Baseline Characteristics Of Subjects Research Articles

Data wobbles in hidradenitis suppurativa clinical trials and potential contributing factors: a retrospective review

Background: In some hidradenitis suppurativa (HS) clinical trial study arms, there is an unexpected decline in efficacy between the penultimate visit and the prespecified primary endpoint week, which we have termed a “wobble.” Objective: We aimed to establish how often study arms in HS programs wobble. Methods: In a retrospective review, we identified HS clinical trials listed on ClinicalTrials.gov testing systemic, nonantibiotic medications that utilized Hidradenitis Suppurativa Clinical Response (HiSCR) as an outcome measure. We identified study arms demonstrating greater improvement in a visit prior to the primary endpoint week. Baseline subject characteristics were compared between studies with HiSCR wobble and no HiSCR wobble. Results: A total of 21 studies (randomized control trial [RCT], n = 14; open-label, n = 7) with 35 study drug arms (RCT, n = 27; open-label, n = 8) and 14 placebo arms were identified. HiSCR wobble occurred significantly more often in RCT compared to open-label study drug arms (11/27 [40.7%] vs 0/8 [0%]). In RCT study arms with HiSCR wobble, baseline draining fistula counts were significantly lower (2.3 vs 3.2), and numerically fewer Hurley stage 3 patients (33.2% vs 42.5%), lower weighted total abscess and nodule counts (12.1 vs 12.6), lower weighted dermatology life quality index scores (12.5 vs 14.5), and a higher proportion of female patients (63.9% vs 58.3%) were observed. Limitations: Include low number of HS clinical trials and insufficient data reported in many studies to assess for wobble, degree of wobble, and to compare all baseline characteristics. Conclusion: Nonlinear improvement in study arm response occurs in some HS RCTs. Potential contributing factors include a higher proportion of less severe patients at baseline and more female patients.

#1067 The impact of hemodialysis (HD) versus hemodiafiltration (HDF) on the effect of intradialytic exercise: a multicentre cohort study

Abstract Background and Aims Diminished physical function in HD patients is a critical issue, necessitating strategic approaches to enhance the efficacy of exercise therapy. The differential impacts of HD and HDF on solute clearance, albumin loss, uremic conditions, and malnutrition could influence the success of exercise interventions. Presently, empirical evidence for this is lacking. This investigation explores how HD and HDF modalities influence the efficacy of exercise therapy administered during dialysis sessions. Method This study encompassed intradialytic resistance exercises, involving 414 patients with end-stage renal disease across 10 centers. Participants were voluntarily enlisted in an exercise regimen during their dialysis sessions. The intradialytic regimen comprised stretching and four types of resistance exercises utilizing elastic tubes, conducted thrice weekly over six months. Parameters such as 10-meter walking speed, knee extensor muscle strength, serum albumin levels (Alb), normalized protein catabolic rate (nPCR), and Creatinine Generation Rate (%CGR) were assessed pre-and post-intervention. Statistical analysis included propensity score matching to adjust for baseline characteristics, segregating patients into HD and HDF cohorts. Changes in the aforementioned indicators before and after intervention (Δ) were calculated. Analytical methods included paired t-tests for within-group comparisons and independent t-tests for between-group comparisons of Δ values. A 5% risk threshold was established for statistical significance. Ethical clearance was obtained from the Seirei Christopher University Ethics Committee. Results A propensity score matching yielded 70 matched pairs. There were no significant differences in baseline subject characteristics after propensity score matching. Within-group analyses in the HD group revealed significant improvements in 10-meter walking speed (1.42 ± 0.41→1.60 ± 0.46 m/s, p = 0.000), knee extensor strength (44.3 ± 14.7→49.6 ± 13.8%, p = 0.000), and a reduction in Kt/V (1.69 ± 0.32→1.64 ± 0.32, p = 0.006) after six months. The HDF group significantly enhanced 10-meter walking speed (1.54 ± 0.40→1.72 ± 0.40, p = 0.000), knee extensor muscle strength (51.7 ± 17.1→57.4 ± 17.7%, p = 0.000), nPCR (0.88 ± 0.15→0.94 ± 0.18, p = 0.009), and %CGR (106.3 ± 23.2→112.9 ± 25.2, p = 0.002) (pre to post value, respectively). There are no significant differences in other variables between pre- and post-values in each group. Comparative analysis between groups demonstrated a significantly lower ΔAlb (HD 0.04 ± 0.24 HDF −0.05 ± 0.27, p = 0.045)and a higher 7, p =0(HD 1.47 ± 18.2 HDF 6.65 ± 17.2, p = 0.004)in the HDF group compared to the HD group. Conclusion The study demonstrated a notable HDF group improvement in %CGR, an indicator of muscle mass, despite a decrease in albumin levels. This suggests that albumin loss due to HDF minimally affects the augmentation of physical function. The findings suggest integrating exercise therapy with HDF may positively influence protein consumption and muscle mass enhancement.

