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AnteayerBMJ Open

Dengue epidemic alert thresholds for surveillance and decision-making in Puerto Rico: development and prospective application of an early warning system using routine surveillance data

Por: Thayer · M. B. · Marzan-Rodriguez · M. · Torres Aponte · J. · Rivera · A. · Rodriguez · D. M. · Madewell · Z. J. · Rysava · K. · Paz-Bailey · G. · Adams · L. E. · Johansson · M. A.
Objectives

The Puerto Rico Department of Health (PRDH) seeks to identify dengue epidemics as early as possible with high specificity.

Design

Development and prospective application of an early warning system for dengue epidemics using routine historical surveillance data. A weekly intercept-only negative binomial regression model was fitted using historical probable and confirmed dengue data. A range of threshold definitions was explored using three model-estimated percentiles of weekly dengue case counts.

Setting

Dengue is endemic in Puerto Rico with irregular occurrence of large epidemics with substantial impact on health burden and health systems. Probable and confirmed dengue data are routinely collected from all hospitals and private clinics.

Participants

A total of 86 282 confirmed or probable dengue virus cases were reported from 1 January 1986 to 30 June 2024, with an annual mean of 2212 cases (median: 1533; range: 40–10 356).

Primary and secondary outcome measures

The model was fitted retrospectively to mimic real-time epidemic detection and assessed based on sensitivity and specificity of epidemic detection.

Results

The 75th percentile threshold aligned best with historical epidemic classifications, balancing false alarms and missed detections. This model provides a robust method for defining thresholds, accounting for skewed data, using all historical data and improving on traditional methods like endemic channels.

Conclusions

In March 2024, PRDH declared a public health emergency due to an early, out-of-season surge in cases that exceeded the epidemic alert threshold developed in this study. This real-time application highlights the value of these thresholds to support dengue epidemic detection and public health response. Integrating thresholds with other tools and strategies can enhance epidemic preparedness and management.

Randomised controlled study investigating standard dose continuous renal replacement therapy (CRRT) versus low-dose CRRT in critically ill patients with acute kidney injury (AKI): study protocol for a prospective, randomised, controlled, international, mu

Por: Strauss · C. · Sadjadi · M. · von Groote · T. · Booke · H. · Schöne · L. M. · Hegner · C. · Wempe · C. · Meersch · M. · Gerss · J. · Bernard · A. · Haeberle · H. A. · Rosenberger · P. · Rahmel · T. · Unterberg · M. · Adamzik · M. · Arndt · C. · Wulf · H. · Romagnoli · S. · Bonizzoli · M.
Introduction

The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).

Methods and analysis

The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.

Ethics and dissemination

The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

Trial registration number

clinicaltrials.gov (NCT06021288).

Challenges of using and managing medication: a meta-ethnography of the experiences and perceptions of people with intellectual disability and people who support them

Por: Ghosh · I. · Adams · D. · Auguste · P. · Brown · A. · Chaplin · E. · Flynn · S. · Gauly · J. · Gill · P. · Langdon · P. E. · Mahon · D. · Martin · K. · Patterson · S. · Sutherland · D. · Tromans · S. J. · Chen · Y.-F. · Seers · K. · Supporting Medication use In people with a LEarning d
Objective

To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.

Design

A synthesis of qualitative research using meta-ethnography.

Data source

We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).

Eligibility criteria for selecting studies

We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.

Results

We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.

Conclusions

The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.

PROSPERO registration number

CRD42022362903.

Validity evidence for communication skills assessment in health professions education: a scoping review

Por: Dorrestein · L. · Ritter · C. · De Mol · Z. · Wichtel · M. · Cary · J. · Vengrin · C. · Artemiou · E. · Adams · C. L. · Ganshorn · H. · Coe · J. B. · Barkema · H. · Hecker · K. G.
Objective

Communication skills assessment (CSA) is essential for ensuring competency, guiding educational practices and safeguarding regulatory compliance in health professions education (HPE). However, there appears to be heterogeneity in the reporting of validity evidence from CSA methods across the health profession that complicates our interpretation of the quality of assessment methods. Our objective was to map reliability and validity evidence from scores of CSA methods that have been reported in HPE.

Design

Scoping review.

Data sources

MEDLINE, Embase, PsycINFO, CINAHL, ERIC, CAB Abstracts and Scopus databases were searched up to March 2024.

