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Long-term survival after treatment in certified lung cancer centers and not certified hospitals: Results of a large German cohort study using clinical routine data. 在认证的肺癌中心和非认证的医院治疗后的长期生存率:一项使用临床常规数据的大型德国队列研究的结果。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-07-08 DOI: 10.1055/a-2624-0160
Vinzenz Völkel, Michael Gerken, Kees Kleihues-van Tol, Olaf Schoffer, Veronika Bierbaum, Christoph Bobeth, Martin Roessler, Torsten Blum, Frank Griesinger, Christian Günster, Judith Hansinger, Jochen Schmitt, Monika Klinkhammer-Schalke

Lung cancer represents the second most frequent tumor entity worldwide with an increasing number of patients treated in specialized centers. The aim of the WiZen study was to find out whether treatment at hospitals certified by the German Cancer Society (GCS) was associated with long-term survival benefits.Data for this cohort study was derived from the largest German statutory health insurance (SHI) AOK, four regional population-based clinical cancer registries (CCR), and standardized hospital quality reports. The analyses were based on 173,999 incident lung cancer patients in the SHI dataset and 35,702 patients in the CCR dataset who received primary treatment for lung cancer (ICD-10-GM C33, C34, D38.1) between 2009 and 2017.Distributions of age, sex, comorbidities, and most tumor characteristics were similar among patients treated in certified and non-certified hospitals. The Kaplan-Meier estimator for 5-year overall survival was 28.0% for patients from certified and 16.9% from non-certified hospitals (SHI data; CCR data: 21.4% vs. 13.6%). Cox-regression adjusting for relevant confounders yielded hazard ratios of 0.97 (SHI data; 95%CI 0.94, 1.00) and 0.85 (CCR data; 95%CI 0.82, 0.88) for all-cause mortality. The adjusted hazard ratio for recurrence-free survival (CCR data, UICC stage I-III, R0 only) was 0.82 (95%CI 0.75, 0.90).The presented analyses show that treatment in certified lung cancer centers is associated with relevant survival benefits and should therefore be supported.

肺癌是世界上第二常见的肿瘤实体,越来越多的患者在专业中心接受治疗。威森研究的目的是找出在德国癌症协会(GCS)认证的医院接受治疗是否与长期生存益处有关。这项队列研究的数据来自德国最大的法定健康保险(SHI) AOK,四个区域基于人群的临床癌症登记处(CCR)和标准化医院质量报告。该分析基于2009年至2017年期间SHI数据集中的173999例肺癌患者和CCR数据集中接受肺癌初级治疗(ICD-10-GM C33, C34, D38.1)的35702例患者。年龄、性别、合并症和大多数肿瘤特征的分布在认证医院和非认证医院治疗的患者中相似。来自认证医院的患者5年总生存率的Kaplan-Meier估计值为28.0%,来自非认证医院的患者为16.9% (SHI数据;CCR数据:21.4% vs. 13.6%)。对相关混杂因素进行cox回归调整后,风险比为0.97 (SHI数据);95%CI 0.94, 1.00)和0.85 (CCR数据;95%可信区间为0.82,0.88)。无复发生存的校正风险比(CCR数据,UICC I-III期,仅R0)为0.82 (95%CI 0.75, 0.90)。所提出的分析表明,在经过认证的肺癌中心进行治疗与相关的生存益处相关,因此应该得到支持。
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引用次数: 0
[Mothers with migration background have significantly less knowledge of ante- and postnatal support services than mothers without migration background: cross-sectional survey in two maternity hospitals]. [具有移徙背景的母亲对产前和产后支助服务的了解明显低于没有移徙背景的母亲:两家妇产医院的横断面调查]。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-02-03 DOI: 10.1055/a-2486-6430
Benedikt Selbertinger, David Rothfuß, Maria Hatzipanagiotou, Angela Köninger, Christian Apfelbacher, Michael Kabesch, Susanne Brandstetter

