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

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.

Nutrition supplementation plus standard of care versus standard of care alone or standard of care plus unconditional cash transfer in the prevention of chronic malnutrition in Southern Angola: study protocol for the MuCCUA study, a cluster randomized controlled trial.

BACKGROUND: Chronic malnutrition is a condition associated with negative impacts on physical and cognitive development. It is multi-causal and can start very early in life, already in utero, thus it is especially challenging to find appropriate interventions to tackle it. The government of Angola is implementing a standard of care program with potential to prevent it, and the provision of cash transfers and the supplementation with small quantity lipid-based nutrients (SQ-LNS) are also promising interventions. We aimed to evaluate the impact of the standard of care program alone and of the standard of care plus a cash transfer intervention in the lineal growth of children less than 2 years old and compare it to the effectiveness of a nutrition supplementation plus standard of care program in Southern Angola. METHODS/DESIGN: The three-arm parallel cluster randomised controlled trial is set in four communes of Huila and Cunene provinces. Clusters are villages or neighbourhoods with a population around 1075 people. A total of twelve clusters were selected per arm and forty pregnant women are expected to be recruited in each cluster. Pregnant women receive the standard of care alone, or the standard of care plus unconditional cash transfer or plus nutritional supplementation during the first 1000 days, from pregnancy to the child reaching 24 months. The primary outcome is the prevalence of stunting measured as height-for-age Z-score (HAZ) < -2 in children below 2 years. Impact will be assessed at 3, 6, 12, 18 and 24 months of children's age. Secondary outcomes include mortality, morbidity, caring, hygiene and nutrition behaviours and practices, and women and children's dietary diversity. Quantitative data are also collected on women's empowerment, household food security, expenditure and relevant clinical and social events at baseline, endline and intermediate time points. DISCUSSION: The results will provide valuable information on the impact of the standard of care intervention alone as well as combined with an unconditional cash transfer intervention compared to a nutrition supplementation plus standard of care intervention, carried out during the first 1000 days, in the children´s growth up to 2 years and related outcomes in Southern Angola. TRIAL REGISTRATION: Clinical Trials NCT05571280. Registered 7 October 2022.

The Impact of Forced Separations Between Women and Their Pets in Domestic Violence Situations and the Effectiveness of Crisis Response: Protocol for a Conceptual Framework.

BACKGROUND: Women are at high risk of experiencing trauma, guilt, and stress when forced to separate from their companion animals when fleeing domestic violence. Where little support is available for women and pets to stay together, women may be forced to delay leaving the abusive relationship or leave the pet with the abuser. Forced separation places both women and pets at substantial risk, where pets may be used as a coercive control measure. However, little evidence exists regarding the extent to which Australian services or policies offer support in these circumstances. OBJECTIVE: This research aims to increase the understanding and the impacts of forced separation between women and their pets in domestic violence situations. The research will investigate the effectiveness of service responses for both women and animals, aiming to develop a policy framework that guides service improvement with the goal of enhancing outcomes for women and pets fleeing domestic violence. METHODS: This protocol paper describes the process of developing a conceptual framework of 4 studies that include a scoping review, policy analysis, focus groups, and interviews that guide the design of the qualitative research project. RESULTS: A scoping review of the literature on forced separation from pets in domestic violence, natural disasters, and homelessness situations has led to the development of a conceptual framework that guided the design of the proposed study. The review also confirmed the necessity of the proposed research project in addressing the lack of Australian national frameworks and guidance available for women and pets seeking formal support in domestic violence situations. As of August 2023, supporting organizations have commenced the distribution of the research flyers. Expected data collection will be completed between August and October 2023. The results are expected to be published in June 2025. CONCLUSIONS: Via a systematic process, the importance of the proposed study in improving the understanding of the impact of forced separation between women and their pets at times of domestic violence and the gaps in best supporting both women and their pets has been confirmed. A study design based on the learnings from previous studies and the focus of the current research has been finalized. The impact of the research project in developing an Australian national framework for best supporting women and their pets in crisis situations is anticipated. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52067.

Designing Implementation Strategies for a Digital Suicide Safety Planning Intervention in a Psychiatric Emergency Department: Protocol for a Multimethod Research Project.

