scholarly journals Effectiveness and cost‐effectiveness of longstanding exercise therapy versus usual care in patients with axial spondyloarthritis or rheumatoid arthritis and severe limitations: The protocols of two parallel randomized controlled trials

Author(s):  
Maria. A. T. Wissen ◽  
Max. M. H. Teuwen ◽  
Cornelia. H. M. Ende ◽  
Thea. P. M. Vlieland ◽  
Alfons. A. Broeder ◽  
...  
2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1460-1461
Author(s):  
M. A. T. van Wissen ◽  
M. Teuwen ◽  
C. Van den Ende ◽  
T. P. M. Vliet Vlieland ◽  
A. Den Broeder ◽  
...  

Background:Axial SpondyloArthritis (axSpA) and Rheumatoid Arthritis (RA) are chronic rheumatic diseases with an often progressive course, defined by chronic inflammation. With respect to exercise therapy, in axSpA and RA, multiple systematic reviews concluded that supervised exercise therapy is an effective and safe treatment option, resulting in small to modest improvements in pain, disease activity, functional ability and axial mobility. In general, most of the studies included in these reviews concerned programs of a relatively short duration (<12 weeks) and the studies mostly concerned patients with stable disease, without co-morbid conditions and relatively favorable functional ability (1-5). The group of patients with active disease, irreversible joint damage, multiple joint replacements and/or severe comorbidity hampering participation in exercise therapy programs and in need for individualized, longstanding therapy is therefore likely to be underrepresented in research so far. Consequently, cost-effectiveness studies on longstanding physical therapy are also lacking in these specific subgroups.Objectives:We aim to evaluate the effectiveness and cost-effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning.Methods:In two separate, parallel randomized controlled trials, the effectiveness and cost-effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated (Figure 1). The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation, and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient-Specific Complaints instrument at 52 weeks. For cost-effectiveness analyses, the EuroQol (EQ-5D-5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost-utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow-up assessments are done at 104, 156 and 208 weeks.Figure 1.Study flowchartResults:The results of these studies will provide insights in the effectiveness and cost-effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations.References:[1]Mewes J, de Bekker P, Bossen D, Steuten L. 2016. Systematic review of supervised physical exercise therapy for patients with rheumatoid arthritis. Panaxea.[2]Mewes J, de Bekker P, Bossen D, Steuten L. 2016. Systematic review of supervised phyiscal exercise therapy for patients with ankylosing spondylitis. Panaxea.[3]Swardh E, Brodin N. 2016. Effects of aerobic and muscle strengthening exercise in adults with rheumatoid arthritis: a narrative review summarising a chapter in Physical activity in the prevention and treatment of disease (FYSS 2016). Br J Sports Med 50: 362-7.[4]Sveaas SH, Smedslund G, Hagen KB, Dagfinrud H. 2017. Effect of cardiorespiratory and strength exercises on disease activity in patients with inflammatory rheumatic diseases: a systematic review and meta-analysis. Br J Sports Med 51: 1065-72.[5]Regel A, Sepriano A, Baraliakos X, van der Heijde D, Braun J, Landewe R, Van den Bosch F, Falzon L, Ramiro S. 2017. Efficacy and safety of non-pharmacological and non-biological pharmacological treatment: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. RMD Open 3: e000397.Disclosure of Interests:None declared


2021 ◽  
pp. 026921552110355
Author(s):  
Chun-De Liao ◽  
Hung-Chou Chen ◽  
Shih-Wei Huang ◽  
Tsan-Hon Liou

