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Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

Comunidad compasiva para la inclusión social y calidad de vida de las personas con esclerosis múltiple y sus cuidadores familiares.

Objetivo: evaluar cualitativamente la experiencia de pacientes con esclerosis múltiple (PEM) y cuidadores familiares (CFPEM) vinculados al programa de esclerosis múltiple del Hospital Universitario Nacional de Colombia (PrEM-HUNC), durante la formación y consolidación de una comunidad compasiva (CC), para la inclusión social y promoción de calidad de vida. Materiales y Método: estudio cualitativo interpretativo, con entrevistas a profundidad a nueve colaboradores. Con el método de análisis de espiral de Creswell y Poth, emergieron cuatro categorías y un tema. Resultados: el tema “Un nido comunitario de crecimiento y transformación” señala el proceso de conformación de la CC como una experiencia que posibilitó cambios de significados en torno a la enfermedad, la situación personal y familiar; revela un proceso de descubrimiento y aprendizaje de conformación de diferentes relaciones y roles. Conclusiones: La CC es una opción para construcción de redes de apoyo, fortalecimiento de las capacidades personales y familiares, una forma para hacer frente a los diferentes impactos y retos que implica vivir con esclerosis múltiple, se constituye en una alternativa para la promoción de la calidad de vida y la inclusión social.

Impact of telehealth on stroke survivor–caregiver dyad in at‐home rehabilitation: A systematic review

Abstract

Aim

To examine studies involving the impact of telerehabilitation (TLR), tele-training and tele-support on the dyad stroke survivor and caregiver in relation to psychological, physical, social and health dimensions.

Design

A systematic review was conducted.

Data Sources

The following electronic databases were consulted until September 2023: PsycInfo, CINAHL, Eric, Ovid, PubMed, Scopus, Cochrane Central and Web of Science.

Review Methods

It was conducted and reported following the checklists for Reviews of PRISMA 2020 Checklist. Critical evaluation of the quality of the studies included in the review was performed with the Joanna Briggs Institute Checklists.

Data Synthesis

A total of 2290 records were identified after removing duplicates, 501 articles were selected by title and abstract and only 21 met the inclusion criteria. It included 4 quasi-experimental studies, 7 RCTs, 1 cohort study and 9 qualitative studies. The total number of participants between caregivers and stroke survivors was 1697, including 858 stroke survivors and 839 caregivers recruited from 2002 to 2022. For a total of 884 participants who carried out TLR activities in the experimental groups,11 impact domains were identified: cognitive/functional, psychological, caregiver burden, social, general health and self-efficacy, family function, quality of life, healthcare utilization, preparedness, quality of care and relationship with technology.

Conclusions

The results support the application of telehealth in the discharge phase of hospitals and rehabilitation centres for stroke survivors and caregivers. TLR could be considered a substitute for traditional rehabilitation only if it is supported by a tele-learning programme for the caregiver and ongoing technical, computer and health support to satisfy the dyad's needs.

Impact

Designing a comprehensive telemedicine programme upon the return home of the dyad involved in the stroke improves the quality of life, functional, psychological, social, family status, self-efficacy, use of health systems and the dyad's preparation for managing the stroke.

Patient or Public Contribution

No patient or public contribution.

Physical frailty trajectories in older stroke survivors: Findings from a national cohort study

Abstract

Background

Physical frailty (PF) is highly prevalent and associated with undesirable outcomes in stroke survivors aged 65 years or older. However, the long-term trajectories of PF are understudied in those older stroke survivors.

Aims

To identify PF trajectories and relative predictors associated with the PF trajectories in older stroke survivors.

Design

This is a secondary analysis of a population-based cohort study in the United States.

Methods

Six hundred and sixty-three older stroke survivors from the National Health and Ageing Trends Study from 2015 to 2021 were included. PF was operationally assessed based on the Fried Frailty Phenotype. Trajectories were identified by group-based trajectory modelling. The associations between sociodemographic characteristics, clinical factors, symptoms, cognitive factors and PF trajectories were examined using the design-based logistic regression method.

