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  • Experience Is Not Proficiency: Measuring what surgeons actually do | Show Me The Evidence E10
    2026/08/16
    In this episode, Professor Anthony G. Gallagher is joined by Dr Rui Farinha, a senior consultant urologist in Lisbon who has completed fellowships in Spain, Germany and Belgium in laparoscopic and robotic surgery, and who trained with Professor Alexandre Mottrie in Aalst and at Orsi Academy in Belgium. The two met at Orsi in 2019.The conversation begins with a practical question. Robots are expensive, so what do they actually give the surgeon? Rui sets out the case carefully: tremor filtering and motion scaling for precision, wristed instruments for dexterity in tight anatomy such as the pelvis, magnified stereoscopic vision, better ergonomics over long procedures, and a digital platform capable of recording and analysing performance. Then he adds the caveat that frames the rest of the hour. None of these technical advantages automatically produces a better clinical outcome.From there the discussion turns to how surgeons are trained. Rui traces his own path through three eras: an apprenticeship model in open surgery that depended on which cases turned up and which consultant happened to be supervising, a laparoscopic era in which he discovered that open skills did not transfer and that basic skills belonged outside the operating theatre, and a robotic era that was structured from the start around defined objectives, simulation, proximate feedback and a demonstrated standard.The heart of the episode is Rui's programme of research on robot-assisted partial nephrectomy (RAPN). He explains why he chose a technically demanding, high-risk procedure with clearly separable phases and direct consequences for the patient, and he sets out what the studies found. A complex operation can be deconstructed into observable phases, steps, errors and critical errors, with 100 per cent consensus from an international expert panel. Experienced surgeons made 69 per cent fewer total errors than novices. Within the experienced group, the low-error surgeons made 77 per cent fewer errors than the high-error surgeons, and that high-error expert group performed at roughly the level of the better novices. Procedure-specific binary metrics achieved high inter-rater reliability where a global rating scale did not. And a systematic review of partial nephrectomy training models found models widely rated as realistic and useful, but no randomised controlled trials and no evidence of skill transfer.Rui's conclusion is direct. Realism is not evidence. A simulator is a vehicle, not a training programme. Anyone building a curriculum should define the performance they want first and select or construct the simulation second, which is the opposite of what usually happens. He describes a model he developed deliberately as a delivery vehicle for a metric-based curriculum, using readily available animal tissue and emulating eight of the eleven phases of the human procedure, on the grounds that the useful question is not how realistic a model looks but how much high-quality measurable practice it permits.The episode closes on proficiency-based progression in the skills laboratory and in the operating room, on the value of proximate human feedback in an era of AI-delivered training, and on a central principle: the manufacturer's instructions for use teach the surgeon how the robot functions, while PBP determines whether the surgeon can use it proficiently.Key Topics CoveredWhat the robot actually adds, and what it does not | 0:07Guest introduction: senior consultant urologist in Lisbon, fellowships in Spain, Germany and Belgium, met Professor Gallagher at Orsi Academy in 2019Robots do not replace the surgeon and do not operate independently; they act as an interface that translates the surgeon's movementsPrecision through filtering of physiological tremor and scaling of movement, valuable in delicate dissection, suturing and vascular anastomosis | 1:46Dexterity, vision and endurance | 2:34Wristed instruments provide additional degrees of freedom where rigid laparoscopic instruments cannot, which matters most in narrow spaces such as the pelvisMagnified high-definition three-dimensional view improves depth perception and tissue plane discrimination; the surgeon controls the camera directly | 3:25An adjustable console reduces muscular strain and fatigue, supporting concentration and consistency through long procedures | 4:14The digital platform, and the caveat that matters | 5:04Because the surgeon's actions pass through a computer-controlled interface, robotic systems can record instrument movement, analyse technical performance and integrate imaging or navigationRui's caveat: these technical advantages do not automatically produce better clinical outcomes. Performance still depends on training, case selection, team coordination and appropriate use of the technologyProfessor Gallagher returns to the Dwight Meglan episode and the view that the surgeon, not the platform, makes the decisions | 5:53Three training eras: apprenticeship, laparoscopy, ...
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    1 時間 3 分
  • The end of "see one, do one, teach one" — Prof Stefano Puliatti | Show Me The Evidence Episode 9
    2026/07/31

    Professor Stefano Puliatti is Professor of Urology at the University of Modena, a practising robotic surgeon, a faculty member of Surgquest, and the former Medical Director of Orsi Academy in Belgium, where much of the PBP research discussed here was carried out.


