• Public and patient involvement in prehospital care research development – designing the rapid 2 trial

      Evans, Bridie A.; Bulger, Jenna; Ford, S.; Foster, Theresa; Goodacre, Steve; Jones, S.; Keen, L.; Longo, M.; Lyons, Ronan; Pallister, I.; et al. (2019-04-26)
      Background Involving patients and public members in research helps ensure evidence is relevant, accountable and high quality. Public and patient involvement (PPI) is required in many funding applications. We aimed to involve public contributors in designing a research bid about prehospital management for hip fracture. Method We recruited two public contributors with experience of hip fracture and prehospital care to our research team of academic, clinical and managerial partners developing the RAPID 2 proposal evaluating paramedic administration of Fascia Iliaca Compartment Block, a local anesthetic injection into the hip. We supported them to consult with a public/patient group and identify patient priorities to inform our decisions. We held research development meetings and shared project drafts to gain views, share decisions and amend documents. Results Consultation responses suggested patient priorities after hip fracture were to return home, recover mobility and gain independence. These views guided our decisions on setting primary outcomes which were length-of-hospital-stay and health-related quality-of-life. Their concern about the study design causing delayed access to treatment meant we decided to identify common exclusion criteria before randomisation to expedite access to pain management and reduce attrition. Public contributors also agreed patients should be offered an incentive for completing and returning questionnaires to enhance data completeness. Conclusion Involving public contributors enabled the research team to identify patient-prioritised outcomes and adjust the proposed study design to reflect these in the proposal. Public contributors will remain involved if funding is awarded to ensure patient perspectives inform all stages of research management and dissemination. Conflict of interest None. Funding PRIME Centre Wales. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/., https://bmjopen.bmj.com/content/9/Suppl_2/A8.2 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ DOI http://dx.doi.org/10.1136/bmjopen-2019-EMS.22
    • Research paramedics’ observations regarding the challenges and strategies employed in the implementation of a large-scale out-of-hospital randomised trial

      Green, Jonathan; Robinson, Maria; Pilbery, Richard; Whitley, Gregory; Hall, Helen; Clout, Madeleine; Reeves, Barnaby; Kirby, Kim; Benger, Jonathan (2020-06-01)
      Introduction: AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. This article aims to describe a number of the challenges that were encountered during the out-of-hospital phase of the AIRWAYS-2 trial and how these were overcome. Methods: The research paramedics responsible for conducting the pre-hospital phase of the trial were asked to reflect on their experience of facilitating the AIRWAYS-2 trial. Responses were then collated by the lead author. A process of iterative revision and review was undertaken by the research paramedics to produce a consensus of opinion. Results: The main challenges identified by the trial research paramedics related to the recruitment and training of paramedics, screening of eligible patients and investigation of protocol deviations / reporting errors. Even though a feasibility study was conducted prior to the commencement of AIRWAYS-2, the scale of these challenges was underestimated. Conclusion: Large-scale pragmatic cluster randomised trials are being successfully undertaken in out-of-hospital care. However, they require intensive engagement with EMS clinicians and local research paramedics, particularly when the intervention is contentious. Feasibility studies are an important part of research but may fail to identify all potential challenges. Therefore, flexibility is required to manage unforeseen difficulties. Abstract published with permission.