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      RoB-SPEO: A tool for assessing risk of bias in studies estimating the prevalence of exposure to occupational risk factors from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury

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          Abstract

          Background

          The World Health Organization (WHO) and the International Labour Organization (ILO) are developing joint estimates of the work-related burden of disease and injury (WHO/ILO Joint Estimates). For this, systematic reviews of studies estimating the prevalence of exposure to selected occupational risk factors will be conducted to provide input data for estimations of the number of exposed workers. A critical part of systematic review methods is to assess risk of bias (RoB) of individual studies. In this article, we present and describe the development of such a tool, called the Risk of Bias in Studies estimating Prevalence of Exposure to Occupational risk factors (RoB-SPEO) tool; report results from RoB-SPEO's pilot testing; note RoB-SPEO's limitations; and suggest how the tool might be tested and developed further.

          Methods

          Selected existing RoB tools used in environmental and occupational health systematic reviews were reviewed and analysed. From existing tools, we identified domains for the new tool and, if necessary, added new domains. For each domain, we then identified and integrated components from the existing tools (i.e. instructions, domains, guiding questions, considerations, ratings and rating criteria), and, if necessary, we developed new components. Finally, we elicited feedback from other systematic review methodologists and exposure scientists and agreed upon RoB-SPEO. Nine experts pilot tested RoB-SPEO, and we calculated a raw measure of inter-rater agreement ( P i ) for each of its domain, rating P i  < 0.4 as poor, 0.4 ≤  P i  ≥ 0.8 as substantial and P i  > 0.80 as almost perfect agreement.

          Results

          Our review found no standard tool for assessing RoB in prevalence studies of exposure to occupational risk factors. We identified six existing tools for environmental and occupational health systematic reviews and found that their components for assessing RoB differ considerably. With the new RoB-SPEO tool, assessors judge RoB for each of eight domains: (1) bias in selection of participants into the study; (2) bias due to a lack of blinding of study personnel; (3) bias due to exposure misclassification; (4) bias due to incomplete exposure data; (5) bias due to conflict of interest; (6) bias due to selective reporting of exposures; (7) bias due to difference in numerator and denominator; and (8) other bias. The RoB-SPEO's ratings are low, probably low, probably high, high or no information. Pilot testing of the RoB-SPEO tool found substantial inter-rater agreement for six domains (range of P i for these domains: 0.51–0.80), but poor agreement for two domains (i.e. P i of 0.31 and 0.33 for biases due to incomplete exposure data and in selection of participants into the study, respectively). Limitations of RoB-SPEO include that it has not yet been fully performance-tested.

          Conclusions

          We developed the RoB-SPEO tool for assessing RoB in prevalence studies of exposure to occupational risk factors. The tool will be applied and its performance tested in the ongoing systematic reviews for the WHO/ILO Joint Estimates.

          Highlights

          • WHO and ILO are systematically reviewing occupational exposure prevalence studies.

          • Assessing risk of bias (RoB) in individual studies is a core step of systematic reviews.

          • We developed RoB-SPEO, a tool to assess RoB in occupational exposure prevalence studies.

          • The performance of RoB-SPEO will be tested in the WHO/ILO systematic reviews.

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          Most cited references29

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          The Navigation Guide Systematic Review Methodology: A Rigorous and Transparent Method for Translating Environmental Health Science into Better Health Outcomes

