tbuckley/cabot-search huggingface dataset:
THU0677 Outcome measurement instruments for safety in rheumatology: a scoping review of available instruments to inform the omeract safety working group
Authors: L Klokker, T Woodworth, DE Furst, P Tugwell, D Devoe, P Williamson, CB Terwee, ME Suarez-Almazor, V Strand, AL Leong, N Goel, M Boers, PM Brooks, LS Simon, R Christensen
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> International scientific networks have raised concerns about inadequate reporting of safety outcomes in randomised trials and systematic reviews. Outcome Measures in Rheumatology (OMERACT) has previously developed an adaptation of the US National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE), the RCTC (Rheumatology Common Toxicity Criteria) to collect adverse events in rheumatology clinical trials. To respond to the need to also report safety outcomes from the patient perspective, the Safety Working Group is developing a core outcome set, followed by a core outcome measurement set. A scoping review of available instruments for measuring safety outcomes is needed to inform this work. <h3>Objectives</h3> To identify candidate measurement instruments for safety outcomes in rheumatology clinical trials. <h3>Methods</h3> A systematic search was performed in the MEDLINE database (via PubMed) in January 2017 using MeSH terms covering synonyms for adverse events, rheumatology and measurement instruments and the Boolean operator AND to combine them. Full-text articles about the development or evaluation of instruments for measuring safety in rheumatology were eligible. One reviewer (LK) screened for eligibility based on title and abstracts. Two reviewers (LK and RC) screened the full text articles. <h3>Results</h3> Of 434 unique references identified, 19 were read in full-text, and 8 were included (see figure). The instruments identified were: Glucocorticoid Toxicity Index (GTI), Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC), Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI flare index (cSFI), the BioSecure questionnaire, Rheumatology Common Toxicity Criteria (RCTC), OMERACT 3x3, and the Stanford Toxicity Index (STI). These instruments were specific for substance (GTI, BioSecure questionnaire), setting (PREOS-PC), condition (cSFI), or not fully validated (RCTC, OMERACT 3x3, STI). <h3>Conclusions</h3> The instruments identified are either too specific, or require further development/evaluation, for the purpose of standardizing measurement of safety in rheumatology clinical trials. Thus, we will proceed to gain consensus on the domains that must be measured to develop a core outcome set. <h3>Disclosure of Interest</h3> None declared
FRI0680 Synovial intensity measured by ultrasonography as an indicator for joint inflammation in rheumatoid arthritis patients under treatment
Authors: Y Kondo, K Suzuki, Y Inoue, K Sakata, C Takahashi, M Takeshita, Y Kaneko, K Yamaoka, T Takeuchi
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Ultrasonography (US) is a useful modality that can directly visualize RA joint inflammation. Recently, brightness of thickened synovium is considered to associate with local synovitis. However the accuracy of US findings with the local pathophysiology remains uncertain since synovial biopsy could be heterogeneous depending on the biopsy site and can be influenced by various medications. On another front, synovial fluid (SF) is homogenous, easy to access and contains abundant inflammatory cytokines and growth factors, which play an important role in the local pathogenesis of RA. However, the association between SF proteins and joint US findings is not clear. <h3>Objectives</h3> To clarify whether synovitis detected by US including synovial hypertrophy, vascularity and brightness reflect local joint molecular pathophysiology. <h3>Methods</h3> Forty-four RA patients were recruited. All patients were performed standardized US examination of knee joint. US images were evaluated by semi-quantitative scoring (synovial hypertrophy; grey scale (GS) US, vascularity; power Doppler (PD) US) and quantitative analysis by using Image J (National Institutes of Health, MD, Maryland USA). The average of the pixels of synovial tissue area (GS quant), PD signal area (PD quant) and mean gray values of synovium (Brightness) in 3 areas of the knee joint were calculated. US guided SF aspiration was performed on the same day and concentrations of cytokines and growth factors were measured by Cytometric Beads Array. (BD Biosciences, NJ, USA) <h3>Results</h3> Median age, disease duration and DAS28-ESR were 64 years, 1.5 years and 5.2 respectively. Mean GSUS and PDUS were 2.3 and 2.0. Nineteen patients were untreated. US inflammatory findings especially PD quant were well correlated with corresponding SF IL-6, IL-8, IL-1β and IL-10.