Did the analysis include an intentiontotreat analysis? If so, was this appropriate and were appropriate methods used to account for missing data? Consider how closely the RCT(s) reflects routine clinical practice in England. In addition to parallel group RCTs, there are other randomised designs (for example, randomised crossover trials and randomised cluster trials) in which further quality criteria may need to be considered when assessing bias. Key aspects of quality to be considered can be found in (University of York Centre for Reviews and Dissemination). If there is more than 1 RCT, tabulate a summary of the responses applied to each of the quality assessment criteria. A suggested table format for the quality assessment results is presented below. Table X Quality assessment results for parallel group RCTs Trial number Trial 1 Trial 2 [Add (acronym) more columns as needed] Was randomisation (yes/no/not clear/N/A) (yes/no/not carried out appropriately? Was the concealment (yes/no/not clear/N/A) (yes/no/not clear/N/A) of treatment allocation adequate? Were the groups (yes/no/not clear/N/A) (yes/no/not clear/N/A) similar at the outset of the study in terms of prognostic factors? Were the care (yes/no/not clear/N/A) (yes/no/not clear/N/A) providers, participants and outcome assessors blind to treatment allocation? Were there any (yes/no/not clear/N/A) (yes/no/not clear/N/A) unexpected imbalances in
Did the analysis include an intentiontotreat analysis? If so, was this appropriate and were appropriate methods used to account for missing data? Consider how closely the RCT(s) reflects routine clinical practice in England. In addition to parallel group RCTs, there are other randomised designs (for example, randomised crossover trials and randomised cluster trials) in which further quality criteria may need to be considered when assessing bias. Key aspects of quality to be considered can be found in (University of York Centre for Reviews and Dissemination). If there is more than 1 RCT, tabulate a summary of the responses applied to each of the quality assessment criteria. A suggested table format for the quality assessment results is presented below. Table X Quality assessment results for parallel group RCTs Trial number (acronym) Trial 1 Trial 2 [Add more columns as needed] Was randomisation carried out appropriately? (yes/no/not clear/N/A) (yes/no/not Was the concealment of treatment allocation adequate? (yes/no/not clear/N/A) (yes/no/not clear/N/A) Were the groups similar at the outset of the study in terms of prognostic factors? (yes/no/not clear/N/A) (yes/no/not clear/N/A) Were the care providers, participants and outcome assessors blind to treatment allocation? (yes/no/not clear/N/A) (yes/no/not clear/N/A) Were there any unexpected imbalances in (yes/no/not clear/N/A) (yes/no/not clear/N/A)
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