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  1. Book ; Thesis: Biometrische Aspekte der Planung und Auswertung klinischer Studien

    Heussen, Nicole

    2012  

    Author's details vorgelegt von Nicole Heussen
    Language German ; English
    Size 89 S. : Ill., graph. Darst.
    Publishing country Germany
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Aachen, Techn. Hochsch., Habil.-Schr., 2012
    HBZ-ID HT017516681
    Database Catalogue ZB MED Medicine, Health

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    2014 E 1459 order for loan Magazin

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  2. Article ; Online: Equine-Assisted Therapies for Children With Cerebral Palsy: A Meta-analysis.

    Heussen, Nicole / Häusler, Martin

    Pediatrics

    2022  Volume 150, Issue 1

    Abstract: Context: Equine-assisted therapy in different facets aims to improve the clinical condition of children with cerebral palsy. A more comprehensive overview on the overall effects and on the differences between different treatment modalities seems ... ...

    Abstract Context: Equine-assisted therapy in different facets aims to improve the clinical condition of children with cerebral palsy. A more comprehensive overview on the overall effects and on the differences between different treatment modalities seems desirable.
    Objective: We compared the effectiveness of various equine-assisted treatments on motor capabilities and quality of life of children with cerebral palsy.
    Data sources: We conducted systematic searches of PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials.
    Study selection: Randomized and nonrandomized controlled parallel-group or crossover studies on equine-assisted therapies in comparison with standard of care were included.
    Data extraction: Data on motor function assessed by different instruments were considered as the primary outcome. Secondary outcomes included global, social, physical, and emotional scores of quality of life.
    Results: Strong evidence for a positive effect of equine-assisted therapies, particularly hippotherapy, on global gross motor function and motor capabilities during walking in children with cerebral palsy was identified (SMD 0.24, 95% CI 0.05 to 0.43, P = .01, t2 = 0.00, I2 = 15%; SMD 2.68, 95% CI 1.02 to 4.34, P = .002, t2 = 0.0, I2 = 0%). No evidence for the improvement in quality of life could be shown in the global assessment, nor in any subscore.
    Conclusions: Equine-assisted therapy, particularly hippotherapy, can be a therapeutic tool for children who are learning to walk.
    Limitation: The heterogeneity of tools used in different studies and the low number of studies addressing quality of life issues limited the number of studies available for distinct analyses.
    MeSH term(s) Animals ; Cerebral Palsy/therapy ; Child ; Cross-Over Studies ; Equine-Assisted Therapy ; Horses ; Humans ; Quality of Life
    Language English
    Publishing date 2022-06-03
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Systematic Review
    ZDB-ID 207677-9
    ISSN 1098-4275 ; 0031-4005
    ISSN (online) 1098-4275
    ISSN 0031-4005
    DOI 10.1542/peds.2021-055229
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  3. Article ; Online: Confidence interval comparison: Precision of maximum likelihood estimates in LLOQ affected data.

    Bülow, Tanja / Hilgers, Ralf-Dieter / Heussen, Nicole

    PloS one

    2023  Volume 18, Issue 11, Page(s) e0293640

    Abstract: When data is derived under a single or multiple lower limits of quantification (LLOQ), estimation of distribution parameters as well as precision of these estimates appear to be challenging, as the way to account for unquantifiable observations due to ... ...

    Abstract When data is derived under a single or multiple lower limits of quantification (LLOQ), estimation of distribution parameters as well as precision of these estimates appear to be challenging, as the way to account for unquantifiable observations due to LLOQs needs particular attention. The aim of this investigation is to characterize the precision of censored sample maximum likelihood estimates of the mean for normal, exponential and Poisson distribution affected by one or two LLOQs using confidence intervals (CI). In a simulation study, asymptotic and bias-corrected accelerated bootstrap CIs for the location parameter mean are compared with respect to coverage proportion and interval width. To enable this examination, we derived analytical expressions of the maximum likelihood location parameter estimate for the assumption of exponentially and Poisson distributed data, where the censored sample method and simple imputation method are used to account for LLOQs. Additionally, we vary the proportion of observations below the LLOQs. When based on the censored sample estimate, the bootstrap CI led to higher coverage proportions and narrower interval width than the asymptotic CI. The results differed by underlying distribution. Under the assumption of normality, the CI's coverage proportion and width suffered most from high proportions of unquantifiable observations. For exponentially and Poisson distributed data, both CI approaches delivered similar results. To derive the CIs, the point estimates from the censored sample method are preferable, because the point estimate of the simple imputation method leads to higher bias for all investigated distributions. This biased simple imputation estimate impairs the coverage proportion of the respective CI. The bootstrap CI surpassed the asymptotic CIs with respect to coverage proportion for the investigated choice of distributional assumptions. The variety of distributions for which the methods are suitable gives the applicant a widely usable tool to handle LLOQ affected data with appropriate approaches.
    MeSH term(s) Likelihood Functions ; Models, Statistical ; Confidence Intervals ; Computer Simulation ; Bias
    Language English
    Publishing date 2023-11-02
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0293640
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  4. Article ; Online: The authors reply.