BACKGROUND: Suicide prevention is currently a national health priority in Canada. Emergency departments (EDs) are critical settings for suicide prevention, and in our local psychiatric ED at the Centre for Addiction and Mental Health, we plan to embed an app-based tool called the Hope app to support suicide safety planning intervention. The app is free and available on app stores, and usability tests have been completed. As a next step to embed this new tool into the routine clinical workflow, research is needed to assess determinants of and design strategies for implementation with the end goal of routinization. OBJECTIVE: The purpose of this 2-phased research is to implement the app in the routine clinical workflow in our local psychiatric ED. The specific objectives are as follows: (1) understanding ED clinicians' perceptions and experience of implementing the app in routine practice and identifying barriers to and facilitators of implementation (phase 1) and (2) using findings and outputs from phase 1 and collaborating with service users, families, and ED clinicians to co-design implementation strategies for the app (phase 2). METHODS: We will use an integrated knowledge translation approach throughout this project. In phase 1, we will conduct interviews with ED clinicians to identify implementation determinants using a behavior change framework. In phase 2, a co-design team comprising clinicians, ED service users, and families will design implementation strategies that align with the determinants identified in phase 1. RESULTS: This protocol presents detailed information about the entire structure of the 2-phased research project. Ethics approval for conducting the qualitative descriptive study (phase 1) has been obtained, and the recruitment and data collection processes will be completed no later than December 2023. Ethics approval for phase 2 is underway. CONCLUSIONS: Involving multiple knowledge user groups early in the research and decision-making process is crucial for successful implementation. Although co-designing is commonly practiced during innovation development, there is often a misconception that the responsibility for implementing what has been designed falls on others. This research aims to fill this methodological gap in the health informatics literature. By the end of this project, we will have developed theory-informed implementation strategies to support Centre for Addiction and Mental Health ED clinicians in adopting the Hope app to complete safety planning intervention. These strategies, guided by a behavior change framework, will target clinicians' behavior change and seamlessly integrate the app into the routine clinical workflow. In addition, this research project will provide recommendations on how to involve multiple knowledge user groups and offer insights into how the methodology used can be adapted to other areas within the health informatics literature. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50643.

Developing Health Management Competency for Digital Health Transformation: Protocol for a Qualitative Study.

BACKGROUND: Globally, the health care system is experiencing a period of rapid and radical change. In response, innovative service models have been adopted for the delivery of high-quality care that require a health workforce with skills to support transformation and new ways of working. OBJECTIVE: The aim of this research protocol is to describe research that will contribute to developing the capability of health service managers in the digital health era and enabling digital transformation within the Australian health care environment. It also explains the process of preparing and finalizing the research design and methodologies by seeking answers to the following three research questions: (1) To what extent can the existing health service management and digital health competency frameworks guide the development of competence for health service managers in understanding and managing in the digital health space? (2) What are the competencies that are necessary for health service managers to acquire in order to effectively work with and manage in the digital health context? (3) What are the key factors that enable and inhibit health service managers to develop and demonstrate digital health competence in the workplace? METHODS: The study has adopted a qualitative approach, guided by the empirically validated management competency identification process, using four steps: (1) health management and digital health competency mapping, (2) scoping review of literature and policy analysis, (3) focus group discussions with health service managers, and (4) semistructured interviews with digital health leaders. The first 2 steps were to confirm the need for updating the current health service management curriculum to address changing competency requirements of health service managers in the digital health context. RESULTS: Two initial steps have been completed confirming the significance of the study and study design. Step 1, competency mapping, found that nearly half of the digital competencies were only partially or not addressed at all by the health management competency framework. The scoping review articulated the competencies health service managers need to effectively demonstrate digital health competence in the workplace. The findings effectively support the importance of the current research and also the appropriateness of the proposed steps 3 and 4 in answering the research questions and achieving the research aim. CONCLUSIONS: This study will provide insights into the health service management workforce performance and development needs for digital health and inform credentialing and professional development requirements. This will guide health service managers in leading and managing the adoption and implementation of digital health as a contemporary tool for health care delivery. The study will develop an in-depth understanding of Australian health service managers' experiences and views. This research process could be applied in other contexts, noting that the results need contextualization to individual country jurisdictions and environments. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51884.

