Background: The Cystic Fibrosis (CF) Registry collects clinical data on all patients attending specialist CF centres in the UK. These data have been used to make comparisons between centres on key outcomes such as forced expiratory volume in 1 second (FEV1) using simple rankings, which promote the assumption that those with the highest measures provide ‘better’ care. Objectives: To explore whether or not using statistical ‘process control’ charts that move away from league tables and adjusting for case mix (age, where appropriate; sex; CF genotype; pancreatic sufficiency; and socioeconomic status) could identify exceptional CF care services in terms of clinically meaningful outcomes. Then, using insight from patients and clinicians on what structures, processes and policies are necessary for delivering good CF care, to explore whether or not care is associated with observed differences in outcomes. Design: Cross-sectional analyses. Setting: Specialist CF centres in the UK. Participants: Patients aged ≥ 6 years attending specialist CF centres and clinicians at these centres. Main outcome measures: FEV1% predicted. Data sources: Annual reviews taken from the UK CF Registry (2007–15). Results: We studied FEV1 in many different ways and in different periods. In our analyses of both adult and paediatric centres, we observed that some centres showed repeated evidence of ‘special-cause variation’, with mean FEV1 being greater than the mean in some cases and lower than the mean in others. Some of these differences were explained by statistical adjustment for different measures of case mix, such as age, socioeconomic status, genotype and pancreatic sufficiency. After adjustment, there was some remaining evidence of special-cause variation for some centres. Our data at these centres suggest that there may be an association with the use of intravenous antibiotics. Workshops and focus groups with clinicians at paediatric and adult centres identified a number of structures, processes and policies that were felt to be associated with good care. From these, questionnaires for CF centre directors were developed and disseminated. However, the response rate was low, limiting the questionnaires’ use. Focus groups with patients to gain their insights into what is necessary for the delivery of good care identified themes similar to those identified by clinicians, and a patient questionnaire was developed based on these insights. Limitations: Our data analyses suggest that differences in intravenous antibiotic usage may be associated with centre-level outcomes; this needs to be explored further in partnership with the centres. Our survey of centre directors yielded a low response, making it difficult to gain useful knowledge to inform further discussions with sites. Conclusions: Our findings confirm that the CF Registry can be used to identify differences in clinical outcomes between centres and that case mix might explain some of these differences. As such, adjustment for case mix is essential when trying to understand how and why centres differ from the mean. Future work: Future work will involve exploring with clinicians how care is delivered so that we can understand associations between care and outcomes. Patients will also be asked for their perspectives on the care they receive. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background Patient and public involvement (PPI) is a requirement for UK health and social care research funding. Evidence for how best to implement PPI in research programmes, such as National Institute for Health Research (NIHR) Collaborations for Applied Health Research and Care (CLAHRCs), remains limited. This paper reports findings from an action research (AR) project called IMPRESS, which aims to strengthen PPI within CLAHRC East of England (EoE). IMPRESS combines AR with Normalisation Process Theory (NPT) to explore PPI within diverse case study projects, identifying actions to implement, test and refine to further embed PPI. Methods We purposively selected CLAHRC EoE case study projects for in-depth analysis of PPI using NPT. Data were generated from project PPI documentation, semi-structured qualitative interviews with researchers and PPI contributors and focus groups. Transcripts and documents were subjected to abductive thematic analysis and triangulation within case. Systematic across case comparison of themes was undertaken with findings and implications refined through stakeholder consultation. Results We interviewed 24 researchers and 13 PPI contributors and analysed 28 documents from 10 case studies. Three focus groups were held: two with researchers (n = 4 and n = 6) and one with PPI contributors (n = 5). Findings detail to what extent projects made sense of PPI, bought in to PPI, operationalised PPI and appraised it, thus identifying barriers and enablers to fully embedded PPI. Conclusion Combining NPT with AR allows us to assess the embeddedness of PPI within projects and programme, to inform specific local action and report broader conceptual lessons for PPI knowledge and practice informing the development of an action framework for embedding PPI in research programmes. To embed PPI within similar programmes teams, professionals, disciplines and institutions should be recognised as variably networked into existing PPI support. Further focus and research is needed on sharing PPI learning and supporting innovation in PPI.

