Uwe Siebert, MD, MPH, MSc, ScD
Chair of the Department of Public Health and Health Technology Assessment at UMIT, Austria
Prof. Uwe Siebert, MD, MPH, MSc, ScD, Professor of Public Health, Medical Decision Making and Health Technology Assessment (HTA), is the Chair of the Department of Public Health, Health Services Research and HTA at UMIT – University for Health Sciences, Medical Informatics and Technology in Austria and the Director of the Division for HTA in the ONCOTYROL – Center for Personalized Cancer Medicine in Austria. He is also Adjunct Professor of Health Policy and Management, and Epidemiology, at the Harvard T.H. Chan School of Public Health and Affiliated Researcher of the Program on Cardiovascular Research at the Institute for Technology Assessment and Department of Radiology at the Massachusetts General Hospital, Harvard Medical School, Boston. He is the course director of the Harvard summer course on ‘Decision Analysis in Clinical Research’ and he has an adjunct teaching appointment at the School of Public Health and Epidemiology at the University of Munich.
After medical school, he worked for several years as a physician in international public health projects in West-Africa, Brazil, and Germany. He then earned an MPH at the Munich School of Public Health, and completed an MSc in Epidemiology and a ScD in Health Policy and Management with a concentration in decision sciences at the Harvard School of Public Health. Before he started his faculty position at Harvard Medical School, he was the Director of the Bavarian Public Health Research and Coordinating Center at the University of Munich, Germany, and completed Visiting Scholarship at the Harvard Center for Risk Analysis.
Prof. Siebert is Past-President of the Society for Medical Decision Making (SMDM), a member of the Latin America Consortium Advisory Committee of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), member of the Oncology Advisory Council of the Federal Ministry of Health in Austria, member of the Advisory Board of the GÖG – National Austrian Public Health Institute, member of the Austrian Cochrane Collaboration Branch, and a member of several national and international Directors Boards (Austrian Society of Epidemiology, German Network of EbM; German Association for Medical Informatics, Biometry and Epidemiology). He has served as Vice President of SMDM, and member of the ISPOR Board of Directors, the Society for Medical Decision Making Board of Trustees; the Harvard Flagship Initiative in Comparative Effectiveness Research, the ‘National HTA Strategy’ Expert Group of the Austrian Federal Ministry of Health, the Advisory Board of the Ludwig Boltzmann Institute for HTA in Austria, the International Expert Committee Advising the Institute for Quality and Efficiency in Health Care (IQWiG) on the Methods for Economic Evaluations of Health Care Interventions, the Directors Board of the German Competence Network Heart Failure, and the Extended Board of Directors of the German Association of Health Economics.
He is the Clinical Guideline Commissioner for the Association of the Scientific Medical Societies in Germany (AWMF), Authorized Expert in the COVID-19 Prognosis Consortium and the Scientific Platform Screening- and Monitoring Programs for COVID-19 of AGES – Austrian Agency for Health and Food Safety and GÖG advising the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection, Member of the Task Force for COVID-19 Vaccination Implementation of the State Government Tyrol, Chair of the Horizontal Initiative in Causal Inference of the German Society for Epidemiology (DGEpi), Chair of the Working Group “Effectiveness and Side Effects of Non-Pharmaceutical Interventions” of the Competence Network for Public Health for COVID-19, and Chair of the Working Groups ‘Health Economics’ and ‘Medical Decision Making’ of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). He is Co-Chair of the ISPOR-SMDM Modeling Good Research Practices Task Force, Co-Chair of the ‘Issues in Methodology Section’ of the SMDM Policy Initiative, a Leadership Member of the ISPOR Personalized/Precision Medicine Special Interest Group, and member of the SMDM COVID-19 Modeling Special Committee.
He has worked with several HTA Agencies (e.g., DAHTA@DIMDI/Germany, IQWiG/Germany, NICE/UK, ANVISA/Brazil, IATS/Brazil, CADTH/Canada, LBI-HTA/Austria, GÖG/Austria) and he advises public and government agencies, academic institutions and industry regarding the conduction of HTAs and their impact on policy and reimbursement decisions. He has authored more than 400 publications (> 20,000 citations, H index > 50) including HTA reports, textbook chapters, scientific articles, policy briefs and editorials, and is Editor of the European Journal of Epidemiology, Associate Editor of Public Health Reviews as well as editorial board member of several scientific journals.
