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Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Assessing the impact of the COVID-19 pandemic among internally displaced persons in Burkina Faso, Mali and Niger: a cross-sectional study using respondent-driven sampling

Por: Pham · P. N. · Keegan · K. · Johnston · L. G. · Diallo · D. Y. · OMealia · T. · Goh · M. · Vinck · P.
Objectives

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

Design

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Setting

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

Participants

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

Primary and secondary outcome measures

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Results

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

Conclusions

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

Clinical outcomes of levosimendan administration in veno-arterial extracorporeal membrane oxygenation: a meta-analysis

Por: Zhao · G.-m. · Zhao · G.-m. · Zhang · H. · Chen · W. · Zhou · J.-X. · Li · H.-l.
Objectives

To evaluate the effectiveness of levosimendan in promoting weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with refractory cardiogenic shock through a meta-analysis of clinical trials.

Design

Systematic review and meta-analysis.

Data sources

PubMed, Embase, the Cochrane Library and Web of Science were systematically searched from inception to January 2025.

Eligibility criteria

Studies were included if they were clinical trials comparing outcomes between patients receiving levosimendan and those not receiving it during VA-ECMO support. Eligible studies reported on at least one of the predefined outcomes.

Data extraction and synthesis

Two independent reviewers extracted data and assessed study quality. The primary outcome was successful VA-ECMO weaning. Secondary outcomes included 30-day mortality, in-hospital mortality, duration of ECMO support and length of stay in the intensive care unit (ICU). A random-effects model was used to synthesise data and estimate pooled effect sizes, with heterogeneity assessed using the I² statistic.

Results

Involving 2083 patients across 16 studies, levosimendan significantly improved VA-ECMO weaning success (OR=2.44, 95% CI: 1.72 to 3.48; p2=57%) compared with the control group. Additionally, it notably reduced 30-day mortality (OR=0.48, 95% CI: 0.29 to 0.81; p=0.006; I2=56%) and in-hospital mortality (OR=0.47, 95% CI: 0.26 to 0.88; p=0.02; I2=70%). Noteworthy, however, is the association of levosimendan with prolonged VA-ECMO support (days; n=1314; weighted mean difference (WMD): 2.86, 95% CI: 1.73 to 4.00; p2=60%) and extended ICU stay (days; n=629; WMD: 5.69, 95% CI: 2.19 to 9.20; p=0.001; I2=61%).

Conclusions

Levosimendan improves VA-ECMO weaning success and reduces mortality. Further high-quality randomised controlled trials (RCTs) are required to confirm its clinical benefits in VA-ECMO patients. While the findings consolidate existing evidence favouring levosimendan, they also highlight residual heterogeneity and moderate-to-high risk of bias in several included studies. Therefore, future investigations, particularly well-powered RCTs with robust methodology, may help further delineate its role in specific patient populations.

Incidence and drivers of medication returned to health facilities by patients in low- and middle-income countries: a scoping review protocol

Por: Kutina · C. · Dugle · G. · Bawontuo · V.
Introduction

Medication returned by patients to healthcare facilities is a critical aspect of reverse logistics, intersecting healthcare delivery, patient safety and environmental sustainability, especially in low- and middle-income countries (LMICs) where systemic inefficiencies and socio-cultural factors may exacerbate the issue. While emerging medication return programmes are recognised for their potential to enhance resource efficiency and prevent misuse, they also signal inefficiencies in medical supply chains, prescribing practices and patient-provider interactions. This scoping review aims to systematically map the incidence and drivers of medication returned to health facilities by patients in LMICs.

Methods and analysis

This review follows Arksey and O'Malley’s scoping review framework and the PRISMA-ScR reporting guidelines. Searches will be conducted in Google Scholar, PubMed, CINAHL, Embase, Web of Science and Scopus, supplemented by grey literature sources and reference list screening. Searches will include studies from January 2005 to December 2025 and English-language publications, reflecting both the relevance of recent evidence and practical considerations for screening and analysis. Eligible studies must address the incidence or drivers of medication returned in LMICs and meet predefined inclusion criteria based on the Population, Concept, Context framework. Data will be extracted using a standardised charting form and analysed using narrative synthesis, supported by descriptive statistics and thematic analysis.

Ethics and dissemination

No ethical approval is required as this scoping review will analyse publicly available literature. Findings will be disseminated through peer-reviewed publications, academic conferences and healthcare organisations, with all data and search strategies made openly accessible through Springer Nature’s protocols.io preprint repository to support transparency and future research.

Registration

Springer Nature’s protocols.io dx.doi.org/10.17504/protocols.io.3byl4wd5ovo5/v1.

