Statistical Methods for Healthcare Performance Monitoring PDF
Preview Statistical Methods for Healthcare Performance Monitoring
Statistical Methods for Healthcare Performance Monitoring CompassioCnoamtep assCioonmatpea ssionaCteo mpassionate Editor-in-Chief Shein-Chung Chow, Ph.D., Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina Series Editors Byron Jones, Biometrical Fellow, Statistical Methodology, Integrated Information Sciences, Novartis Pharma AG, Basel, Switzerland Jen-pei Liu, Professor, Division of Biometry, Department of Agronomy, National Taiwan University, Taipei, Taiwan Karl E. Peace, Georgia Cancer Coalition, Distinguished Cancer Scholar, Senior Research Scientist and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, Georgia Bruce W. Turnbull, Professor, School of Operations Research and Industrial Engineering, Cornell University, Ithaca, New York Published Titles Adaptive Design Methods in Clinical Bayesian Analysis Made Simple: Trials, Second Edition An Excel GUI for WinBUGS Shein-Chung Chow and Mark Chang Phil Woodward Adaptive Designs for Sequential Bayesian Designs for Phase I–II Treatment Allocation Clinical Trials Alessandro Baldi Antognini Ying Yuan, Hoang Q. Nguyen, and Alessandra Giovagnoli and Peter F. Thall Adaptive Design Theory and Bayesian Methods for Measures Implementation Using SAS and R, of Agreement Second Edition Lyle D. Broemeling Mark Chang Bayesian Methods for Repeated Measures Advanced Bayesian Methods for Lyle D. Broemeling Medical Test Accuracy Bayesian Methods in Epidemiology Lyle D. Broemeling Lyle D. Broemeling Applied Biclustering Methods for Big Bayesian Methods in Health Economics and High-Dimensional Data Using R Gianluca Baio Adetayo Kasim, Ziv Shkedy, Bayesian Missing Data Problems: EM, Sebastian Kaiser, Sepp Hochreiter, Data Augmentation and Noniterative and Willem Talloen Computation Applied Meta-Analysis with R Ming T. Tan, Guo-Liang Tian, Ding-Geng (Din) Chen and Karl E. Peace and Kai Wang Ng Basic Statistics and Pharmaceutical Bayesian Modeling in Bioinformatics Statistical Applications, Second Edition Dipak K. Dey, Samiran Ghosh, James E. De Muth and Bani K. Mallick Bayesian Adaptive Methods for Benefit-Risk Assessment in Clinical Trials Pharmaceutical Research and Scott M. Berry, Bradley P. Carlin, Development J. Jack Lee, and Peter Muller Andreas Sashegyi, James Felli, and Rebecca Noel Published Titles Benefit-Risk Assessment Methods in Design and Analysis of Bioavailability Editor-in-Chief Medical Product Development: Bridging and Bioequivalence Studies, Third Edition Shein-Chung Chow, Ph.D., Professor, Department of Biostatistics and Bioinformatics, Qualitative and Quantitative Assessments Shein-Chung Chow and Jen-pei Liu Duke University School of Medicine, Durham, North Carolina Qi Jiang and Weili He Design and Analysis of Bridging Studies Biosimilars: Design and Analysis of Jen-pei Liu, Shein-Chung Chow, Series Editors Follow-on Biologics and Chin-Fu Hsiao Byron Jones, Biometrical Fellow, Statistical Methodology, Integrated Information Sciences, Shein-Chung Chow Design & Analysis of Clinical Trials for Novartis Pharma AG, Basel, Switzerland Biostatistics: A Computing Approach Economic Evaluation & Reimbursement: Jen-pei Liu, Professor, Division of Biometry, Department of Agronomy, Stewart J. Anderson An Applied Approach Using SAS & STATA National Taiwan University, Taipei, Taiwan Iftekhar Khan Cancer Clinical Trials: Current and Karl E. Peace, Georgia Cancer Coalition, Distinguished Cancer Scholar, Senior Research Scientist Controversial Issues in Design and Design and Analysis of Clinical Trials and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, Georgia Analysis for Predictive Medicine Bruce W. Turnbull, Professor, School of Operations Research and Industrial Engineering, Stephen L. George, Xiaofei Wang, Shigeyuki Matsui, Marc Buyse, Cornell University, Ithaca, New York and Herbert Pang and Richard Simon Causal Analysis in Biomedicine and Design and Analysis of Clinical Trials with Published Titles Epidemiology: Based on Minimal Time-to-Event Endpoints Adaptive Design Methods in Clinical Bayesian Analysis Made Simple: Sufficient Causation Karl E. Peace Trials, Second Edition An Excel GUI for WinBUGS Mikel Aickin Design and Analysis of Non-Inferiority Trials Shein-Chung Chow and Mark Chang Phil Woodward Clinical and Statistical Considerations in Mark D. Rothmann, Brian L. Wiens, Adaptive Designs for Sequential