Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Cross-sectional survey study, as part of a larger prospective cohort study.

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.

In Bangladesh, evidence on the long-term trajectory of adolescents' sexual and reproductive health (SRH) remains limited, largely due to the lack of longitudinal data to assess the changes over time. To address this gap, the Advancing Sexual and Reproductive Health and Rights (AdSEARCH) project of International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) set up an adolescent cohort study aimed at documenting changes in SRH knowledge, attitudes and practices, and identifying the factors affecting these changes. This article presents the baseline sociodemographic and SRH characteristics of this cohort as a pathway for future analyses.

This cohort study included 2713 adolescents from the Baliakandi Health and Demographic Surveillance System run by icddr,b. The cohort covered three age groups from girls and boys, giving a total of five cohorts: girls aged 12, 14 and 16 years; and boys aged 14 and 16 years. A total of seven rounds of data had been collected at 4-month intervals over 2-years follow-up period.

The majority of adolescents were attending school (90%), and school dropouts were higher among boys. Around 17% of the respondents were involved in income-generating activities, which were mostly boys. Among girls, the mean age of menarche was 12.2 years. Overall, 6% of adolescents had major depressive disorder, with prevalence increasing with age. Gender differences were evident regarding knowledge about conception and contraception. Egalitarian attitudes towards social norms and gender roles were found higher among girls (52%) compared to boys (11%). The majority of adolescents reported experiencing social/verbal bullying (43%), followed by physical violence (38%) and cyberbullying (4%).

This article presents the baseline findings only. A series of papers is in the pipeline for submission to different peer-reviewed journals. The findings from this study will be used to support data-driven policy formulation for future adolescent health programmes.

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

ClinicalTrials.gov ID: NCT06090552.

Advarra Pro 00070994.

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.

To assess the feasibility of conducting a definitive randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a tailored exercise intervention compared with usual care for people aged 80 years and older with hip and/or knee osteoarthritis (OA) and comorbidities.

Two-arm, parallel-design, multicentre, pragmatic, feasibility RCT.

Four National Health Service outpatient physiotherapy services across England.

Adults aged 80 years and over with clinical hip and/or knee OA and ≥1 comorbidity.

Participants were randomised 1:1 via a central web-based system to be offered: (1) a 12-week tailored exercise programme or (2) usual care. Participants and outcome assessors were not blinded to treatment allocation.

(1) Ability to screen and recruit participants; (2) retention of participants at 14-week follow-up; (3) intervention fidelity (proportion of participants who received ≥4 intervention sessions as per protocol) and (4) participant engagement (assessed by home exercise adherence).

Between 12 May 2022 and 26 January 2023, 133 potential participants were screened, of whom 94 were eligible. The main reasons for ineligibility were symptoms not consistent with hip or knee OA (10/39, 25.6%) or already having had a physiotherapy appointment (8/39, 20.5%). 51 of 94 (54%) eligible participants were recruited. Participants had a mean age of 84 years (SD 3.5), 31 (60.8%) were female and 96.1% reported their ethnicity as White British (n=49/51). 45 of 51 participants (88%) provided outcome data at the 14-week follow-up time point. Four or more intervention sessions were attended by 13/25 (52%) participants. Home exercise log completion declined over time: 6/23 participants (26.1%) returned completed exercise logs for all 12 weeks. The median number of days home exercises were recorded each week was 5 (range 0–7).

This study demonstrated that a definitive trial would be feasible. Before proceeding, modifications to ensure recruitment of a diverse population and intervention fidelity should be addressed.

ISRCTN75983430.

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

ISRCTN68786622.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.

Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.

We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.

Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.

To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.

Triangulation to integrate quantitative and qualitative data.

Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.

A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.

To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.

Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.

There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.

ISRCTN66682918.

To assess atrial fibrillation (AF) burden, symptoms and quality of life (QoL) in endurance athletes with paroxysmal AF.

Prospective cohort study.

Otherwise healthy endurance athletes with paroxysmal AF in Norway, Australia and Belgium. The current study presents baseline measurements collected before the intervention of a randomised controlled trial on effects of individually tailored training adaptation.

