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The outcomes of randomisation are recorded on the randomisation database, in the trial master file at Swansea University, at the study site in participants' records, and in the remotely hosted data repository.
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Participating healthcare providers will be asked to invite patients from their listed patient databases to participate in the trial.
While the improvised solution worked flawlessly, the lack of knowledge by the staff, information in the Verizon device database, and the trial and error method used was concerning and cumbersome.
A key finding is that 12.3% of eligible patients on the GP database consented to participate in the trial, a remarkably similar percentage to the 12% found by McCarney et al [ 20] in a trial of acupuncture for migraine.
The blinding process remained complete until all data was entered in the trial database and the accuracy of the data and the database was confirmed.
This record linkage system has been implemented within the general practice research database (GPRD) used in the trials presented here, and could be implemented more widely.
These data will be entered in the trial database.
Baseline glycemia measures and capillary glucose measures throughout treatment were recorded in the trial database.
These questionnaires were optically readable, being consecutively registered in the trial database.
The 12 638 patients included in the trial database were followed up for a mean of 2.5 years (range 0 7.5 years) during which 2422 deaths were observed.
Prior to consent, only basic information is stored in the trial database: screening number, patient initials, year of birth, and encrypted NHS Number.
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