Web-Based Presence for Social Connectedness in Long-Term Care: Protocol for a Qualitative Multimethods Study.

BACKGROUND: The COVID-19 pandemic and resultant restrictions on social gatherings significantly impacted many peoples' sense of social connectedness, defined as an individual's subjective sense of having close relationships with others. Older adults living in long-term care homes (LTCHs) experienced extreme restrictions on social gatherings, which negatively impacted their physical and mental health as well as the health and well-being of their family caregivers. Their experiences highlighted the need to reconceptualize social connectedness. In particular, the pandemic highlighted the need to explore novel ways to attain fulfilling relationships with others in the absence of physical gatherings such as through the use of a hybridized system of web-based and in-person presence. OBJECTIVE: Given the potential benefits and challenges of web-based presence technology within LTCHs, the proposed research objectives are to (1) explore experiences regarding the use of web-based presence technology (WPT) in support of social connectedness between older adults in LTCHs and their family members, and (2) identify the contextual factors that must be addressed for successful WPT implementation within LTCHs. METHODS: This study will take place in south western Ontario, Canada, and be guided by a qualitative multimethod research design conducted in three stages: (1) qualitive description with in-depth qualitative interviews guided by the Technology Acceptance Model (TAM) and analyzed using content analysis; (2) qualitative description and document analysis methodologies, informed by content and thematic analysis methods; and (3) explicit between-methods triangulation of study findings from stages 1 and 2, interpretation of findings and development of a guiding framework for technology implementation within LTCHs. Using a purposeful, maximum variation sampling approach, stage 1 will involve recruiting approximately 45 participants comprising a range of older adults, family members (30 participants) and staff (15 participants) within several LTCH settings. In stage 2, theoretical sampling will be used to recruit key LTCH stakeholders (directors, administrators, and IT support). In stage 3, the findings from stages 1 and 2 will be triangulated and interpreted to develop a working framework for WPT usage within LTCHs. RESULTS: Data collection will begin in fall 2023. The findings emerging from this study will provide insights and understanding about how the factors, barriers, and facilitators to embedding and spreading WPT in LTCHs may benefit or negatively impact older adults in LTCHs, family caregivers, and staff and administrators of LTCHs. CONCLUSIONS: The results of this research study will provide a greater understanding of potential approaches that could be used to successfully integrate WPTs in LTCHs. Additionally, benefits as well as challenges for older adults in LTCHs, family caregivers, and staff and administrators of LTCHs will be identified. These findings will help increase knowledge and understanding of how WPT may be used to support social connectedness between older adults in LTCHs and their family members. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50137.

An Approach to Overcome the Limitations of Surveillance of Asbestos Related Diseases in Low- and Middle-Income Countries: What We Learned from the Sibaté Study in Colombia.

Introduction: The asbestos industry began its operations in Colombia in 1942 with the establishment of an asbestos-cement facility in Sibaté, located in the Department of Cundinamarca. Despite extensive asbestos use and production in Colombia, the country lacks a reliable epidemiological surveillance system to monitor the health effects of asbestos exposure. The Colombian health information system, known as SISPRO, did not report mesothelioma cases diagnosed in the municipality, posing a significant challenge in understanding the health impacts of asbestos exposure on the population of Sibaté. Methods: To address this issue, an active surveillance strategy was implemented in Sibaté. This strategy involved conducting door-to-door health and socioeconomic structured interviews to identify Asbestos-Related Diseases (ARDs). Validation strategies included a thorough review of medical records by a panel of physicians, and the findings were communicated to local, regional, and national authorities, as well as the general population. Results: The active surveillance strategy successfully identified a mesothelioma cluster in Sibaté, revealing the inadequacy of the existing health information system in monitoring asbestos-related diseases. The discovery of this cluster underscores the critical importance of implementing active surveillance strategies in Colombia, where governmental institutions and resources are often limited. Conclusion: The findings of this study emphasize the urgent need for Colombia to establish a reliable epidemiological surveillance system for asbestos-related diseases (ARDs). Active surveillance strategies can play a crucial role in identifying mesothelioma clusters and enhancing our understanding of the health effects of asbestos exposure in low- and middle-income countries.

