The prevalence of foot health problems in people living with a rheumatic condition: a cross-sectional observational epidemiological study.

This study aimed to determine the prevalence of foot health problems in people living with any rheumatic condition and explore potential associations with exposure variables. A cross-sectional observational epidemiological design was applied. The participants were recruited from one regional patient association in southwest Finland. The data were collected in January-February 2019 and included the Self-reported Foot Health Assessment Instrument (S-FHAI) and demographic questions. In total, 495 responses were obtained. Overall, participants had many foot problems. The point prevalence of self-reported foot problems was 99 per 100 people living with a rheumatic condition. The most prevalent problems were foot pain (73%), dry soles (68%), thickened toenails (58%) and cold feet (57%). Lower educational attainment, increased amount of daily standing and accessing medical or nursing care for foot problems were associated with poorer foot health. The results reveal a high frequency of foot pain among people with rheumatic conditions. The study highlighted the importance of person-centred care and the biological focus that underpins and impacts foot health (what we understand, what we do, and our health-seeking behaviour). Interventions to promote biopsychosocial approaches to personalised foot care could advance people's readiness, knowledge and skill to care for their own feet.

The short-term impact of non-removable offloading devices on quality of life in people with recurrent diabetic foot ulcers.

OBJECTIVE: Recurrent diabetic foot ulcers (DFUs) are associated with poor health-related quality of life and reduced mobility. Current guidelines recommend application of non-removable offloading devices (NROLDs) as they may improve the healing of DFUs, but there is a lack of information on the wider effects of wearing these devices. Few studies have examined the impact of NROLDs on holistic wellbeing or physical activity. We aimed to investigate the short-term impact of NROLDs on physical activity and DFU-related quality of life (DFU-QoL) in a small sample of community-dwelling people with recurrent DFUs. METHOD: We measured DFU-QoL and physical activity (GPAQ) in people with DFUs, recruited from a single clinic before NROLD application, and at three and six weeks after device fitting. Participants were aged from 39-81 years (mean 58.4±10.1 years) with an equal number of male and female participants. RESULTS: The study cohort comprised 18 participants, of whom 14 (78%) completed six-week questionnaires. Although there was some interim decline observed within individual domains of the DFU-QoL (financial: mean difference (MD) 16.2 (95% confidence interval (CI) 2.1, 30.2); p=0.03); non-compliance: MD 12.5 (95% CI-0.2, 25.2); p=0.05), no differences were observed over six weeks. Levels of physical activity declined over time, with over half (56%) of participants classified as having low levels of physical activity at baseline, rising to two-thirds (67%) at follow-up. CONCLUSION: Future studies should explore the longer-term holistic impact of NROLDs and develop more personalised approaches to care at the point of prescription, during and post-device use.

National variation in the composition of rheumatology multidisciplinary teams: a cross-sectional study.

The objective of this study is to describe the composition of multidisciplinary teams (MDT) working within rheumatology departments across the UK. All rheumatology departments in the United Kingdom (UK) were invited to participate in a national electronic survey between February 2014 and April 2015 as a part of a national audit for the management of rheumatoid and early inflammatory arthritis commissioned by Healthcare Quality Improvement Partnership. Rheumatology departments were asked to report their MDT composition; defined as a rheumatologist (consultant or specialist trainee), specialist nurse, occupational therapist physiotherapist, and podiatrist. The data were collected as Whole Time Equivalent (WTE) of each professional group at each department adjusted to 100,000 population. The data were grouped according to British Society for Rheumatology regions to study regional variations. The survey was completed by 164/167 departments (98% response rate). All departments reported an MDT comprising a rheumatologist (consultant or specialist trainee) and almost all included a specialist nurse but only 28 (17%) of the departments had MDTs comprising all the professional groups. There was a high degree of regional variation in the provision of Allied Health Professionals (physiotherapists, occupational therapists, and podiatrists) in the UK. MDT care is recommended for the management of inflammatory arthritis, but few UK rheumatology departments have a full complement of healthcare professionals within their MDT. There is a high degree of regional variation in the composition and staffing levels of the rheumatology MDT across the UK; the impact of which warrants further investigation.