Results

Most older stroke survivors were 75 and older (63.32%), female (53.99%), white (80.54%) and partnered (50.64%). Two PF trajectory groups were identified (Group 1: low risk, robust; 49.47%; Group 2: high risk, deteriorating; 50.53%). Individuals were at a higher risk to be assigned to Group 2 if they were 75–84 years (adjusted odds ratio [aOR]: 2.16, 95% CI: 1.23–3.80) or 85+ years (aOR: 2.77, 95% CI: 1.52–5.04), had fair self-reported health (aOR: 2.78, 95% CI: 1.53–5.07) or poor self-reported health (aOR: 3.37, 95% CI: 1.51–7.52), had comorbidities (aOR: 8.44, 95% CI: 1.31–54.42), had breathing problems (aOR: 2.18, 95% CI: 1.18–4.02) and had balance problems (aOR: 1.70, 95% CI: 1.06–2.73).

Conclusion

PF trajectories in older stroke survivors were heterogeneous and were associated with age, self-rated health status, comorbidities, breathing problems and balance problems.

Implication to Clinical Practice

Early, routine, dynamic screening for stroke-related physical frailty (PF) and relative predictors might be beneficial for identifying the most vulnerable individuals. Our findings might help develop strategies to manage PF progression.

Reporting Method

The reporting followed the STROBE guideline.

Mapping health promotion practices across key sectors and its intersectoral approach at the local level: Study protocol

Abstract

Aims

This study outlines a protocol aimed at identifying and mapping health promotion practices in need of development from the perspectives of key sectors responsible for it at the local level and from an intersectoral perspective across four Spanish regions.

Design

A complementary multi-method study combining survey methods and qualitative interviews will be adopted.

Methods

Purposive snowball sampling will be employed to select potentially rich informants from city councils, primary care centres, primary and secondary schools, and public health and civil society organizations in 12 municipalities sensitive to local health. Data on the degree of execution of health promotion activities, the level of intersectorality in their implementation, and their origins will be collected using PromoACTIVA questionnaires, an intersectoral typology model and an interview protocol. A parallel mixed analysis encompassing descriptive statistics and a ‘framework analysis’ will be performed.

Discussion

This study is expected to yield thorough and reliable insights into health promotion practices and omissions at the local level by focusing on key stakeholders, both individually and collaboratively. This information can enhance health promotion planning and improve its effectiveness, efficiency and contextual relevance. The development and testing of a methodology for the integration and interpretation of these data will ensure sustainable capacity building.

Impact

Managers and practitioners interested in health promotion planning in the researched settings can benefit from a comprehensive map of the current state of their practices and insights into the starting points of collaboration. In addition, planners from other local settings will gain access to tools and methodologies to replicate and expand these maps to their own contexts.

Stakeholder Engagement

Engaging key stakeholders with experience working in or with primary care centres, public health organizations, primary and secondary schools, civil society organizations, and city councils was vital to ensure the study's relevance and feasibility.

Integrating genomics into Canadian oncology nursing policy: Insights from a comparative policy analysis

Abstract

Aim

To learn from two jurisdictions with mature genomics-informed nursing policy infrastructure—the United States (US) and the United Kingdom (UK)—to inform policy development for genomics-informed oncology nursing practice and education in Canada.

Design

Comparative document and policy analysis drawing on the 3i + E framework.

Methods

We drew on the principles of a rapid review and identified academic literature, grey literature and nursing policy documents through a systematic search of two databases, a website search of national genomics nursing and oncology nursing organizations in the US and UK, and recommendations from subject matter experts on an international advisory committee. A total of 94 documents informed our analysis.

Results

We found several types of policy documents guiding genomics-informed nursing practice and education in the US and UK. These included position statements, policy advocacy briefs, competencies, scope and standards of practice and education and curriculum frameworks. Examples of drivers that influenced policy development included nurses' values in aligning with evidence and meeting public expectations, strong nurse leaders, policy networks and shifting healthcare and policy landscapes.

Conclusion

Our analysis of nursing policy infrastructure in the US and UK provides a framework to guide policy recommendations to accelerate the integration of genomics into Canadian oncology nursing practice and education.

Implications for the profession

Findings can assist Canadian oncology nurses in developing nursing policy infrastructure that supports full participation in safe and equitable genomics-informed oncology nursing practice and education within an interprofessional context.

