Jose Osorio, Gustavo Morales, Anil Rajendra, Tina D Hunter
{"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 CHA<sub>2</sub>DS<sub>2</sub>-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}
Stefano Del Giacco, Giorgio Walter Canonica, Ioana Agache, David Price, Nicolas Roche, Holger Schunemann, Keith Allan, Ignacio Ansotegui, Simona Barbaglia, Jonathan A Bernstein, Matteo Bonini, Sinthia Bosnic-Anticevich, Jean Bousquet, Fulvio Braido, Victoria Carter, Herberto Jose Chong-Neto, Danilo Di Bona, Kirsty Fletton, Sandra Gonzalez Diaz, Vandana Ayyar Gupta, Richard Hubbard, Jonathan Iaccarino, Ibon Eguiluz-Gracia, Cristina Jacomelli, Janwillem Kocks, Jerry Krishnan, Vera Mahler, Mario Morais-Almeida, Daniel Moreles, Paola Muti, Susanna Palkonen, Nikolaos G Papadopoulos, Ruby Pawankar, Christina Reeb, Helen Reddel, Isabel Rojo, Dermot Ryan, Lydia Sodhi, Maria Torres, Tonya Winders, Kevin C Wilson
{"title":"Expert Perspectives on Next Generation Health Guidelines: How to Integrate RWE in EBM.","authors":"Stefano Del Giacco, Giorgio Walter Canonica, Ioana Agache, David Price, Nicolas Roche, Holger Schunemann, Keith Allan, Ignacio Ansotegui, Simona Barbaglia, Jonathan A Bernstein, Matteo Bonini, Sinthia Bosnic-Anticevich, Jean Bousquet, Fulvio Braido, Victoria Carter, Herberto Jose Chong-Neto, Danilo Di Bona, Kirsty Fletton, Sandra Gonzalez Diaz, Vandana Ayyar Gupta, Richard Hubbard, Jonathan Iaccarino, Ibon Eguiluz-Gracia, Cristina Jacomelli, Janwillem Kocks, Jerry Krishnan, Vera Mahler, Mario Morais-Almeida, Daniel Moreles, Paola Muti, Susanna Palkonen, Nikolaos G Papadopoulos, Ruby Pawankar, Christina Reeb, Helen Reddel, Isabel Rojo, Dermot Ryan, Lydia Sodhi, Maria Torres, Tonya Winders, Kevin C Wilson","doi":"10.2147/POR.S487342","DOIUrl":"10.2147/POR.S487342","url":null,"abstract":"<p><p>Integrating real-world evidence (RWE) into evidence-based medicine (EBM) enhances healthcare decision-making. RWE provides insights into the real-world effectiveness and safety of therapies and health technologies, filling gaps that clinical trials may leave. EBM, which concentrates on therapeutic issues, depends on rigorous evaluation of evidence, including data from randomized controlled trials (RCTs) and RWE. Combining evidence from RCTs and RWE when forming recommendations offers a comprehensive understanding of benefits and risks by considering their strengths, limitations, and standardized methods. The 2nd European Academy of Allergy & Clinical Immunology/Respiratory Effectiveness Group (EAACI/REG) Workshop, held in Rome, Italy, on October 4th, 2023, discussed integrating RWE and EBM. The goals were to develop recommendations for high-quality RWE and its inclusion in evidence syntheses, with a particular focus on airway diseases. During the discussion, key topics emerged. An \"action plan\" is needed to share these topics in various formats. RCTs are currently seen as providing the strongest evidence, so how to incorporate Non-Randomized Studies of Interventions (NRSI) requires careful consideration. An educational plan and collaboration with patients' organizations are also very important. A collaborative approach involving patients, clinicians, and regulators is essential for achieving meaningful results and can be adapted as needed for cultural differences. A \"glossary\" of terms used in this context will be created to improve understanding. Setting benchmarks for data quality and reliability, such as quality thresholds, in disease-specific studies requires collaboration with research method experts. Managing and recording registries according to standardized protocols and quality standards from well-designed registries will ensure the data is valid and accurate.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"169-177"},"PeriodicalIF":2.7,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12436199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145081529","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":"Evaluating the Potential of Prevalent New User Design as an Alternative When New User Design is Impractical.","authors":"Takuma Koinuma, Manabu Akazawa","doi":"10.2147/POR.S517514","DOIUrl":"10.2147/POR.S517514","url":null,"abstract":"<p><strong>Purpose: </strong>The New User Design can be applied if the target drug has not been administered for a specified period. Therefore, comparisons between drugs administered alone are easier to undertake than comparisons of drugs used in combination. Thus, assessing concomitant medications may be associated with several challenges, including limitations to the New User Design. One such limitation is performing analyses that consider the history of administration of drugs of the same class. In the present study, we considered the limitations of the New User Design and proposed solutions based on the potential of the Prevalent New User Design.