Average Baseline Research Articles

Clinical characteristics of open-angle glaucoma progression with peripapillary microvasculature dropout in different locations.

The study attempted to identify clinical characteristics associated with structural progression in open-angle glaucoma (OAG) in the presence of MvD in different locations. A total of 181 consecutive OAG eyes (follow-up 7.3 ± 4.0 years), which demonstrated peripapillary choroidal MvD (defined as a focal capillary loss with no visible microvascular network in choroidal layer) on optical coherence tomography (OCT) angiography (OCTA), were divided based on the location of MvD. Structural progression was determined using trend-based analysis of the Guided Progression Analysis software of Cirrus OCT. MvD was identified in the temporal quadrant in 110 eyes (temporal MvD; 60.5 ± 12.6 years), and in the inferior quadrant in 71 eyes (inferior MvD; 60.3 ± 11.1 years). After adjusting for age, average intraocular pressure (IOP) and baseline retinal nerve fibre layer (RNFL) thickness and visual field mean deviation, inferior MvD eyes showed faster rates of thinning in the inferior RNFL (mean (95% CI); -0.833 (-1.298 to -0.367)) compared to temporal MvD eyes (-0.144 (-0.496 to 0.207)) when long-term IOP fluctuation was larger than the median value (1.7 mmHg; P = 0.022). Long-term IOP fluctuations were independently associated with inferior RNFL thinning in eyes with inferior MvD (P = 0.002) but not in eyes with temporal MvD. In OAG eyes, the rates of RNFL and GCIPL thinning were comparable regardless of MvD locations. However, inferior MvD is associated with faster RNFL and GCIPL thinning in the same quadrant when long-term IOP fluctuation is present. Structural progression in the presence of temporal MvD was less associated with IOP fluctuation.

Special Issue PRO-Analysis of Clinically Meaningful Change on Patient-Reported Outcomes: Renewed Insights About Covariate Adjustment

ABSTRACT Determining clinically meaningful change (CMC) in a patient-reported (PRO) measure is central to its existence in gauging how patients feel and function, especially for evaluating a treatment effect. Anchor-based approaches are recommended to estimate a CMC threshold on a PRO measure. Determination of CMC involves linking changes or differences in the target PRO measure to that in an external (anchor) measure that is easier to interpret than and appreciably associated with the PRO measure. One type of anchor-based approach for CMC is the “mean change method” where the mean change in score of the target PRO measure within a particular anchor transition level (e.g. one-category improvement) is subtracted from the mean change in score of within an adjacent anchor category (e.g. no change category). In the literature, the mean change method has been applied with and without an adjustment for the baseline scores for the PRO of interest. This article provides the analytic rationale and conceptual justification for keeping the analysis unadjusted and not controlling for baseline PRO scores. Two illustrative examples are highlighted. The current research is essentially a variation of Lord’s paradox (where whether to adjust for a baseline variable depends on the research question) placed in a new context. Once the adjustment is made, the resulting CMC estimate reflects an artificial case where the anchor transition levels are forced to have the same average baseline PRO score. The unadjusted estimate acknowledges that the anchor transition levels are naturally occurring (not randomized) groups and thus maintains external validity.

Outcome of Application of Cryopreserved Amniotic Membrane Grafts in the Treatment of Chronic Nonhealing Wounds of Different Origins in Polymorbid Patients: A Prospective Multicenter Study.

To compare the therapeutic efficacy of cryopreserved amniotic membrane (AM) grafts and standard of care (SOC) in treating nonhealing wounds (NHW) through a prospective multicenter clinical trial, 42 patients (76% polymorbid) with 54 nonhealing wounds of various etiologies (mainly venous) and an average baseline size of 20 cm2 were included. All patients were treated for at least 6 weeks in the center before they were involved in the study. In the SOC group, 29 patients (36 wounds) were treated. If the wound healed less than 20% of the baseline size after 6 weeks, the patient was transferred to the AM group (35 patients, 43 wounds). Weekly visits included an assessment of the patient's condition, photo documentation, wound debridement, and dressing. Quality of life and the pain degree were subjectively reported by patients. After SOC, 7 wounds were healed completely, 1 defect partially, and 28 defects remained unhealed. AM application led to the complete closure of 24 wounds, partial healing occurred in 10, and 9 remained unhealed. The degree of pain and the quality of life improved significantly in all patients after AM application. This study demonstrates the effectiveness of cryopreserved AM grafts in the healing of NHW of polymorbid patients and associated pain reduction.

The Minimum Clinically Important Difference for the Patient-Rated Wrist Evaluation in Surgical Fixation of Distal Radius Fractures: Does Hand Dominance Make a Difference?

