The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.

The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).

The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).

NCT06334003

Physicians are increasingly interested in part-time employment. However, the impact of part-time work on efficiency and quality of care of inpatients is unknown.

To investigate the association between part-time clinical work of hospitalists in General Internal Medicine (GIM) and resource utilisation and short-term patient outcomes.

Retrospective study.

GIM wards of 3 Swiss teaching hospitals.

Each inpatient was categorised as having received care mainly (>50%) by part-time or full-time hospitalists. Part-time clinical work was defined as employment of

Primary outcome was length of hospital stay, secondary outcomes included 30-day readmission, in-hospital mortality, hospitalisation cost and time to completion of the discharge letter. We assessed the association between both groups and outcomes using generalised estimating equations, clustering for individual patients and adjusting for patient and hospitalist characteristics.

There was no statistically relevant difference in length of stay in cases cared for mainly by part-time (mean 7.3 days, 95% CI 7.1 to 7.6) compared with full-time hospitalists (mean 7.6 days, 95% CI 7.3 to 7.8; p=0.18). Time to completion of the discharge letter was longer in the part-time (mean 11.4 days, 95% CI 11.0 to 11.8) versus full-time group (mean 10.9 days, 95% CI 10.6 to 11.2, p=0.049). There was no statistically significant difference between groups for the other outcomes.

We found no evidence that part-time clinical work of hospitalists negatively affects resource utilisation and short-term patient outcomes compared with full-time work.

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[¹⁸F]fluoroglucose positron emission tomography/CT ([¹⁸F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [¹⁸F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([¹⁸F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

NCT06082492.

Specialised outpatient palliative care (SOPC) is an important element of the palliative care concept in Germany. The aim of this study is to compare patient characteristics, care processes and outcomes of patients with heart failure (HF) and oncological diseases, using the latter as a reference group to identify disease-specific needs and support the adaptation of SOPC to non-oncological conditions such as HF.

In this cross-sectional study (22 SOPC providers), clinical data of all palliative care patients who were treated between 2017 and 2021 were retrospectively analysed.

Survival was estimated by Kaplan-Meier analysis. To further examine the relationship between patient survival time and various variables, a Cox proportional hazards model was used. Differences in symptom burden were tested for statistical significance using the McNemar test.

Data from 48 882 patients were analysed, with 5387 (11.0%) identified as having a primary HF diagnosis. This cohort was compared against a large oncological group consisting of 34 287 (70.1%) patients.

For HF patients, the mean number of days spent in SOPC was 30.5±67.7 days and for oncological patients 44.1±72.0 days. A significantly higher proportion of oncological patients died in hospices (14.0%) and hospitals (6.9%) compared with HF (2.9% and 2.2%). Age-adjusted Charlson Comorbidity Index at admission into SOPC was 9.4±3.1 in oncological patients compared with 6.7±1.7 in HF (p

HF patients in SOPC exhibit a different clinical profile compared with oncological patients, characterised by significant symptom burden and shorter survival times. These results emphasise the necessity for tailored palliative interventions to address the specific needs of HF patients.

Persecutory delusions are very common in severe mental health disorders such as schizophrenia. Existing treatments often do not work well enough. We developed a face-to-face theory-driven psychological intervention, called Feeling Safe, that produces very large reductions in persistent persecutory delusions. The challenge now is to make Feeling Safe widely available. So, we developed a 6-month supported online version, called Feeling Safer. The aim is an intervention that patients can easily access and use, reduces persecutory delusions and can be supported by a range of mental health professionals in less contact time than face-to-face therapy. Initial proof of concept testing of Feeling Safer was very encouraging. In a randomised controlled trial, we now plan to test whether Feeling Safer is efficacious for patients and can be successfully delivered by any of three different mental health staff groups (peer-support workers, graduate psychologists and cognitive behavioural therapy (CBT) therapists). We will also test whether Feeling Safer works equally across gender, age, ethnicity and cognitive functioning (moderation) and whether Feeling Safer works via the targeted psychological processes (mediation).

