Critical Analysis of RCT Study

Running head: CRITICAL ANAYSIS
RCT Study
Name of the Student
Name of the University
Author Note

1CRITICAL ANAYSIS
Paper to be analyzed
Mody, L., Krein, S. L., Saint, S., Min, L. C., Montoya, A., Lansing, B., ... & Rye, R. A.
(2015). A targeted infection prevention intervention in nursing home residents with
indwelling devices: a randomized clinical trial. JAMA internal medicine, 175(5), 714-723.
Answer 1
Yes.
The trail addressed clearly focused issue. The objective of the study is to analyse
efficacy of multimodal infection program (TIP) in reducing the prevalence of multidrug-
resistant organisms (MDROs) and device-related infections. Thus the intervention includes
TIP and the outcome is decreased prevalence of infection. The main target population was
NHS patients in 12 different community based units covering 137 beds. The enrolment
period of the study is 36 months. The study also used control cohort (Mody et al., 2015).
Malmivaara (2016) stated that in order to design a proper randomized control trial (RCTs), a
proper PICO question must be designed covering the population to be studied, interventions
to be used, comparator used and the outcome of the study. Framing RCT with PICO helps to
strengthened the research framework.
Answer 2
The study selected to randomise NHS instead of the participants by the use of cluster
randomization. Hemming, Eldridge, Forbes, Weijer and Taljaard (2017) reported that cluster
randomisation trials provide increased return as the power along with precision size of the
cluster increases. The designed efficient trials and the number of cultures along with cluster
size concurrently and non-independently and thereby helping to improve the stratification of

2CRITICAL ANAYSIS
the sampling techniques. The authors stated that once the group is stratified, NHS were
assigned to intervention status by the use of computer-generated randomization. This
randomization leads to division of six patients in the intervention group and six under the
control group. The participants were concealed about the process of allocation. The
randomization was done by a separate statistician and thus researcher were also concealed
about the randomization and helping to fetch double blinded trial. Hemming, Eldridge,
Forbes, Weijer and Taljaard (2017) reported that double blind randomised control trail help to
reduce the chance of getting biased result.
Answer 3
No.
The trial was not stopped early and the patients were analysed in the groups under
which they are randomised. However, the there was a drop out among the selected group of
the patients both from the intervention groups and from the control groups during the follow-
up session. As per the research, during the follow-up session in the intervention group, out of
203 nursing home residents, 24 died and 9 withdrew this lead to decrease in the sample size.
Gutner, Suvak, Sloan and Resick (2016) highlighted that decrease in the sample size during
the follow-up session can be regarded as one of the limitations of RCTs and this hampers the
process of data saturation.
Answer 4
Yes.
The patients were not blind about the intervention used in the study. However, the
patients were blinded about the allocation. Wartolowska, Beard and Carr (2017) stated that
blinding patients in clinical trials is a principal methodological procedure. Non-blinded

3CRITICAL ANAYSIS
patients result in the generation of biased result. But the expected degree of bias is unknown.
The microbiologist who was appointed for the analysis of the samples was blinded about the
intervention assignment. This help to get a chance of getting unbiased result as microbiologist
was the main person who was assigned to study the rate of infection. In other words, it can be
said that non-blinded assessors of subjective outcomes cause degree of bias in RCTs in
comparison to the non-blinded patients reporting their symptoms. The blinding of assessors
helps to prevent observer-associated bias, detection bias along with Pygmalion effects.
Pygmalion effects is also popularly known as Rosenthal effects that highlights situation when
the investigators are looking for any particular response are predisposed to interpret the
results in a manner that highlights the overall response.
Answer 5
Yes.
The selection of the in-patients in the NHS centres was done based on the presence of
indwelling infection and other specific criteria were used in order to recruit the participants.
Thus it can be said that groups were similar at the initiation of the trial.
Answer 6
NO
Aside from the experimental interventions, the groups were not treated equally. For
example, the residents were not isolated and they were allowed to socialize and obtain other
rehabilitations that are located outside their room. Thus the degree of socialization outside the
room can vary between one patient to the other and thereby increasing the chance of getting
confounding bias. A RCT is a prospective, comparative and quantitative study. It is the most
rigorous and yet robust process. In order to reduce the confounding bias and to establish