Literature DB >> 27711975

Observational research rigour alone does not justify causal inference.

Keisuke Ejima1, Peng Li1,2, Daniel L Smith3,4,5, Tim R Nagy3,4,5, Inga Kadish6, Thomas van Groen6, John A Dawson1, Yongbin Yang3,4, Amit Patki2, David B Allison1,2,3,4,5.   

Abstract

BACKGROUND: Differing opinions exist on whether associations obtained in observational studies can be reliable indicators of a causal effect if the observational study is sufficiently well controlled and executed.
MATERIALS AND METHODS: To test this, we conducted two animal observational studies that were rigorously controlled and executed beyond what is achieved in studies of humans. In study 1, we randomized 332 genetically identical C57BL/6J mice into three diet groups with differing food energy allotments and recorded individual self-selected daily energy intake and lifespan. In study 2, 60 male mice (CD1) were paired and divided into two groups for a 2-week feeding regimen. We evaluated the association between weight gain and food consumption. Within each pair, one animal was randomly assigned to an S group in which the animals had free access to food. The second paired animal (R group) was provided exactly the same diet that their S partner ate the day before.
RESULTS: In study 1, across all three groups, we found a significant negative effect of energy intake on lifespan. However, we found a positive association between food intake and lifespan among the ad libitum feeding group: 29·99 (95% CI: 8·2-51·7) days per daily kcal. In study 2, we found a significant (P = 0·003) group (randomized vs. self-selected)-by-food consumption interaction effect on weight gain.
CONCLUSION: At least in nutrition research, associations derived from observational studies may not be reliable indicators of causal effects, even with the most rigorous study designs achievable.
© 2016 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.

Entities:  

Keywords:  Causality; nutritional sciences; observational study; randomized controlled trial; research design

Mesh:

Year:  2016        PMID: 27711975      PMCID: PMC5118066          DOI: 10.1111/eci.12681

Source DB:  PubMed          Journal:  Eur J Clin Invest        ISSN: 0014-2972            Impact factor:   4.686


  20 in total

1.  Randomized, controlled trials, observational studies, and the hierarchy of research designs.

Authors:  J Concato; N Shah; R I Horwitz
Journal:  N Engl J Med       Date:  2000-06-22       Impact factor: 91.245

2.  A comparison of observational studies and randomized, controlled trials.

Authors:  K Benson; A J Hartz
Journal:  N Engl J Med       Date:  2000-06-22       Impact factor: 91.245

3.  THE ENVIRONMENT AND DISEASE: ASSOCIATION OR CAUSATION?

Authors:  A B HILL
Journal:  Proc R Soc Med       Date:  1965-05

4.  Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

Authors:  Marc L Berger; Nancy Dreyer; Fred Anderson; Adrian Towse; Art Sedrakyan; Sharon-Lise Normand
Journal:  Value Health       Date:  2012 Mar-Apr       Impact factor: 5.725

5.  Practical implications of modes of statistical inference for causal effects and the critical role of the assignment mechanism.

Authors:  D B Rubin
Journal:  Biometrics       Date:  1991-12       Impact factor: 2.571

Review 6.  Effect of measurement error on epidemiological studies of environmental and occupational exposures.

Authors:  B G Armstrong
Journal:  Occup Environ Med       Date:  1998-10       Impact factor: 4.402

7.  Concordance of randomized and nonrandomized studies was unrelated to translational patterns of two nutrient-disease associations.

Authors:  Thomas A Trikalinos; Denish Moorthy; Mei Chung; Winifred W Yu; Jounghee Lee; Alice H Lichtenstein; Joseph Lau
Journal:  J Clin Epidemiol       Date:  2011-11-01       Impact factor: 6.437

8.  Causal inference from descriptions of experimental and non-experimental research: public understanding of correlation-versus-causation.

Authors:  April Bleske-Rechek; Katelyn M Morrison; Luke D Heidtke
Journal:  J Gen Psychol       Date:  2015

9.  Trials are best, ignore the rest: safety and efficacy of digoxin.

Authors:  Graham D Cole; Darrel P Francis
Journal:  BMJ       Date:  2015-08-30

Review 10.  Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview.

Authors:  Su Golder; Yoon K Loke; Martin Bland
Journal:  PLoS Med       Date:  2011-05-03       Impact factor: 11.069

View more
  7 in total

Review 1.  Risk of Type 2 Diabetes Among Individuals with Excess Weight: Weight Trajectory Effects.

Authors:  Arthur H Owora; David B Allison; Xuan Zhang; Nana Gletsu-Miller; Kishore M Gadde
Journal:  Curr Diab Rep       Date:  2022-07-04       Impact factor: 5.430

2.  Potential Cardiometabolic Health Benefits of Full-Fat Dairy: The Evidence Base.

Authors:  Kristin M Hirahatake; Arne Astrup; James O Hill; Joanne L Slavin; David B Allison; Kevin C Maki
Journal:  Adv Nutr       Date:  2020-05-01       Impact factor: 8.701

3.  Fasting blood glucose as a predictor of mortality: Lost in translation.

Authors:  Dushani L Palliyaguru; Eric J Shiroma; John K Nam; Eleonora Duregon; Camila Vieira Ligo Teixeira; Nathan L Price; Michel Bernier; Simonetta Camandola; Kelli L Vaughan; Ricki J Colman; Andrew Deighan; Ron Korstanje; Luanne L Peters; Stephanie L Dickinson; Keisuke Ejima; Eleanor M Simonsick; Lenore J Launer; Chee W Chia; Josephine Egan; David B Allison; Gary A Churchill; Rozalyn M Anderson; Luigi Ferrucci; Julie A Mattison; Rafael de Cabo
Journal:  Cell Metab       Date:  2021-09-10       Impact factor: 31.373

Review 4.  Application of a Causal Discovery Algorithm to the Analysis of Arthroplasty Registry Data.

Authors:  Camden Cheek; Huiyong Zheng; Brian R Hallstrom; Richard E Hughes
Journal:  Biomed Eng Comput Biol       Date:  2018-02-22

5.  Best Practices for Conducting Observational Research to Assess the Relation between Nutrition and Bone: An International Working Group Summary.

Authors:  Regan L Bailey; Shivani Sahni; Patricia Chocano-Bedoya; Robin M Daly; Ailsa A Welch; Heike Bischoff-Ferrari; Connie M Weaver
Journal:  Adv Nutr       Date:  2019-05-01       Impact factor: 8.701

6.  Inferring causal pathways among three or more variables from steady-state correlations in a homeostatic system.

Authors:  Suraj Chawla; Anagha Pund; Vibishan B; Shubhankar Kulkarni; Manawa Diwekar-Joshi; Milind Watve
Journal:  PLoS One       Date:  2018-10-11       Impact factor: 3.240

7.  Weight Cycling Increases Longevity Compared with Sustained Obesity in Mice.

Authors:  Daniel L Smith; Yongbin Yang; Tim R Nagy; Amit Patki; Joseph R Vasselli; Yiying Zhang; Stephanie L Dickinson; David B Allison
Journal:  Obesity (Silver Spring)       Date:  2018-11       Impact factor: 5.002

  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.