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ID PMID Title PublicationDate abstract
16898029 A descriptive clinical evaluation of arthroscopic synovectomy in rheumatoid knees: a prosp 2006 Mar OBJECTIVE: To evaluate the clinical outcome of arthroscopic synovectomy for persistent rheumatoid synovitis of the knee joints. DESIGN: Prospective clinical study. SETTING: Kasturba Medical College Hospital, Manipal. PATIENTS: Fifty two knee joints in 46 patients. MEASUREMENTS: The effect of the procedure and its influence in the progression of the disease process on knee joints were assessed in terms of reduction of pain, improvement in range of motion, improvement in functional activity and recurrence of synovitis with effusion. RESULTS: During the average follow up period of 5 years, the patients showed appreciable improvement (90% of knee joints) until 3 years of follow up. At the end of 5 years of follow up, it reduced to about 75%. CONCLUSIONS: Arthroscopic synovectomy along with medical treatment can control the disease process and preserve the knee joint function for up to 3 years.
18065866 [Acromelic arthritis: a new entity]. 2007 Oct PURPOSE OF THE STUDY: Few patients with rheumatoid arthritis present isolated acromelic bone and joint destructions. Concerned joints are wrist, MP, PIP, DIP and forefoot. The aim of the current study is to describe and evaluate the long-term results of wrist, hand and forefoot surgery in an acromelic arthritis group. MATERIAL AND METHODS: 93 patients with acromelic arthritis were included in the study. 202 surgical procedures were performed between 1981 and 2001 in addition to medical treatment. 93 procedures concerned dorsal wrist surgery. The mean follow-up of this group was 7 years (24 months-20 years). 78 synovectomies of radio-carpal and medio-carpal joints with a Sauvé-Kapandji procedure were performed and 10 with a radio-lunate arthrodesis and 5 with other surgeries. The main indication for surgery was severe pain. RESULTS: Functional results and radiographic evolution (Larsen X-ray classification) were studied. All patients were satisfied or very satisfied and pain was significantly reduced. Radiographic lesions progressed but Larsen's stage remained unchanged in 73% of patients. All patients with forefoot surgery recovered total walk autonomy. DISCUSSION: Acromelic arthritis is a particular form of rheumatoid arthritis that progresses very slowly. Surgery should be indicated earlier, for a better joint function stabilisation.
18818102 Usefulness of concomitant biceps tenodesis in total shoulder arthroplasty: a prospective c 2008 Nov The purpose of this report is to assess the association of concomitant biceps tenodesis in total shoulder arthroplasty with treatment success 1 year after total shoulder arthroplasty. Of 136 consecutive shoulders (124 patients) undergoing primary total shoulder arthroplasty between 2003 and 2006, 54 (39.7%) underwent biceps tenodesis. For each patient, we obtained potential preoperative confounding data, such as age; gender; presence of rheumatoid arthritis; Short Form 36; number of previous shoulder operations; Disabilities of the Arm, Shoulder and Hand score; Shoulder Pain and Disability Index score; and insurance status. At the 1-year follow-up, we calculated the Constant score of all patients (ranging from 0 [worst] to 100 [best]). We first determined the crude association of concomitant biceps tenodesis with 1-year treatment success (Constant score > or =80) and then fitted a multivariate model correcting for potential confounders to assess the adjusted association of the biceps tenodesis on treatment success. The total number of treatment successes was 46 of 136 shoulders (33.8% of all prosthesis implantations). The crude association (odds ratio) of a concomitant biceps tenodesis with treatment success was 2.38 (95% confidence interval [CI] 1.15 to 4.93; P = .02). When adjusting for potential confounders, we found that this association slightly increased to 2.97 (95% CI 1.00 to 8.85; P = .05). Concomitant biceps tenodesis appears to have a favorable effect on 1-year treatment success after total shoulder arthroplasty.
