Interventions

Here are the required and recommended information to be reported about a trial's interventions. The bolded items are part of the Minimal Data Set.

Click on Descriptor Name for an example of the item.


Interventions

Heading

Required Items

Recommended Items

Optional Items

Experimental Intervention(s)

Drug Interventions

 

  • 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)

 

Intervention Blinding

Method of participant blinding

Method of care provider blinding

Efficacy of Intervention Blinding

 

 

Compliance

Compliance per intervention group

 

Crossovers

Number of crossovers between all pairs of experimental and comparison groups

Reasons for crossovers

 

Treatment Completion

  • 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]

 

[1]Contact us, if you have an example of reporting this element.


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