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Background/Aims Hand impairment is a major driver of disability and reduced quality of life in Systemic Sclerosis (SSc) patients. It is multifactorial and the risk and predictability of functional deterioration are unknown. The aim of this study is to describe hand function changes and predictors of functional deterioration in an observational cohort of SSc patients. Methods Consecutive SSc patients were longitudinally evaluated every 6 months for 3 years for SSc-related hand involvement. Patient-reported hand symptoms were captured with Cochin Hand Disability Score (CHFS), Raynaud Condition Score (RCS) and overall pain intensity on a visual analogue scale (VAS pain). Their minimal clinical important difference (MCID) and patient-acceptable symptom state (PASS) were evaluated according to validated thresholds. Clinical association with CHFS change over time and 36-month clinically meaningful worsening (MCID-Wor) were assessed via ANOVA and binomial logistic regression, respectively. Results One-hundred-seventy-six SSc patients were enrolled in this analysis, 13.6% of them were male and the mean age was 55.1± 12.3 years, the median disease duration was 5.0 years and 31.8% presented a diffuse cutaneous variant. Overall, CHFS worsened over time (p Conclusion SSc-related hand disability affects more than one-third of patients and tends to worsen over time in both cutaneous subsets despite the current standard of care. Identifying patients at risk of deteriorating hand function should inform targeted intervention strategies to prevent hand disability in SSc. Disclosure E. De Lorenzis: None. V. Kakkar: None. S. Di Donato: None. M. Wilson: None. L. Green: None. B. Alcacer-Pitarch: None. F. Del Galdo: Other; FDG received consultancies and research support from Abbvie, AstraZeneca, Boheringer-Ingelheim, Capella, Chemomab, Ergomed, Janssen, Kymab, Mitsubishi-Tanabe.

This guideline will provide a practical roadmap for management of SSc that builds upon the previous treatment guideline to incorporate advances in evidence-based treatment and increased knowledge about assessment, classification and management. General approaches to management as well as treatment of specific complications will be covered, including lung, cardiac, renal and gastrointestinal tract disease, as well as RP, digital vasculopathy, skin manifestations, calcinosis and impact on quality of life. It will include guidance related to emerging approved therapies for interstitial lung disease and account for National Health Service England prescribing policies and national guidance relevant to SSc. The guideline will be developed using the methods and processes outlined in Creating Clinical Guidelines: Our Protocol. This development process to produce guidance, advice and recommendations for practice has National Institute for Health and Care Excellence accreditation.

Background Foot health problems are common in the general population, and particularly so in people with rheumatic and musculoskeletal disorders (RMD). Several clinical guidelines state that people with RMDs should have access to foot health services, although service capacity is often limited. The current COVID-19 pandemic has increased the need for alternative ways to provide patient care. The aim of this clinical audit was to review a newly implemented telephone follow-up appointment service conducted within the Rheumatology Podiatry Department in Leeds, UK. Methods Fifty-eight patients attending the Rheumatology Podiatry Department at Leeds Teaching Hospitals NHS Trust were contacted by telephone approximately 6–8 weeks following initial intervention. During the telephone consultation, all patients were asked pre-defined questions relating to their symptoms, intervention efficacy, the need for further appointments and their preference for the type of consultation. To assess the cost of the telephone consultation the number of attempts needed in order to make successful contact, the duration of the call and the number of telephone follow-up appointments completed in a working day were also recorded. Results Twenty-five patients (43%) were successfully contacted within the 6–8 weeks stipulated time frame and were included in the analysis. Of the 25 contacted, twelve (48%) patients were successfully contacted on the first attempt. Ten (40%) were successfully contacted on the second attempt. The remaining three patients (12%) required 3 or more attempts to make successful contact. Telephone consultations were estimated not to last longer than 10 min, including notes screening and documentation. Eleven patients (44%) reported an improvement in their symptoms, thirteen (52%) reported no change and one patient (4%) reported their symptoms to be worse. Conclusion Telephone follow-up consultations may be a potentially cost-effective alternative to face-to-face appointments when implemented in a Rheumatology Podiatry Department, and provide an alternative way of providing care, especially when capacity for face-to-face contact is limited. The potential cost saving and efficiency benefits of this service are likely to be enhanced when telephone consultations are pre-arranged with patients.

Summary Digital ulcers are a serious, recurrent complication in patients with systemic sclerosis. They are often slow to heal and exquisitely painful. Local wound care, such as debridement of the wound bed, is an essential component in the management of digital ulcers in systemic sclerosis. However, digital ulcer debridement is not a standard of care, and there is substantial international variation in the use of this approach. In this Viewpoint, we discuss the assessment of the wound bed and different methods of debridement using the model of tissue management, infection and inflammation, moisture control, and wound edge or epidermal advancement, known as TIME. We highlight the challenges in standard practice and the need for research into local wound care for this type of ulceration, before suggesting a potential roadmap to develop a standardised approach to support ulcer debridement in systemic sclerosis. Debridement might be the missing component in optimising the management of digital ulcers and we propose that the approach should be rigorously investigated as a standard of care in this common complication of systemic sclerosis.

