The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.
Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.
Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).
Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.
We evaluated the performance of risk models that incorporate ambulatory ECG data and clinical information for prediction of healthcare expenditures related to heart failure (HF) and stroke events in treated and untreated patients.
A retrospective cohort study of Medicare patients who underwent Zio XT ambulatory monitoring in the USA was conducted between 2014 and 2020.
14-day ambulatory ECG data and claims data were evaluated in the study sample which included 89 923 patients in the HF hospitalisation group, 75 870 in the new-onset HF group and 90 159 in the stroke hospitalisation group. Predictive models for new-onset HF, HF hospitalisation and stroke hospitalisation were generated using LASSO Cox regression with ambulatory ECG variables and components of the CHA2DS2-VASc. For each outcome, we scored patients using standardised linear predictors from three composite risk models, and we evaluated the association between risk score and total Medicare cost.
The following hazard ratios per one SD increase in the new risk score were observed for the model that included all CHA2DS2-VASc components and ECG variables: HF hospitalisation in treated 2.94, 95% CI 2.75 to 3.15; new-onset HF in treated 1.84, 95% CI 1.75 to 1.93; HF hospitalisation in untreated 3.51, 95% CI 3.23 to 3.82; and new-onset HF in untreated 1.92, 95% CI 1.85 to 2.00. Risk scores generated by the model were also predictive of Medicare cost in both treated and untreated patients, with patients in the high-risk category for all outcomes having the greatest Medicare costs during 1 year of follow-up.
Integrating arrhythmia data from ambulatory ECG monitoring into clinical risk models allows for better prediction of healthcare utilisation and cost in both treated and untreated patients at high risk for HF and stroke events.
To explore how urinary (UI) and anal incontinence (AI) affect various aspects of quality of life (QoL) and the risk of depression 6 months postpartum, using patient-reported outcome measures (PROMs).
Prospective cohort study.
Women who gave birth between 2020 and 2022 within a local obstetric collaborative network in the Netherlands, including 13 midwifery practices, 5 maternity care organisations at the primary care level, and 1 secondary teaching hospital.
Prospectively collecting data by using the questionnaires of the International Consortium for Health Outcome Measures Pregnancy and Childbirth set at five moments during pregnancy and postpartum.
Associations between UI, AI, QoL and likelihood of depression based on PROMs collected from questionnaire 6 months postpartum.
Of the 663 women who completed the 6-month postpartum questionnaire, 79 women had severe UI, 71 had severe AI and 45 experienced both. These women reported significantly lower QoL as measured by PROMIS-10: 34 (IQR 30.5–38.5), 34 (IQR 30–39.5), and 32 (IQR 27–35), respectively, compared with a score of 37 (IQR 33–42) for the total population. Additionally, the positive rate for depression screening was notably higher among these groups, with rates of 6%, 10% and 18%, respectively, compared with 3% for the overall group.
In this observational cohort study, we found that severe UI and/or AI 6 months postpartum significantly impact QoL and increase the likelihood of depression, as indicated by PROMs. Our findings emphasise the importance of screening, evaluation and treatment of UI and/or AI to improve the QoL and reduce the risk of depressive disorders for postpartum women.
Antenatal care (ANC) is a critical component for improving maternal and newborn health. It provides a platform for essential healthcare services, including health promotion, screening and diagnosis, injury and disease prevention, birth preparedness and preparation for the postnatal period. By implementing timely and appropriate evidence-based practices, ANC can reduce maternal and child morbidity and mortality and optimise overall health and well-being.
To assess the magnitude of utilisation of ANC with eight or more contacts and its associated factors among pregnant women attending ANC in Yayo District, 2023.
