Analysis Of Real-world Data Research Articles

Evaluating the Prognostic and Clinical Validity of the Fall Risk Score Derived From an AI-Based mHealth App for Fall Prevention: Retrospective Real-World Data Analysis.

Falls pose a significant public health concern, with increasing occurrence due to the aging population, and they are associated with high mortality rates and risks such as multimorbidity and frailty. Falls not only lead to physical injuries but also have detrimental psychological and social consequences, negatively impacting quality of life. Identifying individuals at high risk for falls is crucial, particularly for those aged ≥60 years and living in residential care settings; current professional guidelines favor personalized, multifactorial fall risk assessment approaches for effective fall prevention. This study aimed to explore the prognostic validity of the Fall Risk Score (FRS), a multifactorial-based metric to assess fall risk (using longitudinal real-world data), and establish the clinical relevance of the FRS by identifying threshold values and the minimum clinically important differences. This retrospective cohort study involved 617 older adults (857 observations: 615 of women, 242 of men; mean age 83.3, SD 8.7 years; mean gait speed 0.49, SD 0.19 m/s; 622 using walking aids) residing in German residential care facilities and used the LINDERA mobile health app for fall risk assessment. The study focused on the association between FRS at the initial assessment (T1) and the normalized number of falls at follow-up (T2). A quadratic regression model and Spearman correlation analysis were utilized to analyze the data, supported by descriptive statistics and subgroup analyses. The quadratic model exhibited the lowest root mean square error (0.015), and Spearman correlation analysis revealed that a higher FRS at T1 was linked to an increased number of falls at T2 (ρ=0.960, P<.001). Subgroups revealed significant strong correlations between FRS at T1 and falls at T2, particularly for older adults with slower gait speeds (ρ=0.954, P<.001) and those using walking aids (ρ=0.955, P<.001). Threshold values revealed that an FRS of 45%, 32%, and 24% corresponded to the expectation of a fall within 6, 12, and 24 months, respectively. Distribution-based minimum clinically important difference values were established, providing ranges for small, medium, and large effect sizes for FRS changes. The FRS exhibits good prognostic validity for predicting future falls, particularly in specific subgroups. The findings support a stratified fall risk assessment approach and emphasize the significance of early and personalized intervention. This study contributes to the knowledge base on fall risk, despite limitations such as demographic focus and potential assessment interval variability.

Respiratory outcomes of onasemnogene abeparvovec treatment for spinal muscular atrophy: national real-world cohort study

Onasemnogene abeparvovec (OA) is a novel gene replacement therapy for patients with spinal muscular atrophy (SMA). This study provides real-world respiratory data for pediatric SMA patients receiving OA who were assessed before and one year after treatment in a multicenter cohort study conducted from 2019 to 2021. Twenty-five OA-treated SMA patients (23 with type 1 and 2 with type 2; median age at treatment 6.1 months, with a range of 0.36–23 months) were included. Sixteen were treatment-naïve, and nine had received various prior treatments. Two patients died due to respiratory failure during the study period. Of the remaining 23 patients, four were put on non-invasive ventilation (NIV), bringing ventilated patients to a total of ten during the post-treatment year. Three patients required permanent NIV support, while 13 did not require any respiratory support. Ventilation time decreased from 14.3 to 11.1 hours per day, and respiratory hospitalizations decreased by 26% (from 0.76 to 0.57 per life year). Fifteen of the 23 patients maintained full oral nutrition at study closure compared to 20 of the 25 at study initiation. This real-world data analysis demonstrates that OA may improve respiratory outcomes in SMA patients. Importantly, compounding factors, such as age at treatment initiation, treatment combinations, and natural history, may influence the respiratory course, thus highlighting the need for standardized long-term management.What is Known:• Respiratory failure is a leading cause of mortality in untreated spinal muscular atrophy type 1 patients.• Onasemnogene abeparvovec (OA) improves neurological outcomes, but real-world respiratory data are limited.What is New:• Our real-world analysis suggests OA may improve respiratory outcomes.• Age at treatment and treatment combinations may also influence respiratory trajectory.

