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The purpose of this article is to share insights from the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) in delivering research for Multiple Long Term Conditions (MLTC) and to highlight lessons of wider relevance across the research ecosystem.
Designing health and care systems to be more responsive to the needs of people living with MLTC requires a considerable evidence base. When compared with research focused on a single disease area, research relating to MLTC raises unique considerations at the stages of planning, placing, and delivering research studies. Our article describes challenges associated with MLTC research outcomes and outlines different types of interventions to target MLTC, along with related research delivery considerations. Our article also raises important considerations for placing research in the most appropriate setting and highlights the vital role of robust feasibility studies, informed by the lived experience of patients and carers with MLTC, for ensuring that studies are conducted, recruited to, and completed in a timely and appropriate way.
Increasing the evidence base for the prevention and management of MLTC is a necessity for our health and care system. This presents novel challenges that require collaboration between multiple stakeholders. The UK benefits from a unique research infrastructure, including support for the stages of planning and delivery of health and care research. As the health and care system moves towards bringing care closer to patients and service users, the appropriate selection of the health and care settings and research sites in which to deliver MLTC research, in addition to understanding and removing barriers to recruitment and participation for people with MLTCs, are important considerations to enable us to collectively respond to this challenge.
To systematically map the landscape of central venous access device research from 2014 to 2024, identifying critical gaps in evidence that may impact nursing practice and patient outcomes across the full device lifecycle from selection through to removal.
This review was conducted in accordance with the Guidance for producing a Campbell evidence and gap map and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
PubMed, Cumulative Index to Nursing and Allied Health Literature Complete, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched with additional hand-searching of reference lists from included reviews.
We systematically reviewed literature published between 2014 and 2024, mapping 710 studies on central venous access device interventions and outcomes. Studies were categorised by design, population, setting, device characteristics, intervention types, and outcomes. Evidence was evaluated using the National Health and Medical Research Council levels of evidence framework.
Of 710 included studies, 89 were systematic reviews and 621 primary studies, of which 41.1% (n = 292) were randomised controlled trials. Research was primarily conducted in high-income countries (n = 405, 65.2%) and focused on adults (n = 370, 59.6%) in hospital inpatient settings (n = 588, 94.7%). Catheter insertion and infection prevention dominated the evidence base, while device selection and removal procedures were less studied. Infection outcomes were extensively reported (bloodstream infection: n = 455, 13.6% of 3349 outcomes), while patient-reported outcomes (n = 218, 6.5%) and cost (n = 60, 1.8%) were underrepresented.
This review reveals that central venous access device research is predominantly focused on insertion and infection prevention while other key parts of nursing practice are under-supported.
Future nursing research should address these gaps to improve evidence-based care across diverse populations and healthcare contexts, particularly focusing on understudied device types, settings, and vulnerable populations.
This review was conducted and reported in accordance with the Guidance for producing a Campbell evidence and gap map.
This study did not include patient or public involvement in its design, conduct, or reporting.
To determine whether the I-DECIDED assessment and decision tool enhances peripheral intravenous catheter assessment, care and decision-making in paediatrics.
Quasi-experimental, interrupted time-series study.
An interrupted time-series study was conducted in a paediatric inpatient unit at a public teaching hospital in Brazil. The participants were patients aged less than 15 years old with a peripheral intravenous catheter, and their parents or guardians. Data were collected between January and July 2023, encompassing six time points, three pre-intervention and three post-intervention. Evaluation data were based on the I-DECIDED tool, including idle devices, dressings, complications, patient/family awareness, hand hygiene, disinfection and documentation.
We conducted 585 peripheral intravenous catheter observations, with 289 in the pre-intervention phase and 296 in the post-intervention phase, inserted in 65 hospitalised children, 30 in the pre-intervention phase and 35 in the post-intervention phase. After the intervention, reductions were observed in the number of idle catheters, substandard dressings and complications. Patients and family members reported an increase in device assessment, hand hygiene and peripheral intravenous catheter disinfection. Additionally, there was an increase in documentation of decision-making performed by nurses and nursing technicians/assistants.
Implementation of the I-DECIDED assessment and decision tool in a paediatric unit significantly improved the assessment, care and decision-making regarding peripheral intravenous catheters.
Opportunity to enhance practice standards, elevate the quality of care provided to paediatric patients, contribute to improved patient outcomes, advance evidence-based practice in vascular access management and enhance patient experience through increased involvement in care.
To influence clinical practice and healthcare policies aimed at improving peripheral intravenous catheter care and patient safety in paediatric settings.
No patient or public contribution to the design of this study.
Neoadjuvant (chemo)radiotherapy (n(C)RT) followed by resection with total mesorectal excision (TME) constitutes the standard treatment for patients with locally advanced rectal cancer of the middle and lower third. However, n(C)RT has demonstrated no significant impact on overall survival but is associated with adverse effects, including impaired sphincter and sexual function. We hypothesise that omitting n(C)RT in selected patients with a clear circumferential resection margin (CRM) >1 mm as determined through preoperative MRI is not inferior regarding local recurrence rate within 3 years after surgery. That treatment approach may show fewer adverse effects and be more cost-effective.
Selective neoadjuvant therapy of rectal cancer patients (SELREC) is a randomised controlled, parallel-group, open, multicentre, non-inferiority trial. The experimental intervention involves performing TME surgery without n(C)RT. In contrast, the control intervention adheres to German S3-guidelines, incorporating neoadjuvant radiotherapy (nRT) with a dosage of 5x5 Gy or a total of 50.4 Gy. Additionally, if applicable, concomitant chemotherapy (CT) based on 5-fluorouracil is administered, followed by TME surgery within less than 12 weeks. Adjuvant treatment according to guidelines is allowed depending on the (y)pTNM stage.
The inclusion criteria for this study encompass adult patients with primary adenocarcinoma of the rectum in whom the main tumour mass is located less than 12 cm away from the anal verge, as assessed via proctoscopy. Additionally, eligible participants are required to have a preoperative tumour stage determined by MRI of either T1 or T2 with lymph node involvement (N1) or T3 with no lymph node involvement (N0) or with lymph node involvement (N1) and no distant metastases (M0). The assessment of a clear CRM >1 mm, based on MRI, is another prerequisite for inclusion. A total of 1074 patients in approximately 35 centres are planned to be allocated to the trial.
The primary endpoint of the trial is local recurrence within 3 years after surgery. The primary estimand is based on the full analysis set using a logistic mixed model (margin 3%). The first secondary endpoint is no/minor low anterior resection syndrome (LARS) score at 2 years after surgery, and further secondary endpoints include survival outcomes and quality of life. Safety analysis involves describing the frequencies of major intervention-specific complications, such as the acute toxicity of n(C)RT according to CTCAE and perioperative morbidity and mortality according to Clavien-Dindo criteria.
SELREC is financially supported by the German Federal Ministry of Education and Research.
This trial has been prospectively registered in the German Clinical Trials Register.
Previously, the study had been approved by the responsible ethics committee of Heidelberg and the local ethics committees of the collaborating institutions before patient enrolment. Any protocol deviation that has an impact on relevant parameters such as study design, endpoints or patient safety will be reported to the responsible ethics committees.
The results will be published in a peer-reviewed scientific journal and on institutional websites.
German Clinical Trials Register DRKS00030567.
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