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Everyday social contexts influence fluctuations into and out of chronic pain: an ethnographic study in England

Por: Stone · S. · Zeyen · A. · Gooberman-Hill · R.
Objectives

The research explored how individuals experience chronic pain within their everyday social contexts over a 12-month period. The study focused on the interplay between pain and social worlds, through analysis of experiences of social relationships included in engagement in meaningful activities such as hobbies and work.

Design

Drawing on ethnographic approaches from social science, the study involved 295 research visits with 19 participants living with chronic pain (totalling approximately 418 hours of fieldwork) and 48 semistructured interviews (around 30 hours).

Setting

The study was carried out in South West England, UK.

Participants

19 participants were identified through the Avon Longitudinal Study of Parents, 12 women and 7 men, all identifying as white British, aged between 32 and 33 years.

Results

The analysis identified three key themes: (1) Social connections and everyday fluctuations in chronic pain; and (2) the interplay between work, family roles and fluctuations in chronic pain; and (3) Social spiralling and fluctuations in chronic pain. The third theme builds on and combines the patterns identified in the first two themes, drawing together how changes in social connections and balancing of roles coalesce in the experience of fluctuation in chronic pain. Relationships, roles and how these were experienced varied across participants, but all of their descriptions indicated that the constant flux was understood, even if financial or other circumstances meant that people were unable to exert agency that would have proved beneficial. Across themes, interconnected social processes appear to shift and move together, amplifying their collective impact on the experience of chronic pain.

Conclusion

Fluctuations in chronic pain were complex, shaped by and entangled with social contexts that vary in meaningful ways. The findings suggest that to address chronic pain effectively, health and social care may need to move beyond individual-level solutions to consider the multiple, interacting layers of influence that shape and sustain the experience of chronic pain.

Non-randomised trial of a hepatitis C same-day test and treat model using antibody test only for people who inject drugs in Armenia, Georgia and Tanzania: a CUTTS HepC study protocol

Por: Draper · B. L. · Flynn · M. · Schroeder · S. · Wisse · E. · Aikaeli · F. · Han · Z. M. · Ayako · M. · Bajis · S. · Butsashvili · M. · Davtyan · K. · Kordzadze · T. · Lamand · P. · Luhmann · N. · Sargsyan · K. · Senkoro · M. · Scott · N. · Stone · J. · Vickerman · P. · Voloshin · A. · Walker
Introduction

Despite the availability of curative treatments, hepatitis C diagnosis and treatment coverage is suboptimal globally with few countries on track to achieve the WHO’s 2030 elimination targets. In 2022, an estimated 50 million people were living with hepatitis C, with 1 million new infections annually. Most people living with hepatitis C reside in low- and middle-income countries, and people who inject drugs are disproportionately affected by hepatitis C.

Continuing simplification of diagnostic pathways and treatment care models is required to improve linkage to care and reduce costs associated with hepatitis C treatment and cure.

Methods and analysis

This study is a multi-country non-randomised, quasi-experimental, prospective comparative two-arm trial. It aims to assess the feasibility of implementation, retention in hepatitis C care and achievement of cure and cost-effectiveness outcomes, comparing two simplified hepatitis C testing and treatment pathways.

Arm 1 is a standard simplified test and treat model of care following global guidance, and arm 2 is an innovative rapid, same-day treatment initiation model of care using a presumptive treatment approach based on shortened read-time of the point-of-care OraQuick hepatitis C antibody test result. Secondary outcomes include assessing the accuracy of the OraQuick hepatitis C antibody test in predicting viraemia and the acceptability of each pathway.

This study will be implemented in Armenia, Georgia and Tanzania. Treatment-naïve people who inject drugs aged over 18 years in each country will be eligible for enrolment.

Recruitment commenced in October 2024 in Armenia, June 2025 in Georgia and August 2025 in Tanzania and is anticipated to close by December 2026.

Ethics and dissemination

This trial has been reviewed by WHO Ethics Review Committee (ERC), Alfred Hospital Ethics Committee (Australia) and local country ERCs. Alongside journal publications and conferences, the results from this study will be disseminated through summary reports and workshops with key stakeholders and with communities of people affected by HCV through relevant organisations/networks, including the global Community Advisory Board (CAB). The study results will inform national scale-up of simplified care models and inform potential pathways for further simplification of care models, including the potential for one-step diagnostic pathways and same-day treatment in particular scenarios for the three study countries, and other low- and middle-income countries globally.

Trial registration number

NCT06159504.

