Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

‘Healthier Wealthier Families’ (HWF) seeks to reduce financial hardship in the early years by embedding a referral pathway between Australia’s universal child and family health (CFH) services and financial counselling. This pilot study investigated the feasibility and short-term impacts of HWF, adapted from a successful Scottish initiative.

Setting: CFH services in five sites across two states, coinciding with the COVID-19 pandemic. Participants: Caregivers of children aged 0–5 years experiencing financial hardship (study-designed screen). Design: Mixed methods. With limited progress using a randomised trial (RCT) design in sites 1–3 (March 2020–November 2021), qualitative interviews with service providers identified implementation barriers including stigma, lack of knowledge of financial counselling, low financial literacy, research burden and pandemic disruption. This informed a simplified RCT protocol (site 4) and direct referral model (no randomisation, pre–post evaluation, site 5) (June 2021–May 2022). Intervention: financial counselling; comparator: usual care (sites 1–4). Feasibility measures: proportions of caregivers screened, enrolled, followed up and who accessed financial counselling. Impact measures: finances (quantitative) and other (qualitative) to 6 months post-enrolment.

355/434 caregivers completed the screen (60%–100% across sites). In RCT sites (1–4), 79/365 (19%–41%) reported hardship but less than one-quarter enrolled. In site 5, n=66/69 (96%) caregivers reported hardship and 44/66 (67%) engaged with financial counselling; common issues were utility debts (73%), and obtaining entitlements (43%) or material aid/emergency relief (27%). Per family, financial counselling increased income from government entitlements by an average $A6504 annually plus $A784 from concessions, grants, brokerage and debt waivers. Caregivers described benefits (qualitative) including reduced stress, practical help, increased knowledge and empowerment.

Financial hardship screening via CFH was acceptable to caregivers, direct referral was feasible, but individual randomisation was infeasible. Larger-scale implementation will require careful, staged adaptations where CFH populations and the intervention are well matched and low burden evaluation.

ACTRN12620000154909.

Stroke is a significant worldwide cause of death and a prevalent contributor to long-term disability among adults. Survivors commonly encounter a wide array of motor, sensory and cognitive impairments. Rehabilitation interventions, mainly targeting the upper extremities, include a wide array of components, although the evidence indicates that the intensity of practice and task-specific training play crucial roles in facilitating effective results. Assisted therapy with electronic devices designed for the affected upper extremity could be employed to enable partial or total control of this limb, while simultaneously incorporating the aforementioned characteristics in the rehabilitation process.

32 adults who had a subacute or chronic stroke, aged over 18 years old, will be included for this randomised controlled trial aiming to determine the non-inferiority effect of the inclusion of a robotic device (ALBA) to regular treatment against only regular rehabilitation. Participants will be assessed before and after 4 weeks of intervention and at 3 months of follow-up. The primary outcome will be the Fugl-Meyer assessment for upper extremities; secondary outcomes will include the questionnaires Functional Independence Measure, Medical Outcomes Study 36-item Short-Form Health Survey as well as the System Usability Scale.

Full ethical approval was obtained for this study from the scientific and ethical review board Servicio de Salud Metropolitano Oriente of Santiago (approval number: SSMOriente030522), and the recommendations of the Chilean law no 20120 of 7 September 2006, concerning scientific research in the human being, its genome and human cloning, will be followed. Ahead of inclusion, potential participants will read and sign a written informed consent form. Future findings will be presented and published in conferences and peer-reviewed journals.

International ClinicalTrials.gov Registry (NCT05824416; https://clinicaltrials.gov/ct2/show/NCT05824416?term=uMOV&draw=2&rank=1).

Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.

NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.

The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.

ISCRTN16171129; NCT05455424.

The classification of human responses to health conditions or life processes, assuming that human responses are the way that a person responds, referring to the individual’s experiences, feelings, perceptions, behaviours and physical reactions, can be an exercise that, although challenging, is central to nursing diagnoses and, consequently, to nursing practice. It is necessary to gather and organise the existing knowledge about the human responses in adolescents with cancer, starting from the moment of diagnosis, due to the specificities inherent to this stage of human development. A scoping review is an appropriate method to use in order to map the existing knowledge on human responses in adolescents with oncological diseases experienced since the diagnosis.

Will encompass all types of studies, including ‘grey literature’ that centres on human responses related to adolescents aged 10–19 years with oncological diseases. There will be no restrictions based on the type of cancer, disease stage or other contextual factors, whether in home or healthcare settings.

