Extrapulmonary tuberculosis (EPTB) poses a significant diagnostic and economic challenge in HIV endemic, low-resource settings due to its complex presentation and current diagnostic tools limitations. While accurate and timely diagnosis is critical for reducing morbidity, mortality and health system costs, economic evaluations of EPTB diagnostics remain sparse and fragmented. This protocol aims to map existing evidence on the economic evaluation of diagnostic innovations for EPTB in low-resource settings.

This scoping review protocol follows the Joanna Briggs Institute (JBI) methodological framework and registered on the Open Science Framework. Peer-reviewed articles, grey literature and official reports published between 2000 and 2025 will be searched in PubMed, MEDLINE, Google Scholar, Scopus and Science Direct. The search strategy is structured using the Population, Intervention, Comparator, Outcome, Time, Study design and Setting (PICOTSS) framework, and will be peer-reviewed using the Peer Review of Electronic Search Strategies (PRESS) guideline. Study selection, data charting and extraction will be performed independently by two reviewers. Data will be charted iteratively, and the methodological quality of selected economic evaluations will be appraised using the Drummond checklist. Results will be synthesised in narrative summaries and tabular formats. Final reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) reporting guideline.

For review of previously published data, ethical approval is not required. Findings will be disseminated in professional networks, stakeholder meetings and a peer-reviewed journal.

OSF Registration DOI 10.17605/OSF.IO/BTCPG

Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.

The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).

A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.

The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.

ACTRN12618000932268.

Despite its serious impact, anorexia nervosa (AN) remains one of the least understood mental illnesses, with significant gaps in effective treatment options. No medications have been deemed effective and only 50% of individuals respond to conventional psychotherapies. Gastrointestinal (GI) bacteria have been found to be altered in individuals with AN. While, Fecal microbiota transplantation (FMT) has shown potential for alleviating anxiety and depression, its effects remain understudied for individuals with AN. This study aims to determine whether oral capsular FMT is acceptable to adolescents with AN and results in clinical improvement in weight and/or psychological symptoms.

This study will randomise 20 adolescents with AN, ages 12–17 years, to receive either FMT or placebo capsules. These 20 youth, as well as an additional 10 youth who decline trial enrolment, will participate in qualitative interviews. We will track recruitment rates and collect psychological and biological measures (blood, stool, urine and saliva) at multiple timepoints to assess how gut microbiota and their metabolites may influence the symptoms of AN. Interviews with participants and caregivers will explore their experiences and views on FMT as a treatment approach.

This study has received ethics approval by the Hamilton Integrated Research Ethics Board (#17493) and investigational drug approval by Health Canada (Dossier ID: c292423). Informed consent will be obtained by research staff from all participants. Findings will be disseminated through academic conferences, clinical forums and partnerships with advocacy organisations to reach clinicians, researchers and individuals with lived experience.

NCT06593366.

Metformin is the first-line treatment for type 2 diabetes mellitus (T2DM). Long-term use of metformin has been associated with vitamin B₁₂ deficiency, which may lead to serious complications such as anaemia and neuropathy. Although international bodies have recommended screening for vitamin B₁₂ deficiency in patients on long-term metformin, it is unclear how aware clinicians are of this adverse effect and to what extent such guidance is being followed in practice.

A scoping review was conducted using Joanna Briggs Institute (JBI) methodology. Databases searched included MEDLINE, Medical Literature Analysis and Retrieval System Online (PubMed), British Nursing Index (BNI), Google Scholar, Cochrane, Embase, Web of Science and CINAHL, Cumulative Index to Nursing and Allied Health Literature (EBSCO) alongside searching for grey literature such as EThOS (Electronic Theses Online Service), DART (Digital Access to Research Theses) European and Kings College London Research Portal. Studies published in English from 1990 onwards were included if they addressed clinician awareness or screening practices. Data were extracted and summarised using a structured tool, with themes mapped visually. The literature search was conducted between 1 August 2025 and 1 November 2025 and included studies published from January 1990 onwards.