The risk of open angle glaucoma in young adults with allergic diseases: a Nationwide cohort study

This study investigated the potential associations between allergic diseases (asthma, allergic rhinitis, and atopic dermatitis) and the development of primary open-angle glaucoma. We utilized authorized data from the Korean National Health Information Database (KNHID), which provides comprehensive medical claims data and information from the National Health Screening Program. We compared the baseline characteristics of subjects with and without allergic diseases and calculated the incidence and risk of glaucoma development. Cox proportional hazard regression analysis was used to determine the risk of glaucoma development in subjects with allergic diseases. A total of 171,129 subjects aged 20–39 with or without allergic diseases who underwent a general health examination between 2009 and 2015 were included. Subjects with allergic diseases exhibited a higher incidence of glaucoma compared to the control group. The hazard ratio (HR) of glaucoma onset was 1.49 and 1.39 in subjects with at least one allergic disease before and after adjusting for potential confounding factors, respectively. Among allergic diseases, atopic dermatitis showed the highest risk for glaucoma development (aHR 1.73) after adjusting for confounders. Allergic rhinitis showed an increased risk for incident glaucoma after adjustment (aHR 1.38). Asthma showed the lowest but still increased risk for glaucoma (aHR 1.22). The associations were consistent in all subgroup analyses stratified by sex, smoking, drinking, exercise, diabetes, hypertension, dyslipidemia, or history of steroid. In conclusion, allergic diseases are associated with increased risk of glaucoma development. Among allergic diseases, atopic dermatitis showed the highest risk for glaucoma development followed by allergic rhinitis and asthma.

Triglyceride-glucose index for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

To evaluate the triglyceride-glucose index (TyG index) for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents. Subjects with iliac artery stenosis, who underwent an iliac stent intervention and were followed up for at least 2 years were included in the study. Subjects were grouped according to TyG index (Group A, TyG index ≤8.848; Group B 8.849 ≤TyG index ≤9.382 and Group C TyG index ≥9.383). The subject's baseline characteristics, blood parameters, claudication distance, Transatlantic Intersociety Consensus classification, target lesion localization, stent direction, number of stents that were applied, and stent type were noted. Pre- and 1st and 2nd-year post-procedure Rutherford statuses, ankle-brachial index, and stenosis degree were recorded. To calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), Group B and Group C were combined and compared with Group A. In total, 255 subjects were evaluated (female, n=77-30.2%, male, n=178-69.8%). The mean age of the subjects was 66.00±10.00 years (range from 39 to 90 years). The pre-procedure Rutherford measurements were significantly different among the groups (p=0.001). The rates of mild claudication and resting pain in Group A were higher than those in Groups B and C. The rate of moderate claudication in Group C was higher than that in Groups A and B. The rate of severe claudication in Group B was higher than that in Groups A and C. One year after the procedure, there were more asymptomatic cases in Group A than in Groups B and C (p=0.001). The rate of mild claudication in Group C was lower than that in Groups A and B. The rate of moderate claudication in Group C was higher than that in Group A. The rate of severe claudication in Group C was higher than that in Groups A and B. Two years after the procedure, the Rutherford measurements and the rates of mild claudication in Groups A and B were higher than those in Group C. The rate of severe claudication in Group C was higher than that in Groups A and B (p=0.001). One year after the procedure, the computed tomography angiography (CTA) measurements and the rate of full patency in Group A were higher than that in Groups B and C. The rate of 0-50% stenosis in Group B was higher than that in Groups A and C. The rate of 50-70% stenosis in Group C was higher than that in Group A. Two years after the procedure, the CTA measurements and the rates of 70-99% stenosis and 100% occlusion in Group C were higher than those in Groups A and B. The TyG index has high specificity and NPV. However, specificity and PPV levels were found to be quite low. The TyG index was found to be an easy-to-use marker for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

Evaluating the risk of sleep disorders in subjects with a prior COVID-19 infection.

Previous studies have reported a potential occurrence of sleep disorders in patients following a COVID-19 infection. However, these findings were based on surveys or retrospective studies with small sample sizes. This study examined if subjects with a previous COVID-19 infection in 2020 experienced sleep disorders in 2021. Using the 2019-2021 Utah All Payers Claims Database (APCD), adults (≥18 to 62 years old in 2019) covered by private insurance and Medicaid were identified. Sleep disorders were identified from the primary and secondary diagnosis in 2021. Baseline characteristics of subjects such as age, gender, race/ethnicity, type of insurance, and comorbid conditions were identified from the database. Entropy balancing was used to balance the baseline characteristics of subjects with and without a COVID-19 infection in 2020. Weighted logistic regression was used to identify significant factors that were associated with sleep disorders. A total of 413,958 subjects were included in the study. The average (SD) age was 38 (17) years old in 2019 and 58% were female. Among the subjects, about 39% had a COVID-19 infection in 2020. Those who had a COVID-19 infection in 2020 were 53% more likely to have a sleep disorder in 2021 (OR = 1.53; 95% Confidence Interval: 1.48-1.58). Sleep disorders could be one of long-term COVID-19 symptoms. More screening and observations for those who had a COVID-19 infection could be important to improve sleep related problems.

