Experimental Intervention(s)

Drug Interventions

• Generic name and description
• Details of administration

• Trade name and manufacturer
• Adjustment(s) for renal and/or hepatic function
• Other adjustments
• Criteria for terminating treatment

• NDC Drug Code^[1]
• FDA approval status^[1]

Procedures, Devices, or Behavorial Therapy

• Name of procedure, device, or behavorial therapy^[1]
• Name of procedure, device, or behavorial therapy^[1]
• If a device, manufacturer, make and model^[1]
• Description of intervention and its administration^[1]

• Proportion of cases done by each proceduralist^[1]
• Training and experience of procedure personnel^[1]
• Setting of procedure (e.g., outpatient surgicenter)^[1]

FDA approval status of device^[1]

Organizational and Other Interventions (e.g., guidelines, education)

Description of intervention and its administration^[1]

Comparison Intervention

Details of comparison intervention (as above)

• Justification for using this comparison
• Similarity of any placebo to experimental intervention

Intervention Blinding

Method of participant blinding

Method of care provider blinding

• Method of investigator blinding
• Method of study nurse blinding

Efficacy of Intervention Blinding

• Method for assessing the efficacy of blinding^[1]
• Accuracy of guesses at intervention received: participant
• Accuracy of guesses at intervention received: care provider

• Accuracy of guesses at intervention received: investigators
• Accuracy of guesses at intervention received: study nurses

Compliance

Compliance per intervention group

• Compliance per subgroup
• Compliance encouragement method
• Compliance determination method

Crossovers

Number of crossovers between all pairs of experimental and comparison groups

Reasons for crossovers

Treatment Completion

• Proportion of each intervention group completing assigned intervention
• Reasons for stopping treatment
• Number of participants in each intervention group stopping for each reason

• Proportion of each subgroup completing assigned intervention^[1]
• Numbers of participants in each subgroup stopping for each reason^[1]

Delay between randomization and start of intervention

Cointerventions

• Names and descriptions of cointerventions received^[1]
• Use of cointerventions per intervention group^[1]

• Names and descriptions of allowed cointerventions^[1]
• Justification for allowed cointerventions^[1]
• Use of cointerventions per subgroup^[1]