Kibata

Sign In

Our Services

Get 15% Discount on your First Order

Order Now
[rank_math_breadcrumb]

need a response

please respond ro the discussion post attached. Follow the instructions and rubric.

Randomized Controlled Trial Example and Ethical Analysis

Article selection and criteria confirmation

The article I have chosen is a peer-reviewed journal and a pilot, placebo-controlled randomized clinical trial published in the British Journal of Nutrition in April 2024. The paper explicitly describes a parallel-arm, single-blinded, randomized, placebo-controlled, design (Hall et al., 2024).

Article link


Links to an external site.
  

Study summary

Purpose

The purpose was to evaluate whether a “diverse prebiotic fibre supplement” enhances glycaemic, lipid, and inflammatory biomarkers in prediabetic adults in which HbA1c is the main endpoint.

Study population

The participants were men and postmenopausal women diagnosed with prediabetes (HbA1c 5.8% 6.5%) who were not taking glucose-lowering medications; the main exclusion criteria were the use of a weight-loss program and recent diabetes drugs (Hall et al., 2024).

Length of the trial

The recommended duration of the supplement was 16 weeks (the primary endpoint timepoint), with an exploratory extension up to week 24, and the clinic visits were conducted at the baseline, week 16, and week 24.

Data collection methods

The data was gathered by means of fasting clinic measurements, namely blood pressure, fasting blood tests, and oral glucose tolerance test (OGTT) protocol (with timed blood sample of glucose and insulin); the inflammatory cytokine and standard metabolic laboratory measurements were taken with the help of the developed laboratory platforms (Hall et al., 2024).

Outcome measures

The key outcome was a change in HbA1c between baseline and week 16; the secondary outcomes were insulin sensitivity (ISI-OGTT), fasting plasma insulin, lipids, inflammatory markers (for example, CRP, IL-6, TNF-α), and blood pressure.

Results and conclusions

Sixty-six participants were randomized (33/33), and the intervention was well tolerated without any major adverse events related to it; HbA1c did not differ significantly overall at week 16, but individuals with lower baseline HbA1c (<6.0%) had statistically significant HbA1c reduction, and the entire cohort had improvements in insulin sensitivity and CRP compared to placebo (Hall et al., 2024). The authors concluded that a variety of fiber supplement can lead to an improvement in physiologically significant metabolic and inflammatory biomarkers in prediabetes, although larger and sufficiently powered studies are required.

Ethical issues associated with the study

The major ethical concerns are risk–benefit balance, the quality of informed consent, safety monitoring, the use of placebos, and the conflict of interest. The researchers indicate ethics committee approval, informed consent written and in line with the Declaration of Helsinki, and trial registration, which are some of the key protections to uphold respect for persons and independent review (Hall et al., 2024). Nevertheless, due to the potential to induce gastrointestinal symptoms and (in uncommon cases) more severe complications, foreseeable harms, and the adequate reporting of adverse events, participant understanding of them are crucial to beneficence. Lastly, the connection between the sponsor of the study and employment (company-funded trial; some of the authors are employees/shareholders) increases the value of transparency, protection of data integrity, and reporting of unbiased outcomes.

How the experimental design (and randomization) strengthened the evidence

The study had the advantage of an experimental design due to the ability of randomization to balance measured and unmeasured confounders in the two groups and enhance the internal validity of the study as well as causal inferences of whether the supplement caused changes in biomarkers. The expectancy effects are also minimized by the placebo-controlled design, and it facilitates easier attribution of the results to the intervention as opposed to secular trends or co-interventions, especially when they (e.g., symptoms, adherence) can be behaviorally moderated (Hall et al., 2024). Although the authors admit that the limitation of single-blinding exists, the randomized allocation scheme provides greater protection against selection bias compared to observational designs.

References

Hall, C. V., Twelves, J. L., Saxena, M., Scapozza, L., & Gurry, T. (2024). Effects of a diverse prebiotic fibre supplement on HbA1c, insulin sensitivity and inflammatory biomarkers in pre-diabetes: A pilot placebo-controlled randomised clinical trial. British Journal of Nutrition, 132(1), 68-76. 

Links to an external site.
  

· Instructions: Ask a probing question, substantiated with additional background information, evidence, or research.