Bayesian Designs for Phase I–II Personalized Medicine and Ivan S. F. Chan Treatment Allocation Clinical Trials Claudio Carini, Sandeep Menon, and Mark Chang Difference Equations with Public Health Alessandro Baldi Antognini Ying Yuan, Hoang Q. Nguyen, Clinical Trial Data Analysis using R Applications and Alessandra Giovagnoli and Peter F. Thall Ding-Geng (Din) Chen and Karl E. Peace Lemuel A. Moyé and Asha Seth Kapadia Adaptive Design Theory and Bayesian Methods for Measures Clinical Trial Methodology DNA Methylation Microarrays: Implementation Using SAS and R, of Agreement Karl E. Peace and Ding-Geng (Din) Chen Experimental Design and Statistical Second Edition Lyle D. Broemeling Analysis Computational Methods in Biomedical Mark Chang Bayesian Methods for Repeated Measures Research Sun-Chong Wang and Arturas Petronis Advanced Bayesian Methods for Lyle D. Broemeling Ravindra Khattree and Dayanand N. Naik DNA Microarrays and Related Genomics Medical Test Accuracy Bayesian Methods in Epidemiology Computational Pharmacokinetics Techniques: Design, Analysis, and Lyle D. Broemeling Lyle D. Broemeling Anders Källén Interpretation of Experiments Applied Biclustering Methods for Big David B. Allison, Grier P. Page, Bayesian Methods in Health Economics Confidence Intervals for Proportions and High-Dimensional Data Using R T. Mark Beasley, and Jode W. Edwards Gianluca Baio and Related Measures of Effect Size Adetayo Kasim, Ziv Shkedy, Dose Finding by the Continual Bayesian Missing Data Problems: EM, Robert G. Newcombe Sebastian Kaiser, Sepp Hochreiter, Reassessment Method Data Augmentation and Noniterative Controversial Statistical Issues in and Willem Talloen Ying Kuen Cheung Computation Clinical Trials Applied Meta-Analysis with R Ming T. Tan, Guo-Liang Tian, Shein-Chung Chow Dynamical Biostatistical Models Ding-Geng (Din) Chen and Karl E. Peace and Kai Wang Ng Daniel Commenges and Data Analysis with Competing Risks Basic Statistics and Pharmaceutical Hélène Jacqmin-Gadda Bayesian Modeling in Bioinformatics and Intermediate States Statistical Applications, Second Edition Dipak K. Dey, Samiran Ghosh, Ronald B. Geskus Elementary Bayesian Biostatistics James E. De Muth and Bani K. Mallick Lemuel A. Moyé Data and Safety Monitoring Committees Bayesian Adaptive Methods for Benefit-Risk Assessment in in Clinical Trials Empirical Likelihood Method in Clinical Trials Pharmaceutical Research and Jay Herson Survival Analysis Scott M. Berry, Bradley P. Carlin, Development Mai Zhou Design and Analysis of Animal Studies J. Jack Lee, and Peter Muller Andreas Sashegyi, James Felli, Exposure–Response Modeling: Methods in Pharmaceutical Development and Rebecca Noel and Practical Implementation Shein-Chung Chow and Jen-pei Liu Jixian Wang Published Titles Frailty Models in Survival Analysis Monte Carlo Simulation for the Andreas Wienke Pharmaceutical Industry: Concepts, Algorithms, and Case Studies Fundamental Concepts for New Clinical Mark Chang Trialists Scott Evans and Naitee Ting Multiregional Clinical Trials for Generalized Linear Models: A Bayesian Simultaneous Global New Drug Perspective Development Dipak K. Dey, Sujit K. Ghosh, and Joshua Chen and Hui Quan Bani K. Mallick Multiple Testing Problems in Handbook of Regression and Modeling: Pharmaceutical Statistics Applications for the Clinical and Alex Dmitrienko, Ajit C. Tamhane, Pharmaceutical Industries and Frank Bretz Daryl S. Paulson Noninferiority Testing in Clinical Trials: Inference Principles for Biostatisticians Issues and Challenges Ian C. Marschner Tie-Hua Ng Interval-Censored Time-to-Event Data: Optimal Design for Nonlinear Response Methods and Applications Models Ding-Geng (Din) Chen, Jianguo Sun, Valerii V. Fedorov and Sergei L. Leonov and Karl E. Peace Patient-Reported Outcomes: Introductory Adaptive Trial Designs: Measurement, Implementation and A Practical Guide with R Interpretation Mark Chang Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Joint Models for Longitudinal and Time- Demissie Alemayehu, and Tara Symonds to-Event Data: With Applications in R Dimitris Rizopoulos Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Measures of Interobserver Agreement Reporting and Reliability, Second Edition Qi Jiang and H. Amy Xia Mohamed M. Shoukri Quantitative Methods for Traditional Medical Biostatistics, Third Edition Chinese Medicine Development A. Indrayan Shein-Chung Chow Meta-Analysis in Medicine and Randomized Clinical Trials of Health Policy