Epidemiology and health care situation of chronic wounds in Germany

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1 Review Article 75 Epidemiology and health care situation of chronic wounds in Germany K. Heyer; K. Protz; M. Augustin; K. Herberger University Medical Center Hamburg-Eppendorf, Institute for Health Services Research in Dermatology and Nursing (IVDP), Hamburg, Germany Keywords Chronic wounds, epidemiology, leg ulcer, health care situation, health services research Correspondence to Kristina Heyer University Medical Center Hamburg-Eppendorf Institute for Health Services Research in Dermatology and Nursing (IVDP) Martinistr. 52, Hamburg, Germany Tel. +49-(40)/ , Fax Summary Chronic wounds are of great socioeconomic importance. Usually they are associated with a long, complicated and burdensome course of disease and require high nursing and medical expenses. The quality of life of patients with chronic wounds is substantially impaired. This article provides a systematic overview of current studies on the morbidity and the health care situation of patients with chronic wounds, especially in patients with leg ulcers in Germany. Analyses based on routine data of statutory health insurances show higher incidence and prevalence rates, for example of patients with leg ulcers, compared with previously regional surveys. The quality of care is inadequate, particularly in diagnostics and therapy of patients with leg ulcers. To date, there is undersupply and a lack of execution and deficient knowledge about the compression treatment in patients with venous leg ulcers. Thus, there is need for further action in order to establish better implementation of guidelines in the management of patients with chronic wounds. Schlüsselwörter Chronische Wunden, Epidemiologie, Ulcus cruris, Versorgungssituation, Versorgungsforschung Epidemiologie und Versorgungs situation chronischer Wunden in Deutschland Phlebologie 2016; 45: Received: January 22, 2016 Accepted: January 27, 2016 Zusammenfassung Chronische Wunden sind von großer sozioökonomischer Bedeutung. Häufig leiden Patienten mit solchen Erkrankungen unter großer Krankheitslast und die Versorgung erfordert einen hohen pflegerischen sowie medizinischen Aufwand. Zudem sind Patienten mit einer chronischen Wunde stark in ihrer Lebensqualität eingeschränkt. Diese Arbeit gibt einen systematischen Überblick über aktuelle Studien zur Erkrankungshäufigkeit chronischer Wunden und der Versorgungssituation von Patienten mit Ulcus cruris in Deutschland. Analysen auf Basis von Routinedaten der gesetzlichen Krankenversicherung zeigen eine deutlich höhere Erkrankungshäufigkeit beispielsweise des Ulcus cruris verglichen mit bisher publizierten Studien, die auf regionalen Erhebungen basieren. Die Versorgungsqualität von Patienten mit einem Ulcus cruris ist insbesondere bei der Diagnostik und Behandlung unzureichend. Bis heute besteht eine deutliche Unterversorgung, eine mangelnde Ausführung sowie defizitäres Wissen über die Kompressionsbehandlung beim Ulcus cruris venosum. Es besteht weiterer Handlungsbedarf, um die leitliniengerechte Therapie in der Behandlung von Patienten mit chronischen Wunden stärker zu etablieren. Background Chronic wounds include gravitational ulcer, pressure sores and diabetic foot ulcer (4, 21). In the Expert Standard of the German Network for Quality Development in Care (DNQP), a wound is classified as chronic if it fails to show any healing tendency after 4 12 weeks of expert medical care (6). The healing rate is affected by many factors, such as the type and cause of the wound. This temporal definition is thus often abandoned in favour of defining a chronic wound as one that fails to progress through a timely and orderly physiological healing process (12). At %, gravitational ulcers are among the most frequently occurring chronic wounds (4, 21). Chronic wounds are characterised by a high degree of chronicity with long treatment courses and high relapse rates. They are associated with severely impaired quality of life for the patients (3, 7, 15, 26). Care involves considerable nursing and medical expense. Such patients therefore make high demands on the health care system and incur high medical costs (2, 29). As a result of demographic change and the associated rise in vascular disease in the elderly, a further increase in chronic wounds is to be expected (1, 3, 30). Frequency of disease and sociodemographic differences Current analyses based on one statutory health insurance (SHI) scheme show that

