Selected publications Prof. Dr. Meinhard Kieser
2012, 2011, 2010, 2009, 2008, 2007, 2006, 2005, 2004, 2003, 2002, 2001, 2000, 1999, 1998 and earlier
In Press
Englert S, Kieser M. Improving the flexibility and efficiency of phase II designs for oncology trials. Biometrics (epublished ahead of print). DOI: 10.1111/j.1541-0420.2011.01720.x.
Kunz CU, Kieser M. Curtailment in single-arm two-stage phase II oncology trials. Biometrical Journal (accepted).
Pobiruchin M, Kieser M. Sample size calculation and blinded sample size recalculation in clinical trials where the treatment effect is measured by the relative risk. Communication in Statistics - Simulation and Computation (accepted).
Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Büchler MW, Seiler CM. Design and current status of CONTINT: Continuous versus interrupted abdominal wall closure after emergency midline laparatomy - a randomised controlled multicenter tiral. Trials (accepted).
Rauch G, Kieser M. Multiplicity adjustment for composite binary endpoints. Methods of Information in Medicine (accepted).
Stucke K, Kieser M. A general approach to sample size calculation for the three-arm 'gold-standard' non-inferiority design. Statistics in Medicine (accepted).
2012
Combs SE, Kieser M, Habermehl D, Weitz J, Jäger D, Fossati P, Orrechia R, Engenhart-Cabillic R, Pötter R, Djosanjh M, Jäkel O, Büchler MW, Debus J. Phase I/II trial evaluating carbon ion radiotherapy for the treatment of recurrent rectal cancer: the PANDORA-01 trial. BMC Cancer 2012;12:137.
Englert S, Kieser M. Adaptive designs for single-arm phase II trials in oncology. Pharmaceutical Statistics 2012;11:241-249.
Gerlinger C, Edler L, Friede T, Kieser M, Nakas CT, Schumacher M, Seldrup J, Victor N. Considerations on what constitutes a 'Qualified Statistician' in regulatory guidelines. Statistics in Medicine 2012;31:1303-1305.
Hartmann M, Kopf S, Kircher C, Faude-Lang V, Djuric Z, Augstein F, Friederich HC, Kieser M, Bierhaus A, Humpert PM, Herzog W, Nawroth PP. Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetes patients: design and first results of a randomized controlled trial (the HEIDIS-Study). Diabetes Care 2012;35:945-947.
Kamin W, Ilyenko LI, Malek FA, Kieser M. Treatment of acute bronchitis with Eps 7630. A randomized, controlled trial in children and adolescents. Pediatrics International 2012;54:219-226.
Klauss M, Stiller W, Fritz F, Kieser M, Werner J, Kauczor HU, Grenacher L. Computed tomography perfusion analysis of pancreatic carcinoma. Journal of Computer Assisted Tomography 2012;36:237-242.
Rahbari NN, Lordick F, Fink C, Bork U, Stange A, Jäger D, Luntz S, Englert S, Rossion I, Koch M, Büchler MW, Kieser M, Weitz J. 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 randomized controlled multicentre trial. BMC Cancer 2012;12:142.
2011
Diener MK, Mehr KT, Wente MN, Kieser M, Büchler MW, Seiler CM. Risk-benefit assessment of closed intra-abdominal drains after pancreatic surgery: a systematic review and meta-analysis assessing the current state of evidence. Langenbeck's Archives of Surgery 2011;396:41-52.
Diener MK, Seiler CM, Rossion I, Kleef J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch ORC, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Meudecker J, Berrevoet F, Ganzera Sm, Heiss M, Bruckner T, Kieser M, Büchler MW. Effectiveness of stapler versus hand-sewn closure after DIStal PanCreaTectomy (DISPACT trial): a randomised, controlled multicentre trial. Lancet 2011;377:1514-1522.
Friede T, Kieser M. Blinded sample size recalculation for clinical trials with normal data and baseline adjusted analysis. Pharmaceutical Statistics 2011;10:8-13.
Friede T, Kieser M. Sample size reassessment in non-inferiority trials. Internal pilot study designs with ANCOVA. Methods of Information in Medicine 2011;50:237-243.
