Clinical Demographics Research Articles

Baseline cardiovascular risk in subjects with type 2 diabetes and chronic kidney disease from the FLOW trial

Abstract Background Patients with chronic kidney disease and type 2 diabetes (T2D) have a high risk of progression to kidney failure as well as cardiovascular (CV) events. It is established that glucagon-like peptide-1 receptor agonists (GLP-1RAs) improve glycaemic control and reduce body weight. Some CV outcomes trials have shown that GLP-1RAs reduce CV risk in people with T2D at high CV risk; for example, the SUSTAIN 6 trial demonstrated that the GLP-1RA semaglutide significantly lowered the rate of major CV events (CV death, non-fatal myocardial infarction and non-fatal stroke) versus placebo. Some trials have also indicated that GLP-1RAs reduce albuminuria and estimated glomerular filtration rate (eGFR) decline. Based on these previous results indicating potential kidney-protective effects, the FLOW trial (NCT03819153) is evaluating once-weekly, subcutaneous semaglutide 1.0 mg versus placebo on kidney- and CV-related outcomes in participants with T2D. We describe the baseline characteristics and the calculated CV risk of this patient population using the atherosclerotic CV disease (ASCVD) and second manifestations of arterial disease (SMART) risk calculators. Methods FLOW is an ongoing, multicentre, randomised, double-blind, parallel-group, event-driven, phase 3b trial, with participants randomised 1:1 to semaglutide or placebo, each in addition to standard of care. Recruitment is complete and 3,535 participants with T2D, an eGFR ≥25–≤75 mL/min/1.73 m2, and urine albumin-to-creatinine ratio ≥100–≤5,000 mg/g have been enrolled. The primary endpoint is time to first occurrence of a kidney composite that includes ≥50% persistent eGFR reduction, kidney failure (persistent eGFR <15 mL/min/1.73 m2 or initiation of chronic dialysis or kidney transplantation), and kidney-related death, or CV death. Key secondary outcomes include time to first occurrence of CV death, myocardial infarction or stroke. Results The baseline clinical characteristics and demographics are shown (Table 1). Median age was 68 years, 30% were female, mean diabetes duration was 17 years, and 98% had a history of hypertension. Overall, 52% of participants had a previous CV event. The calculated 10-year risk for ASCVD events in those without prior ASCVD was 31% in males and 18% in females, and in those with previous CV events was 37–56% in males and 35–53% in females depending on the type of CV disease reported in the calculator (Table 2). Conclusions The FLOW trial has completed enrolment. Based on the ASCVD and SMART risk calculators, the enrolled population has a substantial risk for adverse CV outcomes. Event ascertainment is ongoing, and the FLOW trial will provide evidence for the potential of semaglutide to improve kidney and CV outcomes in the T2D population. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Novo Nordisk

Impact of proportionate versus disproportionate mitral regurgitation on acute procedural changes and clinical outcomes following transcatheter mitral valve repair

Abstract Background Transcatheter mitral edge-to-edge repair (TEER) with MitraClip offers a less invasive alternative for patients with severe, symptomatic mitral regurgitation (MR) who are considered high risk for surgery. However, patient selection for TEER remains challenging given the variability in underlying MR pathology and current discordance among studies regarding predictors of procedural efficacy and clinical outcomes. Purpose This study aimed to assess acute procedural changes and long-term outcomes in patients who underwent TEER according to the proportionality of MR, defined as the ratio of the effective regurgitant orifice area (EROA) and left ventricular end-diastolic volume (LVEDV). Methods We analyzed patients who underwent TEER at our institution between 2014 and 2020 with available biplane left ventricular volume measurement. Relevant clinical comorbidities, demographics, and anthropometrics, along with pertinent pre- and post-procedural echocardiogram measurements, were obtained by review of the electronic medical record. The EROA to LVEDV index was calculated for all patients who were then stratified by quartiles. Patients with an EROA/LVEDV index in the lowest quartile were defined as having the most proportionate MR and those with an index in the highest quartile were defined as the most disproportionate MR. Baseline and post-TEER parameters were used to assess acute procedural and longitudinal outcomes. Results Baseline clinical and echocardiographic parameters of the 230 subjects according to quartile are shown in the table. Following TEER, there was a larger reduction in the left ventricular end-diastolic diameter and increased MR reduction with increasingly disproportionate MR (p=0.03 and p=0.05, respectively). The change in ejection fraction pre- versus post-TEER did not significantly differ across groups (p=0.64). Median follow up time was 1.7 (0.7–3.5) years; mortality occurred in 77 patients (33.5%) and heart failure hospitalizations occurred in 20 patients (8.7%) during follow up. No significant difference in all-cause mortality or post-procedural heart failure hospitalizations was identified across groups. Conclusions In our series, patients with proportionate MR were similarly symptomatic to those with disproportionate MR but had less severe MR with increased comorbidities. Post-TEER MR grade was similar between groups. Longer-term follow up in larger groups of patients is needed to determine the clinical implications. Funding Acknowledgement Type of funding sources: None.