· Share an insight from having read your classmates’ 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 classmates’ postings by providing additional insights or contrasting perspectives based on readings and evidence.

Note: Your responses to classmates should be substantial (250 words minimum), supported with scholarly evidence from your research and/or the Learning Resources, and properly cited using APA Style. Personal anecdotes are acceptable as part of a meaningful response, but cannot stand alone as a response. Your responses should enrich the initial post by supporting and/or offering a fresh viewpoint, and be constructive, thereby enhancing the learning experience for all students.

Rubric: CONTRIBUTION TO THE DISCUSSION: Second Response (20 possible points)

20 to >19.0 ptsExcellentDiscussion response: • Significantly contributes to the quality of the discussion/interaction and thinking and learning. • Provides relevant examples and thought-provoking ideas that demonstrates new perspectives, and extensive synthesis of ideas supported by the literature. • Second response is supported by 2 or more relevant examples and research/evidence from a variety of scholarly sources including course and outside readings. • Scholarly sources are correctly cited and formatted. • Posts on separate day.

19 to >15.0 ptsGoodDiscussion response: • Contributes to the quality of the interaction/discussion and learning. • Provides relevant examples and/or thought-provoking ideas • Second response is supported by 2 or more relevant examples and research/evidence from a variety of scholarly sources including course and outside readings. • Scholarly sources are correctly cited and formatted. • Posts on separate day.

15 to >12.0 ptsFairDiscussion response: • Minimally contributes to the quality of the interaction/discussion and learning. • Provides few examples to support thoughts. • Information provided lacks evidence of critical thinking or synthesis of ideas. • Minimal scholarly sources provided to support post. • Posts on separate day.

12 to >0 ptsPoorDiscussion response: • Does not contribute to the quality of the interaction/discussion and learning. • Lacks relevant examples or ideas. • No sources provided. • Posts on same day.

20 pts

This criterion is linked to a Learning OutcomeQUALITY OF WRITING (10 possible points)

10 to >9.0 ptsExcellentDiscussion postings and responses exceed doctoral level writing expectations: • Use Standard Academic English that is clear, concise, and appropriate to doctoral level writing. • Make few if any errors in spelling, grammar, that does not affect clear communication. • Uses correct APA 7 format as closely as possible given the constraints of the online platform. • Are positive, courteous, and respectful when offering suggestions, constructive feedback, or opposing viewpoints.

9 to >8.0 ptsGoodDiscussion postings and responses meet doctoral level writing expectations: • Use Standard Academic English that is clear and appropriate to doctoral level writing • Makes a few errors in spelling, grammar, that does not affect clear communication. • Uses correct APA 7 format as closely as possible given the constraints of the online platform. • Are courteous and respectful when offering suggestions, constructive feedback, or opposing viewpoints.

8 to >6.0 ptsFairDiscussion postings and responses are somewhat below doctoral level writing expectations: • Posts contains multiple spelling, grammar, and/or punctuation deviations from Standard Academic English that affect clear communication. • Numerous errors in APA 7 format • May be less than courteous and respectful when offering suggestions, feedback, or opposing viewpoints.

6 to >0 ptsPoorDiscussion postings and responses are well below doctoral level writing expectations: • Posts contains multiple spelling, grammar, and/or punctuation deviations from Standard Academic English that affect clear communication. • Uses incorrect APA 7 format • Are discourteous and disrespectful when offering suggestions, feedback, or opposing viewpoints.

10 pts

Share This Post

Email
WhatsApp
Facebook
Twitter
LinkedIn
Pinterest
Reddit

Order a Similar Paper and get 15% Discount on your First Order

Order Now

Related Questions

Change Implementation and Management Plan

  To Prepare: Review the Resources and identify one change that you believe is called for in your organization/workplace. This may be a change necessary to effectively address one or more of the issues you addressed in the Workplace Environment Assessment you submitted in Module 4. It may also be

help with home work

Help with Homework Nurs 506 Unit 4 Assignment: Case Study: Malpractice and Patient Abandonment Wendy, RN, has worked in the pediatric unit at Hope Hospital for over three years. She has accepted the day shift assignment consisting of five pediatric patients under the age of 10, three RSV patients, and