          Background: Synthesizing what is known about the environmental drivers of health is instrumental to taking prevention-oriented action. Methods of research synthesis commonly used in environmental health lag behind systematic review methods developed in the clinical sciences over the past 20 years. Objectives: We sought to develop a proof of concept of the “Navigation Guide,” a systematic and transparent method of research synthesis in environmental health. Discussion: The Navigation Guide methodology builds on best practices in research synthesis in evidence-based medicine and environmental health. Key points of departure from current methods of expert-based narrative review prevalent in environmental health include a prespecified protocol, standardized and transparent documentation including expert judgment, a comprehensive search strategy, assessment of “risk of bias,” and separation of the science from values and preferences. Key points of departure from evidence-based medicine include assigning a “moderate” quality rating to human observational studies and combining diverse evidence streams. Conclusions: The Navigation Guide methodology is a systematic and rigorous approach to research synthesis that has been developed to reduce bias and maximize transparency in the evaluation of environmental health information. Although novel aspects of the method will require further development and validation, our findings demonstrated that improved methods of research synthesis under development at the National Toxicology Program and under consideration by the U.S. Environmental Protection Agency are fully achievable. The institutionalization of robust methods of systematic and transparent review would provide a concrete mechanism for linking science to timely action to prevent harm. Citation: Woodruff TJ, Sutton P. 2014. The Navigation Guide systematic review methodology: a rigorous and transparent method for translating environmental health science into better health outcomes. Environ Health Perspect 122:1007–1014; http://dx.doi.org/10.1289/ehp.1307175
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            Evaluation of the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation

            Background In 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials. Methods To assess the usability of this tool, we conducted an evaluation by means of focus groups, online surveys and a face-to-face meeting. We obtained feedback from a range of stakeholders within The Cochrane Collaboration regarding their experiences with, and perceptions of, the RoB tool and associated guidance materials. We then assessed this feedback in a face-to-face meeting of experts and stakeholders and made recommendations for improvements and further developments of the RoB tool. Results The survey attracted 380 responses. Respondents reported taking an average of between 10 and 60 minutes per study to complete their RoB assessments, which 83% deemed acceptable. Most respondents (87% of authors and 95% of editorial staff) thought RoB assessments were an improvement over past approaches to trial quality assessment. Most authors liked the standardized approach (81%) and the ability to provide quotes to support judgements (74%). A third of participants disliked the increased workload and found the wording describing RoB judgements confusing. The RoB domains reported to be the most difficult to assess were incomplete outcome data and selective reporting of outcomes. Authors expressed the need for more guidance on how to incorporate RoB assessments into meta-analyses and review conclusions. Based on this evaluation, recommendations were made for improvements to the RoB tool and the associated guidance. The implementation of these recommendations is currently underway. Conclusions Overall, respondents identified positive experiences and perceptions of the RoB tool. Revisions of the tool and associated guidance made in response to this evaluation, and improved provision of training, may improve implementation.
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              The Navigation Guide—Evidence-Based Medicine Meets Environmental Health: Systematic Review of Human Evidence for PFOA Effects on Fetal Growth

              Background: The Navigation Guide methodology was developed to meet the need for a robust method of systematic and transparent research synthesis in environmental health science. We conducted a case study systematic review to support proof of concept of the method. Objective: We applied the Navigation Guide systematic review methodology to determine whether developmental exposure to perfluorooctanoic acid (PFOA) affects fetal growth in humans. Methods: We applied the first 3 steps of the Navigation Guide methodology to human epidemiological data: 1) specify the study question, 2) select the evidence, and 3) rate the quality and strength of the evidence. We developed a protocol, conducted a comprehensive search of the literature, and identified relevant studies using prespecified criteria. We evaluated each study for risk of bias and conducted meta-analyses on a subset of studies. We rated quality and strength of the entire body of human evidence. Results: We identified 18 human studies that met our inclusion criteria, and 9 of these were combined through meta-analysis. Through meta-analysis, we estimated that a 1-ng/mL increase in serum or plasma PFOA was associated with a –18.9 g (95% CI: –29.8, –7.9) difference in birth weight. We concluded that the risk of bias across studies was low, and we assigned a “moderate” quality rating to the overall body of human evidence. Conclusion: On the basis of this first application of the Navigation Guide systematic review methodology, we concluded that there is “sufficient” human evidence that developmental exposure to PFOA reduces fetal growth. Citation: Johnson PI, Sutton P, Atchley DS, Koustas E, Lam J, Sen S, Robinson KA, Axelrad DA, Woodruff TJ. 2014. The Navigation Guide—evidence-based medicine meets environmental health: systematic review of human evidence for PFOA effects on fetal growth. Environ Health Perspect 122:1028–1039; http://dx.doi.org/10.1289/ehp.1307893
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                Author and article information

