SQuIRE-SIM

Simulation-based methodologies are often incorporated into healthcare improvement efforts. A simulation-based extension for the SQuIRE 2.0 writing guideline was developed to provide standards for reporting for simulation-specific elements in improvement research. The guidelines were created using an established consensus process methodology that includes international experts in both simulation education and research and quality improvement research. The use of these simulation-based extensions supports greater understanding of the learning and generalizability of simulation-based projects to improve the care and outcomes for patients.

Publication:

https://pubmed.ncbi.nlm.nih.gov/39162794/

 

Text Section and Item Notes SQuIRE 2.0 Items SQuIRE-SIM Extension
Notes to Authors

 

  • The SQuIRE guidelines provide a framework for reporting new knowledge about how to improve healthcare.
  • The SQuIRE guidelines are intended for reports that describe system level work to improve the quality, safety, and value of healthcare, and used methods to establish the observed outcomes were due to the intervention(s).
  • A range of approaches exists for improving healthcare, SQuIRE may be adapted for reporting any of these.
  • Authors should consider every SQuIRE item, but it may be inappropriate or unnecessary to include every SQuIRE element in a particular manuscript.
  • The SQuIRE glossary contains definitions of many of the key words in SQuIRE.
  • The Explanation and Elaboration documents provides specific examples of well-written SQuIRE items, and an in-depth explanation of each item.
  • Please cite SQuIRE when it is used to write a manuscript.
  • The SQuIRE-SIM extension focuses on strategies for reporting simulation-based studies intended to improve healthcare education and/or delivery where simulation is used as an intervention (simulation used to make change) or method of study (simulation to evaluate a change).
  • For those studies in which simulation is used as an educational intervention, aspects of SQuIRE-EDU may also be applicable.
  • Authors should consider every SQuIRE and SQuIRE-SIM item, but it may be unnecessary to include every SQuIRE or SQuIRE-SIM element in a particular manuscript. Emphasize "simulation as an intervention" in the intervention sections (#8 & #9), and "simulation as the method of study" in measures (#10) and analysis (#11). Although some information may be relevant in multiple sections of the manuscript, select the optimal section and avoid repetition.
  • Please cite SQuIRE-SIM when it is used to write a manuscript.
  • These guidelines may also be useful as a framework when designing a simulation-based quality improvement project to ensure all suggested elements have been met.
Title and Abstract    
1. Title Indicate that the manuscript concerns an initiative to improve the healthcare (broadly defined to include the quality, safety, effectiveness, patient-centeredness, timeliness, cost, efficiency and equity of healthcare. SIM 1: Indicate that the manuscript concerns a simulation-based quality improvement initiative.
2. Abstract

a. Provide adequate information to aid in searching and indexing.

b. Summarize all key information from various sections of the text using the abstract format of the intended publication or a structured summary such as: background, local problem, methods, interventions, results, conclusions.

SIM 2a: Keywords include "simulation," "simulated," or "simulated-based,"

SIM 2b: Include how simulation is used in the study as an intervention, a QI method of study or both.

 
Introduction: Why did you start?    
3. Problem Description Name and significance of the local problem.  - -
4. Available Knowledge Summary of what is currently known about the problem, including relevant previous studies.

SIM 4: Include relevant studies in which simulation was used in the literature review.
5. Rationale Informal or formal frameworks, models, concepts and/or theories used to explain the problem, any reasons or assumptions that were used to develop the intervention(s) and reasons why the intervention(s) was expected to work. SIM 5: Include relevant simulation-specific frameworks, theories or experiences, if available, that guided the choice and implementation of simulation for the current problem.
6. Specific Aims Purpose of the project and of this report.  - -
Methods: What did you do?    
7. Context Contextual elements considered important at the outset of introducing the intervention(s). SIM 7: Include the contextual elements for simulation-based quality improvement projects and simulation team characteristics including enough detail of the simulation-specific aspects of the intervention for reproducibility. See Figure 1 for further details and examples.
8. Intervention(s)

a. Description of the intervention(s) in sufficient detail that others could reproduce it.

b. Specifics of the team involved in the work.

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9. Studies of the Intervention(s)

a. Approach chosen for assessing the impact of the intervention(s).

b. Approach used to establish whether the observed outcomes were due to the intervention.

