tbuckley/cabot-search huggingface dataset:
SAT0565 Adjusting for the intra-articular placebo effect in knee osteoarthritis therapies
Authors: I. Simsek, T. Phalen, A. Bedenbaugh, M. Phillips, J. Tambiah
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Currently, there is a large debate regarding the appropriateness of intra-articular (IA)-saline injection as a "placebo" comparator in knee osteoarthritis (OA) trials and meta-analyses. There is substantial evidence to suggest that the injection of saline into the joint is not without treatment effect. <h3>Objectives</h3> This study aimed to assess the current literature's estimates of the IA-saline treatment effect against a range of appropriate minimal clinically important difference (MCID) values to identify if IA-saline provides a therapeutic effect that is not indicative of a null-effect. <h3>Methods</h3> The treatment effect estimates of IA-saline and topical placebo for knee OA pain, relative to oral placebo, were derived from a published network meta-analysis Bannuru et al, 2015 and compared across a range of plausible MCID values. Effect estimates of pharmacologic knee OA treatments were also extracted from recent high-quality meta analyses, and the effect of IA-saline or topical placebo was used as an adjustment for meta-analyses that used IA-saline or topical placebo as a comparator, respectively. This was done to estimate the therapeutic effect of these treatment options when compared to a truly null treatment option, as IA-saline has been shown to not be a null-effect intervention. The unadjusted and adjusted treatment effect values were compared across an MCID value range of 0.2 to 0.5 standard deviation units representing an effect size range. This range was used to determine if the adjustment for the effect of IA-saline would affect the potential clinical interpretation of the previously published meta-analysis results. <h3>Results</h3> IA-saline provides a therapeutic benefit that is potentially clinically meaningful to patients based on a range of MCID values (figure 1). Across the same range of MCID values, the effects of high molecular weight IA-hyaluronic acid products and IA-corticosteroid treatments were not conclusively clinically significant. However, when reassessing these treatments while accounting for the treatment effect of IA saline, they were found to have a clinically significant effect at the strictest MCID value (figure 2). <h3>Conclusions</h3> The use of IA-saline as a placebo treatment within RCTs of IA injectable therapies is inappropriately underestimating the true effect of these treatments. When the potential therapeutic effect that IA-saline demonstrates is accounted for, these IA therapies show a considerably larger therapeutic effect. <h3>Reference</h3> [1] Bannuru RR, et al. Ann Intern Med2015;163:365–372. <h3>Disclosure of Interest</h3> I. Simsek Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, T. Phalen Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, A. Bedenbaugh Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, M. Phillips Grant/research support from: Samumed, LLC, J. Tambiah Shareholder of: Samumed, LLC, Employee of: Samumed, LLC
FRI0454 Arterial stiffness of the forearm is associated with nail-fold capillary count in ssc: a novel marker of early vasculopathy?
Authors: M.M. Habing, A. Eman Abdulle, A.M. van Roon, A.M. van Roon, H. van Goor, H. Bootsma, A.J. Smit, D.J. Mulder
