Thrombolysis for Wake-Up Stroke Versus Non–Wake-Up Unwitnessed Stroke: EOS Individual Patient Data Meta-Analysis

Stroke, Ahead of Print. Background:Stroke with unknown time of onset can be categorized into 2 groups; wake-up stroke (WUS) and unwitnessed stroke with an onset time unavailable for reasons other than wake-up (non–wake-up unwitnessed stroke, non-WUS). We aimed to assess potential differences in the efficacy and safety of intravenous thrombolysis (IVT) between these subgroups.Methods:Patients with an unknown-onset stroke were evaluated using individual patient-level data of 2 randomized controlled trials (WAKE-UP [Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke], THAWS [Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg]) comparing IVT with placebo or standard treatment from the EOS (Evaluation of Unknown-Onset Stroke Thrombolysis trial) data set. A favorable outcome was prespecified as a modified Rankin Scale score of 0 to 1 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage at 22 to 36 hours and 90-day mortality. The IVT effect was compared between the treatment groups in the WUS and non-WUS with multivariable logistic regression analysis.Results:Six hundred thirty-four patients from 2 trials were analyzed; 542 had WUS (191 women, 272 receiving alteplase), and 92 had non-WUS (42 women, 43 receiving alteplase). Overall, no significant interaction was noted between the mode of onset and treatment effect (Pvalue for interaction=0.796). In patients with WUS, the frequencies of favorable outcomes were 54.8% and 45.5% in the IVT and control groups, respectively (adjusted odds ratio, 1.47 [95% CI, 1.01–2.16]). Death occurred in 4.0% and 1.9%, respectively (P=0.162), and symptomatic intracranial hemorrhage in 1.8% and 0.3%, respectively (P=0.194). In patients with non-WUS, no significant difference was observed in favorable outcomes relative to the control (37.2% versus 29.2%; adjusted odds ratio, 1.76 [0.58–5.37]). One death and one symptomatic intracranial hemorrhage were reported in the IVT group, but none in the control.Conclusions:There was no difference in the effect of IVT between patients with WUS and non-WUS. IVT showed a significant benefit in patients with WUS, while there was insufficient statistical power to detect a substantial benefit in the non-WUS subgroup.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: CRD42020166903.

Leggi
Marzo 2024

10-year follow-up results of the European Achalasia Trial: a multicentre randomised controlled trial comparing pneumatic dilation with laparoscopic Heller myotomy

Objective
As achalasia is a chronic disorder, long-term follow-up data comparing different treatments are essential to select optimal clinical management. Here, we report on the 10-year follow-up of the European Achalasia Trial comparing endoscopic pneumodilation (PD) with laparoscopic Heller myotomy (LHM).

Design
A total of 201 newly diagnosed patients with achalasia were randomised to either a series of PDs (n=96) or LHM (n=105). Patients completed symptom (Eckardt score) and quality-of-life questionnaires, underwent functional tests and upper endoscopy. Primary outcome was therapeutic success defined as Eckardt score

Leggi
Marzo 2024

Can we develop consensus on long-term follow-up and surveillance of primary shoulder arthroplasty? A study protocol using a real-time Delphi technique among expert clinicians in the UK

Background
Shoulder arthroplasty incidence is projected to continue its exponential growth and the resultant burden of monitoring patients with shoulder arthroplasty implants creates significant pressure on orthopaedic services. Surveillance offers the opportunity to study implant longevity, detect failing implants and potentially perform revision at lower morbidity and cost. There is a paucity of evidence to support recommendations on long-term follow-up in shoulder arthroplasty. Prospective studies comparing long-term follow-up and structure are impractical from time, resource and cost perspectives. A real-time Delphi technique represents a mechanism by which experts involved in long-term follow-up of primary shoulder arthroplasty can formulate recommendations via a transparent, reproducible and efficient process. We outline the protocol for a real-time Delphi study seeking consensus on long-term follow-up and surveillance of primary shoulder arthroplasty .

Methods
A real-time Delphi technique will be used. A planning committee will design the Delphi statements. A steering committee will supervise and monitor the real-time Delphi process. Participants will be asked to rate their agreement with statements using a 5-point Likert scale. The Delphi statements will be derived from review of published literature, and the strength of evidence available for each statement will be provided. We will offer participation to all surgeons and extended-scope practitioners who are current members of the British Elbow & Shoulder Society (BESS) and have clinical practice involving shoulder arthroplasty follow-up. The questionnaire will be active for 4 weeks and requires a minimum of 20 participants. Consensus agreement is defined as 70% of participants selecting at least a 4-point on a 5-point Likert scale.