(range of rho;0.40–0.72, p&lt;0.05) synovial brightness also inversely correlated with SF VEGF (rho=-0.41, p&lt;0.05). When we analyzed untreated and treated RA patients separately, GS quant did not correlate with any SF cytokines in treated group although, PD quant and brightness both significantly correlated with SF IL-6 and VEGF (p&lt;0.05). Next, we divided the treated patients into 4 groups according to median of brightness and GS quant to compare the SF IL-6 levels. This analysis showed that SF IL-6 levels were influenced by synovial brightness rather than its hypertrophy. (p&lt;0.05) <h3>Conclusions</h3> Our results suggest that not only US PD signals but also synovial brightness is a useful indicator for joint inflammation rather than synovial hypertrophy itself in treated RA patients. <h3>References</h3> Naredo E et al. Arthritis Rheum 2008; 58: 2248–56. Kelly S et al. Arthritis Res Ther. 2015 Mar 13;17:58. <h3>Disclosure of Interest</h3> None declared
FRI0604 Successful treatment of arthritis induced by checkpoint inhibitors with anti–interleukin-6 receptor antibody: a case series
Authors: ST Kim, A Diab, M Uemura, S Garcia, P Hwu, J Tayar
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Immune checkpoint inhibitors (CPIs) have significantly improved outcomes for patients with various cancers. However, CPIs are associated with immune-related adverse events (irAEs). Two to three percent of patients receiving a CPI develop arthritis. In general, severe irAEs are treated with a high-dose steroid and a tumor necrosis factor inhibitor (TNFi), usually infliximab; however, TNFi treatment is sometimes contraindicated and, furthermore, entails a theoretical concern of impairing antitumor immunity. Therefore, evidence showing the clinical benefits of non-TNFi biologics in the treatment of irAEs is of immediate interest. <h3>Objectives</h3> We described the effects of anti-IL-6R antibody for the treatment of arthritis-irAE. <h3>Methods</h3> Three patients receiving CPI developed arthritis and were treated with anti-IL-6R antibody. Patients were followed up to 15 months. <h3>Results</h3> All patients had metastatic melanoma (Table 1). No patient had a history of autoimmune disease at the time of initiation of CPI treatment. One patient developed arthritis 8 weeks after the completion of anti-CTLA-4 antibody treatment. Two patients were receiving anti-PD-1 antibody when they developed arthritis. Patient 2 continued to receive anti-PD-1 antibody despite of arthritis-irAE while patient 3 discontinued anti-PD-1 antibody due to arthritis-irAE. The pattern of arthritis was symmetric polyarthritis involving small and large joints. Patient 1 had a positive rheumatoid factor (unknown baseline) and patient 3 had a positive ANA (known positive prior to CPI treatment). All patients were treated with anti-IL-6R antibody, which was well tolerated. All patients experienced a 40–100% reduction in global assessment, swollen joint count, and tender joint count, and these effects were maintained for up to 15 months of treatment (Figure 1). As of December 2016, all patients were alive; one patient was in complete remission and two patients had experienced progression of their melanoma. <h3>Conclusions</h3> These three cases suggest that anti-IL-6R antibody is an effective alternative to TNFi for the treatment of arthritis-irAE. <h3>Acknowledgements</h3> None <h3>Disclosure of Interest</h3> None declared
Corticosteroids for treatment of sore throat: systematic review and meta-analysis of randomised trials
Authors: Behnam Sadeghirad, Reed A C Siemieniuk, Romina Brignardello-Petersen, Davide Papola, Lyubov Lytvyn, Per Olav Vandvik, Arnaud Merglen, Gordon H Guyatt, Thomas Agoritsas
Journal: BMJ (2017)

<b>Objective</b>&nbsp;To estimate the benefits and harms of using corticosteroids as an adjunct treatment for sore throat. <b>Design</b>&nbsp;Systematic review and meta-analysis of randomised control trials. <b>Data sources</b>&nbsp;Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), trial registries up to May 2017, reference lists of eligible trials, related reviews. <b>Study selection</b>&nbsp;Randomised controlled trials of the addition of corticosteroids to standard clinical care for patients aged 5 or older in emergency department and primary care settings with clinical signs of acute tonsillitis, pharyngitis, or the clinical syndrome of sore throat. Trials were included irrespective of language or publication status. <b>Review methods</b>&nbsp;Reviewers identified studies, extracted data, and assessed the quality of the evidence, independently and in duplicate. A parallel guideline committee (<i>BMJ</i>&nbsp;Rapid Recommendation) provided