Involving patients and clinicians in the development of a randomised clinical trial protocol to assess spinal manual therapy versus nerve root injection for patients with lumbar radiculopathy: a patient and public involvement project to inform the SALuBRITY trial design

Background Spinal manual therapy and corticosteroid nerve root injection are commonly used to treat patients with lumbar radiculopathy. The SALuBRITY trial - a two parallel group, double sham controlled, randomised clinical trial - is being developed to compare their effectiveness. By gathering patients’ and clinicians’ perspectives and involving them in discussions related to the trial research question and objectives, proposed trial recruitment processes, methods, and outcome measures, we aimed to improve the relevance and quality of the SALuBRITY trial. Methods We involved patients with lived experience of lumbar radiculopathy (n = 5) and primary care clinicians (n = 4) with experience in the treatment of these patients. Involvement activities included an initial kick-off event to introduce the project, establishing a shared purpose statement, and empowering patient and clinician advisors for their involvement, followed by semi-structured group and individual interviews, and questionnaires to evaluate the experience throughout the project. Results Both patient and clinician advisors endorsed the significance and relevance of the trial’s objectives. Patients assessed the proposed trial methods as acceptable within the context of a trusting patient-clinician relationship. A trial recruitment and enrolment target time of up to five days was regarded as acceptable, although patients with chronic radiculopathy may need more time to consider their trial participation decision. All advisors reached consensus on the acceptability of a medication washout phase of 12- to 24-h before pain outcome measurement, with the inclusion of a rescue medication protocol. Both advisory groups preferred leg pain over back pain as the primary clinical outcome, with patient advisors advocating for personalized primary pain localization. Furthermore, patients requested expanding the pain, enjoyment, and general activity scale with peak pain intensity, rather than average pain alone. Patient and clinician advisors evaluated their engagement in clinical research as meaningful and impactful. Conclusion Patient and public involvement resulted in important and relevant considerations for the SALuBRITY trial, spanning all research phases. These findings hold promise for enhancing the trial’s quality and relevance and improving its translation into clinical practice

A Modified Implementation Mapping Methodology for Evaluating and Learning From Existing Implementation

When empirically supported interventions are implemented in real-world practice settings, the process of how these interventions are implemented is highly relevant for their potential success. Implementation Mapping is a method that provides step-by-step guidance for systematically designing implementation processes that fit the respective intervention and context. It includes needs assessments among relevant stakeholders, the identification of implementation outcomes and determinants, the selection and design of appropriate implementation strategies, the production of implementation protocols and an implementation outcome evaluation. Implementation Mapping is generally conceptualized as a tool to prospectively guide implementation. However, many implementation efforts build on previous or ongoing implementation efforts, i.e., “existing implementation.” Learnings from existing implementation may offer insights critical to the success of further implementation activities. In this article, we present a modified Implementation Mapping methodology to be applied when evaluating existing implementation. We illustrate the methodology using the example of evaluating ongoing organized colorectal cancer screening programs in Switzerland. Through this example, we describe how we identify relevant stakeholders, implementation determinants and outcomes as well as currently employed implementation strategies. Moreover, we describe how we compare the types of strategies that are part of existing implementation efforts with those that implementation science would suggest as being suited to address identified implementation determinants. The results can be used for assessing the current state of implementation outcomes, refining ongoing implementation strategies, and informing future implementation efforts

Involving patients and clinicians in a pilot randomised clinical trial of spinal manual therapy versus nerve root injection for lumbar radiculopathy: protocol of a patient and public involvement project

INTRODUCTION A patient and public involvement (PPI) project will be embedded within the SALuBRITY pilot trial, a two parallel group, double sham controlled, randomised clinical trial. The study aims to compare the effectiveness of spinal manual therapy and corticosteroid nerve root injections, two methods commonly used to treat patients with lumbar radiculopathy. We aim to gather patients' and clinicians' perspectives and involve them in decisions related to the research question and objectives, proposed trial recruitment processes and methods, and proposed outcome measures. METHODS AND ANALYSIS A small group of patients with lived experience of lumbar radiculopathy and primary care clinicians with experience in the treatment of patients with lumbar radiculopathy are involved. An initial kickoff event will prepare and empower the advisors for involvement in the project, followed by semistructured patient group and one-on-one clinician interviews. We will follow the Critical Outcomes of Research Engagement framework for assessing the impact of patient engagement in research. We will summarise and feedback PPI content to the patient and clinician advisors during a member-checking process to ensure accurate interpretation of patient and clinician inputs. Inductive and deductive thematic analysis will be used for the qualitative analysis of the interviews. Two surveys will be completed at different points along the trial to track the advisors' and researchers' experiences over the course of the PPI project. Any modifications to the SALuBRITY trial methods due to PPI inputs will be thoroughly documented and recorded in an impact log. ETHICS AND DISSEMINATION The independent research ethics committee of Canton Zurich confirmed that ethical approval for this PPI subproject was not required. PPI results will be disseminated in a peer-reviewed journal and presented at conferences

Implementation of a surgical unit-based safety programme in African hospitals: a multicentre qualitative study.

