A Prospective, Observational, Multicentre Study Concerning Nontechnical Skills in Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy

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Trial

Protocol

A

Prospective,

Observational,

Multicentre

Study

Concerning

Nontechnical

Skills

in

Robot-assisted

Radical

Cystectomy

Versus

Open

Radical

Cystectomy

Alexander

J.W.

Beulens

a,b

,

Willem

M. Brinkman

c

,

Evert

L. Koldewijn

b

,

Ad

J.M.

Hendrikx

b,1

,

Jean

Paul

A. van

Basten

d

,

Jeroen

J.G.

van

Merrie¨nboer

e

,

Henk

G. Van

der

Poel

f

,

Chris

H. Bangma

g

,

Cordula

Wagner

a,h,

*

a_Netherlands _Institute _for _Health _Services _Research _(NIVEL), _Utrecht, _The _Netherlands; b_Department _of _Urology, _Catharina _Hospital, _Eindhoven,

TheNetherlands;c_Department_of_Oncological_Urology,_University_Medical_Centre_Utrecht,_Utrecht,_The_Netherlands;d_Department_of_Urology,_Canisius

WilhelminaHospital,Nijmegen,TheNetherlands;e_School_of_Health_Professions_Education,_Maastricht_University,_Maastricht,_The_Netherlands;f_Department

ofUrology,NetherlandsCancerInstitute-AntonivanLeeuwenhoekHospital,Amsterdam,TheNetherlands;g_Department_of_Urology,_Erasmus_University

MedicalCentre,Rotterdam,TheNetherlands;h_Amsterdam_Public_Health_Research_Institute,_Amsterdam_UMC,_Location_VUmc,_Amsterdam,_The_Netherlands

a v ai l a b l e a t w w w . s c i e n c e d i r e c t . c o m

j o u r n al h o m e p a g e : w w w . e u - o p e n s c i e n c e . e u r o p e a n u r o l o g y . c o m

Articleinfo Articlehistory:

Received21March2020 Receivedinrevisedform 20April2020 AcceptedMay16,2020 Keywords: Nontechnicalskills Cystectomy Surgicalskills Outcome Robot-assistedsurgery Abstract

Introductionandhypotheses: valuationofsurgicalskills,bothtechnicaland non-technical,ispossiblethroughobservationsandvideoanalysis.Besides technical failures,adverseoutcomesinsurgerycanalsoberelatedtohampered communi-cation,moderateteamwork,lackofleadership,andlossofsituationalawareness. Even though somesurgeons are convinced about nontechnical skills being an importantpartoftheirprofessionalisation,thereispaucityofdataaboutapossible relationshipbetweennontechnicalskillsandsurgicaloutcome.Inrobot-assisted surgery,thesurgeonsitsbehindtheconsoleandisataremotepositionfromthe surgical field and team, makingcommunication more important than in open surgery and conventional laparoscopy. A lack of structured research makes it difficult to assess the value of the different analysis methods for nontechnical skills,particularlyinrobot-assistedsurgery.Ourhypothesisincludesthefollowing: (1)introductionofrobot-assistedsurgeryleadstoaninitialdecayinnontechnical skills behaviour during the learning curve of the team, (2) nontechnical skills behaviourismoreexplicitlyexpressedinexperiencedrobot-assistedsurgeryteams thaninexperienced open surgeryteams,and(3)introduction ofrobot-assisted surgeryleadstothedevelopmentofdifferentformsofnontechnicalskills behav-iourcomparedwithopensurgery.

Design: This studyisaprospective, observational, multicentre,nonrandomised, case-controlstudyincludingbladdercancerpatientsundergoingeitheranopen radicalcystectomyorarobot-assistedradicalcystectomyattheCatharinaHospital Eindhoven,the Netherlands,or attheNetherlands Cancer Institute,Antonivan LeeuwenhoekHospitalAmsterdam.Allpatientsareeligibleforinclusion;thereare

*Correspondingauthor.AmsterdamPublicHealthResearchInstitute,AmsterdamUMC,LocationVUmc,Amsterdam,TheNetherlands E-mailaddress:c.wagner@vumc.nl(C.Wagner).

1_Urologist_not_practising.

http://dx.doi.org/10.1016/j.euros.2020.05.003

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Introductionandhypotheses

Qualification and certification of the performance of surgical skills are still in a preliminary phase within all surgicalspecialties,includingurology.Thereare,however, urgentcallsfromthegovernmentandpatientorganisations for well-defined proficiency standards to safeguard the qualityofcare[1,2].Inaddition,professionalsthemselves areincreasinglyinterestedtodefinetheirqualificationsand improveskills[3].

