The National Institute for Health Research: making an impact in imaging research.

Since the inception of the National Institute for Health Research (NIHR) in 2006, the landscape for the delivery of clinical research within the National Health Service (NHS) has been transformed. Clinical radiology has benefitted from funding opportunities for primary imaging research as well as improvements to the supporting research infrastructure to provide imaging for many clinical trials; however, in an increasingly challenging NHS environment, the NIHR and clinical radiology have to evolve an effective working partnership to ensure imaging research is sustainable and will make an impact. A number of initiatives have arisen from discussions between the NIHR, the Royal College of Radiologists (RCR), and stakeholders that will be discussed in this article. It is hoped that these initiatives will be embraced by the imaging community and create a more dynamic sustainable imaging workforce, driving and supporting research and innovation towards future sustainability

Engaging workplace representatives in research: what recruitment strategies work best?

Background Workplaces are key stakeholders in work and health but little is known about the methods used to recruit workplace representatives (WRs), including managers, occupational health advisers and colleagues, to externally funded healthcare research studies. Aims To detail the strategies used in recruiting WRs from three areas of the UK to a qualitative study concerning their experience of employees undergoing hip or knee replacement, to compare the strategies and inform recruitment methods for future studies. Methods Six strategies were used to recruit WRs from organizations of different sizes and sectors. Data on numbers approached and responses received were analysed descriptively. Results Twenty-five WRs were recruited. Recruitment had to be extended outside the main three study areas, and took several months. It proved more difficult to recruit from non-service sectors and small- and medium-sized enterprises. The most successful strategies were approaching organizations that had participated in previous research studies, or known professionally or personally to team members. Conclusions Recruiting a diverse sample of WRs to healthcare research requires considerable resources and persistence, and a range of strategies. Recruitment is easier where local relationships already exist; the importance of building and maintaining these relationships cannot be underestimated. However, the potential risks of bias and participant fatigue need to be acknowledged and managed. Further studies are needed to explore how WRs can be recruited to health research, and to identify the researcher effort and costs involved in achieving unbiased and representative samples

Randomized controlled trial of a lay-facilitated angina management programme

AIMS: This article reports a randomized controlled trial of lay-facilitated angina management (registered trial acronym: LAMP). BACKGROUND: Previously, a nurse-facilitated angina programme was shown to reduce angina while increasing physical activity, however most people with angina do not receive a cardiac rehabilitation or self-management programme. Lay people are increasingly being trained to facilitate self-management programmes. DESIGN: A randomized controlled trial comparing a lay-facilitated angina management programme with routine care from an angina nurse specialist. METHODS: Participants with new stable angina were randomized to the angina management programme (intervention: 70 participants) or advice from an angina nurse specialist (control: 72 participants). Primary outcome was angina frequency at 6 months; secondary outcomes at 3 and 6 months included: risk factors, physical functioning, anxiety, depression, angina misconceptions and cost utility. Follow-up was complete in March 2009. Analysis was by intention-to-treat; blind to group allocation. RESULTS: There was no important difference in angina frequency at 6 months. Secondary outcomes, assessed by either linear or logistic regression models, demonstrated important differences favouring the intervention group, at 3 months for: Anxiety, angina misconceptions and for exercise report; and at 6 months for: Anxiety; Depression; and angina misconceptions. The intervention was considered cost-effective. CONCLUSION: The angina management programme produced some superior benefits when compared to advice from a specialist nurse