    Key takeaways

    • Training quality should not depend on the luck of being assigned a gifted trainer. A shared methodology makes good outcomes reproducible.
    • Errors, not speed or step count alone, are the real indicator of surgical quality. Process measures on their own do not guarantee it.
    • A proficiency benchmark set at expert level is reachable by nearly all trainees, and usually faster than conventional training allows.
    • Good simulation does not have to be expensive. A validated methodology on a low-cost model can outperform costly kit used without one.
    • Diluting the method, for example by dropping the pre-lab benchmark, measurably slows learning and raises cost.


    Evidence and further reading

    The figures cited in this episode come from the peer-reviewed studies below. Please confirm the exact papers you want listed for this episode before publishing.

    • De Groote R, et al. Proficiency-based training and evidence-based methodology: a systematic review and meta-analysis. BJU International. doi:10.1111/bju.70333
    • Mazzone E, Puliatti S, et al. A Systematic Review and Meta-analysis on the Impact of Proficiency-based Progression Simulation Training on Performance Outcomes. Annals of Surgery, 2021. PMID: 33630473
    • Puliatti S, et al. Can all surgical trainees be trained to proficiency for a robotic urethro-vesical anastomotic task using a chicken model? A prospective, randomized trial. PMID: 40351291
    • Randomised trial on the economic impact of proficiency-based progression versus conventional robotic surgical training. PMC12907777
    • Development and validation of the objective assessment of robotic suturing and knot tying skills for a chicken anastomotic model. Surgical Endoscopy, 2020. doi:10.1007/s00464-020-07918-5
    • De Groote R, et al. Proficiency-based progression training for robotic surgery skills training: a randomized clinical trial. BJU International, 2022. doi:10.1111/bju.15811


    Credits

    Show Me the Evidence is hosted by Professor Anthony G. Gallagher and produced by Flux Learning.