Prolactinoma: Clinical Characteristics, Management and Outcome.

Aim Prolactinoma, a prolactin (PRL) secreting functioning pituitary tumor, is the most common of all pituitary adenomas (PA) accounting for 40-60% and dopamine agonists (DA) are the cornerstone of treatment. The aim of this study was to review the clinical presentation, treatment modalities and therapeutic outcomes of patients with prolactinomas in the South Asia region. Methods This retrospective study was conducted in the Endocrinology Department of Shaukat Khanum Memorial Cancer Hospital and Research Centre from December 2011 till December 2019. Medical records were used to retrieve for patient's demographics, clinical features at diagnosis, PRL levels and size of prolactinoma on MRI at diagnosis and after start of dopamine agonists and outcome of medical management. Results A total of 107 patients were included in this study. Mean age at diagnosis was 35 (22-54) years for men and 32 (18-50) years for women and 66.4% (71) of the patients were females. Our study included 38 (35.5%) microadenoma, 50 (46.7%) macroadenoma and 19 (17.8%) giant adenomas. At presentation, the most common symptom among females was menstrual irregularity/amenorrhea seen in 73.2% of females and among males was visual disturbance (80.6%). A significant reduction in PRL levels was seen within six to 12 months of treatment. Mean PRL levels decreased from 3162.8 ng/ml to 1.52 ng/ml. A notable decrease in tumor size was seen with medical management, mean adenoma size decreased from 2.18 cm to 1.04 cm. With cabergoline (CAB) 83.3% biochemical cure was seen compared to bromocriptine (BRC) which has 60.4%. The radiological response rate in CAB and BRC groups was 65.45% and 60%, respectively. Complete resolution of adenoma was seen in 13 patients (nine were microadenoma, two macro and two giant adenomas). The prolactin level at diagnosis was positively correlated with maximum tumor diameter (r = 0.469, P = 0.001). Two patients developed cerebrospinal fluid (CSF) rhinorrhea and the defect was repaired in both patients. Median follow-up duration was 40 (12-288) months. Conclusion Clinical presentation and demographics of prolactinoma are the same in our region when compared to the rest of the world. Cabergoline is superior to bromocriptine in prolactin normalization and tumor shrinkage but still bromocriptine is being used in a significant number of patients in low-income countries as first-line due to its low cost.

Criminal legal involvement among recently separated veterans: Findings from the LIMBIC study.

This study investigated individual-level and neighborhood-level predictors of criminal legal involvement of veterans during the critical transition period from military to civilian life. We hypothesized that substance use, mental health, and personality disorders will increase the incidence of criminal legal involvement, which will be highest among veterans living in socioeconomically disadvantaged neighborhoods after military discharge. We analyzed data from a longitudinal cohort study of 418,624 veterans who entered Department of Veterans Affairs (VA) health care after leaving the military. Department of Defense (DoD) data on clinical diagnoses, demographics, and military history were linked to VA data on neighborhood of residence and criminal legal involvement. Criminal legal involvement in the 2 years following military discharge was most strongly predicted by younger age, substance use disorder, and being male. Other predictors included the military branch in which veterans served, deployment history, traumatic brain injury, serious mental illness, personality disorder, having fewer physical health conditions, and living in socioeconomically disadvantaged neighborhoods. These factors combined in multivariable analysis yielded a very large effect size for predicting criminal legal involvement after military separation (area under the curve = .82). The incidence of criminal legal involvement was 10 times higher among veterans with co-occurring substance use disorder, serious mental illness, and personality disorder than among veterans with none of these diagnoses, and these rates were highest among veterans residing in more socioeconomically disadvantaged neighborhoods. To our knowledge, this is the largest longitudinal study of risk factors for criminal legal involvement in veterans following military discharge. The findings supported the hypothesis that veterans with co-occurring mental disorders living in socioeconomically disadvantaged neighborhoods were at higher risk of criminal legal involvement, underscoring the complex interplay of individual-level and neighborhood-level risk factors for criminal legal involvement after veterans leave the military. These results can inform policy and programs, such as the DoD Transition Assistance Program (TAP) and the VA Military to Civilian Readiness Pathway program (M2C Ready), to enhance community reintegration and prevent criminal legal involvement among veterans transitioning from military to civilian life. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Learning Curve of Laparoscopic Common Bile Duct Exploration: A Systematic Review.