    Soppert, Josefin / Heussen, Nicole Maria / Noels, Heidi

    Kidney international

    2023  Volume 103, Issue 6, Page(s) 1199–1201

    Language English
    Publishing date 2023-05-18
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 120573-0
    ISSN 1523-1755 ; 0085-2538
    ISSN (online) 1523-1755
    ISSN 0085-2538
    DOI 10.1016/j.kint.2023.02.023
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 797: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
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  5. Book ; Thesis: Der Einfluss der Randomisierung in Blöcken zufälliger Länge auf die Auswertung klinischer Studien mittels Randomisationstest

    Heussen, Nicole

    2004  

    Author's details vorgelegt von Nicole Heussen, geb. Weingarten
    Language German
    Size III, 195 S. : graph. Darst.
    Publishing country Germany
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Aachen, Techn. Hochsch., Diss., 2004
    HBZ-ID HT014259543
    Database Catalogue ZB MED Medicine, Health

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    2004 D 1338 order for loan Magazin

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  6. Article ; Online: Protocol for a systematic review and meta-analysis on the effect of hippotherapy and related equine-assisted therapies on motor capabilities in children with cerebral palsy.

    Häusler, Martin / Heussen, Nicole

    Systematic reviews

    2020  Volume 9, Issue 1, Page(s) 48

    Abstract: Background: Equine-assisted treatments of the motor system appear to have an effect on the neuromuscular system and aim to improve the pathological condition of children with cerebral palsy. Hippotherapy is a distinct form of equine-assisted therapy ... ...

    Abstract Background: Equine-assisted treatments of the motor system appear to have an effect on the neuromuscular system and aim to improve the pathological condition of children with cerebral palsy. Hippotherapy is a distinct form of equine-assisted therapy where certified physiotherapists use the horse as a dynamic tool in a medical treatment setting. The objective of the proposed review is to summarize and critically appraise the evidence on the effect of equine-assisted treatments on motor capabilities of children with cerebral palsy.
    Methods: We will identify trials through systematic searches of PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL). Quality assessment of retrieved articles will be conducted using the criteria outlined in the revised tool to assess risk of bias in randomized trials (RoB 2.0) or the ROBINS-I tool (Risk Of Bias In Non-randomized Studies - of interventions), respectively. Quantitative data synthesis will be performed if treatments, participants, and the underlying clinical question are homogenous and provide adequate outcome data for meta-analysis. Otherwise, data will be synthesized, using the narrative synthesis approach.
    Conclusion: This review will provide a critical summary of the evidence regarding the impact of equine-assisted treatments on motor capabilities of children with cerebral palsy. The result from this review will help to inform healthcare practitioners and policymakers on the additional effect of equine-assisted treatments on reducing the burden of cerebral palsy among children.
    Systematic review registration: This systematic review protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number: CRD42018096403. This protocol was prepared using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols checklist (PRISMA-P).
    MeSH term(s) Animals ; Cerebral Palsy/therapy ; Child ; Equine-Assisted Therapy ; Horses ; Humans ; Meta-Analysis as Topic ; Systematic Reviews as Topic
    Language English
    Publishing date 2020-03-05
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2662257-9
    ISSN 2046-4053 ; 2046-4053
    ISSN (online) 2046-4053
    ISSN 2046-4053
    DOI 10.1186/s13643-020-01297-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Facial thermal response to non-painful stressor in premature and term neonates.

