Outcomes and Structures of Care: The European Perspective

Introduction The evaluation of wound care outcomes is seen as a necessary part of the process of care. While two decades ago, there was little requirement to evaluate the outcomes of treatment, with the development of evidence-based care through the systematic review of evidence, a need has developed to understand product performance and the benefits to patients, clinicians, and the healthcare system. Moreover, there is an increasing need for clinicians to evaluate what they are doing to provide the best care for their patients. While the focus of evaluation has been on the complete healing of wounds, changes in patient profiles mean that clinicians must broaden their approach to determining treatment success. For instance, it would appear that there may be a sizeable minority of patients who, despite best care, never achieve complete healing. Clearly, a system that relies on complete healing as the only outcome would consider these patients as treatment failures. The authors would argue, however, that the appropriate management of these patients can bring benefits to patients, whether this is by improvements in symptoms (e.g., pain, exudate levels) or by more holistic changes as those determined by assessment of health-related quality of life (HRQoL). Moreover, there may be benefits to clinicians in terms of a more efficient service provision and less demand for support as the patients become more independent. This paper will review the evidence in two areas of development in Europe, namely the use of HRQoL as an outcome measure and the appropriate use of cost-effectiveness arguments. It will review the initiatives established by the EWMA including the Cost Effectiveness Panel and the Database Panel and finally give two examples of innovations in care developed in Europe, namely the specialist wound healing centers and community leg ulcer clinics. Health-Related Quality of Life in Patients with Chronic Wounds In Europe, clinicians have been evaluating HRQoL in wound care for a number of years, particularly in leg ulceration,[1–7] pressure ulceration,[8] and the diabetic foot.[9–11] While much is known of the impact of wounds on patients, still relatively few studies have used HRQoL as outcome indicators in observational studies and randomized trials of therapy. The emphasis on HRQoL as an outcome has fallen on the use of generic tools in leg ulceration, in particular the Nottingham Health Profile (NHP),[7,12,13] MOS Short Form-36,[6,14] and Euroqol (EQ-5D).[6,15,16] Studies that have used the NHP have found large improvements over time with appropriate treatment, particularly with respect to bodily pain and sleep.[7,12,13] These differences have been greatest for patients whose ulcers healed over the period of follow up. In general, the changes observed using the SF-36 have been less dramatic, with some evidence of improvement in patients with healed ulceration over those patients who failed to heal, particularly in the areas of bodily pain and mental health.[6,14] The difference in magnitude of the effect may be in part due to the sensitivity of the tools in this patient population or a consequence of methodological differences in the studies undertaken, in particular, patient selection, treatments available, and duration of follow up. The Euroqol showed improvements in two studies over 12 weeks[15,16] and deterioration in one study, with later improvement after one year.[6] Despite little evidence of difference in total bodily pain between patients with healed and unhealed ulceration, the McGill pain questionnaire did provide evidence on greater improvements in healed patients, particularly with respect to sensory pain and visual analogue (now) scales.[6] A similar pattern was observed with visual analogue scores used in a study of skin equivalents.[15] At present, only one randomized, controlled trial has demonstrated greater improvements in HRQoL for patients randomized to one treatment compared with an alternative. A factorial design randomizing patients to dressings, bandages, and drug/placebo found significant improvements in pain and mobility in patients randomized to a four-layer compression bandage system compared with a single-layer compression system.[12] A positive effect of healing on the patients’ psychological status was observed in an early study,[17] which showed significantly greater improvements in depression and hostility in patients whose ulcers healed. Clearly, the evaluation of HRQoL has a way to go in wound care studies. However, in Europe the authors believe this to be a key outcome indicator, particularly as healthcare moves toward a more patient-centered approach to care. The EWMA Cost Effectiveness Panel The EWMA Cost Effectiveness Panel was established to provide assistance to those who wish to undertake cost-effectiveness studies in wound management.[18] The panel’s aims are to: • Develop a position paper for EWMA on cost effectiveness • Provide information and advice on the principles and types of cost studies • Assist in the development of cost-effectiveness protocols for health professionals involved in wound care practice. At present, the EWMA panel consists of health scientists, clinicians, health economists, and EWMA industrial partners. The panelists offer their services free of charge and allow access to key information that might help clinicians understand this problem in more detail. Clearly, members of the panel have areas of their knowledge and expertise that they need to keep confidential, and this is respected. However, the authors believe that by sharing information within the umbrella of EWMA, clinicians can place wound care on governments’ agendas to ensure easier access to appropriate care. Key Cost Drivers When one