Critical Appraisal of Ohura et al. (2011) Randomized Controlled Trial

Running head: CRITICAL APPRAISAL
Nursing
Name of the Student
Name of the University
Author Note

CRITICAL APPRAISAL1
JBI Critical Appraisal Checklist for Randomized Controlled Trials
Yes No Unclear NA
1. Was true randomization used for assignment of
participants to treatment groups?
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2. Was allocation to treatment groups concealed? □ □ □ □
3. Were treatment groups similar at the baseline? □ □ □ □
4. Were participants blind to treatment assignment? □ □ □ □
5. Were those delivering treatment blind to treatment
assignment?
□ □ □ □
6. Were outcomes assessors blind to treatment assignment? □ □ □ □
7. Were treatment groups treated identically other than the
intervention of interest?
□ □ □ □
8. Was follow up complete and if not, were differences
between groups in terms of their follow up adequately
□ □ □ □
9. Were participants analyzed in the groups to which they
were randomized?
□ □ □ □
10. Were outcomes measured in the same way for treatment
groups?
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11. Were outcomes measured in a reliable way? □ □ □ □
12. Was appropriate statistical analysis used? □ □ □ □
13. Was the trial design appropriate, and any deviations from
the standard RCT design (individual randomization,
parallel groups) accounted for in the conduct and analysis
of the trial?
□ □ □ □
Overall appraisal: Include □ Exclude □ Seek further info □

CRITICAL APPRAISAL2
Ohura, T., Nakajo, T., Okada, S., Omura, K., & Adachi, K. (2011). Evaluation of effects of
nutrition intervention on healing of pressure ulcers and nutritional states (randomized
controlled trial). Wound Repair and Regeneration, 19(3), 330-336.
DOI:10.1111/j.1524-475X.2011.00691.x.
Critical Appraisal Tool for RCTs (individual participants in parallel groups)
Answers: Yes, No, Unclear or Not Applicable
1. Was true randomization used for assignment of participants to treatment groups?
Unclear. The researchers conducted an open randomized trial where both the research
participants and the researchers were aware of what treatment or intervention was being
administered to them, for the management of nutritional states and pressure ulcer. The
researchers recruited tub-fed patients who had been diagnosed with stage III-IV pressure
ulcer. The researchers randomized the patients either to the intervention group or the control
group, with the use of a minimization method (Ohura et al., 2011). They did not provide any
information on using any random number generator for recruiting the study subjects. In
contrast, they used a procedure based on adaptive stratified sampling for lowering the
imbalance between the total patients allocated to each group, over other factors.
2. Was allocation to groups concealed?
Unclear. Allocation concealment is a procedure used for preventing any kind of selection
bias in randomized controlled trials. The process helps in minimizing confounding and
selection bias during recruitment (Clark, Fairhurst & Torgerson, 2016). It suggests that the
individuals who is randomizing the research participants is not aware of the next treatment
allocation. Although allocation concealment is possible in different kinds of trials, in
addition to unblended trials, the researchers failed to provide any information on whether the