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author:("reddy, Edward")
1.  Foot problems in people with gout in primary care: baseline findings from a prospective cohort study 
Background
Foot problems are common in people with gout yet the prevalence of current foot problems in people with gout and the burden they present to healthcare systems is not known. This cross-sectional study aimed to determine the prevalence and associations of hallux valgus, foot pain and disability in people with gout, and to assess the frequency with which foot problems lead to consultation with healthcare professionals.
Methods
Adults registered with 20 general practices who had consulted their GP about gout or been prescribed allopurinol or colchicine in the preceding two years were mailed a questionnaire. Prevalence of hallux valgus, foot pain in the last month, and disabling foot pain in the mailed population were ascertained using validated instruments and estimated by inverse-weighted logistic regression. Associations with socio-demographic, comorbid and gout-specific factors were examined using logistic regression. Participants were asked if they had seen health care professionals for foot problems within the preceding 12 months.
Results
One thousand one hundred eighty-four questionnaires were received (response 66 %). Prevalence of hallux valgus was 36.3 %, foot pain in the last month 22.3 % and disabling foot pain 14.5 %. Hallux valgus associated with age (adjusted OR 1.47 per 10-year increase, 95 % CI 1.26, 1.72) and female gender (2.03; 1.31, 3.15). Foot pain in the last month associated with age (1.24; 1.00, 1.55), obesity (BMI 30.0–34.9 2.67; 1.32, 5.38; BMI ≥ 35.0 3.16; 1.44, 6.93), mild depression (2.04; 1.09, 3.81) and polyarticular gout attacks (1.86; 1.18, 2.95). Disabling foot pain associated with age (1.42; 1.08, 1.87), obesity (BMI 30.0–34.9 3.73; 1.54, 9.09; BMI ≥ 35.0 4.36; 1.64, 11.64), depression (mild 2.63; 1.25, 5.53; moderate 3.53; 1.11, 11.26) and ischaemic heart disease (2.45; 1.32, 4.53). In the previous 12 months, 495 (42.8 %) reported consulting their GP about their feet and 281 (23.7 %) a podiatrist/chiropodist.
Conclusions
Foot problems are common in people with gout and frequently lead to healthcare consultation. Hallux valgus has similar associations to those seen in the general population, whereas foot pain associates with obesity and gout characteristics, and disabling foot pain with obesity and comorbidity. Patient assessment should consider foot problems and offer specific treatment where relevant.
doi:10.1186/s13047-015-0090-9
PMCID: PMC4512156  PMID: 26207143
Foot; Gout; Pain; Hallux valgus; Epidemiology
2.  The epidemiology of symptomatic midfoot osteoarthritis in community-dwelling older adults: cross-sectional findings from the Clinical Assessment Study of the Foot 
Introduction
The foot is largely overlooked in calls for better characterisation of clinical phenotypes in osteoarthritis (OA). Yet the midfoot complex in particular has the potential to provide important insights into OA pathogenesis given its central role in lower limb load transmission and alignment. Its recent inclusion in radiographic atlases has paved the way for international studies. In this UK study, we provide the first comprehensive account of the descriptive epidemiology of symptomatic midfoot OA.
Methods
Participants aged ≥50 years registered with four general practices were recruited via a mailed health survey (n = 5109 responders) and research clinic (n = 560 responders). Symptomatic midfoot OA was defined as midfoot pain in the last 4 weeks, combined with radiographic OA in one or more joints (1st and 2nd cuneometatarsal, navicular first cuneiform and talonavicular joints) graded from weight-bearing dorso-plantar and lateral radiographs using a validated atlas. Prevalence estimates, overall and stratified by age, gender, and socio-economic class, were derived using multiple imputation and weighted logistic regression. Associations between symptomatic midfoot OA and current body mass index, previous injury, history of high-heeled footwear, nodal interphalangeal joint OA and patterns of comorbidity were estimated using binary logistic regression. Healthcare use was summarised.
Results
Symptomatic midfoot OA was present in 12.0 % (95 % CI: 10.9, 13.2) of the population aged over 50 years. Higher occurrence was observed in females, adults aged over 75 years, and those in intermediate/routine occupational classes. Obesity, previous foot/ankle injury, and pain in other weight-loaded joints, but not high-heeled footwear or nodal interphalangeal joint OA, were associated with increased risk of symptomatic midfoot OA. Persons with symptomatic midfoot OA were also more likely to report multiple non-musculoskeletal comorbidities, including diabetes. In the previous 12 months, the proportions consulting a general practitioner, physiotherapist or podiatrist/chiropodist about foot pain were 46.2 %, 18.5 % and 47.9 % respectively. A total of 64.7 % had used oral analgesia in the past month for foot pain (36.1 % paracetamol, 31.9 % mild/moderate opioids, 27.7 % NSAIDs).