The aim of this study was to describe and analyse knowledge of women in childbed with and without a migration background about ante- and postnatal support services.Questionnaires were provided in 26 languages. In a cross-sectional survey, 641 women answered questions about their knowledge of 11 different regional support services, and information sources for these and other support service providers. Median split was used to derive mothers with good and poor knowledge.German was not the mother tongue of 30% of the participants (n=194) and were therefore defined as "mothers with migration background". Of these, 83% (n=161) were aware of services offered by midwives and<40% knew of other support services. Women with migration background were significantly less likely to know the support services (OR 0.16, 95% CI 0.11 to 0.23), even after controlling for other sociodemographic variables. Furthermore, they obtained significantly less frequently information about relevant services from gynaecologists, midwives, relatives/acquaintances or by themselves.Especially for mothers with migration background, knowledge about ante- and postnatal support services must be made more accessible. In this, midwives could play a decisive role.

本研究的目的是描述和分析有和没有移民背景的育龄妇女关于产前和产后支持服务的知识。问卷以26种语文提供。在一项横断面调查中,641名妇女回答了关于她们对11种不同地区支持服务的了解程度以及这些服务和其他支持服务提供者的信息来源的问题。中位数分割用于推导知识水平好的母亲和知识水平差的母亲。30%的参与者(n=194)的母语不是德语,因此被定义为“有移民背景的母亲”。其中,83% (n=161)知道助产士提供的服务
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引用次数: 0
Blick über die Grenzen. 越过边界。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-12-03 DOI: 10.1055/a-2698-4101
Manfred Wildner
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引用次数: 0
Experiencing digital technologies: The importance of feeling safe in healthcare - A qualitative participatory design. 体验数字技术:在医疗保健中感到安全的重要性——定性参与性设计。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-05-07 DOI: 10.1055/a-2560-1100
Peter Minartz, Carmen Vondeberg, Laura Obert, Christian Bleck, Bernhard Hemming, Mara Vöcking, Claudia Ose, Matti Znotka, Diana Cürlis, Anne Karrenbrock, Frank Oehmichen, Peter Heistermann, Silke Kuske

Digital technologies are increasingly used in healthcare. In this context, perceived safety plays a critical role in their acceptance and implementation. Previous research had focused more on data security or specific digital technologies. There has also been a lack of participatory approaches to consider and empower healthcare recipients (and relatives), providers, and technology experts to broaden the phenomenon.The aim of this study was to present a comprehensive perspective on the needs, influencing factors and related outcomes in the context of feeling safe with digital technologies in healthcare.A qualitative, exploratory, and participatory methodology was used with five guide-based focus group workshops. Each workshop explored one of five digital technology demonstrations provided at the beginning: (1) electronic health records (EHR), (2) robotics, (3) artificial intelligence (AI), (4) smart home, and (5) smart hospital. All participants were invited for a guide-based discussion. The study focused on the levels of 'involvement' and 'collaboration' by also empowering participation. The workshop target groups were actively involved in the development and execution of the workshops and were empowered. The data were analysed via a content analysis approach, with a mostly inductive procedure.Feeling safe was found to affect thoughts, emotions, and actions. For example, a higher level of perceived safety increased the acceptance of digital technologies, whereas a lower level of perceived safety decreased it. The corresponding needs and influencing factors differed in terms of their scope and focus depending on the context. The aspect of 'control' was most frequently addressed by all the target groups and was viewed as relevant in all the workshops. In general, digital technologies were viewed as supplements rather than substitutes for healthcare providers.This study extends beyond the current state of research on perceived safety and the use of digital technologies in healthcare by providing a comprehensive overview of the corresponding needs and influencing factors at various levels, such as the individual, community-organizational, and system-society levels. The perceived safety of healthcare recipients and providers related to digital technologies should be taken into consideration to achieve positive implementation outcomes.

