Propensity Score-matched Control Research Articles

MFOLFOXIRI versus mFOLFOX6 as neoadjuvant chemotherapy in locally advanced rectal cancer: A Propensity Score Matching Analysis

BackgroundPreoperative chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC). However, CRT failed to impact metastatic recurrence and the risk of side effects on bowel and genitourinary remained a concern. Neoadjuvant chemotherapy alone with mFOLFOX6 or FOLFOXIRI had been investigated in LARC. Here, we tried to compare the efficacy of mFOLFOXIRI with mFOLFOX6 as neoadjuvant chemotherapy in LARC. Patients and MethodsBetween January 2014 and December 2019, patients with LARC receiving neoadjuvant chemotherapy with mFOLFOXIRI or mFOLFOX6 were retrospective analyzed, including data from a prospective trial (NCT02217020). All patients underwent total mesorectal excision (TME). The propensity-score matching was preformed to adjust baseline potential confounders and to estimate differences in outcomes between patients receiving mFOLFOXIRI and mFOLFOX6. Survival analysis was done using Kaplan–Meier analysis and Cox proportional regression analysis. ResultsThe median follow-up time was 31.1 months. After propensity score matching, 156 patients were available for comparison in each group. The pathological complete response (pCR) rate was 17.9% vs. 5.1% (P< .001), the incidence rate of anastomotic fistula was 3.2% vs. 9% (P = .03), the 3 year disease-free survival (DFS) rate was 75% vs. 66.7% (P = .047) and the distant metastasis rate was 16.4% versus 26.6% (P = .013) for mFOLFOXIRI and mFOLFOX6 group, respectively. Patients receiving mFOLFOXIRI had higher incidence of grade III and/or IV nausea and/or vomiting (7.6% vs. 2.5%, P = .04). ConclusionsNeoadjuvant mFOLFOXIRI regimens improved pCR rate and survival outcome, reduced the rate of distant metastasis and anastomotic fistula when comparing with propensity-score matched controls of mFOLFOX6 neoadjuvant chemotherapy. MicroAbstractThis trial assessed the short-term and long-term effects of neoadjuvant chemotherapy with mFOLFOXIRI and mFOLFOX6 in patients with locally advanced rectal cancer. Comparing with propensity-score matched historical control of chemoradiotherapy, neoadjuvant mFOLFOXIRI chemotherapy was well tolerated and led to higher rates of 3 year disease-free survival in patients with locally advanced rectal cancer.

Axial spondyloarthritis may protect against poor outcomes in COVID-19: propensity score matched analysis of 9766 patients from a nationwide multi-centric research network.

IntroductionThe outcomes of COVID-19 in patients with axial spondyloarthritis (ax-SpA) have not been explored in detail. Tumour necrosis factor inhibitors (TNFi) are commonly used for ax-SpA patients, and how they influence outcomes may have implications on COVID-19 management.MethodsA nationwide multi-centric research network was queried for patients with ax-SpA, including ankylosing spondylitis (AS) and non-radiographic SpA (nr-SpA) who had developed COVID-19. An equal number of propensity score(PS) matched controls were extracted from the database amongst patients with COVID-19 who did not have any inflammatory arthritis. Outcomes included mortality and others including hospitalization, intensive care unit, ventilation, acute kidney injury (AKI), renal replacement therapy, acute respiratory distress syndrome, cerebral infarction, venous thromboembolism (VTE), and sepsis.ResultsWe identified 9766 patients with ax-SpA (924 AS and 8842 nr-SpA) and 691,862 without SpA who had COVID-19. In the unmatched comparison, patients with ax-SpA had higher risk ratios (RR) for all outcomes. After matching for demographics and comorbidities, patients with ax-SpA had lower RR for mortality [RR: 0.707 (95% CI: 0.598–0.836), p < 0.0001], severe COVID-19 [RR: 0.791 (0.69–0.906), p = 0.0007], hospitalization [RR: 0.872 (0.826–0.921), p < 0.0001], and AKI [RR: 0.902 (0.816–0.997), p = 0.044]. Only the risk of VTE was higher in ax-SpA patients [RR: 1.219 (1.037–1.433), p = 0.016]. Amongst the ax-SpA group, males had worse outcomes in 9 out of the 11 domains except for VTE and cerebral infarction, while blacks had worse outcomes in all except for mortality and the need for renal replacement therapy. AS had similar risk ratios for all outcomes compared with nr-SpA except hospitalization [RR: 1.457 (1.03–2.06), p = 0.0318]. There was no difference in outcomes in patients who had received TNFi in the year previous to COVID-19 infection. Ax-SpA patients who had been prescribed non-steroidal anti-inflammatory drugs in the 3 months prior to COVID-19 had poorer outcomes.ConclusionIn conclusion, COVID-19 outcomes were better in patients with ax-SpA as compared with PS matched controls except for increased risk for VTE. The use of TNFi is not associated with better or worse outcomes. These apparently protective effects observed need to be validated and explored further. Key Points• Patients with axial spondyloarthritis have lower mortality and morbidity during COVID-19 infections as compared with propensity score matched controls.• Axial spondyloarthritis is associated with higher risks for venous thromboembolism during COVID-19.• There is no difference in outcomes between ankylosing spondylitis and non-radiographic spondyloarthritis except in rates of hospitalization, which were higher in ankylosing spondylitis.• Use of tumour necrosis factor inhibitors did not influence COVID-19 outcomes.

