-response. Patient profiles in the anti-IL-17A cohort and other biologics cohort were similar, with more frequent comorbid psoriatic arthritis and less frequent exposure to conventional treatments in the patients receiving anti-IL-17A biologics. At W12, 71.4% of patients who received an anti-IL-17A biologic achieved PASI 90 and/or sPGA 0/1 compared to 58.6% of patients who received other biologics (odds ratios [OR], 1.9; 95% confidence intervals [CI], [1.6, 2.4]). Similar findings were observed for secondary outcomes. These results reflect the high efficacy and early onset of skin clearance of IL-17A inhibitors observed in randomized clinical trials and confirm the effectiveness of anti-IL-17A biologics in the real-world setting.

Comparison of Outcomes of Ischemic Stroke Initially Imaged With Cranial Computed Tomography Alone vs Computed Tomography Plus Magnetic Resonance Imaging

Patients with acute ischemic stroke often undergo magnetic resonance imaging (MRI) in addition to computed tomography (CT), but its association with clinical outcomes is uncertain. To assess whether clinical outcomes of patients with acute ischemic stroke with initial CT alone were noninferior to those with additional MRI. A retrospective observational propensity score-matched cohort study of clinical outcomes at discharge and 1 year for patients hospitalized with acute ischemic stroke was conducted at an academic medical center between January 2015 and December 2017. Data collection from an electronic medical record system performed from May 2020 through January 2022 was not completely blinded. Noninferiority margins were based on the designs of previous randomized clinical trials of ischemic stroke treatments. Statistical analysis was performed in January 2022. Participants were adults hospitalized with acute ischemic stroke with admission diagnosis based on CT. Exclusion criteria were primarily missing data. From 508 eligible patients, all 123 cases with additional MRI were propensity-score matched to 123 controls without. MRI after initial diagnosis. Death or dependence at hospital discharge (modified Rankin Scale score of 3-6) and stroke or death occurring in survivors within 1 year after discharge. Among 246 participants, the median age was 68 years (IQR, 58-78.8 years) and 131 (53.0%) were men. Death or dependence at discharge occurred more often in patients with additional MRI (59 of 123 [48.0%]) than in those with CT alone (52 of 123 [42.3%]; absolute difference, 5.7%; 95% CI, -6.7% to 18.1%), meeting the -7.50% criterion for noninferiority. Stroke or death within 1 year after discharge determined for 225 of 235 (96%) survivors occurred more often in patients with additional MRI (22 of 113 [19.5%]) than in those with CT alone (14 of 112 [12.5%]; relative risk, 1.14; 95% CI, 0.86-1.50), meeting the 0.725 relative risk criterion for noninferiority. This propensity score-matched cohort study of patients hospitalized with acute ischemic stroke found that a diagnostic imaging strategy of initial CT alone was noninferior to initial CT plus additional MRI with regard to clinical outcomes at discharge and at 1 year. Further research is needed to determine which patients hospitalized with acute ischemic stroke benefit from MRI.

Significant reduction in chronic kidney disease progression with sodium-glucose cotransporter-2 inhibitors compared to dipeptidyl peptidase-4 inhibitors in adults with type 2 diabetes in a UK clinical setting: An observational outcomes study based on international guidelines for kidney disease.