数字技术越来越多地应用于医疗保健领域。在这种情况下,感知到的安全性在接受和实施中起着至关重要的作用。以前的研究更多地集中在数据安全或特定的数字技术上。还缺乏参与性方法来考虑和授权医疗保健接受者(及其亲属)、提供者和技术专家来扩大这一现象。本研究的目的是对医疗保健中数字技术带来的安全感的需求、影响因素和相关结果提供一个全面的视角。在五个以指南为基础的焦点小组研讨会中,采用了定性、探索性和参与性方法。每个研讨会都探讨了开始时提供的五个数字技术演示中的一个:(1)电子健康记录(EHR),(2)机器人,(3)人工智能(AI),(4)智能家居,(5)智能医院。邀请所有与会者进行了基于指南的讨论。这项研究的重点是“参与”和“合作”的水平,同时也赋予了参与权力。讲习班目标群体积极参与了讲习班的发展和执行,并获得了授权。数据通过内容分析方法进行分析,主要采用归纳程序。研究发现,安全感会影响思想、情绪和行动。例如,较高的感知安全水平增加了数字技术的接受度,而较低的感知安全水平则降低了数字技术的接受度。相应的需求和影响因素在其范围和重点方面因环境而异。“控制”方面是所有目标群体最常讨论的问题,在所有讲习班中都被认为是相关的。一般来说,数字技术被视为医疗保健提供者的补充而不是替代品。本研究超越了目前对感知安全性和医疗保健中数字技术使用的研究现状,全面概述了各个层面(如个人、社区组织和系统社会层面)的相应需求和影响因素。应考虑到与数字技术相关的医疗保健接受者和提供者的感知安全,以实现积极的实施成果。
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引用次数: 0
Mentor, driving force and companion for healthcare research. 医疗保健研究的导师、推动力和伙伴。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-07-02 DOI: 10.1055/a-2597-5739
Thomas Bierbaum, Martin Härter, Wolfgang Hoffmann, Jochen Schmitt
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引用次数: 0
Transfer of a telemedicine intervention for mental disorders: a comparison between RCT results and regional routine care. 精神障碍远程医疗干预的转移:RCT结果与区域常规护理的比较。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-04-10 DOI: 10.1055/a-2508-8861
Aletta Boerkoel, Ulrike Stentzel, Hans Jörgen Grabe, Deborah Janowitz, Wolfgang Hoffmann, Neeltje van den Berg

Telemedicine for the treatment of depression and anxiety disorders was found to be successful in a randomised controlled trial (RCT); this intervention was then implemented in routine care in the Western Pomerania region in Germany. This made it possible to investigate the effectiveness of the intervention under routine care conditions and compare it with the results of the RCT.For this retrospective controlled analysis, data from routine care (2011-2022) were analysed together with data from the previous RCT (2009-2010). A three-arm comparison (routine care, previous RCT intervention group, previous RCT control group) on the primary outcome of symptom severity (BSI-18) and a longitudinal analysis of the routine care data were conducted. The telemedical intervention was conducted in the university hospital's psychiatric outpatient clinic in north-eastern Germany. All adult patients with an ICD-10 diagnosis of depression, anxiety or somatoform disorders could participate after discharge from the hospital. The telemedicine sessions included structured verbal questionnaires and conversational therapy concerning treatment goals and tasks. Repeated measures Welch ANOVA with the BSI-18 Global Severity Index and subscales (depression, anxiety and somatisation) was performed. A multivariate regression was conducted on the longitudinal regular care data.The n=254 subjects in the telemedical care in routine care arm (181 women, mean [95%CI] age 45.5 [44.0-47.1] years; 6-month follow-up) showed a BSI-18 score improvement M=- 4.1 [-5.3,-2.9], F(2)=3.50, p<0.05 compared to the preceding RCT intervention arms (61 women, mean [95%CI] age 44.7 [41.7-47.6] years. Telemedical care showed a significant difference in BSI-18 scores over a 10-year follow-up: M=- 3.9 [-5.4,-2.5], p<0.0001.The positive results of the 2009 RCT were replicable in routine care. The more patient-centred approach resulted in improved outcomes in this telemedical intervention.

