BACKGROUND: Regulations designed to protect children participating in clinical research often restrict the availability of research data necessary for the development of age-specific therapies and drug dosing. Few data exist on how children experience participation in clinical research, and studies investigating young children undergoing an intensive medical treatment are lacking.
METHODS: Mixed methods with semi-structured interviews and DISCO-RC questionnaires were used to explore young children\'s and their parents\' experiences in clinical research participation during a kidney transplantation trajectory.
RESULTS: Nine children and their parents were interviewed. Children\'s median age at kidney transplantation was 4 years (IQR 4,7); age at interview was 7 years (IQR 6,9). Thematic content analysis of interviews revealed that most children were unaware of having participated in a study. Both children and their parents frequently were unaware whether procedures were standard care or research related. The additional burden attributed to study participation varied from not at all to heavy in combination with intensive medical treatment. Positive experiences included kind healthcare professionals, effective distraction techniques, educational aspects, contributing to science and extra check-ups. Most reported negative experiences were conflicting communication, spending much time in the hospital, missing school and suboptimal planning. Venous puncture was stressful for all children, whereas the discomfort of other procedures varied.
CONCLUSIONS: Pediatric clinical research design should focus on education and fun during research procedures, smart planning, consistent communication, close collaboration between clinical and research team and age appropriate distraction techniques.

BACKGROUND: Research and policy demonstrate the value of and need for systematically identifying and preparing care partners for their caregiving responsibilities while their family member or friend living with dementia is hospitalized. The Care Partner Hospital Assessment Tool (CHAT) has undergone content and face validation and has been endorsed as appropriate by clinicians to facilitate the timely identification and preparation of care partners of older adult patients during their hospitalization. However, the CHAT has not yet been adapted or prospectively evaluated for use with care partners of hospitalized people living with dementia. Adapting and testing the CHAT via a pilot study will provide the necessary evidence to optimize feasibility and enable future efficacy trials.
OBJECTIVE: The purpose of this paper is to describe the study protocol for the adaptation and testing of the CHAT for use among care partners of hospitalized people living with dementia to better prepare them for their caregiving responsibilities after hospital discharge.
METHODS: Our protocol is based on the National Institutes of Health Stage Model and consists of 2 sequential phases, including formative research and the main trial. In phase 1, we will use a participatory human-centered design process that incorporates people living with dementia and their care partners, health care administrators, and clinicians to adapt the CHAT for dementia care (ie, the Dementia CHAT [D-CHAT]; stage IA). In phase 2, we will partner with a large academic medical system to complete a pilot randomized controlled trial to examine the feasibility and estimate the size of the effect of the D-CHAT on care partners\' preparedness for caregiving (stage IB). We anticipate this study to take approximately 60 months to complete, from study start-up procedures to dissemination. The 2 phases will take place between December 1, 2022, and November 30, 2027.
RESULTS: The study protocol will yield (1) a converged-upon, ready-for-feasibility testing D-CHAT; (2) descriptive and feasibility characteristics of delivering the D-CHAT; and (3) effect size estimates of the D-CHAT on care partner preparedness. We anticipate that the resultant D-CHAT will provide clinicians with guidance on how to identify and better prepare care partners for hospitalized people living with dementia. In turn, care partners will feel equipped to fulfill caregiving roles for their family members or friends living with dementia.
CONCLUSIONS: The expected results of this study are to favorably impact hospital-based care processes and outcomes for people living with dementia and their care partners and to elucidate the essential caregiving role that so many care partners of people living with dementia assume.
BACKGROUND: ClinicalTrials.gov NCT05592366; https://clinicaltrials.gov/ct2/show/NCT05592366.
UNASSIGNED: PRR1-10.2196/46808.

