Global Visual Analog Scale Scores Research Articles

Estradiol/nomegestrol acetate as a first-line and rescue therapy for the treatment of ovarian and deep infiltrating endometriosis

Purpose Estradiol valerate/nomegestrol acetate (E2V/NOMAC) is a new combined oral contraceptive with a good tolerability profile and low drop-out rates, which was shown to improve menstrual-related symptoms. This study aims to evaluate its effectiveness in the control of symptoms and progression of disease in women with ovarian endomestriomas and deep infiltrating endometriosis (DIE). Methods This was a retrospective cohort study on 39 women with pelvic endometriosis treated with E2V/NOMAC. We assessed for each patient, at the beginning of treatment and after 6 months, the painful symptoms, through a global VAS (Visual Analogue Scale) index and the size of the greatest ovarian and/or deep infiltrating endometriotic lesions. Results After 6 months of treatment, a significant reduction was observed for the global VAS score for pain symptoms and for the mean size of ovarian endometriomas, whereas DIE lesions did not present significant changes in mean size. Conclusions E2/NOMAC was effective in reducing pain symptoms associated with pelvic endometriosis and the size of ovarian endometriomas, whereas DIE lesions remained stable. This therapy could provide good results in the control of symptoms and disease progression in women with pelvic endometriosis.

Assessment of loneliness in patients with inflammatory arthritis.

This study aimed to explore loneliness and associated factors in Turkish patients with inflammatory arthritis. Adult patients with rheumatoid arthritis (RA) (n=58), ankylosing spondylitis (AS) (n=53), and psoriatic arthritis (PsA) (n=30), respectively, were included in the study. A single-item visual analog scale (VAS) for loneliness, UCLA Loneliness Scale-8 (ULS-8), Beck depression inventory (BDI), Beck anxiety inventory (BAI), revised multidimensional scale of perceived social support, Health Assessment Questionnaire-Disability Index (HAQ-DI) were used for the psychometric and functional assessments. Multiple regression models were generated for predicting the ULS-8 and HAQ-DI scores. There was no difference between disease groups in terms of the ULS-8 and HAQ-DI scores. Among demographic and clinical parameters, only the education status and number of drugs used had associations with the ULS-8 score. Single-item VAS score for loneliness did not predict the ULS-8 score well. There were significant correlations between the ULS-8 and HAQ-DI, depression, anxiety, social support, and physician global VAS scores. Only the education status significantly predicted (β=-0.208) the ULS-8 score in multiple regression analysis (adjusted R2 =0.15, P<.001). Beck depression, anxiety, and patient global VAS scores remained significant for predicting the HAQ-DI after multiple regression with the covariates ULS-8, depression, anxiety, social support, patient and physician global VAS scores, and the number of drugs used (adjusted R2 =0.53, P<.001). Disease activity and the ULS-8 scores were not found to be associated in any disease group. Loneliness is associated with depression, anxiety, lack of social support, disability, higher number of drugs used, and lower education but not with disease activity in Turkish patients with RA, AS, and PsA. Perception and expression of loneliness vary according to the cultural background. Single-item scales for loneliness may lack reliability compared to the more comprehensive ULS-8.

Endometrial thickness in the evaluation of clinical response to medical treatment for deep infiltrating endometriosis: a retrospective study.

