Published in 2018

The Development of Complex Digital Health Solutions: Formative Evaluation Combining Different Methodologies

Lee, A., Sandvei, M., Asmussen, H. C., Skougaard, M., Macdonald, J., Zavada, J., Bliddal, H., Taylor, P. C. & Gudbergsen, H., 16 jul. 2018, I : JMIR research protocols. 7, 7, s. e165

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The development of digital health solutions for current health care settings requires an understanding of the complexities of the health care system, organizational setting, and stakeholder groups and of the underlying interplay between stakeholders and the technology. The digital health solution was founded on the basis of an information and communication technology platform and point-of-care devices enabling home-based monitoring of disease progression and treatment outcome for patients with rheumatoid arthritis (RA).

OBJECTIVE: The aim of this paper is to describe and discuss the applicability of an iterative evaluation process in guiding the development of a digital health solution as a technical and organizational entity in three different health care systems.

METHODS: The formative evaluation comprised the methodologies of contextual understanding, participatory design, and feasibility studies and included patients, healthcare professionals, and hardware and software developers. In total, the evaluation involved 45 patients and 25 health care professionals at 3 clinical sites in Europe.

RESULTS: The formative evaluation served as ongoing and relevant input to the development process of the digital health solution. Through initial field studies key stakeholder groups were identified and knowledge obtained about the different health care systems, the professional competencies involved in routine RA treatment, the clinics' working procedures, and the use of communication technologies. A theory-based stakeholder evaluation achieved a multifaceted picture of the ideas and assumptions held by stakeholder groups at the three clinical sites, which also represented the diversity of three different language zones and cultures. Experiences and suggestions from the patients and health care professionals were sought through participatory design processes and real-life testing and actively used for adjusting the visual, conceptual, and practical design of the solution. The learnings captured through these activities aided in forming the solution and in developing a common understanding of the overall vision and aim of this solution. During this process, the 3 participating sites learned from each other's feed-back with the ensuing multicultural inspiration. Moreover, these efforts also enabled the consortium to identify a 'tipping point' during a pilot study, revealing serious challenges and a need for further development of the solution. We achieved valuable learning during the evaluation activities, and the remaining challenges have been clarified more extensively than a single-site development would have discovered. The further obstacles have been defined as has the need to resolve these before designing and conducting a real-life clinical test to assess the outcome from a digital health solution for RA treatment.

CONCLUSIONS: A formative evaluation process with ongoing involvement of stakeholder groups from 3 different cultures and countries have helped to inform and influence the development of a novel digital health solution, and provided constructive input and feedback enabling the consortium to control the development process.

Originalsprog Engelsk
Tidsskrift JMIR research protocols
Vol/bind 7
Tidsskriftsnummer 7
Sider (fra-til) e165
ISSN 1929-0748
DOI
Status Udgivet - 16 jul. 2018

The effect of glucocorticoids on bone mineral density in patients with rheumatoid arthritis: A systematic review and meta-analysis of randomized, controlled trials

Blavnsfeldt, A-B. G., de Thurah, A., Thomsen, M. D., Tarp, S., Langdahl, B. & Hauge, E-M., sep. 2018, I : The Bone. 114, s. 172-180 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: The role of glucocorticoids in the treatment of rheumatoid arthritis (RA) is widely debated. Impairment of bone formation may be counter-balanced by reduced systemic inflammation. This review aims to assess the effect of prednisolone/prednisone on bone mineral density (BMD) in patients with RA analyzed in randomized, controlled trials.

METHODS: We performed a systematic literature search and identified randomized, double-blinded placebo-controlled studies including patients with RA and using prednisolone or prednisone as the intervention. We selected studies that measured BMD by DXA at baseline and at least once thereafter. Two authors independently performed reference review, data extraction and risk of bias assessment. Primary outcome was mean change in BMD from baseline to follow-up. Secondary endpoints included radiographic scores, RA disease activity indices and fractures. We rated the quality of evidence using the GRADE approach. Outcomes were standardized for meta-analyses and 95% confidence intervals (95% CI) were calculated.

