A randomized controlled, Danish multicenter trial in minimal change nephropathy: The efficacy of high dose prednisolone vs. reduced prednisolone dose and activated vitamin D.
Tilde Kristensen, Department of Clinical Medicine
T. Kristensen, Medical Department, Regional Hospital Viborg, Hospital Unit Midt and Aarhus University, Department of Clinical Medicine; H. Birn, Department of Renal Medicine, Aarhus University Hospital and Aarhus University, Department of Clinical Medicine; P. Ivarsen, Department of Renal Medicine, Aarhus University Hospital
Background
Minimal change nephropathy (MCN) causes 10-25% of adult nephrotic syndrome. Current treatment guidelines involve high dose of steroids. It is usually effective in inducing clinical remission, but with a relapse rate of 30-70%. Many patients require long term steroid therapy associated with significant morbidity and mortality. Nephrotic syndrome is
associated with low vitamin D levels. Active vitamin D reduces proteinuria in both animal and human studies by regulating podocyte function. This trial will examine the efficacy of a reduced prednisolone dose combined with activated vitamin D in patients with MCN.
Hypotheses
Treatment with reduced prednisolone and activated vitamin D is not inferior to standard high dose prednisolone in inducing remission.
Treatment with reduced prednisolone dose and activated vitamin D has fewer side effects.
Methods
A randomized, open-labelled, multicenter trial comparing the efficacy of prednisolone 1mg/kg/d to prednisolone 0.5mg/kg/d plus activated vitamin D 0.5µg/d in patients with primary MCN using a non-inferiority design.
Primary endpoints are the frequency of remission after 16 weeks and time to remission.
Secondary endpoints are the frequency of relapse and objective and subjective side effects to treatment. Blood and urine tests define remission and relapse. Clinical examination and patient questionnaire measure side effects. Follow up is 1 year from remission. Since 2018 38 out of a total of 96 patients have been included from all renal departments in Denmark.
Perspectives
If successful, the study will allow for new treatment regimens to reduce side effects and thus the disease burden for individuals and society.
Keywords: Nephrology, Pharmacology, Public health
Effectiveness of adapted Mindfulness-based Stress Reduction in private companies: preliminary qualitative results of a mixed methods study
Emilie Hasager Bonde, Department of Clinical Medicine, Danish Center for Mindfulness
E.G. Mikkelsen, Department of Psychology, University of Southern Denmark; L.O. Fjorback, Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University; L. Juul, Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University
Background: The programme “Mindfulness-based Stress Reduction” (MBSR) has been found effective in enhancing well-being, reducing perceived stress and symptoms of depression and anxiety. Previous research indicate that mindfulness in a workplace setting has positive effects not only on individual mental well-being but also on the quality of interpersonal relationships.
Purpose: Evaluate the effectiveness of implementing a systematically adapted MBSR course in private companies on both individual competencies and interpersonal relationships.
Methods: Four companies participated in this quasi-experimental study. In total, 40% of employees in the companies enrolled in a 10-weeks MBSR course. After the course, representatives from three companies participated in a workshop on further
implementation of mindfulness in their company. Qualitative data was collected at baseline and post intervention using focus group interviews with managers and
employees from each company. Data was analysed using qualitative content analysis.
Results: Preliminary analyses indicate that at the individual level, participants experience themselves as less reactive under stressful situations and more likely to prioritize taking breaks during the workday. At the interpersonal level, long-standing work-related conflicts were solved following project participation.
Discussion: Implications for companies and future research will be discussed; specifically, the beneficial effects for companies of implementing mindfulness in their organisation. In conclusion, this study illuminates the potential for a systematically adapted MBSR
programme to evoke personal and interpersonal change in private companies.
Keywords: Public health, Work environment and organisation, Qualitative research
Predicting difference in mean survival time from cause-specific hazard ratios for women diagnosed with breast cancer
Eeva-Liisa Røssell Johansen, Department of Public Health, Applied Public Health Research
L. O. Bornhøft, Department of Public Health, Aarhus University; M. L. Lousdal, Department of Public Health, Aarhus University; H. Støvring, Department of Public Health, Aarhus University
Background: Relative reduction in breast cancer mortality is the preferred outcome measure for evaluation of mammography screening. However, mean survival time has been advocated as a better and more intuitive outcome for risk communication. We have previously introduced a method to predict difference in mean survival time from empirical hazard ratios for all-cause mortality. In this article, we aim to investigate the association between hazard ratios for breast cancer mortality and the difference in mean survival time for women diagnosed with breast cancer.
Methods: We retrieved data on all women diagnosed with first-time invasive breast cancer in Norway from 1960 through 2004. Women were followed until emigration or end of follow-up on 31 December 2015, whichever came first. Observed differences in mean survival times and hazard ratios for both breast cancer death and death from causes other than breast cancer were obtained for neighbouring time periods defined by
women’s age and year of diagnosis. Based on previously developed methods, we fitted a linear relationship between observed differences in mean survival and logarithmic hazard ratios.