Deep infiltrating endometriosis (DIE) is associated with severe pelvic pain and functional impairment of bowel, urinary, and sexual functions. Though hormone therapy with progestins, either as single agents or combined with estrogens, is effective in managing symptoms, some patients may experience a suboptimal response. Endometrial thickness assessed by transvaginal ultrasound examination, reflecting the overall estrogen stimulation, may correlate with the clinical response to hormonal treatments. A retrospective study was carried out on 61 women with DIE affecting the bowel or the recto-vaginal septum, undergoing hormone treatment. The symptoms of patients were evaluated at the baseline and after 12months of therapy, calculating a global Visual Analogue Scale score (gVAS) encompassing dysmenorrhea, dyspareunia, chronic pelvic pain, dyschezia, abdominal pain and dysuria. Patients were divided into two subgroups using, as a calculated cut-off value, the mean endometrial thickness in our population at 12months. The change in gVAS score during the 12months of treatment was then compared between the two groups. Women with a thinner endometrium (< 3.3mm) showed a better response to treatment in terms of symptoms control as compared to patients with a thicker endometrium (mean gVAS score reduction 9.2 ± 1.3 vs. 5.2 ± 1.3, p = 0.036). The correlation between endometrial thickness and symptomatic response was also confirmed (p = 0.041) on multivariate linear regression analysis including as covariates age, size of lesions of DIE, presence of uterine adenomyosis, ovarian endometriosis and type of medical treatment. Endometrial thickness on ultrasound transvaginal examination is correlated with better response rates to hormone therapy in terms of symptoms control. A thinner endometrium, probably resulting from a more efficient suppression of estrogen stimulation, is associated with improved symptoms. These results may aid clinicians in monitoring and tailoring hormonal treatments during follow-up of women with symptomatic DIE.

Is fibromyalgia frequency increasing in axial spondyloarthritis? Association with fibromyalgia and biological therapies.

Fibromyalgia (FM) is known a common painful syndrome and its frequency is increased in inflammatory rheumatic diseases. We aimed to assess FM frequency in axial spondyloarthritis (AxSpA) patients and age- and sex-matched healthy controls with the 2011 ACR FM criteria. We evaluated the association between receiving biologic disease-modifying antirheumatoid drugs (bDMARD) and presence of FM. 127 patients with Ax-SpA and 73 age- and sex-matched controls were included. Individuals were assessed according to modified 2011 ACR diagnostic criteria for FM. The pain was evaluated by visual analog scale (VAS). Disease activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activation Score (ASDAS). Spinal limitation, quality of life, and functionality were assessed. Drug therapies were noted. AxSpA and control group had similar FM rates. 43 (33.9%) patients in AxSpA group and 22 (30.1%) patients in control group had FM diagnosis (p = 0.589). Age, gender, BMI, and CRP values were similar in the AxSpA patients with and without FM, while global VAS and ASDAS scores were higher in patients with FM. Biologic DMARD use was higher in the AxSpA patients with FM; however, the difference was not statistically significant. In conclusion, FM frequency does not increase in AxSpA patients as compared to healthy controls. FM awareness is one of the key points to determine the appropriate treatment due to the influence on disease activity.

Simplification of Validated Patient-Reported Outcome Instruments in Inflammatory Bowel Disease

AbstractObjectivesImproving health-related quality of life (HRQoL) is a major treatment goal for inflammatory bowel disease (IBD) patients. Tools to measure HRQoL, including the Pittsburgh Sleep Quality Index and the Short Inflammatory Bowel Diseases Questionnaire, are lengthy and rely on recall. This prospective, proof-of-concept pilot study assessed the feasibility, reliability, and validity of daily, simplified HRQoL and sleep quality data collection using mobile technologies in patients with IBD.MethodsAdult IBD patients were recruited from our center. Daily HRQoL and sleep quality were assessed using visual analog scale (VAS) surveys, and pain was assessed using the Wong-Baker FACES Pain Rating Scale (WBS). HRQoL and sleep were assessed on days 1, 14, and 28 of the study using the short IBD Questionnaire (SIBDQ) and Pittsburgh Sleep Quality Index (PSQI). Correlation between the daily instruments and the biweekly validated instruments were assessed using the Pearson correlation coefficient.ResultsOne hundred patients were enrolled. The correlation between mean global assessment VAS score over 2 weeks and PSQI score taken at 14 days was moderate (r = 0.62, P &amp;lt; 0.0001). The correlation over the same time interval between mean WBS score and SIBDQ score was strong (r = −0.71, P &amp;lt; 0.0001), and the correlation between mean sleep VAS score and PSQI score was moderate (r = −0.55, P &amp;lt; 0.0001).ConclusionsThis study demonstrates the potential for electronic quality of life, sleep quality, and pain assessments as feasible, reliable, and valid tools in IBD patients. Intermittent administration of these simplified electronic assessments may be useful in further reducing patient survey burden without significantly compromising their utility.