RESULTS: We identified 7 studies and included previously unpublished data. Studies were similar regarding study population and intervention. Standard mean difference (SMD) in change in BMD from 0 to 24 months was -0.02 (95%CI -0.16, 0.12) at the lumbar spine and -0.11 (95% CI -0.25, 0.02) at the hip (both high quality evidence) between patients treated with prednisolone/prednisone or not. Data completeness was low in some studies, concomitant treatment of RA differed between studies and differences in use of anti-osteoporotic medication may have influenced the results. However, sensitivity analyses excluding studies in which participants used either the most or the least potent concomitant RA treatment or used anti-osteoporotic therapies did not alter the estimates.

CONCLUSIONS: In patients with early and active RA, we found no difference in change in BMD between patients treated with prednisone/prednisolone versus placebo, suggesting that at least through 24 months, the suppression of inflammation by glucocorticoids may counterbalance their adverse effects on bone remodeling.

Originalsprog Engelsk
Tidsskrift The Bone
Vol/bind 114
Sider (fra-til) 172-180
Antal sider 9
ISSN 0914-7047
DOI
Status Udgivet - sep. 2018

OBJECTIVE: To evaluate if the relative volume of bone marrow lesions (BMLs) changed in patients with knee osteoarthritis (OA) during a therapeutic study.

DESIGN: This study is a sub-study to a larger clinical trial which compared the clinical effects of intra-articular corticosteroid injection in knee OA to placebo injection, both given prior to exercise therapy. Clinical assessment using the Knee injury and Osteoarthritis Outcome Score (KOOS) and magnetic resonance imaging (MRI) examinations with BML assessments were performed at baseline and follow-up after 14 weeks and 26 weeks, respectively. The BML volume was determined using a computer assisted method focusing on participants with valid baseline and follow-up MRI examinations. Any changes in BML and KOOS were analyzed and investigated for associations.

RESULTS: Fifty participants received steroid and placebo injection, respectively, of which 41 and 45 had complete MRI examinations at week 14, and 36 and 33 at week 26, respectively. All participants received 12 weeks of exercise. A significant change in relative BML volume was observed between the corticosteroid group and the placebo group after 14 weeks [-1.1% vs 2.7%; between-group difference, 3.8% (95% CI 0.5-7.0)] but not after 26 weeks [0.8% vs 1.6%; between-group difference, 0.8% (95% CI -2.8 to 4.4)]. No significant association was found between changes in relative BML volume and KOOS.

CONCLUSIONS: Despite the statistically significant difference in BML volume at 14 weeks after corticosteroid injection and 12 weeks exercise therapy compared to placebo injection and exercise, there is very little evidence on a relationship between corticosteroids and BML volume.

EU CLINICAL TRIALS REGISTER: EudraCT number: 2012-002607-18.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and Cartilage
Vol/bind 26
Tidsskriftsnummer 7
Sider (fra-til) 895-902
Antal sider 8
ISSN 1063-4584
DOI
Status Udgivet - jul. 2018

The Effectiveness and Cost-Effectiveness of Hepatitis C Screening for Migrants in the EU/EEA: A Systematic Review

Greenaway, C., Makarenko, I., Chakra, C. N. A., Alabdulkarim, B., Christensen, R., Palayew, A., Tran, A., Staub, L., Pareek, M., Meerpohl, J. J., Noori, T., Veldhuijzen, I., Pottie, K., Castelli, F. & Morton, R. L., 14 sep. 2018, I : International Journal of Environmental Research and Public Health. 15, 9

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Chronic hepatitis C (HCV) is a public health priority in the European Union/European Economic Area (EU/EEA) and is a leading cause of chronic liver disease and liver cancer. Migrants account for a disproportionate number of HCV cases in the EU/EEA (mean 14% of cases and >50% of cases in some countries). We conducted two systematic reviews (SR) to estimate the effectiveness and cost-effectiveness of HCV screening for migrants living in the EU/EEA. We found that screening tests for HCV are highly sensitive and specific. Clinical trials report direct acting antiviral (DAA) therapies are well-tolerated in a wide range of populations and cure almost all cases (>95%) and lead to an 85% lower risk of developing hepatocellular carcinoma and an 80% lower risk of all-cause mortality. At 2015 costs, DAA based regimens were only moderately cost-effective and as a result less than 30% of people with HCV had been screened and less 5% of all HCV cases had been treated in the EU/EEA in 2015. Migrants face additional barriers in linkage to care and treatment due to several patient, practitioner, and health system barriers. Although decreasing HCV costs have made treatment more accessible in the EU/EEA, HCV elimination will only be possible in the region if health systems include and treat migrants for HCV.

