Custom Foot Orthoses for Rheumatoid Arthritis: A Systematic Review

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1 Arthritis Care & Research Vol. 64, No. 3, March 2012, pp DOI /acr , American College of Rheumatology ORIGINAL ARTICLE Custom Foot Orthoses for Rheumatoid Arthritis: A Systematic Review KYM HENNESSY, JAMES WOODBURN, AND MARTIJN P. M. STEULTJENS Objective. To identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in rheumatoid arthritis. Methods. Studies were identified in appropriate electronic databases (from 1950 to March 2011). The search term rheumatoid arthritis with foot and ankle and related terms were used in conjunction with orthoses and synonyms. Included studies were quantitative longitudinal studies and included randomized controlled trials (s), case control trials, cohort studies, and case series studies. All outcome measures were investigated. Quality assessment was conducted using the Cochrane Collaboration criteria with additional criteria for sample population representativeness, quality of statistical analysis, and compliant intervention use and presence of cointerventions. Meta-analyses were conducted for outcome domains with multiple s. Qualitative data synthesis was conducted for the remaining outcome domains. Levels of evidence were then assigned to each outcome measure. Results. The inclusion criteria were met by 17 studies. Two studies had high quality for internal validity and 3 studies had high quality for external validity. No study had high quality for both internal and external validity. Six outcome domains were identified. There was weak evidence for custom orthoses reducing pain and forefoot plantar pressures. Evidence was inconclusive for foot function, walking speed, gait parameters, and reducing hallux abductovalgus angle progression. Conclusion. Custom orthoses may be beneficial in reducing pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle. However, more definitive research is needed in this area. INTRODUCTION Foot and ankle problems continue to be an issue for people with rheumatoid arthritis (RA) (1,2). With the availability of new biologic agents to reduce overall disease activity, clinical remission is now achievable. However, persistent foot and ankle problems may still occur (3,4). This greatly impacts people in regard to pain and functional ability, and ultimately, quality of life (5,6). Consequently, orthoses are commonly used as an adjunct therapy (7). However, the evidence for the effectiveness of orthoses is lacking, as previously shown in other reviews (8,9). Although previous reviews have been conducted, they are now outdated and new randomized controlled trials (s) have been completed since they were conducted. It is a recommendation of the Cochrane Collaboration that Kym Hennessy, BAppSc(Hons), BSc, James Woodburn, PhD, MPhil, BSc(Hons), Martijn P. M. Steultjens, PhD, MSc: Glasgow Caledonian University, Glasgow, UK. Address correspondence to Kym Hennessy, BAppSc(Hons), BSc, Musculoskeletal and Neurological Rehabilitation Research Group, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK. kym.hennessy@gcu.ac.uk. Submitted for publication August 17, 2011; accepted in revised form November 29, systematic reviews are updated biannually, and these previous reviews were completed more than 5 years ago (10). Another concern with the previous reviews is the quality assessment systems used to assess the literature. These did not include assessment of sample representativeness, appraisal of statistical analysis quality, or intervention compliance and presence of cointerventions. Therefore, the outdated nature and lack of quality of the previous reviews indicate the need for a more robust review. The focus of this review will be on custom orthoses. This means the emphasis is on orthotic devices that are specifically made for the participants rather than orthotic devices that can be purchased over the counter. This emphasis is required because the effect of RA on the foot and ankle can be different for each individual person (11). Therefore, the objective of this review was to identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in people with RA for all reported outcome measures. MATERIALS AND METHODS Search strategy. Studies were identified electronically in the following databases: Medline (1950 to March 2011), 311

