Literature Review
Foodborne illness, also known as food poisoning, is any time of illness which comes from spoiled or contaminated food or from toxins that naturally occur in some foods. Currently there are more than 250 different foodborne diseases typically caused by bacteria, viruses and parasites or toxins . It is estimated that each year 48 million people will have some form of foodborne illness and that 128,000 of these people will need to be hospitalized. Foodborne illnesses account for appropriately 3000 deaths each year . Common symptoms include vomiting, stomach cramps, nausea, and diarrhea. However, the symptoms can vary depending on the type of disease . While many people recognize the dangers of consuming spoiled food, one area in which there is often confusion and lack of understanding is that of consuming raw products .
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"The Occurrence of Foodborne Illness Among Individuals Who Consume Raw Dairy".
People generally understand that meat products such as beef and chicken must be thoroughly cooked in order to prevent the occurrence of a foodborne illness. However, this knowledge does not extend to animal by-products. Currently in the United States the consumption of raw animal by-products such as eggs and dairy are on the rise. Previous research has shown that up to one third of raw milk samples can contain pathogens which can make people sick . The pathogens most commonly found in raw milk are Campylobacter, Shiga toxin-producing E. coli and Salmonella. Of these three pathogens Campylobacter was responsible for 81% of the foodborne illnesses associated with raw milk consumption from 2007-2012. During this time period the frequency of foodborne illness from raw milk nearly doubled. As well the rate of illness was four times greater in this time period than in the previously evaluated time period of 1993-2006 . This rapid increase in the rate of foodborne illness from raw milk is concerning. While there is research surrounding how raw milk can cause illness there is a lack of information surrounding specific sources and if there are particular storage practices which can reduce the occurrence of illness.
Within the general population young children, the elderly and immunocompromised individuals are the most at risk for development of foodborne illness from raw milk . Currently there is no scientific evidence supporting the idea that raw milk consumption is better than pasteurized milk consumption. While there have been studies showing the benefits o growing up in a farm environment and exposure to the outdoors in terms of reducing allergies and asthma , however no studies have linked this specifically to raw milk consumption . However, despite this lack of evidence surrounding the health benefits of raw dairy, many individuals believe that is it a more healthy alternative then pasteurized milk. However, previous studies have shown that pasteurization of milk does not alter the nutritional value of milk. As well raw milk does not offer any probiotic protection compared to consuming pasteurized milk. They further determined that any perceived benefit from previous correlative studies was likely due to the farm environment and not due to anything specific to raw milk .
As the number of states who are legalizing raw milk consumption continues to rise it is important that research be focused on ways to prevent illness. This can include investigating the contributing factors such as where the dairy was purchased from and the storage practices of the individuals consuming the raw dairy. In particular it is important to have a complete understanding of the rate of consumption of raw dairy and how it relates to foodborne illness in the local community. As such a study investigating the rate of raw dairy consumption in the community is proposed. In particular this survey based study aims to determine the specific factors that may be contributing to the development of foodborne illness in individuals that consume raw dairy products.
Main Objectives
Within this research proposal there are two main objectives. The first main objective is to determine the rates of illness amongst these individuals who consume raw or pasteurized dairy and the sources and methods of storage of these dairy products. The second objective is to then determine of the individuals presenting with foodborne illness which of these individuals consume raw dairy and what is the source and storage practices associated with this dairy.
Methods Section
Study Design
The patient population will be individuals within a community who have access to raw dairy products. A request for individuals who consume dairy products will be published. Individuals will then be screened to determine the types of dairy products that they consume. A equal number of individuals who consume pasteurized dairy products and those who consume raw or non-pasteurized dairy products will be recruited. Ideally 1000 participants, 500 who consume pasteurized dairy and 500 who consume non-pasteurized dairy will be recruited. These individuals will then be asked to complete a survey. To increase the likelihood of completion of the survey it will be available both online and in paper format. As well a follow-up call to all individuals will be given after several weeks to those who have yet to complete the survey. For the second objective individuals who present with foodborne illness will be asked to complete the same survey in order to identify if consuming raw dairy products may have contributed to their illness.
