Multivariable Generalized Estimating Equations Research Articles

Prevalence and Outcomes of Gastrointestinal Manifestations in an Australian Scleroderma Cohort.

The gastrointestinal tract (GIT) is the most commonly affected internal organ in systemic sclerosis (SSc). We sought to determine the prevalence and impact of GIT symptoms on survival and patient-reported outcomes. A total of 907 consecutive patients from the Australian Scleroderma Cohort Study who had prospectively completed the University of California, Los Angeles, Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 Questionnaire (UCLA GIT) between 2015 and 2021 were included. The associations between UCLA GIT scores and physical function (Scleroderma Health Assessment Questionnaire), quality of life (QoL; Short Form 36), mood (Patient-Reported Outcomes Measurement Information System [PROMIS] anxiety and depression domains), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score), and employment were investigated using multivariable population-averaged panel models using generalized estimating equations (GEEs). Kaplan-Meier curves and multivariable Cox proportional hazard regression models were used to evaluate survival according to total UCLA GIT scores. GIT symptoms were reported in 87% of participants, with 46% to 52% reporting moderate to very severe symptoms of reflux, distension, diarrhea, and constipation. Higher total UCLA GIT scores were associated with worse QoL, physical function, fatigue, anxiety, and depression (P < 0.001). In the multivariable GEE analysis, moderate and severe to very severe total scores, reflux scores, and distension scores were associated with worse physical function, QoL, fatigue, anxiety, and depression compared to mild scores (P < 0.05). Patients with severe total scores and diarrhea scores were more likely to be unemployed compared to those with mild scores (P < 0.05). UCLA GIT total scores were not independently associated with death in our cohort. GIT manifestations are common in SSc and negatively impact QoL, physical function, and employment but are not directly associated with increased death.

Association Between Glucagon-Like Peptide-1 Receptor Agonists Exposure and Intraocular Pressure Change: GLP-1 Receptor Agonists and Intraocular Pressure Change

This study evaluates the effects of glucagon-like peptide-1 receptor (GLP-1R) agonists on intraocular pressure (IOP). Retrospective clinical cohort study. The University of California Health Data Warehouse was queried for patients exposed to GLP-1R agonists or other oral antidiabetics. A total of 1247 glaucoma surgery and treatment naïve eyes of 626 patientson GLP-1R agonists and 1083 glaucoma surgery and treatment naïve eyes of 547 patients on other oral antidiabetics were included. Index date was defined as the date of first exposure to the medication. Eyes with at least one pre-exposure and one post-exposure tonometry records within 365 days of the index date were included. Clinical and laboratory data were extracted. Eyes were excluded upon exposure to glaucoma hypotensive medication or glaucoma surgery. The primary outcome measure was ∆IOP after exposure, which was analyzed using a paired t test and generalized estimating equations (GEE) RESULTS: The median age was 66.2 years [IQR = 18.3]; 607 (51.7%) were female, and 667 (56.9%) were Caucasian. Median pre-exposure IOP, hemoglobin A1c, and body mass index were 15.2 mm Hg [IQR = 3.8], 7.5 [IQR = 2.4], and 29.8 [IQR = 9.4], respectively. A total of 776 individuals (66.1%) had diabetes, with the median number of active oral antidiabetics being 1.0 [IQR = 1.0], and 441 (37.5%) being insulin users. Several pre-exposure characteristics differed between the groups. The mean ∆IOP was -0.4 ± 2.8 mm Hg (paired t test P < .001) and -0.2 ± 3.3 mm Hg (paired t test P = .297) in the GLP-1R agonist and other antidiabetics groups, respectively. Pre-exposure IOP was the only independent predictor of ΔIOP in multivariable GEE. Sensitivity analyses yielded similar results. Although GLP-1R agonists were significantly associated with a decrease in IOP in the paired analysis, they were not associated with ΔIOP in multivariable GEE. Moreover, the difference in ΔIOP between the two groups was small.

Structural Barriers to Primary Care Among Sex Workers: Findings from a Community- Based Cohort in Vancouver, Canada (2014-2021).