16690758 Haplotype analysis revealed no association between the PTPN22 gene and RA in a Japanese po 2006 Nov OBJECTIVE: The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene is a member of the PTPs that negatively regulate T-cell activation. A missense single nucleotide polymorphism (SNP) in the PTPN22 gene known as R620W was recently reported to be associated with several autoimmune diseases including rheumatoid arthritis (RA). The association was confirmed repeatedly in the populations of North European ancestry. However, the SNP was reported to be non-polymorphic in the Asian populations. Because the gene confers an impact on autoimmune diseases, we attempt to explore an association between PTPN22 gene and RA in a Japanese population without restricting to the SNP, R620W. METHODS: We studied 1128 RA patients and 455 controls. In addition to the SNP, R620W, we selected eight testing SNPs spanning 45 kb over the PTPN22 gene using the International HapMap Project. Genotyping was performed using the TaqMan fluorogenic 5' nuclease assay. Associations between RA and each of the SNPs were estimated by the Fisher's exact test. Haplotype was constructed using the expectation-maximization algorithm. RESULTS: R620W was not polymorphic enough in both the patients and the controls, and was therefore excluded from further analysis. Each allele frequency for the eight other SNPs in both groups was compared and no association was detected. Haplotype analysis also revealed that PTPN22 gene was not associated with RA in a Japanese population. CONCLUSION: We found no association between PTPN22 and RA in a Japanese population. The result suggests that the PTPN22 gene is associated with RA only in a specific ethnic group.
18684744 Dose-related patterns of glucocorticoid-induced side effects. 2009 Jul OBJECTIVE: To identify patterns of self-reported health problems relating to dose and duration of glucocorticoid intake in unselected patients with rheumatoid arthritis from routine practice. METHODS: Data from 1066 patients were analysed. The clinical status and drug treatment were reported by the physician, health problems during the past 6 months by the patient using a comprehensive list of symptoms. Patients with ongoing glucocorticoid treatment for more than 6 months and current doses of less than 5, 5-7.5 and over 7.5 mg/day prednisone equivalent were compared with a group without any glucocorticoid treatment for at least 12 months. RESULTS: The frequency of self-reported health problems was lowest in the group without glucocorticoid exposition and increased with dosage. Two distinct dose-related patterns of adverse events were observed. A "linear" rising with increasing dose was found for cushingoid phenotype, ecchymosis, leg oedema, mycosis, parchment-like skin, shortness of breath and sleep disturbance. A "threshold pattern" describing an elevated frequency of events beyond a certain threshold value was observed at dosages of over 7.5 mg/day for glaucoma, depression/listlessness and increase in blood pressure. Dosages of 5 mg/day or more were associated with epistaxis and weight gain. A very low threshold was seen for eye cataract (<5 mg/day). CONCLUSION: The associations found are in agreement with biological mechanisms and clinical observations. As there is a paucity of real-life data on adverse effects of glucocorticoids prescribed to unselected groups of patients, these data may help the clinician to adapt therapy with glucocorticoids accordingly and improve the benefit-risk ratio.
17343249 Indications, complications, and results of shoulder arthroplasty. 2006 Nov OBJECTIVE: To provide estimates of patient outcomes following shoulder arthroplasty using Neer-II type humeral prosthesis and to examine variation in outcomes due to patient and prosthesis characteristics. METHODS: North American and Western European published articles were identified through a computerized literature search and bibliography review. Studies were included if they enrolled 15 or more patients, discriminated between hemi-arthroplasty (HEMI) and total shoulder arthroplasty (TSA) and measured pain relief, gain in range of motion (ROM), radiographic follow-up (> 2 years), short- and long-term complications, and revision surgery. RESULTS: A total of 40 studies satisfied the inclusion criteria. The total number of patients enrolled was 3584. The mean follow-up was 59 months. The mean patient age was 62 years, 65% of patients were women and 73% underwent TSA. All reports showed relevant pain relief, increase in ROM, and high satisfaction rates for HEMI and TSA in both osteoarthritis (OA) and rheumatoid arthritis (RA). The overall rate of revision was 8%. Significant differences between HEMI and TSA for both diagnoses were found for all outcome parameters. CONCLUSION: Shoulder arthroplasty is a safe and effective procedure for OA and RA patients. The diagnosis, shoulder pathology, and prosthesis specifics were significant predictors of outcomes. We therefore emphasize that conclusions on the outcome of shoulder arthroplasty can only be made if differentiated between these patient and prosthesis specifics. Limitations in the reporting style of these articles severely constrain the ability to explore variation in outcomes due to study, patient, or prosthesis characteristics and restrict their generalisability.
