Comparison of spinal mannequin-based simulation teaching with the conventional didactic method of teaching subarachnoid block in novices: A randomized controlled trial

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • Randomization was performed at the individual resident (student) level within a single department, not at the class or school level, and no tutoring exception applies.
    • "The participants were randomly allocated to groups A and B using a computer-generated random sequence, and allocation concealment was ensured through the use of sealed, opaque envelopes."
    • Relevant Quotes: 1) "This study included 50 novice anesthesia residents who were randomly assigned to Group A and Group B." (Abstract, p. 400) 2) "The participants were randomly allocated to groups A and B using a computer-generated random sequence, and allocation concealment was ensured through the use of sealed, opaque envelopes." (p. 401) 3) "A total of 50 residents were randomized into group A and group B." (p. 402) Detailed Analysis: Criterion C requires randomization at the class level or stronger (school level), unless the intervention is a personal/one-to-one tutoring intervention in which case student-level randomization is acceptable. Here the units of randomization were the 50 individual novice residents, allocated one by one via a computer-generated sequence with sealed opaque envelopes. The two teaching arms were delivered as group-based educational formats (a structured mannequin session versus lectures, videos, and observation), not as one-to-one tutoring, so the tutoring exception does not clearly apply. Because randomization occurred at the individual student level rather than by whole class or school, the class-level requirement is not satisfied. Criterion C is not met because randomization was at the individual resident level within a single department, not at the class or school level.
  • E

    Exam-based Assessment

    • Outcomes were measured with custom procedural performance metrics recorded by a blinded observer, not with a standardized, widely recognized exam-based assessment.
    • "They were then assessed on patients within 1 week of completion of training for the number of successful first needle passes or redirections, the time taken to successfully perform neuraxial anesthesia/analgesia, total number of attempts, complications ..., number of needle bone contacts, and ease of landmark palpation of space."
    • Relevant Quotes: 1) "They were then assessed on patients within 1 week of completion of training for the number of successful first needle passes or redirections, the time taken to successfully perform neuraxial anesthesia/analgesia, total number of attempts, complications (vasovagal shock, bloody tap), number of needle bone contacts, and ease of landmark palpation of space." (p. 401) 2) "Each participant was supervised by a consultant anesthesiologist (observer) who was blinded to group allocation." (p. 401) 3) "ease of landmark palpation using the Likert scale" (p. 401) Detailed Analysis: Criterion E requires a standardized, widely recognized exam-based assessment that was not created specifically for the study. The outcomes here were procedural performance measures observed directly on patients: first-pass success, number of attempts, needle redirections, needle-to-bone contacts, procedure time, complications, and a Likert-scale rating of landmark palpation ease. These are bespoke procedural observation metrics devised for this study and scored by a supervising anesthetist, not scores from a standardized examination. No national or otherwise recognized standardized test was used. Criterion E is not met because outcomes were assessed with study-specific procedural performance measures rather than a standardized exam.
  • T

    Term Duration

    • Training was a single 2-3 hour session and outcomes were assessed within one week, far short of the one full academic term required.
    • "They were then assessed on patients within 1 week of completion of training..."
    • Relevant Quotes: 1) "Participants in Group A underwent mannequin-based teaching and were trained on the spinal mannequin ten times, conducted in a single structured training session lasting approximately 2-3 hours with adequate breaks to avoid fatigue, before performing a subarachnoid block on patients." (p. 401) 2) "They were then assessed on patients within 1 week of completion of training..." (p. 401) 3) "Second, we assessed only short-term skill acquisition and not long-term retention or transfer to more complex cases." (p. 404) Detailed Analysis: Criterion T requires that outcomes be measured at least one full academic term (roughly 3-4 months) after the intervention begins. The training here occurred in a single session of approximately 2-3 hours and participants were assessed on patients within one week of completing that training. The authors themselves note that only short-term skill acquisition was assessed. The entire interval from intervention start to outcome measurement is at most about one week, well below one term. Criterion T is not met because the interval from training to assessment was roughly one week, far shorter than a full academic term.
  • D

    Documented Control Group

    • The control (didactic) group's size, novice status, eligibility criteria, and the instruction it received are clearly documented.
    • "Group B novice first-semester residents underwent didactic teaching, which included lectures, videos, and observation of five patients undergoing the procedure."
    • Relevant Quotes: 1) "Group B novice first-semester residents underwent didactic teaching, which included lectures, videos, and observation of five patients undergoing the procedure." (p. 401) 2) "Allocated to Group B (Didactic group) (n=25); Received allocated intervention (n=25); Lost to follow-up (n=0); Analysed (n=25)." (Figure 1, p. 402) 3) "Participants were excluded if they had previously observed or received training in neuraxial anesthesia, declined to participate, or did not consent to undergo assessment." (p. 401) 4) "Study participants included novice postgraduate students from the Department of Anaesthesiology at our institution." (p. 401) Detailed Analysis: Criterion D requires clear documentation of the control group's characteristics, size, and conditions. The didactic (control) group is described as 25 novice first-semester postgraduate anesthesia residents from the same department, all with no prior neuraxial anesthesia exposure (per the exclusion criteria), who received a defined comparison intervention of lectures, videos, and observation of five procedures. The CONSORT flow diagram documents the control arm's size (n=25), full retention (no loss to follow-up), and complete analysis. While detailed demographic tables are limited, the group's composition, size, baseline (novice) status, and the treatment it received are adequately described. Criterion D is met because the control group's size, novice baseline status, eligibility, and the didactic instruction it received are clearly documented.