An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study

BACKGROUND: In comparison with other study designs, randomised trials are regarded as particularly likely to benefit from patient and public involvement (PPI). Using mixed-methods research we investigated PPI from the perspectives of researchers and PPI contributors. METHODS: Randomised trials in receipt of funding from the Health Technology Assessment (HTA) programme between 2006 and 2010 were identified. Funding applications and board and referee comments were obtained and data relevant to PPI extracted. Chief investigators (CIs), PPI contributors and UK Clinical Research Collaboration Registered Clinical Trials Units (RCTUs) were surveyed. Interviews were conducted with researchers and PPI contributors. RESULTS: A total of 111 trials were included. Text relevant to PPI was identified in half of the trials for which the first-stage applications were available, but only one-quarter described PPI within their development. In the second stage of the application, the majority provided some text relevant to PPI, with over half having PPI in their development. Fewer than half of referees commented on PPI, and funding boards rarely provided comments in relation to PPI. Seventy-three per cent (81 of 111) of CIs responded to the survey and 98% (79 of 81) included PPI at some stage in their trial. CIs considered high impact from PPI contributors to occur more frequently in trial setup, with low or no impact being more common during trial conduct, analysis and dissemination. Only one-third of CIs provided PPI contributor contact details but all contributors contacted completed the survey. The majority of contributors felt engaged and valued by the research team. Interviews were conducted with researchers and/or PPI contributors for 28 trials identifying two main influences on perception of PPI impact: whether or not CIs expressed personal goals and plans for PPI; and the quality of their relationship with the PPI contributors. The importance of early engagement was identified, with opportunity for input thereafter limited. Three PPI roles were identified: oversight, managerial and responsive. Oversight roles, as required by funders, were associated with low impact in comparison with responsive or managerial roles. Most researchers could see some value in PPI training for researchers, although those that had received such training themselves expressed concerns about its purpose and evidence base. Training for PPI contributors was considered unnecessary, with conversational approaches preferred, although this did not appear to provide an opportunity for role negotiation. The RCTU survey response rate was 85% (39 of 46). The majority (37 of 39) reported PPI within trials co-ordinated by their unit. Trial characteristics were used by half to determine the approach to PPI. Two-thirds reported recent developments or changes in implementing plans for PPI (21 of 33). Support to PPI contributors was commonly offered through members of staff at the unit. CONCLUSIONS: PPI is occurring in the majority of trials funded by the HTA programme, but uncertainty remains about how it is assessed and valued. Early involvement, building a relationship between researchers and contributors, responsive or managerial roles, and having defined goals for PPI were associated with impact. Efficiency could be gained by utilising the RCTU network to identify and tackle challenges, and develop a risk-based approach utilising trial characteristics. Recommendations are made to trial funders and the research community. Given the difficulties for some informants in recalling PPI contributions, future research using a prospective approach would be valuable. Ethnographic research that combines observation and multi-informant interviews is likely to be informative in identifying impact. The research community needs to give further consideration to processes for selecting PPI contributors and models of implementing PPI

Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service : a protocol for a pilot study.

Introduction: Current UK guidance for the treatment of intermittent claudication (IC) states that supervised exercise programmes (SEPs) should be offered as first-line treatment [1], prior to surgical interventions. However, there is currently a national shortage of dedicated SEPs. It has been suggested that the established network of UK Cardiac Rehabilitation (CR) programmes could cater for IC patients. This study will investigate the feasibility of combining IC and CR patients into one SEP, and explore the patient perception's regarding the treatment programme, to establish whether CR could potentially fill the gap in service provision. Methods and analysis:Patients diagnosed with IC will be incorporated into a CR programme where they will exercise alongside patients with coronary artery disease (CAD). Participants will attend a 2-h class, once a week for a total of 12 weeks. Another group of IC patients will attend an SEP consisting solely of other IC patients (control group). Outcome measures:The study will evaluate the feasibility of recruitment, retention, and participant experience of the intervention as well as physiological outcomes (primary outcome: pain-free walking, and maximal walking distance; secondary outcomes: physical activity levels, perceived walking ability, and disease-specific quality of life). Outcomes will be assessed at baseline and on completion of the SEP. Ethics and dissemination:Ethical approval for this study was obtained from North West- Greater Manchester West Research Ethics Committee on 13th June 2018 (IRAS ID: 230391). This study is registered with clinicaltrials. gov (NCT03564080) and conforms to the Declaration of Helsinki. Results will be disseminated via national conferences and published in peer-reviewed journals

Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review

Background - Acupuncture within pregnancy has frequently been investigated, often with finding this to be more effective than standard care. However, the adverse event severity, types and occurrence are unclear. Objective - To investigate the quality of reporting adverse events and to attempt to identify occurrence, type and severity of adverse events in acupuncture and non-acupuncture groups. Results - Overall quality of reporting of adverse events was poor, with information describing the adverse events often lacking in detail. A number of trends were noted: adverse events occurring within a treatment session was 3%-17% in the acupuncture groups and 4-25% in the non-acupuncture groups. The percentage of women affected by an adverse event was between 14%-17% in the acupuncture groups and 15-19% in non-acupuncture groups. Conclusions - Adverse event reporting within acupuncture trials is generally poor. The trends noted were that adverse events do occur, but would appear to be largely minor and comparable to non-acupuncture related interventions

What factors influence successful recruitment of siblings of individuals with first episode psychosis to e-health interventions? A qualitative study.