A facility-based cross-sectional study was conducted among 301 randomly selected pregnant women attending ANC follow-up in selected health facilities in Yayo District, Southwest Ethiopia, from 1 June 2023 to 30 June 2023. Data were collected using an interviewer-administered structured questionnaire. The collected data were coded and entered into Epi Data V.4.6 and then exported to SPSS V.26 for descriptive and inferential analysis. Both bivariate and multivariate logistic regression models were fitted. Adjusted OR (AOR) with a 95% CI was estimated to assess the strength of associations. A p value
A total of 298 pregnant women participated in the study, yielding a response rate of 99%. Most of the pregnant women, 139 (46.6%), were housewives, and the majority, 248 (83.2%), were married. Adequate utilisation of ANC with eight or more contacts was found to be 7.7%. Factors significantly associated with ANC 8+ contacts utilisation include previous pregnancy-related complications (AOR 5.238 (95% CI 1.004 to 27.31)) and early initiation of ANC (AOR 29.09 (95% CI 8.87 to 95.3)).
The magnitude of ANC 8+ contacts utilisation was remarkably low in the study area. Therefore, greater investment is needed to promote the new ANC approach, emphasising ANC 8+ contacts. Special attention should be given to mobilising mothers to initiate ANC before 12 weeks of gestation to reduce the risk of complications and ensure maximum utilisation of ANC 8+ contacts.
To assess the incidence of delirium and its predictors among adult patients admitted to the intensive care units of comprehensive specialised hospitals in the Amhara region of northwest Ethiopia from 18 October 2024 to 20 February 2025.
A multicentre prospective observational study was conducted.
Four comprehensive specialised hospitals in the Amhara region of northwest Ethiopia, from 18 October 2024 to 20 February 2025.
A total of 351 patients were included in the final analysis during the study period.
The primary outcome measure of this study was the incidence of delirium. Additionally, the study investigated the factors associated with delirium incidence among adult patients admitted to intensive care units.
The incidence of delirium among adult patients in intensive care units was 42.17% (95% CI: 37.08 to 47.42). Pain (adjusted HR (AHR) = 4.74; 95% CI: 2.38 to 9.44), mechanical ventilation (AHR = 2.96; 95% CI: 1.56 to 5.63), age 65 years or older (AHR = 2.18; 95% CI: 1.48 to 3.21) and agitation (Richmond Agitation-Sedation Scale (RASS) ≥1) (AHR = 3.26; 95% CI: 2.09 to 5.09) were statistically significant factors associated with delirium.
In the present study, more than one-third of patients developed delirium. Pain, mechanical ventilation, age 65 or older and agitation (RASS≥1) were significantly associated with delirium occurrence. To reduce the incidence of delirium, the current study recommends treating or preventing pain and agitation. Additionally, special attention should be given to patients receiving mechanical ventilation and those aged 65 or older during care.
The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.
Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.
This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.
The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).
This study aimed to investigate the relationship between coping strategies and compassion fatigue among healthcare professionals in Central Uganda.
A facility-based cross-sectional study conducted between June and July 2023. Three tools were used for data collection: a socio-demographic survey, the Professional Quality of Life Scale (ProQOL-5) and the Brief-Coping, Orientation to Problem Experienced tool. Participants were asked to recall experiences from the previous 30 days.
The study was conducted in five prominent hospitals in Central Uganda.
A total of 548 healthcare providers, including 191 physicians, 256 nurses and 103 technicians.
Compassion fatigue scores.
Most participants were under 29 years old (50.9%) and women (62.0%). High levels of compassion fatigue were reported by 37.8% of participants. Active coping, self-distraction and denial were associated with higher compassion fatigue, while informational support, positive reframing and venting were linked to lower fatigue levels. Seeking social support effectively reduced compassion fatigue.
The findings highlight significant compassion fatigue among healthcare providers in Central Uganda, impacting their well-being and patient care. Coping strategies like active problem-solving and social support are promising in mitigating compassion fatigue. Interventions should focus on reducing self-distraction, enhancing problem-solving skills and fostering supportive work environments to improve healthcare workers’ well-being and patient care quality.
