DISCUSSION: RANDOMIZED TRIALS IN EPIDEMIOLOGY

DISCUSSION: RANDOMIZED TRIALS IN EPIDEMIOLOGY

DISCUSSION: RANDOMIZED TRIALS IN EPIDEMIOLOGY

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RANDOMIZED TRIALS IN EPIDEMIOLOGY

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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.

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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.

Be sure to review the Learning Resources before completing this activity. Click the weekly resources link to access the resources.

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?

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.

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.

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Serena Valino
(https://waldenu.instructure.com/courses/104567/users/72367)
12:07pm
Article SMS SOS: a randomized controlled trial to reduce self-harm and suicide attempts using SMS text me
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Article
SMS SOS: a randomized controlled trial to reduce self-harm and suicide attempts using SMS text messaging.
Purpose
To examine if supportive text messages that were delivered to patients after hospitalization for deliberate self- harm (DSH) reduced the likelihood of readmissions.
Study population.
To be eligible for the study, participants must have been assessed in the emergency department(ED) after presenting with DSH, were at least 16 years old, were English literate, and had access to a mobile phone.
The study took place at three large public hospitals within Western Sydney: Nepean, Blackton, and Westmead Hospital.
Length of the trial
24 months recruitment and 12 months follow-up.
Data collection methods
Both the control group as well as the study group received the typical services a patient who was admitted with DSH might receive in Australia. Typical services that would be offered consist of a hospital or community mental health worker contact within 24 hrs of hospitalization and follow-up care programming which can include mental health, drug/alcohol, and/or general practitioner follow-up.
The study group would receive supportive text messages at 48 hrs, 7 days, 15 days, and then monthly for 12 months after they presented to the ED with DSH. The control group would not receive any text messages.
Patient data was collected when the patient first presented with DSH or at subsequent presentations that would allow researchers to access clinical diagnosis, birthdates, residence, marital status, etc. Patient data was then placed into a colored envelope (green for subsequent admissions and blue for initial presentation). Clinicians would then randomly select a numbered envelope which would determine if the patient was placed into the control group vs the study group.
Outcome measures

Researchers would review the patient’s medical record at 6- and 12-months post DSH discharge to determine the number of times the patient was hospitalized for DSH (after the initial presentation) and if readmitted, how long after DSH discharge the patient readmitted with DSH. Should the patient have died during the study, researchers would use information from the NSW Health, the Center for Health Record Linkage, and other Australian government agencies to determine if the morality was attributed to suicide or something else.
Results and conclusions
There is a 15% re-admission rate for DSH in the following 12 months after admission and a probability survival rate of 0.85% for the group that did not receive supportive text messages (Stevens et al., 2019). The median survival time in the study group was 121.8 days compared to the 73.5 days of the control group(Stevens et al., 2019). The total sample use would be 138 participants (69 in the control group and 69 in the study group), 5% significance, 80% power, and 10% adjustment for correlation of individuals within the hospital (Stevens et al., 2019)
SMS falls into the brief contact interventions (BCI) which have been clinically proven to be effective and affordable ways to reduce hospital re-admission rates from DSH (Stevens et al., 2019). The preferred line of communication with younger individuals (the high-risk group) is text messaging and this study provides an innovate way/cost-effective way of getting a suicidal patient the help that they need.
Ethical issues associated with the study.
The study received approval from the Western Sydney LHD Human Research Ethics Committee and was registered with the Australian and New Zealand Clinical Trials Registry. This study mirrored a previous longitudinal study that took place at a similar Australian Hospital which found a 1% suicide rate after 24 months and a nearly 2% suicide rate after 5 years(Stevens et al., 2019). Therefore, this study was low risk and high reward as the message content that was forwarded to the study participants was not only uplifting but also provided an avenue (crisis hotline number) in which the patient could get help if in crisis.
The randomization and selection process offered participants the opportunity to maintain their privacy but to also be selected to receive a new intervention/service that could prolong their life.
References
Stevens, G., Hammond, T., Brownhill, S., Anand, M., Riva, A., Hawkins, J., Chapman, T., Baldacchino, R., Michallef, J.-A., Andepalli, J., Kotak, A., Gunja, N., Page, A., Gould, G., Ryan, C., Whyte, I., Carter, G., & Jones, A. (2019). SMS SOS: a randomized controlled trial to reduce self-harm and suicide attempts using SMS text messaging. BMC Psychiatry, 19(117). https://link.springer.com/article/10.1186/s12888-019-2104-9 (https://link.springer.com/article/10.1186/s12888-019-2104-9)

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