Why nurses in primary care need to be research active: the case of venous leg ulceration

Venous leg ulceration (VLU) is defined by the National Institute for Health and Care Excellence (NICE) as a loss of skin that takes more than 2 weeks to heal. Caused by sustained venous hypertension, it is the most common type of leg ulcer, accounting for 60–80% of all leg wounds (NICE, 2019). Affecting 2% of the UK adult population, the wound care associated with VLU accounts for over 2% of the national health budget every year, consuming up to £2.7 billion (Rabe and Pannier, 2010). Additionally, patients experience prolonged periods of chronic pain, immobility and embarrassment due to their wounds producing fluid and malodour, resulting in reduced self-esteem, social isolation and a sustained negative effect on their quality of life (QoL) (Isaac and Watson, 2015).

Clinical care and guidance

The optimal care pathway for VLU is set out in the updated 2019 NICE clinical knowledge summary (CKS) (NICE, 2019). The first action for wounds suspected of being venous in origin is appropriate diagnosis and examination by a trained professional. Diagnosis can be made using the ankle-brachial pressure index (ABPI), a clinical tool used to assess for the presence of peripheral arterial disease, involving blood pressure measurements in the ankle and arm (Al-Qaisi et al, 2009). After appropriate wound management, the next step is referral to a vascular specialist within 2 weeks of the ulcer first appearing, following which care should be managed coherently by a multidisciplinary team of primary care nurses, vascular specialists and GPs (NICE, 2019). Unfortunately, since the original publication of the guidelines in 2013, there has been little improvement in how quickly patients are referred to a vascular specialist, with around 70% of new VLU cases not being referred (Davies et al, 2019).

Care for VLU largely takes place in primary care settings and is managed by district and practice nursing teams, who now spend up to 25–50% of their time caring for this patient population (Chamanga et al, 2014). For patients who follow the optimal care pathway, the gold standard therapeutic treatment option for VLU is compression therapy in addition to surgery to treat any underlying venous incompetence (Nicolaides et al, 2018).

The recent publication of a trial of early endovenous ablation in venous ulceration (EVRA) found that treatment of venous reflux within 2 weeks of ulcer presentation, as well as compression therapy, resulted in a significantly shorter time to healing and longer ulcer-free time (Gohel et al, 2018). With up-to-date evidence now supporting the NICE CKS, NHS England has specified a detailed assessment and early referral for VLU patients in the 2020/21 Commissioning for Quality and Innovation framework (NHS England, 2020).

The importance of effective management for hard-to-heal wounds has also been outlined in the 2019 Journal of Wound Care consensus document ‘Implementing TIMERS: the race against hard-to-heal wounds’. This highlights the identification of clinical and non-clinical risk factors, early identification and the fundamentals of standards of care (Atkin et al, 2019).

VLU research

Due to an ageing population, the burden of VLU continues to rise. This has led to an increase in VLU research, with almost 200 studies published in 2018 alone. On examining published evidence for VLU care, it is clear that primary care nursing professionals have a wealth of knowledge and experience regarding the best clinical practice applicable to this area of healthcare (Anderson, 2015; Chapman, 2017). However, despite the majority of VLU care being undertaken in community settings, much of the evidence to support practice is generated in secondary care. Most research studies and large randomised controlled trials (RCTs) are conducted in academic centres, which are usually attached to secondary or tertiary care hospitals, where ‘ideal practice’ is already performed, such as treatment for underlying venous incompetence. This means that the study results may not represent the wider population or apply to community settings (Tsang and Ross, 2017). Thus, to ensure that VLU research evidence is directly applicable to clinical practice, more research must be undertaken in the community, using the knowledge and skills of nurses in primary care alongside the resources of larger institutions, to help generate high-quality, relevant and applicable evidence. Increasing research outputs and harnessing the skills of primary care staff is an initiative championed by the National Institute for Health Research (NIHR). However, further efforts are needed to identify and support research capability among primary care nurses. For example, of the 38 NIHR Nursing Doctoral fellowship awardees, only three projects are related to care within the community, and none focuses on VLU (NIHR, 2020).

Aims

This review aimed to identify the extent to which VLU research is being conducted in primary care and by nurses. It addressed two questions:

• To what extent are nurses involved in publishing VLU research?
• From which care settings are patients recruited to clinical research studies on VLU?

Methods

To gain an understanding of the contribution of nurses to VLU research and which setting research is being undertaken in, three comprehensive searches of the literature were performed.