Originalsprog Engelsk
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 15
Tidsskriftsnummer 9
ISSN 1661-7827
DOI
Status Udgivet - 14 sep. 2018

The effectiveness and cost-effectiveness of screening for active tuberculosis among migrants in the EU/EEA: a systematic review

Greenaway, C., Pareek, M., Abou Chakra, C-N., Walji, M., Makarenko, I., Alabdulkarim, B., Hogan, C., McConnell, T., Scarfo, B., Christensen, R., Tran, A., Rowbotham, N., Noori, T., van der Werf, M. J., Pottie, K., Matteelli, A., Zenner, D. & Morton, R. L., apr. 2018, I : Eurosurveillance. 23, 14

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The foreign-born population make up an increasing and large proportion of tuberculosis (TB) cases in European Union/European Economic Area (EU/EEA) low-incidence countries and challenge TB elimination efforts. Methods: We conducted a systematic review to determine effectiveness (yield and performance of chest radiography (CXR) to detect active TB, treatment outcomes and acceptance of screening) and a second systematic review on cost-effectiveness of screening for active TB among migrants living in the EU/EEA. Results: We identified six systematic reviews, one report and three individual studies that addressed our aims. CXR was highly sensitive (98%) but only moderately specific (75%). The yield of detecting active TB with CXR screening among migrants was 350 per 100,000 population overall but ranged widely by host country (110-2,340), migrant type (170-1,192), TB incidence in source country (19-336) and screening setting (220-1,720). The CXR yield was lower (19.6 vs 336/100,000) and the numbers needed to screen were higher (5,076 vs 298) among migrants from source countries with lower TB incidence (≤ 50 compared with ≥ 350/100,000). Cost-effectiveness was highest among migrants originating from high (> 120/100,000) TB incidence countries. The foreign-born had similar or better TB treatment outcomes than those born in the EU/EEA. Acceptance of CXR screening was high (85%) among migrants. Discussion: Screening programmes for active TB are most efficient when targeting migrants from higher TB incidence countries. The limited number of studies identified and the heterogeneous evidence highlight the need for further data to inform screening programmes for migrants in the EU/EEA.

Originalsprog Engelsk
Tidsskrift Eurosurveillance
Vol/bind 23
Tidsskriftsnummer 14
ISSN 1560-7917
DOI
Status Udgivet - apr. 2018

The Effectiveness and Cost-Effectiveness of Screening for HIV in Migrants in the EU/EEA: A Systematic Review

Pottie, K., Lotfi, T., Kilzar, L., Howeiss, P., Rizk, N., Akl, E. A., Dias, S., Biggs, B-A., Christensen, R., Rahman, P., Magwood, O., Tran, A., Rowbotham, N., Pharris, A., Noori, T., Pareek, M. & Morton, R., 9 aug. 2018, I : International Journal of Environmental Research and Public Health. 15, 8

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Migrants, defined as individuals who move from their country of origin to another, account for 40% of newly-diagnosed cases of human immunodeficiency virus (HIV) in the European Union/European Economic Area (EU/EEA). Populations at high risk for HIV include migrants, from countries or living in neighbourhoods where HIV is prevalent, and those participating in high risk behaviour. These migrants are at risk of low CD4 counts at diagnosis, increased morbidity, mortality, and onward transmission. The aim of this systematic review is to evaluate the effectiveness and cost-effectiveness of HIV testing strategies in migrant populations and to estimate their effect on testing uptake, mortality, and resource requirements. Following a systematic overview, we included four systematic reviews on the effectiveness of strategies in non-migrant populations and inferred their effect on migrant populations, as well as eight individual studies on cost-effectiveness/resource requirements. We assessed the certainty of our results using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The systematic reviews reported that HIV tests are highly accurate (rapid test >90% sensitivity, Western blot and ELISA >99% sensitivity). A meta-analysis showed that rapid testing approaches improve the access and uptake of testing (risk ratio = 2.95, 95% CI: 1.69 to 5.16), and were associated with a lower incidence of HIV in the middle-aged women subgroup among marginalised populations at a high risk of HIV exposure and HIV related stigma. Economic evidence on rapid counselling and testing identified strategic advantages with rapid tests. In conclusion, community-based rapid testing programmes may have the potential to improve uptake of HIV testing among migrant populations across a range of EU/EEA settings.