Due to structural marginalization, sex workers experience health inequities including a high prevalence of sexually transmitted and blood-borne infections, mental health disorders, trauma, and substance use, alongside a multitude of barriers to HIV and substance use services. Given limited evidence on sex workers' broader primary healthcare access, we aimed to examine structural factors associated with primary care access among sex workers over a 7-year period. Data were derived from An Evaluation of Sex Workers Health Access (AESHA), a community-based open prospective cohort of women (cis and trans) sex workers in Metro Vancouver, from 2014 to 2021. Descriptive statistics were used to summarize the proportion of primary care use in the past six months and to assess primary care trends over time from 2014-2021. We used multivariate logistic regression with generalized estimating equations (GEE) to identify structural factors associated with primary care access (seeing a family doctor in the last six months), after adjusting for confounders. Amongst 646 participants, most (87.4%) accessed primary care at some point during the study period, and primary care use in the in the last 6 months was relatively stable (ranging from 60-78%) across each follow-up period. At first available observation, participants faced a high burden of sexually transmitted and blood-borne infections (STBBIs) (48.0%, 11.5%, and 10.4% were HCV, HIV, or STI seropositive, respectively), 56.8% were diagnosed with a mental health disorder, 8.1% had recently overdosed, and 14.7% were recently hospitalized. In multivariable GEE analysis, exposure to intimate partner violence was associated with reduced access to primary care (Adjusted odds ratios (AOR) 0.63, 95% Confidence interval (CI): 0.49 - 0.82), and limited English fluency was marginally associated (AOR 0.76 CI: 0.51 - 1.14). This study characterized primary care access and its structural determinants among sex workers over 7-years. Participants faced a high burden of STBBIs and other health disparities, and a proportion faced gaps in primary care access. Scale-up of trauma-informed, culturally and linguistically tailored, sex worker-friendly primary care models are needed, alongside structural interventions to decriminalize and destigmatize sex work and substance use.

Retinal perfusion related to visual field within the same asymmetric thyroid-associated ophthalmopathy

PurposeTo quantify interocular differences in the retinal microvasculature between disparate eyes and explore associations between the retinal microvasculature and visual field abnormalities within the same asymmetric thyroid-associated ophthalmopathy (TAO) patients. MethodsWithin the same asymmetric TAO eye, the eye with a severer visual field abnormality (based on the mean deviation [MD]) was considered a severe eye, and the fellow eye was considered mild. The densities of radial peripapillary capillary (RPC) and superficial retinal capillary plexuses (SRCP) were determined using optical coherence tomography angiography. Interocular differences in RPC and SRCP densities were analyzed. A generalized estimating equation (GEE) was used to form a predictive model for visual field abnormalities. Pearson's correlation was used to show the correlation between MD and the densities of RPC and SRCP. ResultsIn 57 asymmetric TAO patients, the global RPC density in severe eyes was lower than that in mild eyes (P < 0.001), but there was no significant difference in SRCP density between the two groups (P = 0.114). In a multivariate GEE model with MD as the outcome, MD was associated only with global RPC density (coefficient β=0.327, P < 0.001). The global RPC density was correlated with MD (r = 0.360, P = 0.003) in severe eyes, but not in mild eyes (r = 0.179, P = 0.092). No significant correlation was observed between global SRCP density and MD in either group (Both P > 0.05). ConclusionsRPC density decreased significantly and correlated with visual field abnormalities in severe eyes of TAO patients. Alterations in RPC density may contribute to visual field abnormalities in TAO eyes.

Asymptomatic Rectal Bacterial Pathogens Show Large Prospective Relationships With HIV Incidence in a Cohort of Young Sexual and Gender Minorities: Implications for STI Screening and HIV Prevention.

We estimated the predictive value of rectal (bacterial sexually transmitted infection [bSTI]) pathogen detection for future HIV seroconversion among young adult sexual and gender minorities (YSGMs) assigned male at birth (AMAB). Data were collected between March 2018 and August 2022 from RADAR, a longitudinal cohort study of YSGMs AMAB living in the Chicago metropolitan area (n = 1022). Rates of rectal bSTIs and the proportion of self-reported rectal bSTI symptoms are reported. We examined whether the presence of rectal bSTIs predicted HIV seroconversion using generalized estimating equations (GEEs). Participants tested reactive for rectal Mycoplasma genitalium (MGen), Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT) at a rate of 20.8 (95% CI, 18.4-23.5), 6.5 (95% CI, 5.0-8.2), and 8.4 (95% CI, 6.8-10.3) cases per 100 persons, respectively. There were no statistically significant pairwise differences in self-reported rectal bSTI symptoms between participants with self-collected swabs testing nonreactive vs reactive for rectal MGen (χ2 = 0.04; P = .84), NG (χ2 = 0.45; P = .37), or CT (χ2 = 0.39; P = .46). In multivariate GEE analysis, rectal NG (adjusted odds ratio, 5.11; 95% CI, 1.20-21.77) was a statistically significant predictor of HIV seroconversion after controlling for other bSTIs, demographics, and sexual risk behavior. Our findings provide a robust longitudinal estimation of the relationship between primarily asymptomatic rectal NG nucleic acid detection and HIV infection. These findings highlight the importance of asymptomatic screening for bSTIs and targeting biobehavioral intervention to prevent HIV infection among YSGMs with rectal bSTI agents detected.

Mortality risk factors for crush syndrome after an earthquake in Türkiye: Do systemic inflammatory parameters play any role?