Background: A Surgical Unit-based Safety Programme (SUSP) has been shown to improve perioperative prevention practices and to reduce surgical site infections (SSI). It is critical to understand the factors influencing the successful implementation of the SUSP approach in low- and middle-income settings. We undertook a qualitative study to assess viability, and understand facilitators and barriers to implementing the SUSP approach in 5 African hospitals. Methods: Qualitative study based on interviews with individuals from all hospitals participating in a WHO-coordinated before-after SUSP study. The SUSP intervention consisted of a multimodal strategy including multiple SSI prevention measures combined with an adaptive approach aimed at improving teamwork and safety culture. Results: Thirteen interviews (5 head surgeons, 3 surgeons, 5 nurses) were conducted with staff from five hospital sites. Identified facilitators included influential individuals (intrinsic motivation of local SUSP teams, boundary spanners, multidisciplinary engagement, active leadership support), peer-to-peer learning (hospital networking and positive deviance, benchmarking), implementation fitness (enabling infrastructures, momentum from previous projects), and timely feedback of infection rates and process indicators. Barriers (organisational 'constipators', workload, mistrust, turnover) and local solutions to these were also identified. Conclusions: Participating hospitals benefitted from the SUSP programme structures (e.g. surveillance, hospital networks, formation of multidisciplinary teams) and adaptive tools (e.g. learning from defects, executive rounds guide) to change perceptions around patient safety and improve behaviours to prevent SSI. The combination of technical and adaptive elements represents a promising approach to facilitate the introduction of evidence-based best practices and to improve safety culture through local team engagement in resource-limited settings

Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study)

- Background: The implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial. - Methods and analysis: This mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis. - Ethics and dissemination: Ethics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the intervention to other healthcare contexts. Findings will be disseminated in peer-reviewed journals and conferences. - Protocol registration number: Open science framework (OSF)https://osf.io/8t2ud Registered on 21 December 2022

Documentation of adherence to infection prevention best practice in patient records: a mixed-methods investigation.

BACKGROUND Healthcare-associated infections remain a preventable cause of patient harm in healthcare. Full documentation of adherence to evidence-based best practices for each patient can support monitoring and promotion of infection prevention measures. Thus, we reviewed the extent, nature, and determinants of the documentation of infection prevention (IP) standards in patients with HAI. METHODS We reviewed electronic patient records (EMRs) of patients included in four annual point-prevalence studies 2013-2016 who developed a device- or procedure-related HAI (surgical site infection (SSI), catheter-associated urinary tract infection (CAUTI), ventilator-associated infection (VAP), catheter-related bloodstream infection (CRBSI)). We examined the documentation quality of mandatory preventive measures published as institutional IP standards. Additionally, we undertook semi-structured interviews with healthcare providers and a two-step inductive (grounded theory) and deductive (Theory of Planned Behaviour) content analysis. RESULTS Of overall 2972 surveyed patients, 249 (8.4%) patients developed 272 healthcare-associated infections. Of these, 116 patients met the inclusion criteria, classified as patients with SSI, CAUTI, VAP, CRBSI in 78 (67%), 21 (18%), 10 (9%), 7 (6%), cases, respectively. We found documentation of IP measures in EMRs in 432/1308 (33%) cases. Documentation of execution existed in the study patients' EMRs for SSI, CAUTI, VAP, CRBSI, and overall, in 261/931 (28%), 27/104 (26%), 46/122 (38%), 26/151 (17%), and 360/1308 (28%) cases, respectively, and documentation of non-execution in 67/931 (7%), 2/104 (2%), 0/122 (0%), 3/151 (2%), and 72/1308 (6%) cases, respectively. Healthcare provider attitudes, subjective norms, and perceived behavioural control indicated reluctance to document IP standards. CONCLUSIONS EMRs rarely included conclusive data about adherence to IP standards. Documentation had to be established indirectly through data captured for other reasons. Mandatory institutional documentation protocols or technically automated documentation may be necessary to address such shortcomings in patient safety documentation

Prevention of non-ventilator-associated hospital-acquired pneumonia in Switzerland: a type 2 hybrid effectiveness–implementation trial

Background: Non-ventilator-associated hospital-acquired pneumonia (nvHAP) is a frequent, but under-researched infection. We aimed to simultaneously test an nvHAP prevention intervention and a multifaceted implementation strategy. Methods: In this single-centre, type 2 hybrid effectiveness-implementation study, all patients of nine surgical and medical departments at the University Hospital Zurich, Switzerland, were included and surveyed over three study periods: baseline (14-33 months, depending on department), implementation (2 months), and intervention (3-22 months, depending on department). The five-measure nvHAP prevention bundle consisted of oral care, dysphagia screening and management, mobilisation, discontinuation of non-indicated proton-pump inhibitors, and respiratory therapy. The implementation strategy comprised department-level implementation teams who conducted and locally adapted the core strategies of education, training, and changing infrastructure. Intervention effectiveness on the primary outcome measure of nvHAP incidence rate was quantified using a generalised estimating equation method in a Poisson regression model, with hospital departments as clusters. Implementation success scores and determinants were derived longitudinally through semistructured interviews with health-care workers. This trial is registered with ClinicalTrials.gov (NCT03361085). Findings: Between Jan 1, 2017, and Feb 29, 2020, 451 nvHAP cases occurred during 361 947 patient-days. nvHAP incidence rate was 1·42 (95% CI 1·27-1·58) per 1000 patient-days in the baseline period and 0·90 (95% CI 0·73-1·10) cases per 1000 patient-days in the intervention period. The intervention-to-baseline nvHAP incidence rate ratio, adjusted for department and seasonality, was 0·69 (95% CI 0·52-0·91; p=0·0084). Implementation success scores correlated with lower nvHAP rate ratios (Pearson correlation -0·71, p=0·034). Determinants of implementation success were positive core business alignment, high perceived nvHAP risk, architectural characteristics promoting physical proximity of health-care staff, and favourable key individual traits. Interpretation: The prevention bundle led to a reduction of nvHAP. Knowledge of the determinants of implementation success might help in upscaling nvHAP prevention