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Selected Publications
Haslwanter, Mag Veronika; Rochau, Ursula; Hallsson, Lára R; Siebert, Uwe; Schönherr, Hans-Robert; Lechleitner, Monika; Oberaigner, Willi
The assessment of quality of care of patients with type 2 diabetes mellitus in a population-based cohort in the District of Landeck in Austria Journal Article
In: Prim Care Diabetes, vol. 18, no. 2, pp. 163-168, 2024, ISSN: 1878-0210.
@article{pmid38336533,
title = {The assessment of quality of care of patients with type 2 diabetes mellitus in a population-based cohort in the District of Landeck in Austria},
author = {Mag Veronika Haslwanter and Ursula Rochau and L\'{a}ra R Hallsson and Uwe Siebert and Hans-Robert Sch\"{o}nherr and Monika Lechleitner and Willi Oberaigner},
doi = {10.1016/j.pcd.2024.01.011},
issn = {1878-0210},
year = {2024},
date = {2024-04-01},
urldate = {2024-02-01},
journal = {Prim Care Diabetes},
volume = {18},
number = {2},
pages = {163-168},
abstract = {INTRODUCTION: Structured diabetes care based on evidence-based guidelines is one of the main strategies to improve glycemic control and to reduce long-term complications in diabetes mellitus.nnMETHODS: This study is based on the "Diabetes-Landeck Cohort", a population-based cohort of patients with diabetes mellitus type 2 (T2DM). We assessed the quality of diabetes care and compared it between three groups of care units, that is, general practitioners (GP), diabetes specialists in private practice (DSPP), and hospitals (HOSP).nnRESULTS: The total study population comprised 1616 patients with T2DM, including 378 patients of GP, 281 of DSPP, and 957 from HOSP. We identified statistically significant differences: DSPP showed the highest percentage of structured training, sufficient training, eye examinations and foot examinations. The group HOSP showed the highest proportion for increased HbA1c≥ 7.5 and almost all long-term complications surveyed, that is, nephropathy (23.2%), neuropathy (14.4%), diabetic foot (5.1%), and cerebrovascular diseases (10.9%).nnCONCLUSION: This population-based cohort study on patients with T2DM in Austria showed significant differences in important quality-of-care process and outcome parameters across different groups of care units. Future research should also include prediction modeling for early warning and monitoring systems as well as adjustment for patient characteristics and duration and severity of disease.},
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INTRODUCTION: Structured diabetes care based on evidence-based guidelines is one of the main strategies to improve glycemic control and to reduce long-term complications in diabetes mellitus.nnMETHODS: This study is based on the "Diabetes-Landeck Cohort", a population-based cohort of patients with diabetes mellitus type 2 (T2DM). We assessed the quality of diabetes care and compared it between three groups of care units, that is, general practitioners (GP), diabetes specialists in private practice (DSPP), and hospitals (HOSP).nnRESULTS: The total study population comprised 1616 patients with T2DM, including 378 patients of GP, 281 of DSPP, and 957 from HOSP. We identified statistically significant differences: DSPP showed the highest percentage of structured training, sufficient training, eye examinations and foot examinations. The group HOSP showed the highest proportion for increased HbA1c≥ 7.5 and almost all long-term complications surveyed, that is, nephropathy (23.2%), neuropathy (14.4%), diabetic foot (5.1%), and cerebrovascular diseases (10.9%).nnCONCLUSION: This population-based cohort study on patients with T2DM in Austria showed significant differences in important quality-of-care process and outcome parameters across different groups of care units. Future research should also include prediction modeling for early warning and monitoring systems as well as adjustment for patient characteristics and duration and severity of disease.
Homayra, Fahmida; Enns, Benjamin; Min, Jeong Eun; Kurz, Megan; Bach, Paxton; Bruneau, Julie; Greenland, Sander; Gustafson, Paul; Karim, Mohammad Ehsanul; Korthuis, P Todd; Loughin, Thomas; MacLure, Malcolm; McCandless, Lawrence; Platt, Robert William; Schnepel, Kevin; Shigeoka, Hitoshi; Siebert, Uwe; Socias, Eugenia; Wood, Evan; Nosyk, Bohdan
Comparative Analysis of Instrumental Variables on the Assignment of Buprenorphine/Naloxone or Methadone for the Treatment of Opioid Use Disorder Journal Article
In: Epidemiology, vol. 35, no. 2, pp. 218–231, 2024, ISSN: 1531-5487.
