Motivational interviewing for reducing rehospitalisation and improving patient activation among patients with heart failure or chronic obstructive pulmonary disease: a randomised controlled trial

Objectives
The aim is to evaluate the effects of a motivational interviewing-based intervention, Supporting Patient Activation in Transition to Home, on rehospitalisation and patient activation among patients with heart failure or chronic obstructive pulmonary disease.

Design
A randomised, controlled, analysis-blinded trial was conducted.

Setting
Participants were recruited from two hospitals in mid-Sweden and the intervention and interviews were conducted post-discharge.

Participants
207 participants with heart failure or chronic obstructive pulmonary disease were recruited. Participants were randomised to receive five motivational interviewing sessions post-discharge (n=103) or a control group (n=104).

Outcome measures
Rehospitalisation within 180 days post-discharge was retrieved, and patient activation was assessed using the Patient Activation Measure at baseline, 30, 90 and 180 days post-discharge. We used a generalised estimating equation to assess the difference in the secondary outcome, patient activation, between the intervention group and the control group during the 180-day follow-up.

Results
No statistically significant differences between the groups were found for rehospitalisation (p=0.33 to 0.41) or patient activation over time (B=–1.67, –0.71 and –0.83 (95% CI –5.45 to 2.10, –4.06 to 2.64 and –4.28 to 2.62), respectively).

Conclusion
Post-discharge motivational interviewing to decrease rehospitalisation or support patient activation does not seem beneficial for patients with heart failure or chronic obstructive pulmonary disease. The high disease burden may have limited patient participation in the intervention.

Trial registration number
NCT02823795.

Read More

National survey evaluating the introduction of new and alternative staffing models in intensive care (SEISMIC-R) in the UK

Objective
To report on the findings from a national survey of UK intensive care units (ICUs) exploring nurse staffing models currently in use and changes since COVID-19.

Design
A survey was designed and distributed using a web-based platform to senior unit leads via Intensive care national audit & research centre contacts.

Participants
Senior nurses representing the 331 National Health Service adult ICUs across the UK (across 231 hospitals/155 trusts), including the Channel Islands and Isle of Man.

Outcome measures
A 15-item survey.

Results
A total of 196 survey responses representing 300 units, majority general and single units, resulting in a 90.6% unit-level response rate. ICU unit characteristics included the average number of total, level 3 and level 2 critical care beds of 26.36 (SD=21.48), 15.67 (SD=15.33) and 10.96 (SD=8.86), respectively. Most units reported nurse to patient ratios compliant with national guidelines and service specifications. Post-COVID-19 changes to ICU nurse staffing establishments were reported by 44% respondents, including increases in non-registered staff. However, limited data were provided regarding decision-making around and changes to bedside allocation of nurses since COVID-19.

Conclusions
Increased numbers and use of non-registered staff within the ICU is indicative of an alternative staffing model to address nursing shortages. However, more research is needed to understand how this staffing group is being used compared with, and alongside, registered nurses.

Trial registration number
Clinicaltrials.gov: NCT05917574.

Read More

Mechanism-based modular psychotherapy versus cognitive behavioural therapy for adolescents and young adults with childhood trauma experiences: study protocol for a feasibility trial within the German Center for Mental Health

Introduction
Patients with mental disorders and a history of childhood trauma show an early onset of psychopathology and often a poor response to standard disorder-specific treatments. They represent a patient group which requires more personalised interventions targeting the transdiagnostic mechanisms related to early trauma and its functional consequences. The mechanism-based modular psychotherapy (MeMoPsy) approach is conceptualised as an innovative framework for psychotherapy development. It comprises independent, flexibly applicable interventions from various theoretical backgrounds and evidence-based programmes within a systematic treatment algorithm, thereby tailoring module selection to the specific needs of traumatised adolescents.

