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

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