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N. Ahmad and F. L. Bowling
variation could be explained by the failure to comply with the STROBE criteria [3]
for reporting epidemiological studies. This was because basic demographic details
such as the number, age and gender of both the numerator and denominator populations used to calculate rates were not given. Additionally, the overall population rate
was rarely standardised to a recognised population e.g., England and Wales 2001.
This resulted in ‘comparable’ studies not measuring ‘like for like’ thereby not
allowing analysis of temporal trend.
The main pitfall of analysing such data, particularly that which reports only one
homogenised rate, is that whilst it makes interpretation easy, it hides variation.
Indeed, it is the difference between groups (geographic/population) and the inherent
unfairness this represents that drives change.
How Do Amputation Rates Vary?
Davies etal. [2] noted that Ahmad etal. [4, 5] published amputation rates using the
same dataset (HES and Census data) to describe amputation rates as many previous
reports, but as demographic data of both the numerator and denominator populations was provided (as well as the overall age standardised with specic rates across
geographical, age, gender, ethnic and diabetic groups) variation could be commented upon.
Their analysis showed major lower limb amputation rates were 2.7 times higher
in men, 30% higher in the North of England and 70% higher in the black population
(Fig.17.1). Further, half of all major lower limb amputations were in the population
that did not have diabetes. Additionally, major amputation rates were noted to be
coming down in all groups, but at a faster rate in the diabetic population compared
with the non-diabetic population- but the inequalities across groups remained. It
was also noted that minor amputation rates were rising faster in the non-diabetic
population [4]. The main cause for amputation in those without diabetes is peripheral arterial disease (a common factor also in diabetes-related amputations). Such
analysis provides a completely different interpretation of the problems and solutions that are needed to address them.
East of England
86Ͳ93
89;
99; 98Ͳ101
211
17 How toMeasure Success
North West
West
Midlands
South
West
92;89Ͳ96
92;91Ͳ94
121;117
124
Ͳ
136;134Ͳ137
94;91Ͳ 98
78;76Ͳ79
132;126
138
Ͳ
112;110Ͳ115
114;110Ͳ118
128;126Ͳ129
105;100Ͳ109
86;83Ͳ89
83;82Ͳ84
95;94Ͳ97
North East
Yorkshire & Humber
85;81Ͳ88
81;80Ͳ 83
East Midlands
London
South East
Fig. 17.1 Proportional rate of amputation (upper value) and Revascularisation (lower value).
(95% condence intervals) by English region (England Rate=100). This diagram highlights the
North/South divide for all major lower limb amputations across England [4]
Use ofFreely Available Non-peer Reviewed Databases
toMeasure Success
Although much of the published data for England uses national databases such as
Hospital Episode Statistics (HES), it is possible to go directly online to this source
where data for individual areas and service providers is available at no cost (ref).
There is a wealth of diabetes foot care data available from NHS Digital (ref) and
whilst this is not broken down by age, gender or ethnic group, it is a starting point
for comparisons across geographical areas and services.
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N. Ahmad and F. L. Bowling
There are, however, two specialist national databases that have published analyses pertinent to diabetes foot care and outcomes. These are The National Diabetes
Foot audit (NDFA) [6] and National Vascular Registry (NVR) [7]. Whilst they rely
on voluntarily submitted data from individual units rather than mandated national
collection, the data provides unique insights about the importance of service set up
and outcome.
Measuring Success Through theStructure ofCare
The NDFA is part of the National Diabetes Audit Programme and allows services to
measure their performance against NICE guidelines and peer units. The key message
from this database is that ‘being alive and ulcer free at 12weeks is associated with
having a ‘Foot Protection Service (FPS)’ and step-down care between Multidisciplinary Foot Care Teams and the FPS’. [6] Further, best outcomes are seen in
those who received their rst expert assessment within 2weeks of ulcer onset [6]. This
audit has shown that structure of services and time to rst assessment is a crucial
measure of success. However, this database only covers those patients with diabetes.