Eligibility criteria

We included studies, available in English, that reported validity evidence (content-related, internal structure, relationship with other variables, response processes and consequences) for CSA methods in HPE. There were no restrictions related to date of publication.

Data extraction and synthesis

Two independent reviewers completed data extraction and assessed study quality using the Medical Education Research Study Quality Instrument. Data were reported using descriptive analysis (mean, median, range).

Results

A total of 146 eligible studies were identified, including 98 394 participants. Most studies were conducted in human medicine (124 studies) and participants were mostly undergraduate students (85 studies). Performance-based, simulated, inperson CSA was most prevalent, comprising 115 studies, of which 68 studies were objective structured clinical examination-based. Other types of methods that were reported were workplace-based assessment; asynchronous, video-based assessment; knowledge-based assessment and performance-based, simulated, virtual assessment. Included studies used a diverse range of communications skills frameworks, rating scales and raters. Internal structure was the most reported source of validity evidence (130 studies (90%), followed by content-related (108 studies (74%), relationships with other variables (86 studies (59%), response processes (15 studies (10%) and consequences (16 studies (11%).

Conclusions

This scoping review identified gaps in the sources of validity evidence related to assessment method that have been used to support the use of CSA methods. These gaps could be addressed by studies explicitly defining the communication skill construct(s) assessed, clarifying the validity source(s) reported and defining the intended purpose and use of the scores (ie, for learning and feedback, for decision making purposes). Our review provides a map where targeted CSA development and support are needed. Limitations of the evidence come from score interpretation being constrained by the heterogeneity of the definition of communication skills across the health professions and the reporting quality of the studies.

Feasibility and acceptability of point-of-care ultrasound delivered by midwives during routine antenatal care in Malawi: a prospective implementation science study

Por: Payesa · C. · Seyama · L. · Chimwaza · Y. · Sindani · F. · Kanise · Y. · Bvutula · E. · Phiri · M. · Nyangulu · P. · Gadama · L. · Kachale · F. · Gadama · G. · Mwale · M. · Yenokyan · G. · Sripad · P. · Hyre · A. · Noguchi · L. M. · Dadabhai · S.
Objectives

To evaluate the feasibility and acceptability of integrating point-of-care ultrasound scan (POCUS) by midwives into routine antenatal care (ANC) services.

Design

Prospective, observational, multiphase, implementation science study.

Main outcome measures

Primary outcomes included the proportion of midwives who completed training and competency checks for basic obstetric scanning using a POCUS device; the feasibility and acceptability of midwife-delivered POCUS from the perspectives of midwives and pregnant women captured on structured questionnaires; and the proportion of scans meeting predefined quality standards. Secondary outcomes included responses to acceptability-related questionnaires administered to midwives and pregnant women.

Setting

Rural, periurban and urban health centres in Blantyre District, Malawi.

Participants

Pregnant women attending ANC and midwives providing care at participating health facilities.

Results

Obstetric registrars trained and mentored 45 midwives, and 42 (93%) completed the training. Most midwives (95%, n=40) found providing POCUS during ANC was feasible and acceptable. Overall, device durability was rated positively. Of the 1499 pregnant women who received a scan, 99% (n=1484) reported that receiving an ultrasound from a midwife during ANC was acceptable. Independent assessors determined that over 70% of the subsample of reviewed scans met minimum quality standards.

Conclusions

Midwife-delivered POCUS is feasible and highly acceptable in diverse antenatal settings in Malawi. These findings support task-sharing models as a means of expanding access to this essential ANC service, particularly in low-resource settings.

Cervical precancer thermal ablation versus LLETZ excision comparative efficacy study in WLWH (TALL Study): protocol for a randomised clinical trial in South Africa

Por: Adams · R. A. · Kelly · H. · Van der Merwe · F. H. · Butt · J. L. · Zwanepoel · J. E. · Botha · M. H.
Background

Cervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15–44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa’s cervical cancer prevention policies.

Methods

Randomised controlled trial in which 420 women living with HIV aged 30–60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events.

Ethics and dissemination

The study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No: M20/11/035) and by the Western Cape Department of Health and Wellness via the National Health Research Database (WC_202109_016). All study procedures comply with the Declaration of Helsinki, South African Good Clinical Practice Guidelines and the Medical Research Council’s ethical guidelines. Trial results will be disseminated through peer-reviewed journals, national and international conference presentations and professional associations. A lay summary will be shared with the Community Advisory Board to guide community-level dissemination.