Evaluation of the Effectiveness of Assistive Technology for Executive Function Support for People With Acquired Brain Injury: Protocol for Single-Case Experimental Designs.

BACKGROUND: Executive function, including prospective memory, initiating, planning, and sequencing everyday activities, is frequently affected by acquired brain injury (ABI). Executive dysfunction necessitates the use of compensatory cognitive strategies and, in more severe cases, human support over time. To compensate for the executive dysfunction experienced, growing options for electronic mainstream and assistive technologies may be used by people with ABI and their supporters. OBJECTIVE: We outline the study protocol for a series of single-case experimental designs (SCEDs) to evaluate the effectiveness of smart home, mobile, and/or wearable technologies in reducing executive function difficulties following ABI. METHODS: Up to 10 adults with ABI who experience executive dysfunction and have sufficient cognitive capacity to provide informed consent will be recruited across Victoria and New South Wales, Australia. Other key inclusion criteria are that they have substantial support needs for everyday living and reside in community dwellings. On the basis of the participant's identified goal(s) and target behavior(s), a specific electronic assistive technology will be selected for application. Both identification of the target behavior(s) and selection of the assistive technology will be determined via consultation with each participant (and their key support person, if applicable). The choice of SCED will be individualized for each participant based on the type of technology used in the intervention, the difficulty level of the behavior targeted for change, and the anticipated rate of change. For each SCED, repeated measurements of the target behavior(s) during the baseline condition will provide performance data for comparison with the performance data collected during the intervention condition (with technology introduced). Secondary outcome measures will evaluate the impact of the intervention. The protocol includes 2 customizable Microsoft Excel spreadsheets for electronic record keeping. RESULTS: Recruitment period is June 2022 through March 2024. Trial results for the individual participants will be graphed and analyzed separately using structured visual analysis supplemented with statistical analysis. Analysis will focus on important features of the data, including both within- and between-phase comparisons for response level, trend, variability, immediacy, consistency, and overlap. An exploratory economic evaluation will determine the impact on formal and informal support usage, together with quality of life, following the implementation of the new technological intervention. CONCLUSIONS: The study has been designed to test the cause-effect functional relationships between the intervention-in this case, electronic assistive technology-and its effect in changing the target behavior(s). The evaluation evidence gained will offer new insights into the application of various electronic assistive technologies for people who experience executive dysfunction following ABI. Furthermore, the results will help increase the capacity of key stakeholders to harness the potential of technology to build independence and reduce the cost of care for this population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000835741, https://www.anzctr.org.au/ACTRN12622000835741.aspx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48503.

Integrating a Research Protocol into a Health Care Setting.

Initiating a research protocol into any health care setting requires planning to ensure the research is conducted safely and efficiently, and will yield accurate data. An understanding of basic research principles is essential in this process. One agency that provides Good Clinical Practice guidelines for research is the International Council for Harmonization. This agency mandates Insti tutional Review Board (IRB) oversight for all studies that involve human subjects. The IRB ensures the research design and protocol protect the rights, welfare, and safety of human subjects, as well as appropriate data collection. Once IRB approval is obtained, protocol integration can begin, utilizing the planning described in this article.

An expert patient program to improve the empowerment and quality of life of people with multiple sclerosis: protocol for a multicenter pre-post intervention study.

Introduction: Multiple sclerosis (MS) causes a progressive disability, which substantially impacts the quality of life (QoL). Health interventions that meet the needs and demands of people with MS are essential to minimize QoL impairment. Expert patient programs (EPPs) facilitate health-related empowerment through peer learning. Based on a previous focus group study, we designed an EPP for MS coordinated by nursing professionals for implementation in the different MS reference units of Catalonia (Southwestern Europe). This study aims to evaluate the effects on quality of life, disease-related knowledge, and self-management related to the health process of the participants of the Expert Patient Program Catalonia™ for people with multiple sclerosis (EPPC-MS). Methods: Pre-post intervention multicenter clinical study involving 12 groups of 12 participants: six groups including relapsing and six groups including progressive MS patients, with 144 participants from 7 MS reference units from all over Catalonia, organized in six teams. The intervention will consist of nine telematic learning peer-led sessions (one weekly session). The expert patient (EP) leading the sessions will be an individual with MS with disease-related knowledge, who will be further trained by nurses to lead the sessions. Study variables will be measured before and immediately after the intervention and 6 and 12 months after the end of the sessions and will include: QoL, emotional impact, activation of the person, MS-related knowledge, fatigue, habits and lifestyles, health services use, and program-related experience. Baseline characteristics considered will be sociodemographic data, date of MS diagnosis and type, family history, and treatment characteristics. Variables related to disease follow-up will be new relapses and characteristics and changes in the ongoing treatment. The number of sessions attended will also be collected. Study variables will be analyzed using a pre-post comparison. Discussion: Peer-led learning programs led by EP help empower people with chronic conditions and offer them tools to improve their autonomy and QoL. This study's intervention will be performed remotely, offering advantages both for people with chronic conditions and the healthcare system regarding the facilitation of family and work conciliation, saving time, simplifying attendance to meetings, lowering costs, and using fewer material resources. Trial registration: NCT04988880 on September 22, 2021.