SIM 9a: When simulation is the intervention, describe any iterative changes to the simulation itself or means to standardize simulation delivery.

SIM 9b: When simulation is the intervention, describe how variability across simulations was managed.
10. Measures

a. Measures chosen for studying processes and outcomes of the intervention(s), including rationale for choosing them, their operational definitions and their validity and reliability.

b. Description of the approach to the ongoing assessment of contextual elements that contributed to the success, failure, efficiency and cost.

c. Methods employed for assessing completeness and accuracy of data.

SIM 10a: When simulation is used as the method of study, describe how simulation was used to assess the outcome of the intervention and the means used to enhance and assess the validity and reliability of the measures, e.g. rater training, comparison of independent raters,

SIM10b: When simulation is used as the method of study, describe the approach used to assess simulation-specific contextual elements, such as realism, simulation setting/modality, generalizability, that contributed to the success, failure, efficiency and cost.

SIM 10c: When simulation is the method of study, describe the methods and means of data acquisitions, such as use of checklists, sensors embedded within the simulators, real-time observations, video review, tracking devices, debrief analysis or other means.
11. Analysis

a. Qualitative and quantitative methods used to draw inferences from the data

b. Methods for understanding variation within the data, including the effects of time as a variable.

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SIM 11b: When simulation is the intervention, describe the methods for assessing consistency across simulations.  When simulation is the method of study, describe methods for assessing outcomes related to condensed time intervals.
12. Ethical Considerations Ethical aspects of implementing and studying the intervention(s) and how they were addressed, including, but not limited to, formal ethics review and potential conflict(s) of interest. SIM 12: Describe approaches to mitigate potential risks from simulation such as patient and staff physical safety during an in situ simulation, efforts to maintain psychological safety and confidentiality, especially as it relates to relationship of participants and observers.
Results: What did you find:    
13. Results

a. INitial steps of the intervention(s) and their evolution over time (e.g. time-line diagram, flow chart or table), including modifications made to the intervention during the project.

b. Details of the process measures and outcomes.

c. Contextual elements that interacted with the intervention(s).

d. Observed associations between outcomes, intervention(s) and relevant contextual elements.

e. Unintended consequences such as unexpected benefits, problems, failures or costs associated with the intervention(s).

f. Details about missing data.

SIM 13a: Describe any unintended deviations or iterative changes to the simulation and the impact of these changes on the results.

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SIM 13e. Describe any unintended consequences, unexpected benefits or safety issues that may have resulted from the simulation-based elements of the study.

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Discussion: What does it mean?    
14. Summary

a. Key findings, including relevance to the rationale and specific aims.

b. Particular strengths of the project.

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SIM 14b: Include the stregth of simulation as intervention or method of study as compared to other methods of study, i.e. why might have simulation worked better than other methods?
15. Interpretation

a. Nature of the association between the intervention(s) and the outcomes.

b. Comparison of results with findings from other publications.

c. Impact of the project on people and systems.

d. Reasons for any differences between observed and anticipated outcomes, including the influence of context.

e. Costs and strategic trade-offs, including opportunity costs.

 SIM 15: Describe the transferability of simulation-based training to clinical performance.  Describe the extent to which the simulation-based intervention or outcomes can be generalized to patient-based outcomes.  Discuss cost effectiveness, if applicable.
16. Limitations

a. Limits to the generalizability of the work.

b. Factors that might have limited internal validity such as confounding, bias or imprecision in the design, methods, measurements or analysis.

c. Efforts made to minimize and adjust for limitations.

SIM 16a: Specify the simulation-specific limitations that may limit generalizability such as realism, location, learner acceptance, participant population.

SIM 16b: Specify dimulation-specific factors that may have limited validity.

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17. Conclusions

a. Usefulness of work.

b. Sustainability

c. Potential for spread to other contexts.

d. Implication for practice and for further study in the field.

e. Suggested next steps.

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SIM 17c: Describe the scalability and transferability of the simulation intervention or assessment to other individuals, teams, systems and to real patients or situations.

SIM 17d: If simulation is the intervention, include lessons learned for clinical practice , care experience, education, training, and policy.  If simulation is the method of study, include implications of this assessment process for future studies.

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18 Funding Sources of funding that supported this work. Role, if any, of the funding organization in the design, implementation, interpretation and reporting  - -