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Assessing the sensibility, utility and implementation considerations of the Episodic Disability Questionnaire with older adults living with complex health needs: a cross-sectional measurement study

Por: Khawar · S. · Cameron · S. · Patel · J. · Kukuruzovic · S. · Wong · K. · Stewart · A. · Chan Carusone · S. · OBrien · K. K.
Objectives

The Episodic Disability Questionnaire (EDQ) was developed to measure the presence, severity and episodic nature of disability experienced among persons with chronic conditions. Our aim was to assess the sensibility, utility and implementation considerations of the EDQ among older adults with complex health needs.

Design

Cross-sectional measurement study involving quantitative and qualitative methods of data collection.

Participants

We recruited community-dwelling older adults (65 years of age or older) living with complex health needs receiving care from a primary healthcare team in Toronto, Canada.

Methods

We administered the EDQ, sensibility questionnaire (assessing face and content validity, and ease of usage, with each item scored from 0 to 7 with greater scores indicating greater sensibility) and demographic questionnaire, followed by a semi-structured interview in the home or clinical setting. Using an interview guide, we asked participants about their perspectives on utility, format and implementation of the EDQ in clinical practice. We considered the EDQ sensible if the median score on the sensibility questionnaire was ≥5/7 for ≥80% of items and if none of the items had a median score of ≤3/7. We conducted a team-based directed content analysis of the interview transcripts.

Results

The median age of the 11 participants in this study was 83 years of age. All participants reported living with two or more chronic health conditions, with osteoarthritis (n=5) and diabetes (n=4) most frequently reported. The EDQ met the criterion for sensibility as measured by the sensibility questionnaire. Interview data from participants (n=10) indicated that the EDQ represents the health-related challenges among this sample of older adults with complex health needs, captures the episodic nature of disability and was easy to use. Utility of the EDQ included providing clinicians with a holistic understanding of health challenges older adults face, aiding in intervention planning and measuring changes in disability over time. Six of the participants also expressed uncertainty as to how the EDQ specifically could be used by clinicians in their care. Considerations for implementation included mode of administration (paper or electronic) and the importance of communicating EDQ scores with older adults based on individual preferences.

Conclusions

The EDQ possesses sensibility and utility for use among this sample of older adults living with complex health needs in home or clinical care settings.

Chronic health consequences of the COVID-19 pandemic on school workers: a cross-sectional post-pandemic analysis

Por: Watts · A. W. · Pitblado · M. · Li · S. · Irvine · M. A. · Golding · L. · Coombs · D. · OReilly · C. · OBrien · S. F. · Goldfarb · D. M. · Masse · L. C. · Lavoie · P.
Importance

The COVID-19 pandemic dramatically affected schools. However, there are insufficient data on the chronic physical and mental health consequences of the pandemic in school workers.

Objectives

To determine the prevalence and the functional and mental health impact of pandemic-related chronic health symptoms among school workers towards the end of the COVID-19 pandemic.

Design

Cross-sectional analysis of health questionnaires and serology testing data (nucleocapsid, N antibodies) collected between January and April 2023, within a cohort of school workers.

Setting

Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).

Participants

Active school staff employed in these three school districts.

Exposure

COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.

Main outcomes

Self-reported, new-onset pandemic-related chronic health symptoms that started within the past year, lasting at least 3 months, after a positive viral test among those with a known infection.

Results

Of 1128 school staff enrolled from 185/186 (99.5%) schools, 1086 (96.3%) and 998 (88.5%) staff completed health questionnaires and serology testing, respectively. The N-seroprevalence adjusted for clustering by school and test sensitivity and specificity was 84.7% (95% Credible Interval (95% CrI): 79.2% to 91.8%) compared with 85.4% (95% CrI: 81.6% to 90.3%) in a community-matched sample of blood donors. Overall, 31.1% (95% CI: 28.4% to 34.0%) staff reported new-onset chronic symptoms. These symptoms were more frequently reported in staff with viral test-confirmed infections (38.0% (95% CI: 34.3% to 41.9%)) compared with those with positive serology who were unaware that they had COVID-19 (14.3% (95% CI: 7.6% to 23.6%); p

Conclusions

The pandemic had major health impacts on school workers. To our knowledge, this study is among the first to concurrently quantify a broad range of chronic physical and mental health impacts, highlighting the need for further research and targeted health programmes to address this significant burden.

Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial

Por: Bountogo · M. · Zakane · A. · Ouedraogo · T. A. · Ouermi · L. · Compaore · G. · Compaore · A. · Coulibaly · B. · Koueta · F. · Burroughs · H. R. · Fetterman · I. · La Mons · J. L. · Lebas · E. · Doan · T. · Hsiang · M. · OBrien · K. S. · Arnold · B. · Sie · A. · Oldenburg · C. E.
Introduction

Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

Methods and analysis

This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

Ethics and dissemination

Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

Trial registration number

NCT06010719.

Snapshot of Obstetric National Audit and Research Project (SONAR1): aprotocol for an international observational cohort study

Por: Patel · R. · OCarroll · J. · Kua · J. · Sultan · P. · Carvalho · B. · El Sharawi · N. · Eley · V. · OBrien · P. · Stanford · S. · Hill · S. · Craig · R. · Lucas · N. · Hou · B. · Moonesinghe · S. R.
Introduction

Caesarean birth (CB) under neuraxial anaesthesia (NA) is the most performed inpatient operation in the UK. The incidence of intraoperative pain during caesarean delivery performed under neuraxial anaesthesia is unclear, with limited data that used patient-reported measures to investigate intraoperative pain. The short- and medium-term impacts on patients of this adverse event are unknown.

Methods and analysis

We will undertake a multicentre, prospective observational cohort study to evaluate the incidence and impact of pain experienced by patients during CB performed under neuraxial anaesthesia. Routine audit data will be collected for all patients undergoing caesarean delivery for any indication during a 1 week window at participating hospitals within the UK and Queensland, Australia. The dataset will include patient, anaesthetic, obstetric and neonatal risk factors for intraoperative pain. Local investigators will then seek informed consent from patients either before or within 24 hours of delivery to record patient experience and patient-reported outcomes at 24 hours and 6 weeks postdelivery. Local investigators at participating hospitals will also complete a survey evaluating compliance with evidence-based structural standards at their sites. The patient characteristics, structures, processes and outcomes will be described. Inferential techniques will be used to evaluate the relationship between risk factors and postoperative outcomes.

Ethics and dissemination

This study received ethical approval from the Leicester Health Research Authority and Care Research Wales, REC reference 24/EM/0084) on 24 May 24. The study received ethical approval from the Human Research Ethics Committee of Metro North Health in Australia on 25 March 2024 (REC Ref HREC/2024/MNHA/103767). The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. The results will be disseminated via conference presentations, peer-reviewed academic journals and reports prepared for patients, the public and policy makers.

Trial registration number

ISRCTN15269213.

Leishmaniases in Ethiopia: a scoping review

Por: OBrien · K. · Grifferty · G. · Totten · A. · Asres · M. S. · Ayele · E. · Coombs · P. · Orriols · A. M. · Mosurkal · S. · Krulwich · E. · Oruko · L. · Roman · I. C. · Shah · P. · Fanning-Hughes · R. · Williams · A. L. · Wallace · F. · Wong · M. G. · Roe · S. · Gandhi · K. · Matari · L. · Sha
Objectives

With recent efforts to eliminate visceral leishmaniasis in East Africa, we aimed to map the breadth of research on leishmaniases in Ethiopia, one of the high-endemic countries in the region, to help understand the current literature landscape and highlight priority areas for future research.

Design

The scoping review was conducted in accordance with the JBI Scoping Review Methodology Group’s guidance and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews guidelines.

