Published in 2018

BACKGROUND: Rotator cuff tear is a common cause of shoulder disability and results in patients predominantly complaining of pain and loss of motion and strength. Traumatic rotator cuff tears are typically managed surgically followed by ~ 20 weeks of rehabilitation. However, the timing and intensity of the postoperative rehabilitation strategy required to reach an optimal clinical outcome is unknown. Early controlled and gradually increased tendon loading has been suggested to positively influence tendon healing and recovery. The aim of this trial is therefore to examine the effect of a progressive rehabilitation strategy on pain, physical function and quality of life compared to usual care (that limits tendon loading in the early postoperative phase) in patients who have a rotator cuff repair of a traumatic tear.

METHODS: The current study is a randomized, controlled, outcome-assessor blinded, multicenter, superiority trial with a two-group paralleled design. A total of 100 patients with surgically repaired traumatic rotator cuff tears will be recruited from up to three orthopedic departments in Denmark, and randomized to either a progressive early passive and active movement program or a limited early passive movement program (usual care). The primary outcome measure will be the change from pre-surgery to 12 weeks post-surgery in the Western Ontario Rotator Cuff Index questionnaire. Secondary outcomes include the Disabilities Arm, Shoulder and Hand questionnaire (DASH), range of motion, strength and tendon healing characteristics from ultrasound measurements at 12 months follow up.

DISCUSSION: We hypothesized that patients who receive the progressive rehabilitation strategy will benefit more with respect to pain reduction, physical function and quality of life than those who receive care as usual. If this is confirmed our study can be used clinically to enhance the recovery of patients with traumatic rotator cuff tear.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT02969135 . Registered on 15 November 2016.

Originalsprog Engelsk
Tidsskrift Trials
Vol/bind 19
Tidsskriftsnummer 1
Sider (fra-til) 470
ISSN 1745-6215
DOI
Status Udgivet - 3 sep. 2018

Reliability and Construct Validity of the SENS Motion® Activity Measurement System as a Tool to Detect Sedentary Behaviour in Patients with Knee Osteoarthritis

Bartholdy, C., Gudbergsen, H., Bliddal, H., Kjærgaard, M., Lykkegaard, K. L. & Henriksen, M. 2018 I : Arthritis. 2018, s. 6596278

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Physical inactivity is important to address, and an objective way of measuring inactivity is by accelerometry. The objective of this study was to determine the reliability and construct validity of the SENS motion system to record physical activity and inactivity in patients with knee osteoarthritis. Participants with an age > 40 years and an average weekly pain above 0 on a numeric rating scale (0 = no pain, 10 = worst pain) were included. Participants had a total of two study visits and at each visit participants completed a standardized activity. Data from 24 participants were analysed. A mean agreement of 99% (SD 3%) for sedentary behaviour and a mean agreement of 97% (SD 9%) for active behaviour were found. The agreement for "walking" was 28% (SD 18%). Mean agreement between recordings on the two visits was 96% (SD 8%) for sedentary behaviour and 99% (SD 1%) for active behaviour. The SENS motion activity measurement system can be regarded as a reliable and valid device for measuring sedentary behaviour in patients with knee OA, whereas detection of walking is not reliable and would require further work.

Originalsprog Engelsk
Tidsskrift Arthritis
Vol/bind 2018
Sider (fra-til) 6596278
ISSN 2090-1984
DOI
Status Udgivet - 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

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

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. 4 aug. 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 E-pub ahead of print - 4 aug. 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 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 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

OBJECTIVE: The objective of this population-based cohort study was to investigate the impact of comorbidities on disease activity, treatment response and persistence with the first-tried tumor necrosis factor inhibitor (TNFi) in patients with psoriatic arthritis (PsA).

METHODS: Data on patient characteristics, disease activity and treatment response and persistence was obtained from the DANBIO registry. Information on comorbidities according to the Charlson Comorbidity Index (CCI) was obtained through linkage with the Danish National Patient Register. Kaplan-Meier plots and Cox proportional hazard regression analyses were performed. Percentages of patients achieving relevant clinical responses were calculated.