16864918 Efficacy and safety of leflunomide alone and in combination with methotrexate in the treat 2006 Aug BACKGROUND: Rheumatoid arthritis patients who develop refractoriness are left with no alternatives other than leflunomide and costly biological response modifiers. Leflunomide, though effective, was associated with adverse events and has not been extensively studied in the Indian population. AIMS: Determination of safety and efficacy of leflunomide alone and if not useful, in combination with methotrexate in patients refractory to conventional disease-modifying agents. SETTING AND DESIGN: Open labeled clinical trial with leflunomide [100 mg, OD x 3 days followed by 20 mg, OD x 6 months], if no improvement at three months, combined with methotrexate [5-7.5 mg, OD x 3 months] at a tertiary care hospital. MATERIALS AND METHODS: The primary endpoint in the improvement in EULAR criteria and secondary endpoints were patient and physician global evaluation, incidence of remission and biochemical and clinical adverse events. STATISTICAL ANALYSIS: Chi square test or Fisher's exact test and parametric and non-parametric repeat measure ANOVA were used for analysis. RESULTS: Among 84 patients who were included in the study, leflunomide showed improvement and remission in 52 [62%] and 6 [7%] in six months, by intention to treat analysis. Adverse events were observed in 15, discontinuation in 5 and 24 dropped out. With combination in 11 patients, there was improvement and remission in nine [91%] and one [9%] after three months. Adverse events were observed in six and one discontinued. CONCLUSIONS: If regular monitoring of hepatic function and hematological parameters are performed, leflunomide is an effective and safe drug in the Indian population in resistant rheumatoid arthritis patients, especially if used alone.
18824582 The Death Receptor 3-TNF-like protein 1A pathway drives adverse bone pathology in inflamma 2008 Oct 27 Rheumatoid arthritis (RA) is a chronic inflammatory disease of synovial joints that is associated with cartilage and bone destruction. Death Receptor 3 (DR3), a tumor necrosis factor (TNF) receptor superfamily member, has recently been associated with the pathogenesis of RA. We demonstrate that absence of DR3 confers resistance to the development of adverse bone pathology in experimental antigen-induced arthritis (AIA). DR3(ko) mice exhibited a reduction in all histopathological hallmarks of AIA but, in particular, failed to develop subchondral bone erosions and were completely protected from this characteristic of AIA. In contrast, TNF-like protein 1A (TL1A), the ligand for DR3, exacerbated disease in a dose- and DR3-dependent fashion. Analysis of osteoclast number within AIA joint revealed a reduction in areas susceptible to bone erosion in DR3(ko) mice, whereas in vitro osteoclastogenesis assays showed that TL1A could directly promote osteoclastogenesis in mouse and man. Treatment with antagonistic anti-TL1A mAb protected animals in a systemic model of RA disease collagen-induced arthritis. We therefore conclude that the DR3-TL1A pathway regulates joint destruction in two murine models of arthritis and represents a potential novel target for therapeutic intervention in inflammatory joint disease.