Nonpharmacological Treatments Dalene Stangl and Donald A. Berry Isabelle Boutron, Philippe Ravaud, Mixed Effects Models for the Population and David Moher Approach: Models, Tasks, Methods Randomized Phase II Cancer and Tools Clinical Trials Marc Lavielle Sin-Ho Jung Modeling to Inform Infectious Disease Sample Size Calculations for Clustered Control and Longitudinal Outcomes in Clinical Niels G. Becker Research Modern Adaptive Randomized Clinical Chul Ahn, Moonseong Heo, Trials: Statistical and Practical Aspects and Song Zhang Oleksandr Sverdlov Published Titles Published Titles Frailty Models in Survival Analysis Monte Carlo Simulation for the Sample Size Calculations in Clinical Statistical Methods in Drug Combination Andreas Wienke Pharmaceutical Industry: Concepts, Research, Second Edition Studies Algorithms, and Case Studies Shein-Chung Chow, Jun Shao, Wei Zhao and Harry Yang Fundamental Concepts for New Clinical Trialists Mark Chang and Hansheng Wang Statistical Testing Strategies in the Scott Evans and Naitee Ting Multiregional Clinical Trials for Statistical Analysis of Human Growth Health Sciences Generalized Linear Models: A Bayesian Simultaneous Global New Drug and Development Albert Vexler, Alan D. Hutson, Perspective Development Yin Bun Cheung and Xiwei Chen Dipak K. Dey, Sujit K. Ghosh, and Joshua Chen and Hui Quan Statistical Design and Analysis of Clinical Statistics in Drug Research: Bani K. Mallick Multiple Testing Problems in Trials: Principles and Methods Methodologies and Recent Handbook of Regression and Modeling: Pharmaceutical Statistics Weichung Joe Shih and Joseph Aisner Developments Applications for the Clinical and Alex Dmitrienko, Ajit C. Tamhane, Statistical Design and Analysis of Shein-Chung Chow and Jun Shao Pharmaceutical Industries and Frank Bretz Stability Studies Statistics in the Pharmaceutical Industry, Daryl S. Paulson Noninferiority Testing in Clinical Trials: Shein-Chung Chow Third Edition Inference Principles for Biostatisticians Issues and Challenges Statistical Evaluation of Diagnostic Ralph Buncher and Jia-Yeong Tsay Ian C. Marschner Tie-Hua Ng Performance: Topics in ROC Analysis Survival Analysis in Medicine and Interval-Censored Time-to-Event Data: Optimal Design for Nonlinear Response Kelly H. Zou, Aiyi Liu, Andriy Bandos, Genetics Methods and Applications Models Lucila Ohno-Machado, and Howard Rockette Jialiang Li and Shuangge Ma Ding-Geng (Din) Chen, Jianguo Sun, Valerii V. Fedorov and Sergei L. Leonov Statistical Methods for Clinical Trials Theory of Drug Development and Karl E. Peace Patient-Reported Outcomes: Mark X. Norleans Eric B. Holmgren Introductory Adaptive Trial Designs: Measurement, Implementation and Statistical Methods for Drug Safety Translational Medicine: Strategies and A Practical Guide with R Interpretation Robert D. Gibbons and Anup K. Amatya Statistical Methods Mark Chang Joseph C. Cappelleri, Kelly H. Zou, Statistical Methods for Healthcare Dennis Cosmatos and Shein-Chung Chow Andrew G. Bushmakin, Jose Ma. J. Alvir, Joint Models for Longitudinal and Time- Performance Monitoring Demissie Alemayehu, and Tara Symonds to-Event Data: With Applications in R Alex Bottle and Paul Aylin Dimitris Rizopoulos Quantitative Evaluation of Safety in Drug Statistical Methods for Immunogenicity Development: Design, Analysis and Measures of Interobserver Agreement Assessment Reporting and Reliability, Second Edition Harry Yang, Jianchun Zhang, Binbing Yu, Qi Jiang and H. Amy Xia Mohamed M. Shoukri and Wei Zhao Quantitative Methods for Traditional Medical Biostatistics, Third Edition Chinese Medicine Development A. Indrayan Shein-Chung Chow Meta-Analysis in Medicine and Randomized Clinical Trials of Health Policy Nonpharmacological Treatments Dalene Stangl and Donald A. Berry Isabelle Boutron, Philippe Ravaud, Mixed Effects Models for the Population and David Moher Approach: Models, Tasks, Methods Randomized Phase II Cancer and Tools Clinical Trials Marc Lavielle Sin-Ho Jung Modeling to Inform Infectious Disease Sample Size Calculations for Clustered Control and Longitudinal Outcomes in Clinical Niels G. Becker Research Modern Adaptive Randomized Clinical Chul Ahn, Moonseong Heo, Trials: Statistical and Practical Aspects and Song Zhang Oleksandr Sverdlov Compassionate CompassionatCe omCpoamsspioanssaitoen ate Statistical Methods for Healthcare Performance Monitoring Alex Bottle Imperial College London, United Kingdom Paul Aylin Imperial College