Originalsprog Engelsk
Tidsskrift International Journal of Environmental Research and Public Health
Vol/bind 15
Tidsskriftsnummer 8
ISSN 1661-7827
DOI
Status Udgivet - 9 aug. 2018

The effectiveness and cost-effectiveness of screening for latent tuberculosis among migrants in the EU/EEA: a systematic review

Greenaway, C., Pareek, M., Abou Chakra, C-N., Walji, M., Makarenko, I., Alabdulkarim, B., Hogan, C., McConnell, T., Scarfo, B., Christensen, R., Tran, A., Rowbotham, N., van der Werf, M. J., Noori, T., Pottie, K., Matteelli, A., Zenner, D. & Morton, R. L., apr. 2018, I : Eurosurveillance. 23, 14

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BackgroundMigrants account for a large and growing proportion of tuberculosis (TB) cases in low-incidence countries in the European Union/European Economic Area (EU/EEA) which are primarily due to reactivation of latent TB infection (LTBI). Addressing LTBI among migrants will be critical to achieve TB elimination. Methods: We conducted a systematic review to determine effectiveness (performance of diagnostic tests, efficacy of treatment, uptake and completion of screening and treatment) and a second systematic review on cost-effectiveness of LTBI screening programmes for migrants living in the EU/EEA. Results: We identified seven systematic reviews and 16 individual studies that addressed our aims. Tuberculin skin tests and interferon gamma release assays had high sensitivity (79%) but when positive, both tests poorly predicted the development of active TB (incidence rate ratio: 2.07 and 2.40, respectively). Different LTBI treatment regimens had low to moderate efficacy but were equivalent in preventing active TB. Rifampicin-based regimens may be preferred because of lower hepatotoxicity (risk ratio = 0.15) and higher completion rates (82% vs 69%) compared with isoniazid. Only 14.3% of migrants eligible for screening completed treatment because of losses along all steps of the LTBI care cascade. Limited economic analyses suggest that the most cost-effective approach may be targeting young migrants from high TB incidence countries. Discussion: The effectiveness of LTBI programmes is limited by the large pool of migrants with LTBI, poorly predictive tests, long treatments and a weak care cascade. Targeted LTBI programmes that ensure high screening uptake and treatment completion will have greatest individual and public health benefit.

Originalsprog Engelsk
Tidsskrift Eurosurveillance
Vol/bind 23
Tidsskriftsnummer 14
ISSN 1560-7917
DOI
Status Udgivet - apr. 2018

The EULAR points to consider for health professionals undertaking musculoskeletal ultrasound for rheumatic and musculoskeletal diseases

Siddle, H. J., Mandl, P., Aletaha, D., Vliet Vlieland, T. P., Backhaus, M., Cornell, P., D'Agostino, M-A., Ellegaard, K., Iagnocco, A., Jakobsen, B., Jasinski, T., Kildal, N. H., Lehner, M., Möller, I., Supp, G. M., O'Connor, P., Redmond, A. C., Naredo, E. & Wakefield, R. J., feb. 2018, I : Annals of the Rheumatic Diseases. 77, 2, s. 311-313 3 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 77
Tidsskriftsnummer 2
Sider (fra-til) 311-313
Antal sider 3
ISSN 0003-4967
DOI
Status Udgivet - feb. 2018

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 70
Tidsskriftsnummer 4
ISSN 2151-464X
DOI
Status Udgivet - 2018

Bibliografisk note

COPECARE

The Influence of Hamstring Muscle Peak Torque and Rate Of Torque Development for Sprinting Performance in Football Players: A Cross-Sectional Study

Ishøi, L., Aagaard, P., Nielsen, M. F., Thornton, K. B., Krommes, K. K., Hölmich, P. & Thorborg, K. 14 nov. 2018 I : International journal of sports physiology and performance. s. 1-27 27 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE:: This cross-sectional study aimed to investigate the association between hamstring muscle peak torque and rapid force capacity (rate of torque development: RTD) versus sprint performance in elite youth football players.

