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List of works by Meinhard Kieser

A Bootstrap Procedure for Adaptive Selection of the Test Statistic in Flexible Two-Stage DesignsThis paper is based on a presentation given at the Workshop “Frontiers in Adaptive Designs”, 17.–18. 5. 2001, Vienna/Austria

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A Comparison of Procedures for Adaptive Choice of Location Tests in Flexible Two-Stage Designs

A closer look at the effect of preliminary goodness‐of‐fit testing for normality for the one‐sample t‐test ⬇️

scientific article published on December 6, 2010

A comparison of Bayesian and frequentist methods in random-effects network meta-analysis of binary data

scientific article published on 18 January 2020

A comparison of group sequential and fixed sample size designs for bioequivalence trials with highly variable drugs

scientific article

A general approach for sample size calculation for the three-arm 'gold standard' non-inferiority design

scientific article published on 4 July 2012

A method for using real world data in breast cancer modeling

scientific article

A new conditional performance score for the evaluation of adaptive group sequential designs with sample size recalculation

scientific article published on 06 April 2020

A systematic comparison of recurrent event models for application to composite endpoints

scientific article published on 4 January 2018

A variational approach to optimal two-stage designs

scientific article published on 01 July 2019

A weighted combined effect measure for the analysis of a composite time-to-first-event endpoint with components of different clinical relevance.

scientific article

Adjustment for exploratory cut-off selection in randomized clinical trials with survival endpoint

scientific article published on 07 October 2019

Adjuvant Intensity Modulated Whole-Abdominal Radiation Therapy for High-Risk Patients With Ovarian Cancer (International Federation of Gynecology and Obstetrics Stage III): First Results of a Prospective Phase 2 Study

scientific article published on 4 July 2017

Antibiotic sutures against surgical site infections--Authors' reply

scientific article published on 17 October 2014

Assessing additional benefit in noninferiority trials

scientific article published on 30 June 2014

Assessment of statistical significance and clinical relevance

scientific article published on 28 September 2012

Better tolerability of St. John's wort extract WS 5570 compared to treatment with SSRIs: a reanalysis of data from controlled clinical trials in acute major depression

scientific article

Blinded Sample Size Reestimation in Multiarmed Clinical Trials

Blinded assessment of treatment effects utilizing information about the randomization block length

scientific article published in May 2009

Blinded sample size re-estimation in crossover bioequivalence trials

scientific article published on 9 April 2014

Blinded sample size reassessment in non-inferiority and equivalence trials

scientific article published in March 2003

Blinded sample size recalculation for clinical trials with normal data and baseline adjusted analysis

scientific article

Blinded sample size recalculation in clinical trials incorporating historical data

scientific article

Blinded sample size recalculation in clinical trials with binary composite endpoints

scientific article published on 13 June 2016

Blinded sample size recalculation in multicentre trials with normally distributed outcome.

scientific article published in June 2010

Blinded sample size re‐estimation in superiority and noninferiority trials: bias versus variance in variance estimation ⬇️

scientific article published on March 19, 2013

Blinded versus unblinded covariate selection in confirmatory survival trials

scientific article published in January 2014

COMPARE Family (Children of Mentally Ill Parents at Risk Evaluation): A Study Protocol for a Preventive Intervention for Children of Mentally Ill Parents (Triple P, Evidence-Based Program That Enhances Parentings Skills, in Addition to Gold-Standard

Children of Mentally III Parents at Risk Evaluation (COMPARE): Design and Methods of a Randomized Controlled Multicenter Study-Part I

Choice of futility boundaries for group sequential designs with two endpoints

scientific article published on 8 August 2017

ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

scientific article

Comments on "Adaptive sample size modification in clinical trials: Start small then ask for more?"

scientific article published on 01 January 2020

Comments on 'Hypothesis testing for two-stage designs with over or under enrollment'.

scientific article published in April 2016

Community Violence Exposure and Conduct Problems in Children and Adolescents with Conduct Disorder and Healthy Controls

scientific article published on 6 November 2017

Comparison of carbon ion radiotherapy to photon radiation alone or in combination with temozolomide in patients with high-grade gliomas: explorative hypothesis-generating retrospective analysis

scientific article published in July 2013

Computed tomography perfusion analysis of pancreatic carcinoma

scientific article

Conduct disorder in adolescent females: current state of research and study design of the FemNAT-CD consortium

scientific article published on 09 June 2018

Considerations on what constitutes a 'qualified statistician' in regulatory guidelines

scientific article published on 21 September 2011

Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study

scientific article

Curtailment in single‐arm two‐stage phase II oncology trials ⬇️

scientific article published on May 18, 2012

Decision rules for subgroup selection based on a predictive biomarker

scientific article published on January 2014

DeloRes trial: study protocol for a randomized trial comparing two standardized surgical approaches in rectal prolapse - Delorme’s procedure versus resection rectopexy ⬇️

scientific article published on August 29, 2012

Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583].

