Edward Mascha Research Program | Lerner Research Institute

Principal Investigator

Edward Mascha, PhD

Staff / Head, Section of Biostatistics
Joint Appointment, Department of Outcomes Research, Anesthesiology Institute
Email: [email protected]
Location: Cleveland Clinic Main Campus

Research

The Edward Mascha Research Program focuses on enhancing patient outcomes in perioperative medicine through innovative research design and statistical methods. Dr. Edward Mascha and his team collaborate with Anesthesia Institute investigators on many single and multicenter clinical trials, as well as complex observational studies, all geared towards improving patient outcomes during and after surgery or critical care stays. In that content, Dr. Mascha’s research is focused on improving perioperative medicine research through creating and implementing innovative statistical methods to address current deficiencies or opportunities in the design and analysis of clinical studies. He and his team provide statistical support and guidance for the Departments of Outcomes Research, General Anesthesia, Critical Care Medicine, Cardio-thoracic Anesthesia and Pediatric Anesthesia. Dr. Mascha also provides grant support for many Section of Biostatistics investigators, particularly in grant development.

Biography

Dr. Mascha is Section Head for Biostatistics since 2022, and has led Biostatistical collaboration and research methodology for Cleveland Clinic’s Anesthesiology Institute since 2005. He joined Cleveland Clinic in1994 after four years of experience in multi-center clinical trials and collaborative statistical research at The Henry Ford Health Sciences Center. While at Henry Ford he was statistician for the NINDS t-PA multicenter randomized trial for ischemic stroke headed by Dr. Barbara Tilley, a formative experience in all aspects of clinical trial design, analysis and scientific impact. Once at Cleveland Clinic Dr. Mascha co-formed the Alpha/Beta collaborative team, working with investigators from 45 clinical departments, until he received his PhD in Biostatistics in 2005 from CWRU and accepted an appointment to the Anesthesia Institute. Outside of the Anesthesia Institute Dr. Mascha writes clinical trials grants with researchers in the international Outcomes Research Consortium, and well as from various Departments in the Biostatistics Section. Being an avid teacher, Dr. Mascha developed and leads a 9-month weekly-seminar course on Fundamentals of Clinical Research for Anesthesia Institute researchers which covers research ethics, study designs, basic and advances statistical methods, protocol development and manuscript writing. He also teaches statistical design and analysis methods to anesthesia institute residents and clinical trials method to CCLCM medical students. He further enhances the quality of perioperative medicine research as Statistical Editor for the journal Anesthesia & Analgesia, where he grew and now leads a cadre of 20 statistical reviewers for the Journal.

Education & Professional Highlights

Appointed
2003

Education & Fellowships

Graduate School - Case Western Reserve University
Biostatistics
Cleveland, OH USA
1991

Undergraduate - Borromeo College
Philosophy
Wickliffe, OH USA
1981

Medical Education - Case Western Reserve University
Cleveland, OH USA

Service

Lecturer: Anesthesiology Institute’s Fundamentals of Clinical Research series, Comprehensive Anesthesiology Review, Resident Education, Introduction to Clinical Trials (CMED450)

Statistical Editor: Anesthesia and Analgesia since 2016

Statistical Reviewer: Anesthesia and Analgesia, Anesthesiology, Vascular Surgery.
Merit Review Panels: NIH and PCORI

Research

Dr. Mascha has led Biostatistical collaboration and research methodology for Cleveland Clinic’s Anesthesiology Institute since 2005 and has over 33 years of experience as collaborative Biostatistician in perioperative medicine and in multiple disease areas. He and his QHS team collaborate with Anesthesia Institute investigators in the design and analysis of single and multicenter clinical trials, as well as complex observational studies, with the goal of improving surgical or ICU outcomes through practical perioperative interventions.

For example, we frequently use pragmatic designs such as cluster-randomized multiple crossover (CRXO) clinical trials. In a CRXO trial we treat each operating room suite as a cluster, randomized clusters using statistically optimal crossover patterns, and utilize appropriate techniques to account for within-cluster within- and between-period correlations in both sample size calculations and analysis. Our observational studies include intraoperative and/or postoperative exposures and typically shorter-term outcomes. A common complexity arises when the exposure and outcome periods overlap. We further test intra- and post-operative continuous monitoring devices for their ability to predict patient outcomes and facilitate a pre-emptive clinical “rescue”, or to assist nurses in round-the clock care, or to prevent infections. We have done extensive research in quantifying acceptable amounts of hypotension exposure and various interventions to prevent it.

Dr. Mascha has broad expertise in a host of statistical areas, and has special expertise and interest in design, analysis and monitoring of complex adaptive and group sequential clinical trials. His methodological research addresses current problems in design or analysis of clinical studies as encountered in anesthesiology, critical care medicine and pain management. His dissertation work developed new methods to estimate the variability of unobserved individual treatment effects for binary outcomes using a potential outcomes framework.

Composite outcomes are very common in anesthesia and perioperative medicine, but fraught with criticism. Dr. Mascha developed an “average relative effect” test which assesses the treatment effect on a composite outcome comprising multiple binary correlated events, such as major postoperative complications. This method solves several issues with standard methods for composite outcomes. For example, the estimated treatment effect on the traditional “collapsed composite” (any versus none) composite outcome for binary events such as distinct postoperative complications is highly weighted by the components of the composite with highest frequency, throws away much information and ignores within-patient correlation. Dr. Mascha’s methodology solves these issues by estimating a treatment effect for each component first, then averaging and incorporating the correlation matrix. When relative effects between treatments are more important than absolute difference, this is a highly effective method. The method is currently being expanded to count and time-to-event data types.

