Critical Appraisal of an RCT Research Tool Course 2022

Running Head: CRITICAL APPRAISAL OF AN RCT RESEARCH TOOL
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Critical Appraisal of an RCT Research Tool
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CRITICAL APPRAISAL OF AN RCT RESEARCH TOOL
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Critical Appraisal of an RCT Research Tool
Introduction
Research evidence obtained from randomized controlled trials or RCTs has always been
considered among the top of the evidence pyramid. This is because the clinical practice decisions
which are made out of this method of data collection are evidence-based. Since the RCT based
data collection by Sir Bradford‐Hill when determining the best treatment for tuberculosis, RCTs
have become increasingly common especially when gathering evidence for clinical practices.
However, for RCTs to be effective, they have to be planned appropriately and rigorously
conducted. This has not always been the case because biased RCTs have been reported from time
to time. This paper evaluates the effectiveness of a Randomized Controlled Trial adopted by
Ohura, Nakajo, Okada, Omura & Adachi in research entitled “Evaluation of effects of nutrition
intervention on the healing of pressure ulcers and nutritional states”
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It is worth to note that an effective RCT uses true randomization when assigning
participants to different treatments. However, in the research by Ohura, Nakajo, Okada, Omura
& Adachi, this approach seems unclear. This is because 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

CRITICAL APPRAISAL OF AN RCT RESEARCH TOOL
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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.
There are also other few aspects believed to the backbone of an effective RCT which
have not been set clearly. The allocation to groups has not been concealed. 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 is also not clear whether participants, those who were delivering the treatment as well
as the treatment assessors were blind to the treatment assignment or not. Basically, blinding is an
essential aspect of RCT and helps in minimizing bias, while increasing the validity of the
obtained results. Hence, efforts must have been made to blind the participants who were involved
in the trial (Armijo-Olivo et al., 2017). It is usually performed by masking the type of
intervention that the participants were subjected to. However, the researchers failed to inform
about blinding (Ohura et al., 2011). On the other hand, a single blinding was necessary. Single
blinding generally refers to investigations where the patients are blinded to the intervention that
is being applied but not to the administering researcher. This kind of blinding involves
participants who are not completely conscious (Liu et al., 2016).
This research has its strong areas as far as RCT rules are concerned. For instance,
treatment groups were similar at the baseline, they were treated identically and participants
analyzed in their randomized groups. Presence of any kind of difference between the participants
present in the intervention and control group act as a major form of threat to the internal validity
of any trial that explores the causal association. In addition, the presence of any kind of