Current status of simulation-based training in pediatric surgery: A systematic review

YJPSU-58992; No of Pages 10 Journal of Pediatric Surgery xxx (xxxx) xxx

Contents lists available at ScienceDirect

Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg

Current status of simulation-based training in pediatric surgery: A systematic review Ebrahim Adnan Patel a, Abdullatif Aydın a,⁎, Ashish Desai b, Prokar Dasgupta a, Kamran Ahmed a a b

MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom Dept. of Paediatric Surgery, King's College London NHS Foundation Trust, London, United Kingdom

a r t i c l e

i n f o

Article history: Received 30 July 2018 Received in revised form 9 October 2018 Accepted 5 November 2018 Available online xxxx Key words: Paediatric surgery Pediatric surgery Simulation Training Education

a b s t r a c t Background: Simulation based training enables pediatric surgical trainees to attain proficiency in surgical skills. This study aims to identify the currently available simulators for pediatric surgery, assess their validation and strength of evidence supporting each model. Methods: Both Medline and EMBASE were searched for English language articles either describing or validating simulation models for pediatric surgery. A level of evidence (LoE) followed by a level of recommendation (LoR) was assigned to each validation study and simulator, based on a modified Oxford Centre for EvidenceBased Medicine classification for educational studies. Results: Forty-nine articles were identified describing 44 training models and courses. Of these articles, 44 were validation studies. Face validity was evaluated by 20 studies, 28 for content, 24 demonstrated construct validity and 1 showed predictive validity. Of the validated models, 3 were given an LoR of 2, 21 an LoR of 3 and 12 an LoR of 4. None reached the highest LoR. Conclusions: There are a growing number of simulators specific to pediatric surgery. However, these simulators have limited LoE and LoR in current studies. The lack of NoTSS training is also apparent. We advocate more randomized trials to validate these models, and attempts to determine predictive validity. Type of study: Original / systematic review. Level of evidence: 1. © 2018 Elsevier Inc. All rights reserved.

Contents 1.

2.

Methods . . . . . . . . . . . . . . . . . . . . 1.1. Information sources and search . . . . . . 1.2. Study eligibility criteria . . . . . . . . . . 1.3. Data extraction . . . . . . . . . . . . . 1.4. Data analysis . . . . . . . . . . . . . . Results . . . . . . . . . . . . . . . . . . . . 2.1. Description of studies . . . . . . . . . . 2.2. Generic pediatric skills . . . . . . . . . . 2.3. Gastrointestinal & general pediatric surgery 2.3.1. Appendicectomy . . . . . . . . 2.3.2. Neonatal . . . . . . . . . . . . 2.3.3. General pediatric surgery. . . . . 2.3.4. Upper GI surgery . . . . . . . . 2.3.5. Hepatobiliary . . . . . . . . . . 2.4. Urology . . . . . . . . . . . . . . . . . 2.5. Cardiothoracic surgery . . . . . . . . . .

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⁎ Corresponding author at: MRC Centre for Transplantation, 5th Floor Southwark Wing, Guy's Hospital, King's College London, London SE1 9RT. Tel.: +44 20 7188 8580; fax: +44 20 3312 6787. E-mail address: [email protected] (A. Aydın). https://doi.org/10.1016/j.jpedsurg.2018.11.019 0022-3468/© 2018 Elsevier Inc. All rights reserved.

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

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E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

2.6. Nontechnical skills 2.7. Training courses . 3. Discussion . . . . . . . 3.1. Limitations . . . . 4. Conclusion . . . . . . . References . . . . . . . . . .

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Surgical training in pediatric surgery has traditionally followed the format of multiple other surgical specialties focusing largely around the mantra of ‘see one, do one, teach one’ [1]. However, in the modern age, the traditional form of training is fast becoming outdated. This is owed largely to the increased expectations of patient safety, surgeon performance and transparency. In addition, perioperative mortality has been found to be higher in neonates and infants [2] and case exposure is especially limited in pediatric surgery [3]. This places greater emphasis upon alternative training modalities for pediatric surgery trainees. The use of simulation-based training has demonstrated its merit and shows promise for enabling surgical skill acquisition [4,5]. With the increasing number of surgical simulators in pediatric surgery, it is important that we rigorously determine the validity and reliability of them. The aim of this review is to identify the current simulation-based training models described in the literature, evaluate their validity, level of evidence (LoE), and develop recommendations (LoR) based on the findings.

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model. A modified educational Oxford Centre for Evidence-Based Medicine (OCEBM) classification system, as adapted by the European Association of Endoscopic Surgery was used to determine the LoR and LoE [9]. Here, a recommendation of 1 was the highest, and 4 the lowest (Supplementary Tables 1 and 2).

2. Results 2.1. Description of studies From the 4040 articles retrieved from the search, 49 articles were identified upon screening and 44 simulators and training courses were described (Fig. 1). Of these, 5 articles were purely descriptive, with the remaining 44 studies validating 40 simulators and training courses (Table 1). Results were then categorized into their respective specialty within pediatric surgery; Generic skills, Gastrointestinal and General Pediatric Surgery, Cardiothoracic surgery, Urology, Nontechnical skills, and Training Courses.

1. Methods 1.1. Information sources and search

2.2. Generic pediatric skills

A broad search of the PubMed and EMBASE databases was performed to identify articles that described pediatric surgery simulators and training models. The search terms included “paediatric OR pediatric” and “surg*” and “simulation”. Additionally, procedure specific searches were conducted including a combination of the following terms; “herniotomy”, “circumcision”, “Appendectomy”, “Oesophageal Atresia”, “Tracheooesophageal fistula”, “congenital heart disease”, and “simulation”. Titles and abstracts were screened according to the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines [6].