18840348 [Quality of life of patients with rheumatoid arthritis undergoing out-patient treatment wi 2008 May OBJECTIVE: To assess the quality of life of patients with rheumatoid arthritis undergoing out-patient treatment with TNF inhibitors (etanercept and adalimumab). METHOD: Observational, descriptive and multi-centre study. A specific validated questionnaire was used (QOL-RA Scale) in its Spanish version, with complete confidentiality ensured. To measure the reliability of the results, the Cronbach Alpha Coefficient was used. A descriptive analysis was carried out to compare the results obtained with those obtained from studies in the USA and Colombia. RESULTS: A total of 82 patients were selected who mainly consisted of married housewives who had not undergone any previous studies. The average amount of years from diagnosis was 11.81 years (SD: 7.30) and the average duration of treatment with TNF inhibitors was 1.71 years (SD: 1.03). The results of the questionnaire were: physical ability 5.42 (SD: 1.67), pain 5.10 (SD: 1.83), social life 7.08 (SD: 1.96), support 7.45 (SD: 2.10), mood 6.02 (SD: 2.03), stress 5.50 (SD: 2.01), arthritis 5.15 (SD: 1.86), health 5.50 (SD: 1.77). The results obtained were similar to those from the USA, although they showed a lower score for mood and stress categories. However, the high score in the support and social-life categories was more similar to that obtained with the Colombian questionnaire. All patients considered their quality of life to have improved with the use of TNF inhibitors. CONCLUSIONS: The quality of life in patients with Rheumatoid Arthritis is low, determined by pain and symptoms of depression. The patients believe that TNF inhibitors have improved their quality of life.
19015206 Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheum 2009 Jun BACKGROUND: Tumour necrosis factor alpha (TNFalpha) is a proinflammatory cytokine involved in the pathogenesis of rheumatoid arthritis (RA). Treatment with TNFalpha inhibitors reduces disease activity and improves outcomes for patients with RA. This study evaluated the efficacy and safety of certolizumab pegol 400 mg, a novel, poly-(ethylene glycol) (PEG)ylated, Fc-free TNFalpha inhibitor, as monotherapy in patients with active RA. METHODS: In this 24-week, multicentre, randomised, double-blind, placebo-controlled study, 220 patients previously failing > or =1 disease-modifying antirheumatic drug (DMARD) were randomised 1:1 to receive subcutaneous certolizumab pegol 400 mg (n = 111) or placebo (n = 109) every 4 weeks. The primary endpoint was 20% improvement according to the American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50/70 response, ACR component scores, 28-joint Disease Activity Score Erythrocyte Sedimentation Rate 3 (DAS28(ESR)3), patient-reported outcomes (including physical function, health-related quality of life (HRQoL), pain and fatigue) and safety. RESULTS: At week 24, the ACR20 response rates were 45.5% for certolizumab pegol 400 mg every 4 weeks vs 9.3% for placebo (p<0.001). Differences for certolizumab pegol vs placebo in the ACR20 response were statistically significant as early as week 1 through to week 24 (p<0.001). Significant improvements in ACR50, ACR components, DAS28(ESR)3 and all patient-reported outcomes were also observed early with certolizumab pegol and were sustained throughout the study. Most adverse events were mild or moderate and no deaths or cases of tuberculosis were reported. CONCLUSIONS: Treatment with certolizumab pegol 400 mg monotherapy every 4 weeks effectively reduced the signs and symptoms of active RA in patients previously failing > or =1 DMARD compared with placebo, and demonstrated an acceptable safety profile. TRIAL REGISTRATION NUMBER: NCT00548834.
18316202 Dexamethasone inhibits BAFF expression in fibroblast-like synoviocytes from patients with 2008 May Fibroblast-like synoviocytes (FLS) play a major role in the pathogenesis of rheumatoid arthritis (RA). FLS isolated from patients with RA (FLS-RA) express B cell-activating factor belonging to the TNF family (BAFF), a cytokine that has been associated with the onset and progression of RA. Glucocorticoids are powerful anti-inflammatory drugs used in the treatment of RA. In the present study, we examined the effect of dexamethasone (Dex) on constitutive and TNF-alpha- and IFN-gamma-induced BAFF expression in FLS-RA. BAFF mRNA expression and soluble BAFF were determined by RT-PCR and ELISA, respectively. The results showed that constitutive BAFF mRNA expression was inhibited by Dex in a dose- and time-dependent manner. Also, Dex inhibited the secretion of BAFF in a time-dependent manner reaching 76% of inhibition 72 h after treatment. Moreover, Dex suppressed both mRNA and protein BAFF expression induced by TNF-alpha but had no effect on IFN-gamma-induced BAFF expression. In comparison with B cells cultured alone, B cells co-cultured with FLS-RA exhibited a higher survival, which was inhibited when FLS-RA were pretreated with Dex. However, the enhanced B cell survival was reestablished by the addition of rhBAFF. Therefore, Dex is a potent inhibitor of constitutive and TNF-alpha-induced BAFF expression in FLS-RA.
