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  1. AU="Szimonetta Lohner"
  2. AU="Malley, Kaitlin"
  3. AU="Altahawi, Faysal"
  4. AU="Baolian Yi"
  5. AU="Valdes-Hernández, Jorge"
  6. AU="Caughlin, T Trevor"
  7. AU="Serena Montalbano"
  8. AU="Morroni, Gianluca"
  9. AU="Choi, Kristal S."
  10. AU="Verma, Smita Rastogi" AU="Verma, Smita Rastogi"
  11. AU="Zhou, Bingfeng"
  12. AU="Kivala, Milan"
  13. AU="Salafia, O S"
  14. AU="Taghavi, Fouad J"
  15. AU="Xiao, Jun-Hua"
  16. AU="Vee Sin Lee, Peter"
  17. AU="Zhu, Yali"
  18. AU="Jiang-Qi Liu"
  19. AU="Moores, Roxanna"

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  1. Artikel ; Online: Publication of clinical trials on medicinal products

    Kinga Amália Sándor-Bajusz / Andrea Kraut / Odgerel Baasan / Gergely Márovics / Károly Berényi / Szimonetta Lohner

    Trials, Vol 23, Iss 1, Pp 1-

    follow-up on trials authorized in Hungary

    2022  Band 9

    Abstract: Abstract Background Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The ... ...

    Abstract Abstract Background Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The present research investigates publication rates, time until publication, and characteristics of clinical trials on medicinal products associated with timely publication of results, measures of scientific impact, authorship, and open access publication. Methods Clinical trials authorized in Hungary in 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, PubMed (MEDLINE), and Google. Results Overall, 330 clinical trials were authorized in 2012 of which 232 trials were completed for more than 1 year in June 2020. The proportion of industry initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (26 vs 69 months [median]; hazard ratio = 0.38, 95% CI 0.22–0.66, p< 0.001), and were registered in both EU CTR and clinicaltrials.gov (27 vs 88 months; hazard ratio = 0.24, 95% CI 0.11–0.54; p< 0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. The majority of available publications were published “open access” (70.93%). A minority of identified publications had a Hungarian author (21.5%). Conclusions We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trial results. Publications with domestic co-authors contribute to the research output of a country. Measurable domestic scientific impact of trials on medicinal products needs further improvement.
    Schlagwörter Trial registration ; Publication rates ; Time to publication ; Authorship ; Research impact ; Evidence-based medicine ; Medicine (General) ; R5-920
    Sprache Englisch
    Erscheinungsdatum 2022-04-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  2. Artikel ; Online: Correction to

    Faten Amer / Sahar Hammoud / Haitham Khatatbeh / Szimonetta Lohner / Imre Boncz / Dóra Endrei

    BMC Health Services Research, Vol 22, Iss 1, Pp 1-

    The deployment of balanced scorecard in health care organizations: is it beneficial? A systematic review

    2022  Band 2

    Schlagwörter Public aspects of medicine ; RA1-1270
    Sprache Englisch
    Erscheinungsdatum 2022-02-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  3. Artikel ; Online: The deployment of balanced scorecard in health care organizations

    Faten Amer / Sahar Hammoud / Haitham Khatatbeh / Szimonetta Lohner / Imre Boncz / Dóra Endrei

    BMC Health Services Research, Vol 22, Iss 1, Pp 1-

    is it beneficial? A systematic review

    2022  Band 14

    Abstract: Abstract Background Balanced Scorecard (BSC) has been implemented for three decades to evaluate and improve the performance of organizations. To the best of the researchers’ knowledge, no previous systematic review has performed a comprehensive and ... ...