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    51 分
  • From Physics-Based Simulation to Surgical Robots| Show Me The Evidence E8- Dr Dwight Meglan
    2026/07/18
    Show Me the Evidence, Episode 8Guest: Dr Dwight Meglan Topic: Physics-Based Simulation, Surgical Robotics and Why Simulators Still Don't Measure What MattersEpisode SummaryIn this episode, Professor Tony Gallagher is joined by Dr Dwight Meglan, the engineer who developed one of the first physics-based virtual reality simulators for endovascular procedures in the late 1990s, and who has spent the last two decades building surgical robots. Together they trace 30 years of simulation-based training and ask why so little has changed: simulators are still not verified against real-world physics, the field still measures process rather than skill, and device manufacturers, not educators, still set the agenda. The conversation ranges from haptics and instrumented torquers to Likert scales, credentialing committees, telesurgery risk, and why autonomous surgical robots are a regulatory and financial impossibility rather than a technical one. It closes with the evidence for Proficiency-Based Progression (PBP) and the leadership needed to adopt it.Key Topics Covered1. Building the first physics-based VR simulators | 0:00Meeting at Medicine Meets Virtual Reality in the late 1990sReal-time physics of tool and tissue interaction, fluoroscopy and haptic feedbackWhy the goal was to replicate reality, not design a user experiencePhysics tests to verify simulator correctness still do not exist, 25 years on2. Who really drives simulation: the device manufacturers | 2:24Manufacturers pay for simulation, so manufacturers shape itTraining to use the device versus training to perform the procedureSimulators in exhibition booths: marketing tools first, training tools second3. Haptics and the sensory threshold problem | 3:55The instrumented torquer: measuring what cardiologists actually feelJust noticeable difference thresholds vary between cliniciansStill no published datasets on the forces a cardiologist feels during catheterisationClinicians praising the haptics on simulators where the haptics were switched off4. Using devices safely: the stapler and the defibrillator | 8:52A stapling device with a 6 to 27 per cent leak rate, where one third of patients who develop a leak dieTraining to the instructions for use is device safety training, not surgical skills trainingCardiac defibrillator implantation: clinicians departing from the instructions for useConstruct validity findings: some very senior clinicians perform worse than the worst trainee when assessed with objective, peer-derived metrics5. What should a simulator measure? | 13:19The original approach: record everything, then find the measures that matterMetrics for mechanical thrombectomy for acute stroke, developed from the human procedure with MenticeHow clinician-led metrics forced a redesign of contrast injection, later patentedIt works when you insist on it, but you must start with the metrics6. The state of simulation metrics today | 17:35At a recent conference, almost none of the exhibited simulators had any metrics at allSome manufacturers avoid measurement deliberately: plausible deniabilityValidated metrics as a purchasing condition: if you cannot build them in, we will not buy7. From simulation to surgical robotics | 21:52Why simulation felt like a capped market and robotics did notThe analogous DNA of simulators and robots as real-time information processing systemsVerification versus validation: robots are bench-tested against dozens of specifications, simulators almost never are8. Measuring process, not skill | 26:49Motion tracking and path length: lessons not learned from laparoscopic surgeryAI-driven pattern hunting as a fishing expedition without a hypothesisSuturing as the test case: the physics of tissue apposition has never been publishedPhysical intelligence and humanoid robotics will improve simulation from the outside in9. Likert scales are not measurement | 36:47Binary, procedure-specific metrics require scoring the entire video, reliably, in pairsOne-to-five ratings after watching a few minutes of video are hand waving, not assessmentRing exercises on robotic simulators have never been verified against real forces10. Whose job is it? Credentialing and privileging | 39:27Manufacturers certify device use; professional societies and hospitals grant privilegesPer-procedure privileging in the United States versus broad qualification in EuropeThe credentialing committee problem: standards set by the least experienced memberCase volume, fellowship length and reputation are social proof, not evidence of competence11. A jumbo jet a day: the human cost | 44:43Deaths from surgical skills deficits estimated as equivalent to a full jumbo jet crashing every day, consistent with evidence that around 4.2 million people die within 30 days of surgery each year (Nepogodiev et al., The Lancet, 2019)Why one death at a time never makes headlines the way one crash doesThe Bristol Royal Infirmary case: peers knew for a decade before the front pages forced action (The ...
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    1 時間 1 分
  • Dr Ruben DeGroote, From Proficiency to Wisdom in Surgical Training
    2026/07/03
    Show Me the EvidenceGuest: Dr Ruben De Groote Topic: From Time to Competence: Proficiency-Based Progression and the Reinvention of Robotic Surgical TrainingEpisode SummaryIn this episode, Professor Tony Gallagher sits down with Dr Ruben De Groote, consultant urologist at OLV in Aalst, Belgium, CEO of 4Health and its digital learning platform Surgquest, and the researcher behind a recently completed PhD on Proficiency-Based Progression (PBP) robotic surgical training across three surgical disciplines. Ruben and Tony first met in 2019 while developing and validating the metrics for the robot-assisted radical prostatectomy.Together they examine an uncomfortable reality: the century-old Halstedian apprenticeship model can no longer produce surgeons who are ready to operate independently. Reduced theatre exposure, rising bureaucracy, and working-hours legislation have hollowed out the "see one, do one, teach one" paradigm, leaving as many as one in three residents unready for independent practice. Ruben makes the evidence-based case for PBP: a standardised, metric-driven approach that measures what a surgeon actually does, gives explicit formative feedback, and trains to a benchmark rather than to a clock. The conversation moves from the failings of subjective assessment through a multi-specialty randomised controlled trial, and on to the harder question of how surgeons progress from proficiency to genuine wisdom.Key Topics Covered1. Why the apprenticeship model is breaking down (0:50) The Halstedian "see one, do one, teach one" model relied entirely on graded theatre exposure. Over the last 15 to 20 years, bureaucracy and a legal cap on working hours (departments are penalised for exceeding roughly 60 hours a week on average) have eroded that exposure. The result is a vicious circle in which trainees get less time in the operating room, and fellowships originally meant for super-specialisation are being repurposed simply to reach independence.2. Where the bureaucracy came from (6:06) A wider shift in medicine towards risk aversion and defensive practice. Tasks that were once handled verbally now require written orders, increasing the administrative burden for everyone and pulling ambitious residents out of theatre for half a day or more.3. Robotics as both a challenge and an opportunity (7:52) Robotic