Research Methods For Pharmaceutical Practice and Policy. ISBN 0853698805, 978-0853698807

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Research Methods for Pharmaceutical Practice and Policy

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Research Methods for Pharmaceutical Practice and Policy
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Introduction to the Pharmacy


Business Administration Series

Books in the Pharmacy Business Administration Series have been prepared for
use in university level graduate and professional level courses, as well as for
continuing education and self-study uses. The series includes books covering
the major subject areas taught in Social and Administrative Pharmacy,
Pharmacy Administration, and Pharmacy MBA programs.
World-class authors with well-regarded expertise in the various respective
areas have been selected and the book outlines as well as the books themselves
have been reviewed by a number of other experts in the field. The result of this
effort is a new integrated and coordinated series of books that is up to date in
methodology, research findings, terminology, and contemporary trends and
practices.
This is one book in that series of about 12 subjects in total. It is intended
that each of the books will be revised at least every 5 years. Although the
books were intended for the North American market, they are just as relevant
in other areas.

Titles in the series currently include:


Health Economics
Health Policy and Ethics
Principles of Good Clinical Practice
Pharmaceutical Marketing: A Practical Guide
Financial Analysis in Pharmacy Practice

The series editor-in-chief is Professor Albert Wertheimer, PhD, MBA, of


Temple University School of Pharmacy, Philadelphia
Suggestions and comments from readers are most welcome and should be
sent to Commissioning Editor, Pharmaceutical Press, 1 Lambeth High Street,
London SE1 7JN, UK.
Research Methods for Pharmaceutical Practice and Policy
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Research Methods
for Pharmaceutical
Practice and Policy

Edited by
Rajender R Aparasu MPharm, PhD
Professor and Division Head of Pharmacy Administration and Public Health,
College of Pharmacy, University of Houston, Houston, Texas, USA
Research Methods for Pharmaceutical Practice and Policy
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Published by Pharmaceutical Press

1 Lambeth High Street, London SE1 7JN, UK


1559 St. Paul Avenue, Gurnee, IL 60031, USA

Ó Pharmaceutical Press 2011

is a trade mark of Pharmaceutical Press


Pharmaceutical Press is the publishing division of the
Royal Pharmaceutical Society of Great Britain

First published 2011

Typeset by Thomson Digital, Noida, India


Printed in Great Britain by TJ International, Padstow, Cornwall

ISBN 978 0 85369 880 7

All rights reserved. No part of this publication may be reproduced,


stored in a retrieval system, or transmitted in any form or by any means,
without the prior written permission of the copyright holder.
The publisher makes no representation, express or implied,
with regard to the accuracy of the information contained in this book
and cannot accept any legal responsibility or liability for any errors or
omissions that may be made.
The right of Rajender R Aparasu to be identified as the author of this
work has been asserted by him in accordance with the Copyright,
Designs and Patents Act, 1988

A catalogue record for this book is available from the British Library.
Research Methods for Pharmaceutical Practice and Policy
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Dedication

To my parents, Surender and Anusuya Aparasu, and to my wife, Anu Aparasu


Research Methods for Pharmaceutical Practice and Policy
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Research Methods for Pharmaceutical Practice and Policy
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Contents

Preface xiii
Acknowledgments xvii
About the editor xix
Contributors xxi

1 Scientific approach to pharmaceutical practice


and policy research 1
RR Aparasu
Introduction 1
Pharmaceutical practice and policy research 2
Scientific inquiry 6
Stages of pharmaceutical practice and policy research 9
Summary and conclusions 13
Review topics 13

2 Conceptualizing research 17
CM Brown
Introduction 17
Definition of concepts and constructs 18
Theory in healthcare research 18
Common theoretical models in healthcare utilization and outcomes 21
Importance of using a theoretical framework in pharmaceutical
practice and policy research 29
Types of variables in pharmaceutical practice and policy research 30
Scientific relationships in pharmaceutical practice and policy research 32
Connecting theory and variables in pharmaceutical practice and policy 33
Summary and conclusions 34
Review questions/topics 35
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viii | Contents

