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Table 5 Data collection processes for treatment 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
Frequency of dressing changes in both trial arms This was calculated from the number of treatment monitoring forms completed by the research nurses indicating a dressing change and included forms completed both prospectively and retrospectively
  Such data were collected retrospectively when a participant changed location or was self-caring. In such instances, the research nurse would consult patient notes or records kept by the patient to determine the number of dressing changes over a specified period of time
Duration of treatment with allocated trial treatment Calculated as the difference between the date a patient receiving their allocated treatment to the date they stopped receiving this treatment. This information was available from treatment monitoring forms (as described above)
Reasons for ceasing allocated trial treatment When, in the clinical judgement of the nurses, a patient could no longer receive their allocated trial treatment, the reason for treatment change was recorded on a treatment monitoring form
Define common adverse events in the study population All serious and non-serious adverse events that occurred in participants were recorded on adverse events forms. The nature, description and relationship of the event to trial treatment were recorded. The research nurse indicated whether the event was considered to be related to the reference pressure ulcer
  1. The data processes that were devised to answer the research questions formulated to meet the objectives of the study are shown, as are how and where these data were collected.