Nursing Assignment: Evaluating a Randomized Controlled Trial Study

This assignment is a detailed analysis of a randomized controlled trial (RCT) study in nursing, focusing on the evaluation of a nutritional intervention for pressure ulcer healing. The analysis assesses the study's internal validity, examining key elements such as participant allocation, blinding procedures, and the consistency of treatments between the control and experimental groups. The evaluation scrutinizes whether the study adhered to best practices in RCT design, including the concealment of allocation, the blinding of participants and researchers, and the use of appropriate statistical analyses. The assignment also explores potential biases, such as those arising from differential treatment or follow-up procedures, and evaluates the study's adherence to established guidelines for pressure ulcer treatment. Ultimately, the analysis provides a critical assessment of the RCT's strengths and limitations, and its overall contribution to nursing research.

Running head: NURSING
Nursing
Name of the Student
Name of the University
Author Note

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Answer 1
Yes.
Shea et al. (2017) stated that random allocation of the participants in the treatment and
in the control group helps to increase the internal validity of the RCT design to explore the
casual relationships. In this study the allocation of the individuals in the control and in the
experiment group has occurred purely by chance and is not influence by any specific
characterization of the patients. At first the authors used some initial criteria for the selection
of the final group of participants in the study and then the division between the control and
the experimental group occurred (Ohura et al., 2011).
Answer 2
Unclear
Kahan, Rehal and Cro (2015) stated that an individual who is not aware about that
group is upcoming process of allocation, will perform allocation of the participants in the
control and to the experimental group in the randomised control trial. This helps to avoid the
risk of encountering selection bias. In order to avoid selection bias, concealment of allocation
is done. However, study conducted by Ohura et al. (2011) failed to highlight whether the
allocator is concealed about the next group or it used central randomization.
Answer 3
The differences between the treatment of the participants in the control and in the
experimental group hamper the internal validity of the study (Mulder, 2017). In the study, the
patients who are included in the control group got equal amount of calories as before taking
part in the trial. The participants who are included in the experimental group were
administered calories as per the range of the Basal Energy Expenditure (BEE) that is being

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calculated based on the Harris-Benedict equation. Before the initiation of the study, both the
group underwent through preparation tenure of about 10 days in order to adjust or to switch
their feeding formula. Both the groups were treated as per the Guidelines stated by the Local
Treatment of Pressure Ulcers (Ohura et al., 2011).
Answer 4
Can’t tell
Mulder (2017) stated that if the participants are aware that they are in the treatment or
in the control group then there is a risk that they behave differently and they respond or they
react differently towards the different intervention of interest or towards the control
intervention. In other words it can be said that blinding of the participants signifies the
approach that prevents the participants from understanding under which group they are being
allocated. Blinding of the participants helps to minimize the risk. Here blinding means, the
person are not aware about the group under which they are allocated. In the research paper,
the authors failed to state that whether participants of the study were blinded about the
process of allocation (Ohura et al., 2011).
Answer 5
Can’t tell
This question helps to understand to whether the people who are delivering the
treatment were blind about the process of allocation. Blinding of the allocators helps to avoid
the chances of getting distorted results. For example, of the people who are delivering the
treatment is not blinded then there increase the chances of biasness (Christ, 2014). The main
treatment used in this study is servicing specific calorific food based on the Basal Energy
Expenditure (BEE) X 1.1 X 1.3 to 1.5. The overall period of intervention was 12 weeks.

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However, the authors failed to mention whether the researchers or the individuals who were
responsible for the implementation of the nutritional food to the target group were blinded
about the entire process that is scope and the outcome of the study (Ohura et al., 2011). This
decreased the overall strength of the RCT study.
Answer 6
Can’t tell
The people who assessing the main outcome of the study is require to remain blinded
about the scope of the treatment and also about of the allocation of the group that is who are
allocated under the control group and who are allocated under the experimental group. This
helps to avoid the chances of getting biased result. However, the study conducted by Ohura et
al. (2011) failed to mention that whether the authors applied the procedure of blinding over
the individuals who were appointed to measure the outcome of the study that is decrease in
the severity of the pressure ulcers upon proper nutritional related interventions.
Answer 7
No.
All the patients were treated based on the Guidelines for the Local Treatment of
Pressure Ulcers. Apart from the nutritional interventions or intake of the calorie restricted diet
plan, the wound dressing materials were used in general in this study. The applications of
therapeutic ointments were restricted to agents like bucladesine sodium or alprostadil and use
of other antibacterial ointments. The use of trafermin was strictly prohibited irrespective of
the patients in the different group (Ohura et al., 2011). All the patients were required to
employ ADVAN pressure release mattress and their body position was changed after every 2
hours (Ohura et al., 2011). Thus it can be said that all the patients were treated equally apart