AF burden (percentage time in AF) was measured by insertable cardiac monitors (Confirm Rx, Abbott). AF-related symptoms and QoL were assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) with any score

43 athletes (age 57±10 (mean±SD), range 33–75 years, 3 women) were included. The athletes were monitored for 50±18 days. Median AF burden was 0.18% (IQR 0%–2.6%). Out of 29 athletes with at least one AF episode, 21 (72%) had AF episodes >60 min. 13 athletes (30%) had AFEQT overall score 60 min were associated with reduced QoL (mean AFEQT score 78 vs 90, p=0.001 and 78 vs 90, p=0.001, respectively). There were large individual variations between the athletes concerning AF burden, symptoms and QoL.

Although most athletes were still competing, more than half had troublesome symptoms. One-third had reduced QoL, which was associated with higher AF burden and longer duration of AF episodes. Variations between the athletes highlight the need for individually tailored AF management in athletes with paroxysmal AF.

NCT04991337.

An increasing number of teenagers and young adults (TYA) with chronic conditions and complex needs are transitioning from paediatric to adult services, including admission to intensive care units (ICUs). As these services are often ill-equipped to care for TYA, there is a risk of compromised care. Despite recent guidelines from the UK Paediatric Critical Care and Intensive Care Societies highlighting the importance and urgency of improving ICU transition, current recommendations are not evidence-based and established pathways for ICU transition remain limited.

This mixed-methods research study aims to generate evidence to underpin national policy on transition from paediatric to adult ICUs that will improve clinical care and patient experience. To do this, we will: (1) link and analyse UK national data (years 2017–2024) on paediatric and adult ICU admissions, hospital inpatient, outpatient and emergency care visits and survival status, to determine the clinical characteristics and healthcare resource utilisation from teenage years to early adulthood of people admitted to an ICU as a young person (admission aged 14 and 15), and how these relate to ICU admissions after age 16; (2) conduct semistructured interviews, online forums and surveys with TYA patients, carers and health professionals to understand their experience of transition in ICU services; and (3) synthesise these strands of evidence and use a structured process of stakeholder engagement to propose potential targeted improvements as appropriate.

This study was approved by the East of England - Cambridge South Research Ethics Committee on 1 August 2024 (research ethics committee number 24/EE/0108), and the Health Research Authority Confidentiality Advisory Group (CAG) on 7 October 2024 (CAG number 24/CAG/0068). Study results will be actively disseminated through peer-reviewed journals, conference presentations and accessible lay texts and graphic summaries for the use of charities and patients including those with learning disabilities and neurodevelopmental disorders.

Histopathological evaluation of prostate biopsies using the Gleason scoring system is critical for prostate cancer diagnosis and treatment selection. However, grading variability among pathologists can lead to inconsistent assessments, risking inappropriate treatment. Similar challenges complicate the assessment of other prognostic features like cribriform cancer morphology and perineural invasion. Many pathology departments are also facing an increasingly unsustainable workload due to rising prostate cancer incidence and a decreasing pathologist workforce coinciding with increasing requirements for more complex assessments and reporting. Digital pathology and artificial intelligence (AI) algorithms for analysing whole slide images show promise in improving the accuracy and efficiency of histopathological assessments. Studies have demonstrated AI’s capability to diagnose and grade prostate cancer comparably to expert pathologists. However, external validations on diverse data sets have been limited and often show reduced performance. Historically, there have been no well-established guidelines for AI study designs and validation methods. Diagnostic assessments of AI systems often lack preregistered protocols and rigorous external cohort sampling, essential for reliable evidence of their safety and accuracy.

This study protocol covers the retrospective validation of an AI system for prostate biopsy assessment. The primary objective of the study is to develop a high-performing and robust AI model for diagnosis and Gleason scoring of prostate cancer in core needle biopsies, and at scale evaluate whether it can generalise to fully external data from independent patients, pathology laboratories and digitalisation platforms. The secondary objectives cover AI performance in estimating cancer extent and detecting cribriform prostate cancer and perineural invasion. This protocol outlines the steps for data collection, predefined partitioning of data cohorts for AI model training and validation, model development and predetermined statistical analyses, ensuring systematic development and comprehensive validation of the system. The protocol adheres to Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis+AI (TRIPOD+AI), Protocol Items for External Cohort Evaluation of a Deep Learning System in Cancer Diagnostics (PIECES), Checklist for AI in Medical Imaging (CLAIM) and other relevant best practices.