Trial registration number

Pan African Clinical Trial Registry: PACTR202504820339039.

Effects of antibiotic prescribing for respiratory tract infection on future consultations in primary care: a systematic review and meta-analysis

Por: Adamu · I. · Lambert · A. · Bello · S. · Abdulmalik · F. A. · Marshall · T.
Objectives

Prescribing antibiotics may reinforce patients’ beliefs that antibiotics are needed and increase future consultations for similar symptoms. This review determines the effect of antibiotic prescribing for respiratory infections in primary care on future reattendance.

Design

A systematic review and meta-analysis of randomised controlled trials (RCTs) and cohort studies and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Participants were adults or children presenting with respiratory infection in primary care.

Data sources

MEDLINE (Ovid), PubMed, Embase, the Cochrane Central Register of Controlled Trials, clinical trial registries and grey literature sources were searched from inception until 6 February 2024.

Eligibility criteria

Eligible studies included open-label RCTs or cohort studies of antibiotics compared with no antibiotics in adults or children with respiratory infections. The outcome of interest was reattendance at least 28 days after the initial consultation.

Data extraction and synthesis

Two reviewers independently screened, selected, assessed the quality and extracted data. Separate meta-analyses were presented for RCT and cohort studies and a combined meta-analysis of all studies.

Results

We identified 2128 records and reviewed 48 full texts, of which five met the inclusion criteria. These reported three RCTs (1207 randomised to antibiotics, 672 controls) and three cohort studies (209 138 exposed to antibiotics, 46 469 controls). In the meta-analysis of RCTs, relative risk (RR) of reattendance with antibiotics was 1.10 (95% CI: 0.99 to 1.23), and in cohort studies, RR was 1.21 (95% CI: 0.94 to 1.49). An important limitation is that most studies were in UK primary care.

Conclusion

Evidence suggests prescribing antibiotics for acute respiratory tract infections in primary care probably modestly increases future reattendance for similar conditions. Reducing antibiotic prescribing may help decrease demand for primary care.

PROSPERO registration number

CRD42023470731.

Identifying lifelong factors that impact brain health and functional outcomes in adults with childhood-onset type 1 diabetes: the cognition and longitudinal assessments of risk factors over 30 years (CLARiFY) - diabetes complications study protocol

Por: Brown · A. · Sakowski · S. A. · Moran · C. · Koubek · E. J. · Srikanth · V. K. · Zhao · L. · Collyer · T. · Adamson · C. L. · Northam · E. A. · Beare · R. · Cameron · F. J. · Feldman · E. L.
Introduction

Type 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood.

Methods and analysis

This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children’s Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs).

Ethics and dissemination

The study was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.

Burden of disease using disability adjusted life years in the Middle East and North Africa (MENA) region: protocol of a systematic review

Por: Mathew · S. · Sherif · M. · Al-Rifai · R. H. · Grivna · M. · Östlundh · L. · Devleesschauwer · B. · Adam · B.
Introduction

In the Middle East and North Africa (MENA) region, changing demographic and epidemiological profiles have resulted in a diverse and shifting burden of disease (BoD). Disability-adjusted life years (DALYs), which combine years of life lost (YLL) due to premature mortality and years lived with disability (YLD), offer a valuable metric for assessing disease burden at the national level. While global burden of disease (GBD) estimates provide broad insights, national burden of disease (NBD) estimates offer country-specific data that can better inform tailored health policies and resource allocation. This systematic review protocol outlines our methodology for collating and analysing the NBD estimates in the MENA region using DALYs as the primary outcome measure.

Methods and analysis

This review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will systematically search PubMed, Scopus, Web of Science and EMBASE for studies published from 1993 to 2024 that report national-level DALY estimates for diseases, injuries or risk factors in MENA countries. Eligible studies must report DALY estimates using national methodologies, while studies using exclusively GBD estimates will be excluded. Two independent reviewers will conduct title/abstract and full-text screening, data extraction and quality assessment using Standardised Reporting of Burden of Disease Studies (STROBOD), with disagreements resolved by a third reviewer when necessary.

Ethics and dissemination

Ethical approval is not required for this review as it involves analysis of previously published data. The findings will be disseminated through publication in a peer-reviewed journal and presented at relevant academic and policy forums.