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Microvascular disease, characterised by rarefaction of capillaries, is the hallmark of systemic sclerosis. Remarkably, obliteration of the ulnar and radial artery is regularly observed, implicating involvement of the larger forearm arteries. Pulse wave velocity (PWV) is a widely accepted non-invasive measure for arterial stiffness and may serve as an early biomarker of forearm artery involvement, before the occurrence of irreversible arterial obliteration. <h3>Objectives</h3> The aim of the current study was to investigate arterial stiffness of the aorta and of the upper extremities in SSc patients compared to healthy controls and to correlate these findings with nail-fold capillary count, skin involvement, and extent of disease. <h3>Methods</h3> In total, 19 SSc patients (median age 51 years, 68% female) and 19 age and gender matched healthy controls (median age 53 years, 68% female) were included. Patients characteristics were obtained and blood was drawn. Measurements of arterial stiffness were carried out by using the SphygmoCor System (AtCor Medical, Sydney, Australia) and pressure waveforms were measured at four sites, i.e. carotid, femoral, brachial, and radial. Aortic PWV was defined as carotid-femoral (cf) PWV. Upper extremity PWV was measured as carotid-brachial (cb) and carotid-radial (cr) PWV, and the ratio between cbPWV/crPWV was used as an indication of the relative change in PWV in the forearm. Capillary count was defined as the mean capillary count per 3 mm of 8 fingers. Skin involvement was assessed by the modified rodnan skin score. The number of ACR/EULAR 2013 criteria points was used as a surrogate for extent of disease. <h3>Results</h3> Upper extremity PWV measures were significantly higher compared to aortic PWV in patients and in controls (SSc: p&lt;0.001; HC: p=0.03), but did not significantly differ between both groups (table 1). CbPWV/crPWV ratio correlated strongly with capillary count (r=−0.55, p=0.022, figure 1) in SSc patients with a borderline significant trend in regards to its relation with the extent of disease (r=0.48, p=0.053) and skin involvement (r=0.41, p=0.10). <h3>Conclusions</h3> Our findings demonstrate that arterial stiffness of the forearm has a relationship with nailfold capillary count and tends to be associated with the extent of disease in patients with SSc. These preliminary data may suggest that vascular damage may concomitantly occur in both capillaries as well as larger arteries of the forearm, which may potentially serve as a novel tool for assessing of early vascular involvement in SSc. <h3>Disclosure of Interest</h3> None declared
The impact of acute air pollution fluctuations on bronchiectasis pulmonary exacerbation: a case-crossover analysis
Authors: Pieter C. Goeminne, Bianca Cox, Simon Finch, Michael R. Loebinger, Pallavi Bedi, Adam T. Hill, Tom C. Fardon, Kees de Hoogh, Tim S. Nawrot, James D. Chalmers
Journal: European Respiratory Journal (2018)

In bronchiectasis, exacerbations are believed to be triggered by infectious agents, but often no pathogen can be identified. We hypothesised that acute air pollution exposure may be associated with bronchiectasis exacerbations. We combined a case-crossover design with distributed lag models in an observational record linkage study. Patients were recruited from a specialist bronchiectasis clinic at Ninewells Hospital, Dundee, UK. We recruited 432 patients with clinically confirmed bronchiectasis, as diagnosed by high-resolution computed tomography. After excluding days with missing air pollution data, the final model for particles with a 50% cut-off aerodynamic diameter of 10 µm (PM 10 ) was based on 6741 exacerbations from 430 patients and for nitrogen dioxide (NO 2 ) it included 6248 exacerbations from 426 patients. For each 10 µg·m − ³ increase in PM 10 and NO 2 , the risk of having an exacerbation that same day increased significantly by 4.5% (95% CI 0.9–8.3) and 3.2% (95% CI 0.7–5.8) respectively. The overall (lag zero to four) increase in risk of exacerbation for a 10 μg·m −3 increase in air pollutant concentration was 11.2% (95% CI 6.0–16.8) for PM 10 and 4.7% (95% CI 0.1–9.5) for NO 2 . Subanalysis showed higher relative risks during spring (PM 10 1.198 (95% CI 1.102–1.303), NO 2 1.146 (95% CI 1.035–1.268)) and summer (PM 10 2.142 (95% CI 1.785–2.570), NO 2 1.352 (95% CI 1.140–1.602)) when outdoor air pollution exposure would be expected to be highest. In conclusion, acute air pollution fluctuations are associated with increased exacerbation risk in bronchiectasis.
