Implementing public involvement throughout the research process-Experience and learning from the GPs in EDs study.

BACKGROUND: Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. AIM: This study aimed to describe how we implemented public involvement, reflect on process and effects in a large-scale multi-site research study and present learning for future involvement practice. METHOD: We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co-applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. RESULTS: Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over-professionalizing public contributors. CONCLUSION: We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. PUBLIC CONTRIBUTION: This paper was co-conceived, co-planned and co-authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

Randomised controlled trial of an innovative hypoglycaemia pathway for self-care at home and admission avoidance: a partnership approach with a regional ambulance trust.

Background: Hypoglycaemia is a common and potentially life-threatening condition in people with diabetes, commonly caused by medications such as insulin. Hypoglycaemic events often require in-patient treatment and/or follow-up with a diabetes specialist nurse (DSN) or GP to make adjustments to medication. This referral pathway commonly relies on patient self-referral to primary care, and as a result many patients are not actively followed up and go on to experience repeat hypoglycaemic events. Methods: Randomised controlled trial in partnership with East Midlands Ambulance Service NHS Trust. People with diabetes calling out an ambulance for a severe hypoglycaemic episode and meeting the eligibility criteria were randomised to either a novel DSN-led pathway or to their general practice for routine follow-up. Primary outcome was proportion of participants with a documented consultation with a healthcare professional to discuss the management of their diabetes within 28 days of call-out. Results: 162 people were randomised to one of the pathways (73 DSN arm, 89 GP arm) with 81 (50%, 35 DSN, 46 GP) providing full consent to be followed up. Due to lower than anticipated randomisation and consent rates, the recruitment target was not met. In the 81 participants who provided full consent, there were higher rates of consultation following the call-out when referred to a DSN compared to primary care (90% vs. 65%). Of the 81 participants, 26 (32%) had a second call-out within 12 months. Conclusions: Consultation rates following the call-out were high in the DSN-led arm, but there was insufficient power to complete the planned comparative analysis. The study highlighted the difficulty in recruitment and delivery of research in pre-hospital emergency care. Further work is needed to provide more feasible study designs and consent procedures balancing demands on ambulance staff time with the need for robust well-designed evaluation of referral pathways.

BACKGROUND RADIATION LEVELS NEAR A MINERAL SAND MINING FACTORY IN SRI LANKA: CORRELATION OF RADIATION MEASUREMENTS WITH MICRONUCLEI FREQUENCY.

Lanka Mineral Sands Ltd (LMS) is a company operating in Pulmoddai, Sri Lanka, mining for rare earth minerals along with monazite which contains thorium that emits ionizing gamma and alpha radiation on decay. The objective of the study was to determine the background radiation levels and selected radionuclides and then to correlate these levels with the frequency of micronuclei (MN) among persons residing in the vicinity of LMS. A cross-sectional study was conducted among persons of both sexes between 35 and 45 years of age residing in the vicinity of LMS. Background radiation measurements were obtained by a survey metre, and gamma spectrometry was done on soil samples. Five millilitres of venous blood was drawn for cytokinesis-blocked MN assay. Background radiation levels measured by the survey metre; 232Th, 226Ra and 210Pb mass activities in soil were highest in the samples collected from the LMS. The background radiation measurements positively correlated with MN frequency although the magnitude of the correlation was small (r = 0.176, p = 0.04). This implies that chronic long-term exposure to low-dose radiation may result in genotoxicity. Prospective large-scale studies are recommended to evaluate the long-term effect of exposure to low-dose radiation at Pulmoddai.

Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants.

BACKGROUND: Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. METHODS: We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. Participants were chosen because they were actively involved in, or in their expert capacity (e.g. law) expressed an interest in, ambulance based research. RESULTS: Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. CONCLUSIONS: By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance.

Effectiveness of non-pharmacological interventions for insomnia in children with Autism Spectrum Disorder: A systematic review and meta-analysis.

BACKGROUND: Autism spectrum disorders (ASD) are a set of neurodevelopmental disorders characterised by behavioural, communication and social impairments. The prevalence of sleep disturbances in children with ASD is 40-80%, with significant effects on quality of life for the children and carers. This systematic review aimed to synthesise evidence of the effects of behavioural interventions to improve sleep among children with ASD. METHODS: Databases (MEDLINE, PsycINFO, CINAHL, ScienceDirect, Autism Data, CENTRAL, ClinicalTrials.gov and Current Controlled Trials) were searched for published, unpublished and ongoing randomised controlled trials evaluating the effect of non-pharmacological interventions for insomnia in children with autism spectrum conditions. RESULTS: Three studies met the inclusion criteria, one provided actigraphy data, one Children's Sleep Habits Questionnaire (CSHQ) data, and one both actigraphy and CSHQ data for use in meta-analyses. There were significant differences between the behavioural intervention and comparison groups (actigraphy data) for total sleep time (24.41 minutes, 95% CI 5.71, 43.11, P = 0.01), sleep latency (-18.31 minutes, 95% CI -30.84, -5.77, P = 0.004) and sleep efficiency (5.59%, 95% CI 0.87, 10.31, P = 0.02). There was also a favourable intervention effect evident for the subjective CSHQ data (-4.71, 95% CI -6.70, -2.73, P<0.00001). Risk of bias was low across several key domains (randomisation, allocation concealment and reporting), with some studies being unclear due to poor reporting. CONCLUSIONS: There are very few high quality randomised controlled trials in this area. Here we provide initial synthesised quantitative evidence of the effectiveness of behavioural interventions for treating sleep problems in children with ASD. TRIAL REGISTRATION: Protocol was registered (CRD42017081784) on the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/PROSPERO).

