Proceedings of the 2020 GRAPPA Collaborative Research Network (CRN) Meeting.

At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Collaborative Research Network (CRN) annual meeting, the GRAPPA-CRN group presented a pilot investigator-initiated study protocol to test electronic case report forms (eCRFs) and proposed Standardized Operating Procedures (SOPs) to evaluate biomarkers of psoriatic arthritis (PsA) associated with axial disease. The progress on 3 studies was also presented: BioDAM PsA (Biomarkers as Predictors of structural DAMage in PsA; to validate soluble biomarkers as predictors of structural damage in PsA), PreventPsA (examining the development of PsA and risk factors among patients with psoriasis and no arthritis), and PredictORPsA (Predicting Treatment respOnse in patients with eaRly PsA; in collaboration with Pfizer using samples from the Oral Psoriatic Arthritis TriaL [OPAL], to identify biomarkers of treatment response). GRAPPA-CRN funding partnerships and applications are also underway with both the Innovative Medicines Initiative (IMI) in Europe and Accelerating Medicines Partnerships (AMP) 2.0 in the USA, and the progress of these applications and associated objectives were presented.

Development of an Instrument for Patient Self-assessment in Psoriatic Arthritis.

OBJECTIVE: Due to the recent pandemic caused by the coronavirus disease 2019 (COVID-19), in-person scheduled rheumatology appointments in many countries have been reserved for urgent cases only. Here we report the development of a multidimensional, patient-completed disease assessment tool for use in psoriatic arthritis (PsA). METHODS: A focus group development and education method was used, followed by a paired observation design to assess feasibility and validity. The Psoriatic Arthritis Disease Activity Score (PASDAS) was used as the basis for the clinical assessments, but elements of this tool were modified during the focus group sessions. RESULTS: A preliminary tool assessed tender and swollen joint counts, enthesitis, dactylitis, area of skin involved by psoriasis, and scores for global disease activity, fatigue, and spinal pain. In parallel assessments, good agreement was found between subject and healthcare professional (HCP) assessors, although overall disease activity was low. CONCLUSION: A self-assessment tool for disease activity in PsA has been developed in conjunction with patients, demonstrating generally good agreement between patients and HCPs; however, further validation is needed before it can be recommended for clinical practice.

Evaluation and Validation of a Patient-completed Psoriatic Arthritis Flare Questionnaire.

OBJECTIVE: Evaluation of a psoriatic arthritis (PsA), multidimensional, patient-completed disease flare questionnaire (FLARE). METHODS: The FLARE questionnaire was administered to 139 patients in a prospective observational study. The "gold standard" of flare was based on patient opinion. Test-retest reliability was evaluated by intraclass correlation coefficient (ICC). Disease activity was measured by the Psoriatic Arthritis Disease Activity Score (PASDAS), Group for Research and Assessment of Psoriasis and PsA (GRAPPA) Composite Exercise (GRACE), Composite Psoriatic Disease Activity Index (CPDAI), and Disease Activity Index for Psoriatic Arthritis (DAPSA). RESULTS: The most common symptoms of a PsA flare were musculoskeletal, followed by fatigue, frustration, loss of function, and an increase in cutaneous symptoms. The test-retest ICC for the FLARE questionnaire was 0.87 (95% CI 0.72-0.94). The optimum cut-off to identify a flare of disease was 4/10 (sensitivity 0.82, specificity 0.76; area under the curve 0.85). For those patients scoring ≥ 4, the mean score for the composite measures was as follows (score for those not reporting a flare in parentheses): PASDAS 5.3 ± 1.3 (3.1 ± 1.6); GRACE 4.5 ± 1.2 (2.2 ± 1.4); CPDAI 8.9 ± 2.5 (4.7 ± 3.1); and DAPSA 38.2 ± 20.3 (16.8 ± 14.9). In a new flare, the increase in composite measure score was calculated as follows: 1 for PASDAS and GRACE, 2 for CPDAI, and 7 for DAPSA. Agreement between the definition of flare using the cut-off of 4 from the questionnaire, and that indicated by the subject in a separate, standalone question was 0.57 (Cohen κ). CONCLUSION: A PsA flare displays escalation of symptoms and signs across multiple domains. The FLARE questionnaire has external validity in terms of both composite disease activity and overall patient opinion about the state of their condition.

Proceedings of the 2020 GRAPPA Collaborative Research Network (CRN) Meeting.

