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Statistical Methods for Healthcare Performance Monitoring

(Chapman & Hall/CRC Biostatistics Series Book 92)

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Statistical Methods for Healthcare
Performance Monitoring
Chapman & Hall/CRC Biostatistics Series
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 Trials, Second Edition
Shein-Chung Chow and Mark Chang
Adaptive Designs for Sequential Treatment Allocation
Alessandro Baldi Antognini and Alessandra Giovagnoli
Adaptive Design Theory and Implementation Using SAS and R, Second
Edition
Mark Chang
Advanced Bayesian Methods for Medical Test Accuracy
Lyle D. Broemeling
Applied Biclustering Methods for Big and High-Dimensional Data
Using R
Adetayo Kasim, Ziv Shkedy, Sebastian Kaiser, Sepp Hochreiter, and
Willem Talloen
Applied Meta-Analysis with R
Ding-Geng (Din) Chen and Karl E. Peace
Basic Statistics and Pharmaceutical Statistical Applications, Second
Edition
James E. De Muth
Bayesian Adaptive Methods for Clinical Trials
Scott M. Berry, Bradley P. Carlin, J. Jack Lee, and Peter Muller
Bayesian Analysis Made Simple: An Excel GUI for WinBUGS
Phil Woodward
Bayesian Designs for Phase I–II Clinical Trials
Ying Yuan, Hoang Q. Nguyen, and Peter F. Thall
Bayesian Methods for Measures of Agreement
Lyle D. Broemeling
Bayesian Methods for Repeated Measures
Lyle D. Broemeling
Bayesian Methods in Epidemiology
Lyle D. Broemeling
Bayesian Methods in Health Economics
Gianluca Baio
Bayesian Missing Data Problems: EM, Data Augmentation and
Noniterative Computation
Ming T. Tan, Guo-Liang Tian, and Kai Wang Ng
Bayesian Modeling in Bioinformatics
Dipak K. Dey, Samiran Ghosh, and Bani K. Mallick
Benefit-Risk Assessment in Pharmaceutical Research and Development
Andreas Sashegyi, James Felli, and Rebecca Noel
Benefit-Risk Assessment Methods in Medical Product Development:
Bridging Qualitative and Quantitative Assessments
Qi Jiang and Weili He
Biosimilars: Design and Analysis of Follow-on Biologics
Shein-Chung Chow
Biostatistics: A Computing Approach
Stewart J. Anderson
Cancer Clinical Trials: Current and Controversial Issues in Design and
Analysis
Stephen L. George, Xiaofei Wang, and Herbert Pang
Causal Analysis in Biomedicine and Epidemiology: Based on Minimal
Sufficient Causation
Mikel Aickin
Clinical and Statistical Considerations in Personalized Medicine
Claudio Carini, Sandeep Menon, and Mark Chang
Clinical Trial Data Analysis using R
Ding-Geng (Din) Chen and Karl E. Peace
Clinical Trial Methodology
Karl E. Peace and Ding-Geng (Din) Chen
Computational Methods in Biomedical Research
Ravindra Khattree and Dayanand N. Naik
Computational Pharmacokinetics
Anders Källén
Confidence Intervals for Proportions and Related Measures of Effect
Size
Robert G. Newcombe
Controversial Statistical Issues in Clinical Trials
Shein-Chung Chow
Data Analysis with Competing Risks and Intermediate States
Ronald B. Geskus
Data and Safety Monitoring Committees in Clinical Trials
Jay Herson
Design and Analysis of Animal Studies in Pharmaceutical Development
Shein-Chung Chow and Jen-pei Liu
Design and Analysis of Bioavailability and Bioequivalence Studies,
Third Edition
Shein-Chung Chow and Jen-pei Liu
Design and Analysis of Bridging Studies
Jen-pei Liu, Shein-Chung Chow, and Chin-Fu Hsiao
Design & Analysis of Clinical Trials for Economic Evaluation &
Reimbursement: An Applied Approach Using SAS & STATA
Iftekhar Khan
Design and Analysis of Clinical Trials for Predictive Medicine
Shigeyuki Matsui, Marc Buyse, and Richard Simon
Design and Analysis of Clinical Trials with Time-to-Event Endpoints
Karl E. Peace
Design and Analysis of Non-Inferiority Trials
Mark D. Rothmann, Brian L. Wiens, and Ivan S. F. Chan
Difference Equations with Public Health Applications
Lemuel A. Moyé and Asha Seth Kapadia
DNA Methylation Microarrays: Experimental Design and Statistical
Analysis
Sun-Chong Wang and Arturas Petronis
DNA Microarrays and Related Genomics Techniques: Design,
Analysis, and Interpretation of Experiments
David B. Allison, Grier P. Page, T. Mark Beasley, and Jode W. Edwards
