Critical Appraisal of a Randomized Controlled Trial on Wearable Patient Sensor for Preventing Pressure Injuries

Running head: CRITICAL APPRAISAL
Critical appraisal
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1EVIDENCE BASED PRACTICE
Introduction:
The incidence pressure related injuries is rising in health care setting and despite
advancement in prevention and treatment, pressure related injury is still a burden in health care
setting (Rondinelli et al., 2018). Hospitals are exploring innovative options to prevent pressure
injuries. By review of research literature, a randomized controlled trial by Pickham et al. (2018)
titled ‘’ has been identified which gives innovative solution to address the prevalence of pressure
ulcer injuries in hospital setting. The main purpose of the study can be defined using the PICOT
framework, which is an appropriate framework to define the research population, intervention,
outcome and time of the clinical question (Doody & Bailey, 2016). Pickham et al. (2018)
investigated about the research topic with the following PICOT question:
For acutely ill adults (P), does wearable patient sensor (I) prevent pressure injuries (O) in adult
ICU patients compared to those receiving standard care (O) within 5 months (T)?
The main purpose of the paper is to critically appraise a randomized controlled trial by
Pickham et al. (2018) to address the above PICO question using the Critical Appraisal Skills
Programme (CASP) (2017) framework. The paper will discuss about the validity of the results,
the overall primary and secondary results obtained and the application of the study findings in
the clinical scenario.
Critical appraisal of articles:
The validity of the research by Pickham et al. (2018) will be judged using the CASP to
determine whether outcomes in intervention group occurred due to the effect of the intervention
or because of the influence of confounding factors in research (Kyriacou & Lewis, 2016).

2EVIDENCE BASED PRACTICE
Clarity of aims
From the review of the paper by Pickham et al. (2018), it can be said that the study had a
clear aim as it gave details about the population studies, interventions compared and intended
outcomes to be evaluated. The aim of the RCT paper was to analyse the effects of using a
wearable patient sensor to promote optical turning practice and reduce pressure injuries in
patients admitted in intensive care units. Hence, the primary outcome of focus was optical
turning or positioning strategy and the secondary outcome was turning compliance and
preventing hospital acquired pressure ulcers (HAPUs) (Critical Appraisal Skills Programme,
2017). The outcome take is significant as current practices fail to evaluate the effect of turning in
redistributing pressure and reducing risk of HAPUs (Hommel et al., 2017).
Randomization:
The purpose of randomization in any RCT paper is to ensure that participants are
randomly assigned to treatment and intervention group and any difference between two groups
are eliminated. There may be systematic difference between group and by allocating each
individual to one or other intervention at random, the systematic difference between the group
apart from intervention is eliminated (Bhide, Shah & Acharya, 2018). Pickham et al. (2018)
achieved randomization in the research and allocation concealment using individual opaque
enveloped. For each stratum of participants (ICU unit A and B), randomization was done using
permuted sizes of blocks of two, four and six. This method of randomization ensures that
participants were allocated to different interventions at random without any possibility of biases
(Salazar, Crosby & DiClemente, 2015). In addition, to ensure that all the participants were
properly accounted for at its conclusion, the patients were analysed in the groups to which they

3EVIDENCE BASED PRACTICE
were randomized. At no point, the groups were dropped out from their respective groups
(Critical Appraisal Skills Programme, 2017).
Allocation concealment and blinding
After the process of randomization, a wearable patient sensor was applied to the chest
below the suprasternal notch and the control group received sensor however it was not giving
feedback to clinicians. The clinicians looking for patients in the control group relied on standard
care practices such as traditional turning reminders without the aid of any sensor data. Group
allocation was revealed after enrolments of participants to individual group and patients were
blinded to group allocation. However, clinicians were not blinded to the allocation process. The
independent certified Wound, Ostomy and Continence Nurse, who documented a daily report of
head-to-skin assessment was also blinded from group allocation. Hence, the researchers
considered important study personnel who should be blinded to treatment (Critical Appraisal
Skills Programme, 2017).
Considering the nature of intervention, blinding only patients and the Wound, Ostomy
and Continence Nurse was appropriate to reduce the likelihood of any allocation bias (Pickham
et al., 2018). The main rationale for not blinding clinicians from the allocation process was that
clinicians in each group were supposed to follow wearable sensor reminded or traditional
reminders. Hence, blinding them to treatment would not have been appropriate. In addition,
blinding the Wound, Ostomy and Continence Nurse was justified too as she was documenting
daily outcomes in relation to skin assessment and if she had awareness about group allocation
process, there was a possibility that the documentation process might be influenced by individual
biases (Kahan,Rehal & Cro, 2015; Critical Appraisal Skills Programme, 2017).