UvA-DARE (Digital Academic Repository) Studies on the effectiveness of endoscopic surgery in reproductive medicine Bosteels, J.J.A. Publication date 2014 Document Version Final published version Link to publication Citation for published version (APA): Bosteels, J. J. A. (2014). Studies on the effectiveness of endoscopic surgery in reproductive medicine. General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl) Download date:28 Sep 2021 UNIVERSITY OF AMSTERDAM DISSERTATION Jan Bosteels Studies on The Efffectiveness of Endoscopic Surgery in Reproductive Medicine STUDIES ON THE EFFECTIVENESS OF ENDOSCOPIC SURGERY IN REPRODUCTIVE MEDICINE Jan Bosteels Studies on the effectiveness of endoscopic surgery in reproductive medicine Thesis, University of Amsterdam, the Netherlands Paranimfen: Wim Laurens, Philippe Delattin Lay out: Jan Bosteels Cover design: Coördesign, Leiden Cover illustration: ’ICSI revisited: Independent and Critically Summarized Investigation’ ISBN 978 90 5629 755 8 NUR 870 © J. Bosteels, 2014 All rights reserved. Without limiting the rights under copyright reserved above, no part of this book may be reproduced, stored in or introduced into a retrieval system, or transmitted, in any form or by any means (electronic, mechanical, photocopying, recording or otherwise) without the written permission of both the copyright owner and the author of the book. STUDIES ON THE EFFECTIVENESS OF ENDOSCOPIC SURGERY IN REPRODUCTIVE MEDICINE ACADEMISCH PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam op gezag van de Rector Magnificus prof. dr. D.C. van den Boom ten overstaan van een door het college voor promoties ingestelde commissie, in het openbaar te verdedigen in de Agnietenkapel op dinsdag 2 september 2014, te 14:00 uur door Jan Jeanne Alfons Bosteels geboren te Dendermonde, België Promotiecommissie Promotores: Prof. dr. B.W.J.Mol Prof. dr. F.J.M. Broekmans Co-promotor: Dr. J.C. Kasius Overige leden: Prof. dr. F. van der Veen Prof. dr. P.M.M. Bossuyt Prof. dr. P. de Sutter Dr. W.M. Ankum Dr. A. Timmermans Faculteit der Geneeskunde “Wie beweert dat iets niet kan, mag degene die ermee bezig is absoluut niet storen.” Romeins gezegde “Success is not final, failure is not fatal: it is the courage to continue that counts.” Winston Leonard Spencer Churchill Aan mijn familie, mijn vrienden, mijn collega’s en leermeesters, To all those of the past, the present and the future… TABLE OF CONTENTS Chapter 1 Introduction and outline of thesis 9 Chapter 2 The position of laparoscopy 21 in current fertility practice. Hum Reprod Update 2007; 13(5): 477-485 Chapter 3 The effectiveness of hysteroscopy for 49 improving pregnancy rates in subfertile women: a systematic review. Hum Reprod Update 2010; 16(1): 1-11 Chapter 4 Hysteroscopy for treating subfertility 79 associated with suspected major uterine cavity abnormalities. Cochrane Database Syst Rev 2013, Issue 1 Art. No.: CD009461 Chapter 5 Anti-adhesion barrier gels following 115 operative hysteroscopy for treating female subfertility. A systematic review and meta-analysis. Gyn Surg 2014; 11:113-127 Chapter 6 Anti-adhesion therapy following operative 149 hysteroscopy for treating female subfertility. Cochrane Database Syst Rev 2014, Issue 5 Art. No.: CD011110 Chapter 7 Has there been any progress in evidence 167 based practice in reproductive surgery? F V V in Ob/ Gyn 2010; 2(4): 232-252 F V V in Ob/ Gyn 2011; 3(4): 238-244 Chapter 8 Thesis summary and discussion 191 Samenvatting proefschrift en discussie 209 7 Appendices Abbreviations 237 Co- authors and affiliations 239 List of publications 241 PhD Portfolio 245 Dankwoord 249 Curriculum Vitae 253 8 Introduction and outline of thesis “And while he lives, He wields the boasted prize Whose value all can feel, the weak, the wise, Displays in triumph his distinguish'd boon, The solid honours of the Wooden Spoon” —"The Wooden Spoon" from the Cambridge Tart (1823) Photo scanned from H P Stokes, Ceremonies of the University of Cambridge, Cambridge University Press 1927. Believed to be in the public domain: the photograph was originally published in the UK in 1909 and reprinted in Stokes' book in 1927. 