Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease. Diagnostic delay severely impairs patient access to ALS multidisciplinary clinics, available disease-modifying medications and therapies that may prolong survival.

To investigate how patient and physician perspectives might be leveraged to promote timely ALS diagnosis, and how system-level barriers might be addressed to promote appropriate referral to ALS multidisciplinary care.

A qualitative study in Alberta, Canada, used human-centred design and interviews to map the diagnostic journeys of ALS patients and identify individual-level and system-level diagnostic barriers and opportunities.

30 semistructured interviews (10 patients; 20 physicians) were conducted. Data were inductively analysed with the aid of Miro board software. Patient and physician data were triangulated to identify key phases of the journey from symptom onset to confirmed ALS diagnosis and themes related to the diagnostic barriers and opportunities. Journey maps were created to visualise the diagnostic journey.

Patient journeys were comprised of five phases and commonly involved iterative cycles of referral and testing before an ALS diagnosis was confirmed. Four primary themes related to diagnostic barriers: difficulty recognising and responding effectively to early-stage ALS symptoms, absence of a single definitive diagnostic test, long wait times between referrals and clinical visits, and physician reluctance to pronounce an ALS diagnosis. Analysis indicated three approaches for improving diagnostic processes: increase ALS awareness; improve communication between referring physicians and physicians receiving referrals (consultants); and develop physician, diagnostic testing and multidisciplinary clinic referral forms that will guide symptom assessment and accurate referral.

Timely ALS diagnosis is challenging for patients navigating the frequently prolonged, circuitous diagnostic journey and physicians who struggle with referral pathways and the efficient diagnosis of this rare disease. Findings demonstrate the importance of increased ALS awareness and effective communication and response within referral pathways. Recommendations include strengthening the clinical approach of community-based physicians and supporting access and referral pathways. Current initiatives arising from this investigation seek to achieve meaningful change in timely referrals for progressive neurological diseases like ALS.

Homelessness is a global public health concern which extends to the health and well-being of people working in homelessness, and this mixed-methods systematic review aims to explore their experiences of trauma.

The review protocol followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and a mixed-methods convergent segregated approach, a systematic search for qualitative and quantitative research across seven databases.

CINAHL, MEDLINE, PsychINFO, Psychology Database, Public Health Database, Web of Science and PubMed, searched from inception until May 2023.

A total of 22 articles met the eligibility criteria and were retained for inclusion (12 quantitative, 13 qualitative and 3 mixed methods). The methodological quality was assessed using the Mixed Methods Appraisal Tool, and confidence in the findings was assessed via GRADE-CERQual.

Peer-reviewed empirical research and relevant grey literature, available in English, were considered for inclusion. Data were synthesised per the Joanna Briggs Institute guidance on mixed-methods systematic review synthesis, drawing upon the Substance Abuse and Mental Health Services Administration (SAMHSA) definition of trauma.

The methodological quality of studies varied due to unclear reporting on sample representativeness and confounder control, particularly in quantitative studies. Despite this, a high prevalence of trauma experiences was evidenced, with a significant number of participants across this sector encountering traumatic ‘events’, ‘experiences’ and ‘effects’, as conceptualised by SAMHSA, stressing the urgent need for systemic-level change.

This review provides an important evidence base for future research, policy and practice, and discusses the need for psychologically informed practice, to prevent and alleviate trauma experiences across homelessness, along with nuanced, inclusive and consistent measurements of trauma.

The inadequate handling of obstetrical complications may be attributed to the suboptimal quality of prenatal care (PC) and a lack of trust in healthcare provider (HP) among pregnant women.

This study explores the perceptions of satisfaction among women without social security regarding the PC provided by public health services, and compares the dimensions of satisfaction between those who received group prenatal care (GPC) and those who received individual prenatal care (IPC), as well as to identify the dimensions of satisfaction most valued by women to support the inclusion of said dimensions in primary health guidelines.

We performed a qualitative analysis to explore women’s satisfaction perception regarding PC. Satisfaction was explored using the following dimensions: women-HP relationship, educational support, opportunity of PC, emotional support and perception of clinical procedures.

The study was conducted between 2015 and 2018 across eight primary health facilities, from which four implemented IPC and four implemented GPC. Semi-structured interviews were applied: 28 for women with IPC and 18 for women with GPC. The sample size was defined by theoretical saturation. Content analysis was performed using a combination of deductive–inductive process into dimensions and attributes. To analyse the relationship among dimensions and attributes, we performed onto semiotic networks. ATLAS.ti was used to analyse the information.

Women without social security who received PC care in public health facilities.

Women who received GPC reported higher satisfaction than those who received IPC. In GPC, the most valued dimensions were (1) women-HP relationship, particularly the continuity of care delivered by the same HP and (2) the trust in that same provider. According to semiotic networks, these dimensions showed interconnections with each other, but also connected with attributes of other dimensions. Therefore, they have the potential to enhance trust, communication, the effectiveness of educational activities and emotional support.