@article{pmid38290142,
title = {Comparative Analysis of Instrumental Variables on the Assignment of Buprenorphine/Naloxone or Methadone for the Treatment of Opioid Use Disorder},
author = {Fahmida Homayra and Benjamin Enns and Jeong Eun Min and Megan Kurz and Paxton Bach and Julie Bruneau and Sander Greenland and Paul Gustafson and Mohammad Ehsanul Karim and P Todd Korthuis and Thomas Loughin and Malcolm MacLure and Lawrence McCandless and Robert William Platt and Kevin Schnepel and Hitoshi Shigeoka and Uwe Siebert and Eugenia Socias and Evan Wood and Bohdan Nosyk},
doi = {10.1097/EDE.0000000000001697},
issn = {1531-5487},
year = {2024},
date = {2024-03-01},
journal = {Epidemiology},
volume = {35},
number = {2},
pages = {218--231},
abstract = {BACKGROUND: Instrumental variable (IV) analysis provides an alternative set of identification assumptions in the presence of uncontrolled confounding when attempting to estimate causal effects. Our objective was to evaluate the suitability of measures of prescriber preference and calendar time as potential IVs to evaluate the comparative effectiveness of buprenorphine/naloxone versus methadone for treatment of opioid use disorder (OUD).nnMETHODS: Using linked population-level health administrative data, we constructed five IVs: prescribing preference at the individual, facility, and region levels (continuous and categorical variables), calendar time, and a binary prescriber's preference IV in analyzing the treatment assignment-treatment discontinuation association using both incident-user and prevalent-new-user designs. Using published guidelines, we assessed and compared each IV according to the four assumptions for IVs, employing both empirical assessment and content expertise. We evaluated the robustness of results using sensitivity analyses.nnRESULTS: The study sample included 35,904 incident users (43.3% on buprenorphine/naloxone) initiated on opioid agonist treatment by 1585 prescribers during the study period. While all candidate IVs were strong (A1) according to conventional criteria, by expert opinion, we found no evidence against assumptions of exclusion (A2), independence (A3), monotonicity (A4a), and homogeneity (A4b) for prescribing preference-based IV. Some criteria were violated for the calendar time-based IV. We determined that preference in provider-level prescribing, measured on a continuous scale, was the most suitable IV for comparative effectiveness of buprenorphine/naloxone and methadone for the treatment of OUD.nnCONCLUSIONS: Our results suggest that prescriber's preference measures are suitable IVs in comparative effectiveness studies of treatment for OUD.},
keywords = {},
pubstate = {published},
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BACKGROUND: Instrumental variable (IV) analysis provides an alternative set of identification assumptions in the presence of uncontrolled confounding when attempting to estimate causal effects. Our objective was to evaluate the suitability of measures of prescriber preference and calendar time as potential IVs to evaluate the comparative effectiveness of buprenorphine/naloxone versus methadone for treatment of opioid use disorder (OUD).nnMETHODS: Using linked population-level health administrative data, we constructed five IVs: prescribing preference at the individual, facility, and region levels (continuous and categorical variables), calendar time, and a binary prescriber's preference IV in analyzing the treatment assignment-treatment discontinuation association using both incident-user and prevalent-new-user designs. Using published guidelines, we assessed and compared each IV according to the four assumptions for IVs, employing both empirical assessment and content expertise. We evaluated the robustness of results using sensitivity analyses.nnRESULTS: The study sample included 35,904 incident users (43.3% on buprenorphine/naloxone) initiated on opioid agonist treatment by 1585 prescribers during the study period. While all candidate IVs were strong (A1) according to conventional criteria, by expert opinion, we found no evidence against assumptions of exclusion (A2), independence (A3), monotonicity (A4a), and homogeneity (A4b) for prescribing preference-based IV. Some criteria were violated for the calendar time-based IV. We determined that preference in provider-level prescribing, measured on a continuous scale, was the most suitable IV for comparative effectiveness of buprenorphine/naloxone and methadone for the treatment of OUD.nnCONCLUSIONS: Our results suggest that prescriber's preference measures are suitable IVs in comparative effectiveness studies of treatment for OUD.
Buchberger, Wolfgang; Schmied, Marten; Schomaker, Michael; Rio, Anca Del; Siebert, Uwe
Implementation of a comprehensive clinical risk management system in a university hospital Journal Article
In: Z Evid Fortbild Qual Gesundhwes, vol. 184, pp. 18–25, 2024, ISSN: 2212-0289.
