Premature onset of type 2 diabetes and excess mortality are critical issues internationally, particularly in Indigenous populations. There is an urgent need for developmentally appropriate and culturally safe models of care. We describe the methods for the codesign, implementation and evaluation of enhanced models of care with Aboriginal and Torres Strait Islander youth living with type 2 diabetes across Northern Australia.

Our mixed-methods approach is informed by the principles of codesign. Across eight sites in four regions, the project brings together the lived experience of Aboriginal and Torres Strait Islander young people (aged 10–25) with type 2 diabetes, their families and communities, and health professionals providing diabetes care through a structured yet flexible codesign process. Participants will help identify and collaborate in the development of a range of multifaceted improvements to current models of care. These may include addressing needs identified in our formative work such as the development of screening and management guidelines, referral pathways, peer support networks, diabetes information resources and training for health professionals in youth type 2 diabetes management. The codesign process will adopt a range of methods including qualitative interviews, focus group discussions, art-based methods and healthcare systems assessments. A developmental evaluation approach will be used to create and refine the components and principles of enhanced models of care. We anticipate that this codesign study will produce new theoretical insights and practice frameworks, resources and approaches for age-appropriate, culturally safe models of care.

The study design was developed in collaboration with Aboriginal and Torres Strait Islander and non-Indigenous researchers, health professionals and health service managers and has received ethical approval across all sites. A range of outputs will be produced to disseminate findings to participants, other stakeholders and the scholarly community using creative and traditional formats.

Sickle cell disease (SCD) poses a significant global health burden, particularly affecting individuals in developing countries with constrained healthcare resources. While research on self-management in the context of SCD is emerging, it has predominantly focused on primary studies, and there is a notable dearth of evidence synthesis on SCD self-management in developing countries. This scoping review aims to identify and map self-management needs of individuals living with SCD, the strategies they employed to meet those needs, and the support systems available to them.

The review will be conducted following the Arksey and O’Malley’s (2005) 29 framework to comprehensively examine the landscape of SCD self-management research. Searches will be performed in PubMed, Scopus, Embase and Dimensions AI, with additional searches in other databases and grey literature. Indexed literature published in English from inception to January 2024 will be included. Reference list from included studies will also be searched manually. Two teams will be constituted to independently screen titles, abstracts and full text against the eligible criteria. Data will be extracted from included studies onto a customised data extraction form.

Ethical approval is not required for this review due to the fact that it synthesises information from available publications. The findings will be disseminated through publication in a peer-reviewed journal. Also, the findings will possibly be presented at relevant international and national conferences. This protocol has already been registered with the Open Science Framework. The study characteristics such as design and setting will be descriptively analysed and presented as graphs, tables and figures. Thematic analysis will also be conducted based on the study objectives and presented as a narrative summary.

Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a

Surgery is widely recognised as the treatment of choice for suprasyndesmotic ankle fractures, because of the assumption that these injuries yield instability of the ankle joint. Stability assessment of ankle fractures using weightbearing radiographs is now used regularly to guide the treatment of transsyndesmotic and infrasyndesmotic ankle fractures. Patients with a congruent ankle joint on weightbearing radiographs can be treated non-operatively with excellent results. Weightbearing radiographs are, however, rarely performed on suprasyndesmotic fractures due to the assumed unstable nature of these fractures. If weightbearing radiographs can be used to identify suprasyndesmotic fractures suitable for non-operative treatment, we may save patients from the potential burdens of surgery.

Our aim is to compare the efficacy of operative and non-operative treatment of patients with suprasyndesmotic ankle fractures that reduce on weightbearing radiographs.

A non-inferiority randomised controlled trial involving 120 patients will be conducted. A total of 120 patients with suprasyndesmotic ankle fractures with an initial radiographic medial clear space of

The Regional Committee for Medical and Health Research South East, group A (permission number: 169307), has granted ethics approval. The results of this study will provide valuable insights for developing future diagnostic and treatment strategies for a common fracture type. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.

NCT04615650.

Rotator cuff calcific tendinopathy (RCCT) involves calcific deposits in the rotator cuff. Non-surgical interventions such as extracorporeal shockwave therapy (ESWT) and ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) are recommended for its early management. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been formally tested in RCCT. The main objective of this study is to compare the effectiveness of an ET programme with ESWT and US-PICT in people with RCCT. As a secondary aim, this study aims to describe the natural history of RCCT.

A randomised, single-blinded four-group clinical trial will be conducted. Adults from 30 to 75 years diagnosed with RCCT who accomplish eligibility criteria will be recruited. Participants (n=116) will be randomised into four groups: ET group will receive a 12-week rehabilitation programme; ESWT group will receive four sessions with 1 week rest between sessions during 1 month; US-PICT group will receive two sessions with 3 months of rest between sessions; and (actual) wait-and-see group will not receive any intervention during the 12-month follow-up. The primary outcome will be shoulder pain assessed with the Shoulder Pain and Disability Index at baseline, 2 weeks, 4 months, 6 months and 12 months from baseline. The primary analysis will be performed at 12 months from baseline. Secondary outcomes will include pain, range of motion, patient satisfaction and imaging-related variables. Moreover, the following psychosocial questionnaires with their corresponding outcome measure will be assessed: Central Sensitization Inventory (symptoms related to central sensitization); Pain Catastrophizing Scale (pain catastrophizing); Tampa Scale for Kinesiophobia 11 items (fear of movement); Fear Avoidance Belief Questionnaire (fear avoidance behaviour); Hospital Anxiety and Depression Scale (anxiety and depression); Pittsburgh Sleep Quality Index (sleep quality); and the EuroQol-5D (quality of life). An intention-to-treat analysis will be performed to reduce the risk of bias using a worst-case and best-case scenario analysis.