3 Operationalizing research 37
KM Kamal
Introduction 37
Steps in operationalization 38
Research problems 38
Research questions 41
Hypothesis 45
Operationalization 48
Summary and conclusions 51
Review questions 52

4 Measurement theory and practice 55


RR Aparasu
Introduction 55
Nature and level of measurement 56
Measurement issues 59
Reliability and validity 60
Measurement process and practice 67
Summary and conclusions 68
Review topics 69

5 Experimental designs 71
KA Lawson
Introduction 71
Causal relationships 72
Experimental research 72
Types of experiments 75
Validity considerations in experimental research 76
Types of experimental designs 81
Other experimental design considerations 86
Strengths and limitations of experimental designs 87
Summary and conclusions 87
Review questions/topics 88

6 Nonexperimental research 89
ML Johnson
Introduction 89
Role of nonexperimental research 90
Types of nonexperimental research 92
Bias and confounding in nonexperimental studies 96
Analytic methods to adjust for confounding factors 100
A look at advanced techniques 101
Research Methods for Pharmaceutical Practice and Policy
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Contents | ix

Strengths and limitations of nonexperimental studies 102


Summary and conclusions 103
Review questions/topics 104

7 Sampling methods 107


RR Aparasu
Introduction 107
Sampling terminology 107
Sampling plan 108
Analytical considerations 121
Summary and conclusions 121
Review questions/topics 122

8 Systematic review of the literature 125


D Ashcroft
Introduction 125
Review terminology 125
Getting started 127
Undertaking the review 129
Conducting the literature search 131
Identifying and appraising systematic reviews 138
Summary and conclusions 139
Review questions/topics 140

9 Data collection methods 143


RR Cline
Introduction 143
Qualitative data collection methods 143
Quantitative data collection methods 149
Mixed methods data collection 154
Summary and conclusions 156
Review questions/topics 157

10 Survey design 161


MM Worley
Introduction 161
Getting started in the survey research process 162
Constructing the survey 162
Common scales used in survey research 164
Ordering of survey questions 166
Formatting the survey 167
Design considerations for modes of survey administration 168
Research Methods for Pharmaceutical Practice and Policy
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x | Contents

Considerations for selecting modes of administration 169


Survey implementation 170
Preparing data for analysis 173
Summary and conclusions 175
Review questions 175

11 Statistical analysis 179


JP Bentley
Introduction 179
The purpose and function of statistics in research 179
Some important concepts 180
A classification of statistical techniques 183
Dependence techniques 184
Interdependence techniques 193
Modeling correlated data 196
Setting an appropriate statistical technique 198
Summary and conclusions 199
Review questions/topics 199

12 Secondary data analysis: administrative data 203


BC Martin
Defining administrative data 203
Uses of administrative claims data 204
Medicare and Medicaid data sources 205
Typical administrative claims files structures 212
Inpatient and facility claims 214
Professional services and physician claims 214
Outpatient prescription claims 216
Medical coding conventions 218
Coding for services, procedures, and products 220
Summary and conclusions 222
Acknowledgments 222
Review questions 223

13 Secondary data analysis: commercial data 227


RJ Valuck and B Jackson
Introduction 227
Commercial data source types 229
Administrative databases 229
Clinical databases 234
Considerations in choosing among commercial data sources 239
Summary and conclusions 241
Review topics 242
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Contents | xi

14 Secondary data analysis: national sample data 245


RR Aparasu
Introduction 245
National surveys 246
National survey design and analysis 252
Research considerations 256
Summary and conclusions 259
Review questions/topics 259

15 Program evaluation 261


JC Schommer
Introduction 261
An approach for conducting effective program evaluations 262
Standards for effective program evaluation 268
Misconceptions regarding the purpose of program evaluation 271
Summary and conclusions 272
Review questions 273

