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This nonrandomized clinical trial evaluates the long-term safety and efficacy of continuous treatment with deucravacitinib through 3 years in the POETYK PSO-1, PSO-2, and long-term extension trial.
Background
Globally, approximately 1.9 million cases of tuberculosis (TB) were attributable to undernutrition. Nearly 19 000 deaths occur annually in Ethiopia due to TB. TB makes undernutrition worse and undernutrition deteriorates the body’s defence system thus increasing the chance of developing an active illness. However, there is a dearth of studies regarding undernutrition among adult patients with TB in the study setting.
Objective
This study aimed to assess the magnitude of undernutrition and its associated factors among adult patients with TB in the South Ethiopia Region.
Design
We conducted a multicentre cross-sectional study using structured and pretested questionnaires.
Settings
The study was conducted from 5 August 2022 to 5 September 2022, among adult patients with TB on follow-up care in the South Ethiopia Region.
Participants
Three hundred ninety-eight randomly selected adult patients with TB on follow-up care in public healthcare facilities in the Southern Ethiopia region participated in the study.
Methods
Data were collected using structured and pretested questionnaires. Anthropometric measurements were taken by calibrated instruments. EpiData V.3.1 was used for data entry. Data analysis was done by SPSS V.25. Tables, graphs and texts were used to present descriptive statistics. Variables with a p value
Introduction
Scaling up evidence-based practices (EBPs) in family planning (FP), as recommended by the WHO, has increasingly been accepted by global health actors as core to their mission, goals and activities. National policies, strategies, guidance, training materials, political commitment and donor support exist in many countries to adopt and scale up a range of EBPs, including postpregnancy FP, task sharing for FP and the promotion of social and behaviour change (SBC) for FP. While there has been some success in implementing these practices, coverage remains inadequate in many countries. To gain a better understanding of the factors that may be hindering the sustained scale-up of these interventions, WHO has developed an assessment protocol to systematically identify the health systems’ ‘bottlenecks’ to implementation and to then identify solutions and develop strategies to address them.
Methods and analysis
A mixed method approach that includes document review, secondary data analysis (from surveys, service delivery data and case studies) and key informant interviews with policymakers, programme managers, health providers and community groups will be used to identify bottlenecks. This will be followed by a workshop to prioritise bottlenecks and characterise their root causes. Finally, solutions for the root causes of prioritised bottlenecks will be proposed. The protocol is structured in a modular format, with separate modules on postpregnancy FP, task sharing and SBC. Assessment themes and questions are informed by a wide body of literature on the three programmatic components, as well as studies on health policy implementation and scale-up.
Ethics and dissemination
The protocol was exempt from ethical review by the WHO ethics committee. The findings of the bottleneck analysis will be presented at local, national and international conferences and disseminated through peer-reviewed publications and webinars.
Objective
To determine the involvement of males in antenatal care (ANC) follow-up and its determinants in Ethiopia.
Design
A systematic review and meta-analysis.
Data sources
A systematic search was done on PubMed, African Journals Online, HINARI, ScienceDirect, Google Scholar and direct Google up to 20 November 2023.
Eligibility criteria
We included cross-sectional or case–control studies reporting male involvement in ANC service and its determinants in Ethiopia, which were published as full-length articles in English.
Data extraction and synthesis
The Joanna Briggs Institute checklist was used to appraise the included studies, and the I2 test was used to evaluate heterogeneity among the studies. We assessed publication bias using a funnel plot and Begg’s test. The forest plot presented the combined proportion of male involvement and OR, along with a 95% CI.
Results
The pooled proportion of male involvement in ANC follow-up in Ethiopia was 43.3% (95% CI 31.7% to 54.8%). Male partners with secondary education or higher (Adjusted Odds Ratio (AOR) 2.72, 95% CI 1.81 to 4.10), government employment (AOR 2.09, 95% CI 1.49 to 2.94), attendance at health education (AOR 3.02, 95% CI 1.39 to 6.54) and knowledge about ANC or pregnancy danger signs (AOR 2.36, 95% CI 1.33 to 4.19) demonstrated a significant association with increased male involvement.
Conclusion
Male involvement in ANC in Ethiopia is low. Recommendations include targeted education for males with no formal schooling, improved health education on ANC and pregnancy risks, and interventions for males in the private sector.
PROSPERO registration number
CRD42021258826.
Introduction
The intrauterine device (IUD) inserted immediately after delivery is a safe and effective measure for preventing unplanned pregnancies. Despite exhibiting a higher expulsion rate compared with later insertions, it proves cost-effective due to the high rate of continuity of the method. There is still a gap in the literature regarding the optimal strategy for monitoring these patients, whether it should be through clinical examination, ultrasound or both. The aim of this review is to map the available evidence regarding the proper clinical and ultrasound follow-up procedures of IUDs inserted immediately post partum.