Impact

This study informs Canadian policy development for genomics-informed oncology nursing education and practice. The experiences of other countries demonstrate that change is incremental, and investment from strong advocates and collaborators can accelerate the integration of genomics into nursing. Though this research focuses on oncology nursing, it may also inform other nursing practice contexts influenced by genomics.

Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study

Por: Karihtala · T. · Puttonen · S. · Valtonen · A. M. · Kautiainen · H. · Hopsu · L. · Heinonen · A.
Objectives

This study aimed to investigate the association between recovery from work and insomnia and the role of objectively measured leisure-time physical activity and occupational physical activity in this association.

Design

Cross-sectional.

Setting and participants

Study with female early childhood education and care professionals (N=224) in Finland was conducted between April 2017 and September 2018.

Methods

Recovery from work was measured with the Need for Recovery scale and insomnia with the Jenkins Sleep Scale. Physical activity was measured with an accelerometer for 7 days and analysed to represent leisure-time physical activity and occupational physical activity (min/day).

Results

Both Jenkins Sleep Scale and occupational physical activity significantly predicted Need for Recovery (β=0.29; 95% CI 0.17 to 0.42 and β=0.14; 95% CI 0.01 to 0.27, respectively). A low relationship was observed between the Need for Recovery and Jenkins Sleep Scale (r=0.32, 95% Cl 0.19 to 0.44). After categorising participants into four groups based on median splits of occupational and leisure-time physical activity, relationships between the Need for Recovery and Jenkins Sleep Scale were low to moderate in the high occupational physical activity and leisure time physical activity group (r=0.38, 95% Cl 0.14 to 0.61), and in the high occupational physical activity and low leisure-time physical activity group (r=0.40, 95% Cl 0.18 to 0.63).

Conclusion

Both insomnia and physical activity at work seem to be relevant in recovery from work. To enhance recovery, especially those involved in high physical activity at work, should seek methods to improve recovery, by incorporating activities that promote recuperation both during their workday and in their leisure time. Further research on the relevance of physical activity in recovery with longitudinal setting is warranted.

Trial registration number

NCT03854877.

Factors related to nurses' beliefs regarding pain assessment in people living with dementia

Abstract

Aim

To evaluate registered nurses' beliefs and related factors regarding pain assessment in people living with dementia.

Design

A descriptive cross-sectional survey was conducted between July 2022 and April 2023.

Methods

An online survey comprised of demographics, knowledge scale, and beliefs scale relating to pain assessment in dementia was distributed to registered nurses (RNs) caring for people living with dementia in Australia.

Results

RNs (N = 131) completed the survey. Most respondents were females (87.0%) and self-identified as Caucasian (60.3%). The mean beliefs score was 72.60 (±6.39) out of a maximum possible score of 95. RNs' beliefs about pain assessment varied based on their education, dementia pain assessment knowledge, nursing experience, and ethnicity. Hierarchical multiple regression analysis revealed factors significantly related to the beliefs score (i.e. education and dementia pain assessment knowledge).

Conclusion

The relationship between education and knowledge, and the beliefs score indicates the potential to improve RNs' knowledge and overcome their erroneous beliefs about pain assessment in dementia.

Implications for the profession and/or patient care

Education and training in assessing pain in people living with dementia should be tailored to overcome RNs' misconceived beliefs. These programmes should be integrated into continuous learning programmes.

Impact

Some RNs' beliefs about pain assessment in dementia were not evidence-based, and knowledge and educational status were the strongest factors related to RNs' beliefs. RNs' erroneous beliefs about pain assessment in dementia need to be addressed to improve pain assessment and management. Researchers should explore the potential of educational interventions to overcome RNs' misconceived beliefs about pain assessment in dementia.

Reporting Method

This study was reported adhering to the Strengthening the Reporting of Observational Studies in Epidemiology checklist.

Patient or Public Contribution

RNs caring for people living with dementia participated as survey respondents. Additionally, RNs were involved in the pre-testing of the study's survey instrument.

Individual and social system factors influencing evidence‐based practices among nurses in general hospitals: A cross‐sectional multi‐institutional study

Abstract

Aims and Objectives

To investigate evidence-based practices and examine the influence of individual and social system factors on evidence-based practices among nurses in general hospitals.

