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382 Pages·1986·15.877 MB·English
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Principles and Practice of Research Strategies for Surgical Investigators Principles and Practice of Research Strategies for Surgical Investigators Edited by Hans Troidl Walter o. Spitzer Bucknam McPeek David S. Mulder Martin R McKneally With 37 Illustrations Springer-Verlag Berlin Heidelberg New York London Paris Tokyo Hans Troidl Walter O. Spitzer Bucknam McPeek Department of Surgery Department of Epidemiology and Department of Anaesthesia University of Cologne Biostatistics Harvard University Surgical Clinic Merheim McGill University Massachusetts General Hospital D-5000 Cologne 91 Montreal, Quebec Boston, Massachusetts 02114 Federal Republic of Germany Canada H3A lA2 U.S.A. David S. Mulder Martin F. McKnealIy Department of Surgery Division of Cardio-Thoracic McGill University Surgery Montreal General Hospital Albany Medical College of Montreal, Quebec Union University Canada H3G IA4 Albany, New York 12208 U.S.A. Library of Congress Cataloging in Publication Data Principles and practices of research. Includes bibliographies and index. I. Surgery-Research-Methodology. I. Troidl, Hans. 1938- [DNLM: I. Research. 2. Surgery. WO 20 P957] RD29. P75 1986 617' .0072 86-13896 © 1986 by Springer-Verlag New York Inc. Softcover reprint of the hardcover 1s t edition 1986 All rights reserved. No part of this book may be translated or reproduced in any form without written permission from Springer-Verlag, 175 Fifth Avenue, New York, New York 10010. U.S.A. The use of general descriptive names, trade names, trademarks, etc. in this pUblication, even if the former are not especially identified, is not to be taken as a sign that such names, as understood by the Trade Marks and Merchandise Marks Act, may accordingly be used freely by anyone. While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Media conversion by David Seham Associates, Metuchen, New Jersey. 9 8 7 6 5 432 ISBN-13: 978-3-642-96944-7 e-ISBN-13: 978-3-642-96942-3 DOl: 10.1007/978-3-642-96942-3 This book is dedicated to our children and our students. Each in their own way have added enor mously to our lives. By their questions they have encouraged us to ask why rather than only what. They have not been satisfied with simplistic answers, but have forced us to examine what we know and how well we know it. Their inquiring minds have encouraged us to improve our own knowledge that we might better meet their hunger for honest, forthright help as they build their lives and careers. Foreword For some readers, the title of this book will im emerging on the surgical scene to challenge or mediately raise the question, what exactly is thodoxy. Although these innovations are often meant by surgical research? In the very broadest greeted with great optimism, a factual basis for sense the term can be taken to include all en that enthusiasm is sometimes far from secure deavors, however elementary or limited in and much further work is frequently required to scope, to advance surgical knowledge. Ideally, discover whether we are dealing with genuine it refers to well-organized attempts to establish advances or not. on a proper scientific basis, i.e., to place beyond The most exciting and attractive scenario for reasonable doubt, the truth or otherwise of any surgical research is unquestionably one that de concepts, old or new, within the ambit of sur picts a successful attempt by a researcher to es gery, and, of course, anaesthesia. tablish the accuracy of some bold innovation for The methods used to achieve that end vary which he himself is responsible. Joseph Lister, enormously, depending on the issue being in demonstrating by clinical trial that wound sup vestigated. They comprise a wide range of ac puration could be combated by antiseptic meas tivities in the wards, outpatient clinics, operating ures, comes to mind along with Lester Dragstedt rooms or laboratories, such as simple clinical or showing by experimental and clinical studies operative observations and clinical or laboratory that vagotomy could playa valuable role in the investigations involving biophysics, biochem treatment of peptic ulcer disease. istry, pathology, bacteriology, and other disci In all well-developed countries, and most no plines. Well-planned animal experimentation is tably in the United States, there is now strong exceedingly important and it is well to remember pressure on surgeons in training to engage in a the old truism that every surgical operation is a period of research in order to foster a critical biological experiment whose results, unfortu attitude towards the appraisal of the results of nately, are not always as carefully documented surgical treatment, and stimulate a continuing and analyzed as they should be. When the find interest in combining investigative work with ings of any clinical, operative or laboratory clinical practice. study are being considered, stringent statistical Hitherto, acquainting the tyro researcher with methods must be applied to ensure that any the methods appropriate to his or her particular conclusions rest on a statistically sound basis. project has usually depended on the guidance Surgery provides an almost unlimited range of more experienced colleagues working in the of topics for research. Much of what is practiced same field, and on the acquisition of a gradually and taught in surgery consists of traditional increasing understanding of how to conduct re concepts passed from surgical teacher to surgical search as the result of being in a research en trainee by example, by word of mouth, or by vironment. It is very surprising that there has standard texts, without ever having been sub been no textbook to which the young researcher mitted to really objective assessment. Every could turn to secure a more systematic presen year we see scores of promising new ideas tation of the various matters of importance in viii Foreword undertaking surgical research. Hans Troidl, tions; this book offers very helpful advice on all David Mulder, Martin