Dose Finding by the Continual Reassessment Method
Ying Kuen Cheung
Dynamical Biostatistical Models
Daniel Commenges and Hélène Jacqmin-Gadda
Elementary Bayesian Biostatistics
Lemuel A. Moyé
Empirical Likelihood Method in Survival Analysis
Mai Zhou
Exposure–Response Modeling: Methods and Practical Implementation
Jixian Wang
Frailty Models in Survival Analysis
Andreas Wienke
Fundamental Concepts for New Clinical Trialists
Scott Evans and Naitee Ting
Generalized Linear Models: A Bayesian Perspective
Dipak K. Dey, Sujit K. Ghosh, and Bani K. Mallick
Handbook of Regression and Modeling: Applications for the Clinical
and Pharmaceutical Industries
Daryl S. Paulson
Inference Principles for Biostatisticians
Ian C. Marschner
Interval-Censored Time-to-Event Data: Methods and Applications
Ding-Geng (Din) Chen, Jianguo Sun, and Karl E. Peace
Introductory Adaptive Trial Designs: A Practical Guide with R
Mark Chang
Joint Models for Longitudinal and Time-to-Event Data: With
Applications in R
Dimitris Rizopoulos
Measures of Interobserver Agreement and Reliability, Second Edition
Mohamed M. Shoukri
Medical Biostatistics, Third Edition
A. Indrayan
Meta-Analysis in Medicine and Health Policy
Dalene Stangl and Donald A. Berry
Mixed Effects Models for the Population Approach: Models, Tasks,
Methods and Tools
Marc Lavielle
Modeling to Inform Infectious Disease Control
Niels G. Becker
Modern Adaptive Randomized Clinical Trials: Statistical and Practical
Aspects
Oleksandr Sverdlov
Monte Carlo Simulation for the Pharmaceutical Industry: Concepts,
Algorithms, and Case Studies
Mark Chang
Multiregional Clinical Trials for Simultaneous Global New Drug
Development
Joshua Chen and Hui Quan
Multiple Testing Problems in Pharmaceutical Statistics
Alex Dmitrienko, Ajit C. Tamhane, and Frank Bretz
Noninferiority Testing in Clinical Trials: Issues and Challenges
Tie-Hua Ng
Optimal Design for Nonlinear Response Models
Valerii V. Fedorov and Sergei L. Leonov
Patient-Reported Outcomes: Measurement, Implementation and
Interpretation
Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J.
Alvir, Demissie Alemayehu, and Tara Symonds
Quantitative Evaluation of Safety in Drug Development: Design,
Analysis and Reporting
Qi Jiang and H. Amy Xia
Quantitative Methods for Traditional Chinese Medicine Development
Shein-Chung Chow
Randomized Clinical Trials of Nonpharmacological Treatments
Isabelle Boutron, Philippe Ravaud, and David Moher
Randomized Phase II Cancer Clinical Trials
Sin-Ho Jung
Sample Size Calculations for Clustered and Longitudinal Outcomes in
Clinical Research
Chul Ahn, Moonseong Heo, and Song Zhang
Sample Size Calculations in Clinical Research, Second Edition
Shein-Chung Chow, Jun Shao, and Hansheng Wang
Statistical Analysis of Human Growth and Development
Yin Bun Cheung
Statistical Design and Analysis of Clinical Trials: Principles and
Methods
Weichung Joe Shih and Joseph Aisner
Statistical Design and Analysis of Stability Studies
Shein-Chung Chow
Statistical Evaluation of Diagnostic Performance: Topics in ROC
Analysis
Kelly H. Zou, Aiyi Liu, Andriy Bandos, Lucila Ohno-Machado, and
Howard Rockette
Statistical Methods for Clinical Trials
Mark X. Norleans
Statistical Methods for Drug Safety
Robert D. Gibbons and Anup K. Amatya
Statistical Methods for Healthcare Performance Monitoring
Alex Bottle and Paul Aylin
Statistical Methods for Immunogenicity Assessment
Harry Yang, Jianchun Zhang, Binbing Yu, and Wei Zhao
Statistical Methods in Drug Combination Studies
Wei Zhao and Harry Yang
Statistical Testing Strategies in the Health Sciences
Albert Vexler, Alan D. Hutson, and Xiwei Chen
Statistics in Drug Research: Methodologies and Recent Developments
Shein-Chung Chow and Jun Shao
Statistics in the Pharmaceutical Industry, Third Edition
Ralph Buncher and Jia-Yeong Tsay
Survival Analysis in Medicine and Genetics
Jialiang Li and Shuangge Ma
Theory of Drug Development
Eric B. Holmgren
Translational Medicine: Strategies and Statistical Methods
Dennis Cosmatos and Shein-Chung Chow
Chapman & Hall/CRC Biostatistics Series

