Despite the potential benefits of physiotherapy and physical activity, awareness remains limited among patients with sequela and healthcare professionals. This study aims to explore Danish physiotherapists’ (PTs) perspectives on barriers, facilitators and potential solutions to improve the care of sequelae after cancer in physiotherapy clinics.
This qualitative study used semi-structured interviews with Danish PTs, following a published research protocol and the Criteria for Reporting Qualitative Research checklist. Danish-speaking PTs working in private clinics in Denmark were eligible to participate and were selected via purposive sampling. Online interviews with PTs were conducted in June and July 2022.
A phenomenological approach was employed for data collection and thematic analysis, allowing researchers to set aside preconceptions. Preunderstandings were stated and revisited post-analysis for validation. The interview guide was developed and validated through discussions and pilot testing. A patient panel provided feedback on the interview guide. Interviews were conducted by a trained and experienced PT and transcribed using a standardised key.
Online interviews with 12 PTs were conducted. Five themes were identified: being aware of important physiotherapy competencies, PTs’ basic education and specialisation, patients’ resources, healthcare system and organisation, and sharing knowledge regarding sequelae from cancer and potential treatments. PTs emphasised the need for specialised competencies, emotional resilience and life experience. Patients experienced financial and psychosocial barriers, while systemic issues and poor communication hindered care. PTs suggested public lists of specialised providers and broader dissemination of knowledge to reduce stigma and improve access.
PTs identify clinical and systemic challenges requiring specialisation, improved collaboration and increased awareness to enhance rehabilitation and quality of life for cancer survivors.
This study employs structural equation modelling to explore the inter-relationships among optimal antenatal care (ANC), health facility delivery and early postnatal care (EPNC) in Ethiopia. By identifying both direct and indirect influencing factors, the study offers valuable insights to support integrated maternal health strategies and guide informed decision-making by policymakers and women alike.
The secondary analysis of the Ethiopian Demographic and Health Survey 2016 was performed to investigate inter-relationships between optimal ANC, health facility delivery and postnatal care (PNC) among women in Ethiopia. Data were analysed with R software V.4.3.2. The study used binary logistic regression to examine differences in optimal ANC, health facility delivery and EPNC, focusing on variables with a p value of 0.1 or less. Selected variables were incorporated into a generalised structural equation model (GSEM) using the LAVAAN package to explore both direct and indirect effects. The GSEM method assessed the impact of exogenous variables on endogenous variables, all binary, using a logistic link and binomial family. Missing data were handled with the multiple imputation by chained equations package, and sampling weights were applied to ensure national and regional representativeness.
The source population comprised all women of reproductive age (15–49 years) who gave birth in the 5 years preceding the survey. From 16 650 interviewed households (98% response rate), we identified 7590 eligible women with recent births. Finally, we included 2415 women who had attended four or more ANC visits.
Media exposure significantly boosts the likelihood of using ANC (OR=1.8, 95% CI (1.04 to 3.23), p=0.04), health facility delivery (OR=1.7, 95% CI (1.23 to 2.45), p=0.05) and PNC (OR=2.0, 95% CI (1.6 to 4.01), p=0.01). Urban residence and secondary education also enhance ANC (OR=1.2, 95% CI (1.01 to 2.88), p=0.022; OR=1.3, 95% CI (1.20 to 3.01), p=0.018), health facility delivery (OR=1.1, 95% CI (1.01 to 3.24), p=0.035; OR=1.5, 95% CI (1.22 to 3.45), p=0.03) and PNC (OR=1.6, 95% CI (1.01 to 4.32), p=0.03). ANC directly affects health facility delivery (OR=1.4, 95% CI (1.28 to 3.09), p=0.01) and PNC (OR=1.6, 95% CI (1.01 to 3.80), p=0.03). Additionally, women aged 20–34 years and those from male-headed households positively impact health facility delivery (OR=1.5, 95% CI (1.20 to 4.80), p=0.01; OR=1.3, 95% CI (1.07 to 3.45), p=0.014) and PNC (OR=1.4, 95% CI (1.10 to 2.90), p=0.01; OR=1.2, 95% CI (1.07 to 3.08), p=0.025).
Optimal ANC is vital for encouraging health facility delivery and EPNC. To enhance maternal and neonatal health, policies should integrate these services. Key predictors include being aged 20–34, having secondary and higher education, media exposure, male-headed households and living in urban areas. Improving education and media exposure can boost maternal healthcare service use.