McKneally, Walter these points. Very appropriately, a concluding Spitzer, and Bucknam McPeek are to be con section affords an inspiring appraisal of future gratulated most warmly on their great perspi prospects in surgical research by that great sur cacity in recognizing the claimant need for a geon-researcher, Francis Moore of Boston, work providing this sort of information and, whose contributions to surgical knowledge are even more, on the supremely effective way in legion. which they have met that need by the production I have no doubts that Principles and Practice of their new book. of Research will be very widely read and greatly Principles and Practice of Research covers appreciated, not only by surgical trainees start its subject in an unusually comprehensive way ing on research work, but also by experienced that includes not only the conduct of research researchers and established surgeons who will in general, but also the special faciltities and welcome the wealth of information it provides problems encountered in several personal attri on every facet of surgical research. Since re butes that are conducive to success in research, search in anaesthesia medicine, obstetrics, gy such as a certain amount of open-mindedness naecology, and other fields of clinical activity combined with the enthusiasm and determina follow essentially the same principles, this book tion needed to carry a project through to its ul should prove equally helpful to beginning or es timate conclusion despite the various obstacles tablished investigators in other branches of that may be encountered en route. Not to be health care. It cannot, in my judgement, fail to forgotten in this connection is the decisive role secure an assured place in the libraries of all played by sheer good luck in achieving a suc medical schools, departments of surgery, and cessful outcome in research - as is true of many clinical departments the world over, as well as other activities in life. An important subsidiary in the studies of many individual purchasers. matter in the prosecution of investigative work is how subsequently to present an account of that work and its results, most effectively, at University of Leeds J.e. Goligher meetings or discussion groups and in publica- Leeds, England Acknowledgment Our wives have supported us in so many ways. As editors we owe a special debt to the authors Our special thanks and deepest gratitude must of this textbook. They have cheerfully given of go to the distinguished Canadian scientist and their time to share their experience in diverse editor, Dr. N .LB. Wiggin. We cannot ade fields with us and with you the reader. Like al quately express how much we have enjoyed his most all truly able people they are busy, most wit, wisdom, and good fellowship. Most of the are overcommitted with active lives of scientific uniformity and clarity of expression are due to inquiry. his artistic sense of the English language and his We are especially grateful for the foresight and inciseful clarity of thought. generosity of Wolfgang Schmidt-Von Rohr The fact that this book will appear within less scheid, of the Pfrimmer Corporation, who made than 24 months after conception is due largely possible the Eppan Conference on Surgical Re to the grace and skill of Mrs. Elna Stacey. In search in November of 1984. At this conference addition to managing the preparation of the the editors were fortunate to obtain the advice manuscript and dealing with so many authors of leaders in various fields of surgery from many and editors from across the globe, Mrs. Stacey countries in Europe, North America and Asia. has taught us each more than we can imagine We are particularly grateful to our colleagues about organizational skills, the differential im at the University of Cologne, Harvard Univer portance of tasks and how to maintain a com sity, Albany Medical College, and McGill Uni pletely even keel in the presence of computer versity who have generously assumed some of failures, scholars who do not return phone calls, our own duties and thus made it possible for us authors who are late with promised manuscripts, to work on this project during the last 18 months. and editors who want to redo work long since We have benefited from thoughtful discus completed. sions and the sound advice of many of our col As Elna said, "There is a time when editors leagues, in particular, Dr. Norbert Boenning and authors must sit back and enjoy what they hoff, Dr. Jurgen Klein, Dr. Michael Schweins, have written"; we hope that you will join us in Dr. Andreas Paul, Dr. Lothar Koehler, Dr. this process. Burkhard Viel, Dr. Bertil Bouillon, Dr. Klaus Misses D'Ailleboust, Ward, Deer, Skye, and Roeddecker, Dr. Rudolf Menningen, and Dr. Cohan have cheerfully worked on this manu Andreas Dauber. Dr. Norbert Boenninghoff in script through numerous drafts. particular has helped us with many sections of the manuscript. Contents Foreword J.C. Goligher ................................................................................. vii Acknowledgment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Contributors...... ....... ... ........ ... .... . ...... ...... .. ....... . ... ... ... . ... ...... ...... ... xv Introduction H. Troidl ................................................................................... '" I. The Rationale of Surgical Research Edited by D.S. Mulder....................................................................... 5 1. Historical Evolution: Methods, Attitudes, Goals A. V. Pollock.................................................................................. 7 2. Philosophy of Surgical Research R.L. Cruess................................................................................... 18 3. Roles for the Surgical Investigator R.C.-J. Chiu and D.S. Mulder.............................................................. 20 4. The Development of the Surgical Investigator D.C. Sabiston, Jr............................................................................. 26 5. Facilitating Scholarship: Creating the Atmosphere, Setting, and Teamwork for Research M.F. McKneally, D.S. Mulder, A. Nachemson, F. Mosteller, and B. McPeek......... 