Published in 2018

Kind of blue: A systematic review and meta-analysis of music interventions in cancer treatment

Bro, M. L., Jespersen, K. V., Hansen, J. B., Vuust, P., Abildgaard, N., Gram, J. & Johansen, C. 2018 I : Psycho-Oncology. 27, 2, s. 386-400

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVES: Music may be a valuable and low-cost coping strategy for cancer patients. We conducted a systematic review and meta-analysis to identify the psychological and physical effects of music interventions in cancer treatment.

METHODS: We included randomized, controlled trials with adult patients in active cancer treatment exposed to different music interventions versus control conditions. Qualitative studies and systematic reviews were excluded. We identified a total of 2624 records through 2 systematic searches (June 2015 and September 2016) in PubMed, Scopus, EMBASE, Cinahl, Web of Science, Cochrane, and PsycINFO and used Risk of Bias Assessment, GRADE and Checklist for Reporting Music-Based Interventions to evaluate the music applied and quality of the studies. We conducted meta-analyses using Review Manager (version 5.3). PROSPERO reg. no. CRD42015026024.

RESULTS: We included 25 RCT's (N = 1784) of which 20 were eligible for the meta-analysis (N = 1565). Music reduced anxiety (SMD -0·80 [95% CI, -1.35 to -0.25]), pain (SMD -0.88 [95% CI -1.45 to -0.32]), and improved mood (SMD -0.55 [95% CI, -0.98 to -0.13]). However, studies were hampered by heterogeneity with I2 varying between 54% and 96%. Quality of the studies ranged from very low to low. The most effective mode of music intervention appeared to be passive listening to self-selected, recorded music in a single session design.

CONCLUSIONS: Music may be a tool in reducing anxiety, pain, and improving mood among patients with cancer in active treatment. However, methodological limitations in the studies conducted so far prevent firm conclusions.

Originalsprog Engelsk
Tidsskrift Psycho-Oncology
Vol/bind 27
Tidsskriftsnummer 2
Sider (fra-til) 386-400
ISSN 1057-9249
DOI
Status Udgivet - 2018

Long-term exposure to road traffic noise and incidence of breast cancer: a cohort study

Andersen, Z. J., Jørgensen, J. T., Elsborg, L., Lophaven, S. N., Backalarz, C., Laursen, J. E., Pedersen, T. H., Simonsen, M. K., Bräuner, E. V. & Lynge, E. 5 okt. 2018 I : Breast Cancer Research. 20, 1, s. 119

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Exposure to road traffic noise was associated with increased risk of estrogen receptor (ER)-negative (ER-) breast cancer in a previous cohort study, but not with overall or ER-positive (ER+) breast cancer, or breast cancer prognosis. We examined the association between long-term exposure to road traffic noise and incidence of breast cancer, overall and by ER and progesterone receptor (PR) status.

METHODS: We used the data from a nationwide Danish Nurse Cohort on 22,466 female nurses (age > 44 years) who at recruitment in 1993 or 1999 reported information on breast cancer risk factors. We obtained data on the incidence of breast cancer from the Danish Cancer Registry, and on breast cancer subtypes by ER and PR status from the Danish Breast Cancer Cooperative Group, up to 31 December 2012. Road traffic noise levels at the nurses' residences were estimated by the Nord2000 method between 1970 and 2013 as annual means of a weighted 24 h average (Lden) at the most exposed facade. We used time-varying Cox regression to analyze the associations between the 24-year, 10-year, and 1-year mean of Lden and breast cancer, separately for total breast cancer and by ER and PR status.

RESULTS: Of the 22,466 women, 1193 developed breast cancer in total during 353,775 person-years of follow up, of whom 611 had complete information on ER and PR status. For each 10 dB increase in 24-year mean noise levels at their residence, we found a statistically significant 10% (hazard ratio and 95% confidence interval 1.10; 1.00-1.20) increase in total breast cancer incidence and a 17% (1.17; 1.02-1.33) increase in analyses based on 611 breast cancer cases with complete ER and PR information. We found positive, statistically significant association between noise levels and ER+ (1.23; 1.06-1.43, N = 494) but not ER- (0.93; 0.70-1.25, N = 117) breast cancers, and a stronger association between noise levels and PR+ (1.21; 1.02-1.42, N = 393) than between noise levels and PR- (1.10; 0.89-1.37, N = 218) breast cancers. Association between noise and ER+ breast cancer was statistically significantly stronger in nurses working night shifts (3.36; 1.48-7.63) than in those not working at night (1.21; 1.02-1.43) (p value for interaction = 0.05).

