Treatment and Rehabilitation for Esophageal Cancer-Striving to Meet Obstacles and Long-term Impacts: A Qualitative Descriptive Study.

BACKGROUND: Following esophagogastric cancer treatment, patients with esophageal cancer and their relatives struggle with adjusting to a new everyday life as they experience various challenges after treatment requiring rehabilitation. Health professionals must address long-term impacts on patients' health, everyday life, family functioning, and support needs. OBJECTIVE: This qualitative descriptive study aimed to explore patients', relatives', and health professionals' experience with long-term impacts and rehabilitation after treatment for esophageal cancer. METHODS: A qualitative approach based on a phenomenological-hermeneutical methodology was used. Two methods were selected in the study: focus group interviews with health professionals and individual interviews with patients and relatives. Inductive thematic analysis with inspiration from Braun and Clarke was used for data analysis. RESULTS: Three main themes emerged from the data analysis: (1) forced into limitations in everyday life, (2) learning and navigating a new everyday life, and (3) rehabilitation accepting new normality. CONCLUSION: Patients and relatives experience persistent long-term impacts after treatment for esophageal cancer, making rehabilitation strenuous and demanding. Relatives take considerable responsibility for the patients' rehabilitation but feel invisible and unsupported by health professionals. Health professionals acknowledge the severity of long-term impacts but fail to prepare patients and relatives for the impacts and do not see the relatives' need for support. IMPLICATIONS FOR PRACTICE: The study emphasizes the need for a proactive approach in the healthcare system, addressing patients' and relatives' physical and psychological vulnerability. Cancer nurses need to prepare and involve patients and relatives in treatment, long-term impacts, and rehabilitation.

Being an adolescent with epilepsy during the transition from pediatric to adult hospital care: A qualitative descriptive study.

BACKGROUND: The transition from pediatric to adult care is challenging for adolescent patients despite numerous recommendations in recent decades. However, the perspective of the patients is sparsely investigated. AIM: To explore the experiences and needs of adolescents with epilepsy (AWE) during the transition from pediatric to adult hospital care. METHODS: We conducted 15 semi-structured interviews with AWEs aged 13-20 years and 10 h of field observations of consultations. Interviews were audio-recorded, transcribed, anonymized, and entered into NVivo (version 12, QSR International) with the transcribed field notes. Data were analyzed using systematic text condensation. RESULTS: Three themes were identified: (1) Navigating epilepsy in everyday life; (2) The difficult balance between concealment and openness about epilepsy; and (3) Being seen as an individual and not an illness. AWEs' needs in transition are closely associated with their experiences and perceptions of illness, treatment, consultations, and seizures. Notably, AWEs reveal a significant concern about being overlooked beyond their medical condition in appointments. CONCLUSIONS: This study highlights the vulnerability and challenges of AWEs transitioning to adult care. Overall, AWEs seek understanding, acceptance, and autonomy in managing their epilepsy and transitioning to adult care. Their experiences underscore the importance of holistic support and communication in healthcare settings. A concerted effort from healthcare professionals (HCP) is necessary to foster the recognition of AWEs as individuals with distinct personalities, needs, and capabilities.

Decision making in the oesophageal cancer trajectory a source of tension and edginess to patients and relatives: a qualitative study.

PURPOSE: The curative oesophageal cancer continuum-diagnosis, treatment and survivorship represents different phases with its own challenges for the involved parties. The process of treatment decisions and interactions between patients with oesophageal cancer (EC), relatives and health professionals is vital yet not well described. The purpose of the study was to explore patients' and relatives' experiences with the process of decision-making through the EC illness and treatment trajectory. METHODS: Longitudinal explorative design was employed based on ethnographic fieldwork in the form of participant observations inspired by the American anthropologist James Spradley. RESULTS: Sixteen patients and 18 relatives were recruited for participant observations. In total, 184 hours of participant observations were conducted. The study showed that decision-making was filled with tension and edginess. Four themes were identified: 1) The encounter with the medical authority, 2) The need to see the big picture in the treatment trajectory, 3) A predetermined treatment decision, and 4) Meeting numerous different health professionals. CONCLUSION: The EC trajectory and decision-making were filled with anxiety. Patients and relatives lacked an overview of the treatment pathway, leading to their role in decision-making often being governed by the medical authority. Timing information and continuity are vital factors in decision-making.

Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: A Feasibility Trial.

Chronic foot ulcers have extensive consequences for diabetic patients' quality of life and increase risks of amputation and death. The aim of this trial was to assess the feasibility of conducting a larger clinical trial to evaluate the clinical effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools. This study was a feasibility trial conducted at an outpatient wound care clinic at Zealand University Hospital. Twelve patients with DFUs were included. During a 90-day follow-up, participants visited the clinic 5 times and received inforatio technique twice. Feasibility was assessed with regard to recruitment, acceptability, burden, benefits, protocol adherence, and adverse events. The recruitment rate was 1 patient per eighth day (95% confidence interval [CI] = [4th-13th]), and the retention rate was 100% (95% CI = [74-100]). During follow-up, healing was observed for 4 ulcers (33%, 95% CI = [10-65]) with a mean time for healing of 59 days (range, 22-89) (95% CI = [5-113]). Five ulcers had a reduction of wound area and 3 ulcers had an increase in area from baseline to 90-day follow-up. No temporal relationship was found between inforatio application and wound area increase. There were no patient-reported harmful effects and no adverse events with probable relation to inforatio technique. Patient acceptability and participant adherence were promising. Thus, a larger clinical trial for evaluating the clinical effect of inforatio technique is considered feasible to conduct.

With Fearful Eyes: Exploring Relatives' Experiences With Out-of-Hospital Cardiac Arrest: A Qualitative Study.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) imposes significant consequences for a family, but little is known about relatives' experiences. OBJECTIVE: Our aim was to explore relatives' experiences with the OHCA and the following months after. METHOD: A qualitative approach using phenomenological-hermeneutic methodology was applied. Data consisted of semistructured interviews with 12 relatives of OHCA survivors. We analyzed data based on Paul Ricoeur's theory of interpretation. RESULTS: Relatives experienced OHCA as an abrupt and stressful event filled with imposing concerns for the cardiac arrest survivor. Relatives were fellow sufferers confronted with the possibility of bereavement, watching from the sideline with fearful eyes. After the OHCA, relatives experienced a troubled time with anxiety and edginess, monitoring the survivor for signs of a new cardiac arrest and trying to adapt to a new normality. Relatives' previous identities and positions within their families were disrupted. CONCLUSION: Relatives were challenged with the OHCA and the trajectory after it, experiencing a high level of distress and anxiety. Relatives took on an immense responsibility, always watching the survivor for potential symptoms of a new cardiac arrest. The cardiac arrest and the survivor's possible cognitive impairments gave rise to assuming a new authority as a relative. We advocate for a new family approach to relatives, acknowledging relatives' stress and central role in supporting cardiac arrest survivors.

Caught between competing emotions and tensions while adjusting to a new everyday life: a focus group study with family caregivers of out-of-hospital cardiac arrest survivors.

AIMS: Caring for an out-of-hospital cardiac arrest (OHCA) survivor may impact family caregivers' lives due to the sudden onset of the illness and possible secondary cognitive, emotional, and physical challenges. However, experiences of caring for an OHCA survivor are sparsely described. Thus, this study aimed to explore how family caregivers of OHCA survivors experience the potential burden. METHODS AND RESULTS: Using an explorative qualitative approach, six focus group interviews were conducted with a sample of 25 family caregivers of OHCA survivors and analysed using a phenomenological hermeneutic approach inspired by the philosophy of Ricoeur. The OHCA survivors attended a rehabilitation course, and the family caregivers were interviewed as part of the course.Based on the analysis, three themes emerged: (i) feeling unexpectedly alone and invisible; the family caregivers experienced an emotional burden that could not be shared-leading to caregiving being a lonely experience, (ii) fear of loss; the fear of losing a loved one was a constant companion contributing to the burden, and (iii) adjusting to a new everyday life; the family caregivers had difficulties adjusting to living their lives on the premise of the survivors' needs. CONCLUSION: The findings of this study emphasize the burden experienced by family caregivers and how they can be trapped in competing emotions and tensions. The possible caregiver burden following OHCA should be acknowledged. Interventions to reduce the burden should be tested and implemented as part of the clinical care of OHCA survivors and their families.

Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial.

INTRODUCTION: Diabetic foot ulcers (DFUs) are associated with extensive consequences for the affected patients and treatment of these hard-to-heal ulcers is known for being challenging. New treatment methods to supplement the current standard care may improve the prognosis for these patients.A preceding feasibility trial with promising results, facilitated this trial that aims to study the effect of a novel simple treatment, called inforatio technique, which may promote healing of DFUs. The inforatio technique is a minimally invasive procedure where small cuts are made on wound beds with punch biopsy tools. METHODS AND ANALYSIS: This multicentre randomised clinical trial will be conducted at outpatient clinics at Zealand University Hospital, Herlev University Hospital, Slagelse Hospital and Nykoebing Falster Hospital. 100 participants will be included and randomised in a 1:1 ratio to either a control group that receives usual care or an intervention group that receives both usual care and the inforatio technique.The primary outcome is complete healing evaluated on digital images by blinded observers. It is not possible to blind participants or the outpatient clinic staff because the inforatio technique is visible in wound beds after application. Change in EQ-5D-5L (EuroQoL-5 Dimension- 5 Level) Visual Analogue Scale Score and Wound-QoL Global Score from baseline to end of follow-up are secondary outcomes. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Danish National Committee on Health Research Ethics on 15 December 2021 (approval ID: SJ-904). Trial results are planned to be published in a high-impact peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05189470.

First-in-Human Study of [68Ga]Ga-NODAGA-E[c(RGDyK)]2 PET for Integrin αvß3 Imaging in Patients with Breast Cancer and Neuroendocrine Neoplasms: Safety, Dosimetry and Tumor Imaging Ability.

Arginine-Glycine-Aspartate (RGD)-recognizing cell surface integrins are involved in tumor growth, invasiveness/metastases, and angiogenesis, and are therefore an attractive treatment target in cancers. The subtype integrin αvß3 is upregulated on endothelial cells during angiogenesis and on tumor cells. In vivo assessment of integrin αvß3 is possible with positron emission tomography (PET). Preclinical data on radiochemical properties, tumor uptake and radiation exposure identified [68Ga]Ga-NODAGA-E[c(RGDyK)]2 as a promising candidate for clinical translation. In this first-in-human phase I study, we evaluate [68Ga]Ga-NODAGA-E[c(RGDyK)]2 PET in patients with neuroendocrine neoplasms (NEN) and breast cancer (BC). The aim was to investigate safety, biodistribution and dosimetry as well as tracer uptake in tumor lesions. A total of 10 patients (5 breast cancer, 5 neuroendocrine neoplasm) received a single intravenous dose of approximately 200 MBq [68Ga]Ga-NODAGA-E[c(RGDyK)]2. Biodistribution profile and dosimetry were assessed by whole-body PET/CT performed at 10 min, 1 h and 2 h after injection. Safety assessment with vital parameters, electrocardiograms and blood tests were performed before and after injection. In vivo stability of [68Ga]Ga-NODAGA-E[c(RGDyK)]2 was determined by analysis of blood and urine. PET images were analyzed for tracer uptake in tumors and background organs. No adverse events or pharmacologic effects were observed in the 10 patients. [68Ga]Ga-NODAGA-E[c(RGDyK)]2 exhibited good in vivo stability and fast clearance, primarily by renal excretion. The effective dose was 0.022 mSv/MBq, equaling a radiation exposure of 4.4 mSv at an injected activity of 200 MBq. The tracer demonstrated stable tumor retention and good image contrast. In conclusion, this first-in-human phase I trial demonstrated safe use of [68Ga]Ga-NODAGA-E[c(RGDyK)]2 for integrin αvß3 imaging in cancer patients, low radiation exposure and favorable uptake in tumors. Further studies are warranted to establish whether [68Ga]Ga-NODAGA-E[c(RGDyK)]2 may become a tool for early identification of patients eligible for treatments targeting integrin αvß3 and for risk stratification of patients.

A qualitative study on men's experiences of health after treatment for ischaemic heart disease.