METHODS:: Thirty elite academy youth football players (16.75 ± 1.1 years, 176.9 ± 6.7 cm, 67.1 ± 6.9 kg) were included. Isometric peak torque (Nm/kg) and early (0-100 ms) and late (0-200 ms) phase RTD (RTD100, RTD200) (Nm/s/kg) of the hamstring muscles were obtained as independent predictor variables. Sprint performance was assessed during a 30-m sprint trial. Mechanical sprint variables (maximal horizontal force production (FH0) (N/kg); maximal theoretical velocity (V0) (m/s); maximal horizontal power output (Pmax) (W/kg)) and sprint split times (0-5 m; 0-15 m; 0-30 m; 15-30 m) (s) were derived as dependent variables. Subsequently, linear regression analysis was conducted for each pair of dependent and independent variables.

RESULTS:: Positive associations were observed between hamstring RTD100 and FH0 (r2=0.241, p=0.006) and Pmax (r2=0.227, p=0.008). Furthermore, negative associations were observed between hamstring RTD100 and 0-5 m (r2=0.206, p=0.012), 0-15 m (r2=0.217, p=0.009) and 0-30 m sprint time (r2=0.169, p=0.024). No other associations were observed.

CONCLUSION:: The present data indicate that early-phase (0-100 ms) rapid force capacity of the hamstring muscles plays an important role for the acceleration capacity in elite youth football players. In contrast, no associations were observed between hamstring muscle function and maximal sprint velocity. This indicates that strength training focusing on improving early-phase hamstring rate of force development may contribute to enhance sprint acceleration performance in this athlete population.

Originalsprog Engelsk
Tidsskrift International journal of sports physiology and performance
Sider (fra-til) 1-27
Antal sider 27
ISSN 1555-0265
DOI
Status E-pub ahead of print - 14 nov. 2018

The influence of prenatal exposure to trans-fatty acids for development of childhood haematopoietic neoplasms (EnTrance): a natural societal experiment and a case-control study

Specht, I. O., Huybrechts, I., Frederiksen, P., Steliarova-Foucher, E., Chajes, V. & Heitmann, B. L., 24 jan. 2018, I : Nutrition Journal. 17, 1, s. 13

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Little is known about the causes of childhood cancer, partly as not many children develop cancer, although childhood cancer is a leading cause of death by disease in the young. The young age of the children suggests that risk factors for childhood cancer may be present during pregnancy. Previous studies have shown that exposure to trans-fat, a type of unsaturated fat common in industrially produced foods (iTFA), has adverse health effects in adults, including the risk of developing cancer. Haematopoietic neoplasms are the most common cancer types among European children under the age of 15 years. This study will bring new knowledge as to whether trans-fat and other fatty acids may also increase the risk of developing haematopoietic neoplasms during childhood.

METHODS: We will investigate if the Danish iTFA legislation ban, which radically reduced the use of iTFA in foodstuffs, influenced the risk of childhood haematopoietic neoplasms in children born either before or after the change in legislation, adjusting for relevant secular trends. Further, in a case-control study, we will examine if levels of fatty acids in dried blood spots from newborns can predict the risk of developing childhood haematopoietic neoplasms. Permission from the Danish Data Protection Agency and the Ethical Committee has been granted.

DISCUSSION: The results from this study will provide important information about fatty acids in the mother's diet as a contributor to development of haematopoietic neoplasms during childhood, which may result in relevant preventive action.

TRIAL REGISTRATION: Not relevant.

