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Table 6 Trial data and data collected

From: A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]

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