Supporting translation of research evidence into practice—the use of Normalisation Process Theory to assess and inform implementation within randomised controlled trials: a systematic review

Background: The status of randomised controlled trials (RCTs) as the ‘gold standard’ for evaluating efficacy in healthcare interventions is increasingly debated among the research community, due to often insufficient consideration for implementation. Normalisation Process Theory (NPT), which focuses on the work required to embed processes into practice, offers a potentially useful framework for addressing these concerns. While the theory has been deployed in numerous RCTs to date, more work is needed to consolidate understanding of if, and how, NPT may aid implementation planning and processes within RCTs. Therefore, this review seeks to understand how NPT contributes to understanding the dynamics of implementation processes within RCTs. Specifically, this review will identify and characterise NPT operationalisation, benefits and reported challenges and limitations in RCTs. Methods: A qualitative systematic review with narrative synthesis of peer-reviewed journal articles from eight databases was conducted. Studies were eligible for inclusion if they reported sufficient detail on the use of NPT within RCTs in a healthcare domain. A pre-specified data extraction template was developed based on the research questions of this review. A narrative synthesis was performed to identify recurrent findings. Results: Searches identified 48 articles reporting 42 studies eligible for inclusion. Findings suggest that NPT is primarily operationalised prospectively during the data collection stage, with limited sub-construct utilisation overall. NPT is beneficial in understanding implementation processes by aiding the identification and analysis of key factors, such as understanding intervention fidelity in real-world settings. Nearly three-quarters of studies failed to report the challenges and limitations of utilising NPT, though coding difficulties and data falling outside the NPT framework are most common. Conclusions: NPT appears to be a consistent and generalisable framework for explaining the dynamics of implementation processes within RCTs. However, operationalisation of the theory to its full extent is necessary to improve its use in practice, as it is currently deployed in varying capacities. Recommendations for future research include investigation of NPT alongside other frameworks, as well as earlier operationalisation and greater use of NPT sub-constructs. Trial Registration: The protocol for this systematic review was accepted for public registration on PROSPERO (registration number: CRD42022345427) on 26 July 2022

How do healthcare providers use national audit data for improvement?

Background Substantial resources are invested by Health Departments worldwide in introducing National Clinical Audits (NCAs). Yet, there is variable evidence on the NCAs’ effectiveness and little is known on factors underlying the successful use of NCAs to improve local practice. This study will focus on a single NCA (the National Audit of Inpatient Falls -NAIF 2017) to explore: (i) participants’ perspectives on the NCA reports, local feedback characteristics and actions undertaken following the feedback underpinning the effective use of the NCA feedback to improve local practice; (ii) reported changes in local practice following the NCA feedback in England and Wales. Methods Front-line staff perspectives were gathered through interviews. An inductive qualitative approach was used. Eighteen participants were purposefully sampled from 7 of the 85 participating hospitals in England and Wales. Analysis was guided by constant comparative techniques. Results Regarding the NAIF annual report, interviewees valued performance benchmarking with other hospitals, the use of visual representations and the inclusion of case studies and recommendations. Participants stated that feedback should target front-line healthcare professionals, be straightforward and focused, and be delivered through an encouraging and honest discussion. Interviewees highlighted the value of using other relevant data sources alongside NAIF feedback and the importance of continuous data monitoring. Participants reported that engagement of front-line staff in the NAIF and following improvement activities was critical. Leadership, ownership, management support and communication at different organisational levels were perceived as enablers, while staffing level and turnover, and poor quality improvement (QI) skills, were perceived as barriers to improvement. Reported changes in practice included increased awareness and attention to patient safety issues and greater involvement of patients and staff in falls prevention activities. Conclusions There is scope to improve the use of NCAs by front-line staff. NCAs should not be seen as isolated interventions but should be fully embedded and integrated into the QI strategic and operational plans of NHS trusts. The use of NCAs could be optimised, but knowledge of them is poor and distributed unevenly across different disciplines. More research is needed to provide guidance on key elements to consider throughout the whole improvement process at different organisational levels

Learning from the universal, proactive outreach of the Brazilian Community Health Worker model: impact of a Community Health and Wellbeing Worker initiative on vaccination, cancer screening and NHS health check uptake in a deprived community in the UK