CONCLUSION: Long-term exposure to road traffic noise may increase risk of ER+ breast cancer.

Originalsprog Engelsk
Tidsskrift Breast Cancer Research
Vol/bind 20
Tidsskriftsnummer 1
Sider (fra-til) 119
ISSN 1465-542X
DOI
Status Udgivet - 5 okt. 2018

Long-term wind turbine noise exposure and incidence of myocardial infarction in the Danish nurse cohort

Bräuner, E. V., Jørgensen, J. T., Duun-Henriksen, A. K., Backalarz, C., Laursen, J. E., Pedersen, T. H., Simonsen, M. K. & Andersen, Z. J. dec. 2018 I : Environment International. 121, Pt 1, s. 794-802 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Growing evidence supports the concept that traffic noise exposure leads to long-term health complications other than annoyance, including cardiovascular disease. Similar effects may be expected from wind turbine noise exposure, but evidence is sparse. Here, we examined the association between long-term exposure to wind turbine noise and incidence of myocardial infarction (MI).

METHODS: We used the Danish Nurse Cohort with 28,731 female nurses and obtained data on incidence of MI in the Danish National Patient and Causes of Death Registries until ultimo 2013. Wind turbine noise levels at residential addresses between 1982 and 2013 were estimated using the Nord2000 noise propagation model, as the annual means of a weighted 24-hour average (Lden) at the most exposed façade. Time-varying Cox proportional hazard regression was used to examine the association between the 11-, 5- and 1-year rolling means prior to MI diagnosis of wind turbine noise levels and MI incidence.

RESULTS: Of 23,994 nurses free of MI at cohort baseline, 686 developed MI by end of follow-up in 2013. At the cohort baseline (1993 or 1999), 10.4% nurses were exposed to wind turbine noise (≥1 turbine within a 6000-m radius of the residence) and 13.3% in 2013. Mean baseline residential noise levels among exposed nurses were 26.3 dB, higher in those who developed MI (26.6 dB) than among those who didn't develop MI (26.3 dB). We found no association between wind turbine noise and MI incidence: adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) comparing nurses with 11-years mean residential noise levels of <21.5 dB, 21.5-25.4 dB, 25.4-29.9 dB, and >29.9 dB, to non-exposed nurses were 0.89 (0.64-1.25), 1.20 (0.82-1.77), 1.38 (0.95-2.01), and 0.88 (0.53-1.28), respectively. Corresponding HR (95% CI) for the linear association between 11-year mean levels of wind turbine noise (per 10 dB increase) with MI incidence was 0.99 (0.77-1.28). Similar associations were observed when considering the 5- and 1-year running means, and with no evidence of dose-response.

CONCLUSIONS: The results of this comprehensive cohort study lend little support to a causal association between outdoor long-term wind-turbine noise exposure and MI. However, there were only few cases in the highest exposure groups and our findings need reproduction.

Originalsprog Engelsk
Tidsskrift Environment International
Vol/bind 121
Tidsskriftsnummer Pt 1
Sider (fra-til) 794-802
Antal sider 9
ISSN 0160-4120
DOI
Status Udgivet - dec. 2018

Lower risk of hip fractures among Swedish women with large hips?

Klingberg, S., Mehlig, K., Sundh, V., Heitmann, B. L. & Lissner, L. apr. 2018 I : Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 29, 4, s. 927-935 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

In women, a large hip circumference (HC) related to lower hip fracture risk, independent of age and regardless if HC was measured long before or closer to the fracture. In older women, body mass index (BMI) explained the protection.

INTRODUCTION: In postmenopausal women, HC has been suggested to inversely associate with hip fracture while this has not been investigated in middle-aged women. We examined the association between HC, measured at two different time points, and hip fracture in a Swedish female population-based sample monitored for incident hip fractures over many years.