• Level 2 Criteria

  • S

    School-level RCT

    • This was a single-center study with randomization at the individual resident level, not randomization of schools or institutions.
    • "First, this was a single-center study with a relatively small sample size, which may limit generalizability."
    • Relevant Quotes: 1) "The participants were randomly allocated to groups A and B using a computer-generated random sequence..." (p. 401) 2) "Study participants included novice postgraduate students from the Department of Anaesthesiology at our institution." (p. 401) 3) "First, this was a single-center study with a relatively small sample size, which may limit generalizability." (p. 404) Detailed Analysis: Criterion S requires randomization at the school level, meaning entire educational institutions or units are the randomized unit. This trial was conducted at a single institution and randomized individual residents to the two teaching arms. No multiple schools, sites, or institutions were randomized. Criterion S is not met because the study was a single-center trial randomizing individuals, with no school-level randomization.
  • I

    Independent Conduct

    • The same investigators designed the teaching interventions and conducted the trial; only outcome assessment was blinded, with no independent third-party evaluation.
    • "Each participant was supervised by a consultant anesthesiologist (observer) who was blinded to group allocation."
    • Relevant Quotes: 1) "Each participant was supervised by a consultant anesthesiologist (observer) who was blinded to group allocation." (p. 401) 2) "Hence, we planned this study to see the effect of both didactic teaching and hands-on on a mannequin on the actual performance of the procedure on real patients." (p. 401) 3) "Conflicts of interest: There are no conflicts of interest." (p. 404) Detailed Analysis: Criterion I requires that the study be conducted independently of the team that designed the intervention, typically through external or third-party evaluators. Here the authors planned, designed, delivered, and evaluated both teaching methods themselves. The only independence measure is that the outcome observer (a consultant anesthesiologist) was blinded to group allocation, which reduces assessment bias but does not constitute an external, independent conduct of the trial. There is no statement that an outside body ran the study or that the evaluators were independent of the intervention designers. Criterion I is not met because the same team designed and carried out the study, with only a blinded in-house observer rather than independent third-party conduct.
  • Y

    Year Duration

    • With training in a single session and assessment within one week, the study spanned far less than 75% of an academic year, and criterion T was not met.
    • "They were then assessed on patients within 1 week of completion of training..."
    • Relevant Quotes: 1) "conducted in a single structured training session lasting approximately 2-3 hours..." (p. 401) 2) "They were then assessed on patients within 1 week of completion of training..." (p. 401) 3) "Second, we assessed only short-term skill acquisition and not long-term retention..." (p. 404) Detailed Analysis: Criterion Y requires that outcomes be measured at least 75% of a full academic year (roughly 9-10 months) after the intervention begins. The intervention here was a single 2-3 hour session and outcomes were measured within about one week. In addition, per the prompt rules, if criterion T (Term Duration) is not met then Y cannot be met, and T is not met. Criterion Y is not met because the follow-up interval was about one week, far below a full academic year, and T is not met.
  • B

    Balanced Control Group

    • The teaching method itself is the explicit treatment variable, and both arms received comparable structured training time, making this an active-control comparison.
    • "Hence, we planned this study to see the effect of both didactic teaching and hands-on on a mannequin on the actual performance of the procedure on real patients."
    • Relevant Quotes: 1) "Participants in Group A underwent mannequin-based teaching and were trained on the spinal mannequin ten times, conducted in a single structured training session lasting approximately 2-3 hours..." (p. 401) 2) "Group B novice first-semester residents underwent didactic teaching, which included lectures, videos, and observation of five patients undergoing the procedure." (p. 401) 3) "Hence, we planned this study to see the effect of both didactic teaching and hands-on on a mannequin on the actual performance of the procedure on real patients." (p. 401) Detailed Analysis: Criterion B asks whether any extra time/budget given to the intervention arm is matched in the control arm, unless the additional resource is itself the explicit treatment variable being tested. Here the study explicitly compares two teaching methods: mannequin-based hands-on training versus a didactic package of lectures, videos, and observation of five procedures. Both arms received a structured training intervention rather than the intervention arm getting an add-on on top of the control's business-as-usual. The mannequin apparatus and hands-on practice are the integral treatment variable under investigation, and the didactic arm is an active comparator receiving its own dedicated instructional time. Applying the decision tree: the differing resource (mannequin hands-on teaching) is the treatment being tested, so the control may receive the alternative teaching format by design. Criterion B is met because the teaching method is the explicit treatment variable and both groups received comparable structured training as an active-control comparison.