Muscle-invasive bladder cancer (MIBC) is an aggressive type of cancer. About 50% of patients will die from the disease within 5 years despite radical treatment. This implies that in many patients, the disease has already spread at the time of radical treatment, even though imaging shows no signs of metastasis. We hypothesise that the standard local staging method, transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread. Furthermore, TURBT (and re-TURBT in many patients) contributes to a significant delay to definitive therapy. The aim of this randomised study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with a single outpatient bladder tumour biopsy for histological confirmation, is a safer, faster, less costly and, therefore, more cost-effective diagnostic pathway than TURBT to detect or rule out MIBC.
BladParadigm is a two-arm multicentre randomised controlled trial (RCT) conducted in the Netherlands. Over a 3-year period, patients with clinically suspected MIBC without evidence of metastases will be recruited and randomised 1:1 to either TURBT or 3-Tesla mpMRI with same-day outpatient bladder biopsy. The Vesical Imaging Reporting and Data System (VI-RADS) will be used to standardise mpMRI reporting. Patients will undergo definitive treatment based on the results of the TURBT or mpMRI. The study is powered to demonstrate that the mpMRI-based strategy is at least non-inferior to standard TURBT in patients treated with radical cystectomy alone, assuming a relative hazard of 0.55. The required sample size is 360 patients (180 TURBT, 180 mpMRI). The primary outcome is 2-year progression-free survival. Progression will be assessed by imaging, according to the current standard of care. Secondary outcome measures are time to definitive treatment, quality of life (EuroQol 5D-5L), healthcare costs and cost-effectiveness.
This study has received ethical approval from the Medical Ethical Committee Oost-Nederland (NL83685.091.23). All participants will provide written informed consent prior to inclusion. Findings of this study will be disseminated through peer-reviewed, open-access publications, presentations at scientific conferences and stakeholder briefings.
This study aims to assess the association between neighbourhood socioeconomic deprivation and outcomes reflecting comprehensive diabetes care (CDC).
Retrospective cohort study
US Medicare Advantage (MA) data, 2015–2020.
National sample of MA enrollees with diabetes.
Primary outcomes included six indicators of CDC from the Healthcare Effectiveness Data and Information Set: haemoglobin (Hb) A1c (HbA1c) testing, HbA1c control (9%), blood pressure control (
There were 827 227 enrolments included in the final analysis. After adjusting for demographic (age, sex, race/ethnicity and dual eligibility) and regional characteristics (rurality and primary care providers per capita), high neighbourhood deprivation was associated only with worse glycaemic control (for HbA1c>9%, risk ratio (RR) 1.04, 95% CI 1.02 to 1.07). This relationship was significant for white and Asian patients (RR 1.08, 95% CI 1.05 to 1.11 and RR 1.18, 95% CI 1.05 to 1.32, respectively); outcomes for black and Hispanic patients were worse overall but independent of neighbourhood deprivation (RR 1.00, 95% CI 0.96 to 1.05 and RR 0.98, 95% CI 0.94 to 1.03, respectively). In the fully adjusted model, neighbourhood deprivation was not associated with measures that directly reflect access to care, including the occurrence of HbA1c testing and receipt of eye exams (RR 0.99, 95% CI 0.94 to 1.04 and RR 1.03, 95% CI 1.00 to 1.05).
An increased risk of poor glycaemic control was observed for patients from areas of high neighbourhood deprivation, independent of individual socioeconomic status. Neighbourhood factors and their intersection with racial and ethnic disparities are important considerations for achieving equity in diabetes care.
During the COVID-19 pandemic, a substantial decrease was observed in hospital admissions and in-hospital procedures for patients with acute cardiovascular diseases (CVDs). The extent to which measures to prevent COVID-19 transmission, for example, lockdowns, affected the outpatient care of patients at higher cardiovascular risk remains unclear. We aimed to compare outpatient department (OPD) attendance, cardiovascular risk management (CVRM) and cardiovascular health (CVH) of patients at higher cardiovascular risk referred to an OPD of a tertiary care centre between preCOVID-19, during and postCOVID-19 periods.