Establishing an International Interdisciplinary Research Network in Craniofacial Microsomia: The CARE Program.

OBJECTIVE: Craniofacial microsomia (CFM) is a broad clinical term used to describe a congenital condition most commonly involving the underdevelopment of the external ear, mandible, soft tissues, and facial nerve. Despite medical advances, understanding of the psychological health and healthcare experiences of individuals with CFM and their caregivers remains limited. This article describes a research program designed to address these knowledge gaps, and identify opportunities for psychosocial intervention and improved healthcare provision. DESIGN: The Craniofacial microsomia: Accelerating Research and Education (CARE) research program aims to: 1) Conduct up to 160 narrative interviews with individuals and caregivers to validate a conceptual framework; 2) Administer an online international survey of up to 800 individuals with CFM and caregivers to identify predictors of psychological distress; 3) Perform up to 60 semi-structured interviews with healthcare providers and advocacy leaders to examine the extent to which current healthcare provisions address identified patient needs; and 4) Establish a participant registry to build a longitudinal database and develop an international community. RESULTS: Teams in the USA and UK have been established, alongside an international, interdisciplinary Advisory Committee. Data analysis for Aim 1 is ongoing and informing the delivery of Aims 2-3. Aim 4 is also in development. A dedicated website serves as a recruitment tool, educational resource, and mechanism for engaging with the CFM community. CONCLUSIONS: The CARE program provides a comprehensive approach to understanding the experiences of individuals with CFM and their caregivers. Challenges encountered and lessons learned are shared for the benefit of the community.

How does community engagement evolve in different compassionate community contexts? A longitudinal comparative ethnographic research protocol.

Background: Compassionate communities build on health promoting palliative care that aims to address gaps in access, quality, and continuity of care in the context of dying, death, loss, and grief. While community engagement is a core principle of public health palliative care, it has received little attention in empirical studies of compassionate communities. Objectives: The objectives of this research are to describe the process of community engagement initiated by two compassionate communities projects, to understand the influence of contextual factors on community engagement over time, and assess the contribution of community engagement on proximal outcomes and the potential for sustaining compassionate communities. Research Approach and Design: We use a community-based participatory action-research approach to study two compassionate communities initiatives in Montreal (Canada). We develop a longitudinal comparative ethnographic design to study how community engagement evolves in different compassionate communities contexts. Methods and Analysis: Data collection includes focus groups, review of key documents and project logbooks, participant observation, semi-structured interviews with key informants, and questionnaires with a focus on community engagement. Grounded in the ecology of engagement theory and the Canadian compassionate communities evaluation framework, data analysis is structured around longitudinal and comparative axes to assess the evolution of community engagement over time and to explore the contextual factors influencing the process of community engagement and its impacts according to local context. Ethic: This research is approved by the research ethics board of the Centre hospitalier de l'Université de Montréal (approval certificate #18.353). Discussion: Understanding the process of community engagement in two compassionate communities will contribute to a deeper understanding of the relationships between local context, community engagement processes, and their effect on compassionate communities outcomes.

Identification and Characterisation of Infiltrating Immune Cells in Malignant Pleural Mesothelioma Using Spatial Transcriptomics.