Abstract 11987: Bariatric Surgery Reduces the Incidence of Heart Failure in Patients With Obesity

Introduction: Obesity, and the related metabolic syndrome, is one of the largest public health challenges facing medical systems across the globe. A growing body of evidence supports using bariatric surgery in patients with obesity for weight loss and prevention of cardiovascular disease. However, relatively little research has considered whether bariatric surgery reduces the risk of heart failure. This propensity-score matched UK-wide retrospective study aims to answer that question. Hypothesis: We hypothesised that bariatric surgery would reduce the incidence of heart failure in patients with obesity, as compared to non-surgical management. Methods: Using the Clinical Practice Research Datalink, a study cohort containing 3,052 patients who had received bariatric surgery were matched by propensity score to 3,052 controls. The primary endpoint was development of any heart failure. The secondary endpoints were all-cause mortality, development of heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) specifically, and hospitalisations due to heart failure. These endpoints were assessed using a Cox proportional hazards model. Results: The mean follow-up duration was 7.50 years. Patients who received bariatric surgery had a significantly lower incidence of new heart failure (hazard ratio 0.45, 95% confidence interval 0.28-0.73, p=0.0011) and all-cause mortality (hazard ratio 0.56, 95% confidence interval 0.38-0.83, p=0.0036). There was no significant difference in the rates of HFrEF or HFpEF individually, though these analyses were notably underpowered. Conclusions: In conclusion, this UK retrospective study provides evidence of lower rates of heart failure and all-cause mortality in patients who have bariatric surgery when compared to propensity-score matched controls. Future efforts to understand the mechanism behind this reduction and explore the lifetime benefits in high risk cohorts are paramount.

Full-Thickness Laparoendoscopic Excision for Management of Complex Colon Polyps.

Benign colon polyps are increasingly being detected because of improved colonoscopic screening and early detection of masses on the adenoma-to-carcinoma pathway. Full-thickness laparoendoscopic excision is a colon-preserving technique for endoscopically unresectable polyps consisting of endoscopically guided nonanatomic wedge colectomy. This study aimed to evaluate the safety and success of full-thickness laparoendoscopic excision compared to segmental colectomy for complex polyps not amenable to endoscopic resection. This is a retrospective case-control study. This study was conducted at a tertiary academic center. A prospectively maintained institutional database identified 22 patients with benign complex polyps managed with full-thickness laparoendoscopic excision from 2015 to 2020. These patients were compared with 22 propensity score-matched controls from the same database that underwent laparoscopic segmental colectomy. Primary outcome was inpatient length of stay. Secondary outcomes included operative details and postoperative morbidities. Full-thickness laparoendoscopic excision was successful in all patients. Patients had a median age of 64 years (41-85), and 82% were men. Final pathology revealed complete excision of benign lesions in 20 of 22 patients and adenocarcinoma in 2 of 22. For the adenocarcinomas, 1 patient underwent subsequent elective colectomy without complications, and 1 patient declined surgery. Propensity score matching was successful for age, sex, BMI, ASA score, colon location, and prior abdominal surgery. Compared with controls, cases had significantly shorter operative time (89.5 minutes (46-290) vs 122 minutes (85-200), p = 0.009), length of stay (1 day (0-17) vs 3 days (1-8), p < 0.001), and reduced blood loss (5 mL (2-15) vs 25 mL (10-150), p < 0.001). Thirty-day morbidity (9.1% vs 27.3%, p = 0.240) was not significantly different. An unplanned 30-day reoperation was performed in 1 patient for suspected small-bowel obstruction. There was 1 mortality due to decompensated cirrhosis in the treatment group. This study was limited by its single-institution retrospective design. Full-thickness laparoendoscopic excision is safe and successful compared with corresponding segmental colectomy for complex polyps. Favorable postoperative outcomes, including decreased operative time, length of stay, and blood loss, make it a useful approach for managing complex polyps throughout the colon.