A holistic approach to GPC is essential for ensuring a positive prenatal experience. However, a hybrid model that incorporates elements of both IPC can further enhance overall satisfaction among women. Consistency in care, particularly by providing services in public health facilities with the same HP, should be a fundamental strategy in PC, as it can significantly improve women’s satisfaction.

Aphasia is a language impairment that affects one-third of people who experience a stroke. Aphasia can impact all facets of language: speaking, understanding, reading and writing. Around 60% of people with aphasia have persistent language impairments 1 year after their stroke, requiring ongoing healthcare and support. In recent years, the internet has become a key resource for the self-management of chronic health conditions. Navigating web content, however, requires language use, and as such, people living with aphasia are more likely to be excluded from digital health and support services. Web Content Accessibility Guidelines exist; however, they do not fully address the unique and diverse needs of people with aphasia, and a significant proportion of websites (over 90%) do not fully adhere to them. This protocol paper describes the first two stages of the Bridging the Digital Divide project, which aims to codesign and develop (a) a web-browser extension to re-render webpages to an ‘aphasia-friendly’ (accessible) format, (b) training tools to help users and health professionals customise the web-browser extension and (c) guidelines for developing communication-accessible websites.

The research will be conducted using experience-based codesign. In Stage 1a, focus groups will be held with (1) people with aphasia, (2) family members or significant others and (3) health professionals working with people with aphasia. Participants will be asked to share their experiences of accessing (or supporting a person with aphasia to access) healthcare, information and support services on the web. The nominal group technique (NGT) will be used to identify priorities for improving web accessibility for people with aphasia. Focus group data will be analysed using reflexive thematic analysis, and prioritisation data will be analysed using inductive qualitative content analysis. In Stage 1b, eight codesign workshops will be held with representatives of the three key stakeholder groups to iteratively codesign and develop a web-browser extension, training tools and guidelines to support web accessibility.

Ethical clearance for Stage 1a and Stage 1b of this project has been approved by the University of Queensland Human Research Ethics Committee (Stage 1a approval number: 2023/HE000528, Stage 1b approval number: 2024/HE000721). The outcomes of this research will be disseminated in peer-reviewed journals and presented at national and international conferences. A dissemination and celebration event will be held at the completion of the project.

Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.

A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.

This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.

Housing First (HF) is an evidence-based approach to ending homelessness, particularly for individuals with mental illness. Yet, limited research explores which aspects of HF programmes facilitate change over time, within the context of a programme theory of change (ToC). A particular research gap includes how mechanisms of change within HF programmes differ between men and women. This study examines gender-specific pathways of change in the HF model based on secondary qualitative data from Toronto’s original At Home/Chez Soi (AH/CS) trial, focusing on outcomes of housing stability, socio-economic status, health and overall well-being.

This was a secondary qualitative analysis of the AH/CS trial data. This analysis was guided using a gender-sensitive ToC framework.

This multisector study was conducted in a large Canadian urban centre in Toronto, Canada.

A total of 32 participants (23 men and nine women) who identified themselves as male or female, 18 months after their enrolment in the treatment arm of the Toronto site of the AH/CS randomised controlled trial.

Semistructured interviews were conducted as part of the trial’s qualitative study. Thematic analysis was guided by the ToC framework and conducted using NVivo software. We assessed differences between men and women across the following outcome domains: housing stability, financial status, physical and mental health, substance use recovery and inpatient care.

The findings largely confirmed the ToC with participants, particularly women, experiencing greater improvements across all mechanisms of change, especially in housing stability, financial status and health outcomes. Men faced ongoing challenges, including difficulty maintaining stable income, limited engagement with education/training and continued struggles with mental health and substance use. Despite these improvements, both men and women participants reported ongoing challenges in achieving consistent income and accessing education or training opportunities.

This study provides insight into how mechanisms of change within HF programmes differ between men and women. It underscores the need for ongoing programme adaptation and gender-responsive evaluation to meet the diverse needs of individuals, particularly those with mental health illness and histories of chronic homelessness.

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

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

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

CRD42024564332.

This study aimed to (1) assess Lumos data quality, a New South Wales (NSW) statewide linked health data asset; and (2) determine sociodemographic variation in health service utilisation of general practice, emergency department and admitted services.

A retrospective cohort study using Lumos, a linked health data asset.

A representative statewide sample population of NSW, Australia.

People residing within NSW with an electronic health record at a Lumos participating general practice between January 2010 and June 2023.

Data quality indicators of Lumos including completeness, representativeness against NSW population data, consistency and timeliness. Furthermore, variation in general practice visits, emergency department presentations and hospital admission rates stratified by age, sex, rurality and Index of Relative Socio-economic Disadvantage (IRSD)—a measure of socioeconomic status used in Australia, where lower values represent greater relative disadvantage across a range of metrics such as education and income.

At the time of analysis, Lumos included records from 5.2 million unique patients, representing half (49.7%) of the NSW resident population. Limiting data to 2022, the Lumos population distribution broadly aligned with the 2021 Census except for IRSD quintile four and five which were under-represented (15.0% vs 20.4% (standardised difference –0.14)), and over-represented (29.7% vs 19.9% (standardised difference 0.23)), respectively. Age and greater relative disadvantage were associated with higher rates of general practice visits and hospital admissions. Greater relative disadvantage was also associated with higher rates of emergency department presentations.