Data sources

We searched the following databases and sources: PubMed, Embase, Web of Science, Cochrane Library, Global Medicus Index, PROSPERO, ClinicalTrials.gov and the Pan African Clinical Trials Registry and known local journals.

Eligibility criteria

We included studies addressing the issue of leishmaniasis in Ethiopia that were published in English language.

Data extraction and synthesis

Two reviewers independently extracted data from each study, with conflicts resolved by a third reviewer. The identified studies were analysed using an extensive codebook, which was previously developed by this team and adapted to the Ethiopian context to classify the research into different categories.

Results

A total of 8698 articles were identified. A stepwise review was conducted, and 639 papers were selected for inclusion. The research spans different themes and designs and has steadily increased over the past 14 years. Research on prevention and control, health systems/policies and post-kala-azar dermal leishmaniasis, as well as randomised controlled trials, was lacking. Studies on coinfections with other diseases accounted for 14% of research.

Conclusions

The findings underscore the growing amount of research on leishmaniasis in Ethiopia, addressing several themes and emphasising the need for more research in prevention, control, health systems/policy and high-quality studies for evidence-based treatment.

Developing patient journey maps with Aboriginal and Torres Strait Islander peoples living with dementia or cognitive impairment and their carers: protocol

Por: OBrien · P. · Sinclair · C. · Kinsey · I. · Zanker · J. · Juhrmann · M. · Smith · R. · Thompson · S. · Bessarab · D. · Lo Giudice · D.
Introduction

Although Aboriginal and Torres Strait Islander peoples are increasingly living healthier and longer lives, they continue to experience a high prevalence and incidence of dementia and cognitive impairment. Navigating dementia care services is challenging, and there is limited availability of flexible, culturally secure health and community care services. The aim of this study is to use a culturally adapted patient journey mapping methodology to examine the lived experiences of Aboriginal and Torres Strait Islander Aboriginal peoples living with dementia/cognitive impairment and their carers navigating their care journeys.

Methods and analysis

The overarching principle guiding this project is cultural security, referring to the incorporation of processes such that the research will not compromise the cultural rights, values and expectations of Aboriginal and Torres Strait Islander peoples. In this three-phase participatory action research study, we will (1) formalise relationships with health and home care services as recruitment sites; (2) conduct research yarns (a culturally secure qualitative data collection tool) with Aboriginal and Torres Strait Islander peoples living with dementia or cognitive impairment and their carers about their experiences of healthcare including perceived barriers and enablers to high-quality care. Data collected in research yarns will be analysed using a modified framework approach to map patient journeys and; (3) make recommendations for improving care identified by participants to be discussed and refined with stakeholder groups and to inform best practice guideline development.

Ethics and dissemination

This project follows the National Health and Medical Research Council’s guidelines for ethical conduct in research with Aboriginal and Torres Strait Islander communities and has been designed with active involvement and governance by Aboriginal and Torres Strait Islander peoples. The results will be disseminated through community feedback sessions, newsletters, conference presentations, peer-reviewed publications and best practice guidelines. Dissemination will also be guided by an established Aboriginal Reference Group.

Prospective observational study to assess the performance accuracy of clinical decision rules in children presenting to emergency departments with possible cervical spine injuries: the Study of Neck Injuries in Children (SONIC)

Por: Phillips · N. · Askin · G. N. · Davis · G. A. · OBrien · S. · Borland · M. L. · Williams · A. · Kochar · A. · John-Denny · B. · Watson · S. · George · S. · Davison · M. · Dalziel · S. · Tan · E. · Chong · S.-L. · Craig · S. · Rao · A. · Donath · S. M. · Selman · C. J. · Goergen · S. · Wilson
Introduction

Paediatric cervical spine injury (CSI) is uncommon but can have devastating consequences. Many children, however, present to emergency departments (EDs) for the assessment of possible CSI. While imaging can be used to determine the presence of injuries, these tests are not without risks and costs, including exposure to radiation and associated life-time cancer risks. Clinical decision rules (CDRs) to guide imaging decisions exist, although two of the existing rules, the National Emergency X-Radiography Low Risk Criteria and the Canadian C-Spine Rule (CCR), focus on adults and a newly developed paediatric rule from the Pediatric Emergency Care Applied Research Network (PECARN) is yet to be externally validated. This study aims to externally validate these three CDRs in children.

