Recognising Contributions To Work In Research .

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Accepted ManuscriptRecognising contributions to work in research collaboratives: Guidelines forstandardising reporting of authorship in collaborative researchMatthew J. Lee, On behalf of the National Research Collaborative & Association ofSurgeons in Training Collaborative Consensus 017.12.019Reference:IJSU 4358To appear in:International Journal of SurgeryReceived Date: 25 September 2017Revised Date:19 November 2017Accepted Date: 21 December 2017Please cite this article as: Lee MJ, On behalf of the National Research Collaborative & Associationof Surgeons in Training Collaborative Consensus Group, Recognising contributions to work inresearch collaboratives: Guidelines for standardising reporting of authorship in collaborative research,International Journal of Surgery (2018), doi: 10.1016/j.ijsu.2017.12.019.This is a PDF file of an unedited manuscript that has been accepted for publication. As a service toour customers we are providing this early version of the manuscript. The manuscript will undergocopyediting, typesetting, and review of the resulting proof before it is published in its final form. Pleasenote that during the production process errors may be discovered which could affect the content, and alllegal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPTRecognising Contributions to Work in Research Collaboratives: Guidelines ForStandardising Reporting of Authorship in Collaborative Research.On behalf of the National Research Collaborative & Association of Surgeons in TrainingRIPTCollaborative Consensus Group*SC*Authorship presented in Appendix 1, contributions to paper presented in Appendix 2Corresponding author:MANUMatthew J LeeEmail: m.j.lee@sheffield.ac.ukAddress:Association of Surgeons in Training Council, Association of Surgeons in Training, 35-43TEDLincoln's Inn Fields, London, WC2A 3PE, UKACCEPKeywords: Authorship, Surgery, Collaboration

ACCEPTED MANUSCRIPTRecognising Contributions to Work in Research Collaboratives: Guideline ForStandardising Reporting of Authorship in Collaborative Research.Keywords: Authorship, Surgery, CollaborationAbstractTrainee research collaboratives (TRCs) have been revolutionaryRIPTBackground:changes to the delivery of high-quality, multicentre research. The aim of this studySCwas to define common roles in the conduct of collaborative research, and map theseto academic competencies as set out by General Medical Council (GMC) in theMANUUnited Kingdom. This will support trainers and assessors when judging academicachievements of those involved in TRC projects, and supports trainees by providingguidance on how to fulfil their role in these studies.Methods: A modified Delphi process was followed. Electronic discussion with keyTEDstakeholders was undertaken to identify and describe common roles. These wererefined and mapped to GMC educational domains and International Committee ofMedical Journal Editors authorship (ICJME) guidelines. The resulting roles andEPdescriptions were presented to a face-to-face consensus meeting for voting. TheACCagreed roles were then presented back to the electronic discussion group forapproval.Results: Electronic discussion generated six common roles. All of these were agreedin face-to-face meetings, where two further roles identified and described. All eightroles required skills that map to part of the academic requirements for surgicaltraining in the UK.Discussion: This paper presents a standardised framework for reporting authorshipin collaborative group authored research publications. Linkage of collaborator roles

ACCEPTED MANUSCRIPTto the ICMJE guidelines and GMC academic competency guidelines will facilitateincorporation into relevant training curricular and journal publication policies.RIPTBackgroundThere has been a recent shift towards a collaborative research model in surgery withSCthe advent of the Trainee Research Collaboratives (TRCs). Briefly, this describes‘snap-shot’, protocol-driven, pragmatic multicentre research undertaken by multipleMANUgroups of trainees across a network during a limited time frame1. Trainees gainsignificant experience in the academic and non-academic competencies whilst takingpart in TRC work. The TRCs trainees can lead or contribute to high quality studiesthat influence clinical practice and improve patient care. This has been recognised byTEDjournal editors and peer reviewers, who have accepted work from the TRCs forpublication in high impact journals2–5. Traditionally, clinical surgical research hasbeen of limited quality, with a number of procedures and processes based on ‘singleEPsurgeon, single centre’ case series, or expert opinion6. In promoting multicentreACCcollaboration, the TRC studies improve the size and power of studies, bringinggreater clinical relevance, better generalisability and supporting training andprofessional development.A key quality of a doctor is the ability to contribute to research for the benefit oftheir patients’ care. Indeed, research competencies and the ability to understandand critically analyses medical literature are fundamental for good clinical practiceinternationally. Requirements to complete postgraduate training and obtain a