Deaths with preceding hospitalisations within 180 days in eight countries in sub-Saharan Africa and South Asia: A secondary descriptive analysis of the Child Health and Mortality Prevention Surveillance (CHAMPS) network

Por: Varo · R. · Cole · K. · Madewell · Z. J. · Iglesias · J. F. · Igunza · K. A. · Akelo · V. · Mugah · C. · Onyango · D. · Were · J. A. · Madhi · S. A. · Dangor · Z. · Johnstone · S. · Lala · S. G. · Ruder · T. · Mandomando · I. · Kincardett · M. · Xerinda · E. G. · Scott · J. A. G. · Assefa
Objectives

To describe (1) the proportion of deaths that were in recently hospitalised children and (2) causes of mortality among deceased children aged 0–59 months with preceding hospitalisations who enrolled in a mortality surveillance programme.

Design

Descriptive study using prospectively collected data.

Setting

Eight Child Health and Mortality Prevention Surveillance (CHAMPS) community and healthcare sites in sub-Saharan Africa and South Asia.

Participants

Deaths among children aged 0–59 months enrolled in CHAMPS 2016–2023.

Interventions

None.

Primary and secondary outcome measures

Deaths with antecedent hospitalisations within 180 days of death. Causes of death determined by expert panels who reviewed clinical data and histopathologic and microbiologic results from postmortem minimally invasive tissue sampling.

Results

CHAMPS enrolled 8548 deaths; we excluded 3688 neonates who died before discharge or ≤24 hours of birth and 482 with unclear information on antecedent hospitalisations. Out of the 4378 remaining deaths, 16.7% (95% CI 15.7% to 17.9%) were deaths that occurred within 180 days of a hospitalisation (n=733/4378). Of these, 55.7% (95% CI 52.0% to 59.3%) occurred outside healthcare facilities. Among included deaths with minimally invasive tissue sampling completed (n=337), lower respiratory tract infections (41.2%, 95% CI 36.0% to 46.7%), sepsis (39.8%, 95% CI 34.5% to 45.2%) and undernutrition (n=92, 27.3%, 95% CI 22.7% to 32.4%) were most common causes of death among cases with antecedent hospitalisations. The greatest proportion of deaths with antecedent hospital admissions occurred among cases aged 1–11 months (48.0%, 95% CI 44.4% to 51.7%), compared with those aged 0–1 months (21.7%, 95% CI 18.8% to 24.9%) and those aged 1–5 years (30.3%, 95% CI 27.0% to 33.8%). Moreover, the greatest proportion of deaths with antecedent hospital admissions occurred among infants/children with weight-for-age Z-score of

Conclusions

We observed a high proportion of deaths with antecedent hospitalisations within 180 days among young children across eight sites in sub-Saharan Africa and Asia. Among those deaths, children aged 1–11 months and undernourished infants were over-represented, suggesting early follow-up as a potential point to focus targeted support and future research.

Overcoming Shame to Vocalise During Childbirth: A Qualitative Interview Study

ABSTRACT

Aim

To explore women's experiences of vocalisation during childbirth and the interplay with their feelings of shame.

Design

This interpretive, qualitative study is grounded in a social constructionist theory of gender, which provides a lens for examining the role of vocal toning in childbirth.

Methods

Between November 2023 and March 2024, 18 women in Germany were interviewed postpartum either at home or virtually. Semi-structured interviews were analysed using reflexive thematic analysis.

Results

Two themes were generated: ‘the shame of being heard’ and ‘the value of my voice’. The findings demonstrate challenges women faced when vocalising during childbirth due to feelings of shame. Overcoming social norms were key; previous experience with vocalisation was an advantage. Vocal expression was also facilitated by a safe, supportive birth environment.

Conclusion

Shame influences behaviour during childbirth. A key factor appears to be whether women feel safe and uninhibited in their vocal expression, which can be supported through empathic birth companions. Additionally, vocalising with others can contribute to normalising the experience and reducing feelings of shame.

Implications for the Profession Care

The findings suggest that healthcare professionals can help women overcome shame to use vocalisation as a tool to navigate the challenges of childbirth.

Reporting Method

Reporting adhered to the SRQR checklist.

Patient and Public Involvement

This study did not include client or public involvement in its design, conduct, or reporting.