Background

Evidence-based practice is essential for improving healthcare quality. However, a challenge for nursing worldwide is nurses' limited use of evidence-based practices. It is crucial to determine the individual and social system factors affecting nurses' use of evidence-based practices.

Design

This study employs a multi-institutional cross-sectional design.

Methods

With a multistage random sampling method, 336 registered nurses were recruited from 17 general hospitals in the Republic of the Union of Myanmar. Data were collected through a seven-part questionnaire, including the Evidence-Based Practice Implementation Scale and individual and social system factors. Data were analyzed using descriptive statistics and multiple linear regression.

Results

Nurses in general hospitals perceived low levels of evidence-based practices. Individual factors, such as perceived barriers (p < .001), knowledge (p < .001) and attitudes (p = .001), were related to EBP as well as social system factors, including the work environment (p < .001) which influence nurses' practice, explaining 34% variance among nurses.

Conclusion

Nurses perceived the work environment as the most influencing factor related to evidence-based practices. Individual characteristics, including perceived knowledge, attitudes and barriers, were critical factors in performing evidence-based practices in Myanmar.

Relevance to Clinical Practice

Nurse administrators and policymakers can develop strategies and interventions for improving knowledge, attitudes and work environment towards evidence-based practice. Minimizing the barriers to evidence-based practice will promote evidence-based practices in Myanmar general hospitals.

Impact

In addressing the individual and social system factors influencing the evidence-based practices of nurses, this study contributes to enhancing healthcare quality and outcomes.

Reporting Method

This study adhered to the STROBE checklist.

Patient or Public Contribution

There was no patient or public contribution.

Actualization of evidence‐based nursing in primary, specialized, and social care settings—A cross‐sectional survey

Abstract

Background

Basing practice on evidence is a widely acknowledged requirement for nursing, but shortcomings still exist. An increased understanding of the actualization of evidence-based nursing (EBN) across different nursing contexts is needed to develop better support for EBN and promote uniform high-quality nursing.

Aims

The aim of this study was to compare the actualization of EBN in different organizational contexts in Finland.

Methods

Data for this survey were collected in 2021. The actualization of EBN in primary, specialized, and social care organizations was evaluated with the Actualization of Evidence-Based Nursing instrument, nurses' version, which focuses on individual and organizational-level EBN support structures. Differences between (1) specialized and primary healthcare, and (2) different nursing practice settings were tested with Welch's two sample t-test, the Kruskal–Wallis rank sum test, and the Wilcoxon rank sum test.

Results

Based on nurse (n = 1020) evaluations, those working in specialized healthcare hold more positive attitudes toward EBN (p = .021) and evaluated their organization's methods for monitoring and evaluating nursing practices (p = .004) more positively than those working in primary healthcare. Regarding different nursing practice settings (n = 1241), the most positive results were observed within preventive healthcare where nurses evaluated their attitudes toward EBN, EBN competence, and personal evidence-based practices more positively compared to other nursing practice settings. The results were parallel regarding several organizational structures for EBN. Positive results were also observed within somatic units at university hospitals, and most negative results were within institutional care settings, health centers, and home care settings.

Linking Evidence to Action

There is a need for targeted support to strengthen EBN across different organizational contexts, with special attention to those contexts where nursing professionals with lower education levels work. Future research needs to focus on further analyzing the organizational differences and what can be learned, especially from preventive healthcare but also somatic units at university hospitals.

Engaging people with lived experiences on community advisory boards in community-based participatory research: a scoping review protocol

Por: Nelson · G. · Kettaneh · H. · Knox · B. · Purkey · E. · Chan-Nguyen · S. · Jenkins · M. · Bayoumi · I.
Introduction

Community-based participatory research (CBPR) is a collaborative research approach that equally engages researchers and community stakeholders throughout all steps of the research process to facilitate social change and increase research relevance. Community advisory boards (CABs) are a CBPR tool in which individuals with lived experience and community organisations are integrated into the research process and ensure the work aligns with community priorities. We seek to (1) explore the best practices for the recruitment and engagement of people with lived experiences on CABs and (2) identify the scope of literature on minimising power dynamics between organisations and community members with lived experience who work on CABs together.