The National Vascular Registry records all procedures undertaken by vascular
surgeons and includes amputations and revascularisations in those with and without
diabetes. This database has published data for individual units allowing peer comparison, but again does not provide age or gender specic variation. Nevertheless, it
has shown signicant variation in time to revascularisation and subsequent amputation and has driven the development of the Peripheral Arterial Disease Quality
Improvement Framework (PAD-QiF) [8]. This new framework recognises that better
outcomes are associated with faster revascularisation, with a drive to reduce the time
from presentation to revascularisation to 5days for inpatients and 2weeks for outpatients (ref). Both of these databases have emphasised the principle of ‘time is tissue’.
An example of NICE guidelines regarding structured care practically applied to
service design is given in Fig.17.2:
17 How toMeasure Success
M.A.R.S
Manchester Amputaon ReduconStrategy
Hospital (Tier4)
Invasive invesgaons
Invasive treatments
213
• Idenfy redflags
escalaonofwounds
Appropriatewound and limbcleansing
Apply appropriate dressing regimeunlhealed
Iniate management plansofcomplex cases
• Opmisecomorbidies
• Iniate invasive treatments
• Sepsis management
• Deliver care for complex wounds
• Early escalaon/de
• Reference point for communityadvice
• Provide expert ‘paent,limb, wound’ input
Refertoappropriateer as needed
Tier 3
(Centralcommunity/hospital hub)
Mul disciplinaryTeam
Severe Sepsis management
Overall MARS Ulcer HealingTargets
4 weeks: 50%reduconinwound size
12 weeks: 50%woundshealed
24 weeks: 90%woundshealed
FirstContact
RedFlags
‘3 minute’ assessment
GP, Pracce nurse, district nurse
Idenfy redflags
Iniateimmediate treatment
Refer for specialist assessment
Hospital discharge
Single point of
Self referral
(ifknownto service)
Tier 1
access
Tier 2
(Central community hub)
(Led by band 7/8 Community Wound Specialist
Specialist Assessment&Care
(nurse/AHP)and member of er3MDTteam)
• Single access pointfor community &hospitalservices
• Idenfy redflags
• Performholisc paent, limb, woundassessment
• Iniateholisc paent, limb,wound treatment plans
• Refer to appropriate er for connuedcare
Manage ulcers (foot/leg) andlymphoedemaneeding
specialist but not the MDTinput
Tiered approach to Paent Flow
Lower Limb
Foot ulcerLeg ulcer Lymphoedema
‘Swollen leg’‘Wet leg’‘Red leg’‘blue/black toe’
Vascular/Ulcer Presentaon
Varicose veinsClaudicaon
Appropriatewound andlimb cleansing
Apply appropriate dressing regime unlhealed
(Domiciliary, spoke community clinics, treatmentrooms)
Community Nurse/Podiatry Te ams
• Idenfy red flags
• Early escalaon if wounds not progressing
• Deliver care for non complex wounds
Refer to appropriate er if needed
Fig. 17.2 An example of structured care with step down from multi-disciplinary clinics as per NICE guidelines
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N. Ahmad and F. L. Bowling
The denition of a Multi-disciplinary foot service and skills required have been
dened by NICE [9] and listed in Table 17.1. It is important to note that not all
patients will need to see every specialty every time they access the service.
In addition to the broad structure of care, the individual care patients receive
should also be dened and measured using the best evidence (where available). An
example of a system wide pathway for foot ulcer care is given in Fig.17.3.
