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OBJECTIVES: Frailty is a common geriatric syndrome and is characterised by a decreased physiological reserve and increased vulnerability to stressors. Pre-frailty is a risk-state before frailty. A systematic literature review (SLR) and meta-analysis was conducted to: (1) estimate the prevalence of (pre-)frailty in RA patients; (2) explore whether variation in instruments influences (pre-)frailty prevalence.METHODS: An SLR for the period 2001-2021 was undertaken. All studies (including conference abstracts) that reported on the prevalence of (pre)-frailty in patients with RA were included. Assessment of risk of bias, data extraction and data synthesis were performed by two reviewers independently. A meta-analysis was conducted for studies that used the most commonly accepted frailty instrument (Fried criteria), by obtaining pooled estimates of (pre-) frailty prevalences by random effects models.RESULTS: 25/1,363 studies were included in the SLR. Weighted average age was 58.0 years. Pre-frailty prevalence rates ranged between 20.4%-71% (median: 35.8%); for frailty, rates between 1.2%-75.1% (median: 23.1%) were found. The meta-analysis (Fried criteria), showed a pooled prevalence of 52.8% (95%-CI=42.7-62.8; I2=99%) for pre-frailty and 24.0% (95%-CI= 19.4-28.6; I2=96%) for frailty. (Pre-)frailty was highly prevalent in all age groups. Prevalence was generally higher when the frailty instrument also included psychological and social domains, as compared to instruments that solely focused on the physical domain.CONCLUSIONS: (Pre-)frailty is common in RA patients. Large part of the variation is explained by clinical and methodological heterogeneity. High-quality studies with validated frailty instruments specifically for RA patients are needed.

ObjectiveTo update the evidence on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2022 update of the Assessment of SpondyloArthritis international Society/European Alliance of Associations for Rheumatology (ASAS-EULAR) recommendations for the management of axSpA.MethodsSystematic literature review (2016–2021) on efficacy and safety of bDMARDs in axSpA (radiographic axSpA (r-axSpA)/non-radiographic axSpA (nr-axSpA)). Eligible study designs included randomised controlled trials (RCTs), strategy trials and observational studies (the latter only for safety and extra-musculoskeletal manifestations). All relevant efficacy/safety outcomes were included.ResultsIn total, 148 publications were included. Efficacy of golimumab and certolizumab was confirmed. Tumour necrosis factor inhibitor (TNFi) biosimilar-originator equivalence was demonstrated. RCT (n=15) data on efficacy of interleukin-17 inhibitors (IL-17i) demonstrated clinically relevant effects (risk ratio vs placebo to achieve ASAS40 response 1.3–15.3 (r-axSpA, n=9), 1.4–2.1 (nr-axSpA, n=2)). Efficacy of secukinumab/ixekizumab was demonstrated in TNFi-naïve and TNFi-inadequate responders. IL-23 and IL-12/23 inhibitors (risankizumab/ustekinumab) failed to show relevant benefits. Tapering of TNFi by spacing was non-inferior to standard-dose treatment. The first axSpA treat-to-target trial did not meet its primary endpoint, but showed improvements in secondary outcomes. No new risks were identified with TNFi use in observational studies (data lacking for IL-17i). Secukinumab (n=1) and etanercept (n=2) were associated with increased risk of uveitis in observational studies compared to monoclonal TNFi.ConclusionsNew evidence supports the efficacy and safety of TNFi (originators/biosimilars) and IL-17i in r-axSpA and nr-axSpA, while IL-23i failed to show relevant effects. Observational studies are needed to confirm long-term IL-17i safety.PROSPERO registration numberCRD42021257588

ObjectiveTo update the evidence of non-biological treatments for axial spondyloarthritis (axSpA), as a basis for the 2022 Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology (ASAS-EULAR) recommendations for the management of axSpA.MethodsA systematic literature review (2016–2021) on efficacy and safety of non-pharmacological and non-biological pharmacological treatments was performed, up to 1 January 2022. The research question was formulated according to the PICO format: Population: adult patients with r-axSpA and nr-axSpA; Intervention: non-pharmacological and non-biological pharmacological treatments; Comparator: active comparator or placebo; Outcomes: all relevant efficacy and safety outcomes. Type of studies included were: randomised controlled trials (RCTs), observational studies (for efficacy of non-pharmacological treatments, and safety), qualitative studies. Cohen’s effect size (ES) was calculated for non-pharmacological and risk ratio (RR) for pharmacological treatments.ResultsOf 107 publications included, 63 addressed non-pharmacological interventions, including education (n=8) and exercise (n=20). The ES for education on disease activity, function, mobility was small to moderate (eg. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ES: 0.06–0.59). Exercise had moderate to high ES on these outcomes (eg. BASDAI, ES: 0.14–1.43). Six RCTs on targeted synthetic disease-modifying antirheumatic drugs (DMARDs) showed efficacy of tofacitinib, upadacitinib and filgotinib (phase 2 only) in r-axSpA (range RR vs placebo for ASAS20: 1.91–3.10), while apremilast and nilotinib were not efficacious. Studies on conventional synthetic DMARDs (n=3), non-steroidal anti-inflammatory drugs (NSAIDs, n=8) and other drugs (n=12) did not provide new evidence on efficacy/safety (efficacy of NSAIDs confirmed; limited efficacy of short-term glucocorticoids in one RCT).ConclusionsEducation, exercise and NSAIDs confirmed to be efficacious in axSpA. JAKi were proved efficacious in r-axSpA.

