Fractures over venous sinuses (FOVSs) are associated with difficulties in diagnosis and treatment resulting in a high level of morbidity and mortality. Despite its importance, there are limited aggregate data to guide the management of these fractures ultimately inflicting a major callenge to neurosurgeons. This protocol describes the methodology of a scoping review that aims to synthesise contemporary evidence on the management and outcomes of FOVSs.

The proposed study will be conducted in accordance with the Arksey and O’Malley’s framework for scoping reviews. The research question, eligibility criteria and search strategy were developed based on the population, intervention, comparator and outcome strategy. The following electronic bibliographic databases will be searched without restrictions on language and date of publication: PubMed, WHO Global Index Medicus, African Journals Online, SCOPUS, Embase, Cochrane and ProQuest Central. All peer-reviewed studies of primary data reporting on the management and outcomes of FOVSs will be included. The data extracted from included articles will be presented through descriptive statistics, pooled statistics and a narrative description.

Because this study did not directly involve human individuals, ethical approval was not necessary. Dissemination strategies will include publication in a peer-reviewed journal, oral and poster presentations at local, regional, national and international conferences and promotion over social media.

The study was conducted to assess the diagnostic performance of the Hightop Syphilis Rapid Diagnostic Test (RDT) in comparison with the ELISA test used as a reference method.

A laboratory-based cross-sectional and comparative study was conducted to assess the diagnostic performance of the Hightop Syphilis RDT.

Blood samples obtained from adult participants in eight health facilities were analysed at the National Public Health Laboratory (NPHL), Ministry of Public Health, Yaounde, Cameroon.

From 29 April to 25 August 2023, 583 adult participants of both sexes (aged ≥21 years), including both syphilis positive and syphilis negative, were recruited consecutively in eight health facilities in eight regions of Cameroon.

Blood samples were screened for the detection of anti-Treponema pallidum antibodies using the One Step Rapid Test (Qingdao Hightop Biotech), a non-treponemal test and ELISA (Biorex Diagnostics, UK), a treponemal test used as a reference method. Diagnostic performance of the Syphilis RDT was analysed using Epi Info V.7 and validated through online statistical tools such as StatPages, GraphPad, QuickCalcs and MedCalc software.

Of the 583 samples tested, the Hightop Syphilis RDT revealed a sensitivity of 84.6% (95% CI: 74.8% to 91.1%) and specificity of 98.5% (95% CI: 97.5% to 99.1%). The positive predictive value (PPV) and negative predictive value (NPV) were 84.6% (95% CI: 74.8% to 91.1%) and 98.5% (95% CI: 97.5% to 99.1%), respectively. Regarding the stratification of diagnostic performance by clinical stage, the test showed a sensitivity of 100.0% (95% CI: 71.51% to 100.0%) and specificity of 99.06% (95% CI: 94.86% to 99.98%). The PPV and NPV were 91.67% (95% CI: 61.00% to 98.72%) and 100.0% (95% CI: 96.55% to 100.0%), respectively, in symptomatic individuals. Among asymptomatic individuals, sensitivity was 97.56% (95% CI: 87.14% to 99.94%) and specificity was 100.0% (95% CI: 99.14% to 100.0%). The PPV and NPV were 100.0% (95% CI: 91.19% to 100.0%) and 99.77% (95% CI: 98.40% to 99.97%), respectively.

The Hightop Syphilis RDT demonstrated adequate diagnostic performance, particularly among symptomatic individuals, supporting its utility as a reliable tool for syphilis detection in clinical settings.

Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.

The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.

This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

Pancreatic adenocarcinoma is a major public health concern due to its high metastatic potential and poor prognosis. However, treatment options remain limited. A promising therapeutic strategy involves the sequential administration of standard therapies. In a previous phase Ib-II trial, we evaluated a sequential regimen of gemcitabine plus nab-paclitaxel (GEMBRAX) followed by FOLFIRINOX (FFX), which improved median overall survival (OS), progression-free survival and objective response rate (ORR), with acceptable toxicity. This phase II randomised trial will assess the efficacy of GEMBRAX followed by FFX compared with FFX alone as a first-line treatment for metastatic pancreatic cancer (mPC).