Methods and analysis

This is a multicentre prospective observational study of children younger than 16 years presenting with possible CSI following blunt trauma to 1 of 14 EDs across Australia, New Zealand and Singapore. Data will be collected on presenting features (history, injury mechanism, physical examination findings) and management (diagnostic imaging, admission, interventions, outcomes). The performance accuracy (sensitivity, specificity, negative and positive predictive values) of three existing CDRs in identifying children with study-defined CSIs and the specific CDR defined outcomes will be determined, along with multiple secondary outcomes including CSI epidemiology, investigations and management of possible CSI.

Ethics and dissemination

Ethics approval for the study was received from the Royal Children’s Hospital Melbourne Human Research Ethics Committee in Australia (HREC/69436/RCHM-2020) with additional approvals from the New Zealand Human and Disability Ethics Committee and the SingHealth Centralised Institutional Review Board. Findings will be disseminated through peer-reviewed publications and future management guidelines.

Trial registration number

Registration with the Australian New Zealand Clinical Trials Registry prior to the commencement of participant recruitment (ACTRN12621001050842). 50% of expected patients have been enrolled to date.

Faecal microbiota transplantation in Crohns disease: an Australian randomised placebo-controlled trial protocol

Por: Fehily · S. R. · Wright · E. K. · Basnayake · C. · Wilson-OBrien · A. L. · Stanley · A. · Marks · E. P. · Russell · E. E. · Hamilton · A. L. · Bryant · R. V. · Costello · S. P. · Kamm · M. A.
Introduction

The enteric microbiota drives inflammation in Crohn’s disease. Yet, there are no placebo controlled trials evaluating the efficacy and safety of faecal microbiota transplantation (FMT) in inducing and maintaining remission in patients with active Crohn’s disease. The Microbial Restoration (MIRO) study aims to establish this evidence.

Methods and analysis

At two specialist inflammatory bowel disease centres, 120 enrolled patients will have a 3-week period of diet optimisation (removal of ultra-processed foods) together with a 7-day course of antibiotics (to facilitate subsequent FMT engraftment). Patients will then be stratified to upper gut (for disease proximal to the splenic flexure) or lower gut (distal to the splenic flexure) disease. Patients will then be randomised in a 2:1 ratio to receive anaerobically prepared stool or placebo for 8 weeks either by gastroscopy, or colonoscopy and enemas. Clinical response at 8 weeks (Crohn’s Disease Activity Index (CDAI) reduction ≥100 points or to 70) receive FMT for weeks 8–16.

Patients achieving clinical response from FMT after 8 or 16 weeks will be randomised in a 1:1 ratio to either a 44-week maintenance phase of FMT or placebo. Patients will receive FMT from one donor throughout the study.

The MIRO study will establish whether FMT is an effective and safe therapy to induce and maintain remission in patients with active Crohn’s disease.

Ethics and dissemination

Ethical approval has been received by the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC-A 084/21). The results will be disseminated in peer-reviewed journals and presented at international conferences.

Trial registration number

ClinicalTrials.gov: NCT04970446; Registered on 20 July 2021.

Iron deficiency in patients with cardiogenic shock: protocol for a scoping review

Por: Germinario · L. · Catena · D. · Ott · S. · Roeschl · T. · Ghamri · Y. · Meyer · A. · OBrien · B. · Schoenrath · F.
Introduction

Cardiogenic shock (CS) is a severe condition characterised by low cardiac output and often hypotension, which results in organ hypoperfusion due to cardiac failure. As a form of acute heart failure, this condition seems to share similar underlying pathological mechanisms. It is well established that iron deficiency is correlated with chronic and acute heart failure, causing worsening of the symptoms, reduction of quality of life and survival and simultaneously increasing the rehospitalisation rates for all causes in these patients. It remains unclear whether there is an association between iron deficiency and CS. The objective of this scoping review will be to determine the actual state of the art regarding the significance of iron deficiency in patients affected by CS.