The development of infant mental health (IMH) services globally is still in its early stages. This qualitative study aims to understand the challenges of setting up IMH services and explores the views and experiences of 14 multi-disciplinary stakeholders who are part of the IMH implementation group in a large Scottish health board. Six major themes were identified through thematic analysis. This paper examines the most prominent theme \"Systems\" alongside the theme \"Gaps in Current Service\". The theoretical framework of \"candidacy\" is found to be a valuable way to conceptualize the complex systemic layers of micro, meso, and macro factors that contribute to the challenges of setting up services. At the micro level, key themes included the view that services must be accessible, individualized, and involve families. At the meso level, in line with the aims of the service, multiagency integration, aspects of early intervention, and clear operating conditions were all seen as important. Finally, at the macro level, perhaps the biggest challenge perceived by stakeholders is delivering a service that is entirely infant-focused. These findings will help inform policy makers about factors considered by professionals to be vital in the establishment of IMH services in Scotland and across the globe.
El desarrollo de los servicios de salud mental infantil (IMH) globalmente está aún en sus niveles básicos. Este estudio cualitativo se propone comprender los retos de establecer los servicios IMH y explora los puntos de vista y experiencias de 14 personas interesadas de múltiples disciplinas que son parte de un grupo de implementación de IMH dentro de una extensa junta de salud escocesa. A través de análisis temáticos se identificaron seis temas de mayor importancia. Este estudio examina el tema más prominente según la mayor percepción, “Sistemas,” junto con el tema “Vacíos en la Actual Prestación de Servicio.” Se estima que el marco teorético de trabajo de “candidatura,” es una manera valiosa de conceptualizar los complejos niveles sistémicos de micro, medio y macro factores que contribuyen a los retos de establecer los servicios. Al nivel micro, los temas claves incluyen el punto de vista de que los servicios deben ser accesibles, individualizados y deben involucrar a las familias. Al nivel medio, alineados con las metas del servicio, la integración de agencias múltiples, aspectos de temprana intervención y claras condiciones operativas fueron todas estimadas como importantes. Finalmente, al nivel macro, quizás el mayor reto percibido por las personas interesadas es cumplir con el ofrecimiento de un servicio que esté enteramente enfocado en el infante. Estos resultados ayudarán a informar a quienes determinan las políticas a seguir acerca de los factores que los profesionales consideran vitales en el establecimiento de servicios IMH en Escocia y alrededor del globo.
Au niveau global, le développement de service de santé mentale du nourrisson et de la petite enfance en est encore à ses débuts. Cette étude qualitative s\'est donnée pour but de comprendre les défis que pose l\'installation de services IMH. Elle explore les vues et les perspectives de 14 parties prenantes de diverses disciplines qui font partie d\'un groupe de mise en place IMH dans un grand conseil de santé en Ecosse. Six thèmes principaux ont été identifiés au travers une analyse thématique. Cet article examine le thème ayant été perçu comme le plus grand et proéminent, Systèmes, ainsi que le thème « Brèches dans les services actuels ». La structure théorique de la ‘candidature’ a été utilisée pour trouver une manière utile de conceptualiser les couches systémiques complexes de facteurs micro, méso, et macro qui contribuent aux défis qu\'il y a dans l\'installation de services. Au niveau micro, les thèmes clés ont inclus l\'idée que les services doivent être accessibles, individualisés et engager les familles. Au niveau méso, s\'alignant avec les buts du service, l\'intégration de plusieurs agences, les aspects d\'une intervention précoce et des conditions d\'opération claires ont tous été estimé être importants. Enfin, au niveau macro, le défi étant peut-être le plus grand selon les parties prenantes est d\'offrir un service qui est entièrement focalisé sur le nourrisson. Ces résultats aideront les décideurs pour ce qui s\'agit des facteurs considérés comme étant vitaux par les professionnels pour ce qui concerne l’établissement de services IMH en Ecosse et au travers du globe.