Optimal wound care is an essential component in the management of systemic sclerosis (SSc) digital ulcers (DUs). DU debridement has been suggested to reduce ulcer-related pain and improve tissue healing. However, only a minority of rheumatologists perform DU debridement, and there is no standard of care/protocol. Our objectives were to (i) evaluate the current evidence for the use of debridement in DU management and (ii) assess whether there are any specific protocols. A systematic literature review was performed searching the PubMed database (between 01/01/1950-01/03/2019) in accordance with PRISMA guidelines. Two independent reviewers screened and extracted the abstracts/full manuscripts. Articles in English, which focussed on SSc-DU debridement/curettage, were included. Exclusion criteria included studies of juvenile/paediatric patients and basic/non-clinical research. Our search identified 1497 studies of which 4 studies were included in our final analysis. Three studies used scalpel debridement, and one study used this in combination with autolytic debridement. No studies specifically reported the effect on DU healing from debridement. Autolytic debridement with hyaluronate-based products was associated with significant ulcer pain and inflammation. Local anaesthetic significantly reduces pain both during and after debridement. Combined local and oral analgesia is often required for more severe or infected DUs. DU (scalpel and autolytic) debridement is being used by some clinicians in rheumatology; however, there are no standardised protocols. To improve wound care for SSc-DUs, future research should focus on developing a standardised protocol for SSc-DU debridement, with a view to facilitate randomised controlled trials to demonstrate safety and treatment efficacy.Key Points• Optimal wound care is an essential component in the management of systemic sclerosis-digital ulcers.• 'Sharp' debridement uses a scalpel, whereas 'autolytic' debridement uses dressings to optimize endogenous tissue lysis.• There is significant variation in the use of digital ulcer debridement in systemic sclerosis.• A standardized protocol and randomized controlled trials are needed to demonstrate debridement the safety and efficacy of digital ulcer debridement in systemic sclerosis.

ObjectivesThe aim of this study was to adapt the Systemic Sclerosis Quality of Life Questionnaire (SScQoL) into six European cultures and validate it as a common measure of quality of life in systemic sclerosis (SSc).MethodsThis was a seven-country (Germany, France, Italy, Poland, Spain, Sweden and UK) cross-sectional study. A forward–backward translation process was used to adapt the English SScQoL into target languages. SScQoL was completed by patients with SSc, then data were validated against the Rasch model. To correct local response dependency, items were grouped into the following subscales: function, emotion, sleep, social and pain and reanalysed for fit to the model, unidimensionality and cross-cultural equivalence.ResultsThe adaptation of the SScQoL was seamless in all countries except Germany. Cross-cultural validation included 1080 patients with a mean age 58.0 years (SD 13.9) and 87% were women. Local dependency was evident in individual country data. Grouping items into testlets corrected the local dependency in most country specific data. Fit to the model, reliability and unidimensionality was achieved in six-country data after cross-cultural adjustment for Italy in the social subscale. The SScQoL was then calibrated into an interval level scale.ConclusionThe individual SScQoL items have translated well into five languages and overall, the scale maintained its construct validity, working well as a five-subscale questionnaire. Measures of quality of life in SSc can be directly compared across five countries (France, Poland Spain, Sweden and UK). Data from Italy are also comparable with the other five countries although require an adjustment.

This chapter will briefly cover the epidemiology and pathophysiology of systemic sclerosis and systemic lupus erythematosus, and, to a larger extent, their pathological effect on the lower limb. It will also discuss current evidence for foot pathology management with reference to potential risks and imaging strategies.

ObjectiveThe aim of this study was to investigate whether foot and lower limb related symptoms were associated with work participation and poor mobility in people with Systemic Lupus Erythematosus (SLE).MethodA quantitative, cross-sectional, self-reported survey design was utilised. People with SLE from six United Kingdom (UK) treatment centres and a national register were invited to complete a survey about lower limb and foot health, work participation and mobility. Data collected included work status and the prevalence of foot symptoms. The focus of the analyses was to explore potential associations between poor foot health work non-participation.ResultsIn total, 182 useable surveys were returned. Seventy-nine respondents reported themselves as employed and 32 reported work non-participation. The remaining were retired due to age or reported work non-participation for other reasons. Work non-participation due to foot symptoms was significantly associated with difficulty walking (p = 0.024), past episodes of foot swelling (p = 0.041), and past episodes of foot ulceration (p = 0.018). There was a significant increase in foot disability scores amongst those not working (mean 18.13, 95% CI: 14.85–21.41) compared to those employed (mean 10.16, 95% CI: 8.11–12.21).ConclusionsTwenty-nine% of people with SLE reported work non-participation because of lower limb or foot problems. Our results suggest that foot health and mobility may be important contributors to a persons’ ability to remain in work and should be considered as part of a clinical assessment.

Background Guidelines recommend foot orthoses for people with both early (

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Objective The main aim of this survey was to determine the frequency of self-reported lower limb or foot and ankle complications experienced by participants with systemic lupus erythematosus (SLE). A secondary aim was to determine the frequency of treatments that have been received or that participants with SLE may like to receive if offered. Method A quantitative, cross-sectional, self-reported survey design was utilized. The developed survey was checked for face and content validity prior to patient partner cognitive debriefing in order to ensure usability, understanding of the process of completion and of the questions posed. The full protocol for survey development has been published previously. Results This is the first comprehensive national UK survey of lower limb and foot health problems reported by participants with SLE. A high prevalence of vascular, dermatological and musculoskeletal complications was reported by survey respondents. Additionally, whilst the relative prevalence of sensory loss was low, a quarter of people reported having had a fall related to changes in foot sensation demonstrating a previously unknown rate and cause of falls. Conclusion Complications related to vascular, dermatological and musculoskeletal health are identified as particularly prevalent in participants with SLE. Further, there is a suggestion that the provision of interventions to maintain lower limb health is highly varied and lacks national standardization, despite there being a strong indication of participant reported need. The findings of this work can be used to inform care guideline development in addition to identifying areas for future research.