considers cost in the healthcare setting, there is often a reliance on the cost of products or services. Some studies have examined the cost of wound care products only, while others have also included the cost of nursing/physician care. However, it would seem that to get a reasonable estimate of the impact of the disease and its treatment to society it is important to evaluate the total cost consequences of the disease and its treatment. In essence, costs can be considered as either direct (cost of treating the wound) and indirect (the cost to society of the patient being ill). In the latter, the authors would include the time away from productive work, as this will have a consequence for the Nation in terms of lower productivity and sickness benefit that would otherwise be put toward creating wealth. Key cost drivers are the components of the total that are high cost and likely to vary between different groups of patients. In wound care, the key (direct) drivers are likely to fall into five categories: • Who treats the wounds? • Where are the patients treated? • With what are the wounds treated? • How frequently are they treated? • How often do side effects occur? Who treats the wounds? The decision of who treats the wounds will have a marked effect on the overall cost of care. In different healthcare structures throughout Europe and the wider world, different clinicians take responsibility for decisions on care and practical applications of wound dressing materials. In general, the cost of care is highest for physicians and surgeons, lower for nursing staff, and even lower when patients/relatives are asked to dress their own legs. Clearly, there is a need to ensure that the quality of care is maintained whoever is caring for the wound. Where are the patients treated? The clinical area for care will determine to a large extent the cost of the service. Again, different healthcare systems have alternative clinical areas for care. In general, the cost of hospital inpatient care will be more expensive than outpatient visits. This in turn will normally be more expensive than community (health) center care, which should be more expensive than home care. With what are the wounds treated? Modern wound care products are frequently unavailable in many healthcare systems. This is largely a budgetary decision, since the alternative (saline gauze) is inexpensive. Despite this, saline gauze may not provide the overall most inexpensive care for patients with wounds. The overall cost of care is much more dependent on the frequency of treatment, since nursing/physician costs are a considerably higher proportion of the overall cost of care. How frequently are they treated? The decision on frequency of treatment is largely a clinical one that will be highly dependent on the care required for the individual patient and the effectiveness of the wound care products that are being used. The decision to see patients more frequently is usually in response to symptomatic need. Thus, a product that is inexpensive, such as saline gauze, is not necessarily the most inexpensive option overall since it may require daily or twice daily changes. How often do side effects occur? While serious side effects of treatment for patients with wounds are rare, when they do occur, they can be catastrophic both to the patient and to the healthcare system. The consequences of infection are well known for all types of wounds and can be at a high cost for patients. The need for inpatient stay and the requirement for surgery are both rare in most healthcare systems but will lead to large cost consequences when they do occur. The decision to amputate in patients with a diabetic foot ulceration will require not only the immediate cost of care for the surgery but also resource issues with respect to the rehabilitation of these patients. The EWMA Position Paper on Compression Therapy As part of the Cost Effectiveness Panel work, the authors have undertaken a critical review of the cost effectiveness of compression therapy in the EWMA Position Document on Compression.[19] The findings of this work clearly demonstrate the benefits of using high compression therapy for patients with venous ulceration. The use of compression leads to a reduced frequency of visits for care with a reduced time to heal. While weekly costs of care may be similar between compression and usual care, this shorter healing time has the effect of reducing the total cost. Moreover, there is good evidence of improved outcomes of care (healing). This is a good example of the situation where costs are lower but outcomes better, a clear case of a cost-effective care program. EWMA Database Initiative In order to develop a system that can be used across different societies and healthcare systems, EWMA has established a Wound Database Panel. Wound assessment and documentation are rarely well defined outside specialist units and often do not appear in healthcare database systems. This makes it is almost impossible to produce any specific data related to wounds. The problem has been compounded by the lack of adequate wound diagnosis. Similarly, information on the treatment of wounds including dressing and bandage materials and pharmaceuticals has been lacking. This has led to a dearth of health economic outcomes. The aim of the database initiative is to develop a functional, open-model wound database, which will be based on existing database systems. More specifically, the aims are to: • Create a Minimum Data Set (MDS) • Develop a structure for systematically gathering data on wound care delivery in primary and secondary care across Europe • Capture, analyze, and aggregate data in order to identify best practices • Publish and disseminate findings • Create evidence for cost-effective wound care. A functional