Defining Self-Management for Solid Organ Transplantation Recipients: A Mixed Method Study.

Patients with Solid Organ Transplantations (SOTx) face long-term lifestyle adaptations, psychological and social adjustments, and complex self-care regimes to maintain health post-transplant. Self-management (SM) skills represent important aspects of nursing communication with SOTx patients; however, there is potential for SM to be defined narrowly in terms of medication adherence. The study presented here collated the existing definitions in a mixed method review in order to identify SM attributes for this group (including those unique to this population). Secondary analysis of a dataset and bibliographic analysis and an expert panel were used to develop a comprehensive working definition of SOTx patients. The analysis comprised critical interpretation of the evolving definition content, concepts, and contexts of application in current usages and over time. We identified eight definitions and 63 cited definition sources from bibliographic analysis. Findings identified limitations of the existing definitions. Population-specific attributes included optimisation of transplant outcomes, active engagement in healthy behaviours, control, structure, and discipline characteristics, and moderating factors of patient motivation, self-efficacy, and cognitive function. A critical appraisal of definitions indicated inadequately defined aspects such as setting, temporal dimension, concept interaction, interventions, and measurable outcomes. The bibliographic analysis highlighted the influence of broader chronic illness constructions of SM, underpinning the generalisable SM attributes in current definitions. Further research may advance the development of a definition in exploring the relevance of SOTx-specific attributes of the definition.

Professional Employment in Patients on Ventricular Assist Device Support-A National Multicenter Survey Study.

This study aimed to assess patients of working age returning to professional employment as a surrogate marker for functional recovery and psychosocial reintegration after ventricular assist device (VAD) implantation. A national, multicenter study considered professional employment and its relationship to sociodemographic, psychosocial, and clinical adverse outcomes in outpatients on VAD support. Patient-reported outcome measures were administered. The survey had a 72.7% response rate. Mean age of 375 subjects was 58 ± 11 years, 53 (14%) were female. Thirty-five patients (15.15%; 95% confidence interval [CI] = 10.9-20.6) were employed, and the majority of them (n = 29, 82.9%) were bridged to transplantation. A regression model after variable selection revealed younger age (odds ratio [OR] = 0.95; 95% CI = 0.91-0.98; p < 0.005), and higher education (OR = 3.05; 95% CI = 1.72-5.41; p < 0.001) associated with professional employment. Employed patients reported higher health-related quality of life (HRQoL) (Kansas City Cardiomyopathy Questionnaire [KCCQ] overall sum-score, OR = 1.04; 95% CI = 0.92-1.07; p < 0.007), the OR for those employed was 2.18 (95% CI = 0.89-5.41; p < 0.08) indicating no significant relation for employment and a history of adverse events. In this sample, professional employment was rather small; the likelihood of adverse events was not significantly different between groups. Those employed perceived better overall HRQoL, which may encourage clinicians to support professional employment for selected patients on VAD support.

High level of psychosocial adjustment in patients on ongoing ventricular assist device support in the years one to three after VAD implantation-A national multi-center Study.

BACKGROUND: Advanced heart failure therapies such as durable ventricular assist device (VAD) support require psychosocial adjustment for those affected. Since VAD implantation has become an established treatment strategy, a focus on psychosocial factors is needed. OBJECTIVES: To investigate the construct of psychosocial adjustment and to further understand the role of social support. METHODS: In a nation-wide, multi-center, cross-sectional study, we recruited 393 participants with ongoing VAD support (3mts-3yrs on device; clinicaltrials.gov ID: NCT04234230). Patient demographics, psychosocial adjustment (perceived social support, anxiety, depression, and quality of life), and major adverse events (thromboembolic events, bleeding, driveline infections) were assessed. RESULTS: Overall, 85.8 % of the sample were male; mean age was 58.3 years (range 18-85). The majority of the sample (89.3 %) reported normal to high perceived social support. Participants expressed symptoms of anxiety within the normal range (M=6.0±3.9), mildly elevated depressive symptoms (HADS: M=7.6±2.9; PHQ-9: M=6.2±4.7), and good quality of life (KCCQ: M=65.3±17.9). Higher perceived social support was associated with lower levels of anxiety and depression, and higher levels of quality of life within our sample (all p<0.001). Driveline infection was the most prevalent adverse event (0.304 infections per person-years [32.6 % of patients]). Binary logistic regression models did not identify significant associations for the occurrence of adverse events and variables of psychosocial adjustment. CONCLUSION: Our sample perceived high levels of psychosocial adjustment. High perceived social support was associated with better outcomes in levels of anxiety, depression, and quality of life, demonstrating potential for the future development and evaluation of targeted multi-professional social support interventions including peer- and caregiver support.

Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire.

BACKGROUND: Ventricular assist device (VAD) implantation has become an alternative treatment for patients with end-stage heart failure. In Germany, valid and reliable instruments to assess health-related quality of life in patients with VAD are lacking. OBJECTIVE: The aim of this study was to present the psychometric validation of the German version of the Quality of Life with a Ventricular Assist Device questionnaire. METHODS: In a multicenter, cross-sectional study, 393 participants (mean age, 58.3 years; 85.8% male, 60.3% bridge to transplant, and 72.8% living with VAD for ≤2 years) completed the German Quality of Life with a Ventricular Assist Device questionnaire of physical, emotional, social, cognitive, and meaning/spiritual domains. Item and confirmatory factor analyses were conducted to test item difficulty and discrimination and the underlying structure, respectively. To examine internal consistency, Cronbach α was assessed. Convergent construct validity was tested using the Kansas City Cardiomyopathy Questionnaire and the Patient Health Questionnaire-9. Readability was examined using Flesch Reading Ease index and Vienna Factual Text Formula. RESULTS: The Quality of Life with a Ventricular Assist Device showed reasonable item difficulty (Ptotal = .67) and mostly moderate to high discriminatory power (rit > 0.30). In confirmatory factor analysis, root-mean-square error of approximation (0.07) was acceptable for model fit, but no other indices. Acceptable internal consistency was found (α ≥ 0.79), with the exception of the cognitive domain (α = 0.58). The overall questionnaire and single domains demonstrated convergent validity (r ≥ 0.45, P < .001). The questionnaire showed adequate readability (Flesch Reading Ease, 64.11; Vienna Factual Text Formula, 6.91). CONCLUSION: Findings indicate a promising standardized clinical instrument to assess health-related quality of life in patients with VAD.

Disturbance in bodily experience following ventricular assist device implantation.

BACKGROUND: Disturbance in bodily experience (BE) is a potential adverse consequence of ventricular assist device (VAD) implantation. The concept BE encompasses all cognitive and affective processes related to the subjective experience of one's own body. METHODS: A cross-sectional, multicenter study was performed, involving 365 VAD patients (85% male; time postimplant: 3-36 months). Patients completed a BE questionnaire (BE-S, 5-point Likert scale), and the disturbance in BE was analyzed based on sex, time since implantation (in the first, second, or third years postimplant), and patient acuity (elective vs emergent implantation). Subsidiary, patients' gratitude was surveyed. RESULTS: Disturbance in BE was not particularly pronounced (mean = 2.69, standard deviation = 1.17). Eighty-five percent of patients expressed high levels of gratitude. Disturbance in BE decreased (p = 0.04), while gratitude increased (p = 0.02) with time since implantation. Female patients showed more disturbance in BE (p = 0.01) and less gratitude (p = 0.01) compared to male patients. Among patients who underwent emergency implantation, the decrease in disturbance occurred predominantly in the third year, exceeding the level observed in elective implanted patients (p = 0.03). CONCLUSIONS: Disturbance in BE following VAD implantation does generally not reach excessive levels and tends to decrease over time. Our data indicate more disturbance and less gratitude in female patients. In emergently implanted patients, disturbance in BE is prolonged. Screening for disturbance in BE is recommended during follow-up, especially for these at-risk groups, to ensure early and focused psychological support.