Originalsprog Engelsk
Tidsskrift Nutrition Journal
Vol/bind 17
Tidsskriftsnummer 1
Sider (fra-til) 13
ISSN 1475-2891
DOI
Status Udgivet - 24 jan. 2018

The Parker Model: Applying a Qualitative Three-Step Approach to Optimally Utilize Input from Stakeholders When Introducing New Device Technologies in the Management of Chronic Rheumatic Diseases

Jørgensen, T. S., Skougaard, M., Taylor, P. C., Asmussen, H. C., Lee, A., Klokker, L., Svejstrup, L., Mountian, I., Gudbergsen, H. & Kristensen, L. E., okt. 2018, I : The Patient. 11, 5, s. 515-526 12 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND AND OBJECTIVE: Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lack generalizability. This study aimed to assess the face validity and feasibility of using a composite, three-step qualitative method (the Parker Model), to inform the development and implementation of ava®, an electromechanical device (e-Device) for subcutaneous self-administration of the biologic, certolizumab pegol (CZP), used to treat rheumatic diseases.

METHODS: The Parker Model combines concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE). CM, a structured group process, was used to identify patients' opinions and concerns regarding the e-Device. Patients used this information in iterative PD sessions to create personal e-Device prototypes in cooperation with a designer and a healthcare professional. SE was performed based on semi-structured group and individual interviews with patients and disease-management stakeholders.

RESULTS: The study recruited 14 patients, two doctors, two nurses, one medical secretary, and four other public servants. Three CM workshops revealed four key considerations: technical usability, physical design, concerns, and enthusiasm. Four personalized prototypes were developed during PD sessions. SE confirmed that the identified considerations were pivotal for the implementation and adaptation of the e-Device.

CONCLUSIONS: This study is the first to apply a composite, qualitative research model when introducing an e-Device for the treatment and management of rheumatic disease. Results show that input from patients and other stakeholders using the Parker Model can add value to the development and implementation of an e-Device.

Originalsprog Engelsk
Tidsskrift The Patient
Vol/bind 11
Tidsskriftsnummer 5
Sider (fra-til) 515-526
Antal sider 12
ISSN 1178-1653
DOI
Status Udgivet - okt. 2018

The relation between maximal voluntary force in m. palmaris longus and the temporal and spatial summation of muscle fiber recruitment in human subjects

Claudel, C. G., Ahmed, W., Elbrønd, V. S., Harrison, A. P. & Bartels, E. M., jan. 2018, I : Physiological Reports. 6, 1

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

This study aimed at looking at the frequency (T-score) and the amplitude (S-score) of fiber use during contraction of a forearm muscle, m. palmaris longus, as measured by acoustic myography (AMG). An additional aim was to relate the T- and S-scores to the recorded force obtained from a hand dynamometer. The hypothesis being that temporal and spatial summation of muscle fiber contraction in a given muscle during a given movement, can together describe a given obtained force. Force measurements were carried out on 12 healthy human subjects aged 19-68 years (6 men & 6 women), while their m. palmaris longus contractile function was measured using an acoustic myography CURO device. Force production was varied from 90 to 10% of assessed maximal voluntary force (MVF), and also monitored over a 1 min period of 50% MVF. Linear regression analysis was applied to relate force to spatial and temporal summation. Muscle strength was sustained by changing the frequency and/or the number of active fibere at any given point in time. Force production, whilst stronger for men than women, was regulated in a similar fashion for both sexes and was closely correlated with the AMG T- and S-scores. It is concluded that AMG is a noninvasive method which can be readily applied to accurately describe how a subject uses a given muscle during any given movement. These findings have relevance when considering training strategies in subjects with muscle trauma or disease, in the elderly, or for both amateur and top professional athletes.

Originalsprog Engelsk
Tidsskrift Physiological Reports
Vol/bind 6
Tidsskriftsnummer 1
ISSN 2051-817X
DOI
Status Udgivet - jan. 2018

BACKGROUND: Exercise reduces the amount of visceral adipose tissue (VAT) and the risk of cardiometabolic diseases. The underlying mechanisms responsible for these exercise-induced adaptations are unclear, but they may involve lipolytic actions of interleukin-6 (IL-6). Contracting skeletal muscles secrete IL-6, leading to increased circulating IL-6 levels in response to exercise. The aim of this study is to investigate whether IL-6 is involved in mediating the effects of exercise on visceral and epicardial adipose tissue volume and glycaemic control.