AIM: To identify all possible definitions of "early SpA" employed in the literature, including "early axial SpA (axSpA)" and "early peripheral SpA (pSpA)". METHODS: A systematic literature review was conducted in Medline, EMBASE and the Cochrane Library for studies that included any mention of "early SpA" or its subtypes. The proportion of studies including a definition was calculated, and the different definitions were assessed. RESULTS: Out of 9651 titles identified, 336 publications reporting data from 183 studies were included. Over time, an increasing number of publications were identified. In total, 114 (62%) studies reported a specific definition: 33% of them based it on symptom duration, 31% on radiographic damage, 28% on disease duration, 5% on both symptom/disease duration and radiographic damage, and 3% on other aspects. Overall, 61 (33%) studies included the term "early axSpA", whereas 60 (33%) included "early ankylosing spondylitis (AS)". Regarding the studies that referred to "early axSpA", the most used definition was symptom/disease duration

ObjectiveTo summarise the methodological aspects in studies with work participation (WP) as outcome domain in inflammatory arthritis (IA) and other chronic diseases.MethodsTwo systematic literature reviews (SLRs) were conducted in key electronic databases (2014–2019): search 1 focused on longitudinal prospective studies in IA and search 2 on SLRs in other chronic diseases. Two reviewers independently identified eligible studies and extracted data covering pre-defined methodological areas.ResultsIn total, 58 studies in IA (22 randomised controlled trials, 36 longitudinal observational studies) and 24 SLRs in other chronic diseases were included. WP was the primary outcome in 26/58 (45%) studies. The methodological aspects least accounted for in IA studies were as follows (proportions of studies positively adhering to the topic are shown): aligning the studied population (16/58 (28%)) and sample size calculation (8/58 (14%)) with the work-related study objective; attribution of WP to overall health (28/58 (48%)); accounting for skewness of presenteeism/sick leave (10/52 (19%)); accounting for work-related contextual factors (25/58 (43%)); reporting attrition and its reasons (1/58 (2%)); reporting both aggregated results and proportions of individuals reaching predefined meaningful change or state (11/58 (16%)). SLRs in other chronic diseases confirmed heterogeneity and methodological flaws identified in IA studies without identifying new issues.ConclusionHigh methodological heterogeneity was observed in studies with WP as outcome domain. Consensus around various methodological aspects specific to WP studies is needed to improve quality of future studies. This review informs the EULAR Points to Consider for conducting and reporting studies with WP as an outcome in IA.

ObjectiveTo perform an update of a review of the efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) in psoriatic arthritis (PsA).MethodsThis is a systematic literature research of 2015–2018 publications on all DMARDs in patients with PsA, searching Medline, Embase and the Cochrane Library. Efficacy was assessed in randomised controlled trials. For safety, cohort studies, case–control studies and long-term extensions (LTEs) were analysed.Results56 publications (efficacy: n=33; safety n=23) were analysed. The articles were on tumour necrosis factor (TNF) inhibitors (n=6; golimumab, etanercept and biosimilars), interleukin (IL)-17A inhibitors (n=10; ixekizumab, secukinumab), IL-23-p19 inhibitors (n=2; guselkumab, risankizumab), clazakizumab (IL-6 inhibitor), abatacept (CD80/86 inhibitor) and ABT-122 (anti-TNF/IL-17A), respectively. One study compared ustekinumab (IL-12/23i) with TNF inhibitor therapy in patients with entheseal disease. Three articles investigated DMARD tapering. Trials on targeted synthetic DMARDs investigated apremilast (phosphodiesterase-4 inhibitor) and Janus kinase inhibitors (JAKi; tofacitinib, filgotinib). Biosimilar comparison with bio-originator showed non-inferiority. Safety was evaluated in 13 LTEs, 9 cohort studies and 1 case–control study investigating malignancies, infections, infusion reactions, multiple sclerosis and major cardiovascular events, as well as efficacy and safety of vaccination. No new safety signals were identified; however, warnings on the risk of venous thromboembolic events including pulmonary embolism when using JAKi were issued by regulators based on other studies.ConclusionMany drugs in PsA are available and have demonstrated efficacy against placebo. Efficacy varies across PsA manifestations. Safety must also be taken into account. This review informed the development of the European League Against Rheumatism 2019 updated PsA management recommendations.