Comparison of On-Label Treatment Persistence in Real-World Patients with Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous Interleukin-17A Inhibitors.

Psoriatic arthritis (PsA) is a chronic, multidomain, inflammatory disease requiring long-term treatment. Guselkumab, a fully human interleukin [IL]-23p19-subunit inhibitor, and the IL-17A inhibitors (IL-17Ai) ixekizumab and secukinumab are approved by the US Food and Drug Administration (FDA) for adults with active PsA. Real-world data evaluating on-label treatment persistence is an important consideration for patients. This retrospective claim-based analysis (IQVIA PharMetrics® Plus) included adults with PsA receiving guselkumab or their first subcutaneous (SC) IL-17Ai (ixekizumab/secukinumab) per FDA label ("on-label") between July 14, 2020, and June 30, 2022. Baseline demographicanddisease characteristics were collected in the 12 months preceding the index date (date of first guselkumab or SC IL-17Ai claim); follow-up extended through the earlier of theend of continuous insurance eligibility or end of data availability. Baseline characteristics were balanced between the cohorts by propensity score weighting (standardized mortality ratio [SMR]). Discontinuation was defined as a gap 2 × the FDA-approved maintenance dosing interval (guselkumab:112 days; SC IL-17Ai: 56 days); on-label persistence in the weighted cohorts was assessed using Kaplan-Meier curves and compared with a Cox proportional hazards model. Weighted demographic and disease characteristics were well balanced between the cohorts (guselkumab: N = 910, mean age = 50.4 years, 60.4% female; SC IL-17Ai: N = 2740, mean age = 50.2, 59.4% female). At 12 months, the guselkumab cohort was 1.85 × more likely to remain persistent with on-label therapy vs the SC IL-17Ai cohort (p < 0.001); median time to discontinuation was not reached for guselkumab and was12.3 months for SC IL-17Ai. At 3, 6, 9, and 12 months, persistence rates in the weighted cohorts were higher with guselkumab than with SC IL-17Ai (p < 0.001). In this real-world claims data analysis in adults with PsA, on-label persistence rates were statistically significantly higher with guselkumab, as early as 3 months, with ~ 2 × greater likelihood of persistence at 12 months relative to SC IL-17Ai.

Is tamoxifen good enough for the Asian population in ER+ HER2- post-menopausal women with early breast cancer? A nationwide population-based cohort study.

Numerous clinical trials have compared the efficacy of endocrine therapy in post-menopausal breast cancer patients. This study aims to explore whether there is a difference in recurrence rates between this population using tamoxifen and aromatase inhibitors (AIs) by analyzing real-world data. This retrospective cohort study utilized the National Health Insurance (NHI) claims data and the Taiwan Cancer Registry (TCR). We identified 6,050 patients aged over 55 diagnosed with ER-positive, HER2-negative early breast cancer between 2012 and 2016 (4,451 on AIs alone and 1,599 on tamoxifen alone). Recurrence in both groups was assessed until the end of 2020. Hazards were measured based on age of diagnosis, cancer stage, adjuvant chemotherapy, radiation therapy, type of endocrine therapy used, and adherence. Recurrence‑free survival between the AIs and tamoxifen groups was evaluated using the Kaplan-Meier model. The average age was 65.1 years, with a median follow-up time of 5.7 years and a median duration of endocrine therapy of 4.5 years. The recurrence rate was 2.2%. Using tamoxifen as endocrine therapy reduces the risk of recurrence compared to AIs (adjusted HR: 0.32, p < 0.0001). There was no statistical difference between the two drugs in stage 1 breast cancer. However, in stage 2, the risk of breast cancer recurrence decreased to 0.15 times with the use of tamoxifen compared to AIs (p = 0.0002). Stage 2 cancer, histological grade 3, and non-adherence increased recurrence risk in post-menopausal breast cancer patients. Based on real-world data analysis, in ER-positive, HER2-negative post-menopausal women with early breast cancer in Taiwan, the use of tamoxifen compared to AIs is associated with a lower risk of recurrence. Improved adherence to medication can break the cycle of recurrence and improve health outcomes.

