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Understanding the patient perspective is crucial for enhancing healthcare delivery and outcomes for chronic conditions like diabetic foot ulcers. This qualitative study examined the perspectives of patients with diabetic foot ulcers to inform clinical strategies for both physicians and current patients to enhance care and prevent lower extremity amputations. Fifteen patients with a history of diabetes and diabetic foot ulcers and/or amputations participated in semi-structured interviews which explored their lived experiences and advice for both physicians and fellow patients to improve diabetic foot ulcer related care. Interview transcriptions were analysed to identify recurring themes. Advice for physicians emphasised increasing patient education, initiating preventive foot care at the time of diabetes diagnosis, providing instructions for managing diabetic ulcers early and demonstrating empathetic bedside manner. Advice for fellow patients focused on adopting healthy lifestyle practices, regular foot self-examinations, consistent blood glucose monitoring, medication adherence and seeking prompt medical attention for new or worsening foot lesions. Participants also stressed the importance of routine check-ups with providers to support prevention and management efforts. This qualitative study highlights the value of incorporating patient perspectives to improve our understanding of diabetic foot ulcer onset, care and outcomes and thereby reduce the risk of lower extremity complications.
Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.
Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.
Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.
CRD420251001413.
Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.
This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).
As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.
CRD42025616291.
Fibrosing interstitial lung disease (F-ILD) are a heterogeneous group of diseases with multiple subtypes. Both idiopathic pulmonary fibrosis and other ILDs associated with a risk of developing progressive pulmonary fibrosis (PPF) are subtypes of this category. A multidisciplinary team discussion, including a chest high-resolution CT (HRCT), is usually considered the gold standard for diagnosis of F-ILD. Repeated HRCT is one of several established methods to assess progression and thus development of PPF, but it is associated with substantial costs and radiation exposure. Thoracic ultrasound (TUS) and other ultrasound (US) methods have emerged as radiation-free methods for both diagnosing and monitoring disease severity in F-ILD. Yet, consistent knowledge on the use of different TUS- and US methods in patients with F-ILD is limited.
The LORD study is a prospective cohort study conducted in participants with F-ILD at a tertiary ILD centre in Denmark. Physiological testing and patient-related outcome measures, together with TUS- and US examinations, will be performed at inclusion, after 6 and 12 months. The correlations between these assessments will be evaluated. HRCT will be conducted between 3 months prior to and 1 month after baseline, and after 1 year. At least 34 participants will be included.
The protocol was approved by the Danish Data Protection Agency (journal number: 22/45135) and the Science Ethics Committee for the Region of Southern Denmark (journal number: S-20220036). Results will be published in peer-reviewed international journals and will be presented at an international congress.
Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.
This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.
The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.
Colon cancer (RC) patients holding an intestinal stoma recorded lower health-related quality of life (HRQOL) levels. Intestinal stoma leads to several difficulties, like travel, work, and sporting activities. Patients with an intestinal stoma frequently experienced changes in their HRQOL. The COH-QOL-Ostomy questionnaire comprehensively measured these changes across physical, psychological, social, and spiritual domains. We reviewed literature in order to assess any differences in HRQOL between females and males and between intestinal stoma permanence among these patients. We conducted a literature review from: British Nursing Collection, Embase, MEDLINE, Nursing & Allied Health Database, PubMed, Scopus and Web of Science databases, without any time limits. The protocol was registered with PROSPERO no. CRD420251040414. A total of 492 records were identified. Of these, 362 records were removed, obtaining 130 potential records. However, 126 of these were excluded as they did not meet the inclusion criteria including only 4 records for further analysis. The COH-QOL-Ostomy questionnaire has been considered to assess HRQOL total score and its related sub dimensions, specifically physical, psychological, social and spiritual well-being. For each item, a Likert scale has been associated raging from zero (worse outcome) to 10 (good outcome). A total of 915 observations were collected, specifically 401 related to females and 514 to males. Additionally, a total of 670 observations were recorded: 338 belonging to the temporary group and 332 to the permanent one. Data reported a significant difference in the Psychological Well Being dimensions between the two groups, in favour of the female group (t = −3.66; p = 0.035). Considering the ostomy permanence, the temporary group reported a significant and better total quality of life score (t = −7.53; p = 0.017), Psychological Well Being dimension (t = −5.24; p = 0.035), and in social dimension (t = −8.09; p = 0.015), too. Sex-related differences in HRQOL assessments could help patients to achieve the most appropriate interventions to ameliorate QOL perceptions. Permanence criteria for ostomy could better address healthcare professionals for a specific clinical pathway to improve, especially in social support, which could positively contribute to better self-care for these patients.