Methods and analysis
In a randomised controlled feasibility trial (RCT), N=80 outpatients between 15 and 25 years of age diagnosed with various mental disorders will receive 28 individual sessions with MeMoPsy or standard cognitive behavioural therapy. MeMoPsy includes a basic module that addresses trauma history and three additional modules focusing on functional impairments known to be associated with childhood trauma: rejection sensitivity, emotion regulation and relationship difficulties. These modules are selected based on a self-report algorithm. Techniques from mentalisation-based therapy, cognitive behavioural analysis system of psychotherapy, dialectical behaviour therapy and systemic therapy are integrated in this personalised modular procedure. This proof-of-concept study aims to provide initial evidence for acceptability, feasibility and changes in self-rated and diagnostician-rated psychopathology (post-treatment and 3 months follow-up) of MeMoPsy and elucidate the mechanisms of change using psychotherapy process research, Ecological Momentary Assessment and functional magnetic resonance imaging (fMRI).

Ethics and dissemination
This RCT obtained approval from independent ethics committees of participating centres and is accompanied by a data and safety monitoring board. Findings will be communicated within the research community as well as with patients and the public by the dissemination strategies of the German Center for Mental Health.

Trial registration number
German Clinical Trials Register DRKS00034058.

Read More

Randomised controlled trial of a psychosocial digital health application to promote coping for caregivers of patients undergoing haematopoietic stem cell transplantation: a study protocol for the BMT-CARE app

Introduction
Caregivers of patients undergoing haematopoietic stem cell transplantation (HSCT) experience tremendous psychological distress before, during and after HSCT. However, few interventions are tailored to the protracted needs of these caregivers while considering scalability and accessibility. We previously developed an evidence-based intervention for caregivers of patients undergoing HSCT that improved quality of life (QOL), caregiving burden and mood. We have since adapted this clinician-delivered intervention into a self-administered, digital health application (BMT-CARE app) and are currently evaluating the effect of this intervention on QOL in caregivers of patients receiving HSCT.

Methods and analysis
The study design is a non-blinded randomised controlled trial of a digital health intervention for caregivers of patients undergoing HSCT at the Massachusetts General Hospital Cancer Center. We are enrolling and randomising 125 caregivers to receive the BMT-CARE app or usual care in a 1:1 assignment, stratifying by transplant type (autologous vs allogeneic). Caregivers assigned to the BMT-CARE app complete five self-guided modules designed to improve coping and stress management prior to and up to 60 days post-HSCT. The modules include interactive, gamified features and video vignettes to optimise engagement. Participants complete questionnaires at baseline and days 10, 60 and 100 post-HSCT. The primary outcome is comparison of QOL at day 60 post-HSCT. Secondary outcomes include caregiver burden, anxiety and depression symptoms, as well as post-traumatic stress symptoms. We are also exploring the usability of the BMT-CARE app to inform refinements prior to future testing.

Ethics and dissemination
The study is funded by the Leukemia and Lymphoma Society and approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #22–634 v.1.5). The results of this study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be disseminated at scientific meetings and in peer-reviewed journals.

Trial registration number
NCT05709912; Pre-results.

Read More

Incidence, risk factors and airway management of postoperative haematoma following anterior cervical spine surgery: a retrospective nested case-control study

Objective
The aim of this study was to investigate the incidence, risk factors and airway management of postoperative haematoma following anterior cervical spine surgery (ACSS).

Design
A retrospective nested case-control study.

Setting
A tertiary hospital in China.

Participants
A total of 13 523 patients within a single-centre longitudinal ACSS cohort were identified from March 2013 to February 2022. Patients with postoperative haematoma after ACSS were enrolled as the haematoma group, and others in the cohort without haematoma were randomly selected as the non-haematoma group by individually matching with the same operator, same gender, same surgery year and similar age (±5 years) at a ratio of 4:1. Subsequently, patients with haematoma were included in a subgroup for analysis.

Primary outcome measures
Postoperative haematoma and difficult intubation prior to haematoma evacuation.