The review will be conducted following the guidelines outlined by the Joanna Briggs Institute for scoping reviews. The search will encompass the following databases: CINAHL Complete (EBSCOhost), Cochrane Database of Systematic Reviews (EBSCOhost), MEDLINE Complete (EBSCOhost), Nursing and Allied Health Collection: Comprehensive (EBSCOhost), Cochrane Clinical Answers (EBSCOhost Answers), Latin American and Caribbean Literature on Health Sciences (LILACS) and ‘grey literature’ sources accessible through the Scientific Open Access Repositories of Portugal (RCAAP). A three-step search strategy will be implemented. Titles and abstracts will undergo analysis by two independent reviewers. Articles selected for a full-text review will be organised. The results will be presented in tables and narratively summarised.

Ethics approval and patient consent for publication are not necessary. Findings will be disseminated through publication in scientific journals and through conference presentations.

EXUB4. Registration was made in the Open Science Framework (OSF).

Aortic stenosis (AS) is one of the most common acquired cardiac valvular diseases. The success of transcatheter aortic valve implantation (TAVI) for severe AS has led to increasing interest in its use to earlier disease—moderate AS (MAS).

Model-based study using a Markov microsimulation technique to evaluate the long-term costs and benefits associated with ‘early’ TAVI. Key data inputs were sourced from the international literature and costs were obtained from Australian sources.

Australian health care system perspective.

10 000 hypothetical MAS patients with or without left ventricular diastolic dysfunction or impaired left ventricular ejection fraction.

Comparing early TAVI to medical management over a life time horizon for MAS patients aged >65 years. We evaluated the cost-effectiveness of offering early TAVI in five scenarios (10%, 25%, 50%, 75% and 90% take-up rates).

The primary outcome measure is quality-adjusted life years (QALY) gained and the incremental cost–utility ratio (ICUR). Secondary outcomes are life-years gained and the number of heart failure case avoided.

Offering early TAVI for MAS patients resulted in both higher healthcare costs and greater benefits (an increase of 3.02 QALYs or 3.99 life-years) per person treated. The ICUR was around $A10 867 and $A11 926 per QALY gained for all five scenarios, with the total cost of early TAVI to the healthcare system being anticipated to be up to $A3.66 billion. Sensitivity analyses indicated a 100% probability of being cost-effective with a willingness to pay threshold of $A50 000/QALY. The benefits remained, even with assumptions of high levels of repeat valve replacement after TAVI.

While ongoing randomised controlled trials will define the benefit of TAVI to MAS patients, these results suggest that this intervention is likely to be cost-effective.

Communication during consultations between referring and consultant physicians is often cited as a source of adverse events, medical error and professional incivility. While existing literature focuses on the role of referring physicians, few studies acknowledge the role of consultant physicians in enhancing communication during consultations. This scoping review aims to identify and synthesise available recommendations to enhance the communication practices of consultants during real-time consultations.

A scoping review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Medline, EMBASE and PsycINFO databases were searched from inception to August 2022.

English-language publications which describe recommendations, strategies or frameworks to improve the communication practices of consultant physicians during real-time consultations with referring physicians.

The search strategy included the following concepts: consultation, physician, communication, interprofessional relations and best practice. Two authors independently performed each phase of title and abstract screening, full-text review and data extraction. Discrepancies were resolved by a third author. Extracted data were iteratively analysed and summarised thematically.

Sixteen publications met the inclusion criteria. Synthesis of available recommendations identified organisation, expertise and interpersonal skills as three overarching and interconnected dimensions of communication demonstrated by consultants during effective consultations. Twelve studies identified interpersonal skills as being critical in alleviating the widespread professional incivility that is reported during consultations. Existing recommendations to improve the communication practices of consultants are limited as they lack standardised interventions and fail to comprehensively address all three elements identified in this review.

This scoping review synthesises available recommendations to improve the communication practices of consultant physicians during real-time consultations. An opportunity exists to develop communication tools or educational interventions based on the findings of this review to enhance interphysician consultation encounters.

Implementing ethics is crucial to prevent harm and promote widespread benefits in social experiments based on medical artificial intelligence (MAI). However, insufficient information is available concerning this within the paediatric healthcare sector. We aimed to conduct a comparative survey among paediatricians, nurses and health information technicians regarding ethics implementation knowledge of and attitude towards MAI social experiments at children’s hospitals in Shanghai.

A cross-sectional electronic questionnaire was administered from 1 July 2022 to 31 July 2022, at tertiary children’s hospitals in Shanghai.