2 312 Hennessy et al Significance & Innovations Weak level of evidence supported by meta-analysis for custom foot orthoses decreasing pain in the rheumatoid foot and ankle. Weak level of evidence for custom foot orthoses decreasing forefoot plantar pressures in the rheumatoid foot and ankle. Embase (1979 to March 2011), CINAHL (1981 to March 2011), AMED (1987 to March 2011), PEDro (1990 to March 2011), and the Cochrane Library (1974 to March 2011). Studies were also identified by hand searching the reference lists of the electronically identified studies and the authors own literature databases. A 3-way search strategy was employed using rheumatoid arthritis with foot and ankle and related anatomic terms and with orthoses and related synonyms. Associated wildcards and truncations for each database were also used. The full search strategy is available in Supplementary Appendix A (available in the online version of this article at journal/ /(issn) ). Study selection criteria. Included studies were quantitative longitudinal studies of the following designs: s, case control trials, cohort studies, and case series studies. Single-case studies were excluded. No restrictions were imposed on language or year of publication. Studies reporting patients with RA ages 18 years were included. Studies reporting any disease duration were included provided a definitive diagnosis of RA had been established, either according to the American College of Rheumatology revised criteria (12) or as confirmed by a rheumatologist. Additionally, studies that involved other rheumatologic conditions were included if RA subgroup data were reported separately, and mixed-age studies (adults and children) were included if adult subgroup data were reported separately. Studies of all types of orthoses for the foot and ankle were selected for further analysis. No limitations were imposed on who provided the orthoses. All of the outcome measures were selected for further analysis. However, plantar pressure outcome parameters were limited to the forefoot only. This limitation was imposed because the forefoot is where pressure is usually highest due to an increased prevalence of metatarsophalangeal joint deformity in RA (13) and the interrelationship between rearfoot position and forefoot pressure in RA (14). The abstracts of all of the studies found electronically and through hand searching were compared to the inclusion criteria. The selection of abstracts that appeared to meet the inclusion criteria was conducted by 2 independent reviewers (KH and MPMS). For the selected abstracts, full-text articles were obtained and compared to the inclusion criteria prior to quality assessment. Only full-text original research studies were included for quality assessment. Quality assessment. Study quality was assessed using criteria that looked at internal validity (i.e., how well an individual trial was conducted) and external validity (i.e., how representative the sample was of the target RA population) (15). The assessment criteria were adapted from the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0, and included internal validity criteria of sequence generation; allocation concealment; blinding of participants, personnel, and outcome assessors; incomplete outcome data; and selective outcome reporting (10). Additional internal validity criteria were included to determine if the correct statistical analyses were conducted and to determine intervention compliance and the presence of cointerventions. External validity criteria were added to determine the sample population representativeness of the general population with RA and to determine the restrictiveness of the inclusion and exclusion criteria. Quality assessment was performed by 2 independent reviewers (KH and MPMS). Any disagreement was resolved by a third independent reviewer (JW). Data extraction/evidence grading. For outcome measures that had multiple s available, random-effects model meta-analyses were conducted using the standardized mean difference with the 95% confidence interval (95% CI; Review Manager, version 5.1, Cochrane Collaboration). For outcome measures that did not have multiple s available, qualitative data synthesis was conducted. Following the analysis and synthesis of the extracted data, an evidence rating was assigned according to criteria adapted from Ariëns et al in 2000 (16) (Table 1). The interpretation