Time to first optimal glycaemic control and associated factors among adult patients with diabetes at the University of Gondar Comprehensive Specialized Hospital, northwest Ethiopia: a retrospective cohort study

Por: Getahun · A. D. · Ayele · E. M. · Tsega · T. D. · Anberbr · S. S. · Geremew · G. W. · Biyazin · A. A. · Taye · B. M. · Mekonnen · G. A.
Objective

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

Design

A retrospective cohort study.

Setting

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

Participants

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

Outcome measures

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Results

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

Conclusion

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh

Por: Salwa · M. · Chowdhury · S. M. · Rois · R. · Uddin · M. K. · Akhter · S. · Nahar · K. · Mullick · A. R. · Mannan · M. · Kundu · G. K. · Fatema · K. · Maruf Haque Khan · M. · Haque · M. A.
Background

Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

Methods and analysis

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethics and dissemination

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

Trial registration number

NCT06166550.

Australian research priorities for inherited retinal diseases: a James Lind Alliance priority setting partnership

Por: Robertson · E. G. · Hetherington · K. · Prain · M. · Ma · A. · Ayton · L. N. · Jamieson · R. V. · Shepard · E. · Boyd · L. · Hall · J. · Boyd · R. · Karandrews · S. · Feller · H. · Simunovic · M. P. · Grigg · J. R. · Yamamoto · K. · Wakefield · C. E. · Gonzalez-Cordero · A.
Objectives

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

Design

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Setting

Australia-wide.

Participants

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

Outcome measure

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

Results

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

Conclusion

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared with standard colonoscopy in patients at risk of colorectal disease - a study protocol

Por: Ibrahim · H. · Haritakis · M. · Ballantine · L. · McCormack · K. · Cotton · S. · Hudson · J. · Atkin · K. · Rogers · S. · Nixon · L. S. · Verghese · A. · Holmes · H. · Treweek · S. · MacLennan · G. · Dolwani · S. · Gardner · G. · Hurt · C. · Watson · A. · Turvill · J.
Background

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.

Aims and objectives

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

Methods

We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.

Anticipated impact

The study findings will provide the evidence base to inform future colorectal diagnostic services.

Ethics and dissemination

The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.

Trial registration number

ISRCTN16126290.

How do primary care consultation dynamics affect the timeliness of cancer diagnosis in people with one or more long-term conditions? A qualitative study

Por: Valasaki · M. · Carter · M. · Winder · R. · Shephard · E. · Valderas · J. M. · Merriel · S. W. D. · Farmer · L. · Summers · B. · Dean · S. G. · Morgan-Trimmer · S.
Objectives

To explore how pre-existing conditions affect the diagnostic process for potential cancer in primary care patients.

Design

Qualitative interview study using thematic analysis underpinned by a critical realist approach.

Setting

Primary care practices recruited through four Clinical Research Networks and UK health charities across England.

Participants

Interviews were conducted with 75 patients with one or more pre-existing conditions (anxiety/depression, diabetes, obesity, chronic obstructive pulmonary disease, Parkinson’s disease or multiple long-term conditions (four or more)) and 28 primary care professionals (general practitioners and nurses).

Results

The study identified legitimacy as a central theme influencing patient trajectories in the health system while trying to receive a diagnosis for symptoms with which they presented to primary care. Patients engaged in self-triage to determine whether symptoms were ‘legitimate’ enough to seek care. Subsequent triaging steps (by receptionists, nurses and online systems) acted as gatekeepers, with decisions influenced by effectiveness of describing the symptom and subjective impressions. During consultations, clinicians relied on a mix of symptom narrative clarity, medical history and objective ‘metrics’ (eg, blood results, family history) to determine legitimacy for further investigations. Pre-existing conditions could either lower the threshold for referrals or obscure potential cancer symptoms. The stigma associated with mental health diagnoses often undermined perceived legitimacy and contributed to delays.

Conclusions

Legitimacy is continuously negotiated throughout the diagnostic pathway. It is shaped by social, moral and biomedical judgements. To promote early cancer diagnosis for patients with pre-existing conditions, clinicians must make legitimacy assessments explicit, reduce stigma especially around mental health and standardise triage processes.

Transformative learning through communal documentary viewing: a mixed methods study on kidney transplantation and organ donation in medical education

Por: McCaffrey · D. · Corr · M. · Fergie · R. · Courtney · A. · Brown · T. · Gormley · G.
Objectives

To explore how learner transformation manifests in a communal arts and humanities (AH) educational activity for medical students.

Design

Mixed methods explorative study.

Setting

UK-based medical school that follows a 5-year case-based learning curricular model.

Interventions

A group of 105 first-year medical students attended a group viewing of a TV documentary titled, ‘Life on the List’ as part of their core curriculum. The documentary explores the humanistic aspects of kidney disease, organ donation and transplantation by portraying the personal stories of transplant recipients, donors and healthcare professionals. Following the screening, attendees engaged in a question-and-answer session with an expert panel.