To investigate the effects of organisational interventions on the incidence, healing and management of pressure injuries in adult patients in acute hospital settings.
Systematic review.
The review included adult patients at risk of or with pre-existing pressure injuries in acute hospital settings, excluding mental health units, emergency departments or operating theatres. Interventions employed in the included studies were categorised using the Cochrane Effective Practice and Organisation of Care taxonomy.
Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase, EBSCO CINAHL Complete and Web of Science Core Collection were searched from 01 January 2012 to 31 December 2023.
Of 8861 records identified, 7 prevention studies met the inclusion criteria. Six studies reported reductions in pressure injury incidence. Included studies employed various combinations of 14 organisational strategies to enhance practices. Educational interventions were utilised in six studies, including educational meetings, materials and outreach visits. Other common strategies included audit and feedback, communities of practice and continuous quality improvement. The interventions targeted patients and clinicians, primarily nurses, with some involving multidisciplinary teams. The focus was on enhancing healthcare practices through systematic approaches and stakeholder engagement.
Organisational strategies targeting both patients and clinicians as part of an intervention bundle may enhance the prevention of pressure injuries in acute hospital settings. Further, high-quality effectiveness–implementation hybrid trials are required to evaluate these strategies.
Organisational factors influence clinicians' ability to implement evidence-based practices. The effectiveness of specific organisational strategies in acute settings is uncertain. Multiple organisational strategies targeting patients and clinicians may improve the implementability of a pressure injury prevention intervention.
This study adhered to PRISMA guidelines.
Neither patients nor the public were directly involved in this study.
Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.
The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.
Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.
For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.
The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.
This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.
The Infant Gut Bacterial Study in Nigeria (INBUGS-NG) investigates how delivery mode, antibiotic exposure, feeding practices and environmental factors shape gut microbiome development and acquisition of antibiotic resistance genes (ARGs) during the first year of life in northern Nigeria.
Between February and July 2024, 90 mother–infant dyads were enrolled at a tertiary hospital in Kano city, Nigeria. This was a prospective longitudinal cohort with follow-ups at 10 scheduled time points: days 0, 1, 3, 5, 7, 14, 28, 90, 180 and 365. We also intensified stool sampling after infant antibiotic administration, enabling dense early-life sampling. To date, the cohort has contributed 480 infant stool samples, 232 maternal rectal swabs, 254 breast milk samples and 806 environmental samples (total 1772). In parallel, socio-demographic, clinical and cultural data were collected using Research Electronic Data Capture (REDCap) and household visit diaries.
Baseline data show that 84/90 mothers (93.3%) received postpartum antibiotics, and 26/90 infants (28.9%) received antibiotics within the first 3 months of life. Only 8% of infants were exclusively breastfed, with early water supplementation common. Caesarean deliveries accounted for 25% of births, and the mean gestational age was 38.5 weeks. Across the cohort, high retention was achieved, and the study has generated a unique long-read metagenomic resource from an African infant population, with analyses ongoing.
Shotgun long-read metagenomic sequencing (Oxford Nanopore) will enable strain-level and plasmid-level profiling of microbial communities and ARGs. Planned analyses include associations between early-life exposures and resistome dynamics, as well as cross-cohort comparisons with a parallel study in Pakistan. Follow-up will continue through 12 months.
We investigated symptoms reported before and after heart failure (HF) diagnosis and their associations with 3-month hospitalisation and mortality.
To examine associations between symptoms recorded in primary care and short-term hospitalisation and mortality in HF patients.
Landmark analysis using Royston-Parmar survival models at baseline (diagnosis), 6 and 12 months post-diagnosis.
Primary care database (Clinical Practice Research Datalink) linked to hospital and mortality data (1998–2020).
Adults (>40 years) with a first HF diagnosis.
Shortness of breath, ankle swelling, oedema, fatigue, chest pain, depression and anxiety in the 3 months before diagnosis and at 6 and 12 months.
3-month all-cause hospitalisation and mortality; secondary outcomes included HF and non-cardiovascular hospitalisation.
Among 86 882 HF patients (62 742 and 54 555 surviving to 6 and 12 months, respectively), the magnitude of symptom risk varied by timepoint. Specifically, the symptoms with the strongest associations with adverse outcomes were: depression for all-cause hospitalisation at diagnosis (HR: 1.26; 95% CI 1.15 to 1.39) and 6 months (1.46; 1.25 to 1.70); ankle swelling for mortality (1.49; 1.14 to 1.94) at 6 months and SOB for HF hospitalisation (1.18; 1.12 to 1.26) at diagnosis and 12 months (1.99; 1.68 to 2.35).
