Pragmatic and Observational Research最新文献

{"title":"Development and Internal Validation of a Prediction Model for Major Cardiovascular and Respiratory Events in Chronic Obstructive Pulmonary Disease: Nationwide Primary Care Electronic Medical Records Cohort Study.","authors":"Chris P Gale, Mohit Bhutani, Jeffrey Shi Kai Chan, John Townend, Mehul S Patel, Mohsen Sadatsafavi, William Henley, Cono Ariti, Victoria Carter, Amy Couper, Richard Hubbard, Janwillem W H Kocks, Rachel Pullen, Derek Skinner, David Price","doi":"10.2147/POR.S551291","DOIUrl":"10.2147/POR.S551291","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular diseases are prevalent in individuals with chronic obstructive pulmonary disease (COPD), but current cardiovascular risk assessment models are not optimised for COPD. We aimed to develop a prediction model for the 10-year risk of major adverse cardiovascular and respiratory events (MACRE) in patients with COPD.</p><p><strong>Methods: </strong>We used nationwide primary care electronic health records from individuals with COPD, aged ≥40 years in 2011 without prior myocardial infarction in the UK Optimum Patient Care Research Database. Practices were randomly divided at the practice level into derivation (80%) and validation (20%) datasets. The primary composite outcome (MACRE) consisted of myocardial infarction, coronary revascularization, heart failure, severe COPD exacerbation, and all-cause mortality. Multivariable Cox regression was used to derive the model using the derivation dataset, with the least absolute shrinkage and selection operator used for variable selection and shrinkage. Performance was evaluated using the validation dataset over prediction horizons of five and 10 years.</p><p><strong>Results: </strong>Among the 122,077 patients included (98,959 in the derivation set; whole cohort: 47.9% women and mean age 69.3 (SD 11.2) years), cardiometabolic risk factors were prevalent, and most had moderate (53.4%) or severe (24.7%) COPD. Over a median follow-up of 10.5 [interquartile range: 4.2-12.4] years, MACRE occurred in 50.2% of the validation set. Sixty-one predictor variables constituted the model, which demonstrated good-to-excellent discrimination and satisfactory calibration across prediction horizons (AUROC 0.78 at five years and 0.82 at 10 years, Brier score of 0.18 at five years and 0.16 at 10 years) in the validation set.</p><p><strong>Conclusion: </strong>A model derived using electronic medical records predicts MACRE in COPD with high discrimination and satisfactory calibration across medium and longer-term prediction horizons. Its utility to inform trial enrolment and clinical decisions requires further study.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"17 ","pages":"551291"},"PeriodicalIF":2.7,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12988761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147463733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Potential Impact of GLP-1 Receptor Agonists on Exacerbation Risk in Patients with COPD and Type 2 Diabetes: A Real-World Population-Based Observational Study.","authors":"Bernardino Alcázar-Navarrete, Heath Heatley, Alan Kaplan, Lee Tze Tan, Mariko Siyue Koh, Naveed Sattar, John Townend, Derek Skinner, Victoria Carter, David Price","doi":"10.2147/POR.S550543","DOIUrl":"10.2147/POR.S550543","url":null,"abstract":"<p><strong>Introduction: </strong>There is limited evidence on the impact of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with chronic obstructive pulmonary disease (COPD).</p><p><strong>Material and methods: </strong>We conducted a retrospective matched cohort study including patients aged ≥40 years with COPD and T2D. Patients initiating GLP-1 RAs were matched 1:1 with GLP-1 naïve controls based on age, sex, smoking status, COPD treatment (LABA/LAMA/ICS), and exacerbation history. The index date was defined as the first GLP-1 RA prescription, control's index date was a COPD consultation within 186 days of matched patient index. The primary outcome was the number of COPD exacerbations during the 12 months following the index date. Secondary outcomes included oral corticosteroid (OCS) prescriptions and hospital resource utilization (HCRU). Poisson regression models adjusted for BMI and other confounders were used to estimate incidence rate ratios (IRR).</p><p><strong>Results: </strong>A total of 4479 matched patients were included. There were no significant differences between groups in exacerbation rates or OCS use in the year prior to the index date. During follow-up, patients treated with GLP-1 RAs had significantly fewer exacerbations (adjusted IRR [aIRR] 0.84, 95% CI: 0.79-0.89) and fewer OCS prescriptions (aIRR 0.86, 95% CI: 0.77-0.95) compared with controls. A significant delay in time to first OCS prescription was also observed.</p><p><strong>Conclusion: </strong>In this real-world cohort, initiation of GLP-1 RA treatment in patients with COPD and T2D was associated with lower COPD exacerbations and OCS use. These findings suggest a potential role for GLP-1 RAs in modifying the course of COPD in this comorbid population, warranting randomised trials.