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  • 1
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    Online Resource
    Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial)
    Springer Science and Business Media LLC ; 2022
    In:  Trials Vol. 23, No. 1 ( 2022-09-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 23, No. 1 ( 2022-09-12)
    Abstract: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. Methods This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. Discussion This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. Trial registration ClinicalTrials.gov ID NCT04333303. Registered 30 March 2020.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-022-06576-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2040523-6
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  • 2
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    A multicenter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of transcranial direct current stimulation to the motor cortex after stroke (NETS): study protocol
    Springer Science and Business Media LLC ; 2022
    In:  Neurological Research and Practice Vol. 4, No. 1 ( 2022-12)
    Details
    In: Neurological Research and Practice, Springer Science and Business Media LLC, Vol. 4, No. 1 ( 2022-12)
    Abstract: The WHO estimates that each year 5 million people are left permanently disabled after stroke. Adjuvant treatments to promote the effects of rehabilitation are urgently needed. Cortical excitability and neuroplasticity can be enhanced by non-invasive brain stimulation but evidence from sufficiently powered, randomized controlled multi-center clinical trials is absent. Methods Neuroregeneration enhanced by transcranial direct current stimulation (tDCS) in stroke (NETS) tested efficacy and safety of anodal tDCS to the primary motor cortex of the lesioned hemisphere in the subacute phase (day 5–45) after cerebral ischemia. Stimulation was combined with standardized rehabilitative training and repeatedly applied in 10 sessions over a period of 2 weeks in a planned sample of 120 patients. Primary outcome parameter was upper-extremity function at the end of the 2-weeks intervention period of active treatment or placebo (1:1 randomization), measured by the upper-extremity Fugl-Meyer assessment. Sustainability of the treatment effect was evaluated by additional follow-up visits after 30 and 90 days. Further secondary endpoints included metrics of arm and hand function, stroke impact scale, and the depression module of the patient health questionnaire. Perspective NETS was aimed at providing evidence for an effective and safe adjuvant treatment for patients after stroke. Trial registration : ClinicalTrials.gov Identifier NCT00909714. Registered May 28, 2009.
    Type of Medium: Online Resource
    ISSN: 2524-3489
    URL: Article
    DOI: 10.1186/s42466-022-00171-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2947493-0
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  • 3
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    Prospective postmortem evaluation of 735 consecutive SARS-CoV-2-associated death cases
    Springer Science and Business Media LLC ; 2021
    In:  Scientific Reports Vol. 11, No. 1 ( 2021-09-29)
    Details
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 11, No. 1 ( 2021-09-29)
    Abstract: Coronavirus disease 19 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a global pandemic with significant mortality. Accurate information on the specific circumstances of death and whether patients died from or with SARS-CoV-2 is scarce. To distinguish COVID-19 from non-COVID-19 deaths, we performed a systematic review of 735 SARS-CoV-2-associated deaths in Hamburg, Germany, from March to December 2020, using conventional autopsy, ultrasound-guided minimally invasive autopsy, postmortem computed tomography and medical records. Statistical analyses including multiple logistic regression were used to compare both cohorts. 84.1% (n = 618) were classified as COVID-19 deaths, 6.4% (n = 47) as non-COVID-19 deaths, 9.5% (n = 70) remained unclear. Median age of COVID-19 deaths was 83.0 years, 54.4% were male. In the autopsy group (n = 283), the majority died of pneumonia and/or diffuse alveolar damage (73.6%; n = 187). Thromboses were found in 39.2% (n = 62/158 cases), pulmonary embolism in 22.1% (n = 56/253 cases). In 2020, annual mortality in Hamburg was about 5.5% higher than in the previous 20 years, of which 3.4% (n = 618) represented COVID-19 deaths. Our study highlights the need for mortality surveillance and postmortem examinations. The vast majority of individuals who died directly from SARS-CoV-2 infection were of advanced age and had multiple comorbidities.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    URL: Article