Validation study for assessing COVID-19 pneumonia treatments

This study investigates the effectiveness of Azvudine and nirmatrelvir-ritonavir (Paxlovid) in treating COVID-19 pneumonia through an analysis of real-world clinical data. We retrospectively collected data from COVID-19 patients hospitalized at the Second Xiangya Hospital of Central South University between December 21, 2022, and January 18, 2023. Using kernel density estimation, box-and-whisker plots, and Schoenfeld residual plots, we evaluated the transition of patients to negative status and assessed factors such as age, disease severity, and treatment effects. The findings revealed that both Azvudine and Paxlovid significantly reduced recovery times, with Azvudine showing notable benefits for patients aged 50–80. Our analysis indicated that these drugs improved lung CT values and reduced disease severity in moderate cases. The Cox model demonstrated robustness in predicting outcomes, and a nomogram was developed for individualized recovery probability assessment. These results provide important insights into optimizing COVID-19 treatment and the potential of predictive models in clinical decision-making.

Research on Credit Card Fraud Risk Identification Based on Integrated Logistic Regression Model

Effectively identifying credit card fraud using machine learning methods is a significant issue in the financial sector. In this context, machine learning models encounter challenges such as the imbalanced distribution of sample data labels and the high dimensionality of customer feature sets. Addressing these two critical factors, this paper develops an enhanced method for the logistic regression model. This approach not only balances the sample label distribution through resampling but also mitigates the estimation issues arising from the curse of dimensionality. Furthermore, the proposed method addresses the coverage issue of the entire feature set. It solves that resampling can only partially address the curse of dimensionality problem and employs L1 regularization for each logistic regression submodel to further alleviate this issue. Results from simulation experiments and real-world data analysis demonstrate that the proposed method is competitive with logistic regression and several classical classification techniques. This method is not only effective in resolving credit card fraud risks but also has the potential to be extended to other domains.

Catheter-Based Renal Denervation for Resistant Arterial Hypertension: 10-Year Real-World Follow-Up Data.

This analysis of real-world data examines the efficacy, safety, and long-term outcomes of renal denervation in hypertensive patients for up to 10 years. Sixty-five consecutive patients underwent renal denervation (RDN) (single operator) for uncontrolled resistant hypertension. Efficacy was defined as the interindividual change of office (OBPM) and ambulatory blood pressure monitoring (ABPM) at 1, 6, 12 months, 2-4 and 5-10 years after RDN. Medication changes, renal function, and device generation disparities were analyzed. Of these patients, 42 received RDN with a first-generation device, while 23 underwent the procedure with a second-generation device. Baseline demographics included a predominantly male cohort (57.6%) with an average age of 60.3 years. The mean number of medications at baseline was 4.3. OBPM at baseline was 169.0/87.4mmHg, and ABPM at baseline was 153.4/88.4mmHg. Post-procedure, significant reductions in systolic blood pressure (SBP) were observed in both OBPM and ABPM at 1 month (OBPM 147.9/82.8mmHg; ABPM 141.3/83.0mmHg [SBP, p<0.001]), sustained up to 10 years (OBPM 153.1/84.3mmHg; ABPM 138/80.1mmHg [SBP, p<0.001]). After 1 year around half of patients had a controlled OBPM and 24h ABPM <135/85mmHg, which was associated with a higher number of ablation spots (31.5±14.8vs. 15.5 ± 6.5, p = 0.002) and occurred more often when treated with a second-generation device (2 [12.5%] vs. 7 [77.8%], p=0.002). Renal function displayed a minor physiological decline over 5-10 years. No major complication occurred. Renal denervation demonstrated sustained significant reductions in systolic OBPM and ABPM up to 10 years post-procedure. Controlled blood pressure at 1 year was associated with a higher number of mean ablated spots and the use of a second-generation device. The procedure exhibited a favorable safety profile, indicating its viability in managing hypertension without significant renal function compromise.

Validity of Diagnosis of Disseminated Intravascular Coagulation Based on International Classification of Diseases Coding in a Claims Database.

