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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, theory or goal for testing the intervention components

Patient views’

Patient feedback incorporated in intervention development


Where the intervention was conducted


Inclusion criteria provided for the recipients


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


Description of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities


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


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


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.