Development Of A Standardised Training Curriculum For Robotic Surgery: A Consensus Statement From An...

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Development Of A Standardised Training Curriculum For Robotic Surgery: A Consensus

Statement From An International Multidisciplinary Group Of Experts1

AUTHORS:

Kamran Ahmed <[email protected]>,

MRC Centre for Transplantation, King's College London, Department of Urology, Guy's Hospital,

London, UK.

Reenam Khan [email protected]


London, UK.

Alexandre Mottrie (<[email protected]>)

Department of Urology, OLV Vattikuti Robotic Surgery Institute, OLV Hospital, Aalst, Belgium

Catherine Lovegrove [email protected]


London, UK.

Ronny Abaza "[email protected]". Department of Urology, The Ohio State University

Comprehensive Cancer Center, Arthur G James Cancer Hospital & Richard J Solove Research

Institute, Columbus, OH 43210, USA

Rajesh Ahlawat “[email protected]”

Medanta - The Medicity,

Gurgaon, Haryana, India

Thomas Ahlering <[email protected]>.

Department of Urology, University of California, Irvine, Orange, CA, USA

Goran Ahlgren <[email protected]>,

Department of Urology, Lund University Hospital, Lund, Sweden.

Walter Artibani <[email protected]>

Urology Clinic, A.O.U.I. Verona, Verona.

Eric Barret "[email protected]"

Department of Urology, Institut Mutualiste Montsouris, Paris, France

Xavier Cathelineau "[email protected]"

Department of Urology, Institut Mutualiste Montsouris, Paris, France

Ben Challacombe <[email protected]>

This article has been accepted for publication and undergone full peer review but has not been through the copyediting,

typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of

Record. Please cite this article as doi: 10.1111/bju.12974

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London, UK.

Patrick Coloby "[email protected]" Service d'urologie, centre hospitalier René-Dubos,

95303 Cergy-Pontoise Cedax, France.

Jacques Hubert "[email protected]"

Service d'urologie, CHRU Nancy, 54511 Vandoeeuvre-lès-Nancy, France

M Shamim Khan [email protected]


London, UK

Maurice Stephan Michel "[email protected]"

University Hospital, Mannheim, Germany

Francesco Montorsi <[email protected]>,

Department of Urology, San Raffaele Scientific Institute, Milan, Italy

Declan Murphy <[email protected]>

Peter MacCallum Cancer Centre and the Royal Melbourne Hospital, Australia

Joan Palou ([email protected])

Department of Urology, Fundació Puigvert, Universitat Autònoma de Barcelona, Spain

Vipul Patel (<[email protected]>)

Global Robotics Institute, Florida Hospital Celebration Health, Celebration, FL, USA

Pierre-Thierry Piechaud <[email protected]>,

Clinique Saint-Augustin, 114, avenue Arès, 33000 Bordeaux, France.

Hendrik Van Poppel <[email protected]>

Department of Urology, University Hospital, KU Leuven, Leuven, Belgium

Pascal Rischmann "[email protected]"

Service de Chirurgie Urologique, CHU Purpan, Toulouse

Rafael Sanchez-Salas, Institut Mutualist Monsouris (IMM), Paris

Rafael Sanchez-Salas, [email protected]

Department of Urology, Institut Mutualiste Montsouris,

Paris, France

Stefan Siemer. "[email protected]"

Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes, Homburg/Saar,

Germany

Michael Stoeckle "[email protected]"

Department of Urology, University of Saarland, Homburg, Germany

Jens Uwe Stolzenburg "[email protected]" Department of Urology, Acc

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University of Leipzig , Leipzig , Germany.

Jean Etienne Terrier "[email protected]".