23 sources were included in the review. 7 studies directly assessed clinician awareness of metformin-associated vitamin B₁₂ deficiency, all conducted outside the UK. Across 15 studies reporting screening practices, routine vitamin B₁₂ monitoring was uncommon, with annual testing rates in general below 20% of eligible patients (range 2.6%–19.8%). In a large retrospective cohort study of patients on long-term metformin, 44.9% underwent vitamin B₁₂ testing, with a mean delay of 990 days from treatment initiation. Screening was predominantly symptom-triggered rather than preventive, and older adults and other high-risk groups were consistently less likely to be tested. Reported barriers included lack of clinical prompts, competing priorities and testing costs.

Clinician awareness of the link between long-term metformin use and vitamin B₁₂ deficiency is present but inconsistently translated into practice. Screening practices remain suboptimal despite recent guideline updates. Interventions, such as checklists, prompts and updated training, may support improved adherence. However, no UK-based studies were identified, highlighting a gap in national evidence. Routine, risk-based screening in primary care could prevent significant morbidity associated with undiagnosed vitamin B₁₂ deficiency in this population.

Allergic rhinitis (AR) is a highly prevalent condition worldwide and imposes a substantial public health burden on adults. Although Traditional Chinese Medicine (TCM) therapies have shown potential therapeutic benefits in AR management, the lack of a standardised outcome evaluation framework limits evidence comparability and synthesis. Current studies commonly exhibit inconsistent outcome selection, heterogeneous measurement instruments and unclear assessment time points, reducing the applicability of findings to evidence-based practice and guideline development. Moreover, existing AR-related core outcome set (COS) studies generally target a broad population, with limited focus on adults (aged 18–75 years) and insufficient involvement of patients and other stakeholders. Therefore, this study aims to establish a standardised COS for clinical research in adult allergic rhinitis (COS-AR), with clearly defined outcomes, measurement instruments and recommended assessment time points. This COS-AR will provide a framework for outcome selection and measurement in clinical studies of TCM for adult AR.

The development of COS-AR will be conducted in four sequential phases: (1) A comprehensive review of randomised controlled trials and clinical trial registry entries related to adult AR from major domestic and international databases published between 1 January 2019 and 31 August 2025 will be performed. This phase will involve the systematic categorisation of all reported outcomes, including their definitions, measurement instruments and assessment time points. (2) An online survey will be administered to both clinicians and patients involved in AR management to identify outcomes considered most important by these stakeholders. (3) A modified Delphi process, consisting of two to three rounds of online surveys, will be conducted with over 100 key stakeholders to establish a COS. (4) One or two online consensus meetings will be convened with a representative group of 20–30 key stakeholders to reach final consensus on the outcomes, their definitions, measurement instruments and recommended assessment time points to be included in the COS-AR.

All activities conducted in this study have received ethical approval from the Medical Ethics Committee of Zhejiang Hospital (Ethics Approval Number: 2023 (9K)-X4). Written informed consent will be obtained from all participants prior to participation. The research findings will be disseminated through peer-reviewed publications and relevant academic and professional conferences.

China Clinical Trial Core Outcome Sets Research Centre (ChiCOS). Available at: https://www.chicos.org.cn/cos/1788748723768049665 (accessed 29 December 2025)

Self-injurious behaviour (SIB) consists of persistent, repetitive movements that can result in serious injury without suicidal intent. These behaviours are prevalent among children with neurodevelopmental disorders, including profound autism. Although many individuals benefit from currently available therapies, some exhibit treatment-refractory SIB that necessitates ongoing use of personal protective equipment and restraint, presumably due to stronger neurobiological drivers. We recently completed a phase I, open-label clinical trial demonstrating the safety, feasibility and preliminary efficacy of bilateral deep brain stimulation targeting the nucleus accumbens (NAc-DBS) in children with profound autism and severe, refractory SIB. The objective of the proposed study is to characterise the effectiveness of NAc-DBS in treating severe, refractory SIB in this unique and vulnerable population.

