Richard Shorney kicked off the session on the topic of the current health landscape in the UK and the only factor that remains constant — which, paradoxically, is change. For example, there have been vast changes led by an in-depth review of funding and directed healthcare policies. In line with these changes, discussion was centred on how to overcome challenges facing service delivery of DFU care, including delays in referral to specialist foot care teams (Manu et al, 2018) and an increasing demand for clinical services (Guest et al, 2017).
The role and importance of business cases in supporting the development of clinical care, based on robust clinical evidence, were also highlighted. According to clinical evidence, in the field of DFU management, improving patient outcomes, increasing ulcer-free days and reducing healing time are achievable goals when the appropriate standard of care is provided.
What does standard care mean when treating DFUs?
To support practitioners in the prevention and management of DFUs, scientific societies/medical associations regularly review guidance and recommendations, in line with current clinical evidence (NICE, 2015; SIGN, 2017; Wounds UK, 2018; IWGDF, 2019; Meloni et al, 2019).
The five key elements of standard of care for DFUs (Figure 1) are:
- Offloading
- Metabolic control/holistic management
- Assessment of infection
- Assessment of perfusion/ischaemia
- Evidence-based local wound care.
Use of evidence-based research
Supporting the choice of a wound care product with robust clinical evidence (i.e. with high-quality randomised controlled trials [RCTs]) is possible, as shown with the UrgoStart range of products (Table 1). These dressings benefit from the Technology LipidoColloid with Nano Oligo Saccharide Factor (TLC-NOSF), a lipidocolloid matrix containing sucrose octasulfate potassium salt (Box 1). Based on the results of double-blind RCTs, the efficacy of TLC-NOSF dressings in enhancing wound healing, reducing healing time, and reducing cost have been proven in leg ulcers and DFUs (Meaume et al, 2012; Augustin et al, 2016; Edmonds et al, 2018; Lobmann et al, 2019). This evidence has led to the recently published NICE guidance recommending UrgoStart (TLC-NOSF) treatment for people with venous leg ulcers (VLUs) and DFUs (NICE, 2019).
The performance and safety of the treatment are also supported by a large range of clinical studies, highlighting consistent and positive outcomes, regardless of the indications treated.
In particular, very similar positive outcomes were achieved with the TLC-NOSF dressing with polyabsorbent fibres (UrgoStart Plus dressings), regardless of the wound healing stage at initiation of the treatment (Sigal et al, 2019), while optimal wound healing outcomes were reported when the dressing was used as a
first-line treatment.
Embracing change
Embracing certain new treatments can be challenging; however, it is important for clinicians to have the capability, resources and willingness to embrace, adopt and implement new standard care. The barriers to implementation of standard care can be overcome through education, motivation, optimising practicalities, ownership of wound assessment and skills to encourage deliberate practice. Ultimately, knowledge of diabetic foot aetiology is ever-growing and, as a result, standard of care continues to improve.
Thereby, the updated edition of the IWGDF guideline on interventions to enhance healing of DFUs includes 13 new recommendations (IWGDF, 2019). Among them, and for the first time, the use of a specific dressing has been recommended: the sucrose octasulfate dressings (UrgoStart; see Box 1). This recommendation was made based on the recent double-blind RCT conducted with the dressing used on patients with a neuroischaemic DFU (IWGDF, 2019).
Overcoming organisational barriers
Access to a multidisciplinary team and use of pathways for DFU management that optimise standard care, glucose control, infection control and re-vascularisation (if required), can help to overcome organisational barriers.
Furthermore, there is a need for clinicians to demonstrate that they are engaging with evidence-based cost-effective practice. For example, NICE Medical Technology Guidance (MTG42; NICE, 2019) states that there is convincing evidence to support the adoption of UrgoStart dressings to treat VLUs and DFUs in the NHS, after any modifiable factors such as infection have been treated. Building a business case (as described in the next section) using the evidence and resources available for the UrgoStart Treatment range may help to overcome some of the organisational barriers to implementing this evidence-based treatment into clincial practice. In addition, it is important for clinicians to be confident in the available evidence, to utilise resources and to confirm cost savings.