Department of Urology, Foch Hospital, Suresnes, France

Joachin Thueroff "[email protected]"

University of Ulm, Germany

Christophe Vaessen [email protected]

Service D’Urologie et de Transplantation Réno-Pancréatique, Hôpital Pitié-Salpêtrière, 47-83

Boulevard de l'hôpital, 75651 Paris Cedex 13, France

Henk G Van Der Poel <[email protected]>

Department Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands

Ben Van Cleynenbreugel "[email protected]"

Department of Urology, University Hospital, KU Leuven, Leuven, Belgium

Alessandro Volpe <[email protected]>

OLV Vattikuti Robotic Surgery Institute, Aalst, Belgium; University of Eastern Piedmont, Novara,

Italy

Christian Wagner [email protected]

St. Antonius-Hospital Gronau, Germany

Peter Wiklund <[email protected]>

Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden

Timothy Wilson "[email protected]". Division of Urology, City of Hope, Duarte, California 91010,

USA

Manfred Wirth "[email protected]" Department of Urology, University

Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany

Jörn Witt [email protected]

St. Antonius-Hospital Gronau, Germany

Prokar Dasgupta [email protected]

MRC Centre for Transplantation, King’s College London, Department of Urology, Guy’s Hospital,

London, UK

The authors declare no conflicts of interest.

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ABSTRACT

Objectives: To explore the views of experts about the development and validation of a robotic

surgery training curriculum, and how this should be implemented.

Materials and Methods: An international expert panel was invited to a structured session for

discussion. The study was of a mixed design, including qualitative and quantitative components

based on focus group interviews during ERUS (2012), EAU (2013) and ERUS (2013) meetings.

After introduction to the aims, principles and current status of the curriculum development, group

responses were elicited. Following content analysis of recorded interviews generated themes were

discussed at the second meeting, where consensus was achieved on each theme.. This discussion

also underwent content analysis, and was used to draft a curriculum proposal. At the third meeting,

a quantitative questionnaire about this curriculum was disseminated to attendees to assess the level

of agreement with the key points.

Results: 150 minutes (19 pages) of the focus group discussion was transcribed (21316 words).

Themes were agreed by two raters (median agreement κ 0.89) and they included: need for a training

curriculum (inter-rater agreement κ 0.85); identification of learning needs (κ 0.83); development of

the curriculum contents (κ 0.81); an overview of available curricula (κ 0.79); settings for robotic

surgery training ((κ 0.89); assessment and training of trainers (κ 0.92); requirements for

certification and patient safety (κ 0.83); and need for a universally standardised curriculum (κ 0.78).

A training curriculum was proposed based on the above discussions.

Conclusion: This group proposes a multi-step curriculum for robotic training. Studies are in

process to validate the effectiveness of the curriculum and to assess transfer of skills to the OR.

Key Words: Robotics, training, curriculum, education, validation, learning-needs

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INTRODUCTION

During the last decade, robotic surgery has expanded across several surgical specialties, including

Urology (1). However, as it becomes more common, surgeons are faced with the challenge of

training to use this technology. Whilst some guidelines exist for training and credentialing in open

and laparoscopic surgery, there is no robotic surgery equivalent. This means the quality of training

is highly variable, raising concerns for patient safety. This suggests the need for a validated

curriculum centred on patient safety which can cater for trainees around the world.

Effective curriculum development requires a systematic approach (2). The algorithm starts from

identifying learning needs and integrating elements into one curriculum. This should consider views

of trainees, trainers and regulatory bodies. The curriculum must be validated before

implementation, by analysing key outputs, for example patient outcomes. Retrospective analysis

can identify additional learning needs to update the curriculum. Thus the curriculum is subject to

continual evolution (Figure 1).

This mixed qualitative/quantitative method study aims to explore the views of experts in robotic

surgery and surgical education about the need for a training curriculum for robotic surgery, and how

this should be implemented.

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MATERIALS AND METHODS

Study design and participants

This prospective study included multiple institutions, represented by delegates at ERUS-2012,

ERUS-2013 and EAU-2013. It incorporated qualitative analysis (ERUS-2012/EAU-2013) of two

focus group discussions involving expert surgeons, engineers and medical educators (authors of this

manuscript) on the need for a standardised curriculum, its content and implementation. At the third

meeting (ERUS 2013), a questionnaire distributed to trainees generated quantitative data.

