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People with severe mental illness (SMI) engage in less physical activity (PA) and more sedentary behaviour (SB) than the general population, contributing to poorer physical health outcomes in this population. Therefore, the aim of this study was to evaluate the feasibility of a multi-component behaviour change intervention called Walking fOR Health (WORtH), delivered by community mental health teams, aimed at increasing PA and reducing SB compared with a one-off education session in people with SMI.
Feasibility randomised controlled trial (RCT).
Study recruitment and intervention delivery took place within four community mental health teams in the UK and Ireland.
Eligible participants had a diagnosis of a SMI and no contraindications to participating in physical activity. Fifty-four participants (25 male, 29 female; mean age 51.6 years) were recruited.
Participants were randomised to the 13-week WORtH intervention, comprising education, activity tracking and health coaching or an education-only control.
Feasibility outcomes included recruitment, retention, adherence and acceptability. Clinical outcomes included device-measured (Axivity AX3) and self-reported PA and SB, body anthropometry, physical function and mental well-being.
This feasibility study met 90% target recruitment and 94% of participants provided follow-up data. Adherence to allocated intervention and engagement with all core intervention components was >80%. Qualitative feedback indicated high levels of satisfaction. Valid device-measured moderate-vigorous PA (MVPA), the intended primary outcome for a definitive trial, was obtained from 90% of participants at baseline and 75% of participants at post-intervention. Point estimates indicated a mean increase of 8.6 min/day of MVPA in the intervention group (baseline 54.7 min/day (95% CI 39.5 to 70.0); follow-up 63.3 min/day (95% CI 50.1 to 76.4)) and of 1.0 min/day in the control group (baseline 42.1 min/day (95% CI 24.6 to 59.6); follow-up 43.1 min/day (95% CI 29.6 to 56.5)).
The results of this study support the feasibility of the WORtH intervention in adults with SMI, and findings will be used to optimise the design of a definitive RCT.
To identify key factors influencing the implementation of technology-enabled virtual wards (VWs), also known as hospital at home, drawing on the qualitative accounts of stakeholders involved in implementation, using the updated Consolidated Framework for Implementation Research (CFIR) as a guiding analytical framework.
Qualitative semi-structured interviews with implementation leads. All interviews were conducted online, using MS Teams or Zoom, between January–June 2024, and audio-recorded with consent. Audio-recordings were transcribed, anonymised and exported to NVivo V.12 Pro software for data management. The updated CFIR was used to guide thematic analysis of interview data.
Adult VW services in one regional health and social care system in North West England, UK.
Service implementation leads from 11 hospital sites providing adult VW services. Job titles and roles varied across sites and included both operational and clinical service leads.
20 interviews were conducted with 22 participants. Four implementation themes were identified: (1) complexity and adaptability: the ability to adapt the service to local conditions was valued by leads, but also contributed to wide variation in operational, clinical, workforce and digital components of VW models; (2) resource and infrastructure: workforce capacity was identified as a key implementation challenge along with information technology system capability and interoperability; (3) performance demands: leads were concerned that an excessive focus on bed numbers and occupancy levels, without accounting for patient acuity, could negatively affect implementation, straining the service and staff capacity; and (4) readiness for change: organisational and professional readiness for change was considered crucial for increasing referrals and enabling successful implementation, yet leads reported that the level of behavioural and cultural change required had been underestimated.
Implementation of a national VWs programme has resulted in wide service variation in one UK region, which raises questions about service equity and poses challenges for wider programme evaluation. Despite this variation, common factors found to help or hinder implementation have been identified. This study provides greater understanding of the factors that influence the implementation of VW services and outlines actionable insights to help refine VW strategies. These insights can support future planning and sustainability of technology-enabled inpatient-level care at home more widely.
To evaluate the cost-effectiveness of early lead extraction (≤7 days post-admission) compared with delayed (>7 days) or no extraction for cardiac implantable electronic device (CIED) infections in the UK using a decision-analytic model from the NHS perspective.
A decision-tree model was constructed to simulate clinical and economic outcomes in adult patients with systemic or pocket CIED infections.
Secondary care hospital setting within the UK NHS.
A simulated cohort of adult patients with systemic or pocket CIED infections. Model inputs were sourced from published literature and NHS cost data (2023 £).
Early lead extraction (≤7 days after diagnosis/admission) compared with delayed extraction (>7 days) or no extraction.
Adverse events avoided and total healthcare costs over a 1-year time horizon; deterministic and probabilistic sensitivity analyses were conducted to assess model robustness.
