Occurrence of sensitive topics during ward round: an ancillary analysis of the BEDSIDE-OUTSIDE trial.

OBJECTIVE: Discussing sensitive topics (eg, medical uncertainty, social issues, non-adherence) during ward rounds is challenging and may negatively impact patient satisfaction with the healthcare they are receiving. In the previous multicentre randomised BEDSIDE-OUTSIDE trial focusing on communication during ward rounds, we investigated the interplay between sensitive topics and low reported satisfaction with care. DESIGN: Pre-planned secondary analysis of a randomised controlled trial. For this analysis data of the original trial was pooled across intervention groups. SETTING: Three Swiss teaching hospitals. PARTICIPANTS: Adult patients hospitalised for medical care. INTERVENTIONS: We analysed predefined sensitive health topics and specific elements of communication from audiotapes recorded during ward rounds, for both patients dealing with and without sensitive topics. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was overall patient satisfaction with care; measured on a Visual Analogue Scale from 0 to 100. Secondary endpoints included duration of ward rounds and further satisfaction outcomes. RESULTS: Of the 919 included patients, 474 had at least one sensitive topic including medical uncertainty (n=251), psychiatric comorbidities (n=161), tumour diagnosis (n=137) and social issues (n=125). Compared with patients without sensitive topics, patients with sensitive topics reported lower satisfaction with care (mean (SD), 87.7 (±14.6) vs 90.2 (±12.1), adjusted difference -2.5 (95% CI -4.28 to -0.72), p=0.006. Among patients with sensitive topics, risk factors for low satisfaction included several parameters concerning patient-physician interaction such as disagreements during ward rounds (mean (SD), 14/212 (6.6%) vs 41/254 (16.1%), adjusted OR 2.78 (95% CI 1.47 to 5.27), p=0.002). CONCLUSIONS: A large proportion of medical inpatients must deal with sensitive health topics. This is associated with lower satisfaction with care, particularly if the patient perceives the interaction with doctors during ward rounds as unsatisfactory. Educating physicians on specific communication techniques may help improve care for these patients. TRIAL REGISTRATION NUMBER: NCT03210987.

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial.

BACKGROUND: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders). METHODS: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods). DISCUSSION: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021.

Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial.

BACKGROUND: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. AIMS: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. METHODS: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. RESULTS: Mean age was 66.9 ± 9.8 years; 24% were under 60 years. Older patients had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. CONCLUSIONS: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.

Mapping of atrial fibrillation--basic research and clinical applications.

Despite five decades of intensive research, mechanisms initiating and stabilising atrial fibrillation (AF) are still not fully understood. Nevertheless, mapping studies, next to clinical trials and research on cellular electrophysiology, have provided key information that has led to a much more profound understanding of the arrhythmia. Contact mapping using multi-electrode arrays (MEAs) is the gold standard for high-resolution mapping in basic research and clinical trials, and continuously contributes to a better description of mechanisms perpetuating AF. It thereby provides information needed to target and test new pharmacological and interventional treatment options for AF therapy and to evaluate established ones, which were often implemented based on purely empirical assumptions. In patients undergoing cardiac surgery high- resolution contact mapping studies are performed for basic research purposes to evaluate to which extent data derived from animal models of AF is comparable to data recorded in humans. The goal of these research projects is to develop algorithms that allow the identification and staging of the arrhythmogenic substrate. This information should then help to guide surgical therapy when applicable, or individualise treatment strategy involving catheter ablation, antiarrhythmic drug therapy or simply a rate control strategy. Mapping techniques used in the catheter laboratory by interventional electrophysiologists represent a valuable tool for exact localisation of catheters and the points of interest for ablation. These techniques integrate data on individual anatomy (derived from CT scan or intracardiac ultrasound), local intracardiac electrograms (re-corded point by point with a catheter) and the exact spatial position of the catheter. While mapping techniques used with electrophysiological studies and ablations in patients are highly useful tools to optimise and document ablation results and significantly reduce fluoroscopy time, they fail to display the complexity of atrial activation during AF. This is mainly due to a limited number of simultaneously recorded electrograms and the low spatial resolution which is sufficient for its clinical use. At present, high-resolution mapping of AF in patients is only feasible during cardiac surgery. Endocardial catheter- based systems that have recently become available have to be further evaluated but might provide an option in this setting in the near future.

Necessity for surgical revision of defibrillator leads implanted long-term: causes and management.

BACKGROUND: Defibrillator lead malfunction is a potential long-term complication in patients with an implantable cardioverter-defibrillator (ICD). The aim of this study was to determine the incidence and causes of lead malfunction necessitating surgical revision and to evaluate 2 approaches to treat lead malfunction. METHODS AND RESULTS: We included 1317 consecutive patients with an ICD implanted at 3 European centers between 1993 and 2004. The types and causes of lead malfunction were recorded. If the integrity of the high-voltage part of the lead could be ascertained, an additional pace/sense lead was implanted. Otherwise, the patients received a new ICD lead. Of the 1317 patients, 38 experienced lead malfunction requiring surgical revision and 315 died during a median follow-up of 6.4 years. At 5 years, the cumulative incidence was 2.5% (95% confidence interval, 1.5 to 3.6). Lead malfunction resulted in inappropriate ICD therapies in 76% of the cases. Implantation of a pace/sense lead was feasible in 63%. Both lead revision strategies were similar with regard to lead malfunction recurrence (P=0.8). However, the cumulative incidence of recurrence was high (20% at 5 years; 95% confidence interval, 1.7 to 37.7). CONCLUSIONS: ICD lead malfunction necessitating surgical revision becomes a clinically relevant problem in 2.5% of ICD recipients within 5 years. In selected cases, simple implantation of an additional pace/sense lead is feasible. Regardless of the chosen approach, the incidence of recurrent ICD lead-related problems after lead revision is 8-fold higher in this population.

Drug evaluation: Bay-59-8862.

Bayer Corp, under license from Indena SpA, is developing BAY-59-8862, a taxane synthesized from 14beta-hydroxy-10-deacetylbaccatin III, for the potential treatment of cancer.

Conformational analysis of a stereochemically complete set of cis-enediol peptide analogues.

A conformational analysis of a stereochemically complete set of peptide analogues based on a cis-enediol unit is presented. The cis-enediol unit, which can replace a two or a three amino acid segment of a peptide, contains two "side chains", four asymmetrical carbon atoms, and six free dihedral angles. To determine the accessible conformational space, the molecules are divided into three fragments, each containing two free dihedral angles. The energy surfaces are computed for all dihedral angle values, and the possible conformations of the cis-enediol unit analogues are built using all combinations of the surface minima. Such a "build-up" procedure, which is very fast, is able to reproduce 75% of the minima obtained from a full dihedral angle exploration of the conformational space. The cis-enediol unit minima are compared with the corresponding di- and tripeptide minima; all peptide minima can be closely matched by a cis-enediol unit minimum of low energy (less than 2.2 kcal/mol above the lowest energy conformer). However, there are low energy minima of the cis-enediol unit that have no corresponding minima in peptides. The results are shown to depend strongly on the chirality of the analogues. The ability of each of the stereoisomers to mimic natural peptides, evaluated by the present approach, is correlated with its experimental activity in a renin inhibition assay.