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Dupilumab improves sense of smell and clinical outcomes in patients with severe chronic rhinosinusitis with nasal polyps with anosmia. Dupilumab改善重度慢性鼻窦炎伴鼻息肉伴嗅觉丧失患者的嗅觉和临床结果。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2024-12-14 DOI: 10.1080/03007995.2024.2434083
Andrew P Lane, Joaquim Mullol, Claire Hopkins, Wytske J Fokkens, Stella E Lee, Jerome Msihid, Scott Nash, Harry Sacks, Kinga Borsos, Siddhesh Kamat, Paul J Rowe, Yamo Deniz, Juby A Jacob-Nara

Objective: Loss of sense of smell is a cardinal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP) and significantly impacts health-related quality-of-life. Dupilumab significantly improved smell outcomes (loss of smell [LoS] score; University of Pennsylvania Smell Identification Test [UPSIT]) versus placebo in the phase 3 SINUS-24/-52 studies (clinicaltrials.gov, NCT02898454/NCT02912468) in patients with severe CRSwNP. This post hoc analysis investigated the effect of dupilumab on olfaction using UPSIT smell impairment categories.

Methods: Patients with baseline smell impairment (UPSIT ≤34/≤33 [women/men; score range 0-40] AND LoS score ≥1 [0-3] AND smell/taste item of the 22-item Sinonasal Outcome Test >0 [SNOT-22; 0-5]) treated with dupilumab 300 mg or placebo once every 2 weeks on background intranasal corticosteroids were analyzed.

Results: Of 724 patients, 665 (91.9%) had smell impairment at baseline; most had anosmia (UPSIT 0-18) (dupilumab/placebo: 80.9%/79.8%). At week 24, the proportion of dupilumab-treated patients with anosmia decreased to 28.5%, while 14.9% achieved normosmia; most placebo-group patients (79.2%) remained anosmic and only 1.2% achieved normosmia (odds ratio = 17.3; 95% confidence interval = 5.1-59.0; p <.0001); results were similar at week 52. Improvements in Nasal Polyp Score, nasal congestion, and SNOT-22 total score were moderately correlated with improvements in UPSIT at weeks 24 and 52 (r = -.38 to -.50).

Conclusion: Most patients with severe CRSwNP had anosmia at baseline. Dupilumab treatment significantly improved smell versus placebo, with 14.9% achieving normosmia by week 24. There was a trend for better clinical outcomes in patients with greater smell improvement.

目的:嗅觉丧失是慢性鼻窦炎伴鼻息肉(CRSwNP)的主要症状,并显著影响与健康相关的生活质量。Dupilumab显著改善嗅觉预后(嗅觉丧失[LoS]评分;在严重CRSwNP患者的3期研究(clinicaltrials.gov, NCT02898454/NCT02912468)中,宾夕法尼亚大学嗅觉识别测试(University of Pennsylvania Smell Identification Test [UPSIT])与安慰剂进行了比较。这项事后分析使用UPSIT嗅觉损伤分类调查了dupilumab对嗅觉的影响。方法:基线嗅觉障碍患者(UPSIT≤34/≤33;评分范围0-40]和LoS评分≥1[0-3]和嗅觉/味觉项目的22项鼻窦结局测试>0 [SNOT-22;0-5]),每2周接受1次鼻内糖皮质激素背景治疗,分别使用dupilumab 300 mg或安慰剂。结果:724例患者中,665例(91.9%)在基线时存在嗅觉障碍;大多数患者有嗅觉缺失(UPSIT 0-18)(杜匹单抗/安慰剂:80.9%/79.8%)。在第24周,dupilumab治疗的嗅觉缺失患者比例降至28.5%,而14.9%的患者达到正常嗅觉;大多数安慰剂组患者(79.2%)仍然嗅觉缺失,只有1.2%达到正常嗅觉(优势比:17.3[95%置信区间:5.1,59.0];结论:大多数重度CRSwNP患者在基线时存在嗅觉缺失。与安慰剂相比,Dupilumab治疗显著改善了嗅觉,14.9%的患者在第24周达到正常嗅觉。嗅觉改善更大的患者有更好的临床结果的趋势。
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引用次数: 0
Understanding the different stages of type 1 diabetes and their management: a plain language summary. 了解1型糖尿病的不同阶段及其管理:简单的语言总结。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2025-01-15 DOI: 10.1080/03007995.2024.2436984
Daniel J Moore, Natasha I Leibel, William Polonsky, Henry Rodriguez
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引用次数: 0
Insights into AI advances in immunohistochemistry for effective breast cancer treatment: a literature review of ER, PR, and HER2 scoring. 免疫组织化学在乳腺癌有效治疗中的AI进展:ER、PR和HER2评分的文献综述
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2025-01-06 DOI: 10.1080/03007995.2024.2445142
Genevieve Chyrmang, Kangkana Bora, Anup Kr Das, Gazi N Ahmed, Lopamudra Kakoti