The GABRINOX-2 (GemcitabineABRaxaneIRInotecanOXaliplatine-2) study is an ongoing prospective, multicentre, randomised phase II trial. A total of 162 patients with mPC will be randomised (1:1) to receive GEMBRAX treatment followed by FFX (arm A) or FFX alone (arm B). The primary objective is to compare the efficacy of GEMBRAX followed by FFX with FFX alone as a first-line treatment for mPC. Secondary objectives include treatment tolerability, ORR, disease control rate, OS and patient quality of life. Additionally, we aim to identify novel biomarkers associated with treatment response through the analysis of circulating tumour DNA and assess the messenger RNA signature’s predictive value for OS based on treatment approach.

This study was approved by the comité de protection des personnes Ile de France III (26 July 2021) and the French National Agency for the Safety of Health Products (17 September 2021). It will be carried out in accordance with European Reglementation 536/2014 on clinical trials, the Declaration of Helsinki, Good Clinical Practice guidelines and the French Public Health Code. The results will be published in peer-reviewed journals and presented at national and international conferences.

This trial has been registered on euclinicaltrials.eu (EU 2023-508594-84-00) and on clinicaltrials.gov (NCT05065801).

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

CRD42024564332.

Cardiac surgery remains a high-risk procedure for bleeding despite advances in patient blood management. Conventional centrifugation-based autotransfusion devices primarily recover red blood cells, losing platelets and coagulation factors. The SAME autotransfusion device (i-SEP, Nantes, France) introduces an innovative filtration-based approach, recovering erythrocytes, leucocytes and platelets to enhance perioperative haemostasis. The main objective is to determine whether the filtration-based SAME device reduces significant perioperative bleeding compared with the centrifugation-based system in high-risk cardiac surgery patients.

The Centrifugation-based vs filtration-based intraOperative cell saLvage on qualiTy of peRioperAtive haemostasis iN cardiac surgEry (COLTRANE) trial is a multicentre, parallel-group, single-blinded, superiority-randomised clinical trial. Conducted over 19 months in 10 French hospitals, the study will target patients at high risk of bleeding undergoing on-pump cardiac surgery via sternotomy. A total of 570 patients (285 per group) are required to achieve 80% statistical power for detecting clinically significant differences. Eligible patients will be randomised to either a centrifugation-based or filtration-based autotransfusion group. Both groups will follow standardised perioperative and cardiopulmonary bypass management, with the devices used only intraoperatively. The primary outcome is the proportion of patients with clinically significant perioperative bleeding defined as classes 2 to 4 of the Universal Definition of Perioperative Bleeding. The secondary outcomes include device efficiency and safety, perioperative haemostasis, lengths of intensive care unit and hospital stays, early postoperative morbidity and 30-day all-cause mortality. Ancillary studies will be performed to evaluate cell recovery and washing performance, the viscoelastic properties of retransfused blood (Quantra Qplus; Stago, Asnières-sur-Seine, France), and the effect of salvaged leucocytes on postoperative inflammation and immune function.

This trial has received a favourable opinion from the Committee for the Protection of Persons and authorisation from the French authorities (Comité de protection des personnes Nord Ouest, IDRCB: 2023-A02566-39). Protocol V.1.1 was approved on 22 January 2024. The trial is registered on ClinicalTrials.gov (NCT06425614). The findings will be disseminated through oral communications at national and international scientific meetings and peer-reviewed journal publications. Individual participant data will be made available on reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.

ClinicalTrials.gov, NCT06425614.

To develop and validate a prediction model of Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ALL).

A single-centre retrospective study.

This study analysed 471 newly diagnosed patients with ALL at the Second Affiliated Hospital of Army Medical University from January 2014 to December 2023.

Clinical and laboratory parameters were collected, and the important characteristic parameters were selected using BorutaShap. Multiple machine learning (ML) models were constructed and optimised by using the active learning (AL) algorithm. Performance was evaluated using the area under the curve (AUC), comprehensive indicators and decision curve analysis. The interpretability of the model was evaluated by using SHapley Additive Interpretation (SHAP), and external validation was conducted on an independent test cohort.

10 parameters were selected to construct multiple ML models. The CatBoost model integrated with an AL algorithm (CatBoost-AL) was found to be the most effective model for predicting Ph+ALL within the validation data set. This model achieved an AUC of 0.797 (95% CI 0.710 to 0.884), along with sensitivity, specificity and F1 score of 0.667, 0.864 and 0.777, respectively. The prediction performance of CatBoost-AL was further validated with an external testing set, where it maintained a strong AUC of 0.794 (95% CI 0.707 to 0.881). Using SHAP for global interpretability analysis, age, monocyte count, -glutamyl transferase, neutrophil count and alanine aminotransferase were identified as crucial parameters that significantly influence the diagnostic accuracy of CatBoost-AL.

