Critical Appraisal of a Randomized Control Trial in Nursing: Burns

This report critically appraises a randomized controlled trial (RCT) by Zhang et al. (2020), which investigated the effect of a distraction-type intervention on managing dressing changes in children with burns. The appraisal addresses specific questions from the CASP RCT checklist, including randomization, patient accounting, baseline similarity, equal treatment, treatment effect estimation, and the applicability of results. The report highlights the study's strengths, such as proper randomization and equal treatment of groups, as well as limitations such as the single-center setting affecting the generalizability of the findings. The analysis emphasizes the statistically significant reduction in pain scores in the intervention group and the benefits of the intervention compared to potential harms. References to research methods texts and journals support the answers provided, demonstrating an understanding of the key areas in appraising an RCT. The report concludes that while the study showed promising results, its applicability to the local population is limited due to the research design and the need for further research in diverse settings.

Running head: NURSING
Nursing
Name of the student:
Name of the University:
Author’s note

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2. Randomized allocation of patients to treatment:
Yes. The aim of the randomized trial by Zhang et al. (2020) was to evaluate the effect of
a distraction type intervention in management of dressing changes in children with burns. Total
52 children were included in the review and the process of randomization was completed by
randomly assigning patients into two equal size group. This process of randomization was
completed by a computer random generator that balanced randomization in the ratio of 1:1. The
control group received only dressing changes, whereas the medical screen group received
dressing changes as well as medical screens. The researcher maintained allocation concealment
by completing the randomization process in a secure computer. Allocation concealment is a
process to ensure that implementation of random allocation was done without the knowledge of
which patients will be assigned to which group (Clark, Fairhurst & Torgerson, 2016). The
advantage of considering concealment of random allocation is that it secures randomization
process and prevents selection bias (Sil et al., 2019).
3. Accounting all patients till the conclusion:
Yes, all the patients who entered this trial where properly accounted for till the
conclusion. This is said because Zhang et al. (2020) recruited 26 samples in intervention and
control group and no case of lost to follow-up or discontinuation from the intervention was
found. Even during the analysis stage, data from all the 26 participants in each group was
analyzed and no one was excluded. No lost to follow-up in any RCT indicates that the validity of
the trail was maintained. The disadvantage associated with lost to follow-up is that it leads to
validity issues as the excluded patients may have given a different outcome. While critically
appraising any RCT paper, considering drop-out pattern is crucial as drop-out is a reflection of

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altered random composition which introduced confounding elements in a research paper
(Warschburger Krölle, 2016). Hence, if the proportion of missing values is less, it will be
indicative of a valid and reliable result.
5. Similarity of the groups at the start of the trial:
Yes, similarity of the groups at the start of the trial was considered. The key baseline
characteristics that was considered for the study participants included age, sex, burn factors, burn
locations, TBSA % and burn degree. This aspect was comprehensively explained in the paper as
the authors not only recorded the baseline characteristics for each group, but also calculated
statistical differences in terms of baseline characteristics for both groups. Based on the analysis
of statistical differences in baseline characteristics, no statistically significant different was found
(Zhang et al., 2020). According to de Boer et al. (2015), testing for baseline differences is
reflective of a successful randomization process. Conducting statistical calculations for baseline
difference helps to assess whether differences in baseline characteristics are significant or
important or not. Similarity of groups at the start of the trial is an indication of researcher’s
approach to eliminate selection bias during the research process. This factor should always be
considered while conducting RCT study because differences in baseline characteristics can lead
to chance errors and lack of specificity of the findings (Sedgwick, 2014, Yang et al., 2020).
6. Equal treatment of the groups:
Yes, both the medical screen group and the control group were treated equally in the
study. This can be said because apart from the medical screen intervention, all other elements
such as dressing changes, information sharing and parental involvement was kept same. In the
paper, informed consent was taken from all the parents of the child before the first dressing

