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Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

Por: Harvey · S. · Stone · M. · Zingelman · S. · Copland · D. A. · Kilkenny · M. F. · Godecke · E. · Cadilhac · D. A. · Kim · J. · Olaiya · M. T. · Rose · M. L. · Breitenstein · C. · Shrubsole · K. · OHalloran · R. · Hill · A. J. · Hersh · D. · Mainstone · K. · Mainstone · P. · Unsworth · C. A
Introduction

People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments.

Methods and analysis

This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4).

Ethics and dissemination

Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women’s Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

Por: Hernandez · R. · Jin · H. · Lee · P.-J. · Schneider · S. · Junghaenel · D. U. · Stone · A. A. · Meijer · E. · Gao · H. · Maupin · D. · Zelinski · E. M.
Objectives

This paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing studies where multiple cognitive tests were administered.

Design

Individual participant data meta-analysis.

Participants

Data are from 10 epidemiological longitudinal studies on ageing (total n=209 518) from several Western countries (UK, USA, Mexico, etc). Each study had multiple waves of data (range of 2–17 waves), with multiple cognitive tests administered at each wave (range of 4–17 tests). Only waves with cognitive tests and information on participant dropout at the immediate next wave for adults aged 50 years or older were used in the meta-analysis.

Measures

For each pair of consecutive study waves, we compared the difference in cognitive scores (Cohen’s d) between participants who dropped out at the next study wave and those who remained. Note that our operationalisation of dropout was inclusive of all causes (eg, mortality). The proportion of participant dropout at each wave was also computed.

Results

The average proportion of dropouts between consecutive study waves was 0.26 (0.18 to 0.34). People who attrited were found to have significantly lower levels of cognitive functioning in all domains (at the wave 2–3 years before attrition) compared with those who did not attrit, with small-to-medium effect sizes (overall d=0.37 (0.30 to 0.43)).

Conclusions

Older adults who attrited from longitudinal ageing studies had lower cognitive functioning (assessed at the timepoint before attrition) across all domains as compared with individuals who remained. Cognitive functioning differences may contribute to selection bias in longitudinal ageing studies, impeding accurate conclusions in developmental research. In addition, examining the functional capabilities of attriters may be valuable for determining whether attriters experience functional limitations requiring healthcare attention.

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV,

Por: Young · A. M. · Havens · J. R. · Cooper · H. L. F. · Fallin-Bennett · A. · Fanucchi · L. · Freeman · P. R. · Knudsen · H. · Livingston · M. D. · McCollister · K. E. · Stone · J. · Vickerman · P. · Freeman · E. · Jahangir · T. · Larimore · E. · White · C. R. · Cheatom · C. · Community S
Introduction

Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia.

Methods and analysis

KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness.

Ethics and dissemination

The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings.

Trial registration number

NCT05657106.

A Digitally Enabled, Pharmacist service to detecT medicine harms in residential aged care (nursing home) (ADEPT): protocol for a feasibility study

Por: Boord · M. S. · Brown · P. · Soriano · J. · Meola · T. · Dumuid · D. · Milte · R. · Roughead · E. E. · Lovell · N. H. · Stone · H. · Whitehouse · J. · Janetzki · J. L. · Gebreyohannes · E. A. · Lim · R.
Introduction

This feasibility study aims to develop and test a new model of practice in Australia using digital technologies to enable pharmacists to monitor early signs and symptoms of medicine-induced harms in residential aged care.

Methods and analysis

Thirty residents will be recruited from an aged care facility in South Australia. The study will be conducted in two phases. In phase I, the study team will work with aged care software providers and developers of digital technologies (a wearable activity tracker and a sleep tracking sensor) to gather physical activity and sleep data, as well as medication and clinical data from the electronic medication management system and aged care clinical software. Data will be centralised into a cloud-based monitoring platform (TeleClinical Care (TCC)). The TCC will be used to create dashboards that will include longitudinal visualisations of changes in residents’ health, function and medicine use over time. In phase II, the on-site pharmacist will use the centralised TCC platform to monitor each resident’s medicine, clinical, physical activity and sleep data to identify signs of medicine-induced harms over a 12-week period.