Table 17.1 Composition of a diabetic multi-disciplinary team as per NICE guidelines [9]
Make up of a multidisciplinary foot service Diabetology
Podiatry
Diabetes specialist nursing
Vascular surgery
Microbiology
Podiatric and/or Orthopaedic surgery
Prosthetist/Orthotist
Interventional radiology
Wound Care & Casting Specialist
17 How toMeasure Success
loading(seepage 14)
M.A.R.S
Manchester AmputaonReduconStrategy
Send to AE/VascularHot Clinic /
Tier 3 MDTasappropriate
Yes
First lineoff
Wound/peri wound cleansing
Skin cleansingand emollient
Simplelow adherentdressing
Infecon control
No
Encourage self care
59mmHg
Ischaemia
0 >60mmHg
140
39mmHg
230
3 <30mmHg
2: Low
0 1: Very low
Risk of Amputaon
3: Moderate
4+ High
• Decide correcterof care
• Weekly review
215
8)
paent/limb/woundapproach (p7
• Completehealing by 12 weeks
• Opmisehealing by adopng
• Aim 50% reduconin4weeks
• Tier 3specialist review every 4 weeks
Plan
management
ABPI Vascular
Overall MARSTarget
Allfoot ulcers receive specialist reviewwithin1workingday of referral
(Diabec andNon Diabec)
(Seepage3)
Are there any red flags?
Referfor specialistassessment
(expert assessmentwithin1day)
(See page 2)
(seepage7)
Perform 3minute lower limbassessment
HoliscExpertAssessment
Yes
No
Can youperform aspecialistassessment
Paent/Limb/Wound
andiniate specialist treatment ?
Wound
1 Superficialulcer,nogangrene
0 No ulcer/gangrene
loading,
Management plan;
Nursing, AHP,diabetes,
vascular, microbiology,
orthopaedic review.
Dressing, Off
Calculaon of SINBAD/WIFiScore
Holisc assessmentand management
2. Deep ulcer to tendon/bone/muscle
or gangrenelimited to toes
3. Extensive deteriorang ulcer,
Plan
Ulcer Dressing
Is woundfree of infecon ?
No
Does wound
need surgical or
Yes
Foot Infecon
extensive gangrene
(with or without slough)
Yes
larval debridement
Toe prop
Toes
UrgoStartPlus
0Noinfecon
Ooform wedge
Non specialist measures
No
3Severe (systemic infecon)
2Moderate (>2cm)
1 Mild (<2cm)
loadingSandal+rocker/insole
Off
Medial/lateral
border of foot
(dependent on site)
Sandal with forefoot rocker/insole
Offloading Plan
Socastcup (vascular review first)
Paentsown footwear
Plantar heel/
forefoot/hallux
(seepages 14,15)
?
Doeswound probe
to tendon or bone
Calculate Wound,Ischaemia,
Foot infecon Score(WIFi)and
Removable/non removable
Devices/casts
Specialist
No
Yes
risk of amputaon
Techniques
(under MDFT)
Microbiology plan
Ankle
Vascular ScoreToe
Pressure
pressure
Doesfootneedaddional
Yes
surgical biomechanical correcon
59 70 1000.6 0.79 Refervascular
0(no PAD) >60>100 >0.8Best podiatry
1(mild PAD) 40
No
Orthopaedic/Podiatric
surgical referral
Start anbiocsasper local policy
to cover bone +skininfecon
Topical/oral are first line
iv anbiocsreserved for systemic infecon
Anfungalsif signs of skin infecon
39 50 70 0.4 0.59 Refervascular
2(moderatePAD)30
Vascular Plan
Confirm osteomyeliswithserialXray, MRI, bone biopsy
3 (severePAD)<30 <50 <0.4 Refer vascular
Foot
Foot Ulcer Pathway
Ulcer
UrgoCleanAg
Debride as
Cumed Sorbact
appropriate
Fig. 17.3 An example of a system wide pathway for foot ulcer care
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N. Ahmad and F. L. Bowling
Wider Denitions ofSuccess
Diabetic Foot Care asPart ofaWider Wound Care Strategy
The National Wound Care Strategy [10] has acknowledged the inequality between
diabetic and non-diabetic foot wounds with regards to service access as well as the
wider problem of leg ulcers i.e., they would all benet from a multidisciplinary
approach. To address this, in 2021 they began recruiting sites to develop local strategies to address this inequality of access. The outcomes are eagerly awaited.
