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Randomized Trials in Epidemiology

 Imagine that researchers are conducting a randomized controlled trial of a high-fiber supplement as a preventive measure in persons at increased risk of type 2 diabetes. People enrolled in the study are disease free at the time they agree to participate in the trial, but they all have a family history of type 2 diabetes and are considered at high risk (80%) to develop the disease during their lifetime. The 10,000 participants who start the trial are healthy individuals who are randomly allocated to receive either high-fiber supplements or placebo for several years. As you can imagine, this study will be quite expensive and will require a large infrastructure of personnel and materials to carry it out successfully. 

 

Because type 2 diabetes has reached epidemic proportions in the United States, the potential benefits of this research are important at a population level. Unfortunately, high-fiber supplements have also been shown in a few studies to be associated with gastrointestinal blockage (which can be life-threatening) and reduced nutrient absorption, which may lead to anemia, osteoporosis, and other debilitating chronic diseases. The supplements may also reduce absorption of certain medications and cause gastrointestinal distress. The potential side effects of continuous high-fiber supplementation are only partially understood, and long-term effects are unknown.

For this Discussion, you are asked to identify an example of an experimental study design in the literature and consider the ethical implications of the randomized controlled trial design.

To prepare:

  • Search databases in the Walden Library and locate a peer-reviewed article from the last 5 years that uses a randomized controlled trial study design. The subject of the study may be any topic professionally relevant or interesting to your practice. You may not select an article already posted by one of your colleagues for this Discussion. (Tip: When searching, you may use randomized trial as one of your search phrases.)
  • Critically analyze the following aspects of the research study:
    • Purpose
    • Study population
    • Length of the trial
    • Data collection methods
    • Outcome measures
    • Results and conclusions
    • Ethical issues associated with the study
  • Ask yourself: How did this research study benefit from its experimental design? What was achieved by randomization that might not otherwise have been achieved?
By Day 3 of Week 4

Post a cohesive scholarly response that addresses the following:

  • Summarize the research study addressing the aspects bulleted above.
  • Identify and discuss the ethical issues associated with this study.
  • Be sure to include a link to the article in your post.

 

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