An interpretable ML model and online prediction tool were developed to determine whether newly diagnosed patients with ALL are Ph+ALL. The key parameters identified by the optimal model provided a further understanding of Ph+ALL characteristics and were valuable for accurate diagnosis and treatment of Ph+ALL.

To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.

We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1:1 allocation ratio, using convergent mixed methods.

Home-based care without 24/7 paid care provision, in three UK sites.

Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before the approach, including a known history of substance abuse or carer ability to be trained to competency.

Intervention-group carers received training by local nurses using a manualised training package.

Quantitative data were collected at baseline and 6–8 weeks post-bereavement and via carer diaries. Interviews with carers and healthcare professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.

The secondary outcome measure was time to symptom relief, calculated using data items from the carer diary, after the patient had died.

In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >30% of eligible dyads. The expected recruitment target (50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced (30% (6/20) usual care and 80% (16/20) intervention). The feasibility criterion of >40% retention was, therefore, considered not met. A total of 12 carers (intervention, n=10; usual care, n=2) and 20 healthcare professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The intervention group had a considerably shorter time to medication administration than the usual-care group (median time to administer medication in intervention=5 min, usual-care=105 min). Intervention group carers felt confident in administering medication. Healthcare professional support was sought by intervention group carers in 24 out of 147 (16.3%) medication administration entries. The context of the feasibility study was not ideal, as district nurses were overstretched, unfamiliar with research methods and possibly not in equipoise. A disparity in readiness to consider the intervention was demonstrated between carers, who were uniformly enthusiastic, and healthcare professionals who were not. Findings confirmed methodological and ethics issues pertaining to researching the last days of life care.

The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring healthcare professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.

ISRCTN11211024.

To provide insight into how people cope with living with atrial fibrillation (AF) and taking oral anticoagulants (OACs), informing how services and healthcare delivery could be improved to offer the appropriate support patients require, thereby optimising their quality of life and well-being.

A qualitative study employing focus group discussions (FGDs).

11 primary care units in a socioeconomically deprived area of the Butantan district in São Paulo, Brazil.

Adults (≥18 years) with AF purposively recruited based on sex, age and socioeconomic status.

Saturation was met with three FGDs comprising seven, five and five participants, respectively. Theme one focused on self-management, where many participants discussed their methods for adhering to dietary restrictions and alternative medications, including plant-based options and specific foods, and how they modified their daily activities to reduce AF complications and symptoms. Theme two was rationality, where participants described three main ways that they cope with taking long-term medication (often warfarin): thinking that it controls their AF symptoms; it is an obligation; it prevents morbidity and premature death. Theme three was attitude and emotions, where participants described their initial reactions of shock and fear after diagnosis and ongoing emotions of sadness and frustration due to required self-management activities and regular blood tests. Theme four was medication regimen, where participants discussed difficulties with polypharmacy, changes to AF medication (particularly from non-vitamin K antagonist OACs (NOACs) to warfarin), side effects from taking warfarin and various methods of medication management.

This study presents three key findings with implications for patient care and support. First, the shock and fear experienced during diagnosis due to a lack of knowledge about AF suggests that improvements in public knowledge about AF are needed. Second, people with additional chronic conditions may need improved care and support, given the concern participants had regarding when and how to take their medications safely. Third, improved access to NOACs may reduce the difficulties, frustrations and concerns participants had regarding warfarin use (eg, diet, dose adjustments, self-management and monthly international normalised ratio tests).

Antenatal corticosteroid (ACS) regimens have remained unchanged since the initial trials in 1972, with the optimal regimen still undetermined. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns)-III trial is a three-arm individually randomised double-blind trial evaluating the efficacy and safety of two different ACS dosing regimens (currently used and lower-dose ACS regimens vs placebo) in women with a high probability of having a late preterm birth. This study protocol nested within this trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) effects of two different ACS dosing regimens in pregnant women in the late preterm period (34–36 weeks) to help inform an optimal dosing regimen.

The study will be conducted in two of the five countries participating in the WHO ACTION-III trial—India (Delhi, Belagavi) and Nigeria (Ibadan and Ile-Ife). We will use a population PK approach using sparse sampling to study the PK effects of the two ACS regimens, that is, 6 mg dexamethasone phosphate (DEXp) or 2 mg betamethasone phosphate (BETp), administered intramuscularly every 12 hours for a maximum of four doses or till birth, whichever is earlier, compared with placebo. We will also ascertain the fetal–maternal ratio of DEXp and BETp at birth.