METHODS: Baseline HC, measured in 1968 or 1974 (n = 1451, mean age 47.6 years), or the HC measures that were the most proximal before event or censoring (n = 1325, mean age 71.7 years), were used to assess the effects of HC on hip fracture risk in women participating in the Prospective Population Study of Women in Gothenburg. HC was parameterized as quintiles with the lowest quintile (Q1) as reference. Incident hip fractures over 45 years of follow-up (n = 257) were identified through hospital registers.

RESULTS: Higher quintiles of HC at both baseline and proximal to event were inversely associated with hip fracture risk in age-adjusted models, but only baseline HC predicted hip fractures independently of BMI and other covariates (HR (95% CI) Q2, 0.85 (0.56-1.27); Q3, 0.59 (0.36-0.96); Q4, 0.57 (0.34-0.96); Q5, 0.58 (0.31-1.10)).

CONCLUSIONS: A large HC is protective against hip fracture in midlife and in advanced age, but the association between proximal HC and hip fracture was explained by concurrent BMI suggesting that padding was not the main mechanism for the association. The independent protection seen in middle-aged women points to other mechanisms influencing bone strength.

Originalsprog Engelsk
Tidsskrift Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
Vol/bind 29
Tidsskriftsnummer 4
Sider (fra-til) 927-935
Antal sider 9
ISSN 0937-941X
DOI
Status Udgivet - apr. 2018

Make it REAL: four simple points to increase clinical relevance in sport and exercise medicine research

Bandholm, T., Henriksen, M., Treweek, S. & Thorborg, K. 7 sep. 2018 I : British Journal of Sports Medicine. 52, 22, s. 1407-1408

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift British Journal of Sports Medicine
Vol/bind 52
Tidsskriftsnummer 22
Sider (fra-til) 1407-1408
ISSN 0306-3674
DOI
Status Udgivet - 7 sep. 2018

Management of major organ involvement of Behçet's syndrome: a systematic review for update of the EULAR recommendations

Ozguler, Y., Leccese, P., Christensen, R., Esatoglu, S. N., Bang, D., Bodaghi, B., Çelik, A. F., Fortune, F., Gaudric, J., Gul, A., Kötter, I., Mahr, A., Moots, R. J., Richter, J., Saadoun, D., Salvarani, C., Scuderi, F., Sfikakis, P. P., Siva, A., Stanford, M., Tugal-Tutkun, I., West, R., Yurdakul, S., Olivieri, I., Yazici, H. & Hatemi, G. 1 dec. 2018 I : Rheumatology (Oxford, England). 57, 12, s. 2200-2212 13 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Objective: To assess the efficacy and safety of treatment modalities for major organ involvement of Behçet's syndrome (BS), in order to inform the update of the EULAR recommendations for the management of BS.

Methods: A systematic literature review of all randomized controlled trials, controlled clinical trials, or open label trials assessing eye, vascular, nervous system or gastrointestinal system involvement of BS was performed. If controlled trials were not available for answering a specific research question, uncontrolled studies or case series were also included.

Results: We reviewed the titles and abstracts of 3927 references and 161 studies met our inclusion criteria. There were only nine randomized controlled trials. Observational studies with IFN-α and monoclonal anti-TNF antibodies showed beneficial results for refractory uveitis. Meta-analysis of case-control studies showed that immunosuppressives decreased the recurrence rate of deep vein thrombosis significantly whereas anticoagulants did not. CYC and high dose glucocorticoids decreased mortality in pulmonary arterial aneurysms and postoperative complications in peripheral artery aneurysms. Beneficial results for gastrointestinal involvement were obtained with 5-ASA derivatives and AZA as first line treatment and with thalidomide and/or monoclonal anti-TNF antibodies in refractory cases. Observational studies for nervous system involvement showed improved outcome with immunosuppressives and glucocorticoids. Meta-analysis of case-control studies showed an increased risk of developing nervous system involvement with ciclosporin-A.

Conclusion: The majority of studies related to major organ involvement that informed the updated EULAR recommendations for the management of BS were observational studies.

Originalsprog Engelsk
Tidsskrift Rheumatology (Oxford, England)
Vol/bind 57
Tidsskriftsnummer 12
Sider (fra-til) 2200-2212
Antal sider 13
ISSN 1462-0324
DOI
Status Udgivet - 1 dec. 2018

Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial

Tambour, M., Holt, M., Speyer, A., Christensen, R. & Gram, B. nov. 2018 I : British Journal of Cancer. 119, 10, s. 1215-1222 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer.