    Abstract Abstract Background Balanced Scorecard (BSC) has been implemented for three decades to evaluate and improve the performance of organizations. To the best of the researchers’ knowledge, no previous systematic review has performed a comprehensive and rigorous methodological approach to figure out the impact of BSC implementation in Health Care Organizations (HCO). Aims The current work was intended to assess the impact of implementing the BSC on Health Care Workers’ (HCW) satisfaction, patient satisfaction, and financial performance. Methods The authors prepared the present systematic review according to PRISMA guidelines. Further, the authors customized the search strategy for PubMed, Embase, Cochrane, Google Scholar databases, and Google’s search engine. The obtained studies were screened to isolate those measuring scores related to HCW satisfaction, patient satisfaction, and financial performance. The Risk of Bias (RoB) in the non-Randomized Intervention Studies (ROBINS-I) tool was used to assess the quality of observational and quasi-experimental studies. On the other hand, for the Randomized Controlled Trials (RCTs), the Cochrane (RoB 2) tool was used. Results Out of 4031 studies, the researchers included 20 studies that measured the impact of BSC on one or more of the three entities (HCW satisfaction, patient satisfaction, and financial performance). Throughout these 20 studies, it was found that 17 studies measured the impact of the BSC on patient satisfaction, seven studies measured the impact on HCW satisfaction, and 12 studies measured the impact on financial performance. Conclusion This systematic review provides managers and policymakers with evidence to support utilizing BSC in the health care sector. BSC implementation demonstrated positive outcomes for patient satisfaction and the financial performance of HCOs. However, only a mild impact was demonstrated for effects related to HCW satisfaction. However, it is worth noting that many of the studies reflected a high RoB, which may have affected the ...
    Schlagwörter Performance ; Evaluation ; Assessment ; Health ; Hospital ; Impact ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 306
    Sprache Englisch
    Erscheinungsdatum 2022-01-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  4. Artikel ; Online: A systematic review

    Faten Amer / Sahar Hammoud / Haitham Khatatbeh / Szimonetta Lohner / Imre Boncz / Dóra Endrei

    BMC Health Services Research, Vol 22, Iss 1, Pp 1-

    the dimensions to evaluate health care performance and an implication during the pandemic

    2022  Band 22

    Abstract: Abstract Background The balanced scorecard (BSC) has been implemented to evaluate the performance of health care organizations (HCOs). BSC proved to be effective in improving financial performance and patient satisfaction. Aim This systematic review aims ...

    Abstract Abstract Background The balanced scorecard (BSC) has been implemented to evaluate the performance of health care organizations (HCOs). BSC proved to be effective in improving financial performance and patient satisfaction. Aim This systematic review aims to identify all the perspectives, dimensions, and KPIs that are vital and most frequently used by health care managers in BSC implementations. Methods This systematic review adheres to PRISMA guidelines. The PubMed, Embase, Cochrane, and Google Scholar databases and Google search engine were inspected to find all implementations of BSC at HCO. The risk of bias was assessed using the nonrandomized intervention studies (ROBINS-I) tool to evaluate the quality of observational and quasi-experimental studies and the Cochrane (RoB 2) tool for randomized controlled trials (RCTs). Results There were 33 eligible studies, of which we identified 36 BSC implementations. The categorization and regrouping of the 797 KPIs resulted in 45 subdimensions. The reassembly of these subdimensions resulted in 13 major dimensions: financial, efficiency and effectiveness, availability and quality of supplies and services, managerial tasks, health care workers' (HCWs) scientific development error-free and safety, time, HCW-centeredness, patient-centeredness, technology, and information systems, community care and reputation, HCO building, and communication. On the other hand, this review detected that BSC design modification to include external and managerial perspectives was necessary for many BSC implementations. Conclusion This review solves the KPI categorization dilemma. It also guides researchers and health care managers in choosing dimensions for future BSC implementations and performance evaluations in general. Consequently, dimension uniformity will improve the data sharing and comparability among studies. Additionally, despite the pandemic negatively influencing many dimensions, the researchers observed a lack of comprehensive HCO performance evaluations. In the same vein, ...
    Schlagwörter Balanced scorecard ; Performance ; Indicators ; Health ; Hospital ; Evaluation ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 690
    Sprache Englisch
    Erscheinungsdatum 2022-05-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  5. Artikel ; Online: Self-reported attitudes, knowledge and skills of using evidence-based medicine in daily health care practice

    Mónika Csertő / Károly Berényi / Tamás Decsi / Szimonetta Lohner

    PLoS ONE, Vol 14, Iss 12, p e

    A national survey among students of medicine and health sciences in Hungary.