Breast cancer is a significant health challenge, with accurate and timely diagnosis being critical to effective treatment. Immunohistochemistry (IHC) staining is a widely used technique for the evaluation of breast cancer markers, but manual scoring is time-consuming and can be subject to variability. With the rise of Artificial Intelligence (AI), there is an increasing interest in using machine learning and deep learning approaches to automate the scoring of ER, PR, and HER2 biomarkers in IHC-stained images for effective treatment. This narrative literature review focuses on AI-based techniques for the automated scoring of breast cancer markers in IHC-stained images, specifically Allred, Histochemical (H-Score) and HER2 scoring. We aim to identify the current state-of-the-art approaches, challenges, and potential future research prospects for this area of study. By conducting a comprehensive review of the existing literature, we aim to contribute to the ultimate goal of improving the accuracy and efficiency of breast cancer diagnosis and treatment.

乳腺癌是一项重大的健康挑战,准确及时的诊断是有效治疗的关键。免疫组化(IHC)染色是评估乳腺癌标志物的一种广泛使用的技术,但人工评分费时费力,而且可能存在变异。随着人工智能(AI)的兴起,人们越来越关注使用机器学习和深度学习方法对 IHC 染色图像中的 ER、PR 和 HER2 生物标记物进行自动评分,以实现有效治疗。在这篇叙事性文献综述中,我们将重点关注基于人工智能的 IHC 染色图像乳腺癌标记物自动评分技术,特别是 Allred、组织化学(H-Score)和 HER2 评分。我们旨在确定这一研究领域目前最先进的方法、面临的挑战以及未来潜在的研究前景。通过对现有文献进行全面回顾,我们希望为提高乳腺癌诊断和治疗的准确性和效率这一最终目标做出贡献。
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引用次数: 0
Citation patterns of Cochrane Reviews and other systematic reviews: a bibliometric analysis. Cochrane综述与其他系统综述的引文模式:文献计量学分析。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2025-01-02 DOI: 10.1080/03007995.2024.2442045
Louise Olsbro Rosengaard, Mikkel Zola Andersen, Jacob Rosenberg, Siv Fonnes

Background: The number of systematic reviews is increasing rapidly. Several methodologies exist for systematic reviews. Cochrane Reviews follow distinct methods to ensure they provide the most reliable and robust evidence, ideally based on rigorous evaluations of randomized controlled trials and other high-quality studies. We aimed to examine the difference in citation patterns of Cochrane Reviews and other systematic reviews.

Methods: We conducted a bibliometric analysis of systematic reviews indexed in PubMed from 1993 to 2022. We collected data on citations from The Lens from 1993 to 2023, thus having at least 1-year follow-up on citations. The reviews were linked through their PubMed identifier. Comparisons between the Cochrane Reviews and other systematic reviews included total citations per review, reviews with zero citations, and the time window within which they receive citations.

