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The authors propose a solution to reporting response in rheumatoid arthritis (RA) clinical trials. They consider the success of the American College of Rheumatology (ACR) criteria for 20% improvement in RA disease activity (ACR20) in organizing trial reports and paving interpretation of trial data to direct patient experience. Problems with the classic type of data presentation are discussed. A discussion on the components of the proposed solution is detailed.

The author highlights growing interest of patient reported outcome's use in rheumatoid arthritis (RA) clinical trials and in clinical practice. He discusses several studies that determine differences between patient's and physician's assessments of disease activity, and factors that influence the two measures. It also highlights that a patient's global assessment of ≤1 on a scale of 0-10 is needed as per Boolean remission criteria of the new The American College of Rheumatology (ACR/EULAR).

A letter to the editor is presented in response to the article in the previous issue on the cost-utility analysis of the BeSt (behandelstrategietrialën voor reumatoide artritis) trial.

A letter to the editor is presented in response to the article "How antirheumatic drugs protect joints from damage in rheumatoid arthritis," by Schett and colleagues.

The author reflects on the pathophysiogical aspects of rheumatoid arthritis (RA). He challenges the traditional view of the disease and argues on the unnecessary view of J. R. Kirwan on split and on the intriguing details of the study by A. K. Brown. He views that subclinical joint information shown by ultrasound and magnetic resonance imaging (MRI) best explains the structural deterioration of RA patients.

The author talks about the study conducted to evaluate the effectiveness of spleen tyrosine kinase (Syk) in the suppression of rheumatoid arthritis (RA). The data collected from a 3-month methotrexate (MTX) failure trial suggested the ineffectiveness of fostamatinib in patients with relatively treatment-resistant disease. According to the author, the findings suggest that Syk kinase inhibition with fostamatinib is unreliable.

A letter to the editor in response to the article "Infliximab and Methotrexate As Induction Therapy in Patients With Early Rheumatoid Arthritis" in a 2007 issue and a response by A. E. van der Bijl et al. to the letter are presented.

Objective: We developed a smartphone application for patients with rheumatoid arthritis (RA) that allows them to self‐monitor their disease activity in between clinic visits by answering a weekly Routine Assessment of Patient Index Data 3. This study was undertaken to assess the safety (noninferiority in the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28‐ESR]) and efficacy (reduction in number of visits) of patient‐initiated care assisted using a smartphone app, compared to usual care. Methods: A 12‐month, randomized, noninferiority clinical trial was conducted in RA patients with low disease activity and without treatment changes in the past 6 months. Patients were randomized 1:1 to either app‐supported patient‐initiated care with a scheduled follow‐up consultation after a year (app intervention group) or usual care. The coprimary outcome measures were noninferiority in terms of change in DAS28‐ESR score after 12 months and the ratio of the mean number of consultations with rheumatologists between the groups. The noninferiority limit was 0.5 difference in DAS28‐ESR between the groups. Results: Of the 103 randomized patients, 102 completed the study. After a year, noninferiority in terms of the DAS28‐ESR score was established, as the 95% confidence interval (95% CI) of the mean ΔDAS28‐ESR between the groups was within the noninferiority limit: −0.04 in favor of the app intervention group (95% CI −0.39, 0.30). The number of rheumatologist consultations was significantly lower in the app intervention group compared to the usual care group (mean ± SD 1.7 ± 1.8 versus 2.8 ± 1.4; visit ratio 0.62 [95% CI 0.47, 0.81]). Conclusion: Patient‐initiated care supported by smartphone self‐monitoring was noninferior to usual care in terms of the ΔDAS28‐ESR and led to a 38% reduction in rheumatologist consultations in RA patients with stable low disease activity. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article regarding the changes in the laboratory network of the Animal Health and Veterinary Laboratories Agency (AHVLA).