Methods and analysis

This scoping review will follow the Arksey and O’Malley methodological framework, informed by Levac et al, and will be reported using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Detailed and robust search strategies have been developed for Embase, Medline and PsychINFO. Grey literature references and reference lists of included articles published between 1 January 1990 and 30 March 2023 will be considered. Two reviewers will independently screen references in two successive stages of title/abstract and full-text screening. Conflicts will be decided by consensus or a third reviewer. Thematic analysis will be applied in three phases: open coding, axial coding and abstraction. Extracted data will be recorded and presented in a tabular format and/or graphical summaries, with a descriptive overview discussing how the research findings relate to the research questions. At this time, a preliminary search of peer-reviewed and grey literature has been conducted. Search results for peer-reviewed literature have been uploaded to Covidence for review and appraisal for relevance.

Ethics and dissemination

Formal ethics approval is not required for this review. Review findings will inform ongoing and future CBPR community advisory board dynamics.

Registration

The protocol has been registered prospectively on the Open Science Framework (https://doi.org/10.17605/OSF.IO/QF5D3)

Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry

Introduction

Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.

Methods and analysis

Eligible paediatric patients (N=750–1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24–36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.

Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.

Ethics and dissemination

Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.

Trial registration number

NCT04207892.

Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

Por: Llurba · E. · Crispi · F. · Crovetto · F. · Youssef · L. · Delgado · J. L. · Puig · I. · Mora · J. · Krofta · L. · Mackova · K. · Martinez-Varea · A. · Tubau · A. · Ruiz · A. · Paya · A. · Prat · M. · Chantraine · F. · Comas · C. · Kajdy · A. · Lopez-Tinajero · M. F. · Figueras · F. · Gratac
Introduction

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

Methods and analysis

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

Ethics and dissemination

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04766866.

Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial

Por: Weber · M. · Raab · A. M. · Schmitt · K.-U. · Büsching · G. · Marcin · T. · Spielmanns · M. · Puhan · M. A. · Frei · A.
Introduction

Non-small cell lung cancer (NSCLC) survivors suffer from impaired physical and psychological functioning and reduced health-related quality of life (HRQoL) that persist after active treatment ends. Sustaining rehabilitation benefits, promoting a healthy lifestyle and facilitating self-management at home require a multifaceted aftercare programme. We aim to investigate the effect of a 12-week digital lifestyle intervention on HRQoL and lifestyle-related outcomes in NSCLC survivors after completion of inpatient rehabilitation.

Methods and analysis

QUAlity of life in LUng CAncer Survivors (QUALUCA) is a multicentre randomised controlled trial that follows a hybrid type 1 design. We randomly allocate participants in a 1:1 ratio to the intervention group (digital lifestyle intervention) or the control group (standard care) using block randomisation stratified by tumour stage and study site. Four accredited Swiss inpatient rehabilitation centres recruit participants. Key inclusion criteria are a diagnosis of NSCLC, an estimated life expectancy of ≥6 months and access to a smartphone or tablet. The 12-week intervention comprises physical activity, nutrition and breathing/relaxation, delivered through a mobile application (app). The primary outcome is the change in HRQoL from baseline (1 week after rehabilitation) to follow-up (3 months after baseline), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Secondary outcomes include body mass index, self-reported physical activity, exercise capacity, risk of low protein intake, appetite, psychological distress, cancer-related fatigue, enablement and self-rated health. Explanatory outcomes in the intervention group include app usability, acceptability, appropriateness, and feasibility of the intervention, experiences and satisfaction with the intervention, and app usage data. We aim to enrol 88 participants. For the main statistical analysis, we will use analysis of covariance, adjusted for baseline measures, stratification variables, age and sex.

Ethics and dissemination

The Ethics Committees of the Canton of Zurich (lead), the Canton of Bern and Northwest and Central Switzerland approved the study (2023-00245). We will disseminate study results to researchers, health professionals, study participants and relevant organisations, and through publications in international peer-reviewed journals.

Trial registration number

NCT05819346.