Die Entwicklung von Leistungen für die psychische Gesundheit von Kindern (infant mental health; IMH) befindet sich weltweit noch in einem frühen Stadium. Diese qualitative Studie zielt darauf ab, die Herausforderungen bei der Einrichtung von IMH-Leistungen zu verstehen. Untersucht werden die Ansichten und Erfahrungen von 14 multidisziplinären Interessenvertretenden, die Teil der IMH-Implementierungsgruppe in einem großen schottischen Gesundheitsamt sind. Durch eine thematische Analyse wurden sechs Hauptthemen ermittelt. In diesem Beitrag wird neben dem Thema “Lücken im derzeitigen Angebot” das als am stärksten wahrgenommene Thema “Systeme” untersucht. Der theoretische Rahmen der “Candidacy” hat sich als wertvoller Weg erwiesen, um die komplexen systemischen Schichten von Mikro-, Meso- und Makrofaktoren zu konzeptualisieren, die zu den Herausforderungen bei der Leistungseinrichtung beitragen. Zu den Schlüsselthemen auf der Mikroebene gehörte die Ansicht, dass die Leistungen zugänglich und individuell gestaltet sein und die Familien einbezogen werden müssen. Auf der Mesoebene wurden im Einklang mit den Zielen der Leistung die Integration mehrerer Stellen, Aspekte der Frühintervention und klare Arbeitsbedingungen als wichtig angesehen. Auf der Makroebene schließlich sehen die Beteiligten die vielleicht größte Herausforderung in der Bereitstellung einer Leistung, die ausschließlich auf Kleinkinder ausgerichtet ist. Diese Ergebnisse werden dazu beitragen, die politischen Entscheidungstragenden über Faktoren zu informieren, die von Fachleuten als entscheidend für die Einrichtung von IMH-Leistungen angesehen werden - in Schottland und auf der ganzen Welt.
世界的な乳幼児精神保健(IMH)サービスの開発は、まだ初期段階にある。この質的研究は、IMHサービス立ち上げの際の課題を理解することを目的とし、スコットランドの大規模な保健委員会でIMH実施グループの一員である14人の多職種の関係者の見解と経験を調査するものである。6つの主要なテーマが主題分析法により特定された。本論文では、最も大きく認識され注目しているテーマ「システム」を、テーマ「現状のサービスにおけるギャップ」とともに検証する。「キャンディダシー(candidacy)」という理論フレームワークはサービス立ち上げの課題に寄与するミクロ、メゾ、マクロ因子からなる複雑なシステム層の概念化に有用であるとされている。ミクロレベルでは、サービスはアクセスしやすく、個別化され、家族を含むものでなければならないという見解が主要なテーマに含まれた。メゾレベルでは、サービスの目的に沿って、複数機関の統合、早期介入の側面、明確な運営条件がすべて重要であると考えられている。最後に、マクロレベルでは、関係者が認識しているおそらく最大の課題は、徹底して乳幼児に焦点を当てたサービスを提供することであろう。これらの結果は、専門家がスコットランドや世界のIMHサービスの確立に不可欠とみなしている要素を、政策立案者に情報提供するのに役立つであろう。.
婴儿心理健康 (IMH) 服务的全球发展仍处于早期阶段。这项定性研究旨在了解建立IMH服务的挑战, 并探讨苏格兰一家大型卫生委员会IMH实施团队中14位多学科利益相关者的观点和经验。通过专题分析确定了六大主题。本文探讨了被认为最突出的主题“系统”以及“现有服务的差距”。“候选资格”的理论框架被认为是一种有价值的方法, 可以将微观、中观和宏观因素的复杂系统层概念化, 这些因素导致了建立服务的挑战。在微观层面, 关键主题包括这样一种观点, 即服务必须是易获得的、个性化的, 并让家庭参与。在中观层面, 根据服务目标, 多机构整合、早期干预以及清晰的运行条件都被视为重要因素。最后, 在宏观层面, 利益相关者认为的最大挑战可能是提供一种完全以婴儿为中心的服务。这些发现将有助于决策者了解专业人士认为对在苏格兰和全球建立IMH服务时至关重要的因素。.
لا يزال تطوير خدمات الصحة النفسية للأطفال (IMH) على مستوى العالم في مراحله الأولى. تهدف هذه الدراسة الوصفية إلى فهم تحديات إنشاء خدمات الصحة النفسية للأطفال واستكشاف آراء وخبرات 14 من أصحاب المصلحة متعددي التخصصات الذين يشكلون جزءًا من مجموعة تنفيذ IMH في لجنة إدارة صحية على مستوى عالي في اسكتلندا. تم تحديد ستة مواضيع رئيسية من خلال التحليل المواضيعي. تبحث هذه الدراسة في أكبر موضوع بارز وهو “الأنظمة” إلى جانب موضوع “الثغرات في الخدمة الحالية”. وقد تم استخدام الإطار النظري المعروف بـ (candidacy) أو السعي لتلقي الرعاية الصحية ليكون وسيلة لوضع تصور مفاهيمي لجوانب النظام المعقدة للعوامل الجزئية والمتوسطة والكلية التي تساهم في تحديات إنشاء الخدمات. على المستوى الجزئي ، تضمنت الموضوعات الرئيسية وجهة النظر القائلة بأن الخدمات يجب أن تكون في المتناول ، وأن تكون فردية ، وأن تشمل العائلات. على المستوى المتوسط ، تمشياً مع أهداف الخدمة ، تم اعتبار التكامل وجوانب التدخل المبكر واجراءات العمل الواضحة جميعها مهمة. أخيرًا ، على المستوى الكلي ، ربما يكون التحدي الأكبر الذي يدركه أصحاب المصلحة هو تقديم خدمة تركز بالكامل على الأطفال الرضع. ستساعد هذه النتائج على إعلام صانعي السياسات بالعوامل التي يعتبرها المتخصصون حيوية في إنشاء خدمات الصحة النفسية للأطفال في اسكتلندا وفي جميع أنحاء العالم.

