the Pilot study:

A pilot study, sometimes called a ‘feasibility study’, is a small scale version or a trial that usually precedes the major study to ensure that the proposed research methods are applicable (Polit and Beck, 2010). Piloting or testing the researcher’s data collection tool or intended interventions helps determine their acceptability by subjects, or by other investigators, and also allows the researcher to consider the cost and ease of the planned research procedures (Parahoo, 2006).

The responses the researcher may get from such a trial help him or her to improve the methodology and the research tool. They may also notify the researcher of any errors, ranging from typing errors to much more serious problems that could affect the structure or the proper functioning of the tool (Parahoo, 2006).

For this research, the data collection tool was sent to a small group of PU experts and research colleagues (n=4), one of them with particular experience in paediatric PU. The responses and feedback received helped in improving the tool in the following ways: any identified errors were corrected and any part that was unfeasible in the clinical fields was restructured, the section contents were changed to include more paediatric suitable information, and the format of the tool was amended based on whether it was considered easy to fill in and follow in practice.

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In addition, an inter-rater reliability test between the researcher and a paediatric PU expert was performed, to ensure reliable categorising of the identified PU grades during the actual survey. The researcher assessed 10 PU photographs and categorised them according to the EPUAP classification system as PU categories 1-4, erythema, and moisture lesion. The researcher’s assessments were then compared to the expert assessment and inter-rater reliability was determined using the percentage of agreement and Cohen’s Kappa. The Kappa calculated for this study was 0.872 (p<0.001), and the percentage of agreement between the researcher and the expert was 90%; both indicated an excellent agreement.

Before the actual incidence study was conducted, the researcher also applied the tool to a small group of children (n=5) admitted to one intensive care unit (i.e. PICU). The tool was filled in for each child in one day, a week prior to the commencement of the main data collection period. The gap of one week was chosen to allow sufficient time for the researcher to conduct one more follow up visit to these patients.

The aim of the follow–up visit was to identify any obstacles the researcher may encounter in the follow-up process, and to assess the ease of accomplishing it. The visit was also an opportunity to gauge the accessibility of the hospital computer system for obtaining patients data, and to estimate the time period the researcher would need to perform the assessment on existing patients, while looking at the same time for new recruits. The one day follow-up was not intended to perform an actual assessment of the development of PU. Children in the pilot study were not included in the actual incidence sample or in the statistical analysis.

The researcher assessed the ease of completing the tool, and documented notes on any data for the children that were inaccessible. This helped to underline any obstacles which may have to be confronted as the children’s skin assessments were carried out, or the need for modifications to any section of the tool. In short, the implementation of the tool on this small scale gave the researcher an overview of the advantages and disadvantages that could be encountered during the actual data collection.

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The PICU was selected as the site of the pilot study because of the variety of children of different ages, including neonates, infants, and older children, who would be admitted. Based on what has been outlined above, after the pilot study, the following amendments were made to the data collection sheet:

- The prevalence and the incidence data were separated onto two different data collection sheets (Appendices 3.1 and 3.2); this was for ease of collecting data and managing information, since the studies involved two different samples of patients, measuring different areas, and they were separated by more than one month.

- In the incidence tool, a follow–up table was added, with 12 columns to show the maximum number of follow-up assessments and two rows indicating the date of assessment and the outcome of the assessment (PU developed or not).

- Another table was inserted which would be filled in if any PU was observed. This table included the PU’s characteristics, the date it was first observed on, and the reason for the child’s participation in the survey being discontinued.

- A special table was added to document any existing medical devices, by ticking the type, and writing the number of devices in the relevant space.

- Certain variables, such as ABGs, and PEEP level were added; because of their necessity, mentioned in previous literature, as risk factors for PU occurrence, in ICU patients.

- Certain variables were omitted because of their inapplicability to the paediatric sample. These were, firstly, the presence of the ‘do not resuscitate’ order (DNR), which none of the children in the studied units had, since it is mostly used for adults in this hospital but not in paediatrics; secondly, paralysis, omitted because it would be covered by the ‘mobility and activity’ sub-items of the two scales used; and thirdly, malignancy; which was not observed in any child case during the data collection period.