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  1. Article ; Online: Overcoming denominator problems in refugee settings with fragmented electronic records for health and immigration data: a prediction-based approach.

    Erdmann, Stella / Jahn, Rosa / Rohleder, Sven / Bozorgmehr, Kayvan

    BMC medical research methodology

    2024  Volume 24, Issue 1, Page(s) 81

    Abstract: Background: Epidemiological studies in refugee settings are often challenged by the denominator problem, i.e. lack of population at risk data. We develop an empirical approach to address this problem by assessing relationships between occupancy data in ... ...

    Abstract Background: Epidemiological studies in refugee settings are often challenged by the denominator problem, i.e. lack of population at risk data. We develop an empirical approach to address this problem by assessing relationships between occupancy data in refugee centres, number of refugee patients in walk-in clinics, and diseases of the digestive system.
    Methods: Individual-level patient data from a primary care surveillance system (PriCarenet) was matched with occupancy data retrieved from immigration authorities. The three relationships were analysed using regression models, considering age, sex, and type of centre. Then predictions for the respective data category not available in each of the relationships were made. Twenty-one German on-site health care facilities in state-level registration and reception centres participated in the study, covering the time period from November 2017 to July 2021.
    Results: 445 observations ("centre-months") for patient data from electronic health records (EHR, 230 mean walk-in clinics visiting refugee patients per month and centre; standard deviation sd: 202) of a total of 47.617 refugee patients were available, 215 for occupancy data (OCC, mean occupancy of 348 residents, sd: 287), 147 for both (matched), leaving 270 observations without occupancy (EHR-unmatched) and 40 without patient data (OCC-unmatched). The incidence of diseases of the digestive system, using patients as denominators in the different sub-data sets were 9.2% (sd: 5.9) in EHR, 8.8% (sd: 5.1) when matched, 9.6% (sd: 6.4) in EHR- and 12% (sd 2.9) in OCC-unmatched. Using the available or predicted occupancy as denominator yielded average incidence estimates (per centre and month) of 4.7% (sd: 3.2) in matched data, 4.8% (sd: 3.3) in EHR- and 7.4% (sd: 2.7) in OCC-unmatched.
    Conclusions: By modelling the ratio between patient and occupancy numbers in refugee centres depending on sex and age, as well as on the total number of patients or occupancy, the denominator problem in health monitoring systems could be mitigated. The approach helped to estimate the missing component of the denominator, and to compare disease frequency across time and refugee centres more accurately using an empirically grounded prediction of disease frequency based on demographic and centre typology. This avoided over-estimation of disease frequency as opposed to the use of patients as denominators.
    MeSH term(s) Humans ; Refugees ; Electronic Health Records ; Emigration and Immigration ; Risk Factors ; Electronics
    Language English
    Publishing date 2024-04-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-024-02204-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Using real-world data to predict health outcomes-The prediction design: Application and sample size planning.

    Erdmann, Stella / Edelmann, Dominic / Kieser, Meinhard

    Biometrical journal. Biometrische Zeitschrift

    2023  Volume 65, Issue 6, Page(s) e2200023

    Abstract: The gold standard for investigating the efficacy of a new therapy is a (pragmatic) randomized controlled trial (RCT). This approach is costly, time-consuming, and not always practicable. At the same time, huge quantities of available patient-level ... ...