Early extraction was both clinically and economically superior to delayed or no extraction. For systemic infections, early extraction reduced costs by £123 056 and avoided 9.0 adverse events per 100 patients, with mortality falling from 20.0 to 7.5 per 100 patients. In pocket infections, early extraction lowered costs by £104 904 and avoided 8.4 adverse events per 100 patients, with mortality decreasing from 12.4 to 0.9 per 100 patients. Sensitivity analyses confirmed the robustness of these findings, with antibiotic failure rates being the most influential parameter.
Early lead extraction for CIED infections is a cost-effective, dominant strategy in the UK, reducing mortality, adverse events and overall costs. These results strongly support guideline recommendations for prompt extraction and highlight the need for improved adherence to evidence-based management of CIED infections.
Social camouflaging (SC; ie, the concealing of autistic traits to socially assimilate) is associated with poor mental health, self-identity and quality of life outcomes, yet its typology, consequences and contextual triggers remain unexplored in autistic adolescents. Further study is necessary to identify protective factors against the potentially negative outcomes associated with SC to promote long-term well-being.
The current project will investigate SC in youth and its mental health, cognitive and neurophysiological correlates. Camouflaging will be captured by triangulating self-reported and caregiver-reported SC behaviours, as well as SC behaviours in day-to-day contexts using intensive longitudinal methods (ie, daily diaries). Non-autistic, self-identifying autistic and formally diagnosed autistic adolescents aged 15–18 years (N=150) will be recruited. Adolescents and caregivers will complete rating scales to assess mental health, and adolescents will complete in-lab cognitive assessments of attention, executive function, intellectual ability and theory of mind. Brain neurophysiological function and cortisol concentration over time will be measured during the same visit using electroencephalography and hair samples, respectively. Over the following 7 days, adolescents will complete daily diaries using their smartphones. The daily diaries pose survey questions about the type and degree of SC behaviour used within their daily environment, including the social context, individuals who are present and current well-being. Adolescents will also complete brief performance-based cognitive assessments of attention and executive function integrated within the daily diary surveys. Finally, adolescents and their parents will complete a follow-up of SC behaviours and mental health at 3 months. Correlations and regression analyses will be conducted to explore the associations between SC and mental health/cognitive outcomes and how baseline measures of cognition, mental health and SC predict patterns seen on the daily diaries. Multilevel modelling will be used, nesting daily data to capture within-person and between-group differences in contextual predictors of camouflaging behaviour. Results will contribute to current understanding of the typology of camouflaging, as well as inform intervention to mitigate mental health challenges for autistic youth.
This project is approved by the University of Victoria Human Research Ethics Board (#23–0013) and the University of Calgary Conjoint Faculties Research Ethics Board (#23–0641). Informed consent will be obtained from caregivers and adolescent participants, and safety procedures will be put in place to support the adolescent should mental health concerns arise. Results will be disseminated through academic publications and conferences, as well as summarised and communicated to interested participants and relevant stakeholders.
Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.
A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.
Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.
A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.
Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.
Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.
This cross-sectional survey study evaluates the influence of international observerships organised by the coalition of healthcare professionals from academic institutions—the Ukrainian Alliance for Medical Exchange and Development (UA-MED)—on the professional development, knowledge transfer and clinical practice improvement of Ukrainian healthcare professionals during the war.
A total of 263 international observerships were facilitated for 204 Ukrainian medical professionals across the institutions in the USA, Canada, Europe and Australia during 2022–2024. To assess the impact of these observerships, a survey was administered focusing on overall satisfaction, procedural knowledge gained and challenges faced when implementing new techniques on return. The primary outcome was the success score, defined as a composite score of implementing new procedures, initiating quality improvement projects and knowledge dissemination efforts.
A total of 128 medical professionals from 45 Ukrainian institutions who completed 138 observerships in 27 institutions abroad participated in the survey (response rate of 62.7%). Observers varied by profession: surgeons (32.8%), radiation oncologists (14.8%), medical oncologists (11.7%), anaesthesiologists (11.7%) and others. Observerships lasted a median of 4 weeks; 74.1% included conference attendance. The average success and satisfaction scores were 6.5/10 and 9.3/10, respectively.
The majority (92.7%) reported a shift in perception of how to practise medicine and 75.5% implemented new procedures on returning to Ukraine. Encouraged to disseminate knowledge, participants provided informal training to colleagues (67.3%), prepared presentations for their institutions (65.5%) and national conferences (32.7%), incorporated learnt materials into educational lectures (39.1%) and engaged in all the activities above (15.5%).