Self-management of patients with tracheostomy in the home setting: a scoping review.

PURPOSE: The aim of this study was to create a model of patient-centered outcomes with respect to self-management tasks and skills of patients with a tracheostomy in their home setting. METHODS: A scoping review using four search engines was undertaken (Medline, CINAHL, PsycINFO, Cochrane Library) to identify studies relevant to this issue and published since 2000. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statements for Scoping Reviews (PRISMA-ScR), the Joanna Briggs Institute (JBI) approach of conducting and reporting a scoping review, and the Participants, Concept, Context (PCC) scheme were employed. The following elements of the framework synthesis study data were screened, and presented based on the self-management model of Lorig and Holman. RESULTS: 34 publications from 17 countries met the criteria for study inclusion: 24 quantitative, 8 qualitative and 2 mixed methods designs. Regarding the dimensions of self-management, 28 articles reported on "managing the therapeutic regimen", 27 articles discussed "managing role and behavior changes", and 16 articles explored "managing emotions". A model of self-management of patients with tracheostomy was developed, which placed the patient in the center, since it is this individual who is completing the tasks and carrying out his or her skill sets. CONCLUSION: This scoping review represents the first comprehensive overview and modeling of the complex self-management tasks and skills required of patients with tracheostomy in their home setting. The theoretical model can serve as a cornerstone for empirical intervention studies to better support this patient-centered outcome for this population in the future.

Prevalence of delirium in gastroenterology/hepatology units: A cross-sectional study.

Prevalence rates of delirium amount to 22.0% within acute-care settings. In contrast, 30-40% of patients with liver cirrhosis may develop hepatic encephalopathy, a condition that has been classified as a syndrome of delirium, based on recent pathophysiology findings. However, the prevalence of delirium in gastroenterology and hepatology units is unknown.The aims of the study were (i) to identify delirium prevalence rates in inpatients of gastroenterology/hepatology wards, (ii) to analyze the delirium motor subtype, and (iii) to assess associations between delirium and patient characteristics.In this monocentric, cross-sectional, epidemiological study, point prevalence was assessed at six time points in three gastroenterology/hepatology units within a German university hospital. Delirium was assessed using the 4 'As' Test (4AT) and delirium subtype by the delirium motor subtype scale. Patient characteristics were collected from patient charts.The sample consisted of 188 patients, aged 18 to 98 years (mean age 64, n=110 male). Of them, 18.1% of patients showed delirium symptoms (61.8% hypoactive, 29.4% mixed, and 8.8% hyperactive). For the participants aged ≥65 years (n=96), prevalence of delirium amounted to 26.0%. Significant associations were observed between delirium and the following characteristics: age (p=0.001), length of hospital stay until assessment (p=0.043), cerebrovascular disease (p=0.002), dementia (p=0.010), diabetes mellitus with chronic complications (p=0.012), and gender (nonsignificant trend, p=0.050), while no association was detected between moderate or severe liver disease and delirium (p=0.414).In conclusion, overall prevalence rates of delirium were rather low and did not increase in patients with liver disease.

My hands are running away - learning a complex nursing skill via virtual reality simulation: a randomised mixed methods study.