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema ( HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research. [ABSTRACT FROM AUTHOR]

Little is known about the effects of cumulative trauma and whether traumatized individuals are more vulnerable. In 2000, a fireworks disaster created the possibility to examine this issue among World WarII survivors who were part of an ongoing longitudinal study. Between 1998 and 2000 posttraumatic stress increased in disaster exposed respondents as opposed to the control group. War-related reexperiencing and avoidance also increased. The strongest increase occurred in disaster-exposed respondents who had low levels of wartime stress and a slight decrease occurred in those who had high wartime exposure. This unique controlled observation suggests that disasters do increase the levels of posttraumatic stress, and that reactivation of previous traumatic events generally occurs. However, the vulnerability hypothesis was not supported. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To identify barriers and solutions for the recruitment and retention of older (aged ≥65 years) people in clinical trials. DESIGN: Systematic literature review. METHODS: Three databases (Medline, Embase, and CENTRAL) were searched for articles reporting on barriers or solutions regarding the recruitment or retention of older people. Only original research articles were included. RESULTS: Fifty eligible articles were identified. Exclusion criteria were the most common cause of poor recruitment of older adults (mainly age and comorbidities). Patients' families or physicians often advised against participation (22% of included studies). Lack of interest (18%) and problems with transportation (18%) were also commonly cited as challenges. Fourteen trials (28%) reported that monitoring and adapting their recruitment methods helped, along with a flexible research team (26%) and provision of transportation (24%). Retention was impaired by death (12%), illness (8%), and loss of interest (6%). Methods with a positive effect on retention included financial incentives and regular information about the progress of the study (12%), a low staff turnover (12%), flexibility in appointment making (10%), and expression of appreciation by the staff through letters, gifts, and cards to the participants (10%). CONCLUSION: We identified several barriers and have listed potential solutions that may improve recruitment and lead to fewer dropouts in trials involving older populations. Implementation of our findings may help mitigate the manifold challenges that come with running a trial with older people. See related editorial by Robison et al. in this issue. [ABSTRACT FROM AUTHOR]

Objective To compare rates of sustained low and minimal disease activity and remission according to the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria during 3-year followup in rheumatoid arthritis (RA) patients treated with etanercept and adalimumab in routine care. Methods Four hundred seven RA patients previously unexposed to tumor necrosis factor antagonists were treated with etanercept (n = 203) or adalimumab (n = 204) and assessed at 3- and later 6-month intervals. Treatment allocation was at the discretion of the treating rheumatologist. Clinical parameters were measured at each time point, as were anti-adalimumab antibodies in adalimumab-treated patients. Achievement of clinical outcome was defined as the occurrence of sustained (at least 12 consecutive months) low disease activity (28-joint Disease Activity Score [DAS28] <3.2), minimal disease activity (DAS28 <2.6), or ACR/EULAR remission based on the Simplified Disease Activity Index (SDAI). Non-overlapping response rates were calculated. Results Among the adalimumab group, 13% reached sustained low disease activity but not sustained minimal disease activity, 15% reached sustained minimal disease activity but not sustained remission according to the SDAI, and 16% reached sustained ACR/EULAR remission. In the etanercept group the corresponding rates were 16%, 11%, and 12%, respectively ( P = 0.42, overall test for linear trend). Adalimumab-treated patients without anti-adalimumab antibodies (n = 150 [74%]) had the best outcomes, and adalimumab-treated patients with anti-adalimumab antibodies the worst, with outcomes in etanercept-treated patients in between ( P < 0.0001). Differences were most apparent in the sustained SDAI remission and sustained minimal disease activity categories. For example, 40% of anti-adalimumab antibody-negative patients, 23% of etanercept-treated patients, and 4% of anti-adalimumab antibody-positive patients achieved at least sustained minimal disease activity. Conclusion Overall, etanercept and adalimumab treatment appear similar in inducing a good long-term clinical outcome. However, in the case of adalimumab this is strongly dependent on the presence or absence of anti-adalimumab antibodies. [ABSTRACT FROM AUTHOR]