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from the difference in the intervention provided among the control and in the experimental
group. This approach helps to overcome the chance of bias (Ginsburg & Smith, 2016).
Answer 8
No.
The study failed to mention whether the follow-up conducted and analysed
adequately. The paper also lags a proper tabular representation of data follow-up data. This
created a gap in understanding whether the sample size at the initiation and towards the end
of the study was same (Bothwell et al., 2016).
Answer 9
Yes.
Both the groups were analyzed separately. Ginsburg and Smith (2016) stated that
there are different statistical analysis used in the RCT like intention-to-treat (ITT) analysis
and pre-protocol analysis. However, the authors in this study failed to highlight any specific
statistical protocol used by them.
Answer 10
Yes.
The authors used same protocol in order to measure the outcome of the study. The
outcomes were measured based on the physical parameters and other laboratory parameters.
The measurement of the outcome in an identical manner helps to reduce the chances of
getting biased results (Boers et al., 2014).
Answer 11

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Can’t tell
DESIGN tool, OH scale and Braden scale was used for accessing the severity of
pressure ulcers. The statistical analysis was done by the use of the SPSS tool. The efficacy
parameters were calculated with the help of the ANOVA. The author however, failed to
mention the number of raters or intra-rater reliability of the raters. This can be considered as
one of the limitation of the study.
Answer 12
Yes
The statistical analysis was done by the use of the SPSS tool. The efficacy parameters
were calculated with the help of the ANOVA. Both these are established statistical analysis
tool that are widely used in scientific articles (Sotiriadou, Brouwers & Le, 2014).
Answer 13
No.
The authors failed to conduct a proper randomised control trail as the authors failed to
maintain a proper blinding procedure. It would be wise to conduct a cross-over trail in order
to produce better result that is free from any chance of bias. Since pressure ulcers were in its
chronic state, thus cross-over trials will be suitable for its purpose (Ginsburg & Smith, 2016).

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References
Boers, M., Kirwan, J. R., Wells, G., Beaton, D., Gossec, L., d'Agostino, M. A., ... & March,
L. (2014). Developing core outcome measurement sets for clinical trials: OMERACT
filter 2.0. Journal of clinical epidemiology, 67(7), 745-753.
Bothwell, L. E., Greene, J. A., Podolsky, S. H., & Jones, D. S. (2016). Assessing the gold
standard—lessons from the history of RCTs.
Christ, T. W. (2014). Scientific-based research and randomized controlled trials, the “gold”
standard? Alternative paradigms and mixed methodologies. Qualitative
Inquiry, 20(1), 72-80.
Ginsburg, A., & Smith, M. S. (2016). Do randomized controlled trials meet the “Gold
Standard”. American Enterprise Institute. Retrieved March, 18, 2016.
Kahan, B. C., Rehal, S., & Cro, S. (2015). Risk of selection bias in randomised
trials. Trials, 16(1), 405.
Mulder, G. (2017). Planning for precision with random samples of participants and stimuli.
Retrieved from:
https://www.researchgate.net/profile/Gerben_Mulder/publication/332188849_Plannin
g_for_precision_with_random_samples_of_participants_and_stimuli/links/
5ca5ca36458515f785224eac/Planning-for-precision-with-random-samples-of-
participants-and-stimuli.pdf
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.

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Shea, B. J., Reeves, B. C., Wells, G., Thuku, M., Hamel, C., Moran, J., ... & Henry, D. A.
(2017). AMSTAR 2: a critical appraisal tool for systematic reviews that include
randomised or non-randomised studies of healthcare interventions, or both. Bmj, 358,
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Sotiriadou, P., Brouwers, J., & Le, T. A. (2014). Choosing a qualitative data analysis tool: A
comparison of NVivo and Leximancer. Annals of Leisure Research, 17(2), 218-234.