Published in 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
Udgave nummer 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
Udgave nummer 2
Sider (fra-til) 311-313
Antal sider 3
ISSN 0003-4967
DOI
Status Udgivet - feb. 2018

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

Bibliografisk note

COPECARE

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

TRIAL REGISTRATION: Not relevant.

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

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

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

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

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

Møller-Bisgaard, S. K., Hørslev-Petersen, K., Ejbjerg, B., Hetland, M. L., Ørnbjerg, L. M., Glinatsi, D. E., Møller, J. M., Boesen, M., Christensen, R., Stengaard-Petersen, K., Madsen, O. R., Jensen, B., Villadsen, J., Hauge, E-M., Bennett, P., Hendricks, O., Asmussen, K., Kowalski, M., Lindegaard, H., Nielsen, S. M., & 8 flereBliddal, H., Krogh, N., Ellingsen, T., Nielsen, A. H., Balding, L., Jurik, A. G., Thomsen, H. & Østergaard, M., 2018, I: Annals of the Rheumatic Diseases. 77, Suppl. 2, s. 58-9 2 s., OP0018.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

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

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

Møller-Bisgaard, S. K., Hørslev-Petersen, K., Ejbjerg, B. J., Hetland, M. L., Glinatsi, D. E., Ørnbjerg, L. M., Møller, J. M., Boesen, M., Christensen, R. D. K., Stengaard-Petersen, K., Madsen, O. R., Jensen, B., Villadsen, J. A., Hauge, E-M., Bennett, P., Hendricks, O., Asmussen, K., Kowalski, M. R., Lindegaard, H., Nielsen, S. M., & 8 flereBliddal, H., Krogh, N. S., Ellingsen, T., Nielsen, A., Balding, L., Jurik, A. G., Thomsen, H. S. & Østergaard, M., 2018, I: Arthritis & Rheumatology. 70, S9, 3 s., 1451.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

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

TISSUE PERFUSION IN KNEE OSTEOARTHRITIS: IMPLICATIONS FOR EXERCISE THERAPY

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

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

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

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

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

Thorlacius, L., Garg, A., Ingram, J. R., Villumsen, B., Theut Riis, P., Gottlieb, A. B., Merola, J. F., Dellavalle, R., Ardon, C., Baba, R., Bechara, F. G., Cohen, A. D., Daham, N., Davis, M., Emtestam, L., Fernández-Peñas, P., Filippelli, M., Gibbons, A., Grant, T., Guilbault, S., & 20 flereGulliver, 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
Udgave nummer 3
Sider (fra-til) 715-721
Antal sider 7
ISSN 0007-0963
DOI
Status Udgivet - mar. 2018

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

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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

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

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

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

Trends in the incidence of rheumatoid arthritis in Denmark from 1995–2016: A nationwide register-based study

Cordtz, R. L., Højgaard, P., Zobbe, K. & Dreyer, L., 2018, I: Annals of the Rheumatic Diseases. 77, Suppl. 2, s. 1201-1202 2 s., SAT0707.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer SAT0707
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 77
Udgave nummer Suppl. 2
Sider (fra-til) 1201-1202
Antal sider 2
ISSN 0003-4967
Status Udgivet - 2018

Trial Characteristics as Contextual Factors when Evaluating Targeted Therapies in Patients with Psoriatic Disease: A Meta-Epidemiological Study

Ballegaard, C., Jørgensen, T. S., Skougaard, M., Strand, V., Mease, P. J., Kristensen, L. E., Dreyer, L., Gottlieb, A., de Wit, M., Christensen, R. & Tarp, S., 2018, I: Arthritis Care & Research. 70, 8, s. 1206-1217

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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
Vol/bind 70
Udgave nummer 8
Sider (fra-til) 1206-1217
ISSN 2151-464X
DOI
Status Udgivet - 2018

Bibliografisk note

COPECARE

Unilateral Ultrasound Scoring Methods for Synovitis in Rheumatoid Arthritis: An Agreement Study Exploring the Most Inflammatory Active Side

Terslev, L., Christensen, R. D. K., Aga, A-B., Sexton, J., Haavardsholm, E. A. & Hammer, H. B., 2018, I: Arthritis & Rheumatology. 70, S9, 2 s., 1200.

Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

Originalsprog Engelsk
Artikelnummer 1200
Tidsskrift Arthritis & Rheumatology
Vol/bind 70
Udgave nummer S9
Antal sider 2
ISSN 1537-2960
Status Udgivet - 2018

Validation of Exercise Capacity as a Surrogate Endpoint in Exercise-Based Rehabilitation for Heart Failure: A Meta-Analysis of Randomized Controlled Trials

Ciani, O., Piepoli, M., Smart, N., Uddin, J., Walker, S., Warren, F. C., Zwisler, A. D., Davos, C. H. & Taylor, R. S., jul. 2018, I: JACC. Heart failure. 6, 7, s. 596-604 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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
Udgave nummer 3
Sider (fra-til) 419-424
Antal sider 6
ISSN 0315-162X
DOI
Status Udgivet - mar. 2018

Very Integrated Program (VIP): Smoking and other lifestyles, co-morbidity and quality of life in patients undertaking treatment for alcohol and drug addiction in Sweden

Hovhannisyan, K., Adami, J., Wikström, M. M. & Tønnesen, H., 2018, I: Clinical Health Promotion. 8

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Originalsprog Engelsk
Tidsskrift Clinical Health Promotion
Vol/bind 8
Status Udgivet - 2018

Pages