Medical oxygen supplementation is essential for treating severe illnesses and plays a critical role in managing life-threatening conditions, especially during the period of increased demand, such as the delta wave of COVID-19. The study aims to evaluate oxygen requirements and production to support effective capacity planning for future health crises.
Cross-sectional quantitative study. Data collection was carried out between 15 March and 19 December 2021.
The study used secondary data from Nepal’s Health Emergency Operation Centre. Regarding medical oxygen production, calculations included oxygen generated from both hospital-based oxygen plants and private companies, using their highest capacities for comparison. These production capacities were then assessed using three levels of efficiency (100%, 80% and 50%), revealing significant gaps when compared against the oxygen requirements of hospitalised COVID-19 patients, as guided by WHO recommendations. The results were communicated in terms of J-size cylinders, alongside average daily COVID-19 hospitalizations. Data was inputted and analysed using Microsoft Excel and presented in numbers and percentage.
The country’s oxygen demand relies largely on the production from private enterprises, with meeting approximately 85.2% of the total requirement. Optimal production ensures that national oxygen needs will be met. The analysis highlighted that at 80% operational efficiency, 90.8% of the hospital’s requirements could be fulfilled. However, if operational efficiency drops to 50%, the fulfilment rate diminishes to 56.7%. The differences in requirement and production of oxygen are consistent across the provinces; however, a huge disparity was notable in Karnali and Sudurpaschim.
Continuous assessment of production capacities in both hospital and private enterprises producing oxygen is necessary to plan and address the gaps.
To investigate whether quantitative retinal markers, derived from multimodal retinal imaging, are associated with increased risk of mortality among individuals with proliferative diabetic retinopathy (PDR), the most severe form of diabetic retinopathy.
Longitudinal retrospective cohort analysis.
This study was nested within the AlzEye cohort, which links longitudinal multimodal retinal imaging data routinely collected from a large tertiary ophthalmic institution in London, UK, with nationally held hospital admissions data across England.
A total of 675 individuals (1129 eyes) with PDR were included from the AlzEye cohort. Participants were aged ≥40 years (mean age 57.3 years, SD 10.3), and 410 (60.7%) were male.
The primary outcome was all-cause mortality. Quantitative retinal markers were derived from fundus photographs and optical coherence tomography using AutoMorph and Topcon Advanced Boundary Segmentation, respectively. We used unadjusted and adjusted Cox-proportional hazards models to estimate hazard ratios (HR) for the association between retinal features and time to death.
After adjusting for sociodemographic factors, each 1-SD decrease in arterial fractal dimension (HR: 1.54, 95% CI: 1.18 to 2.04), arterial vessel density (HR: 1.59, 95% CI: 1.15 to 2.17), arterial average width (HR: 1.35, 95% CI: 1.02 to 1.79), central retinal arteriolar equivalent (HR: 1.39, 95% CI: 1.05 to 1.82) and ganglion cell-inner plexiform layer (GC-IPL) thickness (HR: 1.61, 95% CI: 1.03 to 2.50) was associated with increased mortality risk. When also adjusting for hypertension, arterial fractal dimension (HR: 1.45, 95% CI: 1.08 to 1.92), arterial vessel density (HR: 1.47, 95% CI: 1.05 to 2.08) and GC-IPL thickness (HR: 1.56, 95% CI: 1.03 to 2.38) remained significantly associated with mortality.
Several quantitative retinal markers, relating to both microvascular morphology and retinal neural thickness, are associated with increased mortality among individuals with PDR. The role of retinal imaging in identifying those individuals with PDR most at risk of imminent life-threatening sequelae warrants further investigation.
Young-onset type 2 diabetes (YOD), diagnosed before 40 years of age, entails a high disease burden and potential for early dependence on disability benefits. The risk of type 2 diabetes (T2D) varies with socio-economic status and ethnic background, yet the relationship between these factors and age at diagnosis is insufficiently explored. We aimed to study associations between YOD and living on disability benefits, educational level and country background.