surgery combines complex procedures with the mastery of technology, which raises the training bar. It also places a computer between the surgeon's eyes and the patient, making it possible to store video and surgical data, review procedures, give formative feedback, and measure kinematics. This makes robotics a powerful tool for objectively measuring and improving surgical quality.4. Exposure is not enough: the case for structure (9:31) Watching a procedure is not the same as being trained to perform it. Ruben and Tony agree that robotics demands the structure the Halstedian approach once imposed, but delivered through universal, evidence-driven standards and benchmarking, rather than the reputation of a single centre or trainer.5. The systemic problem: a lack of standardisation (12:39) Without standardised curricula, trainees are dependent on the goodwill of whichever consultant they are assigned. Ruben describes a fellowship with six fellows and nine consultants, each teaching the same procedure differently, and warns that patients are effectively used as training models for consultants who were not well trained themselves.6. Who should set and police the standards (17:37) Standards should be set by rigorous scientific research, not opinion. Scientific societies should define the benchmark and authorities should make it mandatory, in the same way prescribing rights follow formal qualification. Ruben cautions against a large role for industry, citing the conflict of interest in paid proctoring, where a proctor can be pushed to guide a novice through complex steps they have not earned the right to attempt.7. The multi-specialty randomised controlled trial (23:15) A blinded RCT deliberately included urologists, general surgeons, and gynaecologists to test the belief that some specialties are inherently more skilled. At baseline all three performed equally, and after training all three performed equally well. The methodology, not the specialty, predicted the skill set. As reported in the episode, 67 per cent of PBP trainees reached proficiency by the end of the day, compared with 17 per cent trained by the apprenticeship model. [See PROVESA / De Groote RCT publications below.]8. Quantifying intraoperative performance: why subjective scales fail (28:18) Likert-based tools such as GEARS are subjective and prone to drift, with a trainer's scoring shifting depending on the video seen just before. For validity, inter-reader agreement should be 80 per cent or higher; in Ruben's study GEARS reached only around 30 per cent, which by default makes it invalid for assessing surgical quality. Binary metrics are the ...
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    1 時間
  • Göran Malmberg, Mentice: Why Simulation Without Metrics Falls Short
    2026/06/28
    Guest: Göran Malmberg, Group CEO and President of Mentice AB (Gothenburg, Sweden), the world leader in physics-based virtual reality simulation for endovascular therapiesHost: Professor Anthony G GallagherTopic: Why Simulation Without Metrics Falls Short, and the Unsettled Question of Who Owns Medical TrainingEpisode SummaryIn this episode, Professor Tony Gallagher is joined by Göran Malmberg, who has led Mentice since 2008 and built it into the global leader in physics-based VR simulation for endovascular therapies. Drawing on more than two decades at the meeting point of engineering, medical devices and clinical training, Göran and Tony confront an uncomfortable structural problem: training is still treated as a cost item rather than a driver of value, and no one can say clearly who owns the responsibility for proving that a clinician is ready to perform a procedure. They make the case that simulation without validated metrics is a suboptimal tool, that proficiency-based progression (PBP) is the route to structured skill, and that the next move belongs to whoever is willing to lead, whether that is a major device manufacturer, a regulator or a professional society.Key Topics Covered1. From High-Tech to High-Stakes — 0:00Göran's route into medical simulation from automotive and industrial B2B technologyWhy selling advanced technology is broadly similar across sectors, and what was genuinely new about medicineMentice and the early years of VR simulation in medicine2. Training as a Cost, Not a Value — 2:13Why structured training is rarely connected to return on investmentHow it has often depended on the goodwill and personal time of passionate cliniciansThe wider concern about a business ethos moving into academic medical centres, and where training and quality assurance fit3. Why Simulation Needs Metrics — 6:40Göran's agreement with Tony's central conclusion: any simulation without metrics is a suboptimal tool for procedure-based trainingThe difference between general-purpose simulation and structured training to a defined level of skillWhere proficiency-based progression fits4. The Hard Part: Defining and Validating Metrics — 7:26Why the biggest hurdle is getting device companies to define and validate metrics before they engage the simulation providerThe mechanical thrombectomy example, where clinicians pushed Mentice to build and subsequently patent a new deviceWho should own the metrics: industry, professional medicine, or departments of healthThe evidence that PBP-trained operators perform around 60% better in the clinical environmentPublication: Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Annals of Surgery. 2002;236(4):458-464. doi:10.1097/00000658-200210000-000085. The Misunderstood Cost of Physics-Based Simulation — 11:12Why a physics-based VR simulation is not a video gameThe months of programming, engineering and validation behind a credible simulatorHow to weigh that cost against the alternative cost of proctored real cases over three to six monthsEvidence that PBP simulation training can cost roughly a third of conventional training, and the question of why medicine has not collated thisPublication: Puliatti S, Rodriguez Peñaranda N, Amato M, De Groote R, Farinha R, Bunting B, van Cleynenbreugel B, Mottrie A, Gallagher AG. Randomised trial on the economic impact of proficiency-based progression versus conventional robotic surgical training. BJU International. 2026;137(3):493-501. doi:10.1111/bju.701306. The Evidence Industry Finds Hard to Hear — 18:00The Birkmeyer finding that suboptimal performance in experienced clinicians leads to worse outcomes, with a difference of roughly 50 to 80 per centThe Mascheroni IMPROF trial, run with Medtronic in Switzerland, where metrics-based training to proficiency produced markedly fewer intraoperative errors than traditional simulation training, and where Tony notes that none of the standard-trained group reached the proficiency benchmarkA Leuven PhD viva on a circular stapler, where PBP training removed the leak rate seen with standard instructions-for-use trainingPublication: Birkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJO. Surgical skill and complication rates after bariatric surgery. New England Journal of Medicine. 2013;369(15):1434-1442. doi:10.1056/NEJMsa1300625Publication: Mascheroni J, Stockburger M, Patwala A, Mont L, Rao A, Retzlaff H, Garweg C, Verbelen T, Gallagher AG. Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial. JAMA Network Open. 2023;6(8):e2322750. doi:10.1001/jamanetworkopen.2023.227507. Whose Job Is It Anyway? — 22:40The sensitivity of telling a clinician they are not ready yet, and why the metrics come ...
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    1 時間 3 分
  • Dr Richard Satava: The Science of Surgical Training- Time, Profit and Surgical Simulation
    2026/06/22