Conclusions
Our study confirms that symptomatic OA frequently affects the midfoot. The patterns of associations are interpreted as being largely consistent with the role of mechanical factors in its pathogenesis.
Electronic supplementary material
The online version of this article (doi:10.1186/s13075-015-0693-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s13075-015-0693-3
PMCID: PMC4499901  PMID: 26166410
3.  Epidemiology of Gout 
Synopsis
Gout is the most prevalent inflammatory arthritis in men. The findings of several epidemiological studies from a diverse range of countries suggest that the prevalence of gout has risen over the last few decades. Whilst incidence data are scarce, data from the US suggests that the incidence of gout is also rising. Evidence from prospective epidemiological studies has confirmed dietary factors (animal purines, alcohol and fructose), obesity, the metabolic syndrome, hypertension, diuretic use, and chronic kidney disease as clinically relevant risk factors for hyperuricemia and gout. Low-fat dairy products, coffee, and vitamin C appear to have a protective effect. Further prospective studies are required to examine other proposed risk factors for hyperuricaemia and gout such as the use of β-blockers and angiotension-II receptor antagonists (other than losartan), obstructive sleep apnoea, and osteoarthritis, and putative protective factors such as calcium-channel blockers and losartan.
doi:10.1016/j.rdc.2014.01.001
PMCID: PMC4119792  PMID: 24703341
Gout; Hyperuricaemia; Prevalence; Incidence; Aetiology; Epidemiology
4.  Increased risk of vascular disease associated with gout: a retrospective, matched cohort study in the UK Clinical Practice Research Datalink 
Annals of the Rheumatic Diseases  2014;74(4):642-647.
Objectives
To determine whether gout increases risk of incident coronary heart disease (CHD), cerebrovascular (CVD) and peripheral vascular disease (PVD) in a large cohort of primary care patients with gout, since there have been no such large studies in primary care.
Methods
A retrospective cohort study was performed using data from the Clinical Practice Research Datalink (CPRD). Risk of incident CHD, CVD and PVD was compared in 8386 patients with an incident diagnosis of gout, and 39 766 age, sex and registered general practice-matched controls, all aged over 50 years and with no prior vascular history, in the 10 years following incidence of gout, or matched index date (baseline). Multivariable Cox Regression was used to estimate HRs and covariates included sex and baseline measures of age, Body Mass Index, smoking, alcohol consumption, Charlson comorbidity index, history of hypertension, hyperlipidaemia, chronic kidney disease, statin use and aspirin use.
Results
Multivariable analysis showed men were at increased risk of any vascular event (HRs (95% CIs)) HR 1.06 (1.01 to 1.12), any CHD HR 1.08 (1.01 to 1.15) and PVD HR 1.18 (1.01 to 1.38), while women were at increased risk of any vascular event, HR 1.25 (1.15 to 1.35), any CHD HR 1.25 (1.12 to 1.39), and PVD 1.89 (1.50 to 2.38)) but not any CVD.
Conclusions
In this cohort of over 50s with gout, female patients with gout were at greatest risk of incident vascular events, even after adjustment for vascular risk factors, despite a higher prevalence of both gout and vascular disease in men. Further research is required to establish the reason for this sex difference.
doi:10.1136/annrheumdis-2014-205252
PMCID: PMC4392302  PMID: 25165032
Gout; Cardiovascular Disease; Epidemiology
5.  Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis of observational studies 
Introduction
To determine the prevalence of chronic kidney disease and nephrolithiasis in people with gout, and the association between gout and prevalent or incident chronic kidney disease and nephrolithiasis.
Methods
Systematic review and meta-analysis of epidemiological studies. Data sources; MEDLINE, EMBASE and CINAHL databases, hand-searched reference lists, citation history and contact with authors. Eligibility criteria: cohort, case–control or cross-sectional studies which examined the occurrence of chronic kidney disease or nephrolithiasis amongst adults with gout (with or without a non-gout comparator group) in primary care or general population samples. Prevalence and risk estimate meta-analyses were performed using a random-effects model.