Association between depression and antibiotic use: analysis of population-based National Health Insurance claims data

BackgroundFrequent exposure to antibiotic treatments may increase the risk of antibiotic resistance, which may threaten the effectiveness of future antibiotic treatments. Thus, it is important to identify the preventable risks in terms of antibiotic use. This study assessed the association between major depressive disorder (MDD) and antibiotic use by comparing the likelihood and extent of antibiotic use between patients with and without MDD.MethodsThis retrospective cross-sectional study utilized the National Patients Sample data from the 2017 Health Insurance Review and Assessment Service. We analyzed 16,950 patients with MDD, defined as those with at least two claims records stating a primary diagnosis of MDD (International Classification of Diseases, 10th revision codes F32–33) and 67,800 patients without MDD (1:4 propensity-score matched control group). Antibiotic use was compared between the patients with and without MDD based on three variables: the presence of antibiotic prescriptions, total prescription days of antibiotics per year, and total medication costs of antibiotics per year.ResultsThe adjusted odds ratio obtained by multivariate regression analysis for the presence of prescription of antibiotics was 1.31 (95% confidence interval [CI]: 1.25–1.36). In the negative binomial model, the number of prescription days was 1.25 times (95% CI: 1.23–1.28) higher in patients with MDD than in those without MDD. Generalized linear model analysis showed a 1.39-fold (95% CI: 1.36–1.43) higher cost of antibiotic prescription in patients with MDD than in those without MDD.ConclusionsOur results suggest a potential association between MDD and the prescription of antibiotics, implying that patients with MDD are relatively vulnerable to infections. It is important to prevent as well as closely monitor the occurrence of infections when managing patients with MDD.

Maternal dyslipidemia and altered cholesterol metabolism in early pregnancy as a risk factor for small for gestational age neonates

We evaluated the relationship between maternal cholesterol levels and its biologically active precursors and metabolites in the first trimester and subsequent risk for small-for-gestational-age birthweight (SGA). This is a secondary analysis of a prospective cohort study which enrolled healthy singleton pregnancies (n = 1337). Maternal fasting blood was taken in the first trimester and followed up till delivery. The lipid parameters were compared between women who delivered SGA neonates (SGA-group, birthweight < 10th percentile, n = 107) and women who did not (non-SGA-group, n = 1230). In addition, metabolic signatures of cholesterol were evaluated in a subset consisting of propensity-score matched SGA (n = 56) and control group (n = 56). Among lipid parameters, maternal high-density lipoprotein cholesterol (HDL-C) levels were significantly lower in SGA-group than in non-SGA-group (p = 0.022). The risk for SGA was negatively correlated with maternal serum HDL-C quartiles (p = 0.003), and this association remained significant after adjustment for confounding variables. In metabolic signatures of cholesterol, the cholesterol/lathosterol ratio in SGA-group was significantly higher than non-SGA-group [(2.7 (1.6–3.7) vs. 2.1 (1.5–2.9), respectively; p = 0.034)], suggesting increased endogenous cholesterol biosynthesis. We demonstrated that dyslipidemia and increased cholesterol biosynthesis led to delivery of SGA neonates even in early pregnancy.

Dementia and the Risk of Periodontitis: A Population-Based Cohort Study

Dementia and Alzheimer’s disease (AD) are proposed to be comorbid with periodontitis (PD). It is unclear whether PD is associated with dementia and AD independent of confounding factors. We aimed at identifying the relationship between the longitudinal risk of developing PD in a cohort of patients with dementia and AD who did not show any signs of PD at baseline. In this retrospective cohort study, 8,640 patients with dementia without prior PD were recruited, and 8,640 individuals without dementia history were selected as propensity score–matched controls. A Cox proportional hazard model was developed to estimate the risk of developing PD over 10 y. Cumulative probability was derived to assess the time-dependent effect of dementia on PD. Of the 8,640 patients, a sensitivity test was conducted on 606 patients with AD-associated dementia and 606 non-AD propensity score–matched controls to identify the impact of AD-associated dementia on the risk for PD. Subgroup analyses on age stratification were included. Overall 2,670 patients with dementia developed PD. The relative risk of PD in these patients was significantly higher than in the nondementia group (1.825, 95% CI = 1.715 to 1.942). Cox proportional hazard models showed that patients with dementia were more likely to have PD than individuals without dementia (adjusted hazard ratio = 1.915, 95% CI = 1.766 to 2.077, P < 0.0001, log-rank test P < 0.0001). The risk of PD in patients with dementia was age dependent (P values for all ages <0.0001); younger patients with dementia were more likely to develop PD. The findings persisted for patients with AD: the relative risk (1.531, 95% CI = 1.209 to 1.939) and adjusted hazard ratio (1.667, 95% CI = 1.244 to 2.232; log-rank test P = 0.0004) of PD in patients with AD were significantly higher than the non-AD cohort. Our findings demonstrated that dementia and AD were associated with a higher risk of PD dependent of age and independent of systemic confounding factors.

Frequent constriction-like echocardiographic findings in elite athletes following mild COVID-19: in the grasp of SARS-CoV-2?