The reliability of a novel magnetic resonance imaging-based tool for the evaluation of forefoot bursae in patients with rheumatoid arthritis: the FFB score.

OBJECTIVE: The aim of this study was to determine the reliability of an MRI-based score that evaluates forefoot bursae (FFBs) in patients with RA. METHODS: Items for inclusion, grading criteria and MRI sequences were determined iteratively. The score was evaluated in 30 patients with established RA. Reader agreement was evaluated using the percentage of exact/close agreement, Bland-Altman plots, kappa and intraclass correlation coefficient analyses. RESULTS: The FFB score assesses nine forefoot regions and contains four items: presence, shape, enhancement and magnetic resonance characteristics. The FFB score showed moderate to good intra- and interreader agreement (κ range = 0.5-0.9 and 0.47-0.87, respectively). CONCLUSION: The FFB score is adequately reliable in the evaluation of bursa-like lesions of the forefoot in patients with RA.

The prevalence of foot pain and association with baseline characteristics in people participating in education and supervised exercise for knee or hip osteoarthritis: a cross-sectional study of 26,003 participants from the GLA:D® registry.

BACKGROUND: Osteoarthritis (OA) affecting the knee or hip is highly prevalent in the general population and has associated high disease burden. Early identification of modifiable risk factors that prevent, limit, or resolve disease symptoms is critical. Foot pain may represent a potentially modifiable factor however little is known about the prevalence of foot pain in people with knee or hip OA nor whether foot pain is associated with clinical characteristics. The main aim of this study was therefore to determine the prevalence of foot pain in people with knee or hip OA attending an education and supervised exercise-based intervention in Denmark (GLA:D®) and determine if baseline demographic or clinical characteristics are associated with foot pain. METHODS: Analysis was conducted on baseline data of 26,003 people with symptomatic knee or hip OA completing a pain mannequin as part of the Good Life with osteoArthritis in Denmark (GLA:D®) primary care programme. Odds Ratios (OR) and 95% confidence intervals (CI) were calculated to estimate the strength of association between baseline clinical characteristics (including pain severity in worst knee/hip joint, number of painful knee/hip joints, pain medication use and physical activity level) and the presence of baseline foot pain. RESULTS: Twelve percent of participants (n = 3,049) reported foot pain. In those people with index knee OA (n = 19,391), knee pain severity (OR 1.01 CI 1.00, 1.01), number of painful knee/hip joints (OR 1.67 CI 1.58, 1.79), and use of pain medication (OR 1.23 CI 1.12, 1.36) were statistically associated with foot pain. Excluding use of pain medication, similar associations were seen in those with index hip OA. CONCLUSION: Twelve percent of people with knee or hip OA participating in GLA:D® had foot pain. Those with worse knee/hip pain, and greater number of painful joints were more likely to report foot pain. This study is the first to demonstrate a significant relationship between clinical characteristics and foot pain in people with knee or hip OA participating in education and supervised exercise. Future investigation should consider the role that foot pain may play on knee and hip related outcomes following therapeutic intervention.

Management and treatment of children, young people and adults with systemic lupus erythematosus: British Society for Rheumatology guideline scope.

The objective of this guideline is to provide up-to-date, evidence-based recommendations for the management of SLE that builds upon the existing treatment guideline for adults living with SLE published in 2017. This will incorporate advances in the assessment, diagnosis, monitoring, non-pharmacological and pharmacological management of SLE. General approaches to management as well as organ-specific treatment, including lupus nephritis and cutaneous lupus, will be covered. This will be the first guideline in SLE using a whole life course approach from childhood through adolescence and adulthood. The guideline will be developed with people with SLE as an important target audience in addition to healthcare professionals. It will include guidance related to emerging approved therapies and account for National Institute for Health and Care Excellence Technology Appraisals, National Health Service England clinical commissioning policies and national guidance relevant to SLE. The guideline will be developed using the methods and rigorous processes outlined in 'Creating Clinical Guidelines: Our Protocol' by the British Society for Rheumatology.

COVID-19 lockdown disrupts support networks integral to maintaining foot health: a mixed-methods study.

