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Two group interviews with members of trial staff based at Thai-Burmese border clinics were conducted, one with two participants and the other with five.
The in-depth process evaluation practices were a group of practices in the QICKD trial which received the same intervention as the main trial practices but were also observed so we could learn about programme fidelity (i.e. the extent to which the intervention ran as planned) and intervention exposure (i.e. the extent to which members of trial practices were exposed to the intervention) [ 19, 15].
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Additionally, providing enough resources to ensure that a member of trial staff is always present to ask patients to join a trial is important.
Acknowledgement will include all local co-ordinators and collaborators, members of the trial committees, the Trial Co-ordinating Centre and trial staff.
TGR & GAF were co-investigators responsible for developing the trial, applying for trial funding and were members of the trial steering committee.
The Trial Management Group (TMG) will include the chief investigator, senior trial manager, trial manager, assistant trial manager, data manager and other members of the trial team when applicable.
At least two members of the trial team evaluate serious events related to the trial and decide if the trial team should be gathered.
The trial protocol was developed in collaboration with health economists, who were members of the trial steering group, and an economics working group including the trial manager and leaders have overseen the economic evaluation.
The analyses for the DMC will be performed by the trial statistician only and no other members of the trial research group will have access to the results.
Acknowledgement will include all members of the trial committees, the data co-ordinating centre, trial staff, and local co-ordinators at all collaborating centres.
We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going.
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CEO of Professional Science Editing for Scientists @ prosciediting.com