BackgroundDistal radius fractures (DRFs) are common orthopaedic injuries. They can be treated in many ways, but the volar locking plate (VLP) is more frequent. Currently, there is limited information regarding the minimum clinically important difference (MCID) in surgically treated DRFs. The purpose of this study was to calculate MCID values for the Patient-Reported Wrist Evaluation (PRWE) in the setting of VLP-treated DRFs. MethodsA retrospective review was conducted for patients with isolated, surgically-treated DRFs with a VLP. Exclusions included any concomitant procedure other than a carpal tunnel release, skeletal immaturity, polytrauma, open fracture, or missing PRWE data. MCID was calculated using PRWE, an overall health question, and the anchor-based method. ResultsA total of 131 patients were identified. Approximately 54.2% injured their dominant hand. AO/OTA classification 23C was the most common (n=89, 67.9%). Average baseline, 6-week, and 12-week PRWE were 71.8 ± 19.6, 34.3 ± 20.1, and 21.2 ± 18.0 respectively. This corresponds to an average change from baseline PRWE at 6 weeks and 12 weeks of -37.5 ± 23.4 and -50.6 ± 22.3, respectively.Average MCID values for 6 weeks and 12 weeks were 43.1 ± 18 and 56.0 ± 20.0, respectively (p<0.001). Hand dominance did not correlate with MCID value (rs = 0.084 at six weeks, rs = 0.099 at 12 weeks). MCID value additionally did not correlate with sex, AO/OTA classification, smoking status, ASA score, or BMI. Treatment at a level 1 trauma center and diagnosis of anxiety and/or depression correlated with a higher 6-week MCID value (rs = 0.308 and rs = 0.410, respectively). Increasing age weakly correlated with higher 12-week MCID value (rs = 0.352). ConclusionsThis study demonstrated an MCID calculation using an overall health anchor. MCID value varied with follow-up time and correlated weakly with age, diagnosis of anxiety and/or depression, and treatment facility, but it did not correlate with injury of the dominant hand. Future research should analyze how to apply MCID and identify successful treatment in the setting of DRF care.

Imaging Analysis of Photonic Integrated Interference Imaging System Based on Compact Sampling Lenslet Array Considering On-Chip Optical Loss

A photonic integrated interference imaging system (PIIIS) is a computational imager based on Michelson interference and photonic integrated circuits (PICs). In this paper, a PIIIS based on a compact sampling lenslet array that can sample the zero spatial frequency through a single lenslet, densely sample the frequency in the azimuth direction through the configuration of a hierarchical multistage lenslet array, and continuously sample the frequency in the radial direction through a Langford sequence is proposed. We introduce the design process of the compact sampling lenslet array in detail and simulate the imaging of the system. The simulation results demonstrate that the lenslet array can effectively improve the imaging quality of a PIIIS. In addition, we design a silicon PIC and a silicon nitride transition PIC that match the compact sampling lenslet array and simulate the imaging of the system under the influence of the on-chip optical loss of PICs (the average interference baseline loss is 15.4 dB at 1550 nm). The results show that on-chip optical loss mainly affects the brightness and contrast of the reconstructed image but has little effect on the structure.

Poster 317: Preoperative and Operative Characteristics in the Context of Patient-Reported Outcomes for ACLR in Patients Aged 40 or Older: Allograft versus Autograft

Poster 317: Preoperative and Operative Characteristics in the Context of Patient-Reported Outcomes for ACLR in Patients Aged 40 or Older: Allograft versus Autograft

Estimating Patient-Specific Relative Benefit of Adding Biologics to Conventional Rheumatoid Arthritis Treatment

Current evidence remains ambiguous regarding whether biologics should be added to conventional treatment of rheumatoid arthritis for specific patients, which may cause potential overuse or treatment delay. To estimate the benefit of adding biologics to conventional antirheumatic drugs for the treatment of rheumatoid arthritis given baseline characteristics. Cochrane CENTRAL, Scopus, MEDLINE, and the World Health Organization International Clinical Trials Registry Platform were searched for articles published from database inception to March 2, 2022. Randomized clinical trials comparing certolizumab plus conventional antirheumatic drugs with placebo plus conventional drugs were selected. Individual participant data of the prespecified outcomes and covariates were acquired from the Vivli database. A 2-stage model was fitted to estimate patient-specific relative outcomes of adding certolizumab vs conventional drugs only. Stage 1 was a penalized logistic regression model to estimate the baseline expected probability of the outcome regardless of treatment using baseline characteristics. Stage 2 was a bayesian individual participant data meta-regression model to estimate the relative outcomes for a particular baseline expected probability. Patient-specific results were displayed interactively on an application based on a 2-stage model. The primary outcome was low disease activity or remission at 3 months, defined by 3 disease activity indexes (ie, Disease Activity Score based on the evaluation of 28 joints, Clinical Disease Activity Index, or Simplified Disease Activity Index). Individual participant data were obtained from 3790 patients (2996 female [79.1%] and 794 male [20.9%]; mean [SD] age, 52.7 [12.3] years) from 5 large randomized clinical trials for moderate to high activity rheumatoid arthritis with usable data for 22 prespecified baseline covariates. Overall, adding certolizumab was associated with a higher probability of reaching low disease activity. The odds ratio for patients with an average baseline expected probability of the outcome was 6.31 (95% credible interval, 2.22-15.25). However, the benefits differed in patients with different baseline characteristics. For example, the estimated risk difference was smaller than 10% for patients with either low or high baseline expected probability. In this individual participant data meta-analysis, adding certolizumab was associated with more effectiveness for rheumatoid arthritis in general. However, the benefit was uncertain for patients with low or high baseline expected probability, for whom other evaluations were necessary. The interactive application displaying individual estimates may help with treatment selection.

Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial

Although empirically validated for fibromyalgia (FM), cognitive and behavioral therapies, including Acceptance and Commitment Therapy (ACT), are inaccessible to many patients. A self-guided, smartphone-based ACT program would significantly improve accessibility. The SMART-FM study assessed the feasibility of conducting a predominantly virtual clinical trial in an FM population in addition to evaluating preliminary evidence for the safety and efficacy of a digital ACT program for FM (FM-ACT). Sixty-seven patients with FM were randomized to 12 weeks of FM-ACT (n = 39) or digital symptom tracking (FM-ST; n = 28). The study population was 98.5% female, with an average age of 53 years and an average baseline FM symptom severity score of 8 out of 11. Endpoints included the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) and the Patient Global Impression of Change (PGIC). The between-arm effect size for the change from baseline to Week 12 in FIQ-R total scores was d = 0.44 (least-squares mean difference, − 5.7; SE, 3.16; 95% CI, − 11.9 to 0.6; P = .074). At Week 12, 73.0% of FM-ACT participants reported improvement on the PGIC versus 22.2% of FM-ST participants (P < .001). FM-ACT demonstrated improved outcomes compared to FM-ST, with high engagement and low attrition in both arms. Retrospectively registered at ClinicalTrials.gov (NCT05005351) on August 13, 2021.

Characteristics predicting the efficacy of SGLT-2 inhibitors versus GLP-1 receptor agonists on major adverse cardiovascular events in type 2 diabetes mellitus: a meta-analysis study

BackgroundRecent large clinical trials have demonstrated cardiovascular benefits of similar overall magnitude for sodium–glucose cotransporter-2 inhibitor (SGLT-2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy in subjects with type 2 diabetes. We sought to identify subgroups based on baseline characteristics with a differential response to either SGLT-2i or GLP-1RA.MethodsPubMed, Cochrane CENTRAL, and EMBASE were searched from 2008 to 2022 for SGLT-2i or GLP-1RA randomized trials that reported 3-point major adverse cardiovascular events (3P-MACE). Baseline clinical and biochemical characteristics included age, sex, body mass index (BMI), HbA1c, estimated glomerular filtration rate (eGFR), albuminuria, preexisting cardiovascular disease (CVD), and heart failure (HF). Absolute and relative risk reductions (ARR and RRR) regarding incidence rates for 3P-MACE with a 95% confidence interval were calculated. The association of average baseline characteristics in each study with the ARR and RRR for 3P-MACE was investigated by meta-regression analyses (random-effects model, assuming inter-study heterogeneity). Meta-analysis was also conducted to investigate whether the efficacy of SGLT-2i or GLP-1RA on 3P-MACE reduction could differ according to the patient’s characteristics (e.g., HbA1c above/below cutoff).ResultsAfter a critical assessment of 1,172 articles, 13 cardiovascular outcome trials with a total of 111,565 participants were selected. In meta-regression analysis, the more patients with reduced eGFR in the studies, the greater ARR by SGLT-2i or GLP-1RA therapy. Similarly, in the meta-analysis, SGLT-2i therapy tended to be more effective in reducing 3P-MACE in people with eGFR < 60 ml/min/1.73 m2 than in those with normal renal function (ARR − 0.90 [–1.44 to − 0.37] vs. − 0.17 [–0.34 to − 0.01] events/100 person-years). Furthermore, people with albuminuria tended to respond better to SGLT-2i therapy than those with normoalbuminuria. However, this was not the case for the GLP-1RA treatment. Other factors including age, sex, BMI, HbA1c, and preexisting CVD or HF did not affect the efficacy of either SGLT-2i or GLP-1RA treatment on the ARR or RRR of 3P-MACE.ConclusionsBecause decreased eGFR [significant] and albuminuria [trend] were found to predict a better efficacy for SGLT-2i in 3P-MACE reduction, this class of drug should be preferred in such patients. However, GLP-1RA may be considered for patients with normal eGFR because it showed better efficacy than SGLT-2i in this subgroup [trend].