Maternal venous blood samples will be collected at 0, 1–4 hours, 8–12 hours after the first dose, and at 24–36 hours, 48–60 hours, 72–96 hours after the last dose, and immediately after birth, along with cord blood. Concentrations of DEXp and BETp will be measured at set time points using a validated liquid chromatography mass spectroscopy assay. PD parameters measured will include total and differential white blood cell count (by automated analysers using electrical impedance), plasma glucose (hexokinase method) and serum cortisol (using a validated electrochemiluminescence immunoassay), at predefined time points. PK models will be developed for each drug using non-linear mixed effects methods. Optimal dosing will be investigated using Monte Carlo simulations.

The study has been approved by the WHO Ethics Review Committee and the site-specific ethics committees of the participating leading institutions. Written informed consent will be obtained from all participants. The study results will be published in a peer-reviewed journal and presented at scientific conferences.

ISRCTN11434567.

The pathogenesis of the long-lasting symptoms which can follow an infection with the SARS-CoV-2 virus (‘long covid’) is not fully understood. The ‘COroNaVirus post-Acute Long-term EffectS: Constructing an evidENCE base’ (CONVALESCENCE) study was established as part of the Longitudinal Health and Wellbeing COVID-19 UK National Core Study. We performed a deep phenotyping case-control study nested within two cohorts (the Avon Longitudinal Study of Parents and Children and TwinsUK) as part of CONVALESCENCE.

From September 2021 to May 2023, 349 participants attended the CONVALESCENCE deep phenotyping clinic at University College London. Four categories of participants were recruited: cases of long covid (long covid(+)/SARS-CoV-2(+)), alongside three control groups: those with neither long covid symptoms nor evidence of prior COVID-19 (long covid(-)/SARS-CoV-2(-); control group 1), those who self-reported COVID-19 and had evidence of SARS-CoV-2 infection, but did not report long covid (long covid(-)/SARS-CoV-2(+); control group 2) and those who self-reported persistent symptoms attributable to COVID-19 but no evidence of SARS-CoV-2 infection (long covid(+)/SARS-CoV-2(-); control group 3). Remote wearable measurements were performed up until February 2024.

This cohort profile describes the baseline characteristics of the CONVALESCENCE cohort. Of the 349 participants, 141 (53±15 years old; 21 (15%) men) were cases, 89 (55±16 years old; 11 (12%) men) were in control group 1, 75 (49±15 years old; 25 (33%) men) were in control group 2 and 44 (55±16 years old; 9 (21%) men) were in control group 3.

The study aims to use a multiorgan score calculated as the cumulative total for each of nine domains (ie, lung, vascular, heart, kidney, brain, autonomic function, muscle strength, exercise capacity and physical performance). The availability of data preceding acute COVID-19 infection in cohorts may help identify the consequences of infection independent of pre-existing subclinical disease and also provide evidence of determinants that influence the development of long covid.

The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

Intervention participants were randomised (1:1) to either standard lifestyle advice or an individualised isometric wall squat prescription, performed 4x2-min bouts three times a week for 6 months.

We assessed deliverability, attrition, adherence and variance in blood pressure (BP) change.

IE was found to be easily deliverable to all participants. At 6 months, 34% had withdrawn. Of those who completed IE, 85% of their sessions were at the correct intensity, meeting our retention criterion for success. Variance in BP change was 14.4 mm Hg. The study was not powered to show a difference in BP between groups; however, BP reductions were seen in the intervention group at all study time points compared with baseline. There were no adverse events related to study participation.

We met our a priori recruitment criteria which allowed us to calculate a sample size (n=542) for a full RCT. The results demonstrate good acceptability and adherence rates to the treatment protocol. Our results show a signal towards a consistent sBP reduction in the IE group compared with baseline.

NCT04936022 (https://classic.clinicaltrials.gov/ct2/show/NCT04936022?cond=isometric+exercise&draw=2&rank=7); registry identifier: ISRCTN 13472393.

To evaluate the burden of asthma in five European countries (5EU; France, Germany, Italy, Spain and United Kingdom [UK]).