London, United Kingdom CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2017 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Printed on acid-free paper Version Date: 20160510 International Standard Book Number-13: 978-1-4822-4609-4 (Hardback) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmit- ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright. com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Library of Congress Cataloging‑in‑Publication Data Names: Bottle, Alex, author. | Aylin, Paul, author. Title: Statistical methods for healthcare performance monitoring / Alex Bottle and Paul Aylin. Description: Boca Raton : Taylor & Francis, 2017. | Series: Chapman & Hall/CRC biostatistics series ; 92 | “A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc.” | Includes bibliographical references and index. Identifiers: LCCN 2016006496 | ISBN 9781482246094 (alk. paper) Subjects: LCSH: Medical care--Evaluation. | Medical statistics. | Medical care--Quality control. | Medical care--Safety measures. Classification: LCC RA399.A1 B68 2016 | DDC 362.1072/7--dc23 LC record available at https://lccn.loc.gov/2016006496 Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com Contents List of Illustrations ................................................................................................xv List of Tables .......................................................................................................xvii Preface ...................................................................................................................xix Authors .................................................................................................................xxi 1. Introduction .....................................................................................................1 1.1 The Need for Performance Monitoring .............................................1 1.2 Measuring and Monitoring Quality...................................................2 1.3 The Need for This Book .......................................................................2 1.4 Who Is This Book For and How Should It Be Used? .......................3 Common Abbreviations Used in the Book ...................................................4 Acknowledgment .............................................................................................6 2. Origins and Examples of Monitoring Systems ........................................7 Aims of This Chapter ......................................................................................7 2.1 Origins ....................................................................................................7 2.2 Healthcare Scandals .............................................................................8 2.2.1 Responses to the Scandals ....................................................12 2.3 Examples of Monitoring Schemes ....................................................14 2.4 Goals of Monitoring ............................................................................15 2.4.1 Accountability ........................................................................15 2.4.2 Regulation and Accreditation ..............................................16 2.4.3 Patient Choice .........................................................................19 2.4.4 Openness and Transparency................................................21 2.4.5 Quality Improvement ............................................................21 2.4.6 Prevent Harm and Unsafe Care ...........................................22 2.4.7 Professionalism ......................................................................23 2.4.8 Informed Consent ..................................................................23 3. Choosing the Unit of Analysis and Reporting .......................................25 Aims of This Chapter ....................................................................................25 3.1 Issues Principally Concerning the Analysis ...................................26 3.1.1 Clustering (*) ...........................................................................26 3.1.2 Episode Treatment Groups ...................................................32 3.2 Issues More Relevant to Reporting: Attributing Performance to a Given Unit in a System................................................................34 ix
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