A mixed methods process evaluation applying the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework will be used to assess the feasibility of the service. Outcome measures include service reach, changes in resident symptom scores (measured using the Edmonton Symptom Assessment System), number of medication adverse events detected, changes in physical activity and sleep, number of pharmacist recommendations provided, cost analysis and proportion of all pharmacists’ recommendations implemented at 4-week, 8-week and 12-week postbaseline period.

Ethics and dissemination

Ethical approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205098). Findings will be disseminated through published manuscripts, conference presentations and reporting to the study funder.

Trial registration number

ACTRN12623000506695.

What are the views of adults with an intellectual disability (AWID), carers and healthcare professionals on a community falls management programme for AWID: a qualitative interview study in the UK

Por: Robinson · K. · Logan · P. · Tucker · C. · Finlayson · J. · van der Wardt · V. · Kilby · A. · Knowles · S. · Vanhegan · S. · Hodgson · S. · Lidstone · N.
Objectives

The aim of this study was to refine a draft of the ACTiON FALLS LD programme based on the views of adults with an intellectual disability (AWID), carers and healthcare professionals (HCPs).

Design, setting and participants

The semistructured interview study included HCP as well as AWID and carers supporting AWID living in the community. Community settings included sheltered living, supported living, AWID living at home with family carers or independently. The interview study explored the first draft of the ACTiON FALLS LD programme as well as the wider falls management for AWID. Interviews with AWID were developed to include a range of approaches (eg, case studies, pictures) to support inclusive participation. Individual interviews were digitally recorded and transcribed. Researcher notes were used during interviews with AWID. All data were analysed using the principles of framework analysis.

Results

14 HCP, 8 carers and 13 AWID took part in the interview process. Five key themes were identified: programme components, programme design, programme approach, who would use the programme and programme delivery.

Conclusions

The views of AWID, HCP and carers showed the need to consider the impact of risk perception, anxiety and fear of falling in the adaption of the ACTiON FALLS programme. The programme needs to be accessible and support the inclusion of AWID in managing falls and ultimately fulfil the requirement for a proactive and educational tool by all.

Preliminary evidence for the validity of the Brief Post-Secondary Student Stressors Index (Brief-PSSI): A cross-sectional psychometric assessment

by Brooke Linden, Amy Ecclestone

The brief version of the Post-Secondary Student Stressors Index (Brief-PSSI) was developed in order to improve the usability of the instrument as a method for evaluating the severity and frequency of stressors faced by post-secondary students. While the original 46-item instrument has been thoroughly psychometrically validated and successfully used among student populations, the length of the instrument limits its utility. Providing a valid, shortened version of the PSSI will enable institutions to include the tool on existing online surveys currently being deployed to surveil the mental health and wellbeing of their students. This study reports preliminary evidence in support of the validity and reliability of the Brief-PSSI using a cross-sectional pilot sample of students attending an Ontario university in 2022. A total of 349 participants (average age 25 (SD = 7.7), range 19–60) completed the first survey, while 149 completed the follow-up survey (average age of 26 (SD = 7.7), range 17–60). Evidence of internal structure, relations to other variables, and of test-retest reliability was assessed according to established index validation guidelines, including the specification of multiple-indicator, multiple-cause models, and Spearman’s rho correlation coefficients. Results provide preliminary support for the validity and reliability of the tool, which demonstrated acceptable goodness-of-fit statistics, statistically significant relationships with like constructs in the hypothesized directions, and good test-retest reliability correlation coefficients. The Brief-PSSI is a useful tool for evaluating the sources of stress among post-secondary students, assessing both the severity of stress experienced and frequency with which each stressor occurred. Future research should explore the practical utility of adding the Brief-PSSI to existing survey assessments as well as pursue the continued collection of validation evidence for the tool among varied student populations.

Primary care quality for older adults: Practice-based quality measures derived from a RAND/UCLA appropriateness method study

by Rebecca H. Correia, Darly Dash, Aaron Jones, Meredith Vanstone, Komal Aryal, Henry Yu-Hin Siu, Aquila Gopaul, Andrew P. Costa