@article{pmid38199940b,
title = {Implementation of a comprehensive clinical risk management system in a university hospital},
author = {Wolfgang Buchberger and Marten Schmied and Michael Schomaker and Anca Del Rio and Uwe Siebert},
doi = {10.1016/j.zefq.2023.11.008},
issn = {2212-0289},
year = {2024},
date = {2024-03-01},
journal = {Z Evid Fortbild Qual Gesundhwes},
volume = {184},
pages = {18--25},
abstract = {BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.nnMETHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.nnRESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .nnCONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.},
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BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.nnMETHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.nnRESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .nnCONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.
van den Beukel, Tim C; Wolters, Frank J; Siebert, Uwe; Spiering, Wilko; Ikram, M Arfan; Vernooij, Meike W; de Jong, Pim A; Bos, Daniel
Intracranial arteriosclerosis and the risk of dementia: A population-based cohort study Journal Article
In: Alzheimers Dement, vol. 20, iss. 2, pp. 869-879, 2024, ISSN: 1552-5279.
@article{pmid37814499,
title = {Intracranial arteriosclerosis and the risk of dementia: A population-based cohort study},
author = {Tim C van den Beukel and Frank J Wolters and Uwe Siebert and Wilko Spiering and M Arfan Ikram and Meike W Vernooij and Pim A de Jong and Daniel Bos},
doi = {10.1002/alz.13496},
issn = {1552-5279},
year = {2024},
date = {2024-02-20},
urldate = {2023-10-01},
journal = {Alzheimers Dement},
volume = {20},
issue = {2},
pages = {869-879},
abstract = {BACKGROUND: The impact of intracranial arteriosclerosis on dementia remains largely unclear.nnMETHODS: In 2339 stroke-free and dementia-free participants (52.2% women, mean age 69.5 years) from the general population, we assessed intracranial carotid artery calcification (ICAC) and vertebrobasilar artery calcification (VBAC) as proxy for arteriosclerosis. Associations with dementia were assessed using Cox models. In addition, indirect effects through cerebral small vessel disease (cSVD) and subcortical brain structure volumes were assessed using causal mediation analyses.nnRESULTS: During a median of 13.4 years (25th-75th percentiles 9.9-14.5) of follow-up, 282 participants developed dementia. Both ICAC presence (hazard ratio [HR]: 1.53, 95% confidence interval [CI]: 1.00-2.32]) and volume (HR per standard deviation: 1.19, 95% CI: 1.01-1.40) increased dementia risk. For VBAC, severe calcifications increased dementia risk (HR for third vs first volume tertile: 1.89, 95% CI: 1.00-3.59). These effects were mediated partly through increased cSVD (percentage mediated for ICAC: 13% and VBAC: 24%).nnDISCUSSION: Intracranial arteriosclerosis increases the risk of dementia.},
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pubstate = {published},
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BACKGROUND: The impact of intracranial arteriosclerosis on dementia remains largely unclear.nnMETHODS: In 2339 stroke-free and dementia-free participants (52.2% women, mean age 69.5 years) from the general population, we assessed intracranial carotid artery calcification (ICAC) and vertebrobasilar artery calcification (VBAC) as proxy for arteriosclerosis. Associations with dementia were assessed using Cox models. In addition, indirect effects through cerebral small vessel disease (cSVD) and subcortical brain structure volumes were assessed using causal mediation analyses.nnRESULTS: During a median of 13.4 years (25th-75th percentiles 9.9-14.5) of follow-up, 282 participants developed dementia. Both ICAC presence (hazard ratio [HR]: 1.53, 95% confidence interval [CI]: 1.00-2.32]) and volume (HR per standard deviation: 1.19, 95% CI: 1.01-1.40) increased dementia risk. For VBAC, severe calcifications increased dementia risk (HR for third vs first volume tertile: 1.89, 95% CI: 1.00-3.59). These effects were mediated partly through increased cSVD (percentage mediated for ICAC: 13% and VBAC: 24%).nnDISCUSSION: Intracranial arteriosclerosis increases the risk of dementia.
Gomes, Manuel; Turner, Alex J; Sammon, Cormac; Dawoud, Dalia; Ramagopalan, Sreeram; Simpson, Alex; Siebert, Uwe
Acceptability of using Real-World Data to Estimate Relative Treatment Effects in Health Technology Assessments: Barriers and Future Steps Journal Article
In: Value Health, 2024, ISSN: 1524-4733.
