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Patient expectations and long-term outcomes in rheumatoid arthritis patients: results from the SARA (Silicone Arthroplasty in Rheumatoid Arthritis) study.

ABSTRACT: Little evidence exists to understand the influence of patient expectations on outcomes for silicone metacarpophalangeal arthroplasty (SMPA). The purpose of this paper is to compare long-term treatment outcome experiences regarding hand function/appearance for a surgical and nonsurgical cohort of rheumatoid arthritis (RA) patients and contrast them to expectations at baseline. This sample is part of a larger multicenter prospective cohort study of RA patients enrolled from 2004 to 2008. A total of 169 RA patients with severe deformities at the metacarpophalangeal (MCP) joints were recruited in the original study. Expectations for SMPA were collected at enrollment. A follow-up patient-reported questionnaire was completed at long-term follow-up. Baseline expectation questionnaires were collected from 137 patients, and follow-up data from 84 patients (average 6.7 years follow-up). At baseline, a significantly higher percent of patients who chose surgery expected to do "Anything I want" or "More activities than I do now" 1 year from enrollment than those who chose nonsurgical treatment. At follow-up, surgical patients remained more likely to indicate that they were currently able to do "Anything" or "More activities" than nonsurgical patients. A higher percentage of surgical patients were "very satisfied" or "quite satisfied" with their treatment compared to nonsurgical patients. RA subjects who chose SMPA reported greater expectations for surgery prior to surgery and also greater levels of hand function and satisfaction at long-term follow-up.

SUBMITTER: Chung KC

PROVIDER: S-EPMC4374599 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Patient expectations and long-term outcomes in rheumatoid arthritis patients: results from the SARA (Silicone Arthroplasty in Rheumatoid Arthritis) study.

Chung Kevin C KC Nellans Kate W KW Burns Patricia B PB Wilgis E F Shaw EF Burke Frank D FD Fox David A DA Kim H Myra HM

Clinical rheumatology 20140930 4

Little evidence exists to understand the influence of patient expectations on outcomes for silicone metacarpophalangeal arthroplasty (SMPA). The purpose of this paper is to compare long-term treatment outcome experiences regarding hand function/appearance for a surgical and nonsurgical cohort of rheumatoid arthritis (RA) patients and contrast them to expectations at baseline. This sample is part of a larger multicenter prospective cohort study of RA patients enrolled from 2004 to 2008. A total o ...[more]

PMID: 25267562

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Project description:BackgroundThere is a paucity of research evaluating the cost-effectiveness of surgical interventions for rheumatoid arthritis patients. Previous reports have challenged the sustainability of improved outcomes after silicone metacarpophalangeal arthroplasty. The authors conducted an economic evaluation of the long-term health outcomes after silicone metacarpophalangeal arthroplasty.MethodsThe authors performed a 5-year prospective cohort study of 170 patients with rheumatoid arthritis (73 surgical and 97 nonsurgical). Objective functional measurements and patient-rated outcomes using the Michigan Hand Outcomes Questionnaire and the Arthritis Impact Measurement Scale 2 were collected at 3 and 5 years. A cost-effectiveness analysis using direct costs from Medicare outpatient claims data (2006 to 2010) was performed to estimate the incremental cost-effectiveness ratios for both the Michigan and Arthritis Impact Measurement Scale 2 measurements.ResultsAt 5 years, the authors observed a statistically significant difference in upper extremity outcomes (Michigan Hand Outcomes Questionnaire) between the two groups, with surgical patients having higher outcomes. Costs associated with improved outcomes 5 years after surgery were $787 to $1150 when measured by the Michigan Hand Outcomes Questionnaire and $49,843 to $149,530 when measured by the Arthritis Impact scale. The incremental cost-effectiveness ratios did not substantially increase with their observed surgical revision rate of 5.5 percent (approximately 4 percent increase in incremental cost-effectiveness ratio) or with previously published long-term revision rates of 6.2 percent (approximately 6 percent increase in incremental cost-effectiveness ratio).ConclusionsShort-term improvements in upper extremity outcomes after silicone metacarpophalangeal arthroplasty are maintained over the 5-year follow-up period. These outcomes are achieved at a relatively low cost, even with the addition of potential surgical complications.