Background Systemic lupus erythematosus (SLE) can manifest with arthralgia and myalgia, and in severe cases, disorganisation of the joints and tendon rupture. Further, Raynaud’s phenomenon and other circulatory problems such as vasculitis have been reported, and may be associated with loss of sensation and ulcers. Associated with impaired peripheral neurovascular function there is the potential for changes in tissue viability leading to thinning of the skin or callus formation. In addition, resistance to infections may be reduced, such as fungal infection of the skin and nails, bacterial infection associated with wounds and viral infections such as verruca. There is a dearth of evidence for the effects of SLE in the foot, the prevalence of foot problems in SLE and the impact of these on the individual. In addition, it is not known if people with SLE and foot problems have access to specialist care through foot health services. Method The first phase of the proposed study was to develop a survey questionnaire. This was achieved through a focus-group which comprised of patient advisers with SLE, consultants who specialised in SLE, specialist rheumatology podiatrists and specialist rheumatology nurses. From this consensus approach to the item generation the draft questionnaire was developed based on agreed themes, question format and overall structure. The Manchester Pain and Disability Questionnaire was included in order to capture levels of pain and associated disability. An iterative process followed with feedback from the focus group reducing the number of other items from 53 until the penultimate version of questionnaire was produced with 50 items. Following on from this, a process of cognitive debriefing was used with two people with SLE naive to the questionnaire. Minor changes to two questions and the layout was required before a final version of the questionnaire was produced Discussion The questionnaire will be used for a study which aims to identify the frequency of patients’ reported foot problems, the impact of foot problems on their lives and the status of foot care provision. This will be achieved through a survey of people with SLE across six clinical sites and interviews with some people in order to explore their experience of foot problems. The results from this study will provide the information required to inform further research. In addition, it could potentially inform the design and delivery of foot health information and services to this patient group.

Background Systemic lupus erythematosus (SLE) can present with a variety of symptoms. Previous research has shown there is a high prevalence of lower limb and foot problems in patients with SLE associated with the musculoskeletal, vascular and neurological changes. Furthermore, there is a high prevalence of infections affecting the feet and a range of common skin and nail problems. However, it is not known how these foot problems impact upon people’s lives. Therefore, we aimed to explore this using a qualitative approach. Method Following ethical approval, 12 participants were recruited who had a diagnosis of SLE, current and/or past experience of foot problems and were over 18 years in age. Following consent, interviews were carried out with an interpretivist phenomenological approach to both data collection and analysis. Results Seven themes provide insight into: foot problems and symptoms; the impact of these foot problems and symptoms on activities; disclosure and diagnosis of foot problems; treatment of foot problems and symptoms; perceived barriers to professional footcare; unanswered questions about feet and footcare; and identification of the need for professional footcare and footcare advice. Conclusion These participants tend to “self-treat” rather than disclose that they may need professional footcare. A lack of focus upon foot health within a medical consultation is attributed to the participant’s belief that it is not within the doctor’s role, even though it is noted to contribute to reduced daily activity. There is a need for feet to be included as a part of patient monitoring and for foot health management to be made accessible for people with SLE.

Background: The Allied Health Professional (AHP) and Nurse Internships Scheme 2015–18 is open to final year students or recent graduates who are predicted to receive a 2:1 or first degree in Occupational Therapy, Physiotherapy, Podiatry, or Nursing. Building on similar schemes it is a successful model of a collaborative project working with our wide consortium of researchers at the Universities of Southampton, Oxford, Salford, Leeds and the West of England. The aim of the scheme is to identify and introduce graduate AHPs and nurses to musculoskeletal (MSK) research. Methods: In 2016, 6 (4 female) graduates from Allied Health and Nursing participated in the scheme. Over an intensive 8 week period the interns contributed to the conduction of research in projects focused on key public health priorities for people with MSK conditions. Projects included both qualitative and quantitative methodology, including an investigation into online self-management support websites for patients and an assessment of footwear choices in knee osteoarthritis. The interns presented their research findings and development journey at a dissemination day held at the University of Leeds. The placements were evaluated through reflective logs and progress reports completed by the interns, supervisors and mentors. The interns completed additional evaluation questionnaires before and after their placements. Evidence of impact of the internships scheme was collated. Results: All of the interns stated their career aspirations and expectations changed over the 8 week period and all reported they now plan a future career in research. One intern quoted “In relation to my career plans, my expectations have completely changed. The scheme has provided me with the skills, knowledge and contacts I need to build my profile and apply for future research opportunities”. Supervisors and mentors reported all of the interns completed required research tasks and met or exceeded initial agreed learning outcomes. Further evidence of impact included two press releases and an article reporting on progress of the first cohort. All 6 interns wrote two blogs (pre- and post-internship) - published on the Arthritis Research UK website and have submitted a conference abstract and a journal article. Further conference and journal submissions are anticipated from all 6 interns alongside the work supporting grant applications. This scheme’s Twitter site has to date gained over 100 followers. Conclusion: Evaluation from the interns has demonstrated how valuable the scheme is in introducing newly qualified AHPs and nurses to a network of rheumatology researchers and linking their clinical roles with the latest research; benefiting patients with MSK conditions with the latest evidence-based care. All interns intend to remain involved in research, providing mentorship for future cohorts, sharing their experiences and promoting the scheme. We thank our consortium for their expertise and dedicated time with our interns.

