Conectar
We compared the cost-effectiveness of alternative fracture risk assessment strategies for people with intellectual disabilities (ID) aged ≥40 years from a UK National Health Services perspective over a lifetime horizon.
Cost-effectiveness analysis using a lifetime decision-analytical model.
UK primary care, with data from literature and national databases.
People with ID.
Three strategies were assessed: (S1) Risk assessment using the UK QFracture score; (S2) use of IDFracture (a fracture risk prediction tool specifically developed for adults with ID); and (S3) conducting a one-time dual-energy X-ray absorptiometry (DXA) scan in all. S1 and S2 were followed by DXA scan for those at risk. At-risk individuals received treatment according to UK practice (bisphosphonates plus vitamin D and calcium for osteoporosis, and vitamin D and calcium alone for osteopenia).
Direct healthcare costs and quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
In the base case, S2 (ICER: –£2568/QALY) was dominant (ie, less costly and more effective) and S3 (ICER: £1678/QALY) was cost-effective relative to S1 for major osteoporotic fracture (MOF). For hip fracture, S2 (ICER: £32 116/QALY) and S3 (ICER: £49 536/QALY) were not cost-effective relative to S1 under the National Institute for Health and Care Excellence-recommended cost-effectiveness thresholds. Findings from the sensitivity analyses were predominantly consistent with the base-case results. Subgroup analyses showed that age-specific and gender-specific strategies could be used.
For people with ID aged ≥40 years, a proactive approach to risk assessment for MOF is not only clinically beneficial, but also cost-effective.
Co-design of the PREDICT-Kidney online tool by patients, members of the public and healthcare professionals (HCPs), to support the communication of the risk of recurrence following surgical treatment for kidney cancer.
Qualitative co-design study. Using an iterative process, feedback was collected (via workshops), prioritised and implemented.
Online workshops with participants from across the UK were conducted between December 2023 and November 2024.
18 adult participants, including patients surgically treated for kidney cancer, members of the public without a history of kidney cancer and HCPs involved in kidney cancer care.
To produce an online tool to support the communication of risk of kidney cancer recurrence that is easy to use, easy to understand and acceptable to stakeholders. Secondary outcomes are the properties of the feedback collected, including volume and type.
Across nine workshops, 99 discrete feedback items were collected, resulting in 71 actionable changes to the initial prototype tool. Differences in priorities were observed between participant groups, especially around the inclusion of information about competing risks of death. Participants valued the tool for improving consistency of follow-up information, supporting shared decision-making and providing multiple visual formats to communicate risk. Iterative feedback led to refinements in terminology, design, content and delivery, including adjustments to the presentation of recurrence and mortality risk.
A co-design approach was used to improve the PREDICT-Kidney online tool to align with the needs of patients and HCPs. A feasibility study is required to evaluate its use and impact in clinical practice.
To report how mentorship influences the educational experiences and training of doctoral nursing students.
Integrative literature review.
Peer-reviewed journal articles, theoretical works and editorials published in English that focused on doctoral nursing education were included. Papers reporting on mentorship for undergraduate nursing students, nursing faculty, educators, academics or clinical placements were excluded. Data were synthesised into an integrative review, with findings presented as a narrative summary.
Relevant papers published between January 2015 and January 2025 were identified using CINAHL, MEDLINE, Web of Science, Scopus, ERIC and Embase electronic databases. Search date March 10, 2025.
The review included 16 articles, mostly from the United States of America (USA), examining mentoring in doctoral nursing education. Key findings highlighted valued mentor attributes, such as role modelling and expertise, along with benefits like enhanced research skills, academic performance and personal development. Mentoring also positively impacted mentors' creative performance. Barriers included limited mentor access and compatibility issues.
This review highlights essential attributes of effective mentors, balancing relational skills with expertise. Mentorship enhances student research skills, performance and personal development, also benefiting mentors' creativity. Limited access and compatibility issues pose barriers for nurse scholars. Doctoral programmes should prioritise mentor training, culturally responsive practices and equitable opportunities. Investing in mentorship can cultivate confident nurse leaders and scholars.
