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The quality of reporting varied amongst trials.
There was no significant heterogeneity (I 2 = 20%) found amongst trials.
Process evaluations have therefore become an important focus of interest amongst trials designers and health services researchers.
PMAs encourage uniformity in common protocol items amongst trials, including data collection and outcome definitions, whilst permitting flexibility in pre-specified protocol details and funding regulations.
This has not always been the case, with almost uniformly poor quality found amongst trials published prior to widespread adherence to CONSORT [ 14, 17- 20, 30].
Due to the nature of the intervention, blinding of trial personnel was not possible and is recognised as a continuing source of weakness amongst trials of therapeutic hypothermia.
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Amongst trial non-participants, the 77 who agreed to be approached for an interview were compared to those who did not (106).
There is now increasing recognition amongst trial methodologists, ethicists and the medical profession that equipoise is less concerned with the opinions of an individual clinician, and more focused on those of the medical community – termed 'clinical' or 'corporate' equipoise.
ANOVA test shows no significant difference in the EC amongst all trials (F = 1.4, P = 0.27 > 0.05).
We formally assessed for heterogeneity amongst the trials contributing to each summary estimate using the chi-square test and considered a p-value of less than 0.10 to indicate significant heterogeneity [ 33].
Dehydration and rehydration protocols were heterogeneous amongst included trials.
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