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Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age (2018)

Chapter: Appendix D: Tools and Methods to Evaluate the Risk of Bias in Individual Studies

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Suggested Citation:"Appendix D: Tools and Methods to Evaluate the Risk of Bias in Individual Studies." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Appendix D

Tools and Methods to Evaluate the Risk of Bias in Individual Studies

Below are examples of tools and methods that were developed to measure the strength of various studies as well as the risk of bias in randomized trials, nonrandomized studies, diagnostic test accuracy, cohort studies, randomized controlled trials, and case control studies. The table below has been adapted from the European Food Safety Authority’s 2017 report The Principles and Methods Behind EFSA’s Guidance on Uncertainty Analysis in Scientific Assessment.

Tool Study Design or Applicable Setting Institution Reference
Office of Health Assessment and Translation Risk of Bias (RoB) Tool Experimental animal studies, human randomized controlled trial (RCT), human observational National Toxicology Programme (NTP) https://ntp.niehs.nih.gov/ntp/ohat/pubs/riskofbiastool_508.pdf (accessed August 6, 2018)
RoB 2.0 Risk of bias in randomized trials Cochrane collaboration https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool (accessed August 6, 2018)
Suggested Citation:"Appendix D: Tools and Methods to Evaluate the Risk of Bias in Individual Studies." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
×
Tool Study Design or Applicable Setting Institution Reference
Robins-I Risk of bias in nonrandomized studies of interventions Cochrane collaboration https://sites.google.com/site/riskofbiastool/welcome/home (accessed August 6, 2018)
RoB Diagnostic Test Accuracy Risk of bias in diagnostic test accuracy Cochrane Canada http://training.cochrane.org/resource/primer-cochrane-diagnostic-test-accuracy-reviews (accessed August 6, 2018)
Tool to assess risk of bias in cohort studies Risk of bias in cohort studies CLARITY Group https://www.evidencepartners.com/resources/methodological-resources (accessed August 6, 2018)
Tool to assess risk of bias in randomized controlled trials Risk of bias in RCT CLARITY Group https://www.evidencepartners.com/resources/methodological-resources (accessed August 6, 2018)
Tool to assess risk of bias in case control studies Risk of bias in case control studies CLARITY Group https://www.evidencepartners.com/resources/methodological-resources (accessed August 6, 2018)

SOURCE: Adapted with permission from EFSA et al., 2018.

REFERENCE

EFSA Scientific Committee, D. Benford, T. Halldorsson, M. J. Jeger, H. K. Knutsen, S. More, H. Naegeli, H. Noteborn, C. Ockleford, A. Ricci, G. Rychen, J. R. Schlatter, V. Silano, R. Solecki, D. Turck, M. Younes, P. Craig, A. Hart, N. Von Goetz, K. Koutsoumanis, A. Mortensen, B. Ossendorp, A. Germini, L. Martino, C. Merten, O. Mosbach-Schulz, A. Smith, and A. Hardy. 2018. Scientific opinion on the principles and methods behind EFSA’s Guidance on Uncertainty Analysis in Scientific Assessment. EFSA Journal 16(1):5122-5235.

Suggested Citation:"Appendix D: Tools and Methods to Evaluate the Risk of Bias in Individual Studies." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
×
Page 141
Suggested Citation:"Appendix D: Tools and Methods to Evaluate the Risk of Bias in Individual Studies." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
×
Page 142
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Recommended intake levels for nutrients and other dietary components were designed initially to prevent nutrient deficiency diseases in a given population, and the original methodological approach used to derive intake values did not include consideration for other applications. However, with the increasing globalization of information and the identification of a variety of factors specific to different population subgroups (e.g., young children and women of reproductive age) that influence their nutritional needs, there has been increasing recognition of the need to consider methodological approaches to deriving nutrient reference values (NRVs) that are applicable across countries and that take into account the varying needs of different population subgroups.

There is a need for guidance and recommendations about methodological approaches, as well as their potential for application to an international process for the development of NRVs, and particularly for young children and women of reproductive age. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age examines these issues and makes recommendations for a unified approach to developing NRVs that would be acceptable globally.

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