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Hendrick2017.Pdf This thesis has been submitted in fulfilment of the requirements for a postgraduate degree (e.g. PhD, MPhil, DClinPsychol) at the University of Edinburgh. Please note the following terms and conditions of use: This work is protected by copyright and other intellectual property rights, which are retained by the thesis author, unless otherwise stated. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This thesis cannot be reproduced or quoted extensively from without first obtaining permission in writing from the author. The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the author. When referring to this work, full bibliographic details including the author, title, awarding institution and date of the thesis must be given. Managing or maintaining bias? Examining the conceptualisation of conflicts of interest in medical journal publishing Rachel A. Hendrick PhD in Public Health The University of Edinburgh 2016 Declaration of originality: I, Rachel Alison Hendrick, hereby declare that the following thesis was composed by me. The work presented here is my own and has not been submitted for any other degree or professional qualification. Signed: _______________________________________________________ Date: ___________________ Word count: 86,225 i ii Abstract BACKGROUND: It has been claimed that the involvement of commercial companies in medical and health research poses risks relating to potential conflicts of interest. In response, many journals have developed conflict of interest policies, and there has been a proliferation of related guidance from publishers, professional associations and commercial companies, mostly centred on processes of voluntary disclosure. Studies and commentaries on these have raised concerns regarding the adequacy of such practices, but there has been limited analysis of the underlying context – how and why policies have been constructed in this way – or exploration of alternative approaches. AIM: This thesis examines how actors within medical journal publishing conceptualise conflicts of interest. It analyses their understandings of conflicts of interest: which types of interest are deemed most significant; which actor groups are seen as conflicted; and how conflicts are managed. Through doing so, it explores the barriers to, and possibilities of, change. METHODS: The study draws on two distinct sets of data. The first is a sample of conflict of interest policies and guidance. The second is 48 semi-structured interviews with actors working in a range of roles related to medical journal publishing. These data were thematically analysed to illustrate how medical journal publishing conceptualises and manages conflicts of interest, to identify perceived strengths and weaknesses of current approaches, and to identify potential opportunities for improvement. RESULTS: There appears to be an established discourse around conflicts of interest, which emphasises particular stakeholders, while others, who also have opportunities to influence journal content, are frequently absent from the debate. Financial interests are readily highlighted, while non-financial ones receive less attention and are thus often unregulated (Chapter 5). High levels of iii consistency characterise the ways in which actors discussed the management of conflicts of interest: for example, self-disclosure was regularly highlighted, despite the acknowledged weaknesses of this approach (Chapter 6). The existence of further mechanisms that offer the potential to assist in managing conflicts of interest were identified, though findings suggest that, in practice, these currently have limited uptake (Chapter 7). Interviewees’ suggestions of how conflicts of interest might be better managed (e.g. through greater data transparency) are also analysed. Overall, narrow interpretations of conflicts of interest and their management appear to have become institutionalised in ways that serve to limit the uptake of alternative approaches. DISCUSSION: Given the substantive importance that medical research can have on health policies and treatments, robust processes are required to protect the integrity and legitimacy of journals. This research shows that existing, institutionalised understandings of conflicts of interest have critical limitations, which leaves medical publishing open to potentially unethical practices that may be a source of bias in published evidence. This poses a significant threat to the desire to attain ethically robust, peer-reviewed medical/health research that can be used to inform policy and practice. Drawing on the interview data, the thesis explores some possible alternatives that may warrant further consideration. iv Acknowledgements I would firstly like to express my gratitude to Professor Jeff Collin and Dr Katherine Smith, for supervising me over the years. Their guidance, advice and intellectual knowledge has been a great source of inspiration, and their patience and encouragement throughout the process has also been much appreciated. I would also like to thank Professor Amanda Amos for offering temporary supervisory cover and providing some extremely welcome suggestions regarding this work. The BMJ provided the initial impetus for this project, and the essential funds to travel to the conferences where I conducted a number of the interviews. I am very also grateful to the ESRC who funded this project through a CASE Studentship. I am extremely thankful to all my interviewees who gave up their valuable time to talk to me and offer me their important insights into the worlds in which they work. Without them, this project would not exist. My parents, Paul and Ruth Hendrick, deserve much credit for supporting me on my return to academia, and providing necessary financial and emotional support during this time. And, importantly, thanks go to my Mum for proofreading this thesis. My friends, both in London and Scotland, who encouraged me during the process of this research must also be mentioned. In particular, Rhiannon Bearne, Emma Bolton, Jen Brown, Sabine Cassays, Sarah-Jane Harding, Laurie Heaps, Lisa-Jane Horrey, Louise Papaspyru-Hoyte, Sarah Slater and Trudi Reid. Most importantly, I want to thank my partner, Andrew Hoskins, without whom I would never have begun this journey. He has always supported and encouraged me and had faith in my ability, and reminded me of this whenever I doubted myself. And of course, finally, thanks to our son Jasper: while his appearance on the scene delayed the completion of this research, he has provided me with the determination to come back and finish it. v vi Acronyms and abbreviations Miscellaneous: AMA: American Medical Association AMC: Academic Medical Centre BAT: British American Tobacco CMA: Canadian Medical Association COIs: Conflicts of Interest CRO: Clinical Research Organisation CTP: Clinical Trial Protocol CTR: Clinical Trial Registration DI: Discursive Institutionalism ESRC: Economic and Social Research Council ETS: Environmental Tobacco Smoke FDA: Food and Drugs Administration GSK: GlaxoSmithKline JCI: Journal Citation Index JOC: Journal Oversight Committee IF: Impact Factor KOL: Key Opinion Leader MPIP: Medical Publishing Insights and Practices MWC: Medical Writing Companies NIH: National Institute of Health SKB: SmithKlineBeecham URM: Universal Requirements for Manuscripts Professional Associations: AMWA: American Medical Writers Association COPE: Committee on Publication Ethics CSE: Council of Science Editors EMWA: European Medical Writers Association vii ICMJE: International Committee of Medical Journal Editors ISMPP: International Society of Medical Publishing Professionals WAME: World Association of Medical Editors Publishers: OUP: Oxford University Press T&F: Taylor and Francis Journals: AJC: American Journal of Cardiology AJM: American Journal of Medicine AJOG: American Journal of Obstetrics and Gynecology Annals: Annals of Internal Medicine BMJ: British Medical Journal CMAJ: Canadian Medical Association Journal IAOEH: International Archives of Occupational and Environmental Health JAACAP: Journal of the American Academy of Child and Adolescent Psychiatry JAMA: Journal of the American Medical Association JCP: Journal of Clinical Psychology JIM: Journal of Internal Medicine JNCI: Journal of the National Cancer Institute NEJM: New England Journal of Medicine Interviewees A: Author AE: Associate editor EIC: Editor in chief ME: Managing editor MW: Medical writer MPC: Medical publishing critic P: Publisher SE: Senior editor viii Definitions of key terms Clinical Trial Registration The registration of clinical trials in a public trials registry. Clinical Trial Protocols A document that provides details of how the trial will be conducted. Ghost-writing/ghost authorship The practice of commissioning professional writers to help develop scientific articles, without declaring the involvement of such writers on the papers. Guest authorship/honorary authorship Listing senior researchers as authors on papers, when in practice their involvement did not constitute authorship status. This is typically done to confer prestige to an article. Such researchers may receive payment from companies to be named used as authors. Impact factor A measure reflecting the yearly average number of citations to recent articles published in a journal. The impact factor is the most commonly used method for determining a journal’s importance in its field. Journal Supplements Collections
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