Results: We included 10,086 Cochrane Reviews and 231,074 other systematic reviews. Other systematic reviews received significantly more citations than Cochrane Reviews from 1993 to 2007. From 1993 to 1997, the median difference was 80 citations (95% CI = 79.6-80.4). From 2008 and forward, the overall number of citations was similar between Cochrane Reviews and other systematic reviews (2018-2022: median difference = 5 [95% CI = 4.9-5.1] in favor of Cochrane Reviews; p = 0.83). Systematic reviews with zero citations were rare in both groups, but it was observed more often among other systematic reviews than Cochrane Reviews. Over the last 30 years, the time window in which all reviews received citations narrowed.

Conclusion: In recent years, Cochrane Reviews and other systematic reviews had similar citation patterns, but other systematic reviews received more citations from 1993 to 2007. Other systematic reviews were more often never cited than Cochrane Reviews, and potentially wasted. The time window in which systematic reviews received citations has been progressively decreasing, possibly indicating a trend toward quicker recognition and uptake of these reviews within the academic community. Cochrane reviews aim to provide robust evidence, but this is not reflected in the citation metrics compared to other systematic reviews.

背景:系统综述的数量正在迅速增加。存在几种用于系统审查的方法。Cochrane综述遵循独特的方法,以确保它们提供最可靠和最有力的证据,理想情况下是基于随机对照试验和其他高质量研究的严格评估。我们的目的是研究Cochrane综述和其他系统综述在引文模式上的差异。方法:对1993 - 2022年PubMed收录的系统综述进行文献计量学分析。我们收集了1993年至2023年《Lens》的引用数据,因此对引用进行了至少一年的随访。这些评论通过它们的PubMed标识符链接在一起。Cochrane综述与其他系统综述的比较包括每篇综述的总引用次数、零引用的综述以及它们收到引用的时间窗口。结果:我们纳入10086篇Cochrane综述和231074篇其他系统综述。从1993年到2007年,其他系统综述的引用量明显高于Cochrane综述。从1993年到1997年,中位差异为80次引用[95% CI 79.6-80.4]。从2008年及以后,Cochrane综述与其他系统综述的总被引次数相似(2018-2022年:中位数差异为5 [95% CI 4.9-5.1], Cochrane综述更有利;p = 0.83)。在两组中,零引用的系统评价都很少见,但在其他系统评价中比在Cochrane评价中更常见。在过去的30年里,所有评论被引用的时间窗口缩小了。结论:近年来,Cochrane综述与其他系统综述的被引模式相似,但1993 - 2007年其他系统综述的被引次数较多。与Cochrane综述相比,其他系统综述从未被引用的情况更多,而且可能被浪费。系统综述获得引用的时间窗口已经逐渐减少,这可能表明学术界对这些综述的认识和吸收越来越快。Cochrane综述旨在提供有力的证据,但与其他系统综述相比,这并没有反映在引用指标上。
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引用次数: 0
Earlier diagnosis of peripheral neuropathy in primary care in Latin America using a simple screening tool (ACT). 拉丁美洲初级保健使用简单筛查工具(ACT)对周围神经病变的早期诊断。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2024-12-19 DOI: 10.1080/03007995.2024.2443109
Hoda Gad, Jose Luis Dinamarca, Pablo Fletcher, Chih Hao Chen Ku, Ruy Lira, John Longa, Carlos Mendivil, Leonardo Palacios, Hermelinda Pedrosa, Luis Miguel Román Pintos, Carlos Solis, Rayaz A Malik

Peripheral Neuropathy (PN) can significantly impair quality of life, but often remains undiagnosed due to limited clinic time, lack of specialist expertise and lack of patient awareness. There are several validated questionnaires for diagnosing PN, but the time taken to administer them in busy primary care clinics limits their utilization. A new, simpler questionnaire was developed following an advisory board meeting in Southeast Asia and was further refined and translated to Portuguese and Spanish following a second advisory board meeting in Latin America. We consider current hurdles and propose a quick and reliable questionnaire that can be widely adopted to enable earlier diagnosis and improved management of PN in resource-limited settings in Latin America.