                Contributors
                Journal
                Environ Int
                Environ Int
                Environment International
                Elsevier Science
                0160-4120
                1873-6750
                1 February 2020
                February 2020
                : 135
                : 105039
                Affiliations
                [a ]Department of Public Health, Environmental and Social Determinants of Health, World Health Organization, Geneva, Switzerland
                [b ]Department of Information, Evidence and Research, World Health Organization, Geneva, Switzerland
                [c ]Charles Perkins Centre, The University of Sydney, Sydney, Australia
                [d ]AP-HP (Paris Hospital “Assistance Publique Hôpitaux de Paris”), Occupational Health Unit, University Hospital of West Suburb of Paris, Poincaré Site, Garches, France
                [e ]Versailles St-Quentin Univ - Paris Saclay Univ (UVSQ), UMS 011, UMR-S 1168, France
                [f ]Inserm, U1168 (VIMA: Aging and chronic diseases. Epidemiological and public health approaches), UMS 011 (Population-based Epidemiologic Cohorts Unit), Villejuif, France
                [g ]Inail, Department of Occupational and Environmental Medicine, Epidemiology and Hygiene, Rome, Italy
                [h ]Centre for Environment and Health, KU Leuven, Leuven, Belgium
                [i ]KIR Department (Knowledge, Information & Research), IDEWE, External Service for Prevention and Protection at Work, Leuven, Belgium
                [j ]Institute of Public Health, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates
                [k ]College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates
                [l ]Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy
                [m ]Department of Health Research Methods, Evidence and Impact, McMaster University, Ontario, Canada
                [n ]Evidence-based Health, Universidade Federal de São Paulo, Sao Paulo, Brazil
                [o ]Cochrane Brazil, Sao Paulo, Brazil
                [p ]Institute of Public Health, College of Medicine & Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates
                [q ]Global Health and Tropical Medicine, Instituto de Higiene e Medicina Tropical, Universidade Nova de Lisboa, Lisbon, Portugal
                [r ]Radboud Institute for Health Sciences, Radboudumc, Nijmegen, the Netherlands
                [s ]Department of Public Health, Aarhus University, Aarhus, Denmark
                [t ]National Research Center for the Working Environment, Copenhagen, Denmark
                [u ]Cesare Maltoni Cancer Research Center, Ramazzini Institute, Bologna, Italy
                [v ]Department of Environmental Health and Engineering, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America
                [w ]National Research Centre for the Working Environment, Copenhagen, Denmark
                [x ]Program on Reproductive Health and the Environment, University of California San Francisco, San Francisco, United States of America
                [y ]School of Occupational and Public Health, Ryerson University, Toronto, Ontario, Canada
                [z ]Workers' Health and Human Ecology Research Center, National School of Public Health Sergio Arouca, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil
                [aa ]Labour Administration, Labour Inspection and Occupational Safety and Health Branch, International Labour Organization, Geneva, Switzerland
                Author notes
                [* ]Corresponding author at: Department of Public Health, Environmental and Social Determinants of Health, World Health Organization, Avenue Appia 20, CH-1211 Geneva 27, Switzerland. pegaf@ 123456who.int
                Article
                S0160-4120(19)30586-0 105039
                10.1016/j.envint.2019.105039
                7479507
                31864023
                6107b80f-d0f0-4f46-a5af-f1c4ce878da9
                © 2019 World Health Organization, International Labour Organization

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/3.0/).

                History
                : 22 February 2019
                : 10 July 2019
                : 19 July 2019
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