We established consensus on practice-based metrics that characterize quality of care for older primary care patients and can be examined using secondary health administrative data. We conducted a two-round RAND/UCLA Appropriateness Method (RAM) study and recruited 10 Canadian clinicians and researchers with expertise relevant to the primary care of elderly patients. Informed by a literature review, the first RAM round evaluated the appropriateness and importance of candidate quality measures in an online questionnaire. Technical definitions were developed for each endorsed indicator to specify how the indicator could be operationalized using health administrative data. In a virtual synchronous meeting, the expert panel offered feedback on the technical specifications for the endorsed indicators. Panelists then completed a second (final) questionnaire to rate each indicator and corresponding technical definition on the same criteria (appropriateness and importance). We used statistical integration to combine technical expert panelists’ judgements and content analysis of open-ended survey responses. Our literature search and internal screening resulted in 61 practice-based quality indicators for rating. We developed technical definitions for indicators endorsed in the first questionnaire (n = 55). Following the virtual synchronous meeting and second questionnaire, we achieved consensus on 12 practice-based quality measures across four Priority Topics in Care of the Elderly. The endorsed indicators provide a framework to characterize practice- and population-level encounters of family physicians delivering care to older patients and will offer insights into the outcomes of their care provision. This study presented a case of soliciting expert feedback to develop measurable practice-based quality indicators that can be examined using administrative data to understand quality of care within population-based data holdings. Future work will refine and operationalize the technical definitions established through this process to examine primary care provision for older adults in a particular context (Ontario, Canada).

Determining the feasibility of a codesigned and personalised intervention (Veg4Me) to improve vegetable intake in young adults living in rural Australian communities: protocol for a randomised controlled trial

Por: Livingstone · K. M. · Rawstorn · J. C. · Partridge · S. R. · Zhang · Y. · O · E. · Godrich · S. L. · McNaughton · S. A. · Hendrie · G. A. · Dullaghan · K. · Abbott · G. · Blekkenhorst · L. C. · Maddison · R. · Barnett · S. · Mathers · J. C. · Alston · L.
Introduction

Diets low in vegetables are a main contributor to the health burden experienced by young adults in rural communities. Digital health interventions provide an accessible delivery model that can be personalised to meet the diverse preferences of young adults. A personalisable digital vegetable intake intervention (Veg4Me) was codesigned to meet the needs of young adults living in rural communities. This study will determine the feasibility of delivering a personalised Veg4Me programme and compare preliminary effects with a non-personalised Veg4Me (control).

Methods and analysis

A 12-week assessor-blinded, two-arm, parallel randomised controlled trial will be undertaken from August 2023 until April 2024. A total of 150 eligible and consenting young adults (18–35 years; eat

Ethics and dissemination

All procedures involving human subjects were approved by Deakin University’s Human Ethics Advisory Group—Health (HEAG-H 06_2023) on 6 March 2023. Dissemination events will be held in the City of Greater Bendigo and the Colac Otway Shire. Summaries of the results will be disseminated to participants via email. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations.

Trial registration number

Australia New Zealand Clinical Trials Registry, ACTRN12623000179639p, prospectively registered on 21 February 2023, according to the World Health Organizational Trial Registration Data Set. Universal Trial Number U1111-1284-9027.

Feasibility and metabolic outcomes of a well-formulated ketogenic diet as an adjuvant therapeutic intervention for women with stage IV metastatic breast cancer: The Keto-CARE trial

by Alex Buga, David G. Harper, Teryn N. Sapper, Parker N. Hyde, Brandon Fell, Ryan Dickerson, Justen T. Stoner, Madison L. Kackley, Christopher D. Crabtree, Drew D. Decker, Bradley T. Robinson, Gerald Krystal, Katherine Binzel, Maryam B. Lustberg, Jeff S. Volek

Purpose

Ketogenic diets may positively influence cancer through pleiotropic mechanisms, but only a few small and short-term studies have addressed feasibility and efficacy in cancer patients. The primary goals of this study were to evaluate the feasibility and the sustained metabolic effects of a personalized well-formulated ketogenic diet (WFKD) designed to achieve consistent blood beta-hydroxybutyrate (βHB) >0.5 mM in women diagnosed with stage IV metastatic breast cancer (MBC) undergoing chemotherapy.

Methods

Women (n = 20) were enrolled in a six month, two-phase, single-arm WFKD intervention (NCT03535701). Phase I was a highly-supervised, ad libitum, personalized WFKD, where women were provided with ketogenic-appropriate food daily for three months. Phase II transitioned women to a self-administered WFKD with ongoing coaching for an additional three months. Fasting capillary βHB and glucose were collected daily; weight, body composition, plasma insulin, and insulin resistance were collected at baseline, three and six months.

