Impact of Simulation-based Learning on the Performance of Cardiorespiratory Skills in Undergraduate Physiotherapy Students: A Stratified Randomised Controlled Trial

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • Randomisation was performed at the individual student level (lottery within academic strata), not at the class or school level, and the intervention is not a one-to-one tutoring exception.
    • "Within each academic stratum students were then randomly allocated to Group A (experimental group) and Group B (control group) using the lottery method."
    • Relevant Quotes: 1) "The present single-blinded stratified randomised controlled experimental study, with participants stratified by academic performance prior to randomisation." (p. 2) 2) "Stratified randomisation was used to assign participants to the experimental and control groups within the academic curriculum setting. Participants were first stratified by their academic performance in the preceding year, i.e., 3rd-year BPT (>75%, 60%-75%, <60%). Within each academic stratum students were then randomly allocated to Group A (experimental group) and Group B (control group) using the lottery method." (p. 2) 3) "Ninety IVth year Bachelor of Physiotherapy (BPT) students participated in a two-day theory session and were then allocated to two groups (n=45 per group)." (Abstract) Detailed Analysis: The C criterion requires randomisation at the class level or stronger (school level), unless the intervention is one-to-one/personal tutoring. Here the unit of randomisation is the individual student: 90 students drawn from a single fourth-year BPT cohort at one institution were stratified by prior academic performance and then individually allocated to experimental or control groups by lottery. Both groups came from the same cohort and shared the same cardiorespiratory ward placements and the same instructor, so treatment and control students were intermixed within the same classes/wards, creating exactly the contamination risk that class-level randomisation is designed to prevent. The intervention (a group-delivered simulation module of 4-5 students per scenario) is not one-to-one personal tutoring, so the tutoring exception does not apply. Criterion C is not met because randomisation was conducted at the individual student level within a single cohort rather than at the class or school level, and no tutoring exception applies.
  • E

    Exam-based Assessment

    • Outcomes were measured with an author-adapted, author-developed checklist that received only face validation, not a widely recognised standardised exam.
    • "The authors obtained permission from the publishers of Judith Wilkinson's Procedural Checklists for Fundamentals of Nursing [18], to adapt to meet the requirements of cardiorespiratory physiotherapy training. The adapted skill, along with author-developed items was combined into a modified checklist."
    • Relevant Quotes: 1) "After a 2-3-day cooling-off period, baseline assessment of basic cardiorespiratory skills was conducted using an adapted clinical procedural checklist by two blinded evaluators (each focusing on different skill sets)." (p. 2) 2) "The authors obtained permission from the publishers of Judith Wilkinson's Procedural Checklists for Fundamentals of Nursing [18], to adapt to meet the requirements of cardiorespiratory physiotherapy training. The adapted skill, along with author-developed items was combined into a modified checklist." (p. 2) 3) "The checklist was then subjected to face validation by three field experts. No other psychometric testing was done for the adapted tool as the instrument was solely used for within cohort pre-post comparison rather than for diagnostic or predictive purposes." (p. 2) 4) "The adapted tool used to compare skills was not subjected to psychometric analysis beyond face validity, limiting generalisability." (p. 5) Detailed Analysis: The E criterion requires a standardised, widely recognised exam-based assessment that was not created specifically for the study. In this study, outcomes were measured with a checklist that the authors assembled by adapting a nursing procedural checklist and adding their own author-developed items. The tool received only face validation by three experts, with the authors explicitly stating that no other psychometric testing was done and that the tool was used solely for within-cohort pre-post comparison. This is a custom, study-specific instrument, not a national or state-wide standardised examination. Criterion E is not met because assessment relied on an author-adapted, author-developed, face-validated checklist rather than a recognised standardised exam.
  • T