周围神经病变(PN)可显著影响生活质量,但由于临床时间有限,缺乏专业知识和缺乏患者意识,通常无法诊断。有几种有效的问卷用于诊断PN,但在繁忙的初级保健诊所管理它们所花费的时间限制了它们的使用。在东南亚咨询委员会会议之后,编制了一份新的、更简单的调查表,并在拉丁美洲咨询委员会第二次会议之后进一步改进并翻译成葡萄牙语和西班牙语。我们考虑了目前的障碍,并提出了一份快速可靠的问卷,可以广泛采用,以便在拉丁美洲资源有限的环境中进行早期诊断和改善PN管理。
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引用次数: 0
Efficacy and safety of lebrikizumab combined with topical corticosteroids in Japanese patients with moderate-to-severe atopic dermatitis: a phase 3, double-blind, placebo-controlled, randomized clinical trial (ADhere-J). lebrikizumab联合外用皮质类固醇治疗日本中度至重度特应性皮炎患者的疗效和安全性:一项3期、双盲、安慰剂对照、随机临床试验(ADhere-J)。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2024-12-13 DOI: 10.1080/03007995.2024.2436982
Norito Katoh, Akio Tanaka, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Ken Igawa

Objective: To evaluate efficacy and safety of lebrikizumab combined with topical corticosteroids (TCS) in Japanese patients with moderate-to-severe atopic dermatitis (AD).

Methods: Phase 3, randomized, double-blind, placebo-controlled study (ADhere-J; NCT04760314) conducted at 37 centers in Japan (March 2021-February 2023), comprising 16-week induction (reported herein) and 52-week maintenance periods. Overall, 286 patients aged ≥12 years and ≥40 kg were randomized (interactive web response system) to subcutaneous placebo, lebrikizumab 250 mg every 4 weeks (Q4W), or lebrikizumab 250 mg every 2 weeks (Q2W) with TCS (82, 81, and 123 patients, respectively). Coprimary endpoints were proportions of patients achieving (1) Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with ≥2-point improvement from baseline, and (2) ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75) at week 16.

Results: At week 16, compared with placebo, a significantly greater proportion of the lebrikizumab Q4W and Q2W groups achieved IGA (0,1) (6.1% vs. 29.1% and 33.4%, respectively; both p < 0.001) and EASI 75 (13.4% vs. 47.2% and 51.2%, respectively; both p < 0.001). Serious adverse events (AEs) occurred in 2.4%, 0%, and 0.8% of placebo, lebrikizumab Q4W and Q2W groups, respectively. Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate.

Conclusion: Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks.