Accuracy in diagnoses recorded using the International Classification of Diseases (ICD) coding is the most important element ensuring the foundation of research using real-world data analyses. To evaluate the validity of ICD coding for diagnoses of disseminated intravascular coagulation (DIC) using the International Society on Thrombosis and Haemostasis (ISTH) overt DIC criteria and the Japanese Association for Acute Medicine (JAAM) DIC criteria as reference standards. This retrospective observational study included adult hospitalized patients diagnosed as having diseases potentially causing DIC extracted from a part of a large-scale database in Japan. The index test was a diagnosis of DIC based on the ICD-10 codes. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated using ISTH overt DIC criteria and JAAM-2 DIC criteria as the reference standards. We also conducted subgroup analyses according to the underlying diseases. We included 84,300 patients in this study. In the overall study population, sensitivity, specificity, PPV, and NPV of the ICD-based diagnosis for ISTH criteria were 26.28, 98.10, 35.12, and 97.14%, respectively. In subgroup analyses according to the underlying disease, sensitivity ranged from 9.48 to 52.08%, and specificity ranged from 96.94 to 99.47%. The accuracy of the ICD-based diagnosis for JAAM-2 criteria was similar to that for ISTH criteria. Identification of DIC patients using ICD-10 codes had relatively low sensitivity but very high specificity for DIC diagnostic criteria. Approximately 65% of patients identified by ICD coding are likely to meet the JAAM-2 DIC criteria.

Examining the safety of belimumab, especially in children: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database

ABSTRACT Background Belimumab was approved in the US in 2019 for children with Systemic lupus erythematosus (SLE), making it the only medicine that can treat SLE in both adults and children. The authors retrospectively investigated adverse events (AEs) by data-mining a self-reported database. Research design and methods PRR, ROR, and BCPNN were used to assess the association between belimumab and AEs. The definition relied on system organ class (SOC) and preferred terms (PT) by the Medical Dictionary for Regulatory Activities (MedDRA). Results A total of 15,316,605 AE reports were retrieved from the FAERS database, and 19,832 AE reports were identified after the data cleaning process. Based on the disproportionality analysis at the PT level, depressive (N = 420), ill-defined disorder (N = 304), injection site hemorrhage (N = 297), lupus nephritis (N = 198), live birth (N = 96) and proteinuria (N = 77) had relatively higher frequencies than other AEs, suggesting that these AEs are more likely to occur in the real world for patients taking belimumab. Conclusions This study explores valuable potential AEs of belimumab at the SOC and PT levels, respectively. To provide a reference for decision-making on belimumab, including its use in children, and to promote rational clinical dosing.

Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model.

To explore the cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) compared to placebo with therapy (PT) in US healthcare settings. A health state-transition model was used to analyze the cost-effectiveness of MDMA-AT for treating patients with chronic PTSD of moderate or higher severity. Both treatment arms consisted of 3 preparation (90-min), 3 interventional (8-h), and 9 integration (90-min) sessions, lasting ~4 months total. All sessions included psychotherapy, with interventional also including MDMA or placebo. After receiving treatment, patients were distributed across health states of No PTSD (not meeting PTSD diagnostic criteria), Non-Severe PTSD (treatment responders), Severe PTSD (treatment non-responders), and death. Each state had unique healthcare costs and utilities sourced from real-world data analysis and patient data from MDMA-AT clinical trials (including long-term follow-up). The base-case analysis considered the payer's perspective with a 5-year horizon, 3.5% annual cost and effect discounts, and an assumed MDMA medication price of $12,000 per session. Trial-derived utilities and US life tables mortality data were used to calculate quality-adjusted life years (QALY). The main outcome was an incremental cost-effectiveness ratio (ICER) with a $150,000 willingness-to-pay (WTP) threshold. The base-case ICER was $83,845 per QALY. Total direct costs were $64,745 in the MDMA-AT and $33,132 in the PT arms ($31,613 increment). The costs of intervention were $48,376 for MDMA-AT and $12,376 for PT. The highest MDMA medication cost to fit under the WTP threshold was $20,314 per session. Costs related to PTSD healthcare visits and other PTSD treatments were lower with MDMA-AT than PT (-$2,511 and -$1,877 increments, respectively). Utility benefits were higher in MDMA-AT than PT, with 3.691 and 3.314 QALYs generated over 5 years, respectively (0.377 QALY increment). These data suggest MDMA-AT may be a cost-effective treatment compared to PT for patients with chronic PTSD of moderate or higher severity.

