Meeting abstract from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)
https://ictmc2019.com

Bostock, Jennifer

Bulbulia, Richard

Chant, Alan

Cook, Jonathan A

Crocker, Joanna C

Farrar, Nicola

Kerr, Polly

Locock, Louise

Olszowski, Sophie

Rees, Sian

Treweek, Shaun

Woolfall, Kerry

Oxford University Research Archive

Trials 2019, 20(Suppl 1):579 Page 26 of 141research sites; including LEAP members in reviewing trial documents;completing a practice run-through of trial assessments; inviting LEAPmembers to sit on the interview panel for recruitment of trial staff.Findings: LEAP feedback was invaluable in the development of thistrial and enabled the research team to make key changes, e.g. avoid-ing medical jargon within participant facing trial documents, specific-ally the information sheet, consent form and advertising materials.LEAP members also advised on visit structure, suggested changes tooutcome measures, and highlighted the importance of consistencyin patient-staff relationships. Following this advice, the treatmentperiod was extended to allow participants more flexibility for attend-ance. Additionally, LEAP members’ inclusion in the interview processensured that empathetic trial staff were appointed.Conclusion: By involving patients with lived experience from the out-set, several changes were made to the trial design to improve patientexperience. The outcome has been promising thus far and we willcontinue these strategies, involving LEAP members in all dissemin-ation activities. Using this approach throughout the trial has the po-tential to improve the experience of participants, and therefore hasimplications for participant retention in future clinical trials intodepression.P-89Uptake of interventions to communicate results of a phase IIIrandomised controlled trial to participants: early results from theShow RESPECT study (ISRCTN96189403)Annabelle South1, Cara Purvis1, Ania Spurdens1, Elizabeth James1, CarlosDiaz-Montana1, Matthew R. Sydes1, William J. Cragg1,2, Katie Gillies3,Sierra Santana1, Nalinie Joharatnam-Hogan1, Archie MacNair1, Andrew J.Copas11MRC Clinical Trials Unit at UCL, London, United Kingdom; 2Clinical TrialsResearch Unit, Leeds Institute of Clinical Trials Research, University ofLeeds, Leeds, United Kingdom; 3Health Services Research Unit, Universityof Aberdeen, Aberdeen, United KingdomTrials 2019, 20(Suppl 1):P-89Introduction: Previous studies show that participants want to be in-formed of the overall results of trials they have taken part in, but thatthis often does not happen. Anecdotal reports suggest even whentrials do attempt to communicate results to participants, it is oftennot done well. Show RESPECT tests three approaches, identified anddeveloped through extensive PPI, to communicating trial results toUK participants of ICON8, a phase III ovarian cancer chemotherapyRCT.Methods: Show RESPECT is a mixed methods cluster randomised fac-torial Study Within A Trial (SWAT), run within ICON8. Over 40 ICON8UK centres (hospitals) are being randomised to communicate resultsto participants using combinations of:-Link to a basic webpage (text only) vs enhanced webpage (includingdiagrams, video, links to further support and information, and theoption to submit questions)-Printed summary vs no printed summary-Invitation to join an email list vs no invitationThe primary outcome measure (OM) of Show RESPECT is participantsatisfaction with how the results are communicated. Data are col-lected from participants, site staff and CTU staff by questionnaires,and qualitative interviews are being carried out with site staff andparticipants.Secondary OMs include uptake of the interventions, which is mea-sured using analytic data from customised links (for webpages andemail list) and data collected on logs by site staff (printedsummaries).Timing of potential results: The final sites will be randomised in May2019. We will present data on the PPI process and intervention up-take (available from August). Results from the primary outcome willbe presented at a later date.Potential relevance and impact: These data have the potential to in-form future approaches to better communicate overall results tosimilar participant populations in other trials, helping trialists meettheir ethical obligations to offer results to patients in accessible ways.P-90MAMMO-50 - Working with the patients to enable multiple typesof data collection within a clinical trialMaria Ramirez1, Andrea Marshall1, John Lindley1, Asha Bhandari1, AnnieYoung1, Maggie Wilcox2, Sophie Gasson1, Peter Donnelly3, Andy Evans4,Janet Dunn11Warwick Clinical Trials Unit, Coventry, United Kingdom; 2ICPV, London,United Kingdom; 3South Devon Healthcare NHS Foundation Trust,Torquay, United Kingdom; 4Ninewells Medical School, Dundee, UnitedKingdomTrials 2019, 20(Suppl 1):P-90Introduction: There is a lack of evidence/consensus amongst sur-geons on optimum frequency or duration of follow-up includingmammography for breast cancer patients aged 50 years and older atdiagnosis. Mammo-50 RCT has the opportunity to gather patient re-ported outcomes and patients’ perspectives on follow-up.Methods: Mammo-50 trial has recruited over 5235 women in a ran-domised trial assessing duration of mammographic surveillance forwomen over 50 years old at diagnosis and 3 years post curative sur-gery. 91% of