AIMS: Globally, ischaemic heart disease (IHD) is one of the leading causes of mortality among men, and the health management of men is pivotal to prevention and recovery. Many men delay help-seeking and lack knowledge of disease symptomologies. Thus, the aim was to explore how men experience and manage their health while suffering from ischaemic heart disease and having received treatment with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). METHODS AND RESULTS: The study applied a qualitative approach designed within a phenomenological-hermeneutical methodology. Interviews were conducted between April and November 2019 with a criterion sample of 21 male patients within 1-2 weeks post-discharge. The analysis was guided by Paul Ricoeur's theory of text interpretation. After analysing the interviews, the following themes were identified: A functioning body as health, illuminating how a functioning body leads to a feeling of independence; misinterpreting signs of illness showing how symptoms are interpreted as signs of ageing rather than disease; and navigating life with ischaemic heart disease focusing on how men retain or maintain health after the threat to life. CONCLUSION: The findings of this study provide insight into men's health and their health management: illuminating how a functioning body can give men a sense of freedom and control, making it difficult to interpret signs of illness, and thus, failing to seek help and feel motivated to make changes when facing a serious health threat. These perspectives should be considered when planning future care and communication with male patients.

Volunteer work among older adults in Denmark, 1997-2017: What can explain the continuous upward trend?

The present study assessed and explained trends in volunteer work among older adults in Denmark against the backdrop of stagnating participation rates in, for example, the USA. Data on volunteering were retrieved from the multidisciplinary Danish Longitudinal Study on Ageing and merged with information from administrative registries. Multiple imputation was used to correct for sample selection, and Blinder-Oaxaca decomposition was applied to analyse the development in volunteering from 1997 to 2017 for 6263 respondents aged 67-77. For this age group, volunteerism increased by 12% points, corresponding to an almost 50% increase from 1997 to 2017. Approximately a quarter of this increase was due to compositional changes, i.e. to changes in respondents' characteristics between the 2 years, whereas three-quarters were due to changes in coefficients, i.e. to changes in the associations between the explanatory variables and volunteering over time. Thus, while larger shares of older adults had more resources in terms of higher levels of education and health in 2017 than in 1997, such resources were less important for volunteerism among Danish older adults in 2017. Despite concerns about declining civic-mindedness and empirical evidence on stagnating participation rates in many Anglo-Saxon countries, Denmark has succeeded in drawing an ever-broader range of older adults into volunteerism over the past decades. The extensive welfare state model and changing norms and perceptions of ageing may together have contributed to the large increase in old-age volunteerism in Denmark.

Being a relative on the sideline to the patient with oesophageal cancer: a qualitative study across the treatment course.

BACKGROUND: Being a relative of patients with oesophageal cancer or cancer in the oesophageal junction is stressful, as the healthcare system often overlooks concerns about the future as well as the roles and needs of relatives. There is a lack of research addressing relatives' experiences, roles and needs for participation in decisions. AIMS AND OBJECTIVES: To explore relatives' experiences before the start of treatment and their subsequent roles and needs for participation in treatment decisions. DESIGN: A qualitative approach based on a phenomenological - hermeneutical methodology was used. METHODS: Data consisted of participant observations and semi-structured interviews with 19 relatives of patients with oesophageal cancer. We analysed data with inspiration from Ricœur's theory of interpretation. RESULTS: The relatives were fellow sufferers, experiencing uncertainties and fear for the future with the patients, but they were simultaneously a challenged anchor during a difficult time, actively involved in handling the diagnosis and the everyday life. The relatives were positioned on the sideline both by the professionals and by themselves; they took a passive and subordinate part in decisions. CONCLUSION: Relatives are central to cancer care and treatment. Adequate and timely information is imperative for relatives as well for patients in order to facilitate shared decision-making. We advocate for a new approach to relatives in order to prepare the relatives for their roles and support their individual needs but also to acknowledge relatives' knowledge about everyday life from the relatives' perspective.

Undertaking responsibility and a new role as a relative: a qualitative focus group interview study.