Cross-sectional data on 8640 individuals with T2D, linked to data on educational level and country background, were compared with population data from the same residential areas. Similar comparisons were made for data on disability benefits among 3854 individuals of working age (
The risk of being dependent on disability benefits was three times higher in YOD (adjusted incidence rate ratio, aIRR (95% CI) 3.1 (2.7 to 3.5)) and twice as high in later-onset T2D (1.9 (1.8 to 2.1)) as in the general population. People of Norwegian background with low educational levels had threefold higher YOD risk (3.3 (2.4 to 4.4)) than those with a tertiary degree, while people of non-Western backgrounds with low educational levels had a smaller increase in YOD risk (1.5 (1.1 to 2.1)). People of non-Western backgrounds had higher YOD risk than those of Norwegian background (4.2 (3.5 to 5.0)), while people of south Asian background had an even greater relative YOD risk (9.0 (7.3 to 11.0)), threefold higher than for later-onset T2D (3.2 (2.8 to 3.7)).
Lifetime risk of being dependent on disability benefits was substantially higher for individuals with YOD than in later onset T2D. Non-Western and particularly south Asian backgrounds were associated with increased YOD risk. Low education was an important YOD risk factor only for people with Norwegian background.
Drug–drug interactions (DDIs) are a significant concern for patients on complex therapeutic regimens, especially involving cardiovascular medications, which are frequently implicated in these interactions.
This study used a standardised interaction database to determine the frequency, severity and risk factors associated with potential DDIs (pDDIs) among cardiovascular disease (CVD) in-patients.
The prospective cross-sectional study was conducted at a tertiary care hospital in Nepal from April 2024 to October 2024. A total of 106 eligible CVD in-patients were evaluated for pDDIs using the Lexicomp DDI checker database, and the interactions were categorised based on severity and risk rating. Binary logistic regression identified factors associated with pDDIs.
The study identified 621 pDDIs using the Lexicomp database, with median values of 8 pDDIs per patient. Patients with at least one pDDI comprised 64.2% of the sample. Most pDDIs were of moderate severity (77.3%) with risk ratings of C (65.7%). The most common cardiovascular medications involved in the detected DDI pairs were diuretics (31.2%), antiplatelets and anticoagulants (23.8%) and calcium channel blockers (12.2%). Multivariate binary logistic regression revealed that patients who stayed longer (adjusted OR (AOR) 9.08, 95% CI 1.027 to 80.216, p=0.047), those receiving more medications (AOR 18.85, 95% CI 2.975 to 119.370, p=0.002) and those who were admitted to the intensive cardiac care unit (AOR 16.31, 95% CI 2.728 to 97.461, p=0.002) were significantly more likely to experience pDDIs.
This study found a higher prevalence of pDDIs. It is advisable to incorporate medication reviews into routine cardiac care and use a drug interaction checker to identify pDDIs.
Early childhood development (ECD) lays the foundation for lifelong health, academic success and social well-being, yet over 250 million children in low- and middle-income countries are at risk of not reaching their developmental potential. Traditional measures fail to fully capture the risks associated with a child’s development outcomes. Artificial intelligence techniques, particularly machine learning (ML), offer an innovative approach by analysing complex datasets to detect subtle developmental patterns.
To map the existing literature on the use of ML in ECD research, including its geographical distribution, to identify research gaps and inform future directions. The review focuses on applied ML techniques, data types, feature sets, outcomes, data splitting and validation strategies, model performance, model explainability, key themes, clinical relevance and reported limitations.
Scoping review using the Arksey and O‘Malley framework with enhancements by Levac et al.
A systematic search was conducted on 16 June 2024 across PubMed, Web of Science, IEEE Xplore and PsycINFO, supplemented by grey literature (OpenGrey) and reference hand-searching. No publication date limits were applied.
Included studies applied ML or its variants (eg, deep learning (DL), natural language processing) to developmental outcomes in children aged 0–8 years. Studies were in English and addressed cognitive, language, motor or social-emotional development. Excluded were studies focusing on robotics; neurodevelopmental disorders such as autism spectrum disorder, attention-deficit/hyperactivity disorder and communication disorders; disease or medical conditions; and review articles.
Three reviewers independently extracted data using a structured MS Excel template, covering study ML techniques, data types, feature sets, outcomes, outcome measures, data splitting and validation strategies, model performance, model explainability, key themes, clinical relevance and limitations. A narrative synthesis was conducted, supported by descriptive statistics and visualisations.
