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Understanding patient experience during Lokomat rehabilitation in children and adolescents: a clinical observational study combining self-evaluation and physiological metrics

Por: Chiappini · M. · Malerba · G. · Dei · C. · Bellazzecca · S. · Falivene · A. · Costantini · S. · Morganti · R. · Diella · E. · Storm · F. · Ambrosini · E. · Cavallo · A. · Biffi · E.
Objectives

To examine the emotional, cognitive and dispositional experience of children and adolescents undergoing Lokomat rehabilitation by integrating self-evaluation, therapist observations and physiological metrics across repeated sessions, with the aim of characterising how patient experience evolves throughout paediatric robot-assisted gait training.

Design

Prospective observational study using a multidimensional assessment approach combining self-report, therapist ratings and physiological measures.

Setting

Inpatients undergoing robot-assisted gait training (RAGT) with the Lokomat at the Scientific Institute Eugenio Medea in Bosisio Parini (Italy).

Participants

42 children and adolescents (N=42; mean age 11.66±5.59 years) undergoing RAGT.

Interventions

Robot-assisted gait therapy with the Lokomat. Participants underwent 30-minute therapy sessions as per routine rehabilitation protocols, with treatment durations ranging from 15 to 20 sessions, as prescribed by their referring clinician.

Primary and secondary outcome measures

Participants completed ad-hoc questionnaires about emotional, cognitive and dispositional factors before and after therapy; therapists provided structured assessments of patient engagement and psychological states. Physiological data, such as heart rate variability (HRV) and electrodermal activity (EDA), were recorded using wearable sensors to capture physiological correlates of emotional and cognitive engagement.

Results

The results showed that by the end of Lokomat therapy, patients displayed increased cognitive engagement and better emotional regulation, along with higher vagal activity (normalised high-frequency) and increased phasic EDA responses. According to the therapists, patients appeared more confident, calm and cooperative. Sympathetic activation observed during satisfaction ratings reflected the involvement of the autonomic nervous system in positive emotional experiences.

Conclusions

This study, therefore, emphasises a multidimensional approach to rehabilitation, which involves subjective patient self-assessments, therapist observations and physiological signals in an effort to capture a more comprehensive patient experience. The findings highlight the importance of personalised, patient-centred approaches and contribute new evidence on the psychological and physiological effects of RAGT in paediatric populations. Further research is warranted to confirm these results and explore their clinical implications.

Trial registration number

NCT05767268.

Improving School Vaccinations for Adolescents With Intellectual and Developmental Disabilities: A Person‐Centred Approach

ABSTRACT

Aims

This article investigates school vaccination for adolescents with intellectual and developmental disability through the lens of person-centred care principles.

Design

This is a theoretical framework analysis in which qualitative interview data were mapped to the principles of a Person-Centred Practice Framework.

Data Sources

Data were drawn from Vax4Health, an empirical study that aims to improve vaccination uptake and experiences for adolescents with disabilities.

Methods

Our four-step process included: identifying elements of the school vaccination programme that relate to the Framework domains; mapping programme capacities and challenges by each domain; identifying key factors influencing person-centredness; and synthesising these key influencing factors into three themes.

Results

We extrapolated three themes: (1) Parents and students expressed strong support for the programme, but there is potential to enhance their participation in vaccination decision-making processes. (2) Nurses bring high levels of motivation, clinical experience, empathy and creativity to vaccinate students, but opportunities remain to enhance disability-specific training and knowledge of individual students' needs. (3) Special schools are committed to supporting families and facilitating the programme, but limited resourcing and unclear responsibilities present challenges that need addressing. We discuss how these themes relate to the five domains of the Framework. Key considerations for vaccination programme improvement towards a more person-centred approach are highlighted.

Conclusion

Applying the Framework to the findings of the Vax4Health study identified a range of opportunities to improve person-centred school-based vaccination for adolescents with IDD. Future research could involve engagement with all stakeholders to co-design interventions aimed at applying person-centred care principles to vaccinating students with IDD.

Impact

The findings from this analysis could be used to inform future implementation research into person-centred approaches to school vaccination aiming for positive outcomes for adolescents with IDD, their families and schools and health professionals.