Overall, 15 validation studies describing 12 models were identified (Table 2). These models tested generic skills such as intracorporeal suturing, and pattern cutting. The Pediatric Laparoscopic Surgery (PLS) simulator and its iterations were by far the most validated with 6 studies. The PLS simulator demonstrated Construct A and Construct B validity in 2 of these studies and was used by 84 participants and 25 respectively [10,11]. A form of concurrent validity was also demonstrated as the model illustrated superiority over its precursor, the fundamentals of laparoscopic surgery (FLS) simulator [10]. Further iterations of the PLS simulator have been developed, with two articles demonstrating construct A and B validity for the PLS with motion tracking software [12,13]. The study by Trudeau et al. incorporated a more complex suturing task and demonstrated concurrent validity when compared to the simple suturing task in previous versions of the PLS simulator [12]. Guana et al. demonstrated construct A, construct B and concurrent validity as they added 3D laparoscopic equipment and compared this with the previous 2D equipment in the PLS [14]. Another iteration of the PLS involved the addition of a SILS™ port compared to the multiport present in the PLS [15]. This iteration again demonstrated construct A and construct B validity. The eoSim® simulator demonstrated content, construct A, construct B and finally concurrent validity when compared to the PLS in a randomized trial [16]. This study and the one by Guana et al. were 2 of the 3 studies which achieved the highest level of evidence, 1b. A rapid-prototyped pediatric chest model demonstrated construct A and B validity for thoracoscopic intracorporeal suturing and knot-tying [17]. Further, concurrent validity was demonstrated as it was compared to a Aesculap® K-ZWEI (Tuttlingen, Germany) box trainer. The same team demonstrated construct A and B validity with 30 subjects [18]. A complementary study by the authors demonstrated the same validity on a larger sample with 53 subjects as well as using the Endoscopic Surgical Skill Qualification to distinguish between skilled and unskilled [19]. Overall, this model was given an LoR of 2, as did the PLS and eoSim® simulator.

1.2. Study eligibility criteria Articles describing a pediatric training simulator or validation of one were included. Models and simulators were then classified into the following categories; VR, bench, cadaver, clay and animal models. Duplicates and non-English articles were excluded, as well as those describing initial design stages of simulators. 1.3. Data extraction Articles were first screened based on title and abstract. The remaining results were then examined, and articles were included if they described or validated a pediatric surgery simulator. 1.4. Data analysis Upon selection, training models were identified and outcomes for validation studies were noted. The definitions of Van Nortwick et al. and McDougall were used to determine type of validation [7,8]. These definitions are well illustrated in Fig. 2. Finally, the level of evidence (LoE) for each validation study was determined. Using this information, a level of recommendation (LoR) was then assigned to each training

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

3

Fig. 1. PRISMA 2009 flow diagram.

A VR simulator again for intracorporeal suturing demonstrated face, content, construct A and construct B validity on 26 subjects [20]. Porcine models were used for a number of thoracoscopic and laparoscopic procedures including esophageal anastomosis and adrenalectomy. These models demonstrated content validity, as they were used over 9 years by 114 subjects [21]. Ovine models demonstrated face validity for flexible endoscopy training with only 2 participants and content validation was assigned by the authors but not experts [22]. Nakajima et al. developed a modular training program which involved the use of the Laparo Trainer® and it demonstrated both construct A and construct B validity among 9 pediatric surgeons [23]. The model was awarded an LoR of 3.

2.3. Gastrointestinal & general pediatric surgery Overall, 24 studies were identified that validated training models for different pediatric gastrointestinal and general surgical procedures (Table 3). These studies were then subcategorized into the following;

Neonatal surgery, Upper GI surgery, Appendicectomy, General Pediatric Surgery and Hepatobiliary. 2.3.1. Appendicectomy Three articles validating VR appendicectomy simulators were identified. Bjerrum et al. developed a VR simulator and recruited 45 participants demonstrating construct A and construct B validity. In addition, each participant had 20 attempts, and the skill improvement led the authors to conclude the model demonstrated content validity as well [24]. Another study aimed to develop a training curriculum for laparoscopic appendicectomy [25]. This involved 38 participants practicing a series of guided and unguided tasks, as well as the entire procedure. The study also randomized inexperienced operators to test construct validity. Overall, the study demonstrated face, content, construct A and construct B validity and was given an LoR of 3. The Virtual Transluminal Endoscopic Surgery Trainer (VTEST™) was used to simulate a number of procedures including appendicectomy using a surgical technique known as Natural orifice transluminal

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

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E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