scientific article published on 30 May 2012

Diagnostic instruments for autism spectrum disorder (ASD)

scientific article

Early tracheostomy in ventilated stroke patients: Study protocol of the international multicentre randomized trial SETPOINT2 (Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2).

scientific article

Easily applicable multiple testing procedures to improve the interpretation of clinical trials with composite endpoints

scientific article

Education to a Healthy Lifestyle Improves Symptoms and Cardiovascular Risk Factors - AsuRiesgo Study

scientific article published on 17 March 2015

Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy: A Randomized Clinical Trial

scientific article published on 26 October 2016

Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial

scientific article published on 7 April 2014

Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso

scientific article published on 28 September 2014

Estimation of secondary endpoints in two‐stage phase II oncology trials ⬇️

scientific article published on August 29, 2012

Group-based cognitive behavioural psychotherapy for children and adolescents with ASD: the randomized, multicentre, controlled SOSTA-net trial

scientific article published on 30 December 2015

HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial) ⬇️

scientific article published on November 1, 2012

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial ⬇️

scientific article

Hypothesis testing in Bayesian network meta-analysis

article published in 2018

Identification of physicians with unusual performance in screening colonoscopy databases: a Bayesian approach

scientific article published on 16 December 2014

Incorporating historical two-arm data in clinical trials with binary outcome: A practical approach

scientific article published on 30 March 2020

Influence of a 7-day treatment with Ginkgo biloba special extract EGb 761 on bleeding time and coagulation: a randomized, placebo-controlled, double-blind study in healthy volunteers

scientific article published in June 2004

Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444).

scientific article published in June 2011

Integrated evaluation of targeted and non-targeted therapies in a network meta-analysis

scientific article published on 23 September 2019

Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541).

scientific article

Ion therapy within the trimodal management of superior sulcus tumors: the INKA trial

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Methods for proper handling of overrunning and underrunning in phase II designs for oncology trials

scientific article published on 17 March 2015

On the inappropriateness of an EM algorithm based procedure for blinded sample size re‐estimation ⬇️

scientific article published on January 30, 2002

Opportunities and challenges of clinical trials in cardiology using composite primary endpoints

scientific article published on January 2015

Opportunities and challenges of combined effect measures based on prioritized outcomes

scientific article published on 13 October 2013

Optimal adaptive two-stage designs for phase II cancer clinical trials

scientific article published on 19 July 2013

Optimal decision rules for biomarker-based subgroup selection for a targeted therapy in oncology

scientific article published on 7 May 2015

Optimal decision-making in oncology development programs based on probability of success for phase III utilizing phase II/III data on response and overall survival

scientific article published on 14 July 2020

Optimal planning of phase II/III programs for clinical trials with multiple endpoints.

scientific article published on 26 April 2018

Outcomes of multimorbid vascular surgery patients with and without major amputation in a German geriatric rehabilitation clinic

scientific article

Partial pancreatoduodenectomy versus duodenum-preserving pancreatic head resection in chronic pancreatitis: the multicentre, randomised, controlled, double-blind ChroPac trial

scientific article

Perioperative chemo(radio)therapy versus primary surgery for resectable adenocarcinoma of the stomach, gastroesophageal junction, and lower esophagus ⬇️

scientific article published on May 31, 2013

Perioperative chemotherapy versus primary surgery for locoregionally advanced resectable adenocarcinoma of the stomach, gastroesophageal junction and lower esophagus

scientific article

Perioperative corticosteroids for patients undergoing elective major abdominal surgery (CORPUS)

scientific article

Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial

scientific article

Phase I/II trial evaluating carbon ion radiotherapy for the treatment of recurrent rectal cancer: the PANDORA-01 trial

scientific article

Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III - The OVAR-IMRT-02 Study ⬇️

scientific article published on January 28, 2011

Placebo controlled continuation treatment with Hypericum extract WS® 5570 after recovery from a mild or moderate depressive episode

Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis

scientific article published on April 2016

Planning and analysis of three-arm non-inferiority trials with binary endpoints

scientific article published in January 2007

Planning and analysis of three-arm non-inferiority trials with binary endpoints

Point estimation in adaptive enrichment designs

scientific article published on 07 August 2017

Power and sample size determination when assessing the clinical relevance of trial results by 'responder analyses'.