1034. COVID-19 Bloodstream Infection Outcomes Stratified by Social Determination Index (SDI) in NYC Public Hospital System

Abstract Background Impact of socioeconomic factors on outcomes was significant during the COVID-19 pandemic. We aim to study disparities in outcomes among hospitalized COVID-19 patients with bloodstream infection (BSI) stratified by SDI in the NYC Public Health System. Methods Retrospective multicenter study of hospitalized patients with COVID-19 in 11 acute care hospitals in the NYC public health system from March 2020 to May 2020 was collected. Hospitals are further stratified according to the median household income of NYC using their zip code area into high (≥$65,000), medium ($40,000-64,999) and low income (< $40,000). Descriptive statistics were used to compare baseline patient characteristics including COVID-19 severity and BSI features. The primary outcome was in-hospital mortality. Logistic regression models were used to adjust for potential confounders. Inclusion Process of Study Population Results Eleven hospitals were stratified based on SDI (high income: 2, medium income: 4, low income: 3), 2 were excluded as they lie on zip codes with overlapping income. Patients’ baseline and BSI characteristics are described in Table 1. For every change in income group: high-middle and middle-low, the odds of mortality increased by 1.33 times (p=0.048). Additionally, for every increase in 1 year of age above 23, the risk of mortality from BSI increased by 2.2% (p=0.004). Baseline Characteristics of Subjects Stratified by Household Income Status Bloodstream Infection Characteristics Stratified by Household Income Status Conclusion The study shows the impact of health disparities during COVID-19 among hospitals with the same standard of care, where higher mortality rates were observed in low and middle-income zip code areas in NYC, likely due to the burden of social determinants of health. Hospital acquired BSI was uniformly high in all income groups, compared to primary BSI. Nonetheless, it provided an insight about the need for further investigation about the impact of socioeconomic factors on mortality and for strategies to address disparities in access to healthcare. Disclosures All Authors: No reported disclosures

A Cautionary Note on Using Propensity Score Calibration to Control for Unmeasured Confounding Bias When the Surrogacy Assumption Is Absent.

Conventional propensity score methods encounter challenges when unmeasured confounding is present, as it becomes impossible to accurately estimate the gold-standard propensity score when data on certain confounders are unavailable. Propensity score calibration (PSC) addresses this issue by constructing a surrogate for the gold-standard propensity score under the surrogacy assumption. This assumption posits that the error-prone propensity score, based on observed confounders, is independent of the outcome when conditioned on the gold-standard propensity score and the exposure. However, this assumption implies that confounders cannot directly impact the outcome and that their effects on the outcome are solely mediated through the propensity score. This raises concerns regarding the applicability of PSC in practical settings where confounders can directly affect the outcome. While PSC aims to target a conditional treatment effect by conditioning on a subject's unobservable propensity score, the causal interest in the latter case lies in a conditional treatment effect conditioned on a subject's baseline characteristics. Our analysis reveals that PSC is generally biased unless the effects of confounders on the outcome and treatment are proportional to each other. Furthermore, we identify 2 sources of bias: 1) the noncollapsibility of effect measures, such as the odds ratio or hazard ratio and 2) residual confounding, as the calibrated propensity score may not possess the properties of a valid propensity score.