Heger U, Voss S, Knebel P, Doerr-Harim C, Neudecker J, Schuhmacher C, Faist E, Diener MK, Kieser M, Seiler CM, Buchler MW. Prevention of abdomial wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial. Trials 2011;12:245.
Kieser M, Friede T. Authors' Reply to the Letter to the Editor by Gang Li concerning the article by M. Kieser and T. Friede: Planning and analysis of three-arm non-inferiority trials with binary endpoints. Statistics in Medicine 26:253-73,2007. Statistics in Medicine 2011;30:300.
Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Büchler MW, Seiler CM. Insertion of totally implantable venous access devices: An expertise-based, randomized, controlled trial. Annals of Surgery 2011;253:1111-1117.
Kunz CU, Kieser M. Optimal two-stage designs for single-arm phase II oncology trials with two binary endpoints. Methods of Information in Medicine 2011; 50:372-377.
Kunz CU, Kieser M. Simon's minimax and optimal and Jung's admissibletwo-stage design with or without curtailment. The Stata Journal 2011;11:240-254.
Löffler T, Seiler CM,Rossion I, Kijak T, Thombusch O, Hodian R, Krüger M, Simon T, Bruckner T, Kieser M, Büchler MW, Weitz J and the HASTA Trial Group. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial. Trials 2011;12:34.
Rochet N, Kieser M, Sterzing F, Krause S, Lindel K, Hrms W, Eichbaum MH, Schneeweiss A, Sohn C, Debus J. 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. BMC Cancer 2011;11:41.
Rochon J, Kieser M. A closer look on the effect of preliminary goodness-of-fit testing for normality for the one-sample t-test. British Journal of Mathemetical & Statistical Psychology 2011;64:410-426.
2010
Combs SE, Kieser M, Rieken S, Habermehl D, Jakel O, Haberer T, Nikoghosyan A, Haselmann R, Unterberg A, Wick W, Debus J. Randomized phase II study evaluating a carbon ion boost applied after combined radiochemotherapy with temezolomide versus a proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma: The CLEOPATRA trial (EudraCT Number 2009-014668-21). BMC Cancer 10:478 (www.biomedcentral.com/1471-2407/10/478).
Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM. ChroPac-Trial: Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head - Trial protocol of a randomised controlled multicenter trial. Trials 2010;11:47.
Jensen K, Kieser M. Blinded sample size recalculation in multicentre trials with normally distributed outcome. Biometrical Journal 2010;52:1-23.
Kamin W, Maydannik V, Malek FA, Kieser M. Efficacy and tolerability of EPs(R) 7630 in children and adolescents with acute bronchitis. International Journal of Clinical Pharmacology and Therapeutics 2010;48:184-191.
Kamin W, Maydannik V, Malek FA, Kieser M. Efficacy and tolerability of EPs 7630 in patients (6-18 years old) with acute bronchitis: a randomized, double-blind, placebo-controlled clinical dose-finding study. Acta Paediatrica 2010;99:537-543.
Kasper S, Gastpar M, Moeller HJ, Mueller W, Volz HP, Dienel A, Kieser M. Better tolerability of St. John's wort extract WS® 5570 compared to treatment with SSRIs. A re-analysis of data from controlled clinical trials in acute major depression. International Clinical Psychopharmacology 2010;25:204-213.
Luik A, Merkel M, Hoeren D, Riexinger T, Kieser M, Schmitt C. Rationale and design of the FreezeAF trial: a randomized controlled non-inferiority trial comparing isolation of the pulmonary veins with the cryoballoon catheter versus radiofrequency isolation. American Heart Journal 2010;159:555-560.
Matthys H, Lizogub VG, Malek FA, Kieser M. Efficacy and tolerability of EPs 7630 in patients (>18 years old) with acute bronchitis: a randomized, double-blind, placebo-controlled clinical dose-finding study. Current Medical Research and Opinion 26;1413-1422.
2009
Bachert C, Schapowal A, Funk P, Kieser M. Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs® 7630: a randomized, double-blind, placobo-controlled trial. Rhinology 2009;47:51-58.
