STROBE Extension for Simulation-Based Research (STROBE-SIM)

What it is

— The STROBE Extension for Simulation-Based Research (STROBE-SIM) is the observational-study arm of a pair of reporting guidelines for health care simulation research (SBR) developed through an INSPIRE (International Network for Simulation-based Pediatric Innovation, Research and Education)-led international consensus process and published by Cheng, Kessler, Mackinnon et al. in 2016. The work produced two coordinated extensions, co-published in Advances in Simulation and Simulation in Healthcare: a CONSORT extension for randomized simulation trials and a STROBE extension for non-randomized/observational simulation studies, each accompanied by an Explanation-and-Elaboration document with worked examples. STROBE-SIM does not replace the parent STROBE checklist; it extends 10 of STROBE's 22 items — title/abstract (1), background/rationale (2), variables (7), data sources/measurement (8), statistical methods (12), descriptive data (14), main results (16), limitations (19), generalizability (21), and funding (22) — with content unique to simulation: the simulator/manikin and its fidelity, scenario standardization, instructional design (feedback, debriefing, mastery learning), participant/learner characteristics, and the validity argument for simulation-derived outcome measures. It is a reporting tool maintained within the EQUATOR Network library: it tells authors, reviewers, and readers what a simulation study must disclose to be appraisable and reproducible. It is not a design recipe, a risk-of-bias instrument, or a quality score. (The "simsurg" slug reflects this catalog's surgical-simulation entry point; the published guideline applies to health care simulation broadly, surgical and procedural simulation included.)

When to use

— Apply STROBE-SIM together with the parent STROBE checklist when you are reporting (or refereeing) a non-randomized/observational study whose intervention, exposure, or measurement instrument is a simulation — for example, an observational cohort evaluating a surgical simulation curriculum, a cross-sectional validity study of a simulator-based skills assessment, or a before-after evaluation of simulation training on procedural performance. The natural home is a peer-reviewed simulation, surgical-education, or medical-education journal. Decision rule for choosing the right family member: if the simulation study is a randomized trial, use the CONSORT simulation extension, not STROBE-SIM; if it is observational, use STROBE + STROBE-SIM. If the study is observational but not about simulation, use base STROBE (or the design/data extension that fits — RECORD/RECORD-PE for routinely-collected health data, STROBE-MR for Mendelian randomization, STROBE-NI for non-inferiority claims). STROBE-SIM governs reporting of the completed study; the protocol of a primary study is pre-specified with SPIRIT (trials) or the relevant primary-study protocol guidance, and a systematic review of simulation studies is reported with PRISMA — never STROBE-SIM.

What it requires

— Beyond the full parent-STROBE disclosures (design named in the title/abstract, setting and time anchors, eligibility and participant flow, explicit variable definitions, statistical methods including confounding control and missing-data handling, both unadjusted and adjusted estimates, and a candid limitations/generalizability discussion), the 10 STROBE-SIM extended items compel the simulation-specific reporting that otherwise makes a study un-reproducible: a clear statement that the work is simulation-based and the type of simulation (item 1); the educational/theoretical rationale for the simulation intervention (item 2); precise definition of the simulation intervention, simulator, and fidelity plus the instructional design — scenario, feedback, debriefing, dosage (items 7-8); the psychometric/ validity evidence for simulation-derived outcome measures and rater training (items 8, 12, 16); full description of participants/learners and the simulation environment (item 14); and explicit discussion of the fidelity gap and transfer — the threat that performance in the simulated setting may not transfer to real patients — under limitations and generalizability (items 19, 21). The validity-of-measurement and transfer requirements are the methodological core: a simulation result is only as interpretable as the argument that the simulated task and its scoring stand in for the real clinical task.

When NOT to use — limitations and common misapplications

— (1) Wrong family member: using STROBE-SIM to report a randomized simulation trial — that is the CONSORT simulation extension's job — or, conversely, citing the CONSORT extension for an observational design. (2) Wrong extension for the design: applying STROBE-SIM to an observational study that has nothing to do with simulation (it belongs to base STROBE/RECORD), or applying base STROBE/RECORD to a simulation study and thereby omitting fidelity, scenario, and validity-of-measurement reporting. (3) Mistaking it for an appraisal tool: STROBE-SIM is a reporting checklist, not a risk-of-bias instrument and not a quality score; ticking the items does not certify that the study is valid, that the simulator is fit for purpose, or that simulated performance transfers to patient care. (4) Checklist-as-theater: listing "high-fidelity simulator" without the make/model, fidelity dimensions, scenario script, debriefing structure, and rater-reliability evidence satisfies the letter and defeats the purpose. (5) Over-claiming external relevance: completing the checklist does not make a simulation-based finding generalizable to real patients; the transfer/fidelity-gap limitation (items 19, 21) must be argued, not asserted.

How it maps to this catalog

— Stated honestly, STROBE-SIM is largely orthogonal to the routinely-collected-data (claims/EHR/registry) RWE concepts that dominate this catalog; its natural neighbors are the parent `strobe` statement it extends and the sibling `consort` family it was co-developed with (the randomized-trial arm of the same simulation guideline pair). Do not expect concepts such as target-trial emulation, high-dimensional propensity scores, the active-comparator new-user design, or claims phenotype algorithms to implement this guideline — they do not, and forcing that mapping would be the very "wrong extension / fabricated relevance" failure mode the guideline warns against. Where genuine overlap exists, it is narrow and item-specific: - Parent reporting backbone: `strobe` supplies the 22 base items STROBE-SIM extends — always cite and complete both. - Generalizability / transfer (items 19, 21): `generalizability-transportability-external-validity-rwe` is the relevant lens for arguing whether simulated performance and the studied learners transport to real clinical settings and patient outcomes. - Statistical methods / estimands (item 12), only if the simulation study is comparative: `estimands-ate-att-intercurrent-events-rwe` clarifies the target estimand and intercurrent-event handling when comparing groups (e.g., curriculum vs control) — relevant when the simulation study is observational-comparative, not when it is a single-arm validity study. - Attrition (parent STROBE item 13): `attrition-and-loss-to-follow-up-rwe` informs the participant-flow accounting when learners drop out across simulation sessions or follow-up to a patient-care outcome.

Applied note

The realistic application is not a claims/EHR analysis. Consider a multicenter observational study of a surgical simulation curriculum measuring skill acquisition on a virtual- reality laparoscopic trainer and transfer to operating-room performance. STROBE-SIM is what forces the report to state the simulator make/model and fidelity, the standardized scenario and case mix, the debriefing and feedback structure and dosage, the learners' baseline experience, the psychometric validity and inter-rater reliability of the scoring instrument, and — under limitations — the fidelity gap and the strength of evidence that simulated performance predicts real patient outcomes. Only if such a study were also linked to routinely-collected patient outcomes (e.g., registry-based complication rates) would the catalog's RWE data-fitness, time-zero, and confounding concepts begin to apply, and then under STROBE/RECORD rather than STROBE-SIM.