P90 Adalimumab treatment for hidradenitis suppurativa: a retrospective analysis of demographics, patient characteristics and treatment outcomes for 107 patients from a tertiary dermatology centre

Abstract Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterized by recurrent painful nodules, abscesses and sinus tracts in predominantly apocrine gland-bearing skin. Adalimumab is an antitumour necrosis factor biologic approved by the National Institute for Health and Care Excellence in June 2016 for the management of moderate-to-severe HS and is the only licensed biologic for HS. We conducted a retrospective review of patients attending our specialist HS service who were initiated on adalimumab. Demographics, Hurley stage, HS physician global assessment (HS-PGA), patient-reported psychosocial outcomes and reasons for treatment discontinuation were examined. The cohort comprised 57% females (53%). Seventy-four per cent of patients were overweight or obese (n = 80), with a mean weight of 90 kg. Seventy-eight per cent were current or ex-smokers (n = 83). Twelve per cent reported a positive family history of HS (n = 13). Patients had an average baseline Hurley score of 2.8, representing moderate-to-severe disease (Hurley stages 2–3) and a HS-PGA of 3.7 (3 = moderate and 4 = severe). Concomitant treatment with antibiotics and/or systemic therapy was required in 44% of patients (n = 48). Oral antibiotics (n = 30; 28%), Septrin® (n = 16; 15%) and acitretin (n = 10; 9%) were the three most commonly coprescribed medicines. Nineteen per cent of patients underwent a surgical procedure for HS during treatment. The average treatment duration of adalimumab was 22 months. Thirty-two per cent of patients discontinued. Reason(s) for discontinuation included primary failure (n = 13), side-effects (n = 12), malignancy (n = 3; lung adenocarcinoma, plasma cell myeloma, extramammary Paget disease), COVID-19 concerns (n = 3), loss to follow-up (n = 2), secondary failure (n = 2), personal stress (n = 1), serious infection (n = 1; tuberculosis) and pregnancy (n = 1). Statistically significant improvements in HS-PGA score at 16 weeks were demonstrated compared with baseline (3.7 vs. 2.8; P &amp;lt; 0.001). Hurley score remained stable at these timepoints. Disease-related quality of life (Dermatology Life Quality Index) also significantly improved from 18.35 at baseline (reflecting severe impact) to 12.4 at 16 weeks (P &amp;lt; 0.001). Statistically significant differences were also found for the following patient-reported outcomes at 16 weeks compared with baseline (rated out of 100): severity (67 vs. 52; P &amp;lt; 0.013), odour (59 vs. 49; P = 0.008), discharge (64 vs. 46; P &amp;lt; 0.001), pain (65 vs. 46; P &amp;lt; 0.001) and fatigue (66 vs. 54; P = 0.006). Paired t-tests were used for all statistical analyses. In summary, adalimumab is an effective treatment for moderate-to-severe HS leading to clinical improvement in the HS-PGA scale and patient-reported outcomes. One-third of patients discontinued treatment due to a lack of response or side-effects. Adalimumab is often used in combination with other systemic therapies and surgery, reflecting the challenges of HS management.

Correlation of serum D-dimer level and the event microvessel cardiac thrombosis observed on core biopsy in post mortem COVID-19 Patients in Dr. Soetomo Hospital Surabaya, Indonesia

Link of Video Abstract: https://youtu.be/ivpwfj9PxWQ Background: Microvascular coronary thrombosis is an emerging risk factor that worsens the prognosis of COVID-19 patients. This study aims to show for the first time a descriptive of histopathologic findings from post-mortem COVID-19 patients and to analyze whether D-Dimer serum level, a marker of hyper-coagulopathy, correlates with coronary microvascular thrombosis from the cardiac core biopsy. Method: This was an observational analytic study with a retrospective cohort design from July-December 2020. Cardiac core biopsy was taken from patients who died while treated at the isolation ICU at Dr. Soetomo due to severe COVID-19. The samples were taken in 1-hour post-mortem and then analyzed histopathologically with Hematoxylin-eosin staining under a light microscope to evaluate the presence of coronary microvascular thrombosis and other pathological findings from the cardiac biopsy. Clinical information and D-Dimer levels from medical records and analyzed for coronary microvascular thrombosis using Man-Whitney and C-statistic analysis using SPSS 22 software. Result: There were 39 samples of post-mortem patients in this study. The majority were men (71.8%), with a mean age of 48.9 years old. Focal microvessel coronary thrombosis was found in 28%). The median D-Dimer level was increased from the average baseline (3460 mg/dl). However, there was no significant difference in D-dimer levels between focal microvessel coronary thrombosis incidents (p-value 0.827, C statistic AUC 0.523). The lack of focal necrosis in the surrounding tissue suggests that the thrombosis resulted from proximal embolization to distal capillary coronary, which already happened before, rather than the primary in-situ process in microvascular, hence may explain why D-Dimer was not correlated with the finding of coronary microvascular thrombosis in this study. Conclusion: D-dimer serum levels were not associated with focal microvessel thrombi in post-mortem COVID-19 patients. This result supports previous studies that showed D-Dimer was not specific to detect thrombosis in microvascular.