Differences in sexual risk behaviours, HIV care utilisation and experiences of stigma between transgender women and cisgender men who have sex with men: findings from integrated biobehavioural surveys in Ukraine 2013-2018

Por: Aijaz · S. · Vickerman · P. · Saliuk · T. · Nicholls · J. · Gillespie · D. · Hood · K. · Stone · J.
Objectives

To assess whether transgender women who have sex with men (TGWSM) sampled in men who have sex with men (MSM) biobehavioural surveys in Ukraine experience different levels of sexual risk, stigma, HIV prevalence and engagement in the HIV care than cisgender MSM (CMSM).

Design

Analysis of secondary data from three population-level cross-sectional surveys.

Setting

The analysis was conducted on data from three rounds of integrated biobehavioural surveys of MSM in 27 cities of Ukraine from 2013 to 2018.

Participants

Data from n=18 621 MSM with n=18 102 CMSM and n=503 TGWSM.

Primary and secondary outcome measures

The primary outcomes were differences in sexual risk behaviours, HIV testing and treatment uptake, and the secondary outcomes were differences in lifetime experiences of stigma, coercive sex and physical assault (in the 2018 survey only) between CMSM and TGWSM.

Results

Compared with CMSM, TGWSM were more likely to be clients of non-governmental organisations (adjusted OR, aOR: 1.39, 95% CI 1.15 to 1.67), engage in commercial sex (last month; aOR: 1.28, 95% CI 1.01 to 1.61), have group sex (aOR: 1.31, 95% CI 1.06 to 1.61), more long-term sex partners (last month; adjusted incidence rate ratio: 1.14, 95% CI 1.03 to 1.27), history of imprisonment (aOR: 1.51, 95% CI 1.00 to 2.31) and engage in chemsex (last month, aOR: 1.58, 95% CI 1.12 to 2.23). We found no difference in HIV prevalence (5.17% in TGWSM vs 5.43% in CMSM, p=0.065). In 2018, more TGWSM reported lifetime experience of stigma from family and friends (aOR: 3.58, 95% CI 2.54 to 5.04), general social stigma (aOR: 3.13, 95% CI 2.22 to 4.41), anticipated healthcare stigma (aOR: 3.63, 95% CI 2.53 to 5.16), physical assault (aOR: 2.73, 95% CI 1.85 to 4.03) and coercive sex (aOR: 3.01, 95% CI 1.99 to 4.55) than CMSM.

Conclusions

TGWSM in Ukraine may be at increased risk of HIV acquisition compared to CMSM due to many factors including elevated levels of stigma and violence. Services specifically tailored for transgender people are needed to help reduce these high-risk behaviours.

Connecting families--randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol

Por: Bayoumi · I. · Parkin · P. C. · Tabassum · F. · Johnson · C. · Sherwood · M. · Mitchell · M. · Birken · C. S. · Bloch · G. · Carsley · S. · Cole · M. · Green · M. · Keown-Stoneman · C. D. G. · Maguire · J. L. · Purkey · E. · van den Heuvel · M. · Weir · S. · Wong · P. · Borkhoff · C. M.
Introduction

Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).

Methods and analysis

This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.

Ethics and dissemination

Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.

Trial registration number

Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov; NCT05091957).

Measuring child development at the 2-21/2-year health and development review in England: a rapid scoping review of available tools

Por: Lysons · J. · Mendez Pineda · R. · Alarcon · G. · Aquino · M. R. J. · Cann · H. · Stoianov · D. · Fearon · P. · Kendall · S. · Kirman · J. · Gladstone · M. · Woodman · J.
Objective

All children in England should receive a health review at 2–21/2 years, with the Ages and Stages Questionnaire third edition (ASQ-3) used to collect public health surveillance data on child development. However, practitioners also value tools that assess individual children’s development—consistent with ASQ-3’s original purpose. Concerns about licensing costs and barriers to digitalisation have prompted interest in alternative tools to the ASQ-3 in England.

Design

To inform policy, we conducted a rapid scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines to identify tools that can measure or assess early child development.

Data sources

Searched PubMed, PsycINFO and Web of Science from January 2012 to November 2022, with targeted search update November 2024.

Eligibility criteria

We included English-language studies published after January 2012 that described or evaluated tools in English which could measure or assess early child development in children

Data extraction

We extracted key features and reliability, validity, sensitivity and specificity of tools which could feasibly be implemented at the 2–21/2-year review (eg, including multiple age versions and

Results

We identified 112 unique publications describing 34 tools; six met our feasibility criteria for the 2–21/2-year review (reported in 53 studies). Only ASQ-3 and CREDI offer domain-specific scoring—a government priority. ASQ-3 moderately detects mild delays and performs better for severe delays in at-risk groups. Caregiver Reported Early Development Instruments (CREDI) was designed for public health surveillance, and we do not yet know how it performs for individual assessment.

