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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
 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].
 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].
 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].
 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].