@article{pmid38369282,
title = {Acceptability of using Real-World Data to Estimate Relative Treatment Effects in Health Technology Assessments: Barriers and Future Steps},
author = {Manuel Gomes and Alex J Turner and Cormac Sammon and Dalia Dawoud and Sreeram Ramagopalan and Alex Simpson and Uwe Siebert},
doi = {10.1016/j.jval.2024.01.020},
issn = {1524-4733},
year = {2024},
date = {2024-02-16},
urldate = {2024-02-01},
journal = {Value Health},
abstract = {OBJECTIVES: Evidence about the comparative effects of new treatments is typically collected in randomized controlled trials (RCTs). In some instances, RCTs are not possible, or their value is limited by an inability to capture treatment effects over the longer-term or in all relevant population subgroups. In these cases, non-randomized studies (NRS) using real-world data (RWD) are increasingly used to complement trial evidence on treatment effects for health technology assessment (HTA). However, there have been concerns over a lack of acceptability of this evidence by HTA agencies. This paper aims to identify barriers to the acceptance of NRS and steps that may facilitate increases in the acceptability of NRS in the future.nnMETHODS: Opinions of the authorship team based on their experience in real-world evidence research in academic, HTA, and industry settings, supported by a critical assessment of existing studies.nnRESULTS: Barriers were identified that are applicable to key stakeholder groups including HTA agencies (e.g., the lack of comprehensive methodological guidelines for using RWD), evidence-generators (e.g., avoidable deviations from best practices), and external stakeholders (e.g., data controllers providing timely access to high-quality RWD). Future steps that may facilitate future acceptability of NRS include improvements in the quality, integration, and accessibility of RWD, wider use of demonstration projects to highlight the value and applicability of non-randomized designs, living and more detailed HTA guidelines, and improvements in HTA infrastructure relating to RWD.nnCONCLUSION: NRS can represent a crucial source of evidence on treatment effects for use in HTA when RCT evidence is limited.},
keywords = {},
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OBJECTIVES: Evidence about the comparative effects of new treatments is typically collected in randomized controlled trials (RCTs). In some instances, RCTs are not possible, or their value is limited by an inability to capture treatment effects over the longer-term or in all relevant population subgroups. In these cases, non-randomized studies (NRS) using real-world data (RWD) are increasingly used to complement trial evidence on treatment effects for health technology assessment (HTA). However, there have been concerns over a lack of acceptability of this evidence by HTA agencies. This paper aims to identify barriers to the acceptance of NRS and steps that may facilitate increases in the acceptability of NRS in the future.nnMETHODS: Opinions of the authorship team based on their experience in real-world evidence research in academic, HTA, and industry settings, supported by a critical assessment of existing studies.nnRESULTS: Barriers were identified that are applicable to key stakeholder groups including HTA agencies (e.g., the lack of comprehensive methodological guidelines for using RWD), evidence-generators (e.g., avoidable deviations from best practices), and external stakeholders (e.g., data controllers providing timely access to high-quality RWD). Future steps that may facilitate future acceptability of NRS include improvements in the quality, integration, and accessibility of RWD, wider use of demonstration projects to highlight the value and applicability of non-randomized designs, living and more detailed HTA guidelines, and improvements in HTA infrastructure relating to RWD.nnCONCLUSION: NRS can represent a crucial source of evidence on treatment effects for use in HTA when RCT evidence is limited.
Egelseer-Bruendl, T; Jahn, B; Arvandi, M; Puntscher, S; Santamaria, J; Brunelli, L; Weissenegger, K; Pfeifer, B; Neururer, S; Rissbacher, C; Huber, A; Fetz, B; Kleinheinz, C; Modre-Osprian, R; Kreiner, K; Siebert, U; Poelzl, G
In: Clin Res Cardiol, 2024, ISSN: 1861-0692.