• Search 1: a search of publications regarding interventions and treatments for VLU. Open Athens was employed to search CINAHL, MEDLINE and EMBASE with the following terms: venous leg ulcer*, venous ADJ2 ulcer*, intervention*, ‘wound manag*’, ablation, ‘radiofrequency ablation*’, foam sclerotherapy, ‘surgical OR surgery’, tissue viability, endovenous, radiofrequency, compression adj2 therapy. Publications related to the following were included: studies examining an intervention or the impact of an intervention for VLU, published study protocols and studies relating to the cost-effectiveness of an intervention.
• Search 2: a search of publications regarding the QoL impact of VLU and its treatments. Open Athens was employed to search CINAHL, MEDLINE, EMBASE and PubMed with the following terms: venous, ulcer, ulceration, quality of life and QoL.
• Search 3: a search of publications investigating qualitative research of any aspect of VLU. Open Athens was employed to search CINAHL, MEDLINE, EMBASE and PubMed with the following terms: venous, ulcer, ulceration, qualitative.

For all searches, once combined using ‘AND’ and ‘OR’, studies were filtered to include only those published in the English language over the past 5 years (2015–2020). The following types of publications were excluded: those not relating directly to intervention, clinical guidelines, studies looking at chronic venous disease as a whole and studies including other types of wounds, such as diabetic foot ulcers and pressure ulcers.

Results

The three searches undertaken resulted in a total of 219 publications on the treatment, care and QoL of patients with VLU, as shown in Figure 1. To address the first aim of the review, the professions of all authors were reviewed. For nurses, an additional note of nursing role was recorded where appropriate, for example, district nurse or clinical lecturer. To address the second aim, the study recruitment setting was reviewed for all empirical studies. International studies written in English were included, resulting in studies from 23 different countries.

Figure 1. PRISMA flow diagram. VLU=venous leg ulceration; QoL=quality of life

Search 1

Reviewed papers on the intervention and treatment of VLU were divided into the following categories: systematic reviews and meta-analyses, RCTs, any other clinical trial, literature reviews, abstracts and any other paper. Any other clinical trials included cohort and observational studies. Any other paper publications included editorials and letters to the editor (Table 2).

Nurse involvement in publishing

Of the 155 papers within this search, 37% listed one or more nurse as an author, 44% had no nurses listed as authors and 19% did not specify the authors' profession. Nurse authors were most likely to be involved in publishing systematic reviews, with 94% of such papers having at least one or more nurse author. More than half the RCTs published also included at least one nurse as an author. However, only 5% of the published abstracts (generally conference proceedings) included a nurse author.

Of the nurse authors whose professional titles were given, almost all were senior, qualified to a masters or PhD level, with titles including nurse specialist, lead nurse, lecturer in nursing and nursing professor. The vast majority (79%) were affiliated with higher education institutes rather than NHS trusts (21%), indicating that relatively few nurses working in clinical practice are engaged in the publication of this type of VLU research.

Recruitment setting

Of the 28 RCTs reviewed, nearly a third of the publications (29%) did not specify the care setting from which they recruited. Some 39% of the studies recruited patients from both secondary and primary care, while 32% recruited only from a secondary care setting. None of the trials were performed in primary care alone. Of the RCTs conducted in the UK, only 29% recruited from both primary and secondary care. Many of the studies recruiting from primary care used a nurse-led wound clinic as a recruitment setting. Only four publications specifically mentioned interventions taking place within primary care or the community setting.

Search 2

Nurse involvement in publishing

Table 3 outlines the studies found pertaining to the QoL of patients with VLU. Of the 42 studies reviewed, 65% listed one or more nurse authors. Some 21% listed no nursing authors, and 14% did not specify the authors' professions. Of the 17 professional titles available, 82% were senior and 18% were junior, with one particular study listing a pre-registration undergraduate nursing student as an author.

Recruitment setting

Of the 42 studies, 32 outlined where patient recruitment took place: 39% of the studies recruited from both primary and secondary care, while 39% recruited from secondary care alone.

Search 3

Nurse involvement in publishing

Table 4 outlines the studies identified when searching for VLU research using a qualitative methodological approach. Of the 22 papers reviewed, 86% listed nurse authors, 5% listed no nurse authors, and 9% did not specify the profession of the authors. Of the 25 professional nursing titles listed, 100% were senior nurses, qualified to masters or PhD level.

Recruitment setting

Of the 21 papers that included details of patient recruitment, 50% used both primary and secondary care, 20% recruited only from secondary care and 30% did not outline where recruitment took place. Since one paper was a systematic review of qualitative studies, it did not include recruitment details (Table 4).

Discussion

With VLU being largely managed by nurses in primary care, this review aimed to examine the contribution of nurses with regard to publishing research on VLU and the strategies of recruitment into clinical studies. The results demonstrated the valuable contributions made by nurses to VLU research, but a disparity was found between nurses publishing more QoL and qualitative studies rather than studies investigating a particular treatment, such as RCTs. Of the nurses who had published, many were senior and affiliated with universities, which may reflect the limited opportunities and support within the NHS for clinical nurses, particularly junior staff, to participate in developing and publishing research. Many of the papers in searches 2 and 3 highlighted the importance of the nurse–patient relationship. An earlier review highlighted the importance of a strong relationship between patients and nurses in addition to continuity of care being key to improved outcomes (Green et al, 2014). Given these findings, it is important that clinical nurses, who are central to improving the experience and outcomes of patients with VLU, are involved in research to a greater extent.