The international observerships played an important role in enhancing the reported skills and knowledge of Ukrainian healthcare professionals during the war. Improvements were reported in clinical practice, medical education and the implementation of new procedures. The success of these observerships underscores the potential for similar programmes in other low-income and middle-income countries/upper-middle-income countries.
To investigate vaccination coverage for influenza and COVID-19 in the SARS-CoV-2 immunity and reinfection evaluation (SIREN) study cohort of healthcare workers (HCWs) between 2020 and 2023 and explore vaccination enablers and barriers.
A mixed-methods study nested within SIREN, a multicentre prospective cohort study of HCWs across the UK. Quantitative and qualitative methods were used sequentially, using an expansion/explanation function, enabling emergent themes observed from the quantitative stage to be explored in the qualitative stage.
SIREN sites include secondary care centres and community mental health trusts in the UK.
Quantitative analysis was conducted on data from 6048 participants. Participants were representative of the HCW workforce, with the majority being women (83%) and of white ethnicity (88%). Nurses made up the largest occupational group (33%). Qualitative analysis of data from 24 participants including five focus groups (n=21) and three semistructured interviews (n=3); 82% women, 26% minority ethnic, all working age from across the UK.
Quantitative: vaccine coverage for COVID-19 and influenza vaccines by demographic with multivariable logistical regression used to assess differences. Qualitative: thematic analysis to explore reasons behind the results seen in the quantitative stage.
COVID-19 vaccination was initially high; 97% received two doses and 94% a first booster. However, coverage was reduced to 77%, for the second booster. Influenza vaccination coverage was lowest in 2020–2021 (46%), increasing to 73% in 2021–2022 and to 79% in 2022–2023. In 2022–2023, vaccination coverage was higher for influenza than for COVID-19. High vaccine coverage for both COVID-19 and influenza was observed in doctors, pharmacists and therapists. Porters, healthcare assistants and staff from minority ethnic groups had lower vaccine coverage for both COVID-19 and influenza. Four themes were identified: (1) attitudes towards vaccination changed throughout the COVID-19 pandemic; (2) HCWs used data to inform vaccination decisions; (3) poor communication in healthcare settings contributed to a reduction in vaccination; (4) there were both positive and negative impacts of the COVID-19 vaccine on influenza vaccine uptake and other vaccination programmes.
Between 2020 and 2023 in our cohort, COVID-19 vaccination coverage decreased, whereas influenza increased. Our study found attitudes to both vaccines have shifted, becoming more favourable to influenza and less to COVID-19 boosters. Barriers to COVID-19 boosters, including concerns about side effects and vaccine effectiveness, need to be addressed with improved communication on the benefits and adverse events. Future vaccination strategies should address the differences we have identified in vaccine coverage across demographics and occupational groups, including continued efforts to improve vaccine equity.
This article on realist reviews is the second in a four-part series on realist research.
Realist reviews (or realist evidence syntheses) are a theory-building, interpretative approach to evidence synthesis. Realist reviews aim to go beyond seeking whether interventions work (ie, are effective), to generating explanations as to...
There are global concerns about the rise in opioid prescribing. Patients undergoing potentially curative surgery for colorectal cancer (CRC) are at high risk of adverse outcomes from opioid-related complications, including delayed discharge and adjuvant chemotherapy, long-term opioid use and reduced cancer-free survival. We aimed to develop a set of actionable quality indicators for opioid stewardship for patients undergoing CRC surgery, and an implementation toolkit to support professional behaviour change to improve appropriateness of perioperative opioid prescribing.
A five-round modified RAND consensus process was conducted in 2021–2024.
14 secondary care trusts across the UK Yorkshire and Humber region.
Consultant anaesthetists and national perioperative opioid stewardship experts (expert panel) and patient and public panel.
Potential indicators were identified from a literature review, guideline search and expert panel. All potential indicators were rated on relevance and actionability (online survey, expert panel) and importance to patient care (online meeting, patient panel). A hybrid consensus meeting involving a patient representative and the expert panel discussed and rerated the indicators. An online expert survey identified potential barriers to implementation. An actionable toolkit was developed using implementation strategies and supporting resources developed where appropriate.
73 potential indicators were identified. All indicators remained in the process through the online survey and patient panel. After the final meeting, four indicators remained: (1) hospital trust presence of an opioid stewardship protocol; (2) inpatient functional post-operative pain assessments; (3) patient education and discharge leaflet; and (4) senior clinician review of ‘strong’ opioids on discharge (British National Formulary definition). The number of barriers identified ranged from 8 to 22 per indicator. 49 different implementation strategies were identified for the toolkit (range 32–45 per indicator).
