Using patient and public involvement to improve the research design and funding application for a project aimed at fostering a more collaborative approach to the NHS Health Check: the CaVIAR Project (better Care Via Improved Access to Records)

Background: Following an initial NHS Health Check appointment, the National Institute for Health and Care Excellence (NICE) suggest patients with QRISK2 scores of ≥ 10% should be offered advice on lifestyle and the risks and benefits of starting a statin. NICE recommend GPs should ascertain patients’ pre-existing knowledge of cardiovascular disease risk, explore health beliefs, assess readiness to change, offer support, and engage family members. Condensing this complex discussion into a short consultation may result in inadequate patient understanding of the benefits of preventive measures. An alternative approach is needed. We propose a digital adjunct giving patients the opportunity to interact with their health check results from home before returning to see their GP. Before embarking on funding applications we sought the views of patients and members of the public. Methods: We consulted the Primary Care Research in Manchester Engagement Resource (PRIMER), an established departmental Patient and Public Involvement (PPI) group (N=9) and then ran a workshop with 19 members of the public, co-facilitated by 4 members of PRIMER. Following a brief presentation on the background to the project, attendees were split into four groups and introduced to Ketso, a toolkit for creative engagement. Ketso was used to encourage group discussions regarding the project idea. Results: This PPI work improved the study design and proposed intervention. Discussions focussed on three themes: 1) positive feedback, 2) challenges and solutions, and 3) improvements/alternatives. Positive feedback included benefits to the NHS and patients. Challenges identified related to: 1) access, 2) data security, 3) engagement, and 4) negative consequences. Workshop members generated various solutions to these challenges and made additional suggestions for improvement relating to: 1) population (e.g. also including those with QRISK2 scores ≤ 10%), 2) duration (e.g. ongoing access to provide continued feedback), and 3) platform content (e.g. signposting to relevant services). Conclusions: This PPI work helped identify potential challenges and solutions not previously considered by the research team. Findings have informed the subsequent intervention design and strengthened the bid for funding. We aim to ensure ongoing patient and public involvement in all future stages

A treatment evaluator tool to monitor the real-world effectiveness of inhaled aztreonam lysine in cystic fibrosis

Background: Studies are required that evaluate real-world outcomes of inhaled aztreonam lysine in patients with cystic fibrosis (CF). Methods: Our treatment-evaluator tool assessed the effectiveness of inhaled aztreonam in routine practice in 117 CF patients across four time periods (6–12 (P2) and 0–6 months (P1) pre-initiation, and 0–6 (T1) and 6–12 months (T2) post-initiation). Outcomes were: changes in %-predicted forced expiratory volume in 1 s (FEV1), body-mass index (BMI), hospitalisation days and intravenous antibiotic usage. Results: Median FEV1% predicted for each 6-month period was 38.9%, 34.6%, 37.1% and 36.5%; median change was − 2.0% between P2 and P1, increasing to + 0.6% (p < 0.001) between P1 and T1. Annualised hospital bed-days was reduced (p = 0.05) post-initiation, as was intravenous antibiotics days (p = 0.001). BMI increased over 6 months post-initiation (p ≤ 0.001). Conclusions: In patients with CF in routine practice, inhaled aztreonam lysine is associated with improved lung function and weight, and reduced hospitalisation and intravenous antibiotic use

Patient information leaflets (PILs) for UK randomised controlled trials : a feasibility study exploring whether they contain information to support decision making about trial participation

Peer reviewedPublisher PD

Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation

Background: Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). Objective: Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. Design: Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. Setting: Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. Participants: Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged < 18 years. Interventions: Patients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene. Main outcome measures: Survival at 30 days following cardiac arrest; survival without significant neurological impairment [Cerebral Performance Category (CPC) score of 1 or 2]. Results: We enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 device and 2819 assigned to control) between 15 April 2010 and 10 June 2013. A total of 985 (60%) patients in the LUCAS-2 group received mechanical chest compression and 11 (< 1%) patients in the control group received LUCAS-2. In the intention-to-treat analysis, 30-day survival was similar in the LUCAS-2 (104/1652, 6.3%) and manual CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression. Limitations: There was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical chest compression was not used for reasons that would not occur in clinical practice. We addressed this issue by using complier average causal effect analyses. We attempted to measure CPR quality during the resuscitation attempts of trial participants, but were unable to do so. Conclusions: There was no evidence of improvement in 30-day survival with LUCAS-2 compared with manual compressions. Our systematic review of recent randomised trials did not suggest that survival or survival without significant disability may be improved by the use of mechanical chest compression. Future work: The use of mechanical chest compression for in-hospital cardiac arrest, and in specific circumstances (e.g. transport), has not yet been evaluated

Process and impact of patient involvement in a systematic review of shared decision making in primary care consultations

BACKGROUND: Patient and public involvement and engagement (PPIE) in systematic reviews remains uncommon, despite the policy imperative for patient involvement in research. The aim of this study was to investigate the process and impact of collaborating with members of a patient Research User Group (RUG) on a systematic review about shared decision making around prescribing analgesia in primary care consultations. METHODS: Five members of an established patient RUG collaborated with researchers undertaking a systematic review with narrative synthesis, through workshops held at three time‐points. These addressed the following: designing the protocol, interpreting the results and planning dissemination. Support from a RUG coordinator and user support worker facilitated collaboration throughout the review process. Researchers reflected on how PPIE modified the review at each time‐point. RESULTS: RUG members identified factors important in shared decision making around analgesic prescribing additional to those initially proposed by the research team. Search terms and specific outcomes of interest were amended to reflect these additional factors. Thirty of the 39 patient‐identified factors were absent in the published literature. The categories of factors identified were used as a framework for the narrative synthesis and for reporting results. RUG members prioritized options for disseminating the results. CONCLUSION: PPIE collaboration throughout the systematic review impacted on the scope of the review, highlighting gaps in the literature that were important to patients. Impact on interpretation and dissemination of findings ensured the review directly reflected patient priorities. Challenges and strategies to facilitate PPIE involvement in systematic reviews and suggestions for future researchers are highlighted