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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.
Resources
Be sure to review the Learning Resources before completing this activity.
Click the weekly resources link to access the resources.
· Curley, A. L. C. (Ed.). (2024).
Population-based nursing: Concepts and competencies for advanced practice (4th ed.). Springer.
· Chapter 2, “Identifying Outcomes in Population-Based Nursing” (pp. 20-38)
· Friis, R. H., & Sellers, T. A. (2021).
Epidemiology for public health practice (6th ed.). Jones & Bartlett.
· Chapter 8, “Experimental Study Designs”
· Goldstein, C. E., Weijer, C., Brehaut, J. C., Fergusson, D. A., Grimshaw, J. M., Horn, A. R., & Taljaard, M. (2018).
Ethical issues in pragmatic randomized controlled trials: A review of the recent literature identifies gaps in ethical argumentationLinks to an external site..
BMC Medical Ethics,
19(1), Article 14.
· Walden University Office of Research and Doctoral Services. (n.d.).
Developing researchLinks to an external site.
.
Examples of Studies Utilizing Experimental and Quasi-experimental Study Designs
These studies should be used as informative examples. Please locate another article on your own to use for the Discussion.
· Hooshmand, M., & Foronda, C. (2018).
Comparison of telemedicine to traditional face-to-face care for children with special needs: A quasiexperimental study.
Telemedicine Journal and E-health: The Official Journal of the American Telemedicine Association,
24(6), 433–441.
· Sawyer, A., Kaim, A., Le, H.-N., McDonald, D., Mittinty, M., Lynch, J., & Sawyer, M. (2019).
The effectiveness of an app-based nurse-moderated program for new mothers with depression and parenting problems (eMums Plus): Pragmatic randomized controlled trialLinks to an external site..
Journal of Medical Internet Research,
21(6), e13689.
· Dennis, C. L., Grigoriadis, S., Zupancic, J., Kiss, A., & Ravitz, P. (2020).
Telephone-based nurse-delivered interpersonal psychotherapy for postpartum depression: Nationwide randomised controlled trialLinks to an external site..
The British Journal of Psychiatry,
216(4), 189–196.
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.
By Day 6 of Week 4
Respond to
at least two colleagues on
two different days in one or more of the following ways:
· Ask a probing question, substantiated with additional background information, evidence, or research.
· Share an insight from having read your colleagues’ postings, synthesizing the information to provide new perspectives.
· Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library.
· Validate an idea with your own experience and additional research.
· Make a suggestion based on additional evidence drawn from readings or after synthesizing multiple postings.
· Expand on your colleagues’ postings by providing additional insights or contrasting perspectives based on readings and evidence.
RESPOND TO THIS POST
Trace
Week 4: Initial Post
This week we shift our focus from observational to experimental study designs. In Hematology Oncology experimental designs are typically used to analyze efficacy and safety. Friis and Sellers (2021) explain that when humans are utilized to evaluate the effects of a treatment, experimental studies tend to carry more weight than observational studies. This discussion will provide a critical analysis of a peer reviewed, randomized controlled trial (RCT) that leverages social media to increase lung cancer screening awareness,
knowledge and uptake among high-risk populations called The INSPIRE-Lung Study.
The study can be accessed:
to an external site.
Purpose
While lung cancer continues to come in third among the most common types of cancer in the United States, it has a persistent lead for the highest mortality (Centers for Disease Control and Prevention, 2025). Early detection through lung cancer screening has shown to be effective, but still not widely adopted in the United States. This paper acknowledges that despite Medicare and Medicaid agreeing to cover Low Dose CT Scans (LDCT), the rates of screening for eligible individuals is at less than five percent (Carter-Bawa et al., 2023). Here the authors seek to determine if increasing awareness through social media will increase lung cancer screenings and ultimately deccrease the mortality rate.
Investigation Layout and data collection
The research team utilized a facebook-targed advertisement (FBTA) across 5 states that had the highest smoking rates and most diverse populations to recruit 500 trial participants. The participants were randomized 1:1and placed in a cohort to receive tailored health communication and decision support versus a non-tailored health communication, both delivered online (Carter-Bawa et al., 2023). The study population was comprised of people who were 50-80 years old with a more than 20-pack year history.
Data collection took place over a 6-month period. Participants were initially asked about their smoking status and received tailored questions. They were provided a video on lung cancer screening and then asked about perceived barriers to screening, this prompted an educational video showing how to overcome the specific barriers (Carter-Bawa et al., 2023). In contrast the control arm, receives a non-tailored video about lung cancer screening to serve as an attention control condition for the nonspecific effects of intervention by balancing attention, treatment effects, and delivery methods (Carter-Bawa et al., 2023).
Facebook analytics was utilized to collect quantitative data such as how many people were reached by the ads, calculated link clicks, and impressions. Descriptive statistics were used to examine the quality of data that had been broken down by age, smoking status, gender, geography, and stage of adoption to lung cancer screening.
Findings
Researchers predict that the tailored reach group will have a 30% increase in
Researchers predict that the tailored reach group will have a 30% increase in lung cancer screening where the non-tailored group will have a 10% increase in screening (Carter-Bawa et al., 2023). Increasing knowledge regarding who should undergo lung cancer screening, minimizing inaccurate information about screening, and addressing barriers will ultimately increase the number of eligible people to get screened for lung cancer.
Ethical Issues
Ethical concerns should be taken into consideration for all studies. Here the researchers mentioned targeting a population that spans over five states that not only have the highest smoking history but are also diverse. Yet they exclude all considered participants that do not speak English. Also, the researchers target participants that are more than 50 years old, but the CDC (2025) shows a rising number of lung cancer cases at a younger age. Another ethical concern is the amount of lung cancer screenings that can come out of a
localized study that have the potential to overwhelm the associated healthcare systems.
This research design was made widely accessible by utilizing a broad social media platform and allowing all the data to be collected and accessed electronically. The study highlights the need to integrate modern technology and platforms into our outreach. Through the uptick in lung cancer screenings, it is possible to see a decline in mortality.
References
Carter-Bawa L, Banerjee SC, Comer RS, Kale MS, King JC, Leopold KT, Monahan PO, Ostroff JS, Slaven JE, Valenzona F, Wiener RS, & Rawl SM. (2023). leveraging social media to increase lung cancer screening awareness, knowledge and uptake among high-risk populations (The INSPIRE-Lung Study): study protocol of design and methods of a community-based randomized controlled trial.
BMC Public Health,
23(1), 975.
to an external site.
Centers for Disease Control and Prevention. (n.d.).
Lung cancer statistics. U.S. Department of Health & Human Services. Retrieved March 19, 2025, from
to an external site.
Friis, R. H., & Sellers, T. A. (2021).
Epidemiology for public health practice (6th ed.). Jones & Bartlett.