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 naive 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.

Purpose The Manchester Foot Pain and Disability Index (MFPDI) is a self-assessment 19-item questionnaire developed in the UK to measure foot pain and disability. This study aimed at conducting cross-cultural adaptation and validation of the MFPDI for use in Spain. Methods Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes measures were followed in the MFPDI adaptation into Spanish. The cross-cultural validation involved Rasch analysis of pooled data sets from Spain and the UK. Results Spanish data set comprised 338 patients, five used in the adaptation phase and 333 in the cross-cultural validation phase, mean age (SD) = 55.2 (16.7) and 248 (74.5 %) were female. A UK data set (n = 682) added in the cross-cultural validation phase; mean age (SD) = 51.6 (15.2 %) and 416 (61.0 %) were female. A preliminary analysis of the 17-item MFPDI revealed significant local dependency of items causing significant deviation from the Rasch model. Grouping all items into testlets and re-analysing the MFPDI as a 3-testlet scale resulted in an adequate fit to the Rasch model, v 2 (df) = 15.945 (12), p = 0.194, excellent reliability and unidimensionality. Lack of cross-cultural invariance was evident on the functional and personal appearance testlets. Splitting the affected testlets discounted the cross-cultural bias and satisfied requirements of the Rasch model. Subsequently, the MFPDI was calibrated into interval-level scales, fully adjusted to allow parametric analyses and cross-cultural data comparisons when required. Conclusions Rasch analysis has confirmed that the MFPDI is a robust 3-subscale measure of foot pain, function and appearance in both its English and Spanish versions.

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.

Systemic lupus erythematosus (SLE) can manifest with arthralgia and myalgia, and, in severe cases, disorganization of the joints and tendon rupture. Further, Raynaud's phenomenon and other circulatory problems such as vasculitis have been reported, and may be associated with loss of sensation and ulcers. Associated with impaired peripheral neurovascular function there is the potential for changes in tissue viability leading to thinning of the skin or callus formation. In addition, resistance to infections may be reduced, such as fungal infection of the skin and nails, bacterial infection associated with wounds and viral infections such as verruca. There is a dearth of evidence for the effects of SLE in the foot, the prevalence of foot problems in SLE and the impact of these on the individual. In addition, it is not known if people with SLE and foot problems have access to specialist care through foot health services. Hence, there is a need to investigate the scale of foot problems associated with SLE. In order to achieve this, a questionnaire needs to be developed in order to carry out a national survey in England.The items required for the questionnaire were generated using a focus group, which comprised patient advisers with SLE, consultants who specialized in SLE, specialist rheumatology podiatrists and specialist rheumatology nurses. From this consensus approach to the item generation, the draft questionnaire was developed with agreement on themes, question format and overall structure. Additionally, the Manchester Pain and Disability Questionnaire was included in order to capture levels of pain and associated disability. An iterative process followed, with feedback from the focus group reducing the number of other items from 53, until the penultimate version of questionnaire was produced with 50 items. Following on from this, a process of cognitive debriefing was used with two people with SLE who were naïve to the questionnaire. Minor changes to two questions and the layout was required before a final version of the questionnaire was produced.The questionnaire will be used for a study which aims to identify the frequency of patients' self-reported foot problems, the impact of foot problems on their lives and the status of foot care provision. This will be achieved through a survey of people with SLE across six clinical sites and interviews with some people in order to explore their experience of foot problems. The results from the present study will provide the information required to inform further research. In addition, it could potentially inform the design and delivery of foot health information and services to this patient group. Copyright © 2015 John WileySons, Ltd.

Background: Along with its skin manifestations, SLE can present with a variety of musculoskeletal signs and symptoms and vascular problems that can affect the feet. Furthermore, there is the potential for reduced tissue viability, leading to thinning of the skin and/or callus formation. Further, systemic resistance to viral, bacterial and fungal infections may be reduced and, together with poor tissue viability, create the opportunity for these infections to proliferate in the feet. A recent survey by the same authors (unpublished) has shown a high prevalence of these infections, with many experiencing the impact of vascular and musculoskeletal problems. To date there is no research that has explored the impact of foot problems on people’s lives. Methods: Following ethical approval, 12 participants who fulfilled the inclusion criteria were recruited: diagnosed with SLE (ACR diagnosis), current and/or past experience of foot/lower limb problems and age �18 years. Consent was obtained and then conversational-style interviews were carried out with an interpretivistic phenomenological approach. The interviews were digitally recorded and complemented by field notes. An opening question was used for all participants: ‘Tell me about your experiences of having foot problems?’ If necessary, further trigger questions were used in order to maintain the conversation and the focus on foot problems. Data were transcribed verbatim and analysed using a thematic framework approach. The transcripts were verified by the participants and were analysed by a second researcher in order to add to the credibility of the analyses. Results: The data was organized into seven themes: Foot problems and symptoms—what they are and the feeling associated with them; Experiences of foot problems being diagnosed; Impact of foot problems on activities; Treatment of foot symptoms/problems; Perceived obstacles to professional foot care; Unanswered questions about feet and foot care; and Recognition of the need for professional foot care and foot care advice. These people experienced a wide variety of foot problems that impact significantly on activities. Some reported working through the pain in order to achieve visible normality while experiencing the negative emotions of anger, frustration and anxiety. Although some had experienced professional foot care, there were obstacles to the foot problems being diagnosed, resulting in many unanswered questions and some inappropriate selfmanagement. Conclusion: Despite reporting foot pain, negative emotions and activity restrictions related to their foot symptoms, people with SLE tend to get on with it and self-treat rather than seeking professional foot care. The lack of focus on the feet in the medical consultation is caused by the participants’ belief that it is not the consultant’s role. There is a clear need for foot assessments to be included in the medical consultation and for professional foot care to be provided.