Table 1 An overview of the available pediatric surgery training models described in the literature (2000–2018). Name of Model (Institution/Manufacturer) Generic Pediatric Laparoscopic Surgery Simulator (Division of General and Thoracic Surgery, Hospital for Sick Children, Toronto, Ontario, Canada) Pediatric Laparoscopic Surgery Simulator with Motion Analysis (Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada) Pediatric Laparoscopic Surgery Simulator with Motion Tracking Software (Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada) Pediatric Laparoscopic Surgery Simulator with 3D equipment (Division of Pediatric General, Thoracic, & Minimally Invasive Surgery, AOU Città della Salute e della Scienza di Torino, Regina Margherita Children's Hospital, Torino, Italy) Pediatric Laparoscopic Surgery Simulator (Division of General and Thoracic Surgery, Hospital for Sick Children, Toronto, Ontario, Canada) SILS™ Port (Covidien, Dublin, Ireland) Pediatric MIS Intracorporeal Suturing Model (Banner Good Samaritan Hospital, Phoenix, Arizona) Porcine Model for Minimally Invasive Simulation (Department of Pediatric Surgery, The Children's Hospital at Westmead, Sydney, Australia) eoSim® (eoSurgical Ltd., Edinburgh, Scotland, United Kingdom) Laparo Trainer®, Nippon Stryker, Japan Rapid Prototyped Chest Model and Motion Sensors for Thoracoscopy (Department of Pediatric Surgery, The University of Tokyo Hospital, Tokyo, Japan) Ex Vivo Ovine Model for Pediatric Flexible Endoscopy (Department of Otolaryngology–Head & Neck Surgery, Temple University School of Medicine, United States) Porcine Models for Minimally Invasive Training (Children's Hospital at Westmead, New South Wales, Australia) Endoscopic Surgical Skill Training Course (Department of Pediatric Surgery, Reproductive and Developmental Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan) Training Course Minimally Invasive Pediatric Surgery Training (Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA) Basic Endoscopic Surgical Skill Training (Faculty of Medical Sciences, Kyushu University, Japan) Nontechnical Skills Integrated Cognitive Simulator (SIMTICS) Neonatal Thoracoscopic Diaphragmatic Hernia Repair Simulator (Ann and Robert H. Lurie Children's Hospital of Chicago, USA) Congenital Diaphragmatic Hernia Repair (Department of Pediatric Surgery, Kyushu University and Kyoto Kagaku Co., Ltd., Japan) 3D Neonatal Ribcage with fetal/bovine tissue for TEF repair (Ann and Robert H Lurie Children's Hospital of Chicago, USA) Synthetic Tissue TEF repair model (Division of Pediatric Surgery, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois) Low cost tissue replica for DA/TEF (Center for Education in Medicine, Feinberg School of Medicine, Northwestern University) Inanimate low cost model for MIS EA/TEF Repair (Pediatric Surgery Department, D.A.D.I—Surgical Simulation Center CeSim, “Prof. Dr. Juan P. Garrahan” Children's Hospital—S.A.M.I.C.,Cuidad Autónoma de Buenos Aires, República Argentina) Duodenal Atresia Repair Simulator (Ann and Robert H Lurie Children's Hospital of Chicago, USA) Baby Sky (Health Cuts Ltd. And Chelsea and Westminster Hospital, London, UK) Gastroschisis baby model -GABBY (Department of Paediatric Surgery, King's Hospital, Denmark Hill, London, United Kingdom)

Fidelity Availability Type of Model

Describing Study

H

Y

Bench

Azzie [10], Nasr [11]

H

Y

Bench

Nasr [13]

H

Y

Bench

Trudeau [12]

H

Y

Bench

Guana [14]

H

Y

Bench

Herbert [15]

H H

Y Y

VR Animal

Hamilton [20] Narayanan [21]

H L H

Y Y y

Bench Bench Bench

H

Y

Animal

Retrosi [16] Nakajima [23] Takazawa [17], Harada [18], Takazawa [19] Isaacson [22]

H H

Y Y

Animal Animal/Bench

Bidarkar [71] Jimbo [45]

H

Y

Bench

Gause [56]

H

Y

Bench/Animal/VR Ieiri [55]

n/a

Y

Software

Loveday [54]

H

Y

Bench

Barsness [33]

H

Y

Bench

Obata [34]

H

Y

Animal/Bench

L

Y

Bench

Davis [27], Barsness [28] Barsness [29]

L

Y

Bench

Hawkinson [30]

H

Y

Bench

Maricic [32]

H L L

Y Y Y

Bench/Animal Bench Bench

Barsness [31] Bacarese-Hamilton [35] Dabbas [36]

Y

Bench

Hawkinson [42]

Y

Bench

Plymale [46]

Y

Bench

Jimbo [44]

L

Y

Bench

L

N

Bench

Jaffer [37], Cho [38] Smith [41]

H

Y

Bench

Roca [40]

L

Y

Clay

Brill [39]

H

Y

Bench

Santos [48]

H L L

Y Y Y

Bench Bench Bench

Schwab [47] Burdall [49] Jimbo [50]

Upper GI Laparoscopic Gastrostomy Tube Placement Simulator (Center for Education in Medicine, Feinberg School of L Medicine, Northwestern University) Middle Fidelity model for Laparoscopic Pyloromyotomy (Department of General Surgery, University of M Kentucky College of Medicine, Chandler Medical Center, Lexington, Kentucky, USA) Laporoscopic Fundoplication Simulator (Department of Pediatric Surgery, Kyushu University and Kyoto H Kagaku Co., Ltd., Japan) General Pediatric Surgery Laparoscopic Paediatric Inguinal Hernia (LPIH) Model (Norfolk and Norwich University Hospital, UK) Silicone Newborn Clamp Circumcision Simulator (University of North Carolina School of Medicine, North Carolina, United States) Neonatal Circumcision model inside high fidelity infant simulator (Milton S. Hershey Medical Center, Toledo, OH, USA) Neonatal Circumcision model (Department of Family Medicine, University of Wisconsin, Milwaukee) Hepatobiliary Laparoscopic Common Bile Duct Simulator (Northwestern University Feinberg School of Medicine, Chicago, USA) + Fundamentals of Laparoscopic Surgery Box Trainer (VTI Medical, Waltham, MA) 3D Choledocal Surgery Simulator (King's College Hospital, London, United Kingdom) Laparoscopic hepaticojejunostomy simulator (Department of Pediatric Surgery, Kyushu University and Kyoto Kagaku Co., Ltd., Japan)

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

5

Table 1 (continued) Name of Model (Institution/Manufacturer)

