Current Medical Research and Opinion最新文献

{"title":"Authors' response to: sting operations are not necessary in biomedical publishing.","authors":"Jaime A Teixeira da Silva, Jens C Türp, Timothy Daly","doi":"10.1080/03007995.2025.2510407","DOIUrl":"10.1080/03007995.2025.2510407","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-3"},"PeriodicalIF":2.4,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sting operations: an unfortunate necessity.","authors":"Frank Houghton","doi":"10.1080/03007995.2025.2510401","DOIUrl":"10.1080/03007995.2025.2510401","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-2"},"PeriodicalIF":2.4,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the symptom control provided by ravulizumab or efgartigimod in myasthenia gravis: an evaluation of the patient experience of two different treatment approaches.","authors":"Christopher A Scheiner, Masayuki Masuda, Tim Hagenacker, Lauren Powell, Pramoda Jayasinghe, Karissa Johnston, Karen S Yee","doi":"10.1080/03007995.2025.2497906","DOIUrl":"10.1080/03007995.2025.2497906","url":null,"abstract":"<p><strong>Objective: </strong>To introduce patient-centric perspectives of symptom control using a novel modeling approach to estimate time spent in health states for the generalized myasthenia gravis (gMG) therapies ravulizumab (terminal complement inhibitor) and efgartigimod (neonatal Fc receptor antagonist).</p><p><strong>Methods: </strong>Myasthenia Gravis Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis (QMG), and Myasthenia Gravis Quality of Life 15-item revised (MG-QOL15r) scores were extracted from the phase 3 CHAMPION MG (ravulizumab; seven time points) and ADAPT (efgartigimod; nine time points) trials and compared with the preceding score to define health states of improving, stable, or worsening, with extrapolation to 1 year. Stable state was evaluated across threshold ranges of 0.2-1.0-point change between observations. The proportion of time spent across health states was calculated for each stability threshold and then averaged for an overall summary across the range of cut points.</p><p><strong>Results: </strong>When extrapolated to 1 year, patients receiving ravulizumab spent more time with stable symptoms compared with patients on efgartigimod as measured by MG-ADL, QMG, and MG-QOL15r across stability thresholds. On average, patients receiving ravulizumab spent more time in stable or improving health states combined according to MG-ADL, QMG, MG-QOL15r (100%, 91%, and 79% of the year, respectively) compared to worsening states (0%, 9%, 21%). Patients receiving efgartigimod also spent more time, on average, stable or improving (83%, 75%, 77%) than worsening (17%, 25%, 23%). Variation in symptom control was smaller with ravulizumab than with efgartigimod.</p><p><strong>Conclusions: </strong>In this analysis, fixed-dose ravulizumab treatment was associated with stable symptom control in patients with gMG, whereas treatment with variable-dose efgartigimod resulted in initial improvement but more variable symptom control over time. Patients' personal goals and quality-of-life should be considered when choosing a gMG therapy.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-11"},"PeriodicalIF":2.4,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-reported real-world experience of risankizumab on-body device (OBD) for the treatment of Crohn's disease in the UK (COMMODUS).","authors":"Adil Jaulim, Anna Stanton, Sherill Tripoli, Ana Ibarra, David Young, Mary Doona, Fraser Cummings, Ally Speight, Shahida Din, James O Lindsay, Rachel Horsfall, Mark Sephton, Mark A Samaan","doi":"10.1080/03007995.2025.2506808","DOIUrl":"10.1080/03007995.2025.2506808","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate real-world patient-reported experience with subcutaneous (SC) risankizumab administered by on-body device (OBD) in patients with Crohn's disease (CD).</p><p><strong>Methods: </strong>Uncontrolled observational cross-sectional study in five UK units between October 2023 and May 2024. Patients who had received maintenance risankizumab <i>via</i> SC injection of four pre-filled syringes (PFS) self-administered in hospital were switched to OBD self-injection. Self-Injection Assessment Questionnaires (SIAQ) were completed pre- and post-first OBD use. The primary end-point was \"Overall, how satisfied are you with your current way of taking your medication (self-injection)?