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Key issues include the use of appropriate comparator groups either in controlled observational studies or in RCT perhaps using cluster designs and multi-level approaches to data analysis.
Furthermore, it necessitates appropriate comparator groups in order to test and validate the biomarker platform (Costello et al, 2012), as the diagnostic algorithm will be determined by the clinical imperative.
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Randomisation is essential for a comparison of safety among those receiving a study intervention compared to an appropriate comparator group.
6 In both cases we compared each intervention group with the most appropriate comparator group as shown in table 1. Massage=Six sessions of therapeutic massage, one session per week.
A followup study with an appropriate comparator group is needed to address this limitation.
A study using an appropriate comparator group (women undergoing expectant management) found "better" outcomes in the elective induction group.
However, it is even more difficult to compose the appropriate comparator group and control for all potential confounding factors in a registry than in a well conducted randomized clinical trial.
Future prospective studies with appropriate non-AKI comparator groups will be required to confirm these results.
The appropriate statistical analysis of such comparator groups in the trial context of equivalent follow up in each arm is an odds ratio rather than incidence rate ratio.
As this was a prevention study, normal care was considered to be no treatment and so a placebo control group was an appropriate comparator.
So any information on costs and cost-effectiveness compared with an appropriate comparator will be presented.
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