Multipleresearchgroupsareinvestigatingtherelation between surgeons’ technical skills and postoperative outcome[4–6].Withtheintroductionoflaparoscopyand thesurgical robot,newandimprovedassessmenttoolsof surgicalskillshavebeendeveloped[5,7–9].

Althoughtheanalysisoftechnicalsurgicalskillsin robot-assisted surgery can lead to major improvements of postoperative outcomes [10], the possible influence of nontechnicalskillsonpostoperativeoutcomesalsomerits attention.

The nontechnical skills neededfor a successful robot-assisted radical cystectomy probably differ from those neededforanopenradicalcystectomy.

Eventhoughseveralgeneralassessmentmethods have been developed for both the entire team [11–13] and individual team members [14–16], the question remains whether these tools can accurately assess nontechnical skills in complex robot-assisted surgeries such as robot-assisted radical cystectomy. Withthe introduction ofthe InterpersonalandCognitiveAssessmentforRoboticSurgery noexclusioncriteria.TheCatharinaHospitalEindhoven,theNetherlands,performs onaverage35radicalcystectomiesayear.TheNetherlandsCancerInstitute,Antoni vanLeeuwenhoekHospitalAmsterdam,performsonaverage100radical cystec-tomiesayear.

Protocoloverview: Thechoiceoftreatmentisatthediscretionofthepatientand thesurgeon.Patientresultswillbeobtainedprospectively.Pathologyresultsaswell as complications occurring within 90 d following surgery will be registered. SurgicalcomplicationswillberegisteredaccordingtotheClavien-Dindosystem. Measurements: Nontechnicalskillswillbeobservedusingﬁvedifferentmethods: (1) NOTSS:NontechnicalSkillsforSurgeons; (2)OxfordNOTECHSII:amodiﬁed theatreteamnontechnicalskills scoringsystem;(3)OTAS:Observational Team-work Assessment for Surgery; (4) Interpersonal and Cognitive Assessment for Robotic Surgery (ICARS): evaluation of nontechnical skills in robotic surgery; and(5)analysisofhumanfactors.Technicalskillsinrobot-assistedradical cystec-tomywillbeanalysedusingtwodifferentmethods:(1)GEARS:GlobalEvaluative AssessmentofRoboticSkilland(2)GERT:GenericErrorRatingTool.

Safetycriteriaandreporting: Formalethicalapprovalhasbeenprovidedby Medi-calresearchEthicsCommitteesUnited(MEC-U),TheNetherlands(reference num-ber W19.048). We hope to present the results of this study to the scientiﬁc communityatconferencesandinpeer-reviewedjournals.

Statisticalanalysis: Frequencystatisticswillbecalculatedforpatient demograph-ical data, and aShapiro-Wilk testwith p>0.05 will beused to define normal distribution.Univariateanalysiswillbeconductedtotestforstatisticallysignificant differences in observation scores between open radical cystectomy and robot-assistedradicalcystectomycohortsacrossallvariables,usingindependentsample ttestsandMann-WhitneyUtesting,asappropriate.Avariable-selectionstrategy will be used to create multivariate models. Binary logistic regression will be conducted to calculate odds ratios and 95%confidence intervalsfor significant predictors on univariate analysis and clinically relevant covariates. Statistical significanceissetatp<0.05basedonatwo-tailedcomparison.

Summary: Thisstudyusesastructuredapproachtotheanalysisofnontechnical skills using extracorporeal videos of both open radical cystectomy and robot-assistedradicalcystectomysurgeries,inordertoobtaindetaileddataon nontech-nicalskillsduringopenandminimallyinvasivesurgeries.Theresultsofthisstudy couldpossiblybeusedtodevelopteam-trainingprogrammes,speciﬁcallyforthe introduction of thesurgical robot in relationto changes in nontechnical skills. Additional analysis of technical skills using the intracorporeal footage of the surgical robot will be used to elucidate the role of surgical skills and surgical eventsinnontechnicalskills.

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(ICARS) [17], adaptation to the robot-assisted surgical settinghasstarted.

Theintroductionofthesurgicalrobothastotallychanged thetraditionalset-upoftheoperatingroom(OR),sincethe scrubnurseandthesurgeonarenolongeronoppositesidesof thepatient.Inrobot-assistedsurgery,thesurgeonislocatedin aseparate controlconsoleduringmostofthesurgery,and thereforedirectcommunication withteammemberscouldbe hampered.Itisconceivablethatlossofnonverbal communi-cationcaninfluencetheworkflowandthereforethequalityof theperformance,includingpatient’ssafety.