Purpose of study and backgroundThe primary aim of the study was to test the feasibility of conducting a full RCT with economic analysis and help to inform the provision of physiotherapy in a specif...

Action research has been characterised as systematic enquiry into practice, undertaken by those involved, with the aim changing and improving that practice: an approach designed to have impact. Whilst much has been written about the process and practice of researching', historically impact' has been somewhat taken for granted. In recent years, however, the impact of all forms of research has become the focus of interest with many funding bodies now demanding that researchers not only articulate the prospective impact of their work, but what kinds of evidence will be proffered to demonstrate that impact. This has raised questions for action researchers, not about whether their work has an impact, but what form that impact takes, how it is recognised and by whom. This paper focuses on difficulties researchers find in both articulating the impact of participatory research and demonstrating links between such forms of research and impact. We draw on discussions about the notion of impact with authors that have self-reported and published their work as participatory. These discussions revealed that not only were there difficulties in clarifying the participatory dimension of their research but that whilst authors were able to discuss particular impacts of their work, articulating and evidencing that impact was often absent from their published papers. This paper offers insights into some of issues and barriers those who undertake participatory research face in explicating, for the external audience (and indeed sometimes for ourselves), the impact of this action-based form of enquiry.

Within current mainstream understandings of patient and public involvement (PPI) in health research, a clear distinction is made between what ‘involvement’ in research is: ‘research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them91 and what it is not: namely ‘engagement with’ and ‘participation in’ research. Research evidence describes problems than can arise when such distinctions are unclear or misunderstood (often by those new or unfamiliar with PPI); or when distinctions are intentionally blurred e.g. by ‘dual roles’ being created within some projects, where research participants also advise on the conduct of projects. What is less widely examined, however, is the blurring of boundaries between the object of enquiry which is the business of PPI for that project, the data which is the object of qualitative collection involving discussion with participants and the purposeful research activities which are best progressed through engagement with stakeholders. This poster draws upon case study findings from two recent, similar National Institute for Health Research (NIHR)-funded evaluations of PPI in health research: RAPPORT (England-wide) and IMPRESS (regional research programme-specific), pertaining to how researchers (from various disciplines, using various research designs) within different case study research projects can blur the boundaries between qualitative research, stakeholder events and PPI. We pose questions pertaining to the consequences of blurred research design boundaries for the success of outcomes of public-research collaborations. We query why, and to what extent, such distinctions matter in co-producing knowledge and in measuring the impact of various investments in collaborative research activities.

Objectives: Adherence to nebulised treatment is typically low among people with cystic fibrosis (CF). This study sought to identify factors differentiating high or low nebuliser adherence patterns (i.e. ≥80% or <50% of all nebulised treatments over one year) among adults with CF. Design: A mixed methods cross-sectional exploratory comparison of low and high adherers to nebulised medications. Methods: Of 36 eligible adults invited from a UK CF centre, 20 were recruited (10 high, 10 low adherers). Adherence was objectively measured using electronic data capture. Participants completed a self-report questionnaire comprising measures of hypothesised predictors (habit, self-control, life chaos, perceived treatment burden, capability, motivation and opportunity), then took part in a semi-structured interview. Quantitative data were compared between groups, and interview data were thematically analysed. Results: High adherers reported stronger habit and greater opportunities, though habit and perceived opportunity scores were highly positively correlated. No other quantitative measure distinguished between groups. Habitual instigation tendency attenuated the relationship between treatment complexity and perceived treatment burden. Indeed, in interviews, high adherers reported that routinisation and greater automaticity made treatment burden more manageable. Conclusions: High adherers seized more opportunities for nebuliser use, adapted their lives more effectively to using nebulisers and were more likely to make nebuliser use habitual. Nebuliser adherence interventions among adults with CF might usefully target development of routines for instigating nebuliser use, and identification of opportune moments for nebuliser use.