ACCEPTED MANUSCRIPTCertificate of Completion of Training (CCT) in the UK include demonstration ofacademic competencies as set out by the General Medical Council (GMC). The exactdemonstration of these competencies varies between specialties. Surgical specialtiesquantify a specific number of publications: for example, the Joint Committee onRIPTSurgical Training (JCST)/Specialty Advisory Committee (SAC) guidelines forcertification in General Surgery requires publication of three peer-reviewed papersSCin PubMed-indexed journals before CCT is awarded. The contribution of the traineeto the paper must have been “significant”. For traditional research paradigms,MANUassessment of the trainee’s contribution is relatively straightforward, for example ifthey are the first author. However, with the advent of the Trainee ResearchCollaboratives (TRCs), there are new challenges in nomenclature and defining aTED“significant” contribution mapped to GMC academic requirements.Collaborative research offers opportunity to improve the quality and quantity ofsurgical research that is now being undertaken, and it has challenged the traditionalEPschemata for nomenclature of authorship. As such, a new nomenclature system forACCstudies conducted by TRCs has evolved5, without formal validation against existingguidelines. The International Committee of Medical Journal editors (ICMJE) lays outfour criteria for an individual to meet for which to be recognised as a named author7:1. Substantial contributions to the conception or design of the work; or theacquisition, analysis, or interpretation of data for the work; AND2. Drafting the work or revising it critically for important intellectual content;AND

ACCEPTED MANUSCRIPT3. Final approval of the version to be published; AND4. Agreement to be accountable for all aspects of the work in ensuring thatquestions related to the accuracy or integrity of any part of the work areRIPTappropriately investigated and resolved.Although the collaborative authorship structure reflects that used by large, publicly-SCfunded, multicentre clinical trials8, it is not widely accepted as evidence of researchactivity by training bodies in surgery, throughout the postgraduate trainingMANUpathway9. One of the principal concerns about recognising TRC research may be thelack of transparency about individual trainees’ contributions and the attainment ofdomains in the GMC competencies framework, rather than a perceived lack ofvalue. The adoption of standardised role descriptions and terminology for theTEDcollaborative research model, with mapping to GMC educational domains and ICMJEACCEPauthorship guidelines should address this.

ACCEPTED MANUSCRIPTMethodA working group from the National Research Collaborative and Association ofSurgeons in Training prepared a consensus document using a modified DelphiRIPTprocess (Figure 1).The principal modification of the Delphi technique was related to generation of rolesSCand descriptors for subsequent voting. As these had to map to existing guidelinesand frameworks, proposed items for consensus were confined to tight domains andMANUdefinitions. Current practices in reporting of authorship in collaborative researchprojects were canvassed from the leads of national and regional groups throughelectronic discussion, throughout March 2017. The CREDIT taxonomy informeddiscussion around this document as it i) demonstrated the authorship model wasTEDacceptable to journal editors and ii) demonstrated common roles and descriptorsalbeit with a laboratory focus10. The GMC descriptors were made available for theEPfirst round of discussion (Appendix 3).ACCThe reported roles and structures of TRC research were synthesised into a commonnomenclature. This nomenclature was reviewed by the consensus meeting andrefined following discussion. Agreed roles were mapped to GMC educationaldomains and presented back to the electronic group.A face-to-face consensus session was held at the Association of Surgeons’ in Training(ASiT) International Conference in April 2017. The voting session was advertised inadvance and was open to all surgical consultants and trainees across all surgical

ACCEPTED MANUSCRIPTspecialities. This included presentation of the proposed framework with supportingdiscussion. Votes were held on agreement with roles and descriptors, withacceptance set at 80% agreement for inclusion in the consensus, as previouslydescribed11. Each role name, task list, and GMC descriptors were voted on andRIPTapproved. The applicability of these roles to different research methods (e.g.randomised trial or cohort study), and typically expected tasks for each role wereSCdiscussed. The description and scope of the roles were simplified followingdiscussion. Confirmation that these roles mapped to ICJME criteria was obtained.MANUVoting was undertaken anonymously using a bespoke smartphone voting app. Afterthe first round of voting, a discussion was held to address queries and discussreasons for voting, prior to the second anonymous vote. If consensus was notreached at the second vote, vote moderators explored whether achievement ofTEDconsensus was likely or not through discussion with the room. If it was possible toachieve consensus through minor modification of wording then this was offered tothe group for consensus. If it was considered that a statement would requireACCEPsignificant modification or was not acceptable to the group, it was discarded.

