Comprehensive Local Research Network Research Articles

A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults.

Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used. To transfer the contents of a brief (three-session) physiotherapist-delivered breathing retraining programme to a digital versatile disc (DVD) and booklet format; to compare the effectiveness of the self-guided intervention with that of 'face-to-face' physiotherapy and usual care for QoL and other asthma-related outcomes; to perform a health economic assessment of both interventions; and to perform a process evaluation using quantitative and qualitative methods. Parallel-group three-arm randomised controlled trial. General practice surgeries in the UK. In total, 655 adults currently receiving asthma treatment with impaired asthma-related QoL were randomly allocated to the DVD (n = 261), physiotherapist (n = 132) and control (usual care) (n = 262) arms in a 2 : 1 : 2 ratio. It was not possible to blind participants but data collection and analysis were performed blinded. Physiotherapy-based breathing retraining delivered through three 'face-to-face' respiratory physiotherapist sessions or a self-guided programme (DVD plus our theory-based behaviour change booklet) developed by the research team, with a control of usual care. The primary outcome measure was asthma-specific QoL, measured using the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included asthma symptom control [Asthma Control Questionnaire (ACQ)], psychological state [Hospital Anxiety and Depression Scale (HADS)], hyperventilation symptoms (Nijmegen questionnaire), generic QoL [EuroQol-5 Dimensions (EQ-5D)], assessments of airway physiology (spirometry) and inflammation (exhaled nitric oxide) and health resource use and costs. Assessments were carried out at baseline and at 3, 6 and 12 months post randomisation. Patient engagement and experience were also assessed using quantitative and qualitative methods. Primary efficacy analysis was between-group comparison of changes in AQLQ scores from baseline to 12 months in the intention-to-treat population with adjustments for prespecified covariates. Significant improvements occurred in the DVD group compared with the control group [adjusted mean difference 0.28, 95% confidence interval (CI) 0.11 to 0.44; p < 0.001] and in the face-to-face physiotherapy group compared with the control group (adjusted mean difference 0.24, 95% CI 0.04 to 0.44; p < 0.05), with equivalence between the DVD and the face-to-face physiotherapy groups (adjusted mean difference 0.04, 95% CI -0.16 to 0.24). In all sensitivity analyses, both interventions remained significantly superior to the control and equivalence between the interventions was maintained. In other questionnaire outcome measures and in the physiological measures assessed, there were no significant between-group differences. Process evaluations showed that participants engaged well with both of the active interventions, but that some participants in the DVD arm would have liked to receive tuition from a professional. Asthma health-care costs were lower in both intervention arms than in the control group, indicating 'dominance' for both of the interventions compared with the control, with lowest costs in the DVD arm. The rate of adverse events was lower in the DVD and face-to-face physiotherapy groups than in the control group. Only 10% of the potentially eligible population responded to the study invitation. However, breathing retraining exercises improved QoL and reduced health-care costs in adults with asthma whose condition remains uncontrolled despite standard pharmacological therapy, were engaged with well by patients and can be delivered effectively as a self-guided intervention. The intervention should now be transferred to an internet-based platform and implementation studies performed. Interventions for younger patients should be developed and trialled. Current Controlled Trials ISRCTN88318003. This project was primarily funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 53. See the NIHR Journals Library website for further project information. Additional financial support was received from Comprehensive Local Research Networks.

Is late-life dependency increasing or not? A comparison of the Cognitive Function and Ageing Studies (CFAS)