BACKGROUND: Being a relative of a patient with oesophageal cancer can evoke strong emotions and uncertainty about the future. As a consequence of the treatment course for oesophageal cancer and an increase in outpatient treatment, relatives are becoming increasingly responsible for patients' physical and emotional care. There is a lack of research exploring relatives' experiences with illness, treatment and decision-making. AIMS AND OBJECTIVES: To explore relatives' experiences with illness, treatment of the patient and decision-making in the context of oesophageal cancer. DESIGN: A qualitative explorative design was chosen. METHODS: We conducted two focus group interviews with 11 relatives. The analysis was based on Ricoeur's theory of interpretation. RESULTS: Throughout illness and treatment, relatives faced the fear of loss, leading to distress and anxiety. Relatives were simultaneously taking responsibility and asserting a new role during treatment as they regarded treatment as a joint affair. Regarding decision-making, relatives positioned themselves on the sidelines, awaiting the authority of the patients and healthcare professionals to give them space for participation. CONCLUSION: Relatives of patients with oesophageal cancer undergoing treatment are suppressing their anxiety and doubt about the future. As they are undertaking responsibility during treatment, they are claiming control in new areas, which leads to changing roles within the family. However, they do not feel empowered in decision-making because they recognise patients' decision-making authority. This study highlights the complexity of balancing patients' authority with acknowledgement of relatives' role as active collaborators.

Noninvasive Molecular Imaging of the Enhanced Permeability and Retention Effect by 64Cu-Liposomes: In vivo Correlations with 68Ga-RGD, Fluid Pressure, Diffusivity and 18F-FDG.

BACKGROUND: The accumulation of liposome encapsulated chemotherapy in solid cancers is dependent on the presence of the enhanced permeability and retention (EPR) effect. Positron emission tomography (PET) imaging with a liposome encapsulated radioisotope, such as liposome encapsulated Cu-64 (64Cu-liposome) may help to identify tumors with high liposome accumulation, and thereby stratify patients based on expected benefit from liposomal chemotherapy. However, intravenous administration of liposomes without a cytotoxic content is complicated by the accelerated blood clearance (ABC) phenomenon for succeeding therapeutic liposome dosing. Alternative markers for assessing the tumor's EPR level are therefore warranted. MATERIALS AND METHODS: To increase our understanding of EPR variations and to ultimately identify an alternative marker for the EPR effect, we investigated the correlation between 64Cu-liposome PET/CT (EPR effect) and 68Ga-RGD PET/CT (neoangiogenesis), 18F-FDG PET/CT (glycolysis), diffusion-weighted MRI (diffusivity) and interstitial fluid pressure in two experimental cancer models (CT26 and COLO 205). RESULTS: 64Cu-liposome and 68Ga-RGD SUVmax displayed a significant moderate correlation, however, none of the other parameters evaluated displayed significant correlations. These results indicate that differences in neoangiogenesis may explain some EPR variability, however, as correlations were only moderate and not observed for SUVmean, 68Ga-RGD is probably insufficient to serve as a stand-alone surrogate marker for quantifying the EPR effect and stratifying patients.

A radical change: A qualitative study of patients' experiences of eating and daily living through the first year after oesophageal resection.

PURPOSE: The purpose of this study is to explore the lived experiences of patients in terms of eating and consequences in everyday life in the first year after oesophageal cancer surgery. METHODS: Thirteen patients participated in qualitative interviews one year after surgery for oesophageal cancer. Descriptions capturing the meaning of the lived experiences of patients were then derived from subsequent analysis and interpretation of the interviews. A phenomenological hermeneutical approach comprised the epistemological stance, and theoretical perspectives were drawn from Schutz' theory of everyday life. RESULTS: Patient descriptions of their experiences with food, eating and everyday life in the first year after oesophageal cancer surgery fell into four themes: Adjusting to a different anatomy - food and eating as a dominant and difficult activity; changed body - food and eating as an underlying shadow; feeling different - social consequences of changed eating; a nutritional jungle - guidance and support in an uncertain time. CONCLUSION: The physical and social consequences of oesophageal cancer resection upend everyday structures, requiring patients to adopt a new, conscious and reflexive approach to food and eating as a social activity. Continuous support from healthcare professionals and patient-to-patient interaction can help redefine everyday life.