Background: Single-stage laparoscopic common bile duct exploration (LCBDE) with cholecystectomy has superior outcomes over two-stage endoscopic retrograde cholangiopancreatogram with interval cholecystectomy. With decreasing trend of LCBDE, this study aims to summarize the literature on learning curve (LC) in LCBDE. Materials and Methods: PubMed, Embase, Scopus, and the Cochrane Library were systematically searched for articles from inception to June 3, 2022 (PROSPERO Ref No: CRD42022328451). Basic clinical demographics were collected. Poisson means (95% confidence interval [95% CI]) was used to determine the number of cases required to surmount the LC (NLC). Results: Eight articles (n = 2071 patients) reported LC outcomes in LCBDE with mean study period of 5.9 ± 2.8 years. Majority of studies (62.5%) used arbitrary methods of LC analysis. Most common outcomes reported were complications (any or major) (75%), open conversion (75%), length of stay (62.5%), and operating time (50%). Mean CBD diameter was 11.3 ± 4.8 mm (n = 1122 patients). Incidence of acute cholecystitis, acute cholangitis, and acute pancreatitis were 13.9% (n = 232/1668), 7.8% (n = 128/1629), and 13.7% (n = 229/1668), respectively. Pooled analysis of all the included studies showed NLC of 78.8 cases (95% CI: 71.9-86.3). Studies that used cumulative sum control chart analysis, nonarbitrary methods, and arbitrary-based LC had NLC of 152.0 (95% CI: 135.4-170.1), 108.0 (95% CI: 96.6-120.4), and 49.7 (95% CI: 42.0-58.3) cases, respectively. NLC was 37.0 cases (95% CI: 29.1-46.5) for single surgeon LC, and 99.8 cases (95% CI: 90.2-110.0) for institutional LC. Conclusion: Studies reporting NLC in LCBDE are heterogeneous. Further studies should use nonarbitrary methods of analysis for patient-reported outcome measures and procedure-specific morbidity.

Worldwide Survey of Clinician Practice on use of Adjunctive Therapies Following Botulinum Toxin Injection for Spasticity.

ObjectiveNon-pharmacological adjunctive therapies can be used alongside botulinum toxin injection to enhance its efficacy. The objective of this global study was to determine the current practice and perception among clinicians of the use of adjunctive therapies after botulinum toxin injections for the treatment of limb spasticity.MethodsA questionnaire with 22 questions on clinical practice demographics, self-reported use and clinician opinion on barriers to the use of complementary therapies, and priorities for future research was translated into 7 languages and distributed worldwide through national and international professional associations concerning (neuro)rehabilitation.ResultsA total of 527 clinicians from 52 countries responded to the survey. Most commonly used physical interventions were: active exercise programmes at home (81%), stretching programmes at home (81%), and splinting (70%), followed by active movement exercises (65%) and within 30 min of botulinum toxin injection and constraint induced movement therapy (63%). The main barriers reported by clinicians to provision of these interventions were clinicians’ lack of time, limited financial resources, and lack of evidence. Future research should focus primarily on immediate active movement exercises and passive stretching.ConclusionWorldwide, clinicians often recommend adjunctive therapies after a botulinum toxin injection to reduce spasticity. The most commonly used physical interventions among clinicians were active exercises at home, stretching at home, and splinting. Lack of evidence, time and financial constraints were identified as barriers to providing these interventions.LAY ABSTRACTA neurological injury, such as a stroke, traumatic brain injury or spinal cord injury, may cause muscle stiffness, a condition known as spasticity. Among available treatments for spasticity, botulinum toxin, a neurotoxin injected into the muscle, is used in cases of focal spasticity. Adjunctive therapies are therapies other than drugs that are used to enhance the efficacy of a treatment, such as botulinum toxin. The aim of this worldwide survey of clinicians was to determine the current clinical practice and perception of the use of adjunctive therapies following botulinum toxin injections. The results showed that the most frequently prescribed adjunctive therapies were active exercises at home, stretching at home, and splinting. The main barriers reported by clinicians to provision of these interventions were clinicians’ lack of time, limited financial resources, and lack of evidence.