    Term Duration

    • The intervention and outcome measurement spanned only about three weeks, far short of a full academic term.
    • "Over three weeks, the control group underwent only traditional bedside teaching, whereas the experimental group completed a 27-hour SBL module in addition to traditional bedside training."
    • Relevant Quotes: 1) "Over three weeks, the control group underwent only traditional bedside teaching, whereas the experimental group completed a 27-hour SBL module in addition to traditional bedside training." (Abstract) 2) "The three-week intervention period included traditional clinical placement for both groups... All the students were then placed in cardiorespiratory wards for a period of three weeks." (p. 2) 3) "3rd week: Consolidation and post-intervention assessment (Both groups)... post-intervention evaluation was conducted by the same blinded evaluators using the same checklist as at baseline." (p. 3) Detailed Analysis: The T criterion requires outcomes to be measured at least one full academic term (approximately 3-4 months) after the intervention begins. Here the entire intervention period was three weeks, with the post-intervention assessment performed at the end of the third week. Although the overall study window (September to December 2022) spans about four months, the intervention-to-measurement interval was only about three weeks, with no longer-term follow-up tracking reported. The authors note in the future scope that long-term impact was not examined. A three-week interval is well short of one academic term. Criterion T is not met because the interval from intervention start to outcome measurement was only about three weeks, far shorter than one full academic term.
  • D

    Documented Control Group

    • The control group's composition, demographics, baseline scores, and condition (traditional bedside teaching only) are clearly documented.
    • "Group B received traditional bedside teaching covering the same set of skills as the experimental group, delivered by the same investigator to maintain consistency in content and instruction."
    • Relevant Quotes: 1) "the control group underwent only traditional bedside teaching" (Abstract) and "Group B (control group)" (n=45 per group). (p. 2) 2) "Group B received traditional bedside teaching covering the same set of skills as the experimental group, delivered by the same investigator to maintain consistency in content and instruction." (p. 3) 3) Table/Fig-3 (Participants' demographic information): "Group B - Female 38 (84.44), Male 7 (15.56), Age, Mean (SD) (Years) 21.04 (0.20)." (p. 3) 4) Table/Fig-4 and Table/Fig-5 report Group B pre and post median (IQR) scores for every skill, e.g. Subjective evaluation B pre 18 (6) post 18 (4); "at baseline, the scores for all the clinical skills were comparable between groups (p>0.05)." (p. 3) Detailed Analysis: The D criterion requires the control group to be well-documented, including demographics, baseline performance, and the conditions/treatment received. This study reports the control group's size (n=45), gender distribution and mean age (Table/Fig-3), full baseline and post-intervention median scores for each of the six skills (Table/Fig-4, Table/Fig-5), confirmation that baseline scores were comparable across groups, and the condition the control group received (traditional bedside teaching only, same content, same investigator). Criterion D is met because the control group's demographics, baseline performance, size, and treatment condition are all clearly documented.

• Level 2 Criteria

  • S

    School-level RCT

    • Randomisation occurred at the individual student level within a single institution, not at the school or institutional unit level.
    • "Within each academic stratum students were then randomly allocated to Group A (experimental group) and Group B (control group) using the lottery method."
    • Relevant Quotes: 1) "Within each academic stratum students were then randomly allocated to Group A (experimental group) and Group B (control group) using the lottery method." (p. 2) 2) "The study was conducted at D.Y. University, Nerul, Navi Mumbai, Maharashtra, India , from September 2022 -December 2022." (p. 2) 3) "Finally, a single-institution setting may limit generalisability." (p. 5) Detailed Analysis: The S criterion requires randomisation at the school level, where 'school' means the institution or unit implementing the intervention. This trial was conducted at a single institution and randomised individual students within one cohort to the two arms. No schools, centres, sites, or institutional units were randomised; indeed the authors themselves flag the single-institution setting as a limitation. Criterion S is not met because randomisation was at the individual student level within one institution, not at the school or unit level.
  • I

    Independent Conduct

    • The same authors designed the simulation module and the same investigator delivered both arms, with no independent third-party evaluator conducting the trial.
    • "Group B received traditional bedside teaching covering the same set of skills as the experimental group, delivered by the same investigator to maintain consistency in content and instruction."
    • Relevant Quotes: 1) "The authors developed a simulation module that underwent face validation by an expert panel..." (p. 2) 2) "Group B received traditional bedside teaching covering the same set of skills as the experimental group, delivered by the same investigator to maintain consistency in content and instruction." (p. 3) 3) "baseline assessment of basic cardiorespiratory skills was conducted using an adapted clinical procedural checklist by two blinded evaluators (each focusing on different skill sets)." (p. 2) Detailed Analysis: The I criterion requires the study to be conducted independently from those who designed the intervention, typically via a third-party evaluation team. Here the authors both developed the simulation module and ran the trial, and the same investigator delivered the intervention to both groups. The only independence element is that the skills checklist was scored by two blinded evaluators; however, blinded outcome assessment is not the same as independent conduct of the study by an external evaluation team distinct from the intervention designers. There is no statement of third-party oversight or an external evaluation agency running the trial. Criterion I is not met because the intervention was designed, delivered, and analysed by the same author team, with blinded scorers but no independent external evaluator conducting the study.
  • Y