Conclusions

ASQ-3 and CREDI are most promising for use at the 2–21/2-year review. However, we lack UK-based validation and norming studies, even for ASQ-3. Ultimately, careful implementation and integration into existing systems will determine a tool’s value for identifying developmental needs, supporting families and producing high quality data for public health surveillance.

Family interventions in dementia mental health environments (FIND ME): a mixed-methods protocol

Por: Wolverson · E. · Gillam · J. · Dunn · R. · Hoe · J. · Underwood · B. R. · Mwale · S. · Credland · N. · Robertson · M. · Wyatt · M. · Lane · R. · Featherstone · K.
Introduction

Admission to a mental health ward can be distressing for people living with dementia and their carers. While carer involvement is associated with improved outcomes, carers often report feeling excluded from decision-making and support during admissions. There is limited understanding of how wards engage with carers and what strategies might enhance involvement. This study seeks to address this gap by exploring carer and patient experiences during and after admission and co-producing evidence-based strategies for improved support and involvement.

Methods and analysis

The FIND ME study uses a convergent parallel mixed-methods design. A national online survey will map provision of mental healthcare for people with dementia across the UK. Narrative interviews will be undertaken with carers of current inpatients (n=24) and recently discharged individuals (n=24), with opportunities for dyadic interviews with people with dementia. Ethnographic fieldwork across three wards (30 days per site) will provide insight into organisational cultures, staff practices and carer involvement. Evidence-based co-design workshops with carers, people with dementia and staff will use these findings to identify priorities and develop practical strategies for service improvement. Finally, a feasibility study will test the acceptability, relevance and potential for implementation of these co-designed strategies. Quantitative data will be analysed descriptively, while qualitative data will undergo narrative and thematic analysis. Triangulation across datasets will ensure rigour.

Ethics and dissemination

Ethical approval has been granted by London Camberwell St Giles Research Ethics Committee and the Health Research Authority (REC Ref: 25/LO/0040). Informed consent will be obtained from all participants, with capacity assessed in line with the Mental Capacity Act (2005). Dissemination will include peer-reviewed publications, conference presentations and freely available multilingual resources for carers, people with dementia and ward staff, supported by NHS and third-sector partners.

Trial registration number

NIHR161439

Primary care for depression before and during the COVID-19 pandemic: a retrospective pre-post study

Por: Howard · M. · Freeman · K. · Hafid · S. · Vanstone · M. · Queenan · J. · Aubrey-Bassler · K. · Drummond · N. · Nicholson · K. · Mangin · D.
Objectives

To compare primary care for depression among patients detected in the first 21 months of the SARS-CoV-2 pandemic to patients detected pre-pandemic, and examine whether depression care was associated with patient characteristics.

Design

Retrospective pre–post study using de-identified data from electronic medical record data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN).

Setting

Primary care clinics enrolled in CPCSSN from 1 January 2018 to 31 December 2021.

Population

Patients with a valid CPCSSN case definition of depression detected between 01 January 2018 and 31 December 2021 were included in the cohort and categorised by detection date (pre-pandemic or during Canadian pandemic waves).

Outcome measures

Primary care encounters, psychotropic prescriptions and selective serotonin reuptake inhibitor (SSRI) prescriptions were observed at 3 and 12 months post-detection. Multivariable regression evaluated associations between patients’ depression detection timing and depression care, adjusting for age, sex, rurality, neighbourhood deprivation quintile, province, number of observable comorbidities and pre-detection psychotropic use.

Results

91 453 patients with depression were identified, of whom 53% were detected pre-pandemic. Patients detected during the pandemic were younger and less comorbid than those detected pre-pandemic. Proportions of patients with any encounter, psychotropic prescriptions and SSRI prescriptions were higher for patients detected during every pandemic wave compared with patients detected pre-pandemic. The adjusted incidence rate ratios (aIRRs) of number of encounters (aIRR=1.15; 95% CI 1.13 to 1.17), psychotropics (aIRR=1.11, 95% CI 1.09 to 1.13) and SSRIs prescribed (aIRR=1.12; 95% CI 1.10 to 1.15) within 3 months of detection were higher among patients detected during the first pandemic wave compared with those detected pre-pandemic. Socio-demographic characteristics had weaker associations with outcomes compared with timing of detection. Results were similar within 12 months of detection.

