Theresa M. Wizemann, Ph.D.

Board on Population Health and Public Health Practice






Washington, D.C.

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SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH A W O R K S H O P S U M M A R Y Theresa M. Wizemann, Ph.D. Rapporteur Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This study was supported by Contract N01-OD-4-2139, TO 246 between the National Academy of Sciences and the National Institutes of Health. Any opin- ions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organiza- tions or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-22524-3 International Standard Book Number 10: 0-309-22524-8 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624- 6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, For more information about the Institute of Medicine, visit the IOM home page at: Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among al- most all cultures and religions since the beginning of recorded history. The ser- pent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2012. Sex-specific reporting of scientific research: A workshop summary. Washington, DC: The National Academies Press.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal gov- ernment on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of out- standing engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engi- neering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

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PLANNING COMMITTEE ON SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH: A WORKSHOP1 NANCY E. ADLER (Chair), Professor of Medical Psychology, Vice Chair of the Department of Psychiatry, Director of the Center for Health and Community, University of California, San Francisco MARIETTA ANTHONY, Director of Women’s Health, Critical Path Institute FLOYD BLOOM, Executive Director of Scientific Communications, Professor Emeritus, Scripps Research Institute JEROME P. KASSIRER, Distinguished Professor of Medicine, Tufts University School of Medicine JON LEVINE, Director of the Wisconsin National Primate Research Center, Professor of Neuroscience, University of Wisconsin– Madison HAROLD C. SOX, Editor Emeritus, Annals of Internal Medicine Study Staff MICHELLE C. CATLIN, Study Director TREVONNE WALFORD, Research Assistant ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice HOPE HARE, Administrative Assistant NORMAN GROSSBLATT, Senior Editor 1 Institute of Medicine planning committees are solely responsible for organizing the workshops, identifying topics, and choosing speakers. Responsibility for the published workshop summaries rests with the workshop rapporteur and the insti- tution. v

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Reviewers This workshop summary has been reviewed in draft form by per- sons chosen for their diverse perspectives and technical expertise in ac- cordance with procedures approved by the National Research Council Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to en- sure that the summary meets institutional standards of objectivity, evi- dence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the delib- erative process. We thank the following for their review of the summary: Nancy E. Adler, Ph.D., Lisa and John Pritzker Professor of Psy- chology, University of California, San Francisco and Chair, Workshop Planning Committee Jeanne Miranda, Ph.D., Professor, Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles Rita F. Redberg, M.D., Director, Women’s Cardiovascular Ser- vices, University of California, San Francisco Medical Center John B. Wong, M.D., Professor of Medicine and Chief, Division of Clinical Decision Making, Informatics, and Telemedicine, Tufts Medical Center, Tufts University School of Medicine Although the reviewers listed above have provided many con- structive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the workshop summary before its release. The review of the summary was overseen by Kristine M. Gebbie, Dr.P.H., R.N., Adjunct Professor, vii

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viii REVIEWERS Flinders University School of Nursing and Midwifery, Adelaide, South Australia. Appointed by the Institute of Medicine, she was respon- sible for making certain that an independent examination of the workshop summary was carried out in accordance with institutional pro- cedures and that all review comments were carefully considered. Re- sponsibility for the final content of the workshop summary rests entirely with the institution.

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Contents OVERVIEW 1 INTRODUCTION 2 INCLUSION OF WOMEN IN CLINICAL TRIALS FUNDED BY THE NATIONAL INSTITUTES OF HEALTH 4 WHY SEX-SPECIFIC REPORTING IS IMPORTANT 5 Early History, 5 The Need to Study Both Sexes, 6 Raising Awareness of Sex Differences, 7 Barriers to Studying Sex Differences, 9 Other Groups, 10 Managing the Data, 10 THE RESEARCHER PERSPECTIVE: COLLECTING, ANALYZING, AND REPORTING SEX-SPECIFIC DATA 11 Collecting the Data: Sex in Biomedical Research, 11 Analyzing the Data: Methods of Subgroup Analysis, 13 Reporting the Data, 17 THE EDITOR PERSPECTIVE: IMPLEMENTING JOURNAL EDITORIAL POLICIES 21 Editorial Policy-Making, 21 Sex and Gender Medicine vs Women’s Health, 23 Preclinical vs Clinical Studies, 25 Moving Toward Broader Sex-Specific Reporting, 26 ix

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x CONTENTS IMPLICATIONS FOR JOURNALS OF SEX-SPECIFIC REPORTING POLICIES OF JOURNALS 26 Nonclinical Science Journals, 26 Interdisciplinary Science Journals, 27 Medical Journals, 28 Suggestions from the Editors, 35 LOOKING FORWARD 36 The Role of Editorial Policy, 37 Statistical Power for Subgroup Analysis, 39 Summary of Participants’ Suggestions for Advancing Sex- Specific Reporting, 39 CLOSING REMARKS 40 REFERENCES 41 APPENDIXES A Workshop Agenda 45 B Speaker Biosketches 49 C Planning Committee Biosketches 59