RESULTS: We identified 1750 patients eligible for analyses. Patients with higher CCI had higher disease activity measures at baseline and increased occurrence of depression and/or anxiety. Kaplan-Meier curves showed shorter persistence with treatment for patients with ≥ 2 CCI (log-rank: p < 0.001) and for patients with depression and/or anxiety (p = 0.027) compared to patients without comorbidities. In multivariate analysis a CCI score ≥ 2 was associated with reduced TNFi persistence compared with patients without comorbidities (hazard ratio 1.72, [1.26 to 2.37], p = 0.001). A smaller proportion of patients with a CCI score ≥ 2 achieved European League Against Rheumatism (EULAR) good response (p < 0.001) and EULAR good-or-moderate response (p < 0.001) at 6 months compared with patients without comorbidities.

CONCLUSION: Presence of comorbidities was associated with higher baseline disease activity, shorter TNFi persistence and reduced clinical response rates in a cohort of Danish patients with PsA. This article is protected by copyright. All rights reserved.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
ISSN 2151-464X
DOI
Status E-pub ahead of print - 2018

Bibliografisk note

COPECARE

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

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

OBJECTIVES: To assess the importance of trial characteristics as contextual factors when evaluating treatment effect of targeted therapies for patients with psoriatic disease.

METHODS: We identified randomized controlled trials (RCTs) evaluating targeted therapies approved for psoriatic arthritis (PsA) and psoriasis (8 biologics and apremilast). The effect of targeted therapies was analyzed in the two psoriatic conditions combined by using drug retention as common outcome, and separately by using ACR20 for PsA and PASI75 for psoriasis. We explored potential effect modification of trial characteristics in stratified and meta-regression analyses. Odds ratios (OR) were calculated and compared among the trial eligibility criteria via the Ratio of Odds Ratios (ROR).

RESULTS: Forty-eight PsA and psoriasis trials (51 comparisons, 17,737 patients) were eligible. Overall retention was OR 2.16 (1.70 to 2.75) with higher odds for PsA trials compared with psoriasis trials (ROR = 2.55 [1.64 to 3.97]). The eligibility criteria "targeted therapy history", "minimum required disease duration", "required negative rheumatoid factor", and "required CASPAR criteria" were of importance for achieving ACR20 in PsA. The eligibility criterion "minimum required disease duration" was of importance for achieving PASI75 in psoriasis. 7 PsA trials had rescue before time point of retention reporting (adaptive trials).

CONCLUSION: From this exploratory meta-epidemiological study we now have evidence from RCTs to support that patients with PsA are more likely to adhere to targeted therapies compared to patients with psoriasis. Furthermore, we identified a few contextual factors of importance in regard to achieving ACR20 in PsA trials and PASI75 in psoriasis trials. This article is protected by copyright. All rights reserved.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
ISSN 2151-464X
DOI
Status E-pub ahead of print - 2018

Bibliografisk note

COPECARE

Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements

Stamp, L. K., Morillon, M. B., Taylor, W. J., Dalbeth, N., Singh, J. A., Lassere, M. & Christensen, R. mar. 2018 I : Journal of Rheumatology. 45, 3, s. 419-424 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To describe the ways in which serum urate (SU) and gout flares are reported in clinical trials, and to propose minimum reporting requirements.

METHODS: This analysis was done as part of a systematic review aiming to validate SU as a biomarker for gout. The ways in which SU and flares were reported were extracted from each study by 2 reviewers.

RESULTS: A total of 22 studies (10 randomized controlled trials, 3 open-label extension studies, and 9 observational studies) were identified. There were 3 broad categories of SU reporting: percentage at target SU, mean SU, and change in SU. A median of 2 (range 1-3) categories were reported across all studies. The most common method of reporting SU was percentage at target in 17/22 (77.3%) studies, with all studies reporting a target of SU < 6 mg/dl. There were 12/22 (54.5%) studies reporting mean SU at some time after study entry, with 7 (58.3%) of these reporting at more than just the final study visit. Two ways of reporting gout flares were identified: mean flare rate and percentage of participants with flares. There was variability in time periods over which flares rates were reported.

