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AnteayerBMJ Open

IMproving psYchosocial adjustment to Traumatic Brain Injury from acute to chronic injury through development and evaluation of the myTBI online psychoeducation platform: protocol for a mixed-methods study

Por: Troeung · L. · Sarunga Raja · T. L. · Mann · G. · Wagland · J. · MacLeod · C. · Martini · A.
Introduction

This protocol describes the myTBI study which aims to: (1) develop an online psychoeducation platform for people with traumatic brain injury (TBI), their family members/caregivers, and healthcare staff to improve psychosocial adjustment to TBI across different phases of injury (acute, postacute, and chronic), and (2) undertake an evaluation of efficacy, acceptability, and feasibility.

Methods and analysis

A three-stage mixed-methods research design will be used. The study will be undertaken across four postacute community-based neurorehabilitation and disability support services in Western Australia. Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. Finally, stage 3 (evaluation) will be a randomised stepped-wedge trial to evaluate efficacy, acceptability, and feasibility. Outcomes will be measured at baseline, postintervention, follow-up, and at final discharge from services. Change in outcomes will be analysed using multilevel mixed-effects modelling. Follow-up surveys will be conducted to evaluate acceptability and feasibility.

Ethics and dissemination

Ethics approval was granted by North Metropolitan Health Service Mental Health Research Ethics and Governance Office (RGS0000005877). Study findings will be relevant to clinicians, researchers, and organisations who are seeking a cost-effective solution to deliver ongoing psychoeducation and support to individuals with TBI across the recovery journey.

Trial registration number

ACTRN12623000990628.

Good School Toolkit-Secondary Schools to prevent violence against students: protocol for a pilot cluster randomised controlled trial

Por: Devries · K. · Tanton · C. · Knight · L. · Nakuti · J. · Nanyunja · B. · Laruni · Y. · Amollo · M. · Apota · J. · Opobo · T. · Pearlman · J. · Allen · E. · Bonell · C. · Naker · D.
Introduction

No whole-school interventions which seek to reduce physical, sexual and emotional violence from peers, intimate partners and teachers have been trialled with adolescents. Here, we report a protocol for a pilot trial of the Good School Toolkit-Secondary Schools intervention, to be tested in Ugandan secondary schools. Our main objectives are to (1) refine the intervention, (2) to understand feasibility of delivery of the intervention and (3) to explore design parameters for a subsequent phase III trial.

Methods and analysis

We will conduct a pilot cluster randomised controlled trial, with two arms and parallel assignment. Eight schools will be randomly selected from a stratified list of all eligible schools in Kampala and Wakiso Districts. We will conduct a baseline survey and endline survey 18 months after the baseline, with 960 adolescents and 200 teachers. Qualitative data and mixed methods process data collection will be conducted throughout the intervention. Proportion of staff and students reporting acceptability, understanding and implementing with fidelity will be tabulated at endline for intervention schools. Proportions of schools consenting to participation, randomisation and proportions of schools and individual participants completing the baseline and endline surveys will be described in a Consolidated Standards of Reporting Trials diagram.

Ethics and dissemination

The ethical requirements of our project are complex. Full approvals have been received from the Mildmay Ethics Committee (0407-2019), the Uganda National Council for Science and Technology (SS 6020) and the London School of Hygiene & Tropical Medicine (16212). Results of this study will be published in peer-reviewed academic journals, and shared with public bodies, policy makers, study participants and the general public in Uganda.

Trial registration number

PACTR202009826515511.

Efficacy and safety of deferoxamine, deferasirox and deferiprone triple iron chelator combination therapy for transfusion-dependent {beta}-thalassaemia with very high iron overload: a protocol for randomised controlled clinical trial

Introduction

Despite the improvement in medical management, many patients with transfusion-dependent β-thalassaemia die prematurely due to transfusion-related iron overload. As per the current guidelines, the optimal chelation of iron cannot be achieved in many patients, even with two iron chelators at their maximum therapeutic doses. Here, we evaluate the efficacy and safety of triple combination treatment with deferoxamine, deferasirox and deferiprone over dual combination of deferoxamine and deferasirox on iron chelation in patients with transfusion-dependent β-thalassaemia with very high iron overload.

Methods and analysis

This is a single-centre, open-label, randomised, controlled clinical trial conducted at the Adult and Adolescent Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into intervention or control groups. The intervention arm will receive a combination of oral deferasirox, oral deferiprone and subcutaneous deferoxamine for 6 months. The control arm will receive the combination of oral deferasirox and subcutaneous deferoxamine for 6 months. Reduction in iron overload, as measured by a reduction in the serum ferritin after completion of the treatment, will be the primary outcome measure. Reduction in liver and cardiac iron content as measured by T2* MRI and the side effect profile of trial medications are the secondary outcome measures.