Of the 759 articles retrieved, 27 met the inclusion criteria. Most studies (78%) originated from high-income countries, with none from sub-Saharan Africa. Supervised ML classifiers (40.7%) and DL techniques (22.2%) were the most used approaches. Cognitive development was the most frequently targeted outcome (33.3%), often measured using the Bayley Scales of Infant and Toddler Development-III (33.3%). Data types varied, with image, video and sensor-based data being most prevalent. Key predictive features were grouped into six categories: brain features; anthropometric and clinical/biological markers; socio-demographic and environmental factors; medical history and nutritional indicators; linguistic and expressive features; and motor indicators. Most studies (74.1%) focused solely on prediction, with the majority conducting predictions at age 2 years and above. Only 41% of studies employed explainability methods, and validation strategies varied widely. Few studies (7.4%) conducted external validation, and only one had progressed to a clinical trial. Common limitations included small sample sizes, lack of external validation and imbalanced datasets.
There is growing interest in using ML for ECD research, but current research lacks geographical diversity, external validation, explainability and practical implementation. Future work should focus on developing inclusive, interpretable and externally validated models that are integrated into real-world implementation.
Cleft lip and palate significantly impact a child’s speech and facial appearance. Children undergo cleft repairs in infancy, but poor results from these initial repairs often lead to secondary surgery. In the late 1990s, cleft care provision in the UK was centralised to approximately 11 managed clinical networks or centres. This centralisation has been associated with improvements in speech and aesthetic outcomes, but little is known about the effect of centralisation on the use of secondary surgery. The purpose of this study was to compare the cumulative incidence of secondary cleft surgeries before and after centralisation and the proportion of children achieving good clinical outcomes without secondary surgery.
Retrospective, cross-sectional.
Two cross-sectional studies of 5-year-old children with non-syndromic unilateral cleft lip and palate were conducted, one precentralisation and one postcentralisation.
The cumulative incidence of secondary surgery from birth through age 5 was compared precentralisation and postcentralisation using Fisher’s exact test, as were facial appearance and speech outcomes at age 5. Risk ratios (RR) were estimated using log-binomial multivariable regression models that adjusted for sex and age at evaluation.
Postcentralisation, the proportion of children achieving good or excellent facial appearance increased from 16% to 42% (p
Centralisation of cleft care was associated with improved outcomes of primary lip and palate repairs and a corresponding reduction in secondary surgery.
Despite advancements in biomedical and healthcare research, the translation of evidence into routine practice within healthcare systems often lags, perpetuating inefficiencies and disparities in care delivery. Learning health systems (LHS), which integrate internal data and external evidence for continuous improvement, hold promise for addressing these gaps. Implementation science (IS), focused on promoting the systematic uptake of evidence-based practices, offers a robust framework to drive sustainable improvements within LHS. However, the practical application of IS principles in LHS remains underexplored. This scoping review aims to systematically map the literature on the application of IS in LHS, highlighting themes, gaps and opportunities for advancing future practices.
This review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews, supported by the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. The review employs a population-concept-context framework, focusing on studies engaged in LHS activities and the application of IS principles in various healthcare settings. Relevant literature will be searched across multiple databases, including OVID/Medline, Embase, Web of Science Core Collection and Health Policy Reference Center. Eligible studies will be screened, and data will be extracted and synthesised using both quantitative and qualitative methods. Key outcomes include characterising IS applications in LHS, evaluating barriers and facilitators, exploring equity integration, and identifying knowledge gaps.
As this study does not involve primary data collection, ethical approval is not required. Findings will be disseminated through peer-reviewed publications and conference presentations to inform future research and practice.
This protocol has been registered on the Open Science Framework (DOI: 10.17605/OSF.IO/BMQ6J).
This systematic review and meta-analysis aimed to determine the pooled prevalence of and factors associated with work-related musculoskeletal disorders (WMSDs) among low- and middle-income countries.
Databases such as PubMed/MEDLINE, CINAHL, LIVIVO, African Journals Online, African Index Medicus (AIM), HINARI, Science Direct, Web of Science, Cochrane Library, Google Scholar, Semantic Scholar and Google were used to retrieve all the relevant articles. The search was carried out from 22 April 2024 to 26 June 2024. Data were analysed via STATA 17 software. With a 95% CI, this meta-analysis with a random-effects model was carried out to determine the pooled prevalence.
The study was conducted in low- and middle-income countries.
Weavers of low- and middle-income countries.
The primary outcome of this study was the prevalence of WMSD.