Preventing Child Maltreatment in Early Childhood: The Clinical Role of Public Health Nurses in Primary Care

ABSTRACT

Aim and Objective

To explore how public health nurses at child and family health clinics work to prevent maltreatment and the experiences of public health nurses in the maltreatment prevention efforts.

Background

Child maltreatment is a serious societal issue with major consequences. Preventive efforts are increasing and have broad political support. A key objective of the child and family health clinic services is to prevent, identify, and stop maltreatment, abuse, and neglect. National clinical guidelines outline, in general terms, how such work should be conducted. However, limited research exists on how public health nurses prevent maltreatment and the effectiveness of their methods.

Design and Method

A qualitative and explorative design was used, based on semi-structured interviews with 14 public health nurses conducted as part of the project ‘Public Health Nurses in Child and Family Clinics' Role in Preventing and Detecting Child Maltreatment’ at Oslo Metropolitan University. The interviews were carried out between August and November 2021. We used qualitative content analysis with an inductive approach to analyse the data.

Result

Three main categories were developed: 1. Structure and system: weaving prevention into daily practice; 2. To dare and endure: a negotiation of courage and understanding, and 3. To empower and uphold: the goal of strengthening and supporting parents. The results show the importance of early intervention, barriers to discussing maltreatment with parents, and the importance of building trust and empowering parents.

Conclusion

Preventing maltreatment is a key part of public health nurses' clinical work, focusing on early risk identification and parental guidance. While building trust with families is prioritised, structural, resource, and guideline-related challenges persist.

Implications for Practice

This study provides knowledge about Norwegian public health nurses clinical work with child maltreatment at the child and family health clinics, which can serve as a valuable foundation for further research as well as for collaborating services.

Reporting Method

EQUATOR guidelines were followed, using the COREQ checklist.

Patient or Public Contribution

No patient or public contribution.

Community Dwelling Adults’ Lived Experiences of Participating in Death Cafés: A Phenomenological Study With Photovoice

ABSTRACT

Aim

To explore community dwelling adults' lived experiences of participating in death café in Singapore.

Design

A descriptive phenomenological study with Photovoice.

Methods

A purposive sample of community dwelling adults who participated in a community-based death café was recruited for this study. Data was collected through online individual semi-structured interviews. The Colaizzi's six-step descriptive phenomenological analysis was conducted for data analysis.

Results

Twenty community dwelling adults who participated in a death café were recruited. Participants' experiences of the death café were expounded in four themes: appeals of attending death cafés, enabling features of death café, engaging in die-logues, and perceived impacts of death café on everyday lives. The participants were attracted to death cafés for various reasons including curiosity and grief. A comfortable environment, accompanied by open dialogues and refreshments, was credited as enablers for death conversations. Through these ‘die-logues’, the participants had a deeper understanding of death and began engaging in advance planning.

Conclusions

Death cafés provide a supportive environment for individuals to engage in death-related conversations that may not easily occur in daily life. By engaging in conversations about mortality within death cafés, participants are encouraged to take proactive steps towards advance planning.

Implications for the Profession and/or Patient Care

Findings from this study can guide the development of community-based interventions by highlighting the essential components required for a death café tailored to the Asian context.

Impact

This study describes the community dwelling adults' lived experiences of participating in a death café. The findings from this study underscore the role of informal conversations about death as a tool to promote population health based palliative care initiatives such as overcoming death taboos and stimulating advance care planning among community dwelling adults.

Reporting Method

The Consolidated Criteria for Reporting Qualitative Studies was used.

Patient and Public Contribution

Community-dwelling adults participated in the interviews.