Fidelity Availability Type of Model

Describing Study

Appendicectomy LapSim virtual reality simulator (Software Version 2013, Surgical Science, Gothenburg, Sweden) Virtual Transluminal Endoscopic Surgery Trainer (VTEST™) LAP Mentor™ VR laparoscopic surgical simulator (Simbionix Corporation, Cleveland, OH, USA)

H H H

Y Y Y

VR VR VR

Bjerrum [24] Sankaranarayanan [26] Sirimanna [25]

Urology Open Dismembered Pyeloplasty Model (Department of Pediatric Surgery, University of Caen Hospital, France) L Porcine Bladder Vesicoureteral Simulator (CHOC Children's Hospital, University of California, Irvine, CA, USA) H

Y Y

Bench Animal/Bench

Rod [51] Soltani [52]

L

Y

Bench

Yoo [53]

H H

N Y

Bench/Animal Animal

Barsness [43] Mavroudis [72]

Cardiothoracic 3D Congenital Heart Disease Models (Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada) Infant Lobectomy Simulator (Ann and Robert H. Lurie Children's Hospital of Chicago, USA) Neonatal Piglets (University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania) Abbreviations: VR, virtual reality; AR, augmented reality; H, high; L, low; Y, yes; N, no.

endoscopic surgery (NOTES) [26]. Here, content validity was demonstrated and participants were asked their preference when compared to animal models. The model was awarded an LoR of 4.

2.3.2. Neonatal Five training models were identified for simulating tracheoesophageal fistula (TEF) repair, duodenal atresia (DA) and esophageal atresia (EA).

Table 2 Validation studies on training models (2000–2016) for generic pediatric skills. Name of Model (Institution / Manufacturer)

Pediatric Laparoscopic Surgery Simulator (Division of General and Thoracic Surgery, Hospital for Sick Children, Toronto, Ontario, Canada)

Type of Model

Study

Validation

Participants

Bench

Azzie (2011) [10] Construct A, Construct B 84 Concurrent- Compared to Adult LS Nasr (2013) [11] Construct A, Construct B 25

n

84

With Suture Evaluation Simulator M57™ (Kyoto Kagaku Co.)

Bench

Trudeau (2017) [12]

Pediatric Laparoscopic Surgery Simulator with Motion Analysis (Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada)

Bench

Nasr (2014) [13]

Bench Pediatric Laparoscopic Surgery Simulator with 3D equipment (Division of Pediatric General, Thoracic, & Minimally Invasive Surgery, Regina Margherita Children's Hospital, Torino, Italy) Bench Pediatric Laparoscopic Surgery Simulator (Division of General and Thoracic Surgery, Hospital for Sick Children, Toronto, Ontario, Canada) + SILS™ Port (Covidien, Dublin, Ireland) Porcine Model for Minimally Invasive Simulation (Department of Pediatric Animal Surgery, The Children's Hospital at Westmead, Sydney, Australia)

eoSim® (eoSurgical Ltd., Edinburgh, Scotland, United Kingdom)

Bench

Pediatric MIS Intracorporeal Suturing Model (Banner Good Samaritan Hospital, VR Phoenix, Arizona) Laparo Trainer® (Nippon Stryker, Japan)

Bench

Rapid Prototyped Chest Model and Motion Sensors for Thoracoscopy (Department of Pediatric Surgery, The University of Tokyo Hospital, Tokyo, Japan)

Bench

Ex Vivo Ovine Model for Pediatric Flexible Endoscopy (Department of Otolaryngology – Head & Neck Surgery, Temple University School of Medicine, United States) Endoscopic Surgical Skill Training Course (Department of Pediatric Surgery, Reproductive and Developmental Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan)

Animal

Animal/ Bench

Guana (2017) [14] Herbert (2015) [15]

60 Construct B Concurrent – Suturing task Construct A, Construct B 75

20 Concurrent vs 2D version Content Construct A, Construct B 41 Concurrent

LoE LoR

Demographics 20 Novice 19 Intermediate 45 Expert 18 Experts 7 Intermediates 20 Novice 19 Intermediate 45 Expert 8 Novices 13 Intermediates 39 Experts 26 Novice 12 Intermediate 37 Expert Pediatric Residents

18 Novices 16 Intermediates 7 Experts Narayanan Content 114 12 Consultants (2014) [21] 74 Registrars 19 Residents 9 Other Trainees 28 8 Experts Retrosi (2015) Content, Construct A, 7 Intermediates [16] Construct B, 13 Novices Concurrent - PLS Hamilton (2011) Content, Construct A, 26 9 Pediatric Surgeons [20] Construct B, Face 7 General Surgeons 10 Residents Nakajima (2003) Construct A, Construct B 9 4 Experienced [23] 5 Novices Takazawa (2016) Concurrent - Aesculap® 53 8 Skilled [19] 45 Unskilled K-ZWEI Construct B, A 9 Experts Takazawa (2014) Concurrent - Aesculap® 28 9 Intermediate [17] K-ZWEI 10 Novices Construct A, construct B Harada (2015) Construct A, construct B 30 10 Experienced [18] Pediatric surgeons 20 Inexperienced Pediatric Surgeons Isaacson (2015) Face, Content- authors 2 Medical Student [22] Pediatric Otolaryngologist Jimbo (2015) Content 7 Surgeons [45]

2b

2

2b 2c

2b

2b

1b

2b

3

4

1b

2

2b

3

2b

3

2b

2

2b

2b

3

4

2c

4

Abbreviations: LoE, Level of Evidence; LoR, Level of Recommendation; VR, virtual reality.