    Abstract The gold standard for investigating the efficacy of a new therapy is a (pragmatic) randomized controlled trial (RCT). This approach is costly, time-consuming, and not always practicable. At the same time, huge quantities of available patient-level control condition data in analyzable format of (former) RCTs or real-world data (RWD) are neglected. Therefore, alternative study designs are desirable. The design presented here consists of setting up a prediction model for determining treatment effects under the control condition for future patients. When a new treatment is intended to be tested against a control treatment, a single-arm trial for the new therapy is conducted. The treatment effect is then evaluated by comparing the outcomes of the single-arm trial against the predicted outcomes under the control condition. While there are obvious advantages of this design compared to classical RCTs (increased efficiency, lower cost, alleviating participants' fear of being on control treatment), there are several sources of bias. Our aim is to investigate whether and how such a design-the prediction design-may be used to provide information on treatment effects by leveraging external data sources. For this purpose, we investigated under what assumptions linear prediction models could be used to predict the counterfactual of patients precisely enough to construct a test and an appropriate sample size formula for evaluating the average treatment effect in the population of a new study. A user-friendly R Shiny application (available at: https://web.imbi.uni-heidelberg.de/PredictionDesignR/) facilitates the application of the proposed methods, while a real-world application example illustrates them.
    MeSH term(s) Humans ; Sample Size ; Research Design ; Bias ; Outcome Assessment, Health Care
    Language English
    Publishing date 2023-07-26
    Publishing country Germany
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 131640-0
    ISSN 1521-4036 ; 0323-3847 ; 0006-3452
    ISSN (online) 1521-4036
    ISSN 0323-3847 ; 0006-3452
    DOI 10.1002/bimj.202200023
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Using independent cross-sectional survey data to predict post-migration health trajectories among refugees by estimating transition probabilities and their variances.

    Erdmann, Stella / Biddle, Louise / Kieser, Meinhard / Bozorgmehr, Kayvan

    Biometrical journal. Biometrische Zeitschrift

    2022  Volume 64, Issue 5, Page(s) 964–983

    Abstract: Health research is often concerned with the transition of health conditions and their relation with given exposures, therefore requiring longitudinal data. However, such data is not always available and resource-intensive to collect. Our aim is to use a ... ...

    Abstract Health research is often concerned with the transition of health conditions and their relation with given exposures, therefore requiring longitudinal data. However, such data is not always available and resource-intensive to collect. Our aim is to use a pseudo-panel of independent cross-sectional data (e.g., data of
    MeSH term(s) Cross-Sectional Studies ; Humans ; Propensity Score ; Quality of Life ; Refugees/psychology ; Self Report
    Language English
    Publishing date 2022-02-20
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 131640-0
    ISSN 1521-4036 ; 0323-3847 ; 0006-3452
    ISSN (online) 1521-4036
    ISSN 0323-3847 ; 0006-3452
    DOI 10.1002/bimj.202100045
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Long-Term Efficacy and Safety of Rituximab Versus Tacrolimus in Children With Steroid Dependent Nephrotic Syndrome.

    Basu, Biswanath / Erdmann, Stella / Sander, Anja / Mahapatra, Tapan Kumar Sinha / Meis, Jan / Schaefer, Franz

    Kidney international reports

    2023  Volume 8, Issue 8, Page(s) 1575–1584

    Abstract: Introduction: In the Rituximab for Relapse Prevention in Nephrotic Syndrome (RITURNS) trial, we demonstrated superior efficacy of single-course rituximab over maintenance tacrolimus in preventing relapses in children with steroid dependent nephrotic ... ...

    Abstract Introduction: In the Rituximab for Relapse Prevention in Nephrotic Syndrome (RITURNS) trial, we demonstrated superior efficacy of single-course rituximab over maintenance tacrolimus in preventing relapses in children with steroid dependent nephrotic syndrome (SDNS) during a 1-year observation. Here we present the long-term outcomes of all 117 trial completers, who were followed up for another 2 years.
    Methods: Relapsing patients in the rituximab arm received a second course of rituximab, either with (
    Results: All 12-month relapse-free patients in the rituximab arm relapsed in the second postexposure year, resulting in similar median relapse-free survival times in the 2 trial arms (62 vs. 59 weeks). Second line rituximab in the tacrolimus arm was less effective than first-line therapy in patients switched to rituximab following a relapse (relapse-free survival 55 vs. 63 weeks,
    Conclusion: The superior therapeutic effect of rituximab in SDNS vanishes during the second year post-exposure. Rituximab appears to yield longer remission when applied as first line as compared to second line therapy. Maintenance MMF following rituximab induces long-term disease remission.
    Language English
    Publishing date 2023-05-29
    Publishing country United States
    Document type Journal Article
    ISSN 2468-0249
    ISSN (online) 2468-0249
    DOI 10.1016/j.ekir.2023.05.022
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Optimal designs for phase II/III drug development programs including methods for discounting of phase II results.