BACKGROUND: Clinical skills training is an essential component of nursing education. However, sometimes education does not sufficiently prepare nurses for the real world. Virtual reality (VR) is an innovative method to complement existing learning strategies, yet few studies investigate its effectiveness. This study compared educational outcomes achieved by three groups learning with either of two different VR simulation variants, with varying technological features, or a video training on the endotracheal suctioning skill. METHODS: The investigated outcomes were knowledge and skill acquisition, learner satisfaction, and technology acceptance. 131 undergraduate nursing students were randomised into three groups, based on the interventions they received. Knowledge was assessed through a pre-post-test design, skill through a post-intervention objective structured clinical examination on a manikin, learning satisfaction and technology acceptance through standardised questionnaires, and qualitative feedback through focus groups. RESULTS: All interventions led to a significant knowledge acquisition, with no significant difference between the groups. The video intervention group performed significantly better than the VR groups in skill demonstration. One of the two VR intervention groups had a significantly higher learner satisfaction than the video group. Technology acceptance was high for both VR groups, with the simpler VR simulation resulting in higher technology acceptance than the one with more experimental features. Students described the VR experience as realistic, interactive, and immersive, and saw the opportunity to practise skills in a safe environment, learn from mistakes, and increase knowledge and confidence. CONCLUSIONS: For the development of VR trainings, we recommend keeping them simple and targeting a specific educational outcome since trying to optimise for multiple outcomes is resource intensive and hard to achieve. Psychomotor skills were easier for participants to learn by watching a video on the procedure rather than practically learning it with the VR hardware, which is a more abstract representation of reality. We therefore recommend using VR as a complementing resource to skills labs, rather than replacing existing learning strategies. Perhaps VR is not ideal for practising practical psychomotor skills at the moment, but it can increase knowledge, satisfaction, motivation, confidence and prepare for further practical training. TRIAL REGISTRATION: Not applicable.

Self-management in adults after solid-organ transplantation: a scoping review protocol.

INTRODUCTION: After solid-organ transplantation (SOTx), recipients must adhere to a lifelong medical regimen, change their lifestyle and cope with physiological and psychosocial challenges. This requires active participation in their care and self-management abilities. The concept of self-management after SOTx has only been described regarding specific organs and focused on adherence to medical treatment. A comprehensive conceptualisation of self-management entailing all solid organs and beyond medical aspects does not exist. This might lead to unmet self-management support needs of SOTx recipients and hinder a more holistic and integrative approach in self-management support. Therefore, a better understanding of the concept of self-management after SOTx is needed to facilitate a comprehensive evidence base for healthcare providers and researchers. The purpose of this scoping review is to explore existing evidence on self-management in adults after SOTx. METHODS AND ANALYSIS: To identify relevant evidence, six electronic databases and three study registers will be searched, supplemented by handsearches, reference checking and expert recommendations. Screening and selection of available evidence will be carried out in a two-step process by two independent reviewers. International evidence published in English or German reporting on adults after heart, lung, liver, pancreas, kidney or small bowel transplantation will be considered. To meet inclusion criteria, articles have to focus on either: self-management, self-management support or recipients' or healthcare providers' perspectives of challenges and needs potentially addressable by self-management. Data extraction will be performed by two reviewers independently using a structured form. Data will be analysed descriptively and using content analysis procedures. Findings will be summarised narratively and presented in tabular format. ETHICS AND DISSEMINATION: The consultation and approval of an ethics committee is not required for this scoping review. Findings of the scoping review will be published in a peer-reviewed open-access journal and presented at conferences.

[Experiencing brain death, physician view-a phenomenological approach]. / Hirntod erleben, ärztliche Sichtweise ­ ein phänomenologischer Ansatz.

AIM: The aim of the study was to examine how physicians experience caring for (potentially) brain-dead patients. METHODS: Episodic interviews were conducted. Their evaluation was based on Benner's interpretative phenomenology. RESULTS: Eleven physicians were interviewed. The following phenomena were extracted from the data: (1) encounter with the relatives, (2) making relatives understand brain death, (3) brain death is death, (4) experience of the nurses and (5) burdens. CONCLUSION: The results show the complexity that is perceived by physicians when caring for a (potentially) brain-dead patient. The transition from saving the patient's life to preserving organs or switching off the equipment and informing the relatives requires a high level of expertise on the part of the physicians. The patients' symptoms provide the physicians with clear diagnostic procedures and any remaining ambiguities in the (treatment) process should be resolved.

Competencies and needs of nurse educators and clinical mentors for teaching in the digital age - a multi-institutional, cross-sectional study.