Simultaneous Treatment with Subcutaneous Injection of Golimumab and Intra-articular Injection of Triamcinolone Acetonide (K-Method) in Patients with Rheumatoid Arthritis Undergoing Switching of Biologics: Retrospective Case-Control Study.

BACKGROUNDTight control of severe rheumatoid arthritis (RA) in patients with high disease activity, even when using biologics, is sometimes difficult using a treat-to-target strategy. Switching from one biologic to another is associated with lower efficacy than that in treatment-naive cases. We developed the K-method that involves simultaneous treatment with golimumab and intra-articular joint injection of triamcinolone acetonide (TA) in patients undergoing switching of biologics. We performed this retrospective case–control study to investigate the efficacy of achieving an immediate treatment response using the K-method.METHODSThis study involved 20 patients with RA (control group, 10 patients; K-method group, 10 patients). Patients in the control group were switched to golimumab from other biologics without intra-articular injection of TA. The K-method involved injection of 1 mL of TA (40 mg/mL) and 2 mL of 1% lidocaine hydrochloride into swollen or painful joints on the same day as golimumab treatment. A quick response one day after treatment was compared between the two groups according to the disease activity score 28 based on C-reactive protein (DAS28 CRP), clinical disease activity index (CDAI), simplified disease activity index (SDAI), European League Against Rheumatism (EULAR) response, and remission rate. These parameters were investigated for 24 weeks.RESULTSThe K-method group showed significant improvements in DAS28 CRP, CDAI, and SDAI at one day, 12 weeks, and 24 weeks compared with the control group. The number of swollen and tender joints and the patient and doctor global visual analog scale scores were also significantly different between the two groups. The remission rates based on DAS28 CRP were 30% at one day, 50% at 12 weeks, and 60% at 24 weeks in the K-method group. The EULAR good/moderate response rates were 80% at one day, 90% at 12 weeks, and 90% at 24 weeks in the K-method group; however, these rates were only 10%, 40%, and 40%, respectively, in the control group. No adverse events occurred in either group.CONCLUSIONSimultaneous treatment with biologics and intra-articular injection of TA is useful for cases involving switching of biologics for RA. This strategy is safe and practical for RA treatment.

Allergic rhinitis, chronic rhinosinusitis and nasal polyposis in Asia Pacific: impact on quality of life and sleep.

Allergic rhinitis (AR), often considered to be a trivial health problem, affects up to 20% of the world population and is the most common chronic disease [1]. The importance of AR lies in the fact that it is predominantly associated with bronchial asthma, a disease which affects 300 million patients worldwide [2]. Furthermore, these patients often have associated sinusitis which is now termed as chronic rhinosinusitis (CRS). To compound the problem, patients with CRS are often affected by nasal polyposis (NP) which is now considered as a subgroup since they share the same pathophysiology. Rhinosinusitis and associated NP often go undiagnosed resulting in inappropriate management and suboptimal control [3]. The burden of AR and associated morbidities in the Asia Pacific region is immense as highlighted by the Phase III (1999-2004) of the International Study on Asthma and Allergy in Childhood studies conducted on two age groups of 6-7 and 13-14 years. The prevalence of allergic rhinoconjunctivitis ranged from 3.6% in Indonesia to 24.2% in Taiwan across both age groups [4]. Not only does AR restrict the physical, psychological and social aspects of the patients, this bothersome disease can also impact their functions at work or school. Many quality of life (QoL) studies have highlighted that adult patients were bothered by sleep disturbances, annoying practical problems like having to blow their noses and carrying tissues, and limitations in their daily activities [5,6,7,8]. Adolescents had problems with concentration along with hampering of the process of learning and school performance. Although younger children were less disturbed by emotional dysfunction and disturbances in daily routine, they were more troubled by having to take medications and carrying tissues. Moreover, their parents appeared to be more bothered than the children themselves [9]. Apart from poor quality of sleep, day-time fatigue and sleepiness were often seen in children [10]. A majority of the patients with AR have underlying CRS and NP. Both these inflammatory nasal disorders lead to further impairment in QoL and sleep. Coexistent CRS was found in 63-89% of our adult patients with AR [11,12,13] and 65% of children [14]. When present, CRS added to the morbidity as evidenced by poorer subjective scores. Further, these patients had significant nocturnal sleep disturbances and excessive daytime sleepiness as compared to those without CRS. The QoL too was significantly impaired in this subset of patients when compared to those with AR alone [15]. The presence of NP in patients with AR and CRS further worsens the outcomes. We have demonstrated a significant deterioration in the mean Lund Mackey score, Global Visual Analog Scale score, Sino-Nasal Outcome Test 22 score and QoL scores in AR/CRS patients with NP [13]. Apart from the negative impact on QoL, sleep disturbances are more profound in patients with NP [16]. Even when the presence of NP and CRS in AR is sought for, inadequate treatments, both medical and surgical, along with troublesome adverse effects of the medications add to the problem. In this issue of the Journal, a study from Malaysia surveys the current management practices in AR/CRS and highlights that drowsiness/sedation even with nonsedating antihistamines was the major unmet need [17]. Unfortunately, AR and associated comorbidities do not elicit the importance that these disease complexes deserve, neither from the patient nor from the care givers. The importance of diagnosing and treating CRS and NP cannot be overemphasized especially when a significant proportion of population is afflicted with negative impact on their daily lives, both during the day as well as night [18].