METHODS/DESIGN: Seventy-five physically inactive males and females aged > 18 years with a waist-to-height ratio > 0.5 and/or waist circumference ≥ 88 cm (females) or ≥ 102 cm (males) are being recruited to participate in a 12-week intervention study. Participants are randomly allocated to one of five groups (1:1:1:1:1). Two groups consist of supervised endurance exercise training combined with the IL-6 blocker tocilizumab (ET) or saline used as placebo (EP), two groups consist of no exercise combined with tocilizumab (NT) or placebo (NP), and one group consists of resistance exercise and placebo (RP). Although the study is an exploratory trial, the primary outcome is change in VAT volume from before to after intervention, with secondary outcomes being changes in (1) epicardial adipose tissue, (2) pericardial adipose tissue and (3) gastric emptying. Depots of adipose tissue are quantitated by magnetic resonance imaging Gastric emptying and glucose metabolism are assessed using mixed-meal tolerance tests.

DISCUSSION: Understanding the role of IL-6 in mediating the effects of exercise on visceral and epicardial adipose tissue and glycaemic control may lead to novel therapeutic approaches in the prevention of cardiometabolic diseases.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT02901496 . Registered on 1 August 2016 and posted retrospectively on 15 September 2016.

Originalsprog Engelsk
Tidsskrift Trials
Vol/bind 19
Tidsskriftsnummer 1
Sider (fra-til) 266
ISSN 1745-6215
DOI
Status Udgivet - 2 maj 2018

The value of adding MRI to a clinical treat-to-target strategy in rheumatoid arthritis patients in clinical remission: Clinical and radiographic outcomes from the IMAGINE-RA randomised controlled trial

Møller-Bisgaard, S. K., Hørslev-Petersen, K., Ejbjerg, B., Hetland, M. L., Ørnbjerg, L. M., Glinatsi, D. E., Møller, J. M., Boesen, M., Christensen, R., Stengaard-Petersen, K., Madsen, O. R., Jensen, B., Villadsen, J., Hauge, E-M., Bennett, P., Hendricks, O., Asmussen, K., Kowalski, M., Lindegaard, H., Nielsen, S. M., Bliddal, H., Krogh, N., Ellingsen, T., Nielsen, A. H., Balding, L., Jurik, A. G., Thomsen, H. & Østergaard, M., 2018, I : Annals of the Rheumatic Diseases. 77, Suppl. 2, s. 58-9 2 s., OP0018.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer OP0018
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 77
Tidsskriftsnummer Suppl. 2
Sider (fra-til) 58-9
Antal sider 2
ISSN 0003-4967
Status Udgivet - 2018

The Value of Adding MRI to a Clinical Treat-to-Target Strategy in Rheumatoid Arthritis Patients in Clinical Remission: Clinical and Radiographic Outcomes from the Imagine-RA Randomized Controlled Trial

Møller-Bisgaard, S. K., Hørslev-Petersen, K., Ejbjerg, B. J., Hetland, M. L., Glinatsi, D. E., Ørnbjerg, L. M., Møller, J. M., Boesen, M., Christensen, R. D. K., Stengaard-Petersen, K., Madsen, O. R., Jensen, B., Villadsen, J. A., Hauge, E-M., Bennett, P., Hendricks, O., Asmussen, K., Kowalski, M. R., Lindegaard, H., Nielsen, S. M., Bliddal, H., Krogh, N. S., Ellingsen, T., Nielsen, A., Balding, L., Jurik, A. G., Thomsen, H. S. & Østergaard, M., 2018, I : Arthritis & Rheumatology. 70, S9, 3 s., 1451.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer 1451
Tidsskrift Arthritis & Rheumatology
Vol/bind 70
Tidsskriftsnummer S9
Antal sider 3
ISSN 1537-2960
Status Udgivet - 2018

TISSUE PERFUSION IN KNEE OSTEOARTHRITIS: IMPLICATIONS FOR EXERCISE THERAPY

Bandak, E., 31 mar. 2018, Eget forlag, København. 66 s.

