Case study 1. Leeds Foot and Ankle Studies - introducing evidence-based podiatry for musculoskeletal services
Submitting InstitutionUniversity of Leeds
Unit of AssessmentAllied Health Professions, Dentistry, Nursing and Pharmacy
Summary Impact TypePolitical
Research Subject Area(s)
Medical and Health Sciences: Clinical Sciences
Summary of the impact
Since 1998 the University of Leeds has developed the Leeds Foot
and Ankle STudies in
Rheumatology (FASTER) programme — to drive improvements in UK
musculoskeletal foot care
services. Results from FASTER clinical trials and a national survey of
podiatry services directly
informed NICE guidelines on foot care in arthritis. FASTER's research also
provided key evidence
for a national consensus on standards of care and aided a shift in the
treatment paradigm for foot
care in arthritis patients. These standards and NICE recommendations are
included in the latest
Royal College of GPs curriculum. They have also informed government
policies on commissioning
for podiatry services throughout England. Since the inception of the
independent reports suggest that access to foot health services for people
with rheumatoid arthritis
has increased from less than 50% immediately prior to FASTER, to nearly
80% of patients today.
Early work: Initial work (1998-2003) conducted at
the University of Leeds by James Woodburn
(Medical Research Council Fellow, 1994-2003) and other colleagues from
Leeds, and Bradford
Hospitals NHS Trust identified a role for mechanical foot therapy (i.e.
adding contoured inserts into
footwear) in the treatment of rheumatoid arthritis (RA). These studies
were the first to show that
this form of therapy could reduce pain in the short-term and slow the
progression of foot deformity
over the long-term . In 2002, Anthony Redmond was appointed as
Campaign Lecturer (later Senior Lecturer) to formalise the implementation
of an evidence-based
approach in this field under the banner of the Leeds FASTER programme, and
extend work in RA
into related musculoskeletal (MSK) conditions.
Establishing the landscape — MSK podiatry service in the UK:
Around half of patients aged
over 55 years and as many as 90% of patients with RA suffer from
foot-related problems, ranging
from stiffness and pain to severe immobility. With more than 500,000 RA
patients in the UK,
between 2002 and 2005 Redmond spearheaded a programme
systematically to describe and
evaluate MSK foot health services across more than 200 centres in the UK.
The study found that
only 6% of these specialist centres had referral guidelines for foot
services for RA patients ,
revealing the need for greater service access, training and dissemination
of findings from the
Woodburn study  and further clinical research on foot therapies.
New methods to evaluate MSK podiatry interventions: To
enable the FASTER team to acquire
data for the systematic evaluation of different foot therapies, Redmond
has created a series of
measures for clinical outcomes. In particular, his foot posture index
(FPI) was the first-ever
criterion-referenced quantitative system for evaluating foot posture in
relation to pathologies .
The FPI provides a quantitative, objective measure of pathology and the
effect of therapy, paving
the way for trials of new therapeutic interventions. An international
population normative dataset
was produced during the census period. Collaborators from the Universities
of Sydney, LaTrobe
and Cardiff worked on data processing, programming and patient
recruitment. Alongside this,
between 2002 and 2005 Philip Helliwell (Senior Lecturer,
1993-present) led the development of
the Leeds Foot Impact Scale. This assessment tool quantifies the impact of
RA on foot problems.
Novel therapies and insights into mechanisms of action:
Between 2002 and 2013 Heidi
Siddle (nee Davys) (NIHR Research Fellow, 2008-present) built on
earlier work by Woodburn and
combined Doppler power imaging and biomechanical studies to reveal
disease processes and structural changes in the forefoot. In particular,
she showed that failure of
the plantar plate was a key component of catastrophic damage to forefoot
joints in RA .
Over a period of seven years, with funding from Arthritis Research UK, Redmond
with collaborators from the Universities of Perth and Leeds to explore the
pathology and treatment
of osteoarthritis affecting the first metatarsophalangeal joint. This was
the first research to
describe the effect of bone remodelling, function and inflammation which
occurs in the joints . A
linked, large-scale community study led by Anne-Maree Keenan
(Senior Lecturer, 2001-present)
studied the prevalence of joint problems in >14,000 people. It was the
first to establish the
importance of the cumulative effect of multiple joint involvement and the
impact on quality of life .
