Validating the Danish version of the Eating Disorder Quality of Life Scale (EDQLS) in anorexia nervosa.

PURPOSE: The aim of this study was to explore the factor structure of the Danish translation of the eating disorder quality of life scale and evaluate the internal reliability and convergent validity of the scale in a Danish cohort of women with AN. METHODS: The total sample comprised 211 patients diagnosed with anorexia nervosa age 13-40 years. Patients completed questionnaires assessing eating disorder psychopathology, physical and social functioning, and well-being. RESULTS: Factor analyses were not able to support the current division of the scale into 12 factors. We found excellent internal consistency of the eating disorder quality-of-life scale total score. We found relevant associations between quality of life and pre-determined variables. CONCLUSION: This study supports the use of the total score of the eating disorder quality of life scale in assessing quality of life in patients with anorexia nervosa. However, future studies should explore the factor structure of the scale further. LEVEL OF EVIDENCE: III: Evidence obtained from cohort or case-control analytic studies.

Time trends in treatment modes of anorexia nervosa in a nationwide cohort with free and equal access to treatment.

BACKGROUND: Treating patients with anorexia nervosa (AN) remains a major challenge. The choice between an inpatient or an outpatient care setting is an essential issue for the patients and for their relatives with major health economic implications. However, health services-related studies are lacking. The present study was a descriptive exploration of time-trends in treatment modes of patients with free and equal access to health services. METHODS: The study was based on a nationwide cohort of patients diagnosed for the first time with AN, each followed for 5 years in the registers covering the years 1994-2018. The per patient number of hospital admissions, cumulated number of days of hospitalization and number of outpatient visits during the first 5 years after initial diagnosis were considered. RESULTS: The cohort of patients with AN with at least 5 years of follow-up amounted to N = 7,505. A clear trend was observed in the per patient five-year cumulated number of inpatient days, decreasing by 6% per year after adjustment for age at diagnosis, parental mental diagnosis, and family income. The five-year number of hospital admissions after initial diagnosis decreased by 2% per year, while no trend was observed for outpatient visits. CONCLUSIONS: The per patient number of hospitalizations and cumulated days of hospitalization during 5 years after diagnosis were reduced for patients initially diagnosed with AN while there was no change in the number of outpatient visits. The factors contributing to these changes of treatment modes over time are in need of further study.

Experience of family function, family involvement, and self-management in adult patients with type 2 diabetes: A thematic analysis.

AIM: To describe the patient's experience of family function and its importance in diabetes-related self-management. BACKGROUND: Many patients fail to reach the targeted glycemic level due to low self-management adherence. Knowledge is needed regarding the impact of family function on diabetes self-management. DESIGN: A qualitative descriptive design. METHODS: A purposive sample of 20 patients with type 2 diabetes. Data were collected in March-June 2017 via audio-recorded semi-structured interviews, field notes and Eco-maps. Analysed using thematic framework matrix and thematic analysis. RESULTS: Four themes were identified: (1) Downplaying disease. The disease was trivialized creating a barrier to family involvement; (2) Second guessing. When diabetes was not discussed, patient and family made their own assumptions; (3) Going it alone. The participants preferred sole disease responsibility to maintain usual family life; (4) No regrets. The participants managed their disease with medications only to maintain family cohesion and 'the good life'. CONCLUSION: The participants in our study downplayed the consequences of type 2 diabetes and chose to control their disease medically rather than by lifestyle changes. They renounced family involvement to maintain their lifestyle and promote family cohesion. IMPACT: During clinical check-ups, patients should be encouraged to involve their family in lifestyle changes. Healthcare professionals need to recognize illness- and treatment beliefs and the impact of family function in disease management.

[Autonomy and Participation As Common Goals of Nursing, Therapy and Social Medicine: Proposal for an Organizational Configuration Model on the Basis of Service Blueprinting]. / Selbstbestimmung und Teilhabe als gemeinsame Ziele von Pflege, Therapie und Sozialmedizin: Entwurf eines Organisationsmodells auf Basis einer Kontaktpunktanalyse.