Main outcome measures

Perceived transformation of learning was measured using a quantitative Likert-scale paired pre-screening and post-screening questionnaire. Additionally, the qualitative study used facilitated focus groups (FGs) to explore how learners may or may not have transformed their learning based on the AH educational activity.

Participants

Inclusion criteria were: (a) first-year medical students and (b) those who attended the screening. Those not meeting these criteria were excluded. The quantitative questionnaire was completed by 94 participants, while 19 attended FG interviews.

Results

Paired t-tests were conducted to compare pre-screening and post-screening responses across five questions. All results demonstrated statistical significance (phow learning was transformed: (1) an absorbing experience; (2) confronting and challenging: different ways of seeing the world; (3) collective reflection: the power and safety of the crowd; (4) ‘everything just came into perspective’: accepting the world in a new way; and (5) willing to change the world: advocacy and agency. By this collective experience focusing on real patient stories and providing an opportunity for discussion and reflection, participants were offered a holistic view on kidney medicine and transplantation. Overwhelmingly, participants were inspired to strive for person-centred care, with many being motivated to explore kidney medicine and transplantation as career options.

Conclusion

Couched in pedagogy, an AH educational activity for medical students can leverage learner transformation and promote person-centred care. With respect to kidney medicine, organ donation and transplantation, such activities can provide early career exposure to these fields. Students may be inspired to act as positive ambassadors for organ donation and transplantation and further explore these areas as future career options. Further research should investigate AH interventions in diverse groups from a longitudinal perspective to consider long-term effects in promoting holistic and empathetic patient care.

Stunting incidence and reversal as metrics of postnatal linear growth faltering in low- and middle-income countries: a critical appraisal and simulation study

Por: Roth · D. E. · Watson · K. M. · Bassani · D. G.
Objectives

Length-for-age z-scores (LAZ) and stunting prevalence (%LAZ

Methods

We simulated a synthetic cohort with a harmonically downward-shifting LAZ trajectory from birth to 24 months of age, with mean LAZs similar to the HBGDki pooled South Asian cohorts, and without any input parameters intended to differentially affect individuals’ growth across the height distribution or at different ages. We compared HBGDki empirical estimates of age interval-specific frequencies of incident stunting onset and stunting reversal with those from the synthetic cohort. Using synthetic cohorts, we examined how estimates of incident onset and reversal were affected by missing data, magnitude of the whole-population shift in the LAZ distribution and strength of the between-time-point correlation. We also compared the 3–24 month pattern of linear growth faltering expressed as age-related trajectories of average growth delay (chronological age minus height–age), mean LAZ or stunting prevalence.

Results

Empirical estimates of age interval-specific incident stunting onset and stunting reversal in the HBGDki cohorts were similar to those observed in a synthetic cohort. Variability in LAZ threshold-crossing event rates is explained by starting LAZ, between-time-point correlation and the magnitude of the whole-population shift in the LAZ distribution. Incident stunting onset is also affected by missing data in preceding intervals. Stunting reversal occurs due to within-child variability (ie, imperfect between-time-point correlation) in the absence of any other phenomena that cause stunted children to become non-stunted at a later age. The linear growth faltering pattern based on growth delay differed from corresponding age-related trajectories of mean LAZ or stunting prevalence.

Conclusions

In longitudinal studies of linear growth faltering in LMICs, LAZ threshold-crossing indicators are byproducts of whole-population shifts in LAZ and within-child variability and should be interpreted accordingly. Reporting incident stunting onset and reversal rates, or analyses in which children are grouped by the timing of LAZ threshold-crossing events, may detract from efforts to understand when and why nearly all children in LMICs grow more slowly than expected for their age. Since mean LAZ and stunting prevalence are unsuitable for quantifying the rate and timing of population-average postnatal linear growth faltering, growth delay is recommended for consideration as a preferred metric.

Association of type 2 diabetes with reoperation, adverse events and mortality after hip and knee replacement: a Swedish register-based study including 109 938 hip and 80 897 knee replacements

Por: Vinblad · J. · Bülow · E. · Nyberg · F. · Eeg-Olofsson · K. · W-Dahl · A. · Limbäck · G. · Englund · M. · Abbott · A. · DellIsola · A. · Rolfson · O.
Objective

Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

Design

Observational study based on prospectively collected registry data analysed retrospectively.