A single-centre, randomised double-blinded, crossover trial is proposed. Informed by the results of our pilot study, 25 subjects with autism spectrum disorder and severe, refractory SIB will undergo bilateral NAc-DBS. Following a 4-week recovery period, participants will be randomised to either group A (stimulation ON then OFF) or group B (stimulation OFF then ON). Each block will last 12 weeks, separated by a 2-week washout period. Following completion of the second block, all participants will enter a 6-month open-label phase with stimulation ON. The primary outcome is the difference in the Repetitive Behaviour Scale–Revised total score, between DBS-ON and DBS-OFF conditions. Secondary outcomes include measures of quality of life, caregiver burden, daily logs of SIB events and direct observation of SIB under structured analogues.

The proposed trial has been approved by the institutional Research Ethics Board (1000081171). Trial results will be disseminated through peer-reviewed publications and conference presentations.

NCT06529380

Guided by Straussian Grounded Theory, this study aimed to explore patients’ dynamic trade-off processes in evaluating bariatric surgery outcomes and to construct a patient-centred theoretical framework to inform clinical assessment and intervention.

Qualitative study using Straussian Grounded Theory, semi-structured, in-depth interviews were conducted. Data were analysed using open, axial and selective coding. Reporting followed the Standards for Reporting Qualitative Research guidelines.

This study was conducted at a tertiary hospital in China between June 2023 and August 2023.

A total of 11 patients who had undergone bariatric surgery were enrolled, aged 21–54 years, with postoperative follow-up durations ranging from 1 to 10 years.

A core category—Dynamic Trade-off Evaluation of Bariatric Surgery Outcomes—was identified, characterised by dynamism, trade-off and subjectivity. The framework comprises four inter-related components: trade-off basis, trade-off moderation, trade-off process and comprehensive evaluation. Outcome evaluation emerged as a non-linear process progressing through four stages: burden-dominant, contradiction-coexistence, contradiction-persistence and meaning-reconstruction stages. Individual goal orientation and psychological resilience served as key moderating factors shaping evaluative trajectories.

This study proposes a novel theoretical framework elucidating how patients dynamically evaluate bariatric surgery outcomes. By revealing stage-specific mechanisms and moderating factors, the framework provides a theoretical basis for improving preoperative expectation management and postoperative support.

To investigate the risk factors for primary non-central malposition of peripherally inserted central catheter (PICC) tip in neonates admitted to the neonatal surgical department, compare the malposition rates across different insertion sites in disease types, and explore whether different diseases affect PICC tip malposition.

A retrospective case–control study conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.

A 3A women’s and children’s hospital in South China (Guangdong Province).

A total of 558 neonates aged ≤28 days who underwent PICC insertion between January 2019 and November 2024 were enrolled. Neonates with congenital circulatory system malformations, incomplete clinical data and death or treatment withdrawal before tip positioning were excluded.

The primary outcome was the incidence of primary non-central PICC tip malposition confirmed by X-ray or ultrasound within 24 h after insertion. Secondary outcomes included comparison of primary non-central PICC tip malposition rates across different insertion sites and comparison of primary PICC tip malposition rates by insertion sites across different disease groups.

558 neonates were included in this study, including 460 cases with PICC tip in place and 98 with PICC tip malposition. In binary logistic regression analysis, the PICC insertion site was considered an independent risk factor (OR 2.908, 95% CI 1.748, 4.840, p

Medical staff can choose appropriate upper or lower limb veins for PICC insertion without worrying about the impact of abdominal diseases or thoracic diseases on non-central PICC tip malposition. PICC insertion via the head and neck veins should be performed with caution in neonates, as these sites carry a high risk of primary non-central tip malposition compared with other insertion sites.

Domestic sex trafficking is a major health and human rights concern associated with profound social, physical and psychological harms, including complex trauma. People who are being/have been sex trafficked often present to emergency departments (EDs) with unmet health needs and in contexts shaped by coercion, control and fear of authority. ED encounters represent an important setting for identifying sex trafficking, building trust, making referrals to specialised resources and facilitating an exit out of sex trafficking. This scoping review will explore the care experiences and processes for sex trafficked persons in EDs by synthesising existing evidence on the barriers and facilitators to providing high quality, equitable and effective emergency care. This review represents the first phase of a multi-stage study to develop quality indicators (QIs) for ED clinicians providing care for people experiencing domestic sex trafficking in Canada.