In this meta-analysis, a total of 21 articles with 7322 study participants were included. The pooled prevalence of WMSDs was 72.20%. Working more than 8 hours per day, working in a chair with no back support, working in an uncomfortable posture, not performing regular physical exercise, lacking knowledge of the causes of WMSD and lacking job satisfaction were factors significantly associated with WMSDs.
A high prevalence of WMSDs among weavers in low- and middle-income countries was recorded. This indicates the need to take effective intervention measures. Rigorous ergonomic training, providing lengthy breaks and building centres for physical exercise, improving workplace ergonomic design and increasing job satisfaction are recommended.
CRD42024561064.
Data on postdischarge care for stroke and myocardial infarction (MI) patients remain limited. Logistical barriers, including fragmented communication and poor coordination between patients and physicians, contribute to suboptimal outcomes and hinder secondary prevention. Mobile health (mHealth) offers a promising strategy to support continuity of care. We aimed to synthesise existing literature and evaluate mHealth interventions for postdischarge MI and stroke care.
This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guideline.
PubMed, CINAHIL, Scopus and Cochrane were searched from 26 July 2016 to 5 July 2024.
This scoping review included randomised controlled trials and observational studies published in peer-reviewed journals that evaluated mHealth interventions for postdischarge care in MI and stroke. Studies reporting outcomes such as mortality, functional capacity, readmissions or adverse events were included.
Two authors independently extracted and summarised the data. Subsequently, methodological quality was independently assessed by two other authors using the Joanna Briggs Institute checklist.
We identified 31 eligible studies, with 14 631 participants and 59.9 mean years old. Most participants were male. Among these, three (%) originated from low-middle income, seven (%) from upper-middle income and 21 (%) from high-income countries. Overall, we identified 17 studies using mobile apps: eight as a single intervention, and nine combined with remote sensors, seven with SMS, three studies used web-based platforms, two used phone calls, one study combined SMS and phone calls and another used remote sensors only. Multimodal telerehabilitation reported better outcomes compared with single-mode mHealth interventions. Most studies assessed functional capacity (26 studies) and quality of life (21 studies).
This review highlighted increased mHealth uptake among postdischarge MI and stroke patients, including significant underrepresentation of female participants, scarce studies from low-middle-income countries or rural areas and limited reporting of hard clinical endpoints. While mHealth showed positive outcomes across most studies, it further highlights contextual factors that account for digital disparity and the need to prioritise inclusive, user-centred designs and integrate objective measurement tools on future trials and policy frameworks.
Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.
We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.
The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).
ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).
This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.
A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.
Data were sourced from the published literature and input from international stakeholders.
pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.
A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.
We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.
Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.
A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.
The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.
Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.
Opioid use disorder (OUD) is a debilitating condition characterised by the overuse of opioid medications and the development of physical and/or psychological dependence. Consequences of this condition include chronic impairment, distress and later life-altering health conditions such as overdose, all of which have been highlighted by the prominence of OUD in the USA in recent years. Buprenorphine is a standard OUD treatment and commonly used for pain management. Understanding changes in distribution patterns across the USA is vital for continuing to improve outcomes for OUD patients.
This study used the Drug Enforcement Administration’s Automated Reports and Consolidated Ordering System (ARCOS) and the US Census Bureau Population Estimates databases to analyse changes in buprenorphine distribution among pharmacies and hospitals from 2019 to 2023, to determine temporal patterns and to identify state-level disparities using the data. The data were corrected for population to identify patterns of buprenorphine distribution in the USA from 2021 to 2022 and 2022 to 2023 through examining percent changes in milligrams per 100 population at the national and state levels.
The year-to-year percent change of national buprenorphine distribution from pharmacies has remained positive but changed from a 12.2% increase from 2019 to 2020 (figure 4) to a four per cent increase every year from 2020 to 2023. From 2021 to 2022, there was a +4.9% increase in total grams of buprenorphine distributed to pharmacies and a 95% CI [–5.1, 14.9], with the District of Columbia, South Dakota and Nebraska outside of the 95% CI. Distribution to hospitals increased by 10.2% [-32.3, 52.7] during 2021–2022, with Hawaii, New Hampshire and Delaware being outside of 95% CI. From 2022 to 2023, there was an increase of +5.7% and 95% CI [–3.5, 14.9] in pharmacy distribution, with states including Washington, Rhode Island and Kansas remain outside of the 95% CI. Hospital distribution has decreased from twenty per cent between 2019 and 2020 (figure 4) to eighteen per cent between 2022 and 2023.