The role of business cases
As pointed out by Lord Carter in his review, Operational productivity and performance in English NHS acute hospitals: Unwarranted variations (2016), Trusts should rationalise their use of resources in the most cost-effective manner. In order to do so, a systematic approach is required, which should include the effective use of business cases.
Business cases are particularly useful for illustrating clinical experiences or sharing wound management issues. They may be helpful in order to rationalise and clinically justify the need for a resource, and to support potential changes to a Trust’s corporate service. Local and national NHS templates for a business case are available, e.g. at NHS Improvement (2018) and NHS Digital (2020). Business cases enable us to identify:
- Purpose
- Stakeholders
- End product
- Success criteria.
Of note, in the case of patients with a DFU, when optimising care, it is essential to truly understand the journey of the patient from the first occurrence of their wound and to take into account the metrics of quality of care, which can be broken down into three domains: patient safety, patient experience and effectiveness of care.
How business cases can implement change
James Cowden was part of the College of Podiatry Leadership Programme cohort 2019, where one task of the course was to develop and submit a business case. The development of the business case was to justify increasing the size of service in Sheffield Teaching Hospitals NHS Foundation Trust. James presented what the business case involved, challenges faced and outcomes.
This business case comprised two parts:
The first part was with a view of patients with current ulceration, and this included the integration of a Podiatric Surgery Team into the Diabetic Foot Unit to assist in the management of diabetic patients with current foot ulceration and/or infection. It was expressed that more research/evidence is needed on this, particularly with regards to theatre capacity, utilisation of resources, ward staff and number of patient beds. However, despite this, there is evidence for surgical intervention in this area. This part concluded with successfully appointing a new Vascular Specialist Podiatrist and Musculoskeletal (MSK) Specialist Podiatrist to work in the Diabetic Foot Clinic in Sheffield.
The second part of the business case focused on preventing ulcer occurrence in those patients at risk of ulceration, and included the implementation of a ‘predict and prevent’ approach, with a screening service for medium- to high-risk patients. This involved a triad of clinicians: vascular specialists, MSK specialists and a podiatric surgery team, looking to identify those at risk of ulceration, and ways to reduce ulcer occurrence in the first instance. The service was designed to work alongside the current DFU setup with medical management of diabetes, although it would involve a system overhaul along with significant time, staff and financial input. The biggest challenge on this side of the business case was that this was very much a long-term vision, and there was a need for data to be gathered to show statistical significance in the reduction of ulceration figures.
Nevertheless, evidence does not determine the success of a business case in all situations and it is important for the following to be taken into account:
- Who decides and how/why do they come to the decision?
- Does it fit into the bigger organisational aims and objectives?
- Is the cost/reward benefit significant enough to warrant the outlay?
- Are the stakeholders going to benefit from the implementation?
- Is there funding available?
- Is a project/treatment realistic to implement?
What are the barriers to developing a business case?
There are also organisational barriers to overcome when developing a business case, and it is important to take the following three phases into account:
Along with this, it is important that the right language is learnt, time is spent putting in the legwork, that it appeals to the audience it is being presented to and, most importantly, that the case is shouted, presented and published — it is only by completing these business cases that the DFU speciality will widen.
Conclusion
In conclusion, according to the interesting discussions exchanged between experts during this symposium, it appears that the key principles to overcoming barriers can be applied to all business cases that seek to implement evidence-based practice (in particular looking at this in the context of wound care management), which can lead to great outcomes. When treating patients with DFUs this can mean:
For clinicians:
- Improved patient outcomes
- Confidence in selecting the best treatment based on the highest level of evidence.
For patients:
- Increased ulcer-free days
- Reduced pain
- Improved quality of life and reduced risk of infection and associated complications.
For the health economy:
- Cost savings associated with reduced healing time
- Reduced variation