Patient-reported Health-related Quality of Life with Apremilast for Psoriatic Arthritis: A Phase II, Randomized, Controlled Study

Apremilast, a specific inhibitor of phosphodiesterase 4, modulates proinflammatory and antiinflammatory cytokine production. A phase IIb randomized, controlled trial (RCT) evaluated the effect of apremilast on patient-reported outcomes (PRO) in psoriatic arthritis (PsA). In this 12-week RCT, patients with active disease (duration > 6 mo, ≥ 3 swollen and ≥ 3 tender joints) received apremilast (20 mg BID or 40 mg QD) or placebo. PRO included pain and global assessment of disease activity [visual analog scale (VAS)], Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Medical Outcomes Study Short-Form 36 Health Survey (SF-36) assessing health-related quality of life (HRQOL). Percentages of patients reporting improvements ≥ minimum clinically important differences (MCID) and correlations between SF-36 domains and pain VAS, HAQ-DI, and FACIT-F were determined. Among the 204 randomized patients (52.5% men; mean age 50.6 yrs), baseline SF-36 scores reflected large impairments in HRQOL. Apremilast 20 mg BID resulted in statistically significant and clinically meaningful improvements in physical and mental component summary scores and 7 and 6 SF-36 domains, respectively, compared with no change/deterioration in placebo group. Patients receiving apremilast 20 mg BID and 40 mg QD reported significant improvements ≥ MCID in global VAS scores and FACIT-F versus placebo, and significant improvements in pain VAS scores. Moderate-high, significant correlations were evident between SF-36 domains and other PRO. Apremilast resulted in statistically significant and clinically meaningful improvements in HRQOL, pain and global VAS, and FACIT-F scores.

Health outcomes, education, healthcare delivery and quality – 3040. Occurrence and effects of nasal polyps in patients with bronchial asthma and/or allergic rhinitis