5-Fluorouracil for Treatment of Vocal Fold Scar

Vocal fold (VF) scar can result from trauma, neoplasm, inflammatory processes, congenital causes, surgery and other etiologies. In general, once the vibratory margin of the VF has been scarred, it has not been possible to return VF function to normal; but often it can be improved. The drug 5-fluorouracil (5-FU) is a pyrimidine antimetabolic that has many clinical applications ranging from systemic chemotherapy to topical treatment of actinic keratosis and basal cell carcinoma of the skin. Local injection with 5-FU also has been used for hypertrophic scar and keloids. 5-FU was shown to have benefit in animal models of VF scar and subglottic stenosis. The present study aimed to evaluate the effect of 5-FU injection on VF vibratory function in patients with VF scar. Outcomes of 5-FU injection were compared to controls injected with dexamethasone. Adult voice center patients who had undergone VF injection with dexamethasone or a series of three 5-FU injections for treatment of VF scar were included in the study. Postoperative outcomes included percentage of subjects demonstrating improvement after injection, change in scar size, glottic closure, and VF stiffness, as well as digital image analysis measurements of mucosal wave. Outcomes were compared between subjects who received 5-FU and those who received dexamethasone. There were 58 VFs injected with 5-FU and 58 historical controls injected with dexamethasone. Baseline subject characteristics and etiology of scar did not differ significantly between the 5-FU and dexamethasone cohorts, except that scar size was greater in the 5-FU group and mucosal wave was worse at baseline. After a series of three 5-FU injections, 61.22% improved, 8.16% demonstrated no change, and 30.61% worsened. In the dexamethasone cohort, 51.06% improved, 0.00% demonstrated no change, and 48.94% worsened. The response differed significantly between the 5-FU and dexamethasone cohorts, with a greater proportion of subjects who underwent 5-FU injection demonstrating improvement postoperatively. In the 5-FU cohort, 32.76% of subjects previously had undergone and failed dexamethasone injection for VF scar: and within that group 84.21% improved, 5.26% demonstrated no change, and 10.53% worsened following 5-FU injection. On digital image analysis, the percent improvement in postoperative mucosal wave was significantly greater in the 5-FU cohort compared to the dexamethasone group, which demonstrated a worsening of mucosal wave. A series of three intralesional injections with 5-FU outperformed dexamethasone for improving mucosal wave in patients with VF scar. A prior failed trial of dexamethasone injection predicted a favorable response to 5-FU. Further research is encouraged to confirm or refute these findings.

Efficacy of Ultrasonic Tenotomy and Debridement and Platelet-Rich Plasma Injections for Lateral Elbow Tendinopathy

To determine the efficacy of treatment of lateral elbow tendinopathy (LET) with platelet-rich plasma (PRP) injection and ultrasonic tenotomy and debridement (USTD) as well as risk factors for treatment failure. This was a retrospective study including patients treated for LET with PRP or USTD between January 2018 and December 2021. The efficacy of both procedures was assessed using pain-related patient-reported outcome measures at the 12-week follow-up. Baseline subject characteristics and diagnostic ultrasound findings were analyzed as risk factors for failure of treatment. Failure was classified as a surgical indication for LET within a year of the PRP or USTD. Ultrasonic tenotomy and debridement and PRP both led to significant improvement in patient pain within the 12-week follow-up period. There was no significant difference in efficacy between the two procedures. Common extensor tendon tearing on ultrasound and Worker's Compensation cases were found to be risk factors for failure of USTD. Lateral collateral ligament complex involvement and injection were found to be risk factors for failure of PRP. Platelet-rich plasma and USTD are both effective interventions for LET. They have separate risk factors for failure that should be taken in consideration while deciding the treatment approach. These procedures are minimally invasive alternatives to some of the more invasive surgical options to treat LET. Therapeutic III.

Anterior Chamber Washout During Ahmed Valve Glaucoma Surgery Reduces the Incidence of Hypertensive Phase.

Intraoperative anterior chamber (AC) washout reduces the odds of hypertensive phase (HP) by 95% compared with those not receiving washout during Ahmed glaucoma implant (AGI), suggesting AC washout is an effective prophylaxis for postoperative HP. To characterize the incidence of postoperative HP in patients receiving AC washout at the time of AGI. A total of 24 patients with medically refractory glaucoma who underwent AGI surgery at a tertiary academic medical center in Southern California from December 2018 through March 2021 were included in this retrospective comparative case series. Patients who received a pediatric implant and underwent concurrent intraocular surgery or did not complete a minimum of 6 months of follow-up were excluded. Nine patient's eyes received AC washout and 15 controls that were analyzed through 6 months postprocedure. HP was defined as intraocular pressure (IOP) above 21mmHg within 6 months postprocedure with maximum tolerated medical therapy. AC washout was performed by irrigating the AC with a 5mL balanced salt solution before placing the tube of the AGI into the AC. The rate of postoperative HP, defined as peak IOP >21mmHg, at 6 months follow-up, was observed as the primary outcome measure. Patients included in the study had a high mean preoperative IOP ( X̅ = 44.11, SD = 13.85). There were no baseline differences between the washout and control groups. The odds of HP were significantly reduced (odds ratio: 0.050; 95% CI: 0.004, 0.706; P = 0.027) for patients who underwent intraoperative AC washout compared with those who did not. Bivariate analysis of subject baseline characteristics revealed that only washout status was significantly different in subjects with HP compared with subjects without HP ( P = 0.015). A multivariate logistic regression model using washout status and autoimmune conditions as covariates was significant in predicting HP ( X2 (2) = 12.337, P = 0.002), with washout as a significant predictor when controlling for autoimmune comorbidities ( P = 0.027). AC washout significantly decreases the odds of HP after AGI surgery. AC washout with balanced salt solution adds minimal time and risks to surgery and therefore may be an effective adjunct during AGI placement.

Twice-daily injections and multiple daily injections of insulin in toddlers with type 1 diabetes: a retrospective cohort study.