To confirm the reno-protective effects of sodium-glucose cotransporter-2 (SGLT2) inhibitors compared with dipeptidyl peptidase-4 (DPP-4) inhibitors on the onset and progression of chronic kidney disease (CKD) in routine clinical practice. We conducted a retrospective cohort study using the Clinical Practice Research Datalink Aurum database linked to Hospital Episode Statistics. The primary outcome was risk of the composite CKD endpoint based on the recent consensus guidelines for kidney disease: >40% decline in estimated glomerular filtration rate (eGFR), kidney death or end-stage kidney disease (ESKD; a composite of kidney transplantation, maintenance of dialysis, sustained low eGFR <15 ml/min/1.73m² or diagnosis of ESKD). Secondary outcomes were components of the composite CKD endpoint, analysed separately. Patients were propensity-score-matched 1:1 for SGLT2 inhibitor versus DPP-4 inhibitor use. A total of 131 824 people with type 2 diabetes (T2D) were identified; 79.0% had no known history of CKD. During a median follow-up of 2.1 years, SGLT2 inhibitor initiation was associated with lower risk of progression to composite kidney endpoints than DPP-4 inhibitor initiation (7.48 vs. 11.77 events per 1000 patient-years, respectively). Compared with DPP-4 inhibitor initiation, SGLT2 inhibitor initiation was associated with reductions in the primary composite CKD endpoint (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.56-0.74), all-cause mortality (HR 0.74, 95% CI 0.64-0.86) and ESKD (HR 0.37, 95% CI 0.25-0.55), reduced the rate of sustained low eGFR (HR 0.33, 95% CI 0.19-0.57), and reduced diagnoses of ESKD in primary care (HR 0.04, 95% CI 0.01-0.18). Results were consistent across subgroup and sensitivity analyses. In adults with T2D, initiation of an SGLT2 inhibitor was associated with a significantly reduced risk of CKD progression and death compared with initiation of a DPP-4 inhibitor.

An observational study of outcomes of proximal fibular osteotomy (PFO) in Medial Compartment osteoarthritis of knee joints

An observational study of outcomes of proximal fibular osteotomy (PFO) in Medial Compartment osteoarthritis of knee joints

Record linkage and big data—enhancing information and improving design

Background and ObjectivesTo highlight the potential of multiple file record linkage. Linkage increases the value of existing information by supplying missing data or correcting errors in existing data, through generating important covariates, and by using family information to control for unmeasured variables and expand research opportunities. MethodsRecent Manitoba papers highlight the use of linkage to produce better studies. Specific ways in which linkage helps deal with different substantive issues are described. ResultsWide data files—files containing considerable amounts of information on each individual—generated by linkage improve research by facilitating better design. Nonexperimental work in particular benefits from such linkages. Population registries are especially valuable in supplying family data to facilitate work across different substantive fields. ConclusionSeveral examples show how record linkage magnifies the value of information from individual projects. The results of observational studies become more defensible through the better designs facilitated by such linkage.

Abstract 1333: Dual blockade of the EP2 and EP4 PGE2 receptors with TPST-1495 is an optimal approach for drugging the prostaglandin pathway

Abstract Prostaglandin E2 (PGE2) is a bioactive lipid produced by tumor cells that drives disease progression through stimulating tumor proliferation, enhancing angiogenesis and suppressing immune function in the TME1, 2. PGE2 is also a mediator of adaptive resistance to immune checkpoint inhibitor therapy via the upregulation of cyclooxygenase-2 (COX-2). While the role of PGE2 signaling in cancer is clear, how best to inhibit PGE2 for cancer treatment remains under investigation. Inhibition of COX-1 and/or COX-2 has shown promising results in observational studies and meta-analyses, but inconsistent results in prospective studies. PGE2 signals through four receptors, EP1-4, that are variably expressed on tumor and immune cells and have distinct biological activities. The EP2 and EP4 receptors signal through cAMP and drive pro-tumor activities, while the EP1 and EP3 receptors signal through calcium flux and IP3 and drive immune activation and inflammation. While COX-2 and single EP inhibitors continue to be developed, the nature of PGE2 signaling supports our rationale to inhibit PGE2 by dual antagonism of the pro-tumor EP2/EP4 receptors, while sparing the pro-immune EP1/EP3 receptors. To our knowledge, TPST-1495 is the first clinical-stage dual inhibitor of both the EP2 and EP4 receptors. In mouse and human whole blood assays, dual blockade of EP2 and EP4 receptors with TPST-1495 reversed PGE2-mediated suppression of LPS-induced TNF-α, while single receptor antagonists were unable to block suppression at higher PGE2 concentrations. Similarly, in murine and human T cells in vitro, TPST-1495 inhibited PGE2-mediated suppression, resulting in a significant increase of IFN-γ production in response to stimulation with cognate peptide antigen. In vivo, TPST-1495 monotherapy significantly reduced tumor outgrowth in CT26 tumor-bearing mice and correlated with increased tumor infiltration by NK cells, CD8+ T cells, AH1-specific CD8+ T cells, and other anti-tumor myeloid and adaptive immune cell populations. The relative contribution of increased immune infiltration may be simultaneously dependent on the immunogenicity of the tumor model and on the direct antitumor effect of TPST-1495, because we also observed significant tumor regression in metastatic burden in the LS174T xenograft model in NSG mice as well as CT26 tumors in RAG2-/- animals, both of which are deficient in immune cell development. To that end, TPST- 1495 monotherapy significantly decreased the tumor burden compared to COX2 inhibition and EP2 or EP4 single antagonism in the Adenomatous Polyposis (APCmin/+) model, a model that is hypo-responsive to PD-1 monotherapy. TPST-1495 is currently being evaluated in an ongoing Phase 1 first-in-human study (NCT04344795) to characterize PK, PD, safety, and to identify a recommended phase 2 dose for expansion cohorts in key indications and biomarker-selected patients. Citation Format: Brian Francica, Justine Lopez, Anja Holtz, Dave Freund, Dingzhi Wang, Amanda Enstrom, Raymond Dubois, Francielle Kipper, Dipak Panigrahy, Chan Whiting, Sam Whiting, Thomas W. Dubensky. Dual blockade of the EP2 and EP4 PGE2 receptors with TPST-1495 is an optimal approach for drugging the prostaglandin pathway [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1333.