of the findings was based on combining the meta-analyses/qualitative data synthesis and the evidence grading system. RESULTS A total of 268 articles were retrieved using the detailed search strategy. Figure 1 outlines the flow chart used to identify studies for inclusion (17). The inclusion criteria were met by 17 studies and each included study is described in Table 2. Two studies had high quality for internal validity and 15 had low quality for internal validity. Three studies had high quality for external validity and 14 had low quality for external validity. No study had high quality for both internal and external validity (Table 3). Six outcome domains were identified from the included studies, consisting of pain, foot function, walking speed, forefoot plantar pressure, gait parameters, and hallux abductovalgus (HAV) angle progression.. Six s investigated pain (19 24). The metaanalysis showed a moderate effect for custom orthoses reducing pain, although the result was not significant (effect size 0.45; 95% CI 0.00, 0.90) (Figure 2A). However,

3 Review of Effectiveness of Custom Orthoses in Foot and Ankle RA 313 Table 1. Strength of evidence criteria (16) Strong At least 2 high-quality studies with consistent findings* Moderate 1 high-quality study and at least 2 low-quality studies with consistent findings* Weak At least 2 low-quality studies with consistent findings* Inconclusive Insufficient or conflicting studies * Consistent findings are the agreement of 75% of studies. due to the strength of the trend, guarded conclusions can be drawn. Additionally, 5 observational studies also investigated pain (26 28,30,34). The observational studies supported the meta-analysis by showing significant results for the reduction of pain using custom orthoses. The metaanalysis and observational study results show that there is weak evidence to support the effectiveness of custom orthoses in reducing pain. Foot function. Three s investigated foot function (20,21,24). The meta-analysis showed a minimal effect for custom orthoses increasing foot function and the result was not significant (effect size 0.07; 95% CI 0.41, 0.55) (Figure 2B). These s used the Foot Function Index (FFI) as their outcome measure. Another investigated foot function; however, it could not be included in the meta-analysis (19). This was due to the assessment of foot function being 3 portions each of the Robinson Bashall Functional Assessment and the Toronto Activities of Daily Living Measure (6 measures in total), and these were reported individually rather than as a total. The results of this agreed with the meta-analysis in that foot orthoses did not increase foot function. Additionally, 2 observational studies investigated foot function (27,34). These studies used the FFI and the FFI disability subscale, respectively, as their outcome measures. The observational studies disagreed with the meta-analysis results and showed significant results for increasing foot function. Overall, there was inconclusive evidence for custom orthoses increasing foot function. However, the trend was toward custom orthoses not increasing foot function. Walking speed. Three s investigated walking speed (19,22,23). The meta-analysis showed a minimal effect for custom orthoses increasing walking speed and the result was not significant (effect size 0.09; 95% CI 0.27, 0.45) (Figure 2C). Additionally, 3 observational studies investigated walking speed. One observational study agreed with the meta-analysis results showing no significant results for custom orthoses increasing walking speed (33). However, the other observational studies did show significant results (32,34). Overall, there was inconclusive evidence for custom orthoses increasing walking speed. However, the trend was toward custom orthoses not increasing walking speed. Forefoot plantar pressure. One (23) and 3 observational studies (28,29,31) investigated forefoot plantar pressure. Three of the 4 studies showed significant results for custom orthoses decreasing forefoot plantar pressure. Therefore, there was weak evidence for the ability of custom orthoses to decrease forefoot plantar pressure (Table 4). Figure 1. Flow chart of literature search for custom orthoses in rheumatoid arthritis. * multiple outcome measures meant some trials were used for meta-analysis and qualitative studies. Adapted from ref Two s (22,25) and 4 observational studies (28 30,33) investigated a variety of gait parameters. Although there were 2 s available, a metaanalysis could not be conducted due to the variety of the gait variables assessed. Some studies found significant results for stride and step lengths (22,30,33) and joint motion time integral (25). However, the majority of studies showed no significant results for changes in gait parameters. Therefore, the level of evidence for custom orthoses

