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 |