Discussion
We anticipate the outlined study will achieve consensus on long-term follow-up and surveillance of primary shoulder arthroplasty. We intend to use the expert consensus recommendations achieved, in addition to the limited applicable published evidence available, to produce BESS-affiliated guidelines on long-term follow-up and surveillance of primary shoulder arthroplasty.
Ethics
Ethical approval is not required for the real-time Delphi study.
We expect the results of this initiative will be published in a peer-reviewed, high-impact journal.

Leggi
Febbraio 2024

Orthopaedic trauma patients experiences with emergency department care and follow-up through Virtual Fracture Care review: a qualitative study

Objectives
This study aimed to identify factors influencing orthopaedic trauma patients’ experiences and satisfaction with emergency department (ED) care and follow-up through Virtual Fracture Care (VFC) review workflow.

Design
This study employed an explorative, descriptive, qualitative design using individual, semistructured interviews.

Setting
An urban level 2 trauma centre and teaching hospital in Amsterdam, the Netherlands.

Participants
Eligible patients were Dutch-speaking or English-speaking orthopaedic trauma patients, aged 18 years or above, who visited the hospital’s ED between June and September 2022, and were treated through VFC review workflow. Exclusion criteria were: reason for follow-up other than injury, eye/motor/verbal score

Leggi
Febbraio 2024

Mortality and health-related quality of life in older adults with long-term use of opioids, z-hypnotics or benzodiazepines: a prospective observational study at 5 years follow-up

Objectives
Disease and medication use in older age is a consequence of age-related declining health. Multimorbidity followed by polypharmacy is common. Central nervous system depressing (CNSD) drugs such as opioids, benzodiazepines and z-hypnotics are not recommended for long-term use in older adults but are in use by many. We aimed to assess mortality and change in health-related quality of life (HRQoL) in older adults with long-term use of CNSDs.

Method
A prospective observational study was conducted at Akershus University Hospital, Norway, 2017–2019, with follow-up in 2021–2022, including 246 participants aged 65–90. At 5-year follow-up, 78 (32%) participants had passed away. Mortality data were collected from patient electronic health records. Of the surviving 168 (68%), we collected further follow-up data from 38 (16%) participants. Follow-up included demographic and clinical data. The EuroQuol Group EQ-5D-5L questionnaire was used to measure HRQoL. Analysis include Cox regression model for survival data and linear mixed model for change in HRQoL over time.

Results
At follow-up, 78 (31.7%) were deceased. Mean survival time was 3.3 years. Total time for survival data was 4.7 years. Mortality was higher among participants with long-term use of CNSD (HR 1.9 95% CI (1.2 to 3.2), p=0.01). The multivariable analysis found being older (HR 1.1 95% CI (1.0 to 1.1), p=0.020) and male sex (HR 2.1 95% CI (1.2 to 3.5), p=0.008) to be associated with increased risk of mortality. According to the linear mixed model (n=38), there was no significant difference between surviving users and non-users in change in HRQoL EQ-5D-5L index from baseline to follow-up.

Conclusion
Mortality was higher for long-term users of CNSDs at 5-year follow-up. Being older and male sex were associated with mortality. Among survivors, there was no significant difference between the groups in change of HRQoL over time.

Trial registration number
NCT03162081; 22 May 2017.

Leggi
Febbraio 2024

Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study

Background
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Future estimations suggest an increase in global burden of AF greater than 60% by 2050. Numerous studies provide growing evidence that AF is not only associated with stroke but also with cognitive impairment and dementia.

Aim
The main goal is to assess the impact of the combined use of cardiac rhythm monitoring devices, echocardiography, biomarkers and neuroimaging on the early diagnosis of AF, silent strokes and cognitive decline, in subjects at high risk of AF.