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

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E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

Table 3 Validation studies on training models for gastrointestinal and general pediatric surgery. Name of Model (Institution / Manufacturer)

Appendicectomy Lapsim virtual reality simulator (Software Version 2013, Surgical Science, Gothenburg, Sweden)

Type of Model

Study (Year)

VR

Bjerrum (2017) [24]

Validation

Participants n

Demographics

Construct A, Construct B, Content- authors Content

45

15 Novice 15 Intermediate 15 Expert 17 General Surgeon 4 Gastroenterologist 1 Thoracic Surgeon 10 Experienced 8 Intermediate 20 Inexperienced

Virtual Transluminal Endoscopic Surgery Trainer (VTEST™) for Natural orifice VR translumenal endoscopic surgery

Sankaranarayanan (2013) [26]

LAP Mentor™ VR laparoscopic surgical simulator (Simbionix Corporation, Cleveland, OH, USA)

Sirimanna (2017) [25]

Face, Content, Construct A, Construct B

38

Animal/Bench Davis (2013) [27]

Face, Content

11

Barsness (2014) [28] Bench Barsness (2015) [29] Bench/Animal Barsness (2015) [31] Bench Hawkinson (2014) [30]

Face, Content, Construct B, Content

Bench

Maricic (2016) [32]

Face, Content, Construct A, Construct B

2 Pediatric Surgeons 9 Fellows 20 8 Experienced 12 Novice 47 14 experienced 30 Novice 18 6 Experienced 12 Novice n/a Faculty surgeons Pediatric surgical trainees 39 7 Experts 10 Intermediate 22 Beginner Surgeons

Bench

Barsness (2013) [33] Obata (2015) [34]

Face, Content

40

Construct A, Construct B Face Construct A, Construct B, Face

29

Bench/Animal Dabbas (2009) [36]

Face, Content

17

Bench

Face, Content

30

Construct A, Construct B, Face, Content

21

Construct A, Construct B

12

Neonatal 3D Neonatal Ribcage with fetal/bovine tissue for TEF repair (Ann and Robert H Lurie Children's Hospital of Chicago, USA)

Synthetic Thoracoscopic Esophageal Atresia/Tracheoesophageal Fistula Repair Simulator (Ann and Robert H Lurie Children's Hospital of Chicago, USA) Duodenal Atresia Repair Simulator (Ann and Robert H Lurie Children's Hospital of Chicago, USA) Low cost tissue replica for DA and TEF (Center for Education in Medicine, Feinberg School of Medicine, Northwestern University) Inanimate low cost model for MIS EA/TEF Repair (Pediatric Surgery Department, D.A.D.I—Surgical Simulation Center CeSim, “Prof. Dr. Juan P. Garrahan” Children's Hospital—S.A.M.I.C.,Cuidad Autónoma de Buenos Aires, República Argentina) Thoracoscopic Diaphragmatic Hernia Repair Simulator (Ann and Robert H. Lurie Children's Hospital of Chicago, USA) Congenital Diaphragmatic Hernia Repair (Department of Pediatric Surgery, Kyushu University and Kyoto Kagaku Co., Ltd., Japan)

VR

Bench

Baby Sky (Health Cuts Ltd. And Chelsea and Westminster Hospital, London, UK) Bench

Gastroschisis baby model; GABBY (Department of Pediatric Surgery, King's Hospital, Denmark Hill, London, United Kingdom)

Hepatobiliary Laparoscopic Common Bile Duct Simulator (Northwestern University Feinberg School of Medicine, Chicago, USA) + Fundamentals of Laparoscopic Surgery Box Trainer (VTI Medical, Waltham, MA) 3D Choledocal Surgery Simulator (King's College Hospital, London, United Kingdom) Laparoscopic hepaticojejunostomy simulator (Department of Pediatric Surgery, Kyushu University and Kyoto Kagaku Co., Ltd., Japan) General Pediatric Surgery Laparoscopic Paediatric Inguinal Hernia (LPIH) Model (Norfolk and Norwich University Hospital, UK) Silicone Newborn Clamp Circumcision Simulator (University of North Carolina School of Medicine, North Carolina, United States) Neonatal Circumcision model inside high fidelity infant simulator (Milton S. Hershey Medical Center, Toledo, OH, USA) Neonatal Circumcision model (Department of Family Medicine, University of Wisconsin, Milwaukee) Upper GI Middle Fidelity model for Laparoscopic Pyloromyotomy (Department of General Surgery, University of Kentucky College of Medicine, Chandler Medical Center, Lexington, Kentucky, USA) Laporoscopic Gastrostomy Tube Placement Simulator (Center for Education in Medicine, Feinberg School of Medicine, Northwestern University) Laporoscopic Fundoplication Simulator (Department of Pediatric Surgery, Kyushu University and Kyoto Kagaku Co., Ltd., Japan)

Bench` Bench

Bacarese Hamilton (2013) [35]

Schwab (2016) [47] Santos (2012) [48]

Content Face

23

18 18

2b

3

2c

4

2a

3

3

3

2b 2b

3

2b

3

3

3

2b

3

2b

3

2b

3

2b

3

3

4

Pediatric surgery trainees 5 Experienced 16 Novices Surgical Trainees

3

3

2b

3

3

4

6 Experts 6 Novices

2a

3

34 Residents, 6 Surgeons 10 Experts 19 Trainees Trainees 5 Pediatric surgeons, 9 pediatric surgical registrars 2 Core Surgical Trainees 2 Medical students 5 consultant surgeons 10 trainees 2 junior trainees

Bench

Burdall (2016) [49] Jimbo (2016) [50]

Bench

Cho (2013) [38]

Predictive

n/a Surgical Trainees

2c

4

Bench

Smith (2013) [41]

Content

7

3

4

Bench

Roca (2012) [40]

Face, Content

Clay

Brill (2007) [39]

Face, Content

18

17 Residents 1 Student

3

4

Bench

Plymale (2010) [46]

Face, Content, Construct A

29 23

2b

3

Bench

Hawkinson (2014) [42] Jimbo (2017) [44]

Content

15

Pediatric Surgeons 19 Medical Students 4 Junior Residents Pediatric Surgeons

3

4

Content, Construct A, Construct B

49

24 Trainees 15 Pediatric Surgeons, 10 General Surgeons

2b

3

Bench

10

LoE LoR

Pediatric Residents Resident

4

Abbreviations: LoE, Level of Evidence; LoR, Level of Recommendation; VR, virtual reality.