SummaryBackgroundLittle is known about how the proportions of dependency states have changed between generational cohorts of older people. We aimed to estimate years lived in different dependency states at age 65 years in 1991 and 2011, and new projections of future demand for care.MethodsIn this population-based study, we compared two Cognitive Function and Ageing Studies (CFAS I and CFAS II) of older people (aged ≥65 years) who were permanently registered with a general practice in three defined geographical areas (Cambridgeshire, Newcastle, and Nottingham; UK). These studies were done two decades apart (1991 and 2011). General practices provided lists of individuals to be contacted and were asked to exclude those who had died or might die over the next month. Baseline interviews were done in the community and care homes. Participants were stratified by age, and interviews occurred only after written informed consent was obtained. Information collected included basic sociodemographics, cognitive status, urinary incontinence, and self-reported ability to do activities of daily living. CFAS I was assigned as the 1991 cohort and CFAS II as the 2011 cohort, and both studies provided prevalence estimates of dependency in four states: high dependency (24-h care), medium dependency (daily care), low dependency (less than daily), and independent. Years in each dependency state were calculated by Sullivan's method. To project future demands for social care, the proportions in each dependency state (by age group and sex) were applied to the 2014 England population projections.FindingsBetween 1991 and 2011, there were significant increases in years lived from age 65 years with low dependency (1·7 years [95% CI 1·0–2·4] for men and 2·4 years [1·8–3·1] for women) and increases with high dependency (0·9 years [0·2–1·7] for men and 1·3 years [0·5–2·1] for women). The majority of men's extra years of life were spent independent (36·3%) or with low dependency (36·3%) whereas for women the majority were spent with low dependency (58·0%), and only 4·8% were independent. There were substantial reductions in the proportions with medium and high dependency who lived in care homes, although, if these dependency and care home proportions remain constant in the future, further population ageing will require an extra 71 215 care home places by 2025.InterpretationOn average older men now spend 2·4 years and women 3·0 years with substantial care needs, and most will live in the community. These findings have considerable implications for families of older people who provide the majority of unpaid care, but the findings also provide valuable new information for governments and care providers planning the resources and funding required for the care of their future ageing populations.FundingMedical Research Council (G9901400) and (G06010220), with support from the National Institute for Health Research Comprehensive Local research networks in West Anglia and Trent, UK, and Neurodegenerative Disease Research Network in Newcastle, UK.

Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.

BackgroundAssessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal ‘PRO alerts’: psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint.Methods and FindingsWe conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. 20% of research nurses did not view completed PRO questionnaires and were not in a position to discover alerts, 39–50% of the remaining respondent group participants reported encountering PRO alerts. Of these, 83% of research nurses and 54% of data managers/trial coordinators reported taking action to assist the trial participant, but less than half were able to record the intervention in the trial documentation. Research personnel reported current PRO alert guidance/training was insufficient.ConclusionsResearch personnel are intermittently exposed to PRO alerts. Some intervene to help trial participants, but are not able to record this intervention in the trial documentation, risking co-intervention bias. Other staff do not check PRO information during the trial, meaning alerts may remain undiscovered, or do not respond to alerts if they are inadvertently encountered; both of which may impact on patient safety. Guidance is needed to support PRO alert management that protects the interests of trial participants whilst avoiding potential bias.

The randomised Complete versus Lesion-only PRimary percutaneous coronary Intervention Trial: Cardiovascular Magnetic Resonance imaging substudy (CvLPRIT-CMR)