women agreed to participate in a quality of life sub-study (QoL) and 75% of women consented to enter the Qualitativesub-study (QSS). In addition, a national patient-led survey on follow-up was developed by the Independent Cancer Patients’ Voice (ICPV)to gather patients’ experience of follow-up.Results: Mammo-50 patient questionnaires indicated that 28% of pa-tients had high levels of distress due to concerns about fatigue,sleep, worry/anxiety, memory/concentration, hot flushes and pain.Mammo-50 focus groups (6 at multiple sites) and individual inter-views (32 telephone interviews) indicated that patients in generalwere satisfied with their care and happy to be in a trial. The inter-views reached saturation quickly with patients being concernedabout early discharge from hospital follow-up and the fear of recur-rence. The ICPV survey indicated that over 2/3rds of respondents saidthey had some unmet needs during their follow up period; thesewere varied and included both physical and psychological needs.Discussion: In summary, focus groups and individual interviews sug-gest that patients, when followed-up by the trial team, are happy withtheir care. When given the opportunity to report unmet needs throughquestionnaires/surveys, patients often report things which could becausing them distress, but which may go unnoticed in routine follow-up. Clinical trials have the opportunity to collect patient reported expe-riences alongside the standard QoL booklets, providing a rich source ofadditional data.P-91Abstract omittedP-92PIRRIST: Patient and public involvement (PPI) to enhancerecruitment and retention in surgical trialsJoanna C. Crocker1,2, Jennifer Bostock3, Shaun Treweek4, Nicola Farrar5,Alan Chant3, Jonathan A. Cook6, Polly Kerr2, Sian Rees7, Louise Locock1,4,Kerry Woolfall8, Sophie Olszowski9, Richard Bulbulia10,111Health Experiences Research Group, Nuffield Department of PrimaryCare Health Sciences, University of Oxford, Oxford, United Kingdom;2National Institute for Health Research (NIHR) Oxford BiomedicalResearch Centre, Oxford, United Kingdom; 3Patient/Lay Partner, UnitedKingdom; 4Health Services Research Unit, University of Aberdeen,Aberdeen, United Kingdom; 5Population Health Sciences, University ofBristol, Bristol, United Kingdom; 6Surgical Intervention Trials Unit,University of Oxford, Oxford, United Kingdom; 7Oxford Academic HealthScience Network, Oxford, United Kingdom; 8Institute of PopulationHealth and Society, University of Liverpool, Liverpool, United Kingdom;9SPZ Associates Ltd., United Kingdom; 10Clinical Trial Service Unit,Nuffield Department of Population Health, University of Oxford, Oxford,United Kingdom; 11Cheltenham General Hospital, GloucestershireHospitals NHS Foundation Trust, Cheltenham, United KingdomTrials 2019, 20(Suppl 1):P-92Trials 2019, 20(Suppl 1):579 Page 27 of 141Introduction: Poor recruitment and retention are common chal-lenges to the successful delivery of surgical trials. Patient and publicinvolvement (PPI) has the potential to improve both but there havebeen few attempts to formally investigate this. We aimed to developan evidence-based PPI Intervention to enhance Recruitment and Re-tention In Surgical Trials (‘PIRRIST’).Methods: Four stages: (1) Online survey to identify current PPI prac-tice in UK surgical trials; (2) Stakeholder focus groups and interviewsto explore PPI needs and challenges, issues with participant recruit-ment and retention, and how PPI might address these; (3) Two on-line surveys to estimate the frequency and importance of theidentified issues with recruitment, retention and PPI in surgical trials;(4) Stakeholder workshop to determine key features of the final PPIintervention.Results: 393 individuals took part across four stages of data col-lection. Based on the findings, we made recommendations forPPI in surgical trial design including: use a two-tier model of PPI(ongoing partnership with individuals plus consultation with thewider patient population); involve patients/carers with personalexperience of the target health condition; budget for staff timeon PPI. We held eight events with surgical trial staff and patient/public contributors across the UK to review these recommenda-tions and plan next steps. From this we developed succinct, prac-tical guidance to aid Chief Investigators (CIs) in planning PPI insurgical trials. We involved a professional graphic designer, user-tested the guidance with CIs and consulted many stakeholdersincluding PPI contributors and trial managers.Discussion: Our evidence-based guidance will help CIs to plan PPIthat should boost participant recruitment and retention (evaluationneeded). Although based on evidence gathered from surgical trials,the guidance could be applied to other clinical trials within the UK.The guidance will be available online from June 2019 viawww.phc.ox.ac.uk/pirristP-93Patient and Public Involvement & Engagement in UKCRCRegistered Clinical Trials Units – A Scoping ExerciseHeather Bagley1, Steven Blackburn2, Claire L Vale3, Delia Muir4, CallyRick5, John Cleland6, Kym Thorne7, Laura Mader8, Daniel Beever9, AdwoaParker101Liverpool Trials Collaborative, University of Liverpool, Liverpool, UnitedKingdom; 2Research Institute for Primary Care and Health Sciences, KeeleUniversity, Keele, United Kingdom; 3 MRC Clinical Trials Unit atUniverisity