E VIDENCE -B ASED E NDOCRINOLOGY

E ^VIDENCE -B ^ASED E NDOCRINOLOGY

C ONTEMPORARY E NDOCRINOLOGY

Evidence-Based Endocrinology, edited by V

M. M

, 2006

Stem Cells in Endocrinology, edited by L

B.

L

, 2005

Office Andrology, edited by P

E. P

D

E. B

, 2005

Male Hypogonadism: Basic, Clinical, and Therapeutic Principles, edited by S

J. W

, 2004

Androgens in Health and Disease, edited by C

J. B

W

J.

B

, 2003

Endocrine Replacement Therapy in Clinical Practice, edited by A. W

M

, 2003 Early Diagnosis of Endocrine Diseases, edited

by R

S. B

, 2003

Type I Diabetes: Etiology and Treatment, edited by M

A. S

, 2003

Handbook of Diagnostic Endocrinology, edited by J

E. H

L

K. N

, 2003 Pediatric Endocrinology: A Practical Clinical

Guide, edited by S

R

M

H. M

G

, 2003

Diseases of the Thyroid, 2nd ed., edited by L

E. B

, 2003

Developmental Endocrinology: From Research to Clinical Practice, edited by E

A.

E

O

H

P

, 2002 Osteoporosis: Pathophysiology and Clinical

Management, edited by E

S. O

M

B

, 2002

Challenging Cases in Endocrinology, edited by M

E. M

, 2002

Selective Estrogen Receptor Modulators:

Research and Clinical Applications, edited by A

M

M

F.

V

, 2002

Transgenics in Endocrinology, edited by M

M

, C

W. B

,

T. R

K

, 2001

Assisted Fertilization and Nuclear Transfer in Mammals, edited by D

P. W

M

Z

-W

, 2001 Adrenal Disorders, edited by A

N.

M

G

P. C

, 2001 Endocrine Oncology, edited by S

P.

E

, 2000

Endocrinology of the Lung: Development and Surfactant Synthesis, edited by C

R.

M

, 2000

Sports Endocrinology, edited by M

P.

W

N

W. C

, 2000 Gene Engineering in Endocrinology, edited by

M

A. S

, 2000

Endocrinology of Aging, edited by J

E. M

L

B

, 2000

Human Growth Hormone: Research and Clinical Practice, edited by R

G. S

M

O. T

, 2000

Hormones and the Heart in Health and Disease, edited by L

S

, 1999

Menopause: Endocrinology and Management, edited by D

B. S

E

A.

K

, 1999

The IGF System: Molecular Biology, Physiology, and Clinical Applications, edited by R

G.

R

C

T. R

, J

., 1999 Neurosteroids: A New Regulatory Function in

the Nervous System, edited by E

- E

B

, M

S

,

P

R

, 1999

Autoimmune Endocrinopathies, edited by R

V

, 1999

Hormone Resistance Syndromes, edited by J. L

J

, 1999

Hormone Replacement Therapy, edited by A. W

M

, 1999

Insulin Resistance: The Metabolic Syndrome X, edited by G

M. R

A

L

, 1999 Endocrinology of Breast Cancer, edited by

A

M

, 1999

Molecular and Cellular Pediatric Endocrinology, edited by S

H

, 1999 Gastrointestinal Endocrinology, edited by

G

H. G

, J

., 1999 The Endocrinology of Pregnancy, edited by

F

W. B

, 1998

Clinical Management of Diabetic Neuropathy, edited by A

V

, 1998

G Proteins, Receptors, and Disease, edited by A

M. S

, 1998

Natriuretic Peptides in Health and Disease, edited by W

K. S

E

R. L

, 1997

P. Michael Conn, S ^ERIES E ^DITOR

E ^VIDENCE -B ^ASED E NDOCRINOLOGY

H ^UMANA P ^RESS

T ^OTOWA , N ^EW J ^ERSEY

Edited by

V ^ICTOR M. M ^ONTORI , ^MD , ^MSc

Mayo Clinic College of Medicine, Rochester, MN

© 2006 Mayo Foundation for Medical Education and Research

For additional copies, pricing for bulk purchases, and/or information about other Humana titles, contact Humana at 999 Riverview Drive, Suite 208, Totowa, NJ 07512 or at any of the following numbers: Tel: 973- 256-1699; Fax: 973-256-8341; E-mail: [email protected] or visit our website at http://humanapress.com All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise without written permission from the Mayo Foundation.