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"17 ","pages":"550543"},"PeriodicalIF":2.7,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13015956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147521660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validity of Using Prescription Medications to Classify Disease - A Retrospective Observational Study Using Routinely Collected Electronic Health Records from the UK.","authors":"Christian Schnier, John Busby, Aziz Sheikh, Jennifer K Quint, David B Price, Liam G Heaney","doi":"10.2147/POR.S553011","DOIUrl":"10.2147/POR.S553011","url":null,"abstract":"<p><strong>Background: </strong>Epidemiological studies rely on valid classifications of patients' disease status. However, in the absence of perfect information on every patients' health status, researchers use proxy information with variable and often unknown validity.</p><p><strong>Methods: </strong>To investigate the validity of using prescription records for disease classification, we conducted a retrospective observational study on a UK-wide database of medical prescriptions and clinical records (Optimum Patient Care Research Database). We used electronic health records of 25,000 randomly selected patients for each year between 2004 and 2020 (total N=425,000) and compared disease classification of 18 different chronic conditions based on clinical records for a period of three years (gold standard) with disease classification based on prescription records for the same period. We then used logistic regression to analyse if positive and negative predicted values (PPV and NPV) were associated with known predictors of disease.</p><p><strong>Results: </strong>Results showed large variations in PPV ranging from 8% (heart failure) to 94% (all type diabetes) and smaller variations in NPV ranging from 96% (anxiety) to 100% (Type 1 diabetes). Age, sex, ethnicity, and year but not socio-economic status were associated with variations in validity, especially in classifying dementia, diabetes, and depression.</p><p><strong>Discussion: </strong>Varying validity can partly be explained by different (stratum-specific) prevalence of disease. Additionally, conditions like heart failure can be treated with medication that can also be prescribed for other conditions or can be treated without medication. However, varying validity can also be attributed to imperfect clinical records, which we used as gold standard. As a consequence of low validity, the apparent prevalence based on using prescription records was between 1.3 times lower (all-type diabetes) and up-to 11 times higher (heart failure) than the true prevalence based on the clinical records.</p><p><strong>Conclusion: </strong>Studies using prescription data to classify disease status run a substantial risk of misclassification bias.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"17 ","pages":"553011"},"PeriodicalIF":2.7,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12817061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relapse Predictors of Idiopathic Retroperitoneal Fibrosis: A Long-Term Cohort Study.","authors":"Sicheng Huang, Anqi Wang, Yimeng Jia, Wei Han, Nan Zhao, Tingting Wang, Weiguo Zhu, Lidan Zhao, Linyi Peng, Jiaxin Zhou, Mengtao Li, Wen Zhang, Yunyun Fei","doi":"10.2147/POR.S562743","DOIUrl":"10.2147/POR.S562743","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to identify predictive factors for the relapse of idiopathic retroperitoneal fibrosis (IRF) and provide instructions for the optimization of the maintenance therapy.</p><p><strong>Methods: </strong>All patients with a clinical diagnosis of IRF were enrolled and followed up every 3-6 months. Their clinical characteristics, laboratory data and treatment strategies were recorded at each visit.</p><p><strong>Results: </strong>96 IRF patients (77 males and 19 females) with a median age of 55 years (interquartile range [IQR], 50-61) were enrolled. The median follow-up time was 2.50 (IQR, 1.75-4.13) years. During the follow-up, 21 patients experienced at least one relapse, with cumulative relapse rates of 10.6%, 32.3%, and 62.4% at 2.5, 5, and 7.5 years, respectively. Initial hydronephrosis was an independent predictor of relapse (Hazard ratio [HR], 5.35; p=0.001). Discontinuation of maintenance therapy (HR, 3.41; 95% CI, 1.4-8.314; p=0.007) was closely associated with relapse. Use (HR, 0.12; p<0.001) and dose (HR, 0.73; p=0.01) of glucocorticoids (GC) in maintenance period were protective factors against relapse. Among patients with hydronephrosis, those who discontinued GC had a higher relapse rate (p=0.009). GC monotherapy or combined immunosuppressants (IM) therapy were more effective in preventing relapse than IM alone (p<0.001).</p><p><strong>Conclusion: </strong>Our study reveals that initial hydronephrosis and GC withdrawal during maintenance therapy are significant predictors of IRF relapse. Long-term, low-dose GC therapy is benefit for maintaining remission and preventing relapse, especially in patients with initial hydronephrosis.