Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.

This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.

This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.

The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.

The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.

Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.

Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.

Prediabetes (PD), defined by impaired glucose tolerance or impaired fasting glucose, represents a growing global health challenge, with a prevalence projected to increase substantially. PD is a critical intervention target because of its high annual progression rate (5–10%) to type 2 diabetes mellitus (T2DM) and elevated cardiovascular disease (CVD) risk. Non-surgical interventions (NSIs), particularly lifestyle modifications (LMs) and pharmacological therapies, are the cornerstone of PD management, demonstrating efficacy and cost efficiency over surgical options. However, despite LM’s ability to reduce T2DM incidence by 40–70% in trials such as the Diabetes Prevention Program, real-world implementation faces barriers, including resource intensity and complex delivery requirements, which increase upfront costs. We aim to review scientific literature reporting on the effectiveness and cost-effectiveness of NSIs for preventing the progression of PD to T2DM among adults.

Alliance ruptures constitute a high risk of premature treatment termination and poor psychotherapy outcome. The Alliance-Focused Training (AFT) is a promising transtheoretical approach to enhance therapists’ skills in dealing with alliance ruptures.

To evaluate the effectiveness of Modified AFT with doubling (MAFT-D), a randomised, patient and evaluator-blinded, multicentre trial was designed comparing MAFT-D (delivered to trainee therapists and supervisors) and psychotherapy training/treatment as usual (TAU) for therapists (n=120) and their patients with depressive disorders (n=240). A total of 17 cooperating centres, each offering either cognitive-behavioural or psychodynamic psychotherapy training, will contribute to recruitment. Stratification by centre (both for therapists and patients) and hence therapeutic approach (cognitive-behavioural vs psychodynamic psychotherapies), and by comorbid personality disorder (yes vs no, for patients) will be carried out. The two hierarchically ordered primary hypotheses are: In MAFT-D compared with TAU, a stronger reduction of depressive symptoms and a lower rate of patient dropout is expected from baseline to 20 weeks after baseline. Follow-up assessments are planned at 35 weeks, 20 months and 36 months postbaseline to evaluate the persistence of effects. Secondary patient-related and therapist-related outcomes as well as predictors, moderators and mediators of change will be investigated. Mixed models with repeated measures will be used for the primary analyses.

Ethical approvals were obtained by the institutional ethics review board of the main study centre as well as by review boards in each federal state where one or more cooperating centres are located (secondary votes). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

DRKS00014842; https://drks.de/search/de/trial/DRKS00014842.

Adolescent idiopathic scoliosis (AIS) often imposes a significant psychological burden on teenagers. Cognitive and behavioural strategies have demonstrated the potential to alleviate these challenges. Chatbots, with their real-time interaction capabilities, provide a promising and accessible approach to delivering psychological interventions for young people.

This pilot trial will evaluate a chatbot-delivered, structured psychological intervention (SPI-Bot) incorporating cognitive and behavioural strategies for teenagers with AIS. Conducted as a single-centre, parallel-group randomised controlled trial, the study aims to assess the feasibility, acceptability and preliminary effectiveness of SPI-Bot. Fifty-two teenagers with AIS and mild to moderate psychological symptoms will be block-randomised into two groups. The intervention group will complete an 8-week, evidence-based SPI-Bot programme, while the control group will engage in casual conversations with another chatbot that does not include specific psychological health content. Assessments will be conducted at baseline, postintervention (8 weeks) and follow-up (12 weeks). Primary outcomes include feasibility and acceptability, measured through recruitment rates, adherence rates, attrition rates, engagement, working alliance, usability, user experience and adverse events. Secondary outcomes focus on effectiveness, including psychological distress, psychological well-being, perceived social support and quality of life. Participants in the intervention group will be purposively sampled for semistructured interviews to explore their perceptions of the intervention process.

This study has been approved by the Institutional Review Board of the Hong Kong Polytechnic University (Reference: HSEARS20240919007). The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.

NCT06698952

Examples of poor research practices have received much attention in academic and public arenas. Such practices persist and threaten the health of the public and the reputation and impact of research and researchers.

In this article, we argue that research—though intended to improve health—can lead to patient harm through the proliferation of honest (though occasionally dishonest) yet unacceptable research practices.

We argue that deliberate dishonest research practices—termed questionable research practices—are widely prevalent and insidious and influenced by both individual and cultural factors. Drawing on credible conceptualisations of poor research practices, we define honest yet unacceptable research practices to be different from questionable research practices involving dishonesty, but just as serious due to their wide prevalence and damaging impacts. Finally, we present recommendations for people and organisations to better protect patients’ interests from honest yet unacceptable research practices.

Our recommendations can serve as the basis for preventing honest yet unacceptable poor research practices to safeguard public trust in health professions, researchers and practices.

Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of a new major cardiovascular event or death (MACE). We aim to determine the effectiveness and cost-effectiveness of the RISE (Reduce and Interrupt sedentary behaviour using a blended behavioural intervention to Empower people at risk towards sustainable 24-hour movement behaviour change) intervention by improving 24-hour movement behaviour for prevention of MACE and gaining quality-adjusted life years (QALYs) in community-dwelling people at risk with a first-ever stroke.

This assessor-blinded multicentre randomised controlled trial includes about 1000 participants with a first-ever stroke, of which 752 participants require secondary prevention based on their 24-hour movement behaviour. Participants will be randomly assigned to the experimental group (RISE intervention + usual care) or control (usual care) group. RISE is a 15-week blended care intervention: primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of: (1) an activity monitor, (2) a smartphone application that provides real-time feedback and contains e-learning modules and (3) a monitoring dashboard for the physiotherapist. A close relative of the participant is involved during the intervention to provide social support. The primary outcome is the effectiveness of the RISE intervention regarding the prevention of MACE measured at one year post randomisation using survival analysis comparing the experimental and control groups. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using compositional data analysis.

Ethical approval is obtained from Medical Ethics Review Committee Utrecht, NedMec NL83940.000.23. Findings will be disseminated through international peer-reviewed journals and conferences. A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with stroke. The RISE intervention offers this foundation by integrating behaviour change techniques, the RISE eCoaching system, involvement of participatory support and extensively trained RISE physiotherapists. Consequently, the RISE intervention is expected to be (cost-)effective compared with usual care, and hence, this study will offer a foundation for implementing the RISE intervention in standard poststroke care.

NCT06124248.

Early detection of cardiovascular disease in primary care is a public health priority, for which the clinical and cost-effectiveness of an artificial intelligence-enabled stethoscope that detects left ventricular systolic dysfunction, atrial fibrillation and cardiac murmurs is unproven but potentially transformative.

TRICORDER is a pragmatic, two-arm, multi-centre (decentralised), cluster-randomised controlled trial and implementation study. Up to 200 primary care practices in urban North West London and rural North Wales, UK, will be randomised to usual care or to have artificial intelligence-enabled stethoscopes available for use. Primary care clinicians will use the artificial intelligence-enabled stethoscopes at their own discretion, without patient-level inclusion or exclusion criteria. They will be supported to do so by a clinical guideline developed and approved by the regional health system executive board. Patient and outcome data will be captured from pooled primary and secondary care records, supplemented by qualitative and quantitative clinician surveys. The coprimary endpoints are (i) difference in the coded incidence (detection) of heart failure and (ii) difference in the ratio of coded incidence of heart failure via hospital admission versus community-based diagnostic pathways. Secondary endpoints include difference in the incidence of atrial fibrillation and valvular heart disease, cost-consequence differential, and prescription of guideline-directed medical therapy.

This trial has ethical approval from the UK Health Research Authority (23/LO/0051). Findings from this trial will be disseminated through publication of peer-reviewed manuscripts, presentations at scientific meetings and conferences with local and national stakeholders.

NCT05987670

Adverse events during paediatric anaesthesia are common, with hypoxaemia during the induction period being a leading cause, as infants and children are particularly vulnerable to hypoxaemia during periods of apnoea. The administration of supplementary oxygen, referred to as apnoeic oxygenation, has been shown to prolong safe apnoea times and increase first-pass intubation success rates. Despite these benefits, apnoeic oxygenation is not routinely used in paediatric anaesthesia. Low-flow apnoeic oxygenation, delivered via a standard nasal cannula, is a simple approach to provide supplementary oxygen during paediatric airway management without requiring additional equipment. However, its efficacy in airway management during elective surgeries has not been adequately studied.

The ApOx-Pedi-Trial is a single-centre, cluster randomised, controlled clinical trial comparing the use of low-flow apnoeic oxygenation during the induction of general anaesthesia in infants and children up to 6 years of age undergoing elective surgery at the Department of Pediatric Surgery at Heidelberg University Hospital to standard of care (no apnoeic oxygenation). Randomisation is conducted using a weekly cluster randomisation method, where all patients presenting for surgery in a given week either receive apnoeic oxygenation or standard of care during the induction of general anaesthesia, based on the week’s group allocation.

The study population will consist of two independent, age-stratified cohorts (24 months to 6 years), each including 100 patients. Statistical analysis of study endpoints will be conducted separately for each cohort to allow for age-specific assessment of outcomes.

The primary objective of this trial is to evaluate whether apnoeic oxygenation can prevent a decrease in transcutaneous haemoglobin saturation (SpO₂) during the induction of general anaesthesia in infants and children. The primary outcome measure will be the lowest recorded SpO₂ value throughout the apnoeic period.

The ApOx-Pedi-Trial received permission from the local ethics committee (Ethics Committee of the medical faculty at Heidelberg University, Heidelberg, Germany) under the registration number S-074–2024. The study is following institutional Guidelines and the Declaration of Helsinki of 1975 in its most recent version. Trial results will be submitted to peer-reviewed journals and presented at national and international conferences.

The trial is prospectively registered on ClinicalTrials.gov with the number NCT06576596.