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Development and psychometric evaluation of an expanded urinary catheter self‐management scale: A cross‐sectional study

Abstract

Aim

To develop and test the psychometric properties of an expanded catheter self-management scale for patients with in-dwelling urinary catheters.

Design

A cross-sectional validation study. Despite the utility of the original 13-item catheter self-management scale, this instrument did not include bowel management, general hygiene and drainage bag care, which are fundamental skills in urinary catheter self-management to prevent common problems resulting in unnecessary hospital presentations. The expanded catheter self-management scale was developed with 10 additional items to comprehensively assess all five essential aspects of urinary catheter self-management.

Methods

A total of 101 adult community-dwelling patients living with indwelling urinary catheters were recruited from Western Sydney, Australia. Using exploratory factor analysis with Varimax rotation, the number of factors to be extracted from the expanded 23-item expanded catheter self-management scale was determined using a scree plot. The reliability of the overall scale and subscales was measured using Cronbach's alpha. Convergent validity was assessed using Spearman's correlations between clinical characteristics, overall scale and subscales.

Results

The 23-item expanded catheter self-management scale yielded a 5-factor solution, labelled as: (i) self-monitoring of catheter function, (ii) proactive, help-seeking behaviour function, (iii) bowel self-care function, (iv) hygiene-related catheter site function and (v) drainage bag care function. Cronbach's alpha of the expanded catheter self-management scale indicating all 23 items contributed to the overall alpha value. Convergent validity results showed a negative correlation between the overall expanded catheter self-management scale and catheter-related problems.

Conclusion

The 5-factor structure provided a comprehensive assessment of key aspects of urinary catheter self-management essential to reduce the likelihood of catheter-related hospital presentations.

Implications

The expanded catheter self-management scale can be used to assess and monitor effective patient-centred interventions for optimal self-management to prevent catheter-related problems and improve the quality of life of patients.

Impact

Many patients start their journey of living with a urinary catheter unexpectedly and are not supported with quality information to care for their catheter. The findings of this study show the correlation between catheter self-management skills and catheter-related problems. The expanded catheter self-management scale (E-CSM) assists with analysing the self-management skills of patients living with a catheter and developing tailored interventions to prevent problems and improve their quality of life. In addition, this screening tool can be included in policies, guidelines, and care plans as a standard for improving catheter management and developing educational resources for patients.

Reporting Method

STROBE checklist was used to report all aspects of this study comprehensively and accurately.

Patient or Public Contribution

Patients living with indwelling urinary catheter and their carers have participated in surveys, interviews and co-designing interventions. This paper reports the psychometric analysis of the expanded catheter self-management scale (E-CSM) used in the patient survey as part of the main study ‘Improving Quality of Life of Patients Living with Indwelling Urinary Catheters: IQ-IDC Study’ (Alex et al. in Collegian, 29:405–413, 2021). We greatly value our consumers' contributions and continue to communicate the progress of the study to them. Their contributions will be acknowledged in all publications and presentations. In addition, all participants will be provided the option of receiving the interventions and publications generated from this study.

Effectiveness of a culturally tailored diabetes education curriculum with real-time continuous glucose monitoring in a Latinx population with type 2 diabetes: the CUT-DM with CGM for Latinx randomised controlled trial study protocol

Por: Ehrhardt · N. · Cedeno · B. · Montour · L. · Sinclair · K. · Ferguson · G. · Berberian · P. · Comstock · B. · Wright · L.
Introduction

The prevalence of type 2 diabetes (T2D) is increasing in the Latinx community. Despite telehealth and technology becoming more available, these resources are not reaching the Latinx population. Diabetes education is a cornerstone of treatment; however, access to culturally tailored content is a barrier to the Latinx population. Real-time continuous glucose monitoring (RT-CGM) is a patient-empowering tool that can improve glycaemic control, but it is not readily available for Latinx patients with T2D. We aim to evaluate a culturally tailored diabetes self-management education and support (DSMES) curriculum, using a team-based approach to improve glycaemic control, promote healthy behaviours and enhance patient access with the use of telehealth in Latinx individuals. The primary aim of the study is to evaluate the additive effectiveness of RT-CGM on glycaemia and behavioural changes among Latinx patients undergoing a culturally tailored DSMES. A sub aim of the study is to evaluate family members’ change in behaviours.

Methods

We propose a randomised controlled trial of blinded versus RT-CGM with 100 Latinx participants with T2D who will receive DSMES via telemedicine over 12 weeks (n=50 per group). The study will be conducted at a single large federally qualified health centre system. The control group will receive culturally tailored DSMES and blinded CGM. The intervention group will receive DSMES and RT-CGM. The DSMES is conducted by community health educators weekly over 12 weeks in Spanish or English, based on participant’s language preference. Patients in the RT-CGM group will have cyclical use with a goal of 50 days wear time. The primary outcomes are changes in haemoglobin A1c and CGM-derived metrics at 3 and 6 months. The secondary outcomes include participants’ self-management knowledge and behaviour and household members’ change in lifestyle.

Ethics and dissemination

The study proposal was approved by the University of Washington ethics/institutional review board (IRB) Committee as minimal risk (IRB ID: STUDY00014396) and the Sea Mar IRB committee.

Trial registration number

ClinicalTrials.gov identifier: NCT05394844

Study protocol for Care cOORDInatioN And sympTom managEment (COORDINATE) programme: a feasibility study

Por: Koirala · B. · Badawi · S. · Frost · S. · Ferguson · C. · Hager · D. N. · Street · L. · Perrin · N. · Dennison Himmelfarb · C. · Davidson · P.
Introduction

Sustainable approaches to support care coordination and symptom management needs of critically ill adults living with multimorbidity are needed to combat the challenges and complexity that multimorbidity presents. The study aims to test the feasibility of the Care cOORDInatioN And sympTom managEment (COORDINATE) intervention to improve health outcomes of adults living with multimorbidity.