This scoping review will follow Arksey and O’Malley’s framework, as updated by Levac and colleagues, which consists of: (1) identifying a research question(s); (2) identifying relevant literature; (3) selecting studies; (4) charting/extracting data; (5) collating, summarising and reporting results; and (6) consulting with community partners. Five databases will be systematically searched to find scholarly, empirical studies describing emergency care experiences and processes for people being sex trafficked. Data will be extracted using a standardised charting tool developed by the lead author and research team.

Research Ethics Board (REB) approval is not required for this study as it involves an analysis of published literature only. Findings will be synthesised into a set of candidate QIs to be disseminated.

To explore existing qualitative research on patients’ experiences from the onset of symptoms to the diagnosis of sarcoma, with the purpose of identifying patient-perceived barriers at both patient and healthcare system levels and to highlight opportunities for improvement.

Systematic review of qualitative studies using thematic synthesis.

We systematically searched Medline [Ovid], Embase [Ovid], PsycINFO [EBSCOhost] and CINAHL [EBSCOhost] from database inception to 11 April 2025 for qualitative studies reporting sarcoma patients’ experiences during their diagnostic trajectory. The final search was conducted on 11 April 2025. All articles were screened against predefined inclusion and exclusion criteria and methodological quality was appraised using the Critical Appraisal Skills Programme qualitative checklist. Six studies conducted in Australia, the Netherlands and the UK were included. Data were analysed using a thematic synthesis approach guided by Thomas and Harden (2008). Confidence in the synthesised findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation - Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERqual) approach.

Four overarching themes emerged: patients’ experience and interpretation of symptoms, diagnostic pathways, healthcare system factors, and reflections and recommendations. Key contributors to delayed diagnosis were symptom normalisation, misattribution by both patients and healthcare professionals, limited continuity of care and communication challenges. These findings were consistent across multiple countries, indicating relevance and validity in many settings. Patients emphasised the importance of disease awareness, persistence of patients and coordinated care.

Diagnostic delays in sarcoma are influenced by both patient and healthcare systemic factors. Addressing these factors requires increased disease awareness among healthcare professionals and the public, improved coordination within the healthcare system, and targeted research to guide future interventions. This review provides cross-country insights into barriers to early sarcoma diagnosis, informing future priorities in clinical practice and research.

CRD420251030726.

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Multicentre observational cohort study.

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

NCT04749212

Older adults admitted to intensive care units (ICUs) following elective surgery face heterogeneous trajectories of recovery spanning the physical, cognitive and social domains. Biological ageing processes, including cellular senescence, may modulate these outcomes. Here, we present the protocol for an analytic prospective observational cohort study integrating biopsychosocial assessments and senescence-associated biomarkers to identify predictors of health-related quality of life (HRQoL) and post-ICU recovery.

Single-centre, prospective cohort study at the University Hospital Halle (Saale), Germany. Adults aged 60 years or older scheduled to undergo elective surgery and who have a planned postoperative stay in the ICU of at least 24 hours and who are able to provide consent will be enrolled. Baseline pre-ICU data will include the following: medical history, comorbidity, medications, routine laboratory values and a comprehensive geriatric assessment (eg, frailty, mobility, handgrip strength, Timed Up & Go, cognition, mood, loneliness, social status and EuroQol 5-Dimension 5-Level, EQ-5D-5L). A 5 mL serum sample will be collected for a senescence-associated secretory phenotype panel and additional ageing biomarkers. Skin autofluorescence will be used to estimate advanced glycation end-products. Telephone follow-ups at 3 and 6 months ascertain HRQoL, functional outcomes, psychosocial outcomes, rehospitalisations and institutionalisation. The primary endpoint is defined as a stable or improved HRQoL (EQ-5D-5L) at 3/6 months vs baseline. We intend to use multivariable predictive modelling with elastic-net regularisation and conduct internal validation using bootstrap resampling and cross-validation.

This study has been approved by the Ethics Committee of the Medical Faculty, Martin-Luther-University Halle-Wittenberg (No. 2025-112). Written informed consent is obtained from all participants. The results of this study will be reported in a peer-reviewed journal.

DRKS00037969.

To clarify and define the clinical practice concept of early mobilisation after abdominal surgery.