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"265-277"},"PeriodicalIF":2.7,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12731247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145834516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"INSIGHTS Asthma Pragmatic Registry - A Pragmatic Approach to High-Validity Real-World Evidence for Asthma.","authors":"Karynsa Kilpatrick, Urmila Chandran, Robert Urman, Jean-Pierre Llanos, Nestor A Molfino, Rayna K Matsuno, Daniel J Riskin","doi":"10.2147/POR.S517474","DOIUrl":"10.2147/POR.S517474","url":null,"abstract":"<p><strong>Purpose: </strong>Asthma is a heterogenous disease, and up to 10% of asthma patients have severe disease. While critical, clinical trials in these patients are generally not representative of the broader ambulatory patient population, warranting the need for reliable and rich real-world data to enable clinical, payer, and regulatory decision-making. Currently, observational registries of consented patients rely on longitudinal, clinically rich data to support real-world evidence generation, but are resource intensive. This manuscript describes an asthma pragmatic registry that incorporates rigorous data reliability standards while offering scalability for research.</p><p><strong>Patients and methods: </strong>The INSIGHTS Asthma Pragmatic Registry is a real-world, retrospective cohort of adult and adolescent patients with moderate-to-severe asthma geographically distributed throughout the United States. The data set is purposely designed to meet data reliability standards of accuracy, completeness, and traceability. Efforts include continuous improvements in the capture of key clinical features (including disease severity) from electronic health records using advanced technology, linkage across electronic health records, medical and pharmacy claims, and death registry, and process to trace data elements back to a source of truth.</p><p><strong>Results: </strong>The pragmatic registry implementation includes patients meeting moderate-to-severe asthma eligibility criteria since Jan 1, 2014, with routine data refreshes, resulting in 9,185 patients meeting eligibility criteria through August 1, 2024. The median age of patients is 53 years. At least two-thirds of patients are female, of white race, and non-Hispanic ethnicity. On average, patients were followed for more than five years.</p><p><strong>Conclusion: </strong>The INSIGHTS Asthma Pragmatic Registry is a new paradigm in observational research, which blends the data reliability and richness of traditional, consented registries while incorporating the flexibility and scale of utilizing routinely collected data. Ongoing efforts include maintaining longitudinality of patient data and improvements to sustain high data reliability per regulatory standards to support this unique data set for asthma research.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"253-264"},"PeriodicalIF":2.7,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12720969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145820566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Derivation and Definitions of Clinical Study Variables for Multiple Long Term Conditions in Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Modified Delphi Methods and Consensus Study on Behalf of the International Cardiovascular and Respiratory Alliance.","authors":"Tobin Joseph, Mohit Bhutani, Amy Couper, Rachel Pullen, Ramesh Nadarajah, Luis Alves, Maria Felicia Montero-Arias, Riyad Al-Lehebi, David D Berg, Nathaniel M Hawkins, John R Hurst, Christine R Jenkins, Alan Kaplan, Janwillem W H Kocks, Konstantinos Kostikas, Carolyn S P Lam, Therese S Lapperre, Chin Kook Rhee, Naveed Sattar, Daiana Stolz, Gary Tse, Tonya Winders, David Price, Chris P Gale","doi":"10.2147/POR.S550533","DOIUrl":"10.2147/POR.S550533","url":null,"abstract":"<p><strong>Background: </strong>Standardized variables and their definitions are essential for robust delivery and reporting of clinical studies and quality improvement in chronic obstructive pulmonary disease (COPD). This protocol describes the rationale and methodology for the derivation and definition of clinical study variables for patients with multimorbidity or at high risk of multimorbidity in COPD.</p><p><strong>Methods and analysis: </strong>We will follow a four-step process. This will include the formation of an Executive Committee, a Steering Committee and an International Consensus Group. We will conduct a systematic review of the literature from which potential clinical study variables will be extracted and their definitions proposed. Using a modified Delphi process, the Steering Committee will select candidate clinical study variables and as necessary refine their definitions. All three groups will then vote and give feedback on the candidate clinical study variables in a modified Delphi process (with rounds until consensus is achieved) to reach a final suite of internationally agreed hierarchically classified clinical study variables.</p><p><strong>Ethics and dissemination: </strong>It is anticipated that the results will be published in a peer-reviewed journal and presented in a variety of forums. Ethical approval was not required for this study.