Data collection and usage were approved by the respective ethical review boards of each participating clinical laboratory, and centralised anonymised data handling was approved by the Swedish Ethical Review Authority. The study will be conducted in agreement with the Helsinki Declaration. The findings will be disseminated in peer-reviewed publications (open access).

To explore healthcare workers’ (HCWs) experiences, barriers and facilitators in managing patients with symptoms of possible breast, cervical or colorectal cancer.

A qualitative in-depth interview study with HCWs managing patients with breast, cervical and colorectal cancer symptoms. We also conducted workshops with a group of HCWs to check the credibility of the interview findings.

The study was conducted with staff working in primary, secondary and tertiary public health facilities in the Eastern and Western Cape in South Africa (SA), and Harare and Bulawayo and their referral provinces in Zimbabwe.

HCWs with experience in managing patients with symptoms of possible breast, cervical or colorectal cancer were recruited for the study. Participants were purposively sampled based on region, healthcare level and job role. A total of 56 participants (26 in SA and 30 in Zimbabwe) participated in the in-depth interviews. 26 (12 in SA and 14 in Zimbabwe) participated in four clinical advisory group workshops across both countries.

Drawing on the Model of Pathways to Treatment, HCWs’ perceptions of patient-level factors influencing the diagnostic interval included financial limitations, patients’ absence and delays in attendance. Healthcare provider and system factors included: challenges with referral and feedback systems; training needs; low awareness of protocols and guidelines; inappropriate and suboptimal clinical assessments; and broader socioeconomic factors and resource limitations.

Improving the timely diagnosis of breast, cervical and colorectal cancer in Southern Africa necessitates targeted strategies that address both patient-related, provider and health-system delays.

Potassium-enriched salt substitutes have favourable effects on blood pressure, but it has not been tested in Iran. The present protocol is a double-blinded, randomised-controlled trial designed to investigate the effects of potassium-enriched salt substitutes on blood pressure in Iranian hypertensive patients.

The primary objectives are to determine the effects on systolic and diastolic blood pressure at 3 months and 6 months. The secondary objectives are to assess the effects on serum levels of potassium, sodium, urea and creatinine; the urinary ratio of sodium to potassium; participants’ attitudes toward the use of salt or salt substitutes; the recurrence of hypertensive crisis; and the occurrence and/or reoccurrence of strokes, transient ischaemic attack and cardiovascular accidents. Eligible individuals will receive the usual salt (100% sodium chloride) in the control group or salt substitute (70% sodium chloride and 30% potassium chloride) in the intervention group. A total of 500 hypertensive participants aged 40–65 years will be recruited and randomised to intervention or control groups. Potassium-enriched salt substitution in Iran will be considered to improve CVD complications and prevent deaths. Continuous and categorical baseline characteristics will be tested using the independent t-test and ² test. The effect of the intervention on primary and secondary outcomes will be assessed using the intention-to-treat method and two-way mixed ANOVA models.

This study has been approved by Alborz University of Medical Sciences (0-0-103-6369) and has received ethics approval (IR.ABZUMS.REC.1402.293). We will publish our study findings for peer-reviewed publications, conference presentations and digital stories.

IRCT20240121060757N1.

Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth.

A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

ACTRN12624000776505.

V.2.3, 20 March 2025.

Teenage pregnancy remains a critical global health issue, particularly in low- and middle-income countries. The intergenerational transmission of teenage pregnancy underscores the need for targeted interventions. Existing research on intergenerational approaches is fragmented, with varying methodologies and outcomes. This scoping review seeks to address this gap by answering the following research questions: What are the available intergenerational interventions for teenage pregnancy, and what are the associated risks and protective factors for early and late teenage pregnancy?

This study does not involve primary data collection and therefore does not require ethical approval. The review will be conducted in five stages: identifying the research question; identifying relevant studies; study selection; charting the data; and collating, summarising and reporting the results. A comprehensive search of electronic databases, grey literature and relevant organisational websites will be conducted for literature published between 2014 and 2024. Data will be extracted using a standardised form and synthesised narratively. Stakeholder consultation will be conducted to refine findings and ensure relevance. The findings will be reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) extension for Scoping Reviews guidelines. The results will be presented through narrative synthesis, with tables and charts used to summarise key information.