</p><p><strong>Patients and methods: </strong>Using the Japan Medical Data Center database (JMDC), patients diagnosed with diabetes mellitus who received sulfonylureas (SUs) between December 2009 and December 2010 with subsequent addition or switch to dipeptidyl peptidase-4 inhibitors (DPP4Is) were categorized into the SU+DPP4I group. The odds ratio (OR) was estimated using conditional logistic regression analysis. Using the \"elapsed time\" and \"number of prescriptions\" axes of the Prevalent New User Design, records from 1,426 and 1,342 individuals, respectively, were analyzed.</p><p><strong>Results: </strong>The hypoglycemia risk ORs were 1.50 (95% confidence interval [CI] 0.25-9.00) for the \"elapsed time\" axis and 1.67 (95% CI 0.40-7.00) for the \"number of prescriptions\" axis. These findings are consistent with the results of a meta-analysis of previous randomized controlled trials.</p><p><strong>Conclusion: </strong>Our findings suggest that the Prevalent New User Design can be effectively applied for real-world risk assessment scenarios; this design constitutes a potential alternative design to the New User Design. We adopted a Prevalent New User Design considering the patients' treatment history. However, there was a limitation in that we could not obtain information regarding the patients' perceptions of treatment prior to initiating therapy.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"155-168"},"PeriodicalIF":2.7,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12323799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144789763","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}
Paul E Pfeffer, Heath Heatley, Richard Hubbard, John Townend, David Price
{"title":"Association of Frequent Short-Acting Beta-Agonist Inhaler Prescriptions with Acute Cardiovascular Events.","authors":"Paul E Pfeffer, Heath Heatley, Richard Hubbard, John Townend, David Price","doi":"10.2147/POR.S522323","DOIUrl":"10.2147/POR.S522323","url":null,"abstract":"<p><strong>Background: </strong>Frequent usage of short-acting beta-agonist (SABA) reliever inhalers is strongly associated with exacerbations of asthma and chronic obstructive pulmonary disease (COPD), in turn associated with cardiovascular events. Patients with high SABA usage commonly report symptoms of heart racing and palpitations. However, many patients who overuse SABA inhalers have no history of frequent exacerbations, and the cardiovascular risks of SABA overuse in these patients has been poorly described to date.</p><p><strong>Aim: </strong>To establish whether frequent SABA usage is associated with adverse acute cardiovascular events (ACE) in patients who do not have a history of frequent exacerbations requiring oral corticosteroids.</p><p><strong>Methods: </strong>A case-series analysis was conducted with ACE as the event and SABA prescription as the exposure, comparing 3-month quarters with frequent SABA prescription to quarters with no SABA prescription, using primary care data from the Optimum Patient Care Research Database (OPCRD).</p><p><strong>Results: </strong>About 97082 patients with at least one period of frequent SABA prescription and who had no more than one exacerbation requiring oral corticosteroids prior to first ACE formed the primary analysis population, and 63824 patients who had no oral corticosteroids prior to first ACE were included in a sensitivity analysis. A significantly increased incidence of ACE was evident during quarters in which SABA inhalers were prescribed compared to quarters without SABA prescription, with Incidence Rate Ratio (IRR) 1.80 (95% CI 1.70-1.89) for the primary analysis; IRR 2.20 (95% CI 2.02-2.46) for the sensitivity analysis. A clear dose response was evident with increasing risk as the number of SABA prescribed per quarter increased.</p><p><strong>Conclusion: </strong>Frequent SABA usage appears to be associated with an increased risk of ACE even in patients not having oral corticosteroids for exacerbations of asthma or COPD. The risks of frequent SABA usage need both further research and clinical consideration, and prescription of frequent SABA inhalers should not be viewed as a benign prescription.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"147-154"},"PeriodicalIF":2.7,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144744419","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}
Dan Jackson, Anna Quinton, Fanni Zhang, Hana Müllerová, Christer Janson, Mohsen Sadatsafavi