Endogenous oxytocin levels in extracted saliva elevates during breastfeeding correlated with lower postpartum anxiety in primiparous mothers

BackgroundBreastfeeding in the early postpartum period is expected to have mental benefits for mothers; however, the underlying psychobiological mechanisms remain unclear. Previously, we hypothesized that the release of oxytocin in response to the suckling stimuli during breastfeeding would mediate a calming effect on primiparous mothers, and we examined salivary oxytocin measurements in primiparous mothers at postpartum day 4 using saliva samples without extraction, which was erroneous. Thus, further confirmation of this hypothesis with a precise methodology was needed.MethodsWe collected saliva samples at three time points (baseline, feeding, and post-feeding) to measure oxytocin in 24 primiparous mothers on postpartum day 2 (PD2) and 4 (PD4) across the breastfeeding cycle. Salivary oxytocin levels using both extracted and unextracted methods were measured and compared to determine the qualitative differences. State and trait anxiety and clinical demographics were evaluated to determine their association with oxytocin changes.ResultsBreastfeeding elevated salivary oxytocin levels; however, it was not detected to a significant increase in the extraction method at PD4. We found a weak but significant positive correlation between changes in extracted and unextracted oxytocin levels during breastfeeding (feeding minus baseline); there were no other significant positive correlations. Therefore, we used the extracted measurement index for subsequent analysis. We showed that the greater the increase in oxytocin during breastfeeding, the lower the state anxiety, but not trait anxiety. Mothers who exclusively breastfed at the 1-month follow-up tended to be associated with slightly higher oxytocin change at PD2 than those who did not.ConclusionsBreastfeeding in early postpartum days could be accompanied by the frequent release of oxytocin and lower state anxiety, potentially contributing to exclusive breastfeeding.

Biofilm formation is not an independent risk factor for mortality in patients with Acinetobacter baumannii bacteremia.

In the past decades, due to the high prevalence of the antibiotic-resistant isolates of Acinetobacter baumannii, it has emerged as one of the most troublesome pathogens threatening the global healthcare system. Furthermore, this pathogen has the ability to form biofilms, which is another effective mechanism by which it survives in the presence of antibiotics. However, the clinical impact of biofilm-forming A. baumannii isolates on patients with bacteremia is largely unknown. This retrospective study was conducted at five medical centers in Taiwan over a 9-year period. A total of 252 and 459 patients with bacteremia caused by biofilm- and non-biofilm-forming isolates of A. baumannii, respectively, were enrolled. The clinical demographics, antimicrobial susceptibility, biofilm-forming ability, and patient clinical outcomes were analyzed. The biofilm-forming ability of the isolates was assessed using a microtiter plate assay. Multivariate analysis revealed the higher APACHE II score, shock status, lack of appropriate antimicrobial therapy, and carbapenem resistance of the infected strain were independent risk factors of 28-day mortality in the patients with A. baumannii bacteremia. However, there was no significant difference between the 28-day survival and non-survival groups, in terms of the biofilm forming ability. Compared to the patients infected with non-biofilm-forming isolates, those infected with biofilm-forming isolates had a lower in-hospital mortality rate. Patients with either congestive heart failure, underlying hematological malignancy, or chemotherapy recipients were more likely to become infected with the biofilm-forming isolates. Multivariate analysis showed congestive heart failure was an independent risk factor of infection with biofilm-forming isolates, while those with arterial lines tended to be infected with non-biofilm-forming isolates. There were no significant differences in the sources of infection between the biofilm-forming and non-biofilm-forming isolate groups. Carbapenem susceptibility was also similar between these groups. In conclusion, the patients infected with the biofilm-forming isolates of the A. baumannii exhibited different clinical features than those infected with non-biofilm-forming isolates. The biofilm-forming ability of A. baumannii may also influence the antibiotic susceptibility of its isolates. However, it was not an independent risk factor for a 28-day mortality in the patients with bacteremia.

Primary hyperparathyroidism in pregnancy: experience of a tertiary centre

Background and purposeThe management of primary hyperparathyroidism (PHPT) during pregnancy is challenging and there is no clear consensus on whether it increases the risk of complications in pregnancy. We conducted this study to review the maternal and fetal outcomes of pregnant women treated for PHPT in a single centre.MethodsData on relevant clinical parameters, demographics, management strategies, maternal and fetal outcomes were collected from the medical records of pregnant patients with PHPT diagnosed between 2012 and 2019.ResultsOf 15 pregnant women with PHPT, 6 were managed medically and 9 underwent surgery. The median age at their index pregnancy was 28 years [range 19–42]. The median highest adjusted calcium level in the medical group was 2.90 [range 2.61–3.25] mmol/L vs. 3.11 [2.78–4.95] mmol/L in the surgical group. There was one miscarriage and the stillbirth of twins in the medical group, but no such outcomes in the surgical group. The median gestational ages were 39 + 3 weeks [range 24 + 2–41 + 2 weeks] and 39 + 4 weeks [range 37 + 1–39 + 5 weeks] in the medical and surgical groups, respectively. No birth was complicated by neonatal tetany or convulsions.ConclusionMore complications developed in the pregnant PHPT patients who were managed medically than in those who underwent surgery. Surgery performed during the second trimester resulted in good outcomes. Multi-centre prospective studies are required to ascertain the risk of various complications in women with PHPT during pregnancy.