目的:评价lebrikizumab联合外用皮质类固醇(TCS)治疗日本中重度特应性皮炎(AD)患者的疗效和安全性。方法:3期,随机,双盲,安慰剂对照研究(粘附- j;NCT04760314)在日本37个中心进行(2021年3月- 2023年2月),包括16周的诱导期(本文报道)和52周的维持期。总体而言,286名年龄≥12岁、体重≥40公斤的患者随机(互动网络反应系统)接受皮下安慰剂、每4周250mg来布单抗(Q4W)或每2周250mg来布单抗(Q2W)联合TCS治疗(分别为82例、81例和123例)。主要终点是达到(1)研究者总体评估得分为0或1 (IGA[0,1]),较基线改善≥2点的患者比例,以及(2)第16周湿疹面积和严重程度指数(EASI 75)较基线改善≥75%的患者比例。结果:在第16周,与安慰剂相比,lebrikizumab Q4W和Q2W组达到IGA(0,1)的比例显著增加(分别为6.1%对29.1%和33.4%;结论:与全球数据一致,lebrikizumab在16周内对患有中重度AD的日本成人和青少年表现出临床改善,具有积极的获益-风险特征。
{"title":"Efficacy and safety of lebrikizumab combined with topical corticosteroids in Japanese patients with moderate-to-severe atopic dermatitis: a phase 3, double-blind, placebo-controlled, randomized clinical trial (ADhere-J).","authors":"Norito Katoh, Akio Tanaka, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Ken Igawa","doi":"10.1080/03007995.2024.2436982","DOIUrl":"10.1080/03007995.2024.2436982","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate efficacy and safety of lebrikizumab combined with topical corticosteroids (TCS) in Japanese patients with moderate-to-severe atopic dermatitis (AD).</p><p><strong>Methods: </strong>Phase 3, randomized, double-blind, placebo-controlled study (ADhere-J; NCT04760314) conducted at 37 centers in Japan (March 2021-February 2023), comprising 16-week induction (reported herein) and 52-week maintenance periods. Overall, 286 patients aged ≥12 years and ≥40 kg were randomized (interactive web response system) to subcutaneous placebo, lebrikizumab 250 mg every 4 weeks (Q4W), or lebrikizumab 250 mg every 2 weeks (Q2W) with TCS (82, 81, and 123 patients, respectively). Coprimary endpoints were proportions of patients achieving (1) Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with ≥2-point improvement from baseline, and (2) ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75) at week 16.</p><p><strong>Results: </strong>At week 16, compared with placebo, a significantly greater proportion of the lebrikizumab Q4W and Q2W groups achieved IGA (0,1) (6.1% vs. 29.1% and 33.4%, respectively; both <i>p</i> < 0.001) and EASI 75 (13.4% vs. 47.2% and 51.2%, respectively; both <i>p</i> < 0.001). Serious adverse events (AEs) occurred in 2.4%, 0%, and 0.8% of placebo, lebrikizumab Q4W and Q2W groups, respectively. Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate.</p><p><strong>Conclusion: </strong>Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767039","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}
引用次数: 0
Effects of brexpiprazole on patient life engagement in schizophrenia: post hoc analysis of Positive and Negative Syndrome Scale data. brexpiprazole对精神分裂症患者生活参与的影响:阳性和阴性综合征量表数据的事后分析。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2025-01-03 DOI: 10.1080/03007995.2024.2440059
Zahinoor Ismail, Stine Rasmussen Meehan, Anja Farovik, Shivani Kapadia, Anton M Palma, Zhen Zhang, Roger S McIntyre

Objective: Patients with schizophrenia value improved life engagement, a term that describes positive health aspects across emotional, physical, social, and cognitive domains. This post hoc analysis of clinical trial data aimed to investigate the effect of brexpiprazole on patient life engagement in schizophrenia over the short and long term.

Methods: Data were pooled from three 6-week, randomized, double-blind, placebo-controlled clinical trials (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380; N = 1385) and two 52-week, open-label extension studies (NCT01397786, NCT01810783; N = 408) of brexpiprazole in adults with schizophrenia. Patient life engagement was measured using a subset of 14 Positive and Negative Syndrome Scale items (score range: 14 [best] to 98 [worst]) that has previously demonstrated content validity. Mean score changes and response rates (based on minimal clinically important difference estimates of ≥5 and ≥10 points) were calculated.

Results: Greater improvement in patient life engagement from baseline to Week 6 was observed for brexpiprazole 2-4 mg/day (least squares mean [standard error] change: -8.3 [0.3]; n = 868) versus placebo (-5.7 [0.4]; n = 517), with a least squares mean difference of -2.58 (95% confidence interval: -3.57 to -1.58; p < 0.001; Cohen's d effect size: 0.28). These improvements were maintained over 58 weeks on brexpiprazole 1-4 mg/day (n = 399). At Week 6, response rates among patients treated with brexpiprazole versus placebo were 71.6% versus 58.0% (≥5-point improvement; p < 0.001) and 43.5% versus 32.8% (≥10-point improvement; p < 0.001). At Week 58 (n = 179), response rates among patients treated with brexpiprazole were 90.5% (≥5-point improvement) and 78.2% (≥10-point improvement).

