Ann‐Kathrin Ozga

Methods for analyzing recurrent and terminal events considering composite and competing endpoints in clinical trials: a practical overview

Alidan Duoerkongjiang, Antonia Zapf, Paulus Kirchhof, Ann‐Kathrin Ozga

Time to event endpoints like time to myocardial infarction, relapse, or death are often of primary interest in clinical trials. To describe the whole disease process and gain a complete picture of treatment effects, methods for recurrent time to event analysis considering …

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The “Hamburg Life After Cancer Program”: Development, Implementation and Evaluation of a Structured Survivorship Program - Study Protocol of a Hybrid Effectiveness-Implementation Study

Hannah Führes, Julia von Grundherr, Franziska Wolters, Mareike Rutenkröger et autres

Abstract Background Advances in multimodal oncological treatment have improved survival, resulting in a growing population of cancer survivors. Yet, many survivors experience physical and psychosocial late and long-term effects after completing active cancer treatment, highlighting the need for follow-up care that extends …

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Additional file 2 of Methods for analyzing recurrent and terminal events considering composite and competing endpoints in clinical trials: a practical overview

Alidan Duoerkongjiang, Antonia Zapf, Paulus Kirchhof, Ann‐Kathrin Ozga

Additional file 2. Appendix 2. Format: PDF. R code used for model implementation, including data preparation and implementation-level data structures required for model fitting, corresponding output, and supplementary results.

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Additional file 2 of Methods for analyzing recurrent and terminal events considering composite and competing endpoints in clinical trials: a practical overview

Alidan Duoerkongjiang, Antonia Zapf, Paulus Kirchhof, Ann‐Kathrin Ozga

Additional file 2. Appendix 2. Format: PDF. R code used for model implementation, including data preparation and implementation-level data structures required for model fitting, corresponding output, and supplementary results.

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Additional file 1 of Methods for analyzing recurrent and terminal events considering composite and competing endpoints in clinical trials: a practical overview

Alidan Duoerkongjiang, Antonia Zapf, Paulus Kirchhof, Ann‐Kathrin Ozga

Additional file 1. Appendix 1. Format: PDF. Supplementary methodological information, including model specification, estimation, interpretation, and underlying assumptions, as well as an application-specific interpretation table for the EAST-AFNET 4 example.

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Additional file 1 of Methods for analyzing recurrent and terminal events considering composite and competing endpoints in clinical trials: a practical overview

Alidan Duoerkongjiang, Antonia Zapf, Paulus Kirchhof, Ann‐Kathrin Ozga

Additional file 1. Appendix 1. Format: PDF. Supplementary methodological information, including model specification, estimation, interpretation, and underlying assumptions, as well as an application-specific interpretation table for the EAST-AFNET 4 example.

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The Challenge of Time‐to‐Event Analysis for Multiple Events: A Guided Tour From Time‐to‐First‐Event to Recurrent Time‐to‐Event Analysis

Sandra Schmeller, Alexandra A. Erdmann, Jan Beyersmann, Christiane Angermann et autres

Clinical trials often compare a treatment to a control group concerning multiple possible combined time-to-event endpoints like hospital-free survival. Thereby, the first endpoint may occur more than once ("recurrent"), whereas the second endpoint is absorbing. Inclusion of all observed events in the …

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Patient-centred interprofessional teleconsultation for post-viral symptom complexes in German primary care—protocol for the cluster-randomised controlled COVI-Care M-V trial

Christin Löffler, Anne Daubmann, Daniela Endlicher, Viacheslav Galchenko et autres

BACKGROUND: Post-viral syndromes, including long- and post-COVID, often lead to persistent symptoms such as fatigue and dyspnoea, affecting patients' daily lives and ability to work. The COVI-Care M-V trial examines whether interprofessional, patient-centred teleconsultations, initiated by general practitioners in cooperation with specialists, …

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Dual-energy CT liver fat fraction as prognostic imaging biomarker in critically ill patients

Jennifer Erley, Julia Breckow, Kevin Roedl, Ann‐Kathrin Ozga et autres

OBJECTIVES: To analyze changes in the liver dual-energy CT fat fraction (liver DECT FF) at the intensive care unit (ICU), and its prognostic value. MATERIALS AND METHODS: ). The skeletal muscle index, muscle radiodensity attenuation, subcutaneous/visceral adipose tissue area, and waist circumference …

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Retinoic acid-induced 2 deficiency impairs genomic stability in breast cancer

Lena Boettcher, Sarah Greimeier, Kerstin Borgmann, Shabbir S. Mughal et autres

BACKGROUND: Genome instability is a fundamental feature and hallmark of cancer, associated with aggressiveness, drug resistance and poor prognosis. RAI2 was initially identified as a novel metastasis suppressor protein specifically associated with the presence of disseminated tumour cells in the bone marrow …

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SARS-CoV-2 infection in patients with autoimmune hepatitis

Gustav Buescher, Thomas Marjot, Alfred Sidney Barritt, Marcial Sebode et autres

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Evaluation of the Health‐Related Quality of Life and Mental Health of Parents With Children and Adolescents With a Rare Disease Based on the Results of a Randomized Controlled Trial to Investigate a Family‐Based Intervention and an Online Intervention for Affected Families ( CARE ‐ FAM ‐ NET )

Johannes Boettcher, Anna Leidger, Ania Carolina Muntau, Jonas Denecke et autres

Parents caring for children with rare diseases are more impaired regarding health-related quality of life (HRQoL) and mental health than healthy controls and norm data. To address the research gap in psychological care for these parents, this study evaluates the effectiveness of …

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