YISELL ASSESS

The goal of this assignment is to help you develop critical thinking skills by exploring how to approach common clinical complaints that nurses frequently encounter. You will examine possible differential diagnoses and discuss how these conditions are evaluated in different care settings. Complaint: Headache For the above complaint: Identify three

nursing outcome

Nursing Program Occupational Violence Course CDC *To be completed anytime throughout the semester – due with SIM Day 4 documents LINK: Complete this course (approximately 3 hours) & submit a screenshot of proof of completion to the Sim Day 4 assignments folder. The training includes video clips, so please bring headphones

The Introduction Discussion

The Introduction Please answer the questions below. 1. What should be included in an introductory paragraph of the research paper? 2. Select an introduction from scholarly, peer-reviewed research, and appraise the introduction to assess whether it includes the necessary elements of an introduction. Why and why not? 3. How does

Literature Review and Evidence Matrix

Literature Review & Evidence Matrix Assignment For this assignment, you will prepare a 3 to 4-page review of the literature pertinent to hypertension for healthcare research and use that review to propose a methodology to address the problem. My PICOT is: In adults with hypertension, does advanced practice nurse–led self-management

GUIDED REFLECTION

GUIDED REFLECTION Study without reflection is a waste of time, Reflection without study is dangerous.  —Confucius (Clark, 2011). Reflection of an experience, lesson learned, and/or importance of a role, demonstrates a clear understanding of process, comprehension, and expertise. To reflect requires an ability to consider lessons learned, personal connections, and

Lorem, Ipsum

Unit 4 Literature for the Problem Identification Paper Instructions: Choose one article that will serve as the Clinical Practice Problem addressed by KTA Framework 1. Bailey, N., Mitchell, K., & Miller, T. (2024). Opioid misuse harm reduction. Journal of Addictions Nursing, 35(1), 3-14. 2. Bhochhibhoya, S., Allen, J., Cheney, M.,

Can you help by tomorrow?

PHIL 347 Critical Reasoning Week 4 Guided Learning Activity: Inductive Reasoning and Causal Evaluation Directions: Type the letter answer into Canvas. You may also include the whole line. The letter comes before the line or sentence Example: [A] Paris is the biggest city in France. [B] It is a major

Question

1. What factors differentiate the history and experience of African Americans from those of Asian, Latino, and Native Americans? 2. Define African American Studies & enumerate its major educational and social objectives. 3. What is the role of culture in Black Studies and how does this make it different from

Nursing Literature

See Attachment While the implementation plan prepares students to apply their research to the problem or issue they have identified for their capstone project change proposal, the literature review enables students to map out and move into the active planning and development stages of the project. A literature review analyzes

Nursing Homework

Week 5 Literature Summary assignment General Instructions   1. Select and review five research articles related to the practice issue and proposed intervention of your PICOT question developed in Week 2.  These articles may include quantitative, qualitative, or mixed methods studies (original research), systematic reviews, meta-analyses, or meta-syntheses (synthesis), or clinical

Nursing Assignment

NAME ADDRESS TOWN, STATE January 12, 2024 Jane Doe Director of Nursing Eldercare of Bemidji 123 Smart Street Bemidji, MN 56601 Dear Jane Doe: It is with a heavy heart that I submit my resignation from my position as LPN Coordinator effective January 15th. This decision was not an easy

Nursing Population assignment

 concerning one of the patient cases listed  Determine which medication would be most appropriate to prescribe from the assigned vulnerable population patient case medication choices. Explain your rationale for choosing this medication. Explain why the other medications listed are not appropriate for this patient. Explain the dosing schedule for the

Sys ip 4

Explain why it is a public health issue and what is currently being done to address it at the local, state, and federal levels.  Discuss any applicable health policies and regulations that may be in place to address the issue.

Ip Sys 3

Provide a thorough analysis of managed care, and discuss how it, as a delivery method, has facilitated the transfer of health services to outpatient and other nontraditional settings of care.  Discuss the impact that managed care has on the access, financing, and delivery of healthcare in the United States.  Discuss

Sys db 3

Complete the following tasks: Compare and contrast the ways that state and local governments can work with healthcare organizations to foster integration between primary care and public health.  Discuss the importance of linking primary care and public health and some of the challenges in doing so.