Moderate and increased physical activity is not detrimental to live birth rates among women with unexplained infertility and obesity

To determine if moderate physical activity is associated with live birth rates in women with unexplained infertility and obesity. Secondary analysis of the Improving Reproductive Fitness through Pretreatment with Lifestyle Modification in Obese Women with Unexplained Infertility trial. US fertility centers, 2015-2019. A total of 379 women participated in Improving Reproductive Fitness through Pretreatment with Lifestyle Modification in Obese Women with Unexplained Infertility trial, a lifestyle modification program with increased physical activity (phase I, 16 weeks) and up to three cycles of clomiphene citrate treatment and intrauterine insemination (phase II). Participants were instructed to add 500 steps/day weekly until a maximum of 10,000 steps/day was reached and maintained. Participants were stratified as active (top third, N = 125) and less active (lower third, N = 125) on the basis of the average number of steps per day recorded using a FitBit activity tracker. Live birth rate. Active participants were more physically active at the time of enrollment than less active participants (average baseline steps per day, 8,708 [7,079-10,000] vs. 4,695 [3,844-5,811]; P ≤ 0.001) and were more likely to reach 10,000 steps/day than less active participants (average steps per day, 10,526 [9,481-11,810] vs. 6,442 [4,644-7,747]; P ≤ 0.001), although both groups increased their average steps per day by a similar amount (1,818 vs.1,747; P = 0.57). There was no difference in live birth rates (24/125 [19.2%] vs. 25/125 [20%]; P = 0.87) between active and less active participants nor were there differences in clinical pregnancy rates (P = 0.45) or miscarriage rates (P = 0.49) between the two groups. Active participants were more likely to achieve the physical activity goal, although this was not associated with benefit or harm with respect to live birth. ClinicalTrials.gov (NCT02432209), first posted: May 4,2015.

Intraoperative electromyographic monitoring in children using a novel pediatric sensor.

Train-of-four (TOF) monitoring is essential in optimizing perioperative outcomes as a means to assess the depth of neuromuscular blockade and confirm recovery following the administration of neuromuscular blocking agents (NMBAs). Quantitative TOF monitoring has been limited in infants and children primarily due to lack of effective equipment. The current study evaluates a novel electromyography (EMG)-based TOF monitor with a recently developed pediatric-sized self-adhesive sensor in infants and children. Consented pediatric patients undergoing inpatient surgery requiring the administration of NMBAs were enrolled. The EMG electrode was placed along the ulnar nerve on the volar aspect of the distal forearm. The muscle action potentials from the adductor pollicis muscle were recorded throughout surgery at 20-second intervals. Data from the monitor's built-in memory card were later retrieved and analyzed. The final study cohort included 51 patients who ranged in age from 0.2 to 7.9 years and in weight from 4.2 to 36.0 kilograms. Thirty patients weighed less than 15 kgs. Supramaximal stimulus current intensity (mA) at a pulse width of 200 μsec was 30 mA in 8%; 40 mA in 29%; 50 mA in 16%; and 60 mA in 20% of the patients. Supramaximal stimulus current intensity (mA) at a pulse width of 300 μsec was 50 mA in 4%; 60 mA in 24%. The muscle action potential baseline amplitude was 8.7 ± 3.3 mV and recovered to 7.2 ± 3.7 mV after antagonism of neuromuscular blockade. The average baseline TOF ratio was 100 ± 3% and recovered to 98 ± 7% after antagonism of neuromuscular blockade. No technical issues were noted with application of the sensor or subsequent use of the monitor. Neuromuscular monitoring can be performed intraoperatively in pediatric patients who are less than 8 years of age using a novel commercially available EMG-based monitor with a recently developed pediatric sensor. The novel sensor allows use of an EMG-based monitor in infants and children in whom acceleromyography or subjective (visual) observation of the TOF response may not be feasible. Automatic detection of neuromuscular stimulating parameters (supramaximal current intensity level, baseline amplitude of the muscle action potential) was feasible in pediatric patients of all sizes including those weighing less than 15 kilograms or when there was limited access to the extremity being monitored.