We identified four actionable quality indicators and developed an implementation toolkit that represents consensus in defining quality of care in opioid stewardship for CRC surgery.
Public involvement in mental health research enhances research quality. The use of citizen science methods in mental health research has been described as a conclusion of a movement towards increased public involvement; however, this field is in its early stages of development. Our objective was to create a theory of change (ToC) for how citizen science can be used to enhance mental health research quality.
Iterative consultation with the stakeholders of an existing citizen mental health science study, that is, change for citizen science to achieve co-production at scale (C-STACS: https://www.researchintorecovery.com/research/c-stacs/)
We co-developed a ToC through an iterative consultation with C-STACS stakeholders who were (a) representatives of mental health community organisations (n=10), individuals with public involvement experience (n=2) and researchers (n=5). In keeping with established ToC practice, entities were identified, including long-term impacts, outcomes needed to create an impact, stakeholder assumptions and indicators for tracking progress.
A desired primary long-term impact of greater co-production of research was identified between researchers and members of the public, which would create a secondary impact of enhancing public capacity to engage in citizen mental health science. We proposed long-term outcomes needed to enable this impact: (1) greater co-production of research objectives and pathways between researcher and the public, (2) greater embedment of citizen mental health science into funder processes (eg, the creation of specific funding calls for citizen mental health science proposals, (3) greater clarity on the boundaries between citizen science and other participatory approaches (eg, so that there is not loss of impact due to conceptual confusion between these, (4) increased knowledge around effective frameworks to enable mass public participation and (5) greater availability of technology platforms, enabling safe and accessible engagement with citizen mental health science projects.
The proposed ToC is grounded in the C-STACS project, but intended to be broadly applicable. It allows the continued formation of a community of practice around citizen mental health science and should be reviewed, as greater knowledge is developed on how citizen mental health science creates change.
The harmful health effects of children’s exposure to secondhand smoke (SHS) are well established. Most SHS exposure now occurs in the home, in low-income households. Previous research suggests that using nicotine replacement therapy (NRT) in the home can help with temporary smoking abstinence and could reduce smoking indoors. This pilot randomised controlled trial tests the feasibility of providing parents, carers and relatives with posted-to-home nicotine replacement therapy alongside fortnightly telephone support to reduce children’s exposure to SHS.
100 participants are being recruited through existing National Health Service (NHS) Lanarkshire initiatives and social media. Parents/carers who are at least 18 years old, smoke in the home and care for one or more children aged 0–16 years are eligible to take part. Participants are randomised to either the intervention (Group A) or control (Group B) arm. Group A receives NRT posted to their home for 12 weeks free of charge, alongside fortnightly telephone calls and materials to support them in reducing children’s exposure to SHS. Group B is signposted to the Scottish Government’s ‘Take it Right Outside’ website which provides interactive advice on creating a smoke-free home. To quantify the child’s exposure to SHS, participants instal an air quality monitor to measure fine particulate matter (PM2.5) concentrations in their living room for 7 days at baseline and 12-week follow-up and/or collect and post saliva samples from their youngest child (age 5 or over) for cotinine analysis. Qualitative interviews explore intervention experience, NRT use and adherence and changes to home-smoking behaviours/smoking-related expenditure. Descriptive data analyses will be performed to address the feasibility of recruitment, randomisation, retention and adherence, data collection and intervention delivery. Analysis will also include pre/post changes (paired t-test) in both child’s salivary cotinine and PM2.5 levels to provide preliminary data on intervention effectiveness and difference between the intervention and control arms of the study. Health economics and resource use data will be collected and assessed for completeness, to test the process of data collection and estimate mean cost of both study arms.
NHS ethical approval has been obtained by the West of Scotland Research Ethics Service (15 December 2023, ref 23/WS/0153; 13 December 2024, ref AM01). The findings will be disseminated to participants, funders, NHS Lanarkshire and other health services, and in peer-reviewed journals and academic conferences. Findings will inform new approaches that are timely and important, providing valuable evidence to help reduce children’s exposure to SHS in the home in Scotland and elsewhere.
To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.
Triangulation to integrate quantitative and qualitative data.
Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.
A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.
To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.
Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.
There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.