ObjectivesTo perform a systematic literature review (SLR) concerning the safety of synthetic (s) and biological (b) disease-modifying anti rheumatic dugs (DMARDs) to inform the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis (RA).MethodsAn SLR of observational studies comparing safety outcomes of any DMARD with another intervention for the management of RA. A comparator group was required for inclusion. For treatments still without registry data (eg, sarilumab and the Janus kinase (JAK) inhibitors baricitinib, upadacitinib), randomised controlled trials (RCTs) and long-term extensions (LTEs) were used. Risk of bias (RoB) was assessed according to standard procedures.ResultsForty-two observational studies fulfilled the inclusion criteria, addressing safety outcomes with bDMARDs and sDMARDs. Nine studies showed no difference in the risk of serious infections across bDMARDs and two studies (high RoB) showed an increased risk with bDMARDs compared with conventional synthetic (cs) DMARDs (adjusted incidence rate ratio 3.1–3.9). The risk of Herpes zoster infection was similar across bDMARDs, but one study showed an increased risk with tofacitinib compared with abatacept (adjusted HR (aHR) 2.0). Five studies showed no increased risk of cancer for bDMARDs compared with csDMARDs. An increased risk of lower intestinal perforation was found for tocilizumab compared with csDMARDs (aHR 4.5) and tumour necrosis factor inhibitor (TNFi) (aHR 2.6–4.0). Sixty manuscripts reported safety data from RCTs/LTEs. Overall, no unexpected safety outcomes were found, except for the possibly increased risk of venous thromboembolism (VTE) with JAK inhibitors.ConclusionData obtained by this SLR confirm the known safety profile of bDMARDs. The risk of VTE in RA, especially in patients on JAK inhibitors, needs further evaluation.

ObjectivesTo inform the 2019 update of the European League against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA).MethodsA systematic literature research (SLR) to investigate the efficacy of any disease-modifying antirheumatic drug (DMARD) (conventional synthetic (cs)DMARD, biological (b) and biosimilar DMARD, targeted synthetic (ts)DMARD) or glucocorticoid (GC) therapy in patients with RA was done by searching MEDLINE, Embase and the Cochrane Library for articles published between 2016 and 8 March 2019.Results234 abstracts were selected for detailed assessment, with 136 finally included. They comprised the efficacy of bDMARDs versus placebo or other bDMARDs, efficacy of Janus kinase (JAK) inhibitors (JAKi) across different patient populations and head-to-head of different bDMARDs versus JAKi or other bDMARDs. Switching of bDMARDs to other bDMARDs or tsDMARDs, strategic trials and tapering studies of bDMARDs, csDMARDs and JAKi were assessed. The drugs evaluated included abatacept, adalimumab, ABT-122, baricitinib, certolizumab pegol, SBI-087, CNTO6785, decernotinib, etanercept, filgotinib, golimumab, GCs, GS-9876, guselkumab, hydroxychloroquine, infliximab, leflunomide, mavrilimumab, methotrexate, olokizumab, otilimab, peficitinib, rituximab, sarilumab, salazopyrine, secukinumab, sirukumab, tacrolimus, tocilizumab, tofacitinib, tregalizumab, upadacitinib, ustekinumab and vobarilizumab. The efficacy of many bDMARDs and tsDMARDs was shown. Switching to another tumour necrosis factor inhibitor (TNFi) or non-TNFi bDMARDs after TNFi treatment failure is efficacious. Tapering of DMARDs is possible in patients achieving long-standing stringent clinical remission; in patients with residual disease activity (including patients in LDA) the risk of flares is increased during the tapering. Biosimilars are non-inferior to their reference products.ConclusionThis SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR’s RA management recommendation.

Adherence to chronic disease medication regimens depends in part on successful self-regulation. However, the overall benefit of interventions targeting self-regulatory mechanisms is not well-understood. Accordingly, we conducted a meta-review of meta-analyses assessing the effect of interventions targeting self-regulation on medication adherence. For this meta-review, meta-analyses appearing between January 2006 and March 2019 were eligible if they included experimental trials that assessed the effect of an intervention targeting self-regulation on adherence to chronic disease medication. A systematic literature search of multiple databases for published and unpublished literature identified 16,001 abstracts. Twelve meta-analyses met eligibility criteria and had variable quality according to AMSTAR 2 item completion (M = 50%; range: 31-66%). Overall, meta-reviews showed small to medium effect sizes for interventions that targeted self-monitoring, provided personalized feedback on adherence, or involved complete self-management. Other interventions, such as goal setting, barrier identification and problem solving, and stress management showed little evidence of improving adherence. Only a limited number of self-regulation intervention components were able to be evaluated. Additional research is needed to advance the understanding of the efficacy of adherence interventions focused on self-regulation by expanding the scope of self-regulation elements targeted (e.g., emotion regulation).

ObjectivesReview of efficacy and safety of Janus kinase (JAK) inhibition in immune-mediated inflammatory diseases (IMIDs).MethodsA systematic literature research (SLR) of all publications on JAK inhibitors (JAKi) treatment published until March 2019 using MEDLINE, EMBASE and the Cochrane Library. Efficacy and safety were assessed in randomised controlled trials (RCTs), integrating long-term extension periods additionally for safety evaluation.Results3454 abstracts were screened with 85 included in the final analysis (efficacy and RCT safety: n=72; safety only: n=13). Efficacy of RCTs investigating tofacitinib (TOFA, n=27), baricitinib (BARI, n=9), upadacitinib (UPA, n=14), filgotinib (FILGO, n=7), decernotinib (DEC, n=3) and peficitinib (PEF, n=7) was evaluated. Six head-to-head trials comparing JAKi with tumour necrosis factor inhibitors (TNFi) were included. Efficacy of JAKi was shown in rheumatoid arthritis (RA) for all agents, psoriatic arthritis (TOFA, FILGO), ankylosing spondylitis (TOFA, FILGO), systemic lupus erythematosus (BARI), chronic plaque psoriasis (TOFA, BARI, PEF), ulcerative colitis (TOFA, UPA), Crohn’s disease (UPA, FILGO) and atopic dermatitis (TOFA, BARI, UPA). Safety analysis of 72 RCTs, one cohort study and 12 articles on long-term extension studies showed increased risks for infections, especially herpes zoster, serious infections and numerically higher rates of venous thromboembolic events. No increased malignancy rates or major adverse cardiac events were observed.ConclusionJAKi provide good efficacy compared to placebo (and to TNFi in RA and Pso) across various IMIDs with an acceptable safety profile. This SLR informed the task force on points to consider for the treatment of IMIDs with JAKi with the available evidence.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:\ud \ud \ud To determine the benefits and harms of marine oil supplements for people with rheumatoid arthritis (RA).