BackgroundComplete revascularisation in patients with multivessel disease who are treated with primary percutaneous coronary intervention (PPCI) may improve outcomes compared with an infarct-related artery (IRA)-only strategy. However, non-IRA percutaneous coronary intervention (PCI) may result in additional myocardial infarction (MI).ObjectivesTo determine whether or not in-hospital complete revascularisation was associated with increased total infarct size (IS) in patients participating in the Complete versus Lesion-only PPCI trial (CvLPRIT). Secondary objectives were to assess whether or not myocardial salvage index, myocardial ischaemia and final IS at follow-up were different with a complete revascularisation versus an IRA-only strategy.DesignMulticentre, prospective, randomised, controlled and open-label trial with blinded end-point analysis.SettingSeven PPCI centres in England, UK.ParticipantsST-segment elevation MI (STEMI) patients with multivessel disease (angiographic stenosis &gt; 70% in one view or &gt; 50% in orthogonal views) presenting within 12 hours of symptom onset and treated with the PPCI. Coronary artery bypass surgery, cardiogenic shock and contraindications to cardiovascular magnetic resonance (CMR; substudy only) imaging were exclusions.InterventionsPatients were randomised to either complete in-hospital revascularisation or an IRA-only strategy.Main outcome measuresThe primary outcome was IS as measured by CMR undertaken at 48–72 hours post PPCI. Secondary outcome measures included microvascular obstruction, myocardial salvage index, left ventricular volumes and ejection fraction and final IS on the acute and follow-up CMR carried out at 9 months post STEMI.ResultsPatients were recruited from May 2011 until May 2013 and followed up for 12 months. Of 296 patients randomised in the main CvLPRIT, 205 consented to participate in the CMR substudy and 203 had analysable images for the primary end point. Patients in the IRA-only group (n = 105) were well matched to those in the complete revascularisation group (n = 98) for all baseline characteristics {mean age 64.1 years [standard deviation (SD) 10.8 years] vs. 63.1 years (SD 11.3 years); male sex 89% vs. 79%, respectively}. Total IS was not significantly different in the IRA-only and complete revascularisation groups {median 13.5% [interquartile range (IQR) 6.2–21.9%] of left ventricular (LV) mass vs. median 12.6% (IQR 7.2–22.6%) LV mass, respectively; 95% confidence interval –4.09% to 31.17%;p = 0.57}. Myocardial salvage index was also not significantly different in the IRA-only and complete revascularisation groups [median 58.5% (IQR 32.8–74.9%) vs. median 60.5% (IQR 40.6–81.9%), respectively;p = 0.14]. The prevalence of non-IRA MI on acute CMR was higher in the complete revascularisation group than in the IRA-only group (22/98 vs. 11/105, respectively;p = 0.02). There was no difference in total IS, ischaemic burden or LV volumes between treatment groups at follow-up CMR.LimitationsThe CMR substudy population may not be a true representation of the overall study population. The optimal timing of CMR to measure IS post PPCI is uncertain. Myocardial salvage was assessable in only 70% of patients.ConclusionsMultivessel PCI, compared with an IRA-only revascularisation, in the setting of STEMI led to a small increase in CMR imaging-detected non-IRA MI, but total IS was not increased.Future workLarger studies are required to (1) confirm that death and MI are reduced by a complete revascularisation strategy; (2) assess whether or not functional assessment of non-IRA lesions results in similar outcomes to a pragmatic angiographic-based revascularisation strategy; and (3) assess the timing of in-hospital versus staged outpatient complete revascularisation.Trial registrationCurrent Controlled Trials ISRCTN70913605.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. The main CvLPRIT was funded by the British Heart Foundation (SP/10/001) with support from the NIHR Comprehensive Local Research Networks.

Identifying Continence OptioNs after Stroke (ICONS): an evidence synthesis, case study and exploratory cluster randomised controlled trial of the introduction of a systematic voiding programme for patients with urinary incontinence after stroke in secondary care

BackgroundUrinary incontinence (UI) following acute stroke is common, affecting between 40% and 60% of people in hospital, but is often poorly managed.AimTo develop, implement and evaluate the preliminary effectiveness and potential cost-effectiveness of a systematic voiding programme (SVP), with or without supported implementation, for the management of UI after stroke in secondary care.DesignStructured in line with the Medical Research Council framework for the evaluation of complex interventions, the programme comprised two phases: Phase I, evidence synthesis of combined approaches to manage UI post stroke, case study of the introduction of the SVP in one stroke service; Phase II, cluster randomised controlled exploratory trial incorporating a process evaluation and testing of health economic data collection methods.SettingOne English stroke service (case study) and 12 stroke services in England and Wales (randomised trial).ParticipantsCase study, 43 patients; randomised trial, 413 patients admitted to hospital with stroke and UI.InterventionsA SVP comprising assessment, individualised conservative interventions and weekly review. In the supported implementation trial arm, facilitation was used as an implementation strategy to support and enable people to change their practice.Main outcome measuresParticipant incontinence (presence/absence) at 12 weeks post stroke. Secondary outcomes were quality of life, frequency and severity of incontinence, urinary symptoms, activities of daily living and death, at discharge, 6, 12 and 52 weeks post stroke.ResultsThere was no suggestion of a beneficial effect on outcome at 12 weeks post stroke [intervention vs. usual care: odds ratio (OR) 1.02, 95% confidence interval (CI) 0.54 to 1.93; supported implementation vs. usual care: OR 1.06, 95% CI 0.54 to 2.09]. There was weak evidence of better outcomes on the Incontinence Impact Questionnaire in supported implementation (OR 1.22, 95% CI 0.72 to 2.08) but the CI is wide and includes both clinically relevant benefit and harm. Both intervention arms had a higher estimated odds of continence for patients with urge incontinence than usual care (intervention: OR 1.58, 95% CI 0.83 to 2.99; supported implementation: OR 1.73, 95% CI 0.88 to 3.43). The process evaluation showed that the SVP increased the visibility of continence management through greater evaluation of patients’ trajectories and outcomes, and closer attention to workload. In-hospital resource use had to be based on estimates provided by staff. The response rates for the postal questionnaires were 73% and 56% of eligible patients at 12 and 52 weeks respectively. Completion of individual data items varied between 67% and 100%.ConclusionsThe trial was exploratory and did not set out to establish effectiveness; however, there are indications the intervention may be effective in patients with urge and stress incontinence. A definitive trial is now warranted.Study registrationThis study is registered as ISRCTN08609907.Funding detailsThe National Institute for Health Research Programme Grants for Applied Research programme. Excess treatment costs and research support costs were funded by participating NHS trusts and health boards, Lancashire and Cumbria and East Anglia Comprehensive Local Research Networks and the Welsh National Institute for Social Care and Health Research.