At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)- Collaborative Research Network (CRN) annual meeting, the GRAPPA-CRN group presented a pilot investigator-initiated study protocol to test electronic case report forms (eCRFs) and proposed Standardized Operating Procedures (SOPs) to evaluate biomarkers of psoriatic arthritis (PsA) associated with axial disease. The progress on 3 studies was also presented: BioDAM PsA (Biomarkers as Predictors of structural DAMage in PsA; to validate soluble biomarkers as predictors of structural damage in PsA), PreventPsA (examining the development of PsA and risk factors among patients with psoriasis and no arthritis), and PredictORPsA (Predicting Treatment respOnse in patients with eaRly PsA; in collaboration with Pfizer using samples from the Oral Psoriatic Arthritis TriaL [OPAL], to identify biomarkers of treatment response). GRAPPA-CRN funding partnerships and applications are also underway with both the Innovative Medicines Initiative (IMI) in Europe and Accelerating Medicines Partnerships (AMP) 2.0 in the USA, and the progress of these applications and associated objectives were presented.

A clinical and radiographic comparison of patients with psoriatic arthritis from different ethnic backgrounds.

OBJECTIVES: There are few papers concerning ethnic differences in disease expression in PsA, which may be influenced by a number of genetic, lifestyle and cultural factors. This article aims to compare clinical and radiographic phenotypes in people of South Asian (SA) and North European (NE) origin with a diagnosis of PsA. METHODS: This was a cross-sectional observational study recruiting patients of SA and NE origin from two hospitals in a well-defined area in the North of England. RESULTS: A total of 58 SA and 48 NE patients were recruited. SA patients had a more severe clinical phenotype with more tender (median 5 vs 2) and swollen (median 1 vs 0) joints, more severe enthesitis (median 3 vs 1.5), more patients with dactylitis (24% vs 8%), more severe skin disease (median PASI 2.2 vs 1) and worse disease activity as measured by the composite Psoriatic Arthritis Disease Activity Score (mean 4.5 vs 3.6). With regards to patient-completed measures, SA patients had worse impact with poorer quality of life and function (mean HAQ 0.9 vs 0.6; mean PsAQoL 10.8 vs 6.2; mean 36-item short form physical component score 33.5 vs 38.9). No significant differences in current MTX and biologics use were found. CONCLUSIONS: SA patients had a worse clinical phenotype and worse impact of disease than NE patients. Further studies are needed to confirm and explore the reasons behind these differences.

Proceedings of the 2019 GRAPPA Collaborative Research Network Meeting.

At the 2019 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis-Collaborative Research Network annual meeting, the group presented its progress in selecting a database platform; items to include in an electronic case report form (eCRF); and standardized operating procedures (SOP) for the collection, processing, storage, and transport of biomaterial. A pilot investigator-initiated study was also proposed that, in addition to addressing an area of unmet need, would allow for the testing of both the eCRF and SOP.

Comparing Psoriatic Arthritis Low-field Magnetic Resonance Imaging, Ultrasound, and Clinical Outcomes: Data from the TICOPA Trial.

OBJECTIVE: The Tight Control of inflammation in Psoriatic arthritis (TICOPA; isrctn.com: ISRCTN30147736) trial compared standard care (StdC) and tight control (TC) in early psoriatic arthritis (PsA), demonstrating better outcomes for TC. This substudy evaluated the performance metrics of modern imaging outcomes and compared them to the clinical data. METHODS: Non-contrast 0.2T magnetic resonance imaging (MRI; single hand) was assessed using the Outcomes in Rheumatology (OMERACT) PsA MRI Scoring System (PsAMRIS) with an additional global inflammation score. Ultrasound (US; same hand) was scored for greyscale, power Doppler, and erosions at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints and scores summated. RESULTS: Seventy-eight patients had paired (baseline and 48 weeks) US data and 61 paired MRI data; 50 had matched clinical, MR, and US data. Significant within-group changes were seen for the inflammatory PsAMRIS components at MCP level: MRI global inflammation [median difference (range), standardized response mean (SRM)]: 3.25 (-5.0 to 12.0), 0.68; 1.0 (-4.5 to 17.5), 0.45 for TC and StdC, respectively. Similar within-group differences were obtained for US: 1.0 (-13.0 to 23.0), 0.45; 3.0 (-6.0 to 21.0), 0.77 for TC and StdC, respectively. No differences were seen between treatment groups. Significant correlations were found between baseline and change MRI and US scores. A significant correlation was found between baseline PsA disease activity scores and MRI global inflammation scores (Spearman ρ for MCP, PIP: 0.46, 0.63, respectively). No differences in erosion progression were observed. CONCLUSION: The PsAMRIS and US inflammation scores demonstrated good responsiveness. No between-group differences were demonstrated, but this substudy was likely underpowered to determine differences between the 2 treatment strategies.