在一项随机对照试验(RCT)中发现,远程医疗治疗抑郁症和焦虑症是成功的;这一干预措施随后在德国西波美拉尼亚地区的常规护理中实施。这使得在常规护理条件下调查干预的有效性成为可能,并将其与随机对照试验的结果进行比较。在这项回顾性对照分析中,常规护理(2011-2022年)的数据与之前的随机对照试验(2009-2010年)的数据一起进行了分析。对三组(常规护理组、既往RCT干预组、既往RCT对照组)患者症状严重程度主要结局指标(BSI-18)进行三组比较,并对常规护理资料进行纵向分析。远程医疗干预是在德国东北部大学医院的精神病门诊进行的。所有被ICD-10诊断为抑郁、焦虑或躯体形式障碍的成年患者在出院后都可以参加。远程医疗会议包括结构化的口头问卷调查和关于治疗目标和任务的会话治疗。使用BSI-18全球严重程度指数和子量表(抑郁、焦虑和躯体化)进行重复测量Welch方差分析。对纵向常规护理资料进行多元回归分析。常规护理组远程医疗护理254例(女性181例,平均[95%CI]年龄45.5[44.0 ~ 47.1]岁;随访6个月)BSI-18评分改善M=- 4.1 [-5.3,-2.9], F(2)=3.50, p
{"title":"Transfer of a telemedicine intervention for mental disorders: a comparison between RCT results and regional routine care.","authors":"Aletta Boerkoel, Ulrike Stentzel, Hans Jörgen Grabe, Deborah Janowitz, Wolfgang Hoffmann, Neeltje van den Berg","doi":"10.1055/a-2508-8861","DOIUrl":"10.1055/a-2508-8861","url":null,"abstract":"<p><p>Telemedicine for the treatment of depression and anxiety disorders was found to be successful in a randomised controlled trial (RCT); this intervention was then implemented in routine care in the Western Pomerania region in Germany. This made it possible to investigate the effectiveness of the intervention under routine care conditions and compare it with the results of the RCT.For this retrospective controlled analysis, data from routine care (2011-2022) were analysed together with data from the previous RCT (2009-2010). A three-arm comparison (routine care, previous RCT intervention group, previous RCT control group) on the primary outcome of symptom severity (BSI-18) and a longitudinal analysis of the routine care data were conducted. The telemedical intervention was conducted in the university hospital's psychiatric outpatient clinic in north-eastern Germany. All adult patients with an ICD-10 diagnosis of depression, anxiety or somatoform disorders could participate after discharge from the hospital. The telemedicine sessions included structured verbal questionnaires and conversational therapy concerning treatment goals and tasks. Repeated measures Welch ANOVA with the BSI-18 Global Severity Index and subscales (depression, anxiety and somatisation) was performed. A multivariate regression was conducted on the longitudinal regular care data.The n=254 subjects in the telemedical care in routine care arm (181 women, mean [95%CI] age 45.5 [44.0-47.1] years; 6-month follow-up) showed a BSI-18 score improvement M=- 4.1 [-5.3,-2.9], F(2)=3.50, p<0.05 compared to the preceding RCT intervention arms (61 women, mean [95%CI] age 44.7 [41.7-47.6] years. Telemedical care showed a significant difference in BSI-18 scores over a 10-year follow-up: M=- 3.9 [-5.4,-2.5], p<0.0001.The positive results of the 2009 RCT were replicable in routine care. The more patient-centred approach resulted in improved outcomes in this telemedical intervention.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S309-S316"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050929","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
Diagnostic and Therapeutic Consequences of Thyroid Ultrasound: A Retrospective Explorative Cohort Study using Claims Data. 甲状腺超声的诊断和治疗效果:使用索赔数据的回顾性探索性队列研究。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-08-15 DOI: 10.1055/a-2633-5848
Lisette Warkentin, Thomas Kühlein, Johanna Tomandl, Valeria Biermann, David Klemperer, Katharina Sutter, Jan Steffen, Angela Schedlbauer, Susann Hueber