A retrospective cross-sectional study was conducted based on the data from the 2018 National Health and Wellness Survey. Health-related quality of life (HRQoL), work productivity and activity impairment, and healthcare resource utilisation (HCRU) were compared between different groups: asthma versus non-asthma, mild/moderate/severe asthma versus non-asthma and moderate/severe asthma versus mild asthma.

Internet-based survey across Western Europe.

Adult patients (aged ≥18 years) with self-reported physician diagnosis of asthma and experienced asthma symptoms in the past 12 months.

Socio-demographic characteristics, asthma-related outcomes, HRQoL and productivity, HCRU and prevalence of asthma.

The prevalence of asthma in the 5EU was 6.7% (95% CI: 6.5% to 6.9%), with the UK reporting the highest rates (10.4%; 95% CI: 9.9% to 10.9%). About 52.0% of the respondents had mild asthma, 27.9% had moderate and 20.1% had severe asthma. The asthma group reported significantly poorer HRQoL, higher rates of overall work productivity impairment and activity impairment, and a greater number of visits to emergency room, healthcare provider and hospitalisations versus the non-asthma group (all p

Asthma prevalence and burden are still high in Western Europe, indicating the need for effective interventions that could lead to improved outcomes.

Increasing Plasmodium resistance levels to sulfadoxine–pyrimethamine (SP) threaten the effectiveness of intermittent preventive treatment in pregnancy (IPTp) and have prompted the evaluation of alternative strategies. Azithromycin (AZ) could have add-on effects on malaria and treat sexually transmitted infections (STIs), both conditions described as major causes of adverse pregnancy outcomes (APO). Inconsistent findings on the utility of AZ for the prevention of APO were reported; however, thus far, no comprehensive meta-analytic synthesis of data has been published. This review aims to investigate the effects of SP+AZ administered in women as IPTp on the risk of low birth weight in malaria-endemic areas.

Eligible studies will be identified through a pre-established search strategy in several electronic databases (Medline, Cochrane Library, Web of Science, EMBASE, WHO International Clinical Trials Registry Platform, ClinicalTrials.gov and AJOL) and will comprise peer-reviewed papers reporting original data on the effects of SP+AZ on the risk of APO. Only randomised controlled trials published until 30 September 2024 in English or French will be included. IPTp with SP+AZ regimens (intervention) will be compared with IPTp with SP alone or with a placebo (control). As primary outcomes, data on the frequency of low birth weight will be collected. Secondary outcomes include the rates of stillbirth, preterm birth, miscarriage and neonatal death. Data will be extracted independently by two reviewers using a predefined extraction form. If the data quality allows for quantitative synthesis, a fixed-effects meta-analysis will be conducted if there is low inter-study heterogeneity. Otherwise, the random-effects meta-analysis will be conducted to take into account uncertainty in pooled estimates that could be due to inter-study heterogeneity. The review protocol was designed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) guidelines.

Ethical clearance is not needed as the data will be from already published studies in which informed consent and ethical approval were obtained by primary investigators. Our dissemination plan includes the publication in a peer-reviewed journal as well as conference presentations.

CRD42020149592.

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.

The use of e-health interventions has grown in demand due to their accessibility, low implementation costs and their potential to improve the health and well-being of people across a large geographical area. Despite these potential benefits, little is known about the cost-effectiveness of self-guided e-health interventions. The aim of the study was to compare the cost and consequences of ‘iSupport’, an e-health intervention to reduce mental health issues in dementia carers.

A cost-consequence analysis (CCA) of a multi-centre, single-blind randomised controlled trial of iSupport. The CCA was conducted from a public sector (National Health Service, social care and local authority) perspective plus a wider societal perspective. Delivery costs of iSupport were collected using a bottom-up micro-costing approach.

352 participants were recruited from three centres in England, Wales and Scotland.

Participants eligible for inclusion were adults over the age of 18 years who self-identified as an unpaid carer with at least 6 months of experience caring for an individual with a diagnosis of dementia. Between 12 November 2021 and 31 March 2023, 2332 carers were invited to take part in the study. 352 participants were randomised: 175 randomised to the iSupport intervention group and 177 to the usual care control group. The mean age of participants in the intervention and control groups was 63 and 62, respectively.

The CCA presented the disaggregated costs and health-related quality of life measured using the EuroQol five-dimension.