Background: SLE can affect many tissues throughout the body. Anecdotally, it is suggested that people with SLE experience a range of complications in the foot and lower limb, including vascular impairment (e.g. RP), neurological impairment, poor tissue viability (e.g. ulceration), infection and foot pain. However, to date, the precise prevalence of foot complications experienced by people with SLE has not been described. The aim of this survey was to determine self-reported foot and lower limb complications experienced by people with SLE. Methods: The survey was developed via patient and practitioner focus groups. A consensus approach was used to generate items and to formulate themes, categories, question format and survey structure. The survey was checked for face and content validity prior to cognitive debriefing to ensure usability and understanding. Consecutive patients with a confirmed diagnosis of SLE meeting the inclusion criteria attending any of seven UK clinical sites or members of Lupus UK were invited to participate. Ethical approval and participant informed consent was obtained. Results: A total of 182 survey responses were completed. For all responders, the most frequent age range was 40–49 years, mean BMI was 27 (S.D. 7) and mean disease duration was 15 years (S.D. 10). A number of vascular complications were reported, including intermittent claudication [n ¼ 100 (55%)], RP [n ¼ 94 (52%)] and splinter haemorrhage [n ¼ 39 (21%)]. Overall, 164 patients (90%) reported experiencing symptoms of peripheral vascular complications. Symptoms of peripheral neuropathy were reported by 30 patients (16%), while a fall as a consequence of neuropathic symptoms was reported by 45 patients (25%). A range of skin and nail complications were reported, including callus or corns [n ¼ 130 (71%)], onychocryptosis [n ¼ 69 (38%)], rashes or blistering [n ¼ 62 (34%)] and ulceration [n ¼ 45 (25%)]. A high prevalence of infection was reported; a history of viral infection (verrucae pedis) or fungal infection (tinea pedis) was reported by 77 patients (42%), bacterial infection by 28 patients (15%) and onychomycosis by 65 patients (36%). Overall, 170 patients (93%) reported having experienced some form of tissue viability complication. Foot joint pain, stiffness and swelling was reported by 145 (80%), 136 (75%) and 94 (52%) patients, respectively. Foot-related walking impairment was reported by 67 patients (37%). Only 60 patients (33%) reported having ever been asked about their feet by a medical professional. Seventy-seven patients (42%) reported that they would benefit from the provision of general foot health care advice. Conclusion: A large number of people with SLE report vascular complications, impaired tissue viability, musculoskeletal problems and foot pain, as well as a range of infections and conditions of the skin and nails. Despite this, foot health assessment by professionals was infrequent. These results highlight the need to undertake clinical studies investigating lower limb pathologies in SLE.

To evaluate ultrasound Virtual Touch Imaging and Quantification (VTIQ) as a method for determining absolute skin stiffness in patients with systemic sclerosis (SSc).Skin thickness, assessed by the modified Rodnan Skin Score (mRSS) and absolute skin stiffness, using VTIQ, were measured at all mRSS anatomical sites to quantify the shear wave velocity (in m/s) in 26 SSc patients and in 17 age- and gender-matched controls. Correlations between mRSS and absolute skin stiffness, and comparisons between patients and controls were analysed statistically using Mann-Whitney U tests and correlations between variables using Pearson's. P values0.05 were considered significant.Shear wave velocity as a measure of skin stiffness was significantly higher in SSc than in controls in 11 out of 16 mRSS sites investigated. Shear-wave velocity was strongly correlated with the local mRSS in the following anatomical sites: forearm, hand, phalanx, and thigh. In the patient group, clinically unaffected skin could also be differentiated from healthy skin using shear-wave velocity.VTIQ represents an innovative and promising technique that provides, for the first time, a non-invasive, absolute quantification of skin stiffness. Further studies of VTIQ are required, but this early study supports the clinical and scientific potential of this new measure of skin involvement in SSc.

Background The increased prevalence of foot and ankle pathologies in Rheumatic and Musculoskeletal diseases (RMDs) is well documented 1 , however the provision of foot & ankle (F&A) healthcare services for people with RMDs in Europe has not been evaluated. Objectives To assess the current healthcare systems for providing foot & ankle healthcare services for people with RMDs in Europe. Methods A survey was undertaken to evaluate current provision of F&A health care services for people with RMDs across Europe. A questionnaire was distributed to all 22 country presidents representing HP associations within EULAR. The questionnaire used was developed and piloted (in 7 countries) by the EULAR F&A Study Group, and structured to capture the provision and type of F&A services for people with RMDs. When the HP presidents felt unable to answer specific questions they were encouraged to consult a colleague who may be better placed to provide the answers. Results Sixteen questionnaires were completed (Norway, Ireland, Sweden, Hungary, Netherlands, UK, Denmark, Portugal, Italy, Switzerland, Austria, France, Czech Republic, Spain, Belgium, Malta). Of the 16, 13 respondents indicated provision of F&A health care services in their country, but only three countries had services specialising in RMD-related F&A problems (Netherlands, UK, Malta). The professions providing the care for patients with RMD-related F&A problems were different depending on the pathology and the country (Table1). Podiatrists provided care for F&A pain and deformity problems in 11 countries, but provided F&A ulcer care in only 8 countries. Conclusions Only 3 countries have F&A health care services specialised to the needs of people with RMDs. The professions providing the care varied between countries, and also depended on the F&A pathology. Interestingly, F&A healthcare services were provided by professions that do not solely specialised in F&A care. Further research is needed to assess the variation of F&A healthcare services between and within European countries and the impact on healthcare of various F&A healthcare service designs. References Woodburn, J. & Helliwell, P. Foot problems in rheumatology. Rheumatology 36, 932–934 (1997). Disclosure of Interest None declared

