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Table 4 Data collection processes for outcome data collected during the trial

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

Data process How and when measured
Length of follow-up for trial participants The length of time each group participated in the trial was calculated as the difference between date of randomisation and date of trial exit
Frequency of attrition and reasons for attrition Recorded if participant was lost to follow-up on the participant event form
Rates of hospital admission and discharge destinations Date and details of inpatient hospital admission and discharge ecorded as they occurred and recorded on the participant event form
Collection of healing data from trial participants The date the research nurse considered the reference ulcer to have healed was recorded on the participant event form. The time to healing was calculated as the difference between the date of randomisation and the date of healing. Once the reference pressure ulcer was considered to have healed, photographs were taken on the day of healing and then once per week for 3 weeks (so four healing photographs in total)
Blinded outcome assessment of wounds At the end of the trial, a Tissue Viability Clinical expert (blinded to participant treatment allocation) visually inspected baseline, monthly and healing photographs of the reference pressure ulcer. For each series of photos, the assessor was required to state whether they considered the reference pressure ulcer to have healed, the treatment allocation and whether the quality of the photograph was adequate to make a decision about healing
Number of participants who would require translation of trial documentation During pre-trial screening on pre-trial screening forms
Measurement of ulcer-related pain at dressing change and health-related quality of life data Ulcer-related pain was measured on a 10-cm visual analogue scale that ranged from no pain to the worst pain imaginable. This was recorded on treatment monitoring forms pre- and post-application of dressing
  Participants were asked to complete the EQ-5D HR-QoL questionnaire at baseline and 2 weeks, 1, 3 and 6 months post-randomisation. Any difficulties participants had with completing these were noted by the research nurse
Nurses’ views data collection Face-to-face and telephone meetings took place with the research nurse who would provide feedback from nurses on any problems they encountered with completing trial documentation