Results
Seventeen studies were included in the meta-analysis (chronic kidney disease n = 7, nephrolithiasis n = 8, both n = 2). Pooled prevalence estimates of chronic kidney disease stage ≥3 and self-reported lifetime nephrolithiasis in people with gout were 24% (95% confidence interval 19% to 28%) and 14% (95% CI 12% to 17%) respectively. Gout was associated with both chronic kidney disease (pooled adjusted odds ratio 2.41, 95% confidence interval 1.86 to 3.11) and self-reported lifetime nephrolithiasis (1.77, 1.43 to 2.19).
Conclusions
Chronic kidney disease and nephrolithiasis are commonly found amongst patients with gout. Gout is independently associated with both chronic kidney disease and nephrolithiasis. Patients with gout should be actively screened for chronic kidney disease and its consequences.
doi:10.1186/s13075-015-0610-9
PMCID: PMC4404569  PMID: 25889144
6.  Pain reduction with oral methotrexate in knee osteoarthritis, a pragmatic phase iii trial of treatment effectiveness (PROMOTE): study protocol for a randomized controlled trial 
Trials  2015;16:77.
Background
Osteoarthritis (OA) is the fastest growing cause of disability worldwide. Current treatments for OA are severely limited and a large proportion of people with OA live in constant, debilitating pain. There is therefore an urgent need for novel treatments to reduce pain. Synovitis is highly prevalent in OA and is associated with pain. In inflammatory arthritides such as rheumatoid arthritis, methotrexate (MTX) is the gold standard treatment for synovitis and has a well-known, acceptable toxicity profile. We propose that using MTX to treat patients with symptomatic knee OA will be a practical and safe treatment to reduce synovitis and, consequently, pain.
Methods/Design
Pain Reduction with Oral Methotrexate in knee Osteoarthritis, a pragmatic phase III trial of Treatment Effectiveness (PROMOTE) is an investigator-initiated, multi-centre, randomized, double-blind, pragmatic placebo-controlled trial. A total of 160 participants with symptomatic knee OA will be recruited across primary and secondary care sites in the United Kingdom and randomized on a 1:1 basis to active treatment or placebo, in addition to usual care, for 12 months. As is usual practice for MTX, dosing will be escalated over six weeks to 25 mg (or maximum tolerated dose) weekly for the remainder of the study. The primary endpoint is change in average knee pain during the past week (measured on an 11-point numerical rating scale) between baseline and six months. Secondary endpoints include other self-reported pain, function and quality-of-life measures. A health economics analysis will also be performed. A magnetic resonance imaging substudy will be conducted to provide an explanatory mechanism for associated symptom change by examining whether MTX reduces synovitis and whether this is related to symptom change. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modelling analyses. All analyses will be conducted on an intention-to-treat basis.
Discussion
The PROMOTE trial is designed to examine whether MTX is an effective analgesic treatment for OA. The MRI substudy will address the relationship between synovitis and symptom change. This will potentially provide a much needed new treatment for knee OA.
Trial registration
Current Controlled Trials identifier: ISRCTN77854383 (registered: 25 October 2013).
doi:10.1186/s13063-015-0602-8
PMCID: PMC4351849  PMID: 25872649
Double-blind; Knee osteoarthritis; Methotrexate; Placebo-controlled; Randomized
7.  Maximising response from GPs to questionnaire surveys: do length or incentives make a difference? 
Background
General Practitioners (GPs) respond poorly to postal surveys. Consequently there is potential for reduced data quality and bias in the findings. In general population surveys, response to postal questionnaires may be improved by reducing their length and offering incentives. The aim of this study was to investigate whether questionnaire length and/or the offer of an incentive improves the response of GPs to a postal questionnaire survey.
Methods
A postal questionnaire survey was sent to 800 UK GPs randomly selected from Binley’s database; a database containing contact details of professionals working in UK general practices. The random sample of GPs was assigned to one of four groups of 200, each receiving a different questionnaire, either a standard (eight sides of A4) or an abbreviated (four sides of A4) questionnaire, with or without the offer of an incentive (a prize draw entry for a £100 voucher) for completion. The effects of questionnaire length and offer of incentive on response were calculated.
Results
Of 800 mailed questionnaires, 19 GPs did not meet inclusion criteria and 172 (adjusted response 22.0%) completed questionnaires were received. Among the four groups, response ranged from 20.1% (standard questionnaire with no incentive and abbreviated questionnaire with incentive) through 21.8% (standard questionnaire with incentive), to 26.0% (abbreviated questionnaire with no incentive). There were no significant differences in response between the four groups (p = 0.447), between the groups receiving the standard versus the abbreviated questionnaire (% difference -2.1% (95% confidence interval (CI) -7.9, 3.7)) or the groups offered an incentive versus no incentive (% difference -2.1% (95% CI -7.9, 3.7).
