Validação Clínica

Estudos de validação clínica são aqueles que, avaliando o simulador, demonstram uma experiência de treinamento melhor ou igual às metodologias atualmente vigentes.

A definição de competência cirúrgica está relacionada com a capacidade cognitiva e técnica do cirurgião, sendo este apto a realizar procedimentos em um nível aceitável (Patil et al., 2003).

O treinamento em cirurgia videolaparoscópica deve ser realizado em etapas, onde o nível de dificuldade deve aumentar progressivamente, primeiro com aquisição de habilidades básicas necessárias a compreensão das ferramentas utilizadas no procedimento e a seguir os procedimentos de acordo com o grau de complexidade (Nácul et al., 2015).

Os cronogramas foram baseados em teorias já bem estabelecidas na literatura médica, no qual as habilidades motoras são adquiridas e a perícia no procedimento é desenvolvida, a partir da repetição das atividades, levando a automação (Reznick & MacRae, 2006). No primeiro estágio, o trainee intelectualiza a atividade, seu desempenho é baixo e o procedimento é dividido em etapas, por exemplo, no caso da videolaparoscopia, ter noção de profundidade, coordenar movimentos e compreender o efeito fulcro (Nisky et al, 2012). Com repetição e acompanhamento do desempenho, o trainee desenvolve as habilidades motoras adequadas para iniciar atividades mais complexas que levam ao estágio de automação. Nesse estágio, não há mais a necessidade de pensar nas etapas do procedimento, pois este se encontra automatizado, deixando espaço para tomada de decisões importantes como por exemplo, complicações.

De acordo com a literatura médica e os casos aqui exemplificados (a seguir), fica claro a importância da continuidade do treinamento, com um cronograma estruturado para permitir que o trainee alcance o terceiro estágio da curva de aprendizagem, automatizando o procedimento.

Referências

Nisky, I., Huang, F., Milstein, A., Pugh, C.M., Mussa-Ivaldi, F.A., Karniel, A. Perception of stiffness in laparoscopy – the fulcrum effect. Studies in Health technology and informatics. 2012; 173: 313-9. Patil NG, Cheng SW, Wong J. Surgical competence. World Journal of Surgery 2003; 27:943-947. Nácul, M.P., Cavazzola, L.T., Melo, M.C. Current status of residency training in laparoscopic surgery in Brazil: Acritical Review. ABCD Arq Bras Cir Dig. 2015; 28(1): 81-85. Reznick, R.K & MacRae, H. Teaching surgical skills – Changes in the wind. The New England Journal of Medicine. 2006; 355(25): 2664-69.

Realidade virtual na educação médica

The Utility of Simulation in Medical Education: What Is the Evidence? Yasuharu Okuda et al., MOUNT SINAI JOURNAL OF MEDICINE, 76:330–343, 2009.

The efficacy of virtual reality simulation training in laparoscopy: a systematic review of randomized trials. Larsen CR, Oestergaard J, Ottesen BS, Soerensen JL., Acta Obstet Gynecol Scand. 2012 Jun 13. doi: 10.1111/j.1600-0412.2012.01482.x. Simulation-based mock codes significantly correlate with improved pediatric patient cardiopulmonary arrest survival rates. Andreatta P, Saxton E, Thompson M, Annich G, Pediatr Crit Care Med. 2011 Jan;12(1):33-8. Simulation based medical education: an opportunity to learn from errors. Ziv A et al., Med Teach. 2005. 27(3):193-199.

An approach to EVAR simulation using patient specific modeling. Davis GR1, Illig KA2, Yang G2, Nguyen TH2, Shames ML2. 1Division of Vascular & Endovascular Surgery, USF Health Morsani School of Medicine, Tampa, FL. 2Division of Vascular & Endovascular Surgery, USF Health Morsani School of Medicine, Tampa, FL.Ann Vasc Surg. 2014 Oct;28(7):1769-74.

BACKGROUND: The Simbionix Angiomentor Procedure Rehearsal Studio (PRS) offers accurate virtual anatomy for measurement, stent graft selection, and deployment of endovascular aneurysm repair (EVAR) devices.

METHODS: Selected Gore Excluder EVAR cases from our EVAR database were reviewed and DICOM data loaded into the Simbionix Angiomentor simulator using PRS software. Using centerline measurements created on PRS, neck diameter (D1), length from lowest renal artery to each iliac bifurcation (Ll and Lr), and common iliac artery diameter (Dl and Dr) were recorded. All measurements for device selection were made based on data recorded on the simulator. Simulated EVAR was then performed using PRS on a dual limb endovascular simulator. Changes in device selection based on intraoperative measurements and use of three-dimensional (3D) anatomic overlay made by the attending vascular surgeon performing the case were recorded.

The devices actually used for successful repair were considered gold standard for comparison. At the completion of each virtual case, an experienced vascular surgeon for realism, imaging quality, and final product on a 5-point scale, rated simulations. RESULTS: Ten cases with complete operative data and available computed tomography scans were chosen at random. Fifty percent of the cases (5/10) had changes in device length when using the “in vivo” 3D volume filled model and angiographic measurements. Analysis of variance revealed no significant differences between the groups in any measurement-main body diameter P = 0.960; main body length P = 0.643; and contralateral limb length P = 0.333. Review of simulation scoring showed ratings of diminished realism (average 2.3/5) due to unrealistic ease of wire passage and gate cannulation; however, simulation imaging and final product were scored favorably (3.7 and 3.4, respectively).

CONCLUSIONS: The use of centerlines, angiographic measurements, and 3D modeling within the PRS software approaches real-life device selection and represents an opportunity for high fidelity patient-specific preoperative EVAR case rehearsal.

Virtual Reality Laparoscopic Simulator: Face Validity of Essential Gynecological Procedures. Bharathan R, McLaren J.S, Ind T. St George’s Healthcare NHS Trust, Blackshaw Rd, London SW17 0QT

INTRODUCTION: Simulation-based skills training in laparoscopic surgery leads to enhanced quality of performance, reduced errors, shorter operative time and superior patient safety profile. The aim of this study was to determine trainers and trainees assessment of face validity of the Simbionix LAP MentorTM III in three essential gynecological procedures. METHODS: 27 gynecologists (5 Consultants, 3 Senior Registrars, 13 Registrars, 6 Senior House Officers) were orientated to the training modules. Subsequently, at their convenience they performed bilateral tubal ligation, bilateral salpingo-oopherectomy and right salpingectomy, for tubal ectopic pregnancy.

Following completion, a ten-point Likert-scale questionnaire was completed evaluating each task based on appearance of instruments and pelvic tissue, manoeuvring and function of instruments, response to tissue manipulation, depth perception, ergonomics of the simulator and overall utility as a training tool.

RESULTS: The median Likert-scale scores for the appearance of instruments, hand-eye coordination and utility as a training device tasks were scored 9. The instrument manoeuvring & function of instruments, appearance of tissue and response to manipulation, depth perception, bimanual handing and simulator’s ergonomics were rated a median score of 8.

CONCLUSION: Instrumentation, tissue depiction and response to manipulation appear to have high face validity. The Simbionix LAP Mentor™ III was regarded as a valid training tool. In our next steps, construct and predictive validity assessments will enable construction of a proficiency based curriculum. We believe the simulation based training can translate to clinical benefit in gynecology.

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