    Year Duration

    • Because criterion T is not met and the study spanned only about three weeks, the year-duration requirement cannot be satisfied.
    • "Over three weeks, the control group underwent only traditional bedside teaching, whereas the experimental group completed a 27-hour SBL module in addition to traditional bedside training."
    • Relevant Quotes: 1) "Over three weeks, the control group underwent only traditional bedside teaching..." (Abstract) 2) "The three-week intervention period included traditional clinical placement for both groups." (p. 2) 3) "Future scope: Further research could examine the long-term impact of SBL on students' clinical competencies and patient outcomes." (p. 5) Detailed Analysis: The Y criterion requires outcomes to be measured at least 75% of a full academic year (roughly 9-10 months) after the intervention begins, and it cannot be met if criterion T is not met. This study's intervention and measurement spanned only about three weeks, with no long-term follow-up; the authors explicitly note that long-term impact is left for future research. Criterion Y is not met because the tracking interval was only about three weeks, far below a full academic year, and criterion T was not met.
  • B

    Balanced Control Group

    • The additional 27-hour SBL module is the explicit treatment variable being tested against a business-as-usual traditional-training control, so the resource difference is integral to the study design.
    • "the study hypothesised that integrating SBL with traditional bedside teaching will produce greater gains in cardiorespiratory clinical skills than bedside training alone."
    • Relevant Quotes: 1) "the study hypothesised that integrating SBL with traditional bedside teaching will produce greater gains in cardiorespiratory clinical skills than bedside training alone." (p. 2) 2) "Over three weeks, the control group underwent only traditional bedside teaching, whereas the experimental group completed a 27-hour SBL module in addition to traditional bedside training." (Abstract) 3) "Group A (Experimental group): Participated in 27 hours of experiential learning through the prevalidated SBL module over three days, alongside traditional bedside teaching during the remainder of the week." (p. 2) 4) "Group B received traditional bedside teaching covering the same set of skills as the experimental group, delivered by the same investigator to maintain consistency in content and instruction." (p. 3) Detailed Analysis: Following the criterion B decision tree: extra resources are present (the experimental group received an additional 27-hour SBL module on top of the traditional bedside training that both groups received), and the control group did not receive a matching block of extra time. The difference is not negligible (27 hours). The decisive question is whether these additional resources are the explicit treatment variable. They are: the study's stated hypothesis is that "integrating SBL with traditional bedside teaching will produce greater gains ... than bedside training alone," meaning the SBL module itself is the intervention being tested against a business-as-usual baseline. The control received the same core bedside training delivered by the same investigator, with SBL being the single added, integral component under investigation. Per the spec exception, when additional resources are the primary treatment variable tested against business-as-usual, the control may remain at the standard level by design. Criterion B is met because the extra 27-hour SBL module is the explicit, integral treatment variable being tested against a business-as-usual traditional-training control rather than a separable, confounding add-on.

• Level 3 Criteria

  • R

    Reproduced

    • No independent replication of this specific trial by a different team is reported or identified.
    • Relevant Quotes: 1) "The study is unique in its stratified randomised controlled design, which allows integration of SBL into the existing academic curriculum..." (p. 4) 2) "These findings are consistent with Dairo YM et al., who emphasised development of profession-specific subjective and objective skills through SBL [8]." (p. 4) 3) "Blackstock FC, Watson KM... Simulation can contribute a part of cardiorespiratory physiotherapy clinical education: Two randomized trials." (Ref 31) Detailed Analysis: The R criterion requires that this specific study (its central experimental claim, in the same context and design) be independently replicated by a different team in a peer-reviewed outlet. The paper describes its own design as "unique" and cites related SBL/simulation studies (Walker & Roberts 2020, Blackstock et al. 2013, Dairo et al. 2024) only for thematic context; these are pre-existing different studies by different teams in different settings, not replications of this particular stratified RCT of SBL for cardiorespiratory skills in Indian physiotherapy students. Internet searching (Google Scholar / PubMed / journal site) on the title, authors, DOI 10.7860/JCDR/2026/85100.22758, and topic identified only these earlier related trials and no subsequent paper attempting to reproduce this specific April-2026 trial; given the paper's very recent publication date, no independent replication exists yet. Criterion R is not met because no independent replication of this specific study is reported or found; the cited works are related but not replications.
  • A

