Back to Week at a Glance
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
·
DENISE
·
·
Evaluating the PRO-P Trial Design Summarized
· I examined the PRO-P study by Al-Monajjed and colleagues (2024), which investigates how electronic symptom tracking might benefit prostate cancer patients after surgery.
·
Study Summary
· The researchers designed this randomized controlled trial to see if electronic patient-reported outcome (ePRO) monitoring improves quality of life for men recovering from prostate surgery. Their hypothesis makes intuitive sense—if doctors can spot complications earlier through digital monitoring, patients should experience better recovery.
· The study will include 430 men preparing for radical prostatectomy across multiple German hospitals. I appreciate that they’ve set clear eligibility requirements—participants need to be adults who can provide informed consent, understand German, and use the necessary technology. Each man will be followed for 6 months after surgery, with checkpoints before the procedure, at discharge, and at 1, 3, and 6 months afterward.
· The data collection approach is straightforward but effective. Both groups complete the same electronic questionnaires about their symptoms and wellbeing, but only the intervention group’s responses trigger alerts to healthcare providers when symptoms appear. Their primary goal is measuring quality of life at the 6-month mark using a standardized questionnaire, along with tracking several secondary outcomes like symptom severity and healthcare utilization. Since this is only a protocol paper, we don’t have results yet, but the research team expects electronic monitoring to lead to better
· symptom management and recovery experiences.
· Ethical Considerations
· I was astonished by how thoroughly the researchers addressed ethical concerns. As Goldstein et al. (2018) recommend for such trials, they obtained proper ethics committee approval and implemented comprehensive informed consent procedures. Both groups receive standard medical care, maintaining what researchers call “clinical equipoise,” with the intervention group receiving additional monitoring. They’ve also taken steps to protect patient data.
· I question the potential access disparities. The technology requirements might unintentionally exclude older patients or those less comfortable with digital tools. There’s also the question of whether withholding potentially beneficial monitoring from the control group raises ethical concerns, though this is an inherent challenge in many clinical trials.
· Benefits of Experimental Design
· What makes this study particularly valuable is its randomized controlled design. As Friis and Sellers (2021) explain, randomization allows researchers to determine if the electronic monitoring causes improvements. By randomly assigning patients to groups, factors like age, disease severity, and technological comfort are distributed evenly.
· Without this random assignment, the results would be far less reliable—tech-savvy patients might naturally gravitate toward the electronic monitoring option, skewing outcomes. The randomized approach ensures that any improvements in recovery can be credited to the monitoring system itself rather than pre-existing differences between patients.This methodically designed study could provide healthcare providers with evidence they need to implement electronic symptom monitoring as a standard practice in prostate
· cancer care.
· The article can be accessed at:
Links to an external site.
· References
· Al-Monajjed, R., Albers, P., Droop, J., Fugmann, D., Noldus, J., Palisaar, R.-J., Ritter, M., Ellinger, J., Krausewitz, P., Truß, M., Hadaschik, B., Grünwald, V., Schrader, A.-J., Papavassilis, P., Ernstmann, N., Schellenberger, B., Moritz, A., Kowalski, C., Hellmich, M., & Karger, A. (2024). PRO-P: Evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial. Trials, 25(1), Article 754.
Links to an external site.
· Friis, R. H., & Sellers, T. A. (2021). Epidemiology for public health practice (6th
· ed.). Jones & Bartlett.
· 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 argumentation. BMC Medical Ethics, 19(1), Article 14.
Links to an external site.
·
Reply