CDKL5 Deficiency Disorder-Related Epilepsy: A Review of Current and Emerging Treatment.

Cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) is a developmental and epileptic encephalopathy with infantile-onset epilepsy. Most individuals with CDD develop refractory epilepsy with multiple seizure types. Management of seizures in CDD remains challenging for clinicians given the highly refractory nature of seizures and the limited number of disease-specific studies that offer a high level of evidence. Epileptic spasms are the most common seizure type in CDD and are more often refractory to standard first-line treatment than are spasms of other etiologies. In other seizure types, the effectiveness of antiseizure medications is limited and wanes over time. Ketogenic diet and palliative surgical treatments have both had mixed results in observational studies. When treating refractory seizures in CDD, we recommend carefully balancing seizure control and treatment-related side effects to optimize each individual's overall quality of life. Clinical trials of medications targeting epilepsy in CDD have been conducted, and additional investigational small molecules, gene therapy, and other disease-modifying therapies are in development for CDD.

IDCRP Combat-Related Extremity Wound Infection Research.

Extremity trauma is the most common battlefield injury, resulting in a high frequency of combat-related extremity wound infections (CEWIs). As these infections are associated with substantial morbidity and may impact wounded warriors long after initial hospitalization, CEWIs have been a focus of the Infectious Disease Clinical Research Program (IDCRP). Herein, we review findings of CEWI research conducted through the IDCRP and discuss future and ongoing analyses. Military personnel with deployment-related trauma sustained between 2009 and 2014 were examined in retrospective analyses through the observational Trauma Infectious Disease Outcomes Study (TIDOS). Characteristics of wounded warriors with ≥1 open extremity wound were assessed, focusing on injury patterns and infection risk factors. Through a separate trauma-associated osteomyelitis study, military personnel with combat-related open fractures of the long bones (tibia, femur, and upper extremity) sustained between 2003 and 2009 were examined to identify osteomyelitis risk factors. Among 1,271 wounded warriors with ≥1 open extremity wound, 16% were diagnosed with a CEWI. When assessed by their most severe extremity injury (i.e., amputation, open fracture, or open soft-tissue wound), patients with amputations had the highest proportion of infections (47% of 212 patients with traumatic amputations). Factors related to injury pattern, mechanism, and severity were independent predictors of CEWIs during initial hospitalization. Having a non-extremity infection at least 4 days before CEWI diagnosis was associated with reduced likelihood of CEWI development. After hospital discharge, 28% of patients with extremity trauma had a new or recurrent CEWI during follow-up. Risk factors for the development of CEWIs during follow-up included injury pattern, having either a CEWI or other infection during initial hospitalization, and receipt of antipseudomonal penicillin for ≥7 days. A reduced likelihood for CEWIs during follow-up was associated with a hospitalization duration of 15-30 days. Under the retrospective osteomyelitis risk factor analysis, patients developing osteomyelitis had higher open fracture severity based on Gustilo-Anderson (GA) and the Orthopaedic Trauma Association classification schemes and more frequent traumatic amputations compared to open fracture patients without osteomyelitis. Recurrence of osteomyelitis was also common (28% of patients with open tibia fractures had a recurrent episode). Although osteomyelitis risk factors differed between the tibia, femur, and upper extremity groups, sustaining an amputation, use of antibiotic beads, and being injured in the earlier years of the study (before significant practice pattern changes) were consistent predictors. Other risk factors included GA fracture severity ≥IIIb, blast injuries, foreign body at fracture site (with/without orthopedic implant), moderate/severe muscle damage and/or necrosis, and moderate/severe skin/soft-tissue damage. For upper extremity open fractures, initial stabilization following evacuation from the combat zone was associated with a reduced likelihood of osteomyelitis. Forthcoming studies will examine the effectiveness of common antibiotic regimens for managing extremity deep soft-tissue infections to improve clinical outcomes of combat casualties and support development of clinical practice guidelines for CEWI treatment. The long-term impact of extremity trauma and resultant infections will be further investigated through both Department of Defense and Veterans Affairs follow-up, as well as examination of the impact on comorbidities and mental health/social factors.