This article was originally published online on 23 April 2013 The occurrence of nasal polyps (NP) in bronchial asthma (BA) and/or allergic rhinitis (AR) remains largely undiagnosed and adversely affects quality of life (QoL). The study comprised 220 consecutive patients (males/females, 123/97), 15 to 60 years with BA and/or AR enrolled from outpatients department of VP Chest Institute, University of Delhi. BA/AR was diagnosed according to GINA/ARIA guidelines respectively. Group1 comprised 35 patients with BA, group2, 43 patients with AR and group3, 142 patients with both diseases. CT-PNS, done in all patients, assessed CRS/NP and was scored with Lund Mackey Score (LMS). To assess the effect of NP, asthmatics responded to asthma QoL questionnaire (MiniAQLQ), and the 15-17 years to MiniPAQLQ. Rhinitics responded to rhinoconjunctivitis QoL questionnaire (RQLQ) and the 15-17 years to AdolRQLQ. Patients with nasal symptoms responded to Sinonasal Outcome Test 22 (SNOT 22) and Visual Analogue Scale (VAS). Of the 220 patients, 190(86.4%) had CRS. Of these, 138(72.6%) had NP. CRS was seen in 26/35(74.3%) patients in group1, 38/43(88.4%), in group2 and 126/142(88.7%), in group3. NP was seen in 18/26(69.2%), 30/38(78.9%) and 90/126(71.4%) in groups 1, 2 and 3 respectively. The presence of NP increased mean LMS score from 5 in CRS to 8(P=0.005) in CRS/NP patients. In group2, occurrence of NP increased mean Global VAS score from 5 to 7(P=0.029), SNOT 22 scores from 43 to 44(P=0.029) and in RQLQ scores, activities score rose from 1.7 to 3.1(P=0.007), nasal symptom score from 3.9 to 4.1(P=0.033), non hayfever symptom score from 2.3 to 3.5(P=0.045) and RQLQ overall scores from 2.4 to 3.1(P=0.023). In group3, NP increased mean SNOT 22 scores from 39 to 42(P= 0.002), RQLQ nasal symptom score from 4.2 to 4.4(P=0.001) and RQLQ troubled sleep score from 1.7 to 1.9(P=0.021). There were no significant differences in group1. In all three groups, presence of NP increased mean RQLQ activities score from 3 to 3.3(P=0.033) and RQLQ troubled sleep score from 1.7 to 2(P=0.010). NP was seen in nearly two-third (62.7%) of patients with BA and/or AR. QoL was maximally impaired when AR was complicated with NP followed by patients with both diseases.

Changes in novel biomarkers of disease activity in juvenile and adult dermatomyositis are sensitive biomarkers of disease course

Muscle enzyme levels are insensitive markers of disease activity in juvenile and adult dermatomyositis (DM), especially during the active treatment phase. To improve our ability to monitor DM disease activity longitudinally, especially in the presence of immunomodulating agents, we prospectively evaluated whether interferon (IFN)-dependent peripheral blood gene and chemokine signatures could serve as sensitive and responsive biomarkers for change in disease activity in adult and juvenile DM. Peripheral blood and clinical data were collected from 51 patients with juvenile or adult DM prospectively over 2 study visits. We performed disease activity measurements and calculated whole-blood type I IFN gene and chemokine scores. We also measured serum levels of other proinflammatory cytokines, including interleukin-6 (IL-6). Changes in juvenile and adult DM global disease activity correlated positively and significantly with changes in the type I IFN gene score before adjustment for medication use (r = 0.33, P = 0.023) and with changes in the IFN chemokine score before and after adjustment for medication use (r = 0.53, P < 0.001 and r = 0.50, P < 0.001, respectively). Changes in muscle and extramuscular visual analog scale (VAS) scores correlated positively with changes in IFN gene and chemokine scores (P = 0.002, P < 0.001, P = 0.095, P < 0.001). Serum levels of IL-6, IL-8, and tumor necrosis factor α (TNFα) correlated positively with changes in global, muscle, and extramuscular VAS scores (P < 0.05). Our findings suggest that changes in type I IFN gene and chemokine scores as well as in levels of IL-6, IL-8, and TNFα may serve as sensitive and responsive longitudinal biomarkers of change in disease activity in juvenile and adult DM, even in the presence of immunomodulating agents.

Follistatin-like protein 1 is elevated in systemic autoimmune diseases and correlated with disease activity in patients with rheumatoid arthritis