Background Delays in preventative service uptake are increasing in the UK. Universal, comprehensive monthly outreach by Community Health and Wellbeing Workers (CHW), who are integrated at the GP practice and local authority, offer a promising alternative to general public health campaigns as it personalises health promotion and prevention of disease holistically at the household level. We sought to test the ability of this model, which is based on the Brazilian Family Health Strategy, to increase prevention uptake in the UK. Methods Analysis of primary care patient records for 662 households that were allocated to five CHWWs from July 2021. Primary outcome was the Composite Referral Completion Indicator (CRCI), a measure of how many health promotion activities were received by members of a household relative to the ones that they were eligible for during the period July 2021-April 2022. The CRCI was compared between the intervention group (those who had received at least one visit) and the control group (allocated households that were yet to receive a visit). A secondary outcome was the number of GP visits in the intervention and control groups during the study period and compared to a year prior. Results Intervention and control groups were largely comparable in terms of household occupancy and service eligibilities. A total of 2251 patients in 662 corresponding households were allocated to 5 CHWs and 160 households had received at least one visit during the intervention period. The remaining households were included in the control group. Overall service uptake was 40% higher in the intervention group compared to control group (CRCI: 0.21 ± 0.15 and 0.15 ± 0.19 respectively). Likelihood of immunisation uptake specifically was 47% higher and cancer screening and NHS Health Checks was 82% higher. The average number of GP consultations per household decreased by 7.4% in the intervention group over the first 10 months of the pilot compared to the 10 months preceding its start, compared with a 0.6% decrease in the control group. Conclusions Despite the short study period these are promising findings in this deprived, traditionally hard to reach community and demonstrates potential for the Brazilian community health worker model to be impactful in the UK. Further analysis is needed to examine if this approach can reduce health inequalities and increase cost effectiveness of health promotion approaches

Collaborative robotics: Enhance maintenance procedures on primary flight control servo-actuators

Electro-Hydraulic Servo-Actuators (EHSAs) are mainly used to command primary flight control surfaces in military and commercial aircraft. Since these devices are crucial for vehicle stability and maneuverability, a correct assessment of their health status is mandatory. Within this framework, a joint research project (HyDiag), held by Politecnico di Torino and Lufthansa Technik AG (LHT), aims to provide a more efficient and reliable procedure to determine the operating conditions of the EHSA. A smart and automatic sequence, able to extract several health features of the Unit Under Test (UUT), has been developed and integrated. The present paper discusses the implementation of a collaborative robot, equipped with a vision system and customized tools, for both health features extraction, and maintenance tasks on unserviceable servo-actuators. The main challenges related to the automation of such complex tasks in a real working environment are highlighted, togetherwith the advantages brought by the proposed approach. The paper also presents the first results of an ongoing experimental campaign. Specifically, it reports the enhancements of the maintenance procedures using collaborative robotics and possible future developments

Oral health promotion in acute hospital setting: a quality improvement programme

Tooth extraction is the most common hospital procedure for children aged 6–10 years in England. Tooth decay is almost entirely preventable and is inequitably distributed across the population: it can cause pain, infection, school absences and undermine overall health status. An oral health programme (OHP) was delivered in a hospital setting, comprising: (1) health promotion activities; (2) targeted supervised toothbrushing (STB) and (3) staff training. Outcomes were measured using three key performance indicators (KPI1: percentage of children/families seeing promotional material; KPI2: number of children receiving STB; KPI3: number of staff trained) and relevant qualitative indicators. Data were collected between November 2019 and August 2021 using surveys and data from the online booking platform. OHP delivery was impacted by COVID-19, with interventions interrupted, reduced, eliminated or delivered differently (eg, in-person training moved online). Despite these challenges, progress against all KPIs was made. 93 posters were deployed across the hospital site, along with animated video 41% (233/565) of families recalled seeing OHP materials across the hospital site (KPI1). 737 children received STB (KPI2), averaging 35 children/month during the active project. Following STB, 96% participants stated they learnt something, and 94% committed to behaviour change. Finally, 73 staff members (KPI3) received oral health training. All people providing feedback (32/32) reported learning something new from the training session, with 84% (27/32) reporting that they would do things differently in the future. Results highlight the importance of flexibility and resilience when delivering QI projects under challenging conditions or unforeseen circumstances. While results suggest that hospital-based OHP is potentially an effective and equitable way to improve patient, family and staff knowledge of good oral health practices, future work is needed to understand if and how patients and staff put into practice the desired behaviour change and what impact this may have on oral health outcomes

Diffraction-free light droplets for axially-resolved volume imaging

An ideal direct imaging system entails a method to illuminate on command a single diffraction-limited region in a generally thick and turbid volume. The best approximation to this is the use of large-aperture lenses that focus light into a spot. This strategy fails for regions that are embedded deep into the sample, where diffraction and scattering prevail. Airy beams and Bessel beams are solutions of the Helmholtz Equation that are both non-diffracting and self-healing, features that make them naturally able to outdo the effects of distance into the volume but intrinsically do not allow resolution along the propagation axis. Here, we demonstrate diffraction-free self-healing three-dimensional monochromatic light spots able to penetrate deep into the volume of a sample, resist against deflection in turbid environments, and offer axial resolution comparable to that of Gaussian beams. The fields, formed from coherent mixtures of Bessel beams, manifest a more than ten-fold increase in their undistorted penetration, even in turbid milk solutions, compared to diffraction-limited beams. In a fluorescence imaging scheme, we find a ten-fold increase in image contrast compared to diffraction-limited illuminations, and a constant axial resolution even after four Rayleigh lengths. Results pave the way to new opportunities in three-dimensional microscopy