Background While foot problems in patients with systemic sclerosis (SSc) have been described previously and the association with disability noted, the impact of such problems on the quality of life (QoL) in people living with SSc has yet to be quantified. Objectives To identify the factors, including those arising from foot pathology, that impact on QoL in SSc. Methods Structural equation modelling (SEM) was used to explore the multifactorial pathways impacting on QoL in a cross section cohort of people with SSc. Potential candidate factors were identified through: i) a literature review with expert consultation; and ii) a cross-sectional study capturing clinical features. QoL was measured using the disease-specific SScQoL questionnaire. Results One hundred and twenty one patients with SSc were recruited (106 female; median age 59, ranges 25 to 86 years) with a median disease duration of nine years (IQR:4,13) and a median modified Rodnan Skin Score of 2 (IQR:0, 5). The model that best explained the factors contributing to the SSc impact on QoL showed complex inter-relationships between 11 factors (Figure1) (c2=37.022, df=37, p=0.468, RMSEA=0.002, GFI=0.951, CFI=1.000). Combined, these factors explained 84% of the impact on QoL (R2 =0.84) in patients with SSc. General disease factors, including physical function (standardised total effect 0.64), breathing problems (standardised total effect 0.493), and depression (standardised total effect 0.428) had the greatest impact. Foot problems had a substantial but indirect effect on quality of life (foot function and foot pain standardised total effect 0.343 and 0.327). A summary of the effects of the factors included in the model is provided in the Table 1. Conclusions The impact of SSc on QoL is substantial and complex. While loss of physical function is the most influential factor on QoL, followed by breathing difficulty and depression, foot problems significantly contribute to this impact. Disclosure of Interest None declared

Background The Systemic Sclerosis Quality of Life (SScQoL) questionnaire is a 29-item tool developed in UK to measure needs-based patient-reported quality of life in people with systemic sclerosis (SSc). Objectives To undertake a cross-cultural adaptation and validation of the SScQoL in six European countries. Methods This was a cross-sectional study involving six European countries: Germany, France, Italy, Spain, Sweden and UK. Adult patients with a definite diagnosis of SSc, who were willing and able to complete the SScQoL were eligible. The English SScQoL was adapted into the five European languages using a forward-backward translation process. 1 The translated SScQoL was completed by patients and the data was analysed using Rasch models. Where local response dependency was evident, items were grouped into subscales (function, emotion, sleep, social and pain) and re-analysed to test the scaling properties and cross-cultural equivalence, thus allowing calibration of the SScQoL into an interval scale. Results The adaptation of the SScQoL into European languages was seamless except in Germany, where patients reported problems in deciding yes/no responses for some items. Cross-cultural validation included 849 patients (mean age =57.9 years, SD =13.9), 87% of whom were women. All country-specific data except Germany had good fit to the Rasch model after correcting for local dependency. See table 1. After excluding Germany from the analysis, the scale was validated and calibrated with cross-cultural adjustment for Italy in the social subscale. Conclusions The SScQoL translated versions can be used as a valid common measure in France, Spain, Sweden, UK and Italy; the latter with adjustments in the social subscale. The German version requires further work. References Beaton DE, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25(24):3186–91. Disclosure of Interest None declared

Background Foot problems associated with Systemic Sclerosis (SSc)/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale) prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

The vascular and cutaneous alterations evident in systemic sclerosis/scleroderma (SSc) place the foot at risk of ulceration. The UK Podiatry Rheumatic Care Association (PRCA)/Arthritis and Musculoskeletal Alliance standards of care recommend that all people with SSc should receive at least basic information about their foot health, and that those with foot problems should have access to self-management advice and care where needed. The aim of this study was to evaluate foot health services offered in Leeds (UK) for people with SSc, against nationally agreed standards of care. Ninety-one consecutive patients with SSc were selected from either the connective tissue disease outpatient clinic (n = 70) or the specialist rheumatology foot health clinic (n = 21) at Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust. All the patients completed a disease-specific audit tool developed by the UK PRCA that evaluates provision of foot health care for patients with SSc. Sixty-one patients (67%) reported having had foot problems at some point in time and 54 (59%) had current foot problems. Of these 54 patients, 17 (32%) had not received any foot care. Only 36 (39%) of the 91 patients had received any foot health information. This audit demonstrates that patients with SSc have a relatively high prevalence of self-reported foot problems. Foot health care and information are inadequate for people with SSc and foot problems, and preventative information is almost non-existent. Improved foot health information will better empower patients to self-manage low risk problems, and help identify high risk problems which require specialist care.