Results
The incidence of postoperative haematoma out of all ACSS was 0.4% (55/13 523). A total of 275 patients were enrolled in the study, including 55 patients in the haematoma group and 220 patients in the non-haematoma group. Anterior cervical corpectomy and fusion (ACCF) (OR 2.459; 95% CI 1.302 to 4.642; p =0.006) and the maximum mean arterial pressure (MAP) during recovery (OR 1.030; 95% CI 1.003 to 1.058; p =0.028) were identified as independent risk factors for haematoma. In the subgroup analysis, 29% of patients with haematoma experienced difficult intubation, and retropharyngeal haematoma (OR 10.435; 95% CI 1.249 to 87.144; p =0.030) was identified as an independent risk factor for difficult intubation. Patients with haematoma had longer hospitalisation duration (p

Read More

Margin thermal ablation eliminates size as a risk factor for recurrence after piecemeal endoscopic mucosal resection of large non-pedunculated colorectal polyps

Background
Lesion size is an independent risk factor for recurrence following endoscopic mucosal resection of large (≥20 mm) non-pedunculated colorectal polyps. Post-resection margin thermal ablation (MTA) reduces the risk of recurrence. Its impact on the uncommon larger (≥40 mm) lesions is unknown.

Objective
We sought to analyse the impact of MTA on ≥40 mm lesions in a large, prospective cohort.

Design
A prospective cohort of patients with colorectal polyps ≥20 mm treated with piecemeal endoscopic mucosal resection in an expert tissue resection centre was divided into three phases: ‘pre-MTA’, July 2009–June 2012; ‘MTA-adoption’, July 2012–June 2017 and ‘standardised-MTA’, July 2017–July 2023. Recurrence was defined as adenomatous tissue endoscopically and/or histologically detected at the first surveillance colonoscopy. The primary outcome was the recurrence rate over the three time periods in three size groups: 20–39 mm, 40–59 mm and ≥60 mm.

Results
Over 14 years until July 2023, 1872 sporadic colorectal polyps ≥20 mm in 1872 patients underwent endoscopic mucosal resection (median lesion size 35 mm (IQR 25–45mm)). Of these, 1349 patients underwent surveillance colonoscopy at a median of 6 months (IQR 4–8 months). The overall rates of recurrence in the pre-MTA, MTA-adoption and standardised-MTA phases were 13.5% (n=42/310), 12.6% (n=72/560) and 2.1% (n=10/479), respectively, (p≤0.001). When MTA was applied in the standardised-MTA phase, the rate of recurrence was the same among 20–39 mm (1.5% (3/205)), 40–59 mm (1.6% (3/190)) and ≥60 mm polyps (1.4% (1/73)) (p=1.00).

Conclusion
MTA negates the effect of size on the incidence of recurrence after piecemeal endoscopic mucosal resection of colorectal polyps ≥40 mm.

Trial registration number
Australian Colonic Endoscopic Resection cohort (NCT01368289; NCT02000141).

Read More

Accuracy of histopathology evaluation in diminutive colonic polyps diagnosed as neoplastic by computer-aided characterisation

Message The removal of colorectal polyps followed by histological evaluation is the current standard of care. Intracolonoscopy computer-aided characterisation (computer-assisted diagnosis (CADx)) has emerged as an alternative strategy to possibly avoid histopathology after removal. However, each of these approaches can be limited by cases in which a diagnosis is not possible or inaccurate. We conducted a post hoc analysis of a prospective clinical study involving 249 diminutive polyps diagnosed by CADx in 164 consecutive patients. Of those polyps, 29 were diagnosed as ‘normal mucosa’ on histopathology (11.6%). Polyps diagnosed as ‘normal mucosa’ were reviewed by two independent blinded pathologists, and 24.1% were reassessed as adenomas after additional sections were performed. Besides superficial sectioning (24.1%), fragmentation (44.8%) and inadequate specimen preparation and handling (31.0%) were considered as reasons for misdiagnosis. Reassessment decreased the overall accuracy of histopathology to 88.4% (95% CI 83.7% to 92.1%). On the other hand, in…