Results

Capillary βHB indicated women achieved nutritional ketosis (Phase I mean: 0.8 mM (n = 15); Phase II mean: 0.7 mM (n = 9)). Body weight decreased 10% after three months, primarily from body fat. Fasting plasma glucose, plasma insulin, and insulin resistance also decreased significantly after three months (p Conclusions

Women diagnosed with MBC undergoing chemotherapy can safely achieve and maintain nutritional ketosis, while improving body composition and insulin resistance, out to six months.

‘Bringing forth’ skills and knowledge of newly qualified midwives in free‐standing birth centres: A hermeneutic phenomenological study

Abstract

Aim

To understand and interpret the lived experience of newly qualified midwives (NQMs) as they acquire skills to work in free-standing birth centres (FSBCs), as well as the lived experience of experienced midwives in FSBCs in Germany who work with NQMs.

Background

In many high-, middle- and low-income countries, the scope of practice of midwives includes autonomous care of labouring women in all settings, including hospitals, home and FSBCs. There has been to date no research detailing the skills acquired when midwives who have trained in hospitals offer care in out-of-hospital settings.

Methods

This study was underpinned by hermeneutic phenomenology. Fifteen NQMs in their orientation period in a FSBC were interviewed three times in their first year. In addition to this, focus groups were conducted in 13 FSBCs. Data were collected between 2021 and 2023.

Findings

Using Heidegger's theory of technology as the philosophical underpinning, the results illustrate that the NQMs were facilitated to bring forth competencies to interpret women's unique variations of physiological labour, comprehending when they could enact intervention-free care, when the women necessitated a gentle intervention, and when acceleration of labour or transfer to hospital was necessary.

Conclusion

NQMs learned to effectively integrate medical knowledge with midwifery skills and knowledge, creating a bridge between the medical and midwifery approaches to care.

Implications

This paper showed the positive effects that an orientation and familiarization period with an experienced team of midwives have on the skill development of novice practitioners in FSBCs.

Impact

The findings of this study will have an impact on training and orientation for nurse-midwives and direct-entry midwives when they begin to practice in out-of-hospital settings after training and working in hospital labour wards.

Patient and Public Contribution

This research study has four cooperating partners: MotherHood, Network of Birth Centres, the Association for Quality at Out-of-Hospital Birth and the German Association of Midwifery Science. The cooperating partners met six times in a period of 2 ½ years to hear reports on the preliminary research findings and discuss these from the point of view of each organization. In addition, at each meeting, three midwives from various FSBCs were present to discuss the results and implications. The cooperating partners also helped disseminate study information that facilitated recruitment.

Protocol for a systematic review of reviews on training primary care providers in dermoscopy to detect skin cancers

Por: McCaffrey · N. · Bucholc · J. · Ng · L. · Chai · K. · Livingstone · A. · Murphy · A. · Gordon · L. G.
Introduction

Globally, incidence, prevalence and mortality rates of skin cancers are escalating. Earlier detection by well-trained primary care providers in techniques such as dermoscopy could reduce unnecessary referrals and improve longer term outcomes. A review of reviews is planned to compare and contrast the conduct, quality, findings and conclusions of multiple systematic and scoping reviews addressing the effectiveness of training primary care providers in dermoscopy, which will provide a critique and synthesis of the current body of review evidence.

Methods and analysis

Four databases (Cochrane, CINAHL, EMBASE and MEDLINE Complete) will be comprehensively searched from database inception to identify published, peer-reviewed English-language articles describing scoping and systematic reviews of the effectiveness of training primary care providers in the use of dermoscopy to detect skin cancers. Two researchers will independently conduct the searches and screen the results for potentially eligible studies using ‘Research Screener’ (a semi-automated machine learning tool). Backwards and forwards citation tracing will be conducted to supplement the search. A narrative summary of included reviews will be conducted. Study characteristics, for example, population; type of educational programme, including content, delivery method, duration and assessment; and outcomes for dermoscopy will be extracted into a standardised table. Data extraction will be checked by the second reviewer. Methodological quality will be evaluated by two reviewers independently using the Critical Appraisal Tool for Health Promotion and Prevention Reviews. Results of the assessments will be considered by the two reviewers and any discrepancies will be resolved by team consensus.