Serum Level of Antibodies Against Hepatitis B Core Protein Is Associated With Clinical Relapse After Discontinuation of Nucleos(t)ide Analogue Therapy
Authors: Heng Chi, Zhandong Li, Bettina E. Hansen, Tao Yu, Xiaoyong Zhang, Jian Sun, Jinlin Hou, Harry L.A. Janssen, Jie Peng
Journal: Clinical Gastroenterology and Hepatology (2018)
Change in Diagnostic Criteria for Noninvasive Follicular Thyroid Neoplasm With Papillarylike Nuclear Features
Authors: Yuri E. Nikiforov, Zubair W. Baloch, Steven P. Hodak, Thomas J. Giordano, Ricardo V. Lloyd, Raja R. Seethala, Bruce M. Wenig
Journal: JAMA Oncology (2018)

A study from the international multidisciplinary group, published in April 2016, proposed reclassification of a type of lowrisk thyroid cancer as noninvasive follicular thyroid neoplasm with papillarylike nuclear features (NIFTP), eliminating the term cancer from the tumor name. 1 Since then, the new term has been recommended for use by many professional societies and included as a new thyroid tumor entity in WHO Classification of Tumours of Endocrine Organs from the World Health Organization published in 2017.Over the course of 18 months, more than 80 peer-reviewed publications have reported institutional experience with NIFTP.Methods | We reviewed English-language publications through PubMed (January 24, 2018), using a keyword search for NIFTP.We focused on large patient cohorts with tumors meeting the diagnostic criteria for NIFTP.Results | Five studies, all retrospective, reported large series of patients (>70) with NIFTP (Table ). [2]3][4][5][6] The first 3 studies included 285 patients; they reported no tumor-related adverse events after a mean follow-up ranging from 5.8 to 11.2 years. [2]][4] These series included patients with multifocal and bilateral tumors and those with large tumors (>4 cm), supporting the initial finding of indolent clinical behavior of NIFTP.However, 2 other studies reported that 4% to 6% of patients with nodules meeting the diagnostic criteria for NIFTP were found to have metastasis. 5,6 Many of these tumors had at least some papillary structures identified, revealed BRAF V600E mutation, and showed metastasis to regional lymph nodes and not distant sites.All of these features are characteristics of classic papillary thyroid carcinoma (PTC) and are rarely seen in an invasive encapsulated follicular variant of PTC, which is an invasive counterpart of NIFTP.The initial report that established NIFTP as a
Prolonged clinical benefit with metronomic capecitabine plus oral vinorelbine as treatment of metastatic breast cancer: Results from a phase II study.
Authors: Laura Orlando, Palma Fedele, Paola Schiavone, Angelo Nacci, Nicola Calvani, Enrica Mazzoni, Annamaria Quaranta, Margherita Cinefra, Saverio Cinieri
Journal: Journal of Clinical Oncology (2012)

e11547 Background: Metronomic chemotherapy regimens have shown efficacy in patients with metastatic breast cancer through antiangiogenic mechanisms. We present preliminary data of a phase II trial of metronomic capecitabine (CAP) in combination with oral vinorelbine (VIN) as treatment of metastatic breast cancer (MBC). Methods: Patients with advanced breast cancer, pretreated or not for metastatic disease, were treated with VIN (60 mg/m2, on days 1 and day 8 of a 21-day cycle) combined with metronomic CAP (1500 mg daily). Primary end-point was overall response rate (ORR), secondary end-point time to progression (TTP), clinical benefit rate (CBR; PR+ CR + prolonged SD for ≥ 24 weeks) and tolerability. Results: A total of 31 patients with histologically confirmed, Her2 negative MBC, have been enrolled, 22 actually valuable for response and toxicity. Median age was 62 years (range 34-75), visceral metastases were present in 18 patients (58%), 11 patients (35%) were pretreated with chemotherapy, most of them with anthracycline and taxanes. Triple negative tumors were 5 (16%). Median number of cycles was 12 (range 4-34). The ORR was 54.5 % (95% CI, 44-63%), with two CR (9 %) and 10 PR (45%). Seven patients had SD, 5 prolonged (23%). The CBR was 77% (95% CI , 71%-84%). Three progressions of disease were observed (14%). Median TTP was 8 months (range 3- 24 +). Median overall survival was 32 months (range, 6-39 + ). The most frequent toxicities were WHO diarrhea grade 1 and neutropenia grade 2. Grade 3 skin toxicity was observed in two patients subsequently found to have DPD enzyme deficiency. No grade 2 alopecia was reported. Conclusions: In this phase II study, the all oral combination of low dose metronomic CAP combined with VIN seems to be very active, confirming data with standard doses, and allows a very long duration of response and treatment. The observed toxicity was mild and manageable. Thus, patients accrual is ongoing to the pre-set target of 66 patients.