Conclusions
Strategies known to improve response to postal questionnaire surveys in the general population do not significantly improve the response to postal questionnaire surveys among GPs. Further refinements to these strategies, or more novel strategies, aimed at increasing response specifically among GPs need to be identified in order to maximise data quality and generalisability of research results.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2288-15-3) contains supplementary material, which is available to authorized users.
doi:10.1186/1471-2288-15-3
PMCID: PMC4293861  PMID: 25563390
Cross-sectional survey; Postal questionnaires; General practice; Incentive; Non-response; Questionnaire length; Response
8.  “Somebody to Say ‘Come On We Can Sort This’”: A Qualitative Study of Primary Care Consultation Among Older Adults With Symptomatic Foot Osteoarthritis 
Arthritis Care & Research  2013;65(12):2051-2055.
Objective
To examine the experiences of primary care consultation among older adults with symptomatic foot osteoarthritis (OA).
Methods
Eleven participants (6 women and 5 men) ages 56–80 years who had radiographically confirmed symptomatic foot OA and consulted a general practitioner in the last 12 months for foot pain were purposively sampled. Semistructured interviews explored the nature of the foot problem, help-seeking behaviors, and consultation experiences. Verbatim transcripts were analyzed using interpretative phenomenological analysis.
Results
The decision to consult a physician was often the outcome of a complex process influenced by quantitative and qualitative changes in symptoms, difficulty maintaining day-to-day roles and responsibilities and the effect this had on family and work colleagues, and a reluctance to present a fragile or aging self to the outside world. Self-management was commonly negotiated alongside multimorbidities. Upon seeking help, participants often believed they received limited information, they were given a brief or even cursory assessment, and that treatment was focused on the prescription of analgesic drugs.
Conclusion
This is the first qualitative study of primary care experiences among patients with symptomatic foot OA. The experience of primary care seldom appeared to move beyond a label of arthritis and an unwelcome emphasis on pharmacologic treatment.
doi:10.1002/acr.22073
PMCID: PMC4225467  PMID: 23861315
9.  Risk of vascular events in patients with polymyalgia rheumatica 
Background:
Polymyalgia rheumatica is one of the most common inflammatory rheumatologic conditions in older adults. Other inflammatory rheumatologic disorders are associated with an excess risk of vascular disease. We investigated whether polymyalgia rheumatica is associated with an increased risk of vascular events.
Methods:
We used the General Practice Research Database to identify patients with a diagnosis of incident polymyalgia rheumatica between Jan. 1, 1987, and Dec. 31, 1999. Patients were matched by age, sex and practice with up to 5 patients without polymyalgia rheumatica. Patients were followed until their first vascular event (cardiovascular, cerebrovascular, peripheral vascular) or the end of available records (May 2011). All participants were free of vascular disease before the diagnosis of polymyalgia rheumatica (or matched date). We used Cox regression models to compare time to first vascular event in patients with and without polymyalgia rheumatica.
Results:
A total of 3249 patients with polymyalgia rheumatica and 12 735 patients without were included in the final sample. Over a median follow-up period of 7.8 (interquartile range 3.3–12.4) years, the rate of vascular events was higher among patients with polymyalgia rheumatica than among those without (36.1 v. 12.2 per 1000 person-years; adjusted hazard ratio 2.6, 95% confidence interval 2.4–2.9). The increased risk of a vascular event was similar for each vascular disease end point. The magnitude of risk was higher in early disease and in patients younger than 60 years at diagnosis.
Interpretation:
Patients with polymyalgia rheumatica have an increased risk of vascular events. This risk is greatest in the youngest age groups. As with other forms of inflammatory arthritis, patients with polymyalgia rheumatica should have their vascular risk factors identified and actively managed to reduce this excess risk.
doi:10.1503/cmaj.140266
PMCID: PMC4162802  PMID: 25070989
10.  Evaluation of the measurement properties of the Manchester foot pain and disability index 
Background
The Manchester Foot Pain and Disability Index (MFPDI, 19 items) was developed to measure functional limitations, pain and appearance for patients with foot pain and is frequently used in both observational studies and randomised controlled trials. A Dutch version of the MFPDI was developed. The aims of this study were to evaluate all the measurement properties for the Dutch version of the MFPDI and to evaluate comparability to the original version.