Process (figure 2)

a. First focus group interview: The open discussion was took place around the following topics: 1;

A curriculum over-view; Proposal for Robotic Surgery and Certification Criteria, 2; Integration of

technical / non-technical skills, 3; Simulation in Robotic Surgery Training. The group discussion

was audiotaped and transcribed (RK). This transcript was examined by two reviewers (KA and

RK), to generate themes.

c. Second focus group interview: This adopted a semi-structured approach to discussion, with an

agenda comprising the themes from the first interview. Reactions to these topics were explored

through group discussion, in which each delegate was asked to contribute their opinion to reach a

consensus. Two authors independently examined the transcript (KA and RK). Supplementary data

was categorized into pre-existing themes. A curriculum proposal was then generated.

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c. Quantitative Survey Generation and Analysis: An anonymised questionnaire was circulated

amongst attendees at ERUS 2013 to make a quantitative assessment of responses to the curriculum

proposal. The survey comprised six sections, based on different aspects of the curriculum proposal.

Each section contained a series of statements and responses were assessed using a 5-point Likert

Scale. Additional blank spaces in each section allowed for general comments.

Outcome parameters / themes

The themes generated from the first meeting and discussed at the second meeting were outcomes of

interest. These were used to create the curriculum proposal. In the opinion survey (c), the outcome

parameters were the mean and standard deviation of the Likert Scale responses.

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RESULTS

The first unstructured interview lasted 60 minutes. Nineteen pages (7975 words) were transcribed

over 13 hours. Second meeting was 90 minutes. Twenty-four pages (13341 words) were transcribed

over 16 hours.

(A) DEVELOPMENT OF THEMES AND CONSOLIDATION OF OPINION

Eight themes were identified (Figure 3) after the first focus group meeting (ERUS 2012). Average

inter-rater (KA & RK) agreement for the themes was k=0.89. Results are described relative to each

theme.

1. Recognition of the need for a training curriculum:

Members expressed concern that current robotic surgery training is ‘random’ and ‘insufficient to

ensure patient safety’. It was deemed that learning curves “are no longer acceptable” in surgery.

Participants agreed a need for “a standardized way in which we train the next generation of robotic

surgeons”, and Consensus on training methods was deemed important to justify expensive training

equipment.

2. Identification of learning needs:

Increased exposure to robotics: “Over half of residents have no Da Vinci Robot available in their

centre”, and where available, “only 20% have the option of doing some console training”.

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Variability of learning needs amongst individuals: There is “large variability amongst surgeons’

skills” e.g., “some surgeons have been trained in laparoscopy and others have not”. Specialists will

require “fewer training hours than those starting from scratch”. .

Basic and advanced training: Robotic surgeons should receive “basic training” followed by

advanced “procedure specific (modular) training”. Pre-operative, operative and post-operative

aspects of surgery must be considered. Task deconstruction would identify specific learning needs.

For instance, tasks involved in prostatectomy could include port insertion, dropping of bladder,

dissection of prostate / seminal vesicles / bladder neck, urethro-vesical anastomosis and pelvic

lymph node dissection.

3. Development of the contents of the curriculum:

The curriculum should develop technical and non-technical skills:

Technical skills: “Console operators must be familiar with tying knots, suturing, transfer, and

dissection”. Other skills sets include use of camera, diathermy, safe tissue dissection, manoeuvring

of robotic arms and patient-side assistance. They should demonstrate correct wrist articulation in

manoeuvring the robotic arms for good tissue handling and appropriate bedside training.

Non-technical skills: Members argued, “many trainees think that robotic surgery is all about

operating the console” but “only 50% of the problems that can occur happen at the console…. in

fact, non-technical skills are also involved”. Trainees should be able to apply knowledge of

“troubleshooting of the robot, robotic technology, and device parameters” Decision making and

clinical judgement is important in relation to “patient selection and indicators, pre-operative Acc

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preparation, patient and system positioning, the procedural steps an d management of

complications”. Trainees should know the “limitations of the system” and when to seek for help.

Other important non-technical aspects included “ “situation awareness”, “teamwork” and

“communication effectiveness”. A dry-lab simulator alone may not address these skills, though for

someone who has already completed their training, this may be less problematic.