FRI0193 Prognostic markers in axial spondyloarthritis (PROMISE) – cross sectional evaluation of serum biomarkers in axspa, mechanical back pain and healthy controls
Authors: E. Reilly, C. Fisher, R. Sengupta
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> In recent years there has been increasing interest in biomarkers in axial spondyloarthritis, for diagnosis, disease prognostication, and to monitor treatment effect.<sup>1 2</sup> Many biomarkers have been evaluated, but the role each of these plays and how they may interact is unclear. <h3>Objectives</h3> Our aim was to evaluate a broad panel of serum biomarkers in a large mixed cohort of patients, with Ankylosing Spondylitis (AS), non radiographic axial Spondyloarthritis (nr-axSpA), mechanical back pain (MBP) and healthy controls (HC), in order to identify any potential biomarkers for diagnosis by assessing the differences between the groups. <h3>Methods</h3> Cross sectional evaluation of 46 serum biomarkers was undertaken by Myriad RBM using multiplexed immunoassays of Multi-Analyte Panels, in a cohort of patients from a tertiary referral centre, consented as part of the Bath Spondyloarthritis BioBank. Validated patient reported outcomes (including BASDAI, BASFI) and BASMI were completed. 50 HC blood samples were also collected at University College London for biomarker analysis. <h3>Results</h3> 331 patients were included in the study, of which 59.5% AS, 8.2% nr-axSpA, 15.7% mechanical back pain, 15.1% HC. 64.7% were male, mean age 44.2 years (SD 16.6), mean disease duration in the AS group of 22.4 years (SD 13.6) with 84% HLA B27 positive. IL1 alpha and beta, IL1 receptor antagonist, IL2, 3, 4, 5, 7, 10, 15, 17, IL12 subunit p70, factor VII, GMCSF, IFN gamma, MMP9, TNF beta were the only biomarkers not to show statistical differences across the diagnostic groups (table 1.). 12 biomarkers showed a statistical difference between genders (table 1, column 1, p value significance indicated with *&lt;0.05, **&lt;0.01 using Mann Whitney U, in addition to Factor VII*). <h3>Conclusions</h3> Serum biomarkers have been shown to vary with gender and diagnosis. Further work is planned to evaluate their relationship to disease activity using outcome measures such as the BASDAI, and radiographic scoring, to better understand the role of each factor and combination of factors, and any causal link. <h3>References</h3> [1] Maksymowych WP. An update on biomarker discovery and use in axial spondyloarthritis. Expert Rev Mol Diagn [Internet]. 2017Nov;217(11):965–74. [cited 2017 Dec 7]. Available from: https://www.tandfonline.com/doi/full/10.1080/14737159.2017.1381562 [2] Reveille JD. Biomarkers for diagnosis, monitoring of progression, and treatment responses in ankylosing spondylitis and axial spondyloarthritis. Clin Rheumatol [Internet]2015Jun 5;34(6):1009–18. [cited 2017 Jul 10]. Available from: http://link.springer.com/10.1007/s10067-015-2949-3 <h3>Acknowledgements</h3> This study was undertaken as part of an ongoing piece of work that is being funded by Celgene. <h3>Disclosure of Interest</h3> None declared
Reducing Calories to Lose Weight—Reply
Authors: Eve Guth
Journal: JAMA (2018)

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AB1456-HPR Shared decision making in practice and needs of rheumatic patients on nursing support
Authors: J.H.E Voorneveld-Nieuwenhuis
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Value Based Health Care entails creating value for the patient by providing meaningful care. Meaningful care can be given with focus at the perspective of the patient. Nurses play a role in measuring and monitoring care outcomes, but also have an important role in providing information about, treatment options and counselling of patients with their illness and treatment. Nurse consultation is part of the clinical pathway for rheumatoid arthritis patients. <h3>Objectives</h3> What are the needs and expectations of a patient at a consultation with the rheumatology nurse? What do rheumatology nurses discuss with patients and their relatives during the nursing consultation and does this fit with the nursing competences from the generic self-management model? <h3>Methods</h3> Beside literature research two focus groups with patients about nursing care in the out-patient clinic where held. Also 10 nurse consultations where analysed from 3 different nurses. Qualitative data from both focus groups and observations where analysed and encoded with Atlas.ti. <h3>Results</h3> Patients where positive about the time spending for education and information. They expect the nurse to be a guide and give reliable