Christine Adrion - Academia.edu (original) (raw)

Papers by Christine Adrion

Circulation, Nov 10, 2015

Introduction: In animal models, we have previously shown that a combined progenitor cell therapy ... more Introduction: In animal models, we have previously shown that a combined progenitor cell therapy comprising G-CSF treatment and a pharmacological inhibition of DPP4 can enhance the recruitment of c...

BMJ Open, Nov 1, 2021

Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres): study proto... more Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial. BMJ Open 2021;11:e056191.

BMJ Open, Sep 1, 2020

Spies , 2 on behalf of the ERIC study group To cite: Adrion C, Weiss B, Paul N, et al. Enhanced R... more Spies , 2 on behalf of the ERIC study group To cite: Adrion C, Weiss B, Paul N, et al. Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes. BMJ Open 2020;10:e036096.

Deutsches Arzteblatt International, Jun 13, 2008

Introduction: Screening colonoscopy is an effective means for early detection of colorectal carci... more Introduction: Screening colonoscopy is an effective means for early detection of colorectal carcinoma. Any exhaustive evaluation of the method must take further factors into account: epidemiology of colorectal adenomas and carcinomas in the target population, acceptance by the patients, structure, process, and outcome quality, and health economics.

Deutsches Ärzteblatt, 2008

S creeningkoloskopien sind ein wirksames Mittel zur Früherkennung kolorektaler Karzinome und ihre... more S creeningkoloskopien sind ein wirksames Mittel zur Früherkennung kolorektaler Karzinome und ihrer Vorstufen. Ihre Überlegenheit gegenüber anderen Screeningmethoden erklärt sich aus ihrer hohen Sensitivität und Spezifität sowie der Möglichkeit der Polypektomie beziehungsweise Biopsie (1). Eine bevölkerungsmedizinische Bewertung muss die folgenden Aspekte berücksichtigen. b Akzeptanz: Seit 2002 haben Mitglieder der Gesetzlichen Krankenversicherung im Alter ab 55 Jahren Anrecht auf zwei Früherkennungskoloskopien in zehnjährigem Abstand. Idealerweise sollten jährlich 10 % einer Altersdekade die Maßnahme nutzen. b Epidemiologie kolorektaler Neoplasien: Je höher die A-priori-Wahrscheinlichkeit ist, desto höher sind die Entdeckungsraten und der Anteil richtig positiver Verdachtsbefunde. Es kann sinnvoll sein, das Screening auf Ältere oder Hochrisikogruppen zu beschränken. Screeningstrategien können nicht unkritisch von anderen Populationen übernommen werden. b Strukturqualität: In der Krankenversorgung akzeptable Unannehmlichkeiten, Unzulänglichkeiten und Risiken sind bei präventiven Maßnahmen untragbar. Da Screening sich an beschwerdefreie und mehrheitlich gesunde Klienten richtet, folgt eine ethische Verpflichtung zur systematischen Qualitätssicherung. Strukturelle Aspekte, wie Qualifikation und apparative Ausstattung, sind in Deutschland in der Qualitätssicherungsvereinbarung zur Koloskopie vom 24. 7. 2006 geregelt (www.kvb.de/rechtsquel len/2500.html). b Prozessqualität: Trotz intakter Strukturen können Prozesse suboptimal ablaufen. Seit 2002 ist daher die Vergütung für Screeningkoloskopien an die standardisierte Dokumentation und epidemiologische Auswertung aller Screeninguntersuchungen gebunden (3). Entscheidend ist die Patientensicherheit. Bei bevölkerungsweiter Durchführung einer im Einzelfall wenig riskanten Maßnahme können viele Komplikationen auftreten, die den Nutzen konterkarieren. b Ergebnisqualität: Surrogatkriterien für den Erfolg des Programms sind die Entdeckungsraten sowie die Dignität der entdeckten Neubildungen. Langfristig ist der bevölkerungsbezogene Nachweis eines Rückgangs der Inzidenz kolorektaler Karzinome sowie der darmkrebsbedingten Mortalität zu fordern. b Gesundheitsökonomie: Stehen Kosten und Risiken in einem vernünftigen Verhältnis zum Nutzen?

Intensive Care Medicine

Purpose: Supporting the provision of intensive care medicine through telehealth potentially impro... more Purpose: Supporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany. Methods: We conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447). Results: Between September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection

Additional file 3. Patient symptom diary (original German version; word-for-word English translat... more Additional file 3. Patient symptom diary (original German version; word-for-word English translation).

Additional file 1 Supplementary information.

JAMA Network Open, 2021

IMPORTANCE Cerebellar ataxia is a neurodegenerative disease impairing motor function characterize... more IMPORTANCE Cerebellar ataxia is a neurodegenerative disease impairing motor function characterized by ataxia of stance, gait, speech, and fine motor disturbances. OBJECTIVE To investigate the efficacy, safety, and tolerability of the modified essential amino acid acetyl-DL-leucine in treating patients who have cerebellar ataxia. DESIGN, SETTING, AND PARTICIPANTS The Acetyl-DL-leucine on Cerebellar Ataxia (ALCAT) trial was an investigator-initiated, multicenter, double-blind, randomized, placebo-controlled, clinical crossover trial. The study was conducted at 7 university hospitals in Germany and Austria between

Additional file 4. Procedural and statistical methods.