Conclusion

Overall, primary care for depression was maintained during the pandemic despite challenging circumstances. Increases in paediatric encounter rates and increased prescribing in younger adults warrant further investigation to understand the factors driving these patterns.

Trial registration number

ClinicalTrials.gov NCT05813652.

Study protocol for a pilot randomised controlled trial assessing prehospital whole blood versus component therapy in traumatic haemorrhage: SWiFT Canada (study of whole blood in frontline trauma)

Por: Lin · Y. · Peddle · M. · Callum · J. · Beckett · A. · da Luz · L. T. · Drennan · I. · Pavenski · K. · Mack · J. · McGowan · M. · Ahghari · M. · Smith · J. · Green · L. · Keown-Stoneman · C. D. G. · Nolan · B. · on behalf of the SWiFT Canada Investigators
Introduction

Major haemorrhage is the leading cause of preventable death in trauma, and prehospital blood transfusion may improve survival and outcomes for patients with prolonged out-of-hospital times. Globally, there is increasing interest in the use of whole blood in the prehospital environment, with randomised controlled trials ongoing. However, the results of these studies may not be generalisable to the longer out-of-hospital times seen in the Canadian trauma environment. The aim of this trial is to determine the feasibility of performing a randomised clinical trial evaluating the use of leukocyte-reduced whole blood transfusion compared with component blood transfusion in the Canadian prehospital environment. The secondary objective is to explore whether whole blood transfusion is better in reducing the proportion of patients who die or require massive transfusion within 24 hours.

Methods and analysis

This is a multi-centre, open-label, randomised controlled feasibility trial. Patients aged 16 years or older will be eligible if they have suffered a major traumatic haemorrhage, are attended by the provincial air ambulance service and require a prehospital blood transfusion. The primary outcome is feasibility as measured by the following metrics: proportion of patients enrolled with full data collection, proportion of patients who received at least one prehospital transfusion prior to arriving at the receiving trauma centre, proportion of patients who completed transfusion of all assigned blood units, number of patients unable to be enrolled due to lack of whole blood availability and number of whole blood units produced for the study that were wasted or expired. The secondary outcome is a composite outcome of death (all-cause mortality) or receipt of massive transfusion (receipt of 10 units of blood or more) within the first 24 hours from randomisation. We plan to recruit 60 patients, with an anticipated post-randomisation exclusion of ~10 patients for traumatic cardiac arrest or who do not meet eligibility criteria.

Ethics and dissemination

Provincial ethics approval was obtained (Clinical Trials Ontario REB ID: CTO-4921). An opt-out consent model will be employed for participants. The SWiFT Canada trial will recruit 60 patients through the provincial air ambulance organisation in Ontario who are transported to one of the six participating lead trauma centres. It will investigate the feasibility of a pre-hospital transfusion clinical trial in Canada to compare the effectiveness of whole blood compared with component blood therapy in a future definitive trial.

Trial registration number

ClinicalTrials.gov: NCT06495294 (https://clinicaltrials.gov/study/NCT06495294), Clinical Trials Ontario: CTO-4921.

Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

Exploring the Service Features of Telephone Cancer Information and Support Services From Callers' Experiences: A Qualitative Evidence Synthesis

ABSTRACT

Aim

This study aims to synthesise evidence on users' experiences of telephone cancer information and support services (CISS) to identify important service features and inform service development.

Design

A qualitative evidence synthesis.

Methods and Data Sources

OVID MEDLINE, EMBASE, CINAHL, PsycINFO and SocINDEX databases were searched for peer-reviewed qualitative literature fitting the inclusion criteria from database inception to 30 March 2023. The included articles were double-screened, and quality appraised using the CASP checklist. GRADE-CERQual was used as a tool to assess the confidence of review findings. Content synthesis combined the qualitative data with the Loiselle cancer experience measurement framework guiding analysis. This paper is reported as per the equator network recommended SRQR checklist.

Results

Of the 607 articles screened, seven studies were included. Four main themes and 14 sub-themes about CISS aspects were identified: psychological well-being (managing emotions/coping, hope/reassurance, supporting close others and a reluctance to call the CISS); knowledge is power (information seeking, the burden of knowledge and empowerment); truth and clarity (adjunct support, credible source and improved understanding and confidence); and service adequacy (operators' ability to connect with users, convenience, service provision and awareness, and the cancer journey).

Conclusion

Findings suggest people with cancer and their carers accessing a CISS value emotional support combined with trusted information, topic expertise and a connection with the service operator. future service provision should address the lack of awareness regarding the range of services and the convenience extended operating hours may offer.