{"title":"Mapping EQ-5D-5L Score From SGRQ in Patients with Asthma and/or COPD in NOVELTY.","authors":"Dan Jackson, Anna Quinton, Fanni Zhang, Hana Müllerová, Christer Janson, Mohsen Sadatsafavi","doi":"10.2147/POR.S508814","DOIUrl":"10.2147/POR.S508814","url":null,"abstract":"<p><strong>Purpose: </strong>The St George's Respiratory Questionnaire (SGRQ) measures health status in obstructive airways disease. Starkie et al proposed an algorithm for mapping the SGRQ to EQ-5D-5L, a preference-based utility measure, in chronic obstructive pulmonary disease (COPD) (Value Health 2011;14:354-60); only SGRQ total score, its squared value, and sex were included as covariates. We aimed to determine if including additional covariates could improve the performance of this algorithm type and whether amendments were required to extend this mapping to asthma or asthma+COPD.</p><p><strong>Patients and methods: </strong>SGRQ and EQ-5D-5L were measured from a large, global, prospective, longitudinal study in asthma and/or COPD (NOVELTY; NCT02760329). We fitted six longitudinal linear mixed models to the development sample (baseline and Year 1 data), with EQ-5D-5L as the response variable. Each model had a different combination of covariates. Mixed model repeated measures methodology was used to enable the accommodation of within-patient correlation among measurements. Restricted maximum likelihood and an unstructured covariance matrix were used to fit all models. Performance (mean square errors [MSE]) was evaluated relative to the Starkie et al algorithm in the validation sample (Year 2 and Year 3 data).</p><p><strong>Results: </strong>A total of 6813 patients (asthma: 3546; asthma+COPD: 872; COPD: 2395) with available EQ-5D-5L and SGRQ data were included at baseline. MSEs indicated good performance, were similar across models (Year 2: 0.0302-0.0308 [45-46% variance explained]; Year 3: 0.0272-0.0277 [47-48% variance explained]), and were modestly smaller than those obtained by Starkie et al (Year 2: 0.0340; Year 3: 0.0296). Performance was similar across models in the asthma and COPD subgroups.</p><p><strong>Conclusion: </strong>Including additional covariates and SGRQ domains resulted in similar model performance to Starkie et al, suggesting their covariates are adequate for mapping in asthma and/or COPD. NOVELTY coefficients broaden the population with chronic airways disease for whom this mapping can be applied.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"135-145"},"PeriodicalIF":2.3,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12152420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144275800","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}
Nina L Wittwer, Christoph R Meier, Martin J Recknagel, Samuel Allemann, Cornelia Schneider
{"title":"Comprehensive Description of an Automated Drug Dispensing System Database.","authors":"Nina L Wittwer, Christoph R Meier, Martin J Recknagel, Samuel Allemann, Cornelia Schneider","doi":"10.2147/POR.S488210","DOIUrl":"https://doi.org/10.2147/POR.S488210","url":null,"abstract":"<p><p>Medifilm is a company that blisters drug therapies recorded by pharmacists in the Medifilm software. The Medifilm dataset collates this information and provides details on drug substances, dosages, pharmacotherapy duration, the sequence of therapies, as well as demographic data on the patients. This article aims to provide an overview of the database, to describe the contents, and to demonstrate possibilities for researchers. The database and the recorded information were described. Furthermore, the data coverage was characterized in terms of the number of available pharmacies, patients, and their drug regimens. The database has been recording data since 2013 and has registered 470,801 blistered therapies for 45,594 patients ordered by 441 pharmacies so far. The longitudinal nature of the database allows researchers to study drug utilization, including medication changes, initiations, and discontinuations over time.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"129-134"},"PeriodicalIF":2.3,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11994459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144064369","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}
Emma L Richard, Judith J Stephenson, Nihar R Desai, Vincent J Willey, Alain Gay, Charlie Scott, Kerstin Folkerts, Elena Pessina, Rakesh Singh, Chia-Chen Teng, Nikolaus G Oberprieler
{"title":"Steroidal Mineralocorticoid Receptor Antagonist Side Effects and Reasons for Discontinuation: A Patient Survey (RELICS-PS).","authors":"Emma L Richard, Judith J Stephenson, Nihar R Desai, Vincent J Willey, Alain Gay, Charlie Scott, Kerstin Folkerts, Elena Pessina, Rakesh Singh, Chia-Chen Teng, Nikolaus G Oberprieler","doi":"10.2147/POR.S489802","DOIUrl":"10.2147/POR.S489802","url":null,"abstract":"<p><strong>Purpose: </strong>To understand steroidal mineralocorticoid receptor antagonists (sMRAs) treatment patterns and side effects from patients' perspectives.</p><p><strong>Methods: </strong>The RELICS-PS study, a complement to the claims-based RELICS study, used a cross-sectional patient survey targeting adults with commercial or Medicare Advantage health insurance who had at least one pharmacy claim for sMRAs (spironolactone or eplerenone) between July 2021 and June 2022. It used the Healthcare Integrated Research Database (HIRD<sup>®</sup>) as the sampling frame to identify eligible patients. A total of 600 completed surveys were targeted from current and past sMRA users between November and December 2022. The survey collected data on demographics, chronic conditions, prespecified side effects, and reasons for discontinuation among past sMRA users, describing the data without inferential testing.