By my signature below, I confirm that I have read, understood and agree to adhere to all conditio... more By my signature below, I confirm that I have read, understood and agree to adhere to all conditions, instru ctions and restrictions as specified in this Clinical Trial Protocol. I will discuss the Clinical Trial Protocol in detail with my colleagues and ensure that they are comprehensively informed about the trial compound / preparation and the execution of the clinical trial. I confirm that I and my colleagues will conduct this clinical trial in compliance with the Declaration of Helsinki, the ICH-GCP guidelines, and that I will abide by the national laws and regulations. Furthermore I and my colleagues commit ourselves not to commence subject enrollment before the authorization of the authorities and acceptance by the relevant and responsible Ethics Committee. I recognize that any changes in the protocol must be approved by the Sponsor / Sponsor Delegated Person (SDP), the Coordinating Investigator ("Leiter der klinischen Prüfung / LKP" in accordance with the German Drug Law), the Ethics Committee and, if applicable, the respective authority before implementation except when necessary to eliminate hazards to the subjects or when changes involve only logistical or administrative aspects of the clinical trial. Under my supervision I will have copies of this Clinical Trial Protocol and possible updates as well as access to all information regarding the carrying out of this clinical trial put at the disposal of my colleagues; in particular I will promptly forward all information from the Sponsor / Sponsor Delegated Person (SDP) on pharmaceutical safety (SUSAR) to my colleagues. I agree to ensure that the confidential information contained in this document will not be used for any purpose other than the evaluation or conduct of the clinical investigation without prior written consent of the Sponsor / Sponsor Delegated Person (SDP). The investigational medicinal products will be used only for the purpose of the clinical trial.

SPIRIT 2013 Checklist. (DOC 120 kb)

Background Traumatic events like critical illness and intensive care are threats to life and bodi... more Background Traumatic events like critical illness and intensive care are threats to life and bodily integrity and pose a risk factor for posttraumatic stress disorder (PTSD). PTSD affects the quality of life and morbidity and may increase health-care costs. Limited access to specialist care results in PTSD patients being treated in primary care settings. Narrative exposure therapy (NET) is based on the principles of cognitive behavioral therapy and has shown positive effects when delivered by health-care professionals other than psychologists. The primary aims of the PICTURE trial (from "PTSD after ICU survival") are to investigate the effectiveness and applicability of NET adapted for primary care with case management in adults diagnosed with PTSD after intensive care. Methods/design This is an investigator-initiated, multi-center, primary care-based, randomized controlled two-arm parallel group, observer-blinded superiority trial conducted throughout Germany. In total, 3...

Additional file 1. Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist of informa... more Additional file 1. Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist of information to include when reporting a randomized trial.

Einleitung 3 Zusammenfassende Bewertung und Vorstellung der Beiträge Paper I: Bayesian model sele... more Einleitung 3 Zusammenfassende Bewertung und Vorstellung der Beiträge Paper I: Bayesian model selection techniques as decision support for shaping a statistical analysis plan of a clinical trial: An example from a vertigo phase III study with longitudinal count data as primary endpoint. .. .. .. . .

BMC Medical Research Methodology, 2021

Background To model the progression of geographic atrophy (GA) in patients with age-related macul... more Background To model the progression of geographic atrophy (GA) in patients with age-related macular degeneration (AMD) by building a suitable statistical regression model for GA size measurements obtained from fundus autofluorescence imaging. Methods Based on theoretical considerations, we develop a linear mixed-effects model for GA size progression that incorporates covariable-dependent enlargement rates as well as correlations between longitudinally collected GA size measurements. To capture nonlinear progression in a flexible way, we systematically assess Box-Cox transformations with different transformation parameters λ . Model evaluation is performed on data collected for two longitudinal, prospective multi-center cohort studies on GA size progression. Results A transformation parameter of λ =0.45 yielded the best model fit regarding the Akaike information criterion (AIC). When hypertension and hypercholesterolemia were included as risk factors in the model, they showed an asso...

Deutsches Ärzteblatt international, 2008

Introduction Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and... more Introduction Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach preserving PD variants exist: pylorus preservation (ppPD), or pylorus resection (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, e.g. adjuvant chemotherapy. Evidence is lacking to assess which variant of PD entails fewer postoperative DGE. Methods and analysis The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE ...

Introduction Survival after critical illness has noticeably improved over the last decades due to... more Introduction Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there are an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium- or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognized as post intensive care syndrome (PICS). There are evidence- and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients' long-term outcomes if adhered to. Methods and analysis The protocol of a multicentre, pragmatic, stepped wedge cluster-randomized controlled, quality improvement trial is presented. During three predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a 1-way crossover from the control to the intervention condition. Af...