Read More

Perturbation of mRNA splicing in liver cancer: insights, opportunities and challenges

Perturbation of mRNA splicing is commonly observed in human cancers and plays a role in various aspects of cancer hallmarks. Understanding the mechanisms and functions of alternative splicing (AS) not only enables us to explore the complex regulatory network involved in tumour initiation and progression but also reveals potential for RNA-based cancer treatment strategies. This review provides a comprehensive summary of the significance of AS in liver cancer, covering the regulatory mechanisms, cancer-related AS events, abnormal splicing regulators, as well as the interplay between AS and post-transcriptional and post-translational regulations. We present the current bioinformatic approaches and databases to detect and analyse AS in cancer, and discuss the implications and perspectives of AS in the treatment of liver cancer.

Read More

Predictors of response to low-dose amitriptyline for irritable bowel syndrome and efficacy and tolerability according to subtype: post hoc analyses from the ATLANTIS trial

Background
Low-dose amitriptyline, a tricyclic antidepressant (TCA), was superior to placebo for irritable bowel syndrome (IBS) in the AmitripTyline at Low-dose ANd Titrated for Irritable bowel syndrome as Second-line treatment (ATLANTIS) trial.

Objective
To perform post hoc analyses of ATLANTIS for predictors of response to, and tolerability of, a TCA.

Design
ATLANTIS randomised 463 adults with IBS to amitriptyline (232) or placebo (231). We examined the effect of baseline demographic and disease-related patient characteristics on response to amitriptyline and the effect of amitriptyline on individual symptoms and side effects by subtype.

Results
There was a quantitative difference in amitriptyline effectiveness in those ≥50 years vs

Read More

Genetic variation at 11q23.1 confers colorectal cancer risk by dysregulation of colonic tuft cell transcriptional activator POU2AF2

Background
Common genetic variation at 11q23.1 is associated with colorectal cancer (CRC) risk, exerting local expression quantitative trait locus (cis-eQTL) effects on POU2AF2, COLCA1 and POU2AF3 genes. However, complex linkage disequilibrium and correlated expression has hindered elucidation of the mechanisms by which genetic variants impart underlying CRC risk.

Objective
Undertake an interdisciplinary approach to understand how variation at 11q23.1 locus imparts CRC risk.

Design
We employ analysis of RNA sequencing, single-cell RNA sequencing, chromatin immunoprecipitation sequencing and single-cell ATAC sequencing data to identify, prioritise and characterise the genes that contribute to CRC risk. We further validate these findings using mouse models and demonstrate parallel effects in human colonic mucosa.

Results
We establish rs3087967 as a prime eQTL variant at 11q23.1, colocalising with CRC risk. Furthermore, rs3087967 influences expression of 21 distant genes, thereby acting as a trans-eQTL hub for a gene-set highly enriched for tuft cell markers. Epigenomic analysis implicates POU2AF2 as controlling the tuft cell-specific trans-genes, through POU2F3-correlated genomic regulation. Immunofluorescence confirms rs3087967 risk genotype (T) to be associated with a tuft cell deficit in the human colon. CRISPR-mediated deletion of the 11q23.1 risk locus genes in the mouse germline exacerbated the ApcMin/+ mouse phenotype on abrogation of Pou2af2 expression specifically.

Conclusion
We demonstrate that genotype at rs3087967 controls a portfolio of genes through misregulation of POU2AF2. POU2AF2 is the primary transcriptional activator of tuft cells with a tumour suppressive role in mouse models. We therefore implicate tuft cells as having a key tumour-protective role in the large bowel epithelium.