wound database will be beneficial for patients, healthcare personnel, researchers, administrators, and companies. The key benefits will be the ability to collect and use all types of information about the patients and their wounds, which has not been possible with the databases currently used for healthcare evaluation. Development of the clinical datasets together with economic outcome data will make it possible to evaluate different types of treatment with respect to both clinical and cost effectiveness. A system like this will allow for the analysis of clinical trials, meta-analyses, and cost-effectiveness investigations. Minimum Data Set (MDS). To ensure a valid European research-based data collection on wound treatments, a common dataset is necessary. However, several wound databases currently available collect slightly different information. It is essential that clinicians find a common group of variables that are compatible with all systems. The existing databases will be examined and adapted to produce a set that is appropriate to reflect the needs of different countries in relation to wound assessment and treatment. The Database Panel of EWMA is currently working on this topic. When complete, it is intended that the Panel will act to coordinate the different databases available in Europe. The intention is to modify the existing databases to make them compatible with each other and to then allow for comparisons across Europe. It is the intention of the Panel to improve the coordination of database-related wound healing research across Europe and bring together different types of research partners in order to develop research and bid for European funding. At present, the Panel is focussing on the German Wound Net,[20] but other systems are also being evaluated. A pilot study in Denmark started in 2004 and will be followed by two centers in the UK collecting 12 months of clinical data. The result of this pilot will determine the more detailed future development of the project. Developing Structures that Improve Outcomes The benefits to the healthcare system of a structural approach to care may include lower costs due to this greater efficiency and, more importantly, a greater cost effectiveness. Here, scarce health resources are used in a more efficient way to either reduce the cost burden of a condition or allow for a greater number of patients to be cared for within the existing health budget. In Europe, the challenges are manifold due to the numbers of different countries, their cultures, and different healthcare systems. This can lead to conflicts in management, particularly when products have limited availability in certain countries, differences in health culture, such as the status of nurses as independent practitioners, and the relative emphasis on acute (hospital) care, compared with that offered in the community. Health outcomes that may be relevant to one society may not be so to others. Moreover, the standardization of health outcomes may require translation and validation within the different populations. In EWMA, the authors believe that while clinical outcomes are important, clinicians must not forget the patient-centered outcomes and those that are likely to lead to greater efficiency as determined by cost effectiveness. Significant improvements in service provision have occurred over the past 15 years as a result of a number of initiatives: • Evidence-based guidelines • Systematic reviews of evidence • Enhanced assessment procedures • Developments in wound care products • Availability of products through reimbursement. The remit of this paper is not to evaluate these in detail. Instead, the authors have chosen two models of care that have been developed in Europe to assess and treat wounds, with evidence on how they may improve outcomes of care. Wound Healing Centers Until recently, the management of wounds has generally lacked a standardized approach to care. New developments have led to a more systematic approach, including recommendations on treatment and referral, multidisciplinary collaboration, continuous audit of treatments, developments in health professionals’ and patients’ education, treatment structures, and developments in both basic and clinical research. An investigation in the primary healthcare sector in the central part of Copenhagen documented the problems prior to the development of these innovations. In patients with chronic wound problems, only 51 percent had a significant diagnostic examination; 40 percent of patients with suspected venous leg ulcers had not been treated with compression; 34 percent of patients with foot ulceration were not investigated for diabetes mellitus; and only half of the patients with pressure ulceration had care that included pressure relief. Lack of organization and care delivery by individuals instead of a team seems to have been the major problem.[21] The team approach and collaboration between all healthcare professionals is required to facilitate good quality holistic care.[22–25] Recognition of the talent and creativity of all employees in the multidisciplinary team will increase the chance of success in establishment of the concept.[26] There has been some discussion over the most appropriate term to describe this collaborative working, whether it should be described as multidisciplinary or interdisciplinary.[27] Multidisciplinary was chosen because it focuses more directly on equal collaboration with all disciplines working within a single unit. The idea of a multidisciplinary team working in a center of excellence is attracting increasing interest as the best way to improve wound healing and care in complex patients. The concept of multidisciplinary care is a well-established paradigm in medicine. Multidisciplinary teams have for years performed treatment of burns. In 1994, a multidisciplinary approach to the treatment of pressure ulcers was recommended, and other organizations, such as the American Diabetes Organization’s Council on Foot Care, have recognized the need for consulting practitioners from various disciplines in the treatment of the diabetic foot.