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Sex and gender reporting and differences in trials evaluating patient decision aids: a secondary analysis of systematic review with meta-analysis

Por: Stacey · D. · Legare · F. · Lewis · K. B. · Smith · M. · Carley · M. E. · Barry · M. J. · Bennett · C. · Bravo · P. · Steffensen · K. D. · Finderup · J. · Gendler · Y. · Gogovor · A. · Gunderson · J. · Kelly · S. E. · Pacheco-Brousseau · L. · Trenaman · L. · Trevena · L. · Volk · R. J. · G
Objectives

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.

Design

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.

Primary and secondary 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.

Results

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

Conclusions

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.

Social Isolation and Loneliness Among Older Asian Immigrants Through the Lens of Sense of Coherence: Systematic Review of Qualitative Studies

ABSTRACT

Aim

To explore the meaning older Asian immigrants attribute to social isolation and loneliness, their management strategies, utilisation of resources and impact on health.

Design

Systematic review of qualitative studies.

Data Sources

AgeLine, CINAHL, MEDLINE, ProQuest, PsycINFO, Scopus, and Web of Science databases were searched in September 2024.

Methods

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.

Results

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.

Conclusion

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.

Implications for the Profession and Patient Care

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.

Reporting Method

The review was undertaken and reported using the PRISMA guidelines.

Patient or Public Involvement

None.

Protocol Registration

PROSPERO (CRD42023425752)

Patient and public involvement and engagement in target trial emulation framework: a scoping review protocol

Por: Egesa · I. J. · Baldwin · F. D. · Wells · M. · Maden · M. · Mbizvo · G. K. · Marson · A. G. · Tudur-Smith · C.
Introduction

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.

Methods and analysis

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 and dissemination

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.

What do patients think about home-based testing for better asthma diagnosis? Insights from a qualitative study

Por: Khatoon · B. · Smith · J. · Fowler · S. · Simpson · A. · Murray · C. · Wang · R.
Background

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.

Objective

To explore patients’ views on performing spirometry and FeNO at home during the asthma diagnostic process.

Design

A qualitative study using semistructured interviews. Data were analysed using the framework approach.

Setting

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).

Participants

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.

Results

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.

Conclusion

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.

Trial registration number

ISRCTN11676160.

Multicentre, adaptive, double-blind, three-arm, placebo-controlled, non-inferiority trial examining antimicrobial prophylaxis duration in cardiac surgery (CALIPSO): trial protocol

Por: Peel · T. · McGiffin · D. · Smith · J. · Forbes · A. · Marasco · S. · Pilcher · D. · Stewardson · A. J. · Petrie · D. · Peleg · A. Y. · Wisniewski · J. · Forster · S. · Druce · P. · Roney · J. · Astbury · S. · Berkovic · D. · Mccracken · P. · Myles · P. S. · on behalf of the CALIPSO Tria
Introduction

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.

Methods and analysis

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 and dissemination

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.

Trial registration number

NCT05447559.

Top 10 research priorities for adolescent and young adult cancer in Canada: a James Lind Alliance priority setting partnership

Por: Tutelman · P. R. · Thurston · C. · Ranger · T. · Rader · T. · Henry · B. · Abdelaal · M. · Blue · M. · Buckland · T. W. · Del Gobbo · S. · Dobson · L. · Gallant · E. · Heykoop · C. · Jansen · M. · Larsen · L. · Maseja · N. · Oberoi · S. · Ramasamy · V. · Smith · M. · Wendowsky · N. · Beattie
Objectives

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.

Design

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.

Setting

A national sample was recruited to participate from across Canada.

Participants

Participants were patients, caregivers, and clinicians with lived personal and/or professional experience of AYA cancer in Canada.

Outcome measures

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.

Results

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.

Conclusions

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.

Understanding Nurses' Needs Regarding Tailored, Evidence‐Based Sleep Education and Training

ABSTRACT

Aim

Identify desired training content for shift-working nurses to improve their sleep and fatigue.

Design

A descriptive qualitative design.

Methods

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.

Results

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.

Conclusions

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.