Conclusion: Beyond its efficacy on psychotic symptoms, brexpiprazole has the potential to improve patient life engagement - an important patient-centered outcome in schizophrenia.

目的:精神分裂症患者重视改善生活参与度,这一术语描述了情感、身体、社会和认知领域的积极健康方面。本文对临床试验数据进行事后分析,目的是研究brexpiprazole对精神分裂症患者短期和长期生活参与的影响。方法:数据来自3项为期6周的随机、双盲、安慰剂对照临床试验(ClinicalTrials.gov识别码:NCT01396421、NCT01393613、NCT01810380;N = 1385)和两项52周的开放标签扩展研究(NCT01397786, NCT01810783;N = 408) brexpiprazole在成人精神分裂症患者中的应用。患者的生活参与度是用14个阳性和阴性症状量表项目(得分范围:14[最好]到98[最差])的一个子集来测量的,这些项目之前已经证明了内容效度。计算平均评分变化和缓解率(基于最小临床重要差异估计≥5分和≥10分)。结果:从基线到第6周,brexpiprazole (2-4 mg/day)对患者生活参与度有较大改善(最小二乘平均[标准误差]变化:-8.3 [0.3];N = 868)与安慰剂(-5.7 [0.4];N = 517),最小二乘平均差为-2.58(95%置信区间:-3.57 ~ -1.58;P效应量:0.28)。这些改善在brexpiprazole 1- 4mg /天(n = 399)的治疗下维持了58周。在第6周,brexpiprazole与安慰剂治疗患者的有效率分别为71.6%和58.0%(≥5点改善;P P n = 179), brexpiprazole治疗组有效率分别为90.5%(改善≥5点)和78.2%(改善≥10点)。结论:除了对精神病症状的疗效外,brexpiprazole还具有改善患者生活参与度的潜力,这是精神分裂症中一个以患者为中心的重要结果。
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引用次数: 0
The Tango to Modern Collaboration and Patient-Centric Value Generation in Health Care - a real-world guide from practitioners for practitioners. 医疗保健领域现代协作和以患者为中心创造价值的探戈舞曲》--一本由从业者为从业者提供的真实世界指南。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2024-12-06 DOI: 10.1080/03007995.2024.2433245
Lisa Hefti, Hanna Boëthius, Detlef Loppow, Nakisa Serry, Rocio Martin, Katrin Rupalla, Dietmar Krämer, Isabelle Juchler, Caitlin Masters, Verena Voelter

Background: Value-Based Health Care (VBHC) represents a pivotal shift from volume-based to outcome-driven quality metrics centered on patient-valued outcomes. This approach requires collaboration across all participants in the health care value chain; providers, payers, pharma, policymakers and patients (collectively known as the 5Ps). Despite substantial theoretical endorsement of VBHC's potential for improving health outcomes and system efficiency, empirical evidence detailing its practical implementation remains limited. This field study evaluates the real-word implementation of VBHC within a health care organization.

Methods: In 2022, a health care collaboration Think Tank initiated this investigation during a breakout session, gathering insights from 12 leading international organizations to construct an empirical VBHC transformation reference guide. Real-world data was collected through structured interviews over a 1-year period, covering the 5 P value chain in various healthcare settings. The VBHC initiatives were analyzed through four stages: initiation, data acquisition, collaborative frameworks, and results evaluation.

Results: The 12 interviews identified five key enablers for successful VBHC implementation: 1. Organizational Purpose: defining core motivators for change; 2. People: identifying pivotal roles and leadership to endorse change; 3. Resources: securing personnel and financial support; 4. Data Infrastructure: developing interoperable IT systems for effective data sharing and collection; 5. Execution: prioritizing sustained implementation processes.

Conclusion: The findings highlight that VBHC implementation and adoption is complex and requires incremental advancements, dedicated leadership, and resilient strategic framework spanning over multiple years. A comprehensive understanding of patient populations, risk stratification, and appropriate outcome metrics are essential to measure and deliver the VBHC transformation. Executive endorsement and transition funding during the transformation process are paramount to support this systemic shift. Collaboration among all 5 P stakeholders is essential for success. This field study underscores the importance of continuous learning and adaptation, providing a practical guide to enhance health care quality and efficiency that serves all stakeholders.