16 The future of pharmaceutical policy research 275


AI Wertheimer
Introduction 275
Future direction for pharmaceutical policy research 275
Methods and metrics 276
Measuring quality 279
Policy issues 280
Unresolved policy issues 281
Summary and conclusions 286
Review topics 286

Appendix 1 Selected peer-reviewed pharmaceutical practice


and policy research journals 289
Appendix 2 Selected pharmaceutical practice and policy research
funding sources 295

Index 299
Research Methods for Pharmaceutical Practice and Policy
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Research Methods for Pharmaceutical Practice and Policy
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Preface

In recent years, pharmaceutical practice and policy research has gained prom-
inence due to the increasing visibility of pharmacists, pharmaceuticals, phar-
macist services, and pharmacy systems in the healthcare system. Providers,
patients, payers, and policy makers are concerned about cost, access, and
quality of pharmaceutical care. There is increasing pressure on pharmacists
and pharmacy systems to improve efficiency, effectiveness, and safety of
pharmaceuticals and pharmacist services. This requires evidence-based prac-
tices and policies rooted in sound scientific principles to achieve the desired
healthcare goals.
Scientific innovations have played a prominent role in the growth of the
pharmaceutical market. Pharmaceutical firms have traditionally funded
basic and applied research on pharmaceuticals. Federal agencies such as the
National Institutes of Health (NIH) and the Agency for Healthcare Research
and Quality (AHRQ) have strongly supported safety and effectiveness studies
for pharmaceutical products. These funding mechanisms have led to extensive
growth in the pharmaceutical product knowledge base in terms of safety and
effectiveness. It is not only vital to have a scientific knowledge base but also
important to incorporate the existing knowledge into current practices and
policies. This is often referred to as evidence-based practice and policy.
Increasingly evidence-based medicine has become synonymous with quality
of health. Several nonfederal agencies, such as the Joint Commission and
National Committee for Quality Assurance, have developed process measures
of quality from these proven practices. The AHRQ (2008) has funded several
centers across the nation to generate and promote evidence-based practices
and the emphasis on their implementation continues to increase.
Recently, researchers and practitioners are focusing on comparative effec-
tiveness to improve efficient use of pharmaceutical products. The goal of the
comparative research is to provide information to decision makers at
both individual and population levels (Institute of Medicine 2009). The com-
parative effectiveness research has come to the forefront due to limited com-
parative data on safety and effectiveness. The efficacy data derived from
placebo-controlled clinical trials are designed for the drug approval process.
Research Methods for Pharmaceutical Practice and Policy
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xiv | Preface

Comparative effectiveness research is based on the concepts of evaluation of


alternatives to select an appropriate agent to optimize patient outcomes. In
fact, the AHRQ (2009) has funded the Centers for Education and Research on
Therapeutics (CERTs) to conduct research to optimize use of medications.
The growth of the knowledge base and funding support from federal and
nonfederal agencies clearly demonstrates the need and importance of phar-
maceuticals in healthcare. However, the knowledge base and support for
pharmacist services or pharmacy systems research has been limited when
compared with other professional services and pharmaceutical product-based
research. Concepts such as pharmaceutical care and medication therapy man-
agement need a strong knowledge base and a wider acceptance to implement
evidence-based patient care practices. This requires concerted effort to move
from abstraction to operationalization and evaluation. There is a need to
develop a knowledge base that has internal validity (efficacy) and external
validity (effectiveness). The effectiveness research has the additional benefit of
providing generalizable information for policy making (Wells and Strum,
1996). With increasing emphasis on efficiency, effectiveness, and safety, the
scientific knowledge base will be a critical component of pharmaceutical
practice and policy.
Pharmaceutical practice and policy research has evolved over the years
consistent with the changes in the profession, delivery of pharmaceutical care,
and applied research methodologies. These applied research methodologies
are derived from various disciplines. Consequently, faculty and students
involved in pharmaceutical practice and policy research have traditionally
used research methods textbooks from education, psychology, behavior
sciences, and other applied research areas. Although there are several text-
books relevant to health services research, very few are available in pharma-
ceutical practice and policy research. This book is an earnest attempt to bring
relevant content and expertise to conducting pharmaceutical practice and
policy research. Its structure and content is based on years of experience
teaching and applying the principles of pharmaceutical practice and policy
research.
This textbook covers a wide range of topics for conducting scientific
research starting with conceptualizing research and ending with statistical
analysis. Traditionally graduate courses emphasize the theoretical aspect
of applied research to provide a strong research foundation. However, this
can lead to a strong understanding of concepts without appreciation for
application. Pharmaceutical practice and policy research is applied research
to address issues related to pharmacists, pharmaceuticals, pharmacist ser-
vices, and pharmacy systems. The goal of the book is to provide both a
theoretical and a practical framework for conducting pharmaceutical practice
and policy research. Special emphasis is placed on examples and practical
procedures that are important in implementing research.
Research Methods for Pharmaceutical Practice and Policy
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Preface | xv