We included all adult patients at higher cardiovascular risk referred to the cardiology, vascular medicine, diabetology, geriatrics, nephrology or multidisciplinary vascular surgery OPDs of the University Medical Centre Utrecht, the Netherlands, between March 2019 and December 2022, in a prospective cohort study.
We assessed trends in the number of first and follow-up appointments and in the completeness of extractable CVRM indicators from the electronic health record (EHR) as a proxy for CVRM guideline adherence. CVH was determined using the Life’s Essential 8 metric (score 0–100, the higher score, the better). We investigated whether CVH differed between COVID-19 periods compared with the reference period (ie, 2019) and stratified by OPDs, using multivariable linear regression, adjusted for age, gender, CVD history and whether the patient had a previous appointment before the reference period.
Among 15 143 patients, we observed a 33% reduction in the weekly number of first appointments during the COVID-19 pandemic, with the largest reductions in the cardiology and nephrology OPDs, with no differences between women and men. Follow-up appointments conducted remotely, compared with before the COVID-19 pandemic, increased significantly for all OPDs. CVRM indicators were up to 11% less extractable during the first lockdown yet returned to prepandemic levels directly after the first lockdown period. The CVH score of patients visiting the nephrology, vascular medicine and geriatrics OPDs during the first lockdown was 11.23 (95% CI 2.74 to 19.72), 5.68 (95% CI 0.82 to 10.54) and 5.66 (95% CI 0.01 to 11.31) points higher, respectively, compared with the prepandemic period. In between the second and third lockdowns, the CVH score was comparable to the preCOVID reference period, yet for the cardiology OPD it was significantly higher (5.54, 95% CI 2.04 to 9.05).
During the COVID-19 pandemic, weekly numbers of first appointments to OPDs decreased, and a population with a higher CVH score (ie, better CVH) visited certain OPDs, especially during the first lockdown period. These suggest that patients with poorer CVH more often avoided or were unable to visit OPDs, which might have resulted in missed opportunities to control cardiovascular risk factors and potentially may have led to preventable disease outcomes. For future epidemics and pandemics, it seems vital to develop a strategy that includes an emphasis on seeking healthcare when needed, with specific attention to patients at higher CVD risk.
Ethiopia, the second most populous country in Africa, faces significant demographic transitions, with fertility rates playing a central role in shaping economic and healthcare policies. Family planning programmes face challenges due to funding limitations. The recent suspension of the US Agency for International Development funding exacerbates these issues, highlighting the need for accurate birth forecasting to guide policy and resource allocation. This study applied time-series and advanced machine-learning models to forecast future birth trends in Ethiopia.
Secondary data from the Ethiopian Demographic and Health Survey from 2000 to 2019 were used. After data preprocessing steps, including data conversion, filtering, aggregation and transformation, stationarity was checked using the Augmented Dickey-Fuller (ADF) test. Time-series decomposition was then performed, followed by time-series splitting. Seven forecasting models, including Autoregressive Integrated Moving Average, Prophet, Generalised Linear Models with Elastic Net Regularisation (GLMNET), Random Forest and Prophet-XGBoost, were built and compared. The models’ performance was evaluated using key metrics such as root mean square error (RMSE), mean absolute error (MAE) and R-squared value.
GLMNET emerged as the best model, explaining 77% of the variance with an RMSE of 119.01. Prophet-XGBoost performed reasonably well but struggled to capture the full complexity of the data, with a lower R-squared value of 0.32 and an RMSE of 146.87. Forecasts were made for both average monthly births and average births per woman over a 10-year horizon (2025–2034). The forecast for average monthly births indicated a gradual decline over the projection period. Meanwhile, the average births per woman showed an increasing trend but fluctuated over time, influenced by demographic shifts such as changes in fertility preferences, age structure and migration patterns.
