One composite noninferiority trial of IV replacement timing, appraised question by question against the JBI randomized trial checklist and rated for level, NU325 Unit 5. Searches like "nu 325 unit 5 assignment example", "nu325 unit 5 sample" and "nu325 unit 5 example" land here.
Noninferior, but Less Convincing Than the Abstract: A JBI Critique of a Composite Trial on IV Removal
[Student Name]
Purdue University Global
NU325: Evidence-Based Nursing
Unit 5 Assignment
[Instructor Name]
[Date]
The trial appraised is a composite written for teaching; its figures are illustrative.
Summary
The composite trial was a pragmatic randomized trial at two hospitals. Adults needing a peripheral IV catheter for more than three days, 1,406 in all, were allocated by a web-based system to removal on clinical indication or routine replacement at 96 hours. The primary outcome was phlebitis on the Visual Infusion Phlebitis scale. The authors prespecified a noninferiority margin of 3 percentage points. Phlebitis occurred in 6.4 percent of the clinical-indication group and 5.9 percent of the routine group, a difference of 0.5 points; the 95 percent confidence interval ran from -1.8 to 2.8. Because the upper limit fell below the 3-point margin, the authors concluded that clinical-indication removal was noninferior.
Appraisal Against the Checklist
The revised JBI tool for randomized trials asks about randomization, concealment, blinding, outcome measurement, analysis and trial design (Barker et al., 2023). Each item is answered yes, no, unclear or not applicable.
True randomization: yes; a computer-generated sequence is described. Allocation concealed: yes; allocation was revealed only after enrollment through the web system. Groups similar at baseline: yes; the baseline table shows similar ages, diagnoses and insertion sites. Participants blinded: not applicable in practice; patients could see whether their catheter was changed, but it is unlikely to affect phlebitis. Those delivering treatment blinded: no; nurses knew each patient's group. Outcome assessors blinded: no. Bedside nurses scored the sites knowing the group, and phlebitis scoring involves judgment, so knowledge of the group could shift scores. Groups treated identically apart from the intervention: unclear; site checks may have been more frequent in the clinical-indication group. Follow-up complete: yes; loss to follow-up was under 2 percent. Analyzed in the groups randomized: partly; the main text reports intention-to-treat results, and the per-protocol results appear only in a supplement. Outcomes measured the same way: yes, with the same scale in both groups. Outcomes measured reliably: unclear; interrater reliability of the scoring is not reported. Appropriate statistical analysis: yes; the margin and sample size calculation match. Appropriate trial design: yes; a pragmatic design suits a question about everyday practice.
Which Way Each Weakness Pushes
In a noninferiority trial, anything that makes the two arms behave alike biases the result toward a finding of no difference, which is the finding the authors hoped for (Piaggio et al., 2012). The most important weakness is a protocol deviation: in the routine arm, 17 percent of catheters were not changed at 96 hours, often because the patient was discharged or the line was removed early for other reasons. That made the routine arm more like the clinical-indication arm and pushes the result toward noninferiority. The per-protocol analysis, which excludes such deviations, is the more conservative test in a noninferiority trial, and its placement in a supplement is a reporting weakness. The supplement shows a similar result, which is reassuring, but readers of the abstract would not know it.
Unblinded outcome assessment could push either way. The absence of reliability data for phlebitis scoring adds uncertainty to the primary outcome.
Rating
Using the Johns Hopkins model, this is Level I evidence, a randomized controlled trial, of good quality (B): sound design and adequate sample, with some inconsistency in reporting and blinding (Dang et al., 2022).
What It Can and Cannot Support
The trial supports the claim that removing peripheral catheters on clinical indication does not produce a meaningfully higher rate of phlebitis than routine replacement at 96 hours in adult inpatients. It cannot support any claim about bloodstream infection, which was too rare to compare, and it does not by itself show a benefit for patients. It is one strong piece of the picture, not the whole of it.
References
Barker, T. H., Stone, J. C., Sears, K., Klugar, M., Tufanaru, C., Leonardi-Bee, J., Aromataris, E., & Munn, Z. (2023). The revised JBI critical appraisal tool for the assessment of risk of bias for randomized controlled trials. JBI Evidence Synthesis, 21(3), 494-506. https://doi.org/10.11124/JBIES-22-00430
Dang, D., Dearholt, S. L., Bissett, K., Ascenzi, J., & Whalen, M. (2022). Johns Hopkins evidence-based practice for nurses and healthcare professionals: Model and guidelines (4th ed.). Sigma Theta Tau International.
Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J. W., & Altman, D. G. (2012). Reporting of noninferiority and equivalence randomized trials: Extension of the CONSORT 2010 statement. JAMA, 308(24), 2594-2604. https://doi.org/10.1001/jama.2012.87802
How this NU325 Unit 5 example is structured
A summary stays short and neutral so no judgment leaks in early. Each checklist item then receives a ruling backed by a line from the article, and the critique uses every item rather than only the ones that fail. Credit comes first where it is earned: true randomization, concealed allocation, similar groups at baseline and a sample size calculation matched to the margin. The discussion then gathers the weaknesses and asks which way each pushes the result. Protocol deviations in the routine arm matter most, because in a noninferiority trial anything that makes the two arms behave alike biases the answer toward no difference. The critique checks whether the authors reported both intention-to-treat and per-protocol results, and finds the per-protocol figure only in a supplement. A final paragraph rates the study and states what it can and cannot support.
Get an NU325 Unit 5 example written to your instructions
Critique formats vary: JBI, CASP, a Johns Hopkins appraisal tool, or a question set the instructor wrote. Send the assigned or self-selected study, the Unit 5 instructions and the rubric, and the critique comes back item by item with the direction of each weakness explained. First sample free, returned in 24-48h. The paper above is an original model document written by our desk, not a submitted student paper and not an official Purdue University Global document.
NU325 Unit 5 questions, answered
What is the JBI checklist for randomized controlled trials?
A critical appraisal tool published by JBI, formerly the Joanna Briggs Institute, at the University of Adelaide. It asks a set of questions about randomization, allocation concealment, baseline similarity, blinding at several levels, follow-up, analysis and outcome measurement, each answered yes, no, unclear or not applicable. The answers feed an overall judgment about whether the study is sound enough to rely on.
Why does a noninferiority trial look at the confidence interval instead of the p-value?
Because the question is whether the new approach could be worse by more than the stated margin. If the whole confidence interval for the difference sits on the acceptable side of that margin, noninferiority is supported. A large p-value alone only says no difference was detected, which is not the same as showing the two approaches are close enough.
Can I critique a study my instructor did not assign?
Many sections let you choose, usually from your own search, but some assign one article to the whole class. Check the instructions for design requirements, since a quantitative critique needs a quantitative study, and some rubrics require a primary study rather than a review. If you choose, pick one with a methods section detailed enough to appraise.