Objective To evaluate the effects of oral nonsteroidal antiinflammatory drugs (NSAIDs) on C-reactive protein (CRP) levels in rheumatoid arthritis (RA) patients, with a prespecified focus on the different NSAIDs. Methods We performed a systematic search in Medline via PubMed, the Cochrane Central Register of Controlled Trials, EMBase via OVID, the Institute for Scientific Information Web of Science, and other sources. Eligible trials were parallel-group, randomized, placebo-controlled trials of oral NSAID therapy in RA patients for which there were extractable CRP data. Standardized mean differences (SMDs) with 95% confidence intervals (95% CIs) were calculated from the differences in means of CRP levels between groups (active treatment minus placebo) divided by the pooled SDs. For the meta-analysis, a random-effects model was used to estimate the overall change in CRP level, and stratified analysis was used to examine differences among NSAIDs. Results We included 19 trials of 10 different NSAIDs. Overall, NSAIDs showed no effect on the CRP level (SMD 0.01 [95% CI −0.03, 0.06], P = 0.62). However, the prespecified stratified analysis indicated varying effects on the CRP level according to the different NSAIDs; lumiracoxib caused a statistically significant and consistent (I2 = 0%) increase in the CRP level (SMD 0.13 [95% CI 0.01, 0.25], P = 0.037), whereas naproxen caused a statistically significant and consistent (I2 = 0%) decrease in the CRP level (SMD −0.11 [95% CI −0.20, −0.02], P = 0.022). Conclusion Overall, NSAIDs have no effect on the CRP level. However, the nonselective NSAID naproxen was associated with a significant decrease in the CRP level, whereas the cyclooxygenase 2-selective NSAID lumiracoxib was associated with a significant increase in the CRP level. This finding is interesting considering the suspected influence of NSAIDs on cardiovascular complications. [ABSTRACT FROM AUTHOR]

The article presents a study which examines the effects and safety of selective estrogen receptor α (ERα) agonist Org 37663 in rheumatoid arthritis (RA) patients. It states that a 10-week, randomized, and proof-of-concept trial was initiated in RA postmenopausal female patients who receive background treatment with methotrexate or sulfasalazine. The results showed that Org 37663 was safe and well tolerated, but was not effective in influencing the disease activity in RA patients.

The author comments on getting patients involved in their rheumatology experience. Topics covered include the important role of clinicians in educating patients regarding how to effectively manage their health conditions. Also mentioned is the need for clinicians to help their patients understand the effects of inflammatory arthritis.

The article discusses the study on the association of rheumatoid arthritis (RA) with an increased risk of cardiovascular disease (CVD). It reveals that the incidence of CVD in patients with RA was nine percent and 4.3 percent in the general population. It is concluded that there is an increased risk of CVD in RA that is equivalent to the risk for CVD in type 2 diabetes mellitus (DM).

Background: Helicobacter pylori and nonsteroidal antiinflammatory drugs (NSAIDs) are the major causes of gastroduodenal ulcers. Studies on the benefit of eradication of H. pylori in NSAID users yielded conflicting results. Objective: To investigate whether H. pylori eradication in patients on long-term NSAIDs reduces the incidence of gastroduodenal ulcers. Methods: Patients on long-term NSAID treatment and who are H. pylori positive on serologic testing, were randomly assigned to either H. pylori eradication (omeprazole, amoxicillin, and clarithromycin) or placebo. Primary endpoint was the presence of endoscopic gastric or duodenal ulcers 3 months after randomization. Results: One hundred sixty-five (48%) of a total of 347 patients were on gastroprotective medication. At endoscopy, gastroduodenal ulcers were diagnosed in 6 (4%) and 8 (5%) patients in the eradication and placebo group, respectively ( p = .65). During follow-up of 12 months, no symptomatic ulcers or ulcer complications developed. No significant differences were found in the development of gastroduodenal erosions, dyspepsia, or in quality of life. Conclusion: H. pylori eradication therapy in patients on long-term NSAID treatment had no beneficial effect on the occurrence of ulcers, erosions, or dyspepsia. Ulcer rates in both study arms are remarkably low, in both patients with and without gastroprotective therapy. [ABSTRACT FROM AUTHOR]