Ultrasound (US) screening for thyroid cancer and other non-indicated US of the thyroid lead to the detection of mostly benign nodules or small papillary carcinomas. Although US screening for thyroid cancer is discouraged by guidelines, it continues to be performed. We aimed to explore the effects of thyroid US early in the diagnostic process on further diagnostic and therapeutic procedures in Germany.In a retrospective observational cohort study, we analysed claims data from 2012 to 2016 of patients without history of thyroid disease. After propensity score matching for sociodemographic characteristics, a selection of symptoms and diagnoses (e. g. fatigue, hypertension) and morbidity in the last year, patients with an initial TSH test and a thyroid US within 28 days after the test were compared to patients receiving an initial TSH test but no early US. Patients with hypo- or hyperthyroidism diagnosed directly after the initial TSH were excluded. Thyroid-specific morbidity, follow-up tests and therapeutic pathways were analysed.In total, 5,390 patients remained in each group after data selection and matching (mean age: 46.5 years (SD=15.0), 58% female). Early US was associated with higher thyroid-specific morbidity, especially regarding thyroid nodules. Additionally, more patients in the observation group received thyroid-related follow-up test. The utilization of ambulatory healthcare services in the first year was higher in this group, especially for internal medicine working in general practice, internal medicine, nuclear medicine, and radiology.Early use of US was associated with increased thyroid-specific morbidity, even after excluding patients with hypo- or hyperthyroidism after the initial TSH. Subsequently more diagnostic and therapeutic procedures were performed. Increased morbidity may be due to overtesting with diagnostic cascades resulting in overdiagnosis and overtreatment. Further research is needed to estimate the true number of overdiagnoses.

超声(US)筛查甲状腺癌和其他无指征的甲状腺超声可检出多数为良性结节或小乳头状癌。尽管美国的指导方针不鼓励进行甲状腺癌筛查,但仍在继续进行。我们的目的是探讨在德国早期诊断过程中甲状腺US对进一步诊断和治疗程序的影响。在一项回顾性观察队列研究中,我们分析了2012年至2016年无甲状腺疾病史患者的索赔数据。在社会人口学特征的倾向得分匹配之后,选择症状和诊断(例如:在过去的一年中,首次TSH测试并在测试后28天内进行甲状腺US的患者与接受首次TSH测试但未进行早期US的患者进行了比较。排除初始TSH后直接诊断为甲状腺功能低下或甲状腺功能亢进的患者。分析甲状腺特异性发病率、随访检查和治疗途径。经资料选择和匹配后,每组共保留5390例患者(平均年龄46.5岁(SD=15.0),其中58%为女性)。早期美国甲状腺特异性发病率较高,尤其是甲状腺结节。观察组接受甲状腺相关随访检查的患者较多。该组第一年使用门诊医疗服务的比例较高,特别是从事全科、内科、核医学和放射学工作的内科医生。早期使用US与甲状腺特异性发病率增加相关,即使排除初始TSH后甲状腺功能低下或甲状腺功能亢进的患者。随后进行了更多的诊断和治疗程序。发病率的增加可能是由于过度检测和诊断级联导致过度诊断和过度治疗。需要进一步的研究来估计过度诊断的真实数量。
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引用次数: 0
Travel costs and ecologic imprint associated with different fractionation schedules in prostate cancer radiotherapy. 前列腺癌放射治疗中不同分级方案的差旅费用和生态印记。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-03-05 DOI: 10.1055/a-2512-9269
Georg W Wurschi, Maximilian Graf, Steffen Weimann, Matthias Mäurer, Christoph Straube, Daniel Medenwald, Justus Domschikowski, Marc Münter, Klaus Pietschmann