    All-subject Exams

    • Outcomes were limited to cardiorespiratory physiotherapy skills using a custom checklist, with no standardised all-subject exam assessment, and criterion E is not met.
    • "Both groups were assessed at baseline and after three weeks of basic cardiorespiratory skills training such as subjective evaluation, Blood Pressure (BP) measurement, auscultation, teaching breathing exercises, nebulisation techniques, and transfers using an adapted, validated checklist."
    • Relevant Quotes: 1) "Both groups were assessed at baseline and after three weeks of basic cardiorespiratory skills training such as subjective evaluation, Blood Pressure (BP) measurement, auscultation, teaching breathing exercises, nebulisation techniques, and transfers using an adapted, validated checklist." (Abstract) 2) "Six skills were included, with varying performance items (subjective evaluation=13 items, blood pressure measurement=17, auscultation=20, breathing exercises=11, nebulisation=11, and patient transfer=13)." (p. 2) Detailed Analysis: The A criterion requires impact to be measured across all main subjects using standardised exam-based assessments, and it cannot be met if criterion E is not met. Here outcomes are confined to six cardiorespiratory physiotherapy skills measured with a custom, face-validated checklist. No other subjects are assessed, and the assessment is not a standardised exam. Because criterion E is not met, criterion A automatically fails as well. Criterion A is not met because only a single, specialised skill domain was assessed with a non-standardised custom checklist, and criterion E is not met.
  • G

    Graduation Tracking

    • Outcomes were measured at three weeks with no follow-up, and criterion Y is not met, so graduation tracking is not satisfied.
    • "Future scope: Further research could examine the long-term impact of SBL on students' clinical competencies and patient outcomes."
    • Relevant Quotes: 1) "3rd week: Consolidation and post-intervention assessment (Both groups)... post-intervention evaluation was conducted by the same blinded evaluators using the same checklist as at baseline." (p. 3) 2) "Future scope: Further research could examine the long-term impact of SBL on students' clinical competencies and patient outcomes." (p. 5) Detailed Analysis: The G criterion requires tracking participants until graduation, and it cannot be met if criterion Y is not met. This study measured outcomes immediately after a three-week intervention, with no longer-term follow-up and no tracking through to BPT graduation; the authors explicitly defer long-term outcomes to future research. Internet searching for subsequent follow-up publications by the same authors (Karthik, Thakur, Shahane, Tipnis) tracking this cohort to graduation returned no such paper, so no graduation-tracking evidence exists in this paper or in any follow-up publication. Criterion G is not met because measurement stopped at three weeks with no graduation tracking, and criterion Y is not met.
  • P

    Pre-Registered

    • No pre-registration of the protocol on any trial registry before data collection is mentioned anywhere in the paper.
    • Relevant Quotes: 1) "The study received ethical approval from the Institutional Ethics Committee (IEC) for Biomedical and Health Research, D.Y. Patil School of Medicine, Navi-Mumbai (IEC Ref. No: DYP/IECBH/2020/074)." (p. 2) 2) "Date of Submission: Oct 29, 2025 ... Date of Acceptance: Jan 01, 2025 ... Date of Publishing: Apr 01, 2026." (p. 6) Detailed Analysis: The P criterion requires the full study protocol to be pre-registered on a public registry (e.g., ClinicalTrials.gov, CTRI, ISRCTN) before data collection begins, with a verifiable registration date and ID. The paper reports only institutional ethics committee approval, which is not a public pre-registration of hypotheses and analysis plans. No registry name, registration number, or pre-registration date is provided anywhere in the paper, and no trial-registry entry (CTRI/ClinicalTrials.gov) for this study was located by internet search. Criterion P is not met because there is no reference to any pre-registered protocol or trial-registry entry before data collection.