METHODS: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T-MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status.

RESULTS: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T-MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, -4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were -6.8%(1.2) and -5.7% (1.2) in the T+MLD and T-MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis.

CONCLUSION: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.

Originalsprog Engelsk
Tidsskrift British Journal of Cancer
Vol/bind 119
Tidsskriftsnummer 10
Sider (fra-til) 1215-1222
Antal sider 8
ISSN 0007-0920
DOI
Status Udgivet - nov. 2018

Multicentric reticulohistiocytosis is a rare form of paraneoplasia

Anderson, A. M., Todberg, T., Kofoed, K., Iversen, T. Z., Andersen, M., Hjorth, S. V. & Fassi, D. E. 1 jan. 2018 I : Ugeskrift for laeger. 180, 1

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

A 59-year-old woman developed a rash and severe arthralgia, which primarily affected her fingers. She displayed digital arthritis and nodules on the hands, chest, face, and oral cavity. Blood samples were normal. Skin biopsies revealed histiocytic proliferation. The surface marker profile and clinical findings were consistent with multicentric reticulohistiocytosis, which may occur as a paraneoplastic phenomenon. On workup, she was diagnosed with an otherwise asymptomatic stage IVC fallopian tube cancer. She experienced little effect of prednisolone, but her condition improved on antineoplastic treatment.

Originalsprog Dansk
Tidsskrift Ugeskrift for laeger
Vol/bind 180
Tidsskriftsnummer 1
ISSN 0041-5782
Status Udgivet - 1 jan. 2018

National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy

Stochkendahl, M. J., Kjaer, P., Hartvigsen, J., Kongsted, A., Aaboe, J., Andersen, B. M., Andersen, M. Ø., Fournier, G., Højgaard, B., Jensen, M. B., Jensen, L. D., Karbo, T., Kirkeskov, L., Melbye, M., Morsel-Carlsen, L., Nordsteen, J., Palsson, T. S., Rasti, Z., Silbye, P. F., Steiness, M. Z., Tarp, S. & Vaagholt, M. 2018 I : European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 27, 1, s. 60-75

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

PURPOSE: To summarise recommendations about 20 non-surgical interventions for recent onset (<12 weeks) non-specific low back pain (LBP) and lumbar radiculopathy (LR) based on two guidelines from the Danish Health Authority.

METHODS: Two multidisciplinary working groups formulated recommendations based on the GRADE approach.

RESULTS: Sixteen recommendations were based on evidence, and four on consensus. Management of LBP and LR should include information about prognosis, warning signs, and advise to remain active. If treatment is needed, the guidelines suggest using patient education, different types of supervised exercise, and manual therapy. The guidelines recommend against acupuncture, routine use of imaging, targeted treatment, extraforaminal glucocorticoid injection, paracetamol, NSAIDs, and opioids.

CONCLUSION: Recommendations are based on low to moderate quality evidence or on consensus, but are well aligned with recommendations from international guidelines. The guideline working groups recommend that research efforts in relation to all aspects of management of LBP and LR be intensified.

Originalsprog Engelsk
Tidsskrift European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Vol/bind 27
Tidsskriftsnummer 1
Sider (fra-til) 60-75
ISSN 0940-6719
DOI
Status Udgivet - 2018

Non-farmakologisk behandling og rehabilitering

Schiøttz-Christensen, B., Amris, K. & Wæhrens, E. E. 2018 Reumatologi. 4 udg. FADL's Forlag, s. 463-481 18 s.