Codesigning enhanced models of care for Northern Australian Aboriginal and Torres Strait Islander youth with type 2 diabetes: study protocol

Por: Kirkham · R. · Puszka · S. · Titmuss · A. · Freeman · N. · Weaver · E. · Morris · J. · Mack · S. · O'Donnell · V. · Boffa · J. · Dowler · J. · Ellis · E. · Corpus · S. · Graham · S. · Scott · L. · Sinha · A. K. · Connors · C. · Shaw · J. E. · Azzopardi · P. · Brown · A. · Davis · E. · Wicklow
Introduction

Premature onset of type 2 diabetes and excess mortality are critical issues internationally, particularly in Indigenous populations. There is an urgent need for developmentally appropriate and culturally safe models of care. We describe the methods for the codesign, implementation and evaluation of enhanced models of care with Aboriginal and Torres Strait Islander youth living with type 2 diabetes across Northern Australia.

Methods and analysis

Our mixed-methods approach is informed by the principles of codesign. Across eight sites in four regions, the project brings together the lived experience of Aboriginal and Torres Strait Islander young people (aged 10–25) with type 2 diabetes, their families and communities, and health professionals providing diabetes care through a structured yet flexible codesign process. Participants will help identify and collaborate in the development of a range of multifaceted improvements to current models of care. These may include addressing needs identified in our formative work such as the development of screening and management guidelines, referral pathways, peer support networks, diabetes information resources and training for health professionals in youth type 2 diabetes management. The codesign process will adopt a range of methods including qualitative interviews, focus group discussions, art-based methods and healthcare systems assessments. A developmental evaluation approach will be used to create and refine the components and principles of enhanced models of care. We anticipate that this codesign study will produce new theoretical insights and practice frameworks, resources and approaches for age-appropriate, culturally safe models of care.

Ethics and dissemination

The study design was developed in collaboration with Aboriginal and Torres Strait Islander and non-Indigenous researchers, health professionals and health service managers and has received ethical approval across all sites. A range of outputs will be produced to disseminate findings to participants, other stakeholders and the scholarly community using creative and traditional formats.

Design and content validation of a checklist about infection‐prevention performance of intensive care nurses in simulation‐based scenarios

Abstract

Objective

To design, develop and validate a new tool, called NEUMOBACT, to evaluate critical care nurses' knowledge and skills in ventilator-associated pneumonia (VAP) and catheter-related bacteraemia (CRB) prevention through simulation scenarios involving central venous catheter (CVC), endotracheal suctioning (ETS) and mechanically ventilated patient care (PC) stations.

Background

Simulation-based training is an excellent way for nurses to learn prevention measures in VAP and CRB.

Design

Descriptive metric study to develop NEUMOBACT and analyse its content and face validity that followed the COSMIN Study Design checklist for patient-reported outcome measurement instruments.

Methods

The first version was developed with the content of training modules in use at the time (NEUMOBACT-1). Delphi rounds were used to assess item relevance with experts in VAP and CRB prevention measures, resulting in NEUMOBACT-2. Experts in simulation methods then assessed feasibility, resulting in NEUMOBACT-3. Finally, a pilot test was conducted among 30 intensive care unit (ICU) nurses to assess the applicability of the evaluation tool in clinical practice.

Results

Seven national experts in VAP and CRB prevention and seven national simulation experts participated in the analysis to assess the relevance and feasibility of each item, respectively. After two Delphi rounds with infection experts, four Delphi rounds with simulation experts, and pilot testing with 30 ICU nurses, the NEUMOBACT-FINAL tool consisted of 17, 26 and 21 items, respectively, for CVC, ETS and PC.

Conclusion

NEUMOBACT-FINAL is useful and valid for assessing ICU nurses' knowledge and skills in VAP and CRB prevention, acquired through simulation.

Relevance for Clinical Practice

Our validated and clinically tested tool could facilitate the transfer of ICU nurses' knowledge and skills learning in VAP and CRB prevention to critically ill patients, decreasing infection rates and, therefore, improving patient safety.

Patient or Public Contribution

Experts participated in the Delphi rounds and nurses in the pilot test.