There was no significant difference in generic health-related quality of life measured using the EQ-5D-5L (p=0.67). Both groups reported higher mean costs between baseline and 6 months, but the change in costs was significantly lower in the intervention group. Between baseline and 6 months, the mean change in total resource use costs from the public sector perspective was significantly different between groups (p=0.003, r=–0.161) reporting a mean change per participant of £146 (95% CI: –33 to 342) between the intervention and control groups. From the wider societal perspective, there was no significant difference (p=0.23) in the mean change in total resource use and informal care costs between the two groups from baseline to 6 months.

Use of iSupport was associated with reduced health and social care resource use costs for carers compared with care-as-usual. Self-guided e-health interventions for dementia carers may have the potential to reduce health and social care resource use and wider societal costs, but evidence relating to their effectiveness and cost-effectiveness is lacking.

ISRCTN17420703.

In high-income countries (HICs), migrants living with HIV (MLHIV) are more likely than other HIV subpopulations to encounter problems which hamper their adherence to the care process; these include social and administrative insecurity, discrimination and psychological distress.

This systematic review aimed to determine the specific features of adherence to the HIV care process among MLHIV in HIC.

Three researchers independently selected studies from a search for papers focusing on empirical studies on MLHIV’s adherence to the care process in HIC, published between 1 January 2010 and 1 November 2024 in the following databases: MEDLINE, Embase, CINAHL, PsycINFO and Google Scholar. The three dimensions evaluated for adherence to the care process were adherence to treatment, retention in care and virological response. HICs were characterised according to the World Bank’s definition.

Of 601 studies screened, 69 were included (26 (38%) analysing treatment adherence 44 (64%) 44 (64%) retention in care and 34 (48%) virological response). In 49 (71%) of these studies, MLHIV from sub-Saharan Africa accounted for the majority of persons included. MLHIV were mainly categorised according to their geographical region of origin. Only one study considered the reasons for migration. Of 52 statistically significant associations, only five found that being a migrant (vs being a non-migrant) was associated with a better HIV care process. Moreover, several individual (sociodemographic, clinical and psychological), and structural (care system organisation and political) factors associated with difficulties in adhering to the HIV care process were identified.

MLHIV living in HIC had poorer adherence to the HIV care process for all three dimensions studied (ie, treatment adherence, retention in care and virological response). Research studies categorise MLHIV according to their geographical origin. However, this type of categorisation does not adequately capture social inequalities in health. To overcome this, studies must instead categorise MLHIV according to various intersecting factors, including, among other things, their reason for migrating, the length of time living in the destination country and violence experienced during their migratory journey.

CRD42021253280.

Telerehabilitation (also known as virtual rehabilitation) refers to the use of telecommunication technologies to deliver remote rehabilitation services synchronously or asynchronously to patients. Systematic reviews seem to validate the efficacy and efficiency of telerehabilitation services for diverse patient conditions while offering in addition potential cost savings in healthcare. However, integrating telerehabilitation into clinical settings raises several ethical issues, including the risk of exacerbating existing health inequities in the provision of care. Despite the apparent scarcity of the literature addressing ethical issues related to telerehabilitation, some of these fundamental concerns have already been discussed in health ethics publications. The main objectives of this study are therefore to first scrutinise what has been published to date and second to critically examine the way in which these dimensions have been conceptualised, especially the philosophical and ethical conceptions on which they are based.

To meet these objectives, we will conduct a Critical Interpretive Synthesis (CIS). By using an iterative and interactive process, a CIS aims to critically examine the literature and develop a theoretical understanding grounded in review studies. As per the steps described by Dixon-Woods, we will start by conducting a systematic search of the literature within five selected databases: CINAHL, EMBASE, MEDLINE, Web of Science and PsycINFO. The search strategy will be based on two main concepts: (1) telerehabilitation and (2) ethics. This systematic search will be completed by other research strategies: searching the list of references of selected articles and contacting experts within and outside our team’s expertise. Search results will be imported within the Covidence software to be assessed for relevance. We will include all empirical and non-empirical articles that specifically investigate or discuss the ethical dimensions of telerehabilitation. Only studies published in English and French will be included. The search and selection of the articles will be carried out interactively and inductively throughout the stages of extraction and development of a theoretical understanding of the data to fill emerging conceptual gaps. The analysis and critical synthesis will be led by the first author but carried out by our multidisciplinary research team. This study, through its critical dimension, has the potential to provide a more comprehensive overview of the many ethical issues surrounding telerehabilitation.

This review does not require ethical approval. We aim to publish the results in a peer-reviewed journal and do presentations at local, national and/or international research meetings and workshops for all stakeholders.