36 II. Starting the Research Process Edited by H. Troidl and M.F. McKneally.................................................. 43 1. Systematically Reviewing Previous Work S. Wood-Dauphinee and B. McPeek........................................................ 45 2. Endpoints for Clinical Studies: Conventional and Innovative Variables S. Wood-Dauphinee and H. Troidl.......................................................... 53 3. Statistics Demystified M.S. Kramer and H. Troidl ................................................................. 69 4. Organizing a Clinical Study L. Del Greco, J.I. Williams, and D.S. Mulder............ .......... ............ ........... 88 5. Some Things You Should Know About Computers G.G. Bernstein and R.G. Margolese.............. ............ ............ ........ .......... 96 xii Contents 6. Ten Tips on Preparing Research Proposals W.O. Spitzer.................................................................................. 106 7. Critical Appraisal of Published Research M.T. Schechter and F.E. LeBlanc.......................................................... 112 8. Ethical Principles in Surgical Research D.J. Roy, P. Black, and B. McPeek........................................................ 118 III. Selected Strategies of Research Edited by B. McPeek and W.O. Spitzer.................................................... 133 1. The Marburg Experiment W. Lorenz and H. Troidl .................................................................... 137 2. Animal Experimentation W.H. Isselhard and J. Kusche .............................................................. 149 3. A Case Study of the Evolution of a Surgical Research Project R.C.-J. Chiu and D.S. Mulder.............................................................. 162 4. Clinical Research B. Walters and D.L. Sackett................................................................ 166 5. Multicentre Collaborative Clinical Trials in Surgical Research R.G. Margolese .............................................................................. 180 6. Evaluation of the Diagnostic Process M.T. Schechter............................................................................... 195 7. Health Services Research: Focus on Surgery J.I. Williams and W.R. Drucker............................................................ 207 8. Selected Non-Experimental Methods: An Orientation W.O. Spitzer.................................................................................. 222 IV. Reporting Y our Work Edited by B. McPeek and W.O. Spitzer.................................................... 231 1. Writing an Effective Abstract B.A. Pruitt, Jr. and A.D. Mason, Jr. ....................................................... 233 2. The Ten-Minute Presentation M. Evans and A. V. Pollock................................................................. 236 3. The Longer Talk B. McPeek and C. Herfarth ................................................................. 240 4. Presenting Your Work at International Meetings T. Aoki and J-H. Alexandre ........................... , ...... '" ... . ... .. .. .... .... .. .. . .... 246 5. Chairing Panels, Seminars and Consensus Conferences M.F. McKneally, B. McPeek, D.S. Mulder, W.O. Spitzer, and H. Troidl............... 249 6. The Poster Session, Audio Visual Aids Y. Reid and K-H. Vestweber................................................................ 254 Contents xiii 7. Writing for Publication N.J.B. Wiggin, J.C. Bailar III, C.B. Mueller, W.O. Spitzer, and B. McPeek........... 268 8. What to Do When You Are Asked to Write a Chapter for a Book B. Lewerich and D. Gotze................................................................... 276 V. International Perspectives on Surgical Research Edited by H. Troidl and M.F. McKneally.................................................. 279 1. Surgical Research in Canada D.S. Mulder.................................................................................. 281 2. Contributions from France J-H. Alexandre ............................................................. " . ....... .. ..... . 289 3. Traditions and Transitions in Germany H. Troidl and N. Boenninghoff .......... " ........ '" .. ........... . .. . ... .. . . . . . .. . .. . .... . 293 4. Japan's Integration of Eastern Values and Modern Science T. Aoki, K. Hioki, and T. Muto............................................................. 299 5. New Initiatives and Ideas in Spain P.A. Sanchez................................................................................. 306 6. Orderly Evolution to a Better Future in Sweden S. Fasth and L. Hulten...................................................................... 318 7. The Confluence of Private and Public Resources in Switzerland F. Largiader.................................................................................. 324 8. Historical and Organizational Influences Upon Surgical Research in the United Kingdom R. Shields..................................................................................... 327 9. Research Challenges and Solutions in the United States M.F. McKneally.. ......... .............. .............. .... ... .......... ..... ..... ............ 336 10. Common Characteristics and Distinctive Diversity in Surgical Research: An International Analysis M.F. McKneally, H. Troidl, D.S. Mulder, W.O. Spitzer, and B. McPeek............... 344 VI. Opportunities in Surgical Research Edited by H. Troidl, D.S. Mulder, B. McPeek, and W.O. Spitzer........................ 357 1. Future Horizons in Surgical Research F.D. Moore................................................................................... 359 Appendix A. The Declaration of Helsinki. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 369 Appendix B. Books on the Handling and Care of Animals............................... 371 Index.......................................................................................... 373

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Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.