Article Synopsis
- Short-term trials often rely on surrogate measures rather than definitive outcomes to study chronic diseases, which can lead to issues with validity due to delayed effects of interventions.
- The concerns about carryover effects, particularly in crossover trials, are well-known in the realms of pharmacology and statistics but are frequently overlooked in non-pharmaceutical research, like dietary studies.
- Dietary trials are prone to significant bias since the body can take weeks or longer to adapt to major dietary changes; the article discusses this bias and suggests ways to improve causal inference in nutrition research and other areas.
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Article Abstract
Short term trials with surrogate measures instead of hard outcomes are often used to study chronic diseases. The effects of an intervention may, however, take time to develop and persist after discontinuation, producing wash-in and washout effects that threaten trial validity. This problem, especially involving carryover effects in crossover trials, is well recognized in the pharmacology and statistics literature but commonly disregarded in some areas of non-pharmaceutical research. Dietary trials, including feeding studies, are highly susceptible to bias because physiological adaptation to a major change in nutrients may take several weeks or longer. This article describes the nature and extent of this bias in nutrition research, as an important and illustrative case; considers implications for various other interventions; and proposes measures to strengthen causal inference.
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| http://dx.doi.org/10.1136/bmj-2024-082963 | DOI Listing |
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