Publikation: Bidrag til bog/antologi/rapportBidrag til bog/antologiUndervisningpeer review

Originalsprog Dansk
Titel Reumatologi
Antal sider 18
Forlag FADL's Forlag
Publikationsdato 2018
Udgave 4
Sider 463-481
???Chapter??? 23
ISBN (Trykt) 978-87-7749-969-2
Status Udgivet - 2018

Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent

Kristensen, L. E., Alten, R., Puig, L., Philipp, S., Kvien, T. K., Mangues, M. A., van den Hoogen, F., Pavelka, K. & Vulto, A. G. okt. 2018 I : BioDrugs. 32, 5, s. 397-404 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The nocebo effect is defined as the incitement or the worsening of symptoms induced by any negative attitude from non-pharmacological therapeutic intervention, sham, or active therapies. When a patient anticipates a negative effect associated with an intervention, medication or change in medication, they may then experience either an increase in this effect or experience it de novo. Although less is known about the nocebo effect compared with the placebo effect, widespread interest in the nocebo effect observed with statin therapy and a literature review highlighting the nocebo effect across at least ten different disease areas strongly suggests this is a common phenomenon. This effect has also recently been shown to play a role when introducing a medication or changing an established medication, for example, when switching patients from a reference biologic to a biosimilar. Given the important role biosimilars play in providing cost-effective alternatives to reference biologics, increasing physician treatment options and patient access to effective biologic treatment, it is important that we understand this phenomenon and aim to reduce this effect when possible. In this paper, we propose three key strategies to help mitigate the nocebo effect in clinical practice when switching patients from reference biologic to biosimilar: positive framing, increasing patient and healthcare professionals' understanding of biosimilars and utilising a managed switching programme.

Originalsprog Engelsk
Tidsskrift BioDrugs
Vol/bind 32
Tidsskriftsnummer 5
Sider (fra-til) 397-404
Antal sider 8
ISSN 1173-8804
DOI
Status Udgivet - okt. 2018

Nutritional recommendations for gout: An update from clinical epidemiology

Nielsen, S. M., Zobbe, K., Kristensen, L. E. & Christensen, R. nov. 2018 I : Journal of Autoimmunity. 17, 11, s. 1090-1096 7 s.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

OBJECTIVE: To present the evidence for nutritional lifestyle changes recommended for gout patients; an explicit focus will be on the evidence for weight loss in overweight gout patients based on a recent systematic review and to describe methodological details for an upcoming weight loss trial.

METHODS: We did a pragmatic but systematic search in MEDLINE for current guidelines that had made an attempt to make nutritional recommendations for gout. The quality of the evidence for the nutritional recommendations was evaluated based on the guidelines' own ratings and converted into a common simple version based on the GRADE system. The recently published systematic review on weight loss for gout, was based on six databases from which longitudinal studies that had quantified the effects following weight loss were included. The internal validity was assessed with the ROBINS-I tool and the quality of the evidence was assessed with the GRADE approach. Based on the results of the systematic review, a trial was designed, adhering to the principles of evidence based research.

RESULTS: We included 17 guidelines. Most guidelines recommend avoiding or limiting alcohol intake (15; i.e. 88%), lose weight if relevant (12; 71%), and reduce fructose intake (11; 65%). The majority of the evidence for the nutritional recommendations was rated Moderate/Low or Very Low quality. Our recent systematic review on weight loss included 10 studies and found that the available evidence indicates beneficial effects of weight loss for overweight and obese gout patients, but the evidence is of low to moderate quality. As a consequence, researchers from the Parker Institute are launching a randomized trial to explore the short-term effects related to a diet-induced weight loss in obese gout patients.

CONCLUSIONS: The nutritional recommendations for gout are generally based on low quality evidence. In terms of weight loss as a management strategy, the available evidence is in favor of weight loss for overweight/obese gout patients. However, since the current evidence consists of only a few studies (mostly observational) of low methodological quality, the Parker Institute are now initiating a rigorous exploratory randomized trial. Similar efforts are needed for other nutritional management strategies for gout.

Originalsprog Engelsk
Tidsskrift Journal of Autoimmunity
Vol/bind 17
Tidsskriftsnummer 11
Sider (fra-til) 1090-1096
Antal sider 7
ISSN 0896-8411
DOI
Status Udgivet - nov. 2018

One year effectiveness of neuromuscular exercise compared with instruction in analgesic use on knee function in patients with early knee osteoarthritis: the EXERPHARMA randomized trial

Holsgaard-Larsen, A., Christensen, R., Clausen, B., Søndergaard, J., Andriacchi, T. P. & Roos, E. M. jan. 2018 I : Osteoarthritis and Cartilage. 26, 1, s. 28-33 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To test long-term effectiveness of neuromuscular exercise (NEMEX) with instructions in optimized pharmacological treatment (PHARMA) on activities of daily living (ADL) in patients with early knee osteoarthritis.