DoD-VA Trauma Infection Research Collaboration.

In the aftermath of wars, there is a surge in the number of wounded service members who leave active duty and become eligible for healthcare through the Department of Veterans Affairs (VA). Collaborations between the Department of Defense (DoD) and VA are crucial to capture comprehensive data and further understand the long-term impact of battlefield trauma. We provide a summary of the development, methodology, and status of an effective collaboration between the Infectious Disease Clinical Research Program and the St. Louis VA Health Care System with the multicenter, observational Trauma Infectious Disease Outcomes Study (TIDOS), which examines the short- and long-term outcomes of deployment-related trauma. As part of TIDOS, wounded service members who transitioned to participating military hospitals in the United States (2009-2014) were given the opportunity to enroll in a prospective follow-up cohort study to continue to capture infection-related data after their hospital discharge. Enrollees in the TIDOS cohort who left military service and received health care through the VA also had the option of consenting to have relevant VA medical records abstracted and included with the study data. Infections considered to be complications resulting from the initial trauma were examined. Among 1,336 TIDOS enrollees, 1,221 (91%) registered and received health care through the VA with 633 (47%) consenting to follow-up using VA records and comprising the TIDOS-VA cohort. Of the first 337 TIDOS-VA cohort enrollees, 38% were diagnosed with a new trauma-related infection following hospital discharge (median: 88 days; interquartile range: 18-351 days). Approximately 71% of the infections were identified through DoD sources (medical records and follow-up) and 29% were identified through VA electronic medical records, demonstrating the utility of DoD-VA collaborations. The TIDOS DoD-VA collaboration has also been utilized to assess intermediate and long-term consequences of specific injury patterns. Among 89 TIDOS-VA cohort enrollees with genitourinary trauma, 36% reported sexual dysfunction, 21% developed at least one urinary tract infection, 14% had urinary retention/incontinence, and 8% had urethral stricture. The rate of urinary tract infections was 0.05/patient-year during DoD follow-up time and 0.07/patient-year during VA follow-up time. Wider capture of infection-related outcome data through the DoD-VA collaboration provided a clearer picture of the long-term infection burden resulting from deployment-related trauma. Planned analyses include assessment of osteomyelitis among combat casualties with amputations and/or open fractures, evaluation of mental health and social factors related to injury patterns, and examination of health care utilization and cost in relation to infectious disease burdens.

Magnet and button battery ingestion in children: multicentre observational study of management and outcomes.