18174220 The effectiveness and medication costs of three anti-tumour necrosis factor alpha agents i 2008 Sep AIM: to evaluate the effects of adalimumab, etanercept and infliximab on disease activity, functional ability and quality of life and the medication costs in a naturalistic design. METHODS: All patients from the Dutch Rheumatoid Arthritis Monitoring (DREAM) register starting on tumour necrosis factor (TNF)alpha-blocking agents for the first time were monitored and assessed by trained research nurses every 3 months. The primary outcome was the Disease Activity Score (DAS28) course over the 12 months follow-up, analysed by linear mixed models. Secondary outcomes were the Health Assessment Questionnaire (HAQ), EuroQol five dimensions (EQ-5D) and the Short-Form 36 items (SF36) scores, and medication-related total costs. RESULTS: The DAS28 and SF-36 physical component scale decreased in all three medication groups over 12 months, but the decrease was larger for adalimumab and etanercept in comparison to infliximab (p<0.001). The analyses of the HAQ and the EQ-5D scores showed the same (non-significant) trend, namely that at 12 months, the functionality and quality of life was better for adalimumab and etanercept patients. With regard to the medication costs, infliximab treatment resulted in significantly higher costs over the follow-up period than treatments with either adalimumab or etanercept. The comparison between adalimumab and etanercept showed a significant difference in the 12-month DAS28 course (p = 0.031). There were no additional indications for differences in effectiveness or costs between adalimumab and etanercept. CONCLUSION: The evaluation of the effectiveness and costs showed that adalimumab and etanercept are more or less equal and favourable compared to infliximab in the first year of treatment.
18491481 Interstitial granulomatous dermatitis in a patient with rheumatoid arthritis on etanercept 2008 Apr Tumor necrosis factor-alpha (TNF-alpha) has been implicated in the pathogenesis of numerous inflammatory conditions, possibly facilitating the induction and maintenance of these diseases through lymphocyte activation and cytokine production. Inhibitors of TNF-alpha have proven efficacious in the treatment of autoimmune diseases such as psoriasis, rheumatoid arthritis, inflammatory bowel disease, and lymphoproliferative disorders. However, recent cases of adverse cutaneous reactions have been reported in anti-TNF-alpha therapy, most notably those of granulomatous morphology. We report a patient with rheumatoid arthritis who had been treated with etanercept (50 mg/wk) for 6.5 years. The patient subsequently developed pink and red papules on large areas of the upper and lower extremities. Skin biopsy specimens revealed both poorly formed and well-circumscribed nonnecrotizing epithelioid granulomas in the superficial dermis. Application of clobetasol propionate ointment 0.05% without discontinuation of anti-TNF-alpha therapy led to complete resolution of the skin lesions. While the precise mechanisms of physiologic and pathologic TNF activity remain to be determined, it is clear that granulomatous lesions may emerge as a complication of anti-TNF-alpha therapy. Treatment with topical corticosteroids may be sufficient to eliminate such lesions.
18775493 Role of B cells in systemic lupus erythematosus and rheumatoid arthritis. 2008 Dec B cell tolerance to many self-proteins is actively maintained by either purging self-reactive B receptors through clonal deletion and receptor editing, or by functional silencing known as anergy. However, these processes are clearly incomplete as B cell driven autoimmune diseases still occur. The significance of B cells in two such diseases, rheumatoid arthritis and systemic lupus erythematosus, is highlighted by the ameliorative effects of B cell depletion. It remains to be determined, however, whether the key role of the B cell in autoimmune disease is autoantibody production or another antibody-independent function.
