Evaluation of the risk of bias in non-randomized studies of interventions (ROBINS-I) and the ‘target experiment’ concept in studies of exposures: Rationale and preliminary instrument development

Environment International

Volumn 120, Issue , 2018, Pages 382-387

  Morgan, Rebecca L ^a   Thayer, Kristina A ^b   Santesso, Nancy ^a   Holloway, Alison C ^a   Blain, Robyn ^c   Eftim, Sorina E ^c   Goldstone, Alexandra E ^c   Ross, Pam ^c   Guyatt, Gordon ^a   Schünemann, Holger J ^a  

^a MCMASTER UNIVERSITY   (Canada)

^b U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^c ICF INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GRADING; HEALTH; HEALTH RISKS; INDUSTRIAL HYGIENE; RISK ASSESSMENT;

CROSS-SECTIONAL STUDY; ENVIRONMENTAL EXPOSURE; EXPOSURE ASSESSMENT; HEALTH INTERVENTIONS; INSTRUMENT DEVELOPMENT; MEASUREMENT METHODS; OCCUPATIONAL HEALTH; RANDOMIZED EXPERIMENTS;

QUALITY CONTROL;

EXPERIMENTAL STUDY; HEALTH RISK; OCCUPATIONAL EXPOSURE; RATIONALIZATION; RISK ASSESSMENT; RISK FACTOR;

ARTICLE; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; ENVIRONMENTAL EXPOSURE; HUMAN; NOMENCLATURE; OCCUPATIONAL HEALTH; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; SYNTHESIS; SYSTEMATIC REVIEW; STATISTICAL BIAS;

BIAS; CROSS-SECTIONAL STUDIES; ENVIRONMENTAL EXPOSURE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85051678292     PISSN: 01604120     EISSN: 18736750     Source Type: Journal    
DOI: 10.1016/j.envint.2018.08.018     Document Type: Article

References (31)