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

All the simulation models in this category achieved an LoR of 3, with no conducted randomized trials. The most work in this field has been done by Barsness et al., whose team were responsible for 4 (80%) of the TEF/ atresia simulators. The first of these was a hybrid 3D neonatal ribcage with fetal bovine/porcine tissue [27]. Here, the model demonstrated face and content validity among 11 participants, and this was followed by another study [28], whereby the model demonstrated face, content and construct B validity among 20 pediatric surgeons. The model failed to demonstrate construct A validity in the same study. The same authors developed a purely synthetic tissue model, designed to lower costs, and the model demonstrated face and content validity [29]. The team has also developed a DA model as well as a low-cost combined DA/TEF model, both of which attained a level of recommendation of 3 [30,31]. A low-cost model for EA/TEF repair demonstrated greater validity, with a study by Maricic et al. involving 39 participants confirming its face, content, construct A and construct B validity [32]. A high-fidelity 3D neonatal ribcage with fetal bovine tissue was developed by Barsness et al. to simulate thoracoscopic repair of a diaphragmatic hernia [33]. The study involved a large sample of 40 participants, and demonstrated content validity with weaker results for face validity. Another congenital diaphragmatic hernia model by Obata et al. demonstrated face validity among 18 trainees as well as construct A and construct B validity among a further 29 experts and trainees [34]. Both models were awarded an LoR of 3. Two articles described models which simulate silo application for gastrochisis. The first, named Baby Sky, demonstrated construct A, construct B as well as face validity [35]. The second model, GABBY, involved a combination of bovine sausage and toy doll, demonstrated face and content validity among 17 participants [36]. The latter model however was given an LoR of 4 unlike Baby Sky, which was given an LoR of 3. 2.3.3. General pediatric surgery Two articles describing and then validating a pediatric inguinal hernia repair simulator were identified. A low fidelity, inexpensive laparoscopic pediatric inguinal hernia repair simulator was described by Jaffer et al. [37]. This later demonstrated predictive validity as it was incorporated into a structured training program with consultant supervised sessions, and the long-term outcomes of patients were not adversely affected by the training program [38]. However, the study did not detail the number of surgeons or trainees that participated, and the model achieved an LoR of 4 only. Three articles for neonatal circumcision simulators were identified. A low fidelity, inexpensive clay and glove model demonstrated face and content validity among 16 medical residents and 1 medical student [39]. An improvement of the above model was proposed by Roca et al. [40]. Here, the model was attached to a high fidelity infant simulator and demonstrated further face and content validity achieving an LoR of 4. A training program involving web accessible learning materials, checklists, mentor feedback and a bench model for new-born clamp and circumcision was developed by Smith et al. [41]. The program demonstrated content validity among 7 participants and again was given an LoR of 4. 2.3.4. Upper GI surgery A simulator for gastrostomy tube placement was developed by Hawkinson et al. and demonstrated content validity among 15 participants [42]. The same team has developed numerous models including those for diaphragmatic hernia and TEF as mentioned earlier [28–30,33,43]. Jimbo et al. developed a laparoscopic fundoplication simulator and demonstrated content, construct A and construct B validity among 49 trainees, pediatric and general surgeons [44]. The Simulator was then used in an endoscopic surgical skill training course involving training on live tissue and bench models [45].

7

The ProMIS simulator (Haptica, Inc., Boston, MA) was modified to create a middle fidelity laparoscopic pyloromyotomy model and demonstrated face and content validity among 29 pediatric surgeons as well as construct A validity among 23 medical students and residents [46]. 2.3.5. Hepatobiliary There were three simulation models identified for use in training pediatric hepatobiliary procedures. The first; a laparoscopic common bile duct simulator demonstrated face and content validity for pediatric surgical education [47]. The model has previously demonstrated construct A, construct B and concurrent validity among nonpediatric surgeons and was subsequently given an LoR of 3 [48]. A reproducible 3D choledocal surgery model was validated by 10 pediatric surgery trainees and demonstrated face and content validity; however, it also achieved an LoE of 3 [49]. A study by Jimbo et al. designed a simulator for laparoscopic hepatojejunostomy to explore the appropriate port location for the surgery [50]. In doing so, the simulator demonstrated construct A and B validity, and the authors noted its potential use in training for pediatric surgeons. 2.4. Urology Two articles describing models for pediatric urology were identified (Table 4). Rod et al. developed and demonstrated face, content and construct B validity for a pyeloplasty simulator among 118 participants [51]. A combined bench and porcine bladder model was used in a simulator curriculum for endoscopic correction of vesicoureteral reflux and demonstrated face and construct B validity [52]. 2.5. Cardiothoracic surgery Two validation studies were identified for cardiothoracic surgery (Table 4). The first was a 3D congenital heart disease model and demonstrated content validity among 50 subjects [53]. The second model by Barsness et al. was a lobectomy simulator which demonstrated both face and content validity and was given an LoR of 3 [43]. 2.6. Nontechnical skills There were two articles describing nontechnical skills acquisition (Table 4). The first was a randomized trial by Loveday et al. [54], which evaluated a cognitive simulator for laparoscopic appendicectomy. The earlier mentioned Baby Sky model [35] for gastrochisis also tested nontechnical skills in a simulation scenario. 2.7. Training courses Five validated training programs were identified. These include the previously mentioned modular laparoscopic training program by Nakajima et al. [23], the inguinal hernia repair program [38], laparoscopic appendicectomy program [25], new-born clamp and circumcision program [41] and the endoscopic surgical skill training course using a laparoscopic fundoplication simulator [45]. Two articles describing training courses were not validated (Table 1). The first, a 2-day course for pediatric endoscopic skill training, demonstrated some merit in improving generic endoscopic skills among 477 pediatric and general surgeons [55]. Another article detailed two minimally invasive pediatric surgery training courses [56], which used several validated models identified earlier [27,31,43,47]. 3. Discussion The present study applies a standardized validation terminology to assess pediatric simulators, which has been used to review simulation-based training in multiple other specialties such as urology,