Lumos’s ability to overcome historical limitations of separately managed health data in Australia and its demonstrated data quality present an opportunity to enhance health system policy and planning in NSW. The variation in service utilisation across primary and tertiary care by population and geography apparent in Lumos reinforces the need for tailored service planning.

VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants’ perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.

This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis.

Cancer treatment sites in the UK.

Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.

Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.

A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials.

NCT04523116.

The cavum septi pellucidi (CSP) is a fluid-filled cavity box situated on the midline between the medial walls of the two lateral ventricles and placed above the fornix and below the corpus callosum. The formation of the CSP begins at 14 weeks and is completed around 17 weeks.

A regular CSP indirectly indicates the correct development of the corpus callosum and the midline of the fetal brain. Therefore, its evaluation is mandatory during routine obstetric scans. The available guidelines do not report specific recommendations on the morphology or biometry of the fetal CSP, thus leaving to the experience of the operator and, thus, to a subjective evaluation, the identification of potential anomalies.

Our aim is to construct methodologically robust reference charts for the CSP’s width, length and length-to-width ratio in relation to gestational age and fetal biparietal diameter.

The REC-FAST study (Reference Charts for the Fetal cAvum SepTi pellucidi) is a prospective monocentric cross-sectional study on consecutively enrolled pregnant women accessing our Obstetric Unit at the Foundation IRCCS San Gerardo dei Tintori, Monza, Italy, for fetal ultrasound evaluation.

Women will be eligible if carrying an uncomplicated singleton pregnancy between 19^0/7 and 36^6/7 weeks’ gestation with a certain pregnancy dating by first trimester ultrasound with crown-rump length measurement, and if aged between 18 and 45 years.

After signing the informed consent, the ultrasound scan will be performed and the CSP’s width and length will be measured by means of the inner-to-inner technique and its morphology recorded.

In order to achieve the statistical power required for properly constructing reference charts, we will divide our population into six groups according to the gestational age when the ultrasound scan will be performed (each group will cover a 3-week interval starting at 19^0/7 until 36^6/7 weeks). A minimum sample size of 80 will be reached for each gestational age group. Before charting, the data will be checked for consistency to identify any outliers. Where possible, outliers will be corrected by comparing with the original values (computation errors); otherwise, such data will be excluded. The fetal charts will be traced using the Cole and Green-Lambda, Median, and Sigmamethod (CG-LMS); in addition, the use of alternative modelling approaches, such as parametric models derived from the Extended Mechanistic Growth Function method, will be explored.

Ethical approval for this study was obtained by the Lombardy Ethics Committee n.3 (15 December 2023) prior to the commencement of the research. Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time.

Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of obstetrics and fetal medicine. Also, they will be disseminated to study participants through dedicated online and in-person meetings and to the public through reach-out activities involving families and healthcare specialists.

To codevelop (with children and young people with diabetes (CYPD)) an intervention to improve diabetes control and future health outcomes of CYPD from ‘underserved’ groups, to reduce treatment outcome inequalities between different socioeconomic and ethnic groups. To follow Medical Research Council guidance for complex interventions and the COM-B (Capability, Opportunity, Motivation, Behaviour) model for behaviour change intervention development.

In phase 1 (previously reported), we established the evidence base, conducted literature reviews and analysed data from semistructured interviews with CYPD and their carers. In phase 2 (this report), we applied the COM-B framework to identify intervention components; in phase 3 (this report), we evaluated these components, including focus groups with CYPD, their carers’ and healthcare practitioner (HCP) surveys, using the Acceptability, Practicability, Effectiveness, Affordability, Spill-Over Effects, Equity criteria.

Secondary care; children, young people and their carers’ were approached from two large paediatric diabetes services in England, both with socioeconomically and ethnically diverse underserved populations; paediatric diabetes HCPs were surveyed across four English regions.

N=69 underserved CYPD (aged 5–19 years) and/or family members took part in interviews; N=48 paediatric diabetes HCP survey respondents (survey 1); N=34 paediatric diabetes HCP survey respondents (survey 2); N=3 young people’s advisory group participants; N=17 underserved CYPD/carers focus group participants; N=9 wider stakeholder participants.

The codevelopment process and integration of COM-B established four elements for an intervention package: (1) an enhanced peer support/mentoring programme; (2) provision of a health and well-being coach to CYPD/families; (3) family/community support to address social and community issues and (4) training for HCPs, including cultural competence, poverty proofing and to emphasise the need for increased sensitivity and better supported communication in work with CYPD from underserved groups.

The Diversity in Diabetes codevelopment work informed an intervention to improve diabetes care in underserved groups, reflecting sociocultural contexts and plausible support options at the individual, community and clinical levels. The ‘Diversity in Diabetes’ programme will next test feasibility and further refine the intervention package in two more paediatric diabetes centres in England.

The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA).

A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres).

The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.

NCT06185452/EUCT number: 2023-503963-41-00.