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Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis.

ABSTRACT: Background:Foot orthoses (FOs) are prescribed as an important conservative treatment option in patients with foot problems related to rheumatoid arthritis. However, a broad variation in FOs is used, both in clinical practice and in research. To date, there is no overview on the outcomes of the treatment with different kinds of FOs in patients with rheumatoid arthritis and a specific foot problem. The objectives of the present study were to summarize the comparative effectiveness of FOs in the treatment of various foot problems in patients with rheumatoid arthritis, on the primary outcomes foot function and foot pain, and the secondary outcomes physical functioning, health related quality of life, compliance, adverse events, the costs of FOs and patient satisfaction. Methods:Studies comparing different kinds of FOs, with a presumed therapeutic effect, in the treatment of foot problems related to rheumatoid arthritis were included. A literature search was conducted in The Cochrane Central Registry for Controlled Trials (CENTRAL), PubMed, EMBASE and PEDro up to May 18th, 2018. Data was meta-analyzed, when this was not possible qualitative data analysis was performed. Results:Ten studies were identified, with a total number of 235 patients. These studies made a comparison between different materials used (soft versus semi-rigid), types of FOs (custom-made versus ready-made; total-contact versus non-total contact), or modifications applied (metatarsal bars versus domes). Also, different techniques to construct custom-made FOs were compared (standard custom-molding techniques versus more sophisticated techniques). A medium effect for (immediate) reduction of forefoot plantar pressure was found in favor of treatment with soft FOs compared to semi-rigid FOs (SMD 0.60, 95% CI 0.07-1.14; P?=?0.03; 28 participants). Other comparisons between FOs resulted in non-significant effects or inconclusive evidence for one kind of FOs over the other. Conclusions:Foot orthoses made of soft materials may lead to more (immediate) forefoot plantar pressure reduction compared to foot orthoses constructed of semi-rigid materials. Definitive high quality RCTs, with adequate sample sizes and long-term follow-up, are needed to investigate the comparative (cost-) effectiveness of different kinds of foot orthoses for the treatment of foot problems related to rheumatoid arthritis.

SUBMITTER: Tenten-Diepenmaat M

PROVIDER: S-EPMC6567436 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis.

Tenten-Diepenmaat Marloes M Dekker Joost J Heymans Martijn W MW Roorda Leo D LD Vliet Vlieland Thea P M TPM van der Leeden Marike M

Journal of foot and ankle research 20190613

<h4>Background</h4>Foot orthoses (FOs) are prescribed as an important conservative treatment option in patients with foot problems related to rheumatoid arthritis. However, a broad variation in FOs is used, both in clinical practice and in research. To date, there is no overview on the outcomes of the treatment with different kinds of FOs in patients with rheumatoid arthritis and a specific foot problem. The objectives of the present study were to summarize the comparative effectiveness of FOs i ...[more]

PMID: 31210785

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Project description:BackgroundGuidelines recommend foot orthoses for people with both early (< 2 years) and established rheumatoid arthritis (RA). While prefabricated foot orthoses are cheaper and can exhibit comparable effects to customised devices, the available evidence for their effectiveness is inconsistent. Little is known about what types of foot orthoses clinicians prescribe. This study describes the foot orthoses prescription habits of podiatrists for people with rheumatoid arthritis.MethodsOne hundred and eighty-three podiatrists from the United Kingdom (UK) (n = 88), Australia (n = 68) and New Zealand (n = 27) completed a self-administered, online survey regarding the types of foot orthoses prescribed in clinical practice for people with RA. This study forms part of a wider international survey exploring foot orthosis prescription habits.ResultsUK respondents were more likely to prescribe prefabricated orthoses for early RA (n = 47, 53%) and customised orthoses for established RA (n = 47, 53%). Respondents in Australia were more likely to prescribe customised orthoses for both early (n = 32, 47%) and established (n = 46, 68%) RA, whilst respondents in New Zealand were more likely to prescribe prefabricated orthoses for both early (n = 16, 59%) and established (n = 10, 37%) disease.Irrespective of disease stage, the use of foam impression boxes was more prevalent in the UK and New Zealand when capturing a model of the feet prior to manufacturing customised orthoses. In contrast, electronic scanning and plaster of Paris were more common in Australia. Computer aided manufacture was utilised more frequently among respondents in Australia than in the UK and New Zealand. Respondents in all three countries specified more flexible shell materials for established RA, compared to early disease. Cushioning top covers (e.g. PORON® or polyurethane) were most frequently specified in all countries for both disease stages.ConclusionsConsiderable variation was seen in the self-reported foot orthoses prescription habits of respondents for people with RA. Variation between countries and disease stage was seen in type of orthoses, specific brands, manufacturing methods, and materials prescribed. The results allow podiatrists and broader health service providers to compare their practice against reported national and international patterns.