ACCEPTED MANUSCRIPTResultsElectronic discussion generated a list of six generic roles in collaborative research.The applicability of these roles to different research methods (e.g. randomised trialor cohort study), and typically expected tasks for each role were discussed. TheRIPTpanel mapped these to the relevant educational domains and a preliminaryframework was developed. The makeup of groups consulted in the electronicSCdiscussion and face to face consensus is presented in table 1.MANUThe resulting framework was presented at the ASiT 2017 meeting to a consensusgroup of 25 delegates, all of whom had engaged with collaborative research. Twofurther roles: data analysis and advisory group were proposed during the meeting,and agreed by subsequent electronic discussion. The final eight roles and descriptorsTEDare listed here, summarised in Table 2.Steering committee: Agree/Strongly Agree 93%EPA member of the steering committee is involved in the conception, development,ACCadministration and delivery of a study. They will typically be involved in study design,development of tools, preparation of the protocol, and dissemination plan. They willhave in depth understanding of governance and research principles behind thestudy. The steering group will have critically appraised the literature in order tounderstand appropriate study methods and relevant data points.GMC Educational Domains: 1-6ICMJE Adherent: Yes

ACCEPTED MANUSCRIPTWriting group: Agree/Strongly Agree 88%The writing group is responsible for reviewing existing evidence, assessing and/oranalysing data from the project, and preparing a manuscript for publication. In orderto do so, they will have critically appraised the literature and synthesised knowledgeGMC Educational Domains: 1-6ICMJE Adherent: YesMANURegional lead: Agree/Strongly Agree 89%SCRIPTin context of project findings.Not all studies will require a regional lead and it is likely to be an ‘optional’ roledepending on the structure of the study. Large multi-centre national studies oftenrequire individuals at a regional level to coordinate centres in that region to takeTEDpart in the study. The regional lead is involved in the recruitment and support ofparticipating sites. They share information between regions and the steering group.These individuals need to have an understanding of the research governanceEPprocesses in order to open the study at local sites. The regional leads will beACCcirculated summaries of analyses, and be required to approve a final manuscript forsubmission ahead of peer-review.GMC Educational Domains: 3-4ICMJE Adherent: YesLocal lead: Agree/Strongly Agree 88%

ACCEPTED MANUSCRIPTThe local lead is responsible for hospital or trust level co-ordination. They identifyand confirm the names of local collaborators and support the named local clinician(where applicable). They should ensure that an appropriate number of localcollaborators are involved and listed accordingly in any documentation. A key role ofRIPTthe local lead is to ensure local clinical governance approvals are obtained andadhered to. They should also ensure that the findings of the study are presentedSClocally, or have a date arranged for local presentation, as part of audit sign-off. Theyare usually involved in collecting data for the project. Similarly, the local leads will besubmission ahead of peer-review.GMC Educational Domains: 3-4TEDICMJE Adherent: YesMANUcirculated summaries of analyses, and be required to approve a final manuscript forLocal collaborator: Agree/Strongly Agree 94%Local collaborators are responsible for the collection and return of data during theEPstudy. Each site may have more than one local collaborator. As well as trainees, aACClocal consultant providing oversight to the group may be listed as a localcollaborator. The collaborator will be familiar with the study protocol and operatewithin local governance frameworks and approvals. Depending on the nature of thestudy, eligible patient numbers may vary. It is important that this is recognised byeach steering group and targets adjusted accordingly. A final manuscript is circulatedand reviewed by local collaborators ahead of peer-review.GMC Educational Domains: 3-4

