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Reducing Bias in Public Health Guidelines

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Reducing Bias in Public Health Guidelines Reducing Bias in Public Health Guidelines Nicholas Chartres A thesis submitted to fulfil requirements for the degree of DOCTOR OF PHILOSOPHY School of Pharmacy, Faculty of Medicine and Health, The University of Sydney Statement of Originality I Nicholas Chartres, declare that to the best of my knowledge, the content of this thesis is my own work. This thesis has not been submitted for any degree or other purposes. I certify that the intellectual content of this thesis is the product of my own work and that all the assistance received in preparing this thesis and sources have been acknowledged. Nicholas Chartres Date: 07/06/2019 ii Reducing Bias in Public Health Guidelines Abstract Background and Objectives Bias in research and the methods used for developing public health guidelines may put the public’s health at risk. This dissertation explores three possible sources of influence on the recommendations made in public health guidelines: • Commercial Influences on Nutrition Research: Primary research studies and systematic reviews form the evidence base for dietary guidelines. The association between funding sources and the outcomes of nutrition studies was therefore explored; • Methods Used for Public Health Guideline Development: Heterogenous methodologies used in the development of public health guidelines may lead to conflicting recommendations. I conducted a systematic analysis of the methods used in their development; • Social Influences on Public Health Guideline Development: The interactions within guideline groups may be a significant influence on the final recommendations made. I aimed to understand the experiences of the participants involved in developing public health guidelines. Methods My methods included: 1) Meta-analysis and systematic review to measure bias in primary nutrition research; 2) Content analysis to understand the methods used in synthesising evidence for public health guidance development; and 3) Qualitative analysis of interviews to understand social influences on guideline development. iii Results My major findings were: I found an association with industry sponsorship with the outcomes of studies, even when controlling for the internal validity between the studies; I established heterogenous methodologies are being used by organisations that conduct hazard identification and risk assessment; and I identified that the public health guideline process in Australia is a divided one. Conclusions Through greater transparency of funding practices, the development of nutrition study registries and improvements in risk of bias tools used to evaluate the evidence, industry influence on the outcomes of nutrition studies relevant to dietary guidelines can be accounted for. Further, the use of standardised, transparent methodological processes and collaboration between systematic review teams and guideline groups will lead to increased comparability and validity of guidelines and ensure that the recommendations made from them will protect the public’s health. iv Table of Contents Statement of Originality ..................................................................................................................... ii Abstract ............................................................................................................................................. iii Table of Contents ................................................................................................................................ v List of Publications .............................................................................................................................vii Authorship Attribution Statement ..................................................................................................... ix Acknowledgements ............................................................................................................................ xii Introduction: Commercial and Methodological Influences on Research ........................................... 1 Chapter One: Measuring Commercial Influences in Nutrition Research .......................................... 30 i. Association of industry sponsorship with outcomes of nutrition studies: A Systematic Review and Meta-analysis ii. The association of industry ties with outcomes of studies examining the effect of wholegrain foods on cardiovascular disease and mortality: Systematic review and Meta- analysis iii. The association of industry sponsorship with findings of randomised controlled trials examining the effect of wholegrain foods on cardiovascular disease outcomes, Systematic review and Meta-analysis iv. The association of food industry ties with findings of studies examining the effect of dairy foods intake with cardiovascular disease and mortality: Systematic review and Meta-analysis Chapter Two: Examining Biases in Methods Used for Public Health Guideline Development ...... 252 i. A Review of Methods Used for Hazard Identification and Risk Assessment of Environmental Hazards v Chapter Three: Understanding the Social Influences on Public Health Guideline Development ... 287 i. “It’s not smooth sailing”: Bridging the gap between methods and content expertise in public health guideline development Chapter Four: Discussion; Solutions to Reduce Commercial and Methodological Bias in Nutrition Research and Public Health Guidelines........................................................................................... 320 Appendix: Additional Related Publications .................................................................................... 340 i. Study Sponsorship and the Nutrition Research Agenda: Analysis of randomized controlled trials included in systematic reviews of nutrition interventions to address obesity ii. Study sponsorship and the nutrition research agenda: Analysis of cohort studies examining the association between nutrition and obesity iii. Reporting bias in the literature on the associations of health-related behaviors and statins with cardiovascular disease and all-cause mortality iv. The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures v. Associations between industry involvement and study characteristics at the time of trial registration in medical research vi List of publications First author publications relating to this Thesis Published Manuscripts • Chartres N, Fabbri A, Bero LA. Association of Industry Sponsorship with Outcomes of Nutrition Studies: A Systematic Review and Meta-analysis. JAMA Internal Medicine. 2016;176(12):1769-77. • Chartres N, Bero LA, Norris SL. A review of methods used for hazard identification and risk assessment of environmental hazards. Environ Int. 2019;123:231-239. • Chartres N, Fabbri A, McDonald S, et al. Association of industry ties with outcomes of studies examining the effect of wholegrain foods on cardiovascular disease and mortality: systematic review and meta-analysis. BMJ Open. 2019;9(5):e022912. Submitted Manuscripts • Chartres N, McDonald S, Turton J, Allman-Farinelli M, Mckenzie JR, Bero LA. The association of industry sponsorship with findings of randomised controlled trials examining the effect of wholegrain foods on cardiovascular disease outcomes: Systematic review and Meta-analysis. (under review) • Chartres N, Fabbri A, McDonald S, Diong J, Mckenzie JR, Bero LA. The association of food industry ties with findings of studies examining the effect of dairy foods intake with cardiovascular disease and mortality: Systematic review and Meta-analysis. (under review) • Chartres N, Grundy Q, Parker L, Bero L. “It’s not smooth sailing”: Bridging the gap between methods and content expertise in public health guideline development. (under review) vii Additional publications related to the work presented in this Thesis1 Published Manuscripts • Fabbri A, Chartres N, Scrinis G, Bero LA. Study sponsorship and the nutrition research agenda: analysis of randomized controlled trials included in systematic reviews of nutrition interventions to address obesity. Public health nutrition. 2017;20(7):1306-1313. • Fabbri A, Chartres N, Bero LA. Study sponsorship and the nutrition research agenda: analysis of cohort studies examining the association between nutrition and obesity. Public health nutrition. 2017;20(17):3193-3199. • de Rezende LFM, Rey-Lopez JP, de Sa TH, Chartres N, Fabbri A, Powell L, Stamatakis E, Bero L. Reporting bias in the literature on the associations of health-related behaviors and statins with cardiovascular disease and all-cause mortality. PLoS biology. 2018;16(6):e2005761. • Bero L, Chartres N, Diong J, et al. The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures. Syst Rev. 2018;7(1):242. Submitted Manuscripts • Seidler LA, Hunter K, Chartres N, Askie L. Associations between industry involvement and study characteristics at the time of trial registration in medical research. (under review) 1 These publications are listed in the Appendix as the PhD candidate is not the lead author but has contributed to these studies as a co-author. viii Authorship Attribution Statement Chapter One of this Thesis includes the publications: i. Association of industry sponsorship with outcomes of nutrition studies: A Systematic Review and Meta-analysis ii. The association of industry ties with outcomes of studies examining the effect of wholegrain foods on cardiovascular disease and mortality: Systematic review
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