Following increases in buprenorphine distribution during the COVID pandemic, a consistent increase has continued year-over-year in most states and the country overall by both pharmacies and hospitals. Some states (eg, Rhode Island, Georgia, District of Columbia) have not followed this pattern. Notably, Hawaii went from the most negative percent change in hospital distribution to the most positive change in the timeframe analysed. This may offer opportunities to analyse more specific impacts of the increased buprenorphine distribution on populations and their outcomes associated with OUD.
Vaccination against SARS-CoV-2 was a crucial public health measure during the COVID-19 pandemic. Among the multiple strategies developed to increase vaccine uptake, governments often employed vaccine mandates. However, little evidence exists globally about the impact of these mandates and their subsequent removal on vaccine uptake, including in Australia, France, Italy and the USA. The aim of this study is to provide a protocol to evaluate and quantify the impact of COVID-19 vaccine mandates and removals on vaccine uptake in these countries, with a specific focus on comparing Australian policies with those from Europe and the USA. Actualising the work outlined in this protocol will help to provide policy and technical guidance for future pandemic preparedness and routine immunisation programmes.
This protocol outlines a retrospective study using existing data sources including Australian Immunisation Register-Person Level Integrated Data Asset for Australia and publicly available data for France, Italy and California (USA). Causal inference methods such as interrupted time series, regression discontinuity design, difference-in-differences, matching and synthetic control will be employed to assess the estimated effects of vaccine mandates and removals on vaccine uptake.
The University of Newcastle’s human research ethics committee has approved the study (reference number: H-2024-0160). Peer-reviewed papers will be submitted, and results will be presented at public health, immunisation and health economic conferences nationally and internationally. A lay summary will be published on the MandEval website.
While chronic kidney disease (CKD) is well characterised in adults, less is known about the prevalence of CKD in children and adolescents, where it is rare and associated with unique characteristics and implications for long-term health outcomes. This study protocol outlines a systematic review to assess the global prevalence of CKD in children and adolescents along with causes and associated risk factors. This is warranted to better characterise prevalence and to identify at-risk groups that would benefit from screening efforts. We will explore the risk and burden of CKD and its variations by sociodemographic characteristics (age group, race, sex/gender) and geographical regions (country, International Society of Nephrology region and income groups based on World Bank country classifications).
We will conduct a systematic review of studies reporting on the prevalence of CKD in children and adolescents following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 (PRISMA-P-2015) and the PRISMA 2020 methodological guidelines (PRISMA 2020). Searches will be undertaken in the following databases with the date range from 2000 to date: Ovid MEDLINE, Ovid Embase, CINAHL, Cochrane Library, ProQuest Dissertations & Theses Citation Index (via Clarivate), Web of Science Core Collection, Google Scholar and grey literature sites (registries, government reports) to identify studies that report on the prevalence of CKD in children and adolescents from ages 0 to 18. The primary outcome will be the global prevalence of CKD in children and adolescents. Secondary outcomes will include the causes of and risk factors for CKD, and examining differences and temporal trends in CKD prevalence across countries, geographical regions, income levels and sociodemographic characteristics.
No direct involvement with patient data will be used in this systematic review, as data will be obtained from previously published reports. Ethical approval is therefore not required. Our findings will be published in an open-access peer-reviewed journal and presented at scientific conferences.
CRD42024547467.
Haematological cancers are common in the UK, with a variety of morphologies. Stem cell transplants and chimeric antigen receptor (CAR) T-cell therapies provide significant options for hard to treat haematological cancers, although with difficult to predict outcomes. Research into the determinates of treatment efficacy, and access to treatments, is key to ensuring equal benefit across patients and patient safety. With this, there are concerns about the small representation of minority groups in related research. We aim to report on the current knowledge to guide future research.
A variety of databases will be searched for literature on UK minority ethnic populations receiving haematopoietic stem cell transplant or CAR T-cell therapy. Searches will be restricted to the year 2011 or later. Many outcomes will be analysed, covering the patient care pathway for those of the target population, although with a focus on follow-up after therapy. Plans have been made to conduct narrative synthesis, with meta-analysis where applicable.