Methods and analysis
Two-year follow-up of a cohort of individuals aged 65–85 years at high risk for AF, with no prior diagnosis of either stroke or dementia. The study involves baseline echocardiography, biomarkers, and neuroimaging, yearly cardiac monitoring, and semiannual clinical assessments. Different parameters from these tests will be analysed as independent variables. Throughout the study period, primary outcomes: new diagnoses of AF, stroke and cognitive impairment, along with any clinical and therapeutic changes, will be registered. A first descriptive and bivariate statistical analysis, appropriate to the types of variables, will be done. The information obtained from the data analysis will encompass adjusted risk estimates along with 95% confidence intervals. Event risk predictions will rely on multivariate Cox proportional hazards regression models. The predictive value of the model will be evaluated through the utilisation of receiver operating characteristic curves for area under the curve calculation. Additionally, time-to-event analysis will be performed using Kaplan-Meier curves.

Ethics and dissemination
This study protocol has been reviewed and approved by the Independent Ethics Committee of the Foundation University Institute for Primary Health Care Research-IDIAP Jordi Gol (expedient file 22/090-P). The authors plan to disseminate the study results to the general public through various scientific events. Publication in open-access journals and presentations at scientific congresses, seminars and meetings is also foreseen.

Trial registration number
NCT05772806.

Leggi
Febbraio 2024

Lessons learnt and best practices in scaling up an emergency transportation system to tackle maternal and neonatal mortality: a qualitative study of key stakeholders in Shinyanga, Tanzania

Objective
This study aimed to document lessons learnt and best practices for scaling up an innovative emergency transportation system, drawing insights from the m-mama programme implemented in Shinyanga, Tanzania. The m-mama pilot programme was implemented in phases from 2014 to 2016 in two districts and later scaled up to include all districts in Shinyanga region in 2017. The programme employed an emergency transportation system and technical and operational support of the health system to address the three delays leading to maternal and neonatal mortality.

Design
Cross-sectional, qualitative research with key healthcare system stakeholders from the national, regional and district levels.

Setting
The study was conducted in Kahama and Kishapu districts in Shinyanga, Tanzania. The two districts were selected purposefully to represent the programme implementation districts’ rural and urban or semiurban settings.

Participants
District, regional and national stakeholders involved in implementing the m-mama pilot programme in Shinyanga were interviewed between February and March 2022.

Results
Lessons learnt from implementing the m-mama programme were grouped into four key themes: community engagement, emergency transportation system, government engagement, and challenges and constraints in technical implementation. Stakeholder engagement and collaboration at all levels, community involvement in implementation, adherence to local contexts and effective government partnerships were identified as key drivers for programme success. Coordination, supervision and infrastructure enhancement were crucial in implementing the emergency transportation system.

Conclusions
Facilitating community involvement, understanding the local context and adapting to existing structures can enhance programme ownership and utilisation. The government serves as the central coordinator, overseeing resource mobilisation and distribution. A well-executed and coordinated emergency transportation system holds promise in addressing delays and curbing maternal and neonatal mortality. Collaborative knowledge-sharing among implementers is essential for identifying best practices and gaining insights into practical strategies for addressing anticipated challenges.

Leggi
Febbraio 2024

Patient experiences with patient-led, home-based follow-up after curative treatment for colorectal cancer: a qualitative study

Objectives
The number of patients with colorectal cancer (CRC) in need of oncological follow-up is growing. As a response, patient-led, home-based follow-up (PHFU) was developed, implemented and assessed. The aim of this study was to investigate how patients experienced PHFU.

Design
A qualitative study with individual semistructured interviews. Interviews were transcribed verbatim, and thematically analysed through an inductive, double-coding approach.

Setting
A university medical centre in the Netherlands.

Participants
12 curatively treated patients with CRC who received PHFU were included after purposive sampling.

Results
Overall, participants (N=12) were satisfied with PHFU. The time and cost-saving aspects for patient and hospital were evidently valued. PHFU was experienced as a shared effort, but patients felt like the primary responsibility remained in the hospital. Patients mentioned a decreased personal interaction with their healthcare provider (HCP) and felt a higher threshold to ask for help. However, all major questions were still addressed. Patients felt sufficiently competent to interpret their individual test results but experienced difficulty in interpreting repeated increases in carcinoembryonic antigen levels within the normal range. Educational status, age and a complicated disease course were seen as factors limiting the applicability of PHFU, and it was expressed that PHFU should be offered as an alternative instead of a novel standard of care.

Conclusions
According to patients, PHFU has great potential. However, PHFU may not be suitable for every CRC patient, and factors such as educational status, age and disease course should be taken into consideration. Patient and HCP have a shared responsibility to help successfully organise PHFU in practice.

Leggi
Febbraio 2024