With the goal of improving perioperative medicine research, Dr. Mascha has written multiple in-depth and comprehensive expositions of design and analysis methods to guide biostatisticians and clinical researchers, including new methods for analyzing composite outcomes, mediation analysis, joint hypothesis testing, propensity score methods, in-depth methods for noninferiority and equivalence testing, segmented regression for an interrupted time series and difference-in-difference methods for studies implementing a systemic change, and more. These methods are now being used by many perioperative medicine researchers.

Our Team

Publications

Selected Publications

View publications for Edward Mascha, PhD
(Disclaimer: This search is powered by PubMed, a service of the U.S. National Library of Medicine. PubMed is a third-party website with no affiliation with Cleveland Clinic.)

Mascha EJ, Sessler DI. Segmented Regression and Difference-in-Difference Methods: Assessing the Impact of Systemic Changes in Healthcare. Anesthesia & Analgesia, 2019 [EPUB] [PUBMED]
Schulte PJ, Mascha EJ. Propensity Score Methods: Theory and Practice for Anesthesia Research. Anesthesia & Analgesia 2018; 127(4):1074-1084. [PUBMED]
Mascha EJ. Identifying the Best Cut-Point for a Biomarker, or Not. Anesthesia & Analgesia, 2018; 127(4):820–822. [PUBMED]
Mascha EJ, Vetter TR, Pittet JF: An appraisal of the Carlisle-Stouffer-Fisher method for assessing study data integrity and fraud. Anesth Analg 2017; 125: 1381-5 [PUBMED]
Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Anesthesiology. 2017;126(1):47-65. [PUBMED]
Koch CG, Sessler DI, Mascha EJ, Sabik JF, Li L, Duncan AI, Zimmerman NM, Blackstone EH..A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery. Ann Thorac Surg. 2017;104(4):1243-1250. [PUBMED]
Mascha EJ, Yang D, Weiss S, Sessler DI: Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology 2015; 123: 79-91[PUBMED]
Mascha EJ. Alpha, Beta, Meta: Guidelines for assessing Power and Type I error in meta-analyses. Anesthesia & Analgesia 2015; 121(6):1430-3. [PUBMED]
Komatsu R, You J, Mascha EJ, Sessler DI, Kasuya Y, Turan A: The Effect of Hypothyroidism on a Composite of Mortality, Cardiovascular and Wound Complications After Noncardiac Surgery: A Retrospective Cohort Analysis. Anesth Anal 2015; 121: 716-726 [PUBMED]
Mascha EJ, Dalton J, Kurz A, Saager L. Understanding the mechanism: Mediation analysis in randomized and non-randomized studies. Anesth Analg 2013, 117: 980-94.[PUBMED]
Abdelmalak BB, Bonilla A, Mascha EJ, Maheshwari A, Tang WH, You J, Ramachandran M, Kirkova Y, Clair D, Walsh RM, Kurz A, Sessler DI (2013). Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial. Br J Anaesth 111, 209-221.[PUBMED]
Mascha EJ, Turan A. Joint hypothesis testing and gatekeeping procedures for studies with multiple outcomes. Anesth Analg 2012, 114(6):1304-1317.[PUBMED]
Mascha EJ, Sessler DI. Statistical grand rounds: Equivalence and noninferiority testing for regression models and repeated measures designs. Anesth Analg 2011, 112: 678–687.
Mascha EJ, Sessler DI. Statistical grand rounds: Design and Analysis of Binary-Event Composite Endpoint Studies: Guidelines for Anesthesia Research. Anesth Analg, 2011, 112(6):1461-71.[PUBMED]
Mascha EJ, Imrey PB: Factors affecting power of tests for multiple binary outcomes. Statistics in
Medicine 2010; 29: 2890-2904. [PUBMED]
Mascha E, Albert J. Estimating treatment effect heterogeneity for binary outcomes via Dirichlet multinomial constraints. Biometrical Journal 49 (3): 378-393, 2007. [PUBMED]
Mascha E, Albert J. Statistical properties of bound estimators on treatment effect heterogeneity for binary outcomes. Journal of Modern Applied Statistical Methods 5(1), 181-193, 2006. [PUBMED]
Albert J, Gadbury G, Mascha E. Assessing treatment heterogeneity in clinical trials with blocked binary outcomes. Biometrical Journal 47 (2005) 5, 662-673. [PUBMED]

Basic Statistical TUTORIALS
Vetter, TR, Schober P, Mascha EJ. Diagnostic Testing and Decision-Making: Beauty Is Not Just in the Eye of the Beholder. Vetter, Thomas R.; Schober, Patrick; Mascha, Edward J. Less
Anesthesia & Analgesia 2018; 127(4):1085-1091. [PUBMED]
Mascha EJ, Vetter TR: Significance, Errors, Power, and Sample Size: The Blocking and Tackling of Statistics. Anesthesia & Analgesia 2018; 126: 691-698. [PUBMED]
Vetter TR, Mascha EJ. Unadjusted Bivariate Two-Group Comparisons: When Simpler is Better. Anesth Analg. 2018: 126(1):338-342. [PUBMED]
Vetter TR, Mascha EJ. Bias, Confounding, and Interaction: Lions and Tigers, and Bears, Oh My! Anesth Analg. 2017: 125(3):1042-1048. [PUBMED]
Vetter TR, Mascha EJ. Defining the Primary Outcomes and Justifying Secondary Outcomes of a Study: Usually, the Fewer, the Better. Anesth Analg. 2017: 125(2):678-681. [PUBMED]
Vetter TR, Mascha EJ. In the Beginning-There Is the Introduction-and Your Study Hypothesis. Anesth Analg. 2017 May;124(5):1709-1711. [PUBMED]

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