BackgroundMagnets and button batteries (BBs) are dangerous ingested foreign bodies in children. The scale and consequences of this public health issue in the UK are unknown. This study aims to report the current management strategies and outcomes associated with paediatric magnet and BB ingestion in the UK.MethodsThis multicentre, retrospective observational study involved 13 UK tertiary paediatric surgery centres. Children aged under 17 years, admitted between 1 October 2019 and 30 September 2020, following magnet, or BB ingestion were included. Demographics, investigations, management, and complications were recorded.ResultsIn total, 263 patients were identified, comprising 146 (55.5 per cent) magnet, 112 (42.6 per cent) BB, and 5 (1.9 per cent) mixed magnet BB ingestions. Median (interquartile range) age was 4.8 (2.0–9.1) years and 47.5 per cent were female. In the magnet group, 38 (26.0 per cent) children swallowed single magnets, 3 of whom underwent endoscopic retrieval for oesophageal or gastric impaction. Of the 108 (74.0 per cent) children who swallowed multiple magnets, 51 (47.2 per cent) required endoscopic or surgical intervention, predominantly for failure of magnets to progress on serial imaging. Bowel perforations occurred in 10 children (9.3 per cent). Younger age and ingestion of greater numbers of multiple magnets were independently associated with surgery. BB ingestion caused morbidity in 14 children (12.5 per cent) and life-threatening injuries in two (1.8 per cent); the majority were caused by oesophageal BBs (64.3 per cent).ConclusionMultiple magnet and BB ingestions are associated with significant morbidity. Action must be taken at an international level to regulate the sale of magnets and BBs, and to raise awareness of the risks that these objects pose to children.

Relationship between Atherosclerosis and Cancer: An observational outcome study

Background and aims: It was investigated whether there is a relationship between advanced atherosclerosis of the carotid artery and cancer. Method: The carotid Total Plaque Area (TPA), the maximum plaque thickness, and the cardiovascular risk based on Framingham calculator using body-mass-index were determined in healthy subjects using ultrasound. We compared the outcome in subjects with advanced atherosclerosis of the carotid artery (type III-IV b finding) with and without statin treatment. The follow-up was collected as part of occupational health check-ups. Result: In 4207 healthy men aged 35-65 years (50±8 years) we found 578 subjects with advanced atherosclerosis of the carotid artery (type III-IV b finding). A follow-up was available for 566 (97.9%) subjects. The average follow-up time was 48 months (range 0 to 139 months). Ten subjects were excluded because of missing data on treatment. A total number of 230 subjects was treated with a statin, 326 received no statin. Within the group of these subjects (54±6 years), 33 men died (15 cancer, 4 strokes, 11 heart attacks, 1 COPD, 1 sepsis, 1 cirrhosis of the liver). In the group with CVD death, two subjects were treated with a statin, 13 were untreated. In the group with cancer death, two subjects were treated with a statin, 13 were untreated. The death rate because of cancer and CVD was 1.7% for the treated subjects and 8.0% for the untreated subjects. In the group with low risk (n= 1890), six men died (2 traffic accidents, 1aneurysm bleeding, 2 cancer, 1 unclear, a follow-up examination has been completed for 43.9% (n= 830) of the subjects, mean follow-up time of 65 months (0-137 months). One man died (Parkinson) within the group with intermediate risk. In this group (n= 482) a follow-up examination has been completed for 55% (n= 265) with a mean follow-up time of 55 months (total range: 0-130 months). In the reference group (no atherosclerosis; n= 1257) follow-up has been completed in 38.3% (n= 482) with a mean follow-up time of 60 (0-145) months and nobody died. In 3203 healthy women aged 35-65 years nobody died of cancer. Conclusion: The development of cancer in men with advanced atherosclerosis of the carotid artery appears to be noticeable. The question of whether there is a causal relationship requires further investigations.

A retrospective observational study of patient analgesia outcomes when regional anaesthesia procedures are performed by consultants versus supervised trainees.

