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Posted by / 07-Oct-2020 11:54

A key concern in complex pragmatic factorial trials is keeping the logistics simple and avoiding errors at the point of intervention delivery.

If clear advice is given to patients, there is probably little to choose between the different strategies of delayed prescription. Acute respiratory tract infections are the commonest acute conditions managed in primary care, and the control of symptoms is a central concern of patients and parents of young patients.1 2 Patients’ expectations and practitioners’ perceptions of those expectations have helped fuel prescribing, and antibiotic use in primary care is rising progressively again after a reduction that followed a peak in the late 1990s (gov.uk/health/2012/11/eaad-resources).It used previously validated formats11 15 for rating symptoms (0=no problem, 6=as bad as it could be).Symptoms included feeling generally unwell, sleep disturbance, fever, interference with normal activities, sore throat, cough, short of breath, facial or sinus pain, earache, and runny or blocked nose.If the doctor thought that immediate antibiotics were definitely required, they prescribed antibiotics, otherwise patients were randomised to one of four methods of delayed antibiotic prescribing.We assessed evidence of subversion of randomisation by monitoring the order of use of envelopes (there was no evidence of selective envelope use) and the baseline table (which showed that the groups were well balanced).

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During the study, it became clear from systematic reviews that delayed prescribing might result in higher antibiotic use than no initial prescription.8 We therefore added a no prescription group to facilitate interpretation of the effect of delayed prescription compared with the alternatives strategies, particularly because both the delayed and no prescription groups in the current study had higher antibiotic use than in previous studies.

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