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- Chalmers, J. R., et al.
(författare)
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Report from the fifth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)
- 2018
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Ingår i: British Journal of Dermatology. - : John Wiley & Sons. - 0007-0963 .- 1365-2133. ; 178:5, s. E332-E341
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Tidskriftsartikel (refereegranskat)abstract
- This is the report from the fifth meeting of the Harmonising Outcome Measures for Eczema initiative (HOME V). The meeting was held on 12-14 June 2017 in Nantes, France, with 81 participants. The main aims of the meeting were (i) to achieve consensus over the definition of the core domain of long-term control and how to measure it and (ii) to prioritize future areas of research for the measurement of the core domain of quality of life (QoL) in children. Moderated whole-group and small-group consensus discussions were informed by presentations of qualitative studies, systematic reviews and validation studies. Small-group allocations were performed a priori to ensure that each group included different stakeholders from a variety of geographical regions. Anonymous whole-group voting was carried out using handheld electronic voting pads according to pre-defined consensus rules. It was agreed by consensus that the long-term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long-term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon.
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| 2. |
- Semb, G, et al.
(författare)
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Erratum
- 2017
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Ingår i: Journal of plastic surgery and hand surgery. - 2000-6764. ; 51:2, s. 158-158
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Tidskriftsartikel (refereegranskat)
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| 3. |
- Smolen, JS, et al.
(författare)
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EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update
- 2017
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Ingår i: Annals of the rheumatic diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 76:6, s. 960-977
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Tidskriftsartikel (refereegranskat)abstract
- Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to—or adding—another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatology societies, hospital officials, social security agencies and regulators about EULAR's most recent consensus on the management of RA, aimed at attaining best outcomes with current therapies.
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| 6. |
- Jong, Miek C., 1968-, et al.
(författare)
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Hypnotherapy or transcendental meditation versus progressive muscle relaxation exercises in the treatment of children with primary headaches : a multi-centre, pragmatic, randomised clinical study
- 2019
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Ingår i: European Journal of Pediatrics. - : Springer Science and Business Media LLC. - 0340-6199 .- 1432-1076. ; 178:2, s. 147-154
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Tidskriftsartikel (refereegranskat)abstract
- Many children suffer from headaches. Since stress may trigger headaches, effective techniques to cope with stress are needed. We investigated the effectiveness of two mind-body techniques, transcendental meditation (TM) or hypnotherapy (HT), and compared them with progressive muscle relaxation (PMR) exercises (active control group). Children (9–18 years) suffering from primary headaches more than two times per month received either TM (N = 42), HT (N = 45) or PMR (N = 44) for 3 months. Primary outcomes were frequency of headaches and ≥ 50% reduction in headaches at 3 and 9 months. Secondary outcomes were adequate relief, pain coping, anxiety and depressive symptoms, somatisation and safety of treatment. Groups were comparable at baseline. Headache frequency was significantly reduced in all groups from 18.9 days per month to 12.5 and 10.5 at respectively 3 and 9 months (p < 0.001), with no significant differences between the groups. Clinically relevant headache reduction (≥ 50%) was observed in 41% and 47% of children at 3 and 9 months respectively, with no significant differences between the groups. No differences were observed in secondary outcome measures between the intervention groups. No adverse events were reported. Conclusion: All three techniques reduced primary headache in children and appeared to be safe. Trial registration: NTR 2955, 28 June 2011 (www.trialregister.nl)What is Known:• Stress may be an important trigger for both tension type headache and migraine in children.• Good data are lacking on the effect of transcendental meditation, hypnotherapy or progressive muscle relaxation as possible stress-reducing therapies in children with primary headaches.What is New:• Three non-pharmacological techniques, i.e., transcendental meditation, hypnotherapy and progressive muscle relaxation exercises, all result in a clinically significant reduction of headaches and use of pain medication.• No large differences between the three techniques were found, suggesting that children can choose either one of the three techniques based on personal preferences.
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| 7. |
- van Houten, C. B., et al.