Project description:Flexible pes planus (flat feet) in children is a common presenting condition in clinical practice due to concerns amongst parents and caregivers. While Foot Orthoses (FOs) are a popular intervention, their effectiveness remains unclear. Thus, the aim of this systematic review was to update the current evidence base for the effectiveness of FOs for paediatric flexible pes planus.A systematic search of electronic databases (Cochrane, Medline, AMED, EMBASE, CINHAL, SportDiscus, Scopus and PEDro) was conducted from January 2011 to July 2017. Studies of children (0-18 years) diagnosed with flexible pes planus and intervention to be any type of Foot Orthoses (FOs) were included. This review was conducted and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. McMaster critical review form for quantitative studies, was used to assess the methodological quality of the included studies. Given the heterogeneity of the included studies, a descriptive synthesis of the included studies was undertaken.Out of 606 articles identified, 11 studies (three RCTs; two case-controls; five case-series and one single case study) met the inclusion criteria. A diverse range of pre-fabricated and customised FOs were utilised and effectiveness measured through a plethora of outcomes. Summarised findings from the heterogeneous evidence base indicated that FOs may have a positive impact across a range of outcomes including pain, foot posture, gait, function and structural and kinetic measures. Despite these consistent positive outcomes reported in several studies, the current evidence base lacks clarity and uniformity in terms of diagnostic criteria, interventions delivered and outcomes measured for paediatric flexible pes planus.There continues to remain uncertainty on the effectiveness of FOs for paediatric flexible pes planus. Despite a number of methodological limitations, FOs show potential as a treatment method for children with flexible pes planus.CRD42017057310.

Project description:BACKGROUND: Foot orthoses are widely used in the management of flexible pes planus, yet the evidence to support this intervention has not been clearly defined. This systematic review aimed to critically appraise the evidence for the use of foot orthoses for flexible pes planus in adults. METHODS: Electronic databases (Medline, CINAHL, Cochrane, Web of science, SportDiscus, Embase) were systematically searched in June 2013 for randomised controlled, controlled clinical and repeated measure trials where participants had identified flexible pes planus using a validated and reliable measure of pes planus and the intervention was a rigid or semi-rigid orthoses with the comparison being a no-orthoses (shoes alone or flat non-posted insert) condition. Outcomes of interest were foot pain, rearfoot kinematics, foot kinetics and physical function. RESULTS: Of the 2,211 articles identified by the searches, 13 studies met the inclusion criteria; two were randomised controlled trials, one was a controlled trial and 10 were repeated measure studies. Across the included studies, 59 relevant outcome measures were reported with 17 calculated as statistically significant large or medium effects observed with use of foot orthoses compared to the no orthoses condition (SMD range 1.13 to -4.11). CONCLUSIONS: No high level evidence supported the use of foot orthoses for flexible pes planus. There is good to moderate level evidence that foot orthoses improve physical function (medial-lateral sway in standing (level II) and energy cost during walking (level III)). There is low level evidence (level IV) that foot orthoses improve pain, reduce rearfoot eversion, alter loading and impact forces; and reduce rearfoot inversion and eversion moments in flexible pes planus. Well-designed randomised controlled trials that include appropriate sample sizes, clinical cohorts and involve a measure of symptom change are required to determine the efficacy of foot orthoses to manage adult flexible pes planus.

Project description:Background: The treatment of rheumatoid arthritis (RA), a chronic systemic inflammatory autoimmune disease, is based on disease-modifying anti-rheumatic drugs (DMARDs). Typically, it starts with conventional synthetic DMARDs (csDMARDs), and depending on the patient's response to the treatment and the adverse events experienced, biological DMARDs (bDMARDs) are initiated. bDMARDs are more specific to inflammatory factors than csDMARDs and more efficient in inducing remission and low disease activity. Thus, this study aimed to assess the effectiveness of biological therapy in patients with rheumatoid arthritis in administrative health databases. Methods: PubMed, Embase, Lilacs, Ovid, Scopus, and Web of Science databases were searched from inception to 21 October 2021, to identify observational studies that evaluated the effectiveness of biological therapy in patients with rheumatoid arthritis using administrative databases and real-world data. The methodological quality was assessed by the methodological index for non-randomized studies (MINORS). A fixed or random-effects model estimated risk ratios with 95% confidence intervals. The analysis was divided into four groups: tumor necrosis factor inhibitors (TNFi) versus non-TNFi; TNFi versus TNFi (adalimumab, etanercept, and golimumab versus infliximab); bDMARDs versus Janus kinase inhibitors (JAKi); and bDMARDs monotherapy versus combination therapy (bDMARDs and MTX). Results: Twenty-one records were eligible for inclusion in this systematic review and meta-analysis; seven population-based cohorts, eight prospective, and six retrospective cohort studies. Overall, 182,098 rheumatoid arthritis patients were evaluated. In the meta-analysis, lower effectiveness was observed among TNFi users than in non-TNFi (RR: 0.88; 95% CI: 0.81-0.95; p < 0.01; I2 = 94.0%) and bDMARDs than in JAKi (RR: 0.86; 95% CI: 0.79-0.94; p < 0.01; I2 = 93.0%). Higher effectiveness among adalimumab, etanercept, and golimumab than in infliximab (RR: 1.19; 95% CI: 1.05-1.36; p < 0.01; I2 = 96.0%) was found. No significant differences in the effectiveness of bDMARD monotherapy compared to combination therapy (RR: 0.83; 95% CI: 0.68-1.00; p < 0.01; I2 = 81.0%) was observed. E-value analysis indicated that the estimates were not robust against unmeasured confounding. Conclusion: According to the available real-world data, our results suggest that biological therapy effectively treats patients with rheumatoid arthritis, indicating higher effectiveness with non-TNFi and JAKi than with TNFi. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID#CRD42020190838, identifier CRD42020190838.