Publikation: Bog/antologi/afhandling/rapportPh.d.-afhandlingForskning

Originalsprog Engelsk
Forlag Eget forlag, København
Antal sider 66
Status Udgivet - 31 mar. 2018

To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry

Glintborg, B., Loft, A. G., Omerovic, E., Hendricks, O., Linauskas, A., Espesen, J., Danebod, K., Jensen, D. V., Nordin, H., Dalgaard, E. B., Chrysidis, S., Kristensen, S., Raun, J. L., Lindegaard, H., Manilo, N., Jakobsen, S. H., Hansen, I. M. J., Dalsgaard Pedersen, D., Sørensen, I. J., Andersen, L. S., Grydehøj, J., Mehnert, F., Krogh, N. S. & Hetland, M. L. 5 nov. 2018 I : Annals of the Rheumatic Diseases.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.

METHODS: Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).

RESULTS: 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months' preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers' clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.

CONCLUSION: Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
ISSN 0003-4967
DOI
Status E-pub ahead of print - 5 nov. 2018

Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC consensus meetings I and II

Thorlacius, L., Garg, A., Ingram, J. R., Villumsen, B., Theut Riis, P., Gottlieb, A. B., Merola, J. F., Dellavalle, R., Ardon, C., Baba, R., Bechara, F. G., Cohen, A. D., Daham, N., Davis, M., Emtestam, L., Fernández-Peñas, P., Filippelli, M., Gibbons, A., Grant, T., Guilbault, S., Gulliver, S., Harris, C., Harvent, C., Houston, K., Kirby, J. S., Matusiak, L., Mehdizadeh, A., Mojica, T., Okun, M., Orgill, D., Pallack, L., Parks-Miller, A., Prens, E. P., Randell, S., Rogers, C., Rosen, C. F., Choon, S. E., van der Zee, H. H., Christensen, R. & Jemec, G. B. E., mar. 2018, I : British Journal of Dermatology. 178, 3, s. 715-721 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items.

OBJECTIVES: To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains.

METHODS: The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey.

RESULTS: Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments.

CONCLUSIONS: The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings.

Originalsprog Engelsk
Tidsskrift British Journal of Dermatology
Vol/bind 178
Tidsskriftsnummer 3
Sider (fra-til) 715-721
Antal sider 7
ISSN 0007-0963
DOI
Status Udgivet - mar. 2018

Treating Early Undifferentiated Arthritis: A Systematic Review and Meta-Analysis of Direct and Indirect Trial Evidence

Lopez-Olivo, M. A., Kakpovbia-Eshareturi, V., des Bordes, J. K., Barbo, A., Christensen, R. & Suarez-Almazor, M. E., sep. 2018, I : Arthritis Care & Research. 70, 9, s. 1355-1365 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: We undertook a systematic review and meta-analysis of direct and indirect trial evidence to evaluate the efficacy of treatments for patients with undifferentiated arthritis (UA).

METHODS: We searched 4 electronic databases from inception to January 2016, clinicaltrials.gov, and bibliographies of relevant articles. Two reviewers independently screened and evaluated the studies. The primary outcome was development of rheumatoid arthritis (RA).

RESULTS: Nine studies were included. Interventions included methotrexate, abatacept, infliximab, intraarticular or intramuscular glucocorticoids, and radiation synovectomy. Treating patients resulted in lower rates of RA at 12 months compared to placebo or no treatment (odds ratio [OR] 0.49 [95% confidence interval (95% CI) 0.26, 0.90]). From direct meta-analysis, patients treated with methotrexate were less likely to develop RA at 12 months compared to patients treated without methotrexate (OR 0.13 [95% CI 0.03, 0.48]). This difference was no longer significant at 30 or 60 months. From indirect comparisons, most interventions showed decreased risk of developing RA compared to placebo at 12 months, reaching statistical significance for methotrexate (OR 0.16 [95% CI 0.08, 0.33]) and intramuscular methylprednisolone (OR 0.72 [95% CI 0.53, 0.99]). Most individual interventions included a limited number of studies.

CONCLUSION: Treating patients with UA resulted in a statistically significant delay in the development of RA, with the largest effect observed for methotrexate. These findings suggest that there is a window of opportunity to treat patients with UA early, to delay subsequent progression to RA.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 70
Tidsskriftsnummer 9
Sider (fra-til) 1355-1365
Antal sider 11
ISSN 2151-464X
DOI
Status Udgivet - sep. 2018

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