Table 6.

Trial data and data collected

Data collected in pilot trial	Aspect of full trial and/or cost effectiveness modelling and value of information analysis this informs
Number of participants recruited over 12 months	Number of participating centres required
	Duration of recruitment period
	Eligibility criteria
Time to healing of participants’ pressure ulcers	Duration of follow-up required and sample size
Number of participants who withdraw from the study or die before study completion or who are lost to follow-up	Initial sample size
	Whether attrition is likely to threaten the validity of a future trial (due to attrition bias)
Reasons for withdrawal	Strategies to anticipate and minimise withdrawals
Rates of hospital admission, discharge, destinations	Which settings should be involved and how to ensure continuity of data collection
Photographs of pressure ulcers	Whether camera phones can be used to monitor healing in real time and whether photographs are adequate for blinded outcome assessment
Time of ulcer healing	Can assessment of healing be undertaken by blinded assessors from photographs?
Preferred language of (potential) participants	What proportion of future participants is likely to require translation of documentation into which languages?
Pain and health-related quality of life	Are the visual analogue scale (VAS) and EQ-5D questionnaire suitable in this population?
Nurses’ views of trial documentation	How can we optimise the data collection for a full trial to ensure completion by NHS staff?
Frequency of dressing changes	Resource use and structure of data collection tool
Time to change to treatment/nature of change to treatment and reasons	Resource use and structure of data collection tool
Adverse events (rates and nature)	Cost effectiveness and future data collection