The COVID-19 pandemic had a major impact on the sports community as well. Despite the vast majority of athletes experiencing mild symptoms, potential cardiac involvement and complications have to be explored to support a safe return to play. Accordingly, we were aimed at a comprehensive echocardiographic characterization of post-COVID athletes (P-CA) by comparing them to a propensity-matched healthy, non-COVID athlete (N-CA) cohort.One hundred and seven elite athletes with COVID-19 were prospectively enrolled after an appropriate quarantine period and formed the P-CA group (23±6 years, 23% female). From our retrospective database comprising 425 elite athletes, 107 age-, gender-, body surface area-, and weekly training hours-matched subjects were selected as a reference group using propensity score matching (N-CA group). All athletes underwent a comprehensive clinical investigation protocol comprising 2D and 3D echocardiography. Left (LV) and right ventricular (RV) end-diastolic volumes (EDVi) and ejection fractions (EF) were quantified using dedicated softwares. To characterize LV longitudinal deformation, 2D global longitudinal strain (GLS) and the ratio of free wall versus septal longitudinal strain (FWLS/SLS) were also calculated. In order to describe septal flattening (SF – frequently seen in P-CA), LV eccentricity index (EI) was measured.P-CA and N-CA athletes had comparable LV and RV EDVi (P-CA vs N-CA; 77±12 vs 78±13mL/m2; 79±16 vs 80±14mL/m2, respectively). P-CA group had significantly higher LV EF (58±4 vs 56±4%, p<0.001) and GLS (−18.2±1.8 vs −17.6±2.2%, p<0.05). Eccentricity index was significantly lower in P-CA (0.89±0.10 vs 0.99±0.04, p<0.001), which was attributable to a distinct subgroup of P-CA athletes with a prominent SF (n=34, 32%), further provoked by inspiration. In this subgroup, the eccentricity index was markedly lower compared to the rest of the P-CA group (0.79±0.07 vs 0.95±0.07, p<0.001).In the SF subgroup, LV EDVi was significantly higher (80±14 vs 75±11 mL/m2, p<0.001), while RV EDVi did not differ (82±16 vs 78±15mL/m2). Moreover, the FWLS/SLS ratio was significantly lower in the SF subgroup (0.92±0.09 vs 0.97±0.08, p<0.01). Interestingly, P-CA athletes with SF experienced fatigue (17 vs 34%, p<0.05) or chest pain (0 vs 15%, p=N/A) less frequently during the course of the infection; however, the presence of a mild pericardial effusion was more common (41 vs 12%, p<0.01).Elite athletes following COVID-19 showed distinct morphological and functional cardiac changes compared to a propensity score-matched control athlete group. These results are mainly driven by a subgroup, which presented with some echocardiographic features characteristic of constrictive pericarditis (septal flattening, lower FWLS/SLS ratio, pericardial effusion). Follow-up of athletes and further, higher case number studies are warranted to determine the clinical significance and potential effects on exercise capacity of these findings.Funding AcknowledgementType of funding sources: None. Post-Covid athlete with SF

The Association Between Asthma and Narcolepsy: A Nationwide Case-Control Study in Taiwan.

PurposeAsthma, which is caused by inflammation of the airways, affects the sensitivity of nerve endings. Narcolepsy is a chronic sleep disorder that may be caused by autoimmunity. Recent studies have reported a positive association between narcolepsy and asthma. We aimed to examine the association between asthma and narcolepsy and determine the effects of therapeutic corticosteroid or bronchodilator use.Materials and MethodsWe conducted a nationwide population-based, nested case-control study using Taiwan’s National Health Insurance Research Database (NHIRD) between 2000 and 2013. Subjects with narcolepsy (ICD-9-CM code 347) were enrolled, with 1:3 estimated propensity score-matched controls based on sex, age, and index year. The association between narcolepsy and asthma was assessed using multiple logistic regression analyses. The covariates included sex, age, monthly insurance premiums, geographical area of residence, urbanization level of residence, level of care, and presence of diseases related to immune response and central nervous system. The effects of corticosteroid and bronchodilator use were also analyzed.ResultsOverall, 2008 subjects were identified from the NHIRD (502 patients with narcolepsy and 1506 controls). The participants with narcolepsy had almost three times the level of previous asthma diagnosis than controls. Compared to those without asthma, patients with asthma had an adjusted odds ratio (OR) of 3.181 for narcolepsy comorbidity (95% confidence interval [CI]: 2.048–4.941, p<0.001). The use of inhaled corticosteroids was associated with a lower risk of narcolepsy comorbidity, with an adjusted OR of 0.465 (95% CI, 0.250–0.634; p<0.001), in patients with asthma when compared to those without treatment.ConclusionThis study demonstrated a significantly higher level of previous asthma diagnosis in patients with narcolepsy. The use of inhaled corticosteroids was associated with a lower risk of narcolepsy comorbidity in asthma patients, compared to those without treatment.

Risk of chronic spontaneous urticaria in reproductive-aged women with abnormal uterine bleeding: A population-based cohort study.