Patients' Experiences With Illness, Treatment, and Decision-Making for Esophageal Cancer: A Qualitative Study in a Danish Hospital Setting.

Patients with curable esophageal cancer or cancer in the esophageal junction face several challenges during the course of their treatment because of the burden of uncertainty in their prognoses and complexity and side effects of the treatment. The aim of this study is to explore patient experiences with illness, treatment, and decision-making in the context of esophageal cancer. A qualitative approach using phenomenological-hermeneutical methodology was used. Data consisted of participant observations and interviews. We analyzed the data based on Ricoeur's theory of interpretation. The results show that patients with esophageal cancer are putting their ordinary lives on hold and experiencing the meal as a battleground during treatment. Patients strive to maintain autonomy, gain control, and take ownership. The results emphasize the need for a systematic approach to establish an ongoing dialogue with patients throughout the course of treatment.

Angiogenesis PET Tracer Uptake (68Ga-NODAGA-E[(cRGDyK)]2) in Induced Myocardial Infarction and Stromal Cell Treatment in Minipigs.

Angiogenesis is considered integral to the reparative process after ischemic injury. The αvß3 integrin is a critical modulator of angiogenesis and highly expressed in activated endothelial cells. 68Ga-NODAGA-E[(cRGDyK)]2 (RGD) is a positron-emission-tomography (PET) ligand targeted towards αvß3 integrin. The aim was to present data for the uptake of RGD and correlate it with histology and to further illustrate the differences in angiogenesis due to porcine adipose-derived mesenchymal stromal cell (pASC) or saline treatment in minipigs after induction of myocardial infarction (MI). Three minipigs were treated with direct intra-myocardial injection of pASCs and two minipigs with saline. MI was confirmed by 82Rubidium (82Rb) dipyridamole stress PET. Mean Standardized Uptake Values (SUVmean) of RGD were higher in the infarct compared to non-infarct area one week and one month after MI in both pASC-treated (SUVmean: 1.23 vs. 0.88 and 1.02 vs. 0.86, p < 0.05 for both) and non-pASC-treated minipigs (SUVmean: 1.44 vs. 1.07 and 1.26 vs. 1.04, p < 0.05 for both). However, there was no difference in RGD uptake, ejection fractions, coronary flow reserves or capillary density in histology between the two groups. In summary, indications of angiogenesis were present in the infarcted myocardium. However, no differences between pASC-treated and non-pASC-treated minipigs could be demonstrated.

Examining barriers to healthcare providers' adoption of a hospital-wide electronic patient journey board.

BACKGROUND: The dynamic environment that characterizes patient care in hospitals requires extensive communication between staff. Electronic status board applications are used to improve the flow of communication in hospitals. To date there has been limited work exploring the adoption of these applications in general acute ward settings. AIM: This study aimed to identify barriers to the adoption of an electronic patient journey board (EPJB)1 application in acute wards of a hospital. METHOD: Data were collected at a large public teaching hospital in Sydney, Australia. The EPJB was implemented across all hospital wards with the aim of improving multidisciplinary communication in wards. Observations (29.5 h) and contextual interviews (n = 33) with hospital staff were conducted in two acute wards of the hospital. RESULTS: Two manual whiteboards were used on wards, in addition to the EPJB, to compensate for information not being available or accessible on the EPJB. Despite the stated purpose of the EPJB, the tool did not appear to support team communication on wards. Barriers to adoption and optimal use of the EPJB included inappropriate location and configuration of the system, limitations in information timeliness, quality and lack of customisation (for different user groups), inconsistent information updates and the absence of a shared understanding of the purpose of the EPJB among the various user groups. CONCLUSION: Multiple socio-technical barriers influenced uptake and optimal use of the EPJB by healthcare providers. Engaging users early in the design and implementation of electronic status board applications is required to ensure effective use of these complex interventions on general wards.

Improving the effectiveness of sickness benefit case management through a public-private partnership? A difference-in-difference analysis in eighteen Danish municipalities.