Objectives Depression frequently co-occurs with multiple chronic diseases in complex, costly, and dangerous patterns of multimorbidity. The field of health psychology may benefit from evaluating the temporal characteristics of depression's associations with common diseases, and from determining whether depression is a central connector in multimorbid disease clusters. The present review addresses these issues by focusing on 4 of the most prevalent diseases: hypertension, ischemic heart disease, arthritis, and diabetes. Method Study 1 assessed how prior chronic disease diagnoses were associated with current depression in a large, cross-sectional, population-based study. It assessed depression's centrality using network analysis accounting for disease prevalence. Study 2 presents a systematic scoping review evaluating the extent to which depression was prospectively associated with the onset of the 4 prevalent chronic diseases. Results In Study 1 depression had the fourth highest betweenness centrality ranking of 26 network nodes and centrally connected many existing diseases and unhealthy behaviors. In Study 2 depression was associated with subsequent incidence of ischemic heart disease and diabetes across multiple meta-analyses. Insufficient information was available about depression's prospective associations with incident hypertension and arthritis. Conclusions Depression is central in patterns of multimorbidity and is associated with incident disease for several of the most common chronic diseases, justifying the focus on screening and treatment of depression in those at risk for developing chronic disease. Future research should investigate the mediating and moderating roles of health behaviors in the association between depression and the staggered emergence over time of clusters of multimorbid chronic diseases. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Background Single-patient, multiple cross-over designs (N-of-1 or single-case randomized clinical trials) with systematic data collection on treatment effects may be useful for increasing the precision of treatments in health psychology. Purposes To assess the quality of the methods and statistics, describe interventions and outcomes, and explore the heterogeneity of treatment effect of health psychology N-of-1 trials. Methods We conducted a systematic review of N-of-1 trials from electronic database inception through June 1, 2015. Potentially relevant articles were identified by searching the biomedical electronic databases Ovid, MEDLINE, EMBASE, all six databases in the Cochrane Library, CINAHL, and PsycINFO, and conference proceedings, dissertations, ongoing studies, Open Grey, and the New York Academy's Grey Literature Report. Studies were included if they had health behavior or psychological outcomes and the order of interventions was randomized. We abstracted study characteristics and analytic methods and used the Consolidated Standards of Reporting Trials extension for reporting N-of-1 trials as a quality checklist. Results Fifty-four N-of-1 trial publications composed of 1,193 participants were included. Less than half of these (36%) reported adequate information to calculate the heterogeneity of treatment effect. Nearly all (90%) provided some quantitative information to determine the superior treatment; 79% used an a priori statistical cutoff, 12% used a graph, and 10% used a combination. Conclusions N-of-1 randomized trials could be the next major advance in health psychology for precision therapeutics. However, they must be conducted with more methodologic and statistical rigor and must be transparently and fully reported.

Objectives: To perform a systematic literature review on imaging techniques for diagnosis, outcome prediction and disease monitoring in large vessel vasculitis (LVV) informing the European League Against Rheumatism recommendations for imaging in LVV.\ud \ud \ud \ud Methods: Systematic literature review (until 10 March 2017) of diagnostic and prognostic studies enrolling >20 patients and investigating ultrasound, MRI, CT or positron emission tomography (PET) in patients with suspected and/or established primary LVV. Meta-analyses were conducted, whenever possible, obtaining pooled estimates for sensitivity and specificity by fitting random effects models.\ud \ud \ud \ud Results: Forty-three studies were included (39 on giant cell arteritis (GCA), 4 on Takayasu arteritis (TAK)). Ultrasound (‘halo’ sign) at temporal arteries (8 studies, 605 patients) and MRI of cranial arteries (6 studies, 509 patients) yielded pooled sensitivities of 77% (95% CI 62% to 87%) and 73% (95% CI 57% to 85%), respectively, compared with a clinical diagnosis of GCA. Corresponding specificities were 96% (95% CI 85% to 99%) and 88% (95% CI 81% to 92%). Two studies (93 patients) investigating PET for GCA diagnosis reported sensitivities of 67%–77% and specificities of 66%–100% as compared with clinical diagnosis or temporal artery biopsy. In TAK, one study each evaluated the role of magnetic resonance angiography and CT angiography for diagnostic purposes revealing both a sensitivity and specificity of 100%. Studies on outcome prediction and monitoring disease activity/damage were limited and mainly descriptive.\ud \ud \ud \ud Conclusions: Ultrasound and MRI provide a high diagnostic value for cranial GCA. More data on the role of imaging for diagnosis of extracranial large vessel GCA and TAK, as well as for outcome prediction and monitoring in LVV are warranted.