Laniakea: a Galaxy-on-demand Provider Platform Through Cloud Technologies

Galaxy is rapidly becoming the de facto standard workflow manager for bioinformatics. Although several Galaxy public services are currently available, the usage of a private Galaxy instance is still mandatory or preferable for several use cases, including heavy workloads, data privacy concerns or particular customization needs. In this context, cloud computing technologies and infrastructures can provide a powerful and scalable solution to avoid the onerous deployment and maintenance of a local hardware and software infrastructure. Laniakea is a software framework that facilitates the provisioning of on-demand Galaxy instances as a cloud service over e-infrastructures, by leveraging on the open source software catalogue developed by the INDIGO-DataCloud H2020 project, which aimed to make cloud e-infrastructures more accessible by scientific communities. End-users interact with Laniakea through a web front-end that allows a general setup of a Galaxy instance. The deployment of the virtual hardware and of the Galaxy software ecosystem is subsequently performed by the INDIGO Platform as a Service layer. At the end of the process, the user gains access to a private, production-grade, fully customizable, Galaxy virtual instance. Laniakea features the deployment of a stand-alone or cluster backed Galaxy instances, shared reference data volumes, encrypted data volumes and rapid development of novel Galaxy flavours for specific tasks. We present here the latest development iteration of Laniakea, introducing a novel and strongly configurable web interface that facilitates a more straightforward customisation of the user experience through human readable YAML syntax and a reworked encryption procedure that exploits Hashicorp Vault as encryption keys management system

Laniakea : an open solution to provide Galaxy "on-demand" instances over heterogeneous cloud infrastructures

Background: While the popular workflow manager Galaxy is currently made available through several publicly accessible servers, there are scenarios where users can be better served by full administrative control over a private Galaxy instance, including, but not limited to, concerns about data privacy, customisation needs, prioritisation of particular job types, tools development, and training activities. In such cases, a cloud-based Galaxy virtual instance represents an alternative that equips the user with complete control over the Galaxy instance itself without the burden of the hardware and software infrastructure involved in running and maintaining a Galaxy server. Results: We present Laniakea, a complete software solution to set up a \u201cGalaxy on-demand\u201d platform as a service. Building on the INDIGO-DataCloud software stack, Laniakea can be deployed over common cloud architectures usually supported both by public and private e-infrastructures. The user interacts with a Laniakea-based service through a simple front-end that allows a general setup of a Galaxy instance, and then Laniakea takes care of the automatic deployment of the virtual hardware and the software components. At the end of the process, the user gains access with full administrative privileges to a private, production-grade, fully customisable, Galaxy virtual instance and to the underlying virtual machine (VM). Laniakea features deployment of single-server or cluster-backed Galaxy instances, sharing of reference data across multiple instances, data volume encryption, and support for VM image-based, Docker-based, and Ansible recipe-based Galaxy deployments. A Laniakea-based Galaxy on-demand service, named Laniakea@ReCaS, is currently hosted at the ELIXIR-IT ReCaS cloud facility. Conclusions: Laniakea offers to scientific e-infrastructures a complete and easy-to-use software solution to provide a Galaxy on-demand service to their users. Laniakea-based cloud services will help in making Galaxy more accessible to a broader user base by removing most of the burdens involved in deploying and running a Galaxy service. In turn, this will facilitate the adoption of Galaxy in scenarios where classic public instances do not represent an optimal solution. Finally, the implementation of Laniakea can be easily adapted and expanded to support different services and platforms beyond Galaxy

Laniakea@ReCaS: an ELIXIR-ITALY Galaxyon-demand cloud service

Although several Galaxy public services are available, a private Galaxy instance is still mandatory or preferable for several use cases including heavy workloads, data privacy concerns or particular customization needs. Cloud computing technologies provide a viable way to deploy Galaxy private instances, freeing users from the onerous deployment and maintenance of local IT infrastructures. In the last few years, ELIXIR-IT led the development of Laniakea, a software framework that facilitates the provisioning of on-demand Galaxy instances as a cloud service over e-infrastructures. The user interacts with a Laniakea service through a web front-end that allows to configure and launch a production-grade Galaxy instance in a straightforward way. Through the interface, the user can deploy Galaxy instances over single VMs or virtual clusters, link them to shared reference data volumes and plain or encrypted volumes for storing data. A selection of \u201cflavours\u201d, that is Galaxy instances pre-configured with sets of tools for specific tasks, is also available. When the users is satisfied, Laniakea takes oved and deploys the desired Galaxy instance over the cloud, providing a public IP and full administrative privileges over the new instance. In Dec-2018, we launched the beta-test phase of the first Laniakea-based Galaxy on-demand ELIXIR-IT service: Laniakea@ReCaS. After six months of helpful testing, we are now ready to announce the production phase of this service. Access to the service will be provided on a per-project basis through an open-ended call defining terms and conditions, project proposals will be evaluated by a scientific and technical board. Accepted proposals will be granted a package of computational resources for running on-demand Galaxy instances for a duration compatible with the project requirements