BACKGROUND: Every person who is in the need of long-term care (according to German Social Code SGB XI §14) fulfills the requirements of disability according to German Social Code SGB IX, § 2. The right of participation and autonomy must be specially protected and realized for persons with long-term care needs because these persons have a limited capacity to advance their interests. The rights of people in the need of long-term care or assistance are protected not only by the national constitution but also by the UN Disability Rights Convention. Participation is an important principle of these extra-statutory regulations and has an extraordinary significance and individual meaning for quality of life. For concretizing the aim of participation and for realizing participation in daily practice, the following question arises: How must organizations be configured to achieve individual aims of participation for persons with long-term care need, complex health care needs and with potential for rehabilitation across sectoral, disciplinary and professional borders? This analysis focuses on people older than 70 years with geriatric-relevant multimorbidity and with potential for rehabilitation. AIM: The aim of this study was to create a configuration model for the organization of interdisciplinary cooperation in rehabilitation out of a case study and on the basis of the service blueprinting method [1]. In a next step this configuration model can be evaluated concerning its effectiveness for achieving individual participation goals and quality of life of persons with long-term care need and with potential for rehabilitation. METHOD: For creating the configuration model, the service blueprinting method [1] on the basis of Dervin's sense making theory [11] was applied to a case vignette of geriatric rehabilitation against a background of organization theories and nursing science concepts. With the case study the configuration model can be applied exemplarily at the setting of restorative care, therapy and rehabilitation. With the service blueprinting method, the rehabilitation process is aligned onto the geriatric patient's individual health care needs, perceptions of participation and quality of life. RESULTS: As a result of the sequencing and service blueprinting process we offer a dynamic model for the coordination of responsibility of interdisciplinary rehabilitation teams with a user-centered alignment. Its effectiveness (and side-effects) for interdisciplinary cooperation and for patient's individual goals of participation and quality of life must be evaluated in further studies. A mixed-method design should be used to evaluate objective outcome parameters such as dependency on nursing care, hospital admission rates and subjective outcome parameters such as patient's perception of participation, autonomy and quality of life. IMPLICATIONS FOR HEALTHCARE PRACTICE: The configuration model can be used for evaluating already implemented geriatric rehabilitation processes and organizations. The configuration model can be used in health care research or organizational research. After more evidence for desirable effects, it can be implemented into the health care system. Side effects should be monitored.This paper was written in cooperation with the working group "Nursing", department "Practical Social Medicine and Rehabilitation" of the German Society of Social Medicine and Prevention (Deutsche Gesellschaft für Sozialmedizin und Prävention DGSMP e.V.).

[Social Medicine and Interfaces in Sectoral Health Care Provision]. / Sozialmedizin und Schnittstellen in der sektoralen Versorgung.

In addition to the consideration of individual medicine, social medicine focuses on the social references of health and sickness. In this context, it reflects the structures of the entire health care system, its functions and its functional deficits. It deals with the specific interaction between medicine and society and functions such as a link to the classical social sciences (1). Of particular interest in this context are the interfaces to sectoral health care provision. The working group "Nursing Care" of the Department "Practical Social Medicine and Rehabilitation" of the German Society for Social Medicine and Prevention examines the fundamental interfaces in our sectoral health care system from the perspective of social medicine in their current functions and perspectives, particularly in view of the future demographic challenges to be faced. Of particular importance is the interface between medicinal and nursing care in the areas of acute inpatient and homecare as well as in the area of geriatric care, including preventive measures. The aim of this article is to start a discussion on this subject.

Risk stratification by endocrinologists of patients with type 2 diabetes in a Danish specialised outpatient clinic: a cross-sectional study.