Value-Based Healthcare in Practice: IDEATE, a Collaboration to Design and Test an Outcomes-Based Agreement for a Medicine in Wales.

To develop a sustainable, scalable methodology for the design of outcome-based agreements (OBAs) that works on the ground and dynamically overcomes historical challenges. Project IDEATE co-created solutions to known (and emergent) challenges via iterative workshops and real-world data analysis to develop and refine a hypothetical model for an OBA in a trusted research environment. A cross-disciplinary collaboration between National Health Service (NHS) Wales, industry and academia was developed. Data were collected from Welsh national datasets and used to construct a novel linked dataset. OBA scenarios, with different contract parameters, were analysed to assess impact on the proportion of contract payment due and the volatility of payments. An approved, in market, locally advanced and metastatic breast cancer treatment was selected as the test case. The total number of patients in the treatment cohort (2017-2020) was n = 99, and 286 in the control cohort (2014-2016). The final outcome variables selected were: (1) 1-year survival,( 2) intolerance to treatment (deferral), and (3) the total days disrupted by care. The primary scenario included all three outcomes measured at the population level and used a linear payment model. Volatility analyses demonstrated contract parameters can dramatically alter the contract output with greatest risk from a single, binary outcome contract design. The design of an OBA is a complex process that requires a multi-disciplinary approach. By assessing solutions to data, outcomes and contracting challenges, IDEATE provides a strong foundation for future success of OBAs in the UK. Outcome-based agreements (OBAs) are a way to pay for medicines if they help patienthealth in a specific way over time. These agreements can make it faster for people to get new medicines, but they also have challenges, like needing a lot of time and effort to manage them. A team from the NHS Wales, life sciences, and Swansea University created Project IDEATE to find a better way to design OBAs and solve some of these problems. Welsh datasets were used to create a new breast cancer dataset to test different OBAs and see how payments would change. A breast cancer treatment was used for the project. The project had 99 patients who got the medicine (2017-2020) and 286 patients who had breast cancer but did not get the medicine (2014-2016). Three health outcomes were measured: (1) living for one year after treatment, (2) patients needing to stop the medicine, and (3) days spent in care. The main OBA option we tested used all three health outcomes; the more the outcomes improved, the more the payments could go up until they hit the highest amount agreed. The analysis showed that the way an OBA is designed can make a big difference in how stable or risky it is, especially if one ofthe health outcomes has only two options. Project IDEATE showed that making an OBA can be hard, but when people from different fields work together, they can overcome many challenges and succeed.

Generalized Gaussian Distribution Improved Permutation Entropy: A New Measure for Complex Time Series Analysis.

To enhance the performance of entropy algorithms in analyzing complex time series, generalized Gaussian distribution improved permutation entropy (GGDIPE) and its multiscale variant (MGGDIPE) are proposed in this paper. First, the generalized Gaussian distribution cumulative distribution function is employed for data normalization to enhance the algorithm's applicability across time series with diverse distributions. The algorithm further processes the normalized data using improved permutation entropy, which maintains both the absolute magnitude and temporal correlations of the signals, overcoming the equal value issue found in traditional permutation entropy (PE). Simulation results indicate that GGDIPE is less sensitive to parameter variations, exhibits strong noise resistance, accurately reveals the dynamic behavior of chaotic systems, and operates significantly faster than PE. Real-world data analysis shows that MGGDIPE provides markedly better separability for RR interval signals, EEG signals, bearing fault signals, and underwater acoustic signals compared to multiscale PE (MPE) and multiscale dispersion entropy (MDE). Notably, in underwater target recognition tasks, MGGDIPE achieves a classification accuracy of 97.5% across four types of acoustic signals, substantially surpassing the performance of MDE (70.5%) and MPE (62.5%). Thus, the proposed method demonstrates exceptional capability in processing complex time series.