Evaluating the clinical care, quality of life and overall experiences of patients with primary biliary cholangitis (PBC) during the pandemic: A Canadian mixed-methods study

by Elizabeth Baguley, Madelyn Knaub, Jessica VanDyke, Gideon Hirschfield, Mark G. Swain, Gail Wright, Deirdre McCaughey, Abdel Aziz Shaheen

Pandemic restrictions impacted healthcare, particularly during the first year. We evaluated the impact of the pandemic on quality of life and clinical care among patients with primary biliary cholangitis (PBC). This mixed-methods study administered quality of life surveys (Fear of COVID-19 Scale [FCV-19S], EuroQol 5-dimension 3-level [EQ-5D-3L], 29-item Patient-Reported Outcomes Measurement Instrument Survey [PROMIS-29]) and a PBC Care Delivery questionnaire to 348 Canadian PBC patients, followed by two focus groups with patients (n = 14) and stakeholders (n = 3). Quality of life scores were compared among sub-groups (i.e., care delays and pandemic appointment type) and with various reference populations. Most participants were female (94.0%) and Caucasian (88.2%), with a median age of 63.0 years (IQR: 55.9–71.2). During the pandemic, 75.8% had the majority (≥ 50%) of their hepatologist appointments virtually, but only 22.4% preferred to continue with virtual care post-pandemic. Participants with care delays had worse scores on the FCV-19S (p = 0.014), EQ-5D-3L (p = 0.009), and PROMIS-29 (i.e., fatigue, anxiety, sleep disturbance, ability to participate in social roles and activities, p p 

Protocol for a non-randomised stepped-wedge pilot trial for 'Nra:gi Ya:yun (very good foods): a co-designed type 2 diabetes and metabolic syndrome initiative with Aboriginal people living on Ngarrindjeri Ruwe

Por: Omodei-James · S. · Kropinyeri · R. · Wilson · S. · Cameron · D. · Mendham · A. E. · Kartinyeri · N. · Scriven · T. · Wingard · S. · Kerrigan · C. · Spaeth · B. · Stranks · S. N. · Kaambwa · B. · Wilson · A. · Ullah · S. · Denton · J. · McLaren · K. · Mittinty · M. · Otieno · L. · Henderso
Introduction

Type 2 diabetes mellitus (T2D) and metabolic syndrome (MetS) have reached epidemic proportions for Indigenous populations globally. In Australia, disproportionate rates of T2D and MetS are inextricably tied to the experience of colonisation. As part of a growing shift towards strengths-based, Aboriginal-led initiatives, this project sought to co-design and assess the feasibility of a metabolic remission initiative, whereby Aboriginal people living on Ngarrindjeri Ruwe (Country) are supported to adopt a low-carbohydrate diet.

Methods and analysis

This 28-week pilot takes the form of a non-randomised stepped-wedge design. Aboriginal adults (≥18 years) living on Ngarrindjeri Ruwe with T2D or MetS will be recruited to two sites in rural South Australia. Participants will transition through three phases (control phase, remission phase and maintenance phase) with repeated measures taken across five key time points (T1–T5). While centring on the adoption of a low-carbohydrate diet, participants will be equipped with continuous glucose and ketone monitors and meal boxes and offered ongoing support through weekly to fortnightly check-ins. The primary outcome is to assess the feasibility of Nra:gi Ya:yun in preparation for a large-scale clinical trial of similar design. Feasibility will be assessed through recruitment, retention and adherence rates. Self-reported dietary recall, out-of-pocket food costs and national pharmaceutical and medical benefits scheme data will also be examined. Qualitative data obtained using the Aboriginal research method of yarning will aid analysis and interpretation of results. Clinical measures (such as blood pressure, weight, waist circumference, capillary ketones and capillary glucose) and venous blood draws will assist in the evaluation of our secondary outcome, namely the initiatives’ preliminary effect on participant metabolic health.

Ethics and dissemination

Findings will be disseminated to Community, participants and policymakers in the form of digital posters, manuals, infographics and peer-reviewed publications. Lessons from this study have the potential to provide insights and benefits to Australian public health policy and research, as well as Indigenous populations globally who face similar metabolic challenges. Findings will be used to advise on an implementation strategy for a large-scale clinical trial. Pilot trial approved by the Aboriginal Health Research Ethics Committee (HREC), Flinders University HREC and Southern Adelaide Local Health Network HREC.

Trial registration number

Pilot prospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12624001019594.

