Published in 2018

Reliability of standing weight-bearing (0.25T) MR imaging findings and positional changes in the lumbar spine

Hansen, B. B., Hansen, P., Christensen, A. F., Trampedach, C., Rasti, Z., Bliddal, H. & Boesen, M. jan. 2018 I : Skeletal radiology. 47, 1, s. 25-35 11 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To test the reliability and absolute agreement of common degenerative findings in standing positional magnetic resonance imaging (pMRI).

METHODS AND MATERIALS: Low back pain patients with and without sciatica were consecutively enrolled to undergo a supine and standing pMRI. Three readers independently evaluated the standing pMRI for herniation, spinal stenosis, spondylolisthesis, HIZ lesions and facet joint effusion. The evaluation included a semi-quantitative grading of spinal stenosis, foraminal stenosis and spinal nerve root compression. The standing pMRI images were evaluated with full access to supine MRI. In case lower grades or the degenerative findings were not present in the supine images, this was reported separately as position-dependent changes. A subsample of 20 pMRI examinations was reevaluated after two months. The reproducibility was assessed by inter- and intra-reader reliability (kappa statistic) and absolute agreement between readers.

RESULTS: Fifty-six patients were included in this study. There was fair-to-substantial inter-reader reliability (κ 0.47 to 0.82) and high absolute agreement (72.3% to 99.1%) for the pMRI findings. The intra-reader assessment showed similar reliability and agreement (κ 0.36 to 0.85; absolute agreement: 62.5% to 98.8%). Positional changes between the supine and standing position showed a fair-to-moderate inter- and intra-reader reliability (κ 0.25 to 0.52; absolute agreement: 97.0% to 99.1).

CONCLUSION: Evaluation of the lumbar spine for degenerative findings by standing pMRI has acceptable reproducibility; however, positional changes from the supine to the standing position as an independent outcome should be interpreted with caution because of lower reliability, which calls for further standardisation.

Originalsprog Engelsk
Tidsskrift Skeletal radiology
Vol/bind 47
Tidsskriftsnummer 1
Sider (fra-til) 25-35
Antal sider 11
ISSN 0364-2348
DOI
Status Udgivet - jan. 2018

Response to: 'Mandatory, cost-driven switching from originator etanercept to its biosimilar SB4: possible fallout on non-medical switching' by Cantini and Benucci

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. 20 dec. 2018 I : Annals of the Rheumatic Diseases.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
ISSN 0003-4967
DOI
Status E-pub ahead of print - 20 dec. 2018

BACKGROUND: A recent systematic review found that 87% of athletes return to sport after hip surgery for femoroacetabular impingement syndrome. However, the proportion of athletes returning to preinjury sport at their preinjury level of sport is less clear.

PURPOSE: The main purpose of this study was to determine the rate of athletes returning to preinjury sport at preinjury level including their associated sports performance after hip arthroscopy for femoroacetabular impingement syndrome. Furthermore, self-reported hip and groin function was investigated.

STUDY DESIGN: Cross-sectional study; Level of evidence, 3.

METHODS: Eligible subjects were identified in the Danish Hip Arthroscopy Registry. A self-reported return to sport questionnaire was used to collect data after hip arthroscopy. If athletes reported they were engaged in preinjury sport at their preinjury level, the associated sports performance and participation were assessed as either (1) optimal sports performance including full sports participation; (2) impaired sports performance, but full sports participation; or (3) impaired sports performance including restricted sports participation. Self-reported hip and groin function was assessed for all athletes by use of the Copenhagen Hip and Groin Outcome Score.

RESULTS: The study included 189 athletes (mean ± SD age at follow-up, 26.9 ± 3.4 years) at a mean ± SD follow-up of 33.1 ± 16.3 months after surgery. At follow-up, 108 athletes (57.1%) were playing preinjury sport at preinjury level, whereas the remaining 81 athletes (42.9%) failed to return to preinjury sport at preinjury level. Of the 108 athletes engaged in their preinjury sport at preinjury level at follow-up, 32 athletes (29.6%) reported optimal sports performance including full sports participation, corresponding to 16.9% of the study sample. Better self-reported hip and groin function was observed in athletes who were engaged in preinjury sport at preinjury level compared with athletes who were not.