DESIGN: 12-months follow-up from a randomized controlled trial. Participants with mild-to-moderate medial tibiofemoral knee osteoarthritis were randomly allocated to 8 weeks NEMEX or PHARMA. The primary outcome measure was the ADL-subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcome measures included the other four KOOS-subscales, the University of California Activity Score (UCLA) and the European Quality of Life-5 Dimensions.

RESULTS: Ninety-three patients (57% women, 58 ± 8 years, body mass index 27 ± 4 kg/m2) were randomized to NEMEX (n = 47) or PHARMA group (n = 46) with data from 85% being available at 12-months follow-up. Good compliance was achieved for 49% of the participants in NEMEX (≥12 sessions) and 7% in PHARMA (half the daily dose of acetaminophen/NSAIDs ≥ 28 days). Within-group improvements in NEMEX were considered to be clinically relevant (≥10 points) for all KOOS-subscales, except Sport/Rec whereas, no between-groups difference in the primary outcome KOOS ADL (3.6 [-2.1 to 9.2]; P = 0.216) was observed. For KOOS Symptoms, a statistically significant difference of 7.6 points (2.6-12.7; P = 0.004) was observed in favor of NEMEX with 47% improving ≥10 points.

CONCLUSIONS: No difference in improvement in difficulty with ADL was observed. NEMEX improved knee symptoms to a greater extent with half of patients reporting clinically relevant improvements. CLINICALTRIALS.

GOV IDENTIFIER: NCT01638962 (July 3, 2012).

ETHICAL COMMITTEE: S-20110153.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and Cartilage
Vol/bind 26
Tidsskriftsnummer 1
Sider (fra-til) 28-33
Antal sider 6
ISSN 1063-4584
DOI
Status Udgivet - jan. 2018

Opportunities and challenges for real-world studies on chronic inflammatory joint diseases through data enrichment and collaboration between national registers: the Nordic example

Chatzidionysiou, K., Hetland, M. L., Frisell, T., Di Giuseppe, D., Hellgren, K., Glintborg, B., Nordström, D., Aaltonen, K., Törmänen, M. R., Klami Kristianslund, E., Kvien, T. K., Provan, S. A., Björn Guðbjörnsson, B., Dreyer, L., Kristensen, L. E., Jørgensen, T. S., Jacobsson, L. & Askling, J. 2018 I : RMD Open. 4, 1, s. e000655

Publikation: Bidrag til tidsskriftReviewForskningpeer review

There are increasing needs for detailed real-world data on rheumatic diseases and their treatments. Clinical register data are essential sources of information that can be enriched through linkage to additional data sources such as national health data registers. Detailed analyses call for international collaborative observational research to increase the number of patients and the statistical power. Such linkages and collaborations come with legal, logistic and methodological challenges. In collaboration between registers of inflammatory arthritides in Sweden, Denmark, Norway, Finland and Iceland, we plan to enrich, harmonise and standardise individual data repositories to investigate analytical approaches to multisource data, to assess the viability of different logistical approaches to data protection and sharing and to perform collaborative studies on treatment effectiveness, safety and health-economic outcomes. This narrative review summarises the needs and potentials and the challenges that remain to be overcome in order to enable large-scale international collaborative research based on clinical and other types of data.

Originalsprog Engelsk
Tidsskrift RMD Open
Vol/bind 4
Tidsskriftsnummer 1
Sider (fra-til) e000655
ISSN 2056-5933
DOI
Status Udgivet - 2018

Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol

OMERACT-Adherence Group 27 mar. 2018 I : Trials. 19, 1, s. 204

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology.

METHODS/DESIGN: This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology.

DISCUSSION: Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.

Originalsprog Engelsk
Tidsskrift Trials
Vol/bind 19
Tidsskriftsnummer 1
Sider (fra-til) 204
ISSN 1745-6215
DOI
Status Udgivet - 27 mar. 2018

Background: Biomechanical studies show varying results regarding the elongation of adjustable fixation devices. This has led to growing concern over the stability of the ToggleLoc with ZipLoop used in anterior cruciate ligament (ACL) reconstruction (ACLR) in vivo.