Ethics and dissemination

Ethics approval is not required to conduct the planned systematic review of peer-reviewed, published articles because the research does not involve human participants. Findings will be published in a peer-reviewed journal, presented at leading public health, cancer and primary care conferences, and disseminated via website postings and social media channels.

PROSPERO registration number

CRD42023396276.

What is the current global health participation and future interest of healthcare students and National Health Service (NHS) staff? A cross-sectional research study of healthcare students and NHS staff in England

Por: Goldstone · R. · Hinds · R. · McCarthy · R. · Byrne · G. · Keen · D.
Objectives

This research aimed to understand the prior and current global health participation, current availability of and future interest in participating in global health activities healthcare students and National Health Service (NHS) staff.

Design

An online survey was conducted on NHS staff and healthcare students in England between July and November 2021. The survey was disseminated to all secondary care providers in the English NHS and universities in England. A volunteer sample of 3955 respondents, including 2936 NHS staff, 683 healthcare students, 172 individuals combining NHS working and study and 164 respondents classified as other.

Results

Most (80%) respondents had not participated in a global health activity before, with 6% having previously participated, a further 3% currently participating and 11% unsure. Among those who had participated, the most common types of activity were attending global health events (75%). The most common reason for not participating was a limited knowledge of opportunities (78%). When asked about their future interest in global health participation, more than half of respondents (53%) indicated an interest and 8% were not interested. There was an significant proportion (39%) answering unsure, indicating a possible lack of understanding about global health participation.

Conclusions

Global health has gathered increasing significance in recent years, both in policy and in education and training for healthcare professionals. Despite recognition of the role global learning plays in knowledge enhancement, skill development and knowledge exchange, this study suggests that global health participation remains low among NHS staff and healthcare students.

Development and testing of a patient‐reported experience measure for cancer: A cross‐sectional survey

Abstract

Aim

To develop and psychometrically test the Patient-reported Experience Measure-Cancer (PREM-C), reflecting patients' perceptions of cancer care experiences according to the Institute of Medicine domains.

Design

A three-phase cross-sectional survey was conducted.

Methods

Development, reliability and validity testing of the PREM-C measure was undertaken. Data collection included three phases: firstly (development) between October and November, 2015; secondly (psychometric testing), May 2016–June, 2017, and finally, (revision and psychometric testing) May 2019–March 2020.

Results

The final PREM-C structure, created using the Institute of Medicine domains, was psychometrically sound with five factors identified in the Exploratory Factor Analysis, demonstrating internal reliability ranging from 0.8 to 0.9. Confirmatory Factor Analysis indicated the hypothesized model fitted well (Root mean square error of approximation = 0.076). External convergent and divergent validity was established with the PREM-C found to be moderately correlated with the Picker Patient Experience Questionnaire but weakly correlated with the WHOQoL-BREF.

Conclusion

The development and testing of the PREM-C demonstrated good fit as a clinically relevant measure of ambulatory cancer patients' experiences of care. To make meaningful changes to nursing practice and health services, patient experience measures such as the PREM-C might support staff to identify areas for service improvement.

Impact

Few reliable measures and less validated measures collect patients' perceptions of the quality of their healthcare provision. Rigorous psychometric testing of the newly developed PREM-C demonstrated good internal consistency, test–retest reliability, and external convergent and divergent validity. The PREM-C is a potentially relevant measure of cancer patients' experiences of care. It might be used to assess patient-centred care and guide safety and quality improvements in clinical settings. PREM-C use might inform service providers of experiences of care in their institution and inform policy and practice development. This measure is sufficiently generic, allowing potential use in other chronic disease populations.

Patient or Public Contribution

This conduct of this study was supported by the participating patients of the hospital Cancer Outpatients Service.

Feasibility of linking universal child and family healthcare and financial counselling: findings from the Australian Healthier Wealthier Families (HWF) mixed-methods study

Por: Price · A. M. H. · White · N. · Burley · J. · Zhu · A. · Contreras-Suarez · D. · Wang · S. · Stone · M. · Trotter · K. · Mrad · M. · Caldwell · J. · Bishop · R. · Chota · S. · Bui · L. · Sanger · D. · Roles · R. · Watts · A. · Samir · N. · Grace · R. · Raman · S. · Kemp · L. · Lingam · R. · Eape
Objectives

‘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.

Methods

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.

Results

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.

Conclusions

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.

Trial registration number

ACTRN12620000154909.

