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Table 3 á…Ÿ

From: Clinical interventions, implementation interventions, and the potential greyness in between -a discussion paper

 

Standard for Quality Improvement Reporting Excellence (SQUIRE) [57]

Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2) [55]

Developing Standards for Reporting Phase IV Implementation studies (StaRI) [48]

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide [56]

Overview

18-item checklist for reporting system-level interventions, where methods focused on attributing change to interventions

13-item checklist based on development (4 criteria), feasibility and piloting (1 criteria) and evaluation (8 criteria) of complex interventions

35-item checklist focused on reporting for both intervention impact and implementation process for complex interventions

13-item checklist for intervention completeness and replicability; applies questions: why, what, who, how, where, when and how much, assessing tailoring, modifications, and how well

Checklist content

1. Title – focus on the initiative

2. Abstract – summarize key info

3. Problem description - nature and significance of issue

4. Available knowledge – summary of what is known

5. Rationale – theoretical foundations and assumptions

6. Specific aims – report purpose

7. Context – elements considered key at the outset

8. Intervention(s) – details of intervention and team

9. Study of intervention(s) – approach to assess outcomes

10. Measures – both process and impact measures; methods

11. Analysis – methods for making inferences, assessing variation

12. Ethical considerations – how addressed including formal review, conflicts of interest

13. Results – initial steps, evolution, modifications made, contextual elements, associations, unintended consequences, missing data

14. Summary - key findings and project strengths

1. Theoretical basis for intervention

2. Intervention components (rationale, aims, core functions)

3. Intended interactions between components

4. Details of context’s characteristics and role in intervention

5. Pilot test description and impact

6. Control condition description and rationale

7. Details of the intervention delivery strategy

8. Details of materials and tools used

9. Details of delivery fidelity relative to study protocol

10. Process evaluation -description, theoretical basis

11. Facilitators and barriers revealed as influencers via process evaluation

12. External factors influencing intervention delivery or how it worked

13. Cost or resources for delivery

1. Title and abstract

Introduction:

2. description of aspect of care that is the focus

3. rationale

4. evidence and

5. theory underpinning the implementation intervention,

6. study aims and distinction between intervention and implementation

Method (criteria 7–22): setting, intervention description (new service), population, randomization, data, and analysis details

Results (criteria 23–33): population (participation rates and compliance/attrition), fidelity (including modifications/adaptations), outcomes (process and clinical)

Discussion:

34. findings interpreted in context of literature, implications

General:

35. regulatory, ethical approval, and other registrations, funding, and conflicts of interest

Brief name:

1. name to describe intervention

Why:

2. rationale, theory, or goal of intervention components

What:

3. physical or other materials, including where to access

4. procedure/process description, including support activities

Who provided:

5. intervention provider (expertise, background, and specific training)

How:

6. modes of delivery and whether provided individually or in groups

Where:

7. type(s) of location(s) of the intervention, including infrastructure or relevant features

When and How Much:

8. frequency and time frame

Tailoring:

9. details of personalization or adaptation

Modifications:

10. description of changes

How well:

11. planned (how adherence or fidelity assessed; strategies to enhance fidelity)

12. actual (if adherence/fidelity assessed, extent of intervention delivery as planned)