    Kretschmer, Sophie C A / Paul, Michael / Heussen, Nicole / Leonhardt, Steffen / Orlikowsky, Thorsten / Heimann, Konrad

    Pediatric research

    2023  Volume 94, Issue 4, Page(s) 1422–1427

    Abstract: Background: This study is a preliminary clinical investigation with the objective to evaluate the facial thermal response of premature and term neonates to a non-painful stressor (hunger) using infrared thermography (IRT). The development of objective ... ...

    Abstract Background: This study is a preliminary clinical investigation with the objective to evaluate the facial thermal response of premature and term neonates to a non-painful stressor (hunger) using infrared thermography (IRT). The development of objective and reliable parameters to monitor pain and stress is of relevance for optimal neonatal outcome and achieving a better management of patient comfort.
    Methods: We enrolled 12 neonates ranging from 27 to 39 weeks gestation (median: 34) and aged 3-79 days (median: 13). Recordings were performed before and after feeding, with and without hunger. Six regions of interest were chosen for evaluation (nose tip, periorbital and corrugator region, forehead, perioral and chin region).
    Results: There was an increase in the facial temperature in infants immediately prior to their next feed relative to infants who were not hungry, with the nasal tip being the facial evaluation site with the greatest temperature change.
    Conclusions: The IRT appears to be a feasible and suitable method to detect changes in the neonatal patient. The thermal variations observed seem to reflect an arousal mediated by the parasympathetic nervous system, which has been described in existing infant stress research.
    Impact: This is the first study to examine the use of infrared thermography (IRT) in monitoring the facial thermal response to a mild stressor (hunger) in premature and term neonates. Hunger as a mild, non-pain-associated stressor showed a significant effect on the facial temperature. The thermal signature of the regions of interest chosen showed hunger-related thermal variations. Results suggest the feasibility and suitability of IRT as an objective diagnostic tool to approach stress and changes in the condition of the neonatal patient.
    MeSH term(s) Infant, Newborn ; Infant ; Female ; Humans ; Pain/diagnosis ; Face ; Premature Birth ; Gestational Age ; Nose
    Language English
    Publishing date 2023-05-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 4411-8
    ISSN 1530-0447 ; 0031-3998
    ISSN (online) 1530-0447
    ISSN 0031-3998
    DOI 10.1038/s41390-023-02614-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 564: Show issues Location:
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  8. Article ; Online: Randomization in survival studies: An evaluation method that takes into account selection and chronological bias.

    Rückbeil, Marcia Viviane / Hilgers, Ralf-Dieter / Heussen, Nicole

    PloS one

    2019  Volume 14, Issue 6, Page(s) e0217946

    Abstract: The random allocation of patients to treatments is a crucial step in the design and conduct of a randomized controlled trial. For this purpose, a variety of randomization procedures is available. In the case of imperfect blinding, the extent to which a ... ...

    Abstract The random allocation of patients to treatments is a crucial step in the design and conduct of a randomized controlled trial. For this purpose, a variety of randomization procedures is available. In the case of imperfect blinding, the extent to which a randomization procedure forces balanced group sizes throughout the allocation process affects the predictability of allocations. As a result, some randomization procedures perform superior with respect to selection bias, whereas others are less susceptible to chronological bias. The choice of a suitable randomization procedure therefore depends on the expected risk for selection and chronological bias within the particular study in question. To enable a sound comparison of different randomization procedures, we introduce a model for the combined effect of selection and chronological bias in randomized studies with a survival outcome. We present an evaluation method to quantify the influence of bias on the test decision of the log-rank test in a randomized parallel group trial with a survival outcome. The effect of selection and chronological bias and the dependence on the study setting are illustrated in a sensitivity analysis. We conclude with a case study to showcase the application of our model for comparing different randomization procedures in consideration of the expected type I error probability.
    MeSH term(s) Humans ; Random Allocation ; Selection Bias ; Survival Analysis ; Time Factors
    Language English
    Publishing date 2019-06-03
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0217946
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  9. Article ; Online: Influence of Clinical Expertise Between Clinician-Instructors Versus Student-Instructors on the Effectiveness of Ultrasound Courses.