    The evidence that simulation and proficiency-based training produce better, safer surgeons has been settled for over two decades. So why has surgery been so slow to take it up?


    Professor Tony Gallagher talks to surgical simulation pioneer Dr Richard "Rick" Satava, Professor Emeritus of Surgery at the University of Washington and a former DARPA programme manager, about the study they ran together at Yale, why the operating room is the wrong place to learn basic skills, and why the real barriers to change are time, leadership and money rather than the science. They close on the limits of what AI can assess today, and what comes next, from telesurgery to surgery in space.


    (0:00) Thirty years, and one seminal study

    (2:07) Simulation as a revolution, transposed from the military

    (3:23) Why the operating room is the wrong place to learn basic skills

    (6:30) Treating surgical education as a science is disruptive

    (9:39) The 2002 Yale study, and the end of "see one, do one"

    (11:58) Disruption keeps coming: telesurgery, space and directed energy

    (13:01) The barrier is not the evidence, it is selling it

    (16:21) Leadership: the skills lab before theatre

    (18:06) Who should own the standards and credentialing

    (21:00) Twenty-five years on: training hours and fellowships

    (25:52) You cannot compress the time, people learn at different rates

    (32:26) Why proficiency-based progression is demanding to deliver

    (35:07) Protected time in practice: the Wednesday afternoon model

    (44:18) Why proficiency-based progression has not gained traction

    (45:08) Formative feedback and the meaning of progression

    (50:28) Where AI actually is today

    (52:02) Convincing the establishment that simulation is patient care

    (58:49) Service over training, and the business of medicine


    Studies mentioned:


    Seymour, Gallagher, Satava et al. Virtual reality training improves operating room performance. Annals of Surgery, 2002. https://journals.lww.com/annalsofsurgery/abstract/2002/10000/virtual_reality_training_improves_operating_room.8.aspx


    Satava, Stefanidis, Levy et al. Fundamentals of Robotic Surgery (FRS) skills curriculum trial. Annals of Surgery, 2020. https://pubmed.ncbi.nlm.nih.gov/30720503


    Gallagher, Ritter, Satava et al. Proficiency-based training as a paradigm shift. Annals of Surgery, 2005. https://pubmed.ncbi.nlm.nih.gov/15650649