4 314 Hennessy et al Table 2. Descriptions of included studies* Author, year (ref.) Study type Participant description Entered/ completed study, no. Followup period Intervention Outcome measures Budiman-Mak et al, 1995 (18) Chalmers et al, 2000 (19) Cho et al, 2009 (20) Conrad et al, 1996 (21) Mejjad et al, 2004 (22) Novak et al, 2009 (23) Woodburn et al, 2002 (24) Woodburn et al, 2003 (25) Age years Foot pain Radiologic changes, stage I/II in feet Active disease Flexible functional discrepancies Age 18 years Minimum 2 subluxed MTP joints bilaterally MTP joint pain Stable disease Foot pathology Independent walking Age years Foot pain Radiologic changes, stage I/II in feet Active disease Flexible functional discrepancies Age years Forefoot pain only No midfoot or hindfoot involvement Community walker DAS Stable pharmacologic management Correctable deformities in midfoot/forefoot Intact skin Not using orthoses or orthopedic shoes History of bilateral ST joint or ankle or TN joint pain Valgus heel deformity Normal ROM for ST joint/ankle/mt joint History of bilateral ST joint or ankle or TN joint pain Valgus heel deformity Normal ROM for ST joint/ankle/mt joint 102/88 3 years Functional foot orthoses Placebo orthoses 28/24 12 weeks Semirigid orthoses (in supportive shoes) Soft orthoses (in supportive shoes) Supportive shoes 42/34 6 months Custom semirigid orthoses (in extra-depth forefoot rocker shoes) Ready-made simple soft insoles (in extra-depth forefoot rocker shoes) 102/88 3 years Functional foot orthoses Placebo orthoses 16/16 1 month Custom orthoses (palliative) No orthoses 40/39 6 months Functional foot orthoses Unshaped material 98/81 30 months Custom orthoses No orthoses 98/81 30 months Custom orthoses No orthoses HAV angle 50-foot walking test Foot function FFI FFI Walking speed Plantar pressure 6-minute walking test FFI (continued)

5 Review of Effectiveness of Custom Orthoses in Foot and Ankle RA 315 Table 2. (Cont d) Author, year (ref.) Study type Participant description Entered/ completed study, no. Followup period Intervention Outcome measures Carl et al, 2006 (26) De P Magalhães et al, 2006 (27) Hodge et al, 1999 (28) Jackson et al, 2004 (29) Kavlak et al, 2003 (30) Li et al, 2000 (31) Locke et al, 1984 (32) MacSween et al, 1999 (33) Van der Leeden et al, 2011 (34) ful rheumatoid foot deformity Ability to walk on treadmill Foot pain Age years 1 month without orthoses Forefoot pain on shod weight bearing Forefoot pain on shod weight bearing Treated by rheumatologist Community walker Stable disease (for 3 months) Steinbrocker functional class II Ambulatory No ulceration Foot pain Able to walk without shoes or aids Gait not limited by hip, knee, metatarsal area Age 16 years Bilateral forefoot pain Prescribed custom orthoses Able to walk unaided Podiatry referral for RA-related foot symptoms Age 18 years Uni- or bilateral foot symptoms Prescribed customized orthoses 20/20 6 months Custom orthoses Shoe only 36/ days Made-to-measure orthoses Customized orthoses 11/11 None Custom orthoses Custom orthoses with metatarsal dome Custom orthoses with metatarsal bar Prefabricated orthoses Shoe only 11/11 None Prefabricated insole with metatarsal dome (customized) Prefabricated insole with metatarsal bar (customized) Shoe only 18/18 3 months Custom orthoses Shoe only 12/12 None Custom orthoses No orthoses 10/10 None UCBL orthoses Shoes Barefoot 8/8 None Custom orthoses No orthoses 135/ months Customized orthoses FFI Plantar pressure Plantar pressure Plantar pressure Walking velocity Walking velocity FFI disability subscale 10-meter walking time * randomized controlled trial; RA rheumatoid arthritis; HAV hallux abductovalgus; MTP metatarsophalangeal; FFI Foot Function Index; DAS28 Disease Activity Score in 28 joints; ST subtalar; TN talonavicular; ROM range of motion; MT midtarsal; UCBL University of California Biomechanics Laboratory. Repeat-measures design.