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

8

E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

Table 4 Validation studies on training models (2000–2018) for cardiothoracic surgery, urology and non-technical skills. Model (Institution / Manufacturer)

Type of Model

Study

Bench

Yoo (2017) [53]

Validation

Participants

LoE LoR

n

Demographics

Content

50

Surgeons/Trainees

3

4

Animal/Bench Barsness (2015) [43]

Face, Content

33

11 Experienced 22 Novice

2b

3

Urology Open Dismembered Pyeloplasty Model (Department of Pediatric Surgery, University of Caen Hospital, France)

Bench

Face, Content, Construct B

2b

3

Porcine Bladder Vesicoureteric Simulator (CHOC Children's Hospital, University of California, Irvine, CA, USA)

Animal/Bench Soltani (2016) [52]

Face, Construct B

118 44 Experts 25 Fellows 49 Residents 16 5 Pediatric Urologist 11 Urology Trainees

2b

3

Nontechnical Skills Integrated Cognitive Simulator (SIMTICS)

n/a

Content

58

Trainees

2a

3

Baby Sky (Health Cuts Ltd. And Chelsea and Westminster Hospital, London, UK)

Bench

Construct A, Construct B, Face

18

5 Pediatric Surgeons, 9 pediatric surgical registrars 2 Core Surgical Trainees 2 Medical students

2b

3

Cardiothoracic Surgery 3D Congenital Heart Disease Models (Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada) Infant Lobectomy Simulator (Ann and Robert H. Lurie Children's Hospital of Chicago, USA)

Rod (2018) [51]

Loveday (2010) [54] Bacarese Hamilton (2013) [35]

Abbreviations: LoE, Level of Evidence; LoR, Level of Recommendation; VR, virtual reality.

orthopedics and otolaryngology [57–59]. This enables a comparison between them and an indication of areas where simulation based training in pediatrics may be improved. Urology has particularly led the way for simulation based training, with multiple curricula using various training modalities and simulators achieving the highest level of evidence and recommendation. Pediatric surgery simulators identified in the present study are outnumbered by those identified in otolaryngology and orthopedics, and lack incorporation into validated procedure specific skills curricula. Incorporating simulation-based training into a structured training program can result in superior skills transfer to the operative setting [60]. Efforts should therefore be made to implement existing and future procedure-specific models into broader training curricula. An example of this would be the Fundamentals of Laparoscopic Surgery (FLS) curriculum which employs the use of a box trainer and has been well validated within the literature [61]. It is promising to see that a pediatric counterpart (PLS) to this box trainer has been developed and validated [10]. Nevertheless, efforts should be made to determine whether the model possesses predictive validity, as well as implementing it into a skills curriculum, much like the FLS skills curriculum which has been adapted for other specialties [62]. Indeed, such a curriculum could model itself on the adult counterpart with the modifications appropriate to training pediatric specific skills. Nontechnical skills simulation was also lacking in pediatric simulation, with only two studies present [35,54]. Nontechnical skills (NTS) encompass situational awareness, decision-making, teamwork and communication. Deficiency in NTS has been associated with poor outcomes [63,64], and so it is important that more effort is made to develop training tools for the acquisition of NTS in pediatric surgery. Further, the use of full immersion simulation training which involves simulating the operative environment has been validated in other specialties such as urology [65] and has shown to benefit the acquisition of both technical and nontechnical skills. While this has been implemented for pediatric emergencies such as initiating extracorporeal membrane oxygenation [66], its use in pediatric surgical training is yet to be determined and could prove beneficial. The most appraised simulators in the literature were the Rapid Prototyped Chest Model and Motion Sensors for Thoracoscopy model [19], and the PLS, highlighting the prevalence of pediatric simulators for generic surgical skills. This is particularly welcome, as it is important that pediatric trainees are given the opportunity to develop the skills