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"243-251"},"PeriodicalIF":2.7,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12712702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145805421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Disease Modifying Therapies and Prognostic Factors Affecting Multiple Sclerosis Progression in a Local Centre of Hong Kong.","authors":"Bobby Chun Man Lui, Jessica Tsz Ching Li, Wai Ting Lo, Wing Chi Fong","doi":"10.2147/POR.S556886","DOIUrl":"10.2147/POR.S556886","url":null,"abstract":"<p><strong>Introduction: </strong>Multiple sclerosis (MS) is a major demyelinating disease causing disability in young adults. Scarce data exists on the clinical benefits and persistence of disease modifying therapies (DMTs) amongst our local population. The primary aim of this study was to investigate the effectiveness, tolerability and discontinuation pattern of various DMTs amongst Hong Kong patients.</p><p><strong>Methods: </strong>This was a retrospective study of adult MS patients treated in a tertiary hospital in Hong Kong from 1st December 2012 to 30th November 2022. Demographic, clinical and radiological characteristics were retrieved.</p><p><strong>Results: </strong>A total of 103 patients were analysed. Interferons (annualised relapse rate (ARR) reduction 0.492, p <0.001) and fingolimod (ARR reduction 0.557, p = 0.038) had significant ARR reductions in our cohort. Overall treatment persistence were comparable, but teriflunomide had more discontinuation due to side effects and/or intolerance (hazard ratio (HR) 7.50, p = 0.029). Baseline Expanded Disability Status Score (EDSS) more than or equal to 4.0 (odds ratio (OR) 4.56, p = 0.045), and presence of brainstem lesions on magnetic resonance imaging (OR 3.15, p = 0.039) were associated with greater disability progression, while visual onset symptoms at diagnosis (OR 0.14, p = 0.007) were associated with lower risk.</p><p><strong>Discussion: </strong>This study illustrated the complexity of managing MS patients. Patients' clinical characteristics, disease activity, risk appetite and treatment side effects should be taken in consideration to reach an informed decision on the use of DMTs in our local MS patients.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"221-241"},"PeriodicalIF":2.7,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12682569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145715194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"One Year Risk Prediction Model for Cardiovascular Disease for Adults with Asthma in England.","authors":"Jessica Baskaran, Vesselin A Novov, Jennifer K Quint, Constantinos Kallis","doi":"10.2147/POR.S520056","DOIUrl":"10.2147/POR.S520056","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease (CVD) continues to be a significant health threat to humans globally, and a significant burden on healthcare systems. Cardiovascular risk prediction utilizing machine learning (ML) models in patients with asthma remains vastly underexplored.</p><p><strong>Methods: </strong>In this cohort study consisting of 641,042 participants, we used routinely collected electronic healthcare record data to explore various ML algorithms including logistic regression, penalized logistic regression, decision trees, random forest and gradient boost to develop a model with high specificity.</p><p><strong>Results: </strong>The penalized logistic regression model was identified to be the best and simplest classification model in terms of discriminatory power (AUC = 0.85). The gradient boost model was found to be the best predictive model in terms of calibration where the predicted and observed probabilities at risk of CVD match or are closely aligned. In all models, the number of previous cardiovascular events was the most influential predictor, followed by age and prescriptions related to cardiovascular medications. The top predictor alone produced a reasonable level of predictive power (AUC = 0.66).</p><p><strong>Conclusion: </strong>We have created a novel prediction model for predicting CVD within a year of asthma diagnosis for patients with asthma at least 50 years old. Using penalized logistic regression, we achieved a high level of accuracy. By implementing this model, it would be possible to screen out patients with low risk of CVD with high specificity and acceptable sensitivity. Penalized logistic regression and gradient boost models have similar accuracy in screening out individuals at low risk of CVD. For this objective, penalized logistic regression may be more suitable than gradient boost models for implementation as it is simpler to use and more transparent. At the probability threshold of 8% (outcome prevalence), both models' effectiveness in reducing unnecessary treatments was by approximately 52%. These ML models performed better compared with traditional statistical-based risk prediction models. The unique contribution of the study is the construction of prediction models for CVD disease within 12 months from asthma diagnosis based on regression and machine learning models and the comparison of their accuracy to identify the best model based on suitable statistical measures such as AUC and calibration. Further prospective studies using different populations and external validation are required to assess and validate the ML risk prediction models.