Miller, F, Friede T, Kieser M. Blinded assessment of treatment effects utilizing information about the randomization block length. Statistics in Medicine 2009;28:1690-1706.
Seiler, CM, Bruckner, T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel HP. Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions. A multicenter randomized trial (INSECT). Annals of Surgery 2009;249:576-582.
Slanger TE, Schwarzbach M, Hofheinz R, Kienle P, Jensen K, Kieser M, Ronellenfitsch U. Perioperative chemotherapy versus primary surgery for locoregionally advanced resectable adenocarcinoma of the stomach, gastroesophageal junction and lower oesophagus. Cochrane Database of Systematic Reviews 2009, Issue 4.
2008
Diener M, Knaebel HP, Witte S, Rossion I, Kieser M, Büchler M, Seiler CM. DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIstal PAnCreaTectomy - study rationale and design. Clinical Trials: Journal of the Society of Clinical Trials 2008;5:534-545.
Kasper S, Gastpar M, Müller WE, Volz HP, Dienel A, Kieser M, Möller HJ. Efficacy of St. John’s wort extract WS® 5570 in acute treatment of mild depression: a reanalysis of data from controlled clinical trials. European Archives of Psychiatry and Clinical Neuroscience 2008;258:59-63.
Kasper S, Volz HP, Möller HJ, Dienel A, Kieser M. Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after recovery from an acute episode of mild to moderate despression - a double-blind, randomized, controlled long-term trial. European Neuropsychopharmacology 2008;18:803-813.
2007
Kieser M, Friede T. Planning and analysis of three-arm non-inferiority trials with binary endpoints. Statistics in Medicine 2007;26:253-273.
Woelk H, Arnoldt KH, Kieser M, Hoerr R. Ginko biloba special extract EGb 761® in generalized anxiety disorder and adjustment disorder with anxious mood: a randomized, double-blind, placebo-controlled trial. Journal of Psychiatric Research 2007;41:472-480.
Wolff HH, Kieser M. Hamamelis in children with skin disorders and skin injuries: results of an obeservational study. European Journal of Pediatrics 2007;166:943-948.
2006
Anghelescu IG, Kohnen R, Szegedi A, Klement S, Kieser M. Comparison of Hypericum extract WS® 5570 and paroxetine in ongoing treatment after recovery from an episode of moderate to severe depression: results from a randomized multicenter study. Pharmacopsychiatry 2006;39:213-219.
Friede T, Kieser M. Sample size recalculation in internal pilot study designs: a review. Biometrical Journal 2006;48:537-555.
Kasper S, Anghelescu IG, Szegedi A, Dienel A, Kieser M. 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. BMC Medicine 2006;4:14.
2005
Friede T, Kieser M. Author’s Reply to Letter to the Editor by A.L. Gould and W.J. Shih: On the inappropriateness of an EM algorithm based procedure for blinded sample size re-estimation. Statistics in Medicine 2005;24:154-156.
Gaus W, Westendorf J, Diebow R, Kieser M. Identification of adverse drug reactions by evaluation of a prescription database, demonstrated for ‘risk of bleeding‘. Methods of Information in Medicine 2005;44:697-703.
Kieser M. A note on adaptive modification of hypotheses in flexible designs. Drug Information Journal 2005;39:215-222.
Kieser M. Discussion of the paper ‘Drop-the-Losers design: normal case’ by A.R. Sampson and M.W. Sill. Biometrical Journal 2005;47:271-273.
Kieser M. Letter to the Editor: Research data closer to expectation than compatible with random sampling by T.J. Cleophas. Statistics in Medicine 2005;24:319-320.
Kieser M, Hauschke D. Assessment of clinical relevance by considering point estimates and associated confidence intervals. Pharmaceutical Statistics 2005;4:101-107.
Kieser M, Szegedi A. Predicting stable response in patients with major depression treated with Hypericum extract WS® 5570/5572. Pharmacopsychiatry 2005;38:194-200.
Schneider LS, DeKosky ST, Farlow MR, Tariot PN, Hoerr R, Kieser M. A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer´s type. Current Alzheimer Research 2005;2:541-551.
Szegedi A, Kohnen R, Dienel A, Kieser M. Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John’s wort): randomised controlled double blind non-inferiority trial versus paroxetine. British Medical Journal 2005;330:503-506.