    2019  Band 0225641

    Abstract: In order to map attitudes, knowledge and skills related to evidence-based medicine (EBM) in students of medical and health sciences faculties, we performed an online survey during the spring semester 2019 in all medical and health sciences faculties in ... ...

    Abstract In order to map attitudes, knowledge and skills related to evidence-based medicine (EBM) in students of medical and health sciences faculties, we performed an online survey during the spring semester 2019 in all medical and health sciences faculties in Hungary. In total, 1080 students of medicine and 911 students of health sciences completed the online questionnaire. The attitude towards EBM was generally positive; however, only a small minority of students rated their EBM-related skills as advanced. There were large differences in the understanding of different EBM-related terms, with 'sample size' as the term with the highest (65%) and 'intention-to-treat analysis' with the lowest (7%) proportion of medical students being able to properly explain the meaning of the expression. Medical students who already participated in some EBM training rated their skills in searching and evaluating medical literature and their knowledge of EBM-related terms significantly better and had a more positive attitude towards using EBM in the practice than students without previous EBM training. EBM trained medical students were more likely to choose online journals (17.5% compared to 23.9%, p<0.05) and professional guidelines (15.4% compared to 6.1%, p<0.001) instead of printed books (33.6% compared to 52.6, p<0.001) as the main source of healthcare information retrieval and used Pubmed/Medline, Medscape and the Cochrane Library to a significant higher rate than students without any previous EBM training. Healthcare work experience (OR = 1.59; 95% CI = 1.01-2.52), conducting student research (OR = 2.02; 95% CI = 1.45-2.82) and upper year university students (OR = 1.65; 95% CI = 1.37-1.98) were other factors significantly influencing EBM-related knowledge. We conclude that the majority of students of medical and health sciences faculties are keen to acquire EBM-related knowledge and skills during their university studies. Significantly higher EBM-related knowledge and skills among EBM trained students underline the ...
    Schlagwörter Medicine ; R ; Science ; Q
    Thema/Rubrik (Code) 302
    Sprache Englisch
    Erscheinungsdatum 2019-01-01T00:00:00Z
    Verlag Public Library of Science (PLoS)
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  6. Artikel ; Online: Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

    Anette Blümle / Katharina Wollmann / Karin Bischoff / Philipp Kapp / Szimonetta Lohner / Edris Nury / Kai Nitschke / Jasmin Zähringer / Gerta Rücker / Martin Schumacher

    BMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-

    2021  Band 20

    Abstract: Abstract Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically ... ...

    Abstract Abstract Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial’s impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs. Conclusion An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.
    Schlagwörter Randomized controlled trials as topic ; Registries ; Access to information ; Evidence-based medicine ; Publishing ; Systematic reviews as topic ; Medicine (General) ; R5-920
    Thema/Rubrik (Code) 610
    Sprache Englisch
    Erscheinungsdatum 2021-08-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  7. Artikel ; Online: Nonregistration, discontinuation, and nonpublication of randomized trials