Method
The MFPDI was translated into Dutch using a forward/backward translation process. The dimensionality was evaluated using exploratory and confirmatory factor analysis. Measurement properties were evaluated per subscale according to the COSMIN taxonomy consisting of: reliability (internal consistency, test-retest reliability and measurement error), validity (structural validity, content validity and cross-cultural validity comparing the Dutch version to the English version) responsiveness and interpretation.
Results
The questionnaire consists of three scales, measuring foot function, foot pain and perception. The reliability of the foot function scale is acceptable (Cronbach’s α > 0.7, ICC = 0.7, SEM = 2.2 on 0-18 scale). The construct validity of the function and pain scale was confirmed and only the pain scale contains one item with differential item functioning (DIF). The responsiveness of the function and pain scale is moderate when compared to anchor questions.
Conclusion
Results using the Dutch MFPDI version can be compared to results using the original version. The foot function sub-scale (items 1-9) is a reliable and valid sub-scale. This study indicates that the use of the MFPDI as a longitudinal instrument might be problematic for measuring change in musculoskeletal foot pain due to moderate responsiveness.
doi:10.1186/1471-2474-15-276
PMCID: PMC4244846  PMID: 25115354
11.  A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563) 
Background
Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients’ short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care.
Methods/design
Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically.
Discussion
This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates.
Trial registration
ISRCTN: ISRCTN93634563.
doi:10.1186/1471-2474-15-254
PMCID: PMC4123500  PMID: 25064573
Knee osteoarthritis; Knee pain; Physiotherapy; Exercise; Primary care; Adherence; Randomised controlled trial
12.  Rocker-sole footwear versus prefabricated foot orthoses for the treatment of pain associated with first metatarsophalangeal joint osteoarthritis: study protocol for a randomised trial 
Background
Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain, stiffness and impaired ambulation. Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition, but their effectiveness has not been rigorously evaluated. This article describes the design of a randomised trial comparing the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis.
Methods
Eighty people with first metatarsophalangeal joint osteoarthritis will be randomly allocated to receive either a pair of rocker-sole shoes (MBT® Matwa, Masai Barefoot Technology, Switzerland) or a pair of individualised, prefabricated foot orthoses (Vasyli Customs, Vasyli Medical™, Queensland, Australia). At baseline, the biomechanical effects of the interventions will be examined using a wireless wearable sensor motion analysis system (LEGSys™, BioSensics, Boston, MA, USA) and an in-shoe plantar pressure system (Pedar®, Novel GmbH, Munich, Germany). The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8 and 12 weeks. Secondary outcome measures will include the function, footwear and general foot health subscales of the FHSQ, severity of pain and stiffness at the first metatarsophalangeal joint (measured using 100 mm visual analog scales), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 questionnaire), use of rescue medication and co-interventions to relieve pain, the frequency and type of self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention to treat principle.
Discussion
This study is the first randomised trial to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with osteoarthritis of the first metatarsophalangeal joint, and only the third randomised trial ever conducted for this condition. The study has been pragmatically designed to ensure that the findings can be implemented into clinical practice if the interventions are found to be effective, and the baseline biomechanical analysis will provide useful insights into their mechanism of action.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12613001245785
doi:10.1186/1471-2474-15-86
PMCID: PMC3995518  PMID: 24629181
13.  Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial) 
Background
Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness.
Methods/Design
The study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed.
Discussion
This protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial.
Trial registration
Current controlled trials ISRCTN42399123.
doi:10.1186/1471-2474-15-81
PMCID: PMC3995668  PMID: 24625273
Subacromial impingement syndrome; Shoulder pain; Randomised controlled trial; Corticosteroid injection; Musculoskeletal ultrasound; Exercise; Physiotherapy
14.  Musculoskeletal clinical assessment and treatment services at the primary-secondary care interface: an observational study 
The British Journal of General Practice  2013;63(607):e141-e148.
Background
Management of musculoskeletal conditions in the UK is increasingly delivered in multidisciplinary clinical assessment and treatment services (CATS) at the primary–secondary care interface. However, there is little evidence concerning the characteristics and management of patients attending CATS.
Aim
To describe the characteristics, investigation, and treatment of adults attending a musculoskeletal CATS.
Design and setting
Cross-sectional analysis of cohort study baseline data from a musculoskeletal CATS in Stoke-on-Trent Primary Care Trust, UK.