The study design is a multicentre, single-blind (outcome assessor), parallel, four-arm randomised controlled trial; 484 patients with persistent persecutory delusions will be randomised to one of the four conditions (1:1:1:1): Feeling Safer (added to treatment as usual (TAU)) supported by peer-support workers, or Feeling Safer (added to TAU) supported by graduate mental health workers including assistant psychologists, or Feeling Safer (added to TAU) supported by CBT therapists or TAU. Feeling Safer will be provided for 6 months with a staff member. Assessments will be conducted at 0, 3, 6 and 9 months by research assistants blind to group allocation. The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale—Delusions. The secondary outcomes are other psychiatric symptoms (depression, anxiety, insomnia, agoraphobia and paranoia), psychological well-being, recovery, activity and health-related quality of life. Analysis will be conducted under a treatment policy strategy following the intention-to-treat principle, incorporating data from all participants including those who do not complete treatment. Moderation and mediation will be tested. A within-trial cost-effectiveness analysis will be conducted of Feeling Safer compared with TAU.

The trial has received ethical approval from the NHS Health Research Authority (23/LO/0951). Informed consent will be obtained from all participants. A key output will be an open-access publication in a peer-reviewed journal reporting on the clinical effectiveness of a high-quality supported online programme for the treatment of persecutory delusions that has the potential to be used at scale in mental health services.

ISRCTN93974770.

The principal aim of this study was to investigate differences in the characteristics and physiological parameters of critically ill patients who underwent interhospital transportation.

Prospective observational cohort study.

Multicentre study within the Euregio Meuse-Rhine, including Dutch and German hospitals.

A representative sample of critically ill adult patients who underwent interhospital transport accompanied by a physician was included.

None.

Data on patient characteristics, transport logistics, interventions and adverse events were recorded using an online questionnaire. The cohort was divided into Dutch and German subsets and further stratified based on the transportation modality. Descriptive statistics were utilised to present the cohort characteristics.

Dutch patients (89%) were mainly transported by mobile intensive care unit (MICU). For the present investigation, in Germany, the Intensivtransportwagen was included in this MICU category, whereas German patients (48%) were mainly transported by intensive care ambulance (ICA). An intensivist accompanied most transports in the Netherlands, whereas various specialists transported patients in Germany. Interventions were primarily performed in the MICU for Dutch patients and in the ICA for German patients. Adverse events were reported in 5% of the cases.

These comprehensive data provide insights into the transportation differences of critically ill patients. This serves as a foundation for future investigations concerning the quality and efficacy of interhospital transportation.

This study was registered in the Dutch National Trial Registration (NTR4937).

Animal studies suggest that elevated sympathetic nervous system (SNS) activity can accelerate bone loss. However, this area has not been well researched in humans. High-intensity Resistance and Impact Training (HiRIT) is recognised as an effective treatment for osteoporosis and osteopenia. Alternate forms of exercise such as mind-body exercise may be used to modulate sympathetic activity, which could have an additive benefit for skeletal adaptation when used in conjunction with HiRIT. The aim of this study is to investigate whether the combination of mind-body exercise (Tai Chi) and HiRIT can be used to concurrently modulate SNS activity and improve skeletal health.

The CHILL BONES trial is a semi-randomised controlled trial where consenting adults over 60 years, who have low bone mass (total hip, femoral neck and/or lumbar spine T-score

Ethical approval was granted by the Griffith University Human Research Ethics Committee (GUHREC; GU Ref No: 2023/448). Trial findings will be disseminated to participants via a plain-language summary upon completion. Results will be formally reported through peer-reviewed journals and conference presentations.

ACTRN12623001209684; Australian New Zealand Clinical Trials Registry.

Over half of children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have difficulties with emotion dysregulation (EDR) and/or sleep, yet the interrelations between emotional regulation and sleep are not well-characterised in this population. This systematic review will address the relationship between these difficulties and investigate whether specific aspects of EDR are more strongly related to sleep problems in youth with ADHD.

We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analysis guideline for systematic reviews. A wide set of electronic databases will be searched for peer-reviewed quantitative studies investigating the relationship between EDR and sleep in children and adolescents (ages 5 to 18 years) with ADHD. In addition, the reference list of all studies will be searched for other relevant studies, and Scopus will be used to search for citations of the included studies. We will also contact experts in the field to request published and unpublished studies. The primary outcome will be the effect size of the relationship between EDR and sleep in children and adolescents with ADHD. We will look at EDR and sleep broadly and also consider the multifaceted nature of both terms. Secondary outcomes will include which facets of EDR and sleep have been measured and how they have been measured, developmental differences between children and adolescents with ADHD and how—and the extent to which—studies controlled for the use of CNS medications and cooccurring disorders in their study design and/or statistical analyses. The quality and risk of bias of the included studies will be assessed using the Mixed Methods Appraisal Tool.