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Printed in the United States of America. 10 9 8 7 6 5 4 3 2 1 Library of Congress Cataloging-in-Publication Data

Evidence-based endocrinology / edited by Victor M. Montori.

p. cm. -- (Contemporary endocrinology) Includes bibliographical references and index.

ISBN 1-58829-579-6 (alk. paper)

1. Endocrinology. 2. Evidence-based medicine. I. Montori, Victor M. II. Series: Contemporary endocrinology (Totowa, N.J.) [DNLM: 1. Endocrine System Diseases. 2. Endocrinology.

3. Evidence-Based Medicine. WK 140 E92 2006]

RC649.E96 2006

616.4--dc22

2005012487

v

P ^REFACE

This book is about evidence-based endocrinology, but it is not a “how-to-do-it”

evidence-based medicine manual (indeed several other books are available that fulfill this objective optimally). It is a broad-ranging collection of essays, each with its own voice, that place evidence-based medicine in the context of endocrine practice and policy. My instruction to each one of the generous contributors to this volume was to be honest, be clear, and be bold. Some went beyond this request and submitted controversy and irritation, and I thank them for taking this risk. I expect all of these chapters to provoke thought and reflection in the curious reader who faces their content with an open but critical mind.

Evidence-Based Endocrinology is divided into four sections. An initial section outlines the past, present, and future of evidence-based medicine. A series of chapters on the practical aspects of evidence-based endocrinology follows. The third section is about the “evidence” in evidence-based medicine. The final section offers case-based discussions by practicing evidence-based clinicians. These chapters highlight both the usefulness of evidence-based medicine in endocrinology and its limitations as we cur- rently understand these.

I selected the authors from among people I respect for their expertise, integrity, and rigor. My deepest gratitude goes to them and to their families for allowing them to produce these chapters mostly during their personal time. I hope the readers will appre- ciate this book as a testament of friendship, generosity, and scholarship.

I was honored to edit Evidence-Based Endocrinology at a particularly exciting point in my career and in my life. I ask the reader to imagine my professional life as one surrounded by the talent of those who have authored the chapters in this book. At the risk of offending those whom I am not mentioning, I want to single out three friends who have been instrumental in my personal and professional growth: Sean Dinneen introduced me to the excitement of endocrinology and systematic reviews; Steven Smith introduced me to health services research, to information technology, and to the “Jimmy Carter” way of getting things done when organizational hairballs limit progress; and Gordon Guyatt, the father of evidence-based medicine, who has shown me that genius, consequence, loyalty, friendship, citizenship, and mentorship can all be qualities of the same wonder- ful human being. Thank you.

My sons and my wife Claudia have been proverbially patient and extremely generous with their time, and have filled me with unconditional love. They are the best available evidence that I am the luckiest man alive. The time away from them editing this book is the greatest gift I can give to my patients who, I hope, will one day expect, demand, and benefit from the care of evidence-based endocrinologists.

Victor M. Montori, ^MD , ^MS

C ^ONTENTS

vii

Preface ... v Contributors ... ix

1 The New Endocrinologist: Evidence-Based Medicine Meets Endocrine Practice

Victor M. Montori ... 1

P ART I P AST , P RESENT , AND F UTURE

2 A Short History of Evidence-Based Medicine: Issues for the Clinician

Jeanne Daly ... 11 3 The Philosophy of Evidence-Based Medicine

Gordon H. Guyatt and Jason W. Busse ... 25 4 Preparing Future Generations of Evidence-Based

Endocrinologists

Michael L. Green ... 35

P ART II P RACTICING E VIDENCE -B ASED E NDOCRINOLOGY

5 Finding Current Best Evidence in Endocrinology

R. Brian Haynes and Cynthia J. Walker-Dilks ... 61 6 Integrating Evidence Into Clinical Diagnosis

W. Scott Richardson ... 69 7 Supporting Evidence-Based Endocrine Practice

Steven A. Smith and Geoffrey S. Gates ... 87 8 Supporting Patients’ Participation in Decision Making