This review underscores the necessity of structured mentorship within doctoral nursing education. Effective mentorship directly influences student development, enhancing their research capabilities, academic achievements and readiness for professional roles. Prioritising mentor training and implementing culturally responsive mentorship frameworks can foster inclusive environments that better support diverse doctoral students, ultimately strengthening the nursing profession's academic and clinical leadership.
This integrative review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
To explore the views and preferences for advance care planning from the perspectives of residents, family members and healthcare professionals in long-term care facilities.
A qualitative descriptive design.
We conducted semi-structured interviews with 12 residents of long-term care facilities, 10 family members and 14 healthcare professionals. Data were analysed using reflexive thematic analysis. The social ecological model was used to develop implementation recommendations.
We constructed a conceptual model of barriers and facilitators to advance care planning in long-term care facilities, drawing upon four dominant themes from the qualitative analysis: (1) The absence of discourse on end-of-life care: a lack of cultural climate to talk about death, the unspoken agreement to avoid conversations about death, and poor awareness of palliative care may hinder advance care planning initiation; (2) Relational decision-making process is a dual factor affecting advance care planning engagement; (3) Low trust and ‘unsafe’ cultures: a lack of honest information sharing, risks of violating social expectations and damaging social relationships, and risks of legal consequences may hinder willingness to engage in advance care planning; (4) Meeting and respecting residents' psychosocial needs: these can be addressed by readiness assessment, initiating advance care planning in an informal and equal manner and involving social workers.
Our findings show that residents' voices were not being heard. It is necessary to identify residents' spontaneous conversation triggers, articulate the value of advance care planning in light of the family's values and preferences, and respect residents' psychosocial needs to promote advance care planning in long-term care facilities. Advance care planning may alleviate the decision-making burden of offspring in nuclear families.
The evidence-based recommendations in this study will inform the implementation of context-specific advance care planning in Asia-Pacific regions.
Patients and caregivers contributed to the interview pilot and data collection.
Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.
Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.
Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.
Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p
In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.
To explore the meaning older Asian immigrants attribute to social isolation and loneliness, their management strategies, utilisation of resources and impact on health.
Systematic review of qualitative studies.
AgeLine, CINAHL, MEDLINE, ProQuest, PsycINFO, Scopus, and Web of Science databases were searched in September 2024.
Inclusion criteria: participants were Asian immigrants to Western countries aged 65 and over, community-living and experiencing social isolation and loneliness. Antonovsky's Sense of Coherence was used to frame the thematic analysis.
Ten papers were included and analysed deductively using elements of the sense of coherence framework: • Comprehensibility: Social isolation and loneliness are viewed as multifaceted, influenced by cultural and environmental dislocation, language barriers, intergenerational conflicts, deteriorating health and mobility, and socioeconomic challenges. • Manageability: included engaging in culture-specific community programs, family and ethnic community support and living within ethnic enclaves mitigated isolation and loneliness. • Meaningfulness: Strong family ties, active community involvement, spirituality, volunteerism, and cultural practices fostered resilience. However, accepting the changing values of their new world, living independently, and carving their own niche provided meaning to their transformed reality.
Older Asian immigrants experience social isolation and loneliness through a cultural lens, shaped by migration experiences, language barriers, and shifting family dynamics. Cultural roots, family ties, spirituality, community, acceptance, and independence enhance sense of coherence. Recognising the dynamic interplay between cultural identity, resilience, and adaptation is key to understanding their lived experience.
This review informs culturally sensitive interventions, guiding healthcare, community services, and policy to support social participation, mitigate loneliness through ethno-specific activities, and improve the quality of life for aging immigrant populations in Western countries.
The review was undertaken and reported using the PRISMA guidelines.
None.
PROSPERO (CRD42023425752)
Target trial emulation (TTE) has emerged as a methodological framework to strengthen causal inference from observational health data when randomised controlled trials are infeasible. The credibility of TTE studies depends not only on rigorous design and transparent reporting, but also on their relevance and acceptability to patients and the public. Patient and public involvement and engagement (PPIE) has been shown to enhance the relevance, transparency and impact of health research by shaping research priorities, informing study design and ensuring outcomes reflect patient perspectives. However, the extent to which PPIE has been incorporated into TTE studies remains unclear. This scoping review aims to systematically map the use and reporting of PPIE in published TTE studies.
