Begonya Alcacer-Pitarch

Foot health needs in people with systemic sclerosis: an audit of foot health care provision.

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.

Pressure and pain in Systemic sclerosis/Scleroderma - An evaluation of a simple intervention (PISCES): Randomised controlled trial protocol

BackgroundFoot 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.MethodsThe 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.DiscussionThis 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 numberISRCTN: ISRCTN02824122

The prevalence of self-reported lower limb and foot health problems experienced by participants with systemic lupus erythematosus: Results of a UK national survey:

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.

Patients’ experiences of lupus-related foot problems: a qualitative investigation

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.

OP0305 Assessment of Skin Involvement by Acoustic Radiation Force Impulse (ARFI) Imaging in Patients with Systemic Sclerosis

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 3rd 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

Common measure of quality of life for people with systemic sclerosis across seven European countries: a cross-sectional study

Objectives The 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). Methods This 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. Results The 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. Conclusion The 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.

OP0064-HPR A Model Including Foot-Related Factors Impacting on Quality of Life (QOL) in Systemic Sclerosis

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.Table 1. Standardised direct, indirect and total effect of the variables as they relate to QoL, including foot problems Variable Direct effect Indirect effect Total effect Physical function 0.454 0.186 0.640 Breathing problems interference 0.000 0.493 0.493 Depression 0.270 0.158 0.428 Foot function 0.000 0.343 0.343 Foot pain 0.000 0.327 0.327 Raynauds interference 0.000 0.294 0.294 General pain 0.000 0.284 0.284 Disease severity 0.160 0.076 0.236 Anxiety 0.236 −0.003 0.233 DU interference 0.000 0.162 0.162 GI problems interference 0.000 0.095 0.095 DU: digital ulcers; GI: gastro intestinal. 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

THU0640-HPR Provision of Care Services for Rheumatic and Musculoskeletal Diseases-Related Foot and Ankle Problems: A Survey from Sixteen European Countries: Table 1.

Background The increased prevalence of foot and ankle pathologies in Rheumatic and Musculoskeletal diseases (RMDs) is well documented1, 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.Table 1. Number of countries reporting which professions are involved in providing the health services specialising in RMD-related F&A problems. Only professions that were present in ≥10 countries were included Professions Foot problems F&A pain F&A deformity F&A ulcers No. Countries (N=16) No. Countries (N=16) No. Countries (N=16) General Practitioner 14 7 10 Rheumatologist 15 11 10 Rehabilitation Medical Dr 11 10 5 Nurses 9 5 14 Podiatrist 11 11 8 Physiotherapist 14 11 3 Orthotist/prosthetist 14 14 8 Orthopaedic surgeon 12 14 7 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

OP0060-HPR Cross-Cultural Validation of The Systemic Sclerosis Quality of Life Questionnaire in Six European Countries: A Tool Validation Study: Table 1

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.Table 1 Item Fit Residual Person Fit Residual Chi Square Interaction Reliability Mean SD Mean SD Value (DF) p-value PSI N A. Analysis of the 29 individual items  UK −0.232 1.043 −0.233 0.680 48.932 (29) 0.012 0.919 112  Germany −0.704 2.034 −0.484 1.456 398 (116) <0.001 0.881 263  France −0.291 1.048 −0.271 0.855 34.868 (29) 0.209 0.893 111  Sweden −0.264 0.910 −0.273 0.728 60.886 (29) <0.001 0.892 101  Spain −0.166 0.751 −0.220 0.654 42.439 (29) 0.051 0.906 95  Italy −0.205 1.051 −0.285 0.756 88.662 (58) 0.006 0.890 125  Pooled −0.416 1.676 −0.229 0.882 410.802 (261) <0.001 0.896 807 B. Analysis of the 5 subscales (testlets)  UK 0.016 1.535 −0.288 0.848 4.992 (5) 0.417 0.896 109  Germany −0.698 2.795 −0.285 0.873 61.952 (20) <0.001 0.852 263  France 0.020 1.380 −0.280 0.895 2.368 (5) 0.796 0.826 106  Sweden −0.136 0.793 −0.253 0.819 25.665 (44) 0.988 0.813 95  Spain −0.265 1.346 −0.221 0.711 11.430 (5) 0.043 0.846 92  Italy −0.137 1.888 −0.315 0.831 4.281 (5) 0.510 0.818 125  Pooled* −0.394 2.928 −0.310 0.859 63.909 (45) 0.033 0.840 536  Pooled-Adj** −0.420 2.724 −0.310 0.862 65.579 (54) 0.134 0.841 536 SD, Standard deviation; DF, Degrees of freedom; PSI, Person separation index reliability; Pooled* excludes Germany dataset; Pooled-Adj** adjusted to account for Italy differential response 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

FRI0390 Effects of pressure relieving insoles for foot problems in people with ssc: the pisces randomized controlled trial

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<0.01)), but in the forefoot the difference between insole types was not significant; pressure change -17.2 kPa (-61,19) for active insoles and -10.8kPa (-39,0) for sham insoles (p=0.31). 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