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4) What short-term outcome indicators could be used to monitor the effectiveness of trial interventions?
The majority of trial interventions included some form of outpatient physiotherapy.
Quality control templates support the informed consent process and fidelity of trial interventions and outcomes assessment.
Consent for the child's participation in the trial can therefore be sought from parents or legal guardians after his/her enrolment and the administration of trial interventions.
The current study went further than our earlier study in that it reports the frequency of poor reporting of specific aspects of trial interventions.
We recommend that RECs begin to network with each other to build consensus about adolescent trials, including the acceptability of trial interventions in terms of national risk standards.
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The daily diary will include records of trial intervention intake, other treatments used and occurrence of adverse events.
The burden of trial intervention was reported by each patient at the end of each therapy session, however, overall trial burden to patients and family was not evaluated.
Block randomisation in batches of eight using computer-generated random numbers is being used to assign women to one of the four combinations of trial intervention.
Where possible, a comprehensive description of trials interventions has been presented for the majority of trials (additional file 2).
This simple approach breaks new ground in cross tabulating qualitative evidence with the characteristics of trialled interventions.
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