@article{pmid38353683,
title = {Cost-effectiveness of a multidimensional post-discharge disease management program for heart failure patients-economic evaluation along a one-year observation period},
author = {T Egelseer-Bruendl and B Jahn and M Arvandi and S Puntscher and J Santamaria and L Brunelli and K Weissenegger and B Pfeifer and S Neururer and C Rissbacher and A Huber and B Fetz and C Kleinheinz and R Modre-Osprian and K Kreiner and U Siebert and G Poelzl},
doi = {10.1007/s00392-024-02395-5},
issn = {1861-0692},
year = {2024},
date = {2024-02-14},
urldate = {2024-02-14},
journal = {Clin Res Cardiol},
abstract = {OBJECTIVE: This study aimed to assess the cost-effectiveness of the telemedically assisted post-discharge management program (DMP) HerzMobil Tirol (HMT) for heart failure (HF) patients in clinical practice in Austria.nnMETHODS: We conducted a cost-effectiveness analysis along a retrospective cohort study (2016-2019) of HMT with a propensity score matched cohort of 251 individuals in the HMT and 257 in the usual care (UC) group and a 1-year follow-up. We calculated the effectiveness (hospital-free survival, hospital-free life-years gained, and number of avoided rehospitalizations), costs (HMT, rehospitalizations), and the incremental cost-effectiveness ratio (ICER). We performed a nonparametric sensitivity analysis with bootstrap sampling and sensitivity analyses on costs of HF rehospitalizations and on costs per disease-related diagnosis (DRG) score for rehospitalizations.nnRESULTS: Base-case analysis showed that HMT resulted in an average of 42 additional hospital-free days, 40 additional days alive, and 0.12 avoided hospitalizations per patient-year compared with UC during follow-up. The average HMT costs were EUR 1916 per person. Mean rehospitalization costs were EUR 5551 in HMT and EUR 6943 in UC. The ICER of HMT compared to UC was EUR 4773 per life-year gained outside the hospital. In a sensitivity analysis, HMT was cost-saving when "non-HF related costs" related to the DMP were replaced with average costs.nnCONCLUSIONS: The economic evaluation along the cohort study showed that the HerzMobil Tirol is very cost-effective compared to UC and cost-saving in a sensitivity analysis correcting for "non-HF related costs." These findings promote a widespread adoption of telemedicine-assisted DMP for HF.},
keywords = {},
pubstate = {published},
tppubtype = {article}
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OBJECTIVE: This study aimed to assess the cost-effectiveness of the telemedically assisted post-discharge management program (DMP) HerzMobil Tirol (HMT) for heart failure (HF) patients in clinical practice in Austria.nnMETHODS: We conducted a cost-effectiveness analysis along a retrospective cohort study (2016-2019) of HMT with a propensity score matched cohort of 251 individuals in the HMT and 257 in the usual care (UC) group and a 1-year follow-up. We calculated the effectiveness (hospital-free survival, hospital-free life-years gained, and number of avoided rehospitalizations), costs (HMT, rehospitalizations), and the incremental cost-effectiveness ratio (ICER). We performed a nonparametric sensitivity analysis with bootstrap sampling and sensitivity analyses on costs of HF rehospitalizations and on costs per disease-related diagnosis (DRG) score for rehospitalizations.nnRESULTS: Base-case analysis showed that HMT resulted in an average of 42 additional hospital-free days, 40 additional days alive, and 0.12 avoided hospitalizations per patient-year compared with UC during follow-up. The average HMT costs were EUR 1916 per person. Mean rehospitalization costs were EUR 5551 in HMT and EUR 6943 in UC. The ICER of HMT compared to UC was EUR 4773 per life-year gained outside the hospital. In a sensitivity analysis, HMT was cost-saving when "non-HF related costs" related to the DMP were replaced with average costs.nnCONCLUSIONS: The economic evaluation along the cohort study showed that the HerzMobil Tirol is very cost-effective compared to UC and cost-saving in a sensitivity analysis correcting for "non-HF related costs." These findings promote a widespread adoption of telemedicine-assisted DMP for HF.
Buchberger, Wolfgang; Schmied, Marten; Schomaker, Michael; Rio, Anca Del; Siebert, Uwe
Implementation of a comprehensive clinical risk management system in a university hospital Journal Article
In: Z Evid Fortbild Qual Gesundhwes, 2024, ISSN: 2212-0289.
@article{pmid38199940,
title = {Implementation of a comprehensive clinical risk management system in a university hospital},
author = {Wolfgang Buchberger and Marten Schmied and Michael Schomaker and Anca Del Rio and Uwe Siebert},
doi = {10.1016/j.zefq.2023.11.008},
issn = {2212-0289},
year = {2024},
date = {2024-01-01},
journal = {Z Evid Fortbild Qual Gesundhwes},
abstract = {BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.nnMETHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.nnRESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .nnCONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.},
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pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.nnMETHODS: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.nnRESULTS: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .nnCONCLUSION: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.
Coll-Planas, Laura; Carbó-Cardeña, Aina; Jansson, Anu; Dostálová, Vladimira; Bartova, Alzbeta; Rautiainen, Laura; Kolster, Annika; Masó-Aguado, Montse; Briones-Buixassa, Laia; Blancafort-Alias, Sergi; Roqué-Figuls, Marta; Sachs, Ashby Lavelle; Casajuana, Cristina; Siebert, Uwe; Rochau, Ursula; Puntscher, Sibylle; Holmerová, Iva; Pitkala, Kaisu H; Litt, Jill S
In: BMC Public Health, vol. 24, no. 1, pp. 172, 2024, ISSN: 1471-2458.