    DOI: 10.1038/s41598-021-98499-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2615211-3
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  • 4
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    Long-Term Antibody Response to SARS-CoV-2 in Children
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Clinical Immunology Vol. 43, No. 1 ( 2023-01), p. 46-56
    Details
    In: Journal of Clinical Immunology, Springer Science and Business Media LLC, Vol. 43, No. 1 ( 2023-01), p. 46-56
    Abstract: Almost 2 years into the pandemic and with vaccination of children significantly lagging behind adults, long-term pediatric humoral immune responses to SARS-CoV-2 are understudied. The C19.CHILD Hamburg (COVID-19 Child Health Investigation of Latent Disease) Study is a prospective cohort study designed to identify and follow up children and their household contacts infected in the early 2020 first wave of SARS-CoV-2. We screened 6113 children  〈  18 years by nasopharyngeal swab-PCR in a low-incidence setting after general lockdown, from May 11 to June 30, 2020. A total of 4657 participants underwent antibody testing. Positive tests were followed up by repeated PCR and serological testing of all household contacts over 6 months. In total, the study identified 67 seropositive children (1.44%); the median time after infection at first presentation was 83 days post-symptom onset (PSO). Follow-up of household contacts showed less than 100% seroprevalence in most families, with higher seroprevalence in families with adult index cases compared to pediatric index cases (OR 1.79, P  = 0.047). Most importantly, children showed sustained seroconversion up to 9 months PSO, and serum antibody concentrations persistently surpassed adult levels (ratio serum IgG spike children vs. adults 90 days PSO 1.75, P   〈  0.001; 180 days 1.38, P  = 0.01; 270 days 1.54, P  = 0.001). In a low-incidence setting, SARS-CoV-2 infection and humoral immune response present distinct patterns in children including higher antibody levels, and lower seroprevalence in families with pediatric index cases. Children show long-term SARS-CoV-2 antibody responses. These findings are relevant to novel variants with increased disease burden in children, as well as for the planning of age-appropriate vaccination strategies.
    Type of Medium: Online Resource
    ISSN: 0271-9142 , 1573-2592
    URL: Article
    DOI: 10.1007/s10875-022-01355-w
    RVK:
    XA 10000
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2016755-6
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  • 5
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    Diagnostic accuracy of cerebrospinal fluid biomarkers for the differential diagnosis of sporadic Creutzfeldt–Jakob disease: a (network) meta‐analysis
    Wiley ; 2022
    In:  European Journal of Neurology Vol. 29, No. 5 ( 2022-05), p. 1366-1376
    Details
    In: European Journal of Neurology, Wiley, Vol. 29, No. 5 ( 2022-05), p. 1366-1376
    Abstract: There are no systematic reviews of cerebrospinal fluid and blood biomarkers for sporadic Creutzfeldt–Jakob disease (sCJD) in specialized care settings that compare diagnostic accuracies in a network meta‐analysis (NMA). Methods We searched Medline, Embase, and Cochrane Library for diagnostic studies of sCJD biomarkers. Studies had to use established diagnostic criteria for sCJD and for diseases in the non‐CJD groups, which had to represent a consecutive population of patients suspected as a CJD case, as reference standard. Risk of bias was assessed with QUADAS‐2. We conducted individual biomarker meta‐analyses with generalized bivariate models. To investigate heterogeneity, we performed subgroup analyses based on QUADAS‐2 quality and clinical criteria. For the NMA, we applied a Bayesian beta‐binomial ANOVA model. The study protocol was registered at PROSPERO (CRD42019118830). Results Of 2976 publications screened, we included 16 studies, which investigated 14–3‐3β ( n  = 13), 14–3‐3γ ( n  = 3), neurofilament light chain (NfL, n  = 1), neuron‐specific enolase ( n  = 1), p‐tau181/t‐tau ratio ( n  = 2), RT‐QuIC ( n  = 7), S100B ( n  = 3), t‐tau ( n  = 12), and t‐tau/Aβ42 ratio ( n  = 1). Excluded diagnostic studies had strong limitations in study design. In the NMA, RT‐QuIC (0.91; 95% CI [0.83, 0.95]) and NfL (0.93 [0.78, 0.99] ) were the most sensitive biomarkers for the diagnosis of definite, probable, and possible sCJD cases. RT‐QuIC was the most specific biomarker (0.97 [0.89, 1.00]). Heterogeneity in accuracy estimates was high between studies. Conclusions We identified RT‐QuIC as the most accurate biomarker, partially confirming currently applied diagnostic criteria. The shortcomings identified in many diagnostic studies for sCJD biomarkers need to be addressed in future studies.
