Blazeby, JM

Burnside, G

Conroy, E

Cook, JA

Gamble, C

Rosala-Hallas, A

Conroy, Elizabeth

Rosala-Hallas, Anna

Blazeby, Jane M

Burnside, Girvan

Cook, Jonathan A

Gamble, Carrol

Oxford University Research Archive

Trials 2019, 20(Suppl 1):579 Page 6 of 141The IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework provides a pathway for evaluating surgi-cal innovations. This targeted review examined outcome selectionand reporting in self-identified IDEAL studies to identify current prac-tice and inform conceptualisation of domains for a COS.Methods: Electronic database searches for articles citing key IDEALpublications was undertaken. Records with ‘IDEAL’ in the title/ab-stract were selected and screened for eligibility. Excluded were sys-tematic reviews, secondary studies, letters/editorials and studies notincluding humans or surgery. Data were extracted from full-text pub-lications with outcomes extracted verbatim. Descriptive study charac-teristics including detail on outcome selection and reporting weresummarised. Outcomes were reviewed by the study team and itera-tively grouped into domains.Results: of 786 records citing key IDEAL papers, 98 (12%) stated‘IDEAL’ in the title/abstract. Some 29 (30%) eligible studies (24 re-ports, 5 protocols) were included. Studies self-identified as IDEALstage 1 (n=10), 2a (n=8), 2b (n=5), 3(n=1), multiple stages (n=4) ornot stated (n=1). Detail on outcome selection and reporting variedconsiderably across studies. Over 1000 verbatim outcomes weregrouped into 30 domains with several unique to innovation (e.g.modifications to procedures/devices; surgeon’s experiences).Conclusion: This review further highlights the need to standardiseoutcome selection and reporting in studies of surgical innovations.Findings have informed a Delphi survey to reach consensus on aCOS and reporting guidelines to promote standardised, transparentoutcome reporting for safe evaluation.P-20Managing learning and clustering effects at the design stage inrandomised surgical trials: a retrospective cohort of trial fundingapplicationsElizabeth Conroy1, Anna Rosala-Hallas1, Jane M Blazeby2, GirvanBurnside1, Jonathan A Cook3, Carrol Gamble1,41Department of Biostatistics, University of Liverpool, a member ofLiverpool Health Partners, Liverpool, United Kingdom; 2Centre forSurgical Research, Population Health Sciences, Bristol, United Kingdom;3Centre for Statistics in Medicine, University of Oxford, Oxford, UnitedKingdom; 4North West Hub for Trials Methodology Research, Universityof Liverpool, Liverpool, United KingdomTrials 2019, 20(Suppl 1):P-20Background: Complexities associated with delivering surgical inter-ventions, such as clustering effects, by centre or surgeon, and surgi-cal learning, should be considered at trial design. This work aims toprovide insight into current practice in the management, and ac-knowledgement, of these considerations during the development ofrandomised surgical trials.Methods: The cohort searched comprised funded applications, withina four year period, from the National Institute of Health ResearchHealth Technology Assessment and Efficacy and Mechanism Evalu-ation funding streams. Data were extracted on considerations forlearning and clustering effects and the driver, funder or applicant,behind these.Results: Fifty applications were eligible. Managing learningthrough establishing pre-defined centre and surgeon credentialswas common. Few applications also planned exploratory analysisof learning within centre (n=1), and surgeon (n=2) specifically.Clustering, by centre and surgeon, was commonly managedthrough stratifying randomisation, with the majority also planningto subsequently adjust the main analysis (81% for centre strati-fied and 60% surgeon stratified). One-third of responses to ref-erees contained funder led changes in support of learning and/orclustering consideration.Discussion: This review indicates that researchers are familiar withthe need to do consider the impact of learning and clustering, bycentres and surgeon, at trial outset. Furthermore, the funder isidentified as a potential driver of