BACKGROUND: The impact of technology and digitalization on health care systems will transform the nursing profession worldwide. Nurses need digital competencies to integrate new technology in their professional activities. Nurse educators play a crucial role in promoting the acquisition of digital competences and therefore need to be digitally competent themselves. Research on digital competencies of nursing educators is scarce but suggests lack of digital knowledge and skills and support needs. Although digitalization is to be seen as a global process, regional contexts need to be taken into account, such as pre-existing competencies, local conditions, and individual needs. Thus, it remains unclear which competencies nurse educators possess and which support needs they have. Aim of this study was to assess nurse educators' and clinical mentors' digital competencies and explore their needs and requirements concerning the digital aspects of their pedagogy and teaching activities in Germany. METHODS: A descriptive exploratory study with a cross-sectional design was conducted. Participants were identified using a convenience sampling approach. Data were collected during July and September 2020 using a standardized self-reported questionnaire that was developed specifically for this study. The questionnaire was provided in a paper and online format and participants could decide which format to use. It contained open- and closed-ended questions. Data were analyzed using descriptive and content analysis. Additionally, explorative subgroup analyses based on job designation, age, and gender were performed. Reporting of this study adhered to the STROBE checklist. RESULTS: A total of 169 educating nurses participated in the survey. The respondents considered themselves as digitally competent and showed a positive attitude towards the integration of digital technology in their teaching activities. Their perceived preparedness to integrate digital technology into teaching and training varied. Almost all respondents (98%) declared a need for further training and seemed motivated to participate in corresponding educational events. There were some indications for differences in competencies or needs between subgroups. CONCLUSIONS: Educating nurses appear to possess basic digital competencies but there is a need to support their professional development in terms of new technologies. Findings can be used as a basis for developing supportive interventions. Further qualitative investigations could inform the design and content of such interventions.

A Systematized Review of Professional Employment Following Thoracic Transplantation.

INTRODUCTION: Acknowledging the evolved landscape in thoracic transplantation, professional employment becomes an important outcome measure to quantify the success of this costly procedure. OBJECTIVE: We aimed to assess rates of and characterize factors associated with professional employment in patients following thoracic transplantation, and create an evidence-base on the relationship between professional employment and relevant outcome parameters. METHODS: We systematically searched Medline, Cinahl, and GoogleScholar to identify studies published between 1998 and 2021 reporting on professional employment following heart and lung transplantation. RESULTS: Twenty-two studies from 11 countries with varying sample sizes (N = 27; 10 066) were included. Employment rates ranged from 19.7% to 69.4% for heart, and from 7.4% to 50.8% for lung transplant recipients. Most frequently reported positively associated factors with employment after transplant were younger age, higher education, and history of pretransplant employment. Longer duration of unemployment prior to transplantation and Medicaid coverage were the most frequently reported negatively associated factors. Relationships between professional employment and clinical outcomes included lower rates of acute and chronic rejection, less infection episodes, and better quality of life among working patients; one study reported a lower 5-year-mortality rate. Reasons not to work were "physical or mental health-related," "employment-related," "financial reasons," and "lifestyle choices." DISCUSSION: Substantial proportions of patients following thoracic transplantation are not professionally employed, potentially diminishing the success of transplantation on individual and societal levels. Considering adverse clinical outcomes in employed transplant recipients were low, more efforts are needed to identify modifiable factors for employment in these populations.

Translation and Psychometric Evaluation of the German Version of the Thirst Distress Scale for Patients With Heart Failure.

