Critical Appraisal of Randomised Control Trial

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Critical Appraisal of Randomised Control Trial
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Critical Appraisal: Amiri, M., Khademian, Z. and Nikandish, R., 2018. The effect of nurse
empowerment educational program on patient safety culture: a randomized controlled trial. BMC
medical education, 18(1), p.158.
Section A: Are the results for the trial valid?
2. Was the assignment of the Patients to treatments randomised?
Comments: The selection of the participants was randomised into experimental and control
groups for the pre-test and post-tests. For instance, the nurses were allocated into the groups
based on the proportional stratified sampling that ensured that the selected number from each
unit was equivalent to the total number of the nurses in the randomised control trial (Buchanan
et al., pp.1193-1209). Concisely, randomisation was used to determine the allocation of
individual nurses to certain ICUs, which were categorised into the experimental and control
group based on the permuted block randomisation. On the other hand, the supervisors, which
formed the second group of patients in the study, were randomised into two using the
permuted block randomised, which ensured that the patients were randomly allocated into
treatment group while maintaining a balance across the treatment groups (Van der Feltz-
Cornelis et al., 2018). Additionally, the technique ensured that each group or block had a
specified number of randomly allocated treatment assignments and concealed from the
researchers and patients.
3. Were all the patients who entered the trial properly accounted for at its conclusion?

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Comment: The article illustrates that some of the patients opted out of the study before its
completion. The authors alluded that one patient (a nurse) did not complete the post-test for
the experimental group whereas two patients (supervisors) failed to complete the post-test for
the control group (Amiri, Khademian, and Nikandish, 2018, p.158). However, the trial study
did not stop earlier than the allocated time of research, which could be one of the reasons that
made some patients opt out of the investigation. Analysis of the patients was done in the
groups in which they were randomised as illustrated in the article. The act of opting out of
study could also be associated with the Hawthorns effects which ascertain that the behaviour
of the patients in the Randomised Control Trials (RCT) could change in the course of the study
making the participant to opt out (Zhang and Doherty, 2018, pp.82-86). Furthermore, the
effects of internal validity such as history or participant mortality among other effects could
attribute to opting out of the study (Flannelly, Flannelly, and Jankowski, 2018, pp.107-130).
Is it worth continuing?
4. Were patients, health workers and study personnel ‘blind’ to treatment?
Comment: Throughout the article, the researchers have not specified whether the treatment to
the patients was blinded. Blinding is an essential practice in ensuring that the potential biases
are limited or eliminated in the study (Sandsjö, Alwin, Sörbo, Lindgren, and Ertzgaard,
2018). Such preferences include the selection biases during randomisation of the patients into
experimental and control groups. The failure to mention whether the participants were blinded