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"201-219"},"PeriodicalIF":2.7,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12630010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145588119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Treatment Patterns and Overall Survival (OS) of Patients with Metastatic Castration-Resistant Prostate Cancer in Italy.","authors":"Melania Dovizio, Daniela Castelletti, Paolo Luraghi, Serena Losi, Andrea Gervasi, Matteo Risi, Melania Leogrande, Luca Degli Esposti, Giuseppe Procopio","doi":"10.2147/POR.S539229","DOIUrl":"10.2147/POR.S539229","url":null,"abstract":"<p><strong>Purpose: </strong>This real-world analysis described the characteristics and therapeutic management of patients with metastatic castration-resistant prostate cancer (mCRPC) in Italy before and after 2015, when androgen receptor signalling inhibitors (ARPI) entered clinical practice.</p><p><strong>Patients and methods: </strong>An observational retrospective analysis was conducted using administrative healthcare databases from a pool of Italian Local Health Units, covering ~6.2 million residents. Adult men with ≥1 prescription of androgen deprivation therapy (ADT) from January 2011 to June 2022 were identified. mCRPC was proxied by treatment patterns-addition of docetaxel/cabazitaxel or ARPI to ADT-and confirmed by hospital discharge for metastasis. Patients were stratified according to their inclusion (date of the last inclusion criterion met): pre-2015 (2011-2014) and post-2015 (2015-2020).</p><p><strong>Results: </strong>Among 1890 mCRPC patients identified, 551 (29%) received ≥2 treatment lines. Chemotherapy (CHT) was the predominant first-line (1L) therapy in both cohorts [97.2% vs 82.9%], followed by ARPI [2.8% vs 17.1%]. In a 2020 sensitivity analysis (n=406), 1L therapy was ARPI in 76% and CHT in 24%. Among pre- and post-2015 patients, 29.4% and 31.6% received second-line (2L) therapy, mostly ARPI. Median OS from ADT initiation was 46.4 months (pre-2015) and 53.9 months (post-2015). In post-2015 patients, median OS from mCRPC index-date-reflecting the proxy-based diagnosis-was 14.2 months.</p><p><strong>Conclusion: </strong>In Italian clinical practice, CHT remains the most common 1L therapy though ARPI use has increased since 2015. While OS from ADT initiation has improved, survival from mCRPC diagnosis-based on proxies in administrative data-remains poor, underscoring an unmet clinical need. Differences in OS estimates depending on the starting point (ADT initiation vs mCRPC diagnosis) should be considered when interpreting results.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"189-199"},"PeriodicalIF":2.7,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12619622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145542062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcomes of Ablation for Persistent Atrial Fibrillation with Zero or Minimal Fluoroscopy.","authors":"Jose Osorio, Gustavo Morales, Anil Rajendra, Tina D Hunter","doi":"10.2147/POR.S526839","DOIUrl":"10.2147/POR.S526839","url":null,"abstract":"<p><strong>Purpose: </strong>Recent developments in electroanatomical mapping (EAM), intracardiac echocardiography, and sheath technology have allowed for a pronounced reduction or complete elimination of fluoroscopy during catheter ablation of atrial fibrillation (AF). This real-world study evaluates the procedural efficiency, clinical effectiveness, and safety of a zero- to minimal-fluoroscopy workflow in an exclusively persistent AF (PsAF) population.</p><p><strong>Methods: </strong>Data on consecutive PsAF catheter ablations performed with a fluoroscopy minimization workflow by three operators at a single high-volume center in the United States between January 2017 and December 2018 were collected and analyzed. All procedures were performed with EAM guidance and a contact force ablation catheter. Patients were followed for a year post-ablation for safety, arrhythmia recurrences, and reablation. Outcomes of interest included procedural efficiency measures, single-procedure success (freedom from reablation at any time or recurrence after 90-day blanking), and procedure-related complications.</p><p><strong>Results: </strong>The study included 406 PsAF patients (age 67.8 ± 10.1 years, 65.3% male, and CHA₂DS₂-VASc score 2.9 ± 1.5). Over 85% of ablations were performed without fluoroscopy, and ablations utilizing fluoroscopy averaged only 0.6 ± 1.5 minutes for a mean fluoroscopy time of 0.1 ± 0.6 minutes overall. Mean procedure time was 89.5 minutes, with 96.3% of the procedures including ablation beyond the pulmonary veins. Single-procedure success was 73.6% (95% confidence interval: [68.7%, 77.8%]). Eight patients (2.0%) experienced a procedure-related complication.</p><p><strong>Conclusion: </strong>Minimal-fluoroscopy ablation was performed safely and without compromise to procedural efficiency or clinical effectiveness in a real-world population of PsAF patients, despite more extensive ablation than a typical paroxysmal AF population.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"179-187"},"PeriodicalIF":2.7,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12476173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}