Twice-daily injections and multiple daily injections of insulin in toddlers with type 1 diabetes: a retrospective cohort study.

A descriptive study to assess the knowledge on biomedical waste management among health team member in selected hospital, Mangalore

A descriptive designs were used to gain more information about characteristics within a particular field of study on knowledge of health team members regarding biomedical waste management in selected hospitals, Mangalore, overall 40 samples were participated in the study. Probability stratified random sampling technique is used to select the sample for the study. Result: Analysis of base line characteristics of subjects reveals that among the health team members 60% belong to the age group of 20-25 years,92.5% are females ,30% are MBBS/PG,55% have 0-2 years of experience,72.5% are working in wards,50% are underwent training programme and 50% are not underwent training programme. Assessment of knowledge of health team members regarding biomedical waste management reveals the majority 72.50% of health team members has good knowledge and 25% of health team members have average knowledge and 2.50% have excellent and 0% has poor knowledge. The study is supported by similar study conducted in Mangalore, Karnataka on assessing the knowledge and practices of health care providers in handling biomedical waste. Knowledge of health team members had significant association between knowledge regarding biomedical waste management. Conclusion: The management of waste remains a challenge for the nation at large.it is our responsibility as individual, institutions, companies and organization to play our much needed roles in order to arrest situation. The agency shall continue to work rigorously hand in glove with all stakeholders. Safe and effective management of waste is not only a legal necessity but also a social responsibilities. So try to reduce the waste generation, use recyclable products, individual awareness and participation, communicate about work place hazards.

Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation

Abstract Background Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized. Purpose To evaluate regional variations in patient selection and procedural characteristics for PVI with cryoablation in the Cryo Global Registry (NCT02752737). Methods Patients with AF were enrolled from May 2016 to October 2021 at 128 sites in 37 countries. Patients were treated with cryoballoon ablation according to local clinical practice. Baseline subject and procedural characteristics were summarized for 8 regions (Central Asia and Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Procedure-related serious adverse events (SAEs) were evaluated in a subset of patients with ≥7 days of follow-up. Results A total of 3680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was more commonly performed in patients with paroxysmal vs. persistent AF in all regions, and in males vs. females in all regions except Central Asia and Russia. Mean age ranged from 47±12 in the Middle East to 64±11 in East Asia. Regional variations were observed in the proportion of patients with common AF comorbidities undergoing cryoablation (Table 1). Median procedure time ranged from 61 (49–68) minutes in Central Asia and Russia to 95 (76–120) minutes in Southeast Asia. Median fluoroscopy time was ≤20 minutes in all regions. The use of 3D mapping was relatively uncommon except in North America (63.3%). Large variation was observed in the use of esophageal monitoring, whereas phrenic nerve monitoring was used in ≥97.7% of cases in all regions (Table 2). Same-day discharge was uncommon except in North and South America (37.8% and 26.5% of cases, respectively). Average freeze duration ranged from 153±41 seconds in Southeast Asia to 230±29 seconds in Central Asia and Russia. Mean number of applications per vein ranged from 1.2±0.4 in Central Asia and Russia to 2.1±1.0 in North America. Acute procedural success was ≥94.7% in all geographies and focal radiofrequency touch-up was required in ≤13.0% of cases. In 3126 subjects with ≥7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%), and 1 procedure-related death was reported during data collection. Conclusion(s) Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation is performed with high acute success and short procedural times around the world. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic, Inc.

S196 Clostridioides difficile Infection (CDI) Increased in Individuals Diagnosed With Prior Colorectal Adenomas