As the review is based on publicly available data, ethical approval is not required. Ethical clearance will be sought for stakeholder consultations, if necessary. Findings will be disseminated through peer-reviewed publications, conferences, policy briefs and shared openly on the Open Science Framework (OSF). This protocol is registered in the OSF (https://doi.org/10.17605/OSF.IO/CM9WK).

Orthorexia nervosa (ON) is a newly recognised condition characterised by an excessive fixation with healthy eating, yet the prevalence of ON is poorly understood. This protocol presents the methodology to undertake a systematic review and meta-analysis on the prevalence of ON in a wide range of populations (including general population and ‘high-risk’). To the authors’ knowledge, the proposed review will be the first systematic review to critically appraise the quality and quantity of evidence on this topic.

The protocol has been developed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. Eligible studies will be identified through a systematic search of electronic databases (eg, Medline Complete, PsycInfo and CINAHL complete via the EBSCOHost platform and Embase). Two reviewers will independently screen and review the full text of records, extract the data and critically appraise the evidence using the Joanna Briggs Institute critical appraisal checklist for prevalence studies. A descriptive synthesis will present the characteristics of the included studies and key findings in text and tables. Where appropriate, meta-analysis will be conducted to determine the proportion of individuals with ON (yes/no) according to population groups of interest (ie, general and ‘high-risk’ populations) and/or ON tools.

This review will include published data only; thus, ethical permission will not be necessary. Results of this review will be published in a relevant peer-reviewed scientific journal and presented at conferences in related fields.

CRD42024576557.

The benefits of physical activity (PA) are compelling for all ages and abilities. For children with cerebral palsy (CP), two distinct health behaviours, being physically active and reducing sedentary time, are critical to target as an early intervention to reduce long-term morbidity. One approach may be to increase PA participation by empowering parents who are key to making family lifestyle changes. This study will compare Active Start Active Future, a participation-focused intervention, to usual care in a mixed-methods randomised waitlist-controlled trial.

A total of 40 children with CP (3–7 years), classified in Gross Motor Function Classification System (GMFCS) levels II–V, will be stratified (GMFCS II vs III, IV vs V) and randomised to receive either (1) Active Start Active Future, an 8-week intervention for 1 hour per week in any setting or (2) usual care followed by delayed intervention. Active Start Active Future aims to increase PA and reduce sedentary behaviour of young children with CP by providing participatory opportunities to promote PA behaviour change. Outcomes will be measured at baseline (T1), immediately postintervention at 8 weeks (T2) and at 26 weeks postbaseline (T3). The primary outcomes are the Canadian Occupational Performance Measure for both child and parent participation goals and child physical performance goal. Secondary outcomes include daily time spent in moderate to vigorous PA and sedentary time, gross motor function, quality of life, barriers to participation for the children and parents’ PA and sedentary time. Intervention acceptability and experiences of PA participation will be explored using a qualitative descriptive approach.

The Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/23/QCHQ/100850) and The University of Queensland Human Research Ethics Committee (2024/HE000054) have approved this study. The results of the study will be disseminated to families and community agencies as guided by our advisory group and as conference abstracts and presentations, peer-reviewed articles in scientific journals and institution newsletters and media releases.

ACTRN12624000042549, Universal Trial Number: U1111-1300-7421; Australian New Zealand Clinical Trials Registry.

Hospitals have been identified as one of the drivers accelerating climate change, and in response, they have recently been incorporating environmentally sustainable goals into their organisations. Given the significant role that healthcare workers play in pursuing hospitals’ environmental goals through such actions as energy conservation and waste reduction, the scoping review is intended to comprehensively map and summarise the literature on these workers’ green behaviours within hospital settings.