Clinical trials: The FASTER team has led a number of
clinical trials, using instruments such as
the FPI and the Leeds Foot Impact Scale to assess clinical outcomes from
studies to Woodburn's early research (2002-2013) have shown that
functional orthoses —
inserts which actively change the function of a patient's foot when they
walk — have a role to play in
managing symptoms in other diseases such as connective tissue disease and
Redmond also compared the relative costs of treatment approaches,
finding that off-the-shelf
devices have comparable mechanical properties to customised inserts. In
another series of clinical
trials, latterly funded by NIHR, Siddle established that the
removal or reduction of calluses is of no
benefit in the foot care of people with RA .
References to the research
1. Woodburn J, Barker S & Helliwell PS (2002). A
randomized controlled trial of foot orthoses in
rheumatoid arthritis. Journal of Rheumatology, 29:1377-83.
This peer-reviewed paper reports on an MRC-funded trial. It is
referenced in NICE guidance (see
Section 4) and in two systematic reviews. The paper has 75
2. Redmond AC, Waxman R & Helliwell PS (2006). Provision of
foot health services in
rheumatology in the UK. Rheumatology, 45:571-6.
This peer-reviewed paper on the ARUK funded assessment of podiatry
provision UK rheumatology
departments provides a benchmark on foot health service delivery in MSK
diseases. 16 citations
including the ARMA/PRCA National Standards of Care for people with
musculoskeletal foot health
problems and the RCGP curriculum statement.
3. Redmond AC, Crosbie J & Ouvrier RA (2006). Development and
validation of a novel rating
system for scoring standing foot posture: the Foot Posture Index. Clinical
This peer-reviewed paper was the No.1 most cited paper
in the journal Clinical Biomechanics in
the period Dec 2006-Dec 2011 (source: Elsevier journal citation report
[Accessed 5 Jan 2012] :
136 citations. http://www.elsevier.com/wps/find/journaldescription.cws_home/30397/description).
4. Siddle HJ, Hodgson RJ, O'Connor PJ, Grainger AJ, Redmond AC,
Wakefield RJ, Helliwell
PS (2012). Magnetic Resonance Arthrography of Lesser
Metatarsophalangeal Joints in Patients
with Rheumatoid Arthritis: Relationship to Clinical, Biomechanical, and
Journal of Rheumatology, 39:1786-1791. DOI:
This Arthritis Research UK funded study is one of a series of reports
by Siddle on the pathology
and impact of failure of the plantar plate in the forefoot of people
with RA. It has fundamentally
changed our understanding of the forefoot in RA. This work has been
recognised by the award of
an Arthritis Research UK Silver medal for best research and `Jewel in
the Crown' status at the
College of Podiatry annual congress.
5. Keen HI, Redmond A, Wakefield RJ, Freeston J, Grainger AJ, Hensor
EM, Emery P,
Conaghan PG (2011). An ultrasonographic study of metatarsophalangeal
joint pain: synovitis,
structural pathology and their relationship to symptoms and function. Annals
of the Rheumatic
Diseases, 70:2140-3. DOI: 10.1136/annrheumdis-2011-200349.
This study, the fourth in series of linked projects, was published in
the world's top ranked
rheumatology journal and highlighted the relationship between patient
reported outcomes and state
of the art imaging.
6. Keenan AM, Tennant A, Fear J, Emery P & Conaghan PG
(2006). Impact of multiple joint
problems on daily living tasks in people in the community over age
fifty-five. Arthritis Care and
Research, 55:757-764. DOI: 10.1002/art.22239.
This paper is part of a body of work by Keenan defining foot problems
in the broader context of
multiple joint involvement and comorbidity. The quality of the work in
this paper has been
recognized through the award of the Arthritis Research UK Silver medal
for best research. 42
7. Davys [now Siddle] HJ, Turner DE , Helliwell PS, Conaghan PG,
Emery P, Woodburn J
(2005). Debridement of plantar callosities in rheumatoid arthritis: a
randomized controlled trial.
Rheumatology, 44:207-210. DOI: 10.1093/rheumatology/keh435
This clinical trial is the second in what is now a series of three
trials that has investigated the short
and longer term efficacy of callus reduction in people with RA. This
work was cited directly in NICE
guidance CG 79. 18 citations.