Women with abnormal uterine bleeding (AUB) have been reported to develop chronic spontaneous urticaria (CSU). Nevertheless, whether or not AUB women have an increased risk of CSU has not been examined in large-scale epidemiologic studies. This study aimed to investigate the risk of CSU among reproductive-aged women with AUB. A total of 79595 patients and 79107 propensity-score matched controls were recruited from Taiwan's National Health Insurance Research Database to conduct a nationwide cohort study. The Cox proportional-hazard regression model was applied to examine the adjusted hazard ratios (aHR) and 95% confidence intervals (CI) for CSU in relation to AUB. We found that women with AUB had a higher risk for CSU (aHR=1.83; 95% CI, 1.76-1.90) than women without AUB. Subgroup analyses revealed that AUB with an abnormal bleeding frequency (aHR=1.70; 95% CI, 1.60-1.79), irregular bleeding (aHR=1.80; 95% CI, 1.71-1.89), and intermenstrual bleeding (aHR=1.65; 95% CI, 1.49-1.83) were associated with an increased risk of CSU compared with those without abnormalities. The Kaplan-Meier analysis revealed that the cumulative incidence of developing CSU was consistently higher in the AUB cohort than in the non-AUB cohort during the entire follow-up period (log-rank test, p<0.001). In conclusion, reproductive-aged women with AUB were found to have a higher risk of developing CSU. This study emphasizes the importance of enquiring CSU patients about menstrual problems in clinical practice. Further consultation with obstetrician-gynecologists may be beneficial.

Adverse Events Associated with Routine Colonoscopy in Patients with End-Stage Renal Disease.

Although colonoscopy has been widely performed in patients with end-stage renal disease (ESRD), studies on the safety of routine colonoscopy, including bowel preparation and sedation, in these patients are limited. This study aimed to investigate the safety of colonoscopy in patients with ESRD who underwent peritoneal dialysis (PD) or hemodialysis (HD). We retrospectively reviewed 538 patients with ESRD who underwent colonoscopy between 2010 and 2020. We compared the incidence of adverse events (AEs) between the ESRD group and a propensity score-matched control group of healthy adults. Cardiovascular/pulmonary and procedure-related AEs were analyzed. We also compared the rates of AEs between patients who underwent PD or HD. The overall rate of AEs was 5.7% in patients with ESRD, which was significantly higher than that in healthy adults (0.6%, P<0.001). All AEs were cardiovascular/pulmonary in nature, but no perforation or bleeding occurred. Most AEs were not severe and resolved with medical treatment. The incidence of AEs was higher in the HD group than in the PD group, but the difference was not significant (6.1% vs. 3.5%, respectively, P=0.451). In the HD group, patients with AEs were significantly older than those without AEs (P=0.009). The rate of colonoscopy-related AEs in patients with ESRD on dialysis was higher than that in healthy adults, but most AEs were not severe. Routine colonoscopy may be safely performed in patients with ESRD regardless of the method of dialysis, but more carefully in older patients on HD.

SARS-CoV-2 Vaccine Effectiveness in a High-Risk National Population in a Real-World Setting.

With the emergency use authorization of multiple vaccines against SARS-CoV-2 infection, data are urgently needed to determine their effectiveness in a real-world setting. To evaluate the short-term effectiveness of vaccines in preventing SARS-CoV-2 infection. Test-negative case-control study using conditional logistic regression. U.S. Department of Veterans Affairs health care system. All veterans who had testing for SARS-CoV-2 infection between 15 December 2020 and 4 March 2021 and no confirmed infection before 15 December 2020. SARS-CoV-2 vaccination with either the BNT-162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine as part of routine clinical care. Effectiveness of vaccination against confirmed SARS-CoV-2 infection. Among 54360 persons who tested positive and 54360 propensity score-matched control participants, the median age was 61 years, 83.6% were male, and 62% were White. Median body mass index was 31 kg/m2 among those who tested positive and 30 kg/m2 among those who tested negative. Among those who tested positive, 9800 (18.0%) had been vaccinated; among those who tested negative, 17825 (32.8%) had been vaccinated. Overall vaccine effectiveness 7 or more days after the second dose was 97.1% (95% CI, 96.6% to 97.5%). Effectiveness was 96.2% (CI, 95.5% to 96.9%) for the Pfizer-BioNTech BNT-162b2 vaccine and 98.2% (CI, 97.5% to 98.6%) for the Moderna mRNA-1273 vaccine. Effectiveness remained above 95% regardless of age group, sex, race, or presence of comorbidities. Predominantly male population; lack of data on disease severity, mortality, and effectiveness by SARS-CoV-2 variants of concern; and short-term follow-up. Currently used vaccines against SARS-CoV-2 infection are highly effective in preventing confirmed infection in a high-risk population in a real-world setting. None.

Vitamin D supplementation and COVID-19 risk: a population-based, cohort study.

