Week 4: Analytic Epidemiology Designs: Experimental

In the fall of 2011, the FDA announced a shortage of important chemotherapy drugs; this shortage, in turn, disrupted clinical trials and led to potential challenges in assessing data from those studies. Experimental research, which includes clinical trials, plays a pivotal role in the advancement of disease prevention and treatment. Once a risk factor has been established, the next step is testing an intervention through experimental research methods. Does this drug actually prevent or ameliorate symptoms?

In Week 3, you examined observational study designs, an important form of analytic epidemiology. This week, the focus turns to experimental studies. As you explore this topic, think about why experimental research is considered the “gold standard” of epidemiology. You will also begin developing Assignment 2 (Sections 1 and 2 of Major Assessment 7) and consider which research design will best address your selected population health problem.

Learning Objectives

Students will:

· Analyze a randomized controlled trial research study

· Analyze ethical issues with a randomized control trial study

· Evaluate epidemiologic study designs to answer a population health study question

· Evaluate the strengths and limitations of health data sources to answer a population health study question

· Determine primary data collection methods for a specific population health problem

  

Learning Resources

Required Readings

Friis, R. H., & Sellers, T. A. (2021). Epidemiology for public health practice (6th ed.). Jones & Bartlett.

• Chapter 8, “Experimental      Study Designs”

This chapter examines experimental and quasi-experimental study designs.

Milligan, K., Niccols, A., Sword, W., Thabane, L., Henderson, J., Smith, A., & Liu, J. (2010). Maternal substance use and integrated treatment programs for women with substance abuse issues and their children: A meta-analysis. Substance Abuse Treatment, Prevention & Policy, 5, 21–34.

This article examines programs that integrate substance abuse treatment and pregnancy, parenting, or child services. The authors conclude that there is a need for funding of high-quality randomized control trial and improved reporting practices. This article also demonstrates the application of analytic research designs to explore a population health problem.

Stead, L. F., Koilpillai, P., Fanshawe, T. R., & Lancaster, T. (2016). Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database of Systematic Reviews, (3). doi:10.1002/14651858.CD008286.pub3

The authors examine how both behavioral support and pharmacotherapies can be effective in helping people to stop smoking. By adopting a randomized or quasi-randomized controlled trial, the authors are able to evaluate whether such combinations of pharmacotherapy and behavioral support compared to receiving usual care or brief advice assists individuals in smoking cessation.

Physicians’ Health Study (2010). Retrieved from http://phs.bwh.harvard.edu/

 

This large-scale, randomized clinical trial that began in 1982 was designed to test the effectiveness of aspirin and beta carotene in preventing heart attacks (myocardial infarctions, or MIs) in male physicians aged 40–84. The first phase of the trial, which included more than 22,000 study subjects, demonstrated that low-dose aspirin does, in fact, reduce the risk of a first MI by 44%. This article provides a good example of the types of large-scale studies conducted using epidemiologic principles that lead to improved population health.

 

Wang, Z., Lapinski, M., Quilliam, E., Jaykus, L. A., & Fraser, A. (2017). The effect of hand-hygiene interventions on infectious disease-associated absenteeism in elementary schools: A systematic literature review. American Journal of Infection Control, 45(6), 682-689.

Required Media

Laureate Education (Producer). (2012). Epidemiology and population health: Experimental studies [Video file]. Baltimore, MD: Author.

Note: The approximate length of this media piece is 5 minutes.

In this program, the presenters discuss experimental studies, including the effect of randomization and blinding on study results.

Accessible player  –Downloads– Download Video w/CC Download Audio Download Transcript 

Optional Resources

Groopman, J. (2006, December 18) Medical dispatch—The right to a trial: Should dying patients have access to experimental drugs? New Yorker, 82(42), 40–47.

Dorak, M. T. (2006). Epidemiologic study designs [PowerPoint presentation]. Retrieved from http://www.dorak.info/epi/design.ppt

 

Alexander, L., Lopes, B., Ricchetti-Masterson, K., & Yeatts, K. B. (2018). Randomized controlled trials. ERIC Notebook Periodical Second Edition No. 10. Retrieved from https://nciph.sph.unc.edu/tws/HEP_ERIC10/certificate.php

  

Discussion 1: Epidemiology in the News: Randomized Trials

According to the Centers for Disease Control (CDC), asthma is a leading chronic illness in children ages 5 to 17, a leading cause of school absenteeism, and the third highest cause of hospitalizations in children younger than 15 (2011). The costs associated with treating this chronic illness are high.

A number of randomized control trials have examined the effect of instituting a home management program for treating asthma in combination with pharmaceuticals. These studies found that, by implementing a structured home management program, the morbidity, severity, and frequency of asthmatic episodes were reduced (Agrawl, Singh, Mathew, & Malhi, 2005). Recent research is also exploring how and when to cut back on levels of medication as asthma episodes become controlled, further reducing the cost of this chronic illness; however, controversy remains over the long-term effects of reducing levels of medication due to the disparateness of asthma (Rogers & Reiberman, 2012).

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

To prepare:

· Search the Internet and credible websites to locate a news piece or article that features a randomized trial study design. The article should be from a widely distributed news source, accessible to and written for a lay audience. Possible sources include, but are not limited to, online magazines, online newspapers, and health news websites. Be sure to include a link to the article in your posting. You may not select an article already posted by one of your colleagues for this Discussion.

· Critically analyze the following aspects of the research study:

o Purpose

o Study population

o Length of the trial

o Data collection methods

o Outcome measures

o Results and conclusions

o Ethical issues associated with the study

· Ask yourself: How did this research study benefit from its randomized design? What was discovered by randomization that might not otherwise have been demonstrated?

By Day 3

Post a cohesive scholarly response that addresses the following:

· Summarize the research study addressing the aspects bulleted above. In your posting, provide a link to the article you selected.

· Identify and discuss the ethical issues associated with this study.

Write 2 pages in APA and cite at least 5 sources of the given sources