    Type of Medium: Online Resource
    ISSN: 1351-5101 , 1468-1331
    URL: Issue
    URL: Article
    DOI: 10.1111/ene.v29.5
    DOI: 10.1111/ene.15258
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2020241-6
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  • 6
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    Nonparametric meta‐analysis for diagnostic accuracy studies
    Wiley ; 2015
    In:  Statistics in Medicine Vol. 34, No. 29 ( 2015-12-20), p. 3831-3841
    Details
    In: Statistics in Medicine, Wiley, Vol. 34, No. 29 ( 2015-12-20), p. 3831-3841
    Abstract: Summarizing the information of many studies using a meta‐analysis becomes more and more important, also in the field of diagnostic studies. The special challenge in meta‐analysis of diagnostic accuracy studies is that in general sensitivity and specificity are co‐primary endpoints. Across the studies both endpoints are correlated, and this correlation has to be considered in the analysis. The standard approach for such a meta‐analysis is the bivariate logistic random effects model. An alternative approach is to use marginal beta‐binomial distributions for the true positives and the true negatives, linked by copula distributions. In this article, we propose a new, nonparametric approach of analysis, which has greater flexibility with respect to the correlation structure, and always converges. In a simulation study, it becomes apparent that the empirical coverage of all three approaches is in general below the nominal level. Regarding bias, empirical coverage, and mean squared error the nonparametric model is often superior to the standard model, and comparable with the copula model. The three approaches are also applied to two example meta‐analyses. Copyright © 2015 John Wiley & Sons, Ltd.
    Type of Medium: Online Resource
    ISSN: 0277-6715 , 1097-0258
    URL: Issue
    URL: Article
    DOI: 10.1002/sim.v34.29
    DOI: 10.1002/sim.6583
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2015
    detail.hit.zdb_id: 1491221-1
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  • 7
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    What makes a biostatistician?
    Wiley ; 2019
    In:  Statistics in Medicine Vol. 38, No. 4 ( 2019-02-20), p. 695-701
    Details
    In: Statistics in Medicine, Wiley, Vol. 38, No. 4 ( 2019-02-20), p. 695-701
    Abstract: Biostatisticians play an important role in medical research. They are co‐responsible for an appropriate and efficient study design, they are involved in monitoring the study conduct, they plan and perform the data analysis, and they are involved in interpreting and publishing the results. However, how are the biostatisticians prepared for their tasks and responsibilities? Graduate programs in biostatistics are being offered, but some practicing biostatisticians completed their studies in a mathematical or epidemiological program, or obtained their degree in subject‐specific fields (such as medicine or biology). Therefore, the expertise and the competencies can vary widely between the individual biostatisticians, also depending on the application field. In this article, focusing on European and US practices, we discuss the required professional expertise for the main areas of applications in the medical field as well as the necessary soft skill competencies of a biostatistician.
    Type of Medium: Online Resource
    ISSN: 0277-6715 , 1097-0258
    URL: Issue
    URL: Article
    DOI: 10.1002/sim.v38.4
    DOI: 10.1002/sim.7998
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 1491221-1
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  • 8
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    Breath‐hold and free‐breathing 2D phase‐contrast MRI for quantification of oxygen‐induced changes of pulmonary circulation dynamics in healthy volunteers
    Wiley ; 2017
    In:  Journal of Magnetic Resonance Imaging Vol. 46, No. 6 ( 2017-12), p. 1698-1706
    Details
    In: Journal of Magnetic Resonance Imaging, Wiley, Vol. 46, No. 6 ( 2017-12), p. 1698-1706
    Abstract: To evaluate the effect of inhaled 100% oxygen on pulmonary circulation dynamics in healthy volunteers using 2D phase‐contrast magnetic resonance imaging (2D PC MRI). Materials and Methods Twenty‐one healthy volunteers were examined at 1.5T. Through‐plane 2D PC MRI measurements were performed in the main pulmonary artery during free‐breathing and breath‐hold. Acceleration time and volume, maximum and minimum area, area change, average and maximum mean velocity, forward volume, heart rate, as well as blood pressure were determined. At baseline, subjects breathed room air. After application of a closed‐fit full face mask, three further measurements were conducted: at room air (control), directly after starting 15 L/min 100% oxygen (wash‐in), and after 5 minutes during continuous oxygen supply (saturation). Data were analyzed with a mixed linear model. Skewed distributed variables were rank‐transformed. Tukey contrasts with family‐wise adjusted P ‐values were applied for pairwise comparisons. Results Inhaled oxygen affected several hemodynamic parameters. Average mean velocity ( P 〈 0.01: breath‐hold during wash‐in and saturation, P = 0.03: free‐breathing during saturation) and maximum mean velocity ( P 〈 0.01: breath‐hold and free‐breathing during saturation) decreased. When obtained during free‐breathing, acceleration volume ( P = 0.02: saturation), area change ( P = 0.02: saturation), and maximum area ( P = 0.02: wash‐in, P = 0.03: saturation) increased, while minimum area and forward volume did not change. Conclusion Oxygen alters pulmonary circulation dynamics in the main pulmonary artery of healthy volunteers, which can be reliably detected using 2D phase‐contrast MRI. Level of Evidence: 2 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2017;46:1698–1706.