BACKGROUND: In patients with chronic heart failure, thirst can be perceived as an intensive and burdensome symptom, which may have a negative impact on patients' quality of life. To initiate thirst-relieving interventions, assessment of thirst and its related distress is essential. At the time of this study, no instrument was available to evaluate thirst distress in patients with heart failure in Germany. OBJECTIVE: The aims of this study were to translate the "Thirst Distress Scale for patients with Heart Failure" (TDS-HF) from English into German and to test validity and reliability of the scale. METHODS: The English version of the TDS-HF was translated into German. A linguistically and culturally sensitive forward-and-backward translation was performed. Psychometric evaluation included confirmatory factor analysis, reliability in terms of internal consistency, and concurrent validity. RESULTS: Eighty-four hospitalized patients (mean age, 72 ± 10 years; 29% female; mean left ventricular ejection fraction, 36% ± 12%; 62% New York Heart Association functional classes III-IV, 45% on fluid restriction) from an acute care hospital were involved in the study. The item-total correlation ranged from 0.58 to 0.78. Interitem correlations varied between 0.37 and 0.79. Internal consistency was high, with a Cronbach α of 0.89. There was a high correlation between the total score of the TDS-HF and the visual analog scale to assess thirst intensity ( r = 0.72, P ≤ .001), and a low correlation with fluid restriction ( r = 0.35, P = .002). CONCLUSIONS: The evaluation of the German TDS-HF showed satisfactory psychometric properties in this sample. The instrument is usable for further research and additional psychometric testing.

Hand hygiene monitoring technology: A descriptive study of ethics and acceptance in nursing.

BACKGROUND: Nosocomial infections represent a serious challenge for healthcare systems worldwide. Adherence to hand hygiene plays a major role in infection prevention and control. These adherence rates can be improved through behaviour tracking innovations. This requires the systems to be widely implemented and accepted. Therefore, both a systematic analysis of the normative issues related and the evaluation of technology acceptance are equally important. OBJECTIVES: To explore and describe relevant aspects regarding the acceptance of technology and ethical implications using a tracking device to measure and improve adherence to hand hygiene. RESEARCH DESIGN: A quantitative study with a descriptive design was performed. PARTICIPANTS AND RESEARCH CONTEXT: A total of 75 questionnaires were collected in three hospitals in Germany. Acceptance of technology was measured with n = 60 participants (n = 50 nurses; n = 9 physicians; n = 1 not disclosed) and ethical assessment with n = 15 participants (nurses only). ETHICAL CONSIDERATIONS: Ethical approval for this study was obtained from the institutional review board. FINDINGS: The acceptance of technologies improving hygiene in general was good (median = 80.5, interquartile range = 28, range: 0-100). The experience with technologies in general (median = 48.5, interquartile range = 57, range: 0-100) and the acceptance of the specific technology (mean = 82.23, standard deviation = 15.16 (range: 23-138)) was moderate. There was a significant positive correlation between the acceptance and experience of technology in general (r = 0.217, p = .025). Ethical concerns played a minor role. The need for practical support was a key topic. DISCUSSION: Study participants accepted technologies improving hygiene; however, the specific device implemented was only moderately accepted. This creates specific opportunities in the implementation process for higher later acceptance. More practical support and an increase in experience may create opportunities for device implementation with high acceptance and low ethical concerns. CONCLUSION: Study results indicate a vast potential for improving the implementation process of hand hygiene technologies. Ethical concerns in this study did not seem to be a relevant barrier for successful implementation of hand hygiene technologies.

Balancing normalcy and safety: health-related needs in patients with a ventricular assist device within their home environment.

AIMS: Ventricular assist device (VAD) implantation has become a well-established treatment strategy for patients suffering from advanced heart failure. Ventricular assist device treatment attempts to ameliorate the symptom burden but may create new challenges in patients' lives. Lacking are insights into perceived challenges and health-related needs of patients with VAD within their home environment. Our study aimed to explore the perceived health-related needs of patients living with a VAD in their home environment. METHODS AND RESULTS: We used a qualitative approach based on a hermeneutic, directed content analysis design. Telephone-based interviews were conducted with 10 patients with VAD from a single cardiology centre in Germany. Data collection and analyses were carried out using content-structuring content analyses. Normalcy and safety were identified as overarching themes: participants expressed a need to balance daily activities between striving for normalcy and maintaining safety. Underlying necessities reflecting this balance were categorized as functional, social, and mental health-related needs. Learning by doing, social-, and peer support were described as relevant requisites. Fulfilling these health-related needs could aid patients living with VAD in achieving the sense of normalcy and safety they seek. CONCLUSION: Balancing health-related needs with striving for normalcy and safety, emerged as a new core concept for patients with VAD. Thus, being cognizant of this balance when caring for these patients, could facilitate coping after VAD implantation through increasing acceptance of limitations to daily functions by enhancing individual safety. A supportive social environment, including peer support, becomes vital in self-management programs preparing patients with VAD for their home environment.