4. An overview of the proposed curriculum:

Representative bodies: ERUS involvement was considered important “to establish the procedure

and standardize it”. Participants mentioned the importance of juniors’ opinions in curriculum

development.

Proposed curriculum for robotic surgery: Members discussed the “Robotic Surgery Structured

Training Programme” comprising: Online theoretical training (EBRUS Course): An online,

knowledge-based exam on subjects such as “history of robotic surgery, robotic surgery hardware,

etc.”. Simulation training and case observations (“Discovery Course”): Two days’ generic

training in a dry-lab with one day of live surgery in an experienced centre. This would be followed

by a five-day training course with theory-based, procedure-specific courses, dry and wet-lab

sessions and live surgery observation.

After this programme would be a fellowship programme of six months. This would include

transition from observation to bedside assisting, to performing segments of a procedure before

undertaking a whole procedure (modular-training / dual console).

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Validation and implementation: Curriculum validation was deemed essential, involving “local

trials and then randomized controlled trials with cross over, comparing people who have been

trained with the training curriculum and without it”. The curriculum should be piloted in a centre of

excellence in robotics, after which trainees’ performance will be videoed. Distribution to

anonymous experts means that “excellent validation should be possible” with global rating scales

and standardized methods. Participants recognised that following validation, curriculum-based work

must undergo a systematic process with governing bodies, for example, the EAU etc.

Challenges in the curriculum development process: Main concern was the financial cost of

“getting trainees into these robotic centres for training and then getting experts to assess them”.

Telementoring or “Skype” for observational components could reduce costs.

Another concern was whether “the proposed programme will be tailored to have sites big enough to

be able to accept all the residents”. National societies should decide who provides training in their

country. For fellowships, there must be sufficient centres; therefore the programme will need to

start on a small scale.

5. Settings for robotic surgery training:

Online: Online teaching is practical for disseminating theoretical knowledge such as “where you

put the incision, where to put the ports, the complications that occur. You have to identify the

problem that occurs and how to fix it- these things cannot be simulated on a model”.

Simulation in the lab setting: Although only basic virtual reality simulation has been developed

for robotic surgery, software in laparoscopic surgery “has proved effective in the general surgery

arena” thus it was suggested that aspects could be transferred to robotic surgery. Dry-labs facilitate Acc

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co-ordination and dissection on cheap models, e.g., the “Venezuelan chicken” for dissection of

pelvic vessels from tissue. Some delegates raised concerns about “ethical issues” and maintenance

costs of wet-labs. It was suggested that dry models from laparoscopy, which are reasonably priced

and widely available, might be useful in robotics.

Training in the workplace: “Full-immersion simulation” was considered for assessing non-

technical skills. Simulation could occur in an operating theatre. Training centres should include a

surgery room “to understand the logistics of robotic surgery and how the surgery is set up”.

6. Assessment and trainers:

How will tasks be assessed? The need for objective, validated assessment was agreed. Procedure-

specific checklists should be developed through task analysis and the scoring list should be

circulated for consensus, ensuring acceptability. Experts in psychomotor and cognitive

communication should have input in development.

Who will be trainers? Trainees may later adopt mentorship and proctor roles. In robotic surgery

centres, medical directors may certify trainees, but for those at other training centres, this could be

problematic.

7. Requirements for certification and patient safety:

Certification requirements: Some argued that laparoscopic training should be a pre-requisite for

robotic training as safe port access (“laparoscopic skill”) is crucial. Others argued: “port access

can be learned without doing the rest of laparoscopic training”, through modules on port access. Acc

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Fellows will need to complete the proposed “Robotic Surgery Structured Training Programme”. It

was agreed that not everyone requires fellowship but should have completed “an accredited

specialist training programme”. In terms of ‘numbers required’ attendees said, “It’s not for this

group to comment on how many cases one needs to do to become proficient. It’s more about

ensuring that things are in place to maximize patient safety”. Certification should be from

accredited, regional training centres.

Ensuring patient safety: Progression from online training, to laboratory simulation, to assisting

before using the console, was considered important for patient safety. Participants agreed that

surgeons should not operate until deemed safe; “the certification process is not something that runs

parallel to clinical experience outside of the formal training setting”.