背景:以价值为基础的医疗保健(VBHC)代表着从以数量为基础的质量指标向以患者价值为中心的结果驱动型质量指标的关键转变。这种方法需要医疗保健价值链上的所有参与者(医疗服务提供者、支付者、制药商、政策制定者和患者)(统称为 5P)通力合作。尽管 VBHC 在提高医疗效果和系统效率方面的潜力得到了大量理论支持,但详细说明其实际实施情况的经验证据仍然有限。本实地研究评估了 VBHC 在医疗机构中的实际实施情况:2022 年,一个医疗保健合作智囊团在一次分组会议上发起了这项调查,收集了 12 家国际领先组织的见解,以构建一个经验性的 VBHC 转型参考指南。在为期一年的时间里,通过结构化访谈收集了真实世界的数据,涵盖了各种医疗机构的 5P 价值链。通过启动、数据获取、合作框架和结果评估四个阶段对 VBHC 计划进行了分析:结果:12 次访谈确定了成功实施 VBHC 的五个关键因素:1.组织目标:确定变革的核心动力;2.人员:确定支持变革的关键角色和领导力;3.资源:确保人员和资金支持;4.数据基础设施:开发可互操作的信息技术系统,以实现有效的数据共享和收集;5.执行:优先考虑持续的实施过程:研究结果突出表明,VBHC 的实施和采用非常复杂,需要逐步推进、专职领导和跨越多年的弹性战略框架。全面了解患者群体、风险分层和适当的结果指标对于衡量和实施自愿基础保健转型至关重要。转型过程中的行政认可和过渡资金对于支持这一系统性转变至关重要。所有 5P 利益相关者之间的合作对于成功至关重要。这项实地研究强调了持续学习和适应的重要性,为提高医疗质量和效率提供了实用指南,为所有利益相关者服务。
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引用次数: 0
Sting operations in biomedical publishing violate truthfulness and undermine trust in research. 生物医学出版中的诱骗行为违反了真实性,破坏了对研究的信任。
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2024-12-17 DOI: 10.1080/03007995.2024.2441340
Jaime A Teixeira da Silva, Jens C Türp, Timothy Daly

Biomedical research cannot function without the trust of peers and society. The truthfulness of claims made by knowledge-producing agents, such as authors of research, is a prerequisite for their trustworthiness, and violations of truthfulness are rightly seen as a threat to the existence and validity of such research. While most reflection on the lack of truthfulness has focused on fake research, little attention has been paid to how sting operations and hoaxes arguably pose an equally great risk to the ethical integrity of publishing. This paper posits that sting operations, like fake research, are examples of breaches of truthfulness. We also argue that for both fake research, as well as stings and hoaxes, the lack of respect for the ethical criterion of truthfulness makes those researchers who engage in them untrustworthy. Sting operations are akin to fighting fire with fire, further undermining trust in biomedical research. From a deontological perspective, we also argue that the reliance on anonymity in sting operations makes them just as bad, if not worse, than fake research. We advocate for critical scholarship as an alternative to hoaxes and sting operations to expose fake research, in order to promote truthfulness rather than violate it. Finally, we argue that journalists reporting on sting operations should insist less on their entertainment and sensationalist value, and focus more on their unethical nature.