Aims: Wedescribe how patient and public involvement (PPI) was integrated into the design of an intervention for a randomised controlled trial (RCT) based within primary care. The RCT, known as the PLEASANT trial, aimed to reduce unscheduled medical contacts in children with asthma associated with start of the new school year in September with a simple postal intervention, highlighting the importance of maintaining asthma medication for helping to prevent increased asthma exacerbations. Background: PPI is a key feature of UK health research policy, and is often a requirement of funding from the National Institute for Health Research. There are few detailed accounts of PPI in the design and conduct of clinical trials in the PPI literature for researchers to learn from. Methods: We held PPI consultation events to determine whether the proposed intervention for the trial was acceptable to children with asthma and their parents, and to ascertain whether enhancements should be made. Two PPI consultation events were held with children with asthma and their parents, prior to the research commencing. Detailed field notes were taken by the research team at each consultation event. Findings: At the first consultation event, parents and children endorsed the trial's rationale, made suggestions to the wording of the trial intervention letter, and made recommendations about to whom the letter should be sent out. At the second consultation event, parents discussed the timing of the intervention, commented on the lay summary of the Research Ethics Application, and were invited to join the trial's steering committee, while the children selected a logo for the study. PPI has resulted in enhancements to the PLEASANT study's intervention. A further PPI consultation event is scheduled for the end of the trial, in order for children with asthma and their parents to contribute to the trial's dissemination strategy.

Objectives: To understand the differences between high or low nebuliser adherers (i.e. used ≥80% or ≤40%, respectively, of all nebulised treatments over one year) among adults with cystic fibrosis (CF). Methods: Of 36 eligible adults with CF invited from a UK CF centre, 20 were recruited (10 high, 10 low adherers). Adherence was objectively measured using electronic data capture. Participants took part in a semi-structured interview and provided quantitative measures of habit, self-control, life chaos, perceived treatment burden, capability, motivation and opportunity. Quantitative measures were compared between groups and interview data were thematically analysed. Results: High adherers reported stronger habit and greater opportunities, though habit and perceived opportunity scores were highly positively correlated. No other quantitative measure distinguished between groups. Habit strength attenuated the relationship between treatment complexity and perceived treatment burden. Indeed, in interviews, high adherers reported that routinisation and greater automaticity made treatment burden more manageable. Conclusions: High adherers appear more likely to make nebuliser use habitual, and adapt more effectively to using nebulisers by creating and seizing opportunities for nebuliser use. Nebuliser adherence interventions might usefully target the development of routines for instigating nebuliser use, and identification of opportune moments for nebuliser use.

Reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation (Julious SA et al. Public Health 2007;121(6):482-4). A drop in prescription collection in the month of August has been observed which was associated with an increase in the number of unscheduled contacts after the return to school in September. The aim of the study was to assess whether a primary care intervention reduced the number of unscheduled medical contacts after the school return. A letter was sent from the GP to parents/carers of children aged 5-16 years with asthma at the start of school summer holidays reminding them to take their preventer medication prior to the start of the new school year. The study was a cluster randomised trial with a control group that received usual care. The intervention did not reduce unscheduled care in September (odds-ratio 1.09; 95% CI 0.96 to 1.25) against the intervention. It did succeed in increasing the proportion of children collecting prescriptions in August (odds-ratio 1.43; 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month. For the wider time intervals (Sep-Dec 2013 and Sep-Aug 2014) there was weak evidence of effect. The economic analysis estimated a high probability that the intervention was cost saving. A higher uptake of prescriptions and scheduled contacts in August may indicate that the letter triggered parents to arrange asthma reviews in children whose prescriptions had lapsed. GPs and commissioning groups may wish to implement this intervention in areas with high rates of asthma and low rates of scheduled asthma reviews.