The aim of our study is to assess the prognostic impact of the neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), and platelet-to-lymphocyte ratio (PLR) on 28-day mortality in patients admitted to the intensive care unit with crush syndrome following the Kahramanmaraş earthquake in Türkiye. A total of 63 adult patients with crush syndrome admitted to the intensive care unit after the earthquake were enrolled in this study. The medical records of the patients were examined using follow-up forms and the hospital data system. The mean age of the patients was 38.9±17.3 years, and the median time under debris was 31.5 hours. The 28-day mortality rate was 27%. In univariate generalized estimating equations (GEE) and other analyses, variables that are significant (or candidate variables) between 28-day mortality groups included age as a biological factor. These variables were included in the multivariate GEE model. The effects of continuous renal replacement therapy (CRRT), serum sodium concentration, Sequential Organ Failure Assessment (SOFA) score, and PLR on mortality were statistically significant. Elevated SOFA scores, the necessity for CRRT, increased serum sodium levels, and decreased PLR values are associated with increased 28-day mortality in patients with crush syndrome after an earthquake.

Involuntary discharge from drug or alcohol treatment programs in Vancouver, Canada

BackgroundRetention in substance use treatment is essential to treatment success. While programmatic factors are known to influence retention, less is known about the role of involuntary discharges from drug or alcohol treatment programs. Therefore, we sought to identify the prevalence of and factors associated with involuntary discharge due to ongoing substance use.MethodsData were derived from two community-recruited prospective cohort studies of people who use drugs in Vancouver, Canada. Generalized estimating equation (GEE) analyses were used to identify variables associated with involuntary discharge from treatment programs due to ongoing substance use.ResultsBetween June 2017 and March 2020, 1487 participants who accessed substance use treatment and completed at least one study interview were included in this study. Involuntary discharge from a treatment program due to ongoing substance use was reported by 41 (2.8%) participants throughout the study, with 23 instances reported at baseline and another 18 reported during study follow-up. In a multivariable GEE analysis, involuntary discharge was positively associated with homelessness (Adjusted Odds Ratio [AOR] = 3.22, 95% Confidence Interval [95% CI]: 1.59–6.52), daily injection drug use (AOR = 1.87, 95% CI 1.06–3.32) and recent overdose (AOR = 2.50, 95% CI 1.38–4.53), and negatively associated with age (AOR = 0.93, 95% CI 0.90–0.96). In sub-analyses, participants have most commonly been discharged from in-patient treatment centres (52.2%), recovery houses (28.3%) and detox programs (10.9%), and for using heroin (45.5%) and/or crystal methamphetamine (36.4%).ConclusionsWhile involuntary discharge was a relatively rare occurrence, those who were discharged due to active substance use possessed several markers of risk, including high-intensity injection drug use, homelessness, and recent non-fatal overdose. Our findings highlight the need for increased flexibility within treatment programs to account for those who re-initiate or continue to use substances during treatment.

Prevalence of Hemoplasma spp. positivity in potential feline blood donors and study of the association with selected clinical variables.

Hemotropic mycoplasmas, hemoplasmas, are epi-erythrocytic parasitic bacteria that can be transmitted through blood transfusion. To study the prevalence of hemoplasma infection of potential feline blood donors and investigate the association between Hemoplasma spp. quantitative polymerase chain reaction (qPCR) positivity in blood units and selected variables. Seven thousand five hundred seventy-three blood units from 4121 privately-owned potential donor cats. Retrospective observational cross-sectional study. The Banco Sangue Animal (BSA)-Animal Blood Bank medical database was reviewed for all feline donations performed in 2022 in Portugal, Spain, and Belgium. Baseline characteristics and results of blood-borne pathogens screening tests were extracted from the medical records. Two hundred twelve of 4034 Portuguese donor cats and 2 of 70 Spanish donor cats tested positive for Hemoplasma spp. qPCR in 2022 leading to an overall estimated prevalence of 5.2% (95% CI: 4.5%-5.9%) in potential blood donors. Using multivariable generalized estimation equation models, Hemoplasma spp. qPCR was more often positive among blood units issued from male cats (OR = 1.9, 95% CI: 1.4-2.6, P < .0001), units positive for FeLV (OR = 2.8, 95% CI: 1.4-5.6, P = .0023), and units collected in winter months (OR = 2.5, 95% CI: 1.7-3.6, P < .0001). This study underscores the importance of Hemoplasma spp. and other relevant blood-borne pathogens screening at every donation. Implementing stringent screening protocols is crucial to mitigate the risk of hemoplasma transmission via blood transfusions, thereby safeguarding the health and welfare of cats receiving transfusions.

Nurse Staffing, Work Hours, Mandatory Overtime, and Turnover in Acute Care Hospitals Affect Nurse Job Satisfaction, Intent to Leave, and Burnout: A Cross-Sectional Study.