This review will follow the Joanna Briggs Institute methodology for scoping reviews and will be reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews checklist. We will search MEDLINE (Ovid) and Embase (Ovid) from January 2011 to present, limited to English-language publications. Eligible studies will be studies that self-identify as using the TTE framework and report empirical analyses of health outcomes using observational or trial data. We will exclude protocols, methodological or simulation-only studies, preprints, conference abstracts and grey literature. Three reviewers will independently screen titles and abstracts, and then full texts, with disagreements resolved by discussion or adjudication. Data extraction will include study characteristics and PPIE information guided by the Guidance for Reporting Involvement of Patients and the Public 2-Short Form checklist. Findings will be summarised using descriptive statistics, tables, figures and narrative synthesis.
Ethics approval is not required, as this review will use publicly available data. Results will be disseminated through a peer-reviewed publication and presented at conferences.
Asthma is misdiagnosed in one-third of patients . Due to its variable nature, international guidelines recommend performing key diagnostic tests during symptomatic periods or in the morning to improve accuracy. Limited access to timely clinic appointments and community-based diagnostics makes this difficult. Handheld spirometry and fractional exhaled nitric oxide (FeNO) are feasible for home use, enabling timely and flexible testing.
To explore patients’ views on performing spirometry and FeNO at home during the asthma diagnostic process.
A qualitative study using semistructured interviews. Data were analysed using the framework approach.
This prospective observational study was conducted at a National Institute for Health and Care Research Clinical Research Facility, based within a large National Health Service Trust, as part of the Rapid-Access Diagnostics for Asthma (RADicA) study (ISRCTN11676160).
A purposive sample of 15 symptomatic adult patients with general practitioner-suspected asthma who were referred for diagnostic evaluation of the condition; all patients were given home spirometry and FeNO devices during their diagnostic processes.
Three themes emerged from the analysis: ‘Perceived value of, and burdens of home testing’, ‘Views on device usability and acceptability’ and ‘Information and support needs’. Home testing was generally welcomed by patients as a way of improving their understanding of their condition and enabling an accurate diagnosis of their symptoms. Key barriers (eg, testing frequency, lack of privacy) and enablers to improve feasibility (eg, training and support) were also identified.
This study provides valuable insights into the barriers and enablers of home-based diagnostic strategies for asthma. Findings can inform service design and implementation approaches to enhance the feasibility and effectiveness of home testing.
Administration of antibiotics before incising the skin (‘surgical antimicrobial prophylaxis’) is a critical infection prevention strategy in surgery. Extending doses of prophylaxis into the postoperative period is a common practice in cardiac surgery; however, the benefit has not been clearly established and may lead to emergence of antimicrobial resistance and patient harm. We present the protocol for a large international multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial to compare the incidence of surgical site infection after three different durations of postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery.
This adaptive, multi-arm multistage non-inferiority trial will compare intraoperative only (Arm A), to intraoperative and 24 hours (Arm B) and, to intraoperative and 48 hours (Arm C) of intravenous cefazolin and placebo as surgical antimicrobial prophylaxis in 9180 patients undergoing cardiac surgery. The adaptive design allows for potential dropping of any of the three arms if clear inferiority is indicated at any of the scheduled interim analyses. The trial will evaluate the clinical and cost-effectiveness of the three different antibiotic prophylaxis durations.
Ethics approval will be obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. Patients and members of the public will also be involved in the dissemination and translation of the trial results.
Cancer in adolescents and young adults (AYAs; ages 15–39 years) is a rising global epidemic. Yet, AYAs remain an understudied population, and little is known about what research topics should be prioritised according to those with lived experience. The AYA Cancer Priority Setting Partnership (PSP) was established to identify the top 10 research priorities for AYA cancer in Canada according to patients, caregivers, and clinicians.