PWE-165 A Real World Study To Describe The Patient Pathways And Nhs Resource Use Associated With The Management Of Irritable Bowel Syndrome (ibs) In Uk Clinical Practice

IntroductionIrritable bowel syndrome (IBS) is often a diagnosis of exclusion, with poor diagnosis coding in primary care. This makes identification of eligible research participants challenging.We present the methodology development of...

“IT'S A MARATHON NOT A SPRINT” – SETTING THE PACE IN DEVELOPMENT OF A REGIONAL PALLIATIVE CARE RESEARCH SPECIALTY GROUP

BackgroundResearch in palliative care is imperative to improve the evidence base and maintain the best quality care for patients and families. In 2011, the Sussex Cancer Network (SCN) Palliative Care...

A longitudinal, multicentre, cohort study of community rehabilitation service delivery in long-term neurological conditions

ObjectivesPart A: To pilot the use of a register to identify and monitor patients with complex needs arising from long-term neurological conditions. Part B: To determine the extent to which...

What's in this issue?

What's in this issue?

Using the Clinical Research Network for psychosocial cancer research: lessons learned from two observational studies

BackgroundPatient recruitment to psychosocial oncology research has increased but the many studies have been single-site or small-scale. The National Institute for Health Research Clinical Research Network, supports National Institute for...

FRI0323 Level of physical activity in primary sjögren’s syndrome and its predictors

BackgroundThere is now clear evidence that supports the health promoting and disease preventing benefits of physical activity. To date, little research has been undertaken to evaluate physical activity levels in...

The Impact of the National Institute for Health Research on Regional Intensive Care Research: A Case Study from Cumbria and Lancashire

This article illustrates the regional experience of participation in research following the introduction of the National Institute for Health Research (NIHR) Comprehensive Local Research Networks (CLRNs) and the Critical Care Specialty Groups. Prior to this, research was focused in academic centres and tertiary hospitals. Clinicians in smaller regional hospitals had little opportunity or support to participate in clinical trials or other important studies. CLRNs were introduced to ensure that NHS research funding is spread widely throughout the NHS, ensuring all patients can potentially benefit from participation. This maximises research efficiency and results are likely to be more generalisable to the whole NHS, which may lead to wider and more rapid translation of positive studies into clinical practice.

The Ophthalmology Specialty Group and the National Institute for Health Research: the first 6 years

The Ophthalmology Specialty Group and the National Institute for Health Research: the first 6 years

Critical care research in a district general hospital: the first year

Until recently, research in critical care units has usually taken place in university teaching hospitals. The 'general' critical care unit patient population is broader than this and the research needs to reflect this. As a general critical care unit in a district general hospital we wanted to set-up research within our own department, as part of the critical care team and part of our culture. With extensive background communication, drive and hard work, the support of the hospital Research and Development department was gained and Comprehensive Local Research Network funding successfully applied for. A research team was established and a model for the Research Nurse role was developed and implemented. This model is described. Participation in national trials commenced and the research portfolio is growing. Networking with other teams also proved valuable. Research has been established as part of the 'culture' of the day-to-day work and the staff have embraced this. Dedicated Research Nurse posts and education of the whole team have ensured successful implementation and recruitment of the studies. Experiences of the first year are shared and discussed here. Sharing experience of developing research within a critical care unit in a district general hospital, and a suggested model for a new Research Nurse role, may benefit other similar units in their efforts to establish research.