Background Measurement of skin involvement is essential for diagnosis and assessment of prognosis in systemic sclerosis (SSc). The modified Rodnan Skin Score (mRSS) is the gold standard outcome measure for assessment of skin thickness by palpation. The mRSS has been criticised for being associated with high inter-observer variability and requiring a skilled trained investigator. There is a need therefore for a reliable and objective method to assess skin stiffness. Elastography Ultrasound (EUS) is a new, non-invasive method, which has allowed qualitative and quantitative measurements of relative skin stiffness. Recently, acoustic radiation force impulse (ARFI) with a new 3 rd generation technology, virtual touch quantification (VTQ), has added a new dimension, reporting absolute values for the wave propagation speed (absolute tissue stiffness). The use of VTQ technology has never before been reported in patients with SSc. Objectives To assess skin absolute stiffness in SSc using VTQ. Methods Skin absolute stiffness was measured by VTQ at 5 of the 17 anatomical sites of the mRSS (forearm, hand, phalanx, leg and foot, of the dominant limb). Eight patients and eight age and gender matched controls were included in the study. Ultrasound measurements of absolute skin stiffness were compared with mRSS. Absolute skin stiffness measurements are presented as median plus interquartile ranges. Spearman correlation tests were used to calculate associations between ultrasound measurements and mRSS. Results Absolute skin stiffness measurements were systematically higher in SSc patients vs controls in 4 out of 5 measurements sites: forearm [2.4 (0.5) vs 1.7 (0.3)], hand [3.0 (1.4) vs 2.0 (0.9)], phalanx [3.8 (3.0) vs 2.1 (0.5)] and dorsum of the foot [4.4 (3.3) vs 3.1 (1.9)]. Forearm absolute skin stiffness correlated with the total mRSS (r=0.707, p=0.002). Hand absolute skin stiffness correlated with the local mRSS for this site of analysis (r=0.609, p=0.012). figure 1 VTQ of the volar aspect of the forearm in a control (A) and in a patient with SSc (B). Skin absolute stiffness values (shear-wave velocities) are presented (m/s) (right side). Red indicates stiff tissue, green/yellow intermediate stiffness and blue low stiffness. Tissues with a higher shear-wave velocity have higher stiffness. Image/graph Conclusions VTQ is a novel and promising application of ARFI imaging. It provides a very precise quantification of absolute skin stiffness and has potential as an objective measure for skin assessment. Further studies are warranted to define the potential contribution of VTQ to the clinical evaluation and for its use as potential outcome measure of skin involvement in SSc. References Clements PJ, et al Arthritis Rheum.1990;Iagnocco A, et al J Rheumatol. 2010;Di Geso L, et al Clin Exp Rheumatol. 2011. Disclosure of Interest None Declared

Background Foot problems associated with systemic sclerosis (SSc; scleroderma) are common and disabling. To-date there have been no formal studies of interventions directed at the foot problems experienced in people with SSc. Objectives The main objective of this randomized controlled trial was to evaluate whether foot pain in SSc can be improved through the routine provision of a simple pressure-relieving and insulating insole. Methods A multicentre RCT conducted in four UK participating centres. A total of 141 consenting patients with confirmed SSc (ARA/ACR 1980 criteria) and plantar foot pain were randomised to receive either a commercially available pressure-relieving thermally insulating insole (Prothotic™ Duoform, RRP £8.55) or a sham insole identical in appearance to the active intervention but with minimal cushioning or thermal properties. Randomisation on a 1:1 basis was performed centrally using a 24-hour, automated randomisation system at a UKCRC registered clinical trials research unit. The primary end point was a reduction in pain measured using the 100mm pain subscale of the Foot Function Index, after 12 weeks of intervention. Sample size was determined a priori on a requirement to detect a 15mm difference (SD 25.7, alpha =0.05 and power =90%). In a subset of 49 patients at the lead centre (Leeds), plantar pressure measures (maximum mean pressure at heel and forefoot, with and without insoles in situ) were also obtained for entry into an exploratory analysis. Results Analysis of baseline characteristics indicated excellent comparability between the active intervention and sham group for centre, gender, age, SSc subset and Rodnan skin score. One hundred and thirty patients provided valid data for the primary endpoint. In both groups there was a systematic improvement in FFI pain subscale scores from baseline to 12 weeks (Active group -13.1mm, 95%CI -18.66 to-7.55 ; Sham group -10.7, 95%CI -16.17 to -5.28). An ANCOVA model adjusting for centre, gender and baseline FFI score confirmed no difference in effect between the intervention and sham groups (difference=-2.4, 95%CI -7.70 to 2.94, p=0.3778). Compared to a shoe-only baseline measure, pressure was lowered in the heel region by use of the active insole (median difference (range) -24kPa (-75,22)) compared to the sham -4.6kPa ((-23,10), (p Conclusions The study compared a simple therapeutic insole with a sham device and found that over 12 weeks both produced a clinically worthwhile improvement in patient reported foot pain but with no difference between intervention arms. The active device produced a significantly greater reduction in pressure than the sham at the heel although not at the forefoot. This exploratory analysis suggests therefore, that despite careful selection the sham device introduced some unintended physical effect. The difficulty with employing a true sham as a control in physical intervention trials such as this may suggest the need for a zero intervention arm for similar studies in future. Acknowledgements Funding: Arthritis Research UK Clinical Studies Group for Autoimmune Rheumatic Diseases (award number 18826). Trial regn. ISRCTN 02824122 Our thanks to all TSC and TMG contributors and to the clinical staff at each site. Disclosure of Interest : None Declared