(författare)
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Observational multi-centre, prospective study to characterize novel pathogen-and host-related factors in hospitalized patients with lower respiratory tract infections and/or sepsis - the "TAILORED-Treatment" study
- 2018
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Ingår i: BMC Infectious Diseases. - : Springer Science and Business Media LLC. - 1471-2334. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background: The emergence and spread of antibiotic resistant micro-organisms is a global concern, which is largely attributable to inaccurate prescribing of antibiotics to patients presenting with non-bacterial infections. The use of 'omics' technologies for discovery of novel infection related biomarkers combined with novel treatment algorithms offers possibilities for rapidly distinguishing between bacterial and viral infections. This distinction can be particularly important for patients suffering from lower respiratory tract infections (LIT(1) and/or sepsis as they represent a significant burden to healthcare systems. Here we present the study details of the TAILORED-Treatment study, an observational, prospective, multi-centre study aiming to generate a multi-parametric model, combining host and pathogen data, for distinguishing between bacterial and viral aetiologies in children and adults with LRTI and/or sepsis. Methods: A total number of 1200 paediatric and adult patients aged 1 month and older with LRT1 and/or sepsis or a non-infectious disease are recruited from Emergency Departments and hospital wards of seven Dutch and Israeli medical centres. A panel of three experienced physicians adjudicate a reference standard diagnosis for all patients (i.e., bacterial or viral infection) using all available clinical and laboratory information, including a 28-day follow-up assessment. Nasal swabs and blood samples are collected for multi-omics investigations including host RNA and protein biomarkers, nasal microbiota profiling, host genomic profiling and bacterial proteomics. Simplified data is entered into a custom-built database in order to develop a multi-parametric model and diagnostic tools for differentiating between bacterial and viral infections. The predictions from the model will be compared with the consensus diagnosis in order to determine its accuracy. Discussion: The TAILORED-Treatment study will provide new insights into the interplay between the host and microorganisms. New host- or pathogen-related biomarkers will be used to generate a multi-parametric model for distinguishing between bacterial and viral infections. This model will be helpful to better guide antimicrobial therapy for patients with LRTI and sepsis. This study has the potential to improve patient care, reduce unnecessary antibiotic prescribing and will contribute positively to institutional, national and international healthcare economics.
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| 9. |
- Jong, Miek C., 1968-, et al.
(författare)
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A Randomized Study of Yoga for Fatigue and Quality of Life in Women with Breast Cancer Undergoing (Neo) Adjuvant Chemotherapy
- 2018
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Ingår i: Journal of Alternative and Complementary Medicine. - : Mary Ann Liebert Inc. - 1075-5535 .- 1557-7708. ; 24:9-10, s. 942-953
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To compare the effectiveness of yoga added to standard care (SC) versus SC only, in women with breast cancer during chemotherapy. Design: A multicenter pragmatic, randomized controlled study. Settings/Location: Three hospitals in the Netherlands. Subjects: Women with stage I-III breast cancer undergoing chemotherapy. Interventions: Women were randomized either to a program based on Dru Yoga, once a week yoga sessions for 12 weeks (N=47), or SC only (N=36). Outcome measures: Primary outcome fatigue (Multidimensional Fatigue Inventory [MFI]; general fatigue) and secondary outcomes fatigue (MFI, Fatigue Quality List [FQL]), quality of life (30-item Quality of Life Questionnaire-C of the European Organization for Research and Treatment of Cancer [EORTC-QLQ-C-30]) and psychological distress (Hospital Anxiety Depression Scale [HADS], Impact of Events Scale [IES]) were measured at baseline (T0), 3 months (T1), and 6 months (T2) and analyzed on observed cases. Other outcomes were adequate relief, reintegration to work, and adverse events. Results: No significant differences were found in general fatigue at T1 (MFI: yoga; 14.64.5 vs. SC; 14.2 +/- 4.2, p=0.987). Similar findings were observed for other fatigue (sub)scales of MFI and FQL and functional domains of EORTC. With respect to EORTCs symptom scales, women in the yoga group reported significantly less nausea and vomiting compared with SC at T2 (p=0.004), but not at T1 (p=0.807). Depressive symptoms were significantly lower with yoga at T1 (HADS: yoga; 4.7 +/- 4.1 vs. SC; 5.1 +/- 4.2, p=0.031). More women in the yoga group experienced adequate relief compared with SC at T1 (yoga; 51% vs. SC; 19%) and had returned to work at T2 (yoga; 53% vs. SC; 23%). No adverse events were reported with yoga. Conclusions: A Dru-based yoga program failed to demonstrate a significant beneficial effect on fatigue. Possible favorable effects of the yoga program on nausea and vomiting and early return to work in breast cancer survivors warrant further research.
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