17117492 Risk factors for surgical site infections and other complications in elective surgery in p 2007 Apr OBJECTIVE: To identify risk factors for surgical site infection (SSI) in patients with rheumatoid arthritis (RA) with special attention for anti-tumor necrosis factor (anti-TNF) treatment. METHODS: All patients with RA who had undergone elective orthopedic surgery since introduction of anti-TNF were included in a retrospective parallel-cohort study with a one-year followup. Primary endpoint was a SSI according to the 1992 Centers for Disease Control and Prevention criteria and/or antibiotic use. Cohort 1 did not use anti-TNF, cohort 2 used anti-TNF but had either stopped (2A) or continued anti-TNF preoperatively (2B), the cutoff point being set at 4 times the half-life time of the drug. Infection rates were compared between cohorts, and logistic regression analysis was performed to examine risk factors. RESULTS: In total, 1219 (768 patients) procedures were included, and crude infection risks were 4.0% (41/1023), 5.8% (6/104), and 8.7% (8/92) in cohorts 1, 2A, and 2B, respectively. Elbow surgery (OR 4.1, 95% CI 1.6-10.1), foot/ankle surgery (OR 3.2, 95% CI 1.6-6.5), and prior skin or wound infection (OR 13.8, 95% CI 5.2-36.7) were associated with increased risk of SSI, whereas duration of surgery (OR 0.42, 95% CI 0.23-0.78) and sulfasalazine use (OR 0.21, 95% CI 0.05-0.89) were associated with decreased risk. Perioperative use of anti-TNF was not significantly associated with an increase in SSI rates (OR 1.5, 95% CI 0.43-5.2). CONCLUSION: The most important risk factor for SSI is history of SSI or skin infection. Although our study was not powered to detect small differences in infection rates, perioperative continuation of anti-TNF does not seem to be an important risk factor for SSI.
18762943 Adalimumab-induced noncaseating granuloma in the bone marrow of a patient being treated fo 2009 Feb Sarcoidosis is a multisystemic disease characterized by noncaseating granulomatous infiltration, primarily of the lungs and lymphatic system. While reports of the efficacy of adalimumab in the treatment of refractory sarcoidosis have been mixed, the more widely used infliximab has demonstrated clear efficacy in this disease. The association between tumor necrosis factor (TNF)-inhibitors and noncaseating granulomas in the lung has been reported in literature. With the exception of one patient treated with adalimumab, who developed pulmonary granuloma, the remaining patients described in literature were treated with etanercept. The current case study is, to our knowledge, the first to describe adalimumab-induced noncaseating granulomas in the bone marrow of a patient being treated for rheumatoid arthritis and suggests that although TNF-inhibitors are used in the treatment of granulomatous disorders, their use should be carefully monitored as, in rare cases, TNF-inhibitors may leave sufficient cytokine activation to support granuloma formation.
19024068 [Aggressive non-Hodgkin lymphoma in 3 patients with rheumatoid arthritis: discontinue the 2008 Oct 25 3 female patients who were being treated with methotrexate developed a non-Hodgkin lymphoma. The first patient, 67 years old, presented with an enlarged thyroid gland. The cytological punction was inconclusive and an open biopsy revealed a B cell non-Hodgkin lymphoma, which was localised. A week before the biopsy the methotrexate was discontinued. The patient herself reported that the swelling of her thyroid gland was diminished after cessation of methotrexate. The lymphoma showed a complete remission without chemotherapy being given. The second patient, a 78-year-old woman, developed a non-Hodgkin lymphoma in one of her tonsils that showed a partial remission after withdrawal of the methotrexate therapy. The third patient, a 66-year-old woman, presented herself with a pulmonary non-Hodgkin lymphoma. In this patient withdrawal of the methotrexate resulted in a complete remission of the non-Hodgkin lymphoma as well. Although no epidemiological study has shown an increased risk of lymphoproliferative disorders during the use of methotrexate, these spontaneous remissions suggest an aetiological link. If a non-Hodgkin lymphoma develops in a patient being treated with methotrexate then the therapy should be discontinued and chemotherapy should not be given straightaway.
