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The design of the intervention trial described here was conceptualised over a number of years, with piloting, modification and feasibility testing carried out prior to commencement of the main trial.
As a result of the piloting, modifications were introduced, and the resulting version was used in the survey.
Piloting and modification: To test for acceptability, lack of ambiguity and content validity we pretested the draft instrument in a pilot group of 30 patients who were asked to complete the IBD-Control and provide verbal or written feedback or annotations regarding content and format.
Based on the overall feedback from the pilot test, modifications were made to the visual aspects of the questionnaires, such as the inclusion of more pictures, using an alternative font, increasing the space between items and changing the colours of headings.
The pro-forma was piloted and modifications were made prior to formal initiation of data collection.
The questionnaire was piloted, and modifications were made according to the feedback.
It was unfortunate that the reduced 3-point option use was not noted in the pilot trial as modification for the main study may have influenced the results.
On the basis of this pilot study, suggested modifications and recommendations were made.
Data were collated and analysed from the pilot survey and modifications were made to improve the readability of the survey, but no major changes were made to the content.
As a result of the pilot courses minor modifications were made to two of the sessions.
Following a pilot test, some modifications in terms of clarification and simplification of wording were done.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com