Methods and analysis

A multicomponent nurse-driven intervention was developed using experience-based co-design and human-centred design. Inclusion criteria include (1) age 55 years and older, (2) admitted to an intermediate care unit, (3) presence of two or more chronic health conditions and (4) signed informed consent. Data collection will occur at baseline (time of recruitment predischarge) and 6 weeks and 3 months following hospital discharge. Outcome of interest from this feasibility study is to evaluate the financial, technical and logistic feasibility of a full-scale study including data collection and protocol adherence. Additionally, Cohen’s d effect sizes for the change in outcomes over time will be computed to establish power calculations required for a full-scale study. The protocol was prepared in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.

Ethics and dissemination

The study has been reviewed and approved by the Institutional Review Board of Johns Hopkins Medical Institutions. Given the success of this feasibility study, the potential for the COORDINATE intervention to decrease the symptom burden and improve participant quality of life among critically ill people with multimorbidity will be tested in a full-scale study, and findings will be actively disseminated.

Trial registration number

NCT05985044.

Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study

Por: Mander · E. S. · Merrick · C. B. · Nicholson · H. A. · Lord · H. K. · Ferguson · M. J. · Smith · G.
Objective

Pembrolizumab is a programmed cell death protein-1 (PD-1) inhibitor used to treat advanced patients with non-small cell lung cancer (NSCLC) with a programmed cell death ligand-1 (PD-L1) tumour proportion score (TPS) ≥50. Further sub-division of TPS-based stratification has not been evaluated in the UK, although smoking-induced tumour mutational burden and the immunogenic effects of prior radiotherapy are suggested to improve response.

Aims

To investigate if PD-L1 TPS ≥80%, smoking status or radiotherapy before or within 2 months of treatment influenced progression-free survival (PFS) in patients with NSCLC treated with pembrolizumab monotherapy.

Methods

PD-L1 TPS, smoking status and radiotherapy exposure were compared in patients with NSCLC in National Health Service (NHS) Tayside (n=100) treated with pembrolizumab monotherapy between 1 November 2017 and 18 February 2022. Survival estimates were compared using log-rank analysis, and Cox proportional hazards analysis was used to investigate the influence of potential confounding factors, including tumour stage and performance status.

Results

PFS was not significantly different (log-rank HR=0.330, p=0.566) comparing patients with PD-L1 TPS 50–79% and PD-L1 TPS ≥80%. Smokers had significantly improved PFS (log-rank HR=4.867, p=0.027), while patients receiving radiotherapy had significantly decreased PFS (log-rank HR=6.649, p=0.012). A Cox regression model confirmed that both radiotherapy (p=0.022) and performance status (p=0.009) were independent negative predictors of PFS.

Conclusions

More rigorous PD-L1 TPS stratification did not influence survival outcomes. Smoking history improved PFS, although it was not an independent response predictor, while radiotherapy and performance status independently influenced clinical response. We suggest that further stratification of PD-L1 TPS is not warranted, while performance status and radiotherapy treatment may be additional clinically useful biomarkers of response to pembrolizumab in patients with NSCLC.

The role of muscle degeneration and spinal balance in the pathophysiology of lumbar spinal stenosis: Study protocol of a translational approach combining in vivo biomechanical experiments with clinical and radiological parameters

by David Koch, Corina Nüesch, Dominika Ignasiak, Soheila Aghlmandi, Alice Caimi, Guido Perrot, Friederike Prüfer, Dorothee Harder, Francesco Santini, Stefan Schären, Stephen Ferguson, Annegret Mündermann, Cordula Netzer

Objective

To describe a study protocol for investigating the functional association between posture, spinal balance, ambulatory biomechanics, paraspinal muscle fatigue, paraspinal muscle quality and symptoms in patients with symptomatic lumbar spinal stenosis (sLSS) before and 1-year after elective surgical intervention.

Design

Single-centre prospective, experimental, multimodal (clinical, biomechanical, radiological) study with three instances of data collection: baseline (study visit 1), 6-month follow-up (remote) and 1-year follow-up (study visit 2). Both study visits include an in vivo experiment aiming to elicit paraspinal muscle fatigue for postural assessment in a non-fatigued and fatigued state.

Experimental protocol

At baseline and 1-year follow-up, 122 patients with sLSS will be assessed clinically, perform the back-performance scale assessment and complete several patient-reported outcome measure (PROMs) questionnaires regarding overall health, disease-related symptoms and kinesiophobia. Posture and biomechanical parameters (joint kinematics, kinetics, surface electromyography, back curvature) will be recorded using an optoelectronic system and retroreflective markers during different tasks including overground walking and movement assessments before and after a modified Biering-Sørensen test, used to elicit paraspinal muscle fatigue. Measurements of muscle size and quality and the severity of spinal stenosis will be obtained using magnetic resonance imaging (MRI) and sagittal postural alignment data from EOS radiographies. After each study visit, physical activity level will be assessed during 9 days using a wrist-worn activity monitor. In addition, physical activity level and PROMs will be assessed remotely at 6-month follow-up.

Conclusion

The multimodal set of data obtained using the study protocol described in this paper will help to expand our current knowledge on the pathophysiology, biomechanics, and treatment outcome of degenerative sLSS. The results of this study may contribute to defining and/or altering patient treatment norms, surgery indication criteria and post-surgery rehabilitation schedules.

Trial registration

The protocol was approved by the regional ethics committee and has been registered at clinicaltrials.gov (NCT05523388).

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