The published aggregate data is variable in the completeness of outcome reporting and in definitions used between trials.
Six key aspects that influence the quality of an RCT were assessed: sequence generation, allocation concealment, patient blinding, personnel and outcome assessors, management of incomplete outcome data, and completeness of outcome reporting, as well as other potential threats to validity.
20 The following domains will be assessed: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, completeness of outcome data, completeness of outcome reporting and other potential sources of bias (eg, baseline imbalance and conflicts of interest).
The assessment included the randomisation methods (allocation sequence generation and allocation concealment), blinding (of participants, personnel and investigators), completeness of outcome data, reporting of data and other biases.
The risk of bias of individual trials was assessed with a low risk of bias being desirable for sequence generation, allocation concealment, and completeness of outcome data reporting.
The quality of the eligible studies was independently assessed by two researchers (EB, MS) using the Cochrane Risk of Bias tool.34 Criteria included randomisation, sequence generation, allocation concealment, blinding (by outcome), completeness of outcome data, selective outcome reporting and presence of other potential sources of bias (e.g. baseline imbalance or incomplete baseline data).
We separately assessed the potential for systematic error within individual studies using the Cochrane risk of bias tool [ 30] and the following dimensions of methodological quality: (1) generation of allocation sequence; (2) allocation concealment; (3) blinding (participant and researchers); (4) blinding of outcome assessors; (5) completeness of outcome data; (6) selective outcome reporting.
The risks of bias criteria assessed were: reporting of sequence generation; allocation concealment; blinding of participants, personnel, and outcome assessors; completeness of outcome data; and selective outcome reporting.
Evaluating the completeness of reporting of reporting guidelines in relation to journals' endorsement might seem straightforward.
The quality items assessed were sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, selective outcome reporting, and other sources of bias.
45 This recommends the explicit reporting of the following individual elements for randomised control trials (RCTs): random sequence generation; allocation sequence concealment; blinding (participants, personnel, outcome assessment); completeness of outcome data, selective outcome reporting; and other sources of bias.