PurposeTo analyze the associations between cholecalciferol or calcifediol supplementation, serum 25-hydroxyvitamin D (25OHD) levels and COVID-19 outcomes in a large population.MethodsAll individuals ≥ 18 years old living in Barcelona-Central Catalonia (n = 4.6 million) supplemented with cholecalciferol or calcifediol from April 2019 to February 2020 were compared with propensity score-matched untreated controls. Outcome variables were SARS-CoV2 infection, severe COVID-19 and COVID-19 mortality occuring during the first wave of the pandemic. Demographical data, comorbidities, serum 25OHD levels and concomitant pharmacological treatments were collected as covariates. Associations between cholecalciferol or calcifediol use and outcome variables were analyzed using multivariate Cox proportional regression.ResultsCholecalciferol supplementation (n = 108,343) was associated with slight protection from SARS-CoV2 infection (n = 4352 [4.0%] vs 9142/216,686 [4.2%] in controls; HR 0.95 [CI 95% 0.91–0.98], p = 0.004). Patients on cholecalciferol treatment achieving 25OHD levels ≥ 30 ng/ml had lower risk of SARS-CoV2 infection, lower risk of severe COVID-19 and lower COVID-19 mortality than unsupplemented 25OHD-deficient patients (56/9474 [0.6%] vs 96/7616 [1.3%]; HR 0.66 [CI 95% 0.46–0.93], p = 0.018). Calcifediol use (n = 134,703) was not associated with reduced risk of SARS-CoV2 infection or mortality in the whole cohort. However, patients on calcifediol treatment achieving serum 25OHD levels ≥ 30 ng/ml also had lower risk of SARS-CoV2 infection, lower risk of severe COVID-19, and lower COVID-19 mortality compared to 25OHD-deficient patients not receiving vitamin D supplements (88/16276 [0.5%] vs 96/7616 [1.3%]; HR 0.56 [CI 95% 0.42–0.76], p < 0.001).ConclusionsIn this large, population-based study, we observed that patients supplemented with cholecalciferol or calcifediol achieving serum 25OHD levels ≥ 30 ng/ml were associated with better COVID-19 outcomes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40618-021-01639-9.

Excess Mortality After COVID-19 in Swedish Long-Term Care Facilities

ObjectiveTo compare 30-day mortality in long-term care facility (LTCF) residents with and without COVID-19 and to investigate the impact of 31 potential risk factors for mortality in COVID-19 cases. DesignRetrospective cohort study. Setting and ParticipantsAll residents of LTCFs registered in Senior Alert, a Swedish national database of health examinations in older adults, during 2019-2020. MethodsWe selected residents with confirmed COVID-19 until September 15, 2020, along with time-dependent propensity score–matched controls without COVID-19. Exposures were COVID-19, age, sex, comorbidities, medications, and other patient characteristics. The outcome was all-cause 30-day mortality. ResultsA total of 3731 residents (median age 87 years, 64.5% female) with COVID-19 were matched to 3731 controls without COVID-19. Thirty-day mortality was 39.9% in COVID-19 cases and 5.7% in controls [relative risk 7.05, 95% confidence interval (CI) 6.10-8.14]. In COVID-19 cases, the odds ratio (OR) for 30-day mortality was 2.44 (95% CI 1.57-3.81) in cases aged 80-84 years, 2.99 (95% CI 1.93-4.65) in cases aged 85-89 years, and 3.28 (95% CI 2.11-5.10) in cases aged ≥90 years, as compared with cases aged <70 years. Other risk factors for mortality among COVID-19 cases included male sex (OR, 2.60, 95% CI 2.22-3.05), neuropsychological conditions (OR, 2.18; 95% CI 1.76-2.71), impaired walking ability (OR, 1.45, 95% CI 1.17-1.78), urinary and bowel incontinence (OR 1.51, 95% CI 1.22-1.85), diabetes (OR 1.36, 95% CI 1.14-1.62), chronic kidney disease (OR 1.37, 95% CI 1.11-1.68) and previous pneumonia (OR 1.57, 95% CI 1.32-1.85). Nutritional factors, cardiovascular diseases, and antihypertensive medications were not significantly associated with mortality. Conclusions and ImplicationsIn Swedish LTCFs, COVID-19 was associated with a large excess in mortality after controlling for an extensive number of risk factors. Beyond older age and male sex, several prevalent clinical risk factors independently contributed to higher mortality. These findings suggest that reducing transmission of COVID-19 in LTCFs will likely prevent a considerable number of deaths.