input on the design and interpretation of the systematic review, including the selection of outcomes important to patients. Random effects model was used for meta-analyses. Quality of evidence was assessed with the GRADE approach. <b>Results</b>&nbsp;10 eligible trials enrolled 1426 individuals. Patients who received single low dose corticosteroids (the most common intervention was oral dexamethasone with a maximum dose of 10 mg) were twice as likely to experience pain relief after 24 hours (relative risk 2.2, 95% confidence interval 1.2 to 4.3; risk difference 12.4%; moderate quality evidence) and 1.5 times more likely to have no pain at 48 hours (1.5, 1.3 to 1.8; risk difference 18.3%; high quality). The mean time to onset of pain relief in patients treated with corticosteroids was 4.8 hours earlier (95% confidence interval −1.9 to −7.8; moderate quality) and the mean time to complete resolution of pain was 11.1 hours earlier (−0.4 to −21.8; low quality) than in those treated with placebo. The absolute pain reduction at 24 hours (visual analogue scale 0-10) was greater in patients treated with corticosteroids (mean difference 1.3, 95% confidence interval 0.7 to 1.9; moderate quality). Nine of the 10 trials sought information regarding adverse events. Six studies reported no adverse effects, and three studies reported few adverse events, which were mostly complications related to disease, with a similar incidence in both groups. <b>Conclusion</b>&nbsp;Single low dose corticosteroids can provide pain relief in patients with sore throat, with no increase in serious adverse effects. Included trials did not assess the potential risks of larger cumulative doses in patients with recurrent episodes of acute sore throat. <b>Systematic review registration</b>&nbsp;PROSPERO CRD42017067808.
The potential of gum arabic stabilized Au-198 nanoparticles (GA-AuNP) as a radiotherapeutic agent for prostate cancer
Authors: Para Kan, Valerie Rahing, Lisa Watkinson, Terry Carmack, John Lever, Charles Smith, Sudarshan Loyalka, Raghuramen Kannan, Kavita Katti, Kattesh Katti, Cathy Cutler, Silvia Jurisson
Journal: Cancer Research (2008)

3164   The American Cancer Society estimates that 1.4 million people will be diagnosed with cancer in 2007. Men have a 45% probability of developing some form of cancer in their lifetime. Of men diagnosed with cancer, 1-in-3 will be prostate cancer. Current detection methods for prostate cancer involve determining the concentration of prostate specific antigen (PSA) in blood serum. Medications, certain herbs, and genetics can increase PSA levels, thus providing inaccurate results. Current treatment options for prostate cancer include surgery, irradiation, immunotherapy, hormone therapy and chemotherapy.  Gold nanoparticles provide an attractive alternative to treating cancer by delivering high irradiation payloads. Gold-198 (Au-198) radiolabeled nanoparticles stabilized with gum Arabic, a natural additive used in everyday food products and thus non-toxic  in-vivo , are described. These nanoparticles are rapidly produced by using the non-toxic, amino acid derived reducing agent tris-hydroxymethyl phosphine alanine (THPAL). The nuclear properties of Au-198 are well suited for radiotherapy (t 1/2  = 2.7 days, E βmax  = 1.37 MeV). The 411 keV gamma emission (95%) allows tracking of the Au-198 radiolabeled nanoparticles using Single Photon Emission Computed Tomography (SPECT). The high thermal (98.6 barns) and epithermal (1550 barns) nuclear cross-section of natural, monoisotopic Au-197 allows for relatively rapid irradiation to achieve reasonable specific activity. If carrier-free radioactive Au is needed, Au-199 (t 1/2  = 3.1 days, E βmax  = 0.45 MeV, 158 and 208 keV γ-rays) can be obtained from the β -  decay of Pt-199 (t 1/2  = 30.9 min; produced from an enriched Pt-198 target).  Three different routes of administering Au-198 radiolabeled gold nanoparticles (Au-198-GA-AuNP), prepared as described above, were compared using a PC-3 (human prostate cancer) xenograft tumor model in immunocompromised mice. Radiotracer uptake and retention were determined after 30 min, 1 h, 2 h, 4 h, and 24 h. Tumor uptake after 24 h was 1.79 + 0.32% D/g by intravenous (IV) injection, 5.75 + 1.49% D/g by intraperitoneal (IP) injection, and 87.73 + 37.61% D/g by intratumoral (IT) injection. The IV injection also showed high liver (65.2 + 2.30% D/g), lungs (17.9 + 4.92% D/g), and spleen (8.52 + 1.12% D/g) uptake over time. After IP injection, tumor uptake increased steadily over the time course. IT administration showed little to no leakage of Au-198-GA-AuNP from the tumor over the first 4 hr, while 60% of the injected dose was retained at 24 hr, indicating potential as a radiotherapeutic agent.