Two systematic reviews concerning the studies of nontechnical skills in minimally invasive surgery (ie, conventionallaparoscopyandrobot-assistedsurgery)have beenpublished[18,19].Awidevarietyoftoolswereusedin assessmentsofnontechnicalskills,whichmakes compari-sonoftoolsdifficult[18,19].

vander Vlietet al [19] advisesadditional research in nontechnical skills to be performed in different surgical approaches(open,laparoscopic,androbotassisted). More-over,the useofmultiple trainedobserversisadvisedfor assessing audiovisual recordings of the surgical environ-ment to identify and quantify possible interobserver reliability.ThegroupofGjeraaetal[18]advisessystematic identificationofnontechnicalskillsin minimallyinvasive surgeryinordertodevelopeffective,evidence-basedteam trainingprogrammesforminimallyinvasivesurgeries.

The present study aims to perform a structured evaluationofnontechnicalskillsin bothopenand robot-assisted complex surgery, to investigate the manner in whichtheintroductionofasurgicalrobotinfluencesboth nontechnicalskills and surgical outcomes during the 1st year of robot-assisted radical cystectomycompared with openradicalcystectomy.

Inaddition,analysisoftechnicalskillsinrobot-assisted radical cystectomy will be performed to evaluate the possiblerelationshipbetweentechnical andnontechnical skills. Radical cystectomy was chosen for this analysis becauseitisalengthy,complex,anddemandingsurgeryfor thesurgeonandotherteammembers.

Sinceradicalcystectomysurgeries takemanyhoursto complete,along-termanddetailedanalysisispossibleper procedure. Radical cystectomy is traditionally performed usinganopensurgicalapproach(openradicalcystectomy) attheCatharinaHospitalEindhoven,butrecentlyashiftis made to robot-assisted radical cystectomy. This shift enables us to investigate in which manner nontechnical skills change during the introduction of robot-assisted radical cystectomy. The nontechnical skills during the

learning curveofrobot-assistedradicalcystectomyinthe Catharina HospitalEindhovenwill becompared withthe nontechnicalskillsduring theopen radicalcystectomyin the same hospital as well the nontechnical skills of an experiencedrobot-assistedradicalcystectomyteaminthe AntonivanLeeuwenhoekHospital.

Theseanalyseswillbeperformedinordertoinvestigate in which manner nontechnical skills change during the introduction ofthe robot-assistedradicalcystectomyand which factors contribute to the learning curve. Results obtainedduringthisstudycouldbebeyondrobot-assisted radicalcystectomy,sincethechangesinoperatingOR set-upandthelossofnonverbalcommunicationareuniversal whenmakingtheshiftfromopentorobot-assistedsurgery.

Ourhypothesisincludesthefollowing:

1. Introductionofrobot-assistedsurgeryleadstoaninitial decay in nontechnical skills behaviour during the learningcurveoftheteam.

2. Inexperienced robot-assisted surgery teams, nontech-nicalskillsbehaviourismoreexplicitlyexpressedthanin experiencedopensurgeryteams.

3. Introduction of robot-assisted surgery leads to the development of different forms of nontechnical skills behaviourcomparedwithopensurgery.

The results of this study could possibly be used to develop team training programmes specifically for the introductionofthesurgicalrobotinrelationtochangesin nontechnical skills. Additional analysis of technical skills usingtheintracorporealfootageofthesurgicalrobotwillbe used to elucidate the role of surgical skills and surgical eventsinnontechnicalskills.

Design

The present study is aprospective, observational, multi-centre,nonrandomised,case-controlstudythatwillinclude allpatientsundergoingeitheranopenradicalcystectomyor a robot-assisted radical cystectomyin CatharinaHospital EindhovenorAntonivanLeeuwenhoekHospital.

Timescales

The inclusion will be from January 2021 until August 2022 in both hospitals simultaneously (Fig. 1). Video collectionwill startoncethefirstpatientisincludedand will continueuntilthelastpatienthashadtheir surgery.

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Follow-updata collectionwillstartinFebruary 2021and willcontinueuntilDecember2022.Dataanalysiswillstart inJanuary2022.