A concept analysis guided by Walker and Avant’s method.

MEDLINE (Ovid), AMED-(Ovid), Embase (Elsevier) and CINAHL (EBSCO) were searched through 5 December 2024.

Relevant studies that included combinations of the terms ‘early mobilisation’, ‘early ambulation’, ‘early acceleration’, ‘abdominal surgery’ and ‘surgical procedures’ were selected. We restricted the search to English full-text publications involving adult patients, limited to the year 2000 and onward. Inclusion criteria were original research articles describing the timing and/or type of mobilisation.

The study derives its defining attributes, antecedents and consequences through data analysis. To enhance understanding of the model, we constructed related and contrary cases of the concept and outlined relevant empirical referents.

In total, 140 studies were included in the analysis. Early mobilisation is characterised by the key defining attributes of initiating active physical movement, including standing, sitting in a chair or walking, within the first 24 hours of surgery. Antecedents include haemodynamic and respiratory stability, adequate pain management, and the patient’s cognitive and physical readiness. Contextual antecedents include competent and adequately staffed healthcare teams. Consequences include improved physiological recovery and enhanced postoperative outcomes.

This analysis provides a clarified, practice-focused definition of early mobilisation after abdominal surgery. By delineating its key attributes and contextual prerequisites, the study offers a conceptual foundation that can support clinical guidelines, promote consistent implementation and inform future research aimed at optimising postoperative recovery.

We compared the cost-effectiveness of alternative fracture risk assessment strategies for people with intellectual disabilities (ID) aged ≥40 years from a UK National Health Services perspective over a lifetime horizon.

Cost-effectiveness analysis using a lifetime decision-analytical model.

UK primary care, with data from literature and national databases.

People with ID.

Three strategies were assessed: (S1) Risk assessment using the UK QFracture score; (S2) use of IDFracture (a fracture risk prediction tool specifically developed for adults with ID); and (S3) conducting a one-time dual-energy X-ray absorptiometry (DXA) scan in all. S1 and S2 were followed by DXA scan for those at risk. At-risk individuals received treatment according to UK practice (bisphosphonates plus vitamin D and calcium for osteoporosis, and vitamin D and calcium alone for osteopenia).

Direct healthcare costs and quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

In the base case, S2 (ICER: –£2568/QALY) was dominant (ie, less costly and more effective) and S3 (ICER: £1678/QALY) was cost-effective relative to S1 for major osteoporotic fracture (MOF). For hip fracture, S2 (ICER: £32 116/QALY) and S3 (ICER: £49 536/QALY) were not cost-effective relative to S1 under the National Institute for Health and Care Excellence-recommended cost-effectiveness thresholds. Findings from the sensitivity analyses were predominantly consistent with the base-case results. Subgroup analyses showed that age-specific and gender-specific strategies could be used.

For people with ID aged ≥40 years, a proactive approach to risk assessment for MOF is not only clinically beneficial, but also cost-effective.

Current Belgian guidelines state that chronic proton pump inhibitor (PPI) therapy is indicated for oesophagitis grade C and D, Barrett’s oesophagus, Zollinger-Ellison syndrome, or to prevent bleeding ulcers with chronic non-steroidal anti-inflammatory drugs (NSAID) intake in patients at risk. Guidelines justify empiric short-term PPI therapy in other cases to control symptoms. Yet, there is insufficient PPI down-titration and/or cessation. As such, concerns have risen related to the impact of PPIs on the healthcare budget and increasing number of risks and side effects. This study aims to provide evidence to determine which strategy provides the most effective approach for stopping chronic intake of PPIs in patients in whom there is no firm medical indication for their continued use.

This is a multicentre, pragmatic, randomised clinical trial. General practitioners will randomise 609 to one of three PPI deprescription strategies. Patients on a high-dose PPI are allowed to participate after down-titrating their dose to a maintenance dose for 1 month before being randomised. Patients unable to decrease the high-dose PPI are not to be randomised. Following randomisation, patients will be requested to adapt their PPI intake for 1 month to the allocated deprescription scheme: (a) on-demand PPI intake, (b) replace PPI to alginate intake and (c) intermittent PPI intake with a fixed scheme. After successfully following the deprescription strategy, patients are requested to completely stop their use of PPI. Patients are followed up for 1 year. The primary endpoint of the study is the percentage of patients achieving a successful therapeutic outcome, defined as limited PPI intake and willingness to continue the therapy, at the end of the follow-up period. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach.