没有同行和社会的信任,生物医学研究就无法发挥作用。知识生产主体(如研究作者)所作声明的真实性是其可信度的先决条件,违反真实性被理所当然地视为对此类研究的存在和有效性的威胁。虽然对缺乏真实性的大多数反思都集中在虚假研究上,但很少有人注意到,诱骗行动和骗局可能对出版业的道德诚信构成同样巨大的风险。这篇论文认为,像虚假研究这样的诱骗行动是违反真实性的例子。我们还认为,无论是假研究,还是圈套和骗局,缺乏对真实性道德标准的尊重,使得从事这些研究的研究人员不值得信任。诱捕行动类似于以毒攻毒,进一步破坏了人们对生物医学研究的信任。从义务论的角度来看,我们还认为,在卧底行动中对匿名的依赖,使它们与虚假研究一样糟糕,如果不是更糟的话。我们提倡批判性学术,作为揭露虚假研究的骗局和诱骗行动的另一种选择,以促进真实性,而不是违反它。最后,我们认为记者在报道卧底行动时应该少强调其娱乐和哗众取闹的价值,而更多地关注其不道德的本质。
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引用次数: 0
Dapagliflozin reduces the white coat effect on systolic blood pressure of patients with type 2 diabetes: a post-hoc analysis from the ADDENDA-BHS 2 trial. 达格列净降低2型糖尿病患者收缩压的白大衣效应:ADDENDA-BHS 2试验的事后分析
IF 2.4 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-01 Epub Date: 2024-12-20 DOI: 10.1080/03007995.2024.2442040
Pamela Nogueira Cavalcante, Joaquim Barreto, Sheila T Kimura-Medorima, Ikaro Breder, Wilson Nadruz, Andrei C Sposito

Background: White coat effect (WCE) is a phenomenon linked to increased cardiovascular risk, where office blood pressure readings exceed home or ambulatory measurements. Excess weight and elevated blood pressure or glucose are associated with WCE in type 2 diabetes (T2D). This study compared dapagliflozin and glibenclamide on WCE in T2D patients under equivalent blood pressure and glucose control.

Methods: This post-hoc analysis of the ADDENDA-BHS2 trial enrolled T2D patients with high cardiovascular risk, defined by stable coronary artery disease or subclinical carotid atherosclerosis. This single-center, open-label, randomized trial included 98 participants, randomized to 12 weeks of dapagliflozin or glibenclamide, in addition to metformin. Baseline blood pressure and glucose control were adjusted to maintain equivalence. This analysis focused on 85 participants with pre- and post-treatment 24-h ambulatory blood pressure data.

Results: Despite blood pressure and glucose control, WCE was present in 28% of participants at baseline. Baseline-adjusted change in WCE on systolic BP showed median changes of -8.6 and 1.7 mmHg for dapagliflozin and glibenclamide groups, respectively (p = 0.048). This effect was not observed on diastolic blood pressure.

Conclusion: Dapagliflozin reduces WCE on systolic blood pressure compared to glibenclamide, even under equivalent blood pressure and glucose control.

Clinical trial registration: The trial was registered at the Clinicaltrials.gov (NCT: 02919345).

背景:白大衣效应(WCE)是一种与心血管风险增加有关的现象,办公室血压读数超过家庭或门诊测量值。体重过重、血压或血糖升高与2型糖尿病(T2D)的WCE有关。本研究比较了达格列净和格列本脲在同等血压和血糖控制下对t2dm患者WCE的影响。方法:这项ADDENDA-BHS2试验的事后分析纳入了具有高心血管风险的T2D患者,其定义为稳定冠状动脉疾病或亚临床颈动脉粥样硬化。这项单中心、开放标签、随机试验包括98名参与者,随机分配到12周的达格列净或格列本脲,以及二甲双胍。调整基线血压和血糖控制以保持等值。这项分析集中在85名参与者的治疗前和治疗后24小时动态血压数据。结果:尽管血压和血糖得到了控制,但28%的参与者在基线时出现了WCE。经基线调整的WCE对收缩压的变化显示,达格列净组和格列本脲组的中位变化分别为-8.6和1.7 mmHg (p = 0.048)。对舒张压没有观察到这种影响。结论:与格列本脲相比,达格列净降低了收缩压的WCE,即使在相同的血压和血糖控制下也是如此。临床试验注册:该试验已在Clinicaltrials.gov注册(NCT: 02919345)。
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