Increasing evidence strongly supports the key role of the tumour microenvironment in response to systemic therapy, particularly immune checkpoint inhibitors (ICIs). The tumour microenvironment is a complex tapestry of immune cells, some of which can suppress T-cell immunity to negatively impact ICI therapy. The immune component of the tumour microenvironment, although poorly understood, has the potential to reveal novel insights that can impact the efficacy and safety of ICI therapy. Successful identification and validation of these factors using cutting-edge spatial and single-cell technologies may enable the development of broad acting adjunct therapies as well as personalised cancer immunotherapies in the near future. In this paper we describe a protocol built upon Visium (10x Genomics) spatial transcriptomics to map and characterise the tumour-infiltrating immune microenvironment in malignant pleural mesothelioma. Using ImSig tumour-specific immune cell gene signatures and BayesSpace Bayesian statistical methodology, we were able to significantly improve immune cell identification and spatial resolution, respectively, improving our ability to analyse immune cell interactions within the tumour microenvironment.

A protocol of an international validation study to assess the clinical accuracy of the eDIS-ICU delirium screening tool.

BACKGROUND: Delirium is a common, yet underdiagnosed neuropsychiatric complication of intensive care unit (ICU) admission, associated with significant mortality and morbidity. Delirium can be difficult to diagnose, with gold standard assessments by a trained specialist being impractical and rarely performed. To address this, various tools have been developed, enabling bedside clinicians to assess for delirium efficiently and accurately. However, the performance of these tools varies depending on factors including the assessor's training. To address the shortcomings of current tools, electronic tools have been developed. AIMS AND OBJECTIVES: The aims of this validation study are to assess the feasibility, acceptability, and generalisability of a recently developed and pilot-tested electronic delirium screening tool (eDIS-ICU) and compare diagnostic concordance, sensitivity, and specificity between eDIS-ICU, Confusion Assessment Method for the ICU (CAM-ICU), and the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V) gold standard in diverse ICU settings. METHODS: Seven hundred participants will be recruited across five sites in three countries. Participants will complete three assessments (eDIS-ICU, CAM-ICU, and DSM-V) twice within one 24-h period. At each time point, assessments will be completed within one hour. Assessments will be administered by three different people at any given time point, with the assessment order and assessor for eDIS-ICU and CAM-ICU randomly allocated. Assessors will be blinded to previous and concurrent assessment results. RESULTS: The primary outcome is comparing diagnostic sensitivity of eDIS-ICU and CAM-ICU against the DSM-V. RELEVANCE TO CLINICAL PRACTICE: This protocol describes a definitive validation study of an electronic diagnostic tool to assess for delirium in the ICU. Delirium remains a common and difficult challenge in the ICU and is linked with multiple neurocognitive sequelae. Various challenges to routine assessment mean many cases are still unrecognised or misdiagnosed. An improved ability for bedside clinicians to screen for delirium accurately and efficiently will support earlier diagnosis, identification of underlying cause(s) and timely treatments, and ultimately improved patient outcomes. CLINICAL TRIAL REGISTRATION NUMBER: This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) on 8th February 2022 (ACTRN12622000220763).

Standardized and validated training to support the charge nurse: Research protocol.

AIM: To develop a standardized training for charge nurses. DESIGN: A developmental research design divided into three parts will be undertaken. METHODS: (1) A scoping review will be used to develop standardized training focusing on charge nurse skills and sub-skills; (2) a Delphi review with nurses, managers and researchers will validate the content of the training; content validity will be assessed over sufficient rounds of review to obtain a content validity index of over 0.7 and (3) a cross-sectional study will pilot test the training with 30 charge nurses. RESULTS: This study will describe the development of updated and empirically validated training to be systematically implemented in healthcare institutions and offered to charge nurses when they begin.

Lung Ultrasound Protocol and Quality Control of Image Interpretation Using an Adjudication Panel in the Household Air Pollution Intervention Network (HAPIN) Trial.