Note: All Leeds researchers in bold. All citation data from SCOPUS
[Accessed 23/10/13]. All
journals are peer-reviewed with international editorial boards. Copies of
all publications are
available from the HEI on request.
Key research grants
a. Backhouse, Buch, Redmond, Arden. Prefabricated and custom
orthoses in early RA
(PREACHER) NIHR Postdoctoral Fellowship. 2013-2017. £429,484.
b. Conaghan, Fisher, Redmond, Kingsbury, Keenan. Experimental
Centre establishment and infrastructure funding. Arthritis Research UK.
c. Redmond, Gray, Halstead, Helliwell, Keenan, Roddy, Grainger.
Functional foot orthoses in
the treatment of symptomatic midfoot OA using clinical and biomechanical
feasibility study. Arthritis Research UK OA Clinical Studies Group Pilot
d. Torgerson, Adamson, Watson, Cockayne, Hewitt, Chang, Menz, Keenan,
Lamb, Redmond, Hull. Randomised trial of a multifaceted podiatry
intervention for falls
prevention. REFORM trial. NIHR Health Technologies Assessment Programme
2014. £1.1 million.
e. Burnett, Hodgson, Redmond. Improving safety and patient
experience in the magnetic
resonance imaging of arthritis. NIHR Clinical Doctoral Fellowship.
f. Alcacer-Pitarch, Redmond, Buch, Emery. Multifactorial pathways
contributing to the
development and impact of foot problems in scleroderma. NIHR Clinical
g. Redmond, Denton, Herrick, Buch, Pavitt, Siddle, Helliwell, Worthy,
Emery. Pressure and
pain In Scleroderma, an Evaluation of a Simple intervention (PISCES).
Campaign CTDs Clinical Studies Group Clinical Trial Award (18826).
h. Wakefield, O'Connor, Davys, Redmond, Emery. Equipment grant
(18620). Arthritis Research
Campaign. 2008-2011. £45,030.
i. Redmond, Keenan, Conaghan, McGonagle. Pathological processes
interventions in mechanically induced foot pain. Arthritis Research
Campaign PhD Studentship
(18256). 2008-2011. £78,000.
j. Redmond. Mechanical and biological interactions in RA and OA
of the foot. Department of
Health/ NIHR: Personal Awards Scheme, PAS3 PDA (03/07/047). 2007-2010.
k. Davys, Redmond, Helliwell, Wakefield. Factors leading to
plantar plate (ligament) damage in
rheumatoid arthritis. Arthritis Research Campaign. 2007-2012. £177,000.
l. Helliwell, Redmond, Davys, Dagg. NIHR, Research for Patient
Benefit Scheme (10143):
Callus Reduction in RA (CARROT) randomised controlled trial. 2007-2010.
m. Redmond, Helliwell. (17866): Predictors of outcome of forefoot
surgery in RA. Arthritis
Research Campaign PhD Studentship. 2007-2011. £75,760.
n. Redmond, Helliwell. Standards of Care for Musculoskeletal Foot
Health Services. Arthritis
Research Campaign. 2007-2009. £28,699.
Details of the impact
Access to specialist RA foot care services: There are
approximately 580,000 people with RA in
the UK; the prevalence of foot problems in this group is consistently
reported to be over 90%. The
publication of the FASTER national evaluation of podiatry services in
provided the NHS with key benchmark data on foot care services to these
patients. Combined with
the findings of a 2004 report by Williams (University of Salford), which
suggested that in northwest
England only 21% of these patients had any access to NHS foot care, the
stimulated significant changes in the provision and delivery of foot care
to RA patients across the
country (detailed in the sub-sections below).
A subsequent national review by Otter and colleagues (University of
Brighton) provided strong
evidence that the care guidelines and NHS policies, based in part on Leeds
transformed practice: by 2011 some 70-78% of patients with RA had access
to foot care.