Objectives: This study examined the impact of nurse staffing, working hours, mandatory overtime, and turnover on nurse outcomes in acute care hospitals. Previous studies have focused on the single characteristics of sub-optimal nurse staffing but have not considered them comprehensively. Methods: Data were collected in July-September 2022 using convenience sampling and an online survey (N = 397). For the analysis, 264 nurses working as staff nurses at 28 hospitals met the inclusion criteria. Univariate analysis and multivariable generalized estimating equation (GEE) were performed. Results: Both nurse staffing (β = -0.036, standard error [SE] = 0.011) and turnover (β = -0.006, SE = 0.003) were significant factors affecting job satisfaction. In the multivariable GEE, only mandatory overtime (β = 0.395, SE = 0.116) was significantly related to intent to leave. Nurse staffing, work hours, mandatory overtime, and turnover were not significantly related to burnout. Subjective health status and workload were significantly associated with burnout. Conclusion: Nurse staffing policies and improvement programs in hospitals should be implemented to improve nurses' job satisfaction. Labor policy should ban mandatory overtime.

Complications during Adolescence Predict Mortality in Young Adults with Childhood Onset Type 1 Diabetes

Objective. Microvascular complications increase the risk of cardiovascular disease and premature death in adults with type 1 diabetes. We examined the association between microvascular complications during adolescence, including cardiac autonomic nerve dysfunction and subsequent mortality. Research Design and Methods. We undertook data linkage with the Australian National Death Index in a cohort of 409 adolescents (diagnosed between 1973 and 1993), 48% male, median age at final complications assessment 17.4 years (interquartile range: 16.0–18.9), followed longitudinally for median 22.3 years (21.0–23.4) from diagnosis. Generalized estimating equations (GEE) were used to examine associations between mortality and adolescent complications. Mortality risk was calculated as standardized mortality ratio (SMR). Results. At final adolescent visit, 20% had CAN abnormality, 30% abnormal pupillary response, 20% albuminuria, 40% early elevation of albumin excretion rate (AER) and 45% retinopathy. Data linkage 8–13 years later showed 14 were deceased (3% of cohort), 57% male, median age 28.3 years (24.8–32.9). Acute or chronic diabetes complications accounted for 25% of deaths. In multivariable GEE, elevated AER (OR 4.54, 1.23–16.80, p=0.030), pupillary abnormality (OR 4.27, 1.20–15.22, p=0.023), systolic blood pressure SDS (OR 2.17, 1.26–3.74, p=0.005) and CAN (OR 4.65, 1.03–21.0, p=0.045) predicted mortality. HbA1c was not significant. SMR was 2.5 (1.4–4.2) and was higher in females (SMR 3.5, 1.3–7.8) but not in males (SMR 2.1, 0.9–4.0). Conclusion. Mortality in young adults with type 1 diabetes is predicted by subclinical markers of autonomic neuropathy and elevated AER during adolescence, but not glycemia. Mortality was over twice that of the background population in females but not in males.

Missed opportunities for treatment of inflammatory arthritis and factors associated with non-treatment: An observational cohort study in United States Veterans with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis

ObjectiveTo identify factors associated with non-treatment with biologic and non-biologic disease modifying anti-rheumatic drugs (DMARDs) during the 12 months after initial inflammatory arthritis (IA) diagnosis. MethodsWe identified Veterans with incident IA diagnosed in 2007–2019. We assessed time to treatment with Kaplan-Meier curves. We identified associations between non-treatment and factors relating to patients, providers, and the health system with multivariate Generalized Estimation Equation (GEE) log-Poisson. Subgroup analyses included IA subtypes (rheumatoid arthritis [RA], psoriatic arthritis [PsA], and ankylosing spondylitis [AS]) and timeframes of the initial IA diagnosis (2007–11, 2012–15, and 2016–19). ResultsOf 18,318 study patients, 40.7 % did not receive treatment within 12 months after diagnosis. In all patients, factors associated with non-treatment included Black race (hazard ratio, 95 % confidence interval: 1.13, 1.08–1.19), Hispanic ethnicity (1.14, 1.07–1.22), Charlson Comorbidity Index ≥2, (1.15, 1.11–1.20), and opiate use (1.09, 1.05–1.13). Factors associated with higher frequency of DMARD treatment included married status (0.86, 0.81–0.91); erosion in joint imaging report (HR: 0.86, 0.81–0.91); female diagnosing provider (0.90, CI: 0.85–0.96), gender concordance between patient and provider (0.91, CI: 0.86–0.97), and diagnosing provider specialty of rheumatology (0.53, CI: 0.49–0.56). ConclusionA high proportion of Veterans with IA were not treated with a biologic or non-biologic DMARD within one year after their initial diagnosis. A wide range of factors were associated with non-treatment of IA that may represent missed opportunities for improving the quality of care through early initiation of DMARDs.