Contemporary outcomes in IDH-mutated acute myeloid leukemia: The impact of co-occurring NPM1 mutations and venetoclax-based treatment.

Isocitrate dehydrogenase 1 or 2 (IDH1 or IDH2) mutations occur frequently in newly diagnosed (ND) acute myeloid leukemia (AML) often with co-occurring NPM1 mutations, which may influence treatment outcomes. Detailed analysis of IDH-mutated AML treated with venetoclax and influence of co-occurring NPM1 mutations remains unclear. This retrospective single-center cohort study evaluated clinical and molecular demographics,response and survival, and impact of co-occurring NPM1 mutations in patients with IDH1 or IDH2-mutated AML. 556 patients with IDH1, IDH2, and/or NPM1 mutated AML were included. Patients with IDH1mut AML (N= 119) were more likely to have older age, sAML, ELN-adverse risk disease, and adverse-risk cytogenetics compared to those with IDH2mut (N= 229) or IDHwt /NPM1mut AML (N= 208). In multivariate analysis, patients with IDH2mut (HR 0.61 [95%CI: 0.43-0.88], p value: .007) or IDHwt /NPM1mut (HR 0.65 [95% CI: 0.45-0.94], p value: .024) AML had a decreased risk of death versus IDH1mut AML. Venetoclax-based lower-intensity regimens partially abrogated the detrimental effect of IDH1mut with similar OS observed between IDH1mut /NPM1wt , IDH2mut /NPM1wt , and IDHwt /NPM1mut AML. With regards to the influence of IDHmut /NPM1mut cases, IC improved survival in IDH2mut /NPM1mut versus IDH2mut /NPM1wt AML (HR: 0.54 [95% CI: 0.2644-1.082], p value: .077), while venetoclax-based therapy improved survival in IDH1mut /NPM1mut versus IDH1mut /NPM1wt AML (HR: 0.094 [95% CI: 0.01-0.74], p value: .0056). Differing outcomes were observed in IDH1mut versus IDH2mut or NPM1mut AML which were influenced by co-occurring NPM1 mutations and partially abrogated with venetoclax-based therapy. Given the differing biology and survival in IDH1mut AML, investigations incorporating molecularly targeted therapies such as IDH inhibitors remain warranted in this subgroup.

Health literacy in patients with intermittent claudication in relation to clinical characteristics, demographics, self-efficacy and quality of life – A cross-sectional study

BackgroundIntermittent claudication requires treatment with secondary prevention to reduce disease progression and the risk of cardiovascular events and to improve quality of life. Health literacy and self-efficacy are important preconditions for the health behaviour changes necessary for adhering to secondary prevention. AimEvaluate health literacy in patients with intermittent claudication regarding clinical characteristics, demographics, self-efficacy and quality of life. MethodsA cross-sectional study evaluating health literacy, self-efficacy and quality of life using questionnaires. Patients with intermittent claudication from vascular units in the south of Sweden were included. ResultsIn total, 158 patients were included, of which, 52.5% reported “inadequate” (0-8 points) or “problematic” (9-12 points) health literacy with no differences between men and women. A significant higher proportion of patients living alone reported “inadequate” or “problematic” health literacy than “sufficient” (13-16 points) health literacy. Patients with “sufficient” health literacy reported significantly higher self-efficacy and quality of life and were more physically active than patients with “inadequate” or “problematic” health literacy. Also, patients with a university degree reported a significantly higher ability to “access” (seek, find and obtain) and “understand” (comprehend the accessed) information relevant to health. ConclusionThe majority of patients with intermittent claudication have “inadequate” or “problematic” health literacy. Also, an “inadequate” or “problematic” health literacy level is more common among patients living alone, and education level appears to be more important when “accessing” and “understanding” information relevant to health. This illuminates the importance of not only the patients’ health literacy but also demographics when planning for secondary prevention.

Curating a knowledge base for individuals with coinfection of HIV and SARS-CoV-2: a study protocol of EHR-based data mining and clinical implementation

IntroductionDespite a higher risk of severe COVID-19 disease in individuals with HIV, the interactions between SARS-CoV-2 and HIV infections remain unclear. To delineate these interactions, multicentre Electronic Health Records (EHR)...

