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      Mechanistic evidence underpinning dietary policy: bringing the jigsaw pieces together?

      Proceedings of the Nutrition Society
      Cambridge University Press (CUP)

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          Abstract

          Observational research, mainly prospective cohort studies (PCS), has represented a long-standing challenge for those attempting to draw up consistent policy recommendations in the area of diet and health. This has been due to the inherent limitations in ascribing causality from observed associations due to problems of confounding of the findings and publication and citation bias. Developments in nutritional epidemiology research over the past 20–30 years have enabled causal criteria to be derived from observational studies and the totality of the primary literature to be reviewed objectively, reducing previous focus on narrative accounts of individual studies. The gold standard approach to assessing causal relationships is via randomised controlled trials (RCT), but neither RCT nor PCS provide direct evidence for biological plausibility, which is a key criterion for assessing causality. Although extensive mechanistic data are available in the literature, a systematic approach to select and assess quality and relevance of published studies has not been available. This limits their use in the development of diet and health policy. Recent studies have investigated a proposed two-step framework and novel methodologies for integrating heterogeneous data from cell, animal and human studies. Pilot and feasibility studies have shown this to be a useful novel approach to studies of diet and cancer, but further refinements are required, including development of appropriate quality criteria which are less dependent on RCT designs. Future studies are needed to fully verify the approach and its potential for use in other diet–disease relationships.

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          The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials

          Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
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            GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.

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              SYRCLE’s risk of bias tool for animal studies

              Background Systematic Reviews (SRs) of experimental animal studies are not yet common practice, but awareness of the merits of conducting such SRs is steadily increasing. As animal intervention studies differ from randomized clinical trials (RCT) in many aspects, the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies. The Cochrane Collaboration developed a Risk of Bias (RoB) tool to establish consistency and avoid discrepancies in assessing the methodological quality of RCTs. A similar initiative is warranted in the field of animal experimentation. Methods We provide an RoB tool for animal intervention studies (SYRCLE’s RoB tool). This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies. To enhance transparency and applicability, we formulated signalling questions to facilitate judgment. Results The resulting RoB tool for animal studies contains 10 entries. These entries are related to selection bias, performance bias, detection bias, attrition bias, reporting bias and other biases. Half these items are in agreement with the items in the Cochrane RoB tool. Most of the variations between the two tools are due to differences in design between RCTs and animal studies. Shortcomings in, or unfamiliarity with, specific aspects of experimental design of animal studies compared to clinical studies also play a role. Conclusions SYRCLE’s RoB tool is an adapted version of the Cochrane RoB tool. Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies. This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the methodological quality of animal studies.
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                Author and article information

                Journal
                Proceedings of the Nutrition Society
                Proc. Nutr. Soc.
                Cambridge University Press (CUP)
                0029-6651
                1475-2719
                May 2023
                November 02 2022
                May 2023
                : 82
                : 2
                : 219-226
                Article
                10.1017/S0029665122002750
                45835011-212d-4fa5-bd2b-1f111138cc1a
                © 2023

                Free to read

                https://creativecommons.org/licenses/by/4.0/

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