CONCLUSION: Fifty-seven percent of athletes returned to preinjury sport at their preinjury level. This is considerably lower than a previously reported return to sport rate of 87% and may reflect that the present study used a clear and strict definition of return to sport. Of note, only one-third of athletes who returned to preinjury sport at preinjury level reported their sports performance to be optimal, corresponding to 16.9% of the study sample. Better self-reported hip and groin function was observed in athletes who were playing preinjury sport at preinjury level compared with athletes who were not.

Originalsprog Engelsk
Tidsskrift The American journal of sports medicine
Vol/bind 46
Tidsskriftsnummer 11
Sider (fra-til) 2578-2587
ISSN 0363-5465
DOI
Status Udgivet - 1 sep. 2018

OBJECTIVE: To study the risk of a second malignant neoplasm (SMN) and mortality in patients with rheumatoid arthritis (RA) with a history of a primary cancer diagnosis and treated with biological disease-modifying antirheumatic drugs (bDMARD).

METHODS: Among patients with RA (n=15 286) registered in the DANBIO Register during 2000-2011, 1678 had a primary cancer according to the Danish Cancer Registry. HRs for SMN and death were calculated.

RESULTS: During follow-up there were 279 patients with RA contributing person-years to the bDMARDs use before their primary cancer diagnosis, 220 to the only after, 92 to the both before and after, while 1203 patients with RA contributed to the non-use strata. Ever use of bDMARDs was associated with a HR of 1.11 (95% CI 0.74 to 1.67) for developing a SMN compared with non-use (cancer site adjusted). The HR for death associated with bDMARD use before the primary cancer diagnosis was increased 1.53 (95% CI 1.13 to 2.09). After further adjustment for extent of the primary cancer, the HR for death was 1.20 (95% CI 0.88 to 1.63) for bDMARDs use before cancer, 1.36 (95% CI 0.78 to 2.39) for bDMARD use only after cancer and 1.22 (95% CI 0.70 to 2.13) for use both before and after the cancer.

CONCLUSIONS: Among patients with RA with a history of cancer, treatment with bDMARDs was not associated with increased risk of SMN. No clear conclusion can be drawn regarding mortality in bDMARD-treated patients with RA.

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

Bibliografisk note

COPECARE

Muscle strain injuries disrupt the muscle-tendon unit, early rehabilitation is associated with a faster return to sports (RTS), but the time course of tissue healing remains sparsely described. The purpose was to examine tissue regeneration and the effectiveness of early versus delayed rehabilitation onset on functional and structural recovery after strain injuries. A total of 50 recreational athletes with a severe acute strain injury in their thigh or calf muscles were randomized to early or delayed rehabilitation onset. Magnetic resonance imaging (MRI) was obtained initially, 3 and 6 months postinjury, and dynamic contrast-enhanced MRI (DCE-MRI) estimated tissue inflammation initially and after 6 months. Muscle strength was determined 5 weeks, 3 months, and 6 months postinjury, and a questionnaire determined soreness, pain, and confidence. DCE-MRI microvascular perfusion was higher in the injured compared to an uninjured muscle acutely (P < 0.01) and after 6 months (P < 0.01), for both groups (P > 0.05) and unrelated to RTS (P > 0.05). Total volume of the injured muscle decreased from the acute to the 3-month scan, and to the 6-month scan (P < 0.01) in both groups. Muscle strength was similar in both groups at any time. There was a nonsignificant trend (P ≤ 0.1) toward less pain and higher confidence with early rehabilitation. One reinjury was recorded. In conclusion, our data showed prolonged tissue repair with the initial response linked to muscle atrophy but did not explain why early rehabilitation onset accelerated recovery considering that structural and functional recovery was similar with early and delayed rehabilitation.