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
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Boca Raton, FL 33487-2742

© 2017 by Taylor & Francis Group, LLC


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Version Date: 20160510

International Standard Book Number-13: 978-1-4822-4609-4 (Hardback)

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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
List of Tables
Preface
Authors

1. Introduction
1.1 The Need for Performance Monitoring
1.2 Measuring and Monitoring Quality
1.3 The Need for This Book
1.4 Who Is This Book For and How Should It Be Used?
Common Abbreviations Used in the Book
Acknowledgment

2. Origins and Examples of Monitoring Systems


Aims of This Chapter
2.1 Origins
2.2 Healthcare Scandals
2.2.1 Responses to the Scandals
2.3 Examples of Monitoring Schemes
2.4 Goals of Monitoring
2.4.1 Accountability
2.4.2 Regulation and Accreditation
2.4.3 Patient Choice
2.4.4 Openness and Transparency
2.4.5 Quality Improvement
2.4.6 Prevent Harm and Unsafe Care
2.4.7 Professionalism
2.4.8 Informed Consent
3. Choosing the Unit of Analysis and Reporting
Aims of This Chapter
3.1 Issues Principally Concerning the Analysis
3.1.1 Clustering (*)
3.1.2 Episode Treatment Groups
3.2 Issues More Relevant to Reporting: Attributing Performance to a
Given Unit in a System

4. What to Measure: Choosing and Defining Indicators


Aims of This Chapter
4.1 How Can We Define Quality?
4.2 Common Indicator Taxonomies
4.3 Particular Challenges of Measuring Patient Safety
4.4 Particular Challenges of Multimorbidity
4.5 Measuring the Health of the Population and Quality of the Whole
Healthcare System
4.5.1 The WHO Annual World Health Statistics Report
4.6 Efficiency and Value
4.6.1 Data Envelopment Analysis and Stochastic Frontier
Analysis (*)
4.7 Features of an Ideal Indicator
4.8 Steps in Construction and Common Issues in Definition
4.9 Validation of Indicators
4.10 Some Strategies for Choosing among Candidates
4.11 Time to Go: When to Withdraw Indicators
4.12 Conclusion