BACKGROUND: In response to the COVID-19 pandemic, populations were advised to remain at home to control viral spread. Government-mandated restrictions on free movement affected individuals' engagement with physical activity, with reported increases leading to biopsychosocial health benefits and conversely increased sedentary behaviour leading to poorer health. Good foot health is key to enabling physical activity and maximal participation in activities of occupation and daily living. METHODS: A population-based cross-sectional study was performed, using a web-based platform. Quantitative and qualitative data were captured through responses to closed and open survey questions. Anybody with a foot health condition was eligible to participate in the online survey. Links were sent through professional networks, support groups and charities, using a snowball strategy to maximise participation. RESULTS: Two hundred fifty-five respondents completed the survey. Most (n = 193, 75.69%) reported an ongoing foot pain or problem that had been present for 4 weeks or longer, whilst 49 respondents (19.22%) noted a new pain or problem. Pain was the most frequently reported symptom (n = 139, 54.51%), whilst change in appearance of the foot was also commonly reported (n = 122, 47.84%), often alongside the observable presence of swelling. Musculoskeletal foot symptoms were frequently reported (n = 123, 48%), and were significantly associated with reported reduced physical activity (X2 = 6.61, p = 0.010). Following qualitative analysis five themes and 11 subthemes emerged, informed by 49 independent codes. A central theme of lockdown disrupting support networks, both formal (healthcare providers) and informal (friends or family members) emerged. The 5 sub-themes were: 1. foot pain is a constant companion, 2. self-care, 3. 'cope or crumble' scenarios, 4. future intent to access healthcare and 5. reduced ability to undertake physical activity. CONCLUSIONS: Pain was the most frequently reported foot problem during COVID-19 lockdown restriction. Lockdown restrictions disrupted support networks integral to maintaining foot health. Poor foot health impacted people's ability to remain physically active. Complaints previously considered relatively 'minor' such as support for skin and nail care, were found to be exacerbated by restricted support networks, leading to greater negative impact.

Exploring the use of musculoskeletal ultrasound imaging by podiatrists: an international survey.

BACKGROUND: Podiatrists, in musculoskeletal services, are demonstrating an expansion of their practice skills through the use of ultrasound imaging. There is an assumption that this practice is beneficial within the context of patient care and health systems. The aim of this research was to further investigate the use of musculoskeletal ultrasound (MSUS) by podiatrists within their clinical setting and gain additional insights into the impact that they perceive use of MSUS has on their approaches to management of musculoskeletal foot and ankle problems. METHOD: An international study utilising a cross-sectional design and an internet-based platform was undertaken. The survey was developed and implemented through three phases: 1. survey development, 2. face validity agreement via questionnaire review, and 3. survey distribution and data collection. Twenty-two survey questions were developed and set as a two-step approach collecting quantitative data (part 1) and qualitative free text data (part 2). Data was exported from SurveyMonkey and analysed using Microsoft Excel software. Counts and frequencies were calculated for responses to all twenty closed questions. Responses to the two final open-ended questions were analysed using thematic analysis to search for patterns related to podiatrists' perceptions of impact. RESULTS: Two hundred and thirty-two eligible participants consented to complete the survey. The majority (n = 159) of respondents were from the UK and Spain. Commonly MSUS has been used in practice for (i) diagnosing pathology, (ii) supporting rehabilitation, (iii) supporting interventions or (iv) research purposes. Most frequently, MSUS was used to assist in the diagnosis of injury/pathology (84%). A range of free text comments were received from the participants in response to the question relating to their thoughts on the impact of using MSUS imaging in their practice (n = 109) and on their perceptions of how the use of MSUS has influenced their approaches to management of their patients' musculoskeletal foot and ankle problems (n = 108). Thematic analysis of the free text comments generated four themes: (i) diagnosis, (ii) delivery and access of care, (iii) patient education and engagement, and (iv) patient empowerment. CONCLUSION: The perceived benefit podiatrists indicated in using MSUS as part of their practice is the perceived improvement in patient journeys through tighter, focused management plans and reduced waiting times. An additional novel finding was that MSUS provided the capacity for podiatrists to better inform patients of their diagnosis, which they believed led to improved engagement and consequent empowerment of patients in their treatment plans. We propose further investigation of patient experiences as well as testing of the model that embeds podiatrists' use of MSUS as a key skill in musculoskeletal foot and ankle services.