210.1: Immunosuppression Minimization During COVID Infection: Is It Safe?

Introduction: Managing post-transplant COVID-19 patients has proven challenging. On one hand, they are more vulnerable due to their immunocompromised status, and on the other hand, reducing immunosuppression (IS) may result in graft rejection and formation of de-novo donor specific antibodies (DSA). Here, we share our experience of balancing disease treatment and the risk of rejection in a cohort of renal post-transplant recipients. Methods: We retrospectively collected data on 136 renal transplant recipients who were diagnosed with COVID-19 between May 2020 and December 2021. Clinical information, demographics and HLA antibody data were extracted from patients’ medical records. Results: The median time from transplant to COVID-19 diagnosis in our cohort was 4.1 years (range 13 days to 30.8 years). The average age at diagnosis was 50.5 and 63% were males. 28% of the patients were hospitalized and 13.2% had died as a result of their infection. The most common therapies included Monoclonal antibodies (39.7%), Dexamethasone (22%) and Remdesivir (18.4%). IS modulation, which primarily included holding off the anti-metabolite, was done in 98/136 patients (72%), and was later resumed in 70 of the 98 patients with a median time of 8.6 days (range 2-204) from holding off to resuming IS. 25 patients had pre- and post-infection DSA data. Despite the modulation in IS, 23 out of the 25 patients did not exhibit a change in DSA status (within a median time follow up of 70 days) nor a significant change in sensitization status as determined by calculated panel reactive antibody (cPRA). Only two patients developed de-novo DSA post COVID-19 infection, however a biopsy performed on one patient did not show acute rejection. Four patients progressed to graft failure post infection - Two due to worsening chronic antibody mediated rejection, one had renal injury due to direct effects of COVID-19 infection, and one had failing graft before COVID-19, suffered a severe disease including intubation and lost his graft shortly after recovering. Conclusions: Reduction of the anti-metabolic immunosuppressive therapy for a short period of time did not seem to correlate with development of de-novo DSA or increased rates of acute rejection in our expanded cohort. Studies on larger cohorts will help further determine the impact of IS reduction on transplant outcomes following COVID-19 infection in renal transplant recipients.

Increasing Incidence of Invasive Group A Streptococcus Disease, Idaho, USA, 2008-2019.

We investigated invasive group A Streptococcus epidemiology in Idaho, USA, during 2008–2019 using surveillance data, medical record review, and emm (M protein gene) typing results. Incidence increased from 1.04 to 4.76 cases/100,000 persons during 2008–2019. emm 1, 12, 28, 11, and 4 were the most common types, and 2 outbreaks were identified. We examined changes in distribution of clinical syndrome, patient demographics, and risk factors by comparing 2008–2013 baseline with 2014–2019 data. Incidence was higher among all age groups during 2014–2019. Streptococcal toxic shock syndrome increased from 0% to 6.4% of cases (p = 0.02). We identified no differences in distribution of demographic or risk factors between periods. Results indicated that invasive group A Streptococcus is increasing among the general population of Idaho. Ongoing surveillance of state-level invasive group A Streptococcus cases could help identify outbreaks, track regional trends in incidence, and monitor circulating emm types.

Faster postoperative recovery by robotic-assisted surgery in elderly patients with sigmoid colon and rectal cancer

BackgroundCurrently, no published studies have compared the short-term and long-term outcomes of robotic-assisted and open surgery for elderly patients (aged 65 years or older) with sigmoid colon and rectal cancer in China. Hence, our study was conducted to assess whether robotic-assisted surgery is superior to traditional approaches. MethodsA total of 208 patients who received either open resection (n ​= ​93) or robotic-assisted resection (n ​= ​115) between October 2010 and October 2014 were included in the study. We compared clinical characteristic variables and patient demographics between the two approaches and assessed short- and long-term outcomes. ResultsPatient characteristics were not significantly different between the groups. First flatus postoperative days (P ​< .001), less time to liquid diet (P ​= ​.004), and shorter postoperative hospital stay (P ​= ​.046) were found in the robotic-assisted surgery group. The operation time was also more in the robotic-assisted surgery group (P ​= ​.03). The 3-year overall survival rate was 83.0% in the robotic-assisted surgery group and 78.0% in the open surgery group (P ​= ​.938). The 3-year disease free survival rate was 76.0% and 72.0% in the robotic-assisted surgery and open surgery groups, respectively (P ​= ​.817). No significant difference was found in the overall survival and disease-free survival between the two approaches. ConclusionsRobotic-assisted surgery is safe and feasible for elderly patients with sigmoid colon and rectal cancer and is associated with more operation time and faster recovery as compared to open surgery. No significant differences were found in 3-year survival outcomes between the two groups.