Annette M. O’Connor, Dawn Stacey,

and France Légaré ... 101 9 Incorporating Evidence Into Health Policy Decisions

Eduardo Ortiz and Janelle Guirguis-Blake ... 117

P ART III R ESEARCH E VIDENCE FOR E VIDENCE -B ASED E NDOCRINE P RACTICE

10 The Value of Observational Studies in Endocrinology

L. Joseph Melton III ... 141

viii Contents

11 Clinical Research Center-Based Investigations and Evidence-Based Medicine

William L. Isley ... 155 12 The Value of Systematic Reviews in Endocrinology:

The Impact of the Cochrane Metabolic and Endocrine Disorders Review Group

Bernd Richter ... 165 13 Health-Related Quality-of-Life Assessment in Endocrinology

Elie A. Akl and Holger J. Schünemann ... 179 14 Decision Analysis in Endocrinology

Evelyn Mentari and David Aron ... 207 15 Clouded Thinking: The Misguided Use of Cost-Effectiveness

Analysis and the Implications for Endocrine Interventions Amiram Gafni ... 225 16 Translation Research in Diabetes: Asking Broader Questions

Russell E. Glasgow, Elizabeth Bayliss,

and Paul A. Estabrooks ... 241

P ART IV C ASE S TUDIES IN E VIDENCE -B ASED P RACTICE

17 The Patient With Type 1 Diabetes and Hypoglycemia Yogish C. Kudva, Teck-Kim Khoo,

and Peter J. Tebben ... 259 18 The Patient With Medically Complicated Obesity

Kurt A. Kennel ... 275 19 The Patient at Risk for Diabetes: Considering Prevention

Sarah E. Capes ... 289 20 An Evidence-Based Approach to Type 2 Diabetes

Robert K. Semple and Sean F. Dinneen ... 303 21 The Patient With Diabetes Using Alternative Medicine

Dugald Seely, Edward Mills, and Beth Rachlis ... 323 22 Evidence-Based Case Studies in Osteoporosis

Clifford J. Rosen and Sue A. Brown ... 343 23 The Neuroendocrinology of Medically Unexplained

Syndromes: The Example of Chronic Fatigue Syndrome

Jason W. Busse... 367

Index ... 381

E LIE A. A KL , MD , MPH , Departments of Medicine and Social and Preventive Medicine, School of Medicine and Biomedical Sciences, University at Buffalo, State

University of New York, Buffalo, NY

D AVID A RON , MD , MS , Department of Medicine, Division of Clinical and Molecular Endocrinology, Case Western Reserve University School of Medicine, and VA Health Services Research and Development Center for Quality Improvement Research, Louis Stokes Department of Veterans Affairs Medical Center, Cleveland, OH

E LIZABETH B AYLISS , MD , MSPH , Clinical Research Unit, Kaiser Permanente Colorado, Penrose, CO

S UE A. B ROWN , MD , Division of Endocrinology, Department of Medicine, University of North Carolina, Chapel Hill, NC

J ASON W. B USSE , DC , MS c , Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

S ARAH E. C APES , MD , MS , Department of Medicine at McMaster University, Diabetes Care and Research Center, Division of General Internal Medicine, Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada

J EANNE D ALY , P h D , Mother and Child Health Research Centre at La Trobe University, Melbourne, Australia

S EAN F. D INNEEN , MD , MSC , FRCP ( I ), FACP , National University of Ireland, and University College Hospital, Galway, Ireland

P AUL A. E STABROOKS , P h D , Clinical Research Unit, Kaiser Permanente Colorado, Penrose, CO

A MIRAM G AFNI , BSC , MSC , DS c , P h D , Department of Clinical Epidemiology

and Biostatistics, Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada

G EOFFREY S. G ATES , MD , Department of Internal Medicine, Division of Endocrinology, Mayo Clinic College of Medicine, Jacksonville, FL