\" from post-injection SIAQ. Baseline patient data were collected retrospectively from medical records.</p><p><strong>Results: </strong>The study recruited 50 patients with moderate-to-severe CD, 48 completed the study. Most (81%) were satisfied/very satisfied with self-injection using OBD vs only 54% with PFS. Satisfaction with the OBD was highest with home use (90% vs 65%). Confidence was high with the OBD; numerically higher rates of patients were confident in giving themselves an injection in the right way (83% vs 64%), in a clean and sterile way (90% vs 74%) and safely (85% vs 72%) post-OBD than before using OBD. Self-injection using the OBD was reported as easy by 92% and convenient by 83% of participants. Most participants reported that they would continue to use the OBD (82%) and be confident to self-inject at home (81%). The OBD was well tolerated.</p><p><strong>Conclusion: </strong>The OBD provides a safe, easy to use and convenient way to self-administer risankizumab at home using one injection with improved satisfaction and confidence vs self-administration of four PFS in hospital.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-11"},"PeriodicalIF":2.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of whether use of a professional medical writer is associated with time to publication of papers reporting phase III oncology clinical trials in two high-impact general medicine journals.","authors":"Moamen Hammad, Thomas Carvell-Miller, Bernard Kerr, Valerie Moss","doi":"10.1080/03007995.2025.2505697","DOIUrl":"10.1080/03007995.2025.2505697","url":null,"abstract":"<p><strong>Objective: </strong>Professional medical writers assist authors with ethical and accurate publication of scientific research. We hypothesized that the support of a medical writer would enable timely publication of research and explored their association using papers reporting phase III oncology trials from 2019-2023. Given the time frame of this research, we also assessed the impact of the coronavirus disease 2019 (Covid-19) pandemic on publication volume as a secondary objective.</p><p><strong>Methods: </strong>We searched PubMed for phase III clinical trials published in <i>New England Journal of Medicine</i> (<i>NEJM)</i> and the <i>Lancet</i> between 01/01/2019 and 12/31/2023. Publications reporting oncology trials were reviewed in full to document acknowledgement of medical writing support, data cut-off date, publication date and other key characteristics. Time from data cut-off to publication was compared for papers with and without medical writing support.</p><p><strong>Results: </strong>Our search identified 442 papers reporting any phase III clinical trials, of which 164 (37%) reported oncology trials; 122/164 (74%) disclosed medical writing support. Mean time to publication was significantly shorter for papers disclosing medical writing support than those without (307 vs. 466 days; <i>p</i> < 0.0001). Median time to publication for papers with medical writing support appeared stable from 2019 to 2023. The volume (oncology and non-oncology) of phase III trials published in <i>NEJM</i> and the <i>Lancet</i> between 2019 and 2023 was lowest during 2020 to 2022 (<i>n</i> = 70-88) and highest in 2023 followed by 2019 (<i>n</i> = 110 and <i>n</i> = 96, respectively).</p><p><strong>Conclusions: </strong>Medical writing support is associated with timely publication of clinical trial results, even during events that may disrupt publication development such as the Covid-19 pandemic.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-7"},"PeriodicalIF":2.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world repeat screening adherence to multi-target stool DNA for colorectal cancer in a large, national Spanish-speaking population.","authors":"Mallik Greene, Timo Pew, Shrey Gohil, A Burak Ozbay, Juliana Lopez, Paul Limburg, Martha Duarte","doi":"10.1080/03007995.2025.2508764","DOIUrl":"https://doi.org/10.1080/03007995.2025.2508764","url":null,"abstract":"<p><strong>Introduction: </strong>Limited English proficiency may hinder completion of colorectal cancer (CRC) screening in Spanish speakers. This study evaluated CRC re-screening adherence using the multi-target stool DNA (mt-sDNA) test with Spanish language navigation, and patient characteristics associated with re-screening adherence.