[Interprofessional knowledge and skills training of the insertion technique for the PEG placement on simulators - development and testing of a national curriculum for physicians and nurses]. / Interprofessionelles Wissens- und Skillstraining der PEG-Anlage an Simulatoren ­ Entwicklung und Testung eines nationalen Curriculums für Ärzte und spezialisierte Pflegende.

INTRODUCTION: Expert opinion within the field of gastroenterology mandates a national training curriculum to be completed prior to performing a percutaneous endoscopic gastrostomy (PEG).The goal of the present study is both the development and evaluation of such a curriculum, thus aiming to provide physicians and nurses with the necessary knowledge and skills to safely perform the PEG procedure. METHODS: Testing was performed using a non-randomized, interventional pilot study on simulators. This included a: (1) preparatory, (2) theoretical, and (3) practical phase. Following the theoretical phase, cognitive skills were assessed with a knowledge test. During the practical phase, each participant's puncture procedure was recorded with a multi-channel video, and sensorimotor skills were evaluated with an assessment instrument (AS-PEG). Finally, participant satisfaction was evaluated using a questionnaire. RESULTS: Seven physicians and 17 nurses completed all phases and final examinations, as defined in the curriculum. An average of 70.3 ±â€Š3.7 (61-75) of 76 points and 37.1 ±â€Š2.1 (32-40) of 42 points were achieved in the knowledge and acquired sensorimotor skills tests, respectively. Overall, the evaluation revealed a high level of satisfaction among the participants with respect to content, achievement of learning objectives, and acquired practical skills. CONCLUSION: Dissemination of the curriculum is deemed useful and necessary to provide the theoretical and practical knowledge for physicians and nurses through a structured inter-professional knowledge and skills-training format and to offer nurses a legally secure framework.

Development and Pilot Validation of an Instrument Assessing Sensorimotor Skills for Percutaneous Gastral Puncture.

INTRODUCTION: The acquisition of sensorimotor skills, so-called "technical skills", plays an essential part in the professional and continuing educational training of medical and nursing staff. Facilities turn to simulator training to promote the safe and accurate performance of endoscopic examinations. Thus, this study aimed to develop and pilot-test a corresponding assessment instrument to monitor necessary sensorimotor or "technical" skills of the examiner for a safe percutaneous endoscopic gastrostomy (AS-PEG). MATERIALS AND METHODS: Instrument development and pilot validation involved four stages: identification of potential items and initial draft of the AS-PEG; expert panel with 11 experts (content validity index [CVI] calculated); empirical validation using a quasi-experimental intervention on simulators; revision of the pilot AS-PEG taking expert assessment, and empirical testing into consideration. RESULTS: The initial instrument yielded 13 categories and 44 items describing the PEG procedure. Experts rated 30 out of 44 items (68%) extremely or very important for the safety of the puncture of the stomach. Initial item-CVIs ranged from 0.00 to 1.00; scale-CVI was 0.61. Twenty-four trainees (7 physicians, 17 nurses) participated in the pilot simulation study. On average, 8:25 min were required for PEG placement (min-max 5:59-13:38 min, SD = 1:43). The revised AS-PEG version was reduced to 14 items with a range of the item CVI from 0.8 to 1.0, and a scale-CVI of 0.90. CONCLUSION: The AS-PEG instrument facilitates the evaluation of sensorimotor skills during percutaneous gastric puncture procedures within the context of PEG placement, across professions and without relating to the number of procedures previously performed. The instrument is economical and shows satisfying content validity.