Implications for Patient Care

The results add to our understanding of CISS service provision. However, knowledge gaps remain regarding preferences among service features and the hierarchy of CISS characteristics to be prioritised to enhance services.

Impact

Focused CISS awareness campaigns will inform communities and healthcare professionals of the available resources to improve the lives of those affected by cancer. Ongoing service review will enable resources to be tailored to callers' needs, potentially easing the burden on existing services that are overwhelmed and under-resourced.

Patient or Public Contribution

This qualitative evidence synthesis did not directly involve patient or public contribution to the manuscript.

Trial Registration

Systematic Review Registration Number (PROSPERO): CRD42023413897

From knowledge to action: protocol for a mixed-methods evaluation of First Nations-led knowledge mobilisation on prenatal opioid exposure

Por: Medeiros · P. · Mazzucco · A. · Wilkinson · L. · Altiman · M. · Glover · J. · Stone · A. · Taylor · B. · Guttmann · A. · Kerpan · S.
Introduction

First Nations communities in Canada are disproportionately impacted by prenatal opioid exposure (POE) and neonatal abstinence syndrome (NAS). In response, we developed a research partnership with 13 First Nations communities in Ontario. Phase I of the research project, initiated in 2018, included the development of mixed-methods reports on the impact of POE for each community. This protocol outlines the evaluation of phase II, during which nine communities individually co-designed and implemented community-specific knowledge mobilisation (KMb) plans informed by findings from phase I. The evaluation aims to assess advisory working group engagement, KMb implementation and perceived community-level impacts.

Methods and analysis

This mixed-methods evaluation integrates survey and qualitative data to assess First Nations-led KMb products and activities. The Public and Patient Engagement Evaluation Tool, a validated survey instrument, will be administered to advisory group members and analysed descriptively. Focus groups and interviews will be conducted to explore advisory working group members’ experiences and analysed using phenomenological methods. Qualitative findings will be mapped to the Engage with Impact framework to assess outcomes across engagement domains.

Ethics and dissemination

Ethics approval has been granted by Vancouver Island University. All community contacts and advisory working group members will provide informed consent prior to data collection. Phase II activities are governed by formal community agreements. In alignment with First Nations Principles of OCAP (Ownership, Control, Access and Possession), First Nations community partners retain ownership of their KMb products and are actively involved in the design, implementation and dissemination of the project evaluation. Results will be shared through peer-reviewed publications, community reports and knowledge-sharing events.

Educational outcomes for children and young people with cancer: study protocol for a population-based cohort study using linked education and hospital data from England

Por: Nath · S. · Stone · T. · Lam · J. · Feltbower · R. G. · Hargrave · D. · McCabe · M. G. · Brown · H. · Hickinbottom · L. C. L. · Jackson · K. · Paget · L. · Stanley · T. · Watts · P. S. · Harron · K.
Introduction

Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects.

Methods and analysis

We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4.

Ethics and dissemination

Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.

Examining the care priorities, service needs and lived experiences of rural people with cognitive impairment and dementia in Canada: a scoping review protocol

Por: Bacsu · J.-D. R. · Berlinguette · C. · Smith · M. · Stone · C. · Vazquez · C. · Singer · J. · Rahemi · Z. · Funk · M. · Abudu-Birresborn · D. · Chai · H. W.
Introduction

Older age is one of the greatest risk factors of dementia, and the rural demographic is ageing in Canada. Compared with their urban counterparts, rural older adults often face unique challenges in accessing cognitive healthcare, which is exacerbated by a shortage of healthcare specialists, public transportation, finances, education, services and dispersed geography. This scoping review protocol outlines the methodology that will be used to examine the literature about the care priorities, service needs and lived experiences from the perspectives of rural older adults living with cognitive impairment and dementia in Canada.

Methods and analysis

Our scoping review protocol will follow the guidance of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions for Scoping Reviews checklist. Our search strategy will identify relevant peer-reviewed literature in databases including Cumulated Index in Nursing and Allied Health Literature (CINAHL), EMBASE, PsycINFO, PubMed, Web of Science and Scopus. The database search dates for this scoping review will be from 1 January 2015 to 1 January 2025. The data will be charted by two reviewers using a standardised data extraction table. Inductive content analysis will be performed using a three-step process.

Ethics and dissemination

Given this scoping review will be an examination of the published literature, human subjects will not be included in this research. Therefore, ethics approval is not required. Knowledge mobilisation and dissemination strategies will include peer-reviewed journal articles, conference presentations, community workshops, newsletter articles and webinars. This study may provide valuable information for healthcare practitioners, community leaders and policymakers working to support people living with cognitive impairment and dementia in rural communities.