[23] During the last 10 years, different types of multidisciplinary teams for treatment of problem wounds have been suggested.[28–40] Multidisciplinary approaches to wound care in the primary healthcare sector as well as in hospitals have demonstrated a reduction in home visits and the number of products used. Standardizing treatment plans seems to improve healing of certain chronic wounds. After embracing the multidisciplinary concept, an 84 percent reduction in the incidence of major lower-extremity amputations was achieved in diabetic patients.[41] Similar results have been achieved in other institutions.[24] It has also been shown that multidisciplinary team approaches decreased the incidence of pressure ulcers from 23 percent to 8 percent after three years in one institution and decreased the prevalence of nosocomial pressure ulcers by 15 percent in another institution over a one-year period.[25] In Denmark, plans for a multidisciplinary expert area in wound healing, called Clinical Wound Healing, and a proposal for its structure have been published.[42] All interested and relevant specialties are invited to participate. The proposal is based on the existing structure of the healthcare system but with new elements focusing especially on problem wounds. Two centralized wound-healing centers have been established and are key components of the new structure. The organization of the centers is given below. Center Organization The figures are primarily based on the Copenhagen Wound Healing Center (CWHC),[40] because this center has existed for more than eight years, while University Center of Wound Healing (UCWH) in Odense[21,42] was started in 2003. General structure. The Centers are part of a specialty department (CWHC: dermatology, UCWH: plastic surgery), and the government pays all expenses in the socialized hospital. The departments consist of an outpatient clinic and an inpatient ward. The clinical staff (CWHC: 45, UCWH: 27) work full time with problem wounds irrespective of their previous education and specialty. Number of patients, stay, and referrals. In the outpatient clinic of CWHC, approximately 7,000 consultations take place each year with approximately 340 patients referred to the inpatient ward annually. The duration of the problem wound varies from a few months to several years. In all, 45 percent of referrals are treated in the outpatient clinic, each patient on average receiving two consultations. Of the hospitalized patients, 15 to 20 percent have had a previous admission. The mean stay at the department is approximately 16 days. Leg/foot ulcers in nondiabetic patients account for 53 percent in the outpatient clinic and 38 percent for admissions. Almost all patients have received care prior to referral without evidence of healing. Venous leg ulcers. Venous leg ulcers are treated with a standardized conservative regimen consisting of a local wound treatment and compression bandages primarily of two layers. If this regimen fails to improve healing after three months, the patients are offered surgery. Approximately 15 percent of patients have isolated superficial venous insufficiency; the remaining 85 percent have isolated deep or combined deep and superficial insufficiency. One-year ulcer recurrence rate for all ulcer etiologies is 35 percent.[43] Economic analysis has shown that where no recurrences occur within one year postoperatively, surgery is a cost-effective method of management. In all, 65 percent of the patients with nonhealing wounds still were healed 12 months postoperatively. Diabetic ulcers. Fifty-five percent of patients on the ward and 39 percent of outpatients suffer from diabetes. A combination of procedures has decreased the major amputation rate for this type of patients to approximately 20 percent of that given 10 to 15 years ago.[40] Pressure ulcers (decubitus). In the outpatient clinic of CWHC, six percent of patients have a pressure ulcer in the hip/sacral region. This low number is probably a result of the policy of this center: organizing the treatment of the patients in their homes as long as possible. UCWH is the national center for the most problematic pressure ulcers like those found in tetraplegic patients. For this reason, 25 to 30 percent of hospital beds are for pressure ulcer patients. Other types of wounds. Problems related to surgical or traumatic wounds, primarily infections, are treated in the surgical departments in CWHC, while at UCWH, these are managed within the Center. Scientific activity. The structure of the centers allows for the development of clinically related research. The high throughput of patients means that many are available for randomized clinical trials and large observational studies. Studies can be related to clinical or cost-effectiveness outcomes. Educational activity. The center structure is ideal for pre- as well as postgraduate education for all health professional groups. The clinical facilities and the many different types of patients allow an educational activity covering basic as well as specialized education levels. Establishment of the multidisciplinary centers have resulted in the development of a higher degree of continuity of the treatment and allowed the development of standardized treatment courses. Unpublished studies have shown a high level of satisfaction (83%) with treatment courses assessed by a Scandinavian expert group and between 85 percent and 93 percent patient satisfaction with wound treatments and quality of care (Kjær et al, unpublished data). In Table 1, important factors for the establishment of optimal expert concepts are described. Community Leg Ulcer Clinics The focus of cost-effectiveness evaluation of systems has come from the UK with the introduction of community leg ulcer clinics run by community nurses in collaboration with specialist nurses from the hospital and direct links to specialist physicians and surgeons. While this is not the only potential model of care, to date, it is the only one that has evaluated costs together with outcomes of treatment. The concept of community clinics was developed in the Riverside Leg Ulcer project undertaken during the late 1980s and early 1990s.