Introduction: Completion of the renal transplant evaluation has been associated with several barriers for patients who identify as Black or African American. This study sought to prioritize barriers to and motivators of completing the renal transplant evaluation. Methods/Approach: Semi-structured interviews and focus groups with a nominal group technique were used to generate priority scores. Transplant professionals (N = 23) were recruited from 9 transplant centers in the Mid-Atlantic, Mid-Western, and Southeastern parts of the United States. Black or African American identifying renal patients (N = 30) diagnosed with end-stage kidney disease were recruited from 1 transplant center in the Mid-Atlantic region. Findings: Priority scores were created to assess the quantitative data of participant rankings of top barriers and motivators. The most significant barriers identified by both patients and transplant professionals comprised financial constraints, insurance issues, difficulty navigating the healthcare system, transportation difficulties, and multiple health problems. Facilitators consisted of family/social support, transplant education, patient navigators, comprehensive insurance, and physician repertoire and investment. A qualitative description of the ranked factors resulted in themes classified as intrapersonal, health, socioeconomic, transplant-specific healthcare, and general healthcare. Conclusion: These findings provided vital information to transplant centers nationwide about assessing the influences of renal transplant evaluation completion. Achieving equity in access to transplantation for Black or African American renal patients requires multilayered approaches.

UNASSIGNED: Many people with dementia (PwD) live and die with undiagnosed and untreated pain and are no longer able to report their suffering. Several pain assessment tools have been developed, tested, and implemented in clinical practice, but nursing home patients are reported to be still in pain. Clinicians and research groups worldwide are seeking novel approaches to encode the prediction, prevalence, and associations to pain in PwD.
UNASSIGNED: The data in this analysis are acquired from the COSMOS study, a cluster-randomized controlled trial (2014 to 2015), aimed to improve the quality of life in nursing home patients (N = 723) through the implementation of a multicomponent intervention. We utilize baseline data of PwD (N = 219) with complete datasets of pain and agitation.
UNASSIGNED: Systems analysis explores the relationship between pain and agitation using the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Pain Scale, Cohen-Mansfield Agitation Inventory (CMAI), and Neuropsychiatric Inventory-Nursing Home version (NPI-NH). For each patient, the individualized continuous time trajectory, and rates of change of pain and agitation are estimated. We determine the relationship between these rates by analyzing them across the entire group.
UNASSIGNED: We found that the new analysis method can generate individualized estimations for pain and agitation evolution for PwD, as well as their relationship. For 189 of 219 PwD, results show that whenever pain increases or decreases, agitation does too, with the same rate. The method also identifies PwD for whom pain or agitation remains constant while the other varies over time, and patients for whom agitation and pain do not change together. The algorithm is scalable to other variables and compatible with wearable devices and digital sensors.
UNASSIGNED: We presented a new approach to clinical data analysis using systems concepts and algorithms. We found that it is possible to quantify and visualize relationships between variables with a precision only dependent on the precision of measurements. This method should be further validated, but incipient results show great potential, especially for wearable-generated continuous data.

BACKGROUND: The clinical benefit of implementing the quick Sepsis-related Organ Failure Assessment (qSOFA) instead of early warning scores (EWS) to screen all hospitalised patients for critical illness has yet to be investigated in a large, multicentre study.
METHODS: We conducted a cohort study including all hospitalised patients ≥18 years with EWS recorded at hospitals in the Central Denmark Region during the year 2016. The primary outcome was intensive care unit (ICU) admission and/or death within 2 days following an initial EWS. Prognostic accuracy was examined using sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV). Discriminative accuracy was examined by the area under the receiver operating characteristic curve (AUROC).
RESULTS: Among 97 332 evaluated patients, 1714 (1.8%) experienced the primary outcome. The qSOFA ≥2 was less sensitive (11.7% (95% CI: 10.2% to 13.3%) vs 25.1% (95% CI: 23.1% to 27.3%)) and more specific (99.3% (95% CI: 99.2% to 99.3%) vs 97.5% (95% CI: 97.4% to 97.6%)) than EWS ≥5. The NPV was similar for the two scores (EWS ≥5, 98.6% (95% CI: 98.6% to 98.7%) and qSOFA ≥2, 98.4% (95% CI: 98.3% to 98.5%)), while the PPV was 15.1% (95% CI: 13.8% to 16.5%) for EWS ≥5 and 22.4% (95% CI: 19.7% to 25.3%) for qSOFA ≥2. The AUROC was 0.72 (95% CI: 0.70 to 0.73) for EWS and 0.66 (95% CI: 0.65 to 0.67) for qSOFA.
CONCLUSIONS: The qSOFA was less sensitive (qSOFA ≥2 vs EWS ≥5) and discriminatively accurate than the EWS for predicting ICU admission and/or death within 2 days after an initial EWS. This study did not support replacing EWS with qSOFA in all hospitalised patients.

