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Table 1 Summary of checklist items suggested by the literature

From: Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi

Checklist section

Suggested checklist item

Introduction

 

 Background

Report the care or quality gap (e.g. failure to implement guidelines) that the intervention seeks to address [29].

 

Report the evidence behind the intervention to be implemented (e.g.: RCTs, controlled trials, systematic reviews) [11,29].

 

Report the theory behind the intervention [10,31,29] and how the theory influenced the study design [10].

Methods

 

 Setting

Describe the study setting [10,11,31].

 

Describe any changes or modifications required to adjust to the intervention [7,10].

 

Report readiness to change (also those not eager to change) [29].

 

How did the setting enable or hinder the implementation? [10]

 Participants

Report method of recruitment [4] which should be to the clinical service not the research [11]. Participants recruited to research should be considered as a sub-group [11].

 Intervention

Provide detailed description of intervention strategies:

 

Components/content for each group [10,31,29].

 

Frequency [10], duration [4,10,31,29] and intensity [10,31,29] of the intervention

 

Mode of delivery [31,29] and materials used [31,29].

 

What is the relationship of components to the theory discussed above? [10]

 

What is the target population? [4,11]

 

Provide details of participants receiving the intervention (eligibility criteria?) [10,11,31].

 

Provide detailed characteristics of those promoting and undertaking the intervention [4,10,31].

 

What were the processes for ensuring intervention fidelity? [4,7,10,31]

 

Describe the intervention received by control group (not just describe as ‘usual care’) [31].

The intervention must be delivered as part of routine care [11].

 Analysis

Describe measurements used to assess implementation effectiveness [29].

Outcomes should be assessed at the population level, typically with routine data [11]. Describe methods of statistical analysis [31,29].

Results

 

 Participant flow

Report the process by which eligible patients were invited to participate (e.g. number invited and timescale) and any exclusions [4].

 

Report participation rate among the eligible population [4,11] and the representativeness of participants compared to whole eligible population [4].

 Setting

Report characteristics of the setting to enable assessment of representativeness [4].

 Intervention

Cost of the intervention [4].

 

Report any modifications or adaptation [4,11,28].

 

Report any intervention feasibility, acceptability, and potential sustainability [28].

Discussion

 

 Reflections

Reflect on the implementation process [10,11].

 

Report any lessons learned from the implementation process [10].

 

Report any barriers or facilitators for implementing in routine care [9].

 

Discuss the relationship between adaptations/modifications and treatment outcomes, implementation outcomes and adverse events [28].