R USSELL E. G LASGOW , P h D , Clinical Research Unit, Kaiser Permanente Colorado, Penrose, CO

M ICHAEL L. G REEN , MD , MS c , Department of Medicine, Yale University School of Medicine, New Haven, CT

J ANELLE G UIRGUIS -B LAKE , MD , Department of Family and Community Medicine, Georgetown University School of Medicine, Washington, DC

G ORDON H. G UYATT , MD , MS c , Departments of Medicine and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

R. B RIAN H AYNES , MD , P h D , Department of Clinical Epidemiology and Biostatistics, Health Information Research Unit, McMaster University, Hamilton, Ontario, Canada

C ONTRIBUTORS

ix

W ILLIAM L. I SLEY , MD , Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic College of Medicine, Rochester, MN

K URT A. K ENNEL , MD , Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic College of Medicine, Rochester, MN

T ECK -K IM K HOO , MD , Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, MN

Y OGISH C. K UDVA , MD , MBBS , Division of Endocrinology, Mayo Clinic College of Medicine, Rochester, MN

F RANCE L ÉGARÉ , MD , P h D , CCFP , FCFP , Département de Médecine Familiale, Université Laval, Québec City, Québec, Canada

L. J OSEPH M ELTON III, MD , MPH , Division of Epidemiology, Department of Health Sciences Research, Division of Endocrinology, Department of Medicine, Mayo Clinic College of Medicine, Rochester, MN

E VELYN M ENTARI , MD , Division of Nephrology, Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, OH

E DWARD J. M ILLS , MS c , Department of Clinical Epidemiology, Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada, and Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada V ICTOR M. M ONTORI , MD , MS c , Knowledge and Encounter Research Unit, Divisions

of Endocrinology, Diabetes, and Internal Medicine, Mayo Clinic College of Medicine, Rochester, MN

A NNETTE M. O’C ONNOR , RN , MS c N , P h D , Ottawa Health Research Institute, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada

E DUARDO O RTIZ , MD , MPH , Department of Veterans Affairs, Washington DC VA Medical Center, Washington, DC, and Division of Health Sciences Informatics, Johns Hopkins University School of Medicine, Baltimore, MD

B ETH R ACHLIS , BS c , Department of Clinical Epidemiology, The Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

W. S COTT R ICHARDSON , MD , Department of Internal Medicine, Wright State University School of Medicine, Dayton, OH

B ERND R ICHTER , MD , P h D , Department of Endocrinology, Diabetology,

and Rheumatology, Coordinating Editor Metabolic and Endocrine Disorders Cochrane Review Group, Heinrich-Heine University, Duesseldorf, Germany C LIFFORD J. R OSEN , MD , Maine Center for Osteoporosis Research and Education,

St. Joseph Hospital, Bangor, ME, and The Jackson Laboratory, Bar Harbor, ME H OLGER J. S CHÜNEMANN , MD , P h D , McMaster University, Hamilton, Ontario, Canada, Departments of Medicine and Social and Preventive Medicine, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York;

Buffalo, NY, and National Cancer Institute, Rome, Italy

D UGALD S EELY , ND , Department of Clinical Epidemiology, The Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

R OBERT K. S EMPLE , MA , MB , BCHIR , Department of Clinical Biochemistry, Addenbrooke’s Hospital, Cambridge, UK

x Contributors

S TEVEN A. S MITH , MD , Division of Endocrinology, Diabetes, Nutrition, and Metabolism, Division of Health Care Policy and Research, Department of Internal Medicine, Medical Director, Section of Patient Education, Mayo Clinic College of Medicine, Rochester, MN

D AWN S TACEY , MS c N , RN , P h D , Ottawa Health Research Institute, The Ottawa Hospital, Ottawa, University of Ottawa, Ontario, Canada

P ETER J. T EBBEN , MD , Division of Pediatric Endocrinology, Department of Adolescent and Pediatric Medicine, Mayo Clinic College of Medicine, Rochester, MN

C YNTHIA J. W ALKER -D ILKS , MLS , Department of Clinical Epidemiology and Biostatistics, Health Information Research Unit, McMaster University, Hamilton, Ontario, Canada

Contributors xi