Primary breast lymphoma in males: Incidence, demographics, prognostic factors, survival, and comparisons with females.

BackgroundPrimary breast lymphoma (PBL) is a rare disease condition and is mainly observed in females. No male PBL cohorts were reported previously. This study aims to investigate the incidence, clinical characteristics, prognostic factors, and survival outcomes among male PBL patients and also to perform comparisons between males and females.MethodsPatients diagnosed with PBL between 2000 and 2019 from the Surveillance, Epidemiology, and End Results (SEER) database were identified. Age-adjusted incidence rates were calculated by year and age for trend analysis. Univariate and multivariate Cox hazard proportional regression analyses were performed to identify prognostic factors. Survival comparisons were conducted using the Kaplan–Meier method and the log-rank test. The propensity matching score (PSM) method was used to balance demographics.ResultsThe incidence rate of 122 male PBL patients diagnosed in the period of 2000 to 2019 was 0.169 (95% CI: 0.140–2.203) per million persons, which was much lower than that of 2,543 females (1.59, 95% CI: 1.53–1.65). Clinical demographics were similar between females and males, except for lymphoma subtype distribution (P = 0.025). A higher age [hazard ratio (HR) = 1.08, 95% CI: 1.05–1.12, P < 0.001] and not receiving radiotherapy (receiving vs. not receiving: HR = 0.41, 95% CI: 0.21–0.78, P = 0.007) were significant risk factors associated with overall survival (OS) in males. Radiotherapy (OS: P = 0.023) can offer benefits in OS. Using the PSM method, we also revealed that male PBL patients had significantly worse OS and cancer-specific survival rates than females.ConclusionsThis study first analyzed male patients with PBL involving incidence, clinical characteristics, and survival data. Sex disparity was also observed in the survival outcome of the disease.

Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis of Clinical Trial Demographics.

Simple SummaryHPV-associated oropharyngeal squamous cell carcinoma (OPSCC) is unique amongst oropharyngeal cancers in its high responsiveness to treatment and its lower mortality rate. As a result, numerous clinical trials have been conducted to identify treatment modalities and protocols. In order for these trials to have meaningful impact on HPV-associated OPSCC patients, proper demographic representation by trial participants is essential. The aim of our systematic review and meta-analysis was to assess the demographics of trial participants for HPV-associated OPSCC clinical trials and compare them with those reported by national databases. We determined that clinical-trial participants were predominately non-smoking white men, with tonsils as the primary tumor site. These findings reflect the demographics reported by the National Cancer Database. Our results imply that HPV-associated OPSCC clinical trials appropriately represent the target population and offer immense benefit.The objective of our paper was to answer the following question: how do patients with HPV-related oropharyngeal squamous cell carcinoma OPSCC (Population) enrolled in clinical trials (Intervention), compared with national database reports of HPV-associated OPSCC patients (Comparison), present demographically (Outcome)? We conducted a systematic review and meta-analysis of studies pertaining to clinical trials of HPV-associated OPSCC and participant demographics in the United States. PubMed, Scopus, CINAHL, and the Cochrane Library were searched from inception to 2 February 2022. Studies of overlapping participant cohorts and/or studies conducted outside of the United States were excluded. Primary outcomes were patient age, sex, and race. Secondary outcomes were smoking history, alcohol history, history of prior cancer, and tumor origin site. Meta-analysis of single means (mean, N for each study, and standard deviation) for age, pack years, and smoking years was performed. Pooled prevalence rates of gender, race, alcohol history, tobacco history, and tumor origin site were expressed as a percentage, with 95% confidence intervals. Meta-analysis found patients to be predominately non-smoking white males, with tumors originating from the tonsil. Our findings reflected the demographics reported by the National Cancer Database (NCDB) for HPV-associated OPSCC. This indicates that HPV-associated OPSCC patients are appropriately represented in clinical trial demographics.

Late-onset cutaneous lupus erythematosus patients have distinctive clinical features and demographics versus early-onset patients.