Studypopulation

ThesurgicalteamintheORwillbethestudypopulation. Individualpermissionswillbeobtainedfromallmembers of the surgical team, that is, urologists, OR nurses, and anaesthesiologists. Surgeries will be performed by three urologists, one surgeon will perform all open radical cystectomies,one surgeonwill performallrobot-assisted radicalcystectomiesintheCatharinaHospitalEindhoven, and one surgeon will perform all robot-assisted radical cystectomiesandopenradicalcystectomiesintheAntoni vanLeeuwenhoekHospital.ORnursesforeachopenradical cystectomy and robot-assisted radical cystectomy in the Catharina Hospital Eindhoven will be selected based on shiftschedulesfromtheexperienceddedicatedteamofsix urologyORnurses.ORnursesforeachsurgeryintheAntoni van Leeuwenhoek Hospital will be selected from the experienced dedicated team of six urology OR nurses. Anaesthesiologists will be selected randomly for each surgeryfrom thetotalnumber ofanaesthesiologists who havesignedaninformedconsentform.Allteammembers haveworkedtogetherbefore.

Afterfiverobot-assistedradicalcystectomyprocedures, asurveybasedon thesurvey developedbyMcBrideetal [20](Supplementarymaterial)willbeheldamongtheOR nurses in the Catharina Hospital Eindhoven in order to investigate the point of view of the OR nurses on the potential benefits of robot-assisted surgery. All surgeons willbeaskedwhatlevelofpriorexperience/trainingthey havepriortothestartofthestudy.

Inclusioncriteria

Patientswhowill undergoeither anopen radical cystec-tomy or arobot-assisted radical cystectomy in Catharina HospitalEindhovenorAntoni vanLeeuwenhoek Hospital areeligibleforthisstudy.Thechoiceoftreatmentisatthe discretionofthepatientandthesurgeon.

Forstudyinclusion,thefollowingcriteriamustbemet: 1. Patientsmustbeaged18yr.

2. Patients must be able to understand and sign an informedconsentform.

3. Patientswillundergoeitheranopenradicalcystectomy or a robot-assisted radical cystectomy in Catharina HospitalEindhovenorAntonivanLeeuwenhoek hospi-tal.

4. Indicationfortheradicalcystectomymustbeurothelial cellcarcinomaofthebladder.

5. Informed consent of the patient must be obtained to gatherdataandperformobservationsduringsurgery.

Exclusioncriteria

Noexclusioncriteriawillbeusedforthisstudy.

Recruitmentandconsent

Informed consentfrom both patientandORstaff willbe obtained, allowing observationof the surgical procedure andcollectionofpatientdata.

Withdrawalofindividuals/employees

Boththepatienttoundergothesurgeryandallemployees present during the surgery can always withdraw their consenttotheuseoftheirpersonaldata/recordingofthe surgery.Thedatacollecteduptothemomentofwithdrawal of consent and the recording of the surgery will be destroyedafterconsenthasbeenwithdrawn.Consentcan bewithdrawnupto6moaftersurgeryinordertohavethe recorded surgery destroyed. After 6 mo, the recorded surgerywillbeautomaticallydestroyed.

Centredetails

Basedonpriordata,onaverageatotalof35openradical cystectomiesareperformedyearlyintheCatharinaHospital Eindhoven.Sincetherobot-assistedradicalcystectomyhas just been introduced, the total number of open radical cystectomieswillbedividedovertheopenradical cystec-tomyandtherobot-assistedradicalcystectomymodalities; itisexpectedthathalfoftheradicalcystectomieswillbe performedusingarobot–assistedsurgicalapproach.Inthe Antoni van Leeuwenhoek Hospital, on average a total of 50robot-assistedradicalcystectomiesand50openradical cystectomies are performed each year. It is possible to includefurtherhospitalsinthefuture.

Protocoloverview

Patient results will be obtained prospectively. Pathology resultswillberegisteredaswellascomplicationsoccurring within 90 d following surgery. Complications will be registeredaccordingtotheClavien-Dindosystemsurgery.

Measurements

Nontechnical skills will be observed using five different methods:

1. NOTSS:NontechnicalSkillsforSurgeons[16].

2. OxfordNOTECHSII:amodifiedtheatreteam nontechni-calskillsscoringsystem[11,12].

3. OTAS:ObservationalTeamworkAssessmentforSurgery [21].

4. ICARS: evaluation of nontechnical skills in robotic surgery[17].

5. Analysisofhumanfactors[22].

Nointracorporealvideosofopenradicalcystectomycan berecordedduetoblockingoftheimagebythesurgeons andtheORlights,anddifficultygettingaclearview into thesurgicalareainthepelvicregionfromadistance.The analysisoftechnicalskillswillbeperformedonlyusingthe

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robot-assistedradicalprostatectomyvideos.Thismethodof analysiswill beperformedto investigatetheinfluence of robot-assisted surgery experience on nontechnical skills and outcome of the surgery. Technical skills in robot-assisted radical cystectomy will be analysed using two differentmethods:

1. GEARS:GlobalEvaluativeAssessmentofRoboticSkill[7]. 2. GERT:GenericErrorRatingTool[5].

Datacollectionandhandling

Datacollectionwillconsistofvideocapturingandanalysis ofpatientrecords.Twotrainedobservers(observer1and2, bothhaveabackgroundinmedicine),withorientationand training inboth nontechnical skillsand technical assess-mentmethods,willindependentlyobservesurgicalvideos. Allvideoswillbeanalysedbybothresearchers.Incaseof disagreement,athirdindependentexpertwitha psycholo-gyandleadershipassessmentbackground(observer3)will beaskedtoperformathirdanalysis.Inter-raterreliability willbeanalysedusingCohen’skappa.