    Hofer, Matthias / Kamper, Lars / Heussen, Nicole / Martin, Ole / Heverhagen, Johannes

    Ultraschall in der Medizin (Stuttgart, Germany : 1980)

    2020  Volume 43, Issue 1, Page(s) 58–63

    Abstract: Purpose:  To investigate how the extent of an ultrasound instructor's clinical expertise influences the level of hands-on ultrasound competency achieved by clinicians after three-day ultrasound courses in abdominal and emergency ultrasound. The second ... ...

    Title translation Einfluss klinischer Erfahrung zwischen ärztlichen und studentischen Sono-Instruktoren auf die Effektivität praktischer Ultraschallkurse.
    Abstract Purpose:  To investigate how the extent of an ultrasound instructor's clinical expertise influences the level of hands-on ultrasound competency achieved by clinicians after three-day ultrasound courses in abdominal and emergency ultrasound. The second goal was to determine how physicians in residency rate the sonographic and didactic skills of student instructors compared to medical staff instructors.
    Method:  A total of N = 100 residents participating in a 3-day ultrasound workshop were randomly trained either by 15 student instructors or by clinical staff physicians, both with > 2 years of teaching experience. Both instructor groups had previously completed 120 hours of didactic instructor training. Ultrasound competencies were assessed by a standardized objective structured clinical examination (OSCE) of healthy individuals. The sonographic and didactic skills of both instructor groups were rated by questionnaires with six-step Likert items (1 = excellent, 6 = poor).
    Results:  The cohort, trained by student instructors, achieved the same scoring level as the second cohort, trained by physician instructors (mean score 76.4, versus 73.7 of max. 100 points, p = 0.28) in the final OSCE. The sonographic qualification was rated for student educators as 1.44 (mean) [1.1-1.62], versus residents 1.46 [1.26-1.61], versus attendings 1.29 [1.05-1.61]. Didactic skill levels were rated without significant differences with means of 1.53, 1.57 and 1.53, respectively.
    Discussion & conclusion:  The didactic competence of student instructors does not differ statistically from the competency levels of experienced physicians. In terms of the acquired ultrasound skills of trainees, our data indicate that student instructors can be as efficient as staff instructors. Therefore, student instructors can be employed as resource-saving ultrasound educators without decreasing the skills level achieved by course participants, provided that they previously underwent a comprehensive didactic and sonographic training program.
    MeSH term(s) Clinical Competence ; Humans ; Internship and Residency ; Students ; Surveys and Questionnaires ; Ultrasonography
    Language English
    Publishing date 2020-06-03
    Publishing country Germany
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 801064-x
    ISSN 1438-8782 ; 1439-0914 ; 1431-4894 ; 0172-4614
    ISSN (online) 1438-8782
    ISSN 1439-0914 ; 1431-4894 ; 0172-4614
    DOI 10.1055/a-1176-0622
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    Zs.A 1572: Show issues Location:
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  10. Article ; Online: The impact of selection bias in randomized multi-arm parallel group clinical trials.

    Uschner, Diane / Hilgers, Ralf-Dieter / Heussen, Nicole

    PloS one

    2018  Volume 13, Issue 1, Page(s) e0192065

    Abstract: The impact of selection bias on the results of clinical trials has been analyzed extensively for trials of two treatments, yet its impact in multi-arm trials is still unknown. In this paper, we investigate selection bias in multi-arm trials by its impact ...

    Abstract The impact of selection bias on the results of clinical trials has been analyzed extensively for trials of two treatments, yet its impact in multi-arm trials is still unknown. In this paper, we investigate selection bias in multi-arm trials by its impact on the type I error probability. We propose two models for selection bias, so-called biasing policies, that both extend the classic guessing strategy by Blackwell and Hodges. We derive the distribution of the F-test statistic under the misspecified outcome model and provide a formula for the type I error probability under selection bias. We apply the presented approach to quantify the influence of selection bias in multi-arm trials with increasing number of treatment groups using a permuted block design for different assumptions and different biasing strategies. Our results confirm previous findings that smaller block sizes lead to a higher proportion of sequences with inflated type I error probability. Astonishingly, our results also show that the proportion of sequences with inflated type I error probability remains constant when the number of treatment groups is increased. Realizing that the impact of selection bias cannot be completely eliminated, we propose a bias adjusted statistical model and show that the power of the statistical test is only slightly deflated for larger block sizes.
    MeSH term(s) Models, Theoretical ; Randomized Controlled Trials as Topic ; Selection Bias
    Language English
    Publishing date 2018
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0192065
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