The incidence of peanut allergies among infants has become increasingly prevalent in the western world. The long-standing guidelines for allergy prevention promoted the avoidance of peanuts during childhood years however this is currently being challenged with the notion that the converse, peanut consumption, is vital to prevent the development of peanut allergies.
The Journal article “Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy *cite featured in the New England Journal of Medicine, a prestigious Medical Journal, on the 26th of February 2015 aims to test this alternate hypothesis. It was primarily funded by the National Institute of Allergy and infectious diseases. The purpose of this journal was to test whether the controlled consumption of peanut proteins by infants likely to develop peanut allergies reduces the number likelihood of developing peanut allergies*. The journal is in the form of a randomized control trial which essentially compares two cohorts assigned either early consumption and peanut avoidance. The results of these groups are then compared through the means of risk difference and two-tailed Chi Square test. The results were produced by an intention-to-treat and per-protocol basis. The studies concluded that early peanut consumption lead to a significant reduction in peanut allergy development in children who are at risk of developing a peanut allergy.
The online media article “New peanut allergy prevention guidelines start in infancy” refers to the findings of the Journal Article through the form of guidelines published in “Journal of Allergy and Clinical Immunology”. This article published by CNN aims to inform the public, of these new guidelines with regards to peanut consumption and does so in a manner which is clear and concise to concerned parents. The article backs up these guidelines not only with findings from the journal article but by providing statements from the **** and
The author of this article, Susan Scutti aims to relay the guidelines provided by the* to the public. Scutti begins with the headline “New peanut allergy prevention guidelines start in infancy”, this is particularly eye-catching as it gives a sense of urgency through mentioning that the guidelines begin with infancy. The overall tone of the article is relative informative however at times there is a tone of confidence or absoluteness with regards to the validity of the research. Following with 2 summary points, Scutti goes on to introduce the problems that peanut allergies have caused in the population. She mentions death, which would be particularly alarming to parents. However, she quickly diffuses this by presenting the main contention of this article and in doing so providing relief to the readers. Scutti provides background to the guidelines, mentioning how they were made and introducing the “LEAP study” conducted as part of the journal. The reasoning for these guidelines is aptly provided by Dr Anthony Fauci, the director of the National Institute of allergies, as simply to ‘spread the word”. Scutti then goes on to describe the guidelines with a quote from Fauci, as “really simple and straightforward”. This captures the essence of not only the purpose of the guidelines but the purpose of the article. The article aims to relay the information found by the study in a way which is easily communicable to the relevant demographic, in this case expecting parents. This is the targeted demographic as expectant parents are pivotal in prevention of peanut allergies in their children and would also be concerned about a topic of this nature. This is mostly achieved with the provision of three guidelines based on the child’s predisposition to allergy. A parent can easily interpret these and follow advice tailored to their situation. This is where the article ends, allowing the guidelines to be fresh in the reader’s minds. Overall, the article is clear-cut and very absolute it in its claims. Giving great weight to the “rigorous” nature of the study to further solidify the proposed guidelines.
Therefore, a parent reading this article would be likely to consider these guidelines and enquire further with their GP. They may be particularly concerned about not only the validity of these guidelines but their child’s current immunological status to better inform their child’s consumption plan.
The Journal Article, "Randomised Trial of Peanut Consumption in Infants at risk for Peanut Allergy", tests the notion that early introduction of dietary peanut could serve as an effective primary and secondary strategy for the prevention of peanut allergy in infants at risk. This study is termed as a LEAP study (Learning Early About Peanut Allergy) and is commissioned by the National institute of Allergy and Infectious Diseases. This study is a "randomised, open-label, controlled trial", which revolves around comparing the impact of infant peanut consumption and avoidance with regards to Peanut allergies.
The study begins by obtaining a sample population of 640 infants which are at risk of developing a peanut allergy. This population is then further differentiated by the means of a skin-prick wheal test (SPT) to determine a sub-cohort which is at a greater risk of specifically developing a peanut allergy. Half of each of these groups are now prescribed to either a peanut avoidance or a peanut consumption plan. To ensure that peanut is maximally avoided, the adherence was assessed with a validated food-frequency questionnaire. Additionally, some of the avoidance families also agreed to having peanut protein levels measured from bed dust to ensure minimal contact to allergens. Clinical assessments were also undertaken at the baseline (4-11 months), 12 months, 30 months and then each month after. Moreover, scheduled between-visit phone consultations were also undertaken. With regards to the interpretation of results, non-adherence was considered by using worst-case calculations to account for the lost data.
This study design, a randomised control trial, is a relatively appropriate study design as it can accurately isolates the variable of peanut consumption. As the research question considers the idea of peanut consumption as a means of allergy reduction in infants. The use of a randomised control trial allows the researchers to effectively measure the effects of peanut consumption and its correlation to allergy development. The inherently prospective nature of the study allowed researchers to ensure complete adherence and obtain vital health data over the course of the study. This meant that the data could be further stratified through either intention-to-treat or per-protocol analysis. The researchers could account for the non-adherence by factoring in worst-case calculations and allowing for a full set of data to be analysed.
With regards to weaknesses of this study design, the main weakness acknowledged by the study itself is the lack of a placebo regimen. This would have been helpful* in displaying a clear cause and effect relationship between peanut consumption and allergy or lack thereof. ** HOW WAS IT MITIGATED
Additionally, with regards to the sample size, although the total cohort is adequate, the secondary cohort of infants with a positive SPT was considerably smaller in proportion to the negative cohort. This would mean that the data would be less accurate and this is shown by the confidence intervals discussed later.
With regards to the conclusory statements, although they do report notable findings with the cohort, further follow-up would also be vital to mitigate the potential of new cases arising after the study. ***** WORDING THIS IS BAD
The primary outcome of this study was based on a range of tests, primarily an oral food challenge, to determine whether the children had developed a peanut allergy by the age of 60 months. Out of the 542 children who initially tested negative for the SPT, 530 could be evaluated for the primary outcome. The results showed that by 60 months 13.7% of the avoidant group had developed a peanut allergy as compared to 1.9% of the consumption group. In the cohort of 98 children (all evaluable) with positive SPT tests, 35.3% of the avoidant group and 10.6% of the consumption group developed a peanut allergy. These statistics were calculated by intention-to-treat analysis therefor contain data of all the samples regardless of adherence. However, per-protocol analysis in addition to worse-case calculations showed consistent results. These results indicate that peanut consumption in infantile years is effective as a means of primary and secondary prevention.
The LEAP study was approved by the institutional review board of the National Research Ethics Service Committee (London-Fulham). When considering the ethics around this trial, what comes to mind is the notion that the Research team is actively putting infants at harm as they are being exposed to a potential allergen. This could be viewed from two perspectives. Through the lens of previous ideals around infant peanut consumption, the researchers are placing the consumption group at risk. Conversely, when considering the hypothesis of the researchers, in their eyes they are placing the avoidant group at a detrimental position, although not in the way of immediate danger but certainly to develop peanut allergies. However, in retrospect it is uncovered that there were no significant differences in adverse effects in either group, therefor this ethical hitch was diminished.
Alternative study designs would have been weaker or impractical with regards to the research question. This is partially due to the fact the randomised control standards are the gold standard with regards to study trials. Other study designs would not be able isolate the variable of peanut consumption to such a degree. However, some study designs may avoid the ethical dilemma posed earlier due to their retrospective nature. Additionally, there may also be bias if the study is industry funded and specific data is used.