Symptoms persisted and were more prominent at 6 and 12 months post-diagnosis than at diagnosis.
by Erschena Reichle, Martin Frei-Erb, Sven Streit
The shortage of general practitioners (GPs) and the aging workforce of established GPs in Switzerland are persistent. Furthermore, data on GPs with additional training in complementary medicine (CM) are lacking. This study aimed to obtain information on GPs with training in CM. A nationwide cross-sectional study was conducted using an anonymous online survey to assess the demographics, practice structures, workloads, and future perspectives. The participants were members of four CM societies representing doctors with CM certificates (n = 1,067) in traditional Chinese medicine/acupuncture (TCM/A), homeopathy (HOM), anthroposophical medicine, and phytotherapy. Overall, 206 GPs were included and divided into three groups: TCM/A (n = 73), HOM (n = 76), and others (n = 57). Most participants were male, and approximately half worked in double or group practices. They worked an average of 36 h per week, which had decreased by 13 h over the past 5 years, with plans for further reduction in the future. Approximately 18% planned to continue working beyond the retirement age, and 4% wanted to retire before that age. The majority expressed optimism about the future of CM in Swiss healthcare but less for individual CM disciplines. Compared to the 2015 Swiss Workforce Study, more CM GPs were female, worked less often in group practices, made fewer house calls, and were more optimistic about the future. CM-GPs in Switzerland face the same challenges as conventional GPs. National action and collaboration are needed to improve working conditions and to address the trend towards part-time work and an ageing workforce to safeguard healthcare for the population.People with disabilities are underrepresented in clinical trials, which impacts generalisability and ethical integrity of results. Despite international mandates to diversify participants, there is a lack of guidance on how to make trials disability-inclusive. This scoping review identifies and synthesises guidance, practices and recommendations supporting the inclusion of people with disabilities in clinical trials.
We conducted a scoping review following the Arksey and O'Malley framework and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses for scoping reviews.
Medline (OVID) and Public Affairs Information System Index (October 2024) searches identified peer-reviewed articles. Grey literature was identified through targeted advanced Google searches and website reviews (February–March 2025). Google Scholar was searched to identify recently published documents between March and April 2025.
Documents with guidance or policies related to inclusion of people with disabilities in clinical trials published in English from 2019 to 2025 were included.
Two independent reviewers screened titles, abstracts and full texts and extracted data, with adjudication by a third reviewer.
A total of 69 documents met inclusion criteria. Thematic synthesis identified eight recommendation domains: (1) inclusive and universal trial design, (2) accessible recruitment, (3) inclusive data collection, (4) equitable data analysis, (5) accessible reporting and dissemination, (6) ethical oversight and institutional review board inclusion, (7) supported and accessible consent processes and (8) the inclusion of people with disabilities as researchers and stakeholders. Themes cutting across all domains included guidance emphasising universal design, anti-ableist frameworks, supported decision-making, flexible protocols and engagement with disability communities.
Disability-inclusive clinical trials are essential to ensure the validity of clinical trial results, uphold ethical responsibilities and advance health equity. While emerging frameworks offer direction on how to include people with disabilities in trials, current implementation remains inconsistent and largely voluntary. Clear, enforceable standards are needed to support governments, ethics boards, institutions and funders in making clinical trials more disability-inclusive.
Involuntary sterilisation, the non-consensual medical control of an individual’s fertility, is recognised by the WHO, United Nations High Commissioner for Refugees and UN Women as a serious human rights violation and form of gender-based violence. Survivors of involuntary sterilisation who can prove they were sterilised in their countries of origin have a legal path to asylum in the USA. This study aims to describe the experiences of women seeking asylum in the USA who were subjected to involuntary sterilisation in their countries of origin.
Semistructured, first-person interviews.
A New York City-based medical human rights programme.
14 adult women who experienced involuntary sterilisation at an average age of 27 years old in their countries of origin (79% from Honduras, 14% from Guatemala, 7% from Mexico) before applying for protected immigration status in the USA.
Inductive qualitative analysis identified common themes across participants including shared experiences of discrimination due to race/ethnicity, exposure to lifelong violence in women’s home countries, involuntary sterilisation during antepartum and intrapartum care, lack of informed consent, psychological symptoms, delayed discovery, an appreciation for more responsive healthcare in the USA and a desire to have additional children. Of note, only 43% of participants were aware that they had been sterilised and were therefore eligible for asylum when they entered the USA. 71% of participants had been granted protected status in the USA at the time of interview; 29% were engaged in the asylum process.
The results of the study can inform clinicians about the impact of involuntary sterilisation, heighten awareness of this violation in the context of gender-based violence as a nexus for asylum and advance advocacy in healthcare and policy. Results suggest women would benefit from more comprehensive screening for involuntary sterilisation before and during the asylum process, as well as culturally-responsive and trauma-informed support.