Foot orthoses for people with rheumatoid arthritis: a survey of prescription habits among podiatrists.

BACKGROUND: Guidelines 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. METHODS: One 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. RESULTS: UK 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. CONCLUSIONS: Considerable 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.

A survey of foot orthoses prescription habits amongst podiatrists in the UK, Australia and New Zealand.

BACKGROUND: Foot orthoses are frequently used but little is known about which types are used in contemporary practice. This study aimed to explore the types of foot orthoses currently used by podiatrists and the prescription variations in a range of conditions. METHODS: A web-based, cross-sectional survey was distributed through professional bodies in the United Kingdom (UK), Australia, and New Zealand. Questions focussed on foot orthosis prescription habits in relation to 26 conditions affecting the back and lower limb. RESULTS: Two hundred and sixty-four podiatrists practising in 19 different countries completed the survey; the majority practised in the UK (47%, n = 124), Australia (30%, n = 79) and New Zealand (12%, n = 32). Respondents qualified between 1968 and 2016, and 147 (56%) were female. Respondents worked in different healthcare sectors and this varied between countries: 42 (34%) respondents in the UK worked solely in the public sector, compared to 3 (4%) in Australia and 2 (6%) in New Zealand. Forty-four (35%) respondents in the UK worked solely in private practice, compared to 64 (81%) in Australia and 14 (44%) in New Zealand.UK respondents prescribed more prefabricated orthoses per week (mean 5.5 pairs) than simple insole-type devices (±2.7) and customised devices (±2.9). Similarly, respondents in New Zealand prescribed more prefabricated orthoses per week (±7.7) than simple (±1.4) and customised (±2.8) devices. In contrast, those in Australia prescribed more customised orthoses per week (±4.4) than simple (±0.8) and prefabricated (±1.9) orthoses. Differences in the types of orthoses prescribed were observed between country of practice, working sector, and the condition targeted. Generally, prefabricated orthoses were commonly prescribed for the 26 highlighted conditions in the UK and New Zealand. Australian podiatrists prescribed far fewer devices overall, but when they did prescribe, they were more likely to prescribe custom devices. Respondents in all three countries were more likely to prescribe customised orthoses for people with diabetes complicated by peripheral neuropathy than for diabetes without this complication. CONCLUSIONS: Foot orthosis prescription habits vary between countries. Prefabricated orthoses were frequently prescribed in the UK and New Zealand, and customised orthoses in Australia. Prescriptions for people with diabetes differed depending on the presence of neuropathy, despite a lack of robust evidence supporting these decisions. This study provides new insight into contemporary practice.

An educational leaflet improves response to invitation for screening for arthritis in patients with psoriasis in primary care, but only in practices in the most deprived areas.

This study hypothesises that an educational leaflet about psoriatic arthritis (PsA) will improve psoriasis patients' attendance for screening for PsA. A random sample of patients ≥18 years old with a coded diagnosis of psoriasis and no diagnosis of PsA, rheumatoid arthritis or ankylosing spondylitis were identified from five GP surgeries in Yorkshire, UK. Patients were randomised 1:1 to receive study information alone or with the educational leaflet, with an invitation to attend for a screening examination by a dermatologist and rheumatologist. Nine hundred thirty-two invitation packs were sent to recruit 191 (20.5%) participants. One hundred sixty-nine (88.5%) had current or previous psoriasis and 17 (10.1%) had previously undiagnosed PsA. The estimated prevalence of PsA was 18.1% (95% CI: 16.2, 20.1%).The response rate was lower than expected and was not significantly higher when patients received the educational leaflet (22.8 vs 18.3%, p = 0.08). Response rates varied by practice (14.7 to 30.6%). However, deprivation scores for each practice revealed a significant increase in response with the leaflet for deprivation decile of 3 (p < 0.001) but no significant differences in the other practices. An educational leaflet about PsA improves attendance for screening in primary care, but only in those practices with higher levels of socioeconomic deprivation.