Methods and analysis

We will conduct a systematic review of the literature using MEDLINE and EMBASE via ‘Ovid’ (Elsevier) and Web of Science (2024 Clarivate). The goal is to analyse the incidence and clinical significance of iron deficiency in patients affected by cardiogenic shock. To gain a deeper insight into the underlying pathophysiological mechanisms, the review will include basic research conducted on both human subjects and on animal models as well as observational, randomised controlled studies and systematic reviews and meta-analysis. To maximise the identification of relevant reports and reduce loss of information, a systematic search of the literature will be performed from inception until January 2025 using the terms "iron deficiency" as well as "iron", "ferritin", "transferrin", "transferrin saturation", "hepcidin" and "soluble transferrin receptor" matching these terms with the keywords "cardiogenic shock", "acute heart failure", "advanced heart failure", "decompensated heart failure", "lvad", "left ventricular assist device", "mechanical circulatory support", "VA-ECMO" and "Extracorporeal Life Support". We will also use the corresponding MeSH and Emtree terms. In order to find grey literature, we will use the OADT.org internet-based database.

Ethics and dissemination

No additional ethics approval is required, as this review is based on existing research without new data collection. Only studies with ethics approval will be included. We plan to publish our findings in a peer-reviewed journal and present them at international conferences on cardiology, intensive and acute cardiovascular care, cardiac surgery and cardioanaesthesiology.

Personalised selection of medication for newly diagnosed adult epilepsy: study protocol of a first-in-class, double-blind, randomised controlled trial

Por: Thom · D. · Chang · R. S.-k. · Lannin · N. A. · Ademi · Z. · Ge · Z. · Reutens · D. · OBrien · T. · DSouza · W. · Perucca · P. · Reeder · S. · Nikpour · A. · Wong · C. · Kiley · M. · Saw · J.-L. · Nicolo · J.-P. · Seneviratne · U. · Carney · P. · Jones · D. · Somerville · E. · Stapleton · C.
Introduction

Selection of antiseizure medications (ASMs) for newly diagnosed epilepsy remains largely a trial-and-error process. We have developed a machine learning (ML) model using retrospective data collected from five international cohorts that predicts response to different ASMs as the initial treatment for individual adults with new-onset epilepsy. This study aims to prospectively evaluate this model in Australia using a randomised controlled trial design.

Methods and analysis

At least 234 adult patients with newly diagnosed epilepsy will be recruited from 14 centres in Australia. Patients will be randomised 1:1 to the ML group or usual care group. The ML group will receive the ASM recommended by the model unless it is considered contraindicated by the neurologist. The usual care group will receive the ASM selected by the neurologist alone. Both the patient and neurologists conducting the follow-up will be blinded to the group assignment. Both groups will be followed up for 52 weeks to assess treatment outcomes. Additional information on adverse events, quality of life, mood and use of healthcare services and productivity will be collected using validated questionnaires. Acceptability of the model will also be assessed.

The primary outcome will be the proportion of participants who achieve seizure-freedom (defined as no seizures during the 12-month follow-up period) while taking the initially prescribed ASM. Secondary outcomes include time to treatment failure, time to first seizure after randomisation, changes in mood assessment score and quality of life score, direct healthcare costs, and loss of productivity during the treatment period.

This trial will provide class I evidence for the effectiveness of a ML model as a decision support tool for neurologists to select the first ASM for adults with newly diagnosed epilepsy.

Ethics and dissemination

This study is approved by the Alfred Health Human Research Ethics Committee (Project 130/23). Findings will be presented in academic conferences and submitted to peer-reviewed journals for publication.

Trial registration number

ACTRN12623000209695.

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