</p><p><strong>Results: </strong>Of 600 respondents, 49.2% reported at least one side effect. Side effects varied from 5.5% (weak pulse and chest pains) to 40.0% (sluggishness or fatigue). Reports of symptoms of male gynecomastia were noticeably higher than in medical claims in RELICS (17.4% vs 2.9%). Past users, consisting of 24.3% of respondents, were more likely to report experiencing side effects, experiencing them more frequently, and being more affected by them. Approximately a third of these respondents reported side effects as a deciding factor for discontinuation. Healthcare providers' recommendations, often informed by medication effectiveness and patient tolerance, were the most cited reason for discontinuation.</p><p><strong>Conclusion: </strong>Although half of the respondents reported experiencing side effects, 39.0% of past users identified side effects as a reason for discontinuation. This suggests a gap between patient experience and perceived reasons for discontinuation. A notable finding from the study is the significant role of healthcare providers in influencing the decisions to start or stop sMRA treatment. Therefore, future research should focus on exploring the factors that shape healthcare providers' decision-making processes when initiating and discontinuing treatment options.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"121-127"},"PeriodicalIF":2.3,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11974567/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804099","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}
Brenda G Grift, Peggy C J M van Spreuwel, Josef J J M Bruers, Katarina Jerković-Ćosić
{"title":"Shifting from Traditional to Pragmatic Randomized Controlled Trials: Insights and Lessons Learned from the Toddler Oral Health Intervention.","authors":"Brenda G Grift, Peggy C J M van Spreuwel, Josef J J M Bruers, Katarina Jerković-Ćosić","doi":"10.2147/POR.S493195","DOIUrl":"10.2147/POR.S493195","url":null,"abstract":"<p><strong>Purpose: </strong>This article examines the implementation of the Toddler Oral Health Intervention (TOHI) protocol, emphasizing feasibility, recruitment, retention, and protocol adherence rather than clinical outcomes. It discusses encountered challenges, necessary adjustments, and key lessons learned during the shift from a traditional randomized controlled trial (RCT) to a pragmatic RCT, thereby offering guidance for future research on similar complex interventions.</p><p><strong>Methods: </strong>The methods of the RCT study protocol are presented, including (1) recruitment of well-baby clinics and oral health coaches, (2) recruitment of the study population; (3) implementation of the intervention and (4) outcome measures, alongside with the process of implementation and gathered feedback needed for required adjustments. A systematic analysis identified key protocol elements, modifications made, and lessons learned.</p><p><strong>Results: </strong>Specific protocol modifications, including adjustments due to the COVID-19 pandemic, demonstrate how a traditional RCT can be adapted to real-world conditions without compromising outcome reliability. Key lessons include the necessity of robust contingency planning to manage unforeseen disruptions, effective recruitment and retention strategies to sustain participant and interventionists engagement, and the adoption of standardized data collection processes to ensure data integrity. These findings underscore the importance of addressing practical and contextual factors alongside measuring effectiveness, ensuring that study outcomes are both applicable and useful in clinical practice.</p><p><strong>Conclusion: </strong>The findings demonstrate that carefully planned and documented pragmatic adjustments not only preserve scientific rigor but also enhance the relevance and applicability of the results, maintaining the methodological robustness expected of traditional RCTs.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"111-120"},"PeriodicalIF":2.3,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773133","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}
Brooklyn Stanley, Jatin Chapaneri, Mina Khezrian, Ekaterina Maslova, Soram Patel, Mark Gurnell, Giorgio Walter Canonica, Helen K Reddel, Liam G Heaney, Arnaud Bourdin, David L Neil, Victoria Carter, David B Price