All the eligible individuals were recruited. The inclusion criteria were as follows: (1) should be a paediatrician, nurse and health information technician, (2) should have been engaged in or currently participating in social experiments based on MAI, and (3) voluntary participation in the survey.

Ethics implementation knowledge of and attitude to MAI social experiments among paediatricians, nurses and health information technicians.

There were 137 paediatricians, 135 nurses and 60 health information technicians who responded to the questionnaire at tertiary children’s hospitals. 2.4–9.6% of participants were familiar with ethics implementation knowledge of MAI social experiments. 31.9–86.1% of participants held an ‘agree’ ethics implementation attitude. Health information technicians accounted for the highest proportion of the participants who were familiar with the knowledge of implementing ethics, and paediatricians or nurses accounted for the highest proportion among those who held ‘agree’ attitudes.

There is a significant knowledge gap and variations in attitudes among paediatricians, nurses and health information technicians, which underscore the urgent need for individualised education and training programmes to enhance MAI ethics implementation in paediatric healthcare.

Telenursing is a component of telehealth that occurs when nurses use information and communication technologies to provide care and nursing services remotely. To understand how telenursing services in surgical oncology patients can be better implemented, it is important that the success models are collected and studied. Therefore, the general objective is to develop the scoping review protocol for the survey of existing evidence on the practice of oncological perioperative telenursing.

The scoping review will be conducted following the scoping review directions of the Joanna Briggs Institute with the use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist for the review report. The databases that will be used for these searches will be: MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library. To search for grey literature, Google Scholar, WorldWideScience and Global ETD Search will be used. Primary studies, observational or experimental, published in any year or language will be considered. For the selection and extraction of data, two independent reviewers will read the title, summary and full text using the Rayyan software and a form prepared by the authors. The data to be extracted are related to the characterisation of the study (study design, country and year of publication) and details of the telenursing programme (surgery or surgical specialty, perioperative period, tools used, organisation and operation, outcome indicators and treatment methods and content in telenursing). Among others, the difficulties and potentialities for the development or implementation of telenursing will also be extracted, as the main result of the study.

The study does not require ethical approval as it will use previously published research data. The results will be shared in journals and scientific events and may be used for the development and implementation of oncological perioperative telenursing programmes.

The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

The study was conducted online.

Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Serum prokineticin-1 (s-PROK1) in the second and third trimester of pregnancy is positively correlated to preeclampsia, intrauterine growth restriction (IUGR) and preterm delivery. Women with polycystic ovary syndrome (PCOS) are prone to these adverse pregnancy outcomes. However, the contribution of PROK1 to the development of pregnancy complications and the effect of metformin and hyperandrogenism on s-PROK1 in PCOS have not been studied previously.

This work is a post hoc analysis of two prospective, randomised, placebo-controlled trials.

Pregnant women with PCOS were included from 11 study centres in Norway.

From 313 women, 264 participated in the present study after exclusions due to dropouts or insufficient serum samples.

Women with PCOS were randomly administered with metformin or placebo, from first trimester to delivery.

s-PROK1 was analysed using ELISA at gestational week 19 and related to pregnancy complications, fasting insulin levels, homoeostatic model assessment for insulin resistance (HOMA-IR), testosterone, or androstenedione levels, metformin use, PCOS phenotype and hyperandrogenism.

Maternal s-PROK1 in the second trimester did not predict pregnancy-induced hypertension, pre-eclampsia or late miscarriage/preterm delivery in women with PCOS. However, s-PROK1 was lower in women who used metformin before inclusion, both in those randomised to metformin and to placebo, compared with those who did not. s-PROK1 was also lower in those who used metformin both at conception and during pregnancy compared with those who used metformin from inclusion or did not use metformin at all. s-PROK1 was lower in hyperandrogenic compared with normo-androgenic women with PCOS.

Maternal s-PROK1 in the second trimester did not predict pregnancy complications in PCOS. Those who used metformin at conception and/or during pregnancy had lower s-PROK1. PCOS women with hyperandrogenism exhibited lower s-PROK1 compared with normo-adrogenic phenotypes.

NCT03259919 and NCT00159536.

The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications.

This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of

The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal.

NCT05375474.

Multisectoral collaboration highlighted as key in delivering on the Sustainable Development Goals (SDGs), but still little is known on how to move from rhetoric to action. Cambodia has made remarkable progress on child health over the last decades with multisectoral collaborations being a key success factor. However, it is not known how country stakeholders perceive child health in the context of the SDGs or multisectoral collaborations for child health in Cambodia.