Medication nonadherence contributes to morbidity/mortality, but adherence interventions yield small and inconsistent effects. Understanding the mechanisms underlying initiation and maintenance of adherence could improve interventions. The National Institutes of Health (NIH) support adherence research, but it is unclear whether existing NIH-funded research incorporates mechanisms. We conducted a systematic review to determine the proportion of NIH-funded adherence trials that have tested hypothesized mechanisms of intervention effects. We included randomized and quasi-randomized NIH-funded trials with medication adherence in adults as the primary outcome. Studies were identified by searching electronic databases from inception to 6/2016, references, and clinicaltrials.gov. Two of 18 (11%) NIH-funded trials tested a hypothesized mechanism of an intervention's effect on medication adherence. Another 44 studies with medication adherence as a secondary outcome were described in protocol form, and are either ongoing or never published results, but none mentioned mechanism tests. Overall, 3% of NIH-funded trials with adherence as an outcome conducted, or plan to conduct, tests of behavior change mechanisms. These results mirror previous findings that very few studies of behavior change interventions actually test the mechanism by which the intervention is hypothesized to improve health behaviors. We must understand mechanisms if we are to improve the effectiveness of interventions.

ObjectivesTo assess the safety of synthetic (s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) for the management of rheumatoid arthritis (RA) to inform the European League Against Rheumatism recommendations for the management of RA.MethodsSystematic literature review (SLR) of observational studies comparing any DMARD with another intervention for the management of patients with RA. All safety outcomes were included. A comparator group was required for the study to be included. Risk of bias was assessed with the Hayden's tool.ResultsTwenty-six observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria (15 on serious infections, 4 on malignancies). Substantial heterogeneity precluded meta-analysis. Together with the evidence from the 2013 SLR, based on 15 studies, 7 at low risk of bias, patients on bDMARDs compared with patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1 to 1.8)—without differences across bDMARDs—a higher risk of tuberculosis (aHR 2.7 to 12.5), but no increased risk of infection by herpes zoster. Patients on bDMARDs did not have an increased risk of malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5).ConclusionsThese findings confirm the known safety pattern of bDMARDs, including both tumour necrosis factor-α inhibitor (TNFi) and non-TNFi, for the treatment of RA.

Background Mobile health (mHealth) is often reputed to be cost-effective or cost-saving. Despite optimism, the strength of the evidence supporting this assertion has been limited. In this systematic review the body of evidence related to economic evaluations of mHealth interventions is assessed and summarized. Methods Seven electronic bibliographic databases, grey literature, and relevant references were searched. Eligibility criteria included original articles, comparison of costs and consequences of interventions (one categorized as a primary mHealth intervention or mHealth intervention as a component of other interventions), health and economic outcomes and published in English. Full economic evaluations were appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist and The PRISMA guidelines were followed. Results Searches identified 5902 results, of which 318 were examined at full text, and 39 were included in this review. The 39 studies spanned 19 countries, most of which were conducted in upper and upper-middle income countries (34, 87.2%). Primary mHealth interventions (35, 89.7%), behavior change communication type interventions (e.g., improve attendance rates, medication adherence) (27, 69.2%), and short messaging system (SMS) as the mHealth function (e.g., used to send reminders, information, provide support, conduct surveys or collect data) (22, 56.4%) were most frequent; the most frequent disease or condition focuses were outpatient clinic attendance, cardiovascular disease, and diabetes. The average percent of CHEERS checklist items reported was 79.6% (range 47.62–100, STD 14.18) and the top quartile reported 91.3–100%. In 29 studies (74.3%), researchers reported that the mHealth intervention was cost-effective, economically beneficial, or cost saving at base case. Conclusions Findings highlight a growing body of economic evidence for mHealth interventions. Although all studies included a comparison of intervention effectiveness of a health-related outcome and reported economic data, many did not report all recommended economic outcome items and were lacking in comprehensive analysis. The identified economic evaluations varied by disease or condition focus, economic outcome measurements, perspectives, and were distributed unevenly geographically, limiting formal meta-analysis. Further research is needed in low and low-middle income countries and to understand the impact of different mHealth types. Following established economic reporting guidelines will improve this body of research.

To assess the efficacy and safety of non-biological therapies in patients with axial spondyloarthritis (axSpA) to inform the update of the Assessment of SpondyloArthritis international Society (ASAS)/European League Against Rheumatism (EULAR) recommendations for the management of axSpA. A systematic literature review (2009-2016) of all non-pharmacological treatments, non-biological drugs (except targeted synthetic disease-modifying antirheumatic drugs (DMARDs)) and surgical therapies was performed. Randomised controlled trials (RCTs) and clinical controlled trials were assessed for efficacy and safety, while observational studies with a comparator were assessed for safety. All relevant efficacy and safety outcomes were included. Study heterogeneity precluded data pooling. If possible, Cohen's effect size was calculated for non-pharmacological treatments. In total, 45 papers and 2 abstracts were included. Studies on non-pharmacological treatments were very heterogeneous but overall confirmed a benefit for regular exercises, with small improvements in disease activity, function and spinal mobility. New studies on non-steroidal anti-inflammatory drugs (NSAIDs) confirmed their efficacy and new safety signals were not found. NSAIDs used continuously compared with on-demand did not reduce the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) mean change over 2 years in patients with ankylosing spondylitis with normal C reactive protein (CRP

