A randomized clinical trial, referred to as the University Group Diabetes Progra

Question

A randomized clinical trial, referred to as the University Group Diabetes Program (UGDP) was performed to evaluate different methods of treatment of diabetes. The principle features of this clinical trial included the establishment a common protocol for the collection of comparable data, random allocation of patients to treatment groups, the inclusion of a comparable placebo treated group, double blind evaluation of the oral drugs, long term observation of patients, and central collection, editing, and monitoring of the study data. The selected for the UGDP had non-insulin dependent diabetes mellitus (NIDDM) and did not require insulin to remain symptom free. This type of diabetes constitutes the majority (over 90%) of the US diabetic population. Based on the results observed, the researchers reached the following conclusions: (a) Insulin is no more effective than diet alone in prolonging life among patients with NIDDM. (b) Diet plus tolbutamide (the most commonly used oral hypoglycemic agent) is no more effective than diet alone in prolonging life among patients with NIDDM. (c) There is a statistically significant excess of cardiovascular deaths among tolbutamide group (n=50) compared with the placebo group (n=50).(1) What was the goal of this study? (2) Was this a well designed study? List 5 steps taken that suggest it was ('nt) a good study. (3) Can the results conclusions reached be generalized to the US population? Why or why not? (4) Why was randomization essential for this study? What did it accomplish?

Explanation / Answer

Answer to questioN# 1)

The goal of the study was to evalaute different methods of treatments of diabetes

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Answer to question# 2)

Yes it a well desinged study.

The five points are enlisted below:

1. This design is to find the effectiveness of the treatment , in such a case included a placebo is the study is must

The study includes a placebo.

2. The design ensures that the patients are randomly assigned to the groups , to ensure bias-free study

3. It is a double blind study , which helps exclude any bias from the side of Examiner

4. Selection of data is done using a common protocol for all the comparable data

5. Since finding the fact whether the impact of disease has decreased or not is a long process , gradual process, the study surely demands a long time observation. As is mentioned above this study has taken car eo fthis point aas well by conducting long term observational study.

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Answer to question# 3)

The study concerns to 90% of the population , thus yes the results can be generalised to the US population

Reason: The research relates to the 90% of the entire US population. Hence any conclusion drawn from the study relates to majority of the US population, thus allowing us to generalize the results of the study.

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Answer to question# 4)

we need to select patients for different groups , in order to make them comparable it is really important to ensure that all the groups are same. It is not that one sort of patients formed one group , and a different set of patients formed second group. In such a scenario it would not be possible to compare two different groups. In order to make the groups comparable it is necesaary to ensure that all the groups are same and it consists of patients selected on a purely random basis.

This helps in getting the accurate outcomes for the main concern of the question , and definitely helps avoid any ind of biasedness generated due to the different types of groups.

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