Predicting Forefoot-Orthosis Interactions in Rheumatoid Arthritis Using Computational Modelling.

Foot orthoses are prescribed to reduce forefoot plantar pressures and pain in people with rheumatoid arthritis. Computational modelling can assess how the orthoses affect internal tissue stresses, but previous studies have focused on a single healthy individual. This study aimed to ascertain whether simplified forefoot models would produce differing biomechanical predictions at the orthotic interface between people with rheumatoid arthritis of varying severity, and in comparison to a healthy control. The forefoot models were developed from magnetic resonance data of 13 participants with rheumatoid arthritis and one healthy individual. Measurements of bony morphology and soft tissue thickness were taken to assess deformity. These were compared to model predictions (99th% shear strain and plantar pressure, max. pressure gradient, volume of soft tissue over 10% shear strain), alongside clinical data including body mass index and Leeds Foot Impact Scale-Impairment/Footwear score (LFIS-IF). The predicted pressure and shear strain for the healthy participant fell at the lower end of the rheumatoid models' range. Medial first metatarsal head curvature moderately correlated to all model predicted outcomes (0.529 < r < 0.574, 0.040 < p < 0.063). BMI strongly correlated to all model predictions except pressure gradients (0.600 < r < 0.652, p < 0.05). There were no apparent relationships between model predictions and instances of bursae, erosion and synovial hypertrophy or LFIS-IF score. The forefoot models produced differing biomechanical predictions between a healthy individual and participants with rheumatoid arthritis, and between individuals with rheumatoid arthritis. Models capable of predicting subject specific biomechanical orthotic interactions could be used in the future to inform more personalised devices to protect skin and soft tissue health. While the model results did not clearly correlate with all clinical measures, there was a wide range in model predictions and morphological measures across the participants. Thus, the need for assessment of foot orthoses across a population, rather than for one individual, is clear.

Self-management approaches to reduce the ill-health burden associated with musculoskeletal foot and ankle problems: A scoping review protocol.

INTRODUCTION: The high ill-health burden associated with musculoskeletal (MSK) disease has been widely reported, and various treatment approaches proposed. Increasingly, treatments have sought to reflect personalised care and incorporate self-management (SM). However, the range of SM approaches proposed for foot and ankle MSK problems, and their relative clinical or cost-effectiveness, has not been reviewed. A scoping review is required to understand the need/appropriateness of a systematic review on this topic. METHODS AND ANALYSIS: The scoping review will be conducted in line with the PRISMA-ScR framework. We will perform an initial search across two databases to confirm search syntax. We will then complete a full search across three databases (Embase [Ovid], CINAHL [EBSCO], and Medline [EBSCO]) and grey literature (Cochrane Library, The British Library, The Canadian Agency for Drugs and Technologies in Health [CADTH], The Health Foundation, The Kings Fund, and MedNar). We will use a snowballing strategy to review the reference list of retrieved texts, as per inclusion criteria, to identify previously unretrieved texts of potential relevance. In an iterative process, the protocol outlined above will be refined and repeated as new key terms come to light. ETHICS AND DISSEMINATION: The scoping review will synthesise what is known and not known about SM approaches for MSK foot and ankle problems. The review will form the first step in outlining future research recommendations and areas of potentially unmet clinical need. The findings will be submitted for publication and shared in written form with stakeholder groups involved in the design of future research.

Black elderberry (Sambucus nigra) supplementation effectively treats upper respiratory symptoms: A meta-analysis of randomized, controlled clinical trials.

Upper respiratory symptoms are often treated with over the counter drugs, antibiotics, and antiviral medications. Due to concerns about safety and efficacy, there is a demand for an alternative solution. Black elderberry (Sambucus nigra) has been used to treat cold and flu symptoms, but there are no large-scale studies or meta-analyses. This meta-analysis quantifies the effects of elderberry supplementation and evaluates moderators including vaccination status and the underlying pathology. This analysis included a total of 180 participants and evaluates moderators such as vaccination status and cause of the upper respiratory symptoms. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. These findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.