Access to therapy for child sexual abuse survivors: Preliminary dialogue of barriers and facilitators between caregivers

by Jonathan Jin, Huda Al-Shamali, Lorraine Smith-MacDonald, Matthew Reeson, Wanda Polzin, Yifeng Wei, Hannah Pazderka, Peter H. Silverstone, Andrew J. Greenshaw

Background

Difficulties in access to therapy were highlighted by COVID-19 measures restricting in-person gatherings. Additional challenges arise when focusing on caregivers of child sexual abuse (CSA) survivors in particular, which are a population that has been historically difficult to engage with due to issues of stigma and confidentiality.

Objectives

To present preliminary qualitative results from caregivers of CSA survivors.

Methods

This study was conducted with caregivers of CSA survivors. Two hybrid webinar/focus groups were conducted using a video conferencing platform in fall of 2021 with two groups of stakeholders (11 caregivers and 5 moderators/clinical staff at Little Warriors, an intensive episodic treatment facility). Sessions were recorded, transcribed, and thematically-analyzed using standard qualitative methodology.

Results

A total of 11 caregivers contributed to the data. Themes include: (1) Challenges of starting and maintaining treatment (i.e., emotional impact of intake day, challenges of enrolling), (2) Therapeutic benefits of specialized treatment (i.e., feeling safe and supported and the importance of trauma-informed care), and (3) Barriers and facilitators of treatment (i.e., avenues to scale-up and self-care).

Conclusion

The importance of a strong therapeutic alliance was highlighted by both caregivers/clinical staff and further support is needed for families post-treatment. The present hybrid webinar/focus group also achieved engagement goals in a population that is typically difficult to reach. Overall, the response rate (12%) was equivalent to reported registrant attendance rates for general business to consumer webinars and the recommended focus group size. This preliminary approach warrants replication in other populations outside our clinical context.

Experience and impact of gender-based violence in Honiara, Solomon Islands: a cross-sectional study recording violence over a 12-month period

Por: Chadwick · V. · Kluckow · H. · Mapstone · K. · Whiffin · V. · Ryder · B. · Rimon · M. · Hebala · H. · Hill · S. · Martiniuk · A. L.
Objective

This study aims to collect data on the experience and impact of gender-based violence experienced by women attending health clinics in Honiara, Solomon Islands.

Method

Any woman over the age of 18 who attended a local health clinic in Honiara, Solomon Islands during the time of recruitment (ten consecutive weekdays in May 2015) was eligible to participate in an interviewer administered, in-person survey, gathering data on gender-based violence over the past 12 months.

Results

A total of 100 women were recruited into this study. Of these women, 47% of women reported experiencing physical or sexual violence in the past 12 months. The most common perpetrators were the woman’s husband or boyfriend. There are low rates of reporting, particularly through formal avenues such as to police or village leaders. Alcohol was involved in more than half the cases of reported violence.

Conclusion

Women in this study report high rates of gender-based violence. To our knowledge, this is the only study examining women’s personal experience of gender-based violence in the Solomon Islands, with self-reported data on the frequency and nature of the violence, and the impact on women, including physical and mental, utilisation of healthcare services, police and legal involvement. Efforts to reduce gender-based violence should aim to reduce intimate partner violence, increase reporting and address wider social attitudes towards gender equality.

How to extend value-based healthcare to population-based healthcare systems? Defining an outcome-based segmentation model for health authority

Por: Torkki · P. · Leskelä · R.-L. · Mustonen · P. · Linna · M. · Lillrank · P.
Objectives

Value-based healthcare (VBHC) is considered the most promising guiding principle for a new generation of health service production. Many countries have attempted to apply VBHC to managerial and clinical decision-making. However, implementation remains in its infancy and varies between countries. The objective of the study is to help health systems implement a value-based approach by building an outcome-based population segmentation model for health authorities (HAs).

Design

First, we define the principles according to which segmentation models in healthcare could be developed. Second, we merge the theoretical characteristics of outcomes with population segmentation dimensions identified in previous literature and design a flow model that establishes population segments from these combinations. We then estimate the size of the segments based on national register data.

Results

The population can be divided into 10 different segments based on relevant outcomes, goals and the outcome measurement logic. These segments consist of healthy, help, increased risk, mild curable without risk, mild curable with risk, severe curable without risk, severe curable with risk, single chronic, multimorbid and terminal. The representatives of Finnish HAs found the segments meaningful for evaluating and managing the healthcare system towards improved population health.