Methods and analysis
Using the well-established scoping review methodology outlined by the Joanna Briggs Institute, a five-stage review is outlined: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. The search strategy will be applied to nine databases reflecting empirical and grey literature. A two-step screening process will be used to determine eligibility of articles. To be included in the review, articles must describe how postpartum women (adolescents or adults) who had an IUD inserted immediately after birth (vaginal or caesarean) were followed up. All articles will be independently assessed for eligibility, and data from eligible articles will be extracted and charted using a standardised form. Extracted data will be analysed using narrative and descriptive analyses.
Ethics and dissemination
Ethics approval is not required. The results will be disseminated to the health science community through professional networks, conference presentations and publication in a scientific journal.
Objective
The prognosis of older adults is strongly influenced by the relation of multifactorial geriatric syndromes (GS) and their health-maintaining counterparts, geriatric resources (GR). The present analysis aimed to identify clusters of comorbidities, GS and GR, and to measure their multidimensional prognostic signature in older patients admitted to different healthcare settings.
Design
Pooled secondary analysis of three longitudinal interventional studies with the 3- and 6-month follow-up data collection on mortality and rehospitalisation.
Setting
Inpatients in an internal medicine ward (n=495), inpatients in an ageing medicine ward (n=123) and outpatients from a general practice (n=105).
Participants
A total of 734 patients with multimorbidity who aged over 60 years were recruited between August 2016 and July 2020 (mean age 77.8 years, SD 6.2 and 43% female).
Outcome measures
Comprehensive Geriatric Assessment (CGA), including Cumulative Illness Rating Scale (CIRS), 17 GS and 10 GR, and the CGA-based Multidimensional Prognostic Index (MPI) as a measure of multidimensional prognosis and frailty were assessed. Based on a general linear model and a hierarchical clustering method, clusters of comorbidities, GS and GR were obtained.
Results
The study identified five clusters of GR-related GS, namely, psychosocial, iatrogenic, neurovegetative, sensorimotor and fluid dysbalance, along with two clusters related to GR, focusing on independence achievement and requirements- circumstances. Additionally, two clusters were identified pertaining to the CIRS, encompassing sensory-vegetative and heart-kidney morbidity. Patients within the iatrogenic cluster exhibited significantly higher MPI and readmissions during follow-up compared with those outside this cluster (p
Stroke, Volume 56, Issue 1, Page 46-55, January 1, 2025. BACKGROUND:Risk profile of recurrence may influence the effect of antiplatelet therapy. This study aimed to evaluate the efficacy and safety of clopidogrel-aspirin initiated within 72 hours after symptom onset for acute mild stroke or high-risk transient ischemic attack stratified by risk profile.METHODS:This is a secondary post hoc analysis of the INSPIRES (Intensive Statin and Antiplatelet Therapy for Acute High-risk Intracranial or Extracranial Atherosclerosis) randomized clinical trial that enrolled patients 35 to 80 years old with acute mild ischemic stroke or high-risk transient ischemic attack between 2018 and 2022. Patients were stratified into different groups based on the Essen Stroke Risk Score (ESRS) and modified ESRS. The primary efficacy outcome was any new stroke within 90 days. The primary safety outcome was moderate-to-severe bleeding within 90 days.RESULTS:Among 6100 patients (3050 each in the clopidogrel-aspirin group and aspirin group), the median age was 65 years (interquartile range, 57–71 years), and 3915 (64.2%) were male. Clopidogrel-aspirin was associated with a reduced risk of new stroke in patients with an ESRS of
Objectives
To evaluate the cost-effectiveness of percutaneous repair (PR) for secondary mitral regurgitation.
Design
An economic evaluation using a time-varying Markov model comprising three states to assess the cost and effectiveness of PR added to guideline-directed medical treatment (GDMT) compared with GDMT alone. Clinical outcomes considered within the model were overall survival and heart failure (HF) hospitalisations (HFH), and the incremental cost-effectiveness ratio (ICER) was calculated. Cost data were derived from a literature search. Sensitivity analyses were undertaken.
Setting
The French healthcare system perspective assuming a lifetime horizon.
Participants
Published data at 5 years obtained from patients enrolled in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation study.
Results
In our base case, we chose cubic spline models to extrapolate overall survival, and we used log-logistic models to estimate cumulative HFH. After discounting, the model generated life-years of 3.843 years and 3.055 years for PR+GDMT and GDMT, respectively. Discounted total quality-adjusted life-year (QALY) values were 2.572 and 1.945 for PR+GDMT and GDMT, respectively (incremental 0.627 QALY). Discounted total costs were 42 709 and 20 732 for the intervention and the control groups, respectively (incremental 21,977), resulting in an ICER of 35,068/QALY. At a threshold of 50 000 per QALY, PR had a 0.85 probability of being cost-effective.