College London, London, United Kingdom; 4Leeds ClinicalTrials Research Unit, University of Leeds, Leeds, United Kingdom;5Nottingham Clinical Trials Unit, University of Nottingham, Nottingham,United Kingdom; 6Glasgow Clinical Trials Unit, University of Glasgow,Glasgow, United Kingdom; 7Swansea Clinical Trials Unit, SwanseaUniversity, Swansea, United Kingdom; 8Patient Led Research Hub,University of Cambrdige, Cambridge, United Kingdom; 9Sheffield ClinicalTrials Research Unit, University of Sheffield, Sheffield, United Kingdom;10University of York, York, United KingdomTrials 2019, 20(Suppl 1):P-93Introduction: The UK National Institute for Health Research ‘BreakingBoundaries’ review of patient and public involvement (PPI) in re-search highlighted the need for a more strategic approach to PPI,recommending that PPI leads should have opportunities to networkand share best practice. Furthermore, there is increasing emphasison public engagement within clinical trials, including public dialogueabout the need for and design of trials.The UK Clinical Research Collaborative (UKCRC) Registered ClinicalTrials Unit (CTU) Network established a Patient and Public Involve-ment and Engagement (PPI&E) Task and Finish Group to conduct ascoping exercise to:•Identify different approaches for delivering PPI&E within CTUs•Map existing PPI&E resources during the course of clinical trials•Develop more effective collaborative PPI&E working across regis-tered CTUs.Methods: We conducted an e-survey with registered CTUs to investi-gate the current PPI&E landscape and challenges. Responses werediscussed at a workshop with targeted activities to explore PPI&Epractices. 4 public contributors also attended the workshop, sharingtheir perspectives on how CTUs should involve and engage patientsand the public.Results:•46/51 registered CTUs completed the survey, 39 attended the work-shop. Findings included:•15/46 CTUs reported one person with overall PPI &E responsibility•11 CTUs had PPI guidance for trial staff, 2 CTUs had PE guidance. 6CTUs used PPI standard operating procedures•No CTUs stated they would be unwilling to collaborate in PPI&Eactivity.Discussion: This scoping exercise illustrated that PPI&E is evolving,with involvement currently more advanced than engagement. Re-sources to support PPI&E varied amongst CTUs. There is duplicationof activities, suggesting a need for a formal sharing mechanismacross the Network. The UKCRC PPI&E group will be developing a na-tional communication strategy and central repository for resourcesand training for PPI&E to address the findings of this scopingexercise.P-94Research nurse and patients perspective on innovative early phasetrial designsAimee Jackson, Ceri Armstrong, Faye Lowe, Christina YapUniverstiy Of Birmingham, Birmingham, United KingdomTrials 2019, 20(Suppl 1):P-94Introduction: In recent years there has been a significant increase inthe use of novel trial designs increasing statistical efficiency, particu-larly in the early phase setting. Little work has been done to assesshow these designs impact patients and research nurses. We set outto develop an understanding of their views on novel early phase de-signs including Continual Reassessment Method, exploring if trial de-signs can be more patient-centred.Methods: We conducted a joint interview with two research nursesworking in early phase oncology trials (RN) and held a group discus-sion with nine representatives from a Patient and Public Involvementgroup (PPIgroup) to identify the aspects of trial design that matteredmost. An interactive session was held at the NIHR Statistics - Earlyphase trials meeting, February 2019 (EPmeeting).Results: 78% (7/9) in the PPIgroup and 48% (20/42) of EPmeeting feltthat increased trial design complexity would have no impact on pa-tient recruitment. Members of PPIgroup felt that an increase in logis-tical complexity would discourage trial recruitment but that trialdesign complexity would not. 39/44 delegates at the EPmeeting feltthat patients would feel less secure joining a first –in-man trial how-ever RN reported no concerns with recruiting to these trials; 1 mem-ber of the PPIgroup commented “We were clutching at straws andwould have done anything”. When asked about dose selection in adose-finding trial, EPmeeting gave mixed responses across doseranges however; the PPIgroup felt that patients would be reluctantto receive the highest dose due to potential toxicities.Discussion: Trialists understanding of patients’ needs may not ne-cessary be in line with patients’. In order to ensure that innova-tive designs achieve benefits that matter most to patients, theyneed to be designed with patients as co-developers. Further workis required to identify how to encourage a more patient-centredapproach.

English

PIRRIST: Patient and public involvement (PPI) to enhance recruitment and retention in surgical trials

ORA - Oxford University Research Archive

University of Liverpool Repository

http://livrepository.liverpool.ac.uk/3069391/1/Crocker%20et%20al%202019%20-%20Trials%20PIRRIST.pdf

PIRRIST: Patient and public involvement (PPI) to enhance recruitment and retention in surgical trials

Abstract

Similar works

Full text

Available Versions

Oxford University Research Archive

ORA - Oxford University Research Archive

University of Liverpool Repository