5. Sources of Data
Aims of This Chapter
5.1 How to Assess Data Quality
5.2 Administrative Data
5.2.1 Coding Systems for Administrative Data
5.2.2 Use of Administrative Databases to Flag Patient Safety
Events
5.3 Clinical Registry Data
5.4 Accuracy of Administrative and Clinical Databases Compared
5.5 Incident Reports and Other Ways to Capture Safety Events
5.6 Surveys
5.7 Other Sources
5.8 Other Issues Concerning Data Sources
5.9 Conclusion

6. Risk-Adjustment Principles and Methods


Aims of This Chapter
6.1 Risk Adjustment and Risk Prediction
6.2 When and Why Should We Adjust for Risk?
6.3 Alternatives to Risk Adjustment
6.4 What Factors Should We Adjust For?
6.4.1 Factors Not under the Control of the Provider
6.4.2 Proxies Such as Age and Socioeconomic Status
6.4.3 Comorbidity
6.4.4 Disease Severity
6.5 Selecting an Initial Set of Candidate Variables
6.6 Dealing with Missing and Extreme Values
6.7 Timing of the Risk Factor Measurement
6.8 Building the Model
6.8.1 Choosing the Final Set of Variables from the Initial Set of
Candidates
6.8.2 Decide How Each Variable Should Be Entered into the
Model
6.8.3 Decide on the Statistical Method for Modelling (*)
6.8.4 Assess the Fit of the Model (*)
6.8.4.1 Adjusted R2
6.8.4.2 Area under the Receiver Operating Characteristic
Curve: c Statistic
6.8.4.3 The Hosmer–Lemeshow Statistic for Calibration
6.8.5 Which Is More Important, Discrimination or Calibration?
6.8.6 What Can Be Done If the Model Fit or Performance Is
Unacceptable?
6.8.7 Convert Regression Coefficients into a Risk Score If
Desired
7. Output the Observed and Model-Predicted Outcomes (*)
Aims of This Chapter
7.1 Ratios versus Differences
7.2 Deriving SMRs from Standardisation and Logistic Regression
7.3 Other Fixed Effects Approaches to Generate an SMR
7.4 Random Effects–Based SMRs (*)
7.5 Marginal versus Multilevel Models (*)
7.6 Which Is the “Best” Modelling Approach Overall? (*)
7.7 Further Reading on Producing Risk-Adjusted Outcomes by Unit

8. Composite Measures
Aims of This Chapter
8.1 Some Examples
8.2 Steps in the Construction
8.2.1 Specify the Scope and Purpose
8.2.2 Choose the Unit
8.2.3 Select the Data and Deal with Missing Values
8.2.4 Choose the Indicators and Run Descriptive Analyses
8.2.5 Normalise the Metrics
8.2.6 Assign Weights and Aggregate the Component Indicators
8.2.7 Run Sensitivity Analyses
8.2.8 Present the Results
8.3 Some Real Examples
8.3.1 AHRQ’s Patient Safety Indicator Composite
8.3.2 Leapfrog Group Patient Safety Composite
8.4 Pros and Cons of Composites
8.5 Alternatives to the Use of Composites

9. Setting Performance Thresholds and Defining Outliers


Aims of This Chapter
9.1 Defining Acceptable Performance
9.1.1 Targets
9.1.2 Historical Benchmarks
9.1.3 Referring to Inter-Unit Variation
9.2 Bayesian Methods for Comparing Providers
9.3 Statistical Process Control and Funnel Plots
9.4 Multiple Testing (*)
9.4.1 Multivariate Statistical Process Control Methods (*)
9.4.2 Further Reading on SPC
9.5 Ways of Assessing Variation between Units
9.6 How Much Variation Is “Acceptable”?
9.7 Impact on Outlier Status of Using Fixed versus Random Effects to
Derive SMRs
9.8 How Reliably Can We Detect Poor Performance?
9.9 Some Resources for Quality Improvement Methods