</p><p><strong>Methods: </strong>Data from Exact Sciences Laboratories, LLC, (01/01/2023-12/31/2023) were used. Patients (45-75 years) with insurance who indicated Spanish as their preferred language and were shipped an mt-sDNA test during the study period and had completed mt-sDNA screening with a negative result ≥2.5 years prior were included. Re-screening adherence and mean time to test return were compared among payer types; regression models were used to determine the relationship between these outcomes and patient characteristics.</p><p><strong>Results: </strong>Among 8,651 patients (45-64 years: 58.9%; female: 59.0%), partial digital with SMS only (46.3%) was the most frequent outreach type. Re-screening adherence was 80.4%, with numerically highest rates in patients insured through managed care organizations (83.7%). Mean (standard deviation) overall time to test return from shipment of mt-sDNA kit to receipt of valid test was 26.6 (38.2) days (range across payer types: 26.1 [38.9]-29.8 [41.5]). Medicare patients had a 42% higher likelihood of adherence than commercially insured patients (p = 0.004); patients who received SMS and email had a 59% higher likelihood of adherence than patients with no digital outreach (p < 0.001).</p><p><strong>Conclusion: </strong>Re-screening adherence of the mt-sDNA tests with Spanish language navigation was high, at 80.4%, across all payer types in patients selecting Spanish as their preferred language.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-14"},"PeriodicalIF":2.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of appetite loss and related factors in older patients with cancer: validation of the cancer appetite and symptom questionnaire (CASQ) in Turkish patients.","authors":"Digdem Dogan Akagunduz, Hilal Şahin, Ferhan Elmalı, Baran Akagunduz","doi":"10.1080/03007995.2025.2502669","DOIUrl":"https://doi.org/10.1080/03007995.2025.2502669","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to validate the Cancer Appetite and Symptom Questionnaire (CASQ) for Turkish older cancer patients and identify factors influencing appetite loss and related symptoms. The research question focused on whether the CASQ is a reliable tool for assessing appetite-related symptoms and determining associated risk factors in this population.</p><p><strong>Methods: </strong>A total of 240 cancer patients aged ≥70 years were recruited from a Turkish oncology clinic. Demographic, cancer-related, nutritional, functional, and psychological data were collected. Appetite was assessed using the CASQ and Simplified Nutritional Appetite Questionnaire (SNAQ). Structural validity, reliability, and diagnostic performance were evaluated through exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Logistic regression was performed to identify factors associated with appetite loss.</p><p><strong>Results: </strong>The CASQ demonstrated high reliability and validity, with a Cronbach's alpha of 0.971 and Kaiser-Meyer-Olkin (KMO) of 0.907. EFA and CFA supported a single-factor structure. A CASQ cutoff score of 32 showed high diagnostic accuracy (AUC: 0.971) with 88.9% sensitivity. Appetite loss was reported in 53.7% of patients and was significantly associated with stage IV cancer (OR: 10.112, <i>p</i> < .001), chemotherapy (OR: 2.960, <i>p</i> = .016), severe pain (OR: 3.089, <i>p</i> = .003), malnutrition (OR: 4.459, <i>p</i> = .033), polypharmacy (OR: 2.213, <i>p</i> = .040), and poor performance status (OR: 5.245, <i>p</i> = .017).</p><p><strong>Conclusions: </strong>The CASQ is a validated, reliable tool for assessing appetite-related symptoms in Turkish older cancer patients. Findings underscore the need for integrated nutritional and psychological care. Future research should develop targeted interventions to mitigate appetite loss and its impact on quality of life in this population.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-9"},"PeriodicalIF":2.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases.","authors":"Frank Andersohn, Michael Cronquist Christensen, Lambert Creuwels, Ignacio Aznar-Lou, Maria Rubio-Valera, Fernie Penning-van Beest, Eline Houben, Pilar Hernandez, Katja M Hakkarainen, Elin H Reines","doi":"10.1080/03007995.2025.2505692","DOIUrl":"https://doi.org/10.1080/03007995.2025.2505692","url":null,"abstract":"<p><strong>Objective: </strong>Vortioxetine is a multimodal antidepressant approved for the treatment of major depressive episodes. As part of the overall European risk-management plan, we aimed to fill data gaps on relevant missing information such as the extent of vortioxetine use in special populations and assessment of selected potential risks.</p><p><strong>Methods: </strong>This non-interventional post-authorization safety study used longitudinal administrative claims/medical records data from 10,358 patients newly prescribed vortioxetine in Finland, Spain, and the Netherlands (EU-PAS register: EUPAS19199).</p><p><strong>Results: </strong>Elderly patients (≥75 years) accounted for 3-14% of the assessed populations, while off-label pediatric prescribing was low (0.1-0.5%). Patients with a comorbid diagnosis of mania/hypomania accounted for 0.4-10% of the population, while patients with comorbid neurological conditions accounted for ≤3% of patients. The median prescribed daily vortioxetine dose was 10mg and mean exposure was 72-238 days. The proportions of patients who had one of the events of interest (suicidal events, epilepsy, convulsions/seizures, severe renal or hepatic events) recorded during vortioxetine exposure were all ≤1%.</p><p><strong>Conclusion: </strong>In this European healthcare database study, the extent and characteristics of vortioxetine use were in line with clinical trial experience and the current label. Analyses of events, including those of special interest, did not raise any new safety concerns.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-16"},"PeriodicalIF":2.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Functional improvement as a treatment goal in major depressive disorder: a narrative review of the evidence for vortioxetine.","authors":"Pratap Chokka, Lene Hammer-Helmich, Simon Nitschky Schmidt, Martine Hubert, Elin H Reines, Iria Grande","doi":"10.1080/03007995.2025.2503976","DOIUrl":"https://doi.org/10.1080/03007995.2025.2503976","url":null,"abstract":"<p><p>This narrative review used manufacturer-sponsored vortioxetine clinical trial database (doses of 5-20 mg) to evaluate the effect of vortioxetine treatment on short- and long- term functional outcomes in major depressive disorder (MDD), in both the clinical trial setting and in routine practice. The Sheehan Disability Scale (SDS) was the most used functional scale and, based on this measure, short-term, placebo-controlled studies demonstrated significant improvements with vortioxetine 10 mg (reductions ranged from -0.92 to -2.10 points vs placebo after 6-8 weeks treatment) and 20 mg (reductions ranged from -0.88 to -3.92 vs placebo). Of note, the acute beneficial effects of vortioxetine on functionality were seen in patients with severe baseline depressive symptoms as well as those with significant anxiety. Long-term open-label extension studies further showed that maintenance treatment was associated with continued functional improvements over one year (reaching an average reduction of -6.2 SDS points from baseline) that were correlated with continued improvements in residual symptoms. Evidence from real-world studies, using multiple functional outcomes, further demonstrated generalizability to routine practice where patients are living with multiple comorbidities previously excluded from the randomized controlled trials. Taken overall, the findings from several head-to-head studies indicated a functional advantage of vortioxetine compared with other classes of antidepressants and demonstrated the effectiveness of vortioxetine as first-line treatment while also confirming its effectiveness in improving functional outcomes when given later in the treatment journey. In summary, vortioxetine is an effective treatment option for improving functional outcomes in people living with MDD.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A response to: A letter to the editor in response to: Indirect comparison of the relative vaccine effectiveness of mRNA-1283 vs. BNT162b2 vaccines against symptomatic COVID-19 among US adults.","authors":"Ekkehard Beck, Mihaela Georgieva, Nicolas Van de Velde, Oscar Patterson-Lomba, Fan Mu","doi":"10.1080/03007995.2025.2504627","DOIUrl":"https://doi.org/10.1080/03007995.2025.2504627","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-5"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}