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Table 5 Major differences between pre-defined subgroups*

From: Guidelines for randomized clinical trial protocol content: a systematic review

Methods Recommendations
Guidelines specific to RCTs versus those with a broader scope (RCT + other study designs)
No differences RCT only guidelines are more likely to recommend including:
  · a systematic review as part of study background
  · reason for degree of blinding
  · methods to generate allocation sequence
  · methods to implement randomization (who will generate sequence, who will enroll participants, who will allocate participants)
Guidelines with explicitly described methods of development versus those without
Those with explicit methods are more likely to: Those with explicit methods are more likely to recommend including:
· describe multiple dissemination methods · Procedures to break the blind
  · Specific issues of consent with respect to vulnerable populations (for example, children, non-literate populations)
  · Dosing frequency
  · Duration of subject participation
Guidelines with explicit sources of funding versus those without
Funded guidelines are more likely to: Guidelines with funding are more likely to recommend including:
· Have explicitly described methods (including informal consensus methods, searching for evidence, informal tool validation) · Procedures to break the blind
  · Specific issues of consent with respect to vulnerable populations (for example, children, non-literate populations)
· More likely to describe multiple dissemination methods  
  · Dosing frequency
· Have multiple contributors (Median [IQR] = 9 [3, 15]versus 1 [1, 3]) · Site representative/investigator
  · Time and event schedules table
  1. *Subgroups were compared descriptively; as sample sizes were small only major differences are noted. IQR: Inter-quartile range; RCT: randomized clinical trial.