Wüst K, Kieser M. Including long- and short-term data in blinded sample size recalculation for binary endpoints. Computational Statistics & Data Analysis 2005;48:835-855.
Wüst K, Kieser M. Monitoring continuous long-term outcomes in adaptive designs. Communications in Statistics – Computation and Simulation 2005;34:321-341.
2004
Albrecht DM, van Ackern K, Bender HJ, Hof H, Kox W, Victor N, Funk P, Kieser M, Köhler S, Krausch D, Marzi I, Menges T, Schmidt H. Efficacy and safety of the platelet-activating factor receptor antagonist BN 52021 (Ginkgolide B) in patients with severe sepsis - a randomized, double-blind, placebo-controlled multicenter trial. Clinical Drug Investigation 2004;24:137-147.
Friede T, Kieser M. Sample size recalculation for binary data in internal pilot study designs. Pharmaceutical Statistics 2004;3:269-279.
Kasper S, Dienel A, Kieser M. Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after successful acute treatment of mild to moderate depression – rationale and study design. International Journal of Methods in Psychiatric Research 2004;13:176-183.
Kieser M, Röhmel J, Friede T. Power and sample size determination when assessing the clinical relevance of trial results by ‘responder analyses’. Statistics in Medicine 2004;23:3287-3305.
Köhler S, Funk P, Kieser M. 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. Blood Coagolation and Fibrinolysis 2004;15:303-309.
2003
Friede T, Kieser M. Blinded sample size reassessment in non-inferiority and equivalence trials. Statistics in Medicine 2003;22:995-1007.
Friede T, Kieser M, Neuhäuser M, Büning H. A comparison of procedures for adaptive choice of location tests in flexible two-stage designs. Biometrical Journal 2003;45:292-310.
Kieser M, Friede T. Simple procedures for blinded sample size adjustment that do not affect the type I error rate. Statistics in Medicine 2003;22:3571-3581.
Victor N, Kieser M. Configural frequency analysis and association analyses in contingency tables. Computational Statistics & Data Analysis 2003;44:419-29.
Wüst K, Kieser M. Blinded sample size recalculation for normally distributed outcomes using long- and short-term data. Biometrical Journal 2003;45:915-930.
2002
Friede T, Kieser M. On the inappropriateness of an EM algorithm based procedure for blinded sample size re-estimation. Statistics in Medicine 2002;21:165-176.
Kieser M. Methoden zur Entscheidungsunterstützung in klinischen Studien mit adaptivem Design. Forschungsbericht der Abteilung Medizinische Biometrie, Universität Heidelberg, Bd. 39, Heidelberg 2002.
Kieser M, Schneider B, Friede T. A bootstrap procedure for adaptive selection of the test statistic in flexible two-stage designs. Biometrical Journal 2002;44:641-652.
Le Bars PL, Velasco FM, Ferguson JM, Dessain EC, Kieser M, Hörr R. Influence of the severity of cognitive impairment on the effect of the Ginkgo biloba extract EGb 761 in Alzheimer´s disease. Neuropsychobiology 2002;45:19-26.
Lecrubier Y, Clerc G, Didi R, Kieser M. Efficacy of St. John´s wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. American Journal of Psychiatry 2002;159:1361-1366.
2001
Friede T, Kieser M. A comparison of methods for adaptive sample size adjustment. Statistics in Medicine 2001;20:3861-3873.
Friede T, Kieser M. A loss-function based approach for dose-response trials with adaptive two-stage designs. Journal of Epidemiology and Biostatistics 2001;6:317-324.
Friede T, Kieser M. Sample size adjustment in clinical trials for proving equivalence. Drug Information Journal 2001;35:1401-1408.
Friede T, Miller F, Bischoff W, Kieser M. A note on change point estimation in dose-response trials. Computational Statistics & Data Analysis 2001;37:219-232.
Hauschke D, Kieser M. Multiple testing to establish noninferiority of k treatments with a reference based on the ratio of two means. Drug Information Journal 2001;35:1247-1251.