The impact of an unsanctioned compassion club on non-fatal overdose

ObjectivesIn 2022, the Drug User Liberation Front opened an unsanctioned compassion club in Vancouver where members could purchase illicit drugs that had been rigorously tested to ensure quality and a lack of potentially fatal contaminants. We sought to evaluate the impact of access to this novel safer supply intervention on non-fatal overdose. MethodsData were obtained from 47 club members via surveys completed at 3-month intervals between August 2022 and October 2023. We conducted multivariable generalized estimating equations (GEE) analyses to examine the association between club enrolment and the outcomes of: (1) any non-fatal overdose; and (2) any non-fatal overdose involving naloxone administration. ResultsThe final sample, including 47 study participants, contributed a total of 225 observations and 44.4 person-years of follow-up during the study, and a median follow-up duration of 12.2 months (quartile 1 - 3: 10.4 – 14.7) per participant. In multivariable GEE analyses, enrolment in the compassion club was associated with reduced likelihood of non-fatal overdose (Adjusted Odds Ratio [AOR] = 0.51, 95% Confidence Interval (CI): 0.26 – 0.99) and non-fatal overdose involving naloxone administration (AOR = 0.37, 95% CI: 0.16 – 0.84) after adjusting for potential confounders. DiscussionIn this study, enrolment in an unsanctioned compassion club was found to be associated with reductions in any type of non-fatal overdose and non-fatal overdose involving naloxone administration. These findings highlight the need for ongoing research on safer supply interventions, as well as the potential of non-medicalized compassion clubs to complement existing safer supply programming and reduce overdose events.

Effect of nutrition education integrating the health belief model and theory of planned behavior on dietary diversity of pregnant women in Southeast Ethiopia: a cluster randomized controlled trial

BackgroundMaternal anemia, miscarriage, low birth weight (LBW), preterm birth (PTB), intrauterine growth restriction (IUGR), prenatal and infant mortality, morbidity, and the risk of chronic disease later in life are all increased by a lack of dietary diversity during pregnancy. However, evidence for the effect of nutrition education on the dietary diversity score (DDS) among pregnant women was sparse in Ethiopia, particularly in the study areas. This study aimed to assess the effect of nutrition education on dietary diversity among pregnant women in urban settings in Southeast Ethiopia.MethodsA community-based two-arm parallel cluster randomized controlled trial was conducted among 447 randomly selected pregnant women attending antenatal care (224 intervention group and 223 control group) at health facilities from February to December 2021. A multistage cluster sampling technique, followed by systematic sampling, was used to select the pregnant women. Pregnant women who participated in the interventions were given nutrition education starting at 16 weeks of gestation and continuing for 6 months. We used a pre-tested, interviewer-administered, structured questionnaire to collect the data. A 24-hour qualitative dietary recall was used to calculate the dietary diversity score (DDS). A multivariable generalized estimating equation (GEE) model was conducted to evaluate the intervention effect.ResultsAfter the intervention, the proportion of adequate dietary diversity was 14.15% higher in the intervention arm compared to the control group (45.09% versus 30.94%, P = 0.002). The overall difference in adequate dietary diversity between the two groups was 8.5%. After adjusting for background characteristics, the multivariable GEE binary logistic model revealed that having received intervention [(AOR = 1.89, 95% CI: 1.27, 2.79)], being literate [(AOR = 3.41, 95% CI: 1.13, 10.23)], and having high wealth [(AOR = 1.60, 95% CI: 1.09, 2.35)] significantly improved adequate dietary diversity.ConclusionThe findings indicated that having received the intervention, being literate, and having a high level of wealth significantly improved maternal dietary diversity. Efforts should be made to increase nutrition education using the health belief model (HBM) and the theory of planned behavior (TPB). Moreover, there is a need to improve literacy and economic empowerment through income-generating activities to enhance adequate dietary diversification during pregnancy.Trial registrationClinicaltrials.gov (PACTR202201731802989, Retrospectively registered on 24 January 2022).

Gaps in health coverage for racialized im/migrant sex workers in metro Vancouver: Findings of a community-based cohort study (2014–2021)

BackgroundSex workers face substantial health inequities related to sexual health and gender-based violence, many of which are amplified for the large proportion of workers who are racialized im/migrants. While criminalization and stigma are known barriers to health care for this population, we know little about health insurance coverage, and in particular how this relates to im/migration experience and racialization. We examined associations between im/migration status, duration, and racialization on gaps in health insurance coverage in a cohort of women sex workers. MethodsAnalyses used data from a prospective, community-based cohort of women sex workers in Vancouver, BC (Sept 2014-August 2021). Interviewer-administered questionnaires were by experiential (current/former sex workers) and community-based staff. We developed multivariable logistic regression confounder models with generalized estimating equations (GEE) to examine associations between migration and racialization exposures of interest and health insurance coverage. ResultsOf 644 sex workers, 411 (63.8%) reported lacking health insurance coverage for services needed during the 7-year study. In multivariable GEE analysis, precarious im/migration status (adjusted odds ratio (AOR) 2.37, 95% confidence interval (CI) 1.56 – 3.60), recent (AOR 4.22, 95% CI 2.42 – 7.35) and long-term (AOR 2.13, 95% CI 1.54 – 2.96) migration, and being a racialized Asian im/migrant (AOR 3.06, 95% CI 2.14 – 4.39) were associated with recent lack of health insurance coverage. ConclusionPolicy and program reforms are needed to decouple health insurance access from immigration status, remove mandatory waiting periods for health insurance coverage, and ensure that provincial insurance provides sufficient coverage for marginalized women's healthcare needs.