Social Determinants ofCare
A holistic approach to improving care involves addressing factors not directly
related to wounds or chronic disease management. A holistic approach requires
access to psychological therapies and exercise programmes, as well as addressing differences in socioeconomic circumstances and increasing access to digital care. The newly developing Integrated Care Systems where each
neighbourhood’s (defined as a population of 30–50,000) health and social care
system work together to address the social determinants of health is an example
of how a ‘whole system’ can work together to improve outcomes. A holistic
approach to improving outcomes, therefore, requires planners across Public
Health, Health and Social Care and the Council to work together and integrate
strategies.
Patient andStaff Experience ofCare
In addition to provision of and access to care, the experience of it is an important
measure of success. Many services now have patient experience teams who can be
deployed to gain patient views to help improve service delivery. Allied to this is staff
wellbeing, which if done properly benets morale, which in turn then drives engagement with education/training and therefore improves standards.
Clinical Measures ofSuccess
It is no longer adequate to document clinical outcomes in studies involving the diabetic foot in terms of minor or major amputation rates. Attention should be given to
the use of the more clinically meaningful composite outcome measure of ulcer free,
17 How toMeasure Success
217
amputation free, survival in patients with diabetic foot ulcers given that this cohort
of complex patients also suffer from high rates of cardiovascular events resulting in
premature death.
Few studies assess the return to function of patients following treatment for diabetic foot ulcers. Regaining mobility and the ability of patients to carry out their
activities of daily living should be a measure of successful care. Examples of instruments used for measuring this outcome in research or clinical practice are the
Dependence/Daily Life subscale of the Diabetic Foot Ulcer Scale-Short Form
(DFS-SF) and the Impact of Weight on Activities of Daily Living Questionnaire
(IWADL). Both have been extensively used to measure physical functioning in
studies for patients with type 2 diabetes.
Future clinical studies should also consider the impact of diabetic foot ulcers on
patient quality of life (QOL). In addition to generic instruments for the assessment
of QOL such as the SF-36 or EQ-5D, patient reported outcomes measures (PROMS)
are now available for patients with Diabetic Foot Ulcers and the use of validated
condition specic patient reported health related QOL tools such FHSQ (foot health
status questionnaire) should be encouraged [11].
Conclusion
It is important to dene the correct problem in order to dene success. The inequalities of outcomes i.e., how different people experience care is central to understanding why amputation rates and or complications are different. Unfairness is often at
the heart of this variation and therefore the provision of, access to and experience of
services is central to understanding how to improve them. Working with teams to
co-design a solution is central to sustainability and scalability of any change.
Clinical studies in diabetic foot care should also evolve beyond the utilisation of
amputation rates to measure success to adopting more meaningful outcomes for
patients such as ulcer free survival, return to function and assessment of quality
of life.
Key Points
1. Peer reviewed epidemiological data should meet STROBE guidelines.
2. Variation in epidemiological outcomes is central to understanding inequalities.
3. Success needs to measure the structure and processes of care not just the ‘bottom
line’ of amputation numbers.
4. Time to rst expert assessment and speed of intervention is a critical measure of
success.
5. Clinical studies in diabetic foot care should aim to utilise meaningful outcomes
such as ulcer free, amputation free survival, assess patient return to function and
measure the impact of illness and treatment on patient quality of life.A holistic
approach to patient care requires a holistic approach to planning and implementation of services.
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N. Ahmad and F. L. Bowling
References
1. Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt
PJ.Lower extremity amputations—a review of global variability in incidence. Diabetic Med.
2011;28:1144–53.
2. Davies M, Burdett L, Bowling F, Ahmad N, McClennon J.The epidemiology of major lower
limb amputation in England: a systematic review highlighting methodological differences of
reported trials. Diabetic Foot J. 2019;22(4):53–60.
3. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, etal. Strengthening the
reporting of observational studies in epidemiology (STROBE): explanation and elaboration.