Members were in favour of a “robotic surgery safety checklist” for pre-operative, intra-operative

and post-operative care, developed using FMEA (Failure Mode and Effect Analysis) involving

expert opinion.

8. Global use of a standardized curriculum:

A global standard was deemed important. “The skeleton will have to be the same, even though the

specifics will vary from country to country”. Representatives from different countries should be

involved to ensure that needs are met.

(B) OUTCOMES OF QUANTITATIVE SURVEY

Twenty-four robotic surgery specialists at the ERUS 2013 focus group meeting responded to the

survey (Appendix 1). The responses were categorised into opinions on: Programme Requirements Acc

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(agreement: 87%); Online training (83%); Simulation and Observation (88%); Fellowship (87%);

Certification (79%); and Independent Practice (81%). All the participants either agreed or strongly

agreed with the need for the curriculum development and the proposed curriculum. There was a

consensus that the next stage is to validate the proposed curriculum.

DISCUSSION

Robotic surgery training should occur in a modular fashion, beginning with online theoretical

training, then simulation training. Subsequent theatre experience should begin with assisting, then

console operation under supervision, before independent operation. Assessment will address

procedures whose key elements can be determined by task analysis. Video technology allows

anonymous accreditation and performance evaluation. For patient safety, certification will be a pre-

requisite for independent practice. Additionally, checklists specific to robotic surgery should be

incorporated into practice. Progress has been made, however there are financial and practical

limitations to consider prior to large-scale implementation.

E-learning should be used as a first step in the curriculum (3, 4). Dulan et al describe the use of an

e-learning programme to teach basic aspects of system components (5). Various E-learning courses

are available on the training organisations websites such as AUA. These components could be used

for knowledge acquisition (6, 7) . Following the adoption of e-modules, it is important to evaluate

trainee satisfaction, usability and applications. Following e-learning, skills training through

simulation allows progression through the learning curve, without compromising patient safety.(8)

(9). Simulation skills have been shown to transferable to clinical practice (10). Despite its benefits,

simulation is not widely used in urology training, possibly due to perceived cost or that it is limited Acc

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to dedicated simulation centres (11).

There are currently five robotic surgery simulation platforms on the market. The Mimic dV- trainer,

ProMIS, Sim Surgery Educational Platform (SEM) and Intuitive Systems showed construct, face

and content validity(12). The Robotic Surgical SimulatorTM system demonstrated face and content

validity.

Physical synthetic or animal-based models may be used in wet/dry-labs. Cost and ethical

uncertainties surrounding the use of animals makes them less favourable than synthetic models.

After developing basic robotic surgical techniques in a lab setting, trainees would progress to a

simulated theatre. Here, authentic, team-based approaches to training particularly consolidate non-

technical skills (13).

These include situation awareness, decision-making, communication, teamwork, stress

management and leadership skills (14). Analysis suggests that poor non-technical skills, rather than

technical failures, are often responsible for adverse events (15) (16). Despite acknowledgement of

their value, formal training and certification currently do not include non-technical skills. Non-

technical skills can be assessed using objective behaviour rating systems, such as “non-technical

skills for individual surgeons (NOTSS)”. Teamwork rating systems include the Objective

Teamwork Assessment System (OTAS) and the surgical NOTECHS (Non-technical skills) (17)

(18).

A structured fellowship programme in a recognised institution can increase exposure to procedures

and involving mentoring by instructors. This protects patient safety while ensuring that residents

gain experience with patients. Observation would be followed by performing increasingly complex Acc

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procedures with mentors’ supervision, and this is termed as ‘modular training’. Abboudi et al

discuss successful mentorship programmes (19). It is important that mentors receive training and

accreditation. They should be advised on teaching skills and their responsibilities to the trainee and

regulating body. Telementoring could be employed for observation and feedback, ensuring that

trainees in centres without certified robotic surgeons would not be disadvantaged.

For patient safety, certification should be based on demonstrating proficiency in robotic surgery

rather than caseload. The “learning curve” currently employed in surgical training does not protect

against adverse events. Certification criteria need to be defined as they determine safety of a

procedure.