Prospero Registration Number

PROSPERO CRD42024498688.

Tertiary prevention interventions for patients with stroke in African countries: a systematic review

Por: Adam · L. · Unverzagt · S. · Ngeh · E. · Wubete · B. Y. · Frese · T. · Kantelhardt · E. J. · Kroeber · E. S.
Objectives

To summarise the best available evidence on tertiary prevention interventions for patients with stroke conducted in African countries, identify the gaps in stroke prevention research and augment efforts to establish stroke rehabilitation guidelines in African countries.

Design

We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement on the basis of a published protocol.

Data sources

We conducted a systematic search of nine electronic databases, including PubMed, the Cochrane Library and African Index Medicus, published until August 2023 and additionally contacted authors and screened reference lists.

Eligibility criteria

We included randomised controlled trials (RCTs) and prospective cohort studies on African adult patients with a clinical diagnosis of stroke. The primary outcome was global disability, and secondary outcomes were neurologic function scales.

Data extraction and synthesis

Two authors independently screened the search results, with data extracted by one author and verified by a second author. The data were narratively synthesised. A meta-analysis was done using a random-effects model for metric data using standardised mean differences. Risk of bias was assessed using the Cochrane Risk of Bias tool.

Results

Of 3305 publications, 25 studies met the inclusion criteria involving cumulatively 973 patients with subacute and chronic stroke. Two-thirds of the trials were conducted in Nigeria and Egypt. The interventions covered physiotherapeutic, electrophysiologic, psychotherapeutic and transitional care domains with mostly beneficial outcomes. All included studies were RCTs with some concerns about methodologic quality.

Conclusion

This systematic review comprises heterogeneous effective interventions for tertiary stroke prevention mostly conducted in small productive research clusters. There is a growing body of research from African countries covering important fields of stroke rehabilitation, including local adaptations of the rehabilitation process and new knowledge concerning transcranial magnetic stimulation. There remains an urgent need to implement interventions aimed at overcoming barriers to stroke rehabilitation.

PROSPERO registration number

CRD42020159125.

Does the change in Liver Frailty Index over the first week of hospitalisation predict mortality in patients with acute-on-chronic liver failure? A prospective cohort study from a Slovak liver centre

Por: Skladany · L. · Liska · D. · Mesikova · K. · Havaj · D. · Adamcova-Selcanova · S. · Sulejova · K. · Zilincanova · D. · Kohout · P.
Objective

Hospital admissions for advanced chronic liver disease (ACLD) are associated with increased mortality, disability, a decline in quality of life and significant economic costs. Being admitted to the hospital usually indicates a triggering event that disrupted a previously stable condition, leading to decompensation or complications of ACLD. The most acute and severe manifestation of this imbalance is acute-on-chronic liver failure (ACLF), a syndrome representing a critical juncture. Reliable prognostic stratification of patients admitted with ACLF could facilitate the systematic delivery of tailored care, ranging from palliative care to intensive interventions like extracorporeal liver support devices and prioritised liver transplantation. Disease-specific prognostic tools, such as the Model for End-Stage Liver Disease score, are effective but have limitations, particularly in reflecting a patient’s potential for recovery. The concept of the body’s functional reserve in the context of ACLD/ACLF is gaining attention, with the Liver Frailty Index (LFI) potentially emerging as a recommended diagnostic tool.

Methods

Patients were selected from our cirrhosis registry (RH7). The LFI serves as an indicator of the patient’s prognosis. The LFI measurement takes place at two time intervals: on the patient’s admission and after 7 days of hospitalisation.

Results

Our RH7 registry included 154 patients (15.1%) who were diagnosed with ACLF. The primary cause of the underlying ACLD was alcohol-associated liver disease in the majority (79.8%) of cases. The mean value of LFI at admission was 4.50 (± 0.94). When patients with liver cirrhosis were categorised into three subgroups based on the LFI on day 7, survival exhibited a statistically significant decrease (p≤0.05) across all three ACLF grades. This decline in survival was observed from the ‘improved LFI’ cohort, through the ‘stable LFI’ group, to the ‘worsened LFI’ group.

Conclusion

The impact of day 7 LFI on the survival of patients with ACLF is notable. Nevertheless, it does not markedly enhance the predictive capability of the LFI assessed on admission. Consequently, the initial LFI on day 1 continues to be the most valuable and commonly used instrument for promptly recognising individuals with ACLF.