There are 16 chapters in this textbook. Each chapter is designed to provide


an understanding and application of the critical elements for conducting
pharmaceutical practice and policy research. Chapter 1 defines pharmaceu-
tical practice and policy research in the context of health services research,
and explains the process of scientific inquiry in general and the overall process
of pharmaceutical practice and policy research in particular. Chapter 2
explains concepts and constructs, and discusses the testing and application
of common theories relevant to pharmaceutical practice and policy
research. Chapter 3 focuses on the operationalization process, with emphasis
on developing research problems, research questions, hypotheses, and oper-
ational definitions. Chapter 4 describes the concept and levels of measure-
ment, discusses reliability and validity, and methods commonly used to
evaluate reliability and validity. Chapters 5 and 6 provide experimental and
nonexperimental approaches for conducting pharmaceutical practice and
policy research. Chapter 5 discusses various types of experimental research
designs to address cause and effect relationships and issues related to validity
threats and Chapter 6 provides an overview of observational designs and
techniques relevant for conducting nonexperimental research. Chapter 7 pre-
sents the key steps in designing a sampling plan including target population
definition, sampling approaches, and determinants of sample size.
Chapter 8 provides a practical guide to understanding and implementing
systematic reviews to uncover the existing knowledge base by ordering
and evaluating the available literature. Chapters 9 and 10 discuss issues
related to research methodologies in pharmaceutical practice and policy
research. Chapter 9 provides an overview of qualitative, quantitative, and
mixed data collection methods and Chapter 10 examines principles of
survey design to provide a practical framework for designing and conduct-
ing effective surveys. Chapter 11 provides the statistical framework to
analyze data for various research designs and questions. Chapters 12–14
describe research approaches based on secondary data: Chapter 12 provides
the analytical framework including analytical files, data structure, and
medical coding conventions to conduct research based on Medicare and
Medicaid data; Chapter 13 provides an overview of the major types of
commercial data and discusses issues to be considered when choosing com-
mercial data sources; and Chapter 14 provides descriptions of common
national survey data sources and research and analytical considerations
in using national survey data for research. Chapter 15 describes approaches
and reviews standards for conducting effective program evaluations.
Finally, Chapter 16 examines major issues and trends influencing the future
of pharmaceutical practice and policy.
This textbook is designed for entry-level graduate students in pharmacy
administration, pharmaceutical evaluation or policy, or health services
research focusing on pharmaceutical policy and practice issues. The contents
Research Methods for Pharmaceutical Practice and Policy
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xvi | Preface

of the book can be delivered in one semester. Each chapter builds on the
previous chapters to logically progress from conceptualization to implemen-
tation of research studies. Additional reading and a project/proposal can
improve the critical thinking skills of the students and also provide a mech-
anism to implement the research techniques. The online resources and chapter
references can be used to supplement the content. In addition, recent journal
articles relevant to the chapter can be useful in strengthening the conceptual
and practical understanding of principles and techniques of conducting phar-
maceutical practice and policy research. This book can also be an excellent
resource for pharmacy students in professional programs, undergraduate
students in pharmaceutical sciences, and pharmacists in residencies and fel-
lowships, while also providing a useful tool to pharmacy practitioners and
researchers.
I would really appreciate feedback from students and faculty for future
editions. All knowledge is considered as work in progress including the con-
tents of this book.

