- Overview
- 1 - Title and Abstract
- 2 - Introduction
- 3-12 - Methods
- 3a - Trial design
- 3b - Changes to trial design
- 4a - Participants
- 4b - Study settings
- 5 - Interventions
- 6a - Outcomes
- 6b - Changes to outcomes
- 7a - Sample size
- 7b - Interim analyses and stopping guidelines
- 8a - Randomisation: sequence generation
- 8b - Randomisation: type
- 9 - Randomisation: allocation concealment mechanism
- 10 - Randomisation: implementation
- 11a - Blinding
- 11b - Similarity of interventions
- 12a - Statistical methods
- 12b - Additional analyses
- 13-19 - Results
- 20-22 - Discussion
- 23-25 - Other information
- Further explanations
- Flow Diagram
- Citing CONSORT
- Permission to use CONSORT
- Translations
- References
Similarity of interventions
Item 11b - If relevant, description of the similarity of interventions
Example
“Jamieson Laboratories Inc provided 500-mg immediate release niacin in a white, oblong, bisect caplet. We independently confirmed caplet content using high performance liquid chromatography … The placebo was matched to the study drug for taste, color, and size, and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”(172)
Explanation
Just as we seek evidence of concealment to assure us that assignment was truly random, we seek evidence of the method of blinding. In trials with blinding of participants or healthcare providers, authors should state the similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35) (173)
Some people have advocated testing for blinding by asking participants or healthcare providers at the end of a trial whether they think the participant received the experimental or control intervention.(174) Because participants and healthcare providers will usually know whether the participant has experienced the primary outcome, this makes it difficult to determine if their responses reflect failure of blinding or accurate assumptions about the efficacy of the intervention.(175) Given the uncertainty this type of information provides, we have removed advocating reporting this type of testing for blinding from the CONSORT 2010 Statement. We do, however, advocate that the authors report any known compromises in blinding. For example, authors should report if it was necessary to unblind any participants at any point during the conduct of a trial.
Page last edited: 24 March 2010