Methods to ensure patient safety even for independent robotic surgeons are vital. It is estimated that

up to 15% of patients admitted to hospital experience an adverse event, and around half are

avoidable (20) (21). The WHO checklist is a generic safety checklist comprising 19 items, designed

to improve team communication and consistency of care (22). It has reduced surgical morbidity and

mortality (23). Use of this checklist, is mandatory for all operations in the UK (24). Through task-

analysis, a checklist for robotic procedures can be constructed to minimise errors endangering

patient safety. Patient safety can also be increased through adopting simulation technology in

routine practice. Research demonstrates that pre-operative virtual reality work-up for 3-5 minutes

can improve subsequent performance and reduce error (25). Therefore, simulation need not be

limited to training.

AUA guidelines exist for the standard robotic surgery practice (26). However, this doesn’t include

the training pathways for various robotic surgical procedures. Structured and evidence-based

guidelines and curricula are needed for training, assessment and credentialing in robot-assisted Acc

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surgery. The existing curricula include the Fundamentals of Robotic Surgery (FRS), and

Fundamental Skills in Robotic Surgery (FSRS) (27, 28). This study has initiated development and

validation of the ERUS (EAU Robotic Urology Section) Curriculum. They are in different stages of

development and validation and offer a mix of knowledge and skills training. Whilst the FSRS is

based on tasks on virtual reality Robotic Surgical Simulator (RoSS), FRS is being designed for use

on both simulators and the surgical robot. The proposed ERUS curriculum will benefit from a

combination of dry lab, wet lab and virtual reality components, which may allow skills to be more

transferable to the operating rooms (OR). The ERUS curriculum also takes into account the OR

modular training programme as table assistant and console surgeon. All these curricula require

rigorous validation processes.

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CONCLUSIONS

There is a need for a standardized curriculum in robotic surgery due to innovations in technology.

Potential training paths following the robotic surgery curriculum have been proposed and experts in

robotic surgery are in agreement with this proposal. Nevertheless, validation studies are required

prior to large-scale implementation.

ACKNOWLEDGEMENTS PDG and KA acknowledge support from the NIHR Biomedical Research Centre, MRC Centre for Transplantation, King’s Health Partners, Guy’s and St. Thomas’ Charity, School of Surgery, London Deanery, Royal College of Surgeons of England, Intuitive Surgical, The Urology Foundation, Olympus, EU-FP7, Prostate Cancer UK, Technology Strategy Board and The Vattikuti Foundation.

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20. Neale G, Woloshynowych M, Vincent C. Exploring the causes of adverse events in NHS hospital practice. J R Soc Med. 2001;94(7):322-30. 21. Flin R, Mitchell L. Safer Surgery. Aldershot: Ashgate; 2009. 22. Organisation WH. Surgical Safety Checklist 2009 [cited 2013 07.10.2013]. Available from: http://www.who.int/patientsafety/safesurgery/en/index.html. 23. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5):491-9. 24. Agency NPS. National Patient Safety Agency, Alert 0861 London2009 [cited 2013 07.10.2013]. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=59860. 25. Sethi AS, Peine WJ, Mohammadi Y, Sundaram CP. Validation of a novel virtual reality robotic simulator. J Endourol. 2009;23(3):503-8. 26. American Urological Association. Standard Operating Practices (SOP'S) For Urologic Robotic Surgery [cited 2014 21.09.2014]. Available from: https://http://www.auanet.org/common/pdf/about/SOP-Urologic-Robotic-Surgery.pdf 27. Smith R, Patel V, Satava R. Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development. Int J Med Robot. 2014;10(3):379-84. 28. Stegemann AP, Ahmed K, Syed JR, Rehman S, Ghani K, Autorino R, et al. Fundamental skills of robotic surgery: a multi-institutional randomized controlled trial for validation of a simulation-based curriculum. Urology. 2013;81(4):767-74.

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Figure 1: Pathway for development of training curriculum

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Figure 2: Summary of study methodology

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Figure 3: Themes generated and some key definitions

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Figure 4: Proposed curriculum

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