A discrete choice experiment to explore patients' willingness to risk disease relapse from treatment withdrawal in psoriatic arthritis.

The objective of this study is to assess patient preferences for treatment-related benefits and risk of disease relapse in the management of low disease states of psoriatic arthritis (PsA). Focus groups with patients and a literature review were undertaken to determine the characteristics of treatment and symptoms of PsA important to patients. Patient preferences were assessed using a discrete choice experiment which compared hypothetical treatment profiles of the risk and benefits of treatment withdrawal. The risk outcome included increased risk of disease relapse, while benefit outcomes included reduced sickness/nausea from medication and changes in health-related quality of life. Each patient completed 12 choice sets comparing treatment profiles. Preference weights were estimated using a logic regression model, and the maximum acceptable risk in disease relapse for a given improvement in benefit outcomes was elicited. Final sample included 136 patients. Respondents attached the greatest importance to eliminating severe side effects of sickness/nausea and the least importance to a change in risk of relapse. Respondents were willing to accept an increase in the risk of relapse of 32.6 % in order to eliminate the side effects of sickness/nausea. For improvements in health status, the maximum acceptable risk in relapse was comparable to a movement from some to no sickness/nausea. The study suggests that patients in low disease states of PsA are willing to accept greater risks of relapse for improvements in side effects of sickness/nausea and overall health status, with the most important benefit attribute being the elimination of severe sickness or nausea.

Development of a Flare Instrument for Use in Psoriatic Disease: A Report from the 2015 GRAPPA Annual Meeting.

OBJECTIVE: The objective of this Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) initiative is to develop a questionnaire to determine the presence of a flare of disease activity in psoriatic disease (PsD), for use in clinical care and research settings. METHODS: In 2014 and 2015, 2 online Delphi surveys of patients and physicians attempted to achieve consensus about items that might discriminate a flare of disease. In the first round, items were derived from previous qualitative studies with patients; in the second round, new items, suggested by both patients and physicians, were added. Survey results were discussed at the 2015 GRAPPA annual meeting, and 8 breakout groups discussed specific aspects of PsD flares. RESULTS: Survey participants were patients (n = 103 and n = 57 in rounds 1 and 2) and physicians (n = 125 and n = 81). Items for flare covered 6 domains (joints, skin, emotion, participation, fatigue, and unclassified). Patients agreed that 20 items were important (10 joints, 1 participation, 8 fatigue, 1 unclassified), and physicians agreed on 23 items (5 skin, 11 joints, 4 participation, 3 unclassified). Eight items were selected as important by both groups: 7 joint items and 1 unclassified. Patients emphasized fatigue and physicians emphasized skin and participation. Breakout groups concluded that the components of a flare instrument should be derived from patients. A flare should be defined as a change in disease state requiring intervention. CONCLUSION: The concept of flare in PsD covers articular, skin, emotional, participation, and fatigue domains. Further work is required to specify items that represent these domains.

A feasibility study for a randomised controlled trial of treatment withdrawal in psoriatic arthritis (REmoval of treatment for patients in REmission in psoriatic ArThritis (RETREAT (F)).

TNF therapy is effective for all aspects of psoriatic disease, but these drugs are costly and the long-term effects are unknown. Further, methotrexate causes concern with long-term adverse events. The purpose of this pilot study was to test the feasibility of drug withdrawal from patients with psoriatic arthritis, in stable low disease state. We examined the availability of patients, their willingness to participate, study procedures, and the proportion of patients in the withdrawal arm who relapsed during the study. Low disease state was defined by minimal disease activity criteria (MDA), and relapse by failure to achieve these criteria. Patients in the withdrawal group underwent a phased withdrawal of medication where the last treatment added was the first withdrawn. Assessments were monthly for 3 months before study exit. Seventy-two patients were invited to participate, of which 57 were found to be eligible. Twenty-six (36.1 %) subsequently attended the screening visit but 9 failed eligibility criteria so that 17 patients (29.8 % of the 57 eligible patients, 95 % confidence interval (CI) 18.4, 43.4 %) were randomised at a ratio of 2:1 in favour of the withdrawal arm (11 withdrawals, 6 standard care). Six patients experienced a flare, all of whom were in the withdrawal arm (relapse rate 54.6 %, 95 % CI 23.4, 83.3 %). Four of the flares were apparent from visit 3 (8 weeks after starting withdrawal). Given the high relapse rate, an alternative trial design of partial treatment withdrawal, possibly including a patient preference arm, is recommended.