42-OR: The Impact of a Digital Health Coaching Program on a Rural Population

Compared to urban areas, the prevalence of diabetes is higher in rural areas. The effects of diabetes are compounded by barriers endemic to rural populations, such as limited access to care and health education. A digital health coaching (DHC) program may address these barriers. This retrospective analysis explored how a DHC program influenced outcomes among patients with T2DM who live in a rural area. Individuals with T2DM were enrolled in a 6-month condition-specific DHC program via an employer/payor program or physician. A comparative analysis assessed changes in physical, mental, and emotional health metrics among those living in a rural area, defined as areas located outside of a U.S. Census Bureau Urbanized Area (an urban area of 50,000 or more people). Paired t-tests were used to determine differences between the overall average baseline and month 6 scores. From January 1, 2021, to September 30, 2022, 584 rural participants were enrolled in the DHC program. Most participants were female (75%) with an average age of 55. At 6 months, there were significant improvements in diabetes distress scores (2.6 to 2.0, P=0.0007) and HbA1c (8.3 to 7.2, P=0.0071). Participants in the program showed improved outcomes for diabetes-related quality of life measures at 6 months. This analysis suggests that implementing a DHC program that addresses modifiable behaviors and barriers can help reduce the burden of diabetes in a rural population. Disclosure J.Moore: None. S.Rutland: None. V.T.Tran: None. B.Burton: None.

959-P: Hands-On Continuous Glucose Monitor Training for Primary Care Providers in a Rural Family Medicine Residency Clinic

Continuous glucose monitors (CGMs) are helpful tools in managing diabetes, and it is important that primary care providers (PCPs) receive adequate training on how to use them. There are various on-demand lectures about CGMs that are available for clinicians, but these programs lack a hands-on component. In a rural Family Medicine residency clinic, two clinical pharmacists created a training program for PCPs which included an educational module, a hands-on experience wearing an intermittently-scanned CGM for 2 weeks, and a debriefing module. This study describes and evaluates this training program. The investigators created a questionnaire aimed to measure PCPs confidence and knowledge of CGMs. PCPs were given the identical questionnaire at baseline, after the educational module (midpoint), and after the debriefing module (final). Descriptive statistical analysis was performed to assess differences in confidence and knowledge levels throughout the program. A total of 21 PCPs completed the program, including 13 medical residents, six physician faculty, and two nurse practitioners. On a scale from 1 to 10, PCP’s rated their average baseline knowledge of CGMs at 3.8. This increased to 5.3 at midpoint, and 7.9 at final. For the knowledge-based portion of the questionnaire, PCPs scored an average of 20.35% at baseline, and this increased to 75.32% at midpoint, and 90.48% at final. After completion of the training program, all 21 participants either agreed or strongly agreed that having the opportunity to wear a CGM provided them with more confidence in working with patients with CGMs, compared to a lecture-based training program alone. This study demonstrates that a training program including a hands-on experiential component can improve PCPs confidence and knowledge levels regarding CGMs. Disclosure J.Prudencio: None. M.Kim: None. C.Chan: None. Funding Abbott Medical Education (2182022)

Changes in the normal baseline due to changes in the Coast's dynamics and Their effects on the sea boundary in Weh Island, Nanggroe Aceh Darussalam, Indonesia

The United Nations Convention on the Law of the Sea (UNCLOS) 1982 gave archipelagic states the authority to set maritime boundaries based on such baselines. The basepoint is any point on the usual normal baseline. The base point must be established where the beach's sea level and lowest tide coincide. The location of the base point will change if the coastline's terrain or sea level changes due to physical land- and water-based causes. The reference to establish marine limits will change if the base point changes.It is possible to discover deviations from the average baseline by combining multitemporal satellite imagery with remote sensing techniques. Using satellite images, the position of the shoreline is established according to the time of image acquisition. Utilizing tidal analysis data on changes in vertical position and the slope of the coastal topography, the position of the immediate coastline is then restored to the low water line/normal baseline. Using normal baseline data, the Digital Shoreline Analysis System (DSAS) method is utilized to calculate the rate and rate of temporal changes.According to calculations of the usual baseline's speed and acceleration on the eastern portion of Weh Island, which has a Base Point (TD) of 178, the baseline has drifted 21 m seaward between 2017 and 2022, growing on average approximately 5 m per year. Consequently, coastal dynamics must be taken into account when calculating the base point if the location of TD 178 is updated in accordance with UNCLOS 1982 standards.