Implications for the Profession

Identifying themes relevant to nurses may help increase the development and availability of sleep education and training currently tailored for nurses.

Impact

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.

Reporting Method

Standards for Reporting Qualitative Research.

Patient or Public Contribution

No patient or public contribution.

Trial and Protocol Registration

Clinicaltrials.gov, NCT06105307

Impacts of Financial Stress on Mental Health and Wellbeing of Nursing Students: A Systematic Integrative Review

ABSTRACT

Aim

To explore the direct relationship between financial stress and mental health and wellbeing of nursing students and characterise the effectiveness of available support mechanisms.

Design

Systematic integrative review.

Data Sources

Academic Search Complete, CINAHL, Education Research Complete, MEDLINE, ProQuest Central, PsycNET, Scopus and Web of Science were searched in January and October 2024.

Methods

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.

Results

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.

Conclusion

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.

Implications for the Profession

While financial stress cannot be fully eradicated, targeted support for at-risk students can mitigate its impacts, improving their mental health and educational outcomes.

Impact

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.

Reporting Method

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Statement.

Patient or Public Contribution

No patient or public contribution.

Trial Registration: PROSPERO: CRD42024514262

Weathering the Double Storm—Resilience in Chinese Older Cancer Patients With Long COVID: A Qualitative Study

ABSTRACT

Aim

To explore the lived experiences of Chinese older adult cancer patients in Hong Kong navigating the challenges of long COVID.

Design

A descriptive phenomenological study.

Methods

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.

Results

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.

Conclusion

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.

Originality/Novelty

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.

Impact

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.

Reporting Method

The study adhered to the consolidated criteria for reporting qualitative research (COREQ) checklist.

Patient or Public Contribution

No patient or public contribution.

Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA): protocol for a randomised, double-blind, placebo-controlled trial of enhanced primary therapy with obeticholic acid

Por: Dunn · S. · Evans · L. · Kennedy · C. · Wafer · R. · Moody · S. · Wolstenhulme · F. · Burton · E. · Konkoth · A. B. · Fisher · H. · Chadwick · T. · Banham · A. · Hale · F. · Christie · M. · Barclay · S. T. · Dyson · J. · Smith · R. · Aithal · G. · Culver · E. · Aspinall · R. · Thorburn · D.
Introduction

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.

Methods and analysis

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).

Ethics and dissemination

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).

Trial registration number

ISRCTN17176388.

NewbornsInSA multi-omic newborn screening: protocol for a prospective cohort study

Por: Anastasi · L. · Chowdhury · A. · Ashenden · A. · Rozek · T. · Louise · J. · Lam · K. · Skinner · S. · Stallard · K. · Merlin · T. · Schubert · C. · Vogan · A. · Morris · S. · Cohen-Woods · S. · Smith · N. · Ranieri · E. · Saxon · B. · Scott · H. S. · Bratkovic · D. · Barnett · C. P. · Siu · C
Introduction

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.

Methods

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.

Ethics and dissemination

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.

Validity, Reliability and Responsiveness of Wound‐QoL‐14 Quality of Life Questionnaire in Patients With Diabetes Related Foot Ulcers

ABSTRACT

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.

Protocol for a systematic review and meta-analysis of pharmacological and non-pharmacological interventions for chronic pain management in chronic kidney disease

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

Background

Chronic 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.

Objectives

This 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.

Methods

The 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 results

This 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.

Significance

This 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.

Applications of artificial intelligence for real-world evidence generation: a protocol for a living scoping review

Por: Oikonomidi · T. · Raad · H. · Diaz-Decaro · J. · Li · H. · Y Smith · M. · Rivera · D. R. · Liu · W. · Soriano Gabarro · M. · Bennett · D. · Mack · C. D. · Teltsch · D. Y. · Gerber · J. E. · Bray · B. · Dickinson · H. · Jani · M. · Naidoo · N.
Introduction

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.

Methods and analysis

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).

Ethics and dissemination

Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.