Introduction: Clostridioides difficile infection (CDI) is increased in patients with colorectal cancer, but no one has investigated if CDI is also higher in individuals with prior history of colorectal adenomas seen on colonoscopy. Methods: We conducted a hospital-based cohort study composed of patients with diarrhea admitted to University of Michigan from 3/2016 to 12/2017 who were tested for C. difficile. Two hundred ninety-six diagnosed with C. difficile and 571 with non-C. difficile diarrhea were enrolled into the larger study. We abstracted prior colonoscopy reports and pathology reports from the medical records. Patients who had undergone colonoscopy were included in this analysis. Six hundred forty-seven underwent colonoscopy and 111 were diagnosed with colorectal adenomas prior to enrollment in the study. Logistic regression models were used to derive odds ratios (ORs) and 95% confidence intervals (95% CI) to evaluate comparisons between cases diagnosed with C. difficile and non-C. difficile diarrhea controls. We analyzed the association between history of colorectal adenoma diagnosis and CDI. (Figure, Table) Results: We found an increased risk of CDI in individuals with a prior colorectal adenoma (HR 1.64; 95% confidence interval (CI) 1.06-2.54) after adjusting for age, sex, obesity, complicated and uncomplicated diabetes and inflammatory bowel disease. Notably we also found a significant decreasing association between time since polypectomy and CDI with greater risk associated with greater time since colonoscopy. Conclusion: This study showed a higher incidence of CDI in individuals with a prior history of adenoma.Risk decreases over time since last polypectomy, which lends support to the hypothesis that there is a link between adenomas and subsequent CDI risk. Futures studies are needed to confirm this finding and elucidate mechanisms as this relationship could help target prophylactic measures in these individuals to avoid future infection.Figure 1.: Risk factors of CDI estimated with multivariate logistic regression. Model was adjusted for Complicated DM, Obesity, gender, history of adenoma, and age Table 1. - Baseline characteristics of subjects by Clostridioides difficile infection (CDI) diagnosis 1. Clostridioides difficile infection (CDI), Diabetes mellitus (DM) 2. Pearson's Chi-squared test; Fisher's exact test. 3. Interquartile range (IQR). 4. n (%) Characteristic Non-CDI1 Diarrhea (N=422) CDI1 Diarrhea (N=225) p-value2 Age 53 (39, 64)3 55 (45, 69)3 0.6 Non-Hispanic Caucasian 337 (80%)4 178 (79%)4 0.8 History of adenoma 58 (14%)4 53 (24%)4 0.002 Gender 0.11 Female 249 (59%)4 118 (52%)4 Male 73 (41%)4 107 (48%)4 Obesity 43 (10%)4 34 (15%)4 0.07 IBD 155 (37%)4 57 (25%)4 0.003 Complicated DM1 42 (10.0%)4 48 (21%)4 < 0.001

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training.

Above-normal blood pressure (BP) is a primary risk factor for cardiovascular diseases. In a retrospective analysis of five pilot trials, we assessed the BP-lowering effects of high-resistance inspiratory muscle strength training (IMST) in adults aged 18-82 years and the impact of IMST on maximal inspiratory pressure (PIMAX), a gauge of inspiratory muscle strength and independent disease risk factor. Participants were randomized to high-resistance IMST (75% PIMAX) or low-resistance sham (15% PIMAX) training (30 breaths/day, 5-7 days/wk, 6 wk). IMST (n = 67) reduced systolic BP (SBP) by 9 ± 6 mmHg (P < 0.01) and diastolic BP (DBP) by 4 ± 4 mmHg (P < 0.01). IMST-related reductions in SBP and DBP emerged by week 2 of training (-4 ± 8 mmHg and -3 ± 6 mmHg; P ≤ 0.01, respectively) and continued across the 6-wk intervention. SBP and DBP were unchanged with sham training (n = 61, all P > 0.05). Select subject characteristics slightly modified the impact of IMST on BP. Greater reductions in SBP were associated with older age (β = -0.07 ± 0.03; P = 0.04) and greater reductions in DBP associated with medication-naïve BP (β = -3 ± 1; P = 0.02) and higher initial DBP (β = -0.12 ± 0.05; P = 0.04). PIMAX increased with high-resistance IMST and low-resistance sham training, with a greater increase from high-resistance IMST (+20 ± 17 vs. +6 ± 14 cmH2O; P < 0.01). Gains in PIMAX had a modest inverse relation with age (β = -0.20 ± 0.09; P = 0.03) and baseline PIMAX (β = -0.15 ± 0.07; P = 0.04) but not to reductions in SBP or DBP. These compiled findings from multiple independent trials provide the strongest evidence to date that high-resistance IMST evokes clinically significant reductions in SBP and DBP, and increases in PIMAX, in adult men and women.NEW & NOTEWORTHY In young-to-older adult men and women, 6 wk of high-resistance inspiratory muscle strength training lowers casual systolic and diastolic blood pressure by 9 mmHg and 4 mmHg, respectively, with initial reductions observed by week 2 of training. Given blood pressure outcomes with the intervention were only slightly altered by subject baseline characteristics (i.e., age, blood pressure medication, and health status), inspiratory muscle strength training is effective in lowering blood pressure in a broad range of adults.

747-P: Baseline Characteristics of Subjects in the Once-Weekly (OW) Semaglutide FLOW Kidney Outcomes Trial