Development and testing of new candidate psoriatic arthritis screening questionnaires combining optimal questions from existing tools.

OBJECTIVE: Several questionnaires have been developed to screen for psoriatic arthritis (PsA), but head-to-head studies have found limitations. This study aimed to develop new questionnaires encompassing the most discriminative questions from existing instruments. METHODS: Data from the CONTEST study, a head-to-head comparison of 3 existing questionnaires, were used to identify items with a Youden index score of ≥0.1. These were combined using 4 approaches: CONTEST (simple additions of questions), CONTESTw (weighting using logistic regression), CONTESTjt (addition of a joint manikin), and CONTESTtree (additional questions identified by classification and regression tree [CART] analysis). These candidate questionnaires were tested in independent data sets. RESULTS: Twelve individual questions with a Youden index score of ≥0.1 were identified, but 4 of these were excluded due to duplication and redundancy. Weighting for 2 of these questions was included in CONTESTw. Receiver operating characteristic (ROC) curve analysis showed that involvement in 6 joint areas on the manikin was predictive of PsA for inclusion in CONTESTjt. CART analysis identified a further 5 questions for inclusion in CONTESTtree. CONTESTtree was not significant on ROC curve analysis and discarded. The other 3 questionnaires were significant in all data sets, although CONTESTw was slightly inferior to the others in the validation data sets. Potential cut points for referral were also discussed. CONCLUSION: Of 4 candidate questionnaires combining existing discriminatory items to identify PsA in people with psoriasis, 3 were found to be significant on ROC curve analysis. Testing in independent data sets identified 2 questionnaires (CONTEST and CONTESTjt) that should be pursued for further prospective testing.

The predictors of foot ulceration in patients with rheumatoid arthritis.

This study was conducted to determine the predictors of foot ulceration occurring in patients with rheumatoid arthritis (RA) without diabetes. A multi-centre case control study was undertaken; participants were recruited from eight sites (UK). Cases were adults diagnosed with RA (without diabetes) and the presence of a validated foot ulcer, defined as a full thickness skin defect occurring in isolation on / below the midline of the malleoli and requiring > 14 days to heal. Controls met the same criteria but were ulcer naive. Clinical examination included loss of sensation (10g monofilament); ankle-brachial pressure index (ABPI); forefoot deformity (Platto); plantar pressures (PressureStat); RA disease activity (36 swollen/tender joint counts) and the presence of vasculitis. History taking included past ulceration/foot surgery; current medication and smoking status. Participants completed the Health Assessment Questionnaire (HAQ) and Foot Impact Scale. A total of 83 cases with 112 current ulcers and 190 ulcer naïve controls participated. Cases were significantly older (mean age 71 years; 95 % confidence interval [CI], 69-73 vs. 62 years, 60-64) and had longer RA disease duration (mean 22 years; 19-25 vs. 15, 13-17). Univariate analysis showed that risk of ulceration increases with loss of sensation; abnormality of ABPI and foot deformity. Plantar pressures and joint counts were not significant predictors. HAQ score and history of foot surgery were strongly associated with ulceration (odds ratio [OR] = 1.704, 95 % CI 1.274-2.280 and OR = 2.256, 95 % CI 1.294-3.932). Three cases and two controls presented with suspected cutaneous vasculitis. In logistic regression modelling, ABPI (OR = 0.04; 95 % CI, 0.01-0.28) forefoot deformity (OR = 1.14; 95 % CI, 1.08-1.21) and loss of sensation (OR = 1.22; 95 % CI, 1.10-1.36) predicted risk of ulceration. In patients with RA, ABPI, forefoot deformity and loss of sensation predict risk of ulceration but, in contrast with diabetes, raised plantar pressures do not predict risk.

The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project).