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change. After the dressing change, all the children were treated with same oral narcotics based
on weight. Moreover, all the dressing change was done by the same anaesthesiologist. However,
equal treatment was not done from second day to the fourth day. This was justified because as
part of the intervention, only the intervention groups were supposed to receive the medical
dressing screens for burns. The authors reported about keep the conditions of both the groups
same as far as possible. This is an indication of the researchers consideration to control for
confounding variables in the study and avoiding impact of any change in condition on study
outcome. Some evidence that shows rigour in the area of keeping conditions equal included
making same skilled wound therapist to perform all the dressing changes and record any adverse
effects related to the medical screens. Thus, treatment applications were almost same for both the
group apart from the intervention. Bhide, Shah and Acharya (2018) justifies that all factors that
are influential for outcome should be kept equal between groups in a RCT paper. This can
confirm that the observed effect is seen only because of the intervention and no other
confounding factors.
7. Estimate of treatment effect:
Treatment effect in any research paper is determined by statistical calculations such as
odd ratio, absolute risk difference and probability of healing or recovery. In case of the RCT
study by Zhang et al. (2020), the main outcomes that were measured were pain level and
patient’s satisfaction score. Based on the review of findings, it was found that no adverse events
occurred with the intervention or assessment. Most of the children included in the study had
second or three degree burns. The study reported statistically significance difference in pain
scores for medical screen group compared to the control group. The significant different was
highlighted based on p value of less than 0.001. This finding indicated that the treatment had a

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large effect. The outcome of pain score confirms that medical screen was a major influencing
factor in reducing pain for children with burn during dressing changes. The positive benefits
were also noted based on expressions of children. For example, children in medical screen group
entered crying or screaming before dressing changes and the above expressions reduced after the
children watched the programme content on the computer screen. The finding is consistent with
the study by Kaheni et al. (2017) which revealed that distraction intervention can have a
significance impact on reducing the intensity of pain during dressing change in children.
9. Application of the results to the local population:
No, the results cannot be applied to the local population because of certain limitations.
The study was successful in giving statistically significant results for benefit of medical screens
in reducing pain for children during dressing changes. But to apply the results in local
population, it is necessary to conduct research in multiple centres and with large sample size.
The setting chosen should also be representative of the local population. The setting for the
research was a hospital in Jilin Province of China. There are two limitations that affects the
applicability of the results to the local population. The first limitation is that the study was done
in a single centre and there was a need to conduct the same study in at least four five hospital in
different regions to generalize the findings. But this was not done. Secondly, this study was done
in China. To apply the results in the Australian context, there is a need for conducting similar
research with same research design in Australia. Thus, it can be concluded that there were
internal and external validity issues in the paper which prohibits the application of the results to
local contexts. Kukull and Ganguli (2012) justifies that sample representativeness is an important
factor that should be considered in any research as it facilitates generalizing the study results.

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Faber and Fonseca (2014) support the same by stating that larger sample size can also enhance
the internal and external validity of the study.
11. Benefits of the research compared to harm and cost:
Yes, the benefits of the intervention are worth the harm and effort. This is said because
the study used rigorous method to eliminate confounding variables throughout the search
process. Moreover, based on the analysis of outcome, it was clearly seen that medical screen was
successful in achieving the goal of reducing dressing change related pain in children with burns.
This study confirmed the benefits not just based on pain scores but also based on non-verbal
expressions of pain. For example, the authors discussed about expressions like frowning and
screaming which reduced significants after the children started watching programme content on
the screen. Thus, medical screens can be considered as non-invasive and non-pharmacological
interventions for staffs involved in dressing changes of young children. The benefit is further
confirmed by finding no adverse effects due to use of screen during the research. Hence,
although medical screen cannot be directly introduced in clinical setting until further research,
this research gives enough scopes for clinical managers to consider the benefits of implementing
such screens by comparing it with the time lost without such screen in dealing with children with
burns. This was a very innovative study as no previous research has investigated about the role
of medical screens as a distraction technique. Hence, more future research is likely to give
positive implications for change in clinical practice related to wound dressing for young children.
The finding is further validated by the use of RCT as a research design as it is a hallmark of
evidence based medicine and it favours translating research findings into practice (Spieth et al.,
2015).

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