CONCLUSION: There is inconsistent reporting of SU and flares in gout studies. Reporting the percentage of participants who achieve a target SU reflects international treatment guidelines. SU should also be reported as a continuous variable with a relevant central and dispersion estimate. Gout flares should be reported as both percentage of participants and mean flare rates at each timepoint.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 45
Tidsskriftsnummer 3
Sider (fra-til) 419-424
Antal sider 6
ISSN 0315-162X
DOI
Status Udgivet - mar. 2018

Published in 2017

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study)

Eshoj, H., Rasmussen, S., Frich, L. H., Hvass, I., Christensen, R., Jensen, S. L., Søndergaard, J., Søgaard, K. & Juul-Kristensen, B. 28 feb. 2017 I : Trials. 18, 1, s. 90

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Anterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with little to no post-traumatic rehabilitation. This may be due to lack of evidence-based exercise programmes. In similar, high-impact injuries (e.g. anterior cruciate ligament tears in the knee) neuromuscular exercise has shown large success in improving physical function and QoL. Thus, the objective of this trial is to compare a nonoperative neuromuscular exercise shoulder programme with standard care in patients with traumatic anterior shoulder dislocations (TASD).

METHODS/DESIGN: Randomised, assessor-blinded, controlled, multicentre trial. Eighty patients with a TASD will be recruited from three orthopaedic departments in Denmark. Patients with primary or recurrent anterior shoulder dislocations due to at least one traumatic event will be randomised to 12 weeks of either a standardised, individualised or physiotherapist-supervised neuromuscular shoulder exercise programme or standard care (self-managed shoulder exercise programme). Patients will be stratified according to injury status (primary or recurrent). Primary outcome will be change from baseline to 12 weeks in the patient-reported QoL outcome questionnaire, the Western Ontario Shoulder Instability Index (WOSI).

DISCUSSION: This trial will be the first study to compare the efficacy and safety of two different nonoperative exercise treatment strategies for patients with TASD. Moreover, this is also the first study to investigate nonoperative treatment effects in patients with recurrent shoulder dislocations. Lastly, this study will add knowledge to the shared decision-making process of treatment strategies for clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02371928 . Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.

Originalsprog Engelsk
Tidsskrift Trials
Vol/bind 18
Tidsskriftsnummer 1
Sider (fra-til) 90
ISSN 1745-6215
DOI
Status Udgivet - 28 feb. 2017

A Proposal for a Study on Treatment Selection and Lifestyle Recommendations in Chronic Inflammatory Diseases: A Danish Multidisciplinary Collaboration on Prognostic Factors and Personalised Medicine

Andersen, V., Holmskov, U., Sørensen, S. B., Jawhara, M., Andersen, K. W., Bygum, A., Hvid, L., Grauslund, J., Wied, J., Glerup, H., Fredberg, U., Villadsen, J. A., Kjær, S. G., Fallingborg, J., Moghadd, S. A. G. R., Knudsen, T., Brodersen, J. B., Frøjk, J., Dahlerup, J. F., Nielsen, O. H., Christensen, R., Bojesen, A. B., Sorensen, G. L., Thiel, S., Færgeman, N. J., Brandslund, I., Stensballe, A., Schmidt, E. B., Franke, A., Ellinghaus, D., Rosenstiel, P., Raes, J., Heitmann, B., Boyé, M., Nielsen, C. L., Werner, L., Kjeldsen, J. & Ellingsen, T. 15 maj 2017 I : Nutrients. 9, 5, 499

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Chronic inflammatory diseases (CIDs), including Crohn's disease and ulcerative colitis (inflammatory bowel diseases, IBD), rheumatoid arthritis, psoriasis, psoriatic arthritis, spondyloarthritides, hidradenitis suppurativa, and immune-mediated uveitis, are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF) (i.e., TNF inhibitors). Approximately one-third of the patients do not respond to the treatment. Genetics and lifestyle may affect the treatment results. The aims of this multidisciplinary collaboration are to identify (1) molecular signatures of prognostic value to help tailor treatment decisions to an individual likely to initiate TNF inhibitor therapy, followed by (2) lifestyle factors that support achievement of optimised treatment outcome. This report describes the establishment of a cohort that aims to obtain this information. Clinical data including lifestyle and treatment response and biological specimens (blood, faeces, urine, and, in IBD patients, intestinal biopsies) are sampled prior to and while on TNF inhibitor therapy. Both hypothesis-driven and data-driven analyses will be performed according to pre-specified protocols including pathway analyses resulting from candidate gene expression analyses and global approaches (e.g., metabolomics, metagenomics, proteomics). The final purpose is to improve the lives of patients suffering from CIDs, by providing tools facilitating treatment selection and dietary recommendations likely to improve the clinical outcome.

Originalsprog Engelsk
Artikelnummer 499
Tidsskrift Nutrients
Vol/bind 9
Tidsskriftsnummer 5
ISSN 2072-6643
DOI
Status Udgivet - 15 maj 2017

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