Objective. To determine the efficacy and safety of glucocorticoids (GC), colchicine, nonsteroidal antiinflammatory drugs (NSAID), interleukin-1 (IL-1) inhibitors, and paracetamol to treat acute gout. Methods. We searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials to September 2011. Randomized controlled trials (RCT) or quasi-RCT in adults with acute gout that compared GC, colchicine, NSAID, IL-1 inhibitors, and paracetamol to no treatment, placebo, another intervention, or combination therapy were included. Two authors independently extracted data and assessed risk of bias. Primary endpoints were pain and adverse events. Data were pooled where appropriate. Results. Twenty-six trials evaluating GC (N = 5), NSAID (N = 21), colchicine (N = 2), and canakinumab (N = 1) were included. No RCT assessed paracetamol or intraarticular (IA) GC. No RCT compared systemic GC with placebo. Moderate quality evidence (3 trials) concluded that systemic GC were as effective as NSAID but safer. Low quality evidence (1 trial) showed that both high- and low-dose colchicine were more effective than placebo, and low-dose colchicine was no different to placebo with respect to safety but safer than high-dose colchicine. Low quality evidence (1 trial) showed no difference between NSAID and placebo with regard to pain or inflammation. No NSAID was superior to another. Moderate quality evidence (1 trial) found that 150 mg canakinumab was more effective than a single dose of intramuscular GC (40 mg triamcinolone) and equally safe. Conclusion. GC, NSAID, low-dose colchicine, and canakinumab all effectively treat acute gout. There was insufficient evidence to rank them. Systemic GC appeared safer than NSAID and lower-dose colchicine was safer than higher-dose colchicine.

Purpose This systematic review aims to summarize the current literature regarding potential effects of having both cancer and diabetes on patient-reported outcomes (PROs) and to provide directions for future research. Methods MEDLINE, The Cochrane Library, CINAHL, and PsycINFO were searched from inception to January 2015. All English peer-reviewed studies that included patients with both cancer and diabetes and assessed PROs were included. All included studies were independently assessed on methodological quality by two investigators. Results Of the 3553 identified studies, 10 studies were included and all were considered of high (40 %) or adequate (60 %) methodological quality. Eight of the 10 studies focused on health-related quality of life (HRQoL), functioning, or symptoms and 2 studies assessed diabetes self-management. Overall, HRQoL and functioning was lower, and symptoms were higher among patients with both cancer and diabetes as compared to having cancer or diabetes alone. Furthermore, one study reported that diabetes self-management was impaired after chemotherapy. Conclusions Having both cancer and diabetes resulted in worse PROs compared to having either one of the diseases, however, the considerable heterogeneity of the included studies hampered strong conclusions. Future studies are needed as this research area is largely neglected. As the majority of the included studies focused on HRQoL, future research should address the impact of both diseases on other PROs such as depression, patient empowerment and self-management. Implications for Cancer Survivor Having both cancer and diabetes might result in worse PROs, however, more research is needed as current evidence is scarce. Electronic supplementary material The online version of this article (doi:10.1007/s11764-015-0486-3) contains supplementary material, which is available to authorized users.

Objective.To determine the benefits and harms of nonsteroidal antiinflammatory drugs (NSAID) in axial spondyloarthritis (axSpA).Methods.Systematic review using Cochrane Collaboration methodology. Inclusion criteria: randomized controlled trials (RCT) and quasi-RCT (to June 2014), investigating NSAID versus any control for axSpA, and observational studies of longterm effects (≥ 6 mos) of NSAID on radiographic progression or adverse events. Main outcomes were pain, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index, radiographic progression, number of withdrawals because of adverse events, and number of serious adverse events. Risk of bias was assessed.Results.Thirty-five RCT, 2 quasi-RCT, and 2 cohort studies were included. Twenty-nine RCT and 2 quasi-RCT (n = 4356) were included in pooled analyses [traditional NSAID vs placebo (n = 5), cyclooxygenase-2 (COX-2) vs placebo (n = 3), COX-2 vs traditional NSAID (n = 4), NSAID vs NSAID (n = 24), naproxen vs other NSAID (n = 3), and low- vs high-dose NSAID (n = 5)]. Compared with placebo, both traditional and COX-2 NSAID were consistently more efficacious at 6 weeks and equally safe after 12 weeks. No significant differences in benefits or harms between the 2 NSAID classes and no important differences in benefits or withdrawals because of adverse events between different NSAID were found, especially if studies with high risk of bias were excluded. Single studies suggest NSAID may retard radiographic progression, especially by continuous rather than on-demand NSAID use.Conclusion.High-quality evidence indicates that both traditional and COX-2 NSAID are efficacious for treating axSpA, and harms are not different from placebo in the short term. Various NSAID are equally effective.

The effect of anesthetic technique on post-operative outcomes remains in question. This systematic review compares the role of regional versus general anesthesia, with a particular focus on post-operative cognitive function. Potentially relevant articles were identified by searching publicly available computerized databases for this systematic review. Any surgical procedure was accepted with the exception of cardiac, carotid, and neurosurgical procedures. Any regional anesthetic technique was accepted unless combined with a general anesthetic or in conjunction with propofol as a sedative. Any measure of post-operative cognitive function was accepted as long as it was performed no sooner than seven days post-operatively. Sixteen studies met inclusion criteria and were included in the final analysis. Three studies showed some difference in cognitive function between regional and general anesthesia, while the remaining thirteen showed no difference between regional and general anesthesia on postoperative cognitive function.