This project followed the James Lind Alliance (JLA) Priority Setting Partnership (PSP) methodology that included two national cross-sectional surveys and a final priority setting workshop following an adapted nominal group technique.
A national sample was recruited to participate from across Canada.
Participants were patients, caregivers, and clinicians with lived personal and/or professional experience of AYA cancer in Canada.
In the first survey, open-ended responses were collected from participants about questions they would like answered by research. Responses were collated into overarching summary questions and a literature search was undertaken to verify if questions were true uncertainties and not fully answered by existing evidence. Unanswered questions were ranked by participants in a second survey. The top-ranked questions were prioritised through consensus at the final priority setting workshop. The final outcome was the top 10 priorities for AYA cancer research in Canada.
In the initial survey, 1916 potential research questions were submitted by 275 patients, caregivers, and clinicians. Following data processing, summary question formation, and the evidence check, 58 questions were put forward for interim prioritisation in a second survey (n=285 patients, caregivers, and clinicians). The top 20 questions from the interim prioritisation were ranked at the final priority setting workshop attended by a diverse group of 23 patients, caregivers and clinicians from across Canada. The resulting top 10 priorities reflect topics across the cancer continuum including: diagnostic delays, screening and early detection, novel therapies, psychosocial impacts, end-of-life concerns, and survivorship issues.
This patient-directed research agenda will guide researchers, funding agencies, and policymakers to ensure that future research is aligned with what matters most to the AYA cancer community.
Identify desired training content for shift-working nurses to improve their sleep and fatigue.
A descriptive qualitative design.
We recruited night shift nurses (N = 23) to provide feedback during virtual focus groups/interviews. Data collection occurred in the U.S. between March and June 2024. Participants were presented with sleep and fatigue topics derived from the literature. Focus group/interview data were collected and transcribed. Data were analysed using a hybrid deductive-inductive manifest content analysis with an a priori coding schema based on topics shared during data collection. Data not fitting the schema, yet informing content, were analysed inductively.
Three themes aligned with literature-derived topics. Theme 1, Why We Sleep and Why Should Nurses Care, explains the importance of sleep to health. Theme 2, Sleep Practices for Nurses to Support Health and Social Relationships, describes healthy strategies to promote sleep for enhanced quality of life. Theme 3, Fatigue and Work, illustrates the significance of nurse sleep and fatigue risk mitigation to safe working conditions and patient care.
Study findings highlight night shift nurses' interest in gaining evidence-based information to promote their sleep. Sleep education and training could fill a knowledge and skills gap, not often offered in school or workplace.
Identifying themes relevant to nurses may help increase the development and availability of sleep education and training currently tailored for nurses.
Study findings describe content night shift nurses' desire for sleep and fatigue training, serving as an important first step in developing programmes most relevant to shift-working nurses. Our analysis found the findings largely align with key components workers should receive in sleep education and training and reinforced the need for employers to offer such training. This study could benefit the nursing workforce and employers who expect rested, high-functioning nurses to care for patients.
Standards for Reporting Qualitative Research.
No patient or public contribution.
Clinicaltrials.gov, NCT06105307
To explore the direct relationship between financial stress and mental health and wellbeing of nursing students and characterise the effectiveness of available support mechanisms.
Systematic integrative review.
Academic Search Complete, CINAHL, Education Research Complete, MEDLINE, ProQuest Central, PsycNET, Scopus and Web of Science were searched in January and October 2024.
Studies reporting a direct relationship between financial stress and mental health and wellbeing in nursing students were included. Data related to sources of financial stress, mental health impacts, and support mechanisms were extracted, synthesised narratively, and reported thematically.
Findings from nine studies reveal that financial stress significantly affects nursing students' mental health and wellbeing, contributing to emotional distress and reduced quality of life. Financial stress arises from personal, academic and clinical sources, with the intensity varying based on individual demographic profiles and fluctuating throughout their educational journeys. Marginalised and underserved groups experience greater impacts due to pre-existing disadvantages. Current support mechanisms are largely reactive, providing only short-term relief and failing to address root causes. Additionally, students' efforts to alleviate financial stress in one domain often exacerbated it in another.