Patient-Centered Positive Factors Influencing Glycemic Control in Adolescents with Type 1 Diabetes Mellitus in China: A Cross-Sectional and Longitudinal Study.

This study aimed to explore the stable longitudinalpatient-centered self-protectivefactors of glycosylated hemoglobin (HbA1c) in adolescents with type 1 diabetesmellitus(T1DM). We used both cross-sectional and longitudinal datasets at the Diabetes Education Center and National Endocrine and Metabolism Centre of a university hospital in China from April 2020 to July 2022. Participants were assessed using the Adolescent Diabetic Behavior Rating Scale (DBRS), Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen). HbA1c and other clinical variables were obtained from the medical record at the same time. 266 adolescents (131 male, age 14.1±3.9 years) completed the cross-sectional assessments and 131 (62 male, age 14.6±3.3 years) participated in a follow-up at a 1-year visit interval. Logistic regression analysis of cross-sectional data of 266 cases showed that there were significant positive effects between pump treatment (β=0.090, OR 2.460, P=0.005), DBRS scores (β=2.593, OR 13.366, P=0.002) and the meeting of standard HbA1c (<7.5%, 58 mmol/mol). Disease duration (β=-0.071, OR 0.932, P=0.033) was negatively correlated with it. The longitudinal multivariate generalized estimation equation model showed that DBRS scores (β=3.165, OR 23.681, P=0.009) and DSTAR-Teen scores (β=0.050, OR 1.051, P=0.012) had a positive influence on the meeting of standard HbA1c over one year time of 131 cases. Self-care and resilience had higher cross-temporal stability in influencing glycemic control over time. To reach a better glycemic control and improve long-term health outcomes, attention should be paid to the detection and enhancement of these patient-centered promoters.

Oral Candidiasis in Patients with Rheumatoid Arthritis: A Hospital-Based Cohort Study

Background: Rheumatoid (RA) arthritis is a chronic autoimmune disease characterized by symmetric polyarthritis and systemic inflammation. Systemic complications due to RA and its treatment may affect oral health. Objective: To assess the prevalence and predisposing factors for oral candidiasis in Rheumatoid Arthritis patients treated at a rheumatology referral hospital. Methods: This is a longitudinal study of a panel of repeated measures performed on patients attending the Rheumatology and Oral Diagnosis Outpatient Clinic of the General Hospital of Cuiabá. Patients were followed up between 2018 and 2019, with the information recorded in the medical records and subsequently extracted. A generalized estimation equation model was used to assess the association between oral candidiasis and RA. Results: In the final model, in crude (bivariate) analysis, the use of prednisone (OR 8.3) and tocilizumab (OR 3.7) were significantly associated with oral candidiasis. In the multivariate generalized estimation equation model, the use of prednisone (OR 9.9) and the presence of hyposalivation in male patients (OR 1.8) were the variables that remained statistically associated with oral candidiasis. Conclusion: The use of immunosuppressive drugs and the low rate of salivary flow in male patients increase the risk of oral candidiasis in patients with rheumatoid arthritis, reinforcing the importance of stomatological monitoring, a preventive approach and early diagnosis of this pathology.

Higher CD4+ T Cell Counts after CAR-T in Large B-Cell Lymphomas Are Significantly Associated with Better Overall Survival