Environmental and Volcanic Implications of Volatile Output in the Atmosphere of Vulcano Island Detected Using SO2 Plume (2021–23)

The volatiles released by the volcanic structures of the world contribute to natural environmental pollution both during the passive and active degassing stages. The Island of Vulcano is characterized by solfataric degassing mainly localized in the summit part (Fossa crater) and in the peripheral part in the Levante Bay. The normal solfataric degassing (high-temperature fumarolic area of the summit and boiling fluids emitted in the Levante Bay area), established after the last explosive eruption of 1888–90, is periodically interrupted by geochemical crises characterized by anomalous degassing that are attributable to increased volcanic inputs, which determine a sharp increase in the degassing rate. In this work, we have used the data acquired from the INGV (Istituto Nazionale di Geofisica e Vulcanologia) geochemical monitoring networks to identify, evaluate, and monitor the geochemical variations of the extensive parameters, such as the SO2 flux from the volcanic plume (solfataric cloud) and the CO2 flux from the soil in the summit area outside the fumaroles areas. The increase in the flux of volatiles started in June–July 2021 and reached its maximum in November of the same year. In particular, the mean monthly flux of SO2 plume of 22 tons day−1 (t d−1) and of CO2 from the soil of 1570 grams per square meter per day (g m2 d−1) increased during this event up to 89 t d−1 and 11,596 g m2 d−1, respectively, in November 2021. The average annual baseline value of SO2 output was estimated at 7700 t d−1 during normal solfataric activity. Instead, this outgassing increased to 18,000 and 24,000 t d−1 in 2021 and 2022, respectively, indicating that the system is still in an anomalous phase of outgassing and shows no signs of returning to the pre-crisis baseline values. In fact, in the first quarter of 2023, the SO2 output shows average values comparable to those emitted in 2022. Finally, the dispersion maps of SO2 on the island of Vulcano have been produced and have indicated that the areas close to the fumarolic source are characterized by concentrations of SO2 in the atmosphere higher than those permitted by European legislation (40 μg m−3 for 24 h of exposition) on human health.

ORAL SODIUM BUTYRATE INCREASES DAYTIME SYSTOLIC BLOOD PRESSURE IN HYPERTENSIVE PATIENTS: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Objective: The microbiota-derived short chain fatty acid (SCFA) butyrate has been shown to modulate blood pressure (BP) in rodent studies, while in humans, plasma butyrate levels have been associated with BP. Nonetheless the net effect of butyrate on hypertension in humans remains uncovered. In this study, we aimed to determine the effect of oral butyrate on BP in hypertensive patients. Design and method: We performed a double-blind randomized placebo-controlled trial including 23 patients with grade I hypertension. Antihypertensive medication was discontinued for the duration of the study with a wash-out period of four weeks before starting the intervention. Participants received either oral sodium butyrate capsules 4 g per day or placebo capsules with an equivalent amount of sodium chloride for four weeks. The primary outcome was daytime 24-hours systolic BP. We also collected data on short-term heart rate variability (HRV) using finger photoplethysmography, and extracellular water percentage using body impedance analyses. We measured plasma renin, aldosterone, and fecal SCFA levels. Gut microbiota composition was determined using 16S rRNA sequencing. Differences between groups over time were assessed using linear mixed models (group*time interaction). Results: Study participants had a mean age of 59.0 ± 3.7 years, 56.5% female and an average baseline office systolic BP of 143.5 ± 14.6 mmHg and diastolic BP of 93.0 ± 8.3 mmHg. Daytime 24-hours systolic and diastolic BP significantly increased over the intervention period in the butyrate compared to the -placebo group, with an effect size of 9.65 (95%CI 3.88 - 17.15) mmHg in daytime 24-hours systolic BP and 5.08 (95%CI 1.89 - 8.76) mmHg in diastolic BP in the linear mixed model. Heart rate and extracellular water percentage changes were not significantly different between the groups. There was a trend towards increasing HRV in the butyrate group (group*time p = 0.078), but no significant changes in renin and aldosterone levels, nor in fecal SCFA levels. Butyrate did not impact gut microbiota composition substantially. Conclusions: Four weeks of oral butyrate treatment increased daytime systolic and diastolic BP in hypertensive subjects. Our findings implicate that not all SCFA have beneficial effects on human cardiovascular health which warrants caution in future prebiotic and butyrate intervention studies.