17984582 [Analysis of clinical significance of anti-cyclic citrullinated peptide antibody (anti-CCP 2007 Oct OBJECTIVE: To examine clinical significance of anti-cyclic citrullinated peptide antibody (anti-CCP antibody) in RA. METHODS: Hundred fifteen patients with polyarthralgia (89 females, 26 males) were recruited, and subjected for the study. We studied anti-CCP antibody, ESR, CRP, IgM-RF, IgG-RF, RAPA, MMP-3, CARF, C1q-IC, Stage, Class, Joint score, Sharp score, KL-6, SP-D, chest CT. RESULTS: Anti-CCP antibody test had high specificity (93.5%). In RA with positive anti-CCP antibody, Sharp score (10.9+/-22.4) was higher than those with negative anti-CCP (1.7+/-1.8), and may serve as a prognostic marker of joint destruction (P<0.05). Anti-CCP antibody in RA with interstitial pneumonia is higher (84.5+/-36.4 U/mL) than those without interstitial pneumonia (52.6+/-44.7 U/mL) (P<0.05). CONCLUSION: Anti-CCP antibody is useful for diagnosis of RA, and could be a specific marker of joint destruction. Further investigation is necessary to clarify the relation of anti-CCP antibody with organ involvement and activity of RA.
16877461 A clinical trial of specialist footwear for patients with rheumatoid arthritis. 2007 Feb OBJECTIVES: The structural and functional changes in the RA foot often affect the patient's gait and mobility, impacting on the patient's quality of life. Successful management of these foot pathologies and resultant problems can involve the provision of specialist therapeutic footwear. The aim of the study was to evaluate the value of a new footwear design based on patients' opinions compared with a traditional footwear design. METHOD: A total of 80 patients with RA of 5 yrs or more duration, foot deformity, difficulty in being able to obtain suitable retail footwear and self-reported foot pain were recruited. Patients were randomly assigned to either an intervention group (new design) or the control group (traditional design). Patients completed two specific health-related quality of life scales (Foot Health Status Questionnaire and the Foot Function Index) at baseline and after 12 weeks. RESULTS: Only 36 patients completed the trial. Ten refused the footwear outright and 34 withdrew from the study after the footwear was supplied, due to either non-footwear related problems or reasons related to the footwear. Both the specific health-related quality of life scales demonstrated significant improvement from baseline to week 12 with the intervention group (P < 0.05). There was no significant difference in both specific health-related quality of life scales after week 12 with the traditional group (P > 0.05). CONCLUSIONS: Improvement in pain and patient satisfaction with the new design of footwear for patients with RA over the traditional design indicates the importance of patient involvement in the design process and throughout the process of supplying and monitoring the footwear. The fact that the new-design shoe was based on patients' involvement in the design process in a previous study may be the most important factor in its success. In order to meet the clinical goals of this footwear the patients need to wear them, and to achieve this the patients' requirements need to be acknowledged.
17241662 Indirect immunofluorescent assay for antinuclear antibodies on McCoy-Plovdiv serum-free ce 2007 May Indirect immunofluorescent assay for antinuclear antibodies (IIFA-ANA) on HEp-2 cell substrate is a widely used test for diagnosis of connective tissue diseases. Recently, serum-free fibroblast cell line McCoy-Plovdiv has been developed to provide an alternative substrate. The aim of the present study was to evaluate the diagnostic performance of IIFA-ANA on McCoy-Plovdiv cell substrate for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) and compare it with that of the standard HEp-2 cell substrate. Sera from 72 patients with RA and 23 patients with SLE were tested with IIFA-ANA on both substrates. The control group consisted of 100 sera from healthy individuals. The agreement (Cohen's kappa) and the diagnostic performance (ROC analysis) of both methods were evaluated. IIFA-ANA on McCoy-Plovdiv cells proved to be comparable with the standard IIFA-ANA on HEp-2 cell substrate.