Clinical trials
Clinical trials
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Randomised-control trials (RCTs) are the bedrock of evidence-based medicine. They are the only way to conduct causal inference with confidence. This is because by prospectively allocating participants or clusters to treatment arms at random, the effects of idiosyncratic differences between the groups within each arm tend to equilibrate, allowing for accurate and reliable estimation of the effect of the treatments only. However, it is important that trials are designed and reported rigourously to minimise risk of bias and maximise generalisability to allow others to extrapolate results into clinical practice in different settings.
Treatment allocation in randomised-control trials
Treatment allocation in randomised-control trials
Across medicine and surgery, most RCTs allocate individual patients to treatment arms. However, in ophthalmology there is the option of treating one or two eyes per patient, complicating allocation. It is important that treatment allocation is consistent (controlled) in order to ensure that each intervention group is similar, facilitating fair comparisons.
We conducted a meta-research study (TAO-RCT) of all eye-related RCTs published over a 12-month period to explore the frequency of uncontrolled treatment allocation as well as how often treatment allocation is unclearly reported. 15% of the RCTs exhibited uncontrolled allocation, and the allocation pattern was unclear in 19% of RCTs.
To improve reporting and maximise the clarity and fairness of ophthalmological RCTs, we suggest that researchers use a simple nomenclature system as described in our article in Eye.
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