Thesurgicalvideowillbeassessedinmultiplephases;in eachphase,anontechnicalskillsassessmentmethodwillbe usedtoassess nontechnicalskills.Surgicalvideoswill be analysedusingcustomisablevideoanalysissoftware “Digi-tal Video Coach” developed by ZEAL IT, Einhoven, TheNetherlands(Fig.2).

Thevideoanalysissoftware“DigitalVideoCoach”makes itpossibletoregistertheoccurrenceofnontechnicalskills behaviourandperioperativeevents(ie,peopleenteringor leavingtheOR,phonecalls,etc.)Twosetsoflabelswillbe createdinordertodefinethedifferentnontechnicalskills behaviour and perioperative events present during the surgery. The selection of one of the labels automatically marksthetimecodecorrespondingtothemomentthelabel waspressed.Thismakesitpossibletomeasuretheduration

of the nontechnical skills behaviour and perioperative events.Thelabelsusedforthisanalysiswillbespecificto theassessmentmethodofnontechnicalskills.

Trainingofthetwoobservers(observers1and2)willbe performed using the NOTSS introductory course and advanced course (NOTSS for Trainees and NOTSS in a Box) as developed by the Royal College of Surgeons of Edinburgh[23].Furthertrainingintheremaininganalysis methodswillbeprovidedbyaspecialistintheassessment ofnontechnicalskills(observer3).

Thetechnicalskillsassessmenttrainingwillbeprovidedby anexpertintechnicalskillsanalysiswithproficientknowledge oftheprocedureandrobot-assistedsurgery(observer4,who is a surgeon who has performed over 200 open radical cystectomyandrobot-assistedradicalcystectomyprocedures andisatrainerofnewandexperiencedsurgeons).Observer 4 will act as independent expert in case of disagreement betweenthetwoobservers(observers1and2).

Thevideoswillberecordedusingthreecamerasinstalled atthreedifferentpointsintheOR.Objectsthatshouldbein viewaretheORtable,robotconsoleincaseofrobot-assisted surgery, anaesthesiology equipment, OR door to the nonsterile area of the OR complex, and OR door to the sterileareaoftheOR.Recordingfromthreedifferentangles intheORwillensurethattherewillbea360viewofthe proceedingsintheOR.Thecamerasusedhavea170image angle with high-definition imaging so that maximum coveragecanbeachieved.

Voice data will be collected using personalised voice recorders per staff memberpresent intheOR.The audio feedonthecamerasisstrongenoughtogetageneralview of the conversations during the surgery; for detailed analysis, recording ofthe personalvoice recorderwillbe usedtogaininsightintotheordersgivenduringdifficultor abnormalphasesofthesurgery.

Surgeon-specificdatawillberecordedatthestartofthe operation, which include but are not limited to the age,

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gender,right orleft handedness, gaming experience,and priorsurgicalandrobot-assistedsurgeryexperienceofthe surgeon. If multiple surgeons participate in the same surgery,allwillbeaskedtocompletetheabove-mentioned questionnaire; changes in lead surgeonwill be recorded duringthesurgery.

Caseswillbedeidentifiedandlabelledwithstudycodes. Patientdatawillberecordedduringregularfollow-upvisits byanoncologynurseor thepatient’sphysician.Since all outcome measures are standard data recorded for these surgeries,noadditionalstrainwillbeputonthe participat-ing patients. This study was granted approval by the institutionalmedicalcommittee.

Datafromthecontinuousmonitoringofthe anaesthesiol-ogistare automatically saved inthe patients’ medical file. Thesedatawillbe usedtoidentifythe momentswhenthe patient is in distress, that is, a sudden decrease of blood pressure,asuddenincreaseinheartrate,orasuddendecrease inoxygensaturationofthepatient.Thesemomentswillbeof special interest to the observers in order to observe the reactionoftheteamtosuddenadverseeventsduringsurgery. Datawillbehandled inastrictlyconfidentialmanner, andwillbecoded during theextractionofeither patient characteristicsorvideoanalyses.Itwillbestoredinasecure andencrypteddatabase(researchmanager),andcodelists willexclusivelybestoredatthehospitalofconsultationor treatment until video analysis results and patient char-acteristics have been matched. Afterwards, they will be destroyed. The video andaudio data will bestored for a maximumperiodof6mo.