Frailty and the risk of ICU-acquired infections in a randomised trial: a protocol and statistical analysis plan

Por: Fernando · S. M. · Muscedere · J. · Rochwerg · B. · Johnstone · J. · Daneman · N. · Marshall · J. C. · Lauzier · F. · Rudkowski · J. C. · Arabi · Y. M. · Heels-Ansdell · D. · Sligl · W. · Kristof · A. S. · Duan · E. · Dionne · J. C. · St-Arnaud · C. · Reynolds · S. · Khwaja · K. · Cook
Introduction

Dysregulated immunity may account for an increased risk of infection and other adverse outcomes among frail hospitalised persons. The primary objective of this study is to examine whether baseline frailty is associated with the risk of developing ventilator-associated pneumonia (VAP) or other intensive care unit (ICU)-acquired infections among invasively ventilated adults. Additional objectives are to examine the relationship between frailty and hospital length of stay, discharge to a long-term care facility and vital status. We hypothesise that persons with frailty compared with others would have an increased risk of VAP and other infections, a longer hospital stay, higher probability of discharge to a long-term care facility and higher mortality.

Methods and analysis

This is a preplanned secondary analysis of the PROSPECT trial (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) which enrolled patients across 44 ICUs in three countries. We will use Cox proportional hazards regression analysis to assess the association of frailty with the clinical outcomes of interest, adjusting for other baseline variables. Baseline demographic and descriptive outcome data will be reported using descriptive statistics. Regression results will be presented as adjusted HRs or ORs with 95% CIs for the associations of each independent variable with the primary, secondary and tertiary outcomes.

Ethics and dissemination

Participating hospital research ethics board approved the PROSPECT trial and data collection. The protocol for this study was approved by the Hamilton Integrated Research Ethics Board on 20 August 2015 (Project ID:19128). This study will identify whether frailty is associated with risk of VAP and other healthcare-associated infections in invasively ventilated patients, adjusted for other baseline factors. Results may be useful to patients, their caregivers, clinicians and the design of future research. Findings will be disseminated to investigators at a meeting of the Canadian Critical Care Trials Group. We will present study results at an international conference in the fields of critical care and infectious diseases, to coincide with or precede open-access peer-review publication. To aid knowledge dissemination, we will use a variety of formats. For example, for traditional and social media, we will create two different visual abstracts and infographics of our results suitable to share on clinician-facing and public-facing platforms.

Trial registration number

NCT02462590.

Cohort profile: a prenatal birth cohort study of intergenerational risk and resilience after conflict and forced displacement

Por: Wuermli · A. · Hiott · M. C. · Ugarte · E. · Rahman · M. S. · Elahi · M. · Rahim · A. · Dutta · G. K. · Ahamed · M. S. · Roy · B. R. · Akhter · R. M. · Hossain · E. · Michael · D. · Ayrin · T. K. · Haseen · S. H. · Alam · R. B. · Ratul · T. I. · Horaira · M. A. · Gladstone · M. · Sanin · K.
Purpose

As of 2024, 123.2 million people had been forcibly displaced as a result of persecution, armed conflict or climate-related catastrophes, and these numbers are predicted to rise. There is a growing awareness of possible intergenerational effects of trauma on life-course health and well-being, however few studies have followed individuals longitudinally starting prenatally. This paper describes the first large prenatal birth cohort study in a refugee context in a lower middle-income country. This study aims to investigate the potential lifespan health and developmental implications of being born into a protracted humanitarian context, and what factors can buffer from the adversity posed by conflict and displacement.

Participants

We outline our approach of recruiting, consenting and gathering data from pregnant Rohingya refugee and host community women (N=2888; 80% Rohingya) over the course of 12 months in Cox’s Bazar, Bangladesh.

Findings to date

A fifth wave of data collection, when children were 6 months old, was completed in April 2025. Rohingya women were substantially less literate; were marrying and having children at slightly younger ages, were more likely to live in crowded, resource-limited households and exhibited higher rates of clinically significant post-traumatic stress disorder and anxiety than host community women.

Future plans

There is a critical need for research in displaced populations in order to elucidate potentially lasting transgenerational impacts of experiencing conflict and displacement trauma, and the prenatal and postnatal factors that support health and development across the life span. The next follow-up is planned when the children turn 36 months of age (starting March 2026).