Rajender R Aparasu, MPharm, PhD


Houston, Texas
August 2010

References
Agency for Healthcare Research and Quality (2008). Evidence-based Practice Centers:
Synthesizing scientific evidence to improve quality and effectiveness in health care.
Overview. Rockville, MD: Agency for Healthcare Research and Quality. Online (updated
November 10, 2008). Available at www.ahrq.gov/clinic/epc (accessed October 14, 2009).
Agency for Healthcare Research and Quality (2009). Centers for Education & Research on
Therapeutics (CERTs). Rockville, MD: Agency for Healthcare Research and Quality. Online
(updated March 6, 2009). Available at www.certs.hhs.gov (accessed October 14, 2009).
Institute of Medicine (2009). Initial national priorities for comparative effectiveness research.
Washington, DC: National Academies Pr.
Wells KB, Strum R (1996). Informing the policy process: from efficacy to effectiveness data on
pharmacotherapy. J Consulting Clin Psychol 64: 638–45.
Research Methods for Pharmaceutical Practice and Policy
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Acknowledgments

I take this opportunity to thank my teachers, colleagues, and students who


have influenced and challenged me throughout my career. In particular, I
would like to extend my sincere thanks to two people who were the initial
driving force for undertaking this endeavor, Drs Robert Mikeal and Albert
Wertheimer. I sincerely appreciate their encouragement and support in devel-
oping the master plan for the book. I want to thank all the chapter contribu-
tors who worked diligently with me in developing the content for the book. I
also thank the reviewers for their input to improve the content and flow of
each of the chapters.
Appreciation is also in place for my graduate students for offering input
from a student’s perspective on several of the chapters. I would like specially
to thank Mrs Golda Hallett for her help in all stages of the book’s preparation.
I am sure I would not have completed this book on time without her valuable
assistance. Finally, I am grateful to Pharmaceutical Press and their staff, Ms
Christina De Bono, Ms Lindsey Fountain, and Ms Rebecca Perry, for their
help and support. The editorial assistance of Jane Sugarman and Marion
Edsall is also very much appreciated.
Research Methods for Pharmaceutical Practice and Policy
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Research Methods for Pharmaceutical Practice and Policy
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About the editor

Rajender R Aparasu, MPharm, PhD, is a Professor and Division Head of


Pharmacy Administration and Public Health at the University of Houston
College of Pharmacy. Dr. Aparasu has over 15 years of experience in teaching
and researching in the areas of pharmaceutical practice and policy. He has
received several federal and nonfederal grants to address a wide variety of
quality of pharmaceutical care issues. Dr. Aparasu has served as an expert
consultant on Federal Patient Safety and APhA Medication Therapy
Management Taskforces. He serves on the editorial boards of three peer-
reviewed journals, Research in Social and Administrative Pharmacy, The
Journal of Drug, Healthcare and Patient Safety, and The Open Health
Services and Policy Journal. He is a peer-reviewer for several pharmacy and
medical journals and has been recognized as an exceptional peer reviewer by
Medical Care and Pharmacoepidemiology and Drug Safety. He is also an
associate editor of BMC Geriatrics. Dr. Aparasu has made over 90 presenta-
tions in national and international meetings and has over 45 publications.
Research Methods for Pharmaceutical Practice and Policy
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Research Methods for Pharmaceutical Practice and Policy
Contributors Dated: 27/9/2010 At Time: 10:12:2