IntroductionFollistatin-like protein 1 (FSTL1) is a proinflammation mediator implicated in arthritis in rodent animal models. The present study is aimed at assessing FSTL1 levels in systemic autoimmune diseases and correlating them with disease activity in patients with rheumatoid arthritis (RA).MethodsSerum FSTL1 levels from 487 patients with systemic autoimmune diseases and 69 healthy individuals were measured by enzyme-linked immunosorbent assay (ELISA). FSTL1 expression in synovial fluid (SF) and synovial tissues (STs) was determined by ELISA, immunohistochemistry, real-time polymerase chain reaction (RT-PCR) and western blot analysis in RA patients and trauma controls. FSTL1 levels in fibroblast-like synoviocytes (FLSs) from RA patients were determined by real-time PCR and western blot analysis.ResultsSerum FSTL1 levels were significantly elevated in patients with RA, ulcerative colitis, systemic lupus erythematosus, Sjögren's syndrome (SS), systemic sclerosis and polymyositis/dermatomyositis. Serum FSTL1 levels in the RA and secondary SS patients were substantially higher than those in other patients. Serum FSTL1 levels were increased in early RA, rheumatoid factor (RF)- and anti-cyclic citrullinated peptide antibody (ACPA)-negative patients compared to healthy controls. Moreover, serum FSTL1 concentrations were significantly higher in long-standing RA patients than in early RA patients and in the RF- and ACPA-positive RA patients than in RF- and ACPA-negative RA patients. Elevated FSTL1 levels in the STs and SF of RA patients were also observed. FSTL1 levels in serum were markedly higher than those in SF in RA patients. The strongest FSTL1 staining was detected in the cytoplasm of synovial and capillary endothelial cells from RA synovium. Furthermore, FSTL1 was induced in FLSs by inflammatory mediators. Importantly, serum FSTL1 levels were correlated with several important biologic and clinical markers of disease activity, including erythrocyte sedimentation rate, C-reactive protein, RF, ACPA, swollen joint count, patient global visual analogue scale score and Disease Activity Score 28 in the adult RA patient population. Notably, serum FSTL1 levels were significantly diminished following successful treatment and clinical improvement.ConclusionsElevated FSTL1 levels reflect not only joint diseases but also inflammation and tissue degradation in systemic autoimmune diseases. Serum FSTL1 levels may thus serve as a serological inflammatory marker of disease activity in RA patients.

The Role of Anti-Mutated Citrullinated Vimentin Antibodies in the Diagnosis of Early Rheumatoid Arthritis

Anti-mutated citrullinated vimentin (MCV) antibodies have been reported as a fairly sensitive serological marker of rheumatoid arthritis (RA). We evaluated the diagnostic value of anti-MCV in a large cohort of Chinese patients with early RA. One hundred seventy patients with early RA (<1 yr duration), 66 with other rheumatic diseases, 10 with infectious diseases, and 60 healthy individuals were included in our study. Serum anti-MCV and second-generation anti-cyclic citrullinated peptide antibodies (anti-CCP2) were measured by ELISA, and rheumatoid factor (RF) was measured by rate nephelometry. The associated clinical data of patients with early RA were also evaluated. Then disease activity was scored by the formula for Disease Activity Score (DAS)28, and the degree of radiological changes was assessed by Sharp score. The prevalence of serum anti-MCV in patients with early RA (78.2%, 133/170) was significantly higher than that of other rheumatologic patients and patients with infectious diseases. It was 12% (3/25) in systemic lupus erythematosus, 9.5% (2/21) in primary Sjögren's syndrome, 10% (1/10) in systemic sclerosis, 20% (2/10) in ankylosing spondylitis, 12.5% (1/8) in viral hepatitis type B, and 0% (0/2) in tuberculosis. Anti-MCV was not found in the serum of healthy subjects. The sensitivities of anti-MCV, anti-CCP2, and RF tests for early RA were 78.2%, 61.8%, and 72.4%, respectively, and the specificities were 93.4%, 96.3%, and 80.1%. The combination of anti-MCV and anti-CCP2 positivity showed a very high specificity (97.8%) and positive predictive value (97.1%), but a low sensitivity (58.8%). The sensitivity reached 81.2% when the union of anti-MCV and anti-CCP2 positivities was used as one combined criterion. Statistically, anti-MCV had significant correlation with anti-CCP2 (r=0.587, p=0.01, 2-tailed) and RF (r=0.389, p=0.01, 2-tailed). In addition, it had an interesting correlation with radiological assessment (r=0.349, p=0.05, 2-tailed). The anti-MCV had no significant correlation with other factors, such as erythrocyte sedimentation rate, C-reactive protein, antikeratin antibody, antiperinuclear factor, global visual analog scale score for joint pain, IgA, IgG, IgM, C3, C4, hidden rheumatoid factor for IgA (HRFIgA), HRFIgG, and DAS28. Anti-MCV is a novel diagnostic marker for early RA. It may be more useful if the anti-CCP2 assay is performed concomitantly to diagnose patients with early RA.