Pub Date : 2025-12-01Epub Date: 2025-12-03DOI: 10.1055/a-2698-4101
Manfred Wildner
{"title":"Blick über die Grenzen.","authors":"Manfred Wildner","doi":"10.1055/a-2698-4101","DOIUrl":"https://doi.org/10.1055/a-2698-4101","url":null,"abstract":"","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":"87 12","pages":"709-711"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145670212","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}
Pub Date : 2025-12-01Epub Date: 2025-05-07DOI: 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.
{"title":"Experiencing digital technologies: The importance of feeling safe in healthcare - A qualitative participatory design.","authors":"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","doi":"10.1055/a-2560-1100","DOIUrl":"10.1055/a-2560-1100","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S344-S356"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143989470","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}
Pub Date : 2025-12-01Epub Date: 2025-07-02DOI: 10.1055/a-2597-5739
Thomas Bierbaum, Martin Härter, Wolfgang Hoffmann, Jochen Schmitt
{"title":"Mentor, driving force and companion for healthcare research.","authors":"Thomas Bierbaum, Martin Härter, Wolfgang Hoffmann, Jochen Schmitt","doi":"10.1055/a-2597-5739","DOIUrl":"10.1055/a-2597-5739","url":null,"abstract":"","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S289-S290"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144555307","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}
Pub Date : 2025-12-01Epub Date: 2025-04-10DOI: 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}
Pub Date : 2025-12-01Epub Date: 2025-08-15DOI: 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.
{"title":"Diagnostic and Therapeutic Consequences of Thyroid Ultrasound: A Retrospective Explorative Cohort Study using Claims Data.","authors":"Lisette Warkentin, Thomas Kühlein, Johanna Tomandl, Valeria Biermann, David Klemperer, Katharina Sutter, Jan Steffen, Angela Schedlbauer, Susann Hueber","doi":"10.1055/a-2633-5848","DOIUrl":"10.1055/a-2633-5848","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S357-S364"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859737","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}
Pub Date : 2025-12-01Epub Date: 2025-03-05DOI: 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.
{"title":"Travel costs and ecologic imprint associated with different fractionation schedules in prostate cancer radiotherapy.","authors":"Georg W Wurschi, Maximilian Graf, Steffen Weimann, Matthias Mäurer, Christoph Straube, Daniel Medenwald, Justus Domschikowski, Marc Münter, Klaus Pietschmann","doi":"10.1055/a-2512-9269","DOIUrl":"10.1055/a-2512-9269","url":null,"abstract":"<p><p>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 (CO<sub>2</sub>)-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, CO<sub>2</sub>-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.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S291-S298"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568198","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}
Pub Date : 2025-12-01Epub Date: 2025-04-14DOI: 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.
{"title":"Assessing the time required for qualitative analysis: A comparative methodological study of coding interview data in health services research.","authors":"Charlotte Ullrich, Michel Wensing, Nadja Klafke, Thomas Fleischhauer, Sabrina Brinkmöller, Regina Poß-Doering, Christine Arnold","doi":"10.1055/a-2512-8004","DOIUrl":"10.1055/a-2512-8004","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S299-S308"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034899","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}
Pub Date : 2025-12-01Epub Date: 2025-02-15DOI: 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.
{"title":"[Generalisability of Phase III Clinical Trials Using the Example of Two German Multiple Sclerosis Registries].","authors":"Kris Oliver Jalusic, David Ellenberger, Alexander Stahmann, Klaus Berger","doi":"10.1055/a-2540-1749","DOIUrl":"10.1055/a-2540-1749","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"767-776"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12674891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-01-15DOI: 10.1055/a-2517-8263
Jule Uhl, Simone Schönfeld, Laura Meyer, Annika Reus, Claudia Neumann, Lena Langer, Maren M Michaelsen, Tobias Esch
Nursing care insurance companies in Germany have the legal mandate to develop measures to strengthen the health resources of residents of nursing homes. The present study aimed to examine a mindfulness-informed mind-body intervention (on-site and app) adapted for residents in nursing homes regarding their effect on health-related parameters.A pilot study (DRKS00030409) was carried out with three groups in twelve nursing homes (RCT). There was an on-site intervention in a group (O), an individual app application with technical support (A) and a passive control group (C). The participating residents (nO=28; nA=29; nC=19) were cluster-randomized. Before, after, and three months after the intervention period (December 2022 - January 2023), among other things, subjective well-being (WHO-5, primary outcome) and mindfulness (KIMS-D, including four subscales) were assessed. Differences within and between study groups and participants with different participation intensity were tested. In addition, a sensitivity analysis was carried out with people who did not have severe cognitive impairments at all three survey times.Indications of differences were found in subjective well-being during the intervention period between the study groups of medium size. While a decrease was observed in the control group, there was no change in the intervention groups. When the intensity of participation was taken into account, the difference between the groups became clearer. In addition, the app group showed an increase in mindfulness (subscale Observing) immediately after the intervention compared to the control group.Although further studies with larger samples are needed, the results already indicate that the intervention improves the well-being and mindfulness of the target group. Individual support could explain the higher effectiveness in the app group. The influence of the Covid-19 pandemic and the season (winter) on effectiveness must also be examined.