Through purposive sampling, we conducted semistructured interviews with 29 key child health stakeholders from a range of government and non-governmental organisations in Cambodia. Guided by framework analysis, themes, subthemes and categories were derived.

We found that the adoption of the SDGs led to increased possibility for action and higher ambitions for child health in Cambodia, while simultaneously establishing child health as a multisectoral issue among key child stakeholders. There seems to be a discrepancy between the desired step-by-step theory of conducting multisectoral collaboration and the real-world complexities including funding and power dynamics that heavily influence the process of collaboration. Identified success factors for multisectoral collaborations included having clear responsibilities, leadership from all and trust among stakeholders while the major obstacle found was lack of sustainable funding.

The findings from this in-depth multistakeholder study can inform policy-makers and practitioners in other countries on the theoretical and practical process as well as influencing aspects that shape multisectoral collaborations in general and for child health specifically. This is vital if multisectoral collaborations are to be successfully leveraged to accelerate the work towards achieving better child health in the era of the SDGs.

This study aimed to evaluate primary care networks (PCNs) in the English National Health Service. We ask: How are PCNs constituted to meet their defined goals? What factors can be discerned as affecting their ability to deliver benefits to the community, the network as a whole and individual members? What outcomes or outputs are associated with PCNs so far? We draw policy lessons for PCN design and oversight, and consider the utility of the chosen evaluative framework.

Qualitative case studies in seven PCN in England, chosen for maximum variety around geography, rurality and population deprivation. Study took place between May 2019 and December 2022.

PCN members, staff employed in additional roles and local managers. Ninety-one semistructured interviews and approximately 87 hours of observations were undertaken remotely. Interview transcripts and observational field notes were analysed together using a framework approach. Initial codes were derived from our evaluation framework, with inductive coding of new concepts during the analysis.

PCNs have been successfully established across England, with considerable variation in structure and operation. Progress is variable, with a number of factors affecting this. Good managerial support was helpful for PCN development. The requirement to work together to meet the specific threat of the global pandemic did, in many cases, generate a virtuous cycle by which the experience of working together built trust and legitimacy. The internal dynamics of networks require attention. Pre-existing strong relationships provided a significant advantage. While policy cannot legislate to create such relationships, awareness of their presence/absence is important.

Networked approaches to service delivery are popular in many health systems. Our use of an explicit evaluation framework supports the extrapolation of our findings to networks elsewhere. We found the framework to be useful in structuring our study but suggest some modifications for future use.

This study aimed to examine the association between anxiety disorders and/or major depression disorder (ADs/MDD) and all-cause mortality in a 50-year perspective and to examine specific risk and health factors that may influence such an association.

Observational population study, 1968–2019.

The Population Study of Women in Gothenburg, Sweden (PSWG).

In 1968–1969, 899 (out of 1462) women from PSWG were selected according to date of birth for a psychiatric investigation, including diagnostic evaluation. Eight hundred (89%) were accepted. Twenty-two women were excluded. Of the 778 included, 135 participants (17.4 %) had solely ADs, 32 (4.1%) had solely MDD and 25 (3.2%) had comorbid AD/MDD.

Associations between ADs, MDD, comorbid AD/MDD and all-cause mortality with adjustments for potential confounding factors. Differences between the groups concerning health and risk factors and their association with mortality.

In a fully adjusted model, ADs were non-significantly associated with all-cause mortality (HR 1.17, 95% CI 0.98 to 1.41). When examining age during risk time as separate intervals, a significant association between mortality and AD was seen in the group of participants who died at the age of 65–80 years (HR 1.70, 95% CI 1.26 to 2.29). In the younger or older age interval, the association did not reach significance at the 95% level of confidence. Among confounding factors, smoking and physical activity were the strongest contributors. The association between smoking and mortality tended to be further increased in the group with ADs versus the group without such disorders (HR 2.10, 95% CI 1.60 to 2.75 and HR 1.82, 95% CI 1.56 to 2.12, respectively).

This study suggests potential links between ADs, age and mortality among women with 50 years of follow-up, but does not provide definitive conclusions due to the borderline significance of the results.

Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.

A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted.

From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9–49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews.

Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs.

CRD42021287371.

The number of people with lower limb loss continues to grow, though most research to date has been non-committal and lacks the appropriate clinical guidance required for proper prosthetic prescription. Previous literature using traditional spatiotemporal and biomechanical measures has not accurately identified differences in gait patterns when using different prosthetic devices. Therefore, a knowledge gap remains. To aid in determining the impact of different devices on gait in individuals with lower limb loss, a more sensitive quantitative measure should be used to supplement traditional biomechanical analyses. Continuous measures of coordination and stability, evaluated using relative phase analysis, has been shown to detect changes in gait patterns when traditional variables cannot. However, these measures have yet to be fully assessed in this population. This investigation will fill the knowledge gap by using relative phase analysis to provide a comprehensive description of kinematic behaviour by evaluating continuous interlimb coordination and stability for individuals with lower limb loss.