Survey of ultrasound practice amongst podiatrists in the UK.

BACKGROUND: Ultrasound in podiatry practice encompasses musculoskeletal ultrasound imaging, vascular hand-held Doppler ultrasound and therapeutic ultrasound. Sonography practice is not regulated by the Health and Care Professions Council (HCPC), with no requirement to hold a formal qualification. The College of Podiatry does not currently define ultrasound training and competencies.This study aimed to determine the current use of ultrasound, training received and mentorship received and/or provided by podiatrists using ultrasound. METHODS: A quantitative study utilising a cross-sectional, on-line, single-event survey was undertaken within the UK. RESULTS: Completed surveys were received from 284 podiatrists; 173 (70%) use ultrasound as part of their general practice, 139 (49%) for musculoskeletal problems, 131 (46%) for vascular assessment and 39 (14%) to support their surgical practice. Almost a quarter (n = 62) worked for more than one organisation; 202 (71%) were employed by the NHS and/or private sector (n = 118, 41%).Nearly all (93%) respondents report using a hand-held vascular Doppler in their daily practice; 216 (82%) to support decisions regarding treatment options, 102 (39%) to provide diagnostic reports for other health professionals, and 34 (13%) to guide nerve blocks.Ultrasound imaging was used by 104 (37%) respondents primarily to aid clinical decision making (n = 81) and guide interventions (steroid injections n = 67; nerve blocks n = 39). Ninety-three percent stated they use ultrasound imaging to treat their own patients, while others scan at the request of other podiatrists (n = 28) or health professionals (n = 18). Few use ultrasound imaging for research (n = 7) or education (n = 2).Only 32 (11%) respondents (n = 20 private sector) use therapeutic ultrasound to treat patients presenting with musculoskeletal complaints, namely tendon pathologies.Few respondents (18%) had completed formal post-graduate CASE (Consortium for the Accreditation of Sonographic Education) accredited ultrasound courses.Forty (14%) respondents receive ultrasound mentorship; the majority from fellow podiatrists (n = 17) or medical colleagues (n = 15). Over half (n = 127) who do not have ultrasound mentorship indicated they would like a mentor predominantly for ultrasound imaging. Fifty-five (19%) report they currently provide ultrasound mentorship for others. CONCLUSIONS: Understanding the scope of ultrasound practice, the training undertaken and the requirements for mentorship will underpin the development of competencies and recommendations defined by the College of Podiatry to support professional development and ensure safe practice.

The clinical diagnosis of symptomatic forefoot neuroma in the general population: a Delphi consensus study.

BACKGROUND: There is limited evidence for defining what specific method or methods should be used to clinically influence clinical decision making for forefoot neuroma. The aim of this study was to develop a clinical assessment protocol that has agreed expert consensus for the clinical diagnosis of forefoot neuroma. METHODS: A four-round Delphi consensus study was completed with 16 expert health professionals from either a clinical or clinical academic background, following completion of a structured literature review. Clinical experience ranged from 5 to 34 years (mean: 19.5 years). Consensus was sought on the optimal methods to achieve the clinical diagnosis of forefoot neuroma. Round 1 sought individual input with an open ended question. This developed a list of recommendations. Round 2 and 3 asked the participants to accept or reject each of the recommendations in the list in relation to the question: "What is the best way to clinically diagnose neuroma in the forefoot?" Votes that were equal to or greater than 60% were accepted into the next round; participant's votes equal to or less then 20% were excluded. The remaining participant's votes between 20 to 60% were accepted and placed into the following round for voting. Round 4 asked the participants to rank the list of recommendations according to the strength of recommendation they would give in relation to the question: "What is the best way to clinically diagnose neuroma in the forefoot?" The recruitment and Delphi rounds were conducted through email. RESULTS: In round 1, the 16 participants identified 68 recommendations for the clinical diagnosis of forefoot neuroma. In round 2, 27 recommendations were accepted, 11 recommendations were rejected and 30 recommendations were assigned to be re-voted on. In round 3, 36 recommendations were accepted, 22 recommendations were rejected and 11 recommendations were assigned to be re-voted on. In round 4, 21 recommendations were selected by the participants to form the expert derived clinical assessment protocol for the clinical diagnosis of forefoot neuroma. From these 21 recommendations, a set of themes were established: location of pain, non weight bearing sensation, weight bearing sensation, observations, tests and imaging. CONCLUSION: Following the identification of 21 method recommendations, a core set of clinical diagnostic methods have been prepared as a clinical assessment protocol for the diagnosis of forefoot neuroma. Based on expert opinion, the core set will assist clinicians in forming a clearer diagnosis of forefoot neuroma.