Purpose/Hypothesis: The purpose of this study was to compare passive knee stability 1 year after ACLR in patients in whom the Endobutton or ToggleLoc with ZipLoop was used for femoral graft fixation. The hypothesis was that the ToggleLoc with ZipLoop would be inferior in knee stability to the Endobutton 1 year after primary ACLR.

Study Design: Cohort study; Level of evidence, 2.

Methods: Data from 3175 patients (Endobutton: n = 2807; ToggleLoc with ZipLoop: n = 368) were included from the Danish Knee Ligament Reconstruction Registry (DKRR) between June 2010 and September 2013. Data were retrieved from standardized ACL forms filled out by the operating surgeon preoperatively, during surgery, and at a clinical examination 1 year after surgery. Passive knee stability was evaluated using 1 of 2 arthrometers (Rolimeter or KT-1000 arthrometer) and the pivot-shift test. Using the same database, the number of reoperations performed up to 4 years after primary surgery was examined.

Results: Full data were available for 1654 patients (Endobutton: n = 1538; ToggleLoc with ZipLoop: n = 116). ACLR with both devices resulted in increased passive knee stability (P < .001). Patients who received the ToggleLoc with ZipLoop were found to have a better preoperative (P = .005 ) and postoperative (P < .001) pivot-shift test result. No statistically significant difference regarding the number of reoperations (P = .086) or the time to reoperation (P = .295) was found.

Conclusion: Patients who underwent fixation with the ToggleLoc with ZipLoop had improved passive knee stability 1 year after surgery, measured by anterior tibial translation and pivot-shift test results, similar to patients who underwent fixation with the Endobutton. No difference was seen in knee stability or reoperation rates between the 2 devices.

Originalsprog Engelsk
Tidsskrift Orthopaedic Journal of Sports Medicine
Vol/bind 6
Tidsskriftsnummer 6
ISSN 2325-9671
DOI
Status Udgivet - 1 aug. 2018

Patient-Reported Outcomes Are More Important Than Objective Inflammatory Markers for Sick Leave in Biologics-Treated Patients With Rheumatoid Arthritis

Olofsson, T., Söderling, J. K., Gülfe, A., Kristensen, L-E. & Wallman, J. K. nov. 2018 I : Arthritis Care & Research. 70, 11, s. 1712-1716 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To study the impact of common noncomposite disease activity measures on sick leave in biologics-treated patients with rheumatoid arthritis (RA).

METHODS: Data from study visits by biologics-treated RA patients of working age (<65 years) in the observational South Swedish Arthritis Treatment Group Register between 2005 and 2011, were included (5,118 visits by 941 patients). We performed association analyses between various noncomposite disease activity measures at each visit and the number of days of sick leave during the subsequent month; this information was retrieved from the Social Insurance Agency. Adjusted separate generalized estimating equation regression models were used, and analyses were stratified according to sick leave status for the month preceding each visit (no, partial, or full sick leave). Results are presented as standardized beta coefficients for comparability.

RESULTS: Among modifiable noncomposite disease activity measures, patient's assessment of pain and disease activity scored on a visual analog scale (VAS) were most strongly associated with subsequent sick leave, irrespective of baseline sick leave status. Generally, measures that were more objective (swollen joint count, erythrocyte sedimentation rate, and C-reactive protein) had less impact on sick leave compared with variables that were more subjective (patient's pain and global scores on a VAS, evaluator's global assessment of disease activity on a 5-grade Likert scale, and tender joint count).

CONCLUSION: Measures of disease activity that are more subjective have a greater impact on sick leave in biologics-treated patients with RA compared with variables that are more objective, suggesting a stronger focus on subjective measures when targeting work loss or intervening to reduce it.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 70
Tidsskriftsnummer 11
Sider (fra-til) 1712-1716
Antal sider 5
ISSN 2151-464X
DOI
Status Udgivet - nov. 2018

Peripapillary Ovoid Hyperreflectivity in Optic Disc Edema and Pseudopapilledema

Optic Disc Drusen Studies Consortium okt. 2018 I : Ophthalmology. 125, 10, s. 1662-1664 3 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Ophthalmology
Vol/bind 125
Tidsskriftsnummer 10
Sider (fra-til) 1662-1664
Antal sider 3
ISSN 0161-6420
DOI
Status Udgivet - okt. 2018

BACKGROUND: To evaluate the trends in treatment of patellar dislocation in the Danish population as a whole from 1996 to 2014 and evaluate the incidence of persistent morbidity after Medial Patellofemoral Ligament Reconstruction (MPFL-R).