    Satava and Gallagher. Proficiency-based progression for FRS curriculum development. Annals of Laparoscopic and Endoscopic Surgery, 2020. https://ales.amegroups.org/article/view/5782/html



    Guest: Dr Richard M. Satava


    Host: Professor Anthony G. Gallagher. LinkedIn: https://www.linkedin.com/in/anthony-g-gallagher/

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    1 時間 11 分
  • Dr. Richard Angelo: From Apprenticeship to Proficiency — Rethinking How We Train Surgeons
    2026/05/29
    Episode 4 — Dr. Richard AngeloGuestDr. Richard (Rick) Angelo — Arthroscopic surgeon based in Seattle; former President of the Arthroscopic Association of North America (AANA). Holds a PhD in proficiency-based progression training.HostTony (relationship with Rick spans ~15 years, originating from a chance meeting at a conference in Sweden)Episode OverviewA deep-dive conversation on the fundamental failures of traditional surgical training and how proficiency-based progression (PBP) training offers a scientifically rigorous alternative. The discussion centres on the landmark Copernicus Study — the first study in medicine to use proficiency demonstration as an outcome measure.Key Topics Covered1. Limitations of the Traditional Apprenticeship ModelThe "see one, do one, teach one" model lacks objective assessmentDespite decades of training and significant investment, AANA could not verify whether skill acquisition was actually occurringComplication rates and suboptimal outcomes weren't improving with existing training efforts2. The Founding QuestionRick, during his time in the AANA presidential line, asked: "Is there a better way to train surgical skills?"This led to engagement with Tony's work on proficiency-based progression training3. Proficiency-Based Progression (PBP) Training — Core PrinciplesDefine a clear target: what does quality performance of a procedure look like?Deconstruct tasks into discrete, trainable componentsDevelop objective, binary metrics (did it occur or not?) rather than global rating scalesEstablish inter-rater reliability between assessorsTrainees must demonstrate a benchmark at each stage before progressing (including cognitive pre-course material — 83% threshold)Errors and deviations from optimal performance are trained explicitly — not just steps4. The Bankart Repair — Why It Was ChosenCommon procedure with a broad, transferable skill setSuited to task deconstruction and partial task simulationChosen by Rick and endorsed by the AANA core group5. Curriculum Before SimulationA critical insight: the curriculum and metrics must be developed first; simulation is chosen to match, not the other way aroundContrast with the wider medical field's focus on "eye candy" VR simulators that lack meaningful metricsThe FAST model (Fundamentals of Arthroscopic Surgery Training) was developed with Rob Pedowitz for knot tying — a low-cost, highly accurate partial task trainerEven a simple conical nail punch from a garage became an effective tool for measuring loop elongation6. The Copernicus Study — Design & ResultsThree study groups:Group A (Traditional): Lectures, open-access knot-tying lab, cadaver session — standard AANA approachGroup B (Simulator only): Access to the simulator without the PBP curriculum or metricsGroup C (PBP): Proficiency benchmarks at every stage — cognitive, knot-tying, and shoulder modelResults:Group B was 1.4× more likely than Group A to meet the benchmark (marginal)Group C participants (assigned to PBP, even without passing all benchmarks): 5.5× more likely than Group AGroup C participants who met all proficiency benchmarks: 7.5× more likely to meet the final benchmarkError reduction: ~56% decrease in Bankart errors; ~58% for rotator cuff repairIn one follow-up weekend cohort of 18 trainees: 89% demonstrated proficiency in Bankart repair; 83% in rotator cuff repair7. Key Finding: The Deficiency is in Training, Not TraineesPre-study concern about a "weed-out process" proved unfoundedWith quality training, almost all trainees can master the required skillsReferenced Frank Lewis (former Chair, American Board of Surgery) sharing the same observationStefano Pogliani's study demonstrated near-universal proficiency is achievable8. The Role of Errors in Surgical TrainingDistinguishing novice from expert performers is best predicted by error enactment, not step completionEach deviation from optimal performance creates a cascade risk — even if consequences aren't immediateUpcoming study expected to show errors are the best predictor of patient outcomes9. Broader Applicability to Procedure-Based MedicinePrinciples apply across disciplines — cardiology, robotics, and beyondContrast drawn with VR simulator manufacturers at the European Heart Rhythm Association Conference (Paris), where most simulations had no metricsChicken tissue models used successfully in robotic surgery training at €5 per chicken — effective without being high-tech10. Credentialing and Quality AssuranceDiscussion of whether PBP methodology could or should underpin credentialing for new procedures or devicesDevice failures in the field often attributable to inadequate clinician preparation, not device defectsPractical challenges for societal credentialing (procedure selection, remediation pathways, cost of metric development, legal defensibility)European Commission is moving toward micro-credentials for technical skills — awarded by universities, recognised across EU member ...
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    48 分
  • From the FDA to the operating theatre: how proficiency rewrote the rules of surgical training
    2026/05/25