The anti-citrullinated antibody repertoire in periodontitis: a role in the induction of autoimmunity in rheumatoid arthritis?

BackgroundData suggest that periodontal disease (periodontitis) may be a risk factor for rheumatoid arthritis. Anti-citrullinated peptide/protein antibodies (ACPA) are highly specific for rheumatoid arthritis, and epitope spreading arises years before clinical onset of the disease. The purpose of this study was to determine the immune reactivity to ACPA and their uncitrullinated control peptides in patients with periodontitis. MethodsACPA serology was determined in patients with and without periodontitis, including anti-cyclic citrullinated peptide antibodies (anti-CCP), anti-mutated citrullinated vimentin antibodies (anti-MCV), and antibodies with specificity for different citrullinated peptides, including enolase (CEP-1), vimentin (cit-vim), fibrinogen (cit-fib), and their uncitrullinated forms (REP-1, vim, and fib, respectively). FindingsWe included 96 patients with and 98 without periodontitis, none of whom had rheumatoid arthritis at inclusion. Compared with patients without periodontitis, patients with the disease had a higher frequency of antibodies against CEP-1 (3% [3/98] vs 12% [12/96], p=0·02) and REP-1 (2% [2/98] vs 6% [6/96], p<0·001). Antibodies against fib (negative control peptide for cit-fib) and cparg (negative control peptide for CCP) were also more common among those with periodontitis than in those without (26% [25/96] vs 3% [3/98], p<0·001; and 9% [9/96] vs 3% [3/98], p=0·06, respectively). 79 (49%) of 149 non-smokers with periodontitis had significantly higher titres of antibodies against CEP-1 (103% difference in titres, p<0·001), REP-1 (91%, p=0·001), vimentin (87%, p=0·002), and fib (124%, p<0·001), than did patients without periodontitis, independent of age and sex. InterpretationIn patients without rheumatoid arthritis, periodontitis is associated with higher titres of antibodies to both citrullinated and uncitrullinated peptides in non-smokers suggesting that periodontitis may contribute to the development of autoimmunity related to rheumatoid arthritis. FundingGums & Joints Collaborative EU Framework Programme 7 project and Birmingham and Black Country Comprehensive Local Research Network.

Mutations of TCF12, encoding a basic-helix-loop-helix partner of TWIST1, are a frequent cause of coronal craniosynostosis

BackgroundCraniosynostosis, the premature fusion of the cranial sutures, is the second most common craniofacial malformation. A genetic aetiology can be identified in about 21% of cases, including mutations of TWIST1 that cause Saethre-Chotzen syndrome and are associated with coronal synostosis. By contrast, the cause of non-syndromic craniosynostosis is largely unknown. MethodsWe undertook exome sequencing of seven individuals with bilateral coronal synostosis, identifying mutations of TCF12 in three samples. We sequenced TCF12 in a further 347 patients with craniosynostosis. We performed mutation testing in extended families and determined the effects of mutations on mRNA expression. We examined the genetic interaction between loss-of-function mutations of Tcf12 and Twist1 in mice. FindingsHeterozygous TCF12 mutations were present in 38 of the 347 unrelated patients with craniosynostosis. These included 22 (32%) of 69 with isolated bilateral coronal synostosis, and 14 (10%) of 141 with unilateral coronal synostosis, but none with premature fusion of only the metopic, sagittal, or lambdoid sutures (p<10−6). An additional two patients had either bilateral or right coronal synostosis in addition to sagittal synostosis. 14 cases arose de novo, but vertical transmission was demonstrated in 23 families. 16 mutation-positive individuals (47%) had craniosynostosis or suspicious clinical features, but 19 (53%) of 35 mutation-positive relatives were non-penetrant for craniosynostosis. TCF12 mutations were associated with diminished mRNA expression, indicating haploinsufficiency. With appropriate surgical correction the clinical outcome was usually good; six of 66 individuals had learning disability. Mice doubly heterozygous for Twist1 and Tcf12 mutations had severe bilateral coronal synostosis. InterpretationMutations of TCF12 are a frequent and specific cause of coronal craniosynostosis; mutation testing is indicated in the assessment of these patients. Genetic interaction of Tcf12 and Twist1 is crucial for coronal suture development. FundingNational Institute for Health Research Biomedical Research Centre, Oxford (BRC)/Oxford University Clinical Academic Graduate School (OUCAGS), and Oxfordshire Health Services Research Committee (OHSRC), Oxford Craniofacial Unit Charitable Fund; Thames Valley Comprehensive Local Research Network; The Dutch Center for Translational Molecular Medicine; Carolien Bijl Foundation; US National Institutes for Health; Wellcome Trust.