Objective. To determine the efficacy and safety of lifestyle interventions for treating gout. Methods. Two Cochrane systematic reviews assessed the efficacy and safety of lifestyle interventions for the treatment of acute and chronic gout. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to September 2011, and the 2010–2011 American College of Rheumatology and European League Against Rheumatism conference abstracts. Primary outcomes of interest were joint pain for acute gout, frequency of gout attacks for chronic gout, and withdrawals due to adverse events for both reviews. Results. One trial met inclusion criteria for each review. An unblinded trial (19 participants), at high risk of bias, found that topical ice added to prednisolone and colchicine for acute gout resulted in significantly greater pain reduction at 1 week [mean difference (MD) −3.33 cm, 95% confidence interval (95% CI) −5.84 to −0.82 on 10 cm visual analog scale]. Adverse events were not described. The second trial (120 participants), at moderate risk of bias, compared enriched skim milk powder (glycomacropeptide and G600 milk fat extract) to non-enriched skim milk and lactose powders for treating chronic gout. There were no between-group differences in gout attack frequency over 3 months [MD −0.21 (95% CI −0.76 to 0.34)] or withdrawals due to adverse events [relative risk 1.27 (95% CI 0.53 to 3.03)]. Conclusion. While there is observational evidence for an association between lifestyle risk factors and gout development, there are no high quality trials to support or refute the use of lifestyle interventions for treating acute or chronic gout.

Objective. To assess the efficacy and safety of gout-specific medications in gout patients with a comorbidity and/or comedication. Methods. A systematic literature search for gout, its medication, and the most common comorbidities and comedications, using serum uric acid (SUA) levels as the primary, and adverse events as the secondary outcomes. Results. Eight trials met inclusion criteria. Trials covered treatment with allopurinol, benzbromarone, rasburicase, or febuxostat in a gout population with mild or moderate renal insufficiency. High risk of bias (5/8 trials) and heterogeneity precluded formal metaanalysis. The trials showed the following hierarchy in efficacy (lowering the SUA below 6.0 mg/dl): febuxostat 80 mg (44%-71%) > febuxostat 40 mg (43%-52%) > allopurinol 100 mg or 200 mg (0-46%) after 6 months of therapy; rasburicase (46%) > allopurinol 300 mg (16%) after 7 days of therapy; benzbromarone 100-200 mg (93%) > allopurinol 100-200 mg (63%) after 9-24 months of therapy. The combination of allopurinol and benzbromarone seemed to be effective, with a significant reduction in the SUA from 7.8 to 5.7 mg/dl (p

To analyze the diagnostic utility of clinical, laboratory, and imaging items for gout.A systematic literature search was performed in MEDLINE, EMBASE, and The Cochrane Library; and a manual search of abstracts from the 2010/2011 meetings of the American College of Rheumatology (ACR) and the European League Against Rheumatism, as well as the reference lists of retrieved papers. Studies were included if they evaluated the diagnostic utility of clinical, laboratory, or imaging features or criteria for the diagnosis or classification of gout in adult patients. Two independent reviewers selected papers, extracted the data, and assessed the risk of bias.Nineteen studies were included in the review; 4 used the identification of monosodium urate (MSU) crystals as the reference standard (RS) and the rest used expert opinion or the ACR preliminary criteria. Most features were evaluated in a single study. Evidence for diagnostic utility, using MSU crystals as RS, of over 50 individual clinical, laboratory, and radiographic features was retrieved. Most items showed a positive likelihood ratio (LR+)3, except for the following: response of arthritis to colchicine (LR+ 4.3); presence of tophi on physical examination (LR+ 15.6-30.9); identification of the double-contour sign in ultrasound (US) (LR+ 13.6); and detection of urate deposits by dual-energy computed tomography (DECT) (LR+ 9.5).Individual clinical features show low diagnostic utility, with the exception of tophi and response to colchicine. Some US and DECT findings show better performance than most clinical features.

We aimed to develop evidence-based multinational recommendations for the diagnosis and management of gout. Using a formal voting process, a panel of 78 international rheumatologists developed 10 key clinical questions pertinent to the diagnosis and management of gout. Each question was investigated with a systematic literature review. Medline, Embase, Cochrane CENTRAL and abstracts from 2010-2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, rheumatologists from 14 countries (Europe, South America and Australasia) developed national recommendations. After rounds of discussion and voting, multinational recommendations were formulated. Each recommendation was graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. Combining evidence and clinical expertise, 10 recommendations were produced. One recommendation referred to the diagnosis of gout, two referred to cardiovascular and renal comorbidities, six focused on different aspects of the management of gout (including drug treatment and monitoring), and the last recommendation referred to the management of asymptomatic hyperuricaemia. The level of agreement with the recommendations ranged from 8.1 to 9.2 (mean 8.7) on a 1-10 scale, with 10 representing full agreement. Ten recommendations on the diagnosis and management of gout were established. They are evidence-based and supported by a large panel of rheumatologists from 14 countries, enhancing their utility in clinical practice.