Ethical approval is not required for this study. Outputs will be published in an appropriate journal and discussed with the wider National Institute for Health and Care Research Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics (BTRU) group. Discussions will also be undertaken with the BTRU patient partners group.
Injury to triangular fibrocartilage complex (TFCC) is a common cause of ulnar-sided wrist pain, of which peripheral TFCC tears are amenable to repair. The surgical approaches to treat TFCC tears are well-established, with arthroscopic or arthroscopic-assisted repair as the preferred method. However, the postoperative rehabilitation protocols significantly vary across different studies, ranging from 2 to 9 weeks, often without sufficient justification.
This research is designed to conduct a randomised controlled trial at a single centre with double-blinding to compare the clinical and functional results of two immobilisation protocols of 3 weeks and 6 weeks, following arthroscopic repair of peripheral TFCC tears (ie, Palmar 1B, 1C and 1D) in adults, considering the phase of ligament healing. The hypothesis that there will be no significant difference in outcomes between the two groups is considered. Adults aged 18–60 years of both genders who present with ulnar-sided wrist pain and satisfy the inclusion criteria are included in the study. Following the arthroscopic TFCC repair using the Polydioxanone Suture (PDS) inside-out suture technique, the patients will be immobilised in an above-elbow cast according to their assigned immobilisation groups, which will be determined by a computer-generated 1:1 block randomisation. In this study, each group will have at least 16 participants. The primary outcomes will be evaluated by the weight-bearing press test and the ballottement test. Secondary outcomes, including the Visual Analogue Scale (VAS) score, grip strength, pinch strength, foveal sign, Modified Mayo Wrist Score (MMWS), patient-rated wrist/hand evaluation (PRWHE) score and the range of movements in the wrist and forearm, will be assessed and compared across the groups at each point of assessment, with the results subsequently reported in a detailed manner. The study will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.
The Ethics Committee of Kasturba Medical College, Manipal, approved the trial (approval No. IEC1 - 386). The data from this trial will be presented at academic conferences and published in peer-reviewed international journals.
This trial has been registered at the Clinical Trial Registry of India (registration number: CTRI/2023/03/050692).
The ‘Developing and evaluating an adapted behavioural activation intervention for depression and diabetes in South Asia (DiaDeM)’ trial investigates a psychological intervention, behavioural activation (BA), on people with both diabetes and depression in Bangladesh and Pakistan. This study aimed to aid the intervention and trial design.
This was a modelling study using microsimulation to assess the intervention’s cost-effectiveness. Diabetes was modelled using the UK Prospective Diabetes Study model based on Pakistani patients and depression was modelled using Patient Health Questionnaire-9 (PHQ-9) trajectories allowing for multiple depressive episodes. It was assumed that diabetes-related adverse events increased depression recurrence, while depression impacted haemoglobin A1c, increasing diabetes-related events. The model estimated (1) maximum cost of BA which would be cost-effective (headroom analysis) to inform intervention design, and (2) value of reducing uncertainty around different measures (value of information analysis) to prioritise data collection in the DiaDeM study.
Analysis was conducted from a Pakistani healthcare perspective over a lifetime with costs and outcomes discounted at 3%.
BA plus usual care was compared against usual care. BA involved six sessions by a trained (non-mental health) facilitator. The usual care comparator was the prevailing mix of pharmacological and non-pharmacological treatments used in Pakistan.
The primary outcome was disability-adjusted life-years (DALYs). Secondary outcomes included life years, healthcare costs and the rate of depression and diabetes-related events.
Over their lifetime, individuals receiving BA plus usual care avoid 3.2 (95% credible interval: 2.7 to 3.8) years of mild depression and experience fewer diabetes-related events. BA plus usual care resulted in an additional 0.27 (0.03 to 0.52) life years, 0.98 (0.45 to 1.86) DALYs averted and had incremental healthcare costs of –US$97 (–US$517 to US$142), excluding BA costs. The maximum cost per BA course at which was cost-effective is US$83 (US$9 to US$214). Value of information analysis found the most important measures to include in the trial are the impact of depression on diabetes and PHQ-9 over time.
This is the first model to jointly model depression and diabetes for South Asia and uses novel methods to reflect the diseases and inform intervention and trial design. This evidence has helped to inform the design of the DiaDeM intervention and the trial to evaluate it.
DiaDeM trial: ISRCTN40885204, DOI: ; pre-results, DOI: