Outcomes of participating in the Lets Play programme on 0-5-year-old autistic childrens engagement and caregivers stress: study protocol for a parallel randomised controlled trial

Introduction
Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand’s Let’s Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children’s learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let’s Play programme on autistic children’s engagement and caregiver stress.

Methods and analysis
This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0–5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let’s Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses.

Ethics and dissemination
This trial was approved by Aotearoa New Zealand Ministry of Health’s Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect.

Trial registration number
ACTRN12622001139763.

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The effect of passive leg raising on the cross-sectional area of the right internal jugular vein in obese patients undergoing surgery: a prospective observational study

Objectives
To observe the association between passive leg raising (PLR) and the cross-sectional area (CSA) of the right internal jugular vein (IJV) in obese patients undergoing elective surgery.

Design
Prospective observational study with randomised position sequence.

Setting
Single-centre, tertiary care hospital in Shanghai, China.

Participants
Forty obese patients (body mass index (BMI) >30 kg/m²) scheduled for elective surgery were enrolled. Inclusion criteria were American Society of Anesthesiologists Physical Status Classification (ASA) physical status II–III and age ≥18 years. Exclusion criteria included history of neck surgery, severe cardiovascular disease, end-stage renal disease, severe infection or sepsis and significant coagulopathy.

Observations
Patients underwent ultrasound measurements of the right IJV in two positions: supine (S0) and passive leg raise at 40° (PLR40). Each position was maintained for at least 1 min prior to measurement.

Primary outcome
The primary outcome was to observe whether the CSA of the right IJV differed between the S0 position and passive leg elevation. In post hoc analyses, we examined factors affecting the relative CSA change (CSA), including neck circumference, BMI, age, sex, ASA physical status and heart rate as predictors.

Results
The CSA of the right IJV was significantly larger in the PLR40 position (2.05 cm²) compared to the S0 position (1.67 cm², p=0.003). Linear regression analysis showed a slight positive correlation between neck circumference and the percentage change in CSA (correlation coefficient: 0.066, p

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Post-market quality assessment of antibiotics: findings from a cross-sectional study using standardised patients in Tabalong and Bekasi districts, Indonesia

Objectives
In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.

Design and setting
We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).

Samples and analysis
The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.

Results
Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.

Conclusion
While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.

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Exploring the causes of elevated kinesiophobia in post-coronary stenting patients: a qualitative analysis in a cardiac rehabilitation setting

Objectives
The primary aim of this study is to investigate the factors contributing to the development of kinesiophobia in patients following coronary artery stent implantation, integrating perspectives from both patients and healthcare professionals. The main hypothesis is that understanding and methods for effectively overcoming the fear of exercise and improving the effectiveness of cardiac rehabilitation require further exploration from both patient and professional viewpoints.

Design
This qualitative study used a semi-structured interview approach to gather data from participants.

Setting
The study was conducted at a hospital in Gansu province, China, focusing on the level of care provided to cardiac rehabilitation patients.

Participants
A total of 11 cardiac rehabilitation patients identified as having kinesiophobia (Tampa Scale for kinesiophobia Heart, TSK-SV Heart >37) through screening and nine healthcare professionals participated in the study. The selection criteria included patients undergoing cardiac rehabilitation and professionals involved in their care.

Results
The study identified a core theme, ‘Navigating Fear and Uncertainty’, encompassing five themes that elucidate how various factors contribute to the prevalent phenomenon of kinesiophobia among patients. These were further delineated into 11 subthemes: (1) physiological factors (fatigue, negative illness experiences), (2) psychological factors (hypervigilance, psychogenic anxiety and depression), (3) capacity factors (reduced physical abilities, lack of rehabilitation knowledge and skills), (4) motivational factors (low exercise self-efficacy, rehabilitation cognitive errors) and (5) support systems (primary caregivers, healthcare professionals and medical support). The results provide a qualitative understanding rather than quantitative measures, hence no CIs or statistical significance levels are provided.

Conclusions
The kinesiophobia observed in patients following coronary artery stent implantation stems from the combined influence of multiple factors, warranting early assessment and intervention by healthcare professionals. The study suggests that healthcare institutions should address the practical concerns faced by cardiac rehabilitation patients and enhance familial, medical and societal support systems to increase patient engagement and compliance with exercise rehabilitation. Further research is needed to develop and validate interventions based on these findings.

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Uncovering variation in cholecystitis treatment: protocol and statistical analysis plan for a nationwide observational study – the Dutch Cholecystitis Snapshot Study (Dutch CHESS)

Introduction
Cholecystitis is a highly prevalent disease that imposes a substantial burden on the healthcare system. Despite strong underlying evidence, guideline adherence in the treatment of cholecystitis remains low. Moreover, important gaps in knowledge persist that must be addressed to optimise existing guidelines. The primary aim is to assess the nationwide variation in cholecystitis treatment and identify opportunities to improve guideline adherence. Secondary aims include determining the best cystic duct closure method; the best model to predict concomitant choledocholithiasis; the optimal treatment for cholecystitis lasting 7 days or more at diagnosis and the optimal strategy for gallbladder drainage and post-drainage care.

Methods and analysis
The Dutch CHESS is a multicentre observational cohort study, including 67 out of 69 Dutch hospitals. From 1 April to 30 September 2024, all patients diagnosed with cholecystitis (Tokyo Guidelines definition) will be prospectively identified. Data on patient characteristics, treatment and outcome (with 6-month follow-up) will be collected to address the primary and secondary aims. For the primary aim, guideline adherence is defined as the percentage of patients who undergo early cholecystectomy for cholecystitis lasting 0–7 days. Current adherence, nationally and for each individual hospital, along with predictors of adherence, will be determined. The adherence of each hospital will be set against the national average and best practices. To further support improvement, the impact of guideline adherence on total hospital stay and morbidity will be determined. Three months after performance feedback to the participating hospitals, the impact on local practice will be assessed through questionnaires. Subgroup analyses and statistical methods for addressing both the primary and secondary aims are predefined in this protocol.

Ethics and dissemination
The Medical research Ethics Committees United reviewed the protocol and decided that the Dutch Medical Research Involving Human Subjects Act is not applicable (reference Number: W23.225). Approval was obtained from the institutional review board and board of directors at each participating hospital. Results will be disseminated through peer-reviewed publications and conference presentations.

Study registration number
ClinicalTrials.gov, NCT06349863; Pre-results.

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Associations between multiple acute infarctions and intracranial arterial stenosis with functional outcomes in anterior circulation acute ischaemic stroke reperfusion therapy: results from the China National Stroke Registry III

Objective
This study aims to observe the correlation between infarction pattern and intracranial arterial stenosis (ICAS) on magnetic resonance and functional outcome in acute ischaemic stroke (AIS) patients after reperfusion therapy.

Design
This is a post hoc analysis of the Third China National Stroke Registry (CNSR-III) study.

Setting
The data was derived from the CNSR-III study, which was a nationwide clinical registry of ischaemic stroke or transient ischaemic attack based in China.

Participants
Patients with anterior circulation AIS who underwent reperfusion therapy were included for analysis. The patients were divided into single acute infarction and multiple acute infarctions (MAIs) based on the diffusion-weighted imaging findings. Additionally, patients were categorised according to the degree of ICAS assessed by magnetic resonance angiography as either ≥50% or

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Minimum clinically important difference in Quantitative Lung Fibrosis score associated with all-cause mortality in idiopathic pulmonary fibrosis: subanalysis from two phase II trials of pamrevlumab

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.

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Associations between multiple acute infarctions and intracranial arterial stenosis with functional outcomes in anterior circulation acute ischaemic stroke reperfusion therapy: results from the China National Stroke Registry III

Objective
This study aims to observe the correlation between infarction pattern and intracranial arterial stenosis (ICAS) on magnetic resonance and functional outcome in acute ischaemic stroke (AIS) patients after reperfusion therapy.

Design
This is a post hoc analysis of the Third China National Stroke Registry (CNSR-III) study.

Setting
The data was derived from the CNSR-III study, which was a nationwide clinical registry of ischaemic stroke or transient ischaemic attack based in China.

Participants
Patients with anterior circulation AIS who underwent reperfusion therapy were included for analysis. The patients were divided into single acute infarction and multiple acute infarctions (MAIs) based on the diffusion-weighted imaging findings. Additionally, patients were categorised according to the degree of ICAS assessed by magnetic resonance angiography as either ≥50% or

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Scoping review protocol of the use of eye movement desensitisation and reprocessing in the treatment of birth trauma

Introduction
A traumatic childbirth can have severe negative effects on the mental health of the mother and can negatively impact the child and partner. Eye movement desensitisation and reprocessing (EMDR) is a psychological intervention used to treat symptoms of trauma. The National Institute for Health and Care Excellence guidelines for antenatal and postnatal mental health recommend that trauma-focused cognitive behavioural therapy or EMDR should be offered to women who suffer from post-traumatic stress disorder resulting from a traumatic birth. However, the use of EMDR for birth trauma has not been clearly outlined in the literature.

Objectives
The aim of this scoping review is to explore the extent of the currently available research and to identify knowledge gaps in the use of EMDR for treating birth trauma.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines will be followed to provide a comprehensive scoping review of the use of EMDR for birth trauma. Several databases will be searched, such as PsychInfo, Pubmed, the Cochrane Library, Embase, Scopus and CINAHL, from the date the database was developed, until approximately August 2026. The grey literature sources will also be searched, and searches will be limited to include studies written in the English language. Two researchers will independently screen and extract data from both quantitative and qualitative studies, which meet the inclusion criteria. Data will be analysed in a descriptive and thematic manner. Data extraction may include study characteristics, data collection procedures, outcomes and results. Findings will be presented in tabular and narrative formats.

Ethics and dissemination
Ethical Approval is not necessary for this review, as only secondary data will be used. It is expected that the review will be disseminated at psychological conferences and in relevant journal articles.

Trial registration number
This scoping review protocol has been registered on Open Science Framework. The registration DOI is: https://doi.org/10.17605/OSF.IO/UJZ52.

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Minimum clinically important difference in Quantitative Lung Fibrosis score associated with all-cause mortality in idiopathic pulmonary fibrosis: subanalysis from two phase II trials of pamrevlumab

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.

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Scoping review protocol of the use of eye movement desensitisation and reprocessing in the treatment of birth trauma

Introduction
A traumatic childbirth can have severe negative effects on the mental health of the mother and can negatively impact the child and partner. Eye movement desensitisation and reprocessing (EMDR) is a psychological intervention used to treat symptoms of trauma. The National Institute for Health and Care Excellence guidelines for antenatal and postnatal mental health recommend that trauma-focused cognitive behavioural therapy or EMDR should be offered to women who suffer from post-traumatic stress disorder resulting from a traumatic birth. However, the use of EMDR for birth trauma has not been clearly outlined in the literature.

Objectives
The aim of this scoping review is to explore the extent of the currently available research and to identify knowledge gaps in the use of EMDR for treating birth trauma.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines will be followed to provide a comprehensive scoping review of the use of EMDR for birth trauma. Several databases will be searched, such as PsychInfo, Pubmed, the Cochrane Library, Embase, Scopus and CINAHL, from the date the database was developed, until approximately August 2026. The grey literature sources will also be searched, and searches will be limited to include studies written in the English language. Two researchers will independently screen and extract data from both quantitative and qualitative studies, which meet the inclusion criteria. Data will be analysed in a descriptive and thematic manner. Data extraction may include study characteristics, data collection procedures, outcomes and results. Findings will be presented in tabular and narrative formats.

Ethics and dissemination
Ethical Approval is not necessary for this review, as only secondary data will be used. It is expected that the review will be disseminated at psychological conferences and in relevant journal articles.

Trial registration number
This scoping review protocol has been registered on Open Science Framework. The registration DOI is: https://doi.org/10.17605/OSF.IO/UJZ52.

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[Articles] Effectiveness of introducing pulse oximetry and clinical decision support algorithms for the management of sick children in primary care in Kenya and Senegal on referral and antibiotic prescription: the TIMCI quasi-experimental pre-post study

When implemented in routine health systems at primary care level in Kenya and Senegal, pulse oximetry and CDSAs were not found to be associated with an increase in urgent referrals but likely mediated antibiotic prescription reductions. The absence of referral increase may stem from limited severe illness detection due to low hypoxaemia prevalence and barriers to referral, also affected in Senegal by a protracted post-intervention HCP strike. Strengthening the referral system and implementing broader antibiotic stewardship strategies are likely to be needed to improve the effectiveness of the intervention and its impact on child health outcomes.

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At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial

Introduction
The COVID-19 pandemic disrupted healthcare delivery for patients with breast cancer. eHealth solutions enable remote care and may improve patient activation, which is defined as having the knowledge, skills and confidence to manage one’s health. Thus, we developed the Breast Cancer Treatment Application (app) for patients and practitioners to use throughout the cancer care continuum. The app facilitates virtual assistance, delivers educational resources, collects patient-reported outcome measures and provides individualised support via volunteer e-coaches. Among newly diagnosed patients with breast cancer, we will compare changes in patient activation, other patient-reported outcomes and health service outcomes over 1 year between those using the app and Fitbit, and those receiving standard care and Fitbit only.

Methods and analysis
This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will use the app in addition to standard care and Fitbit for 13 months following diagnosis. The control group (n=100) will receive standard care and Fitbit only. Patients will complete questionnaires at enrolment, 6 and 12 months post-diagnosis to measure patient activation (Patient Activation Measure-13 score), distress, anxiety, quality of life and experiences with their care and information received. All patients will also receive Fitbits to measure activity and heart rate. We will also measure wait times and number of visits to ambulatory care services to understand the impact of the app on the use of in-person services.

Ethics and dissemination
Ethics approval was obtained on 6 January 2023. Protocol version 2.0 was approved on 6 January 2023. The trial is registered with ClinicalTrials.gov. Study findings will be disseminated via publication in a peer-reviewed journal and shared with participants, patient programmes and cancer awareness groups. The app has also been approved as a secure communication method at our trial institution, thus we are well-positioned to support future integration of the app into standard care through collaboration with our hospital network.

Trial registration number
NCT05989477.

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