Exploring patient navigation services in physical activity for people with chronic conditions in Canada: a rapid review protocol

Por: Cheung · L. · Tseung · V. · Abreu · J. · Park · J. · McKenney · S. · Pinili · K. · Bello · C. · Singh · H. · Smith-Turchyn · J. · Richardson · J. · Tang · A.
Introduction

Adults living with chronic conditions may need to access health programmes to mitigate health-related challenges that persist long after discharge from the hospital. Community physical activity programmes represent critical opportunities for health promotion and chronic disease self-management that can extend beyond hospital-based services. However, navigating the healthcare system and connecting to much-needed physical activity programmes can be challenging due to fragmentation of the health and social care system, especially for those who are transitioning between different healthcare providers, settings, stages of recovery and funding sources (eg, public, private). Patient navigation services can assist with this fragmentation by providing tailored support to individuals with chronic conditions. However, our understanding of patient navigation services in Canada is limited. This rapid review seeks to explore the landscape of patient navigation services supporting Canadians with chronic conditions in connecting to physical activity programmes in the community.

Methods and analysis

The rapid review will follow the recommendations published by Garritty et al in 2024. Integrated Knowledge Translation will be employed to facilitate meaningful engagement of people with lived experience of chronic conditions throughout the entire research process. Studies published in English that examine patient navigation services in physical activity for community-dwelling Canadians with chronic conditions will be included. Ovid MEDLINE, Embase, Emcare, CINAHL and Google Canada will be searched for articles published from 1990 to May 2025 to identify the characteristics, strengths and limitations, and prioritised features of patient navigation services for community physical activity programmes. The Mixed Methods Appraisal Tool will be used to assess the quality of included studies.

Ethics and dissemination

This protocol is a rapid review of published literature and does not require ethical approval. Review findings will be disseminated to various key interest groups through publications, presentations, infographics, social media posts and/or videos.

Registration

https://osf.io/gd2zm.

Identifying innovative models of urgent care in rural coastal areas in England: the Elevate study - a mixed-methods protocol

Por: Lampard · P. · Adamson · J. · Anderson · H. · Ballantine · L. · Bell · F. · Benger · J. R. · Blakey · R. L. · Dickinson · P. · Dykes · S. · Gaughan · J. · Maitland-Knibb · S. · Mensah · D. · Ransome · Z. A. · Richardson · G. · Santos · R. · Sheridan · R. · Sivey · P. · Smith · E. · Song · W
Introduction

Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.

Methods and analysis

The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,

Ethics and dissemination

Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.

Trial registration number

Research Registry (researchregistry11126).

Long-term physical health conditions among UK female veterans: a UK Biobank cohort study comparing male veterans and female civilians

Por: Smith · A. C. · Mckenzie · A. · Godier-McBard · L. R. · Fear · N. T. · Stevelink · S.
Objectives

To examine differences in physical health conditions among female veterans compared with male veterans and female civilians.

Design

Cohort analysis using data from the UK Biobank, incorporating self-reported and hospital-derived health information.

Participants

Veteran status was identified using Standard Occupational Classification codes. The study included female veterans (n=546), male veterans (n=2722) and female civilians (n=66 305).

Outcome measures

Physical health conditions were identified through self-report and hospital records. Multivariable logistic regression models estimated associations between veteran status and selected health conditions, adjusting for age, sociodemographic factors, time in service, body mass index and current smoking status.

Results

Compared with female civilians, female veterans had increased odds of chronic obstructive pulmonary disease (adjusted OR (aOR) 1.79, 95% CI 1.04 to 3.08) and lower odds of hypertension (aOR 0.74, 95% CI 0.59 to 0.93), with no significant difference in musculoskeletal conditions or osteoarthritis. Compared with male veterans, female veterans had significantly higher odds of osteoarthritis (aOR 1.61, 95% CI 1.25 to 2.08), migraine (aOR 2.63, 95% CI 1.66 to 4.19) and thyroid disorders (aOR 4.42, 95% CI 2.83 to 6.89).

Conclusions

Female veterans have distinct physical health profiles, including a greater burden of musculoskeletal and respiratory conditions compared with male veterans and female civilians. These findings highlight the need for targeted prevention and clinical interventions for women with a history of military service.

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