Most studies examining potential associations between psychological factors and cardiovascular outcomes have focused on either depression or anxiety. The effect of perceived stress on incident coronary heart disease (CHD) has yet to be reviewed systematically. We conducted a systematic review and meta-analysis of the association between perceived stress and incident CHD. Ovid MEDLINE and PsycINFO were searched as data sources. Prospective observational cohort studies were selected that measured self-reported perceived stress and assessed incident CHD at minimum of 6 months later. We extracted study characteristics and estimates of the risk of incident CHD associated with high perceived stress vs. low perceived stress. We identified 23 potentially relevant articles, of which 6 met our criteria (N = 118,696). Included studies measured perceived stress with both validated measures and non-validated simple self-report surveys. Incident CHD was defined as new diagnosis of, hospitalization for, or mortality secondary to CHD. Meta-analysis yielded an aggregate risk ratio of 1.27 (95% confidence interval 1.12 – 1.45) for the magnitude of the relation between high perceived stress and incident CHD. In conclusion this meta-analysis suggests that high perceived stress is associated with a moderately increased risk of incident CHD.

BACKGROUND: The World Health Organization (WHO) estimates that the number of obese or overweight individuals worldwide will increase to 1.5 billion by 2015. Chronic diseases associated with overweight or obesity include diabetes, heart disease, hypertension and stroke. OBJECTIVES: To assess the effects of interactive computer-based interventions for weight loss or weight maintenance in overweight or obese people. SEARCH METHODS: We searched several electronic databases, including CENTRAL, MEDLINE, EMBASE, CINAHL, LILACS and PsycINFO, through 25 May 2011. We also searched clinical trials registries to identify studies. We scanned reference lists of included studies and relevant systematic reviews. SELECTION CRITERIA: Studies were included if they were randomized controlled trials or quasi-randomized controlled trials that evaluated interactive computer-based weight loss or weight maintenance programs in adults with overweight or obesity. We excluded trials if the duration of the intervention was less than four weeks or the loss to follow-up was greater than 20% overall. DATA COLLECTION AND ANALYSIS: Two authors independently extracted study data and assessed risk of bias. Where interventions, control conditions, outcomes and time frames were similar between studies, we combined study data using meta-analysis. MAIN RESULTS: We included 14 weight loss studies with a total of 2537 participants, and four weight maintenance studies with a total of 1603 participants. Treatment duration was between four weeks and 30 months. At six months, computer-based interventions led to greater weight loss than minimal interventions (mean difference (MD) -1.5 kg; 95% confidence interval (CI) -2.1 to -0.9; two trials) but less weight loss than in-person treatment (MD 2.1 kg; 95% CI 0.8 to 3.4; one trial). At six months, computer-based interventions were superior to a minimal control intervention in limiting weight regain (MD -0.7 kg; 95% CI -1.2 to -0.2; two trials), but not superior to infrequent in-person treatment (MD 0.5 kg; 95% -0.5 to 1.6; two trials). We did not observe consistent differences in dietary or physical activity behaviors between intervention and control groups in either weight loss or weight maintenance trials. Three weight loss studies estimated the costs of computer-based interventions compared to usual care, however two of the studies were 11 and 28 years old, and recent advances in technology render these estimates unlikely to be applicable to current or future interventions, while the third study was conducted in active duty military personnel, and it is unclear whether the costs are relevant to other settings. One weight loss study reported the cost-effectiveness ratio for a weekly in-person weight loss intervention relative to a computer-based intervention as USD 7177 (EUR 5678) per life year gained (80% CI USD 3055 to USD 60,291 (EUR 2417 to EUR 47,702)). It is unclear whether this could be extrapolated to other studies. No data were identified on adverse events, morbidity, complications or health-related quality of life. AUTHORS' CONCLUSIONS: Compared to no intervention or minimal interventions (pamphlets, usual care), interactive computer-based interventions are an effective intervention for weight loss and weight maintenance. Compared to in-person interventions, interactive computer-based interventions result in smaller weight losses and lower levels of weight maintenance. The amount of additional weight loss, however, is relatively small and of brief duration, making the clinical significance of these differences unclear.

Objective: To suggest a behavioural research agenda for patients with end-stage renal disease (ESRD) based on a concise review of seven stages of psychosocial research, a literature review, and current behavioural research in other chronic somatic diseases. Methods: Historical behavioural ESRD research was classified. The specialized register of the Cochrane Behavioral Medicine Field was also checked, and additional papers were selected by screening reference lists and related behavioural science journals, to identify promising areas for future research. Results: The top-five topics identified via the literature search pertain to (1) psychological aspects and interventions, (2) adaptation, coping, and depression, (3) exercise, (4) counseling and education, and (5) compliance. 'Illness and treatment beliefs', 'sexuality', 'suicide', 'family support', and 'self-management interventions', were identified on the basis of research in other chronic illnesses as topics for future research. Regarding theory, the Common-Sense Model (CSM) was judged to offer useful theoretical perspectives: regarding methods, qualitative methods can be a valuable addition to quantitative research methods. Conclusion: Illness beliefs, treatment beliefs, and self-management behaviours are promising concepts in the assessment and clinical care of ESRD-patients. Cognitive-behavioural treatments appear to have potential and should be specified and elaborated for specific categories and problems of ESRD-patients. Practice Implications: This research agenda is in line with moves towards patient-centred disease-management to improve the quality of medical care for ESRD-patients. (C) 2009 Elsevier Ireland Ltd. All rights reserved.