Changing practice — clinical guidelines: The Woodburn and
Siddle clinical trials were
instrumental in shaping recommendations on foot wear and callus reduction
in NICE clinical
guidelines for osteoarthritis [A] and two specific, numbered
recommendations on foot care in
patients with RA [B]. This latter document makes four references to the
Changing practice — new standards of care and GP curriculum:
The FASTER evaluation of
podiatry services and the growing volume of evidence-based recommendations
on foot care
interventions led to Arthritis Research UK funding in 2008, a national
project led and chaired by
Redmond and supported by the UK umbrella body ARMA and the Podiatry
Association, to set out formal, universally agreed standards of care for
the management of foot
related problems in MSK diseases [C]. A total of six citations to Leeds'
research are noted in the
standards which have been distributed to about 5000 specialist
practitioners since 2008.
The contribution of the FASTER group's extensive impact on practice across
the field is reflected in
Redmond's listing in the Times newspaper's list of the top 100
doctors in the UK in 2010 [D].
The adoption of the approach has also been supported by the publication in
2011 of a
commissioned ARUK Topical Review on the subject, co-authored by Helliwell,
Siddle [E]. The review forms part of a long-standing series
published by Arthritis Research UK
which is distributed to all practitioners in the UK and overseas on the
ARUK database, a total of
approximately 4000 primary and secondary care professionals from medical,
surgical, nursing and
allied healthcare backgrounds.
The evidence from the FASTER research and the new standards of care have
been included for
the first time in 2012 in the new musculoskeletal syllabus handbook for
the Royal College of GPs.
This will ensure that all training GPs (~3000 per year) will learn about
foot care for arthritis patients
based on the Leeds research [F].
Redmond, Helliwell and Siddle coordinate the
British Society for Rheumatology annual foot and
ankle course which in the last twelve years has been attended by more than
registrars, GPs and AHPs. Redmond also co-convenes the Society's
foot special interest group
which ensures that the Leeds research directly informs medical training
and, in turn, practice.
Changing government policies: The specific recommendations
of the NICE guidance and
standards documentation were incorporated during 2011-2012 into the
Department of Health
implementation guidelines for Any Qualified Provider (AQP) commissioning
for podiatry services
throughout England [G]. These guidelines highlight how a disease staged
approach, based on the
FASTER body of work, can target types of intervention to patients with
rheumatoid arthritis at the
correct time in the disease.
Redmond has also made contributions to the All Party Parliamentary
Advisory Group on
inflammatory arthritis and given an invited formal address in parliament.
In particular, he provided
background materials and evidence to inform a debate on the provision of
MSK services [H].
Improving foot care research, screening and rehabilitation for
Redmond's development and subsequent validation of the Foot Posture Index
has had impact on
foot care research worldwide [I]. The index is now commonly used to
measure clinical outcomes in
foot care studies. Since 2008 it has been used as an assessment tool in
more than 150 clinical
studies including government-led population studies, military screening
studies and for measuring
the outcomes of rehabilitation approaches.
Sources to corroborate the impact
A. NICE Clinical Guideline CG59: Osteoarthritis. National Collaborating
Centre for Chronic
Conditions. Osteoarthritis: national clinical guideline for care and
management in adults.
London: Royal College of Physicians, 2008.
B. NICE Clinical Guideline CG79: Rheumatoid Arthritis. National
Collaborating Centre for Chronic
Conditions. Rheumatoid arthritis: national clinical guideline for care and
management in adults.
London: Royal College of Physicians, 2009.
C. Arthritis and Musculoskeletal Alliance/Podiatry Rheumatic Care
Associated Standards of Care
for People with Musculoskeletal Foot Health Problems. London 2008.
D. Times top Doctors list 13th Nov 2010. Published as a supplement to the
print edition of the
newspaper and available online at :
(accessed Nov 2010)
E. Arthritis Research UK (2011). Topical Review Series 6 Number 8. The
foot and ankle in
F. Warburton, L. (ed); Musculoskeletal Disorders in Primary Care
(curriculum statement 15.9).
Royal College of General Practitioners, London. 2012. ISBN 9780850843330
G. Department of Health (2012). Any Qualified Provider Implementation
Guidelines for Podiatry.
(Accessed 29th March 2012)
H. Hansard 19/1/2010 Column 1WH. Adjournment motion `Musculoskeletal
I. Letter: Director of Research Rehabilitation Institute, Auckland
University of Technology, NZ