This trial was approved through the platform for Clinical Trials in the European Union by a Belgian ethics committee (CTIS reference: 2022-502375-37-00). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations. Trial registration number NCT05629143.

NCT05629143, clinicaltrial.gov.

Intensive care units (ICUs) can be a particularly challenging environment for patients who are mentally vulnerable. In addition to the physical stress associated with critical illness and its management, there are physiological and psychosocial factors that can negatively impact a patient’s mental health. Approximately half of ICU survivors will experience post-intensive care syndrome, a set of emotional, neuropsychological and physical sequelae that can significantly affect patients’ functionality and quality of life, both in the short and long term. The main objective of this study is to investigate whether the ICU Recovery Answers (ICURA) digital follow-up platform can effectively detect emotional and cognitive problems in critically ill patients and its impact on functionality and health-related quality of life during the first year after ICU discharge.

Multicentre longitudinal prospective study involving ICU adult patients, with randomised follow-up comparing a telemedicine monitoring programme versus usual medical care during 1 year after discharge. A total of 360 participants will be recruited during their ICU admission in two hospitals in Spain. Efficacy outcomes will focus on participants’ level of functioning, assessed with the WHO Short Disability Assessment Schedule, and quality of life, measured with the 12-Item Short Form Survey at 1, 6 and 12 months after ICU discharge. Emotional state and cognitive impairment will be evaluated using the Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 and Treatment-Outcome Post-Traumatic Stress Disorder Scale and the Montreal Cognitive Assessment by telephone at 1, 3, 6, 9 and 12 months after ICU discharge.

The implementation of this project is expected to have a direct impact on the satisfaction of ICU survivors, improving their well-being, personalised follow-up and quality of life. Results from this study will be disseminated at various scientific conferences, national and international meetings, and will be shared with the general public and other relevant parties. The dissemination of these results will occur through scientific publications, allowing the medical and scientific community to benefit from the study’s findings. Ethics approval from the Ethics Board of Parc Taulí Foundation and Balearic Islands with reference numbers 2022/3031 and IB 5072/22 PI: Protocol version 1 of 18 November 2022.

NCT06504979.

Mindfulness-based interventions are widely used, yet concerns about potential negative effects—particularly those related to mindfulness meditation practice—have gained increasing attention. Individuals with difficult-to-treat depression (DTD) represent a population of particular relevance due to heightened vulnerability, but comparative evidence on clinically relevant negative outcomes of mindfulness-based cognitive therapy (MBCT) versus established alternative psychotherapies in this group is lacking. This protocol describes a systematic review and individual participant data (IPD) network meta-analysis to assess and compare the incidence of clinically relevant negative outcomes associated with MBCT and the cognitive behavioural analysis system of psychotherapy (CBASP), an established individual psychotherapy for DTD.

Randomised controlled trials of MBCT and CBASP for adults with DTD were identified through systematic searches of major databases. Eligible studies must compare MBCT or CBASP (alone or with treatment as usual) to each other or to control groups. The primary outcome is clinically significant deterioration, defined as a ≥6-point increase on the Patient Health Questionnaire-9 or equivalent. Secondary outcomes are suicidality and treatment dropout. IPD will be requested from trial investigators; aggregate data will be used when IPD is unavailable. One-stage random-effects IPD network meta-analyses will be conducted to integrate direct and indirect evidence and to examine participant-level moderators of deterioration. Adverse events reported in the included trials will be summarised descriptively at the study level.

No local ethical review was required following consultation with the Swedish Ethical Review Authority. Primary trial investigators obtained local ethical approval and will share pseudonymised IPD. Findings will inform clinical decision-making and guideline development by strengthening the evidence base on potential negative effects of MBCT and CBASP in adults with DTD, including identification of subgroups at increased risk. Results will be disseminated through peer-reviewed publication and accessible summaries for relevant stakeholders.

CRD42022332039