This study demonstrates the effectiveness of combining time-series models and machine learning, with GLMNET and Prophet XGBoost emerging as the most effective. While average monthly births are expected to decline due to demographic transitions and migration, the average births per woman will remain high, reflecting persistent fertility preferences within certain subpopulations. These findings underscore the need for policies addressing both population trends and sociocultural factors.
The efficacy and safety of SMS text message-delivered interventions for providing pain self-management education and improving clinical pain outcomes have been demonstrated in several randomised controlled trials. However, little is known about the feasibility and effectiveness of these interventions within Australian hospital settings. The current protocol describes a trial designed to evaluate the effectiveness and implementation of an SMS text message-delivered intervention designed to support patients’ engagement with pain self-management strategies and improve clinical pain outcomes after total knee replacement surgery.
A hybrid, type 1 effectiveness-implementation trial will be conducted at a private hospital in Australia. Participants (n=130) will be randomised to either the intervention group (receiving a pain self-management educational video prior to surgery, plus daily SMS text message reminders for 3 weeks after surgery) or an active control group (receiving the pre-surgery video alone, without text message reminders) in addition to usual care. Effectiveness outcomes will be pain intensity (primary), opioid dose, knee function and pain-related distress and will be recorded at baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery using self-reported surveys. Pain self-efficacy and health-related quality of life will be measured at 6 weeks, 3 months and 6 months post-surgery. Implementation outcomes (Reach, Experience, Adoption, Implementation, Maintenance) will be evaluated using mixed (qualitative and quantitative) methods. This trial represents a first step towards the translation of digitally delivered postoperative support for engaging with pain self-management in the Australian healthcare system.
The study protocol was reviewed and approved by the Austin Health Human Ethics Research Committee (Australia, HREC/110142/Austin-2024). Study results will be published in a peer-reviewed journal and presented at scientific and professional meetings.
ACTRN12624001060538
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.
Social accountability is a key value and aspirational goal of many medical institutions. While much has been studied on social accountability in the context of medical education and institutions, less research has examined how social accountability influences research. In light of this absence, the objective of our scoping review is to research the following questions: (1) What characterises socially accountable research (SAR), and how is it expressed and experienced? (2) How do language, positionality, and worldview influence SAR?, and (3) What structures and considerations are necessary to support successful SAR in local and global contexts?
To answer the above research questions, the Arksey and O’Malley, Levac et al, Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Joanna Briggs Institute (JBI) guidelines will be followed. The search strategy was adapted and applied to MEDLINE, Embase, ERIC, and CINAHL databases. A total of n=5289 eligible articles were identified. Articles were excluded if they were published before 1995, were in a language other than English, or were duplicates, leaving n=2840 articles for title/abstract screening.
Ethical approval is not required to complete this study. We will take an integrated knowledge translation approach. Throughout the project, results will be disseminated to knowledge users (ie, consultations, following Arksey and O’Malley). Our findings will be presented to the larger academic community, policymakers, and healthcare practitioners through presentations, reports, newsletters, and an online repository.
Open Science Framework 16 July 2024. osf.io/mvhnu.
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
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.
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.
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.
To assess the magnitude of clinical inertia and its associated factors among adult patients with asthma on chronic follow-up at Jimma Medical Center, Ethiopia, from December 2021 to May 2022.
A hospital-based prospective observational study was conducted in Jimma Medical Center from 1 December 2021 to 30 May 2022.
135 patients with asthma who fulfilled the inclusion criteria were enrolled in the study consecutively and followed for 3 months.
Of 148 patients, 135 patients’ data were analysed. The mean (SD) age of the patients was 52.03 (±15.75) years. More than half (54.1%) of the study participants were men. Most of the study participants (68.9%) at the first and (70.4%) at the second visit, which is 3 months after the first visit, had clinical inertia, respectively. Comorbidity (adjusted OR (AOR) 3.35, 95% CI (1.15, 9.81), p
The burden of clinical inertia in this study was high at both visits. Comorbidity, duration of asthma of 5–10 years, moderate persistent and severe persistent asthma were identified as contributing factors to clinical inertia. Policymaker intervention to avoid clinical inertia is necessary to improve asthma treatment outcomes.