Ethics committee approval for this study has been obtained (reference number: 1718862). The results of the main trial will be submitted for publication in a peer-reviewed journal.

NCT05478902.

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m² or a BMI of 25–29.9 kg/m² plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

NCT0555925.

To engage children who have experienced cancer, childhood cancer survivors, their families and professionals to systematically identify and prioritise research questions about childhood cancer to inform the future research agenda.

James Lind Alliance Priority Setting Partnership.

UK health service and community.

A steering group oversaw the initiative. Potential research questions were collected in an online survey, then checked to ensure they were unanswered. Shortlisting via a second online survey identified the highest priority questions. A parallel process with children was undertaken. A final consensus workshop was held to determine the Top 10 priorities.

Children and survivors of childhood cancer, diagnosed before age 16, their families, friends and professionals who work with this population.

Four hundred and eighty-eight people submitted 1299 potential questions. These were refined into 108 unique questions; 4 were already answered and 3 were under active study, therefore, removed. Three hundred and twenty-seven respondents completed the shortlisting survey. Seventy-one children submitted questions in the children’s surveys, eight children attended a workshop to prioritise these questions. The Top 5 questions from children were taken to the final workshop where 23 questions in total were discussed by 25 participants (young adults, carers and professionals). The top priority was ‘can we find effective and kinder (less burdensome, more tolerable, with fewer short and long-term effects) treatments for children with cancer, including relapsed cancer?’

We have identified research priorities for children’s cancer from the perspectives of children, survivors, their families and the professionals who care for them. Questions reflect the breadth of the cancer experience, including diagnosis, relapse, hospital experience, support during/after treatment and the long-term impact of cancer. These should inform funding of future research as they are the questions that matter most to the people who could benefit from research.

Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin–angiotensin–aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients’ quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient’s QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient’s QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient’s QOL, in patients with HK.

This is a prospective cohort study with 6 months of follow-up in 30–40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients’ characteristics. To assess the impact of treatment on a patient’s QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient’s QOL.

Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals.

NCT05297409.

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

Training programmes for obstetrics and gynaecology (O&G) and general surgery (GS) vary significantly, but both require proficiency in laparoscopic skills. We sought to determine performance in each specialty.

Prospective, observational study.

Health Education England North-West, UK.

47 surgical trainees (24 O&G and 23 GS) were subdivided into four groups: 11 junior O&G, 13 senior O&G, 11 junior GS and 12 senior GS trainees.

Trainees were tested on four simulated laparoscopic tasks: laparoscopic camera navigation (LCN), hand–eye coordination (HEC), bimanual coordination (BMC) and suturing with intracorporeal knot tying (suturing).

O&G trainees completed LCN (p

GS trainees performed better than O&G trainees in core laparoscopic skills, and the structure of O&G training may require modification.

ClinicalTrials.gov Registry (NCT05116332).

Listening and communication difficulties can limit people’s participation in activity and adversely affect their quality of life. Hearing, as well as listening and communication difficulties, can be measured either by using behavioural tests or self-report measures, and the outcomes are not always closely linked. The association between behaviourally measured and self-reported hearing is strong, whereas the association between behavioural and self-reported measures of listening and communication difficulties is much weaker, suggesting they assess different aspects of listening. While behavioural measures of listening and communication difficulties have been associated with poorer cognitive performance including executive functions, the same association has not always been shown for self-report measures. The objective of this systematic review and meta-analysis is to understand the relationship between executive function and self-reported listening and communication difficulties in adults with hearing loss, and where possible, potential covariates of age and pure-tone audiometric thresholds.

Studies will be eligible for inclusion if they report data from both a self-report measure of listening difficulties and a behavioural measure of executive function. Eight databases are to be searched: MEDLINE (via Ovid SP), EMBASE (via Ovid SP), PsycINFO (via Ovid SP), ASSIA (via ProQuest), Cumulative Index to Nursing and Allied Health Literature or CINAHL (via EBSCO Host), Scopus, PubMed and Web of Science (Science and Social Science Citation Index). The JBI critical appraisal tool will be used to assess risk of bias for included studies. Results will be synthesised primarily using a meta-analysis, and where sufficient quantitative data are not available, a narrative synthesis will be carried out to describe key results.

No ethical issues are foreseen. Data will be disseminated via academic publication and conference presentations. Findings may also be published in scientific newsletters and magazines.

CRD42022293546.