Project description:BackgroundOutcomes after total ankle arthroplasty (TAA) combined with additive techniques (augmentation of bone strength, control of soft-tissue balance, adjustment of the loading axis) for the treatment of rheumatoid arthritis were evaluated after intermediate to long-term follow-up. The influences of biologic treatment on the outcomes after TAA were also evaluated.MethodsWe performed a retrospective observational study involving 50 ankles (44 patients) that underwent TAA for the treatment of rheumatoid arthritis. The mean duration of follow-up was 7.1 years. Clinical outcomes were evaluated with use of the Japanese Society for Surgery of the Foot (JSSF) scale score and a postoperative self-administered foot-evaluation questionnaire (SAFE-Q). Radiographic findings were evaluated as well. These parameters also were compared between patients managed with and without biologic treatment.ResultsThis procedure significantly improved the clinical scores of the JSSF rheumatoid arthritis foot and ankle scale (p < 0.0001). Forty-eight of the 50 ankles had no revision TAA surgery. Subsidence of the talar component was seen in 8 ankles (6 in the biologic treatment group and 2 in the non-biologic treatment group); 2 of these ankles (both in the biologic treatment group) underwent revision TAA. The social functioning score of the SAFE-Q scale at the time of the latest follow-up was significantly higher in the biologic treatment group (p = 0.0079). The dosage of prednisolone (p = 0.0003), rate of usage of prednisolone (p = 0.0001), and disease-activity score (p < 0.01) at the time of the latest follow-up were all significantly lower in the biologic treatment group.ConclusionsTAA is recommended for the treatment of rheumatoid arthritis if disease control, augmentation of bone strength, control of soft-tissue balance, and adjustment of the loading axis are taken into account. The prevention of talar component subsidence remains a challenge in patients with the combination of subtalar fusion, rheumatoid arthritis, and higher social activity levels.Level of evidenceTherapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Project description:IntroductionAs patients with rheumatoid arthritis (RA) receive treatment with anti-tumour necrosis factors over several years, it is important to evaluate their long-term safety and efficacy. The objective of this study was to examine the safety and benefits of certolizumab pegol (CZP)+methotrexate (MTX) treatment for almost 5 years in patients with RA.MethodsPatients who completed the 24-week Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 2 randomized controlled trial (RCT; NCT00160602), or who were American College of Rheumatology (ACR) 20 non-responders at Week 16, entered the open-label extension (OLE; NCT00160641). After ≥6 months treatment with CZP 400 mg every two weeks (Q2W), dose was reduced to 200 mg Q2W, the approved maintenance dose. Safety data are presented from all patients who received ≥1 dose CZP (Safety population, n=612). Efficacy data are presented to Week 232 for the intent-to-treat (ITT, n=492) and Week 24 CZP RCT Completer (n=342) populations, and through 192 weeks of dose-reduction for the Dose-reduction population (patients whose CZP dose was reduced to 200 mg, n=369). Radiographic progression (modified total Sharp score change from RCT baseline >0.5) to Week 128 is reported for the Week 24 CZP Completers.ResultsIn the RCT, 619 patients were randomized to CZP+MTX (n=492) or placebo+MTX (n=127). Overall, 567 patients (91.6%) entered the OLE: 447 CZP and 120 placebo patients. Of all randomized patients, 358 (57.8%) were ongoing at Week 232. Annual drop-out rates during the first four years ranged from 8.4-15.0%. Event rates per 100 patient-years were 163.0 for adverse events (AEs) and 15.7 for serious AEs. Nineteen patients (3.1%) had fatal AEs (incidence rate=0.8). Clinical improvements in the RCT were maintained to Week 232 in the CZP Completers: mean Disease Activity Score 28 (Erythrocyte Sedimentation Rate) change from baseline was -3.4 and ACR20/50/70 responses 68.4%/47.1%/25.1% (non-responder imputation). Similar improvements observed in the ITT were maintained following dose-reduction. 73.2% of CZP Completers had no radiographic progression at Week 128.ConclusionsIn patients with active RA despite MTX therapy, CZP was well tolerated, with no new safety signals identified. CZP provided sustained improvements in clinical outcomes for almost 5 years.Trial registrationClinicalTrials.gov, NCT00160602 and NCT00160641 . Registered 8 September 2005.

Dataset Information

Patient expectations and long-term outcomes in rheumatoid arthritis patients: results from the SARA (Silicone Arthroplasty in Rheumatoid Arthritis) study.

Publications

Patient expectations and long-term outcomes in rheumatoid arthritis patients: results from the SARA (Silicone Arthroplasty in Rheumatoid Arthritis) study.

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