    Erdmann, Stella / Kirchner, Marietta / Götte, Heiko / Kieser, Meinhard

    BMC medical research methodology

    2020  Volume 20, Issue 1, Page(s) 253

    Abstract: Background: Go/no-go decisions after phase II and sample size chosen for phase III are usually based on phase II results (e.g., the treatment effect estimate of phase II). Due to the decision rule (only promising phase II results lead to phase III), ... ...

    Abstract Background: Go/no-go decisions after phase II and sample size chosen for phase III are usually based on phase II results (e.g., the treatment effect estimate of phase II). Due to the decision rule (only promising phase II results lead to phase III), treatment effect estimates from phase II that initiate a phase III trial commonly overestimate the true treatment effect. Underpowered phase III trials are the consequence. Optimistic findings may then not be reproduced, leading to the failure of potentially expensive drug development programs. For some disease areas these failure rates are described to be quite high: 62.5%.
    Methods: We integrate the ideas of multiplicative and additive adjustment of treatment effect estimates after go decisions in a utility-based framework for optimizing drug development programs. The design of a phase II/III program, i.e., the "right amount of adjustment", the allocation of the resources to phase II and III in terms of sample size, and the rule applied to decide whether to stop or to proceed with phase III influences its success considerably. Given specific drug development program characteristics (e.g., fixed and variable per patient costs for phase II and III, probable gain in case of market launch), optimal designs with respect to the maximal expected utility can be identified by the proposed Bayesian-frequentist approach. The method will be illustrated by application to practical examples characteristic for oncological studies.
    Results: In general, our results show that the program set-ups with adjusted treatment effect estimate used for phase III planning are superior to the "naïve" program set-ups with respect to the maximal expected utility. Therefore, we recommend considering an adjusted phase II treatment effect estimate for the phase III sample size calculation. However, there is no one-fits-all design.
    Conclusion: Individual drug development planning for a specific program is necessary to find the optimal design. The optimal choice of the design parameters for a specific drug development program at hand can be found by our user friendly R Shiny application and package (both assessable open-source via [1]).
    MeSH term(s) Bayes Theorem ; Drug Development ; Humans ; Probability ; Research Design ; Sample Size
    Language English
    Publishing date 2020-10-09
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-020-01093-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: From Research into Practice: Converting Epidemiological Data into Relevant Information for Planning of Regional Health Services for Refugees in Germany.

    Hintermeier, Maren / Gold, Andreas W / Erdmann, Stella / Perplies, Clara / Bozorgmehr, Kayvan / Biddle, Louise

    International journal of environmental research and public health

    2022  Volume 19, Issue 13

    Abstract: Health data of refugees and asylum seekers (ASR) is not routinely collected in Germany. Based on health data of ASR collected in 2018 in regional accommodation centres, we developed a dashboard to estimate regional burden of disease in Baden-Wuerttemberg, ...

    Abstract Health data of refugees and asylum seekers (ASR) is not routinely collected in Germany. Based on health data of ASR collected in 2018 in regional accommodation centres, we developed a dashboard to estimate regional burden of disease in Baden-Wuerttemberg, Germany. We aimed to find out how scientific data can support actors involved in healthcare planning for ASR in Germany and, within this scope, to explore how healthcare planning is conducted in this context. We conducted 12 qualitative semi-structured interviews including a usability test for a health data dashboard with regional decision-makers. Results showed that healthcare planning processes for ASR in Germany involve a complex set of actors in both long- and short-term decision-making. Data gained from representative surveys can support long-term decision-making and thus support the resilience of the health system, but it must balance the need for simple data presentation with transparent communication of potentially complex methods.
    MeSH term(s) Germany/epidemiology ; Health Services ; Health Services Accessibility ; Health Services Needs and Demand ; Humans ; Refugees
    Language English
    Publishing date 2022-06-30
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2175195-X
    ISSN 1660-4601 ; 1661-7827
    ISSN (online) 1660-4601
    ISSN 1661-7827
    DOI 10.3390/ijerph19138049
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Conference proceedings: Using independent cross-sectional survey data to predict post-migration health trajectories among refugees by estimating transition probabilities and their variances