Chronic kidney disease (CKD) is a common complication of type 2 diabetes (T2D) that increases the risk of kidney failure and cardiovascular (CV) disease. Data from CV outcomes trials suggest that glucagon-like peptide-1 receptor agonists have kidney-protective effects. The FLOW trial (NCT03819153) will evaluate kidney outcomes with OW semaglutide in subjects with T2D and CKD. FLOW is an ongoing randomized, double-blinded, multinational, phase 3b trial. Subjects (N=3,535) with T2D, estimated glomerular filtration rate (eGFR) ≥25-≤75 mL/min/1.73 m2, and urine albumin-to-creatinine ratio &amp;gt;100-&amp;lt;5,000 mg/g were assigned 1:1 to OW semaglutide 1.0 mg or placebo, plus standard-of-care. The primary endpoint is time to first occurrence of kidney failure (as measured by persistent eGFR &amp;lt;15 mL/min/1.73 2 or initiation of chronic dialysis or kidney transplantation) ; ≥50% persistent eGFR reduction compared with baseline; kidney or CV death. At baseline, 68.6% of subjects had HbA1c &amp;gt;7.0%, diabetes complications were common, and 15.5% were taking a sodium-glucose co-transporter-2 inhibitor (Table) . The majority of subjects (68.2%) were at very high risk for CKD progression (Kidney Disease: Improving Global Outcomes criteria) . Subjects enrolled in FLOW had substantial diabetes burden and risk for CKD progression. FLOW will assess kidney outcomes with OW semaglutide in this population. Disclosure R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck &amp; Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. V.Perkovic: Advisory Panel; Astellas Pharma Inc., Baxter, DURECT Corporation, Merck &amp; Co., Inc., Metavant Sciences, Mundipharma, Relypsa Inc., Other Relationship; AbbVie Inc., AstraZeneca, Bayer AG, Bristol-Myers Squibb Company, Dimerix, Eli Lilly and Company, Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline plc., Janssen Research &amp; Development, LLC, Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk, Novo Nordisk, Otsuka America Pharmaceutical, Inc., Pfizer Inc., Sanofi, Servier Laboratories, Tricida, Inc., UpToDate. F.M.M.Baeres: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk. G.Bakris: Consultant; Alnylam Pharmaceuticals, Inc., AstraZeneca, DiaMedica Therapeutics, Inc., Horizon Therapeutics plc, Ionis Pharmaceuticals, Merck &amp; Co., Inc., Other Relationship; Novo Nordisk. J.Lawson: Employee; Novo Nordisk A/S. K.W.Mahaffey: Consultant; Novo Nordisk. J.F.Mann: Advisory Panel; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. H.Mersebach: Employee; Novo Nordisk A/S. P.Rossing: Consultant; Astellas Pharma Inc., AstraZeneca, Bayer AG, Gilead Sciences, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Speaker's Bureau; Eli Lilly and Company. K.R.Tuttle: Advisory Panel; Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Consultant; AstraZeneca, Eli Lilly and Company, Research Support; Bayer AG, Goldfinch Bio, Inc., Novo Nordisk, Travere.

Barriers perceived by researchers in pursuing medical research in an evolving medical college of tribal Madhya Pradesh, India.

Introduction:Doing quality medical research that improves patient care, improves medical education, reduces expenditures, and benefits society at large is an important responsibility, though often underrated. Appropriate measures are required to be taken when a medical college is new. Hence, this provided an opportunity to conduct a study at a current medical institution with the aim of identifying the barriers faced by research in various domains.Methods:This cross-sectional study included currently working faculties, including senior residents and demonstrators, as subjects. A structured questionnaire with close-ended responses was used, which covered the baseline characteristics of subjects and perceived research barriers among researchers. After obtaining institutional ethical approval, the study was initiated. During the analysis of the data, an association between variables was significant for P value < 0.05.Results:In the present study, out of 105 eligible subjects, only 98 of them participated. The mean age of the subjects was 36.06 ± 6.48 years. The most frequent barriers expressed were a lack of research training facilities to solve individual research problems (45.9%) and a lack of a sufficient financial budget for research activities (57.1%). The organizational-managerial level domain was significantly associated with the subject’s age, designation, and gender (P < 0.05).Conclusions:The present study identified the barriers faced by the researcher at various levels. Despite the presence of a young workforce, it was surprising to notice that more than half of the faculty members had poor research barrier scores in each of six domains, probably due to a lack of mentorship and acknowledgement, and a lack of skill in using computer-based hardware and software.

Evidence and risk indicators of non-random sampling in clinical trials in implant dentistry: A systematic appraisal.

AimAnalysis of distribution of p‐values of continuous differences between test and controls after randomization provides evidence of unintentional error, non‐random sampling, or data fabrication in randomized controlled trials (RCTs). We assessed evidence of highly unusual distributions of baseline characteristics of subjects enrolled in clinical trials in implant dentistry.Materials and methodsRCTs published between 2005 and 2020 were systematically searched in Pubmed, Embase, and Cochrane databases. Baseline patient data were extracted from full text articles by two independent assessors. The hypothesis of non‐random sampling was tested by comparing the expected and the observed distribution of the p‐values of differences between test and controls after randomization.ResultsOne‐thousand five‐hundred and thirty‐eight unique RCTs were identified, of which 409 (26.6%) did not report baseline characteristics of the population, and 671 (43.6%) reported data in forms other than mean and standard deviation and could not be used to assess their random sampling. Four‐hundred and fifty‐eight trials with 1449 baseline variables in the form of mean and standard deviation were assessed. The study observed an over‐representation of very small p‐values [<.001, 1.38%, 95% confidence interval (CI) 0.85–2.12 compared to the expected 0.10%, 95% CI 0.00–0.26]. No evidence of over‐representation of larger p‐values was observed. Unusual distributions were present in 2.38% of RCTs and more frequent in non‐registered trials, in studies supported by non‐industry funding, and in multi‐centre RCTs.ConclusionsThe inability to assess random sampling due to insufficient reporting in 26.6% of trials requires attention. In trials reporting suitable baseline data, unusual distributions were uncommon, and no evidence of data fabrication was detected, but there was evidence of non‐random sampling. Continued efforts are necessary to ensure high integrity and trust in the evidence base of the field.