This review highlights the multifaceted and compounding effects of financial stress on nursing students' mental health and wellbeing. Proactive strategies, including structured employment programs, embedded financial literacy education, and transparent pre-enrolment information offer promising solutions.
While financial stress cannot be fully eradicated, targeted support for at-risk students can mitigate its impacts, improving their mental health and educational outcomes.
This review addresses the critical issue of financial stress among nursing students, highlighting its disproportionate impact on marginalised and underserved groups. It underscores the need for proactive interventions and systemic reform to improve educational experiences globally.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Statement.
No patient or public contribution.
Trial Registration: PROSPERO: CRD42024514262
To explore the lived experiences of Chinese older adult cancer patients in Hong Kong navigating the challenges of long COVID.
A descriptive phenomenological study.
Semi-structured interviews were conducted with 27 purposively sampled older Chinese cancer survivors in Hong Kong between January 2023 and January 2024. Data were analysed using Colaizzi's thematic analysis method.
Four key themes emerged: (1) the invisible scars of COVID-19: unrecognised and diverse symptoms; (2) the double-edged sword of protection: shielding from COVID-19 while battling cancer and long COVID; (3) forging strength in the crucible: adapting and thriving with cancer and long COVID and (4) nurturing resilience: the integral role of nursing in supporting cancer patients with long COVID during a pandemic.
Older Chinese cancer patients with long COVID experience a dual burden of unrecognised physical symptoms and profound psychological distress from isolation. Despite this, they demonstrate remarkable resilience, a process that can be actively supported through specialised nursing care.
This study offers original contributions to the limited literature on the intersection of cancer, long COVID, and ageing. It provides in-depth insights into the lived experiences of this vulnerable population, highlighting the diversity of long COVID symptoms, the psychological impact of pandemic-related precautions, and the crucial role of nursing in fostering resilience.
This study highlights the urgent need for nurses to recognise the unique challenges of this population. It provides a foundation for developing nurse-led, resilience-focused interventions that integrate tailored education, emotional support, and resource navigation into oncology care. These findings can inform practice and policy to better support the well-being of a vulnerable and growing patient demographic.
The study adhered to the consolidated criteria for reporting qualitative research (COREQ) checklist.
No patient or public contribution.
Primary biliary cholangitis (PBC) is a rare chronic cholestatic disease that despite current therapy has significant ongoing unmet needs, including risks of cirrhosis and life-impairing symptoms. The current treatment approach is a step-up model, wherein first-line therapy, ursodeoxycholic acid (UDCA), is given for a minimum of 12 months before the addition of second-line therapy is considered for non-responding patients. This ‘waiting to fail’ approach, focused on the needs of low-risk patients, allows, we postulate, a key process of biliary epithelial cell (BEC) senescence to become established, driving accelerated bile duct loss and aggressive disease. Preclinical mouse modelling has shown that early use of the farnesoid X receptor agonist obeticholic acid (OCA), currently only used as second-line therapy following UDCA failure, reverses BEC senescence, changing the clinical course of disease. Here, we describe the design of the Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA) trial. The aim of OPERA is to explore a new paradigm for disease-modifying treatment of PBC: risk-informed early treatment stratification, with patients at increased risk offered UDCA and OCA combination with the goal of complete biochemical remission.
OPERA is a multicentre, randomised, double-blind, placebo-controlled trial of OCA in combination with UDCA, as first-line treatment for high-risk PBC. This is a multicentre trial in England, which will be undertaken in specialist clinics in secondary/tertiary referral centres (or as per local set up). These centres will be specialists in the area of PBC management and will manage patients from across their local region. OPERA will recruit and randomise 106 adults, within 6 months of PBC diagnosis, who are at an enhanced risk of non-response to standard first-line therapy, between either: (1) UDCA and OCA or (2) UDCA and matched placebo in a 1:1 ratio. The primary efficacy outcome measure is the percentage of participants showing normalisation of serum alkaline phosphatase and total bilirubin values at 26 weeks (disease remission).