OBJECTIVE: Lung ultrasound (LUS) is an alternative to chest radiography to confirm a diagnosis of pneumonia. For research and disease surveillance, methods to use LUS to diagnose pneumonia are needed. METHODS: In the Household Air Pollution Intervention Network (HAPIN) trial, LUS was used to confirm a clinical diagnosis of severe pneumonia in infants. We developed a standardized definition of pneumonia, protocols for recruitment and training of sonographers, along with LUS image acquisition and interpretation. We use a blinded panel approach to interpretation with LUS cine-loops randomized to non-scanning sonographers with expert review. DISCUSSION: We obtained 357 lung ultrasound scans: 159, 8 and 190 scans were collected in Guatemala, Peru and Rwanda, respectively. The diagnosis of primary endpoint pneumonia (PEP) required an expert tie breaker in 181 scans (39%). PEP was diagnosed in 141 scans (40%), not diagnosed in 213 (60%), with 3 scans (<1%) deemed uninterpretable. Agreement among the two blinded sonographers and the expert reader in Guatemala, Peru and Rwanda was 65%, 62% and 67%, with a prevalence-and-bias-corrected kappa of 0.30, 0.24 and 0.33, respectively. CONCLUSION: Use of standardized imaging protocols, training and an adjudication panel resulted in high confidence for the diagnosis of pneumonia using LUS.

Evaluation of the impact of COVID-19 in people coinfected with HIV and/or tuberculosis in low-income countries: study protocol for mixed methods research in Burkina Faso.

BACKGROUND: An issue of particular concern is the impact of the 2019 novel coronavirus (2019 nCOV) on the people coinfected with the Human Immuno-deficiency Virus (HIV) and/or tuberculosis (TB). Unfortunately, this interaction has not been well explored in African despite the large proportion of these risk populations living with HIV and/or patients and/or tuberculosis (TB) in the African region. This study aims to design a research protocol for assessment of the impact of coronavirus disease 2019 (COVID-19) on these risk populations in response to COVID-19 strategic plans in Burkina Faso by generating serological, epidemiological, virological, clinical and socio-anthropological evidence-based data. METHODS: A multidisciplinary research will be conducted in the city of Bobo-Dioulasso, Burkina Faso using mixed methods. Data will be collected from a cohort of people living with HIV and/or TB patients in the city (i) to determine the proportion of people with specific antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using retrospective data ; (ii) to determine the proportion of people infected with Covid-19 and the dynamics of viral loads and antibodies in these people based on prospective data; (iii) to identify circulating SARS-COV-2 variants and novel biomarkers using prospective data ; (iv) to analyze perceptions, community experiences and response strategies during the public health emergencies imposed by COVID-19 through a qualitative study. DISCUSSION: This study will generate factual and comprehensive data that will contribute in improving response strategies to COVID-19 and the other possible emerging diseases with keen interest on the risk populations living with HIV and/or TB infected patients.

Transitioning a Research Protocol for Videosomnography to Assess Sleep and Nighttime Caregiving Activities in School-Aged Children With Developmental Disabilities During the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic significantly affected children with developmental disabilities (DDs)' sleep. Videosomnography is a noninvasive, portable time-lapse video recording system to objectively obtain a child's sleep-wake behaviors and parents' caregiving activities in a natural environment. METHOD: From September 2020 to February 2021, we conducted a feasibility study using actigraphy (in mothers) and videosomnography in children with DDs for seven consecutive nights to assess sleep and nighttime caregiving activities. Because of the pandemic, we developed and implemented alternative data collection strategies, such as delivering a "study package" with easy-to-follow written instructions and emailed video-recorded instructions on recording a child's sleep. RESULTS: We aimed to enroll 10 mothers and 10 school-aged children with DDs and achieved this goal. Nine out of 10 mothers completed video recordings of their child's sleep, with only 10% missing data for videosomnography. DISCUSSION: This paper shared adaptations to our videosomnography protocol and lessons learned.

Psychometric properties of instruments to measure the well-being of young children: A systematic review protocol