A pilot randomised controlled trial of a critical time intervention for people leaving prison: findings from an integrated process evaluation

Por: Williams · A. D. N. · Jacob · N. · Moriarty · Y. · Madoc-Jones · I. · Fitzpatrick · S. · Mackie · P. · Thomas · I. · Grozeva · D. · Lloyd · B. · Deidda · M. · Achiaw · S. O. · Lewis · K. · Cannings-John · R. · Katikireddi · S. V. · White · J. · Lewsey · J.
Background

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

Objective

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

Design

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Setting

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

Participants

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

Intervention

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

Results

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

Conclusions

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

Trial registration number

ISRCTN46969988.

Critical time intervention for people leaving prison at risk of homelessness in England and Wales (PHaCT trial): a pilot feasibility randomised controlled trial

Por: Williams · A. D. N. · Jacob · N. · Grozeva · D. · Lloyd · B. · Moriarty · Y. · Deidda · M. · Achiaw · S. O. · Thomas · I. · Lewis · K. · Cannings-John · R. · Madoc-Jones · I. · Fitzpatrick · S. · Katikireddi · S. V. · Mackie · P. · White · J. · Lewsey · J.
Objective

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Design

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Setting

Four prisons for men across England and Wales, UK.

Participants

Men leaving prison at risk of homelessness and intervention delivery staff.

Intervention

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Outcome measures

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

Results

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

Conclusion

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

Trial registration number

ISRCTN46969988.

How do musculoskeletal disorders impact on quality of life in Tanzania? Results from a community-based survey

Por: Grieve · E. · Deidda · M. · Krauth · S. J. · Biswaro · S. M. · Halliday · J. E. B. · Hsieh · P.-H. · Kelly · C. · Kilonzo · K. · Kiula · K. P. · Kolimba · R. · Msoka · E. F. · Siebert · S. · Walker · R. · Yongolo · N. M. · Mmbaga · B. · McIntosh · E. · NIHR Global Health Group · Biswaro
Objectives

There are little available data on the prevalence, economic and quality of life impacts of musculoskeletal disorders in sub-Saharan Africa. This lack of evidence is wholly disproportionate to the significant disability burden of musculoskeletal disorders as reported in high-income countries. Our research aimed to undertake an adequately powered study to identify, measure and value the health impact of musculoskeletal conditions in the Kilimanjaro region, Tanzania.

Design

A community-based cross-sectional survey was undertaken between January 2021 and September 2021. A two-stage cluster sampling with replacement and probability proportional to size was used to select a representative sample of the population.

Setting

The survey was conducted in 15 villages in the Hai District, Kilimanjaro region, Tanzania.

Participants

Economic and health-related quality of life (HRQOL) questionnaires were administered to a sample of residents (aged over 5 years old) in selected households (N=1050). There were a total of 594 respondents, of whom 153 had a confirmed musculoskeletal disorder and 441 matched controls. Almost three-quarters of those identified as having a musculoskeletal disorder were female and had an average age of 66 years.

Primary and secondary outcome measures

Questions on healthcare resource use, expenditure and quality of life were administered to all participants, with additional more detailed economic and quality of life questions administered to those who screened positive, indicating probable arthritis.

Results

There is a statistically significant reduction in HRQOL, on average 25% from a utility score of 0.862 (0.837, 0.886) to 0.636 (0.580, 0.692) for those identified as having a musculoskeletal disorder compared with those without. The attributes ‘pain’ and ‘discomfort’ were the major contributors to this reduction in HRQOL.

Conclusions

This research has revealed a significant impact of musculoskeletal conditions on HRQOL in the Hai district in Tanzania. The evidence will be used to guide clinical health practices, interventions design, service provisions and health promotion and awareness activities at institutional, regional and national levels.

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.