West London Primary Care Consortium for Research and Innovation.

The West London Primary Care Consortium for Research and Innovation (WLPCC) supports primary care research in West London. It is a consortium of the eight West London primary care trusts (PCTs), their local authorities and provider service partners. The Consortium was originally set up as the West London Research Network (WeLReN). Its aim is to develop partnerships between universities, local authorities, pharmaceutical companies and local commissioning groups to help recruit patients into research projects and to build a culture of innovation throughout primary care. The latter includes facilitating quality assurance, evaluating service improvements, and improving the skills and capacity of primary care practitioners to inquire and collaborate in improving services. The Consortium, which is based at NHS Brent, works closely with the NIHR Primary Care Research Network – Greater London (PCRN-GL), the London North West London Comprehensive Local Research Network (NWL CLRN), West London CLAHRC and West London NHS Trusts (acute and specialist). It is funded through the NWL CLRN and also receives ad hoc funds from research projects. WLPCC provides the following services: research governance services for West London PCTs and primary care providers including 450 general practices; manages service support costs to support general practice engagement in research (time, equipment, training); liaises with researchers prior to grant applications, including pre-protocol and pilot work; works with research teams to target and facilitate practice recruitment and participation in studies; organises and facilitates training and quality assurance for studies; collaborates with others to enhance learning and opportunities for primary care practitioners; manages a ‘RD provides clinical research officers to support study teams and GP surgeries to recruit into projects.

A1 Financial and time costs of R&D governance and regulation in England and Wales: evidence from the SAFER 2 trial

In response to a recent review targeted at reducing bureaucracy in medical research related to R&D governance and regulation, we collated our experiences from a multi centre trial in prehospital...

The UK clinical research network--has it been a success for dermatology clinical trials?

BackgroundFollowing the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS).MethodsThis report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials.ResultsIn both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment.ConclusionsRecruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

Abstract LB-60: A Local Consumer Research Panel's Role in the work of the National Institute for Health Research (NIHR) in the U.K

Abstract The poster explains how patient advocacy fits into the world of health research, the relationship between research networks, and how research is planned at both the national and local levels in the United Kingdom. It describes the role of a local consumer research panel in helping to enhance research for maximum patient benefit. David Ardon has been a member and chair of a local panel for eight years and of the national consumer research group for seven years. The poster explains where in the research cycle patients and caregivers have been active, demonstrating the logos of local and national research organizations, and in diagrammatic form, showing the kind of activities that a consumer researcher tackles. The North Trent Cancer Research Network Consumer Research Panel was established in 2001 by the Academic Unit of Supportive Care at the University of Sheffield. North Trent is an area in the North East Midlands of England. The panel works alongside and is a constituent of the National Cancer Research Institute Consumer Liaison Group. The panel, composed of 40 past and current cancer patients and caregivers, is funded by the North Trent Cancer Network and the South Yorkshire CLRN to provide a consumer perspective at strategic meetings within North Trent and for individual research studies within the network. The panel has hosted and led ten conferences aimed at raising awareness of clinical research. The objective of the panel is to improve the quality of communication and information exchange between health care professionals, patients, and caregivers by providing a consumer perspective at all stages of cancer research and clinical trials. The governing body of health research in the U.K. is the National Institute for Health Research, which monitors eight research areas, one of which is cancer. Cancer research is governed and managed by the National Cancer Research Institute (NCRI), and the National Cancer Research Network (NCRN). Health research locally is delivered by a Comprehensive Local Research Network (CLRN). Mr. Ardon's local CLRN is the South Yorkshire CLRN, and this group includes the North Trent Cancer Research Network. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr LB-60. doi:10.1158/1538-7445.AM2011-LB-60