The Study Design Categorizer

Q1: Does the study use or collect measurements or assessments about individual humans? YES

Q2: What is the primary mode of inquiry? QUANTITATIVE

Q3: Does the investigator assign one or more interventions? YES

We have now decided that your study is an INTERVENTIONAL study

Question 4: Are there one or more control groups?

• YES
• NO

Additional descriptors:

• Statistical intent: one of superiority, non-inferiority, equivalence
• Sequence generation: one of random, non-random
• Assignment method: one of sequential, adaptive, blocking, stratification, etc. THIS IS NOT QUITE RIGHT
• Allocation method: one of adequate (per Cochrane), inadequate
• Are participants assigned to more than one set of study interventions? Yes = factorial, No = non-factorial
• Is the unit of randomization an individual human? Yes = individual assignment; No = cluster assignment
• Blinding/Masking: Yes or No of each of: participant, investigator, outcomes assessor, statistician
• Control group type: one of active, placebo, sham, usual care, dose comparison, historical
  
• Study phase: one of Phase 0, I, II, III, IV

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Should the line that defines the type of study be made more prominent? -- SimonaCarini - 25 Nov 2008

The lines in red are in the Study Design presentation but not in the Additional descriptor document. Note that the updated ClinicalTrials.gov schema has also Phase 1/Phase 2 and Phase 2/Phase 3

-- SimonaCarini - 23 Dec 2008

Also note that Non-clustered/Clustered is no longer in the decision tree, so I am not sure where to put this: Not clustered + Clustered * Are participants assigned to more than one set of interventions? (yes = factorial, no=parallel group)

-- SimonaCarini - 23 Dec 2008

The following list is in the additional descriptor document and it seems to describe the allocation method: * centralised (e.g. allocation by a central office unaware of subject characteristics) or pharmacy-controlled randomisation • pre-numbered or coded identical containers which are administered serially to participants • on-site computer system combined with allocations kept in a locked unreadable computer file that can be accessed only after the characteristics of an enrolled participant have been entered • sequentially numbered, sealed, opaque envelopes

-- SimonaCarini - 23 Dec 2008