AB0644 Fingerprint abnormalities in systemic sclerosis: a single center survey from india
Authors: K Chanakya, PK Devarasetti, RVP Irlapati, L Rajasekhar
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Fingerprint [FP] abnormalities are known in patients with Systemic Sclerosis [SSc]. Little has been described about their frequency, systemic associations and social impact in literature. <h3>Objectives</h3> To study the fingerprint abnormalities in Systemic Sclerosis patients <h3>Methods</h3> Raynaud9s phenomenon [RP] was taken as the inclusion criteria. Patients with SSc [limited LcSSc and diffuse DcSSc], SSc overlap with other Connective Tissue Diseases [CTDs] and other CTDs with RP were screened for FP abnormalities using a Standardization Testing and Quality Certification (STQC) Directorate certified biometric FP scanner. FP quality assessment was done by recording The National Institute of Standards and Technology [NIST] finger print image quality [NFIQ] scores<sup>1</sup>. NFIQ9s 5 levels of quality are intended to be predictive of fingerprint matching. NFIQ=1 indicates high quality samples and NFIQ=5 indicates poor quality samples. Other associated systemic features of the disease were noted. Also the social difficulties due to fingerprint abnormalities were noted. Healthy controls with no RP were included for comparison. <h3>Results</h3> 40 consecutive patients with RP attending Rheumatology outpatient services of our institute were screened for FP abnormalities. 29 with SSc [20-DcSSc, 9-LcSSc], 8 with overlap syndromes and 1 each of SLE, Undifferentiated Vasculitis and Undifferentiated CTD. It was noted prior to screening that 19 patients experienced some difficulty in the past with biometric recognition of their FPs at various times. On screening with biometric scanner, 15 of 40 [37.5%] had FP abnormalities in the form of non recognition of at least one finger with a median of 2 [range 1–6 fingers]. Of these 15, seven had DcSSc, six had LcSSc and two with overlap syndromes. The mean NFIQ score of these 15 patients was 4.5 [poor] and the mean NFIQ scores in SSc was 3.8. Eleven [27.5%] patients could not get government Identity cards based of FP scanning, four could not avail various government benefit schemes which needed their fingerprints as identity. Sixteen [40%] had history of digital vasculopathy in the form of digital pits, digital ischemia or ulcers. PAH was found in one and eight had Interstitial lung disease. Among the 10 controls all FPs were recognized and the mean NFIQ score was 2.2 indicating a better quality of FPs. <h3>Conclusions</h3> Fingerprint abnormalities occur frequently in patients with systemic sclerosis causing social disabilities in few. The quality of FPs in SSc patients is poor. Raynaud9s phenomenon and vasculopathy are frequently associated. Documentation of this abnormality should allow the use of other biometric tools for personal identification. <h3>References</h3> E. Tabassi, C. Wilson, C. Watson, "Fingerprint Image Quality", NIST Internal Report 7151, National Institute for Standards and Technology, 2004. <h3>Disclosure of Interest</h3> None declared
AB0804 Single-nucleotide polymorphism (SNP) RS143383 growth and differentiation factor 5 (GDF5) in knee osteoarthritis in egyptian population
Authors: M Hassanien, NA Mohamed, SA Mahran
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Osteoarthritis (OA), is an age-related common polygenic disease characterized by the thinning and loss of the articular cartilage in synovial joints such as knees. The etiology and pathogenesis of OA is largely unknown, the single-nucleotide polymorphism (SNP) rs143383 (C/T) influencing OA susceptibility across a range of ethnic groups. <h3>Objectives</h3> The present study investigated to identify the association of polymorphism in GDF-5 gene with osteoarthritis in Egyptian population. <h3>Methods</h3> This Case control study of 100 women and 100 male ≥40 years that fulfilled American College of Rheumatology (ACR) for Knee OA and 100 controls recruited from the outpatient clinic of Department of Rheumatology, Asyut university, Egypt. Clinical symptoms were assessed with WOMAC index and VAS for knee pain. The severity of disease was determined by radiological grades (Kellgren Lawren). Body Mass Index (BMI) was recorded. DNA isolation and genotype analysis the method of (Southam <i>et al</i>., 2007) was followed for determining the GDF-5 gene (T/C; rs143383) polymorphism. Amplification was performed. <h3>Results</h3> There were weak but significant associations present between the GDF5 polymorphism and knee OA at the allele level (C vs. T: 0.85, 95% CI =0.78–0.93) and genotype level (CC vs. TT: 0.72; CT vs. TT: 0.81; CC/CT vs. TT: 0.83; CC vs. CT/TT: 0.78) in the overall population. A stronger significant association was observed for CC vs. TT (OR =0.83, P&lt;0.001) in comparison with other models. In males we identified a second polymorphism, located in the 39-UTR of <i>GDF5</i>, that influenced allelic expression of the gene independent of rs143383. <h3>Conclusions</h3> GDF5 is an OA susceptibility gene with association between the GDF5 polymorphism and clinical symptoms of knee OA in Egyptian population. <h3>Disclosure of Interest</h3> None declared
“The Tunnel at the End of the Light”
Authors: Vineet Chopra, Sanjay Saint
Journal: JAMA (2017)

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Prevalence and predicators of insomnia among cancer survivors.
Authors: Jeffrey M. Peppercorn, Rachel Jimenez, Julia Rabin, Katharine Quain, Garrett Chinn, Allison McDonough, Elizabeth O'Donnell, Elyse R. Park, Giselle Katiria Perez
Journal: Journal of Clinical Oncology (2017)

e21603 Background: Insomnia is prevalent among cancer survivors. However, screening and treatment is inconsistent across U.S. cancer centers. We sought to identify factors associated with moderate to severe insomnia (MSI) to inform the development of a screening and treatment program for survivors. Methods: As part of a comprehensive supportive care needs assessment, we evaluated the prevalence and correlates of insomnia among patients receiving follow-up cancer care. Patients reported on a 5 point Likert scale (0 = never to 5 = always) how often they have “problems falling or staying asleep”. MSI was defined as those who endorsed “4 = very often” or “5 = always,” and remaining responses were characterized as “No Insomnia” (NI). Descriptive statistics summarized patterns of insomnia and sleep hygiene. Chi-square and Fisher’s exact tests compared differences in sleep hygiene, fatigue, anxiety, depression, and other clinical and demographic characteristics between patients with and without insomnia. Results: Among 312 respondents, 83 (27%) endorsed MSI. Women were more likely to endorse MSI compared to men (32% vs. 19%, p = 0.02). Age was not associated with MSI. MSI was most common among patients with hematologic malignancy (36%), breast cancer (32%), gynecologic cancer (31%), and melanoma (29%). Regarding sleep hygiene: Most reported frequent exposure to bright light before sleep (89% MSI vs. 85% NI). Patients with MSI, compared to NI, were more likely to report watching the clock (86% vs. 75%, p = 0.04) and an irregular sleep schedule (47% vs. 32%, p = 0.02). Patients with MSI were also less likely to meet exercise guidelines (31% vs. 45% NI, p = 0.03) and more likely to report fatigue (29% vs. 14%, p = 0.004). Further, those with MSI were more likely to report anxiety (40% vs. 8%), fear of recurrence (74% vs. 46%), and financial concerns (35% vs. 15%) (all p &lt; 0.001). 67% of patients with MSI were interested in supportive care to address insomnia. Conclusions: A simple one-item screener identified survivors susceptible to moderate to severe insomnia. Interventions beyond attention to sleep hygiene are needed to improve insomnia and its impact on fatigue and emotional distress. The relationships between insomnia, fitness, anxiety and distress merit further evaluation.