Results: A linear association was found between breast cancer-specific hazard ratios and difference in mean survival time for women diagnosed with breast cancer. This association was also estimated with adjustment for other causes of death than breast cancer.
Conclusions: The change in mean survival time could be predicted from an estimated reduction in breast cancer mortality. This outcome measure can contribute to better and more understandable risk information about the effect of mammography screening programmes.
Keywords: Public health, Epidemiology and biostatistics, Other
How Context and Program Conditions (CPC) affect the success of
Interprofessional Collaboration in Integrated Care: using the CPC-framework to examine the Interprofessional Collaboration in Danish Primary Care
Andreas Nielsen Hald, Department of Public Health, Applied Public Health Research
M. Bech, Ledelse & VIVE Sundhed, VIVE;
U. Enemark, Department of Public Health – Applied Public Health Research, Aarhus University;
J. Shaw, Institute of Health Policy, Toronto University;
V. Burau, Department of Public Health – Applied Public Health Research, Aarhus University
Introduction
Increasing demands for interprofessional collaboration in health care have increased the interest in studying how different conditions influence the success of collaborations.
However, there are many different conditions; and we know little about the magnitude of interactions between conditions. Studying these interactions will enable us to identify what the most important conditions are.
Thus, the aim of this paper is to further develop the Context and Program Conditions (CPC) framework; and apply it to study home care services for elderly in two Danish
Municipalities. The purpose of the CPC-framework is to conceptualise the relationships between program and context conditions at the professional and organisational level; and to measure how the different conditions influence each other and the success of the collaboration.
Methods
The study was conducted as a multilevel cross-sectional survey in November 2021 in Herning and Holstebro, Denmark. The focus of the study was the interprofessional
collaboration between home care and home nursing units. The study population was all frontline staff in the units, and their respective managers. Data was examined with CB-SEM based on prior hypothesised relationships and index’.
Results
Preliminary results of the analysis shows that the CPC-framework is well-suited to examine how different types of conditions influence the success of collaborations in a Danish primary care setting.
Implications
The CPC-framework can be used as a diagnostic tool to identify what the most important conditions are for a specific collaboration; and subsequently help improve existing
interprofessional collaborations.
Keywords: Public health, Work environment and organisation, Other
Digital documentation practice
Julie Duval, Department of Public Health, Nursing and Health
K. Beedholm, Department of Public Health; L. Ledderer, Department of Public Health
Introduction
I all Danish municipalities, a new documentation method called the “Common Language Platform” is implemented through the digital platform of the electronic health record. Sub study 1 of this PhD-project examines written implementation strategies. The study indicates that the digitalization of documentation requires standardization and transforms health care practice. The aim of sub study 2 is to investigate how the written strategies are translated into health professional practice.
Methods
Sub study 2 is designed as a qualitative single-case study with a social constructivist approach. Empirical data are collected through multiple methods:
• Documents analysis: E.g. teaching materials, instructions, and guidelines on the local documentation practice. The focus is on how the practical documents represent key ideas of digital documentation.
• Field observations: 4-6 months during the planning of services, with health
professionals during visits and collaborative meetings. The focus is on actions and activities in concrete documentation practice.
• Interviews: 15 Semi-structured interviews among the health professionals. The focus is on how health professionals create meaning and maintain their documentation practice.
Theoretical framework and analysis
The study places itself in a theoretical framework of institutional theory, with emphasis on the Scandinavian perspective of translational processes. Empirical data is analyzed to explore how health professionals edit institutional ideas of digital documentation and how translations affect health professional practice in the local organizational context.
Keywords: Public health, Qualitative research, Other
Biomarker levels in migrants and native Danes with type 2 diabetes: a complete-case analysis of an entire country
Anders Aasted Isaksen, Department of Public Health, General Practice
A. Sandbæk, Department of Public Health; M.V. Skriver, Department of Public Health; G.S.
Andersen, Steno Diabetes Center Copenhagen; L. Bjerg, Department of Public Health
Introduction
Current knowledge: Non-western immigrants have a higher risk of type 2 diabetes (T2D) relative to individuals of native Danish origin. Studies have shown poorer glycemic control in migrants with T2D relative to native populations.
Knowledge gap: Quality of T2D care has not been examined on a population-wide level in Denmark. No studies have investigated lipid levels in migrants.
Aim: To investigate potential difference between migrants and native Danes in terms of hemoglobin-A1c (HbA1c) and low-density lipoprotein-cholesterol (LDL-C) using the entire nation as the study population.
Methods
Study Design: Cross-sectional study.
Population: All register-defined prevalent cases of T2D in Denmark age 25-99 with a diabetes duration of at least 6 months on January 1, 2018.
Variable of interest: Country of origin.
Outcomes of interest: Biomarker level at the most recent measurement before January 1, 2018.
Statistical analysis: Explore empirical cumulative distributions of biomarker levels with 95%
confidence intervals computed with Smirnov-Kolmogorov’s D. Model relative risk of exceeding guideline recommendations in modified Poisson regression models with increasing degrees of adjustment.