背景:德国的护理保险公司有法律授权制定措施来加强养老院居民的健康资源。本研究旨在检查正念通知身心干预(现场和应用程序)适用于养老院的居民关于他们对健康相关参数的影响。方法:采用随机对照试验(RCT),在12家养老院进行3组试验(DRKS00030409)。现场干预分为组(O)、有技术支持的个人app应用(a)和被动对照组(C)。参与居民(nO=28;nA = 29;nC=19)为集群随机。在干预期(2022年12月至2023年1月)之前、之后和三个月之后,除其他外,评估了主观幸福感(WHO-5,主要结果)和正念(kis - d,包括四个分量表)。测试了研究组内部和研究组之间以及不同参与强度的参与者之间的差异。此外,对在三次调查中没有严重认知障碍的人进行了敏感性分析。结果:在干预期间,中等规模研究组之间的主观幸福感存在差异。虽然在对照组中观察到下降,但在干预组中没有变化。当考虑到参与的强度时,两组之间的差异就变得更加明显了。此外,与对照组相比,应用程序组在干预后立即显示出正念(亚量表观察)的增加。讨论:虽然需要更大样本的进一步研究,结果已经表明干预改善了目标群体的幸福感和正念。个人支持可以解释应用程序组中较高的效率。还必须审查Covid-19大流行和季节(冬季)对有效性的影响。研究背景:德国的gesgeversicherungen haben den gesetzlichen Auftrag, Maßnahmenvorschläge zur Stärkung von Gesundheitsressourcen der Bewohnenden in stationären Pflegeeinrichtungen zu entwickeln。Ziel der vorliegenden studewar es, fdr . Zielgruppe eine partizipativ angepasste achtsamkeitsinformierte - body - ma ßnahme (Präsenz und App) hinsichtlich ihrer Wirkung auf gesundheitsbezogene Parameter zu untersuchen。方法:Es wurde eine pilot study (DRKS00030409)和drei Gruppen在zwölf Pflegeeinrichtungen durchgef hrt的随机对照试验。河北gab es eine Präsenz-Gruppe (O), eine grouppe mit App-Einzelanwendung和techncher unterst tzung (A)和eine passive control group (C). Die teilnehmenden Bewohnenden (nO=28;nA = 29;nC=19) wurden Cluster-randomisiert。《世界卫生组织-5》(WHO-5, primäres Outcome)和《世界卫生组织- 3》(kim - d, inkl),《世界卫生组织-5》和《世界卫生组织- 3》。维耶·苏斯卡伦·埃尔霍本。我们的学习团队和学生团队将在Teilnahmeintensität学习团队中学习。aue ßerdem wurde eine Sensitivitätsanalyse mit Personen durchgef hrt, die keine cognitiven Einschränkungen aufwiesen (T0-T2)。Ergebnisse: Es gab einen Hinweis auine unschieedliche Entwicklung des subject wohlbefinens während des Interventionszeitraums von mitlerer Größe。Während in der control grouppe eine Verschlechterung zu beobachten war, lag in den interventiongrouppen keredution vor。www.berber. cksichtigung der Teilnahmeintensität wurde der Unterschied deutlicher。Außerdem zeigte die App-Gruppe direct nach der Intervention eine Erhöhung der Achtsamkeit (Subskala Beobachten) in Vergleich zur control gruppe。讨论:Weitere Studien mit größeren Stichproben sind erforderlich。在德国,在德国,在德国,在德国,在德国,在德国,在德国,在德国,在德国,在德国,在德国,在德国。Die höhere Wirksamkeit in der App-Gruppe könnte durch Die einzelbetreung erklärt werden。Der Einfluss von Corona-Maßnahmen sowie Der Jahreszeit (Winter) auf die Wirksamkeit sind zu prefen。
{"title":"(Digital) Mind-Body Intervention to Promote Health and Subjective Well-Being of Residents in Nursing Homes: A Cluster-Randomized Controlled Pilot Study.","authors":"Jule Uhl, Simone Schönfeld, Laura Meyer, Annika Reus, Claudia Neumann, Lena Langer, Maren M Michaelsen, Tobias Esch","doi":"10.1055/a-2517-8263","DOIUrl":"10.1055/a-2517-8263","url":null,"abstract":"<p><p>Nursing care insurance companies in Germany have the legal mandate to develop measures to strengthen the health resources of residents of nursing homes. The present study aimed to examine a mindfulness-informed mind-body intervention (on-site and app) adapted for residents in nursing homes regarding their effect on health-related parameters.A pilot study (DRKS00030409) was carried out with three groups in twelve nursing homes (RCT). There was an on-site intervention in a group (O), an individual app application with technical support (A) and a passive control group (C). The participating residents (n<sub>O</sub>=28; n<sub>A</sub>=29; n<sub>C</sub>=19) were cluster-randomized. Before, after, and three months after the intervention period (December 2022 - January 2023), among other things, subjective well-being (WHO-5, primary outcome) and mindfulness (KIMS-D, including four subscales) were assessed. Differences within and between study groups and participants with different participation intensity were tested. In addition, a sensitivity analysis was carried out with people who did not have severe cognitive impairments at all three survey times.Indications of differences were found in subjective well-being during the intervention period between the study groups of medium size. While a decrease was observed in the control group, there was no change in the intervention groups. When the intensity of participation was taken into account, the difference between the groups became clearer. In addition, the app group showed an increase in mindfulness (subscale <i>Observing</i>) immediately after the intervention compared to the control group.Although further studies with larger samples are needed, the results already indicate that the intervention improves the well-being and mindfulness of the target group. Individual support could explain the higher effectiveness in the app group. The influence of the Covid-19 pandemic and the season (winter) on effectiveness must also be examined.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S324-S333"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014075","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}
