Skip to main content

Table 2 Description of items extracted

From: Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Item label Description of item reported in the publications
Brief name Precise name or phrase describing the intervention
Rationale Rationale, theory or goal for testing the intervention components
Patient views’ Patient feedback incorporated in intervention development
Setting Where the intervention was conducted
Recipient Inclusion criteria provided for the recipients
Provider Sufficient details on who provided the intervention. For example, type of professional or volunteer, their expertise and background and whether they received any training to undertake the intervention
How Description of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities
Tailored Intervention tailored to the recipient, i.e. did it consider the participants’ circumstances or wishes in regards to how they adhered to medication?
Manual or protocol Intervention has been standardized such as in a manual, procedure book or protocol
Intervention sessions Number of intervention sessions provided
Duration of intervention Length of time over which the intervention provided was given
Duration of sessions Indication of the length of each session
Modifications Modification of the intervention during the study
Intervention supporting materials Description of supporting materials, including those provided to participants or used in intervention delivery or in training of the intervention providers
Descriptive aids Details of the intervention provided in the paper in a table, figure or another medium
Supplementary materials References or electronic links to additional information describing the intervention
Comparator arm Any details on what participants in the comparator group received
Fidelity Was the conduct of the intervention observed or recorded?
If so:
• How was this done?
• Who assessed fidelity?
• How did the study seek to maintain fidelity?
• Did they report how well fidelity was maintained?
Word length Length of text devoted to describing the intervention and comparator.