BACKGROUND: The aim of this study was to investigate whether a multidimensional public-private partnership intervention, focussing on improving the quality and efficiency of sickness benefit case management, reduced the sickness benefit duration and the duration until self-support. METHODS: We used a difference-in-difference (DID) design with six intervention municipalities and 12 matched control municipalities in Denmark. The study sample comprised 282,103 sickness benefit spells exceeding four weeks. The intervention group with 110,291 spells received the intervention, and the control group with 171,812 spells received ordinary sickness benefit case management. Using register data, we fitted Cox proportional hazard ratio models, estimating hazard ratios (HR) and confidence intervals (CI). RESULTS: We found no joint effect of the intervention on the sickness benefit duration (HR 1.02, CI 0.97-1.07) or the duration until self-support (HR 0.99, CI 0.96-1.02). The effect varied among the six municipalities, with sickness benefit HRs ranging from 0.96 (CI 0.93-1.00) to 1.13 (CI 1.08-1.18) and self-support HRs ranging from 0.91 (CI 0.82-1.00) to 1.11 (CI 1.06-1.17). CONCLUSIONS: Compared to receiving ordinary sickness benefit management the intervention had on average no effect on the sickness benefit duration or duration until self-support. However, the effect varied considerably among the six municipalities possibly due to differences in the implementation or the complexity of the intervention.

Feasibility of Representing a Danish Microbiology Model Using FHIR.

Achieving interoperability in health is a challenge and requires standardization. The newly developed HL7 standard: Fast Healthcare Interoperability Resources (FHIR) promises both flexibility and interoperability. This study investigates the feasibility of expressing a Danish microbiology message model content in FHIR to explore whether complex in-use legacy models can be migrated and what challenges this may pose. The Danish microbiology message model (the DMM) is used as a case to illustrate challenges and opportunities accosted with applying the FHIR standard. Mapping of content from DMM to FHIR was done as close as possible to the DMM to minimize migration costs except when the structure of the content did not fit into FHIR. From the DMM a total of 183 elements were mapped to FHIR. 75 (40.9%) elements were modeled as existing FHIR elements and 96 (52.5%) elements were modeled as extensions and 12 (6.6%) elements were deemed unnecessary because of build-in FHIR characteristics. In this study, it was possible to represent the content of a Danish message model using HL7 FHIR.

Safety, Dosimetry, and Tumor Detection Ability of 68Ga-NOTA-AE105: First-in-Human Study of a Novel Radioligand for uPAR PET Imaging.

The overexpression of urokinase-type plasminogen activator receptors (uPARs) represents an established biomarker for aggressiveness in most common malignant diseases, including breast cancer (BC), prostate cancer (PC), and urinary bladder cancer (UBC), and is therefore an important target for new cancer therapeutic and diagnostic strategies. In this study, uPAR PET imaging using a 68Ga-labeled version of the uPAR-targeting peptide (AE105) was investigated in a group of patients with BC, PC, and UBC. The aim of this first-in-human, phase I clinical trial was to investigate the safety and biodistribution in normal tissues and uptake in tumor lesions. Methods: Ten patients (6 PC, 2 BC, and 2 UBC) received a single intravenous dose of 68Ga-NOTA-AE105 (154 ± 59 MBq; range, 48-208 MBq). The biodistribution and radiation dosimetry were assessed by serial whole-body PET/CT scans (10 min, 1 h, and 2 h after injection). Safety assessment included measurements of vital signs with regular intervals during the imaging sessions and laboratory blood screening tests performed before and after injection. In a subgroup of patients, the in vivo stability of 68Ga-NOTA-AE105 was determined in collected blood and urine. PET images were visually analyzed for visible tumor uptake of 68Ga-NOTA-AE105, and SUVs were obtained from tumor lesions by manually drawing volumes of interest in the malignant tissue. Results: No adverse events or clinically detectable pharmacologic effects were found. The radioligand exhibited good in vivo stability and fast clearance from tissue compartments primarily by renal excretion. The effective dose was 0.015 mSv/MBq, leading to a radiation burden of 3 mSv when the clinical target dose of 200 MBq was used. In addition, radioligand accumulation was seen in primary tumor lesions as well as in metastases. Conclusion: This first-in-human, phase I clinical trial demonstrates the safe use and clinical potential of 68Ga-NOTA-AE105 as a new radioligand for uPAR PET imaging in cancer patients.