• Level 3 Criteria

  • R

    Reproduced

    • No independent replication of this specific trial by a different team is reported or identifiable; cited studies are related but not replications of this study.
    • "Our study adds to the few existing studies that directly compare simulation and conventional teaching for neuraxial procedures."
    • Relevant Quotes: 1) "Our study adds to the few existing studies that directly compare simulation and conventional teaching for neuraxial procedures." (p. 403) 2) "This aligns with findings from Etezadi et al., who evaluated mannequin-based simulation for anesthesia procedures..." (p. 403) 3) "Our findings are similar to those of Niazi et al., who concluded that simulation training in regional anesthesia led to a greater success rate of regional blocks." (p. 403) Detailed Analysis: Criterion R requires that this specific study be independently replicated by a different research team in a different context and published in a peer-reviewed journal. The paper cites related simulation-training studies (Etezadi, Torrano, Niazi, Barsuk) for supportive context, but these are separate studies of different procedures and designs, not replications of this particular mannequin-versus- didactic subarachnoid-block trial. The authors also describe their work as adding to a small existing literature. An internet search across PubMed, Google Scholar, and clinical trial registries (July 2026) for an independent reproduction of this specific trial (published May 2026) returned no replication by a separate team; no external replication was found. Criterion R is not met because no independent replication of this specific study exists; the cited works are related but not replications.
  • A

    All-subject Exams

    • Only a single procedural skill was assessed with custom measures, and since criterion E is not met, criterion A cannot be met.
    • "The primary objective was to compare the number of successful first attempts of spinal needle placement into the subarachnoid space."
    • Relevant Quotes: 1) "The primary objective was to compare the number of successful first attempts of spinal needle placement into the subarachnoid space." (p. 401) 2) "The secondary objectives were to compare total needle placement attempts, needle-bone contacts, ease of landmark palpation using the Likert scale, time to complete the subarachnoid block, complications..." (p. 401) Detailed Analysis: Criterion A requires assessment across all main subjects using standardized exam-based assessments, and it depends on criterion E being met. Here the study measured only performance of a single procedural skill (subarachnoid block) using study-specific observational metrics, with no standardized exam and no assessment of other subjects. Because criterion E (standardized exam-based assessment) is not met, criterion A is automatically not met, and the single-skill focus independently fails the all-subject requirement. Criterion A is not met because only one procedural skill was assessed with custom measures and criterion E is not met.
  • G

    Graduation Tracking

    • Assessment occurred within one week of training with no follow-up to graduation, and since criterion Y is not met, criterion G cannot be met.
    • "Second, we assessed only short-term skill acquisition and not long-term retention or transfer to more complex cases."
    • Relevant Quotes: 1) "Second, we assessed only short-term skill acquisition and not long-term retention or transfer to more complex cases." (p. 404) 2) "They were then assessed on patients within 1 week of completion of training..." (p. 401) 3) "Future research should address its effects on long-term retention, cost-benefit analysis, transfer to clinical practice, and its utility across differing levels of expertise." (p. 404) Detailed Analysis: Criterion G requires tracking participants until graduation to assess long-term impact, and it depends on criterion Y being met. This study measured outcomes within one week of training and explicitly states it assessed only short-term skill acquisition, with long-term retention left to future research. There is no follow-up through the end of the residents' training or graduation. An internet search for subsequent or follow-up publications by these authors tracking this resident cohort to graduation returned none as of July 2026. Because criterion Y is not met, criterion G is automatically not met. Criterion G is not met because only short-term outcomes were measured, with no graduation tracking, and criterion Y is not met.
  • P

    Pre-Registered

    • The trial was registered in the Clinical Trials Registry of India with a specific identifier, obtained after ethics approval and, per the paper, before participant recruitment.
    • "After obtaining institutional ethics committee approval (IEC/2022/4093) and registering the trial at CTRI (CTRI/2023/03/051215), written informed consent was obtained from all participants who fulfilled the inclusion criteria."
    • Relevant Quotes: 1) "After obtaining institutional ethics committee approval (IEC/2022/4093) and registering the trial at CTRI (CTRI/2023/03/051215), written informed consent was obtained from all participants who fulfilled the inclusion criteria." (p. 401) 2) "This manuscript adheres to the applicable CONSORT guidelines [Figure 1]." (p. 401) Detailed Analysis: Criterion P requires that the study protocol be registered before data collection began, with a registry reference and appropriate timing. The paper provides a specific Clinical Trials Registry of India identifier (CTRI/2023/03/051215); CTRI is a recognized public trial registry that, since 2018, mandates prospective registration before enrollment. The registry identifier embeds a 2023/03 date, and the sentence structure places obtaining ethics approval and registering the trial before written informed consent and participant enrollment, indicating registration preceded data collection. Direct retrieval of the CTRI record (July 2026) was attempted to confirm the exact enrollment date but the registry entry could not be independently accessed online; timing is therefore inferred from the paper's stated sequence and CTRI's prospective- registration mandate. Criterion P is met because the trial carries a specific CTRI registry identifier and was registered, after ethics approval, before participant enrollment and data collection.