PLoS Med. 2007;4(10):e297. https://doi.org/10.1371/journal.pmed.0040297.
4. Ahmad N, Thomas GN, Gill P, Chan C, Torella F.Lower limb amputation in England: prevalence, regional variation and relationship with revascularisation, deprivation and risk factors. A
retrospective review of English hospital data. J R Soc Med. 2014;107(12):483–9.
5. Ahmad N, Thomas GN, Gill P, Torella F.The prevalence of major lower limb amputation in
the diabetic and non diabetic population of England 2003–2013. Diab Vasc Dis Research.
2016;13(5):348–53.
6. National Diabetes Foot Care Audit 2014-2018. NHS Digital 2019. https://les.digital.nhs.uk/
F8/645631/NDFA%204AR%20- %20One- Page%20Summary%20v1.0.pdf
7. Vascular Society of Great Britain and Northern Ireland. National vascular registry. https://
www.vsqip.org.uk/public/
8. Vascular Society of Great Britain and Northern Ireland. A best practice clinical care pathway for peripheral arterial disease 2019. https://www.vascularsociety.org.uk/professionals/
news/110/quality_improvement_for_critical_limb_ischaemia_padqif.
9. NICE guideline NG19. Diabetic foot problems: prevention and management. 2019. https://
www.nice.org.uk/guidance/ng19/chapter/recommendations
10. National Wound Care Strategy. https://www.ahsnnetwork.com/about- academic- health-
science- networks/national- programmes- priorities/national- wound- care- strategy-
programme
11. Elsman EBM, Mokkink LB, Langendoen-Gort M, Rutters F, Beulens J, Elders PJM, Terwee
CB. Systematic review on the measurement properties of diabetes-specic patient-reported
outcome measures (PROMs) for measuring physical functioning in people with type 2
diabetes. BMJ Open Diabetes Res Care. 2022;10(3):e002729. https://doi.org/10.1136/
bmjdrc- 2021- 002729. PMID: 35675952; PMCID: PMC9185403
Chapter 18
Medicolegal Aspects inDiabetic Foot
Disease: How toKeep Patients Safe, What
toDo When Things GoWrong andHow
toAvoid Litigation
PrashVas andVictoriaButler-Cole KC
Over the last 10years the number of claims and the annual cost of litigation across
the UK have increased signicantly. Current costs to the national health service
(NHS) related to ligation are shockingly high, especially in England, even though
only a small proportion of individuals who may have suffered harm choose to pursue litigation. The most recent estimate for clinical negligence claims in England
and Wales during 2020/2021 was £7.9 billion, a staggering increase from £863 million in 2010/2011 [1]. This amounts to approximately 4.5% of the entire NHS budget of £176 billion for 2021.
The percentage of individuals treated by the NHS pursuing litigation is unclear,
however it is understood that increases in claims and associated costs have been
much greater than increases in NHS activity. Furthermore, the factors that drive
individuals to consider litigation remain unclear [2–4]. Evidence from studies from
outside the United Kingdom suggest that several factors can inuence decisions
related to consideration of medico-legal action with the extent of perceived harm
being only one of them. A recent report by the Partnership for Responsive Policy
Analysis and Research (PREPARE) collaboration did not identify features suggestive of a ‘typical claimant’ [2]. One consideration, however, is that when life changing injuries or major harm occurs (for example during childbirth or amputation of a
P. Vas (*)
King’s College Hospital, London, UK
King’s Health Partners’ Institute of Diabetes, Endocrinology and Obesity, London, UK
Diabetes and Diabetes Foot Medicine, Mike Edmonds Foot Unit, King’s College Hospital,
London, UK
e-mail: prashanth.vas@nhs.net
V. Butler-Cole KC
39 Essex Chambers, London, UK
e-mail: Victoria.Butler-Cole@39essex.com
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
C. P. Shearman, P. Chong (eds.), Management of Diabetic Foot Complications,
https://doi.org/10.1007/978-3-031-05832-5_18
219
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