Serum triglyceride to high density lipoprotein cholesterol ratio in late pregnancy as a potential predictor of adverse birth outcomes: an analysis of real-world data

BackgroundThe association between serum triglyceride to high density lipoprotein cholesterol ratio (THR) in late pregnancy and adverse birth outcomes (ABO) remains controversial because of inconsistent results. The present study assessed the association between maternal serum THR and incidence of ABO [preterm birth (PTB), small and large for gestational age (SGA/LGA), low birth weight (LBW) and macrosomia] in a Chinese population.MethodsA total of 11,553 consecutive participants from a real-world database with data on lipid profiles and birth outcomes were included. Logistic regression models were applied to assess the association between THR and incident ABO. Mediation analysis was performed to investigate the contribution of pregnancy complications [gestational diabetes mellitus (GDM), intrahepatic cholestasis of pregnancy (ICP) and pre-eclampsia (PE)] to this association.ResultsApproximately 6.6% (762/11,553), 8.9% (1023/11,553), 15.5% (1792/11,553), 4.3% (494/11,553), and 7.4% (851/11,553) of individuals developed PTB, SGA, LGA, LBW and macrosomia, respectively. Significant trends across the quintiles of THR toward decreasing incidence of SGA and LBW and increasing incidence of LGA and macrosomia were observed. The multivariate-adjusted odds ratios (OR) in the top quintile of serum THR (> 3.16) versus the bottom quintile (< 1.44) were 0.52 for PTB, 0.48 for SGA, 0.64 for LBW, 2.80 for LGA and 3.80 for macrosomia, respectively. A 1-standard deviation (SD) increase in serum THR was associated with decreased risk of PTB [OR = 0.84, 95% confidence interval (CI): 0.76–0.93), SGA (OR = 0.71, 95% CI:0.65–0.78) and LBW (OR = 0.76, 95% CI:0.65–0.90) and increased risk of LGA (OR = 1.40, 95% CI:1.32–1.49) and macrosomia (OR = 1.49, 95% CI:1.38–1.62). In mediation analyses, PE mediated − 19.8%, -10.6% and − 24.6% of THR-associated PTB, SGA and LBW, respectively, GDM accounted for − 3.7%, 6.8% and 4.3% of THR-associated PTB, LGA and macrosomia, respectively, and ICP explained − 1.9% and − 2.1% of THR-associated PTB and LBW, respectively. In addition, incorporating THR to ABO predictive models significantly improved the area under the curve for SGA (0.743 vs. 0.753, P < 0.001), LGA (0.734 vs. 0.745, P < 0.001) and macrosomia (0.786 vs. 0.800, P < 0.001).ConclusionReal-world data showed an association between serum THR in late pregnancy and ABO risk, and this association may be partially mediated by prevalent pregnancy complications (PE/GDM/ICP), suggesting a potential role of THR in predicting ABO (SGA/LGA/macrosomia).

Utilization of Syndromic Vaginitis Diagnostic Testing Reduces 6-Month Follow-Up Outpatient Service Healthcare Costs-A Real-World Data Analysis.

Vaginitis is a common infection among women of reproductive age. Although various diagnostic methodologies exist, diagnosis without the utilization of available diagnostic tests remains prevalent. This study aimed to assess downstream healthcare utilization and the cost of patients with and without diagnostic testing. This retrospective, observational study utilized the IQVIA PharMetrics® Plus database from July 2020 to October 2023. Patients with an index claim (ICD-10 code indicating vaginitis) were categorized into two cohorts: those who received a syndromic polymerase chain reaction (PCR) test and those who had no documented test on the index date or within two days. Total and service-specific healthcare resource utilization and costs were assessed for 6 months following the index event. This study was designed to inform how Syndromic Vaginitis PCR testing is used to make treatment decisions and to track outpatient and inpatient healthcare utilization for 6 months post index date represented by cost. Patients who received a Syndromic Vaginitis PCR test had significantly fewer outpatient medical services in the 6 months following initial diagnosis compared to those who received no diagnostic test. This was largely attributed to a substantial decrease in other medical service visits, resulting in mean cost savings of USD 2067 (Syndromic PCR = USD 6675, SD = USD 17,187; No Test = USD 8742, SD = USD 29,894) (p-value 0.0009). Many vaginitis patients do not receive testing, but Syndromic Vaginitis PCR testing may be an effective diagnostic tool for reducing costs associated with vaginitis infections.