10. Making Comparisons across National Borders


Aims of This Chapter
10.1 Examples of Multinational Patient-Level Databases
10.2 Challenges
10.2.1 Worked Example of Combining Administrative Databases
from Multiple Countries: Stroke Mortality
10.2.2 Clustering within Countries
10.2.3 Countries with Unusual Data or Apparent Performance
10.3 Interpreting Apparent Differences in Performance between
Countries
10.4 Conclusion

11. Presenting the Results to Stakeholders


Aims of This Chapter
11.1 The Main Ways of Presenting Comparative Performance Data
11.2 Effect on Behaviour of the Choice of Format When Providing
Performance Data
11.3 The Importance of the Method of Presentation
11.3.1 Presenting Performance Data to Managers and Clinicians
11.3.2 Presenting Results to the Public
11.4 Examples of Giving Performance Information to Units
11.5 Examples of Giving Performance Information to the Public
11.6 Metadata

12. Evaluating the Monitoring System


Aims of This Chapter
12.1 Study Design and Statistical Approaches to Evaluating a
Monitoring System
12.1.1 Interrupted Time-Series Design and Analysis (*)
12.1.2 Adjusting for Confounding (*)
12.1.3 Difference-in-Differences
12.1.4 Instrumental Variable Analysis
12.1.5 Regression Discontinuity Designs
12.2 Economic Evaluation Methods

13. Concluding Thoughts


13.1 Simple versus Complex
13.2 Specific versus General
13.3 The Future

Appendix A: Glossary of Main Statistical Terms Used

References

Index
List of Illustrations

Figure 6.1 Comparison of percentage of AVSD operations by age at


operation (in months) between Bristol (UBHT) and elsewhere
in England 1991/1992–1994/1995.
Figure 9.1 An example of a run chart showing a run of eight data points
below the median.
Figure 9.2 An example of a Shewhart chart of the data from the run chart
of Figure 9.1, with upper and lower control limits with 3 SD
on either side of the mean.
Figure 9.3 An example of a funnel plot: inner lines represent 95% and
outer lines 99.8% control limits.
Figure 11.1 Traffic light display of fictitious data on multiple indicators by
unit.
Figure 11.2 Spider plot of an imaginary unit’s fictitious data.
Figure 11.3 Benchmarked performance for NHS West Essex CCG’s
commissioned elective knee surgery.
Figure 11.4 Example scatter plot from Public Health England’s
commissioning tool “Fingertips” showing CCG-level
deprivation and adult inactivity.
Figure 11.5 Screenshot from NHS Choices.
Figure 11.6 Illustrative Hospital Compare results for three Seattle hospitals
for readmissions and deaths in patients with COPD.
Figure 11.7 COPD readmission rates for three Seattle hospitals displayed
as bar charts by Hospital Compare.
Figure 12.1 Time segments pre- and post-intervention in an interrupted
time series design.
List of Tables

Table 3.1 Main Methodological Issues When Considering the Unit of


Analysis
Table 4.1 Structure, Process and Outcome Indicators Compared
Table 4.2 Ways of Combining Quality and Cost Measures in a 2014
National Quality Forum White Paper
Table 4.3 Attributes of Ideal Quality Indicators
Table 5.1 Comparison of Key Features of Clinical and Administrative
Databases
Table 6.1 Issues Associated with Common Patient Factors in Risk
Models
Table 7.1 Summary of the Main Types of Standardised Mortality Ratio
Derived from Logistic Regression or Standardisation with the
National Average as the Benchmark Unless Specified
Otherwise
Table 8.1 Main Steps in Composite Indicator Construction
Table 8.2 Common Options for Weighting and Combining Component
Indicators in a Composite
Table 8.3 Main Pros and Cons of Healthcare Composite Measures
Table 9.1 Common Ways to Compare Units
Table 9.2 Common Definitions of Outlying Performance

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