scientific article published in November 2004

Predictors of Residual Tumor in Breast-Conserving Therapy

scientific article published on 30 July 2015

Preoperative chemo(radio)therapy versus primary surgery for gastroesophageal adenocarcinoma: systematic review with meta-analysis combining individual patient and aggregate data

scientific article

Prevalence of intracardiac thrombi under phenprocoumon, direct oral anticoagulants (dabigatran and rivaroxaban), and bridging therapy in patients with atrial fibrillation and flutter

scientific article published on 18 December 2014

Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial ⬇️

scientific article published on November 21, 2011

Prognostic factors, patterns of recurrence and toxicity for patients with esophageal cancer undergoing definitive radiotherapy or chemo-radiotherapy

scientific article published on 23 April 2015

Prognostic relevance of elevated pulmonary arterial pressure assessed non-invasively: Analysis in a large patient cohort with invasive measurements in near temporal proximity

scientific article published on 19 January 2018

Psychophysiological responses to sadness in girls and boys with conduct disorder

scientific article published on 12 November 2020

Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension ⬇️

scientific article published on November 16, 2012

Randomised trial of proton vs. carbon ion radiation therapy in patients with low and intermediate grade chondrosarcoma of the skull base, clinical phase III study

scientific article

Randomised, double-blind, placebo-controlled trial of EPs 7630 in adults with COPD ⬇️

scientific article published on March 7, 2013

Randomized phase II study evaluating a carbon ion boost applied after combined radiochemotherapy with temozolomide versus a proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma: the CLEOPATRA trial

scientific article

Rationale and design of the FreezeAF trial: a randomized controlled noninferiority trial comparing isolation of the pulmonary veins with the cryoballoon catheter versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibril

scientific article

Rejoinder

Relapsed/refractory acute myeloid leukemia: any progress?

scientific article published on 28 August 2017

Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS - a randomised controlled multicentre trial (ISRCTN30964555) ⬇️

scientific article published on April 5, 2012

Risk–benefit assessment of closed intra-abdominal drains after pancreatic surgery: a systematic review and meta-analysis assessing the current state of evidence ⬇️

scientific article published on October 21, 2010

Robotic Radiosurgery for Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence (CYBER-SPACE)-A Single-Center Prospective Randomized Trial

scientific article published on 15 March 2018

Safety and efficacy of artesunate-amodiaquine combined with either methylene blue or primaquine in children with falciparum malaria in Burkina Faso: A randomized controlled trial

scientific article published on 10 October 2019

Sample Size Adjustment in Clinical Trials for Proving Equivalence

Sample size calculations for noninferiority trials with Poisson distributed count data ⬇️

scientific article published on February 8, 2013

Sample size planning for phase II trials based on success probabilities for phase III.

scientific article

Sample size recalculation for binary data in internal pilot study designs

Sample size recalculation in internal pilot study designs: a review

scientific article published on August 2006

Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA) - a randomized monocentric trial

scientific article published on 12 April 2015

Simple procedures for blinded sample size adjustment that do not affect the type I error rate

scientific article published in December 2003

Simulation and data-generation for random-effects network meta-analysis of binary outcome

scientific article published on 09 May 2019

Simulation-based adjustment after exploratory biomarker subgroup selection in phase II.

scientific article published on 24 April 2017

Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas

scientific article published on 28 January 2015

Stem cell Transplantation for Eradication of Minimal PAncreatic Cancer persisting after surgical Excision (STEM PACE Trial, ISRCTN47877138): study protocol for a phase II study

scientific article

Superior efficacy of St John's wort extract WS 5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298].

scientific article published on 23 June 2006

Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study).

scientific article published on 14 February 2012

Test-compatible confidence intervals for adaptive two-stage single-arm designs with binary endpoint.

scientific article

The Impact of Conscious Sedation versus General Anesthesia for Stroke Thrombectomy on the Predictive Value of Collateral Status: A Post Hoc Analysis of the SIESTA Trial.

scientific article published on 08 June 2017

The SETscore to Predict Tracheostomy Need in Cerebrovascular Neurocritical Care Patients

scientific article published on 2 February 2016

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial

scientific article published on 7 January 2013

Time-to-first-event versus recurrent-event analysis: points to consider for selecting a meaningful analysis strategy in clinical trials with composite endpoints

scientific article published on 16 February 2018

Timing of the interim analysis in adaptive enrichment designs

scientific article published on 24 October 2017

To test or not to test: Preliminary assessment of normality when comparing two independent samples

scientific article

Transition probabilities of HER2-positive and HER2-negative breast cancer patients treated with Trastuzumab obtained from a clinical cancer registry dataset

scientific article published on 12 March 2016

Treatment of acute bronchitis with EPs 7630: Randomized, controlled trial in children and adolescents ⬇️

scientific article published on April 1, 2012

Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.

scientific article published in March 2009

Two-stage designs for cross-over bioequivalence trials

scientific article published on 24 March 2015

Urinary excretion of high molecular weight adiponectin is an independent predictor of decline of renal function in type 2 diabetes

scientific article published on 24 December 2013

Utility-based optimization of phase II/III programs

scientific article published on 9 August 2015

Utilizing radar graphs in the visualization of simulation and estimation results in network meta-analysis

scientific article published on 04 May 2020

What makes a biostatistician?

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