Cutaneous lupus erythematosus (CLE) can present later in life, but frequency and risk factors of late-onset CLE patients are not well characterized. The study determined frequency of late-onset CLE and compared the demographic and disease characteristics between early-onset and late-onset CLE in a cohort of patients with CLE. To determine the frequency and compare clinical features of early-onset and late-onset CLE. This was a cross-sectional study of CLE patients seen in outpatient dermatology clinics at University of Texas Southwestern Medical Center (UTSW) and Parkland Health and Hospital System, Dallas, TX, from April 2009 to May 2019. The primary outcome was the age of CLE onset, stratified by early-onset (<50years) and late-onset CLE (≥50years). Predictor variables significantly associated with CLE onset groups were identified by univariate and multivariable logistic regression analyses. Of the 291 CLE patients studied, 79% were early-onset, and 21% were late-onset. Multivariable logistic regression analyses identified that Caucasian race (odds ratio (OR): 2.23, 95% Confidence Interval (CI): 1.19-4.19, p = 0.013), having a CLE subtype other than chronic (OR: 2.18, 95% CI: 1.02-4.65, p = 0.044), and drug-induced cases (OR: 4.65, 95% CI: 1.18-18.24, p = 0.028) were significantly associated with late-onset CLE. Early-onset CLE patients were more likely to have oral ulcers (OR: 3.58, 95% CI: 1.46-8.78, p = 0.005) and renal disorders (OR: 4.02, 95% CI: 1.10-14.71, p = 0.036). This was a single center study. Age of onset was self-reported and late-onset CLE cohort has a small sample size. Our diverse cohort of CLE patients had about one out of five patients with CLE experiencing disease onset after 50years old. These patients have distinct demographic and clinical presentations compared to early-onset CLE patients. Providers should remain mindful of CLE in older patients with photosensitive rashes and mild systemic symptoms.

Development and external validation of DISPAIR fistula risk score for clinically relevant postoperative pancreatic fistula risk after distal pancreatectomy.

Highly utilized risk scores for clinically relevant postoperative pancreatic fistula (CR-POPF) have guided clinical decision-making in pancreatoduodenectomy. However, none has been successfully developed for distal pancreatectomy. This study aimed to develop and validate a new fistula risk score for distal pancreatectomy. Patients undergoing distal pancreatectomy at Helsinki University Hospital, Finland from 2013 to 2021, and at Karolinska University Hospital, Sweden, from 2010 to 2020, were included retrospectively. The outcome was CR-POPF, according to the 2016 International Study Group of Pancreatic Surgery definition. Preoperative clinical demographics and radiological parameters such as pancreatic thickness and duct diameter were measured. A logistic regression model was developed, internally validated with bootstrapping, and the performance assessed in an external validation cohort. Of 668 patients from Helsinki (266) and Stockholm (402), 173 (25.9 per cent) developed CR-POPF. The final model consisted of three variables assessed before surgery: transection site (neck versus body/tail), pancreatic thickness at transection site, and diabetes. The model had an area under the receiver operating characteristic curve (AUROC) of 0.904 (95 per cent c.i. 0.855 to 0.949) after internal validation, and 0.798 (0.748 to 0.848) after external validation. The calibration slope and intercept on external validation were 0.719 and 0.192 respectively. Four risk groups were defined in the validation cohort for clinical applicability: low (below 5 per cent), moderate (at least 5 but below 30 per cent), high (at least 30 but below 75 per cent), and extreme (75 per cent or more). The incidences in these groups were 8.7 per cent (11 of 126), 22.0 per cent (36 of 164), 63 per cent (57 of 91), and 81 per cent (17 of 21) respectively. The DISPAIR score after distal pancreatectomy may guide decision-making and allow a risk-adjusted outcome comparison for CR-POPF.

Ocular syphilis resurgence in an urban underserved community in the United States.

To evaluate the clinical characteristics, demographics, and visual outcomes of patients with ocular syphilis at an urban hospital to increase awareness and assist in earlier diagnosis and treatment of the resurgent disease. A retrospective chart review was performed on patients with ICD-9 and ICD-10 diagnosis codes correlating with syphilis or syphilis-related ocular diseases between 2010 and 2019. Variables evaluated included age, gender, race, vision, ocular findings, human immunodeficiency virus (HIV) status and men who have sex with men status, recreational drug and alcohol use. Ocular syphilis was diagnosed in 40 patients (53 eyes) of a total of 229 patients who tested positive for syphilis via serum and/or cerebrospinal fluid treponemal testing from 2010-2019. Among patients with ocular syphilis, most patients were males, aged 45 or above and Black, and had no diagnosed HIV infection. Approximately 50% patients had 20/40 vision or better. Nearly 50% had non-granulomatous anterior uveitis as their initial presentation, and 49% of patients had involvement of the posterior segment. Neovascular glaucoma (5.7%), papillitis (7.5%), vasculitis (5.7%), and retinal detachment (5.7%) were rarer presentations of the disease and were associated with a poorer visual prognosis. Given the increased prevalence and protean manifestations of syphilis, early diagnosis and treatment are paramount. More studies on ocular syphilis are warranted to understand this resurging disease.