Results
Unfavourably high levels of HbA1c and LDL-C are common in the T2D population in Denmark. Most migrant groups have increased levels of HbA1c and LDL-C compared to native Danes. LDL-C levels were particularly high in migrants from Somalia, who were almost twice as likely to exceed guideline recommendations as native Danes.
Conclusion
Efforts should be made to improve HbA1c and LDL-C in T2D, and should have a special focus on migrants.
Keywords: Public health, Epidemiology and biostatistics, Cardiovascular system
Progressive resistance training compared to neuromuscular exercise in patients with hip osteoarthritis, and the additive effect of exercise booster sessions: Study protocol for a multicenter cluster-randomized controlled trial (The Hip Booster Trial)
Troels Kjeldsen, Department of Clinical Medicine,
U. Dalgas, Exercise Biology, Department of Public Health, Aarhus University; S. T. Skou, The Research Unit PROgrez, Department of Physiotherapy and Occupational Therapy,
Næstved-Slagelse-Ringsted Hospitals and Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark; Maurits van Tulder, Faculty of Behavioural and Movement Sciences, Vrije Universiteit, Amsterdam; Inger Mechlenburg, Department of Orthopaedic Surgery, Aarhus University Hospital and Department of Clinical Medicine, Aarhus University.
Purpose:
The primary purpose of this multicenter cluster-randomized controlled trial is to investigate the effectiveness of 12 weeks of progressive resistance training (PRT) compared to
neuromuscular exercise (NEMEX) on functional performance in patients with hip osteoarthritis (HOA).
Methods:
This randomized controlled trial will be a multicenter trial involving hospitals and physiotherapy clinics across Denmark. A total of 160 patients with clinically diagnosed HOA will be recruited. For the initial 12-week exercise intervention, participants will be cluster-randomized into two treatment arms: NEMEX or PRT. After the initial intervention, each cluster will be randomized to booster sessions or to receive no further treatment.
Booster sessions will be provided at 1, 3, 5 and 7 months after the end of the initial interventions. Outcomes, including functional performance, leg extensor muscle power, self-reported physical function, pain and quality of life, will be measured at baseline, after the initial 12 weeks of intervention, and at 6-, 9- and 12-months follow-up.
Results:
Results will be submitted for publication by November 2023.
Conclusions:
This study evaluates the effectiveness of NEMEX comparing it to another well-established modality; PRT. Additionally, it examines the cost-effectiveness of booster sessions. These findings will fill the research gaps concerning which exercise modality is most effective in HOA and the long-term effectiveness of exercise. The clinical significance of this study is
that patients may receive more effective rehabilitation leading to an increase in quality of life and potential societal cost-savings.
Keywords: Rehabilitation, Public health, Orthopedic surgery
Cardiac CT Measured Low Bone Mineral Density Is Associated with Higher Fracture Rate: A Prospective Cohort Study in Denmark
Josephine Therkildsen, Department of Clinical Medicine
L. Nissen, Department of Cardiology, H.S. Jørgensen, Department of Immunology and Microbiology, J. Thygesen, Department of Clinical Engineering, P. Ivarsen, Department of Nephrology, L. Frost, Department of Clinical Medicine and Department of Cardiology, C.
Isaksen, Department of Radiology, B.L. Langdahl, Department of Endocrinology and Internal Medicine, EM Hauge, Department of Clinical Medicine and Department of Rheumatology, M. Boettcher, Department of Cardiology, S. Winther, Department of Cardiology.
Osteoporosis, a treatable disease associated with a high fracture risk, is highly prevalent and under-diagnosed. Routine cardiac CT could be used to measure bone mineral density (BMD) to assess fracture risk.
Aim: To measure BMD from cardiac CT and assess the association with fracture risk.
Methods: Participants were referred to Cardiac CT for assessment of coronary artery disease between 2014 and 2016. Participants were then follow-up until 2018. Thoracic BMD was measured using quantitative CT. Outcomes were incident fractures and incident osteoporosis-related fractures during follow-up reported to the National Patient Registry.
BMD was grouped as very low (<80), low (80-120), and normal (>120 mg/cm3) and used to calculate hazard ratios (HR).
Results: Overall, 1487 participants were included (mean age 57 yrs ± 9, 52.5% female) and very low BMD measured in 179 (12.0%). Median follow-up was 3.1 yrs. During this period, 80 participants (5.3%) had an incident fracture and in 31, it was osteoporosis-related.
Unadjusted Cox regression analyses revealed, that very low BMD predicted a greater rate for any fracture (HR 2.6, 95% CI: 1.4-4.7, p=.002) and osteoporosis-related fractures (HR 8.1, 95% CI: 2.4-26.7, p=.001) when comparing to normal BMD. Adjusting for age and sex did not change these significant associations.
Conclusion: Thoracic BMD measured from routine cardiac CT is usable to identify
individuals with a greater fracture rate. This study is published in Radiology 2020; 296:499–
508.
Keywords: Rheumatology, Medical technology and diagnostic techniques, Public health