People living with multiple long-term conditions (MLTC) admitted to hospital have worse outcomes and report lower satisfaction with care. Understanding how people living with MLTC admitted to the hospital are cared for is a key step in redesigning systems to better meet their needs. This scoping review aimed to identify existing evidence regarding clinical decision-making and care pathways for people with MLTC admitted to the hospital. In addition, we described research methods used to investigate hospital care for people living with MLTC.
A scoping review methodological framework formed the basis of this review. We took a narrative approach to describe our study findings.
A search of Medline, Embase and PsycInfo electronic databases in July 2024 captured relevant literature published from 1996 to 2024.
Studies that explored care pathways and clinical decision-making for people living with MLTC or co-morbidities, studies conducted fully or primarily in secondary or tertiary care published in English Language and with full text available.
Titles and abstracts were independently screened by two authors. Extracted data included country of origin, aims, study design, any use of an analytical framework or design, type of analyses performed, setting, participant group, number of participants included, health condition(s) studied and main findings. Included studies were categorised as either: studies reviewing existing literature, studies reviewing guidance, studies utilising qualitative methods or ‘other’.
A total of 521 articles were screened, 17 of which met the inclusion criteria. We identified a range of investigative methods. Eight studies used qualitative methods (interviews or focus groups), four were guideline reviews, four were literature reviews and one was classified as ‘other’. Often, researchers choose to combine methods, gathering evidence both empirically and from reviews of existing evidence or guidelines. However, none of the empirical qualitative studies directly or solely investigated clinical decision-making when treating people living with MLTC in acute care and the emergency department. Studies identified complexities in care for people living with MLTC, and some authors attempted to make their own recommendations or draft their own guidance to counter these.
This scoping review highlights the limitations of the current evidence base, which, while diverse in methods, provides sparse insights into clinical decision-making and care pathways for people living with MLTC admitted to hospital. Further research is recommended, including reviews of guidelines and gathering insights from both healthcare professionals and people living with MLTC.
International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.
Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.
The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.
Fatigue is a common and debilitating symptom that is associated with an increased risk of mortality, dialysis initiation and hospitalisation among patients with chronic kidney disease (CKD). The aim of this study was to identify the characteristics, content and psychometric properties of patient-reported outcome measures (PROMs) used to measure fatigue in patients with CKD not requiring kidney replacement therapy (KRT).
Systematic review. The characteristics, dimensions of fatigue and psychometric properties of these measures were extracted and analysed.
We searched MEDLINE, Embase, PsycINFO and CINAHL from database inception to February 2023.
All studies that reported fatigue in patients with CKD stages 1–5 not receiving KRT.
We identified 97 studies (20 (21%) randomised trials, 2 (2%) non-randomised trials and 75 (77%) observational studies). 27 different measures were used to assess fatigue, of which three were author-developed measures. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life – Short Form (KDQOL-SF) were the most frequently used measures (41 (42%) and 24 (25%) studies, respectively). Six (22%) measures were specific to fatigue (Chalder Fatigue Questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue, Fatigue Severity Scale, and author developed Chen & Ku 1998, and Hao et al 2021) while 21 (78%) included a fatigue subscale or item within a broader construct for example, quality of life. Various content domains assessed included tiredness, ability to think clearly, level of energy, muscle weakness, ability to concentrate, verbal abilities, motivation, memory, negative emotions and life participation. Only two measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Kidney Symptom Questionnaire) were developed specifically for CKD, but they were not specific to fatigue. Six measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Functional Assessment of Cancer Therapy – Anemia, Revised Illness Perception Questionnaire, Kidney Symptom Questionnaire, Short Form 6 Dimension and 36-Item Short Form Health Survey) had been validated in patients with CKD not requiring KRT.
PROMs used to assess fatigue in patients with CKD vary in content and few were specific to fatigue in patients with CKD not requiring KRT. Data to support the psychometric robustness of PROMs for fatigue in CKD were sparse. A validated and content-relevant measure to assess fatigue in patients with CKD is needed.
This article is the first in a series exploring realist research, a methodological approach well suited to the complexity of nursing practice. Unlike traditional approaches such as randomised controlled trials (RCTs) and systematic reviews, which focus on whether interventions work, realist research examines how and why interventions work when implemented in specific groups; reflecting the individualised care nurses provide. By introducing the key concepts of realist research, this article highlights its relevance to nursing and lays the groundwork for using realist research to drive meaningful improvements in healthcare.
Realist research offers a unique lens to examine the complexity of healthcare delivery. While traditional research methods often seek to determine if interventions work or not in controlled environments, realist research seeks to explain how, why, for whom and under what circumstances interventions succeed—or fail—in real-world settings.
FreshRSS 