1. ACROBAT-NRSI, A Cochrane risk of bias assessment tool for non-randomized studies of interventions. https://sites.google.com/site/riskofbiastool/. (Accessed 24 September 2014)
2. Authority EFS, Tools For Critically Appraising Different Study Designs, Systematic Review and Literature Searches. 12(7), 2015, EFSA Supporting Publication.
3. Carwile, J.L., Michels, K.B., Urinary bisphenol A and obesity: NHANES 2003–2006. Environ. Res. 111:6 (2011), 825–830.
4. Chevrier, J., Harley, K.G., Bradman, A., Gharbi, M., Sjödin, A., Eskenazi, B., Polybrominated diphenyl ether (PBDE) flame retardants and thyroid hormone during pregnancy. Environ. Health Perspect., 118(10), 2010, 1444.
5. Cochran, W.G., Chambers, S.P., The planning of observational studies of human populations. J. R. Stat. Soc. Ser. A 128:2 (1965), 234–266.
6. Cooper, G.S., Lunn, R.M., Agerstrand, M., Glenn, B.S., Kraft, A.D., Luke, A.M., Ratcliffe, J.M., Study sensitivity: evaluating the ability to detect effects in systematic reviews of chemical exposures. Environ. Int. 92–93 (2016), 605–610.
7. Council NR, Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens. 2014, National Academies Press.
8. Council NR, Review of Advances Made to the IRIS Process. 2018, National Academies Press.
9. Guyatt, G.H., Oxman, A.D., Vist, G.E., Kunz, R., Falck-Ytter, Y., Alonso-Coello, P., Schunemann, H.J., Group GW, GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336:7650 (2008), 924–926.
10. Higgins, J., Green, S., Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 (updated March 2011). http://handbook.cochrane.org, 2011. (Accessed 3 February 2013)
11. Hsu, C.-C., Sandford, B.A., The Delphi technique: making sense of consensus. Pract. Assess. Res. Eval. 12:10 (2007), 1–8.
12. Johnson, P.I., Sutton, P., Atchley, D.S., Koustas, E., Lam, J., Sen, S., Robinson, K.A., Axelrad, D.A., Woodruff, T.J., The navigation guide–evidence-based medicine meets environmental health: systematic review of human evidence for PFOA effects on fetal growth. Environ. Health Perspect. 122:10 (2014), 1028–1039.
13. Koustas, E., Lam, J., Sutton, P., Johnson, P.I., Atchley, D.S., Sen, S., Robinson, K.A., Axelrad, D.A., Woodruff, T.J., The navigation guide - evidence-based medicine meets environmental health: systematic review of nonhuman evidence for PFOA effects on fetal growth. Environ. Health Perspect. 122:10 (2014), 1015–1027.
14. LaKind, J.S., Sobus, J.R., Goodman, M., Barr, D.B., Furst, P., Albertini, R.J., Arbuckle, T.E., Schoeters, G., Tan, Y.M., Teeguarden, J. et al., A proposal for assessing study quality: biomonitoring, environmental epidemiology, and short-lived chemicals (BEES-C) instrument. Environ. Int. 73 (2014), 195–207.
15. Levy, B.S., Occupational and Environmental Health: Recognizing and Preventing Disease and Injury. 2006, Lippincott Williams & Wilkins.
16. Methods Commentary: Risk of Bias in Cohort Studies. https://distillercer.com/resources/methodological-resources/risk-of-bias-commentary/.
17. Morgan, R.L., Thayer, K.A., Bero, L., Bruce, N., Falck-Ytter, Y., Ghersi, D., Guyatt, G., Hooijmans, C., Langendam, M., Mandrioli, D. et al., GRADE: assessing the quality of evidence in environmental and occupational health. Environ. Int. 92–93 (2016), 611–616.
18. Morgan, R.L., Thayer, K., Whaley, P., Schünemann, H., Identifying the PECO: a framework for formulating good questions to explore the association of environmental and other exposures with health outcomes. Environ. Int., 2018 Unpublished, Accepted for publication.
19. Morgan, R., Thayer, K., Holloway, A., Santesso, N., Blain, R., Eftim, S., Goldstone, A., Ross, P., Guyatt, G., Schünemann, H., Risk of Bias Instrument for Non-randomized Studies of Exposures: a Users’ Guide. 2018 Unpublished.
20. National Academies of Sciences E, Medicine, Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-dose Toxicity From Endocrine Active Chemicals. 2017, National Academies Press.
21. NRC (National Research Council), Review of EPA's Integrated Risk Information System (IRIS) Process. http://www.nap.edu/catalog.php?record_id=18764, 2014. (Accessed 1 January 2015)
22. NTP (National Toxicology Program), Handbook for Conducting a Literature-Based Health Assessment Using Office of Health Assessment and Translation (OHAT) Approach for Systematic Review and Evidence Integration. January 9, 2015 release. Available at http://ntp.niehs.nih.gov/go/38673, 2015.
23. NTP (National Toxicology Program), Handbook for Preparing Report on Carcinogens Monographs–July 2015. Available at http://ntp.niehs.nih.gov/go/rochandbook, 2015. (Accessed 3 January 2017)
24. Rooney, A.A., Cooper, G.S., Jahnke, G.D., Lam, J., Morgan, R.L., Boyles, A.L., Ratcliffe, J.M., Kraft, A.D., Schünemann, H.J., Schwingl, P., How credible are the study results? Evaluating and applying internal validity tools to literature-based assessments of environmental health hazards. Environ. Int. 92 (2016), 617–629.
25. Schünemann, H.J., Cuello, C., Akl, E.A., Mustafa, R.A., Meerpohl, J.J., Thayer, K., Morgan, R.L., Gartlehner, G., Kunz, R., Katikireddi, S.V., GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in non-randomized studies should be used to rate the certainty of a body of evidence. J. Clin. Epidemiol., 2018.
26. Sterne, J.A., Hernan, M.A., Reeves, B.C., Savovic, J., Berkman, N.D., Viswanathan, M., Henry, D., Altman, D.G., Ansari, M.T., Boutron, I. et al., ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 355, 2016, i4919.
27. Thayer, K., Rooney, A., Boyles, A., Holmgren, S., Walker, V., Kissling, G., U.S. Department of Health and Human Services, Draft protocol for systematic review to evaluate the evidence for an association between bisphenol A (BPA) exposure and obesity. National Toxicology Program, 2013.
28. The Risk of Bias Instrument for Non-randomized Studies of Exposures. http://heigrade.mcmaster.ca/guideline-development/rob-instrument-for-nrs-of-exposures.
29. The ROBINS-E tool, Risk Of Bias In Non-randomized Studies - of Exposures. https://www.bristol.ac.uk/population-health-sciences/centres/cresyda/barr/riskofbias/robins-e/.
30. Wells, G., Shea, B., O'Connell, D., Peterson, J., Welch, V., Losos, M., Tugwell, P., The Newcastle-Ottawa Scale (NOS) for Assessing the Quality of Nonrandomised Studies in Meta-analyses. 2000.
31. Zhao, X., Wang, H., Li, J., Shan, Z., Teng, W., Teng, X., The correlation between polybrominated diphenyl ethers (PBDEs) and thyroid hormones in the general population: a meta-analysis. PLoS One, 10(5), 2015, e0126989.