Ethics and dissemination

Ethical approval for the study has been obtained from the Ethics Committee of the Faculty of Medicine, University of Kelaniya (Ref. P/06/02/2023). The trial results will be disseminated in scientific publications in reputed journals.

Trial registration number

The trial is registered in the Sri Lanka Clinical Trials Registry (Ref: SLCTR/2023/010).

Use of Artificial Intelligence in the Identification and Management of Frailty: A Scoping Review Protocol

Por: Karunananthan · S. · Rahgozar · A. · Hakimjavadi · R. · Yan · H. · Dalsania · K. A. · Bergman · H. · Ghose · B. · LaPlante · J. · McCutcheon · T. · McIsaac · D. I. · Abbasgholizadeh Rahimi · S. · Sourial · N. · Thandi · M. · Wong · S. T. · Liddy · C.
Introduction

Rapid population ageing and associated health issues such as frailty are a growing public health concern. While early identification and management of frailty may limit adverse health outcomes, the complex presentations of frailty pose challenges for clinicians. Artificial intelligence (AI) has emerged as a potential solution to support the early identification and management of frailty. In order to provide a comprehensive overview of current evidence regarding the development and use of AI technologies including machine learning and deep learning for the identification and management of frailty, this protocol outlines a scoping review aiming to identify and present available information in this area. Specifically, this protocol describes a review that will focus on the clinical tools and frameworks used to assess frailty, the outcomes that have been evaluated and the involvement of knowledge users in the development, implementation and evaluation of AI methods and tools for frailty care in clinical settings.

Methods and analysis

This scoping review protocol details a systematic search of eight major academic databases, including Medline, Embase, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ageline, Web of Science, Scopus and Institute of Electrical and Electronics Engineers (IEEE) Xplore using the framework developed by Arksey and O’Malley and enhanced by Levac et al and the Joanna Briggs Institute. The search strategy has been designed in consultation with a librarian. Two independent reviewers will screen titles and abstracts, followed by full texts, for eligibility and then chart the data using a piloted data charting form. Results will be collated and presented through a narrative summary, tables and figures.

Ethics and dissemination

Since this study is based on publicly available information, ethics approval is not required. Findings will be communicated with healthcare providers, caregivers, patients and research and health programme funders through peer-reviewed publications, presentations and an infographic.

Registration details

OSF Registries (https://doi.org/10.17605/OSF.IO/T54G8).

Community perceptions matter: a mixed-methods study using local knowledge to define features of success for a community intervention to improve quality of care for children under-5 in Jigawa, Nigeria

Por: Iuliano · A. · Shittu · F. · Colbourn · T. · Salako · J. · Bakare · D. · Bakare · A. A. A. · King · C. · Graham · H. · McCollum · E. D. · Falade · A. G. · Uchendu · O. · Haruna · I. · Valentine · P. · Burgess · R.
Objectives

In this study, we used the information generated by community members during an intervention design process to understand the features needed for a successful community participatory intervention to improve child health.

Design

We conducted a concurrent mixed-methods study (November 2019–March 2020) to inform the design and evaluation of a community–facility linkage participatory intervention.

Setting

Kiyawa Local Government Area (Jigawa State, Nigeria)—population of 230 000 (n=425 villages).

Participants

Qualitative data included 12 community conversations with caregivers of children under-5 (men, older and younger women; n=9 per group), 3 focus group discussions (n=10) with ward development committee members and interviews with facility heads (n=3). Quantitative data comprised household surveys (n=3464) with compound heads (n=1803) and women (n=1661).

Results

We analysed qualitative data with thematic network analysis and the surveys with linear regression—results were triangulated in the interpretation phase. Participants identified the following areas of focus: community health education; facility infrastructure, equipment and staff improvements; raising funds to make these changes. Community involvement, cooperation and empowerment were recognised as a strategy to improve child health, and the presence of intermediate bodies (development committees) was deemed important to improve communication and solve problems between community and facility members. The survey showed functional community relations’ dynamics, with high levels of internal cohesion (78%), efficacy in solving problems together (79%) and fairness of the local leaders (82%).

Conclusions

Combining the results from this study and critical theories on successful participation identified community-informed features for a contextually tailored community–facility link intervention. The need to promote a more inclusive approach to future child health interventions was highlighted. In addition to health education campaigns, the relationship between community and healthcare providers needs strengthening, and development committees were identified as an essential feature for successfully linking communities and facilities for child health.

Trial registration number

ISRCTN39213655.

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