Project description:IntroductionCurrently there is limited data to drive clinical decision making regarding the choice of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARD); thus, head-to-head comparisons are needed to help guide prescribing. In recent years, significant advancements have helped clarify the mechanistic basis of the clinical associations of autoantibodies in rheumatoid arthritis (RA). This study evaluated the effectiveness of abatacept versus tofacitinib in anti-cyclic citrullinated peptide (CCP+) patients with rheumatoid arthritis (RA).MethodsCorEvitas (formerly known as CORRONA) Registry patients aged ≥ 18 years, who were CCP+ before initiating abatacept or tofacitinib (December 2012 onwards through October 2019), had 6-month follow-up data (baseline and 6-month Clinical Disease Activity Index [CDAI]), and were not in remission at index were included. Patients were frequency matched 1:1 by prior biologic use before propensity score matching (PSM). Primary (mean change [D] in CDAI) and secondary outcomes 6 months after index were compared using mixed-effects models adjusted for variables that remained unbalanced after PSM.ResultsFollowing PSM, most baseline characteristics for 291 patient pairs were well balanced between treatments, although fewer patients initiating abatacept versus tofacitinib received prior non-TNFi biologic DMARDs, and patients initiating abatacept versus tofacitinib had a higher physician global assessment score, patient-reported fatigue, and modified Health Assessment Questionnaire (mHAQ). In adjusted analyses, there were no significant differences in mean [D] from baseline in CDAI at 6 months with abatacept versus tofacitinib (P = 0.936). Patients naïve for b/tsDMARDs initiating abatacept had a numerically greater mean [D] in CDAI at 6 months versus tofacitinib, although this difference was not statistically significant (P = 0.662). There were no significant differences for any secondary outcomes.ConclusionsIn adjusted analyses, CCP+ patients with RA initiating treatment with abatacept versus tofacitinib did not show a statistically significant difference in reducing disease activity or improving patient-reported outcomes.

Project description:ImportanceThere is a need for observational studies to supplement evidence from clinical trials, and the target trial emulation (TTE) framework can help avoid biases that can be introduced when treatments are compared crudely using observational data by applying design principles for randomized clinical trials. Adalimumab (ADA) and tofacitinib (TOF) were shown to be equivalent in patients with rheumatoid arthritis (RA) in a randomized clinical trial, but to our knowledge, these drugs have not been compared head-to-head using routinely collected clinical data and the TTE framework.ObjectiveTo emulate a randomized clinical trial comparing ADA vs TOF in patients with RA who were new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD).Design, setting, and participantsThis comparative effectiveness study emulating a randomized clinical trial of ADA vs TOF included Australian adults aged 18 years or older with RA in the Optimising Patient Outcomes in Australian Rheumatology (OPAL) data set. Patients were included if they initiated ADA or TOF between October 1, 2015, and April 1, 2021; were new b/tsDMARD users; and had at least 1 component of the disease activity score in 28 joints using C-reactive protein (DAS28-CRP) recorded at baseline or during follow-up.InterventionTreatment with either ADA (40 mg every 14 days) or TOF (10 mg daily).Main outcomes and measuresThe main outcome was the estimated average treatment effect, defined as the difference in mean DAS28-CRP among patients receiving TOF compared with those receiving ADA at 3 and 9 months after initiating treatment. Missing DAS28-CRP data were multiply imputed. Stable balancing weights were used to account for nonrandomized treatment assignment.ResultsA total of 842 patients were identified, including 569 treated with ADA (387 [68.0%] female; median age, 56 years [IQR, 47-66 years]) and 273 treated with TOF (201 [73.6%] female; median age, 59 years [IQR, 51-68 years]). After applying stable balancing weights, mean DAS28-CRP in the ADA group was 5.3 (95% CI, 5.2-5.4) at baseline, 2.6 (95% CI, 2.5-2.7) at 3 months, and 2.3 (95% CI, 2.2-2.4) at 9 months; in the TOF group, it was 5.3 (95% CI, 5.2-5.4) at baseline, 2.4 (95% CI, 2.2-2.5) at 3 months, and 2.3 (95% CI, 2.1-2.4) at 9 months. The estimated average treatment effect was -0.2 (95% CI, -0.4 to -0.03; P = .02) at 3 months and -0.03 (95% CI, -0.2 to 0.1; P = .60) at 9 months.Conclusions and relevanceIn this study, there was a modest but statistically significant reduction in DAS28-CRP at 3 months for patients receiving TOF compared with those receiving ADA and no difference between treatment groups at 9 months. Three months of treatment with either drug led to clinically relevant average reductions in mean DAS28-CRP, consistent with remission.

Dataset Information

Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis.

Publications

Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis.

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