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Introduction
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Background
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Report the care or quality gap (e.g. failure to implement guidelines) that the intervention seeks to address [29].
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Report the evidence behind the intervention to be implemented (e.g.: RCTs, controlled trials, systematic reviews) [11,29].
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Report the theory behind the intervention [10,31,29] and how the theory influenced the study design [10].
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Methods
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Setting
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Describe the study setting [10,11,31].
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Describe any changes or modifications required to adjust to the intervention [7,10].
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Report readiness to change (also those not eager to change) [29].
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How did the setting enable or hinder the implementation? [10]
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Participants
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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].
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Intervention
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Provide detailed description of intervention strategies:
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Components/content for each group [10,31,29].
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Frequency [10], duration [4,10,31,29] and intensity [10,31,29] of the intervention
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Mode of delivery [31,29] and materials used [31,29].
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What is the relationship of components to the theory discussed above? [10]
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What is the target population? [4,11]
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Provide details of participants receiving the intervention (eligibility criteria?) [10,11,31].
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Provide detailed characteristics of those promoting and undertaking the intervention [4,10,31].
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What were the processes for ensuring intervention fidelity? [4,7,10,31]
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Describe the intervention received by control group (not just describe as ‘usual care’) [31].
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The intervention must be delivered as part of routine care [11].
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Analysis
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Describe measurements used to assess implementation effectiveness [29].
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Outcomes should be assessed at the population level, typically with routine data [11]. Describe methods of statistical analysis [31,29].
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Results
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Participant flow
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Report the process by which eligible patients were invited to participate (e.g. number invited and timescale) and any exclusions [4].
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Report participation rate among the eligible population [4,11] and the representativeness of participants compared to whole eligible population [4].
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Setting
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Report characteristics of the setting to enable assessment of representativeness [4].
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Intervention
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Cost of the intervention [4].
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Report any modifications or adaptation [4,11,28].
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Report any intervention feasibility, acceptability, and potential sustainability [28].
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Discussion
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Reflections
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Reflect on the implementation process [10,11].
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Report any lessons learned from the implementation process [10].
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Report any barriers or facilitators for implementing in routine care [9].
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Discuss the relationship between adaptations/modifications and treatment outcomes, implementation outcomes and adverse events [28].
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