Suggested Discussion Questions: Evaluate the internal and external validity of this study. Which, if any, would give pause to medical researchers? Which might be of concern to the cereal manufacturer? To a potential consumer considering trying the product for the first time? Has the study been set up in a way to allow reasonably powerful statistical analysis? Consider in particular the demographics of the participants, the measures taken on each, the overall sample size, and the time frame for the study. Which among these (or other aspects of the study) seems most in need of improvement? How might you go about doing so? Is it a proper use of this research to make health claims for All-Bran cereal? Why or why not? If not, what sort of claims might be ethically reasonable, given the course of research? --------- The following are answers to the questions of case study "Kellogg’s". Please write discussion response to the following posts, 200 words for each posts. post 1: 2. This study has been set up in a way that there can be reasonably powerful statistical analyses drawn from it. Descriptive statistics can be performed on the respondents themselves, giving a background of each participant and their eating/dietary habits before and during the study. The mean, median, and mode can all give information on where participants are among their peers, with things like cholesterol levels, blood pressure, BMI, overall weight, exercise amounts, and so on. Inference analysis can be done on the hypothesis of "does grain psyllium decrease blood cholesterol levels?" There can also be difference analysis performed on the placebo and active medication groups, with their cholesterol levels. The study was conducted on 75 people, ages 24-68, 38 men and 37 women, all with 50-90th percentile cholesterol levels. There are some difference analyses that can be done just between the two groups in the sample, men and women. There can be analyses done on who has the higher average cholesterol level, the higher body mass, and the most fluctuation of; blood pressure, body weight, and other measures during the study. On what needs improvement, I believe that it would be beneficial to do a study of all men, and one of all women, to further investigate whether or not there are major differences in how the two genders adapt to a new diet with higher fiber. There could also be a study done where there is no 12 week diet before the study begins, just a jump right to taking the medication, to see if the change in diet is what actually caused the decrease in cholesterol. The bigger sample size that is taken, the smaller the error is for the study, so I suggest grabbing a higher amount of people for the first step of the study, so that there are in turn more people for the later steps, after the participants who can't adhere to the diet are weeded out. 3. If the study has been completed more than once, so that it is confirmed and valid, then Kelloggs can use it to make health claims for All-Bran cereal. According to the study, psyllium reduced the amount of cholesterol in the bloodstream of the participants who were taking it, with a regular diet. If this is true, that means that Kelloggs can assume that All-Bran will do the same for other people who regulate their diet and intake of cholesterol raising foods. --------------------------------------------------------------------------- post 2: #2 I think the study has been set up properly with good statistical analysis. All the participants had to meet certain requirements. The cholesterol levels were adjusted for age and sex. The participants could not have any medications in their blood stream, and ideal weight which could not vary more than 5% during the study. The mean, mode, and median can be calculated on the participants of this study. Inference analysis can be done on the main question of the study "Does the effect of taking Psyllium as an adjunct to a low-fat diet lower cholesterol levels in patients? The sample size should be increased. The results of this study with only seventy-five participants could possible affect people's health. It is a good start, but a lot more research would need to be done. Also, will the medication work if the participant gains more than 5% of their body weight. The time frame of this study appeared to be sufficient. The longer a medical study lasts, the chances of the respondents to follow the directions decreases. This is especially true when respondents are continuously asked to give blood samples, keep an ideal weight, and take a certain medication or a placebo. #3 I am not totally in agreement that this is a proper use of research to make health claims for All-Bran cereal. It seems that a study involving only 75 patients is not enough to make such a claim that Psyllium can reduce cholesterol in humans by 4.2-4.8%. There have been other studies published that eating a diet high in bran fiber can be associated with a decreased risk in cholesterol. This would also help Kellogg to convince the public. Ethical considerations in research are critical. When a company makes claims on medical research, the company better make sure there is not a possibility that a human subject could develop medical health issues by following the results of a study. I do believe the University of Minnesota have established an Institutional Review Board who insured the safety of participants in this research study, and to make sure their human rights have not been violated. These types of research studies can create other ethical issues. Kellogg most likely reported their results to the press. This gives the cereal company additional publicity they want to sell more All-Bran cereal., Some questions to consider would be: Did the company report any negative results of the study? Did any of the participants get ill from the study? Did the public hear only the positive results of the study? Did the researchers select a city they felt would have favorable results?