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THE UNIVERSITY of NEW SOUTH WALES Thesis/Dissertation Sheet

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THE UNIVERSITY of NEW SOUTH WALES Thesis/Dissertation Sheet THE UNIVERSITY OF NEW SOUTH WALES Thesis/Dissertation Sheet Surname: Adie First name: Sam Abbreviation for degree as given in the University calendar: PhD School: South Western Sydney Clinical School Faculty: Medicine Title: iQuEST: Investigating the Quality and Epidemiology of Surgical Trials Abstract Randomised controlled trials (RCTs) provide clinicians with the best evidence for interventions, but are subject to systematic errors (bias) when methodology is not optimal. These biases occur at any time from the inception, execution, data collection, analysis, and dissemination of results. Performing RCTs for surgical interventions is additionally challenging, given the relative complexities of surgical interventions and patients, and the culture of surgical training. This thesis examined the epidemiology and quality characteristics of RCTs of surgical interventions. A systematic search was conducted to locate recently published surgical RCTs and meta-analyses, in order to attain a sample that would be reflective of the current state of surgical evidence. Data was piloted and collected according to a proforma. The first study assessed the epidemiology and methodological quality of surgical RCTs, and compared these characteristics with what is known about general medical RCTs. The second study assessed reporting quality by compliance with the Consolidated Standards of Reporting Trials (CONSORT) statement. The third study investigated the association between methodological quality and treatment effects in surgical RCTs. The fourth and fifth studies examined patterns of outcome reporting. The association between statistical significance and reporting of outcomes (outcome reporting bias) was explored. The extent to which outcomes measured in surgical RCTs are patient important was also assessed. Finally, the sixth study assessed the epidemiology, reporting and methodological quality of meta-analyses of surgical RCTs. The results show that there is substantial room for improvement in the conduct and reporting of RCTs of surgical interventions. Inadequate methodology was common, and was associated with an exaggeration of treatment effects. There was concerning evidence of unreported outcomes, and complete outcome reporting was associated with statistical significance. Only two thirds of primary outcomes were patient important. If the truth about surgical interventions is to be discerned, the conduct and reporting of surgical trials must improve. Much of this responsibility lies with study authors, but journal editors and reviewers, and the funders of research also have an important role. Existing guidelines need to be promoted and imposed, and existing multicentre models for the conduct of surgical trials should be further explored. Declaration relating to disposition of project thesis/dissertation I hereby grant to the University of New South Wales or its agents the right to archive and to make available my thesis or dissertation in whole or in part in the University libraries in all forms of media, now or here after known, subject to the provisions of the Copyright Act 1968. I retain all property rights, such as patent rights. I also retain the right to use in future works (such as articles or books) all or part of this thesis or dissertation. I also authorise University Microfilms to use the 350 word abstract of my thesis in Dissertation Abstracts International (this is applicable to doctoral theses only). 1 June 2014 Signature Witness The University recognises that there may be exceptional circumstances requiring restrictions on copying or conditions on use. Requests for restriction for a period of up to 2 years must be made in writing. Requests for a longer period of restriction may be considered in exceptional circumstances and require the approval of the Dean of Graduate Research. FOR OFFICE USE ONLY Date of completion of requirements for Award: THIS SHEET IS TO BE GLUED TO THE INSIDE FRONT COVER OF THE THESIS iQuEST: Investigating the Quality and Epidemiology of Surgical Trials Sam Adie BSc(Med) MBBS (Hons) MSpMed MPH A thesis in fulfilment of the requirements for the degree of Doctor of Philosophy South Western Sydney Clinical School Faculty of Medicine, University of New South Wales Sydney, Australia 2014 Table of contents Statement of originality ........................................................................... vii Copyright statement ............................................................................... viii Authenticity statement ............................................................................. ix List of figures ............................................................................................. x List of tables ........................................................................................... xiii List of appendices ................................................................................... xv List of abbreviations .............................................................................. xvi Acknowledgements ............................................................................... xvii Statement of contribution .................................................................... xviii Declaration of funding ......................................................................... xviii Publications arising from this thesis .................................................... xix Presentations arising from this thesis ................................................. xix 1. The evolution of evidence in surgical practice .................................... 1 1.1 Abstract ................................................................................................ 1 1.2 A short history of evidence based medicine .................................... 1 1.3 The rationale of randomised controlled trials .................................. 6 1.4 Bias in randomised controlled trials ............................................... 11 1.4.1 Randomisation- Sequence generation .................................................... 11 1.4.2 Randomisation- Allocation concealment ................................................. 13 1.4.3 Blinding .................................................................................................... 15 1.4.4 Attrition .................................................................................................... 17 1.4.5 Publication and selective reporting bias .................................................. 19 1.4.6 Funding bias ............................................................................................ 22 1.5 Assessing trial quality ...................................................................... 24 1.6 The challenges of surgical trials ...................................................... 27 1.6.1 Challenges for surgeons .......................................................................... 28 1.6.2 Challenges for trial conduct ..................................................................... 30 1.6.3 Challenges for trial participants ............................................................... 32 1.7 Summarising the evidence from surgical randomised trials: systematic review and meta-analysis of surgical interventions ......... 33 1.7.1 Narrative vs. systematic reviews ............................................................. 33 1.7.2 Historical development ............................................................................ 34 1.7.3 The rationale of systematic reviews and meta-analyses ......................... 35 1.7.4 Bias in systematic reviews and meta-analyses ....................................... 37 1.7.5 Measuring the quality of systematic reviews and meta-analyses ............ 39 1.7.6 The importance of systematic reviews and meta-analyses to surgery .... 40 1.8 Development of iQuEST: Investigating the Quality and Epidemiology of Surgical Trials ............................................................. 41 2. Epidemiology and scientific quality of randomised trials of surgical interventions ................................................................................................ 43 2.1 Abstract .............................................................................................. 43 2.2 Introduction ........................................................................................ 45 2.3 Aims .................................................................................................... 47 2.4 Methods .............................................................................................. 48 2.4.1 Study design ............................................................................................ 48 iii 2.4.2 Eligibility criteria ....................................................................................... 48 2.4.3 Sources of RCTs ..................................................................................... 50 2.4.4 Electronic search strategy ....................................................................... 50 2.4.5 Study identification method ..................................................................... 51 2.4.6 Data extraction (including pilot) ............................................................... 52 2.4.7 Items related to scientific quality .............................................................. 53 2.4.8 General characteristics of trials ............................................................... 54 2.4.9 Checking of data .....................................................................................
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