Coates, Laura

McHugh, N

Taylor, Peter

Tillett, W

Torgerson, D

Trials

English

Oxford University Research Archive

Trials 2017, 18(Suppl 2):244 Page 6 of 10ConclusionAltruism was the most important motivation for patients to partici-pate in the cohorts. Some misconceptions exist regarding compo-nents of informed consent. However, these misconceptions do notseem to be more prevalent in cmRCT than in standard RCTs.AcknowledgementsThe abstract is being presented on behalf of the cmRCT study group. Wethank the study team of the PLCRC, PRESENT and UMBRELLA cohort at thedepartment of Radiation Oncology, Imaging Division and Julius Center ofthe University Medical Center Utrecht (UMCU) for running the cohort andcollecting the data.A7Ethical Issues in a TwiCs study in early PsALaura C Coates1, William Tillett2, David Torgerson3, Neil McHugh2,4,Peter Taylor11Nuffield Department of Orthopaedics, Rheumatology andMusculoskeletal Sciences, University of Oxford, Oxford, UK; 2Departmentof Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath,UK; 3York Trials Unit, University of York, York, UK; 4Department ofPharmacy and Pharmacology, University of Bath, Bath, UKCorrespondence: Laura C Coates (Laura.coates@ndorms.ox.ac.uk)Trials 2017, 18(Suppl 2):A7Study DesignThis study will recruit newly diagnosed psoriatic arthritis (PsA)patients. The cohort will receive best practice therapy followingEuropean Recommendations: a “treat to target” approach wheretreatment is escalated aiming for an objective target. Treatmentwill be escalated from one standard disease-modifying agent(DMARD), combination DMARDs and finally to biologics.Two initial studies are planned. A randomised feasibility study will as-sess whether patients with mild PsA could be treated conservativelywithout DMARDs. A powered trial in moderate/severe PsA with twointerventional arms will test more intensive drug therapies within thetreat to target approach. One arm will receive combination DMARDsfrom the time of diagnosis, the other arm will receive an initial6 month course of biologics tapering to DMARDs after this.Ethical issues raised by the TwiCs designThe TwiCs design was chosen to allow analysis of real life outcomesin the cohort and treatment comparisons in the trials, producinggeneralizable results with the aim of changing routine practice.Positive ethical issuesIt will not be practical to “blind” therapy in these studies. This raisesthe issue of disappointment bias in patients who receive the “treat-ment as usual” comparator if they are aware that they have notbeen given the more intensive treatment. The use of the TwiCs de-sign will avoid any disappointment bias allowing accurate compari-sons of treatment.Ethical issues of concernThe two stage consent for the cohort and then potentially for aninterventional study must occur prior to starting treatment in newlydiagnosed patients. Appropriate assessment at baseline in the co-hort will have to rapidly allow randomisation to interventions andthe consent forms and information given will have to be easilyunderstandable to the patients to avoid overwhelming them.In a usual RCT design, only patients consenting to the interventionalstudy would be included in an intention to treat analysis. Whilst weplan to use complex statistical methods to adjust for the patientsoffered the intervention but declining (based on CACE analysis), alow consent rate for the offered interventions may affect our lateranalysis.The studies planned within the TwiCs are both controlled trials ofinvestigational medicinal products. As patients within the cohortwill be acting as a “control” group for the interventions, additionaldetailed information relating to adverse events will have to be col-lected in the cohort beyond that which would normally be col-lected in a cohort placing an additional burden on these patients.A8The importance of oversight in Trials within Cohorts (TwiCs):experiences from the Community Ageing Research 75+(CARE 75+) studyLesley Brown1, Anne Heaven1, John Young2, Andrew Clegg21Bradford Institute for Health Research, Bradford Teaching HospitalsNHS Foundation Trust, Bradford, UK; 2Academic Unit of Elderly Careand Rehabilitation, University of Leeds, Leeds, UKCorrespondence: Lesley Brown (Lesley.brown@bthft.nhs.uk)Trials 2017, 18(Suppl 2):A8The Community Ageing Research 75+ (CARE 75+) study is using a Trialswithin Cohorts (TwiCs) design to build ageing research capacity. TwiCsis also considered a useful method for recruiting potentially hard toreach groups such as people with frailty1. As part of the NIHR Collabor-ation for Leadership in Applied Health Research and Care Yorkshire &Humber (NIHR CLAHRC Y&H), CARE 75+ is recruiting community-dwelling older people (≥75 years) from across the UK (n =280) . Theprimary objective is a prospective epidemiological analysis of frailty,disability and quality of life trajectories with health, social and eco-nomic data captured at baseline, 6, 12, 24 and 48 months.There are recognised challenges of using a multiple studies platformwhich have relevance for other researchers studying frailty, disabilityand cognitive impairment. We have observed that the initial cohortconsent procedure is more complex and time-consuming than usualas researchers explain about requests for future study participationand that their data may be used as control data. We have also ob-served confusion between involvement the CARE 75+ observationalstudy and involvement in sub-studies with participants sometimesnot recognising the discrete nature of different studies.To meet these challenges we have worked alongside our theme-widepatient and public group, the Frailty Oversight Group (FOG)2. Firstly,the FOG have scrutinised all sub-studies at the outset to ensure there isno unnecessary burden for participants, such as replication of outcomemeasures. Secondly, the FOG have observed researchers undertakingconsent and assessments to improve the process from the participants’perspective. Thirdly, we inform all participants of new up-and-comingstudies by newsletters but stagger invitations to ensure equal accesswhilst not overburdening them with information. We will continue towork with the FOG to assist with improving branding of informationsheets and consent forms to ensure clarity and discrimination betweenCARE 75+ and sub-studies. To date, 83% of CARE 75+ participantsagreed to contact about future studies (e.g. qualitative research andpilot work for future randomised controlled trials).References1. Clegg A, Relton C, Young J, Witham M. Improving recruitment of olderpeople to clinical trials: use of the cohort multiple randomised controlledtrial design. Age and Ageing. 2015; 44: 547-550.2. Heaven A, Brown L, Foster M, Clegg A. Keeping it credible in cohortmultiple Randomised Controlled Trials: the Community Ageing Research75+ (CARE 75+) study model of patient and public involvement andengagement. Research Involvement and Engagement. 2016; 2: 30.A9Ethical challenges for trials within cohorts (TwiCs) in low andmiddle income countriesKate Chatfield (kchatfield@uclan.ac.uk)Centre for Professional Ethics, University of Central Lancashire, Preston, UKTrials 2017, 18(Suppl 2):A9BackgroundPoor populations face the greatest burden from disease and disability[1] but medical research priorities are driven largely by the global mar-ket for treatments [2]. Consequently, the healthcare needs of people inlow and middle income countries (LMICs) are often neglected. There isan urgent need for more pragmatic research in LMICs but clinical trialsin LMICs are highly sensitive to what the European Commission de-scribes as ‘ethics dumping’. Due to the progressive globalisation of

Ethical issues in a TwiCs study in early PsA

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Ethical issues in a TwiCs study in early PsA

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