Background. Corporate interests have the potential to influence public debate and policymaking by influencing the research agenda, namely the initial step in conducting research, in which the purpose of the study is defined and the questions are framed. Objectives. We conducted a scoping review to identify and synthesize studies that explored the influence of industry sponsorship on research agendas across different fields. Search Methods. We searched MEDLINE, Scopus, and Embase (from inception to September 2017) for all original research and systematic reviews addressing corporate influence on the research agenda. We hand searched the reference lists of included studies and contacted experts in the field to identify additional studies. Selection Criteria. We included empirical articles and systematic reviews that explored industry sponsorship of research and its influence on research agendas in any field. There were no restrictions on study design, language, or outcomes measured. We excluded editorials, letters, and commentaries as well as articles that exclusively focused on the influence of industry sponsorship on other phases of research such as methods, results, and conclusions or if industry sponsorship was not reported separately from other funding sources. Data Collection and Analysis. At least 2 authors independently screened and then extracted any quantitative or qualitative data from each study. We grouped studies thematically for descriptive analysis by design and outcome reported. We developed the themes inductively until all studies were accounted for. Two investigators independently rated the level of evidence of the included studies using the Oxford Centre for Evidence-Based Medicine ratings. Main Results. We included 36 articles. Nineteen cross-sectional studies quantitatively analyzed patterns in research topics by sponsorship and showed that industry tends to prioritize lines of inquiry that focus on products, processes, or activities that can be commercialized. Seven studies analyzed internal industry documents and provided insight on the strategies the industry used to reshape entire fields of research through the prioritization of topics that supported its policy and legal positions. Ten studies used surveys and interviews to explore the researchers’ experiences and perceptions of the influence of industry funding on research agendas, showing that they were generally aware of the risk that sponsorship could influence the choice of research priorities. Conclusions. Corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. We also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities. Public Health Implications. The influence on the research agenda has given the industry the potential to affect policymaking by influencing the type of evidence that is available and the kinds of public health solutions considered. The results of our scoping review support the need to develop strategies to counteract corporate influence on the research agenda.
BackgroundSystematic reviews, which assess the risk of bias in included studies, are increasingly used to develop environmental hazard assessments and public health guidelines. These research areas typically rely on evidence from human observational studies of exposures, yet there are currently no universally accepted standards for assessing risk of bias in such studies. The risk of bias in non-randomised studies of exposures (ROBINS-E) tool has been developed by building upon tools for risk of bias assessment of randomised trials, diagnostic test accuracy studies and observational studies of interventions. This paper reports our experience with the application of the ROBINS-E tool.MethodsWe applied ROBINS-E to 74 exposure studies (60 cohort studies, 14 case-control studies) in 3 areas: environmental risk, dietary exposure and drug harm. All investigators provided written feedback, and we documented verbal discussion of the tool. We inductively and iteratively classified the feedback into 7 themes based on commonalities and differences until all the feedback was accounted for in the themes. We present a description of each theme.ResultsWe identified practical concerns with the premise that ROBINS-E is a structured comparison of the observational study being rated to the ‘ideal’ randomised controlled trial. ROBINS-E assesses 7 domains of bias, but relevant questions related to some critical sources of bias, such as exposure and funding source, are not assessed. ROBINS-E fails to discriminate between studies with a single risk of bias or multiple risks of bias. ROBINS-E is severely limited at determining whether confounders will bias study outcomes. The construct of co-exposures was difficult to distinguish from confounders. Applying ROBINS-E was time-consuming and confusing.ConclusionsOur experience suggests that the ROBINS-E tool does not meet the need for an international standard for evaluating human observational studies for questions of harm relevant to public and environmental health. We propose that a simpler tool, based on empirical evidence of bias, would provide accurate measures of risk of bias and is more likely to meet the needs of the environmental and public health community.
Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements and their implementation. The situation differs substantially from country to country and the most striking differences are between governmental and self-regulatory approaches, especially with regard to the comprehensiveness of the disclosed data. In many cases, individuals can still opt out and reporting is incomplete, with common influential gifts such as food and drink excluded. Finally, in several countries data are only available as separate PDFs from companies, thus making the payment reports difficult to access and analyse. In order to overcome these gaps, minimum standards for disclosures should be implemented across Europe. All payments to healthcare professionals and organizations should be included, all health-related industries should be required to submit reports, and usability of disclosed data should be guaranteed.
IMPORTANCE Food industry sponsorship of nutrition research may bias research reports, systematic reviews, and dietary guidelines.OBJECTIVE To determine whether food industry sponsorship is associated with effect sizes, statistical significance of results, and conclusions of nutrition studies with findings that are favorable to the sponsor and, secondarily, to determine whether nutrition studies differ in their methodological quality depending on whether they are industry sponsored.
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