Statisticalanalysis

Frequency statistics will be calculated for patient demo-graphicaldata,andaShapiro-Wilktestwithp>0.05willbe usedtodefinenormaldistribution.Univariateanalysiswillbe conductedtotestfor statisticallysignificantdifferencesin observation scores between open radical cystectomy and robot-assistedradicalcystectomycohortsacrossallvariables, using independent sample t tests and Mann-Whitney U testing,asappropriate.Avariable-selectionstrategywillbe usedtocreatemultivariatemodels.Binarylogisticregression willbeconductedtocalculateoddsratiosand95%confidence intervalsforsignificantpredictorsonunivariateanalysisand clinicallyrelevantcovariates.Statisticalsignificanceissetat p<0.05 based on a two-tailed comparison. Statistical analyseswillbeperformedusingSPSSStatisticsversion24 (IBM,Armonk,NewYork,USA).

Primaryoutcomemeasurements

Thefollowingoutcomeswillbereported.

Nontechnicalskillswillbeobservedusingfivedifferent methods:

1. NOTSS[16]:ThefocusoftheNOTSSassessmentmethod liesonthefollowingaspectsofnontechnicalskills: (a) Situation awareness: developing and maintaining

dynamic awareness of the situation in operating

theatre based on assembling of data from the environment, understanding of what they mean, andthinkingaheadaboutwhatmayhappennext. (b) Decisionmaking:skillsfordiagnosingthesituation

and reaching a conclusion in order to choose an appropriatecourseofaction.

(c) Communicationandteamwork:skillsforworkingin a team context to ensure that the team has an acceptablesharedoverviewofthesituationandcan completetaskseffectively.

(d) Leadership: leadingtheteam andproviding direc-tion, demonstrating high standards of clinical practiceandcare,andbeingconsiderateaboutthe needsofindividualteammembers.

2. OxfordNOTECHSII[11,12]:ThefocusoftheNOTECHSII assessment method lies on the following aspects of nontechnicalskills:

(a) Leadershipandmanagement. (b) Teamworkandcooperation.

(c) Problemsolvinganddecisionmaking. (d) Situationawareness.

3. OTAS [21]:Thefocus of theOTAS assessment methodliesonthe

followingaspectsofnontechnicalskills:

(a) Communication. (b) Coordination.

(c) Cooperationandback-upbehaviour. (d) Leadership.

(e) Teammonitoringandsituationalawareness. 4. ICARS[17]:The focusoftheICARSassessment method

liesonthefollowingaspectsofnontechnicalskills: (a) Checklistandequipment.

(b) Interpersonalskills(communicationandteamskills, andleadership).

(c) Cognitive skills (decision making and situational awareness).

(d) Resourceskills(stressanddistractors).

(e) Humanfactoranalysis [22]:Humanfactor analysis consistsoffourlevelsofsystemfailure:unsafeacts, preconditions for unsafe acts, unsafe supervision, andorganisationalinfluences.

5. Perioperativeevents(ie,peopleenteringorleavingthe OR,phonecalls,etc.).

Technicalskillsinrobot-assistedradicalcystectomywill beanalysedusingtwodifferentmethods:

1. GEARS[7]:ThefocusoftheGEARSassessmentmethod lieson generalrobotsurgical principals, thatis, depth perception,bimanual dexterity,efficiency, force sensi-tivity,autonomy,androboticcontrol.

2. GERT[5]:ThefocusoftheGERTassessmentmethodlies on the capture and analysis of technical errors and resultingeventsduringlaparoscopicprocedures.

Secondaryoutcomemeasurements

Age, World Health Organization performance status, Charlson comorbidity index, neoadjuvant chemotherapy, priorlocaltreatment,priorradiationtherapyinthesurgical

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field, diagnosis, prior abdominal and/or pelvic surgery, indicationofsurgery,perioperativecomplications, postop-erative complications according to the Clavien-Dindo system[24],length ofhospitalstay, stayin theintensive careunit,bloodloss,patient-reportedexperiencemeasures, patient-reported outcome measures, method of surgery, andoncologicaloutcome(surgicalmarginsandnumberof resected lymph nodes, and pathology results) will be registered prospectively. Patient follow-up will be for at least30d.Surgeon-specificdatawillberecorded(ie,age, gender,right orleft handedness, gaming experience,and priorsurgicalandrobot-assistedsurgeryexperienceofthe surgeon).