At teaching hospitals, consultants must provide effective supervision, including appropriate selection of teaching cases, such that the outcomes achieved by trainees are similar to that of consultants. Numerous studies in the surgical literature have compared patient outcomes when surgery is performed by consultant surgeons or surgical trainees but, to our knowledge, none exist in the field of anaesthesia. We aimed to compare analgesia outcomes of regional anaesthesia when performed by supervised trainees versus consultants. We designed a retrospective observational study using registry data. The primary outcome was inadequate analgesia, defined as a numerical rating scale (NRS) for pain >5 reported at any time in the post-anaesthesia care unit (PACU). Secondary outcomes included the maximum pain NRS, pain experienced in the PACU, and the requirement for systemic opioid analgesia in the PACU. Of the 1814 patients analysed, the primary proceduralist was a consultant for 514 (28.3%) patients and a trainee for 1300 (71.7%) patients. All trainees were supervised by an on-site consultant. There were no statistically significant differences between consultants and supervised trainees in terms of the primary outcome (NRS >5 in 24.9% and 24.5% of patients, respectively; P = 0.84) and secondary outcomes. Compared to trainees, consultants had a slightly higher rate of patients with a body mass index >30 kg/m2, an American Society of Anesthesiologists Physical Status Classification of 3 or 4, nerve blocks performed under general anaesthesia, paravertebral/neuraxial blocks and blocks with perineural catheter placement. Regional anaesthesia performed by supervised trainees can achieve similar analgesia outcomes to consultant-performed procedures.

An observational cohort study of health outcomes and costs associated with early pregnancy assessment units in the UK

BackgroundThe objective of this study was to assess the impact of consultant presence, volume of patients seen and weekend opening on the health and cost-related outcomes associated with different Early Pregnancy Assessment Unit (EPAU) configurations.MethodsThis was an observational study with a prospective cohort design. Six thousand six hundred six pregnant women (16 years of age and over) attending EPAUs because of suspected early pregnancy complications were recruited from 44 EPAUs across the UK. The main outcome measures were quality of life, costs, and anxiety.ResultsCosts, quality of life and anxiety scores were similar across configurations with little evidence to suggest an impact of consultant presence, weekend opening or volume of patients seen. Mean overall costs varied from £92 (95% CI £85 - £98) for a diagnosis of normally developing pregnancy to £1793 (95% CI £1346 - £2240) for a molar pregnancy. EQ-5D-5L score increased from 0.85 (95% CI 0.84–0.86) at baseline to 0.91 (95% CI 0.90–0.92) at 4 weeks for the 573 women who completed questionnaires at both time points, largely due to improvements in the pain/discomfort and anxiety/depression dimensions. 78% of women reported a decrease in their anxiety score immediately following their EPAU appointment.ConclusionsEPAU configuration, as specified in this study, had limited impact on any of the outcomes examined. However, it is clear that care provided in the EPAU has a positive overall effect on women’s health and emotional wellbeing, with significant improvements in EQ-5D and anxiety shown following an EPAU visit.

The influence of occupational stress on workers’ health: systematic review and meta-analysis

Background/objective: This study is a systematic review and meta-analysis that aims to systematize and synthesize the results of observational studies which demonstrated the occupational stress influence in workers’ health. Methods: The literature review was carried out through searches in PUBMED, WEB OF SCIENCE, EMBASE, SCOPUS, CINAHL, PSCYINFO, and LILACS databases, from July to October 2020, and updated in October 2021. Observational studies that considered occupational stress as exposure, accessed it by the Job Content Questionnaire, and evaluated its influence in workers’ health were included, regardless of their publication year. The risk of bias of the included studies was assessed through the Research Triangle Institute Item Bank on Risk of Bias and Precision of Observational Studies. Results: For the qualitative analysis, the search strategy retained 42 studies, including 182187 participants. Among retained studies, the influence of occupational stress was examined in cardiovascular diseases (CVD) (n=10), as primary outcome, and metabolic syndrome (MS) (n=5), dyslipidemias (n=15), and obesity (n=22), as additional outcomes. Systematized evidence showed that high levels of occupational stress appear to be associated with CVD and MS. However, its influence in dyslipidemias and obesity remain unclear. Meta-analyses of these clinical conditions showed significant associations between occupational stress and CVD (OR 1.34; 95%CI 1.15-1.57) and MS (OR 2.75, CI95% 1.97-3.83), but no significant effect between stress at work and dyslipidemias and obesity. Conclusions: A consistent adverse effect of occupational stress was observed on CVD and MS, considering studies with high methodological quality (low risk of bias). These findings can contribute to the development of actions to attenuate the stress at work to provide a better quality of life for workers. Other: This work received no specific grant from any funding agency and was registered on the PROSPERO platform under the CDR protocol number 102751.