Pub Date : 2025-12-01Epub Date: 2024-12-16DOI: 10.1055/a-2504-0195
Corina Schiegl, Irmgard Schroll-Decker
In 2021, a transitional form of housing for outpatient weaning was certified based on paragraph 17 of the Bavarian Law on Quality Assurance of Care and Housing. In order to get an overview over the research field, we carried out a scoping review. In particular, we focussed on two research questions: 1. What are the factors that contribute to the quality of life of people receiving artificial respiration in an outpatient setting? 2. Which factors necessitate weaning in an outpatient setting and what are the conditions that facilitate weaning?Seven data bases were searched with defined search terms. After two extractions, 401 matches were found. On the basis of an analysis of these abstracts, the results were systematically categorized. In order to answer the research questions, the topic "intensive and respiration care" was chosen for closer analysis; 120 texts were analysed more thoroughly.Results showed that we do not have sufficient data to answer the research questions in a satisfactory manner. The quality of life of ventilated people was found to be heterogenous, but self-determination and empathetic communication between the relevant institutions, on the one hand, and patients, on the other, clearly enhanced it. What was also beneficial was the inclusion of patients in social networks. What was obviously negative was the lack of competent personnel. It was also observed that the weaning potentials in outpatient care were not sufficiently made use of. Intersectoral care concepts are being discussed.The issues of intensive outpatient care as well as weaning and the question of how a self-determined and satisfactory life can be achieved have hardly been evaluated. Moreover, the terms quality of life and self-determination in this setting have hardly been operationalized. Further research is necessary. Nonetheless, self-determination appears to contribute to the life quality of seriously ill patients.
{"title":"[Weaning in the out-of-hospital setting: a Scoping Review].","authors":"Corina Schiegl, Irmgard Schroll-Decker","doi":"10.1055/a-2504-0195","DOIUrl":"10.1055/a-2504-0195","url":null,"abstract":"<p><p>In 2021, a transitional form of housing for outpatient weaning was certified based on paragraph 17 of the Bavarian Law on Quality Assurance of Care and Housing. In order to get an overview over the research field, we carried out a scoping review. In particular, we focussed on two research questions: 1. What are the factors that contribute to the quality of life of people receiving artificial respiration in an outpatient setting? 2. Which factors necessitate weaning in an outpatient setting and what are the conditions that facilitate weaning?Seven data bases were searched with defined search terms. After two extractions, 401 matches were found. On the basis of an analysis of these abstracts, the results were systematically categorized. In order to answer the research questions, the topic \"intensive and respiration care\" was chosen for closer analysis; 120 texts were analysed more thoroughly.Results showed that we do not have sufficient data to answer the research questions in a satisfactory manner. The quality of life of ventilated people was found to be heterogenous, but self-determination and empathetic communication between the relevant institutions, on the one hand, and patients, on the other, clearly enhanced it. What was also beneficial was the inclusion of patients in social networks. What was obviously negative was the lack of competent personnel. It was also observed that the weaning potentials in outpatient care were not sufficiently made use of. Intersectoral care concepts are being discussed.The issues of intensive outpatient care as well as weaning and the question of how a self-determined and satisfactory life can be achieved have hardly been evaluated. Moreover, the terms quality of life and self-determination in this setting have hardly been operationalized. Further research is necessary. Nonetheless, self-determination appears to contribute to the life quality of seriously ill patients.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"748-757"},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142840005","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}