BACKGROUND: To target optimised medical care the Danish guidelines for diabetes recommend stratification of patients with type 2 diabetes (T2D) into three levels according to risk and complexity of treatment. The aim was to describe the T2D population in an outpatient clinic, measure the compliance of the endocrinologists' to perform risk stratification, and investigate the level of concordance between stratification performed by the endocrinologists and objective assessments. METHODS: A cross-sectional study with data collected from medical records and laboratory databases. The Danish risk stratification model contained the following criteria: HbA1c, blood pressure, metabolic complications, microvascular and macrovascular complications. Stratification levels encompassed: level 1 (uncomplicated), level 2 (intermediate risk) and level 3 (high risk). Objective assessments were conducted independently by two health professionals, and compared with the endocrinologists' assessments. In order to test the degree of concordance, we conducted Cohen's kappa, McNemar's test for marginal homogeneity, and Bowker's test for symmetry. RESULTS: Of 245 newly referred patients, 209 (85%) were stratified by the endocrinologists to level 1 (16%), level 2 (55%) and level 3 (29%). By objective assessments, 4% were stratified to level 1, 51% to level 2 and 45% to level 3. Of 419 long-term follow-up patients, 380 (91%) were stratified by the endocrinologists to level 1 (5%), level 2 (57%), level 3 (38%). By objective assessments, 3% were stratified to level 1, 58% to level 2 and 39% to level 3. The concordance rate between endocrinologists' and objective assessments was 63% among newly referred (kappa 0.39; fair agreement) and 67% for long-term follow-up (kappa 0.45; moderate agreement). Among newly referred patients, the endocrinologists stratified less patients at level 3 compared to objective assessments (p < 0.0001). There were no significant differences in marginal distribution within long-term follow-up patients. CONCLUSION: Type 2 diabetes patients, newly referred to or allocated for long-term follow-up in the out-patient clinic, were mainly intermediate and high-risk, complicated patients (96% and 95 %, respectively). Compliance of stratification by endocrinologists was high. The concordance between endocrinologists' and objective assessments was not strong. Our data suggest that clinician-support for stratification level categorisation might be needed.

Cross-border flow of health information: is 'privacy by design' enough? Privacy performance assessment in EUBIROD.

BACKGROUND: The EUBIROD project aims to perform a cross-border flow of diabetes information across 19 European countries using the BIRO information system, which embeds privacy principles and data protection mechanisms in its architecture (privacy by design). A specific task of EUBIROD was to investigate the variability in the implementation of the EU Data Protection Directive (DPD) across participating centres. METHODS: Compliance with privacy requirements was assessed by means of a specific questionnaire administered to all participating diabetes registers. Items included relevant issues e.g. patient consent, accountability of data custodian, communication (openness) and complaint procedures (challenging compliance), authority to disclose, accuracy, access and use of personal information, and anonymization. The identification of an ad hoc scoring system and statistical software allowed an overall quali-quantitative analysis and independent evaluation of questionnaire responses, automated through a dedicated IT platform ('privacy performance assessment'). RESULTS: A total of 18 diabetes registers from different countries completed the survey. Over 50% of the registers recorded a maximum score for accountability, openness, anonymization and challenging compliance. Low average values were found for disclosure and disposition, access, consent, use of personal information and accuracy. A high heterogeneity was found for anonymization, consent, accuracy and access. CONCLUSIONS: The novel method of privacy performance assessment realized in EUBIROD may improve the respect of privacy in each data source, reduce overall variability in the implementation of privacy principles and favour a sound and legitimate cross-border exchange of high quality data across Europe.

Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial - A detailed statistical analysis plan.

Background: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. Methods: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137).We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. Discussions: This statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses. Trial registration: The protocol was approved by the Regional Committee on Biomedical Research Ethics (H-D-2007-112), the Danish Medicines Agency (EudraCT: 2007-006665-33 CIMT), and registered within ClinicalTrials.gov (NCT00657943, 8th of April 2008).

Predictors of effects of lifestyle intervention on diabetes mellitus type 2 patients.

The main aim of the study was to identify predictors of the effects of lifestyle intervention on diabetes mellitus type 2 patients by means of multivariate analysis. Data from a previously published randomised clinical trial, which compared the effects of a rehabilitation programme including standardised education and physical training sessions in the municipality's health care centre with the same duration of individual counseling in the diabetes outpatient clinic, were used. Data from 143 diabetes patients were analysed. The merged lifestyle intervention resulted in statistically significant improvements in patients' systolic blood pressure, waist circumference, exercise capacity, glycaemic control, and some aspects of general health-related quality of life. The linear multivariate regression models explained 45% to 80% of the variance in these improvements. The baseline outcomes in accordance to the logic of the regression to the mean phenomenon were the only statistically significant and robust predictors in all regression models. These results are important from a clinical point of view as they highlight the more urgent need for and better outcomes following lifestyle intervention for those patients who have worse general and disease-specific health.