Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial

Introduction
The follow-up adherence after treatment for a positive screening test is critical for preventing the development of screen-detected abnormalities in cervical cancer. Yet, this poses a major challenge in developing countries like Ethiopia, emphasising the urgency for intervention strategies. Our trial aims to assess which strategies would be effective in improving adherence to follow-up after suspicious cervical lesion treatment in Ethiopia. Thus, the objective of this study is to evaluate key interventions to improve the follow-up adherence rate among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia.

Method and analysis
We will employ a pragmatic randomised control trial study design, using Consolidated Standards of Reporting Trials guidelines for reporting and a Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for developing the protocol, to evaluate intervention effectiveness. These interventions are: (a) structured nurses-led telephone call reminders, (b) home-visit reminders led by health extension workers and (c) application-based automated short message service text reminders. The standard care involves only receiving oral follow-up advice and a baseline follow-up card. The planned start date is 1 November 2024, with an anticipated end date of 1 November 2025. Our study will include women aged 30–49 who are HIV-negative and those over 25 who are HIV-positive, and who have been treated for suspicious cervical lesions after a positive visual inspection with acetic acid (VIA) screening, as per Ethiopian Ministry of Health guidelines for cervical cancer screening eligibility. The required sample size is 460, with 115 participants per arm. Study participants in the intervention group will receive the stated interventions plus the standard care, while the control group will receive only the standard care. The interventions will be delivered three times annually: 4 months from baseline, then at 8 months and finally at 12 months before the appointment due date. The primary outcome of our study is the proportion of adherence to follow-up recommendations, which will be measured by rescreening (VIA) after 1 year (11–13 months after the first screening). Descriptive statistics, 2 test (Fisher’s exact test), binary logistic regression analysis and intention-to-treat will be used to describe and interpret the results.

Ethics and dissemination
The trial protocol has been approved by the institutional review board of Addis Ababa University with protocol number (008/24/SPH). Trial results will be disseminated to study participants, national and international audiences through workshops, conferences and publications in reputable journals.

Trial registration number
NCT06515301.

Leggi
Gennaio 2025

IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers

Introduction
Survivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.

Methods and analysis
This is a single-centre feasibility study. Survivors of critical illness will be eligible if: age ≥18 years, life expectancy ≥6 months and high risk for PICS. We define high risk as ICU stay ≥4 days or involving 1+ of mechanical ventilation, tracheostomy, delirium or lack of access to a primary care physician (PCP). 20 ICU survivor-primary caregiver dyads will be enrolled (n=10 dyads per group) and randomised 1:1 to the intervention versus control group. The intervention will be: (1) diaries to journal patient experiences, (2) information packages on expectations post-discharge and (3) specialised follow-up care at 1 and 3 months post-discharge. The control group will receive standard of care in the ICU and follow-up with their PCP. The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate >70% and (4) data capture rate >80%. Our secondary objective is to explore the perspectives of survivors of critical illness and their families about the intervention and their participation in the study. Tertiary outcomes will be a battery of cognitive, physical functioning and psychiatric outcomes.

Implications
Survivorship from critical illness extends beyond surviving an ICU stay. This project will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improved long-term healthcare.

Ethics and dissemination
This study has received approval (6039808) from the Queen’s University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board. Results will be presented at critical care conferences. A lay summary co-designed with ICU survivor participants will be provided to patients.

Trial registration number
NCT06681649.

Leggi
Gennaio 2025

Tenecteplase Thrombolysis for Stroke up to 24 Hours After Onset With Perfusion Imaging Selection: The CHABLIS-T II Randomized Clinical Trial

Stroke, Ahead of Print. BACKGROUND:Whether it is effective and safe to extend the time window of intravenous thrombolysis up to 24 hours after the last known well is unknown. We aimed to determine the efficacy and safety of tenecteplase in Chinese patients with acute ischemic stroke due to large/medium vessel occlusion within an extended time window.METHODS:Patients with ischemic stroke presenting 4.5 to 24 hours from the last known well, with a favorable penumbral profile and an associated large/medium vessel occlusion, were randomized 1:1 to either 0.25 mg/kg tenecteplase or the best medical treatment. A favorable penumbral profile was defined as a hypoperfusion lesion volume to infarct core volume ratio >1.2, with an absolute volume difference >10 mL, and an ischemic core volume 50% of the involved ischemic territory. Secondary outcomes included recanalization, infarct growth, major neurological improvements, change in the National Institutes of Health Stroke Scale score, hemorrhagic transformation within 24 to 48 hours, systemic bleeding at discharge, and modified Rankin Scale (score 0–1, score 0–2, score 5–6, and modified Rankin Scale distribution) at 90 days. The comparison of the primary outcome between groups was conducted using modified Poisson regression with a log-link function and robust error variance, adjusted for time from the last known well to randomization, the site of vessel occlusion, and planned endovascular treatment.RESULTS:Among 224 enrolled patients, 111 were assigned to receive tenecteplase and 113 to receive the best medical treatment (including 23% [n=26] of participants who received intravenous tissue-type plasminogen activator). The mean (SD) age of the tenecteplase group and the best medical treatment group was 64.2 (10.4) and 63.6 (11.0) years old, with 72.1% (n=80) and 70.8% (n=80) male enrolled, respectively. A proportion of 54.9% (n=123) of patients were transferred to the catheter room for preplanned endovascular treatment. The primary outcome occurred in 33.3% (n=37) of the tenecteplase group versus 10.8% (n=12) in the best medical treatment group (adjusted relative risk, 3.0 [95% CI, 1.6–5.7];P=0.001). Tenecteplase significantly increased the recanalization rate compared with the best medical treatment (35.8% [n=39] versus 14.3% [n=16], adjusted relative risk, 2.5 [95% CI, 1.4–4.4];P=0.002). There were no significant differences in clinical efficacy outcomes or rates of hemorrhagic transformation between the groups.CONCLUSIONS:Administered at a dose of 0.25 mg/kg intravenously, tenecteplase increased reperfusion without symptomatic intracranial hemorrhage in patients with ischemic stroke selected by imaging in late-time window treatment but did not change clinical outcomes at 90 days.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT04516993.

Leggi
Gennaio 2025

Magnitude of undernutrition and determinant factors among adult patients with tuberculosis on follow-up care at public healthcare facilities in South Ethiopia Region: a multicentre cross-sectional study

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

Leggi
Dicembre 2024

Protocol to assess bottlenecks inhibiting the scaling up of evidence-based family planning practices in low-income and middle-income countries using mixed methods

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.

Leggi
Dicembre 2024

Prognostic signature of multimorbidity, geriatric syndromes and resources cluster in older in- and outpatients: a pooled secondary analysis with a 6-month follow-up

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

Leggi
Dicembre 2024

Follow-up of immediate postpartum intrauterine device insertion: a scoping review protocol

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.

Leggi
Dicembre 2024

Male involvement in antenatal care follow-up and its determinants in Ethiopia: a systematic review and meta-analysis

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.

Leggi
Dicembre 2024

Dual Antiplatelet Treatment up to 72 Hours After Ischemic Stroke Stratified by Risk Profile: A Post Hoc Analysis

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

Leggi
Dicembre 2024

Cost-effectiveness of percutaneous mitral repair for patients with severe secondary mitral regurgitation: an updated evaluation using a modelling approach based on COAPT final data after 5-year follow-up

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.

Leggi
Dicembre 2024

Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study

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.

Leggi
Dicembre 2024

Knowledge about diabetic retinopathy, eye check-up service utilisation and associated factors among adult diabetic patients at public hospitals of southeastern Ethiopia, 2022

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.

Leggi
Dicembre 2024