Background@#Child well-being is an important outcome and has received attention from researchers for decades. Until recently, there has been difficulty in drawing conclusions from these studies because of the wide variety of measures used.@*Objective@#This systematic review aims to summarize and assess the measurement properties of existing child well-being instruments presented in the literature.@*Methods@#This systematic review will focus on studies that evaluated the psychometric properties of instruments to measure the well-being of children ages two to seven. The search strategy will aim to locate studies in the English language completed from 2000 to 2023. The databases to be searched include MEDLINE via PubMed, CINAHL Plus, and Psychology & Behavioral Sciences Collection via EBSCOhost. Proquest Dissertations and Theses, Google Scholar, and Research Gate will be used to search unpublished studies. Following the search, all identified citations will be collated in Mendeley. The full text of selected citations will be uploaded to JBI-SUMARI, assessed in detail against the inclusion criteria, and critically appraised using the COSMIN Risk of Bias checklist by two independent reviewers. Data will be extracted using JBI-SUMARI by one reviewer and verified by another. Findings will be reported using a narrative synthesis and tables. If possible, a meta-analysis will be performed. The evidence for each measurement property for each instrument will be compared against acknowledged standards for appropriate measurement characteristics using the COSMIN-proposed "criteria for good measurement properties."@*Expected Results@#This systematic review will provide further evidence regarding the measurement properties of instruments used to measure the well-being of children, specifically in the early years. The findings of this study will be disseminated through a conference presentation and publication in a peer-reviewed journal@*PROSPERO registration number@#CRD4202342T8953

Proposta de Pesquisa Científica para Avaliação da Segurança Microbiológica de Queijos Artesanais fabricados com leite cru e maturados por período inferior a 60 dias produzidos no estado de São Paulo / Scientific Research Proposal for the Microbiological Safety Evaluation of Raw Milk Artisanal Cheeses Ripened for Less than 60 Days in the State of São Paulo

Introdução: No Brasil, a legislação exige maturação mínima de 60 dias para queijos produzidos com leite cru, salvo se houver comprovação científica de que a redução do prazo não compromete a segurança do produto, como ocorreu com alguns queijos artesanais tradicionais de diferentes regiões do estado de Minas Gerais. No estado de São Paulo, onde os produtores seguem formulações e processos específicos individuais, a falta de um padrão de pesquisa validado dificulta a avaliação da segurança microbiológica deste tipo de queijo, pois essas pesquisas são dispendiosas e não há garantia de que os parâmetros estabelecidos pelos pesquisadores seriam aceitos pelos serviços de inspeção. Objetivo: Para abordar este desafio, esta proposta visa estabelecer um modelo de pesquisa científica padronizado para avaliar a segurança de queijos de leite cru maturados por menos de 60 dias. Métodos: Com base na proposta do DIPOA para classificação de Risco de Estabelecimentos, foi criado um checklist para classificação dos estabelecimentos/produtos, considerando risco do produto, volume processado e características de desempenho do estabelecimento em relação às Boas Práticas de Fabricação.  Resultados: A pontuação obtida pela aplicação do checklist na produção do queijo em questão determina o risco do produto como baixo, médio, alto ou muito alto e auxilia no estabelecimento do número mínimo de amostras a serem avaliadas mensalmente. Discussão: Espera-se que essa pesquisa auxilie produtores e órgãos de registro, fiscalização e inspeção no processo de legalização dos queijos artesanais de leite cru, possibilitando o desenvolvimento rural e a fixação de mão de obra no campo. (AU)

Introduction: In Brazil, the legislation requires a minimum ripening period of 60 days for raw milk cheeses, unless scientific evidence shows that the reduction in the ripening time does not compromise food safety, as seen with traditional artisanal cheeses from the state of Minas Gerais. In the state of Sao Paulo, where many producers have developed their own specific formulations and processes, the lack of a standardized validated research protocol for these types of cheese hinders their microbiological safety evaluation, since this type of research is costly and there are no guarantees that the parameters stablished by the researchers would be accepted by the inspection services. Objectives: To address this challenge, this proposal aims to stablish a standardized scientific research protocol for assessing the safety of raw milk cheeses ripened for less than 60 days. Methods: Based on the DIPOA (Department of Inspection of Products of Animal Origin) risk classification model for establishments, a checklist was created to categorize establishments/products, taking into consideration the product's risk, processed volume, and the establishment's performance assessed on the basis of good manufacturing practices. Results: The score obtained through the checklist application determines the final risk level of the product, categorized as low, medium, high, or very high, and helps determining the minimum number of samples to be evaluated monthly. Discussion: This research protocol may help producers, regulatory, inspection, and registration bodies in the legalization process of raw milk artisanal cheeses, enabling rural development and fixation of workforce in rural settings. (AU)