unique to pediatric surgery when compared to general surgery [20]. There were only 2 validated simulation models in Cardiothoracic surgery, with an equal number in Urology. We advocate the development and validation of more simulators in these pediatric specialties. This is especially emphasized when considering the rarity of such technically demanding cases. Indeed, opportunities to train pediatric surgeons in such procedures can be few and far between [67,68]; therefore, it is paramount that greater training opportunities are provided using simulators. Only 4 models were made entirely of animal specimens. This is understandable when considering the ethical and cost considerations. Additionally, animal models fail to fully simulate the aberrant human anatomy seen in many congenital disorders treated by pediatric surgeons [69]. Notably, several tools were designed with the intention of reproducibility and low cost [37,40]. While relatively few models are commercially available, most articles were instructive in creating these models, and had low cost. This aided us in determining the availability of the simulators. Unfortunately, only one model could demonstrate predictive validity [38]. The absence of models displaying predictive validity and relatively low LoE studies suggests there is much work to be done investigating the use of these simulators for pediatric surgery. Only five studies were randomized controlled trials. Consequently, none of the models were assigned an LoR of 1, as per our study methodology. Greater use of randomized trial methods is necessary to enhance the evidence base. Additionally, the absence of predictive validity for most models demonstrates that a translational benefit is yet to be realized for surgical skill acquisition through simulation based training in pediatric surgery. The lack of consistency in the use of validation terminology was persistent. For example, terms such as content validity were used in a different context to that described by Van Nortwick et al. and McDougall [7,8]. Also, some articles failed altogether to label the validity as such, even though it had been demonstrated in the study. Additionally, some articles used different criteria to determine validity such as the Standards for Educational and Psychological Testing developed by the American Educational Research Association [70]. Further, terms such as ‘novice’ and ‘expert’ were used to describe participants in several studies. However, there were discrepancies in the criteria each study used to assign such labels, if such criteria were described at all.

Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

E.A. Patel et al. / Journal of Pediatric Surgery xxx (xxxx) xxx

Ultimately, such issues must be addressed to enable us to rigorously study and compare these models more effectively for use in training pediatric surgeons. 3.1. Limitations Best efforts were made to ensure a rigorous and reproducible search; however, appropriate studies may have been missed. Additionally, pediatric surgery is a generic term used to delineate a variety of subspecialties based on patient age. Within the UK, pediatric surgery encompasses neonatal surgery, urology, cardiothoracic and oncological surgery; however, there are many unaccounted specialties. This makes it difficult to identify appropriate simulators and potentially omit relevant simulators which were not evaluated in the context of pediatric care. Therefore, their validity for pediatric surgery is yet unknown. 4. Conclusion There are many challenges currently facing pediatric surgical training. The growing number of simulators specific to pediatric surgery is promising. However, these simulators have limited LoE and therefore LoR. The lack of nontechnical skills simulators must also be highlighted. We advocate greater use of randomized trials in validating these models, and more efforts to explore predictive validity for current and future simulation models. Supplementary data to this article can be found online at https://doi. org/10.1016/j.jpedsurg.2018.11.019. CRediT authorship contribution statement Ebrahim Adnan Patel: Data curation, Formal analysis, Writing - original draft. Abdullatif Aydın: Conceptualization, Methodology, Data curation, Formal analysis, Writing - review & editing. Ashish Desai: Writing - review & editing. Prokar Dasgupta: Conceptualization, Methodology. Kamran Ahmed: Conceptualization, Methodology, Writing - review & editing. References [1] Kotsis SV, Chung KC. Application of see one, do one, teach one concept in surgical training. Plast Reconstr Surg 2013;131(5):1194–201. [2] de Bruin L, Pasma W, van der Werff DB, et al. Perioperative hospital mortality at a tertiary paediatric institution. Br J Anaesth 2015;115(4):608–15. [3] Smith III PH, Carpenter M, Herbst KW, et al. Milestone assessment of minimally invasive surgery in pediatric urology fellowship programs. J Pediatr Urol 2017;13(1) [110.e1-.e6]. [4] Dawe SR, Windsor JA, Broeders JA, et al. A systematic review of surgical skills transfer after simulation-based training: laparoscopic cholecystectomy and endoscopy. Ann Surg 2014;259(2):236–48. [5] Grant VJ, Cheng Adam. In: Adam I, Levine SDJ, editors. Comprehensive healthcare simulation: pediatrics. Calgary, Alberta, Canada: Springer; 2016. [6] Panic N, Leoncini E, de Belvis G, et al. Evaluation of the endorsement of the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement on the quality of published systematic review and meta-analyses. PLoS One 2013;8 (12):e83138. [7] Van Nortwick SS, Lendvay TS, Jensen AR, et al. Methodologies for establishing validity in surgical simulation studies. Surgery 2010;147(5):622–30. [8] McDougall EM. Validation of surgical simulators. J Endourol 2007;21(3):244–7. [9] Carter FJ, Schijven MP, Aggarwal R, et al. Consensus guidelines for validation of virtual reality surgical simulators. Surg Endosc 2005;19(12):1523–32. [10] Azzie G, Gerstle JT, Nasr A, et al. Development and validation of a pediatric laparoscopic surgery simulator. J Pediatr Surg 2011;46(5):897–903. [11] Nasr A, Gerstle JT, Carrillo B, et al. The Pediatric Laparoscopic Surgery (PLS) simulator: methodology and results of further validation. J Pediatr Surg 2013;48(10): 2075–7. [12] Trudeau MO, Carrillo B, Nasr A, et al. Educational role for an advanced suturing task in the pediatric laparoscopic surgery simulator. J Laparoendosc Adv Surg Tech A 2017;27(4):441–6. [13] Nasr A, Carrillo B, Gerstle JT, et al. Motion analysis in the pediatric laparoscopic surgery (PLS) simulator: validation and potential use in teaching and assessing surgical skills. J Pediatr Surg 2014;49(5):791–4. [14] Guana R, Ferrero L, Garofalo S, et al. Skills comparison in pediatric residents using a 2-dimensional versus a 3-dimensional high-definition camera in a pediatric laparoscopic simulator. J Surg Educ 2017;74(4):644–9.

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Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019

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Please cite this article as: E.A. Patel, A. Aydın, A. Desai, et al., Current status of simulation-based training in pediatric surgery: A systematic review, Journal of Pediatric Surgery, https://doi.org/10.1016/j.jpedsurg.2018.11.019