Randomized Trials In Epidemiology

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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    We are a professional custom writing website. If you have searched for a question and bumped into our website just know you are in the right place to get help with your coursework.

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    • Discussion Questions (DQ)

    Initial responses to the DQ should address all components of the questions asked, including a minimum of one scholarly source, and be at least 250 words. Successful responses are substantive (i.e., add something new to the discussion, engage others in the discussion, well-developed idea) and include at least one scholarly source. One or two-sentence responses, simple statements of agreement or “good post,” and responses that are off-topic will not count as substantive. Substantive responses should be at least 150 words. I encourage you to incorporate the readings from the week (as applicable) into your responses.

    • Weekly Participation

    Your initial responses to the mandatory DQ do not count toward participation and are graded separately. In addition to the DQ responses, you must post at least one reply to peers (or me) on three separate days, for a total of three replies. Participation posts do not require a scholarly source/citation (unless you cite someone else’s work). Part of your weekly participation includes viewing the weekly announcement and attesting to watching it in the comments. These announcements are made to ensure you understand everything that is due during the week.

    • APA Format and Writing Quality

    Familiarize yourself with the APA format and practice using it correctly. It is used for most writing assignments for your degree. Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for APA paper templates, citation examples, tips, etc. Points will be deducted for poor use of APA format or absence of APA format (if required). Cite all sources of information! When in doubt, cite the source. Paraphrasing also requires a citation. I highly recommend using the APA Publication Manual, 6th edition.

    • Use of Direct Quotes

    I discourage over-utilization of direct quotes in DQs and assignments at the Master’s level and deduct points accordingly. As Masters’ level students, it is important that you be able to critically analyze and interpret information from journal articles and other resources. Simply restating someone else’s words does not demonstrate an understanding of the content or critical analysis of the content. It is best to paraphrase content and cite your source.

    • LopesWrite Policy

    For assignments that need to be submitted to Lopes Write, please be sure you have received your report and Similarity Index (SI) percentage BEFORE you do a “final submit” to me. Once you have received your report, please review it. This report will show you grammatical, punctuation, and spelling errors that can easily be fixed. Take the extra few minutes to review instead of getting counted off for these mistakes. Review your similarities. Did you forget to cite something? Did you not paraphrase well enough? Is your paper made up of someone else’s thoughts more than your own? Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for tips on improving your paper and SI score.

    • Late Policy

    The university’s policy on late assignments is a 10% penalty PER DAY LATE. This also applies to late DQ replies. Please communicate with me if you anticipate having to submit an assignment late. I am happy to be flexible, with advance notice. We may be able to work out an extension based on extenuating circumstances. If you do not communicate with me before submitting an assignment late, the GCU late policy will be in effect. I do not accept assignments that are two or more weeks late unless we have worked out an extension. As per policy, no assignments are accepted after the last day of class. Any assignment submitted after midnight on the last day of class will not be accepted for grading.

    • Communication

    Communication is so very important. There are multiple ways to communicate with me: Questions to Instructor Forum: This is a great place to ask course content or assignment questions. If you have a question, there is a good chance one of your peers does as well. This is a public forum for the class. Individual Forum: This is a private forum to ask me questions or send me messages. This will be checked at least once every 24 hours.

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