This protocol is for a review of studies and does not involve any new data collection and therefore does not need ethical or human subjects approval. The results will be presented at international conferences and in a peer-reviewed journal.

CRD42024612984.

Patient activation (PAct)—a measure assessing an individual’s perceived knowledge, skills and confidence in managing their health and well-being—is often used to personalise and evaluate care, although its causal link to self-management behaviours (SMBs) and clinical outcomes remains uncertain. We aimed to synthesise the evidence on the causal association between PAct, SMBs and clinical outcomes in type 2 diabetes (T2D).

Systematic review and narrative synthesis of data summarised in a harvest plot.

We searched Medline, Embase, CENTRAL, PsycInfo, Web of Science and CINAHL up to April 2024 for relevant English articles.

We included studies of any quantitative design that reported on the association of PAct with clinical outcomes or SMBs in adult patients with T2D.

Two independent reviewers were involved, and any disagreements were discussed and resolved collaboratively. Risk-of-bias (RoB) was assessed using an adapted RoB Assessment Tool for Nonrandomised Studies. Levels of evidence were evaluated for each T2D-related outcome.

We identified 21 studies published between 2009 and 2023, including 15 cross-sectional studies and no randomised controlled trials. Eleven studies were conducted in the USA. Seventeen studies used the Patient Activation Measure questionnaire. There is moderate evidence that higher PAct scores are associated with better glycated haemoglobin levels (studies reporting on this association, n=14). There is very limited evidence that PAct improves diet (n=5) and physical activity (n=6). All other clinical outcomes and SMBs had inconclusive results due to either inconsistent or insufficient evidence, or both.

A causal relationship between PAct, clinical outcomes and SMBs in T2D cannot be established due to inconsistent evidence and a lack of high-quality studies. Thus, the use of PAct scores as a tailoring tool and an outcome measure in healthcare services requires further evaluation.

CRD42021230727.

Pancreatic cancer diagnoses are frequently preceded by a new diabetes diagnosis. Screening individuals newly diagnosed with diabetes could enable the earlier detection of pancreatic cancer. We sought to estimate the risk of pancreatic cancer by age, sex, race and time since diabetes diagnosis.

Claims-based cohort study.

Johns Hopkins Medicine conducted this deidentified claims-based cohort study using the Optum Labs Data Warehouse.

Insurance enrollees from 1/2008–9/2018 were identified as non-diabetic or newly diagnosed diabetic. Our risk set included 4 732 313 individuals (424 129 newly diabetic) in 5 844 934 enrolment periods.

Time to pancreatic cancer. Diabetes and cancer were defined using International Classification of Diseases (ICD)-9/10 codes.

Individuals with newly diagnosed diabetes were at an increased HR of pancreatic cancer, but this effect waned over time. The HR of pancreatic cancer following a diabetes diagnosis was higher in younger individuals and varied by race (lower HR in non-White individuals) (p

Consideration of the age–race–sex specific probability of pancreatic cancer and time since diabetes diagnosis is necessary when evaluating the risk of pancreatic cancer following a diabetes diagnosis.

Despite the established status of trauma-focused psychotherapy (TFP) as a first-line treatment for post-traumatic stress disorder (PTSD), a substantial proportion of individuals do not achieve clinically significant improvement or discontinue treatment. Exploring augmentation strategies to enhance treatment outcomes is essential to reduce the overall burden PTSD puts on individuals and society. This protocol outlines a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the efficacy of non-pharmacological augmentation strategies in addition to TFP for PTSD treatment.