The use of antiretroviral therapy has been linked to the development of some components of metabolic syndrome (MetS), specifically glucose intolerance, weight gain and defective lipid metabolism. This study determined the relationship between dolutegravir (DTG) and MetS in a cohort of persons living with HIV (PWH) initiating DTG-based regimen in Ghana.
A 2-year observational prospective study was conducted from September 2020 to August 2022.
Five HIV high-burden facilities providing antiretroviral therapy services at the district and tertiary levels of care in Ghana.
Persons with HIV who were newly enrolled onto DTG.
Waist circumference, body mass index, blood pressure, fasting blood glucose and lipids were the primary outcomes measured at baseline, 3, 6, 12 and at 18 months follow-up to determine the incidence of MetS. MetS was defined using the Joint Consensus definition that combines the International Diabetes Federation and the National Cholesterol Education Programme Adult Treatment Panel III (ATP III) definitions. The Kaplan-Meier estimator was used to estimate the risk of developing MetS. The Cox proportional hazard model was used in estimating HRs.
Of 3664 PWH screened at baseline, 31.4% (1152/3664) had MetS. Of the remaining 2512 with no MetS at baseline, there were 960 incident cases of MetS over the 1.5 years follow-up. The estimated MetS incident rate is 384.2 (95% CI: 360.6 to 409.2) per 1000 person-years with a median time to development of MetS at 6 months (IQR; 3–12 months). Being female (adjsuted HR, aHR: 1.42, 95% CI: 1.19 to 1.70), age ≥50 years (aHR: 1.30, 95% CI: 1.12 to 1.51), having a comorbidity at baseline (aHR: 1.39, 95% CI: 1.12 to 1.51) and being overweight (aHR: 1.46, 95% CI: 1.25 to 1.71) and obese (aHR: 1.62, 95% CI: 1.36 to 1.93) were associated with higher risk of MetS development.
The incidence of MetS was high among our patients, with elevated fasting blood sugar and elevated blood pressure being the most common developed MetS defining components. HIV programmes should institute targeted interventions at addressing central obesity to reduce the risk of MetS.
To assess the upstream pharmaceutical supply chains of 10 high-use pharmaceuticals to detect vulnerabilities that may increase the risk of medicine shortages.
Cohort study.
Dutch outpatient setting in 2022.
A total of 407 authorised medicinal products for 10 pharmaceutical substances with the largest number of outpatients.
The diversity of active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) manufacturers, their geographic locations and the interdependencies between these manufacturers and marketing authorisation holders (MAHs).
For the 407 authorised medicinal products, 50 of the 90 API manufacturing sites were in Asia, and 38 were in Europe. For five pharmaceutical substances, most of the API sites were located outside Europe. Of the 128 FPP manufacturing sites, 94 were in Europe and 31 in Asia. For all 10 substances, at least 47% of FPP sites were located in Europe. API manufacturing for 122 of the 407 products (30%) was entirely performed outside Europe, and FPP manufacturing for 66 of the 407 products (16%). For four substances, more than half of the products depended on API manufacturing outside Europe. The number of distinct API and FPP manufacturing sites per substance was at least four. For amoxicillin, 16 of the 32 products (50%) entirely depended on one and the same API site. For omeprazole, 39 of the 85 products (46%) entirely depended on one and the same FPP site. MAHs applied dual sourcing for API and FPP manufacturing for 61 (15%) of the authorised medicinal products. For three pharmaceutical substances, none of the authorised medicinal products listed at least two API and FPP manufacturing sites.
Our study of the supply chains of high-use pharmaceutical substances indicates the need for a granular assessment of the interdependencies between MAHs, API and FPP manufacturers to identify upstream supply chain vulnerabilities.