    Erdmann, Stella / Biddle, Louise / Kieser, Meinhard / Bozorgmehr, Kayvan

    2021  , Page(s) Abstr. 65

    Event/congress 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS); Berlin; Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie; 2020
    Keywords Medizin, Gesundheit ; transition probabilities ; probabilistic discrete event systems ; cross-sectional survey data ; Rubin's rule ; approximate post-migration health trajectories
    Publishing date 2021-02-26
    Publisher German Medical Science GMS Publishing House; Düsseldorf
    Document type Conference proceedings
    DOI 10.3205/20gmds270
    Database German Medical Science

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  8. Conference proceedings: Using Real World Data to Construct a Synthetic Control Arm – the Prediction Design

    Erdmann, Stella / Edelmann, Dominic / Kieser, Meinhard

    2021  , Page(s) Abstr. 129

    Event/congress 66. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS), 12. Jahreskongress der Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V. (TMF); sine loco [digital]; Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie; 2021
    Keywords Medizin, Gesundheit ; Real World Evidence ; Sample Size ; Linear Regression Model ; Simulation ; Single Arm Trial
    Publishing date 2021-09-24
    Publisher German Medical Science GMS Publishing House; Düsseldorf
    Document type Conference proceedings
    DOI 10.3205/21gmds084
    Database German Medical Science

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  9. Article ; Online: Health monitoring of refugees in reception centres for asylum seekers: Decentralized surveillance network for the analysis of routine medical data.

    Jahn, Rosa / Rohleder, Sven / Qreini, Markus / Erdmann, Stella / Kaur, Sukhvir / Aluttis, Frank / Bozorgmehr, Kayvan

    Journal of health monitoring

    2021  Volume 6, Issue 1, Page(s) 30–52

    Abstract: Refugees and asylum seekers living in reception centres tend to be not adequately included in population-based studies, routine medical data and official statistics. As part of the research project 'Health and primary-care sentinel surveillance in ... ...

    Abstract Refugees and asylum seekers living in reception centres tend to be not adequately included in population-based studies, routine medical data and official statistics. As part of the research project 'Health and primary-care sentinel surveillance in reception- and accommodation-centres for asylum-seekers in Germany' (PriCare), a health-monitoring approach was developed for the secondary use of routine medical data from on-site outpatient clinics in reception centres. To this end, a software application (Refugee Care Manager, RefCare©) for the digitisation and harmonisation of medical records was designed and implemented in reception centres in three German federal states. The approach of distributed computing in a surveillance network allows for the decentralised, harmonised analysis of the routine medical data stored in RefCare© in a manner that fully complies with data protection regulations and circumvents the need for centralised data storage. RefCare© provides an integrated surveillance feature that enables analyses of 64 indicators on population, morbidity, healthcare processes and quality of care to be undertaken across multiple facilities. This article describes the conceptual and practical approach and the technical procedures put in place to do so, and provides examples of the results that have been gained so far.
    Language English
    Publishing date 2021-03-31
    Publishing country Germany
    Document type Journal Article
    ISSN 2511-2708
    ISSN (online) 2511-2708
    DOI 10.25646/7865
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Conference proceedings: Innovative Ansätze zur Auswertung von Routinedaten der medizinischen Versorgung von Geflüchteten in Erstaufnahmeeinrichtungen durch „verteiltes Rechnen im Verbund“

    Jahn, Rosa / Rohleder, Sven / Erdmann, Stella / Conz, Lena / Gold, Andreas W. / Bozorgmehr, Kayvan

    2022  , Page(s) 22chk38

    Event/congress 5. Community Health Konferenz; Bochum; Hochschule für Gesundheit; 2022
    Keywords Medizin, Gesundheit
    Publishing date 2022-11-23
    Publisher German Medical Science GMS Publishing House; Düsseldorf
    Document type Conference proceedings
    DOI 10.3205/22chk38
    Database German Medical Science

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