Introduction Chimeric antigen receptor T-cell (CAR-T) therapy has revolutionized the treatment of large B-cell lymphomas (LBCL), demonstrating remarkable efficacy. However, CAR-T therapy is also associated with significant toxicities, some arising from relative immunologic incompetence after treatment. A key knowledge gap persists regarding how the immune landscape changes post-CAR-T, defined as immune reconstitution (IR), and the influence of IR on patient outcomes. In this study, we set out to describe patterns and determinants of IR following CAR-T as well as impacts of IR on outcomes. Methods Adult patients with primary or transformed LBCL treated with CD19-CAR-T cells, namely axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel), between 2017 and 2022 were included in this single center retrospective study. Immune cell levels were measured at various timepoints after CAR-T. Median cell counts and interquartile range (IQR) at pre-specified time windows (using the first available observation) were used to describe temporal IR patterns. Multivariable generalized estimating equation (GEE) models with cubic time variables were used to investigate the association between cell count trajectory and baseline characteristics. A multivariable Cox model with longitudinal cell count as a time-varying covariate was utilized to assess the association between IR and overall survival (OS), adjusted for confounding factors. Kaplan-Meier (KM) curves were generated for visualization. Results A total of 210 patients were included, of whom 153 had at least one CD4+ T cell measurement from time of CAR-T. The median age was 65 (range 20-86) and most were male (65.7%) and diagnosed with diffuse large B-cell lymphoma (79.5%). Axi-cel (49.5%) was the most common product, followed by tisa-cel (28.6%) and liso-cel (21.9%). Lymphodepletion was mostly cyclophosphamide and fludarabine (82.4%). Of the 210 patients, 58.1% achieved a complete response (CR) and 17.1% a partial response by 100 days after CAR-T. Following CAR-T, CD3+ T cells were the most abundant circulating lymphocyte. By 30 days (±15 days) after CAR-T, median (IQR) values of CD3+ T cells, B cells, and NK cells were 445 (162-776), 0 (0-0), and 90 cells/ul (57-146), respectively; by 60 days (±15 days), median (IQR) values were 498 (220-706), 0 (0-0), and 104 cells/ul (69-169), respectively. Proportions of CD4+ and CD8+ T cells remained similar through one year after CAR-T, with CCR7-45RA+ TEMRA and CCR7-45RA- effector memory cells dominating among CD8's, and CCR7-45RA- effector memory cells being the most abundant among CD4's. Regulatory T cells (CD25+CD127-) comprised about 10% of the CD4+ T cell lymphocyte population, with a median (IQR) of 9 cells/ul (4.5-15.5) by day 30 (±15 days) after CAR-T. Finally, receipt of tisa-cel was associated with greater levels of CD4+ EM T cells compared with axi-cel and liso-cel (median [IQR]: 253 [158-406] vs 81 [51-138] and 113 cells/ul [88-154], respectively), by 30 days (±15 days) after CAR-T. According to a multivariable GEE model, patients receiving tisa-cel had significantly higher CD4+ count trajectories compared to those receiving axi-cel or liso-cel ( p&amp;lt;0.001 for both) ( Figure A). In addition, patients with more extensive pre-treatment (i.e., 6+ prior lines) had significantly lower CD4+ count trajectories compared to those who received 2-3 or 4-5 prior lines ( p=0.015 and p=0.004, respectively). A multivariable Cox model, moreover, indicated that a higher CD4+ count (in units of 50 cells/ul) was significantly associated with better OS (adjusted HR: 0.845; 95% CI, 0.745-0.960; p=0.010), adjusted for product and prior lines of therapy. KM curves by patients above or below the median of the last observed CD4+ count further demonstrated this significant association between longitudinal IR and OS ( Figure B). Conclusion In this single-center retrospective study, we extensively characterized the immune environment at time of and following CAR-T. To the best of our knowledge, this is the largest study of its kind. Additionally, we identified several factors that impact IR, which in turn shapes OS. In doing so, we show that CD4+ T lymphocytes are key players in disease response post-CAR-T and suggest that tracking CD4+ recovery following CAR-T may provide both diagnostic and therapeutic benefit.

A cross-sectional study for prevalence and risk factors of peri-implant marginal bone loss

Progressive peri-implant marginal bone loss and peri-implantitis have become a growing problem, but cross-sectional studies on their prevalence and risk factors are sparse. The purpose of this cross-sectional clinical study was to investigate the prevalence of peri-implant marginal bone loss (MBL) and to identify systemic and local risk factors. All adult patients who had received dental implants at the National Taiwan University Hospital (NTUH) during 2009 or 2010 were included. Their medical records were collected from the NTUH-integrative Medical Database. Consecutive follow-up radiographs were accessed for severity of MBL. The influence of each factor on MBL was estimated by using generalized estimating equations (GEEs). A total of 732 participants with 1873 implants were analyzed (mean follow-up: 5.30 years). The prevalence of MBL was 59.15% at the individual level and 49.55% at the implant level. The risk indicators identified for the presence of MBL were follow-up period of more than 2 years, diagnosis of diabetes within 12 months, radiation therapy (2 years after implant placement), implant location at maxillary canine (compared with mandibular molar), and implants from the Nobel Biocare brands (Brånemark System and NobelActive). A second multivariate GEE model confirmed the association of progressive MBL with implant location at the maxillary canine and mandibular incisor and implant brand or design. The identified risk indicators for MBL were longer follow-up period, diagnosis of diabetes, radiation therapy, implant location at maxillary canine, and implant brand or design.