Conclusions

An outcome-based segmentation model for the entire population is needed if an HA wants to steer the healthcare system employing the principles of VBHC. Segmentation should be based on the outcome measurement logic and outcome measurements relevant to each segment and the number of segments has to be limited.

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

Systematic review of the effect of metabolic syndrome on outcomes due to acute respiratory distress syndrome: a protocol

Por: Stone · G. · Sisk · A. · Brown · M. · Corder · A. · Tea · K. · Zu · Y. · Shaffer · J. · Kashyap · R. · Qadir · N. · Denson · J. L.
Introduction

Acute respiratory distress syndrome (ARDS) is a life-threatening condition commonly seen in the intensive care unit. COVID-19 has dramatically increased the incidence of ARDS—with this rise in cases comes the ability to detect predisposing factors perhaps not recognised before, such as metabolic syndrome (MetS) and its associated conditions (hypertension, obesity, dyslipidaemia and type 2 diabetes mellitus). In this systematic review, we seek to describe the complex relationship between MetS, its associated conditions and ARDS (including COVID-19 ARDS).

Methods and analysis

A systematic search of PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL and Web of Science will be conducted. The population of interest is adults with ARDS and MetS (as defined according to the study author recognising that MetS definitions vary) or any MetS-associated condition. The control group will be adult patients with ARDS without MetS or any individual MetS-associated condition. We will search studies published in English, with a date restriction from the year 2000 to June 2023 and employ the search phrases ‘metabolic syndrome’, ‘acute respiratory distress syndrome’ and related terms. Search terms including ‘dyslipidaemia’, ‘hypertension’, ‘diabetes mellitus’ and ‘obesity’ will also be utilised. Outcomes of interest will include mortality (in-hospital, ICU, 28-day, 60-day and 90-day), days requiring mechanical ventilation and hospital and/or ICU length of stay. Study bias will be assessed using the NIH Bias Scale.

Ethics and dissemination

Ethical approval is not required because this study includes previously published and publicly accessible data. Findings from this review will be disseminated via publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023405816.

Evaluation of variation in special educational needs provision and its impact on health and education using administrative records for England: umbrella protocol for a mixed-methods research programme

Por: Zylbersztejn · A. · Lewis · K. · Nguyen · V. · Matthews · J. · Winterburn · I. · Karwatowska · L. · Barnes · S. · Lilliman · M. · Saxton · J. · Stone · A. · Boddy · K. · Downs · J. · Logan · S. · Rahi · J. · Black-Hawkins · K. · Dearden · L. · Ford · T. · Harron · K. · De Stavola · B. · Gilb
Introduction

One-third of children in England have special educational needs (SEN) provision recorded during their school career. The proportion of children with SEN provision varies between schools and demographic groups, which may reflect variation in need, inequitable provision and/or systemic factors. There is scant evidence on whether SEN provision improves health and education outcomes.

Methods

The Health Outcomes of young People in Education (HOPE) research programme uses administrative data from the Education and Child Health Insights from Linked Data—ECHILD—which contains data from all state schools, and contacts with National Health Service hospitals in England, to explore variation in SEN provision and its impact on health and education outcomes. This umbrella protocol sets out analyses across four work packages (WP). WP1 defined a range of ‘health phenotypes’, that is health conditions expected to need SEN provision in primary school. Next, we describe health and education outcomes (WP1) and individual, school-level and area-level factors affecting variation in SEN provision across different phenotypes (WP2). WP3 assesses the impact of SEN provision on health and education outcomes for specific health phenotypes using a range of causal inference methods to account for confounding factors and possible selection bias. In WP4 we review local policies and synthesise findings from surveys, interviews and focus groups of service users and providers to understand factors associated with variation in and experiences of identification, assessment and provision for SEN. Triangulation of findings on outcomes, variation and impact of SEN provision for different health phenotypes in ECHILD, with experiences of SEN provision will inform interpretation of findings for policy, practice and families and methods for future evaluation.

Ethics and dissemination

Research ethics committees have approved the use of the ECHILD database and, separately, the survey, interviews and focus groups of young people, parents and service providers. These stakeholders will contribute to the design, interpretation and communication of findings.

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