Originalsprog Engelsk
Tidsskrift Scandinavian journal of medicine & science in sports
Vol/bind 28
Tidsskriftsnummer 12
Sider (fra-til) 2579-2591
Antal sider 13
ISSN 0905-7188
DOI
Status Udgivet - dec. 2018

Sensitivity and specificity of post-operative interference gap assessment on plain radiographs after cementless primary THA

Belt, M., Gliese, B., Muharemovic, O., Malchau, H., Husted, H., Troelsen, A. & Gromov, K. 28 dec. 2018 I : Magnetic Resonance Imaging. 54, s. 103-107 5 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Implant performance of cementless THA is often evaluated by radiolucency on plain radiographs, often classified as interference gaps on direct post-operative radiographs. However, the diagnostic performance is unknown. The aim was to evaluate the diagnostic performance of radiographic assessment of post-operative gaps after primary THA by comparing it with CT confirmed gaps, and secondary to define optimal cut-off criteria for assessing gaps on plain radiographs compared with CT.

MATERIAL AND METHODS: Patients (N = 40) with a primary cementless THA performed between July 2015 and March 2016 were enrolled in the study. Radiolucency was assessed on post-operative AP pelvic digital radiographs by two observers independently. Maximum width and percentage of coverage per zone were reported. Gap volume was measured by manual segmentation on CT images.

RESULTS: When defining a gap as a radiolucency extending through >50% of a zone, the interrater agreement Kappa was 0.241. Sensitivity was 65.8% for observer 1 (Kappa = 0.432), and 86.8% for observer 2 (Kappa = 0.383). When defining a gap as a radiolucency with a width >1 mm, the interrater agreement Kappa was 0.302. Sensitivity was 55.3% and 50% for observer 1 and observer 2, respectively. The ROC-curve resulted in an optimal threshold of 0.65 mm (AUROC = 0.888) and 0.31 mm (AUROC = 0.961) for the two observers.

CONCLUSION: The diagnostic performance of observers detecting interference gaps on radiographs showed low sensitivity. Further on, the inter-rater agreement is too low to do a general recommendation about thresholds for defining gaps. Evaluating progression of radiolucency on radiographs should be performed in the light of these findings.

Originalsprog Engelsk
Tidsskrift Magnetic Resonance Imaging
Vol/bind 54
Sider (fra-til) 103-107
Antal sider 5
ISSN 0961-9275
DOI
Status E-pub ahead of print - 28 dec. 2018

Serum urate as surrogate endpoint for flares in people with gout: A systematic review and meta-regression analysis

Stamp, L., Morillon, M. B., Taylor, W. J., Dalbeth, N., Singh, J. A., Lassere, M. & Christensen, R. okt. 2018 I : Seminars in Arthritis and Rheumatism. 48, 2, s. 293-301 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVES: The primary efficacy outcome in trials of urate lowering therapy (ULT) for gout is serum urate (SU). The aim of this study was to examine the strength of the relationship between SU and patient-important outcomes to determine whether SU is an adequate surrogate endpoint for clinical trials.

METHODS: Multiple databases through October 2017 were searched. Randomized controlled trials comparing any ULT in people with gout with any control or placebo, ≥three months duration were included. Open label extension (OLE) trial data were included in secondary analyses. Standardized data elements were extracted independently by two reviewers.

RESULTS: Ten RCTs and 3 OLE studies were identified. From the RCTs (maximum duration 24 months) meta-regression did not reveal an association between the relative risk of a gout flare and the difference in proportions of individuals with SU < 6mg/dL (P = 0.47; R2 = 8%). In a post hoc analysis, the ratio of the time in months at which the proportion of individuals having a flare was reported/time in months at which the proportion of individuals with SU < 6mg/dL was reported was calculated and studies where the ratio was <2 were excluded. Using the remaining 6 studies there was an association between proportion of individuals achieving SU < 6mg/dL and gout flares (over patient years). Duration of ULT was inversely associated with the proportion of patients experiencing a flare. Study duration and variability in reporting of outcomes limited the analysis. Observational studies supported the trend of fewer flares in those with lower SU.