PRELUCA is a randomised, intervention, non-inferiority study designed to use real-time, longitudinal circulating tumour DNA (ctDNA) measurements to evaluate the efficacy of immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). The primary outcome is overall survival between the two groups: the standard of care group (computer tomography scan evaluation) and intervention group (ctDNA evaluation).
The inclusion and exclusion criteria align with European Society for Medical Oncology treatment guidelines and permit broad inclusion of NSCLC patients, ensuring ‘real-world’ representativeness. The study uses a tumour-informed method, using baseline next generation sequencing analyses to design patient-specific droplet digital PCR assays, which are run with collected blood samples 1 week prior to the intended treatment, enabling real-time evaluation via ctDNA Response Evaluation Criteria in Solid Tumours.
Inclusion began in July 2023 and patients are now being actively included in five locations across Denmark. Approval by The Committee on Health Research Ethics of Region Zealand was gained on 4 May 2023.
To explore how public health nurses at child and family health clinics work to prevent maltreatment and the experiences of public health nurses in the maltreatment prevention efforts.
Child maltreatment is a serious societal issue with major consequences. Preventive efforts are increasing and have broad political support. A key objective of the child and family health clinic services is to prevent, identify, and stop maltreatment, abuse, and neglect. National clinical guidelines outline, in general terms, how such work should be conducted. However, limited research exists on how public health nurses prevent maltreatment and the effectiveness of their methods.
A qualitative and explorative design was used, based on semi-structured interviews with 14 public health nurses conducted as part of the project ‘Public Health Nurses in Child and Family Clinics' Role in Preventing and Detecting Child Maltreatment’ at Oslo Metropolitan University. The interviews were carried out between August and November 2021. We used qualitative content analysis with an inductive approach to analyse the data.
Three main categories were developed: 1. Structure and system: weaving prevention into daily practice; 2. To dare and endure: a negotiation of courage and understanding, and 3. To empower and uphold: the goal of strengthening and supporting parents. The results show the importance of early intervention, barriers to discussing maltreatment with parents, and the importance of building trust and empowering parents.
Preventing maltreatment is a key part of public health nurses' clinical work, focusing on early risk identification and parental guidance. While building trust with families is prioritised, structural, resource, and guideline-related challenges persist.
This study provides knowledge about Norwegian public health nurses clinical work with child maltreatment at the child and family health clinics, which can serve as a valuable foundation for further research as well as for collaborating services.
EQUATOR guidelines were followed, using the COREQ checklist.
No patient or public contribution.
La Organización de las Naciones Unidas (ONU) proclamó el 11 de febrero como el Día Internacional de la Mujer y la Niña en la Ciencia, con el objeto de promover el acceso y la participación plena y en condiciones de igualdad a mujeres y niñas en la ciencia, la tecnología y la innovación puesto que, lógicamente, la ciencia no tiene género. Sin embargo, las barreras y prejuicios sistémicos que apunta la ONU como justificación de la necesidad de este día, seguramente sí impactan en nuestra disciplina, altamente feminizada, y puede ser uno de los motivos por los que esta sea entendida más como una carrera vocacional que como una carrera científica, pese a que eso no sea realmente así.
Group A Streptococcus (Strep A) causes a wide spectrum of diseases, ranging from pharyngitis and impetigo to severe invasive infections and immune-mediated conditions such as acute rheumatic fever, rheumatic heart disease and acute post-streptococcal glomerulonephritis. Contemporary data on the global burden of Strep A diseases are lacking. The proposed study aims to use administrative data from numerous jurisdictions to estimate age-specific incidence or prevalence of Strep A diseases, with an emphasis on severe clinical endpoints. Depending on the availability of data, a secondary objective will be to estimate the economic burden of Strep A diseases.
This population-based descriptive study will use routine health data obtained from different low-income and middle-income and high-income countries through international research collaborations to estimate the country-level and global burden of Strep A diseases. Data will be primarily obtained and collated from hospital or national health laboratory databases for individuals across all age groups, along with emergency department, primary care and microbiological datasets where available. Strep A disease endpoints will be identified using International Classification of Diseases 10th Revision or other relevant coding systems and microbiological diagnosis. Age-specific incidence and prevalence rates will be computed using population denominators, and country-level age-adjusted rates will be applied to standard global reference populations to estimate the number of cases globally.
Ethical approval to conduct this study was obtained from the Human Research Ethics Committee at the University of Western Australia (reference: #2024/ET000401) and governance approval was obtained from The Kids Research Institute Australia. The findings from this study will be published in peer-reviewed journals and presented at Strep A Vaccine Global Consortium collaborative meetings.
FreshRSS 