The survey will consist of several different sections. The first is that of demographic information including number of individuals in the household, ages, sex and total household income. The second section will focus on the food choices of the individuals specific to dairy consumption. Individuals will be asked to identify where they purchased the dairy products from and the brands of dairy that they most frequently consume. Furthermore, information on the storage conditions of the dairy will be posed. For example, individuals will be asked if they store their butter on the counter, how they store their milk and cheese and if they pack these products into lunches which are then not refrigerated.
The third and final section will then pose questions on illness. Individuals will be asked to state if they have felt that they had some type of foodborne illness in the last 3 months. As people may not identify their symptoms as being associated with foodborne illness. Therefore, individuals will be asked if they have experienced any common foodborne illness symptoms. As well the frequency of these symptoms will also be recorded. Specifically, to individuals who have been identified as having foodborne illness these surveys will be marked to indicate that they have been positively identified as having this illness.
After all of the data has been obtained, paper surveys will be imputed into the online survey system. All of the information will then be compiled. To ensure patient privacy the names of the individuals filling out the survey will not be associated with the completed survey. The data will then be placed into spreadsheets for analysis. As the survey will contain both numerical and categorical information a combination of different analysis techniques will be required. There are several different ways in which the data can be analyzed. To ensure maximum applicability and utility of the collected data it is important that the data be properly reported. As such previously published methods for analysing qualitative data will be applied . As well for quantitative data all information will be subjected to statistical analysis. The type of test will be determined by the data set. IF the data is normally distributed than parametric tests will be utilized, or alternatively if it is not normally distributed then non-parametric statistically methods will be employed. Plots and graphs will be generated and trends surrounding the storage conditions and the source of the dairy and how this correlates to risk of foodborne illness will be determined. To further help with statistical analysis a recent publication on considerations for how to analyze complex health survey data will be followed .
As this survey is seeking to identify potential sources of foodborne illness it is possible that one company may be identified as be associated with a higher risk of foodborne illness. However, it is important to remember that this data is correlative and not definitive. The identified companies should not be blamed, but instead should be approached and asked to participate in a new research study in order to help determine if there are specific characteristics that can be improved to reduce foodborne illness. It is likely that this proposed research study will generate new avenues of research and may help to discover ways to improve the safety of raw milk consumption.
Ethical Considerations
As with any time of research study there are several different ethical considerations which must be addressed. First before starting the project, appropriate ethical approval must be obtained from the governing regulatory body. Furthermore, to ensure patient privacy no identifying information will be present on the survey. Each survey will not contain the names or addresses of the individual and therefore will be anonymous. In the case of patients which have been positively identified as having foodborne illness a patient number will be assigned to protect their privacy. No identifying patient information will be published and the final results will bear no indication as to the identity of the individual patients.
Timeline
Recruitment for the first phase of the project will take place of the course of one month. Individuals will be given two weeks to fill out the survey. Following which a follow-up call will be placed, and an additional week will be given. For the second part of the project recruitment of individuals with foodborne illness will take place of a period of six months. Health professionals will be asked to provide the individual with information on the study to see if they are willing to participate in the study. After all of the surveys have been completed, imputing of the paper based surveys and subsequent analysis will take place in the following one to two months. Total time for the project will be around 8 months. However, if there are problems with recruiting then an extra two to four months may be necessary to ensure an adequate sample size.
Budget
The main budgetary requirements for this survey is that of a coordinator and funding for the survey software and analysis software. Based on previous values it is likely that the total cost of this project will be around $10,000-$20,000. The bulk of this cost will be for wages for individuals to recruit, follow-up and analyze the data. However, delays or problems with recruitment could also increase the cost and therefore an extra $5,000, a total of $25,000, is requested for additional unpredictable expenses.
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