An unexpected finding was that the second largest number of papers on VLU published between 2015 and 2020 were from Brazil. However, this is perhaps unsurprising considering that, according to the Vein Consult Program, the prevalence rates of chronic venous disease in Brazil range from 49% to 90% (Rabe et al, 2012). However, unlike in other countries, nurses appear to be much more involved in publishing research in Brazil, with 93% of all publications and 100% of RCTs either led by or including nurses as authors. Encouragingly, one study was also found to document an undergraduate nursing student as an author.

Across all types of research included in this review, very few studies focused on interventions delivered in the community, and only five studies specifically mentioned primary care. A qualitative study incorporating focus groups with nurses and GPs found that staff believed research in primary care was important and that they were interested in acquiring research skills and knowledge. However, although the overall experience of conducting research was positive, it was seen as a low priority, and respondents found it difficult to combine clinical and research commitments (Hange et al, 2015). With prolonged pressures on the NHS and a steady decline in community nursing staff (Ford, 2019), difficulties are exacerbated by lengthy set-up processes and delays in regulatory approvals. If systems are not streamlined and simplified, it is likely that research will fall further down the list of priorities for clinical staff (Mallick and O'Callaghan, 2009).

Relieving pressures on clinical staff and improving access to resources and training is an obvious way to improve research engagement in frontline staff. However, the development of a research culture that spans primary and secondary care is also crucial. Strong leadership is seen as instrumental in creating a culture that harnesses evidence-based practice and research awareness (Henderson et al, 2009). The UK is fortunate to have several leading nurses in VLU research and additional support from strong professional networks, such as the Royal College of Nursing District Nursing Forum. This strong leadership network could be used to support research applications and improve awareness of research funding schemes, which many clinical staff are unaware of, such as NIHR pre-doctoral and doctoral fellowships.

There is also a need to increase the number of research nurses in the community. Joint clinical and research roles could allow for development beyond basic research delivery. Student nurses also need to be offered greater opportunities for research involvement. Improving research experience for pre-registration nursing students is recognised as a priority globally, and, on registration, nurses are expected to have a good understanding of evidence-based care and multidisciplinary research (Slattery et al, 2016). Greater emphasis on research principles, critical appraisal for evidence-based practice and the frameworks that support research delivery should be included in all nursing education programmes, to increase research awareness, promote research participation and reduce the research–practice gap.

Comparing the recruitment settings of studies in each of the three searches conducted for this review, the studies that included more nurse authors did better at using primary care settings. This suggests that large RCTs and clinical trials might improve timely recruitment across all settings if they involve nurses to a greater extent. Recruiting participants solely from secondary or tertiary care may make the results of any research performed less generalisable to the majority of the VLU population, which is managed in the community, and it may deny these patients the opportunity to participate in research. Further, since only five of the studies reviewed specifically mentioned VLU interventions taking place within a community setting, there is a need to develop more community-led interventions.

There is now a significant push from leading research bodies such as the NIHR and the James Lind Alliance to reduce research waste. Published evidence outlines that poor recruitment is a considerable form of waste that can be corrected by better-informed choices regarding patient participation (Gillies et al, 2019). Involving nurses at all levels in the processes of research development, implementation and dissemination could be the key to better-informed recruitment strategies and more meaningful research.

Conclusion

Although significant contributions are being made by nurses in VLU research, more needs to be done to encourage and inspire frontline nurses across primary and secondary care to be research active and more involved in the delivery of RCTs and clinical trials in the community. This could be aided by promoting the role of the nurse researcher and research nurse as part of pre-registration training. In setting the agenda for research in primary care, pressures on services, access to training and research support, and investing in the development of a stronger research culture must be addressed if research is to become integral to primary care practice.

KEY POINTS

• Considerable research is being performed internationally to improve the care and experience of patients with venous leg ulceration (VLU), and nurses make valuable contributions to this
• However, most data are generated from randomised controlled trials, which are still conducted in secondary and tertiary care settings, despite the patient group with VLU largely being cared for in primary care settings
• VLU research should be delivered in collaboration with primary care, allowing results to answer questions relevant to community settings
• Establishing a culture of research in primary care is vital, as is engaging with frontline staff, particularly nurses

CPD REFLECTIVE QUESTIONS

• What is the prevalence and effects of venous leg ulceration?
• What is your understanding of the NICE Clinical Knowledge Summary for venous leg ulceration?
• How can you get more involved in research within your practice setting?
• How can research help patients within your practice setting?