Method
All patients referred from primary care between February 2008 and June 2009 were mailed a pre-consultation questionnaire concerning pain duration, general health status, anxiety, depression, employment status, and work absence due to musculoskeletal problems. At the consultation, clinical diagnoses, body region(s) affected, investigations, and treatment were recorded.
Result
A total of 2166 (73%) completed questionnaires were received. Chronic pain duration >1 year (55%), major physical limitation (76%), anxiety (49%), and depression (37%) were common. Of those currently employed, 516 (45%) had taken time off work in the last 6 months because of their musculoskeletal problem; 325 (29%) were unable to do their usual job. The most frequent investigations were X-rays (23%), magnetic resonance imaging (18%), and blood tests (14%): 1012 (48%) received no investigations. Injections were performed in 282 (13%) and 492 (23%) were referred to physiotherapy.
Conclusion
Although most patients presented with musculoskeletal problems suitable for CATS, chronic pain, physical limitation, anxiety, depression, and work disability were commonplace, highlighting the need for a biopsychosocial model of care that addresses psychological, social, and work-related needs, as well as pain and physical disability.
doi:10.3399/bjgp13X663109
PMCID: PMC3553640  PMID: 23561693
anxiety; depression; health services; musculoskeletal diseases; referral and consultation; work disability
15.  Improvement in the management of gout is vital and overdue: an audit from a UK primary care medical practice 
BMC Family Practice  2013;14:170.
Background
Gout is estimated to affect 1.4% of adults in the UK. Appropriate and timely management is essential to reduce the risk of further flares, complications, and to reduce cardiovascular disease risk. The British Society for Rheumatology and British Health Professionals in Rheumatology (BSR/BHPR) and the European League Against Rheumatism (EULAR) have published guidance regarding the management of gout, thereby providing standards against which performance can be measured. This audit was designed to assess the extent to which patients diagnosed with gout in one primary care medical practice in North Staffordshire, UK, are managed in accordance with current best practice guidelines, and to identify strategies for improvement where appropriate.
Methods
Audit criteria were derived from the EULAR and BSR/BHPR guidelines; standards were set arbitrarily, but with consideration of patient comorbidity and other factors which may influence concordance. An electronic search of the practice records was performed to identify adults with a diagnosis of gout. Medical record review with a descriptive analysis was undertaken to assess the extent to which medical management adhered to the predefined standards.
Results
Of the total ≥18 year-old practice population (n = 8686), 305 (3%) patient records included a diagnosis of gout. Of these, 74% (n = 226) had an electronic record of serum uric acid (SUA), and 11% (n = 34) and 53% (n = 162) a measure of estimated glomerular filtration rate (eGFR) ever and serum glucose since diagnosis respectively. 34% (n = 105) of patients had ever taken urate-lowering therapy with 25% (n = 77) currently prescribed this at the time of data extraction. Dose adjustment and monitoring of treatment according to SUA was found to be inadequate. Provision of lifestyle advice and consideration of comorbidities was also lacking.
Conclusions
The primary care management of gout in this practice was not concordant with national and international guidance, a finding consistent with previous studies. This demonstrates that the provision of guidelines alone is not sufficient to improve the quality of gout management and we identify possible strategies to increase guideline adherence.
doi:10.1186/1471-2296-14-170
PMCID: PMC3830984  PMID: 24225170
Gout; Management; Audit; Primary care; Allopurinol; Serum uric acid
16.  Inter and intra-rater repeatability of the scoring of foot pain drawings 
Background
Foot pain drawings (manikins) are commonly used to describe foot pain location in self-report health surveys. Respondents shade the manikin where they experience pain. The manikin is then scored via a transparent overlay that divides the drawings into areas. In large population based studies they are often scored by multiple raters. A difference in how different raters score manikins (inter-rater repeatability), or in how an individual rater scores manikins over time (intra-rater repeatability) can therefore affect data quality. This study aimed to assess inter- and intra-rater repeatability of scoring of the foot manikin.
Methods
A random sample was generated of 50 respondents to a large population based survey of adults aged 50 years and older who experienced foot pain and completed a foot manikin. Manikins were initially scored by any one of six administrative staff (Rating 1). These manikins were re-scored by a second rater (Rating 2). The second rater then re-scored the manikins one week later (Rating 3). The following scores were compared: Rating 1 versus Rating 2 (inter-rater repeatability), and Rating 2 versus Rating 3 (intra-rater repeatability). A novel set of clinically relevant foot pain regions made up of one or more individual areas on the foot manikin were developed, and assessed for inter- and intra-rater repeatability.