Objective: Rheumatoid arthritis and age are associated with high sarcopenia risk. Exercise is an effective treatment for preventing muscle mass loss in older adult populations. It remains unclear whether exercise affects muscle mass in people with rheumatoid arthritis. Thus, this meta-analysis investigated the effect of exercise on muscle mass gain in patients with rheumatoid arthritis. Data sources: PubMed, EMBASE, the Cochrane Library, the Physiotherapy Evidence Database (PEDro), the China Knowledge Resource Integrated Database, and Google Scholar were systematically searched until June 2021. Methods: The present study was conducted according to the guidelines recommended by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Randomized controlled trials (RCTs) that reported the effects of exercise on muscle mass for rheumatoid arthritis were identified. The included RCTs were subject to meta-analysis and risk of bias assessment. Subgroup and random-effects meta-regression analyses were performed to identify any heterogeneity ( I2) of treatment effects across studies. Results: We included nine RCTs with a median PEDro score of 6/10 (range: 4/10–8/10). The weighted mean effect size for muscle mass was 0.77 (95% CI: 0.30–1.24; P = 0.001; I2 = 77%). Meta-regression analyses indicated that the disease duration significantly explained variance of treatment effects across studies (β = −0.006, R2 = 69.7%, P = 0.005). Conclusions: Exercise therapy effectively increased muscle mass in patients with rheumatoid arthritis. Treatment effects may be attenuated in those who have had rheumatoid arthritis for a relatively long time.


2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Vinod Solipuram ◽  
Akhila Mohan ◽  
Roshniben Patel ◽  
Ruoning Ni

Abstract Background Rheumatoid arthritis (RA) is a systemic autoimmune disease. The combination therapy of methotrexate (MTX) and Janus kinase inhibitor (JAKi) is commonly used. Patients with RA are at increased risk of malignancy, however, it remains unclear whether the combination therapy is associated with a higher risk. Objective To assess the malignancy risk among patients with RA receiving combination therapy of JAKi and MTX compared to MTX alone. Methods PubMed, Cochrane and Embase were thoroughly searched for randomized controlled trials (RCTs) in patients with RA receiving JAKi and MTX, from inception to July 2020. Primary endpoints were malignancy events, Non melanomatous skin cancer (NMSC) and malignancy excluding NMSC and secondary endpoints were serious adverse events (SAE), deaths. Risk ratio (RR) and 95% CI were calculated using the Mantel–Haenszel random-effect method. Results 659 publications were screened and 13 RCTs with a total of 6911 patients were included in the analysis. There was no statistically significant difference in malignancy [RR = 1.42; 95% CI (0.59, 3.41)], neither NMSC [RR = 1.44 (0.36, 5.76)] nor malignancies excluding NMSC [RR = 1.12 (0.40, 3.13)]. No statistically significant difference between the two groups for SAE [RR = 1.15 (0.90, 1.47)] and deaths [RR = 1.99 (0.75, 5.27)] was found. Conclusion The adjunction of JAKi to MTX is not associated with an increased risk of malignancy when compared to MTX alone. There is no increased risk of SAE and deaths when compared to MTX alone in patients with RA.


QJM ◽  
2021 ◽  
Author(s):  
K Shah ◽  
D Saxena ◽  
D Mavalankar

Abstract Objective: Current meta-analysis aims to understand the effect of oral supplementation of vitamin D on intensive care unit (ICU) requirement and mortality in hospitalized COVID-19 patients. Methods: Databases PubMed, preprint servers, and google scholar were searched from December 2019 to December 2020. Authors searched for the articles assessing role of vitamin D supplementation on COVID-19. Cochrane RevMan tool was used for quantitative assessment of the data, where heterogeneity was assessed using I2 and Q statistics and data was expressed using odds ratio with 95% confidence interval. Results: Final meta-analysis involved pooled data of 532 hospitalized patients (189 on vitamin D supplementation and 343 on usual care/placebo) of COVID-19 from three studies (Two randomized controlled trials, one retrospective case-control study). Statistically (p&lt;0.0001) lower ICU requirement was observed in patients with vitamin D supplementation as compared to patients without supplementations (odds ratio: 0.36; 95% CI: 0.210-0.626). However, it suffered from significant heterogeneity, which reduced after sensitivity analysis. In case of mortality, vitamin D supplements has comparable findings with placebo treatment/usual care (odds ratio: 0.93; 95% CI: 0.413-2.113; p=0.87). The studies did not show any publication bias and had fair quality score. Subgroup analysis could not be performed due to limited number of studies and hence dose and duration dependent effect of vitamin D could not be evaluated. Conclusions: Although the current meta-analysis findings indicate potential role of vitamin D in improving COVID-19 severity in hospitalized patients, more robust data from randomized controlled trials are needed to substantiate its effects on mortality.


