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 |