Regulationstatement

Asthisisaprospective,observational, noninvasivestudy, participantswillnotbesubjecttoanystudytreatmentsor actions. Even though the Medical Research Involving HumanSubjectsAct(inDutch:Wet Medisch-wetenschap-pelijk Onderzoek met Mensen) does not imply that informed consent will be obtained, this study will be conducted in accordance to the “Code Goed Gebruik” (January2002).Formalethicalapprovalhasbeenprovided bytheMedicalresearchEthicsCommitteesUnited(MEC-U), Nieuwegein (reference number W19.048). The study protocol is registered at the Netherlands Trial Registry underreferencenumberNL8537.

Privacy

Observations during surgery will be performed by two membersoftheurologyin-housestaff (medicallytrained researcherswithtrainingintheanalysisofboth nontech-nical and technical skills); none of the observers have a hierarchicalrelationshipwithanyoftheteammembers.

Asdiscussionofplannedsurgeriesispartofdailystaff meetings,therearenoadditionalprivacyconcerns.

Theobservationsdonotcontainthenameofthepatient, orthedateandtimeofsurgery.Thisisinaccordancewith theGeneralDataProtectionRegulation.

Handlingandstorageofdataanddocuments

Datawillbehandledinastrictlyconfidentialmanner,and will becoded during the extractionof patient character-isticsandvideo analysis.Itwillbestoredinasecure and encrypteddatabase(researchmanager),andcodelistswill exclusively be stored at the hospital of consultation or treatment until video analysis results and patient char-acteristicshavebeenmatched.Thedatawillbestoredfora maximum period of 6 mo. Afterwards, they will be destroyed.

Authorcontributions:AlexanderJ.W.Beulenshadfullaccesstoallthe datainthestudyandtakesresponsibilityfortheintegrityofthedataand theaccuracyofthedataanalysis.

Studyconceptanddesign:Wagner,Beulens. Acquisitionofdata:Beulens,Brinkman. Analysisandinterpretationofdata:Beulens.

Draftingofthemanuscript:Beulens,Brinkman.

Critical revision of the manuscript for important intellectual content: Hendrikx,Bangma,vanMerriënboer,Koldewijn,vanBasten,Wagner,van derPoel,Brinkman,Beulens

Statisticalanalysis:Beulens.

Obtainingfunding:Hendrikx,Koldewijn,Brinkman,Wagner,vanderPoel. Administrative, technical, or material support: Brinkman, Koldewijn, Beulens.

Supervision:Brinkman,Wagner,vanderPoel,Bangma. Other:None.

Financialdisclosures:AlexanderJ.W.Beulenscertifiesthatallconflictsof interest, including specific financial interests and relationships and affiliationsrelevanttothesubjectmatterormaterialsdiscussedinthe manuscript(eg,employment/af_filiation,grantsorfunding, consultan-cies,honoraria,stockownershiporoptions,experttestimony,royalties, orpatentsfiled,received,orpending),arethefollowing:None. Funding/Supportandroleofthesponsor:Thisworkwassupportedby fundingfromAstellasPharmaEuropeLtd.andOlympusNetherlandsB.V. AppendixA. Supplementarydata

Supplementarydataassociatedwiththisarticle canbe found,intheonlineversion,atdoi:10.1016/j.euros.2020.05. 003.

References

[1]DutchHealthInspectorate(InspectievoordeGezondheidszorg).. Insufﬁcient carefulness at the introduction of surgical robots [Onvoldoendezorgvuldigheidbijintroductievanoperatierobots].. Utrecht:Igz;2010.

[2]PortePJ,VerweijLM,BekkersRLM,etal.Roboticsurgeryformedical specialists,basicpro_ﬁciencyrequirementsforthesafeuseofrobotic surgery. Utrecht/Amsterdam, The Netherlands: NIVEL/EMGO+; 2017.

[3]BrinkmanW,deAngstI,SchreuderH,etal.Currenttrainingonthe basicsofroboticsurgeryintheNetherlands:timefora multidisci-plinaryapproach?SurgEndoscOtherIntervTech2017;31:281_–7.

[4]BirkmeyerJD,FinksJF,O_’ReillyA,etal.Surgicalskilland complica-tionratesafterbariatricsurgeryfortheMichiganBariatricSurgery Collaborative.NEnglJMed2013;369:1434–42.

[5]HussleinH,ShirreffL,ShoreEM,LefebvreGG,GrantcharovTP.The genericerrorratingtool:anovelapproachtoassessmentof perfor-manceandsurgicaleducationingynecologiclaparoscopy.JSurg Educ2015;72:1259_–65.