Food pricing: A study on the sales of food in Brazilian private schools

by Ariene Silva do Carmo, Paulo César Pereira de Castro Júnior, Thais Cristina Marquezine Caldeira, Daniela Silva Canella, Rafael Moreira Claro, Luiza Delazari Borges, Larissa Loures Mendes

The present study analyzed the prices of food sold in canteens of Brazilian private schools and described price-based marketing strategies, according to the NOVA food classification system. This is a mixed methods study combining a cross-sectional component and time series analysis, with data from 2,241 canteens in private elementary and secondary schools in the 26 capitals of Brazil and the Federal District, collected between June 2022 and June 2024. Price data collected for unprocessed, minimally processed, or processed foods and culinary preparations based on these foods (UMPCP), and ultra-processed foods and culinary preparations based on these foods (UpCP) sold in school canteens and from the National System of Consumer Price Indices (SNIPC), were used to create a data set containing deflated monthly prices for food and beverages sold between August 2022 and July 2024. Calculations were made for adjusted prices (R$/100 g or ml) and absolute prices (R$ per portion), and frequency of use of strategies such as combos and promotions. UMPCP showed lower adjusted price, but higher absolute price than UpCP, especially for solid foods. About 27% of the study canteens implemented pricing strategies for both food groups. Most of these strategies did not exclusively favor healthy foods, indicating that promotions and combos were used without distinction. The affordability of healthy foods is disadvantaged in school canteens when considering the price per portion, which may negatively influence students’ food choices. The findings show that current prices for food sold in most canteens discourage the purchase of healthy items, but favor the purchase of unhealthy ones. These results reinforce the importance of interventions for promoting healthy foods and making them more affordable.

Validation and cost-effectiveness of an mHealth tool for cognitive impairment detection in Peru: protocol for the IMPACT Salud observational study

Por: Cardenas · M. K. · Anza-Ramirez · C. · Bernabe-Ortiz · A. · Custodio · N. · Montesinos · R. · Miranda · J. J. · Da Re · M. · Belon-Hercilla · M. V. · Lazo-Porras · M. · Hawkins · J. · Diez-Canseco · F. · Moore · G. · Whiteley · W. · Calvo · R. A. · Cuba-Fuentes · M. S. · Landeiro · F.
Introduction

Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.

Methods and analysis

This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.

Ethics and dissemination

The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.

Three infections, one fight: an implementation study to map needle prevalence and evaluate HIV, syphilis and hepatitis C prevention interventions in Regina, Saskatchewan - a protocol

Por: Eaton · A. D. · Rowe · M. W. · Varghese · S. M. · House · H. · Pang · N. · Kwan · S. · Ford · P. · Reddy · V. D. · Acoose · T. · Littleford · J. · Lang · K. · Foreman · E. S. · Sasakamoose · J. · Pandey · M. · Medeiros · P. · Loutfy · M. R. · Grace · D. · Brennan · D. J. · Zhao · K. · Shuper
Introduction

Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.

Methods and analysis

This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.

Ethics and dissemination

Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.

Registration

Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B

Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19

Por: Carinci · F. · Messina · R. · Michelini · M. · Bici · A. · Berardo · A. · Dei Cas · A. · Iezzi · E. · Di Iorio · C. T. · Gualdi · S. · Aldigeri · R. · Fantini · M. P. · Bonadonna · R. C. · Massi Benedetti · M. · Di Bartolo · P.
Introduction

Real-world data and patient-reported outcomes in diabetes in Emilia–Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia–Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.

Methods and analysis

The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019–2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0–6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.

Ethics and dissemination

The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.

Trial registration number

NCT06639100.

Prognostic significance of tumour-infiltrating T lymphocytes in ovarian cancer: a protocol for systematic review and meta-analysis

Introduction

Ovarian cancer remains a significant clinical challenge due to its aggressive nature and high mortality rate. Tumour-infiltrating lymphocytes (TILs) play a critical role in the tumour microenvironment, influencing treatment response and patient survival across various cancer types, including ovarian cancer. A systematic review is warranted to consolidate evidence on TILs as prognostic biomarkers in ovarian cancer, with the goals of integrating them into clinical practice to enhance patient outcomes. This study aims to assess the prognostic significance of TILs in ovarian cancer.

Methods and analysis

A comprehensive literature search will be conducted across multiple databases, including PubMed, Embase, Web of Science, Scopus, Cochrane Library, CINAHL, ScienceDirect and LILACS. No restrictions regarding publication date or language will be applied. Original studies evaluating the role of TILs in women with ovarian cancer will be considered for inclusion. Two independent authors will screen titles and abstracts, and any discrepancies will be resolved through discussion with a third author. The risk of bias in included studies will be assessed using the Quality in Prognosis Studies (QUIPS) tool. Data synthesis will be performed using R software (V.4.3.1).