Favourable ethical opinion was received from London – Riverside Research Ethics Committee (reference: 22/LO/0878). Potential participants will be fully informed of their rights and the benefits and harms of the trial by the research team before giving informed consent to participate in the trial. Results will be disseminated in peer-reviewed publications, at national and international conferences, in peer-reviewed journals and to participants and the public (using lay language).
Newborn bloodspot screening (NBS) is freely and universally available to babies born in Australia, with nearly 300 000 newborns screened each year. The NBS programme screens for approximately 30 conditions; however, there are hundreds of childhood conditions that could be treated if identified earlier and asymptomatically. Contemporary screening platforms have relied on mass spectrometry-based technologies, limiting surveillance to conditions with validated biomarkers detectable within the neonatal period. Advancements in metabolic techniques and genomics have expanded the range of conditions that could be detected. The NewbornsInSA research study will develop, validate and evaluate a novel multi-omic model of newborn screening, integrating metabolomic and genomic newborn screening as complementary methodologies.
Parents can opt in to additional NBS through NewbornsInSA during pregnancy or shortly after birth. One thousand prospectively recruited families will be offered genomic NBS by whole-genome sequencing, including analysis of a virtual gene panel of over 600 genes, and concurrent metabolomic screening. Clinically actionable pathogenic or likely pathogenic genetic variants will be reported to parents and whole genome sequencing data will be available on request for diagnostic reanalysis, if required later in life.
Acceptability of the NewbornsInSA programme will be evaluated through stakeholder engagement activities with healthcare professionals, members of the public and patient advocacy groups. Family experiences will be assessed using online surveys. The diagnostic yield, accuracy and the costs and consequences of the multi-omic NBS model will be assessed by comparison to standard-of-care NBS.
NewbornsInSA will investigate the acceptability, feasibility and cost-effectiveness of a multi-omic newborn screening model in a prospectively recruited South Australian population. We hypothesise that this approach will increase the number of conditions identified, reduce the time to diagnosis and facilitate earlier care with better outcomes for newborns with genetic conditions.
This research study has been ethically approved by the Women’s and Children’s Health Network Human Research Ethics Committee (2022/HRE00258 and 2023/HRE00236). Findings will be disseminated through peer-reviewed publication and conferences.
Diabetes related foot ulcers (DFU) are associated with significant physical, psychological and social dysfunction. Measuring the impact of treatments on patients' overall well-being is vital to ensure care is holistic. This study aimed to validate the Wound-Qol-14 quality of life assessment tool in people with a DFU. A single centre longitudinal prospective validation study in people with DFUs was conducted. Wound-Qol-14, Diabetic Foot Ulcer Scale—Short Form (DFS-SF) and EuroQol 5 dimensions 5 levels (EQ-5D-5L) were completed by people with DFUs at baseline and 6 months. Wound-Qol-14 was repeated within 7 days of the first questionnaire. Correlation coefficients with a cut off of ≥ 0.7 were used to assess convergent validity, divergent validity and responsiveness to changes in DFU severity. Reliability was assessed using Cronbach's α. The study aimed to recruit 100 people. One hundred and seven people were recruited. The mean age was 62 (SD 13) years and 85 (79.4%) were male. The mean DFU duration was 30 (SD 83) days and the mean DFU area was 6.2 (SD 10.7) cm2. Convergent validity was demonstrated in all domains of Wound-Qol-14 and DFS-SF (r − 0.695 to −0.799) except burden/bothered about ulcer care domains (r = −0.443). There was moderate correlation between Wound-Qol-14 domains and EQ-5D-5L dimensions (r = 0.477–0.501). Cronbach's α ranged from 0.683 to 0.919 for the domains of Wound-Qol-14. Wound-Qol-14 was not responsive to changes in DFU severity (r = −0.291; 95% CI −0.501 to −0.048) but was responsive to healing status (healed 1.14 [IQR 0.86] vs. unhealed 1.86 [IQR 1.47]; p = 0.017). Wound-Qol-14 is a valid and reliable tool to measure disease-specific quality of life in people with DFUs. Further work is needed to refine the responsiveness. EQ-5D-5L should be used to measure generic quality of life in people with DFUs.