Safety of a first-day catheter removal after transurethral resection of the prostate (TURP): a propensity score-matched historical control study

Objective: Transurethral resection of the prostate (TURP) is the standard surgical management for patients with benign prostatic hyperplasia (BPH). Postoperative maintenance of bladder catheterization is a routine procedure. However, the timing of catheter removal varies. Our objective is to evaluate the safety of early catheter removal (less than 24 hours) whilst maintaining efficacy, especially in an overcrowded community-based hospital, which has a high rate of preoperative catheterization (47.7%). Materials and Methods: This was a prospective and retrospective observational cohort study of 399 TURP indicated patients from February 2014 to September 2019. Since October 2017, the urological unit protocol has changed the process of removal of the catheter to less than 24 hours after monitoring for safety. Data from 95 patients after October 2017 was prospectively collected as the less than 24 hours group. The information from 2014 to October 2017 was collected and used as the control group. Data was then studied retrospectively for three years. The primary outcome, morbidity, and postoperative stay were compared with a 1:1 nearest neighbor propensity score-matched analysis. Results: After the score was matched and balanced, there was no difference as regards complications between the two groups (Odd ratio (OR): 1, (95% Confidence interval (95% CI): 0.14-7.10, p-value: 1.00). Acute urinary retention and postoperative bleeding were also comparable (OR: 0.5, 95% CI: (0.05-5.51), p-value: 0.57, and p-value: 0.99). The postoperative hospital stay was significantly less in the &lt; 24 hours group (38.1 less hours, 95% CI: (41.82- 34.31), p-value: &lt; 0.01). Conclusion: After TURP early catheter removal was safe even in the hospital with a high preoperative catheterization rate. Experienced surgeons, well-educated and compliant patients without contraindications (neurogenic bladder, urethral stricture, stroke, and some intraoperative complications: urinary bladder perforation, urinary tract infection, prostatic capsule perforation, or intraoperative bleeding) are our recommendation for adopting this protocol.

Economic Analysis of Leak Complications in Anastomoses Performed with Powered versus Manual Circular Staplers in Left-Sided Colorectal Resections: A US-Based Cost Analysis.

PurposeTo estimate the cost impact of using the ECHELON CIRCULAR™ Powered Stapler (ECP) compared with manual circular staplers (standard of care, SOC) among patients undergoing colectomy procedures that involve left-sided anastomosis.MethodsA US hospital-based budget impact model was developed to estimate the impact of ECP in reducing the surgical complication of anastomotic leak. The incremental acquisition cost of ECP vs SOC was compared to the net potential savings from reduced complication costs. The model was based on complication rates from a recently published matching-adjusted indirect comparison (MAIC) that compared clinical and healthcare utilization outcomes of patients using ECP with those of a propensity score-matched retrospective SOC control cohort from a real-world clinical practice population. The model assessed total cost, average length of stay (LOS), proportion of patients with a non-home discharge, and all-cause readmission. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were conducted to evaluate the robustness of the model assumptions and inputs.ResultsDespite a higher device cost of $412 for ECP compared with $298 for a manual stapler, annual savings due to avoided complications with ECP was $53,987 for anastomotic leak, assuming 100 procedures per year with each type of circular stapler. ECP also helped to avoid 27 LOS days, 0.38 readmissions and 0.22 non-home discharges. Sensitivity analyses around potential drivers of costs established the robustness of economic savings with the use of ECP – with annual savings being most impacted by the probability of anastomotic leak complication in the DSA.ConclusionThis model demonstrates that among patients undergoing left-sided colectomy procedures, the incremental cost of using the ECHELON CIRCULAR™ Powered Stapler instead of a manual circular stapler was offset by the savings from lowered incidence and cost of management of anastomotic leaks in the hospital setting.

829-P: Improving Diabetes Self-Management with a Peer-to-Peer Mentoring Program: Final Results of a Pilot Program at a Safety Net Health Care System

New York City Health + Hospitals (NYC H+H) is the largest safety net healthcare system in the nation, serving more than one million patients each year. Most of NYC H+H’s patients are low-income and people of color, who, in NYC as in the rest of the nation, bear a disproportionate burden of chronic diseases. At NYC H+H, 18% of patients have diagnosed diabetes, and nearly 23,000 (39%) of the 59,000 patients monitored in NYC H+H’s diabetes registry have poorly controlled diabetes (A1c ≥ 8). In an effort to support these patients’ diabetes management between their regular visits, NYC H+H launched a pilot program of InquisitHealth, a one-on-one peer mentoring service that matches patients with mentors who have controlled their own diabetes and received training to become peer coaches. Several small, randomized, controlled trials have demonstrated the program’s effectiveness in reducing A1c, but there is limited evidence of its effectiveness in a real-word setting. The key aims of this pilot program were to: 1) bridge the gap between patients and providers outside of clinic visits, 2) increase patient education on and support for diabetes self-management, and 3) improve patients’ diabetes outcomes as evidenced by reductions in A1c. The pilot program enrolled 336 patients at two NYC H+H facilities for a twelve-month intervention. Among the first 180 patients enrolled at one large acute care hospital, the mean reduction in A1c from baseline to six months following enrollment was 1.08. As compared to propensity score-matched control patients at a similar non-participating hospital in the NYC H+H network, participants experienced a greater reduction in A1c of 0.61 (-1.08 vs. -0.47, p&amp;lt;0.01). Results from the 12-month final analysis of all participants will be presented. Disclosure R. Kalyanaraman marcello: None. J. Dolle: None. S. Kaur: None. S. R. Patterson: None. N. Davis: None. Funding National Institutes of Health (UL1TR001445)

Comparison of EQ-5D-3L and metabolic components between patients with hyperhidrosis and the general population: a propensity score matching analysis.