6 316 Hennessy et al Table 3. Quality assessment of included studies* Author, year (ref.) a b c d e f Internal validity External validity Budiman-Mak et al, 1995 (18) High High High High High Low High Low Chalmers et al, 2000 (19) High High Low High High High Low High Cho et al, 2009 (20) Low Low Low Low Low Low Low Low Conrad et al, 1996 (21) High High High High High Low High Low Mejjad et al, 2004 (22) Low Low Low High Low Low Low Low Novak et al, 2009 (23) High High High Low Low Low Low Low Woodburn et al, 2002 (24) High Low High High High Low Low Low Woodburn et al, 2003 (25) High Low High Low High Low Low Low Carl et al, 2006 (26) N/A N/A High Low Low Low Low Low De P Magalhães et al, 2006 (27) N/A N/A High High Low High Low High Hodge et al, 1999 (28) N/A N/A High Low Low Low Low Low Jackson et al, 2004 (29) N/A N/A High Low Low Low Low Low Kavlak et al, 2003 (30) N/A N/A Low Low Low Low Low Low Li et al, 2000 (31) N/A N/A High High Low Low Low Low Locke et al, 1984 (32) N/A N/A Low Low Low Low Low Low MacSween et al, 1999 (33) N/A N/A High Low Low Low Low Low Van der Leeden et al, 2011 (34) N/A N/A High High Low High Low High * Randomized controlled trial: 5 domains for internal validity (a, b, c, d, and e) and 1 domain for external validity (f). trial: 3 domains for internal validity (c, d, and e) and 1 domain for external validity (f). a sequence generation/allocation concealment; b blinding; c incomplete outcome data; d selective outcome reporting/statistical issues; e interventions; f generalizability; N/A not applicable. High quality for validity: all included domains are rated high quality. Low quality for validity: 1 included domain is rated low quality. affecting gait parameters was inconclusive due to conflicting study results (Table 4). HAV angle progression. One investigated HAV angle progression (18). The study found that custom orthoses did reduce the risk of increasing the HAV angle. However, there is an inconclusive level of evidence due to the lack of conducted studies (Table 4). DISCUSSION Weak levels of evidence were found for custom foot orthoses reducing pain and forefoot plantar pressures. Inconclusive evidence was present for foot function, walking speed, gait parameters, and HAV angle progression. Patient-focused outcomes appeared to have higher levels of evidence opposed to mechanistic outcomes. Additionally, the lack of completed studies of custom orthoses led to evidence for some outcomes being classified as inconclusive. These results are similar to previous reviews in this area that showed that foot orthoses may be beneficial for some outcomes such as pain (8,9). However, unlike previous reviews, effect sizes were able to be calculated for 3 outcome measures and a level of evidence was assigned for all outcome measures. The level of evidence was determined by the quality assessment and as all included studies were rated as low quality, a weak level of evidence was the maximum that was achievable for any outcome domain. Therefore, although the meta-analyses allowed an effect size to be determined, and in combination with qualitative data synthesis allowed the consistency of the results to be ascertained, the level to which these results could be seen as a true reflection of effectiveness was determined by the level of evidence grading. To our knowledge, this is the only systematic review in this area to have utilized a quality assessment criterion that emphasizes the external validity of the included studies. When assessing study quality, external validity is important because effectiveness studies are conducted primarily to inform clinical practice. The external validity criteria implemented related to the generalizability of the sample population and the restrictiveness of the inclusion and exclusion criteria. Our findings have shown that external validity issues are not adequately addressed in the majority of studies, with only 3 studies having high quality for external validity. The main reason for the low external validity was that studies were conducted using convenience samples within small areas. This is opposed to multicenter studies, which allow for increased generalizability due to their wider recruitment (35). Despite demonstrating low external validity, many of the studies made unsupported generalizations about the use of the intervention in the general population with RA. This means that in future studies the sample population should reflect the general population that the intervention is to be used for (15). Alternatively, restrictions in the applicability of the interventions should be highlighted. Additional internal validity criteria were added to the quality assessment to increase its robustness. This was required because previous reviews had not used predefined criteria or used criteria that emphasized double blinding. Double blinding is not generally possible in physical intervention studies. This leads to a scale that is not responsive enough to differentiate levels of quality in these studies (36,37). Extended criteria including compliant use of interventions and the presence of cointerventions addressed potential bias resulting from the use of pharmacologic interventions for a systemic disease. This