[6]Goldenberg MG,LeeJY,Kwong JCC,GrantcharovTP,CostelloA. Implementingassessmentsofrobot-assistedtechnicalskillin uro-logicaleducation:asystematicreviewandsynthesisofthevalidity evidence.BJUInt2018;122:501–19.

[7]Goh AC, Goldfarb DW, Sander JC, Miles BJ, Dunkin BJ. Global evaluative assessment of robotic skills: Validation of aclinical assessment tool to measure robotic surgical skills. J Urol 2012;187:247–52.

[8]HusseinAA,GhaniKR,PeabodyJ,etal.Developmentandvalidation ofanobjective scoringtoolforrobot-assistedradical prostatec-tomy:prostatectomyassessmentandcompetencyevaluation.JUrol 2017;197:1237_–44.

[9]BeulensAJW,BrinkmanWM,VanderPoelHG,etal.Linkingsurgical skillsto postoperativeoutcomes:aDelphi studyon the robot-assistedradicalprostatectomy.JRobotSurg2019;13:675–87.

[10] GoldenbergMG, GoldenbergL, GrantcharovTP.Surgeon perfor-mancepredictsearlycontinenceafterrobot-assistedradical pros-tatectomy.JEndourol2017;31:858_–63.

(8)

[11] RobertsonER, Hadi M,Morgan LJ, etal. OxfordNOTECHS II:a modiﬁedtheatreteamnon-technicalskillsscoringsystemIn:Roma PG,editor. PLoSOne,9.2014.p.p.e90320.

[12]MishraA,CatchpoleK,McCullochP.TheOxfordNOTECHSsystem: reliabilityandvalidityofatoolformeasuringteamworkbehaviour intheoperatingtheatre.QualSafHealthCare2009;18:104_–8.

[13]MoorthyK,MunzY,AdamsS,PandeyV,DarziA.Ahumanfactors analysisoftechnicalandteamskillsamongsurgicaltraineesduring proceduralsimulationsinasimulatedoperatingtheatre.AnnSurg 2005;242:631–9.

[14]FlinR,PateyR.Non-technicalskillsforanaesthetists:developing andapplyingANTS.BestPractResClinAnaesthesiol2011;25:215_– 27.

[15]MitchellL,FlinR,YuleS,MitchellJ,CouttsK,YoungsonG. Devel-opmentofabehaviouralmarkersystemforscrubpractitioners’ non-technical skills (SPLINTS system). J Eval Clin Pract 2013;19:317_–23.

[16]SharmaB,MishraA,AggarwalR,GrantcharovTP.Non-technical skillsassessmentinsurgery.SurgOncol2011;20:169–77.

[17] RaisonN,WoodT,BrunckhorstO,etal.Developmentandvalidation ofatoolfornon-technicalskillsevaluationinroboticsurgery—the ICARSsystem.SurgEndosc2017;31:5403–10.

[18] GjeraaK,SpanagerL,KongeL,PetersenRH,ØstergaardD. Non-technicalskillsinminimallyinvasivesurgeryteams:asystematic review.SurgEndosc2016;30:5185–99.

[19] vanderVlietWJ,HaenenSM,Solis-Velasco M,etal.Systematic review of team performance in minimally invasive abdominal surgery.BJSOpen2019;3:252_–9.

[20] McBrideKE,SteffensD,DuncanK,BannonPG,SolomonJ. Knowl-edgeandattitudesoftheatrestaffpriortotheimplementationof robotic-assistedsurgeryinthepublicsector.PLoSOne2019;14:1–8.

[21] UndreS,SevdalisN,HealeyAN,DarziA,VincentCA.Observational teamworkassessmentforsurgery(OTAS):re_ﬁnementand applica-tioninurologicalsurgery.WorldJSurg2007;31:1373_–81.

[22] PatidarN,YadavP,SurekaSK,MittalV,KapoorR,MandhaniA.An auditofearlycomplicationsofradicalcystectomyusing Clavien-Dindoclassiﬁcation.IndianJUrol2016;32:282–7.

[23] TheRoyalCollegeofSurgeonsofEdinburgh.Non-technicalskillsfor surgeons (NOTSS).. 2019, https://www.rcog.org.uk/en/careers- training/about-specialty-training-in-og/assessment-and-progres-sion-through-training/non-technical-skills-for-surgeons-notss/..

[24] CohenTN,WiegmannDA,ReevesST,BoquetAJ,ShappellSA.Coding human factors observations in surgery. Am J Med Qual 2017;32:556–62.