2011 ◽  
Vol 6 (2) ◽  
pp. 51
Author(s):  
Cari Merkley

Objective — To compare the results of searching the MEDLINE database through Ovid and the free online version of PubMed administered by the National Library of Medicine for randomized controlled trials on the subject of the drug methotrexate (MTX) for patients suffering from rheumatoid arthritis. Design — Comparative analysis of search results. Setting — Searches conducted by researchers affiliated with Mahidol University in Bangkok, Thailand, and the University of Toronto and the University Health Network in Toronto, Ontario. Subjects — A total of 3966 search results obtained from Ovid MEDLINE and PubMed. Methods — This study employs an Ovid MEDLINE search strategy originally created for a published systematic review that identified randomized controlled trials on MTX and rheumatoid arthritis (Katchamart, Trudeau, Phumethum, & Bombardier, 2009). Two of the authors of the original systematic review (Katchamart and Bombardier) are among the authors of this current study. Appropriate medical subject heading (MeSH) terms and their synonyms were identified for the three main concepts (rheumatoid arthritis, MTX, and randomized controlled trials). The search was performed in Ovid MEDLINE, seeking articles in any language that met the search criteria, from the earliest date covered by MEDLINE to January 2009. Each MeSH or keyword term within a concept was searched separately, and then combined with other like terms using the Boolean operator OR. The searches for the three concepts were finally combined using AND. The Ovid MEDLINE search was then translated for use in PubMed by an information professional. The formatting and terminology used in some of the original Ovid MEDLINE search statements had to be changed so they would work in the new database environment, but the researchers tried to ensure that the two searches were as similar as possible. The translated search was then executed in PubMed. The final results, as well as the number of articles retrieved for each key search concept (rheumatoid arthritis, MTX, and randomized controlled trials), were then compared. The final results were further analyzed for measures of sensitivity, precision, and number needed to read. Sensitivity is calculated by the number of eligible studies found in a database divided by the “total number of eligible studies in the review” multiplied by 100 (Katchamart, Faulkner, Feldman, Tomlinson, & Bombardier, p. 806). Eligible studies were identified using the inclusion/exclusion criteria developed by Katchamart et al. The figure for “total number of eligible studies in the review” is taken from that same study, which forms the “gold standard” for this analysis (Katchamart et al., p. 806). Precision is calculated by dividing the total number of eligible citations from a database by the total number of citations returned by the database for the search multiplied by 100 (Katchamart et al., p. 806). The number needed to read (NNR) formula used by the authors is 1/precision, taken from a study by Bachman, Coray, Estermann, and Ter Riet (2002). Main Results — The PubMed search found more results than Ovid MEDLINE for each of the three key concepts – rheumatoid arthritis, MTX and randomized controlled trials. Once the three concepts were combined, PubMed found 106 more articles than Ovid MEDLINE (2036 vs. 1930). Once the review eligibility criteria were applied to the search results from PubMed, 18 eligible articles were identified, one more article than in Ovid MEDLINE. The authors indicated that the additional article located in PubMed was from a journal that was not yet indexed by MEDLINE at the time the relevant article was published. To determine database sensitivity, these numbers were then divided by 20, the total number of eligible studies located in the Katachamart et al. 2009 review, which employed tools like EMBASE and strategies like hand searching in addition to MEDLINE in order to identify relevant studies. Because of the additional study it located, the sensitivity of PubMed was determined to be slightly higher than Ovid MEDLINE (90% vs. 85%). There was little difference between the two databases in terms of precision and NNR. Precision for Ovid MEDLINE was calculated at 0.881% and at 0.884% for PubMed. The NNR was 114 for Ovid MEDLINE and 113 for PubMed. Conclusion — The authors state that while PubMed had a higher calculated sensitivity than Ovid MEDLINE in the context of this particular search because it contained content not indexed by Ovid MEDLINE that proved to be relevant for this topic, its precision and NNR were almost equal to MEDLINE’s. Some technical limitations of the PubMed interface were experienced by researchers during the study, such as periodic instability and the inability to save and modify searches and their results line by line. These same issues did not arise while using Ovid MEDLINE. The need for a skilled translation of Ovid MEDLINE searches for use in the PubMed interface was also emphasized by the authors, as differences in syntax and formatting that are not properly addressed could impact PubMed’s sensitivity and precision.


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