Results
Scoring agreement of 100% (all 50 manikins) was seen in 69% (40 out of 58) of individual areas for inter-rater scoring (range 94 to 100%), and 81% (47 out of 58) of areas for intra-rater scoring (range 96 to 100%). All areas had a kappa value of ≥0.70 for inter- and intra-rater scoring. Scoring agreement of 100% was seen in 50% (10 out of 20) of pain regions for inter-rater scoring (range 96 to 100%), and 95% (19 out of 20) of regions for intra-rater scoring (range 98 to 100%). All regions had a kappa value of >0.70 for inter- and intra-rater scoring.
Conclusions
Individual and multiple raters can reliably score the foot pain manikin. In addition, our proposed regions may be used to reliably classify different patterns of foot pain using the foot manikin.
doi:10.1186/1757-1146-6-44
PMCID: PMC3831824  PMID: 24180324
Foot pain; Pain drawings; Manikins; Reliability; Repeatability; Agreement
17.  Health-related quality of life in gout: a systematic review 
Rheumatology (Oxford, England)  2013;52(11):2031-2040.
Objectives. To identify the instruments that have been used to measure health-related quality of life (HRQOL) in gout and assess their clinimetric properties, determine the distribution of HRQOL in gout and identify factors associated with poor HRQOL.
Methods. Medline, CINAHL, EMBASE and PsycINFO were searched from inception to October 2012. Search terms pertained to gout, health or functional status, clinimetric properties and HRQOL. Study data extraction and quality assessment were performed by two independent reviewers.
Results. From 474 identified studies, 22 met the inclusion criteria. Health Assessment Questionnaire Disability Index (HAQ-DI) and Short Form 36 (SF-36) were most frequently used and highest rated due to robust construct and concurrent validity, despite high floor and ceiling effects. The Gout Impact Scale had good content validity. Gout had a greater impact on physical HRQOL compared to other domains. Both gout-specific features (attack frequency and intensity, intercritical pain and number of joints involved) and comorbid disease were associated with poor HRQOL. Evidence for objective features such as tophi and serum uric acid was less robust. Limitations of existing studies include cross-sectional design, recruitment from specialist clinic settings and frequent use of generic instruments.
Conclusion. Most studies have used the generic HAQ-DI and SF-36. Gout-specific characteristics and comorbidities contribute to poor HRQOL. There is a need for a cohort study in primary care (where most patients with gout are treated) to determine which factors predict changes in HRQOL over time. This will enable those at risk of deterioration to be identified and better targeted for treatment.
doi:10.1093/rheumatology/ket265
PMCID: PMC3798715  PMID: 23934311
gout; health-related quality of life; clinimetrics
18.  The association of gout with socioeconomic status in primary care: a cross-sectional observational study 
Rheumatology (Oxford, England)  2013;52(11):2004-2008.
Objective. Little is known about the association between gout and socioeconomic status (SES). Inequalities in rheumatology provision associated with SES may need to be addressed by health care planners. The aim of this study is to investigate the association of gout and SES in the community at both the individual and area levels.
Methods. Questionnaires were sent to all patients older than age 50 years who were registered with eight general practices in North Staffordshire. Data on individual SES were collected by questionnaire while area SES was measured using the Index of Multiple Deprivation derived from respondents’ postcodes. Responders reported their occupation, education and the adequacy of their income; their medical records were searched for consultations for gout.
Results. Of the 348 consultations for gout in this period, at the individual level there was a significant association between gout and income. An association of gout with education was seen only in the unadjusted analyses. No association was found between gout and area level deprivation.
Conclusion. Gout is associated with some aspects of individual level but not area level deprivation. More extensive musculoskeletal services may need to be provided in low income areas, although further research is needed.
doi:10.1093/rheumatology/ket262
PMCID: PMC3798714  PMID: 23901133
gout; primary care; observational study; consultation data; questionnaires socioeconomic status
19.  The association of gout with sleep disorders: a cross-sectional study in primary care 
Background
Both gout and sleep apnoea are associated with the metabolic syndrome. Hyperuricaemia is also prevalent in sleep apnoea syndrome. The objective of this study was to examine the association between gout and sleep apnoea and other sleep disorders.