The scoping review will follow Joanna Briggs Institute methodology and will report findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews checklist. A comprehensive search for relevant sources published from database inception through 31 January 2025 will be conducted across seven electronic databases (PubMed, Cumulative Index of Nursing and Allied Health Literature, Embase, Scopus, Web of Science, PsycINFO and Emerald Journals), using key terms such as "hospital," "healthcare workers" and "green behavior". We will include peer-reviewed journal articles focusing on healthcare workers’ green behaviours in hospitals and relevant grey literature in order to provide an extensive review. Articles that are not written in English or that are intervention-based will be excluded. The study selection process will be presented in a flow diagram, and the text will summarise the findings of eligible studies according to key characteristics.

The scoping review will not require ethical approval. The findings will be disseminated through publication in a peer-reviewed journal and conference presentation.

This protocol has been registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/YU345).

Valid and reliable measurement of early childhood development (ECD) is critical for monitoring and evaluating ECD-related policies and programmes. Although ECD tools developed in high-income countries may be applicable to low- and middle-income countries (LMICs), directly applying them in LMICs can be problematic without psychometric evidence for new cultures and contexts. Our objective was to systematically appraise available evidence on the psychometric properties of tools used to measure ECD in LMIC.

A systematic review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.

MEDLINE, Embase, PubMed, PsycInfo, SciELO and BVS were searched from inception to February 2025.

We included studies that examined the reliability, validity, and measurement invariance of tools assessing ECD in children 0–6 years of age living in LMICs.

Each study was independently screened by two researchers and data extracted by one randomly assigned researcher. Risk of bias was assessed using a checklist developed by the study team assessing bias due to training/administration, selective reporting and missing data. Results were synthesised narratively by country, location, age group at assessment and developmental domain.

A total of 160 articles covering 117 tools met inclusion criteria. Most reported psychometric properties were internal consistency reliability (n=117, 64%), concurrent validity (n=81, 45%), convergent validity (n=74, 41%), test–retest reliability (n=73, 40%) and structural validity (n=72, 40%). Measurement invariance was least commonly reported (n=16, 9%). Most articles came from Brazil, China, India and South Africa. Most psychometric evidence was from urban (n=92, 51%) or urban–rural (n=41, 23%) contexts. Study samples focused on children aged 6–17.9 or 48–59.9 months. The most assessed developmental domains were language (n=111, 61%), motor (n=104, 57%) and cognitive (n=82, 45%). Bias due to missing data was most common.

Psychometric evidence is fragmented, limited and heterogeneous. More rigorous psychometric analyses, especially on measurement invariance, are needed to establish the quality and accuracy of ECD tools for use in LMICs.

CRD42022372305.

The PREgnancy Care Integrating translational Science, Everywhere Network was established to investigate specific placental disorders (pregnancy hypertension, preterm birth, fetal growth restriction and stillbirth) in sub-Saharan Africa. We created a repository of clinical and social data with associated biological samples from pregnant and non-pregnant women. Alongside this, local infrastructure and expertise in the field of maternal and child health research were enhanced.

Pregnant women were recruited in participating health facilities in The Gambia, Kenya and Mozambique at their first antenatal visit or at the time a placental disorder was diagnosed (Kenya and The Gambia only). Follow-up study visits were conducted in the third trimester, delivery and 6 weeks to 6 months postpartum. To elucidate the difference between pregnancy and non-pregnancy biology in these settings, non-pregnant nulliparous and parous women, aged 16–49 years, were recruited opportunistically primarily from family planning clinics in Kenya and Mozambique, and randomly through the Health and Demographic Surveillance System in The Gambia. Non-pregnant participants only had one study visit. Biological samples were processed rapidly and locally, stored initially in liquid nitrogen and then at –80°C, and details entered into an OpenSpecimen database linked to their social determinants and clinical research data.

A total of 6932 pregnant and 1825 non-pregnant women were recruited to the study, providing a repository of clinical and social data and a biorepository of 482 448 samples. To date, baseline descriptive analysis of the cohort has been undertaken, as well as a substudy on the prevalence of COVID-19 in the cohort.

Analysis of data and samples will include an analysis of biomarker and social and physical determinants of health and how these interact in a systemic approach to understanding the origins of common placental disorders. The data from non-pregnant women will provide control data for comparison with the data from normal and complicated pregnancies. Findings will be disseminated to local stakeholders and communities through meetings and ongoing community engagement and globally by publication and presentations at scientific meetings.