Talk:Common currency in health assessments
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What is a good common "currency", i.e. a method to aggregate different benefits and risks into a single indicator in assessments about plant-based food supplements (PFS)?
The identification of the common currency (e.g., QALYs, DALYs) will be informed by the review of task 1 (approaches used and applicability to PFS), by the consumer studies conducted in WP8, by the definition of benefits of WP2 and in consultation with advisory boards. Measurement of benefits that do not involve reduction of disease risk (e.g., enhanced attention) will be achieved through a review of the literature and based on results of WP8 (consumers). Two alternative common currencies will be tested in at least one case study of task 2 and submitted to the scientific advisory board for review. The process of identification will be documented in DWP5-5.
Task leader: THL PM: THL 3, Hylo 2
Revision needed to milestone
Deadline October 7th
Nevertheless, in order to meet the expectations of the reviewers, we would like to give you some suggestions and indicate some amendments to the document, as follows:
- as a general comment, the description of the different common currencies you did should be put more into the context of the project and therefore of plant food supplements. Our suggestion would be to add a short introduction describing the context of the project.
- some amendements to paragraph 4 on "Description of benefits". Our suggestion is to modify the text focusing the attention on benefit without taking into account the placebo effect, which is not part of what experts would consider a positive health effect. The paragraph could start with the description of the definition of benefits provided by EFSA in its risk-benefit guidance and its claims-related work and then adding the definition of benefit which was provided by WP2 in their deliverable and that was specific to benefit deriving from the consumption of food supplements (Benefits reachable by the consumption of food supplements could be defined as "the attainment of specific physiological objectives, such as reduction of risk factors for chronic diseases and the maintenance of the human homeostasis, which is the body’s capability to physiologically regulate wellbeing and ensure stability and balance in response to changes in the external environment". ) In this way we would relate the content of the paragraph to the project and to the activities of other workpackages. Please let us know if we can help with this.
- We would also suggest to include, as example, some health benefits approved by EFSA which are not related to disease reduction but to health improvement, in order to put the paragraph again into the context of the benefits of plant food supplements. Some examples might be: 1) improvement of visual adaptation to the dark, 2) enhancement of mood, 3) improved defense against bacterial pathogens in the lower urinary tract. It should be apparent that we choose a common currency that covers them all.
- in the description of each of the common currencies we think it might be useful to provide some examples in order to clarify the concept behind the general description and making easier the comprehension for the reader. In this sense, it might also be useful if you added a comment on how the common currencies described might be useful when the benefits are those above mentioned (the EFSA ones), maybe this can be done in the table or in the description of each currency. The explanation of the common currencies could also be improved.
Placebo effect, broader definition of benefits
The concept of benefits is often not as clear as it might first seem. The clearest way of presenting health benefits is measuring improved health status due to intake of a substance which has a plausible toxicological mechanism of action in the human body. Modern medicinal treatments should fall into this category. However, often the evaluation of benefits is not that clear. When the effects are possible but small, which often is the case for example in herbal products and food supplements, placebo factor comes relevant (Kaptchuk 2008). Actually, it is a strong factor of various health benefits (Margo 1999). How to take into account this effect in benefit-risk assessments, is an open question (Hunsley and Westmacott 2007) Should the definition of benefits be broadened in a way that also placebo effects are included, and how to do this in a coherent and an objective way?
Margo, CE. 1999. The Placebo Effect. Survey of Ophthalmology Volume 44, Issue 1, 8 July 1999, Pages 31-44
Hunsley, J., and Westmacott, R. 2007. "Interpreting the magnitude of the placebo effect: mountain or Molehill?". J Clin Psychol 63 (4): 391–9.
Kaptchuk, JT., Kelley, JM., Deykinc, A., Waynea, PM., Louis C. Lasagnad, LC., Epsteine, IO., Kirschf, I., and Wechsler, ME. Do “placebo responders” exist? Contemporary Clinical Trials Volume 29, Issue 4, July 2008, Pages 587-595