[44] At that time, leg ulcer care was largely undertaken in the patients’ homes by community nurses with little medical input. The study aimed to implement a system of care that included assessment using Doppler, treatment using high compression four-layer bandaging (4LB), and appropriate referral to specialists within the hospital. Cost effectiveness was undertaken by combining the clinical results prior to and following implementation with the costs of services from questionnaire and audit data provided by patients and professionals. The study indicated that the cost of care (pound 1=$1.9) in Riverside was $823,840 (pound 433,600) prior to the new service compared with just $321,100 (pound 169,000) in the new service.[45] This was also associated with improvements in outcome from a 12-week healing rate of 22 percent prior to the new service rising to 80 percent in the new clinics. In this study, outcomes improved together with reductions in cost making the new service clearly cost effective. Despite this success, there was concern over the use of a historical control group in this analysis. A further implementation study was undertaken by Simon, et al.,[46] in two neighboring health authorities (Stockport and Trafford) in the UK. To minimize the temporal effects on the data, one authority (Stockport) implemented a new service based on the Riverside model, while the other (Trafford) maintained their service using existing practices. In Stockport, the 12-week healing rates improved from a baseline of 26 percent during 1993 to 42 percent in 1994, while in Trafford, they remained static at 23 percent in 1993 and 20 percent in 1994. Annual expenditure reduced in Stockport from $778,983 (pound 409,991) to $481,405 (pound 253,371), while in Trafford, it rose from $1,056,474 (pound 556,039) to $1,279,304 (pound 673,318). Again, the evidence showed improvements in outcome combined with reduction in cost, a powerful cost-effectiveness argument. This work has since been extended by implementing a similar service in the control (Trafford) authority.[47] The Stockport service was able to maintain healing rates at 40 percent, while those in Trafford rose from 20 percent to 42 percent following implementation. The cost of the service increased in Stockport from $124,536 (pound 65,545) to $158,353 (pound 83,344), while in Trafford, it reduced from $287,612 (pound 151,375) to $101,034 (pound 53,176) in 1999. Again, an improved outcome was demonstrated at a lower cost. Despite these studies showing demonstrable improvements of care and lower cost, it has been argued that the use of historical control groups may exaggerate the differences, while comparisons of authorities may be limited due to differences in patients, populations, and other healthcare factors. To overcome this, Morrell, et al.,[48] undertook a randomized, controlled trial comparing patients treated in clinics with high compression bandaging with those being cared for in their homes by nurses providing usual care over a 12-month period. In total, 233 patients were randomized. The annual cost for patients randomized to clinics was $1,668 (pound 878), compared with $1,632 (pound 859) in usual home care setting. Twelve-week healing rates were 34 percent in the clinic compared with 24 percent in home care. Thus, outcomes were improved at a similar cost within the community clinics. While this result cannot prove that community clinics are more cost effective per se, since the treatments offered were different, it does show that the system of care offered within the clinics was superior to the system of care offered in the home by community nurses. Discussion In Europe, clinicians have been examining a range of wound care outcomes. While the emphasis of care revolves around the need to heal patients with wounds, in Europe, clinicians have acknowledged the limitations of such approach. The examination of HRQoL has allowed for a more patient-centered approach to care, outcomes that clinicians believe go well beyond the requirement for complete healing. Wounds that otherwise might appear to be treatment failures due to the inability to completely heal may offer advantages to patients in terms of symptom relief, improvements in mobility, and the ability to socialize more. Furthermore, these may also have beneficial effects on the patients’ psychological status, reducing the need for psychological support from health professionals and families. The EWMA initiative on cost effectiveness has highlighted the need for a greater efficiency in healthcare and illustrated how access to modern wound products can lead to improved outcomes for the healthcare system. Clinicians are in an age where clinical effectiveness is no longer the only requirement but a greater need to use health budgets as widely as possible. There are many opportunities within wound management for new products and systems of care. What is now needed is the evidence behind these to justify how clinicians can manage these wounds in a way that is beneficial for both the patients and the healthcare system within which treatment occurs.