{"title":"Predicting Risk of Morbidities Associated with Oral Corticosteroid Prescription for Asthma.","authors":"Brooklyn Stanley, Jatin Chapaneri, Mina Khezrian, Ekaterina Maslova, Soram Patel, Mark Gurnell, Giorgio Walter Canonica, Helen K Reddel, Liam G Heaney, Arnaud Bourdin, David L Neil, Victoria Carter, David B Price","doi":"10.2147/POR.S484146","DOIUrl":"10.2147/POR.S484146","url":null,"abstract":"<p><strong>Background: </strong>Oral corticosteroids (OCS) are commonly used to treat asthma but increase the risks for multiple morbidities; reducing OCS exposure may benefit patients. We analysed independent risk factors and longitudinal changes in OCS usage among patients with asthma to predict future risks of OCS-related adverse outcomes.</p><p><strong>Methods: </strong>Optimum Patient Care Research Database United Kingdom primary care electronic medical records (EMR) from January 1990 to June 2021 were used to select adults (18-93 years) with asthma who had follow-up data from ≥2 years before to ≥3 years after an index visit for active symptoms; this date was defined by the largest pre-visit to post-visit change in mean annual OCS use. OCS usage during every follow-up year was categorised as none, low (mean <2 prescriptions/year), or high (mean ≥2 prescriptions/year). Pre-index to post-index changes between usage categories were calculated. Risk modelling selected cohorts without 17 morbidities (documented pre-index) reported to be associated with OCS exposure, including type 2 diabetes, osteoporosis, hypertension, and pneumonia. Cox regression analyses selected published risk factors associated with each condition and available in EMR for inclusion in proportional hazards models.</p><p><strong>Results: </strong>The pre-index to post-index OCS usage category remained unchanged in 38.6% of patients, increased in 39.2%, and decreased in 22.2%, with 20.7% having no further OCS prescriptions. In models, the risks of all adverse outcomes increased with projected categoric OCS use; for example, hazard ratios for a one-category increment (none to low, low to high) were 1.55 (1.42-1.69) for type 2 diabetes, 1.56 (1.36-1.78) for post-menopausal osteoporosis, 1.05 (1.00-1.10) for hypertension, and 1.67 (1.52-1.83) for pneumonia (all p < 0.001).</p><p><strong>Conclusion: </strong>OCS exposure in this primary care asthma population usually continued longitudinally. Our models predict increased risk of multiple morbidities with higher projected OCS exposure. These findings support early initiation of strategies to minimise OCS use in asthma.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"95-109"},"PeriodicalIF":2.3,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754303","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}
Yunus Celik, Conor Wall, Jason Moore, Alan Godfrey
{"title":"Better Understanding Rehabilitation of Motor Symptoms: Insights from the Use of Wearables.","authors":"Yunus Celik, Conor Wall, Jason Moore, Alan Godfrey","doi":"10.2147/POR.S396198","DOIUrl":"10.2147/POR.S396198","url":null,"abstract":"<p><p>Movement disorders present a substantial challenge by adversely affecting daily routines and overall well-being through a diverse spectrum of motor symptoms. Traditionally, motor symptoms have been evaluated through manual observational methods and patient-reported outcomes. While those approaches are valuable, they are limited by their subjectivity. In contrast, wearable technologies (wearables) provide objective assessments while actively supporting rehabilitation through continuous tracking, real-time feedback, and personalized physical therapy-based interventions. The aim of this literature review is to examine current research on the use of wearables in the rehabilitation of motor symptoms, focusing on their features, applications, and impact on improving motor function. By exploring research protocols, metrics, and study findings, this review aims to provide a comprehensive overview of how wearables are being used to support and optimize rehabilitation outcomes. To achieve that aim, a systematic search of the literature was conducted. Findings reveal that gait disturbance and postural balance are the primary motor symptoms extensively studied with tremor and freezing of gait (FoG) also receiving attention. Wearable sensing ranges from bespoke inertial and/or electromyography to commercial units such as personal devices (ie, smartwatch). Interactive (virtual reality, VR and augmented reality, AR) and immersive technologies (headphones), along with wearable robotic systems (exoskeletons), have proven to be effective in improving motor skills. Auditory cueing (via smartwatches or headphones), aids gait training with rhythmic feedback, while visual cues (via VR and AR glasses) enhance balance exercises through real-time feedback. The development of treatment protocols that incorporate personalized cues via wearables could enhance adherence and engagement to potentially lead to long-term improvements. However, evidence on the sustained effectiveness of wearable-based interventions remains limited.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"16 ","pages":"67-93"},"PeriodicalIF":2.3,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143692998","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}