information. They wanted emotional support especially when medication change and in the begin period when diagnose is set. Suggestions for subjects for follow up consultation like medication check, co-morbidity screening where positively received. Talking about self management is also a well received subject. A specific tool for self management like the self management web could support both patients and nurses. Observation in practice showed that nurses give education and advice, but coaching is a less used skill. <h3>Conclusions</h3> Patients want emotional support, education about illness and self management support. Nurses are well equipped in give information and advice but must be educated in using there coaching skills and support patients to talk about their experienced problems in daily live. <h3>References</h3> [1] Eijk-Hustings, Y. van, Ammerlaan, J., Voorneveld-Nieuwenhuis, H., Maat, B., Veldhuizen, C., &amp; Repping-Wuts, H. (2013). Patients' needs and expectations with regard to rheumatology nursing care: results of multicentre focus group interviews. Annals of the Rheumatic Diseases, 72(6), 831–835. [2] Porter, M. E. (2010). What is value in health care?. New England Journal of Medicine, 363(26), 2477–2481. [3] Staa, A. L. van, Beck, D., Been-Dahmen, J.M.J., &amp; Massey, E.K. (2017). Ondersteuning bij zelfmanagement: Een nieuwe verpleegkundige interventie. Dé Verpleegkundig Specialist, 12(1), 8–14. <h3>Disclosure of Interest</h3> None declared
AB0853 The association of vitamin d reseptor levels with disease activity parameters in patients with ankylosing spondylitis
Authors: T. Kultur, D. Öztaş, D. Keskin, G. Keskin, A. İnal, H. Kara
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Ankylosing Spondylitis (AS) is a chronic, systemic, inflammatory disease that involves sacroiliac, axial and peripheral joints with an unknown ethology. The role of vitamin D receptor (VDR) in the regulation of multiple pathophysiologic processes, like inflammation, infection and malignancies and systemic disease is not fully understood. <h3>Objectives</h3> The aim of this study, was to investigate the relationship between serum VDR levels and disease activity parameters in patients with AS. <h3>Methods</h3> Sixty-two patients with AS and 32 healthy volunteers were included into the study. Demographic features like age, duration of illness, medication, history of uveitis and peripheral involvement of the patients were recorded. Erythrocyte sedimentation rate (ESR), serum C-reactive protein (CRP) levels were recorded. The Bath AS Disease Activity Index (BASDAI) scores were calculated to determine disease activity. Serum Vitamin D receptor (VDR) level was measured by ELISA. <h3>Results</h3> There was no difference in Serum VDR levels between the patient and the control group (p=0.658). In patients with active AS (BASDAI score ≥4) serum VDR level was significantly high (p=0,000). Also serum VDR levels were statistically significantly high in patients with peripheral joint involvement and enthesis (p=0,000, non-steroidal anti inflammatory drugs (NSAID) compared to patients treated with biological agents (p=0.00). Serum VDR levels were also significantly correlated with BASDAI, CRP and ESR in the patient group (p=0.00, r=0,751, p=0.00, r=0751 p=0.00, r=0806 respectively). <h3>Conclusions</h3> In our study, serum VDR levels are related with disease activity, clinical parameters, peripheral joint involvement and enthesis in patients with AS. Our results suggest that serum VDR level may be used to predict disease activity and prognosis. Further studies in large cohorts are needed to determine the role of Serum VDR level in the pathophysiology of AS. <h3>References</h3> [1] Cistromic and genetic evidence that the vitamin D receptor mediates susceptibility to latitude-dependent autoimmune diseases. Booth DR, Ding N, Parnell GP, Shahijanian F, Coulter S, Schibeci SD, et al. Genes Immun2016;17(4):213–9. [2] [2] Serum vitamin D and colonic vitamin D receptor in inflammatory bowel disease. Abreu-Delgado Y, Isidro RA, Torres EA, González A, Cruz ML, Isidro AA, et al. World J Gastroenterol2016;22(13):3581–91. [1] Cistromic and genetic evidence that the vitamin D receptor mediates susceptibility to latitude-dependent autoimmune diseases. Booth DR, Ding N, Parnell GP, Shahijanian F, Coulter S, Schibeci SD, et al. Genes Immun2016;17(4):213–9. [2] Serum vitamin D and colonic vitamin D receptor in inflammatory bowel disease. Abreu-Delgado Y, Isidro RA, Torres EA, González A, Cruz ML, Isidro AA, et al. World J Gastroenterol2016;22(13):3581–91. <h3>Disclosure of Interest</h3> None declared