ABSTRACTHealth systems analyses are touted as mechanisms through which health policy and planning may be implemented. An example is the WHO health systems approach that connects people (needs, rights, perspectives) with services and technologies (equitable access, quality of care, mix of interventions) and with policies and institutional capacities (laws, regulations, human/physical resources, management and financing). The approach is comprehensive and multi-faceted, which is a strength. We argue, however, that health systems analyses should be supplemented with a focus on reproductive justice. Using the WHO health systems approach as an exemplar, we show how the reparative reproductive justice approach outlined by the first author and colleagues assists with outlining comprehensive remedies to the inequities identified in the systems analysis. We argue for attention to remedies at individual and collective, material and symbolic levels. We illustrate our argument using unsafe abortion, legal abortion services and post-abortion care in Lesotho as a case study. We outline the policies, services and people components of abortion in Lesotho using the WHO systems model, followed by a reparative justice analysis of remedies.

Nudge interventions are widely used to promote health in schools, yet implementation metrics are seldom used to understand intervention outcomes. A multi-component intervention consisting of cafeteria decorations, creative names, social norming taste tests, and flavor station components was implemented in three rural elementary school cafeterias by school nutrition services (SNS) and extension staff. Selection and consumption of fruits and vegetables at lunch were measured through monthly plate waste assessments over eight months (n = 1255 trays). Interviews were conducted with SNS staff (n = 3) upon completion of the intervention to assess implementation outcomes using validated acceptability and feasibility metrics. Consumption findings were generally inconsistent across schools and time points, yet fruit consumption increased at School 1 (p < 0.05) during the taste test and flavor station intervention months and School 2 (p < 0.001) during the creative names intervention months compared to baseline. Odds of selecting a vegetable at School 3 were three times higher than baseline during the taste test intervention months (odds ratio (OR), 3.0; 95% confidence interval (CI), 1.3-6.5). Cafeteria decorations and taste tests had higher reported implementation metrics for acceptability and feasibility than other interventions. Thematic analysis underscored the facilitating role of extension support, as well as systems factors, which served as facilitators and barriers across schools and interventions. These findings suggest that nudge interventions are a promising strategy to improve vegetable selection and fruit consumption in school meal programs.

Complex systems challenges like those facing 21st-century humanity, require system-level solutions that avoid siloed or unnecessarily narrow responses. System-level biomimicry aims to identify and adopt design approaches that have been developed and refined within ecosystems over 3.8 billion years of evolution. While not new, system-level biomimetic solutions have been less widely applied in urban design than the \'form\' and \'process\' level counterparts. This paper explores insights from a selection of system-level case studies in the built environment, using meta-analysis to investigate common challenges and priorities from these projects to support knowledge-sharing and continued development in the field. Using a grounded research approach, common themes are distilled, and findings presented regarding success and barriers to implementation and scaling. Considering the findings, and drawing on complex adaptive systems theory, the paper posits opportunities to facilitate broader implementation and mainstreaming of system-level biomimetic design approaches in the built environment.

UNASSIGNED: This study characterized how an online continuing education activity affected knowledge, attitudes, and practices of healthcare professionals who care for patients with multiple sclerosis (MS) and whether those changes reflected theorized translational mechanisms proposed in The Expanded Learning Model for Systems (TELMS).
UNASSIGNED: This preliminary study used semi-structured interviews (thematic analysis) to assess whether and how translational mechanisms underpinning the TELMS theory might be revealed in learners\' attitudes and practice behavior. Eighteen participants (primarily neurologists and nurses) were interviewed by telephone or online. Thematic analysis identified relevant themes according to sensitizing concepts derived from TELMS and the recognition of emergent themes.
UNASSIGNED: Textual interpretation of interview data revealed that MS providers act in various scenarios that validate the principles of TELMS model of learning engagement. Further, elements of translational mechanisms proposed by TELMS were consistently observed in the narrative reflections. Emergent themes included the importance of practices such as goal setting, coordination of care, systems-level MS care, and economic considerations. Practitioners particularly drew on ideas from TELMS when facing challenges in diverse cultural and sociocultural settings.
UNASSIGNED: We identified mechanisms of change reflected in the TELMS model that is useful for the design and evaluation of future educational activities. These include attitudes and beliefs about the application of evidence-aligned MS care, as well as the commitment to multidisciplinary strategies, enhanced coordination of care, and promotion of systems-based changes. Future studies are needed to further validate the TELMS model.