Identifying the primary outcome for a randomised controlled trial in rheumatoid arthritis: the role of a discrete choice experiment.

BACKGROUND: This study sought to establish the preferences of people with Rheumatoid Arthritis (RA) about the best outcome measure for a health and fitness intervention randomised controlled trial (RCT). The results of this study were used to inform the choice of the trial primary and secondary outcome measure. METHODS: A discrete choice experiment (DCE) was used to assess people's preferences regarding a number of outcomes (foot and ankle pain, fatigue, mobility, ability to perform daily activities, choice of footwear) as well as different schedules and frequency of delivery for the health and fitness intervention. The outcomes were chosen based on literature review, clinician recommendation and patients' focus groups. The DCE was constructed in SAS software using the D-efficiency criteria. It compared hypothetical scenarios with varying levels of outcomes severity and intervention schedule. Preference weights were estimated using appropriate econometric models. The partial log-likelihood method was used to assess the attribute importance. RESULTS: One hundred people with RA completed 18 choice sets. Overall, people selected foot and ankle pain as the most important outcome, with mobility being nearly as important. There was no evidence of differential preference between intervention schedules or frequency of delivery. CONCLUSIONS: Foot and ankle pain can be considered the patient choice for primary outcome of an RCT relating to a health and fitness intervention. This study demonstrated that, by using the DCE method, it is possible to incorporate patients' preferences at the design stage of a RCT. This approach ensures patient involvement at early stages of health care design.

A pilot investigation of the prevalence of US-detectable forefoot joint pathology and reported foot-related disability in participants with systemic lupus erythematosus.

BACKGROUND: The main aim of this study was to determine the prevalence of US-detectable forefoot bursae, metatarsophalangeal (MTP) joint and metacarpophalangeal (MCP) joint synovial hypertrophy (SH), Power Doppler (PD) signal or erosion in participants with systemic lupus erythematosus (SLE). A secondary aim was to determine the strength of potential association between patient reported foot-related disability and US-detected forefoot bursae, MTP joint SH, PD signal or erosion in participants with SLE. METHOD: A cross-sectional observational study of 20 participants with SLE was completed to determine the prevalence of US-detected forefoot bursal, MTP and MCP joint pathology. Patient-reported foot-related impairment and activity limitation (accumulatively referred to as disability) were also recorded. Spearmans' Rank Correlation analyses were completed to determine the potential strength of association between US-detected pathology and patient report disability. RESULTS: The prevalence of MTP joint SH and PD was 80 % (16/20) and 10 % (2/20), respectively. The prevalence of MCP joint SH and PD was 60 % (12/20) and 30 % (6/20) respectively. A significant association was noted between PD scores for the MTP joints and MCP joints (r = 0.556; p = 0.011) although this was not demonstrated for SH scores (r = 0.176; p = 0.459). Significant associations between forefoot bursal prevalence and MTP joint PD were noted (r = 0.467; p = 0.038). The prevalence of bursae and bursal PD (grade 2 or above) was 100 % (20/20) and 10 % (2/20), respectively. Moderate foot-related impairment and activity limitation was reported by 95 and 85 % of participants respectively. CONCLUSION: This pilot study suggests that US-detected MTP, MCP joint and forefoot bursal abnormalities may be prevalent in participants with SLE and they may experience a moderate level of foot-related disability. Further research is required to substantiate these preliminary findings.

An Investigation into the Scale and Impact of Self-Reported Foot Problems Associated with Systemic Lupus Erythematosus: A Study Protocol and Survey Questionnaire Development.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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 Wiley & Sons, Ltd.