CONCLUSIONS: Based on aggregate clinical trial-level data an association between SU and gout flare could not be confirmed. However, based on observational ecological study design data-including longer duration extension studies-SU < 6mg/dL was associated with reduced gout flares.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 48
Tidsskriftsnummer 2
Sider (fra-til) 293-301
Antal sider 9
ISSN 0049-0172
DOI
Status Udgivet - okt. 2018

Severe hidradenitis suppurativa responding to treatment with secukinumab: a case report

Thorlacius, L., Theut Riis, P. & Jemec, G. B. E. jul. 2018 I : British Journal of Dermatology. 179, 1, s. 182-185 4 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

An inappropriate immunological response to an unknown antigen has been suggested to play a role in the pathogenesis of hidradenitis suppurativa (HS). Studies have identified elevated levels of several proinflammatory cytokines, including interleukin (IL)-17A and tumour necrosis factor-α, nominating these as possible therapeutic targets.1 Secukinumab is an IL-17A monoclonal antibody, which binds to IL-17A and inhibits the cytokine interaction with the IL-17 receptors, inhibiting the inflammatory cascade. Here we report a case of a 47-year-old man, with Hurley stage III lesions on the neck, axillae, breasts, genital skin and buttocks, who had experienced only temporary benefit from different medical treatments over several years. After 12 weeks of treatment with secukinumab, the number of lesions reported by the patient within the period of the last 4 weeks was reduced from 23 to seven, his pain visual analogue scale (VAS) score was reduced from 5 to 3 and pain/utility/handicap VAS score was reduced from 7 to 4. These results may be taken to imply that IL-17 blockade could provide a possible therapeutic approach in the treatment of HS.

Originalsprog Engelsk
Tidsskrift British Journal of Dermatology
Vol/bind 179
Tidsskriftsnummer 1
Sider (fra-til) 182-185
Antal sider 4
ISSN 0007-0963
DOI
Status Udgivet - jul. 2018

Shorter sleep duration is associated with higher energy intake and an increase in BMI z-score in young children predisposed to overweight

Rangan, A., Zheng, M., Olsen, N. J., Rohde, J. F. & Heitmann, B. L. jan. 2018 I : International journal of obesity (2005). 42, 1, s. 59-64 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Inadequate sleep has been shown to be a contributor to obesity in both children and adults. Less evidence is available for toddlers and among those with higher obesity risk. The objective of this study was to examine the relationship between sleep patterns and body weight development in a group of young obesity-predisposed children, and to assess whether intakes of energy or macronutrients mediate this relationship.

METHODS: Participants included 368 Danish children aged 2-6 years from the Healthy Start Study, a 1.3 year randomised controlled intervention trial. Sleep habits were measured using a 7-day sleep diary. Multivariate linear regression with adjustment for confounders was used to assess the association of sleep duration and sleep variability with 1.3 year changes (Δ) in body mass index (BMI) z-score from baseline to follow-up.

RESULTS: The average nighttime sleep duration was 10.7 h (range 8.8-12.5 h). After controlling for potential confounders, a significant inverse association between nighttime sleep duration and ΔBMI z-score (β=-0.090, P=0.046) was observed. This relationship was mediated by energy intake, with all macronutrients contributing to this mediation effect. No associations were found for sleep variability and ΔBMI z-score but baseline intake of added sugars and sugary beverages were positively associated with sleep variability.

CONCLUSION: Shorter sleep duration, mediated by energy intake in early in life, seems a risk factor for weight gain among young obesity-predisposed children.