Chronic disease outcomes among South Asian cancer survivors.

e24098 Background: Although racial and ethnic disparities in cancer survivorship are widely known, the understanding of cancer survivorship among South Asian patients is limited, especially in the United States. Previous studies identified significant health-related disparities within the wider Asian diaspora, however, less is known among Asian subgroups. Thus, we conducted a study examining the differences in chronic disease outcomes between South Asian cancer survivors compared to other races/ethnicities. Methods: We used a name list algorithm to identify South Asian patients among cancer survivors treated at Northwestern Medicine between 2005-2020. After patients were identified, we conducted chi-square tests and logistic regression (adjusting for age and gender) to evaluate variation in prevalence of chronic diseases including diabetes mellitus, hypertension, coronary heart disease, and more. Racial and ethnic comparisons were done using the self-reported race fields within the Northwestern Medicine database. Results: The algorithm identified 1,217/102,579 (1.2%) South Asian patients. We found that 49% self-identified as Asian, 18% as White or Caucasian, 17% as Other, and 9.7% as ‘Declined or Unable to Answer’. The self-reported racial comparison groups used were Asian (not South Asian) (n = 2,631, 2.6%), Black (n = 9,350, 9.4%), and White (n = 75,252, 75%). We found that South Asian patients had a higher frequency of leukemia, lymphoma, kidney, and multiple myeloma cancers and a lower frequency of lung, colorectal, liver, cervical, and thyroid cancers compared to Asian (not South Asian) patients (p &lt; .05). We also found the average baseline BMI is greater in South Asians (mean = 26.2, SD = 4.7) compared with Asians (mean = 24.7, SD = 4.4) (p &lt; .05). From the logistic regression models, South Asian cancer survivors had higher odds of diabetes compared with White cancer survivors (OR 1.93 [95% CI 1.50-2.49]). In contrast, the odds of coronary heart disease, hypertension, and heart failure were lower among South Asian compared to Black cancer survivors (0.69 [95% CI 0.53-0.92]; 0.57 [95% CI 0.48-0.68]; 0.49 [95% CI 0.37-0.65], respectively). The odds of atrial fibrillation were lower among South Asian compared to Asian (not South Asian), White, and Black patients (0.59 [95% CI 0.41-0.86]; 0.46 [95% CI 0.34-0.64], 0.58 [95% CI 0.42-0.80], respectively). We did not identify statistically significant associations for these chronic diseases with the other racial groups. Conclusions: These results show there are differences for cancer survivors who were identified as South Asian compared with other groups, even other Asian patients. Analysis of racial and ethnic differences in chronic disease risk among cancer survivors is necessary for understanding the full scope of cancer survivorship. Further understanding the health disparities that exists among the Asian subgroups is important to advancing cancer care for patients from every demographic.

Use of PROMIS to capture patient reported outcomes over time for patients on I-SPY2.

611 Background: Patient reported outcomes (PROs) capture direct feedback from patients in clinical trials. The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) is an open source and validated PRO platform. Data on PROMIS score trajectories over time for breast cancer patients undergoing neoadjuvant chemotherapy (NAC) are limited. Methods: We administered paper surveys to patients enrolled on the I-SPY2 trial, a multicenter, randomized phase 2 trial comparing novel agents to standard NAC in high-risk breast cancer. PRO domains included PROMIS Physical Function, Anxiety, Depression, Applied Cognition and Fatigue. Surveys were administered at baseline (post-consent), C1D1, inter-regimen (~12 wks into NAC), pre-surgery and at 1, 6, 12, and 24 months post-surgery. Responses were scored using the HealthMeasures Scoring Service to generate a standardized T score, with a score of 50 representing the general US population mean. Higher Anxiety, Depression and Fatigue scores represent worse symptoms; higher Physical Function and Applied Cognition scores represent better symptoms. We calculated average scores by time-point and compared changes from baseline to various grouped time points using a paired t-test. Results: From 1/2012 to 7/2020, 1631 patients enrolled in I-SPY 2 with 959 completing the baseline survey. 62% had at least two “on-treatment” surveys, and 52% had at least one follow-up time-point. Average baseline PROMIS scores for Physical Function, Anxiety, Depression, Applied Cognition and Fatigue were 46.7, 55.1, 47.2, 53.3 and 46.0 respectively. Between baseline and the latest on-treatment time point we observed improvement in Anxiety (-5.2) and worsening in Physical Function, Applied Cognition and Fatigue (-5.4, -6.9 and +8.2 respectively). Between baseline and the latest post-surgery time point, we saw improved Anxiety (-5.9) and worsened Physical Function, Applied Cognition and Fatigue (-5.9, -3.6 and +4.3). Depression changed minimally. Conclusions: Using PROMIS, patients on I-SPY2 experienced worse Physical Function, Applied Cognition and Fatigue but improved Anxiety during and after treatment compared to baseline. While changes in Applied Cognition and Fatigue recovered partially after treatment, Physical Function scores did not, suggesting potential for longer term impact on quality of life. Clinical trial information: NCT01042379 . [Table: see text]