Background and Purpose Sciatica is a common clinical condition that can be extremely painful, disabling and life-changing. Whether conservative or surgical treatment for sciatica secondary to an intervertebral disc prolapse is most effective is still much debated. An important component of conservative treatment is physiotherapy, which aims to promote physical and psychological health for the patient, whilst resorption of the disc takes place. This paper reports a qualitative study of patients' views and experiences of a bespoke physiotherapy intervention for the treatment of sciatica. Methods A qualitative study nested within a pilot randomized controlled trial of bespoke physiotherapy for the treatment of patients with sciatica awaiting lumbar microdiscectomy surgery. Patients randomized to receive bespoke physiotherapy in the intervention arm of the trial were invited to take part in semi-structured interviews. Twenty-one in-depth, semi-structured interviews took place. All interviews were recorded, fully transcribed and thematically analysed. Results Most patients in the sample found the physiotherapy valuable, appreciating the individual nature of the approach, the exercises to reduce pain and discomfort, techniques for improving functional spinal movement, walking and dynamic posture, and manual therapy and cardiovascular exercise. A small number did not find the physiotherapy of benefit. Sixteen patients in the sample went on to proceed with surgery, but most of these found value in having had the physiotherapy first. Discussion Many patients with sciatica appreciate the value of physiotherapy prior to surgery. Future research should examine patients' experiences of bespoke physiotherapy delivered within primary care. Copyright © 2016 The Authors Physiotherapy Research International published by John Wiley & Sons Ltd.

Objectives The UK CF Registry annual reports include comparisons between centres on key outcomes such as FEV1 using rankings. While illustrating the distribution between centres, they promote the assumption that those with the highest measures provide “better” care. We hypothesised a more scientific approach based on statistical “process control” using funnel plots and adjustment for case-mix may help to identify exceptional CF care services in terms of clinically meaningful outcomes. Methods We extracted data from annual reviews (2007–2012) on the CF Registry. Our outcomes included FEV1 (% predicted) at 15 years and change in FEV1 between 18 and 21 years. Funnel plots were generated with confidence limits at 2 and 3 standard deviations (SD). Centres with mean values outside these limits are said to display “special cause variation” -variability outside what one would expect. Outcomes were then adjusted for case mix (including gender, genotype, pancreatic sufficiency and socio-economic deprivation) and analysed using funnel plots. Results 31 paediatric centres provided FEV1 data on 15 year olds between 2007 and 2012. Funnel plots of unadjusted FEV1 (% predicted) showed few centres with evidence of special cause variation (2SD limits). Initial case-mix adjustment reduced the number of centres outside these limits to 3. We also identified 28 adult centres providing sufficient data to calculate change in FEV1 (% predicted) between 18–21 years. While there was some evidence of special cause variation (at 2SD limits) in prior to case-mix adjustment, after adjustment none were outside the 2SD limits. None of the centres were outside the 3SD limits in either analysis. Conclusion In conclusion the work to-date illustrates that funnel plots can be used to explore potential differences in FEV1 between specialist centres. Case-mix adjustment models should develop into a useful tool for making centre comparisons which can continue to be used by stakeholders. This is early work, however, and we need to bear in mind that by examining outcomes in small populations risk missing true differences due to low statistical power. Further work is required to assess whether any observed differences are due to chance or are related to the care patients receive.

Objectives The UK CF Registry annual reports include comparisons between centres on key outcomes such as FEV 1 using rankings. While illustrating the distribution between centres, they promote the assumption that those with the highest measures provide better care. We hypothesised a more scientific approach based on statistical process control and adjustment for case-mix may identify exceptional CF care services in terms of clinically meaningful outcomes. Methods We extracted FEV 1 and BMI on patients aged 12–21 from annual review data (2007–2012). Funnel plots were generated with confidence limits at 2 and 3 standard deviations (SD). Centres with mean values outside these limits are said to display cause – variability outside what one would expect. Outcomes were then adjusted for case mix (including gender, genotype, pancreatic sufficiency and socio-economic deprivation) and analysed using funnel plots. Results Using a primary outcome of FEV 1 at age 15, data for 1066 patients from 31 paediatric centres were available. Funnel plots of unadjusted data showed 8 centres with evidence of special cause variation (at 2SD limits). Initial adjustment for case-mix reduced the number of centres outside these limits to 3. None of the centres were outside the 3SD limits in either analysis. Similar patterns were found for BMI percentile in this age group. Conclusion In conclusion the work to-date illustrates that funnel plots can be used to identify differences in FEV 1 and BMI between specialist paediatric centres. Case-mix adjustment models should develop into a useful tool for making centre comparisons which can continue to be used by stakeholders.