ACCEPTED MANUSCRIPTICMJE Adherent: YesData validator: Agree/Strongly Agree 95%A data validator is typically involved in confirming case ascertainment andRIPTestablishing data accuracy. This should ideally be someone who is independent fromthe data collection phase. The validator will be familiar with the study protocol andSCoperate within local governance frameworks and approvals. Depending on thenature of the study, eligible patient numbers may vary. It is important that this isMANUrecognised by each steering group and targets adjusted accordingly. Similarly, a finalmanuscript is circulated and reviewed by local collaborators ahead of peer-review.GMC Educational Domains: 3-4Data Analysis Group:TEDICMJE Adherent: YesThis is someone who may be involved in formulating the statistical analysis planEPand/or uses the data produced in a study to summarise results, carry out statisticalACCtests and draw conclusions, ready for presentation or publication.Educational domains: 1,3,5ICMJE Adherent: YesAdvisory group: Agreed outside voting session.This is someone who provides expert advice on the design and feasibility of acollaborative project. This includes pre-publication peer review, expert advice andguidance.

ACCEPTED MANUSCRIPTEducational domains: 1-6ACCEPTEDMANUSCRIPTICMJE Adherent: Yes

ACCEPTED MANUSCRIPTDiscussionThis paper presents a standardised framework for reporting authorship incollaborative group authored research publications. Linkage of collaborator roles tothe International Committee of Medical Journal Editors (ICMJE) authorshipRIPTguidelines and General Medical Council academic competency guidelines willfacilitate incorporation into relevant training curricula and journal publicationSCpolicies.MANUWhilst different levels of collaboration lead to different levels of educationalattainment, collaborators that make a significant contribution to acquisition oranalysis of data, should have the opportunity to critically review a manuscript,approve the final version before publication, and agreement to be accountable forTEDall aspects of the work, as per ICMJE guidelines7.How to use these guidelinesEPThe roles described here are those typically adopted in primary research studiesACCundertaken using a collaborative research framework1. Not all projects will requirecollaborators in every role, therefore this should not be seen as mandatory structureand should be adapted as groups see fit. It is likely that over time, the nature ofthese roles will change as research questions build in complexity, andinterdisciplinary collaborations evolve. At this point, collaboratives should repeatthis exercise to redefine roles, or describe new ones.

ACCEPTED MANUSCRIPTWhilst the group encourages a single corporate authorship policy, collaborativesmay choose to have headline authorship for some of their writing group. In eithersetting, collaborators should be acknowledged through a statement ‘on behalf of theABC collaborative/ABC collaborators’. Collaborators should be listed in Appendix A,RIPTgrouped by the role that they fulfilled, by their region and by their centre.Collaborators may fulfil more than one role and can be listed multiple timesSCaccordingly. There should be a discussion with any journal ahead of submission forpeer-review to ensure that collaborators will be PubMed indexed under theMANUcollaborative corporate author, and therefore citable. In order to adjust to print runsand size requirements, the appendix may need to be printed in small text, or asonline only data.TEDWhen citing collaborative work on a CV, the format ‘Last name First initial. (Role)Collaborative Group (Year published). Article title. Journal, Volume (Issue), Page(s).’should be used. For example:EPSmith, S. (Regional Lead) National Research Collaborative (2017). RecognisingACCContributions to Work in Research Collaboratives. Journal of ExampleMedicine, 1(35), 399-406.Following the framework set out by this document will allow readers to understandthe contribution that trainees have made to a project, and the skills demonstratedduring research activities. This document can therefore support trainers andassessors when making a judgment about the academic achievements of trainees.Robust reporting of roles with mapping to educational outcomes should reassuretrainers that those engaging in collaborative research are doing more than simply

ACCEPTED MANUSCRIPT‘collecting data’. Appropriate recognition and reward of these roles will ensurecollaborative research remains a viable model for rapid and efficient delivery of highquality, multicentre research data to improve patient care.ReferencesBhangu A, Kolias AG, Pinkney T, Hall NJ, Fitzgerald JE. Surgical research collaborativesin the UK. Lancet [Internet]. Elsevier Ltd; 2013; 382: 1091–1092. Available -9Richards C, Ventham N, Mansouri D, Wilson M, Ramsay G, Mackay C, et al. Anevidence-based treatment algorithm for colorectal polyp cancers: results from theScottish Screen-detected Polyp Can

Recognising contributions to work in research collaboratives: Guidelines for standardising reporting of authorship in collaborative research Matthew J. Lee, On behalf of the National Research Collaborative & Association of Surgeons in Training Collaborative Consensus Group PII: S1743-9191(17)31498-X DOI: 10.1016/j.ijsu.2017.12.019 Reference .

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