Enhanced active case finding of drug-resistant tuberculosis in Namibia: a protocol for the hotspots, hospitals, and households (H3TB) study

Por: Shavuka · O. · Iipumbu · E. · Boois · L. · Günther · G. · Hoddinott · G. · Lin · H.-H. · Nepolo · E. · Niemann · S. · Ruswa · N. · Seddon · J. · Claassens · M. M.
Introduction

Namibia is a high tuberculosis (TB)-burden country with an estimated incidence of 460/100 000 (around 12 000 cases) per year. Approximately 4.5% of new cases and 7.9% of previously treated TB cases are multidrug resistant (MDR) and 47% of patients with MDR-TB are HIV coinfected. Published data suggest a clustering of MDR-TB transmission in specific areas. Identifying transmission clusters is key to implementing high-yield and cost-effective interventions. This includes knowing the yield of finding TB cases in high-transmission zones (eg, community hotspots, hospitals or households) to deliver community-based interventions. We aim to identify such transmission zones for enhanced case finding and evaluate the effectiveness of this approach.

Methods and analysis

H3TB is an observational cross-sectional study evaluating MDR-TB active case finding strategies. Sputum samples from MDR-TB cases in three regions of Namibia will be evaluated by whole genome sequencing (WGS) in addition to routine sputum investigations (Xpert MTB/RIF, culture and drug susceptibility testing). We will collect information on household contacts, use of community spaces and geographical map intersections between participants, synthesising these data to identify transmission hotspots. We will look at the feasibility, acceptability, yield and cost of case finding strategies in these hotspots, and in households of patients with MDR-TB and visitors of hospitalised patients with MDR-TB. A compartmental transmission dynamic model will be constructed to evaluate the impact and cost-effectiveness of the strategies if scaled.

Ethics and dissemination

Ethics approval was obtained. Participants will give informed consent. H3TB will capitalise on a partnership with the Ministry of Health and Social Services to follow up individuals diagnosed with MDR-TB and integrate WGS data with innovative contact network mapping, to allow enhanced case finding. Study data will contribute towards a systems approach to TB control. Equally important, it will serve as a role model for similar studies in other high-incidence settings.

Protocol of a scoping review of outcome domains in dermatology

Por: Nadir · U. · Ahmed · A. · Yi · M. D. · Hisham · F. I. · Dave · L. · Kottner · J. · Ezzedine · K. · Garg · A. · Ingram · J. R. · Jemec · G. B. E. · Spuls · P. I. · Kirkham · J. J. · Cahn · B. · Alam · M.
Introduction

Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases.

Methods and analysis

We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts.

Ethics and dissemination

This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Associations between facial expressions and observational pain in residents with dementia and chronic pain

Abstract

Aim

To identify specific facial expressions associated with pain behaviors using the PainChek application in residents with dementia.

Design

This is a secondary analysis from a study exploring the feasibility of PainChek to evaluate the effectiveness of a social robot (PARO) intervention on pain for residents with dementia from June to November 2021.

Methods

Participants experienced PARO individually five days per week for 15 min (once or twice) per day for three consecutive weeks. The PainChek app assessed each resident's pain levels before and after each session. The association between nine facial expressions and the adjusted PainChek scores was analyzed using a linear mixed model.

Results

A total of 1820 assessments were completed with 46 residents. Six facial expressions were significantly associated with a higher adjusted PainChek score. Horizontal mouth stretch showed the strongest association with the score, followed by brow lowering parting lips, wrinkling of the nose, raising of the upper lip and closing eyes. However, the presence of cheek raising, tightening of eyelids and pulling at the corner lip were not significantly associated with the score. Limitations of using the PainChek app were identified.

Conclusion

Six specific facial expressions were associated with observational pain scores in residents with dementia. Results indicate that automated real-time facial analysis is a promising approach to assessing pain in people with dementia. However, it requires further validation by human observers before it can be used for decision-making in clinical practice.

Impact

Pain is common in people with dementia, while assessing pain is challenging in this group. This study generated new evidence of facial expressions of pain in residents with dementia. Results will inform the development of valid artificial intelligence-based algorithms that will support healthcare professionals in identifying pain in people with dementia in clinical situations.

Reporting Method

The study adheres to the CONSORT reporting guidelines.

Patient or Public Contribution

One resident with dementia and two family members of people with dementia were consulted and involved in the study design, where they provided advice on the protocol, information sheets and consent forms, and offered valuable insights to ensure research quality and relevance.

Trial Registration

Australian and New Zealand Clinical Trials Registry number (ACTRN12621000837820).

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