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Envelopes will be opened only after the enrolled patients have completed all baseline assessments and subsequent appointments have been made based on treatment allocation.
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The properties of these two designs are evaluated based on treatment imbalance and allocation predictability under different sample sizes and unequal allocation ratios.
A treatment colour code was assigned to each village based on the treatment allocation schedule.
As before, note that instruments based on random treatment allocation and network structure (e.g. (tilde {boldsymbol {G}}boldsymbol {t}) and (tilde {boldsymbol {G}^{2}}boldsymbol {t})) will be more plausible than those based on the exogenous characteristics, X, and the network structure (e.g. (tilde {boldsymbol {G}}^{2}boldsymbol {X})) since t has been randomly allocated, whereas X need not be27.
The investigators developed a cost tree based on the treatment allocation for the study patients and reported healthcare costs for the excess cost-generating events (new infections and prolonged ICU stay) that were identified.
Efficacy analyses were based on treatments received.
Similarly, an analysis based on per protocol treatment allocation also showed no evidence for treatment group differences in both an unadjusted and adjusted analysis (Oxford hip score, P=0.574; Harris hip score, P=0.179).
Randomized controlled trials were assessed based on concealment of treatment allocation, blinding of outcome assessors, completeness of follow-up, and the attainment of sufficient power to detect significant differences.
To complete their studies, several investigators conducted part of the trial based on random allocation of treatments, and part based on patient preference [ 25, 26, 29, 36].
In such studies, it cannot be known whether the response to an allocation is based on the actual allocation, the intended allocation, or an interaction between both factors.
The only added feature in pragmatic randomised evaluations is that, among currently accepted treatments where there is no evidence on comparative effectiveness, treatment choices are based on random allocation rather than on arbitrary decisions by clinicians.
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