It is important to understand the characteristics of patients with hyperhidrosis, which are different from the general population, for treating hyperhidrosis. Sympathetic overactivity, which might play an important role in hyperhidrosis, can contribute to metabolic diseases and the decreased quality of life (QoL). We compared the metabolic components and health-related QoL between patients with hyperhidrosis and the general population. We conducted a case-control study and compared the characteristics of the patients (N = 196) with hyperhidrosis and propensity score-matched controls (N = 196) selected from the Korean National Health and Nutrition Examination Survey. Metabolic components and EQ-5D-3L (EQ-5D) index were compared using a two-way mixed analysis of covariance after adjusting for confounders. Patients with hyperhidrosis had significantly higher waist circumference (estimated mean values ± SD for patients and the control group, 85.5 ± 10.8 cm vs 81.3 ± 10.3 cm, p < 0.001), blood pressure (SBP, 121.1 ± 16.9 vs 111.7 ± 10.3, p < 0.001 AND DBP, 77.5 ± 12.8 vs 73.6 ± 8.6, p < 0.001, respectively), fasting glucose (97.1 ± 11.3 vs 91.5 ± 9.2, p < 0.001), and the number of components of metabolic syndrome (1.4 ± 1.3 vs 1.0 ± 1.2, p = 0.002), and significantly lower estimated glomerular filtration rate (144.3 ± 53.2 vs 158.3 ± 55.7, p = 0.002) and EQ-5D values (estimated mean values (standard error) for patients and the control group, 0.92 (0.01) vs 0.97 (0.01), p < 0.001) compared to the control group after adjustment. The patients with hyperhidrosis had more central obesity and unfavorable metabolic parameters and a lower EQ-5D index compared with the general population, emphasizing clinical importance of hyperhidrosis to be cured in aspect of metabolic components as well as patients' QOL.

Influence of Comorbidities on Healthcare Expenditures and Perceived Physical and Mental Health Status Among Adults with Multiple Sclerosis: A Propensity Score-Matched US National-Level Study.

ObjectiveTo evaluate the effect of comorbidities on healthcare expenditures and perceived physical and mental health status among adults with multiple sclerosis (MS) compared to propensity score-matched non-MS controls.MethodsA retrospective, cross-sectional, matched cohort study was conducted using Medical Expenditure Panel Survey (2005–2015) data. The base study sample consisted of adults (age ≥18 years) who were alive and had positive total healthcare expenditures during the survey calendar year. Adults with MS were propensity-matched (1:1) to non-MS controls based on age, gender, and race/ethnicity using greedy matching algorithm. Healthcare expenditures consisted of total and subtypes of expenditures. Health status consisted of perceived physical and mental health status. Comorbidities were identified using ICD-9-CM and Clinical Classification System codes. Ordinary least squares regression and multinomial logistic regression were used to analyze the healthcare expenditures and health status variables, respectively.ResultsFinal study sample consisted of 541 adults in each MS and non-MS control groups after propensity score matching. After adjusting for potential confounders, individuals with MS had greater total and subtypes of expenditures compared to non-MS controls, and several comorbidities (eg, depression, hypertension) were significantly associated with increased healthcare expenditures. Yearly average total expenditures (expressed in 2018 US$) were significantly (p<0.001) higher for adults with MS ($29,396) than propensity score-matched non-MS adults ($7875). Moreover, after adjusting for all individual-level factors, adults with MS experienced 363% (p<0.001) higher total expenditures compared to propensity score-matched non-MS controls. Individuals with MS were more likely to report poorer physical and good mental health status compared to propensity score-matched non-MS controls, and several comorbidities (eg, anxiety, depression) were significant independent predictors of poorer health status. For example, adults with MS were four times more likely (OR: 4.10, 95% CI: 2.42–6.96) to report fair/poor physical health status compared to excellent/very good physical health status compared with non-MS controls. Adults with MS were 42% (OR: 1.42, 95% CI: 1.01–1.99) more likely than propensity score-matched non-MS controls to report good rather than very good or excellent mental health status. However, there was no difference between adults with MS and propensity score-matched non-MS controls in terms of reporting fair or poor than very good or excellent mental health status.ConclusionFindings from this study indicate substantial economic and health status burdens among adults with MS at the US national-level that are significantly influenced by comorbidities.

Convalescent plasma in patients hospitalised with COVID-19

Convalescent plasma in patients hospitalised with COVID-19