Asthma prescribing trends, inhaler adherence and outcomes: a Real-World Data analysis of a multi-ethnic Asian Asthma population

Inhaled corticosteroid (ICS) is the mainstay therapy for asthma, but general adherence is low. There is a paucity of real-world inhaler prescribing and adherence data from Asia and at the population level. To address these gaps, we performed a real-world data analysis of inhaler prescribing pattern and adherence in a multi-ethnic Asian asthma cohort and evaluated the association with asthma outcomes. We performed a retrospective analysis of adult asthma patients (aged ≥18 years) treated in the primary and specialist care settings in Singapore between 2015 to 2019. Medication adherence was measured using the medication possession ratio (MPR), and categorised into good adherence (MPR 0.75-1.2), poor adherence (MPR 0.75) or medication oversupply (MPR > 1.2). All statistical analyses were performed using R Studio. 8023 patients, mean age 57 years, were evaluated between 2015 and 2019. Most patients were receiving primary care (70.4%) and on GINA step 1–3 therapies (78.2%). ICS-long-acting beta-2 agonist (ICS-LABA) users increased over the years especially in the primary care, from 33% to 52%. Correspondingly, inpatient admission and ED visit rates decreased over the years. Between 2015 and 2019, the proportion of patients with poor adherence decreased from 12.8% to 10.5% (for ICS) and from 30.0% to 26.8% (for ICS-LABA) respectively. Factors associated with poor adherence included minority ethnic groups (Odds ratio of MPR 0.75–1.2: 0.73–0.93; compared to Chinese), presence of COPD (OR 0.75, 95% CI 0.59–0.96) and GINA step 4 treatment ladder (OR 0.71, 95% CI 0.61–0.85). Factors associated with good adherence were male gender (OR 1.14, 95% CI 1.01–1.28), single site of care (OR 1.22 for primary care and OR 1.76 for specialist care), GINA step 2 treatment ladder (OR 1.28, 95% CI 1.08–1.50). Good adherence was also associated with less frequent inpatient admission (OR 0.91, 95% CI 0.84–0.98), greater SABA overdispensing (OR 1.66, 95% CI 1.47–1.87) and oral corticosteroids use (OR 1.10, 95% CI 1.05–1.14). Inhaled corticosteroid (ICS) adherence has improved generally, however, poor adherence was observed for patients receiving asthma care in both primary and specialist care, and those from the minority ethnicities.

Equity and Outcome Events in Hidradenitis Suppurativa: Exploring Effect Modifiers Associated with Diagnostic Delay in the Real World.

Patients with hidradenitis suppurativa (HS) experience significantly delayed diagnoses of 7-10years from symptom onset on average, but the reasons for this remain largely unknown. This study investigated drivers of diagnostic delay from the perspective of healthcare system equity. A literature review was performed to identify published factors associated with delayed HS diagnosis to inform data analysis. Clinical and demographic data from the Adelphi HS Disease Specific Programme (DSP)™, a real-world cross-sectional survey of dermatologists and their consulting patients in France, Germany, Italy, Spain, the UK and the USA in 2020/2021, were used to model factors influencing delay to diagnosis from onset of symptoms and first consultation. Factors influencing delay to HS diagnosis in the literature with the most available evidence were misdiagnosis, delay in specialist referral and patient embarrassment. Data analysis revealed that increasing age was associated with reduced diagnostic delay after symptom onset. Patients with HS who were White or in Germany were also more likely to receive a faster diagnosis. Smokers, patients with concomitant conditions, or a family history of HS were slower to be diagnosed. When time to diagnosis following first consultation was assessed, increasing age was associated with quicker diagnosis. Moreover, patients with a family history of HS were diagnosed quicker, whereas those with high body mass index, more concomitant conditions, in employment, managed by multiple physicians or European were more delayed. On the basis of a thorough analysis of real-world data, multiple factors that potentially influenced the timely diagnosis of HS have been identified. For the first time, this study quantifies the relative impact of these modifiers, providing valuable insights into areas that require attention for faster diagnoses and improved disease outcomes.