How can citizen science enhance mental health research quality: theory of change development

Por: Todowede · O. · Rennick-Egglestone · S. · Boyd · D. · Moran · S. · Bell · A. · Sweeney · A. · Hart · A. · Tomlin · A. · Robotham · D. · Repper · J. · Rimmer · K. · Brown · M. · Howells · M. · Singh · S. · Lavis · P. · Higton · F. · Hendy · C. · Slade · M.
Objective

Public involvement in mental health research enhances research quality. The use of citizen science methods in mental health research has been described as a conclusion of a movement towards increased public involvement; however, this field is in its early stages of development. Our objective was to create a theory of change (ToC) for how citizen science can be used to enhance mental health research quality.

Design

Iterative consultation with the stakeholders of an existing citizen mental health science study, that is, change for citizen science to achieve co-production at scale (C-STACS: https://www.researchintorecovery.com/research/c-stacs/)

Methods

We co-developed a ToC through an iterative consultation with C-STACS stakeholders who were (a) representatives of mental health community organisations (n=10), individuals with public involvement experience (n=2) and researchers (n=5). In keeping with established ToC practice, entities were identified, including long-term impacts, outcomes needed to create an impact, stakeholder assumptions and indicators for tracking progress.

Results

A desired primary long-term impact of greater co-production of research was identified between researchers and members of the public, which would create a secondary impact of enhancing public capacity to engage in citizen mental health science. We proposed long-term outcomes needed to enable this impact: (1) greater co-production of research objectives and pathways between researcher and the public, (2) greater embedment of citizen mental health science into funder processes (eg, the creation of specific funding calls for citizen mental health science proposals, (3) greater clarity on the boundaries between citizen science and other participatory approaches (eg, so that there is not loss of impact due to conceptual confusion between these, (4) increased knowledge around effective frameworks to enable mass public participation and (5) greater availability of technology platforms, enabling safe and accessible engagement with citizen mental health science projects.

Conclusion

The proposed ToC is grounded in the C-STACS project, but intended to be broadly applicable. It allows the continued formation of a community of practice around citizen mental health science and should be reviewed, as greater knowledge is developed on how citizen mental health science creates change.

Tailored exercise management versus usual care for people aged 80 years or older with hip/knee osteoarthritis and comorbidities (TEMPO): multicentre feasibility randomised controlled trial in England

Por: Nicolson · P. J. A. · Holden · M. A. · Marian · I. · Saeedi · E. · Williamson · E. · Moylan · D. · Stone · M. · Hopewell · S. · Lamb · S. E. · TEMPO feasibility trial collaborators · Barker · Dickson · Price · Webber
Objective

To assess the feasibility of conducting a definitive randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a tailored exercise intervention compared with usual care for people aged 80 years and older with hip and/or knee osteoarthritis (OA) and comorbidities.

Design

Two-arm, parallel-design, multicentre, pragmatic, feasibility RCT.

Setting

Four National Health Service outpatient physiotherapy services across England.

Participants

Adults aged 80 years and over with clinical hip and/or knee OA and ≥1 comorbidity.

Interventions

Participants were randomised 1:1 via a central web-based system to be offered: (1) a 12-week tailored exercise programme or (2) usual care. Participants and outcome assessors were not blinded to treatment allocation.

Feasibility objectives

(1) Ability to screen and recruit participants; (2) retention of participants at 14-week follow-up; (3) intervention fidelity (proportion of participants who received ≥4 intervention sessions as per protocol) and (4) participant engagement (assessed by home exercise adherence).

Results

Between 12 May 2022 and 26 January 2023, 133 potential participants were screened, of whom 94 were eligible. The main reasons for ineligibility were symptoms not consistent with hip or knee OA (10/39, 25.6%) or already having had a physiotherapy appointment (8/39, 20.5%). 51 of 94 (54%) eligible participants were recruited. Participants had a mean age of 84 years (SD 3.5), 31 (60.8%) were female and 96.1% reported their ethnicity as White British (n=49/51). 45 of 51 participants (88%) provided outcome data at the 14-week follow-up time point. Four or more intervention sessions were attended by 13/25 (52%) participants. Home exercise log completion declined over time: 6/23 participants (26.1%) returned completed exercise logs for all 12 weeks. The median number of days home exercises were recorded each week was 5 (range 0–7).

Conclusions

This study demonstrated that a definitive trial would be feasible. Before proceeding, modifications to ensure recruitment of a diverse population and intervention fidelity should be addressed.

Trial registration number

ISRCTN75983430.

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