Background It is good practice for the public to be involved in developing health research. Resources should be available for researchers to fund the involvement of the public in the development of their grants.Objective To describe a funding award scheme to support public involvement in grant development, managed by an NIHR Research Design Service (RDS). Case examples of how the award contributed to successful grant applications and findings from a recent evaluation of the scheme are presented.Design A case study of resource provision to support public involvement activities in one region of England.Participants University and NHS-based researchers, and members of the public.Findings Between 2009 and 2012, the RDS approved 45 public involvement funding awards (totalling nearly 19 000). These awards contributed to 27 submitted applications at the time of writing, of which 11 were successful (totalling over (sic)7.5 million). The evaluation revealed difficulties encountered by some researchers when involving the public in grant development, which led to suggestions about how the scheme could be improved.Conclusion This award scheme represents an efficient method of providing researchers with resources to involve the public in grant development and would appear to represent good value for money.

Background Despite the promising benefits of adaptive designs (ADs), their routine use, especially in confirmatory trials, is lagging behind the prominence given to them in the statistical literature. Much of the previous research to understand barriers and potential facilitators to the use of ADs has been driven from a pharmaceutical drug development perspective, with little focus on trials in the public sector. In this paper, we explore key stakeholders’ experiences, perceptions and views on barriers and facilitators to the use of ADs in publicly funded confirmatory trials. Methods Semi-structured, in-depth interviews of key stakeholders in clinical trials research (CTU directors, funding board and panel members, statisticians, regulators, chief investigators, data monitoring committee members and health economists) were conducted through telephone or face-to-face sessions, predominantly in the UK. We purposively selected participants sequentially to optimise maximum variation in views and experiences. We employed the framework approach to analyse the qualitative data. Results We interviewed 27 participants. We found some of the perceived barriers to be: lack of knowledge and experience coupled with paucity of case studies, lack of applied training, degree of reluctance to use ADs, lack of bridge funding and time to support design work, lack of statistical expertise, some anxiety about the impact of early trial stopping on researchers’ employment contracts, lack of understanding of acceptable scope of ADs and when ADs are appropriate, and statistical and practical complexities. Reluctance to use ADs seemed to be influenced by: therapeutic area, unfamiliarity, concerns about their robustness in decision-making and acceptability of findings to change practice, perceived complexities and proposed type of AD, among others. Conclusions There are still considerable multifaceted, individual and organisational obstacles to be addressed to improve uptake, and successful implementation of ADs when appropriate. Nevertheless, inferred positive change in attitudes and receptiveness towards the appropriate use of ADs by public funders are supportive and are a stepping stone for the future utilisation of ADs by researchers.

Background: Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders.Methods: We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation.Results: Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles.Conclusions: There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations' funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning.

In England, the National Institute for Health Research (NIHR) encourages public involvement in health research (1). The NIHR identified stroke as a key priority area, establishing the Stroke Research Network (SRN) in 2006. There is now considerable interest in examining how stroke survivors and carers can make an active contribution to stroke research (2–4). The SRN recently conducted a survey to ascertain the extent to which stroke survivors and carers were involved in studies adopted onto the Network’s portfolio, and the extent to which participants were kept informed of study progress and results. Responses were received from Chief investigators (CIs) of 139 studies. Of these studies, 75 (54%) reported stroke survivor/carer involvement in research design and/or conduct, with 36 (26%) reporting involvement in the study steering group and/or data monitoring committee. Contributions made by stroke survivors and carers to study design included: confirming the proposed research was important; refining the question; helping to write the grant application; and developing outcome measures. Contributions to study conduct included: improving the understandability of participant information; developing recruitment material; overseeing the delivery of research; data analysis; and contributing to dissemination. Examples of involvement in specific stroke studies are displayed in Table 1. Of the 108 studies reporting that they had informed, or that they intend to inform, participants about study results, the following approaches were cited: feedback by letter (n = 44), individual feedback to participants especially requesting results (n = 25), results posted on study website (n = 26), results by newsletter (n = 32), and a convened meeting (n = 9). The SRN has acted on the findings of this survey by producing a guide for stroke researchers on approaches to the active involvement of stroke survivors and carers in research design and conduct, and on methods of dissemination to Correspondence: Jonathan Boote*, Patient Experience and Public Involvement, Centre for Research in Primary and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire AL10 9AB, UK. E-mail: j.boote@herts.ac.uk