Improving the sustainability and cost-effectiveness of healthcare systems has become increasingly relevant in times of climate change, energy transition, an aging population and skyrocketing social costs. The selection of an adequate fractionation schedule is of fundamental importance in the field of Radiation Oncology. We evaluated three internationally established fractionation schedules for definitive prostate cancer radiation therapy (RT) with respect to their ecological and health-economic impacts.We analyzed the data of 109 patients with prostate cancer, who underwent outpatient radiation therapy at Jena University Hospital in 2022. After determination of travel distances between their homes and the treatment facility, carbon dioxide (CO2)-emissions and taxi costs were calculated for normofractionated RT (39 fractions, A), moderately hypofractionated RT (20 fractions, B) and ultrahypofractionated RT (5 fractions, C).Travel distances of 1616 km (A), 848 km (B) and 242 km (C) were calculated with corresponding costs ranging from 638 € (C) to 4255 € (A). According to the 2024 German physician's fee schedule, 9,604 € would be invoiced for medical treatment and transportation in (A), with transportation costs accounting for 44% of total treatment costs in normofractionated RT. The travel distance, CO2-emissions and transportation costs could be reduced by up to 85% by hypofractionation.(Ultra-)hypofractionated radiation therapy for prostate cancer has great potential to lower healthcare costs and reduce environmental pollution. Given that and the non-inferiority of oncological outcome and toxicity, hypofractionation should appear beneficial from patient's and healthcare provider's point of view. Current reimbursement structures seem to be inappropriate regarding increased personnel and technical efforts required for highly precise dose application and might hinder comprehensive establishment of ultrahypofraktionated RT in Germany.

在气候变化、能源转型、人口老龄化和社会成本飙升的时代,提高医疗保健系统的可持续性和成本效益变得越来越重要。在放射肿瘤学领域中,选择合适的分诊方案是至关重要的。我们评估了三种国际上确定的前列腺癌放射治疗(RT)的分级方案,其生态和健康经济影响。我们分析了2022年在耶拿大学医院接受门诊放射治疗的109例前列腺癌患者的数据。后确定旅游家园和治疗设施之间的距离,二氧化碳(CO2)排放和出租车成本计算normofractionated RT(39分数),适度hypofractionated RT(20分数,B)和ultrahypofractionated RT(5分数,C) .Travel (A)的距离1616公里,848公里(B)和(C) 242公里计算,相应的成本从638€(C) 4255€(A)。根据2024年的德国医生的费用表,(A)的医疗和运输费用为9,604欧元,运输费用占正常分割放疗总治疗费用的44%。通过低分割,旅行距离、二氧化碳排放和运输成本可减少高达85%。(超)低分割前列腺癌放射治疗具有降低医疗成本和减少环境污染的巨大潜力。考虑到这一点以及肿瘤预后和毒性的非劣效性,从患者和医疗保健提供者的角度来看,低分割应该是有益的。目前的报销结构似乎不适合用于高度精确剂量应用所需的更多人员和技术努力,并可能阻碍在德国全面建立超低分割放射治疗。
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引用次数: 0
Assessing the time required for qualitative analysis: A comparative methodological study of coding interview data in health services research. 评估定性分析所需的时间:卫生服务研究中编码访谈数据的比较方法研究。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-04-14 DOI: 10.1055/a-2512-8004
Charlotte Ullrich, Michel Wensing, Nadja Klafke, Thomas Fleischhauer, Sabrina Brinkmöller, Regina Poß-Doering, Christine Arnold

A reliable estimation of required resources is essential for sound research. So far, there have only been a few studies on researchers' time investment in qualitative studies. The aim of this study, therefore, was to provide an empirical account of the estimation of timescales of qualitative analysis.In this methodological study, time expenditure was documented and compared for the focused coding of transcripts of semi-structured interviews within five qualitative studies in health services research. Data were analyzed descriptively by means of absolute frequencies.Across studies, focused coding was assessed in 94 interviews with a total interview duration of 52 hours and 44 minutes. The number of interviews per study ranged from n=11 to n=27, with a mean duration of 36 minutes. Total coding time amounted to 76 hours, with a mean of 32 min per interview. Coding time per interview time ratio ranged from 0.75 to 1.52 minutes. On average, the time spent on focused coding roughly corresponds to the duration of the interviews. Focused coding tended to get quicker over time, though variation among studies was high.The results of this study provide a reference for estimating timescales of qualitative analysis and highlights the importance of considering factors such as composition of data and researchers' experience and involvement. In a specific research project, this effort must be balanced against the objective of the analysis, including the desired accuracy, detail and depth. Further research is needed to specify how specific parameters (i. e. nature of the study population, method of data analysis and use of concepts and theories) affect coding in qualitative analysis.