OBJECTIVE: To develop new composite disease activity indices for psoriatic arthritis (PsA). METHODS: Data from routine clinic visits at multiple centres were collected in a systematic manner. Data included all domains identified as important in randomised controlled trials in PsA. Decisions to change treatment were used as surrogates for high disease activity. New indices were developed by multiple linear regression (psoriatic arthritis disease activity score: PASDAS) and empirically, utilising physician-defined cut-offs for disease activity (arithmetic mean of desirability functions: AMDF). These were compared with existing composite measures: Composite Psoriatic arthritis Disease Activity Index (CPDAI), Disease Activity for PSoriatic Arthritis (DAPSA), and Disease Activity Score for rheumatoid arthritis (DAS28). RESULTS: 161/503 (32%) subjects had treatment changes. Although all measures performed well, compared with existing indices, PASDAS was better able to discriminate between high and low disease activity (area under receiver operating curves (ROC)) curve with 95% CI: PASDAS 0.773 (0.723, 0.822); AMDF 0.730 (0.680, 0.780); CPDAI 0.719 (0.668, 0.770); DAPSA 0.710 (0.654, 0.766); DAS28 0.736 (0.680, 0.792). All measures were able to discriminate between disease activity states in patients with oligoarthritis, although area under the receiver operating curves (AUC) were generally smaller. In patients with severe skin disease (psoriasis area and severity index>10) both nonparametric and AUC curve statistics were nonsignificant for all measures. CONCLUSIONS: Two new composite measures to assess disease activity in PsA have been developed. Further testing in other datasets, including comparison with existing measures, is required to validate these instruments.

Debridement of painful forefoot plantar callosities in rheumatoid arthritis: the CARROT randomised controlled trial.

The objective of this study was to evaluate the long-term benefits of sharp scalpel debridement of painful forefoot plantar callosities in rheumatoid arthritis (RA). The null hypothesis: sharp scalpel debridement would offer no additional long-term advantage in terms of pain and function. Sixty-five people with RA were randomised to receive regular sharp scalpel debridement of painful forefoot plantar callosities in conjunction with a combined therapeutic approach or a combined therapeutic approach alone. The primary outcome measure was change at 18 months in participant-reported forefoot plantar pain measured by a 100-mm visual analogue scale (VAS). Secondary outcome measures were recorded at baseline and study exit and included revised Foot Function Index, Health Assessment Questionnaire, Foot Impact Scale and gait parameters. At 18 months, there were no differences between groups for the primary outcome VAS-measured forefoot plantar pain (left foot (F = 0.23, p = 0.635), right foot (F = 2.14, p = 0.148)). Within-group changes were highly significant (treatment arm, difference = 16.9 (95 % confidence interval (CI) 9.4, 24.4), t = 4.6, p < 0.0001; control arm, difference = 17.5 (95 % CI 9.4, 25.5), t = 4.4, p < 0.0001). There was little change in scores of overall function and foot impact in either group and there were no significant changes in gait parameters noted. The long-term effects of sharp scalpel debridement of painful forefoot plantar callosities in people with RA, when used in conjunction with a combined therapeutic approach, produced no additional benefit over the combined therapeutic approach alone. Trial registration http://www.controlled-trials.com/ISRCTN05190231.

A case series to describe the clinical characteristics of foot ulceration in patients with rheumatoid arthritis.

The aim of this study was to describe the clinical characteristics of foot ulceration in patients with rheumatoid arthritis (RA). Adults with RA and current foot ulceration but without diabetes were recruited. Clinical examination included assessment of RA disease activity, foot deformity, peripheral vascular disease, neuropathy and plantar pressures. Location, wound characteristics and time to healing were recorded for each ulcer. Participants completed the Health Assessment Questionnaire and Leeds Foot Impact Scale. Thirty-two cases with 52 current ulcers were recruited. Thirteen patients (41%) experienced more than one current ulcer: 5 (16%) had bilateral ulceration, 15 (47%) had previous ulceration at a current ulcer site. The majority (n = 33) of open ulcers were located over the dorsal aspect of the interphalangeal joints (n = 12), plantar aspect of the metatarsophalangeal joints (MTPJs) (n = 12) and medial aspect of first MTPJs (n = 9). In ulcerated limbs (n = 37), ankle brachial pressure index (ABPI) was <0.8 in 2 (5%); protective sensation was reduced in 25 (68%) and peak plantar pressures were >6 kg/cm(2) in 6 (16%). Mean ulcer size was 4.84 by 3.29 mm. Most ulcers (n = 42, 81%) were superficial; five (9.6%) were infected. Time to healing was available for 41 ulcers: mean duration was 28 weeks. Three ulcers remained open. In conclusion, foot ulceration in RA is recurrent and multiple ulcers are common. Whilst ulcers are small and shallow, time to achieve healing is slow, posing infection risk. Reduced protective sensation is common in affected patients. The prevalence of arterial disease is low but may be under estimated due to high intolerance of ABPI.