Setting and participants

Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

Outcome measures

The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

Results

Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

Conclusion

The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

Cohort profile: trajectory of knee health in runners with and without heightened osteoarthritis risk (TRAIL) in Australia--prospective cohort study

Por: De Oliveira Silva · D. · Mentiplay · B. F. · Girdwood · M. · Haberfield · M. J. · Bruder · A. M. · Culvenor · A. G. · West · T. J. · Hill · J. P. · Carey · D. L. · Johnston · R. T. R. · Crossley · K. M.
Purpose

The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Participants

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Findings to date

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Future plans

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.

Determining the indirect costs of suicide in Sweden: a national population-based cross-sectional study, 2010-2019

Por: Wikström · D. · Nystrand · C. · Hadlaczky · G. · Gedin · F.
Objectives

Globally, more than 700 000 people commit suicide annually. In Sweden, the yearly incidence ranges between 1000 and 1500 people, which is higher than the global average. The aim of this study is to estimate the economic burden related to indirect costs that suicide has imposed on Swedish society between 2010 and 2019.

Design

National population-based cross-sectional study.

Participants and setting

All suicides in Sweden between 2010 and 2019, using data from the Swedish National Cause of Death Registry.

Outcomes

Indirect costs associated with suicides, estimated using the human capital approach, including productivity loss over 1-year and lifetime horizons.

Results

Between 2010 and 2019, 1406 to 1591 suicides occurred annually in Sweden, resulting in approximately 26 500 productive life years lost each year. In 2019, the productivity loss due to suicides was estimated at 44 million over a 1-year horizon and 935 million over a lifetime horizon. The corresponding per-person costs were 37 000 and 778 000, respectively.

Conclusions

This study provides valuable insights into the economic burden of suicide on Swedish society. It underlines the potential economic benefits of effective suicide prevention, aligning with previous research highlighting the substantial returns—both monetary and in terms of human well-being—that successful prevention strategies can yield.

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A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

ABSTRACT

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

From bedside to bug side: clinical, haematological and genetic markers of antibiotic-resistant bacterial isolates from children admitted with sepsis in Kaduna State, Nigeria - a protocol for a cross-sectional study

Por: Musa · S. · Aliyu · S. · Abdullahi · N. B. · Khalid · H. L. · Salihu · S. K. · Dahiru · A. U. · Muhammad · A. A. · Abdullahi · K. · Salisu · S. · Gumbi · S. A. · Tanko · Z. L. · Umaru · H. M. · Bello-Manga · H. · Dogara · L. G. · Musa · A. · Usman · I. K. · Lawal · U. W. · Cleary · D. W.
Introduction

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

Methods and analysis

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethics and dissemination

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Understanding Canadian experiences of suicidality during the COVID-19 pandemic: protocol of a pan-Canadian qualitative study

Por: Baharikhoob · P. · Hollenberg · E. · Cuperfain · A. B. · Rudoler · D. · Nicoll · G. · Blumberger · D. · Bolton · J. · Chartier · G. B. · Crawford · A. · Furqan · Z. · Gajaria · A. · Gratzer · D. · Hatcher · S. · Husain · M. I. · Kurdyak · P. · Lam · J. S. H. · Lavergne · M. R. · Marshall
Introduction

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

Methods and analysis

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

Ethics and dissemination

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Effects of an early behavioural change strategy following COPD exacerbation in hospital and outpatient settings in Brazil: protocol for a randomised clinical trial on cardiovascular risk, physical activity and functionality

Por: Kawakami · D. M. d. O. · Karloh · M. · Araujo · G. H. G. · Colucci · M. G. · Pires Di Lorenzo · V. A. · Mendes · R. G.
Introduction

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

Methods and analysis

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

Ethics and dissemination

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Trial registration number

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Phase II randomised controlled basket feasibility trial of a personalised, remotely delivered exercise programme on disease-free survival among early-stage, high-risk cancers: CANFit study protocol

Por: Bullock · A. F. · Cohen · J. · Huang · C. · Jackson · G. · Lind · M. · Pearson · M. · Richardson · G. · Saxton · J. · Twiddy · M. · Wilson · C. · Forbes · C.
Introduction

Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

Methods and analysis

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

Trial registration number

ISRCTN97662203.

"Should be a dynamic tool": Aboriginal and Torres Strait Islander primary health care service staff perspectives on an effective patient reported experience measure (PREM) in Australia - a qualitative study

Por: Chakraborty · A. · Walke · E. · Laycock · A. F. · Piccoli · T. · Matthews · V. · Walpole · R. · Bailie · R. · Burgess · P. · Langham · E. · Larkins · S. · Bainbridge · R. · Brown · B. · Silver · B. · Swaminathan · G. · Smorgon · S. · Turner · N. · Passey · M.
Objectives

The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.

Design

A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.

Setting

Eight partner IPHC services across four Australian states and territories.

Participants

All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.

Results

63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.

Conclusion

Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.

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