对所需资源的可靠估计对于健全的研究至关重要。到目前为止,关于研究者在定性研究中投入时间的研究很少。因此,本研究的目的是提供定性分析的时间尺度估计的经验说明。在这项方法学研究中,记录并比较了卫生服务研究中五项定性研究中半结构化访谈文本集中编码的时间支出。用绝对频率对数据进行描述性分析。在所有研究中,重点编码在94个访谈中进行评估,总访谈时间为52小时44分钟。每项研究的访谈次数从n=11到n=27不等,平均持续时间为36分钟。总编码时间为76小时,平均每次采访32分钟。每次采访的编码时间比率从0.75到1.52分钟不等。平均而言,花在集中编码上的时间大致对应于面试的持续时间。随着时间的推移,集中编码的速度往往会越来越快,尽管研究之间的差异很大。本研究的结果为估计定性分析的时间尺度提供了参考,并强调了考虑数据组成和研究人员经验和参与等因素的重要性。在一个具体的研究项目中,这种努力必须与分析的目标相平衡,包括所需的准确性、细节和深度。需要进一步的研究来明确具体的参数(即。研究人群的性质、数据分析的方法以及概念和理论的使用)影响定性分析中的编码。
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引用次数: 0
[Generalisability of Phase III Clinical Trials Using the Example of Two German Multiple Sclerosis Registries]. 三期临床试验的推广,以两个全联邦范围的多发性硬化症登记为例。
IF 0.8 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-12-01 Epub Date: 2025-02-15 DOI: 10.1055/a-2540-1749
Kris Oliver Jalusic, David Ellenberger, Alexander Stahmann, Klaus Berger

Newly approved therapies usually have unknown adverse events, although the clinical trials that led to approval had already tested them for safety and efficacy. One reason for this is that the inclusion and exclusion criteria of the trials often do not fully reflect the usually heterogeneous patient population in routine clinical care.The aim of the study was to analyse the extent to which patients with multiple sclerosis (MS) in routine clinical care fulfil the inclusion and exclusion criteria for the corresponding clinical phase III trial of the respective drug.Sociodemographic and clinical characteristics as well as (serious) adverse events ((S) AEs) were compared. Data were based on two national, prospective, observational, clinical, multicentre registries, the REGIMS registry and the DMSG MS registry.Patients (28%) in the REGIMS registry and 5% of the patients in the MS registry fulfilled the 4 predefined inclusion criteria and would therefore have been included in a phase III registration trial of the corresponding substance.Our results show a clear selection of patients by specific inclusion criteria in clinical trials of MS therapeutics compared to the patient population receiving this therapy after approval. However, this selection is not associated with a higher risk of AEs for those patients who would not have been included in the corresponding phase III clinical trial.

新批准的疗法通常有未知的不良事件,尽管导致批准的临床试验已经测试了它们的安全性和有效性。其中一个原因是,试验的纳入和排除标准往往不能完全反映常规临床护理中通常异质性的患者群体。该研究的目的是分析多发性硬化症(MS)患者在常规临床护理中满足相应药物临床III期试验的纳入和排除标准的程度。比较社会人口学和临床特征以及(严重)不良事件(S) ae)。数据基于两个国家的、前瞻性的、观察性的、临床的、多中心的注册中心,即regs注册中心和DMSG MS注册中心。regs登记的患者(28%)和MS登记的患者(5%)符合4个预定义的纳入标准,因此将被纳入相应物质的III期注册试验。我们的研究结果显示,与批准后接受该治疗的患者群体相比,在MS治疗的临床试验中,通过特定的纳入标准明确选择了患者。然而,对于那些没有被纳入相应的III期临床试验的患者,这种选择与ae的高风险无关。
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引用次数: 0
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