METHODS: This epidemiological study was performed by retrospectively searching the Danish National Patients Registry from 1996 to 2014. The study investigated the trends in surgery performed on patients with patellar dislocations and the risk of persistent patellar morbidity (PPM) with an eight-year follow-up. PPM was defined as a new patella-related contact to the healthcare system more than a year after surgery.

RESULTS: From 1996 to 2014, a total of 1956 MPFL-R were performed in Denmark. In 2014, MPFL-R constituted 75% of all patella-stabilizing surgery and was performed on almost 10% of patients with patellar dislocation. The mean risk of PPM eight years after surgery was 20.9% (18.3-23.4%), and young patients aged 10-17 showed the highest risk of 28.9% (23.7-33.7%). The risk of PPM over time was significantly higher for other patella-stabilizing surgery (33.8%) and patients receiving conservative treatment (29.4%) compared to MPFL-R.

CONCLUSIONS: A rapid rise in the use of MPFL-R was found from 2005 to 2014, constituting 75% of all patella-stabilizing surgery in 2014. The overall risk of persistent patellar morbidity within eight years after MPFL-R was 21%. MPFL-R was found to give a significantly lower risk of PPM over time as compared to other patella-stabilizing surgery and conservative treatment.

Originalsprog Engelsk
Tidsskrift The Knee
ISSN 0968-0160
DOI
Status E-pub ahead of print - 28 nov. 2018

Plasma MicroRNA Profiles in Patients with Early Rheumatoid Arthritis Responding to Adalimumab plus Methotrexate vs Methotrexate Alone: A Placebo-controlled Clinical Trial

Sode, J., Krintel, S. B., Carlsen, A. L., Hetland, M. L., Johansen, J. S., Hørslev-Petersen, K., Stengaard-Pedersen, K., Ellingsen, T., Burton, M., Junker, P., Østergaard, M. & Heegaard, N. H. H. jan. 2018 I : Journal of Rheumatology. 45, 1, s. 53-61 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The aim was to identify plasma (i.e., cell-free) microRNA (miRNA) predicting antitumor necrosis and/or methotrexate (MTX) treatment response in patients enrolled in an investigator-initiated, prospective, double-blinded, placebo-controlled trial (The OPERA study, NCT00660647).

METHODS: We included 180 disease-modifying antirheumatic drug-naive patients with early rheumatoid arthritis (RA) randomized to adalimumab (ADA; n = 89) or placebo (n = 91) in combination with MTX. Plasma samples before and 3 months after treatment initiation were analyzed for 91 specific miRNA by quantitative reverse transcriptase-polymerase chain reaction on microfluidic dynamic arrays. A linear mixed-effects model was used to test for associations between pretreatment miRNA and changes in miRNA expression and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean (28 joints) remission at 3 and 12 months, applying false discovery rate correction for multiple testing. Using leave-one-out cross validation, we built predictive multivariate miRNA models and estimated classification performances using receiver-operating characteristics (ROC) curves.

RESULTS: In the ADA group, a higher pretreatment level of miR-27a-3p was significantly associated with remission at 12 months. The level decreased in remitting patients between pretreatment and 3 months, and increased in nonremitting patients. No associations were found in the placebo group receiving only MTX. Two multivariate miRNA models were able to predict response to ADA treatment after 3 and 12 months, with 63% and 82% area under the ROC curves, respectively.

CONCLUSION: We identified miR-27a-3p as a potential predictive biomarker of ACR/EULAR remission in patients with early RA treated with ADA in combination with MTX. We conclude that pretreatment plasma-miRNA profiles may be of predictive value, but the results need confirmation in independent cohorts.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 45
Tidsskriftsnummer 1
Sider (fra-til) 53-61
Antal sider 9
ISSN 0315-162X
DOI
Status Udgivet - jan. 2018

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