Prevalence of chronic wounds in hospitalised patients in Catalonia, Spain: a multicentre cross-sectional descriptive observational study

Por: Lopez-Jimenez · M. M. · Romero-Garcia · M. · Adamuz · J. · Berbis-Morello · C. · Pons-Prats · M. · Tapia-Perez · M. · Zuriguel Perez · E. · Castro-Navarro · T. · Juve-Udina · M.-E. · Gonzalez-Samartino · M.
Background

Few studies have investigated the prevalence of chronic wounds and the clinical and sociodemographic characteristics of hospitalised patients affected by them. Understanding these characteristics within the inpatient setting can support improved follow-up, inform care strategies, enhance quality and safety and reduce associated healthcare costs. This study aimed to determine the prevalence and the sociodemographic profile of adult inpatients with chronic wounds admitted to the eight hospitals of the Catalan Institute of Health between 2016 and 2020.

Methods

A descriptive, observational, cross-sectional and retrospective multicentre study was conducted using routinely collected clinical data from 1 January 2016 to 31 December 2020. The study encompassed hospital wards, step-down units and home hospitalisation services across eight public hospitals managed by the Catalan Institute of Health, the main public healthcare provider in Catalonia, Spain. The study included all patients aged 18 years or older who were hospitalised with chronic wounds during the study period. The main variables were nursing diagnoses of chronic wound types: pressure injuries (PIs), arterial ulcers (AUs), venous ulcers (VUs), mixed ulcers and diabetic foot ulcers (DFUs), as recorded in nursing electronic health records. Secondary variables included age, sex, reason for admission, unit of admission, hospital type, source of admission and discharge destination. A descriptive and comparative analysis was performed.

Results

Among 796 698 hospitalised patients, 16 935 (2.1%) presented with at least one chronic wound. The most common types of chronic wounds were PIs and AUs. A slight decline in the prevalence of chronic wounds was observed over the study period. Cardiovascular and respiratory conditions were the leading causes of admission among these patients. AUs and DFUs were more prevalent in men, whereas VUs were more frequently observed in women. Patients with PIs had longer hospital stays, higher rates of intensive care unit admissions and increased in-hospital mortality. In contrast, patients with vascular ulcers more often required continued care after discharge (p

Conclusions

Chronic wounds continue to represent a significant healthcare challenge. It is essential to consider the clinical characteristics and health outcomes of hospitalised patients with chronic wounds in order to improve care quality and safety. Further research is warranted to explore the relationship between patient care complexity and the type of chronic wounds present.

Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM): study protocol of a randomised non-inferiority clinical trial

Por: Aebi · P. S. · Adam · L. · Haller · M. · Bardoczi · J. B. · Gencer · B. · Bonnet · F. · Beer · J.-H. · Carballo · S. · Christ-Crain · M. · Feller · M. · Gabutti · L. · Haynes · A. G. · Moutzouri · E. · Chocano-Bedoya · P. O. · Bassetti · S. · Escher · R. · Egger · M. · Poortvliet · R. K.
Introduction

Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy

Methods and analysis

This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints.

Ethics and dissemination

The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal.

Trial registration number

Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158– IDRCB 2022-A02481-42.

Codevelopment of a complex intervention to reduce inequalities in paediatric diabetes secondary care outcomes for children with type 1 diabetes from underserved groups

Objectives

To codevelop (with children and young people with diabetes (CYPD)) an intervention to improve diabetes control and future health outcomes of CYPD from ‘underserved’ groups, to reduce treatment outcome inequalities between different socioeconomic and ethnic groups. To follow Medical Research Council guidance for complex interventions and the COM-B (Capability, Opportunity, Motivation, Behaviour) model for behaviour change intervention development.

Design

In phase 1 (previously reported), we established the evidence base, conducted literature reviews and analysed data from semistructured interviews with CYPD and their carers. In phase 2 (this report), we applied the COM-B framework to identify intervention components; in phase 3 (this report), we evaluated these components, including focus groups with CYPD, their carers’ and healthcare practitioner (HCP) surveys, using the Acceptability, Practicability, Effectiveness, Affordability, Spill-Over Effects, Equity criteria.

Setting

Secondary care; children, young people and their carers’ were approached from two large paediatric diabetes services in England, both with socioeconomically and ethnically diverse underserved populations; paediatric diabetes HCPs were surveyed across four English regions.