Originalsprog Engelsk
Tidsskrift International journal of obesity (2005)
Vol/bind 42
Tidsskriftsnummer 1
Sider (fra-til) 59-64
Antal sider 6
ISSN 0307-0565
DOI
Status Udgivet - jan. 2018

Smertesensibilisering og generaliserede smertetilstande

Amris, K. 2018 Reumatologi. 4 udg. Købehavn: FADL's Forlag, s. 419-443 24 s.

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

Originalsprog Dansk
Titel Reumatologi
Antal sider 24
Udgivelses sted Købehavn
Forlag FADL's Forlag
Publikationsdato 2018
Udgave 4
Sider 419-443
???Chapter??? 21
ISBN (Trykt) 978-87-7749-969-2
Status Udgivet - 2018

Smoking cessation intervention for reducing disease activity in chronic autoimmune inflammatory joint diseases

Roelsgaard, I. K., Esbensen, B. A., Østergaard, M., Rollefstad, S., Semb, A. G., Christensen, R. & Thomsen, T. 2018 I : Cochrane Database of Systematic Reviews. 2018, 2, 12 s., CD012958

Publikation: Bidrag til tidsskriftReviewForskningpeer review

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To investigate the evidence for an effect of smoking cessation interventions on smoking cessation and disease activity in smokers with IJD.

Originalsprog Engelsk
Artikelnummer CD012958
Tidsskrift Cochrane Database of Systematic Reviews
Vol/bind 2018
Tidsskriftsnummer 2
Antal sider 12
ISSN 1361-6137
DOI
Status Udgivet - 2018

Test-retest reliability of non-linear methods to assess walking dynamics

Raffalt, P., Alkjaer, T., Brynjólfsson, B., J Rgensen, L., Bartholdy, C. R. & Henriksen, M. dec. 2018 I : Journal of Biomechanics.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

The present study investigated the day-to-day reliability (quantified by the absolute and relative reliability) of nonlinear methods that assess human locomotion dynamics. Twenty-four participants completed 5 minutes of treadmill walking at self-selected preferred speed on two separate days. Lower limb kinematics were recorded at 100Hz and hip, knee and ankle joint angles, three dimensional sacrum marker displacement and stride time intervals were extracted for 170 consecutive strides. The largest Lyapunov exponent and correlation dimension were calculated for the joint angle and sacrum displacement data using three different state space reconstruction methods (group average, test-retest average, individual time delay and embedding dimension). Sample entropy and detrended fluctuation analysis were applied to the stride time interval time series. Relative reliability was assessed using intra-class correlation coefficients and absolute reliability was determined by measurement error (ME). The group average state space reconstruction method resulted in the best relative and absolute reliability of the LyE parameter when compared to the individual and test-retest average methods. The detrended fluctuation analysis exhibited good reliability, while sample entropy showed poor reliability. The results comprise a reference material that can inspire and guide future studies of non-linear gait dynamics.

Originalsprog Engelsk
Tidsskrift Journal of Biomechanics
ISSN 0021-9290
DOI
Status Udgivet - dec. 2018

Th17 Inhibitors in Active Psoriatic Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials

Naik, G. S., Ming, W. K., Magodoro, I. M., Akinwunmi, B., Dar, S., Poulsen, H. E., Kristensen, L. E. & Ellervik, C. feb. 2018 I : Dermatology (Basel, Switzerland). 233, 5, s. 366–377

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Several biologics targeting the Th17 pathway have been developed for the treatment of psoriatic arthritis (PsA), a disabling disease with moderate response and an increased incidence of serious infections to first-line biologics (TNF-α antagonists). Th17 inhibitors could replace TNF-α antagonists as first-line biologic agents. We determined the overall treatment effect of Th17 pathway inhibitors compared to placebo or active control on American College of Rheumatology (ACR) 20 response at week 12 (primary objective), risk of infections, discontinuation of treatment due to adverse events, and serious adverse events during the placebo-controlled period (12-24 weeks) in adults with active PsA in published randomized controlled trials.