7 Review of Effectiveness of Custom Orthoses in Foot and Ankle RA 317 Figure 2. Meta-analyses of custom orthoses versus control for outcome measures of A, pain, B, foot function, and C, walking speed. 95% CI 95% confidence interval. has also been overlooked in previous reviews. Therefore, using amended quality assessment criteria, although nonstandard, was necessary to account for these issues. This is also the first review to have utilized a metaanalysis to investigate the effectiveness of custom foot orthoses on various outcome measures. This was possible because more s have been completed since previous reviews were conducted and multiple S are required for this type of analysis. The management of RA has recently taken a more targeted and aggressive pharmacologic approach with the introduction of biologic agents (38). Even though this is the case, custom orthoses are still an important adjunct therapy (11). This is due to a number of reasons: 1) persistent foot and ankle problems still occur even after clinical remission is reached (3), 2) people with increased disease states may have mechanical foot impairments that need treatment in conjunction with systemic management, and 3) people who have not responded to or are ineligible for biologic agents continue to have active foot impairments (11). It is arguable, therefore, that the implementation of custom orthoses should take a more targeted and aggressive approach (11). The included studies had populations that were very heterogeneous in regard to disease duration, which is good for generalizability to the broader population that has RA. However, with a more targeted and aggressive approach to orthoses treatment, studies are required that specifically establish optimal timing for interventions or mechanisms of action, particularly in early disease. Unfortunately, only 2 included studies (using the same sample population) focused on relatively early RA

8 318 Hennessy et al Table 4. Qualitative synthesis results and overview of evidence* Author, year (ref.) Results Level of evidence Plantar pressure Novak et al, 2009 (23) No significant results (0/2) Weak evidence for orthoses 2 forefoot plantar pressure due to 3 of 4 studies showing significant results Hodge et al, 1999 (28) Significant results (11/12) All orthoses types 2 AP more than shoes alone in MTH 1 and 2 (P 0.05) CFOD, CFOB, and PFO 2 AP more than shoes alone in MTH 3 5 (P 0.05) Jackson et al, 2004 (29) Significant results (2/6) CFOD (MD 33.00; P 0.02) and CFOB (MD 58.00; P 0.02)2 PP in MT joints 2 4 more than shoes alone Li et al, 2000 (31) Significant result (1/1) Orthoses 2 PP in forefoot (MD 0.41; P ) Mejjad et al, 2004 (22) Significant result (1/24) Orthoses 1 step length (MD 0.05; P 0.05) Woodburn et al, 2003 (25) Significant results (3/6) Orthoses changed DF/PF MTI compared to barefoot (MD ; P ) Orthoses changed inversion/eversion MTI compared to barefoot (MD ; P ) and shod (MD ; P 0.009) Hodge et al, 1999 (28) No significant results (0/4) Jackson et al, 2004 (29) No significant results (0/2) Kavlak et al, 2003 (30) Significant results (2/4) Orthoses 1 step length (MD 10.00; P 0.05) and stride length (MD 26.00; P 0.05) MacSween et al, 1999 (33) Significant result (1/2) Orthoses 1 average stride (MD 4.35; P 0.05) HAV angle progression Budiman-Mak et al, 1995 (18) Significant result (1/1) Orthoses 2 HAV angle progression (OR 0.3, P 0.05) Inconclusive due to conflicting study results Inconclusive due to lack of studies * 2 decreased; AP average pressure; MTH metatarsal head; CFOD custom foot orthoses with metatarsal dome; CFOB custom foot orthoses with metatarsal bar; PFO prefabricated foot orthoses; MD mean difference; PP peak pressure; MT metatarsal; 1 increased; DF dorsiflexion; PF plantar flexion; MTI motion time integral; HAV hallux abductovalgus; OR odds ratio. (24,25). These issues need to be addressed in further research with the implementation of a definitive for custom foot orthoses. There was conflicting evidence for one outcome, due to 3 observational studies showing a reduction in the outcome and 1 showing no reduction. Due to the low quality of this, it was assigned no greater weighting than the observational studies for this outcome domain. Therefore, as 75% of the studies were in agreement, a weak level of evidence was assigned. The limitations of this systematic review mainly relate to the assumptions made in order to conduct the metaanalyses. The first assumption was that even though designs and materials used for the custom orthoses were different, the orthoses were all made specifically for each individual participant. Although it is usually difficult to compare different designs and materials in this type of analysis, it is justified because this diversity reflects current clinical practice. In clinical practice, orthoses are made according to the individual requirements of the person. This is seen in the different designs and modifications of the orthoses and also the materials that are used to manufacture them (11). The assumption of nonstandardization was also employed for the control conditions. The control conditions in the included trials were either shoe-only (no orthoses) or placebo orthoses. This meant that there may have been an overestimation of effect in the trials that had shoe-only control. This may have had implications for the meta-analysis in that larger effect sizes were being combined. However, conversely there may have been an underestimation of effect of the custom orthoses in the trials that had a placebo control. This is due to these trials making the assumption that the placebo control had no effect, even though this was not tested.