    Guest: Professor Anthony G Gallagher Host: Patrick Kiely
    Episode focus: two landmark studies, the 2004 JAMA carotid stenting paper and the Copernicus arthroscopy trial


    Episode summary

    Professor Tony Gallagher, the founder of Proficiency-Based Progression (PBP), joins Patrick Kiely to revisit two studies that changed how we think about surgical competence.

    The first is the 2004 JAMA paper describing a closed-door meeting at which the US Food and Drug Administration agreed, for the first time, that simulation training should form part of how doctors are approved to perform a procedure. The second is the Copernicus trial in shoulder arthroscopy, which showed that a simulator only improves training when it is paired with validated metrics and a clear proficiency benchmark.

    Together they make a simple, evidence-led case: competence should be measured by the skill a clinician can demonstrate, not by years served or cases counted.


    Chapters

    0:00 Introduction
    0:50 Inside the 2004 closed-door FDA meeting on carotid stenting
    4:43 Why carotid stenting forced the conversation
    7:25 Skill over specialty: ending the turf war
    9:44 The FDA precedent: simulation becomes part of credentialing
    12:03 Why procedure volume is a crude proxy for competence
    14:17 Why the argument had to appear in JAMA
    16:22 A homogeneous skill set, devices, and patient safety
    20:42 The Copernicus Initiative: a paradigm shift in training
    22:53 Three groups, one lesson: a simulator alone is not enough
    25:44 The results: 56 per cent fewer errors and the 7.5 times finding
    27:53 The trainees who did not pass, and distributed training
    30:37 Pass the cognitive exam before the skills lab
    32:33 Task deconstruction: 45 steps and 77 possible errors
    36:04 Errors versus sentinel errors: why minor errors matter most
    39:09 Why fidelity is not the point
    41:59 Why a multi-site trial mattered
    44:20 Where to start: begin with the metrics


    Key points

    • Carotid artery stenting is high risk and crossed three specialties, so the FDA needed a way to be sure each clinician was safe to perform it. PBP simulation let credentialing rest on demonstrated skill rather than on specialty or case numbers.
    • In 2004 the FDA accepted virtual reality simulation as part of the training package for a new device. This was the first time a regulator tied device approval to a training standard.
    • Procedure volume and hours logged are weak indicators of skill. Demonstrated proficiency is a far better one.
    • In the Copernicus arthroscopy trial, traditional training performed worst, adding a simulator alone helped only slightly, and PBP plus the simulator produced the strongest and safest performance.
    • The PBP group made roughly 56 per cent fewer errors, and residents who met every benchmark were 7.5 times more likely to reach the final standard.
    • Minor errors, not only critical ones, predict poor outcomes, so trainees are taught to avoid every avoidable error.
    • To build PBP: find people who are genuinely good at the task, define and validate the metrics, choose simulations that let trainees practise the key steps, train faculty on the metrics first, and require a pass on the online didactic before anyone enters the skills lab.


    Studies referenced

    • Gallagher AG, Cates CU. Approval of virtual reality training for carotid stenting: what this means for procedural-based medicine. JAMA. 2004;292(24):3024-3026. Read on JAMA Network
    • Angelo RL, Ryu RKN, Pedowitz RA, et al. A Proficiency-Based Progression Training Curriculum Coupled With a Model Simulator Results in the Acquisition of a Superior Arthroscopic Bankart Skill Set. Arthroscopy. 2015;31(10):1854-1871. Read on the Arthroscopy journal


    Connect and follow

    • Professor Tony Gallagher on LinkedIn
    • Professor Tony Gallagher on Google Scholar
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    46 分