by Chi Peng Chan, Babaniji Omosule, Courtney Lightfoot, Ellesha A. Smith, Ffion Curtis, James O. Burton, Paul Gardner, Sarah Jasat, Sherna F. Adenwalla, Jyoti Baharani, Daniel S. March
BackgroundChronic pain affects up to 60% of people with chronic kidney disease (CKD), yet remains under-recognised and under-treated. Pain management in this population is complicated by altered drug pharmacokinetics, polypharmacy, and the potential nephrotoxicity of conventional analgesics. Despite the high prevalence and significant impact on quality of life, evidence-based guidance specific to pain management in CKD remains limited.
ObjectivesThis systematic review aims to evaluate the effectiveness and safety of both pharmacological and non-pharmacological interventions in reducing chronic pain intensity among people with CKD on dialysis, not on dialysis, and kidney transplant recipients, across all stages of CKD.
MethodsThe primary outcome is the effectiveness of interventions in reducing chronic pain intensity as assessed by pain assessment tools. We will conduct a comprehensive search of MEDLINE, Embase, CINAHL, Web of Science, and ClinicalTrials.gov from their inception to the present date to identify studies for chronic pain management in people living with CKD. Study screening will be conducted independently by two reviewers. One reviewer will extract data from each study, with a second reviewer cross-checking for accuracy and completeness. Data will be extracted on study characteristics, participant demographics, intervention components, pain outcomes, and adverse events. The certainty of evidence will be evaluated independently by two reviewers using the GRADE approach. Where applicable, data will be combined in meta-analyses using random-effects models. Additionally, a network meta-analysis will be performed if enough studies are available.
Expected resultsThis review will synthesise the current evidence for pain management strategies in CKD, by evaluating effectiveness of interventions among people receiving different renal replacement therapy modalities with varying pain and disease phenotypes. Findings will highlight the comparative effectiveness of various interventions while considering their safety profiles specific to the CKD context. The review will identify gaps in the literature and provide recommendations for clinical practice and future research.
SignificanceThis review seeks to deliver a thorough evaluation of pain management strategies for people living with CKD. This systematic review is supported by the UK Kidney Association (UKKA), and findings will inform the upcoming UKKA guideline on symptoms management in people with CKD, alongside the other symptoms including itch, fatigue, and gastrointestinal symptoms. This review will aid clinicians in making well-informed decisions regarding pain management strategies, ensuring a balance between effectiveness and the specific risks associated with CKD.
Artificial intelligence (AI) is rapidly evolving, offering an expanding suite of capabilities that go beyond the traditional focus on prediction and classification. Generative AI (GenAI) and agentic AI could create transformative practices to support real-world evidence (RWE) generation for health research by streamlining studies, accelerating insights and improving decision-making. However, there is no published overview available describing the range of applications in RWE generation. This review aims to describe where and how genAI and agentic AI are applied across the domains of healthcare research tasks for RWE generation. Additionally, to map applications by tasks and methods across the product lifecycle continuum, and to identify emerging gaps and opportunities.
This Living Scoping Review (LSR) will include studies reporting an application and/or evaluation of genAI or agentic AI applied to one or more RWE generation research tasks. Searches will be conducted in Embase, MEDLINE and additional sources (eg, grey literature). Citations will be independently screened by two human senior reviewers for a substantive training dataset and a commercially available screening algorithm (Robot Screener) will complete screening with a human reviewer. The LSR will include reports of studies (primary or reviews) describing and/or evaluating the application of any genAI model for RWE generation in healthcare, in English, published from 1 January 2025 to the date of search. Data will be extracted from all studies included in the LSR by one independent senior reviewer using a piloted template, with 10% quality check by a second senior reviewer. Descriptive statistics will be used to summarise the applications of genAI per RWE research task, and the results of genAI evaluations. Thematic analysis will be used to describe genAI application patterns, trends, gaps and opportunities. The LSR protocol and reports will be updated annually, and findings will be published on a publicly available website (eg, ISPE—the International Society for Pharmacoepidemiology).
Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.
FreshRSS 