Read More

Does the Burden of CSVD Modify the Efficacy of Dual Antiplatelet Therapy? A Post Hoc Analysis of the INSPIRES Trial

Stroke, Ahead of Print. BACKGROUND:The prevalence of cerebral small vessel disease (CSVD) imaging markers is high, yet their influence on stroke prognosis remains unclear. This study aimed to estimate the effects of CSVD on the efficacy and safety of clopidogrel+aspirin versus aspirin among patients with minor stroke or high-risk transient ischemic attack.METHODS:This was a post hoc subgroup analysis of the INSPIRES trial (Intensive Statin and Antiplatelet Therapy for Acute High-Risk Intracranial or Extracranial Atherosclerosis), which was a double-blind, placebo-controlled, 2×2 factorial, and randomized clinical trial conducted at 222 centers in China from September 2018 to October 2022. Patients were classified into CSVD score 0 to 2 and CSVD score ≥3 groups based on a modified CSVD burden score without microbleeds. The primary efficacy and safety outcomes were stroke recurrence and moderate-to-severe bleeding risk within 90-day follow-up. We used Cox proportional hazards models to test the treatment-by-CSVD group interaction for stroke and bleeding risk.RESULTS:A total of 5126 patients (median age, 65 [57–71] years; 3915 [64.2%] males) were enrolled and 2131 (41.57%) had a modified CSVD score ≥3. Patients with CSVD score ≥3 had numerically higher stroke recurrence rate (9.10% versus 8.05%) and lower risk of moderate-to-severe bleeding (0.56% versus 0.80%) than those with CSVD score 0 to 2 within 90 days. Clopidogrel+aspirin versus aspirin reduced stroke recurrence to a similar relative degree in both CSVD score 0 to 2 (adjusted hazard ratio, 0.78 [95% CI, 0.61–1.01];P=0.06) and CSVD score ≥3 groups (adjusted hazard ratio, 0.82 [95% CI, 0.62–1.09];P=0.12) with no evidence of statistical interaction (P=0.84). Clopidogrel+aspirin versus aspirin increased bleeding risk to a similar relative degree in both CSVD score 0 to 2 (adjusted hazard ratio, 2.83 [95% CI, 1.52–5.27];P=0.03) and CSVD score ≥3 groups (adjusted hazard ratio, 2.13 [95% CI, 1.08–4.19];P=0.22) with no statistical interaction (P=0.68).CONCLUSIONS:In this post hoc subgroup analysis, no significant interaction effect was observed between the antiplatelet treatment and the modified CSVD score, suggesting that clopidogrel+aspirin may not provide a significantly different benefit-risk profile across patients with CSVD score 0 to 2 versus CSVD score ≥3.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03635749.

Read More

Smartphone-based ecological momentary music intervention to reduce stress in Turkish immigrant women: protocol

Background
Immigrant women frequently encounter ethnic discrimination (ED) and/or stressful events in their daily lives. To mitigate the risk of resulting health impairments, we developed an ecological momentary music intervention (EMMI-T) to reduce psychological and biological stress levels in the daily lives of Turkish immigrant women. The feasibility of the EMMI-T was confirmed in a pilot study (n=20). Here, we present the protocol of our proposed study to investigate the effectiveness of the EMMI-T.

Methods
Fifty Turkish immigrant women perceiving chronic ED will take part in the 35-day study. During all three study periods (ie, baseline, intervention and post-intervention), participants will use a smartphone-based app to provide discrimination-related and stress-related data four times a day. Additionally, they will report every discriminatory and/or stressful event. During the intervention period, subsequently after such event-based data entries, participants will be allocated to either an intervention event (music listening for 10 or 20 min) or a control event (no music listening). Irrespective of event type, the app will signal 20 min after the initial event-based data entry for additional data collection. Every data entry will be accompanied by the collection of a saliva sample for analysis of biological stress markers (alpha-amylase, cortisol).

Analysis
This intraindividual randomised design will allow us to test immediate (ie, before vs after music listening) and intermediate (ie, baseline period vs postintervention period) effects of the EMMI-T on psychological and biological stress levels. To test our hypotheses, we will use multilevel modelling.

Ethics and dissemination
Positive ethical approval was given by the institutional review board of the University of Vienna (reference number 00575). The results of our study will be disseminated at conferences and submitted to a peer-reviewed journal.

Trial registration number
NCT05829031.

Read More