    Type of Medium: Online Resource
    ISSN: 1053-1807 , 1522-2586
    URL: Issue
    URL: Article
    DOI: 10.1002/jmri.v46.6
    DOI: 10.1002/jmri.25724
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 1497154-9
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  • 9
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    Refining M1 stage in medulloblastoma: criteria for cerebrospinal fluid cytology and implications for improved risk stratification from the HIT-2000 trial
    Elsevier BV ; 2022
    In:  European Journal of Cancer Vol. 164 ( 2022-03), p. 30-38
    Details
    In: European Journal of Cancer, Elsevier BV, Vol. 164 ( 2022-03), p. 30-38
    Type of Medium: Online Resource
    ISSN: 0959-8049
    URL: Article
    DOI: 10.1016/j.ejca.2021.12.032
    RVK:
    XA 42017.A
    RVK:
    XA 42017
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 1120460-6
    detail.hit.zdb_id: 1468190-0
    detail.hit.zdb_id: 82061-1
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  • 10
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    Promoting rational antibiotic therapy among high antibiotic prescribers in German primary care—study protocol of the ElektRA 4-arm cluster-randomized controlled trial
    Springer Science and Business Media LLC ; 2022
    In:  Implementation Science Vol. 17, No. 1 ( 2022-10-04)
    Details
    In: Implementation Science, Springer Science and Business Media LLC, Vol. 17, No. 1 ( 2022-10-04)
    Abstract: The rational use of antibiotics is of great importance in health care. In primary care, acute respiratory infections are the most common cause of inappropriate antibiotic prescribing. Since existing studies aiming to optimize antibiotic use are usually based on the voluntary participation of physicians, general practitioners (GPs) with inappropriate prescribing behavior are underrepresented. For the first time in Germany, the ElektRA study will assess and compare the effects of three interventions on antibiotic prescribing rates for respiratory and urinary tract infections among high prescribers in primary care. Method ElektRA is a 4-arm cluster-randomized controlled trial among German GPs in nine regional Associations of Statutory Health Insurance Physicians. On their behalf, the Central Research Institute of Ambulatory Health Care in Germany (Zi) analyses all outpatient claims and prescription data. Based on this database, high antibiotic prescribing GPs are identified and randomized into four groups: a control group ( N =2000) and three intervention arms. We test social norm feedback on antibiotic prescribing ( N =2000), social norm feedback plus online training on rational prescribing practice and communication strategies ( N =2000), and social norm feedback plus online peer-moderated training on rational antibiotic prescribing, communication strategies, and sustainable behavior change ( N =1250). The primary outcome is the overall rate of antibiotic prescriptions. Outcomes are measured before intervention (T0, October 2020–September 2022) and over a period of 15 months (T1, October 2022 to December 2023) after randomization. Discussion The aim of the study is to implement individualized, low-threshold interventions to reduce antibiotic prescribing among high prescribers in primary care. If successful, a change in behavior among otherwise difficult-to-reach high prescribers will directly improve patient care. The increase in quality of care will ideally be achieved both in terms of the quantity of antibiotics used as well as the kind of substances prescribed. Also, if effective strategies for high prescribers are identified through this study, they can be applied not only to the antibiotics addressed in this study, but also to other areas of prescription management. Trial registration Current Controlled Trials ISRCTN95468513.
    Type of Medium: Online Resource
    ISSN: 1748-5908
    URL: Article
    DOI: 10.1186/s13012-022-01241-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2225822-X
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