BACKGROUND: Recruitment to clinical research studies can prove complex. This is particularly true of mental health research, given factors such as confidentiality, capacity and consent, or when attempting to recruit family members as opposed to service users themselves. AIM: This study investigated the challenges experienced and strategies employed in the recruitment of siblings of people with first episode psychosis using Early Intervention in Psychosis Services (EIPS) in England. METHODS: As part of a randomized controlled trial (RCT) of an e-health intervention for siblings, we conducted a process evaluation study whereby semistructured interview was undertaken with clinical and research staff involved in recruitment of siblings. Data were analysed thematically. RESULTS: Twelve participants from six EIPS were interviewed. Data analysis revealed seven key themes: (i) limited comprehensive family data available; (ii) data governance and consent issues; (iii) organizational factors; (iv) convoluted recruitment methods; (v) concerns about service users' opinions; (vi) fluidity in siblings' needs and expectations; and (vii) strategies to enhance recruitment. CONCLUSIONS: Recruitment challenges identified in this study concerned administrative, organizational, process and attitudinal issues. These are similar to other studies recruiting mental health service users as well as family members. Failure to recruit to target implies that studies are underpowered to detect potential statistically or clinically meaningful changes. Future studies should establish how best to enhance family inclusiveness in clinical practice and research

PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term - a cluster randomised controlled trial and economic evaluation.

BACKGROUND: Asthma episodes and deaths are known to be seasonal. A number of reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation. A fall in prescription collection in the month of August has been observed, and was associated with an increase in the number of unscheduled contacts after the return to school in September. OBJECTIVE: The primary objective of the study was to assess whether or not a NHS-delivered public health intervention reduces the September peak in unscheduled medical contacts. DESIGN: Cluster randomised trial, with the unit of randomisation being 142 NHS general practices, and trial-based economic evaluation. SETTING: Primary care. INTERVENTION: A letter sent (n = 70 practices) in July from their general practitioner (GP) to parents/carers of school-aged children with asthma to remind them of the importance of taking their medication, and to ensure that they have sufficient medication prior to the start of the new school year in September. The control group received usual care. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of children aged 5-16 years who had an unscheduled medical contact in September 2013. Supporting end points included the proportion of children who collected prescriptions in August 2013 and unscheduled contacts through the following 12 months. Economic end points were quality-adjusted life-years (QALYs) gained and costs from an NHS and Personal Social Services perspective. RESULTS: There is no evidence of effect in terms of unscheduled contacts in September. Among children aged 5-16 years, the odds ratio (OR) was 1.09 [95% confidence interval (CI) 0.96 to 1.25] against the intervention. The intervention did increase the proportion of children collecting a prescription in August (OR 1.43, 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month (OR 1.13, 95% CI 0.84 to 1.52). For the wider time intervals (September-December 2013 and September-August 2014), there is weak evidence of the intervention reducing unscheduled contacts. The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children collecting prescriptions in August as well as having scheduled contacts in the same month. These unscheduled contacts in September could be a result of the intervention, as GPs may have wanted to see patients before issuing a prescription. The economic analysis estimated a high probability that the intervention was cost-saving, for baseline-adjusted costs, across both base-case and sensitivity analyses. There was no increase in QALYs. LIMITATION: The use of routine data led to uncertainty in the coding of medical contacts. The uncertainty was mitigated by advice from a GP adjudication panel. CONCLUSIONS: The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children both collecting prescriptions and having scheduled contacts in August. After September there is weak evidence in favour of the intervention. The intervention had a favourable impact on costs but did not demonstrate any impact on QALYs. The results of the trial indicate that further work is required on assessing and understanding adherence, both in terms of using routine data to make quantitative assessments, and through additional qualitative interviews with key stakeholders such as practice nurses, GPs and a wider group of children with asthma. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03000938. FUNDING DETAILS: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 93. See the HTA programme website for further project information