Epidemiology in the News: Randomized Trials, Research Paper Example

The article I selected for this discussion is entitled “Metabolic Effects of Bariatric Surgery in Patients With Moderate Obesity and Type 2 Diabetes” and can be retrieved from the following link:http://care.diabetesjournals.org/content/36/8/2175.short (Kashyap et al., 2013). This study is an example of a randomized control trial that intended to determine which metabolic effects present in patients who receive bariatric surgery that have also been diagnosed with moderate obesity and type 2 diabetes. The goal of this study is to gain a more comprehensive understanding of the effects of two different bariatric procedures on beta cell function.

The trial utilized 60 subjects with uncontrolled type 2 diabetes. These patients were randomized to three different study groups, including intensive medical therapy (IMT) alone, IMT plus Roux-en-Y gastric bypass, or IMT plus sleeve gastrectomy. Beta cell function was tested through mixed-meal tolerance testing. Measurements were taken at baseline, twelve months following the procedure, and twenty-four months following the procedure. Outcome was measured by comparing the beta cell function between the baseline measurement and the two follow-up measurements. The study found that all three methods of surgery were effective because the glycemic control improved in all three groups at the twenty-four month measurement. Overall, it was concluded that “bariatric surgery provides durable glycemic control compared with intensive medical therapy at 2 years” (Kashyap et al., 2013).

There are many ethical issues associated with this study. While there has not been a study before this one that has allowed researchers to compare all three surgery methods, it is necessary to consider that on many occasionally, two of the three have been compared. Therefore, this study may have not been needed. Rather, a systematic review of prior studies that compare these methods could have been discussed to determine the best way to treat obesity in patients with type 2 diabetes.

An additional ethical concern is an intrinsic factor of the study design selected. Most importantly, it is difficult to determine what the standard of care or control is in this specific setting. It is clear that three different treatments are compared, but there is no real understanding of which treatment should be treated as the control. Therefore, it is difficult to analyze this data in terms of normal statistical calculations in order to gain an understanding of all three processes. While an ANOVA can be used to determine whether the impact of the three treatments cause the beta cell function to vary, it may not be possible to conclude which treatment method is the best as a result.

Despite these problems, the study did benefit from its randomized design. This allowed approximately 20 patients to be assigned to each of the experimental groups in a manner that did not account for their demographic and health characteristics. As a consequence of this randomization, it can generally be assumed that these characteristics have been evenly dispersed across all three trial groups. Furthermore, this randomized prevented both the researchers and patients from allowing bias to confound the study, as physicians were not able to refer their patients to specific groups and the patients were not given the ability to note a treatment preference. This study allowed an equal comparison between the three study groups to be more meaningful because this limits the presence of factors that could bias the relationship being examined.

References

Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, Abdul-Ghani M, Abood B, Pothier CE, Brethauer S, Nissen S, Gupta M, Kirwan JP, Schauer PR. (2013). Metabolic Effects of Bariatric Surgery in Patients With Moderate Obesity and Type 2 Diabetes. Diabetes Care, 36(8): 2175-2182.