Conclusion
Updated trial data have enabled investigators to provide a more reliable estimation of the ICER, which suggests that PR has good value for money compared with GDMT alone.
Introduction
Patients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient’s physical and psychological well-being.
Methods and analysis
The study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis.
Ethics and dissemination
The project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants’ consent, and the invitation letter therefore included information about the purpose of the study and participants’ rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research.
Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association.
Trial registration number
Clinicaltrials.gov NCT06037096.
Objective
The objective of the study is to assess knowledge of diabetic retinopathy, eye check-up service utilisation and associated factors among adult diabetic patients at public hospitals in southeastern Ethiopia in 2022.
Setting
The study was conducted at Ginnir General and Goba Referral Hospital in southeast Ethiopia.
Design
The study was designed as a facility-based cross-sectional study.
Participants
Systematically selected adult diabetic patients were the participants of the study.
Primary outcome
The primary outcomes are knowledge about diabetic retinopathy and eye check-up service utilisation.
Results
Of the 422 samples, 401 study participants participated with a 95% response rate. 254 (63.3%) (95% CI 58.5, 68%) and 37% (95% CI 32.5, 42%) of the participants had good knowledge of diabetic retinopathy and good uptake of eye check-up service, respectively. Educational status of greater than 12th grade, possession of health insurance and good attitude towards diabetic retinopathy prevention were factors associated with good knowledge about diabetic retinopathy. In addition, urban residence, level of education of >grade 12, having health insurance, good knowledge of diabetic retinopathy and good attitude towards prevention of diabetic retinopathy were significantly associated with good utilisation of eye check-up services.
Conclusions
Compared with the WHO and other recommendations, diabetic patients have low knowledge and utilisation of eye check-up services for diabetic retinopathy.
New England Journal of Medicine, Volume 391, Issue 22, Page 2170-2172, December 5, 2024.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Ahead of Print.
Objectives
This study aimed to assess the prevalence of treatment-resistant depression (TRD) and associated factors among patients with major depressive disorder (MDD) on follow-up at Amanuel Mental Specialised Hospital, Addis Ababa, Ethiopia, 2021.
Design and setting
An institution-based cross-sectional study design was employed using systematic random sampling techniques from 17 February to 26 March 2021.
Participants
The study enrolled 412 participants with a response rate of 97.6%. The study population consisted of Saint Amanuel Mental Specialised Hospital follow-up patients with MDDs and all adult patients aged above 18.
Main outcome measures
The main outcome of this study was TRD, which was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D). The collected data were entered into Epi-data software version 3.1 and exported to the statistical package for social science version 20 for analysis. Bivariate and multivariate logistic regression analyses were used to identify associated factors with TRD. The OR with a 95% CI was used to assess the strength of the association.
Results
The prevalence of TRD was 41.5% (95% CI: 37.2 to 46.1). Female sex [AOR=2.43, 95% CI: 1.57 to 3.75], comorbid psychosis [AOR=1.89, 95% CI: 1.19 to 2.99], comorbid medical illness [AOR=1.67, 95% CI: 1.09 to 2.55] and family history of mental illness [AOR=2.27, 95% CI: 1.38 to 3.74] were factors significantly associated with TRD.
Conclusion and recommendation
In this study, the prevalence of TRD among patients with MDDs on follow-up was high. Therefore, to improve outcomes, screening for TRD and creating specific diagnostic techniques are necessary. Additionally, preventive interventions against TRD must be established.
Introduction
Hysterosalpingography (HSG) and hysterosalpingo-foam sonography (HyFoSy) are commonly used tubal patency tests during the fertility work-up. Besides its diagnostic purpose, HSG with oil-based contrast can also be applied for its fertility-enhancing effect, by tubal flushing. HyFoSy is considered as less painful compared with HSG, it lacks exposure to iodinated contrast medium and ionising radiation. The fertility-enhancing effects of HyFoSy are less studied and randomised controlled trials comparing pregnancy rates after HSG and HyFoSy are lacking. This study (FOil study) is initiated to compare the effectiveness of tubal flushing during HSG with oil-based contrast and HyFoSy.
Methods and analysis
The FOil study is a nationwide, multicentre, open label, randomised controlled trial with a superiority design. Infertile women with an indication for tubal patency testing during their fertility work-up will be randomly assigned to HSG with oil-based contrast medium or HyFoSy. The primary outcome is conception within 6 months after randomisation leading to live birth. To demonstrate or refute an 8% difference in conception leading to live birth in favour of HSG with oil-based contrast, 1102 women will be included in the trial. A cost-effectiveness analysis from a societal perspective will be performed alongside the trial.
Ethics and dissemination
The trial is approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers (Ref. No. 2022.0884, date: 17 March 2023) and by the boards of the participating hospitals. The findings will be disseminated in peer-reviewed journals and participants will be informed through the patient organisation.
Trial registration number
NCT05882188.
