Conectar
Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.
We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.
The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.
by Jack Jefferson, Claire Reigate, Alessandra Giacomini, M. Jordana Rivero, Matthew Hitchings, Tamsyn Uren Webster, Konstans Wells
Livestock grazing in confined pastures often means grazing on a less diverse diet than under more natural conditions and increased exposure to gastrointestinal parasites prevailing in these pastures. However, how sward composition influences gut microbiome (GM) diversity and its relationship with parasite burden remains poorly understood. In this study, we analysed the faecal GM of weaned lambs grazing on two distinct sward types (perennial ryegrass and a mixed-species sward) over three consecutive months using 16S rRNA sequencing, in order to assess how microbial diversity and composition are related to environmental conditions and the gastrointestinal nematode (GIN) burden in naturally infected lambs. Sward type and sampling time explained some of the variation in GM alpha diversity and community composition (beta diversity), whereas individual lamb identity accounted for considerably more variation in microbial assemblages. Shifts in the relative abundance of bacterial genera such as Saccharofermentans, Anaerosporobacter, Butyrivibrio in relation to sward type and sampling time suggest mostly adaptive fluctuations in response to diet and pasture condition. Abundance shifts of Negativibacillus, and Candidatus Saccharimonas were also associated with GIN burden, which, in turn, was higher in lambs grazing on mixed swards compared to ryegrass. Our findings add to the growing understanding of how sheep microbiomes vary with pasture management and changes in parasite burden. We highlight that individual identity may shape gut microbiota, and that potential triadic interactions among gastrointestinal parasites, sward exposure, and the gut microbiome underscore the importance of considering host, parasite, and environmental factors collectively when evaluating microbiome dynamics in grazing livestock.
FreshRSS 