Methods
Data were taken from a validated database of general practice records from nine practices in the UK between 2001 and 2008. People consulting for gout were identified via Read codes and each matched with four controls for age, gender, practice and year of gout consultation. Sleep problems and confounding comorbidities were also identified via Read codes. Medications were identified through a linked database of prescription records. The association between gout and sleep disorders was assessed using a logistic regression model, adjusting for ischaemic heart disease, hypertension, diabetes mellitus and diuretic use.
Results
1689 individuals with gout were identified and each successfully matched to four controls. Amongst those with gout, the prevalence of any sleep problem was 4.9%, sleep problems other than sleep apnoea 4.2%, and sleep apnoea 0.7%, compared to 3.5%, 3.2% and 0.3% respectively in controls. Gout was associated with any sleep problem (odds ratio (OR) 1.44; 95% confidence interval (CI) 1.11, 1.87), sleep problems other than sleep apnoea (OR 1.36; 95% CI 1.03, 1.80), and sleep apnoea (OR 2.10; 95% CI 1.01, 4.39). On multivariable analysis, gout remained significantly associated with any sleep problem (OR 1.39; 95% CI 1.06, 1.81) and sleep problems other than sleep apnoea (OR 1.37; 95% CI 1.03, 1.82), however the association with sleep apnoea was attenuated (OR 1.48, 95% CI 0.70, 3.14).
Conclusions
Gout and sleep problems appear to be associated and clinicians should be aware of the co-existence of these two conditions. Larger prospective epidemiological studies are required to explore causality.
doi:10.1186/1471-2474-14-119
PMCID: PMC3621781  PMID: 23557073
Gout; Sleep; Apnea; General practice; Metabolic syndrome X
20.  Prospective observational cohort study of Health Related Quality of Life (HRQOL), chronic foot problems and their determinants in gout: a research protocol 
Background
Gout is the commonest inflammatory arthritis affecting around 1.4% of adults in Europe. It is predominantly managed in primary care and classically affects the joints of the foot, particularly the first metatarsophalangeal joint. Gout related factors (including disease characteristics and treatment) as well as comorbid chronic disease are associated with poor Health Related Quality of Life (HRQOL) yet to date there is limited evidence concerning gout in a community setting. Existing epidemiological studies are limited by their cross-sectional design, selection of secondary care patients with atypical disease and the use of generic tools to measure HRQOL. This 3 year primary care-based prospective observational cohort study will describe the spectrum of HRQOL in community dwelling patients with gout, associated factors, predictors of poor outcome, and prevalence and incidence of foot problems in gout patients.
Methods
Adults aged ≥ 18 years diagnosed with gout or prescribed colchicine or allopurinol in the preceding 2 years will be identified through Read codes and mailed a series of self-completion postal questionnaires over a 3-year period. Consenting participants will have their general practice medical records reviewed.
Discussion
This is the first prospective cohort study of HRQOL in patients with gout in primary care in the UK. The combination of survey data and medical record review will allow an in-depth understanding of factors that are associated with and lead to poor HRQOL and foot problems in gout. Identification of these factors will improve the management of this prevalent, yet under-treated, condition in primary care.
doi:10.1186/1471-2474-13-219
PMCID: PMC3517766  PMID: 23148573
Gout; HRQOL; Foot; Patient experience; Prospective cohort; Primary care
21.  The clinical assessment study of the foot (CASF): study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population 
Background
Symptomatic osteoarthritis (OA) affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care.
Methods
All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only) and three years (clinic attenders and survey participants), and also by review of medical records.
Discussion
This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and clinical examination findings, and their presentation, diagnosis and management in primary care.
doi:10.1186/1757-1146-4-22
PMCID: PMC3180294  PMID: 21892960
22.  Gout. Epidemiology of gout 
Gout is the most prevalent form of inflammatory arthropathy. Several studies suggest that its prevalence and incidence have risen in recent decades. Numerous risk factors for the development of gout have been established, including hyperuricaemia, genetic factors, dietary factors, alcohol consumption, metabolic syndrome, hypertension, obesity, diuretic use and chronic renal disease. Osteoarthritis predisposes to local crystal deposition. Gout appears to be an independent risk factor for all-cause mortality and cardiovascular mortality and morbidity, additional to the risk conferred by its association with traditional cardiovascular risk factors.
doi:10.1186/ar3199
PMCID: PMC3046529  PMID: 21205285
23.  Why does gout target the foot? The pathogenesis of podagra 
doi:10.1186/1757-1146-4-S1-A6
PMCID: PMC3102912
24.  Foot pain: common, of consequence, and consulted about 
doi:10.1186/1757-1146-4-S1-A7
PMCID: PMC3102913

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