METHODS: The SCOPUS database was searched. The Cochrane risk of bias tool was used for assessing quality. The pooled relative risk (RR) was derived from random effects models.

RESULTS: Seven randomized controlled trials were included which randomized 1,718 patients to Th17 inhibitors and 840 to placebo. Patients treated with Th17 inhibitors had an RR of 2.04 (95% CI: 1.79-2.33; p < 0.001) for achieving an ACR20 response at week 12 (I2 = 0%; p = 0.89) compared to placebo-treated patients. There was no evidence of publication bias. The result was consistent for study phase and outcome (ACR50/70), mechanism of action and TNF-α naivety. RR of infections was 1.06 (0.91-1.23), that of candida infections was 3.35 (0.75-14.95), that of serious adverse events was 0.82 (0.42-1.59) and that of discontinuation of treatment was 0.54 (0.31-0.93) among treated versus placebo subjects. No incident cases of tuberculosis were reported.

CONCLUSION: In patients with active PsA, biologics targeting the Th17 axis produce a clinically significant improvement in joint disease activity with acceptable safety and tolerability for short-term treatment compared to placebo.

Originalsprog Engelsk
Tidsskrift Dermatology (Basel, Switzerland)
Vol/bind 233
Tidsskriftsnummer 5
Sider (fra-til) 366–377
ISSN 1018-8665
DOI
Status Udgivet - feb. 2018

INTRODUCTION: Central sensitization plays a pivotal role in maintenance of pain and is believed to be intricately involved in several chronic pain conditions. One clinical manifestation of central sensitization is secondary hyperalgesia. The degree of secondary hyperalgesia presumably reflects individual levels of central sensitization. The objective of this study was to investigate the association between areas of secondary hyperalgesia and volumes of the caudate nuclei and other brain structures involved in pain processing.

MATERIALS AND METHODS: We recruited 121 healthy male participants; 118 were included in the final analysis. All participants underwent whole brain magnetic resonance imaging (MRI). Prior to MRI, all participants underwent pain testing. Secondary hyperalgesia was induced by brief thermal sensitization. Additionally, we recorded heat pain detection thresholds (HPDT), pain during one minute thermal stimulation (p-TS) and results of the Pain Catastrophizing Scale (PCS) and Hospital Anxiety and Depression score (HADS).

RESULTS: We found no significant associations between the size of the area of secondary hyperalgesia and the volume of the caudate nuclei or of the following structures: primary somatosensory cortex, anterior and mid cingulate cortex, putamen, nucleus accumbens, globus pallidus, insula and the cerebellum. Likewise, we found no significant associations between the volume of the caudate nuclei and HPDTs, p-TS, PCS and HADS.

CONCLUSIONS: Our findings indicate that the size of the secondary hyperalgesia area is not associated with the volume of brain structures relevant for pain processing, suggesting that the propensity to develop central sensitization, assessed as secondary hyperalgesia, is not correlated to brain structure volume.

Originalsprog Engelsk
Tidsskrift PLoS One
Vol/bind 13
Tidsskriftsnummer 8
Sider (fra-til) e0201642
ISSN 1932-6203
DOI
Status Udgivet - 2018

The complexity of self-regulating food intake in weight loss maintenance. A qualitative study among short- and long-term weight loss maintainers

Pedersen, S., Sniehotta, F. F., Sainsbury, K., Evans, E. H., Marques, M. M., Stubbs, R. J., Heitmann, B. L. & Lähteenmäki, L. jul. 2018 I : Social science & medicine (1982). 208, s. 18-24 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

RATIONALE: Whether self-regulation of food intake in weight loss maintenance (WLM) differs between being a short-term maintainer (having maintained without regaining less than 12 months) and a long-term maintainer (having maintained without regaining at least 12 months) is under-researched.