Low genetic confirmation rate in South Indian subjects with a clinical diagnosis of maturity-onset diabetes of the young (MODY) who underwent targeted next-generation sequencing for 13 genes.

To screen for maturity-onset diabetes of the young (MODY) variants in subjects with an early age of onset and positive family history of diabetes mellitus. 60 subjects with onset of diabetes between 3 and 30years of age and parental history (onset < 35years) of diabetes were recruited after excluding autoimmune, pancreatic and syndromic forms of diabetes. Detailed pedigree chart and clinical data were recorded. MODY genetic testing (MODY 1-13) was performed and variant classification was done adhering to the ACMG guidelines. Baseline characteristics of subjects were as follows: mean age of onset of diabetes 19.9 ± 7years, mean duration of diabetes 6.3±6.8years, BMI 23.3±3kg/m2 and C-peptide 1.56 ± 1.06nmol/l. Four out of sixty (6.6%) were positive for variants classifiable as pathogenic/likely pathogenic: one patient with HNF4Ac.691C > T, (p.Arg231Trp), two with HNF 1A c.746C > A(p.Ser249Ter) and c.1340C > T(p.Pro447Leu), and one with ABCC8 c.4544C > T (p.Thr1515Met). MODY 1 and MODY 3 variants were documented in the paediatric age group (< 18years). A genetic diagnosis of MODY could be confirmed in only 6.6% (4/60) of patients clinically classifiable as MODY. This is less than that reported in clinically diagnosed MODY subjects of European descent. Newly published population data and more stringent criteria for assessment of pathogenicity and younger age of onset of type 2 diabetes in Indians could have contributed to the lower genetic confirmation rate. Apart from variants in the classical genes (HNF1A, HNF4A), a likely pathogenic variant in a non-classical gene (ABCC8) was noted in this study.

Clinical and epidemiological characteristics of patients seeking COVID-19 testing in a private centre in Malaysia: Is there a role for private healthcare in battling the outbreak?

ObjectiveThis cross-sectional observational study summarized the baseline characteristics of subjects who underwent COVID-19 molecular testing in a private medical centre located in the state of Selangor in Malaysia between 1 Oct 2020 and 31 Jan 2021. We compared the baseline characteristics between subjects who were tested positive and negative of SARS-CoV-2 infection, and identified risk factors which may be predictive of SARS-CoV-2 positivity.Methods and findingsA total of 36603 subjects who were tested for COVID-19 infection via molecular assays at Sunway Medical Centre between Oct 1, 2020 and Jan 31, 2021, and consented to participate in this observation study were included for analysis. Descriptive statistics was used to summarize the study cohort, whereas logistic regression analysis was used to identify risk factors associated with SARS-CoV-2 positivity. Among the reasons listed for COVID-19 screening were those who needed clearance for travelling, clearance to return to work, or clearance prior to hospital admission. They accounted for 67.7% of tested subjects, followed by the self-referred group (27.3%). Most of the confirmed cases were asymptomatic (62.6%), had no travel history (99.6%), and had neither exposure to SARS-CoV-2 confirmed cases (61.9%) nor exposure to patients under investigation (82.7%) and disease clusters (89.2%). Those who presented with loss of smell or taste (OR: 26.91; 95% CI: 14.81–48.92, p<0.001), fever (OR:3.97; 95% CI: 2.54–6.20, p<0.001), running nose (OR: 1.75; 95% CI:1.10–2.79, p = 0.019) or other symptoms (OR: 5.63; 95% CI:1.68–18.91, p = 0.005) were significantly associated with SARS-CoV-2 positivity in the multivariate logistic regression analysis.ConclusionOur study showed that majority of patients seeking COVID-19 testing in a private healthcare setting were mainly asymptomatic with low epidemiological risk. Consequently, the average positivity rate was 1.2% compared to the national cumulative positivity rate of 4.65%. Consistent with other studies, we found that loss of smell or taste, fever and running nose were associated with SARS-CoV-2 positivity. We believe that strengthening the capacity of private health institutions is important in the national battle against the COVID-19 pandemic, emphasizing the importance of public-private partnership to improve the quality of clinical care.