@article{pmid38218784,
title = {Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project},
author = {Laura Coll-Planas and Aina Carb\'{o}-Carde\~{n}a and Anu Jansson and Vladimira Dost\'{a}lov\'{a} and Alzbeta Bartova and Laura Rautiainen and Annika Kolster and Montse Mas\'{o}-Aguado and Laia Briones-Buixassa and Sergi Blancafort-Alias and Marta Roqu\'{e}-Figuls and Ashby Lavelle Sachs and Cristina Casajuana and Uwe Siebert and Ursula Rochau and Sibylle Puntscher and Iva Holmerov\'{a} and Kaisu H Pitkala and Jill S Litt},
doi = {10.1186/s12889-023-17547-x},
issn = {1471-2458},
year = {2024},
date = {2024-01-01},
journal = {BMC Public Health},
volume = {24},
number = {1},
pages = {172},
abstract = {BACKGROUND: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life.nnMETHODS: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called "Friends in Nature" or to the control group. "Friends in Nature" uses modifications of the "Circle of Friends" methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed.nnDISCUSSION: The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections.nnTRIAL REGISTRATION: Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life.nnMETHODS: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called "Friends in Nature" or to the control group. "Friends in Nature" uses modifications of the "Circle of Friends" methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed.nnDISCUSSION: The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections.nnTRIAL REGISTRATION: Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.
Fritz, Josef; Belovari, Katrin; Ulmer, Hanno; Zaruba, Marc-Michael; Messner, Moritz; Ungericht, Maria; Siebert, Uwe; Ruschitzka, Frank; Bauer, Axel; Poelzl, Gerhard
Aetiology, ejection fraction and mortality in chronic heart failure: a mediation analysis Journal Article
In: Heart, vol. 110, no. 4, pp. 290–298, 2024, ISSN: 1468-201X.
@article{pmid37722825b,
title = {Aetiology, ejection fraction and mortality in chronic heart failure: a mediation analysis},
author = {Josef Fritz and Katrin Belovari and Hanno Ulmer and Marc-Michael Zaruba and Moritz Messner and Maria Ungericht and Uwe Siebert and Frank Ruschitzka and Axel Bauer and Gerhard Poelzl},
doi = {10.1136/heartjnl-2023-322803},
issn = {1468-201X},
year = {2024},
date = {2024-01-01},
journal = {Heart},
volume = {110},
number = {4},
pages = {290--298},
abstract = {OBJECTIVE: Clinical decision making in chronic heart failure (CHF) is based primarily on left ventricular ejection fraction (LVEF), and only secondarily on aetiology of the underlying disease. Our aim was to investigate the mediating role of LVEF in the relationship between aetiology and mortality.nnMETHODS: Using data of 2056 Austrian patients with CHF (mean age 57.2 years; mean follow-up 8.8 years), effects of aetiology on LVEF and overall mortality were estimated using multivariable-adjusted linear and Cox regression models. In causal mediation analyses, we decomposed the total effect of aetiology on mortality into direct and indirect (mediated through LVEF) effects.nnRESULTS: For the analysed aetiologies (dilated (DCM, n=1009) and hypertrophic (HCM, n=89) cardiomyopathy; ischaemic (IHD, n=529) and hypertensive (HHD, n=320) heart disease; cardiac amyloidosis (CA, n=109)), the effect of LVEF on mortality was similar (HR=1.07, 95% CI 1.04 to 1.10; p=0.718). HCM and CA were associated with significantly higher, and IHD and DCM with significantly lower LVEF compared with other aetiologies. Compared with respective other aetiologies, the corresponding total effect HRs for mortality were 0.77 (95% CI 0.67 to 0.89), 0.47 (95% CI 0.25 to 0.88), 1.40 (95% CI 1.21 to 1.62), 0.79 (95% CI 0.67 to 0.95) and 2.36 (95% CI 1.81 to 3.08) for DCM, HCM, IHD, HHD and CA, respectively. CA had the highest mortality despite a HR of 0.74 (95% CI 0.65 to 0.83). For all other aetiologies, <20% of the total mortality effects were mediated through LVEF.nnCONCLUSIONS: The direct effect of aetiology on mortality dominates the indirect effect through LVEF. Therefore, clarification of aetiology is as important as measurement of LVEF.