    Benjamin Speich / Dmitry Gryaznov / Jason W Busse / Viktoria L Gloy / Szimonetta Lohner / Katharina Klatte / Ala Taji Heravi / Nilabh Ghosh / Hopin Lee / Anita Mansouri / Ioana R Marian / Ramon Saccilotto / Edris Nury / Benjamin Kasenda / Elena Ojeda-Ruiz / Stefan Schandelmaier / Yuki Tomonaga / Alain Amstutz / Christiane Pauli-Magnus /
    Karin Bischoff / Katharina Wollmann / Laura Rehner / Joerg J Meerpohl / Alain Nordmann / Jacqueline Wong / Ngai Chow / Patrick Jiho Hong / Kimberly Mc Cord-De Iaco / Sirintip Sricharoenchai / Arnav Agarwal / Matthias Schwenkglenks / Lars G Hemkens / Erik von Elm / Bethan Copsey / Alexandra N Griessbach / Christof Schönenberger / Dominik Mertz / Anette Blümle / Belinda von Niederhäusern / Sally Hopewell / Ayodele Odutayo / Matthias Briel

    PLoS Medicine, Vol 19, Iss 4, p e

    A repeated metaresearch analysis.

    2022  Band 1003980

    Abstract: Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether ...

    Abstract Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials ...
    Schlagwörter Medicine ; R
    Thema/Rubrik (Code) 610 ; 310
    Sprache Englisch
    Erscheinungsdatum 2022-04-01T00:00:00Z
    Verlag Public Library of Science (PLoS)
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  8. Artikel ; Online: Reporting quality of clinical trial protocols

    Matthias Briel / Sally Hopewell / Arnav Agarwal / Joerg J Meerpohl / Jason W Busse / Patrick Hong / Matthias Schwenkglenks / Szimonetta Lohner / Benjamin Speich / Viktoria Gloy / Erik von Elm / Sirintip Sricharoenchai / Benjamin Kasenda / Stefan Schandelmaier / Dominik Mertz / Anette Blümle / Jacqueline Wong / Alain Amstutz / Belinda Von Niederhäusern /
    Alain Nordmann / Giusi Moffa / Dmitry Gryaznov / Elena Ojeda-Ruiz / Ayodele Odutayo / Yuki Tomonaga / Christiane Pauli-Magnus / Karin Bischoff / Katharina Wollmann / Laura Rehner / Katharina Klatte / Nilabh Ghosh / Ala Taji Heravi / Ngai Chow / Kimberly A McCord - De Iaco / Ramon Saccilotto / Lars Hemkens

    BMJ Open, Vol 12, Iss

    a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

    2022  Band 5

    Schlagwörter Medicine ; R
    Sprache Englisch
    Erscheinungsdatum 2022-05-01T00:00:00Z
    Verlag BMJ Publishing Group
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  9. Artikel ; Online: Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols

    Dmitry Gryaznov / Ayodele Odutayo / Belinda von Niederhäusern / Benjamin Speich / Benjamin Kasenda / Elena Ojeda-Ruiz / Anette Blümle / Stefan Schandelmaier / Dominik Mertz / Yuki Tomonaga / Alain Amstutz / Christiane Pauli-Magnus / Viktoria Gloy / Karin Bischoff / Katharina Wollmann / Laura Rehner / Szimonetta Lohner / Joerg J. Meerpohl / Alain Nordmann /
    Katharina Klatte / Nilabh Ghosh / Ala Taji Heravi / Jacqueline Wong / Ngai Chow / Patrick Jiho Hong / Kimberly Mc Cord / Sirintip Sricharoenchai / Jason W. Busse / Arnav Agarwal / Ramon Saccilotto / Matthias Schwenkglenks / Giusi Moffa / Lars G. Hemkens / Sally Hopewell / Erik von Elm / Matthias Briel

    Trials, Vol 21, Iss 1, Pp 1-

    the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects

    2020  Band 13

    Abstract: Abstract Background Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ...

    Abstract Abstract Background Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain. Objectives and methods Aims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries. We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results. We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup ...
    Schlagwörter Randomized clinical trials ; Trial protocol ; Reporting quality ; Reporting guideline adherence ; Registration ; Trial discontinuation ; Medicine (General) ; R5-920
    Thema/Rubrik (Code) 621
    Sprache Englisch
    Erscheinungsdatum 2020-10-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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