Ethics and dissemination

This study reviews the published data; thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42024543955.

Antibody development after three mRNA SARS-CoV-2 vaccinations in patients with systemic autoimmune rheumatic disease with and without treatment: an observational cohort study

Por: Simader · E. · Kartnig · F. · Tobudic · S. · Mrak · D. · Deimel · T. · Karonitsch · T. · Haslacher · H. · Perkmann · T. · Mitter · G. · Winkler · S. · Aletaha · D. · Blueml · S. · Mandl · P.
Objectives and design

To further elucidate the effects of rare systemic autoimmune rheumatic diseases (SARD) and their treatment on antibody development after vaccination against SARS-CoV-2, we compared patients with and without immunosuppressive therapy to healthy controls in an observational cohort study.

Participants and setting

We enrolled 52 patients with SARD and 72 healthy subjects in a prospective, observational study at the Medical University of Vienna and measured the humoral response 6 months after two mRNA vaccinations and 2–6 weeks after a third dose.

Results

Patients with vasculitis showed significantly (p=0.02) lower antibody titres 6 months after vaccination (median 247 BAU/mL, IQR [185–437]), as compared with healthy controls (median 514 BAU/mL, [185–437], IQR 323; 928, vasculitis patients: 247, IQR [185; 437], p

Conclusions

Patients with SARD displayed lower antibody development after booster vaccination, even if antibody levels after two immunisations were comparable to healthy controls. Our data may be limited due to sample size, but it provides pointers for a more individualised, antibody-titre-oriented approach and earlier booster vaccination in patients with SARD.

Trends in Spirituality and Spiritual Care in Nursing—A Discursive Paper

ABSTRACT

Aim

This paper outlines key developments, innovations, and milestones in the field of spirituality and spiritual care in nursing.

Design

A discursive paper.

Results

Nursing scholars have significantly influenced the profession and contributed to the development of nursing knowledge, particularly in the field of spirituality and spiritual care. Key research has focused on nurses' perceptions and attitudes toward spirituality, clarifying foundational spiritual concepts, and establishing a framework of core spiritual care competencies for the profession.

Conclusion

Despite these advancements, significant gaps remain in nurses' knowledge, understanding, and experience in providing spiritual care. The development of agreed-upon spiritual care competencies at the European level offers important guidance for the profession, and educational initiatives are underway to support their integration. However, the field remains in an early stage of development, and further research is needed to embed spiritual care competencies into national and international nursing policy and practice. Moreover, continued research is also essential to inform and evaluate current educational programmes and nursing interventions, and to support the translation of evidence-based knowledge into effective spiritual care delivery.

Implications for the Profession and/or Patient Care

Spiritual support is proven to be an important consideration for many patients and families globally. Imbedding spiritual care education into both undergraduate and postgraduate nursing curricula is essential to prepare nurses to address the spiritual needs of patients in healthcare settings. Structured curricula that provide clear instructions on how to recognise, assess, and respond to spiritual concerns in clinical practice can enhance nurses' competence and confidence. Embedding spiritual care into education and training helps normalise spiritual care as a component of holistic nursing, supporting its inclusion in everyday care rather than treating it as an optional or marginal practice. Such educational integration has the potential to improve the consistency and quality of spiritual care across healthcare settings.

Impact

Internationally there are evident gaps in the consistent provision of spiritual care to patients and their families. These are being addressed through conceptual clarity, the agreed-upon competencies, and enhanced educational initiatives. It is essential to continue to increase awareness among the nursing profession on the necessity of addressing spiritual care needs, within the context of cultural perspectives to ensure that value is placed on the significance of these issues on a global scale.

Patient or Public Contribution

There was no patient or publication contribution in this specific commentary.

Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Factors influencing HPV vaccine acceptance in immunosuppressed patient populations: a protocol for a systematic review

Introduction

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

Methods and analysis

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

Ethics and dissemination

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023452537.

Effectiveness of aromatherapy in pain relief postcardiac surgery: a systematic review and meta-analysis protocol

Introduction

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Methods and analysis

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

Ethics and dissemination

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42024568532.

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