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVE: Clinical decision making in chronic heart failure (CHF) is based primarily on left ventricular ejection fraction (LVEF), and only secondarily on aetiology of the underlying disease. Our aim was to investigate the mediating role of LVEF in the relationship between aetiology and mortality.nnMETHODS: Using data of 2056 Austrian patients with CHF (mean age 57.2 years; mean follow-up 8.8 years), effects of aetiology on LVEF and overall mortality were estimated using multivariable-adjusted linear and Cox regression models. In causal mediation analyses, we decomposed the total effect of aetiology on mortality into direct and indirect (mediated through LVEF) effects.nnRESULTS: For the analysed aetiologies (dilated (DCM, n=1009) and hypertrophic (HCM, n=89) cardiomyopathy; ischaemic (IHD, n=529) and hypertensive (HHD, n=320) heart disease; cardiac amyloidosis (CA, n=109)), the effect of LVEF on mortality was similar (HR=1.07, 95% CI 1.04 to 1.10; p=0.718). HCM and CA were associated with significantly higher, and IHD and DCM with significantly lower LVEF compared with other aetiologies. Compared with respective other aetiologies, the corresponding total effect HRs for mortality were 0.77 (95% CI 0.67 to 0.89), 0.47 (95% CI 0.25 to 0.88), 1.40 (95% CI 1.21 to 1.62), 0.79 (95% CI 0.67 to 0.95) and 2.36 (95% CI 1.81 to 3.08) for DCM, HCM, IHD, HHD and CA, respectively. CA had the highest mortality despite a HR of 0.74 (95% CI 0.65 to 0.83). For all other aetiologies, <20% of the total mortality effects were mediated through LVEF.nnCONCLUSIONS: The direct effect of aetiology on mortality dominates the indirect effect through LVEF. Therefore, clarification of aetiology is as important as measurement of LVEF.
Juneau, Carl-Etienne; Briand, Anne-Sara; Collazzo, Pablo; Siebert, Uwe; Pueyo, Tomas
Effective contact tracing for COVID-19: A systematic review Journal Article
In: Glob Epidemiol, vol. 5, pp. 100103, 2023, ISSN: 2590-1133.
@article{pmid36959868,
title = {Effective contact tracing for COVID-19: A systematic review},
author = {Carl-Etienne Juneau and Anne-Sara Briand and Pablo Collazzo and Uwe Siebert and Tomas Pueyo},
doi = {10.1016/j.gloepi.2023.100103},
issn = {2590-1133},
year = {2023},
date = {2023-12-01},
journal = {Glob Epidemiol},
volume = {5},
pages = {100103},
abstract = {Contact tracing is commonly recommended to control outbreaks of COVID-19, but its effectiveness is unclear. Following PRISMA guidelines, we searched four databases using a range of terms related to contact tracing effectiveness for COVID-19. We found 343 papers; 32 were included. All were observational or modelling studies. Observational studies ( = 14) provided consistent, very-low certainty evidence that contact tracing (alone or in combination with other interventions) was associated with better control of COVID-19 (e.g. in Hong Kong, only 1084 cases and four deaths were recorded in the first 4.5 months of the pandemic). Modelling studies ( = 18) provided consistent, high-certainty evidence that under assumptions of prompt and thorough tracing with effective quarantines, contact tracing could stop the spread of COVID-19 (e.g. by reducing the reproduction number from 2.2 to 0.57). A cautious interpretation indicates that to stop the spread of COVID-19, public health practitioners have 2-3 days from the time a new case develops symptoms to isolate the case and quarantine at least 80% of its contacts.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Contact tracing is commonly recommended to control outbreaks of COVID-19, but its effectiveness is unclear. Following PRISMA guidelines, we searched four databases using a range of terms related to contact tracing effectiveness for COVID-19. We found 343 papers; 32 were included. All were observational or modelling studies. Observational studies ( = 14) provided consistent, very-low certainty evidence that contact tracing (alone or in combination with other interventions) was associated with better control of COVID-19 (e.g. in Hong Kong, only 1084 cases and four deaths were recorded in the first 4.5 months of the pandemic). Modelling studies ( = 18) provided consistent, high-certainty evidence that under assumptions of prompt and thorough tracing with effective quarantines, contact tracing could stop the spread of COVID-19 (e.g. by reducing the reproduction number from 2.2 to 0.57). A cautious interpretation indicates that to stop the spread of COVID-19, public health practitioners have 2-3 days from the time a new case develops symptoms to isolate the case and quarantine at least 80% of its contacts.