Kalb R, Trautmann-Sponsel RD, Kieser M. Efficacy and tolerability of Hypericum extract WS 5572 versus placebo in mildly to moderately depressed patients. A randomized double-blind multicenter clinical trial. Pharmacopsychiatry 2001;34:96-103.
Malsch U, Kieser M. Efficacy of Kava-Kava special extract WS 1490 in the treatment of patients with nervous anxiety, tension and restlessness states of non-psychotic origin after pre-treatment with benzodiazepines. Psychopharmacology 2001;157:277-283.
2000
Friede T, Kieser M, Miller F. Modeling the recovery from depressive illness by an exponential model with mixed effects. Methods of Information in Medicine 2000;39:12-15.
Kieser M, Friede T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Statistics in Medicine 2000;19:901-911.
Kieser M, Friede T. Blinded sample size re-estimation in multi-armed clinical trials. Drug Information Journal 2000;34:455-460.
Kieser M, Hauschke D. Statistical methods for demonstrating equivalence in crossover trials based on the ratio of two location parameters. Drug Information Journal 2000;34:563-568.
Le Bars PL, Kieser M, Itil KZ. A 26-week analysis of a double-blind, placebo-controlled trial of the Ginkgo biloba extract EGb 761 in dementia. Dementia and Geriatric Cognitive Disorders 2000;11:230-237.
Lehmacher W, Kieser M, Hothorn L. Sequential and multiple testing for dose-response analysis. Drug Information Journal 2000;34:591-597.
1999
Bauer P, Kieser M. Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine 1999;18:1833-1849.
Hauschke D, Kieser M, Diletti E, Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Statistics in Medicine 1999;18:93-105.
Hauschke D, Kieser M, Hothorn LA. Proof of safety in toxicology based on the ratio of two means for normally distributed data. Biometrical Journal 1999;41:295-304.
Kieser M, Bauer P, Lehmacher W. Inference on multiple endpoints in clinical trials with adaptive interim analyses. Biometrical Journal 1999;41:261-277.
Kieser M, Hauschke D. Approximate sample sizes for testing hypotheses about the ratio and difference of two means. Journal of Biopharmaceutical Statistics 1999;9:641-650.
Kieser M, Reitmeir P, Wassmer G. Letter to the Editor to the paper by R.B. Arani and J.J. Chen A power study of a sequential method of p-value adjustment for correlated continuous endpoints. Journal of Biopharmaceutical Statistics 1999;9:531-533.
Kieser M, Victor N. Configural frequency analysis (CFA) revisited - a new look at an old approach. Biometrical Journal 1999;41:967-983.
Wassmer G, Reitmeir P, Kieser M, Lehmacher W. Procedures for testing multiple endpoints in clinical trials: an overview. Journal of Statistical Planning and Inference 1999;82:69-81.
1998 and earlier
Bauer P, Kieser M. A unifying approach for confidence intervals and testing of equivalence and difference. Biometrika 1996;83:934-937.
Kieser M. A confirmatory strategy for therapeutic equivalence trials. Journal of Clinical Pharmacology and Therapeutics 1995;33:388-390.
Kieser M, Wassmer G. On the use of the upper confidence limit on the variance from a pilot sample for sample size determination. Biometrical Journal 1996;38:941-949.
Laakmann G, Schüle C, Baghai T, Kieser M. St. John's wort in mild to moderate depression: The relevance of hyperforin for clinical efficacy. Pharmacopsychiatry 1998;31(S1):54-59.
Oellrich S, Freischläger F, Benner A, Kieser M. Sample size determination on survival time data – a review. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 1997;28:64-85.
Ortseifen C, Bruckner T, Burke M, Kieser M. An overview of software tools for sample size determination. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 1997;28:91-118.
Roebruck P, Elze M, Hauschke D, Leverkus F, Kieser M. Literaturübersicht zur Fallzahlplanung für Äquivalenzprobleme. Informatik, Biometrie und Epidemiologie in Medizin und Biologie 1997;28:51-63.
Volz HP, Kieser M. Kava-kava extract WS-1490 versus placebo in anxiety disorders – a randomized placebo-controlled 25-week outpatient trial. Pharmacopsychiatry 1997;30:1-5.