Attitudes to Cardiopulmonary Resuscitation and Defibrillator Use: A Survey of UK Adults in 2017.

Background Bystander cardiopulmonary resuscitation ( CPR ) and public access defibrillator ( PAD ) use can save the lives of people who experience out-of-hospital cardiac arrest. Little is known about the proportions of UK adults trained, their characteristics and willingness to act if witnessing an out-of-hospital cardiac arrest, or the public's knowledge regarding where the nearest PAD is located. Methods and Results An online survey was administered by YouGov to a nonprobabilistic purposive sample of UK adults, achieving 2084 participants, from a panel that was matched to be representative of the population. We used descriptive statistics and multivariate logistic regression modeling for analysis. Almost 52% were women, 61% were aged <55 years, and 19% had witnessed an out-of-hospital cardiac arrest. Proportions ever trained were 57% in chest-compression-only CPR, 59% in CPR , and 19.4% in PAD use. Most with training in any resuscitation technique had trained at work (54.7%). Compared with people not trained, those trained in PAD use said they were more likely to use one (odds ratio: 2.61), and those trained in CPR or chest-compression-only CPR were more likely to perform it (odds ratio: 5.39). Characteristics associated with being trained in any resuscitation technique included youth, female sex, higher social grade, and full-time employment. Conclusions In the United Kingdom, training makes a difference in people's willingness to act in the event of a cardiac arrest. Although there is considerable opportunity to increase the proportion of the general population trained in CPR , consideration should be also given to encouraging training in PAD use and targeting training for those who are older or from lower social grades.

Quality assurance of the Applied Knowledge Test (AKT) of the MRCGP examination - an immediate post-test questionnaire evaluation of the candidates' views.

The Applied Knowledge Test (AKT) of the Membership of the Royal College of General Practitioners (MRCGP) examination is a computer-based assessment delivered three times a year. A computerised questionnaire, administered immediately after the test, sought candidates' views as part of the test evaluation. Of 1681 candidates taking the test 1418 (84%) responded. Most candidates believed that the test assessed their knowledge of problems relevant to general practice. Their feedback highlighted areas where improvements could be made. Candidates' views of postgraduate specialty medical examinations in the UK are rarely sought or published. We are not aware of other published evidence. The use of computer-based testing enables immediate candidate feedback and can be used routinely to evaluate the test validity and formats. The views of candidates are an important component of quality assurance in reviewing the content, format and educational experience of a high-stakes examination.

Influenza vaccination and risk of stroke: Self-controlled case-series study.

BACKGROUND: Stroke may be triggered by respiratory infections, including influenza. Influenza vaccination could therefore reduce risk of stroke. Previous studies of this association have shown conflicting results. We aimed to investigate whether influenza vaccination was associated with reduced risk of stroke. METHODS: We used a self-controlled case series design. The General Practice Research Database (GPRD) was used to extract records of patients aged 18 years or over recorded with stroke (fatal or non-fatal) from September 2001 to May 2009. Statistical modelling with conditional Poisson regression was employed to compute incidence rate ratios (IRR). The incidence rate of stroke in fixed time periods after influenza vaccination was compared with the incidence rate during a baseline period. RESULTS: There were 17,853 eligible individuals who received one or more influenza vaccinations and experienced a stroke during the observation period. The incidence of stroke was significantly reduced in the first 59 days following influenza vaccination compared with the baseline period. We found reductions of 55% (IRR 0.45; 95% CI 0.36-0.57) in the first 1-3 days after vaccination, 36% (0.64; 0.53-0.76) at 4-7 days, 30% (0.70; 0.61-0.79) at 8-14 days, 24% (0.76; 0.70-0.84) at 15-28 days and 17% (0.83; 0.77-0.89) at 29-59 days after vaccination. Early vaccination between 1 September and 15 November showed a greater reduction in IRR compared to later vaccination given after mid-November. CONCLUSIONS: Influenza vaccination is associated with a reduction in incidence of stroke. This study supports previous studies which have shown a beneficial association of influenza vaccination for stroke prevention.