9 Introduction INTRODUCTION Each year at St. John’s College of the University of Cambridge the students at the Mathematics faculty awarded a wooden spoon to their fellow student with the lowest marks in the mathematical tripos exams who still earned a third-class degree. It was given for the last time in 1909 to Cuthbert Lempriere Holthouse, who can be seen in the photograph on the previous page. A wooden spoon is a mock or a real award, given to an individual or a team which has come last in a competition. In 1979 the Scottish physician and epidemiologist Archibald Leman Cochrane (Kirklands, 12 January 1909-Dorset, 18 June 1988) awarded a figurative wooden spoon to Obstetrics for not having used the design of the randomized controlled trial (RCT) to assess the effectiveness of interventions related to pregnancy and childbirth. A silver spoon was given to Phtisiology (the study of tuberculosis) for the landmark clinical research conducted by Sir Austin Bradford Hill on the use of streptomycin in patients with tuberculosis (Cochrane, 1979). A randomized controlled trial is an experiment in which two or more interventions are compared by being randomly allocated to participants as opposed to an observational study where the investigators simply observe the course of events and do not seek to intervene (Glossary of Cochrane terms). Some time before, ‘Archie’ Cochrane had already criticized the medical profession in general by stating: “we have not organized a critical summary, by specialty or subspecialty, updated periodically, of all relevant randomized controlled trials” (Cochrane, 1979). Initially perinatal medicine was the first specialty to take up the glove of Cochrane’s provocative challenge by organizing the Oxford Database of Perinatal Trials (Chalmers et al, 1986). The first systematic review of the effectiveness of fertility treatment was published in 1993, hallmarking the introduction of evidence-based practice in the field of reproductive medicine (Vandekerckhove et al, 1993). Evidence-based medicine is the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients (Sackett et al, 1996). The practice of evidence-based medicine (EBM) stands for the integration of individual clinical expertise and the patient’s unique values with the best available evidence from systematic research (Strauss et al, 2005). The essentials to put EBM into practice can be summarized in five steps: first of all, to ask the right answerable question; secondly, to find the best level of evidence available; thirdly, to appraise critically the evidence for risk of bias, clinical relevance and applicability; fourthly, to implement the results of the appraisal in every day clinical practice and fifthly to evaluate the 11 Chapter 1 changes in practice (Farquhar et al, 2006). The highest level of evidence is derived from well written critically appraised systematic reviews of RCTs. Why should clinicians expose their clinical practice to the scrutiny of the RCT (Johnson et al, 2008)? The answer is simple: this study design offers the potential for the least biased measurement of the effectiveness of an intervention. Effectiveness is the extent to which an intervention, when used under ordinary circumstances, does what it is intended to do (Glossary of Cochrane terms). Trials that assess effectiveness are called pragmatic or management trials. A trial may have a slightly different purpose: it may aim to measure the extent to which an intervention produces a benefit for fully co-operative participants under ideal conditions. This design is called an explanatory trial; it aims to measure the efficacy of an intervention (Glossary of Cochrane terms). Observational studies are appropriate for detecting rare events e.g. surgical complications but can be misleading if used in searching for treatment benefits that are small to moderate as those observed in health care interventions. The observation of a statistically significant association between an intervention and its effect can be explained by the following mechanisms: chance, bias/confounding or causality (Elwood, 2007). Bias is a systematic error or deviation in results or inferences from the truth as opposed to imprecision, which is random sampling error (Glossary of Cochrane terms). Many types of bias have been described in studies of the effects of health care interventions; they can be classified into information bias, selection bias and confounding (Groenwold, 2013).