Biomechanical analysis of individuals with lower limb loss during walking activities will be evaluated using relative phase analysis to identify the continuous interlimb coordination and stability relationships between the upper and lower extremities of these individuals. Three-dimensional motion capture will enable kinematic properties of movement to be captured and analysed. Non-traditional measures of analysis will be used.

This study was approved by the Veterans Affairs New York Harbor Healthcare System Institutional Review Board (IRBNet #1573135, MIRB #1775). Findings will be disseminated through peer-reviewed publications, academic conference presentations, invited workshops, webinars and seminars.

Haemophilic arthropathy, a serious complication of haemophilia, results from recurrent joint bleeding, causing progressive joint damage and severely impacting patient quality of life. Rehabilitation therapy (RT) effectively addresses declining physical function due to joint degradation, but pain during RT can hinder its success. Therefore, an effective pain-alleviating treatment method is required. The single-joint hybrid assistive limb (HAL-SJ), a powered exoskeleton, measures bioelectric potential during muscle contraction and provides motorised support, potentially alleviating pain.

This study outlines our protocol for a randomised, prospective, single-blind (evaluator) trial aimed to investigate the effects of HAL-SJ on pain reduction during RT, kinesiophobia and other physical functions in patients with haemophilia.

This two-group comparison intervention study will include 24 male patients aged 12–85 years diagnosed with a bleeding disorder necessitating RT for pain and physical function improvement. The primary outcome measures pain changes during the first and second RT session in patients receiving HAL-SJ-assisted RT compared with traditional RT without HAL-SJ. The secondary outcomes include kinesiophobia (Japanese version of the Tampa Scale for Kinesiophobia), standing position gait (zebris FDM-T treadmill), range of motion (manual goniometer) and body surface temperature (infrared thermography camera) during the study period of up to 3 months or until the end of 10 RTs. RT intensity remains below that required to move the affected joint against gravity, given HAL-SJ’s muscular support. The follow-up period extends to 1 month after the last RT. Intergroup study variables are compared by an unpaired t-test or Mann-Whitney test. Intragroup comparisons of secondary outcomes are analysed by a paired t-test or Wilcoxon signed-rank test.

This study was approved by the accreditation committee of Nara Medical University Hospital. The study results will disseminate through publication in a peer-reviewed journal.

jRCTs052220076.

Catecholamine vasopressors such as norepinephrine are the standard drugs used to maintain mean arterial pressure during liver transplantation. At high doses, catecholamines may impair organ perfusion. Angiotensin II is a peptide vasoconstrictor that may improve renal perfusion pressure and glomerular filtration rate, a haemodynamic profile that could reduce acute kidney injury. Angiotensin II is approved for vasodilatory shock but has not been rigorously evaluated for treatment of hypotension during liver transplantation. The objective is to assess the efficacy of angiotensin II as a second-line vasopressor infusion during liver transplantation. This trial will establish the efficacy of angiotensin II in decreasing the dose of norepinephrine to maintain adequate blood pressure. Completion of this study will allow design of a follow-up, multicentre trial powered to detect a reduction of organ injury in liver transplantation.

This is a double-blind, randomised clinical trial. Eligible subjects are adults with a Model for End-Stage Liver Disease Sodium Score ≥25 undergoing deceased donor liver transplantation. Subjects are randomised 1:1 to receive angiotensin II or saline placebo as the second-line vasopressor infusion. The study drug infusion is initiated on reaching a norepinephrine dose of 0.05 µg kg^-1 min^-1 and titrated per protocol. The primary outcome is the dose of norepinephrine required to maintain a mean arterial pressure ≥65 mm Hg. Secondary outcomes include vasopressin or epinephrine requirement and duration of hypotension. Safety outcomes include incidence of thromboembolism within 48 hours of the end of surgery and severe hypertension. An intention-to-treat analysis will be performed for all randomised subjects receiving the study drug. The total dose of norepinephrine will be compared between the two arms by a one-tailed Mann-Whitney U test.

The trial protocol was approved by the local Institutional Review Board (#20–30948). Results will be posted on ClinicalTrials.gov and published in a peer-reviewed journal.

ClinicalTrials.govNCT04901169