Background Elastography Ultrasound (EUS) is an ultrasound-based method, which allows the qualitative or quantitative measurements of the biomechanical properties of tissues. EUS can be performed using compression-wave or more recently, shear-wave propagation, using acoustic radiation force impulse (ARFI) imaging and associated new virtual touch imaging (VTI) and virtual touch quantification (VTQ) technologies. ARFI estimates tissue stiffness in real time and is quantitative and user independent. The use of VTQ technology has never before been reported in patients with systemic sclerosis (SSc). Objectives To compare the relative and absolute soft tissue stiffness in patients with SSc and healthy controls using compression EUS and ARFI. Methods Twenty-six patients with SSc and twenty-five age and gender matched healthy controls were included in the study. Relative and absolute stiffness of soft tissue were measured on the palmar aspect of the third metacarpophalangeal joint, plantar aspect of the third metatarsophalangeal joint and over the heel. All these sites have an anatomical features associated withbiomechanical stress. Results There was a trend towards greater tissues stiffness values in SSc patients and controls using all three technologies. VTQ was the most consistent measure and provided absolute outputs (Table 1). Conclusions Measurements of tissue stiffness by EUS add a new dimension to the assessment of soft tissues in SSc. The compression EUS and VTI technologies have some limitations for the real-world application in SSc. VTQ however, is a promising technique that provides absolute and objective quantification of tissue stiffness. In the longer term VTQ and similar technologies may offer an objective and quantitative alternative tools to clinical measures such as the modified Rodnan Skin Score. References -Clements PJ, et al Arthritis Rheum. 1990; 33:1256-63; -Drakonaki EE, et al. Br J Radiol. 2012; 85:1435-45; -Iagnocco A, et al J Rheumatol. 2010;37:1688-91; -Di Geso L, et al Clin Exp Rheumatol. 2011; 29:926-32; -Porta F, et al Rheumatology (Oxford). 2012;51:S7. Disclosure of Interest None Declared

Background The Manchester Foot Pain and Disability Index (MFPDI) is a self-assessment questionnaire developed in the UK to measure foot pain and disability in the general population 1 . It has been translated and validated in several languages 2,3 Objectives The aim of this study was to conduct cross-cultural adaptation and validation of the MFPDI into Spanish Methods The cross-cultural adaptation process was undertaken using International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 4 recommendations. This involved 8 stages: i) Forward translation, ii) Reconciliation, iii) Back translation, iv) Back translation review, v) Harmonisation, vi) Pilot, vii) Pilot review, and viii) Proofreading. In the validation phase, the MFPDI datasets from the UK (original) and Spain (adapted) were pooled and subjected to Rasch analysis. Fit to the Rasch model, unidimensionality, reliability and cross-cultural invariance is reported Results The pooled dataset comprised 1015 patients (Spain n=333 and UK n=682) with characteristics summarised in Table 1. Rasch analysis confirmed three subscales for both the Spanish and UK datasets and fit to the Rasch model X 2 (df) = 15.945 (12), p = 0.194 and 31.024 (21), p = 0.073, for Spain and UK. The reliability (Person Separation Index - PSI) was .85 and .82 for Spain and UK respectively. Significant cross-cultural non-invariance was present on the Functional and Personal appearance subscales. Adjustment for the bias was achieved by ‘splitting’ the affected subscales and creation of cultural-specific subscales for each country and cultural-general subscale. Fit to the Rasch model was satisfied following cross-cultural adjustment (Table 1). The MFPDI was calibrated into interval-level scales for Spain and UK to enable future data pooling or comparisons. Conclusions A gold standard translation process (ISPOR) has been used to develop a Spanish (for Spain) version of the MFPDI, a widely used foot-specific patient-reported outcome measure. Rasch analysis has confirmed that the MFPDI is a robust 3-subscale measure of foot pain, function and appearance in both its English and Spanish versions. Future work can make cross-cultural comparisons using the calibrated scales References Garrow AP et al. Development and validation of a questionnaire to assess disabling foot pain. Pain 2000;85(1):107-13 Kaoulla P et al. Development and validation of a Greek language version of the MFPDI. Health Qual Life Outcomes. 2008 Jun 1;6:39 Ferrari SC, et al. Indice Manchester de incapacidade associada ao pe doloroso no idoso. Rev Bras Reumatol.2008;48(6):335-41. Wild D, et al. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures. 2005. Disclosure of Interest None Declared

The vascular and cutaneous alterations evident in systemic sclerosis/scleroderma (SSc) place the foot at risk of ulceration. The UK Podiatry Rheumatic Care Association (PRCA)/Arthritis and Musculoskeletal Alliance standards of care recommend that all people with SSc should receive at least basic information about their foot health, and that those with foot problems should have access to self-management advice and care where needed. The aim of this study was to evaluate foot health services offered in Leeds (UK) for people with SSc, against nationally agreed standards of care. Ninety-one consecutive patients with SSc were selected from either the connective tissue disease outpatient clinic (n = 70) or the specialist rheumatology foot health clinic (n = 21) at Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust. All the patients completed a disease-specific audit tool developed by the UK PRCA that evaluates provision of foot health care for patients with SSc. Sixty-one patients (67%) reported having had foot problems at some point in time and 54 (59%) had current foot problems. Of these 54 patients, 17 (32%) had not received any foot care. Only 36 (39%) of the 91 patients had received any foot health information. This audit demonstrates that patients with SSc have a relatively high prevalence of self-reported foot problems. Foot health care and information are inadequate for people with SSc and foot problems, and preventative information is almost non-existent. Improved foot health information will better empower patients to self-manage low risk problems, and help identify high risk problems which require specialist care.