Evidence of the medical and economic benefits of implementing hygiene measures by a prevention link physician in trauma surgery: Study protocol for a biphasic multicenter prospective interventional pre-post cohort study using a structured intervention bundle development and tools of behavior change management.

INTRODUCTION: The German Commission for Hospital Hygiene and Infection Prevention recommends nominating one authorized medical specialist in every medical department as an infection prevention link physician (PLP). It has been roughly described that a PLP serves as a link between the infection prevention team and the respective clinical departments. No detailed evidence about the contribution made by PLPs to the decrease of infection rates is available in Germany. The "HygArzt" project aims to demonstrate the medical and economic benefits of the implementation of hygiene measures by PLP in trauma surgery/orthopedics. METHODS: A multicenter interventional pre/post cohort study design was chosen. The study will run for a three-year period, including a pre-, post-, and an intervention phase, in four different hospitals, one of which will serve as pilot. A complex intervention containing evidence-based infection control measures will be developed and implemented by a PLP to proof efficacy. After the successful implementation of the preventive measures in the pilot hospital, the concept will be transposed to the three remaining trauma and orthopedic departments to confirm the transferability and generalizability. To enable the PLPs of the non-pilot departments, a subject-specific training program will be developed based on the study results of the pilot hospital and offered to the PLPs. DISCUSSION: Data are intended to provide evidence that and, if so, to which extent the implementation of specific preventive measures by a medical department-specific PLP is possible and results in a reduction of nosocomial infections in orthopedic surgery and traumatology. CONTRIBUTION TO THE LITERATURE: The present study describes a novel complex study design to prove the effectiveness of intervention measures for infection prevention. The study design and newly developed methodological approach could serve as a model for similar studies on infection prevention in the future. For the first time, the presented research project "HygArzt" focuses on the implementation of hygiene measures by an infection prevention link physician (PLP) and investigates whether nosocomial infections, especially surgical site infections, can be reduced by the measures implemented. TRIAL REGISTRATION: German clinical Trials register DRKS-ID:00013,296. Registered on March 5, 2018, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013296.

Self-management for patients on ventricular assist device support: a national, multicentre study: protocol for a 3-phase study.

INTRODUCTION: Self-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The 'SM model for patients on VAD support' will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum. METHODS AND ANALYSIS: This is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3. ETHICS AND DISSEMINATION: Ethical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English. TRIAL REGISTRATION NUMBERS: NCT04234230 and NCT04526964; Pre-results.

Methodological quality of studies assessing validity and reliability of the European Heart Failure Self-care Behaviour Scale: a systematic review using the COSMIN methodology.

AIMS: The European Heart Failure Self-care Behaviour Scale (EHFScBS) is frequently used to assess self-care behaviours in patients with heart failure. This scale has been translated into several languages. The COnsensus-based Standards for the selection of health status Measurement INstrument (COSMIN) Risk of Bias checklist for a systematic review has recently been published. The aim of the study was to assess the methodological quality of studies reporting on psychometric evaluations of the EHFScBS using the COSMIN methodology. METHODS AND RESULTS: To identify relevant studies, a systematic literature search was performed using PubMed and CINAHL databases in December 2019 and the search was updated in June 2020. The COSMIN Risk of Bias checklist was used to assess the methodological quality. In total, 21 relevant studies were rated. The overall methodological quality of content validity was rated as inadequate in 17 studies and a main reason of the inadequate rating was a lack of patient involvement. Structural validity was adequately addressed in 12 studies, internal consistency in seven, and eight of 11 studies reporting on construct validity and had good methodological quality. CONCLUSION: Although the use of the EHFScBS has grown rapidly and the validity and reliability are reported to be good, the methodological quality of studies reporting on psychometric properties of the scale is not optimal. Further studies are necessary to strengthen the evidence on validity and reliability of the EHFScBS.