Association between institutional volume of out-of-hospital cardiac arrest cases and short term outcomes

BackgroundOut-of-hospital cardiac arrest (OHCA) is a serious condition. The volume-outcome relationship and various post–cardiac arrest care elements are believed to be associated with improved neurological outcomes. Although previous studies have investigated the volume–outcome relationship, adjusting for post-cardiac arrest care, intra-class correlation for each institution, and other covariates may have been insufficient. ObjectiveTo investigate the volume-outcome relationships and favorable neurological outcomes among OHCA cases in each institution. MethodsWe conducted a prospective observational study of adult patients with non-traumatic OHCA using the OHCA registry in Japan. The primary outcome was 30-day favorable neurological outcomes, and the secondary outcome was 30-day survival. We set the cutoff values to trisect the number of patients as equally as possible and classified institutions into high-, middle-, and low-volume. Generalized estimating equations (GEE) were performed to adjust for covariates and within-hospital clustering.1Department of Emergency Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan ResultsAmong the 9909 registry patients, 7857 were included. These patients were transported to either low- (2679), middle- (2657), or high- (2521) volume institutions. The median number of eligible patients per institution in 19 months of study periods was 82 (range, 1–207), 252 (range, 210–353), and 463 (range, 390–701), respectively. After multivariable GEE using the low-volume institution as a reference, no significant difference in odds ratios and 95% confidence intervals were noted for 30-day favorable neurological outcomes for middle volume [1.22 (0.69–2.17)] and high volume [0.80 (0.47–1.37)] institutions. Moreover, there was no significant difference for 30-day survival for middle volume [1.02 (0.51–2.02)] and high volume [1.09 (0.53–2.23)] institutions. ConclusionThe patient volume of each institution was not associated with 30-day favorable neurological outcomes. Although this result needs to be evaluated more comprehensively, there may be no need to set strict requirements for the type of institution when selecting a destination for OHCA cases.

SAT397 A Low Dose Cyproterone Acetate In Feminizing Hormone Treatment

Abstract Disclosure: S. Korpaisarn: None. J. Arunakul: None. K. Chaisuksombat: None. T. Rattananukrom: None. Background: A feminizing hormone therapy (FHT) for transgender women (TW) who have not undergone gonadectomy consists of estrogens and antiandrogens. Cyproterone acetate (CPA) is the most common antiandrogen used in Thailand. A standard dose of CPA is 25-50 mg/day. Recent data showed that a low-dose CPA might be effective in testosterone suppression. However, the result was limited due to the small number of subjects. Our recent survey showed that CPA 12.5 mg/day was commonly used among Thai TW. This study aimed to evaluate the effectiveness of CPA 12.5 mg/day in testosterone suppression. Methods: The retrospective cohort chart review was done on all TW receiving FHT in a transgender clinic at Ramathibodi Hospital between January 2014-July 2022. Among the TW who initiated FHT during the study period, the effectiveness and safety of CPA 12.5 mg/day were compared with the standard dose of CPA. Only TW with information at 3-month follow-up were analyzed for a median time of achieving the T level at the goal (&amp;lt;50 ng/dL) using a Cox regression analysis and a proportion of TW achieving T level at goal at 3 months using risk ratio regression model. All TW who initiated CPA were analyzed for changes in laboratory measurements using a generalized estimating equation (GEE). Results: A total of 89 transwomen were initially reviewed. Forty-one TW initiated CPA, and 37 TW had information at the 3-month follow-up visit. Among the latter, 22 TW (59.5%) started with CPA 12.5 mg. The median age of FHT initiation were 19 years (IQR 15-23) in CPA 12.5 mg group and 20 years (IQR 17-27) in the standard CPA dose group (p-value=0.504). Median follow-up time was 7.5 months (IQR 3-12) and 9 months (IQR 6-12), respectively (p-value=0.402). Baseline T levels were not different, with the median level at 518 ng/dL (IQR 173-787) in CPA 12.5 mg and 752 ng/dL (IQR 56-957) in control (p-value =0.653). In terms of effectiveness, the median time when T levels were suppressed at goal (&amp;lt;50 ng/dL) was 3 months in both groups. The proportion of TW who achieved targeted testosterone level within 3 months was 72.7% in CPA 12.5 mg and 86.7% in control with the risk ratio (RR) of 0.84 (95%CI 0.60-1.17, p-value= 0.295) for univariable analysis. The multivariable analysis showed an adjusted RR of 0.85 (95% CI 0.46-1.57, p-value=0.606). The multivariable GEE showed no difference between testosterone level changes. Only the LDL levels was significantly lower in the CPA 12.5 mg dose group with the difference of -13.72 mg/dL (95%CI (-25.86) – (-1.58), p-value=0.027). Other laboratories were not different among the 2 groups. There was no report of cardiovascular disease or new-onset depression in both groups.Conclusion: A CPA of 12.5 mg/day is effective in testosterone suppression as the standard dose of CPA in a FHT for TW with a comparable safety profile. This low-dose CPA regimen could be used as a FHT since it has a 50% cost reduction with equivalent effectiveness. Presentation: Saturday, June 17, 2023