Contributors

Rajender R Aparasu, MPharm, PhD


Professor and Division Head, Pharmacy Administration and Public Health,
Department of Clinical Sciences and Administration, College of Pharmacy,
University of Houston, Houston, TX, USA

Darren Ashcroft, BPharm, MSc, PhD, MRPharmS


Reader in Medicines Usage and Safety and Director, Centre for Innovation in
Practice, School of Pharmacy and Pharmaceutical Sciences, Manchester, UK

John P Bentley, PhD


Associate Professor of Pharmacy Administration and Research Associate
Professor, Research Institute of Pharmaceutical Sciences, School of
Pharmacy, University of Mississippi, MS, USA

Carolyn M Brown, PhD


Professor, Division of Pharmacy Administration, College of Pharmacy, The
University of Texas at Austin, Austin, TX, USA

Richard R Cline, PhD


Associate Professor, Department of Pharmaceutical Care and Health Services,
College of Pharmacy, University of Minnesota, Minneapolis, MN, USA

Betsey Jackson, MS
President, Health Data Services Corporation, Carlisle, MA, USA

Michael L Johnson, PhD


Associate Professor, Department of Clinical Sciences and Administration,
College of Pharmacy, University of Houston, Houston, TX, USA
Research Methods for Pharmaceutical Practice and Policy
Contributors Dated: 27/9/2010 At Time: 10:12:2

xxii | Contributors

Khalid M Kamal, PhD


Assistant Professor, Division of Clinical, Social and Administrative Sciences,
Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA, USA

Kenneth A Lawson, PhD


Associate Professor and Mannino Fellow, Pharmacy Administration
Division, College of Pharmacy, The University of Texas, Austin, TX, USA

Bradley C Martin, PharmD, PhD


Professor and Director of Pharmaceutical Evaluation and Policy, Division of
Pharmaceutical Evaluation and Policy Faculty, University of Arkansas for
Medical Sciences, Little Rock, AR, USA

Jon C Schommer, PhD


Professor and Associate Department Head, Department of Pharmaceutical
Care and Health Systems and Director of Graduate Studies in Social and
Administrative Pharmacy Track, College of Pharmacy, University of
Minnesota, Minneapolis, MN, USA

Robert J Valuck, PhD


Associate Professor, Department of Clinical Pharmacy, School of Pharmacy,
University of Colorado Denver, Aurora, CO, USA

Albert I Wertheimer, PhD


Professor of Pharmacy, School of Pharmacy, Temple University, Philadelphia,
PA, USA

Marcia M Worley, PhD, RPh


Associate Professor, Department of Pharmacy Practice and Pharmaceutical
Sciences, College of Pharmacy, University of Minnesota at Duluth, Duluth,
MN, USA
Research Methods for Pharmaceutical Practice and Policy
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1
Scientific approach to
pharmaceutical practice
and policy research
Rajender R Aparasu

Chapter objectives
* To define pharmaceutical practice and policy research
* To introduce the knowledge base and stakeholders in
pharmaceutical policy research
* To describe the guiding principles for scientific inquiries
* To discuss the stages of pharmaceutical practice and policy
research

Introduction
Pharmaceuticals and pharmacist services are integral parts of healthcare
delivery, and pharmacists and pharmacy systems play a critical role in current
healthcare. Pharmaceutical practice and policy research is an applied field of
research that deals with issues impacting pharmaceuticals, pharmacists, and
pharmacy systems. It has evolved over the decades consistent with changes in
healthcare delivery in general and the evolution of pharmaceutical care in
specific. Applied research methodologies in health services research have also
been instrumental in the growth of pharmaceutical practice and policy
research. Pharmaceutical practice and policy research helps in the growth
of the applied scientific knowledge base to aid decisions relevant to patients,
providers, payers, and policy makers. It also helps to improve the practice of
pharmacy and promote the profession. With increasing complexities of deliv-
ering pharmaceutical care, research has become the cornerstone in safe and
effective delivery of pharmaceutical care.

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