9 Review of Effectiveness of Custom Orthoses in Foot and Ankle RA 319 The second assumption was that the outcome measures within each domain were the same even if the methods of determining these outcomes were different (for example, pain is pain, no matter the measurement method). The differences in outcome measures were accounted for in the meta-analyses by using standardized mean differences (39). In conclusion, current evidence suggests that custom orthoses are beneficial for the treatment of pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle. However, due to the generally low quality of studies, their effectiveness has not been established unequivocally. Therefore, a definitive is still needed for custom orthoses in the treatment of the rheumatoid foot and ankle. ACKNOWLEDGEMENTS The authors would like to acknowledge librarians Marion Kelt and Elizabeth Crawford for their help with developing the search strategy. AUTHOR CONTRIBUTIONS All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Ms Hennessy had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study conception and design. Hennessy, Woodburn, Steultjens. Acquisition of data. Hennessy, Steultjens. Analysis and interpretation of data. Hennessy, Woodburn, Steultjens. REFERENCES 1. Grondal L, Tengstrand B, Nordmark B, Wretenberg P, Stark A. The foot: still the most important reason for walking incapacity in rheumatoid arthritis. Distribution of symptomatic joints in 1,000 RA patients. Acta Orthop 2008;79: Van der Leeden M, Steultjens MP, Ursum J, Dahmen R, Roorda LD, van Schaardenburg D, et al. Prevalence and course of forefoot impairments and walking disability in the first eight years of rheumatoid arthritis. 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10 320 Hennessy et al 31. Li CY, Imaishi K, Shiba N, Tagawa Y, Maeda T, Matsuo S, et al. Biomechanical evaluation of foot pressure and loading force during gait in rheumatoid arthritic patients with and without foot orthosis. Kurume Med J 2000;47: Locke M, Perry J, Campbell J, Thomas L. Ankle and subtalar motion during gait in arthritic patients. Phys Ther 1984;64: MacSween A, Brydson G, Hamilton J. The effect of custom moulded ethyl vinyl acetate foot orthoses on the gait of patients with rheumatoid arthritis. Foot 1999;9: Van der Leeden M, Fiedler K, Jonkman A, Dahmen R, Roorda L, van Schaardenburg D, et al. Factors predicting the outcome of customised foot orthoses in patients with rheumatoid arthritis: a prospective cohort study. J Foot Ankle Res 2011; 4: Multicenter trials. In: Friedman LM, Furberg CD, DeMets DL, editors. Fundamentals of clinical trials. 4th ed. New York: Springer; p Herbison P, Hay-Smith J, Gillespie WJ. Adjustment of metaanalyses on the basis of quality scores should be abandoned. J Clin Epidemiol 2006;59: Olivo SA, Macedo LG, Gadotti IC, Fuentes J, Stanton T, Magee DJ. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther 2008;88: Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 2010;69: Normand ST. Meta-analysis: formulating, evaluating, combining, and reporting. Stat Med 1999;18:

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