We comprehensively searched PubMed, Embase, CENTRAL, PTSDpubs, PsycArticles, PsycINFO, PSYNDEX and CINAHL for RCTs without restrictions on publication dates or languages in October 2024. Study screening is currently ongoing. Additionally, we will perform forward and backward searches of the included studies and relevant reviews. Two reviewers will independently screen and select studies, extract data and assess the risk of bias. We will conduct a narrative review to qualitatively synthesise data and a meta-analysis to quantitatively compare the treatment efficacy of augmented TFP with TFP alone or TFP plus placebo. Primary outcomes will be both symptom severity and response rates. The secondary outcome will be dropout rates. We will explore sources of between-study heterogeneity and potential moderators through subgroup and meta-regression analyses. We will assess the overall quality of the included studies with the Grading of Recommendations Assessment, Development, and Evaluation system.

Ethical approval is not required. We intend to publish results in a peer-reviewed journal and provide materials and data through the Open Science Framework.

CRD42024549435.

Polypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard to patient safety. This study assesses whether the implementation of a clinical decision support system will optimise the process of inpatient medication therapy to prevent inappropriate medication use and thus promote patient safety.

The intervention will be evaluated in a prospective, cluster-randomised controlled trial using a stepped-wedge design. The study will be conducted in 12 hospitals across Germany over a total period of 33 months. Patients will be treated according to the group status of the hospital and receive either standard care or the Transsektorale Optimierung der Patientensicherheit or trans-sectoral optimisation of patient safety intervention. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospitalisation. Secondary endpoints are, for example, inappropriate prescriptions, utilisation of different health services, cost-effectiveness, as well as patient-reported outcome measures. Parameters describing the attitudes of patients and healthcare professionals towards the intervention and organisational change processes will be collected as part of the process evaluation. The primary endpoint will be evaluated using hospital and outpatient claims data from participating statutory health insurances at the population level. There are multiple secondary endpoints with data linkage of primary and secondary data at study participant level. Statistical analysis will make use of (generalised) linear mixed models or generalised estimating equations, taking account of independent covariables. All data analyses of the process evaluation will be descriptive and explorative.

Data collection, storage and evaluation meet all applicable data protection regulations. The trial has been approved by the Ethics Committees of the University of Wuppertal and the Medical Association of Saarland, Germany. Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.

DRKS00025485.

The aim of this study, which was embedded into the ASPIRED randomised controlled trial (ISRCTN10278811), was to explore patient and healthcare professional usability and acceptability of an enhanced (14-day) ambulatory ECG monitoring patch to manage and facilitate discharge of emergency department patients with unexplained syncope.

A qualitative study using semistructured interviews. Data were analysed using thematic analysis and mapped using the theoretical framework of acceptability.

A sample of 20 syncope patients recruited to the ASPIRED RCT and 10 healthcare professionals who had a direct care provider and clinical decision role for syncope patients (eg, consultants, junior doctors, advanced nurse practitioners, advanced care practitioners, emergency nurse practitioners and physician associates) were recruited from four hospitals (two in England and two in Scotland) between February 2023 and January 2024.

Three overarching themes developed that mapped to six of the seven constructs within the theoretical framework of acceptability. The themes were: (1) Efficacy: Patients and healthcare professionals felt that the remote intervention would increase patient reassurance. Healthcare professionals perceived the intervention would improve clinical care pathways by overcoming delays for Holter monitors, but that a standard protocol would be required to ensure appropriate intervention use. (2) Burden: Patients considered that the device was non-obstructive and easy to use. However, healthcare professionals noted that although attaching the device was simple, there would be associated time and resource costs (eg, documentation). (3) Communication and education: Comprehensive verbal and written information were considered necessary to ensure that the intervention was usable by, and acceptable to, patients. Healthcare professionals suggested additional training would be required. Additionally, they considered that feedback from patient monitoring would reinforce their decision-making and improve healthcare professionals’ self-efficacy to use the device appropriately.

An immediate, enhanced (14-day) ambulatory ECG monitoring patch was positively received by patients and offered healthcare professionals an acceptable route for monitoring emergency department patients with unexplained syncope. However, future use should be controlled using standardised pathways to prevent inappropriate use.

ISRCTN10278811.

Ethics approval has been obtained from the Medical Ethics Committee of UZ Brussel (O.G. 016), Peer reflection group Biomedical Ethics, Laarbeeklaan 101, 1090 Brussels. Results will be disseminated in publications and other relevant platforms. This study was registered at Clinicaltrials.gov on 6 July 2023 and posted on 14 July 2023 after National Library of Medicine quality control review. Registration details: NCT05946109

NCT05946109.