considerations. Early considerationof these complexities at trial design will ensure that future trials donot have the same shortfalls as the past.P-21Successful collaboration between a Clinical Trial Unit (CTU) and theNational Radiotherapy Trials Quality Assurance (RTTQA) Group toexpedite opening a complex phase III trial (PIVOTALboost)Clare Cruickshank1, Helen Mayles2, Olivia Naismith3, Nicola Snelson2,Alison Tree4, John Staffurth5, Ann Henry6, Shama Hassan1, StephanieBrown1, Isabel Syndikus7, Emma Hall11The Institute Of Cancer Research, London, United Kingdom; 2NationalRadiotherapy Trials Quality Assurance Group, The Clatterbridge CancerCentre, Wirral, United Kingdom; 3National Radiotherapy Trials QualityAssurance Group, The Royal Marsden NHS Foundation Trust, London,United Kingdom; 4The Royal Marsden NHS Foundation Trust/TheInstitute of Cancer Research, London, UK; 5Cardiff University/VelindreCancer Centre, Cardiff, UK; 6The Leeds Teaching Hospitals NHS Trust,Leeds, UK; 7The Clatterbridge Cancer Centre, Wirral, UKTrials 2019, 20(Suppl 1):P-21Introduction: PIVOTALboost is a multicentre phase III trial which testspelvic nodal irradiation and focused dose-escalation (with high dose-rate brachytherapy (HDR) or intensity modulated radiotherapy (IMRT)to a boost volume) in the treatment of localised prostate cancer. Thecomplex radiotherapy treatment requires close liaison between theclinical investigators, CTU and the National RTTQA group to minimisedeviations from the trial protocol to ensure integrity of trial out-comes. The radiotherapy techniques used within PIVOTALboost werenot routine standard of care for all centres and their implementationrequired a change in practice.Methods: Radiotherapy treatment was accredited using outliningand planning benchmark cases for focal boost and pelvic node treat-ment and radiotherapy quality assurance (RTQA) guidelines weremade available. The benchmarks were sent to participating sites forcompletion prior to a pre-launch, face-to-face training workshopwhere experience was shared and tailored feedback given. Agree-ment was sought between the RTTQA group and CTU on a prioritylist of centres to open, based on their trial approval progress. Tele-conferences were held every 2 weeks between the CTU and RTTQAgroup and issues or problems were escalated between each teamand the priority list amended as necessary.Results: The workshop was well attended with 59 participants from26 sites (21 sites had managed to submit their benchmark cases forprior review). Regular communication between the CTU and RTTQAgroup meant that resources were effectively managed with bothteams working on an agreed priority centre list. Within the 1st yearof PIVOTALboost opening to recruitment, 24 centres were open, and237 patients had been recruited.Discussion: It is proposed that to meet trial milestones close collabor-ation between the CTU, RTTQA team and clinical investigators is needed.This includes managing the pre-trial RTQA schedule and this should con-tinue throughout patient recruitment, follow-up and analysis.P-22Updating recruitment forecasts via simulations to explore impactof availability of experimental arms in the phase III PIVOTALboosttrialNuria Porta1, Vicki Hinder1, Clare Griffin1, Alison Tree1,2, John Staffurth3,Ann Henry4, Shama Hassan1, Stephanie Brown1, Clare Cruickshank1,Isabel Syndikus5, Emma Hall11The Institute of Cancer Research, London, United Kingdom; 2The RoyalMarsden NHS Foundation Trust, London, United Kingdom; 3CardiffUniversity/Velindre Cancer Centre, Cardiff, United Kingdom; 4The LeedsTeaching Hospitals NHS Trust, Leeds, United Kingdom; 5TheClatterbridge Cancer Centre, Wirral, United KingdomTrials 2019, 20(Suppl 1):P-22

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Managing learning and clustering effects at the design stage in randomised surgical trials: a retrospective cohort of trial funding applications

Managing learning and clustering effects at the design stage in randomised surgical trials: a retrospective cohort of trial funding applications

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