OBJECTIVE: The aim of this study was to explore the self-regulatory strategies and self-efficacy beliefs applied by short- and long-term maintainers to the complex set of behaviours comprising food intake in WLM, and to obtain a better understanding of their challenges in the various food-intake processes in WLM.

METHOD: Individual interviews (14 female/4 male) were conducted with nine Danish short- and nine long-term weight loss maintainers. The Health Action Process Approach (HAPA) was applied post-hoc to organise data and support analyses, since the approach focuses on both the cognitions (e.g., self-efficacy, the nature of which differs depending on the phase of behaviour change) and self-regulatory strategies (e.g., action planning and coping planning) involved in behaviour change.

RESULTS: Self-regulatory strategies and self-efficacy beliefs varied between the food-related behaviours and between short- and long-term maintainers. Consistent with the progression suggested by HAPA, with repeated use of action and coping planning, long-term maintainers had formed habitual routines, not only allowing them more flexibility, but also providing them stronger self-control in the behaviours related to WLM such as buying and storing food, and eating at social gatherings. The short-term maintainers often displayed a 'weight loss mind-set.' The short-term maintainers focused on the avoidance of certain behaviours, showed less self-regulatory flexibility, and exhibited more detailed action planning, but their interviews also inferred that they had ambitions to build strong WLM-habits, maintenance, and recovery self-efficacy.

CONCLUSION: The contribution of this study is a more comprehensive view on food intake as an outcome of a set of complex behaviours, revealing insights into the differences in cognitions and strategies applied to the task of WLM, between short- and long-term maintainers.

Originalsprog Engelsk
Tidsskrift Social science & medicine (1982)
Vol/bind 208
Sider (fra-til) 18-24
Antal sider 7
ISSN 0277-9536
DOI
Status Udgivet - jul. 2018

BACKGROUND: Evidence is emerging that pain in rheumatoid arthritis (RA) exists without underlying inflammation. Our objective was to evaluate the prognostic value of pain classification at treatment initiation using the painDETECT questionnaire (PDQ). Outcomes were change in DAS28-CRP and RAMRIS synovitis score.

METHODS: RA patients initiating a disease-modifying anti-rheumatic drug (DMARD) or initiating/ switching a biological agent were included. Follow-up time was 4 months. Clinical examination, imaging (MRI, dynamic contrast-enhanced MRI (DCE-MRI)), and patient-reported outcomes were undertaken. The PDQ was used to differentiate pain mechanisms. Mean change (95% CI) was calculated using ANCOVA. Multivariable regression models were used to determine a prognostic value.

RESULTS: A total of 102 patients were included; 75 were enrolled for MRI. Mean changes in baseline variables were greatest in the high PDQ classification group (> 18), while limited in the intermediate group (13-18). The 12 patients with high baseline PDQ score all changed pain classification group. No prognostic value of PDQ pain classification was found in relation to change of DAS28-CRP, RAMRIS score, or VAS pain. In the unadjusted model, RAMRIS score at baseline was associated with change in DAS28-CRP. The exploratory variables of DCE-MRI did not differ from other inflammatory variables.

CONCLUSIONS: In RA patients a high PDQ score (non-nociceptive pain) at baseline was not associated with worse outcomes, in fact these patients had numerically greater improvement in DAS28-CRP. However, pain classification by PDQ was not independently associated with change in DAS28-CRP, RAMRIS score, or VAS pain in the prognostic models. Furthermore, patients classified with a high baseline PDQ score changed pain classification group. Patients with unclear pain mechanism had reduced numerically treatment response.

TRIAL REGISTRATION: The study was approved by the Regional Ethics Committee of the Capital of Denmark April 18 2013; identification number H-3-2013-049 .

Originalsprog Engelsk
Tidsskrift Arthritis Research & Therapy
Vol/bind 20
Tidsskriftsnummer 1
Sider (fra-til) 105
ISSN 1478-6354
DOI
Status Udgivet - 30 maj 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

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