BRCA and homologous recombination repair deficiency testing in advanced ovarian cancer: A real-world data analysis

BRCA and homologous recombination repair deficiency testing in advanced ovarian cancer: A real-world data analysis

Patterns in maintenance therapy use in advanced ovarian cancer patients: Real-world data analysis

Patterns in maintenance therapy use in advanced ovarian cancer patients: Real-world data analysis

P153 Treatment patterns and outcomes in elderly patients with Castration-Resistant Prostate Cancer (mCRPC): A real-world data analysis

P153 Treatment patterns and outcomes in elderly patients with Castration-Resistant Prostate Cancer (mCRPC): A real-world data analysis

Thyroid-stimulating hormone suppression in low-risk papillary thyroid cancer: a large-scale retrospective analysis of real-world data

Over 500,000 new cases are diagnosed with papillary thyroid cancer (PTC) globally per year, of whom the vast majority are in the low-risk stratification. Although thyroid-stimulating hormone (TSH) suppression is traditionally recommended for all postoperative PTCs in current guidelines, its necessity remains highly controversial in low-risk patients. Since relevant recommendations in current guidelines are still empirical, we aim to provide a direct, large-scale, real-world evidence. This large-scale real-world retrospective study included 11,140 low-risk PTC patients from two Chinese large-volume centers (Fudan University Shanghai Cancer Center [FUSCC] and Cancer Hospital of Chinese Academy of Medical Sciences [CH-CAMS]) treated from January 1, 2000 to June 30, 2022. The mean TSH level was calculated based on postoperative serum TSH values during follow-up. The primary outcome was the association between postoperative TSH level and structural recurrence assessed by Kaplan-Meier, log-rank, multivariate Cox regression analyses and equivalence testing by Two One-Sided Tests (TOST) procedure. Propensity score matching (PSM) was used to adjust for confounders among groups. A total of 11,140 patients with low-risk PTC were included with a median follow-up of 70 months. Based on the mean TSH level, we classified these patients into ≤0.5 (n=1,504, 13.5%), (0.5-1] (n=4,336, 38.9%), (1-2] (n=4,285, 38.5%), (2-3] (n=704, 6.3%) and >3 (n=311, 2.8%) mU/L groups. After PSM adjusting for age, sex, T and N stage, 8991 patients were included in further analysis, for whom the log-rank analyses showed no significant differences between any two groups (all P>0.05) in recurrence-free survival (RFS), locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS), and suppressed TSH was not associated with tumor recurrence in the multivariate Cox analysis (TSH > 2 group vs TSH ≤ 2 group: HR=1.30, 95% CI=0.85-2.01, P=0.23). Furthermore, the TOST equivalence tests showed that tumor recurrence status of any two TSH groups were statistically comparable (all Bonferroni-corrected P values<0.005). Subgroup multivariate analyses showed that TSH level did not impact tumor recurrence regardless of age, tumor size, lymph node metastasis, multifocality, surgical extent, biochemical evidence. Our results suggested that postoperative TSH level was not associated with tumor recurrence in patients with low-risk PTC, for whom deliberate TSH suppression may be exempted to avoid potential secondary complications. Maintaining a TSH level within the normal range may be safe for these patients. The study was supported by the National Natural Science Foundation of China (82072951 to Y.W.; 82373008 to X.S.), Shanghai Hospital Development Center (SHDC2020CR6003-001 to Y.W., SHDC2024CRI087 to Y.-J.W.), the Science and Technology Commission of Shanghai Municipality (22Y21900100/23DZ2305600 to Y.W.; 23ZR1412000 to X.S.), the Shanghai Anticancer Association Foundation (SACA-AX202213 to Yu Wang), Shanghai Municipal Health Commission and Shanghai Medicine and Health Development Foundation (WJWRC202302 to X.S.).