Participants

N=69 underserved CYPD (aged 5–19 years) and/or family members took part in interviews; N=48 paediatric diabetes HCP survey respondents (survey 1); N=34 paediatric diabetes HCP survey respondents (survey 2); N=3 young people’s advisory group participants; N=17 underserved CYPD/carers focus group participants; N=9 wider stakeholder participants.

Results

The codevelopment process and integration of COM-B established four elements for an intervention package: (1) an enhanced peer support/mentoring programme; (2) provision of a health and well-being coach to CYPD/families; (3) family/community support to address social and community issues and (4) training for HCPs, including cultural competence, poverty proofing and to emphasise the need for increased sensitivity and better supported communication in work with CYPD from underserved groups.

Conclusions

The Diversity in Diabetes codevelopment work informed an intervention to improve diabetes care in underserved groups, reflecting sociocultural contexts and plausible support options at the individual, community and clinical levels. The ‘Diversity in Diabetes’ programme will next test feasibility and further refine the intervention package in two more paediatric diabetes centres in England.

Pain management training for people with persistent pain and their informal carers (JOINT SUPPORT): multicentre randomised controlled feasibility trial with embedded qualitative study in English musculoskeletal services

Por: Smith · T. · Khoury · R. · Welsh · A. · Crowther · C. · Hanson · S. · Grant · K. · Clark · A. B. · Ashford · P.-A. · Hammond · M. · Pond · M. · Dures · E. · Adams · J.
Objectives

To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a pain management training intervention to support people with persistent musculoskeletal pain and their informal carers.

Design

Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.

Setting

National Health Service (NHS) providers in four English hospitals.

Participants

Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.

Intervention

Control: usual NHS care. Experimental: usual NHS care plus a carer-patient pain management training intervention (JOINT SUPPORT), comprising five, 1-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.

Randomisation

Central randomisation was computer-generated (2:1 Experimental:Control), stratified by hospital and patient-participant age (≤65 years). There was no blinding.

Main outcome measures

Data collected at baseline and 3 months post-randomisation included screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.

Results

A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.

Conclusions

The JOINT SUPPORT intervention was acceptable to patient-carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.

Trial registration number

ISRCTN78169443.

Data availability statement

The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.

Epidemiology of congenital anomalies in the Gulf Cooperation Council countries: a scoping review

Por: Adam · H. · Ghenimi · N. · ElKhalil · R. · Narchi · H. · Elbarazi · I. · Al-Rifai · R. H. · Ahmed · L. A.
Objectives

Congenital anomalies (CAs) are significant contributors to perinatal mortality and morbidity. The epidemiology of CAs in the Gulf Cooperation Council (GCC) countries remains insufficiently explored. This scoping review aims to provide a comprehensive overview of the existing literature on the epidemiology of perinatally diagnosed CAs in the GCC countries.

Design

Scoping review.

Data sources

We searched MEDLINE, Embase, Scopus and Web of Science for articles published between 1 January 2000 and 1 February 2024.

Eligibility criteria

This review included (a) original observational studies such as cross-sectional, cohort or nested case–control studies, which were sourced from general populations, hospital records or registries; (b) published in English between 2000 and 2024; (c) conducted in any of the six GCC countries; and (d) reporting the prevalence or incidence of CAs.

Data extraction and synthesis

Two reviewers independently screened titles, abstracts and full texts for inclusion and extracted data using Covidence software.

Results

In total, 51 studies reporting the epidemiology of CAs in the GCC countries were eligible and thus summarised. Saudi Arabia dominated with nearly two-thirds of the studies, while Bahrain contributed the least. All studies were hospital based and primarily retrospective. The most researched CAs were cleft lip and cleft palate as well as nervous and circulatory system anomalies, whereas the least researched CAs were chromosomal abnormalities, digestive anomalies and urinary system anomalies. The review reported discrepancies in CA rates across the region, ranging from 2.5 to 68.7 per 1000 live births for multiple anomalies. Few studies explored the association between CAs and risk factors; the main factors reported were advanced maternal age, maternal diabetes and consanguinity.

Conclusions

This review summarises the heightened prevalence of CAs in the GCC countries, discrepancies in estimates and gaps in research on specific anomalies. Future research is warranted to explore the association between CAs and various risk factors, thereby enabling the development of targeted preventive strategies.

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