2 76 K. Heyer; K. Protz; M. Augustin; K. Herberger: Epidemiology and health care situation of chronic wounds in Germany the frequency of disease (prevalence) in 2012 is estimated at 330,000 treated persons (standardised prevalence rate 0.4 %) with a chronic wound in Germany (17). The incidence is estimated at 180,000 newly treated chronic wounds in 2012 (standardised incidence rate 0.2 %). Based on routine data obtained from the statutory health insurance (SHI), an annual increase in prevalence and incidence was determined between 2010 and 2012 ( Fig. 1). Of the persons newly diagnosed with a chronic wound, 96 % of those insured were diagnosed with gravitational ulcer (ICD 10 code) in the period Gravitational ulcer was coded most frequently at 65 %. Arterial ulcer (12 %) and gravitational ulcer of mixed aetiology (7 % presence of both ICD 10 codes) were coded far less frequently. By contrast, in just under 21 % of those insured, the non-specific category (gravitational ulcer not elsewhere classified) was selected. Pressure ulcers were documented in 63 % and diabetic foot ulcer in 43 % (multiple classifications) of cases (17). The prevalence of gravitational ulcer can be estimated at 156,000 persons, taking into account patients with a gravitational ulcer of mixed aetiology and assuming a proportion of 70 % of insured persons with a coded gravitational ulcer not elsewhere classified (17). Compared with the Bonn Vein Study, which estimated the prevalence of gravitational ulcer at 80,000 persons in Germany (31), the analyses based on the routine SHI data in 2012 established the prevalence of gravitational ulcer as being much higher. Furthermore, the analyses of routine SHI data showed that, on average, more women than men suffer from a chronic wound and that the probability of occurrence of a chronic wound increases with age (17). Irrespective of aetiology, regional differences were also identified in disease prevalence. For example, the highest prevalence rate of patients with a chronic wound was observed in the German states of Rhineland-Palatinate, Saxony-Anhalt and Saarland, whereas the lowest rate was seen in Brandenburg ( Fig. 2). From the statutory health insurance viewpoint, the costs of caring for patients with gravitational ulcer are estimated at 8,000 10,000 euros (2, 29). At a mean total cost of 9,000 euros per patient and year and an established prevalence of chronic wounds of 0.4 % (330,000 treated patients with a chronic wound), this results in estimated total costs to the SHI of approximately 3 billion euros annually. Health care situation for patients with gravitational ulcer Some studies have now been published describing the health care situation of patients with gravitational ulcer in Germany (3, 14, 18, 23, 27, 28, 35). In view of the considerable burden of disease and the economic significance, guideline-compliant treatment assumes great importance. Fig. 1 Prevalence and incidence rate of chronic wounds during the observation years with confidence intervals given as percentages (non-standardised). Starting the latter early can reduce both the duration of disease and the number of relapses, thus shortening treatment time and reducing subsequent costs. In addition, qualified and up-to-date therapy contributes greatly to improving patients quality of life and therefore has a positive effect on the overall benefit of wound care. In the studies already published, the care of patients with a gravitational ulcer can be ranked as insufficient and clear deficits are identifiable. The Hamburg Wound Study was a regional investigation of the implementation and establishment of guideline-compliant treatment in patients with a gravitational ulcer (14). Quality indicators were developed in the care of patients with wounds, in order to evaluate and present the quality of medical care (3). The treatment index derived from the individual quality indicators therefore measures compliance with the guidelines, the quality of performance and the extent to which targets are achieved. In the Hamburg Wound Study, which investigated patients with gravitational ulcer, over half of the care providers (62 %) fulfilled the quality indicators. Deficits were particularly evident in the diagnostics. Although a carefully recorded wound status is considered obligatory, both at the outset and during treatment, this was only documented in 27 % of cases. Appreciable omissions were particularly noted in establishing the cause of the wound, an essential prerequisite for causal therapy. In many patients, there was a failure to establish complete vascular status, e.g. the ankle-brachial index was only determined in half of the patients. Pain management also left much to be desired, as was shown by the disparity between the proportion of patients experiencing pain during a dressing change (89 %) and the proportion of those receiving pain relief during a dressing change (9 %) (14). As causal therapy, compression therapy is an important element in the treatment of patients with a gravitational ulcer and includes medical compression stockings (MCS), ulcer stocking systems, multi-component systems, wrap bandages, shortstretch bandages and padding materials. Their efficacy has already been adequately confirmed in many high-quality scientific Phlebologie 2/2016 Schattauer 2016

3 K. Heyer; K. Protz; M. Augustin; K. Herberger: Epidemiology and health care situation of chronic wounds in Germany 77 Fig. 2 Regional distribution of the age-standardised prevalence rate of chronic wounds in 2012 as a percentage. studies (25). Failure to perform compression therapy thus constitutes medical malpractice in patients with venous ulcers. The analysis based on routine SHI data showed a marked deficit in compression therapy in patients with gravitational ulcer (18). In total, 61 % of the insured patients who were included were not prescribed compression therapy in either the year before or after wound onset. Moreover, some regional differences were identified in this analysis. The proportion of compression therapy was lowest in Saarland at 33 %; by contrast, in Bremen and Hamburg, half of the affected patients insured received compression therapy (18). The results are also reflected in the figures from other studies (14, 27, 35). The majority of patients with gravitational ulcer were given no compression therapy, although correct and appropriate medical compression therapy can increase the likelihood of healing and minimise the risk of relapse. Not only was insufficient care identified with regard to this causal therapy, there was also a lack of knowledge and inadequate practical application on the part of both the medical, nursing and therapeutic care providers and of the patients and their relatives. The majority of health care providers are not familiar with the various compression materials, particularly multicomponent systems and ulcer stocking systems (28), although these have been established on the German market since 2000 and their superiority to treatment with short-stretch bandages has been confirmed (25). Moreover, the majority of health practitioners were not familiar with the correct application of short-stretch bandages, so that the latter failed to achieve the effective compression pressure (50 to 60 mmhg) (28). Deficits were also identified in the handling of compression therapy materials.

4 78 K. Heyer; K. Protz; M. Augustin; K. Herberger: Epidemiology and health care situation of chronic wounds in Germany In 50 % of patients, short-stretch bandages were used for four months or longer (27), although worn dressings do not comply with treatment requirements (19). Moreover, care of the dressings was often inappropriate. In addition, 79 % of patients failed to wear their dressings at night, i.e. the dressings were removed again during the day or in the evening before going to bed. In many patients, new bandages were not applied until after rising in the morning. This therefore renders invalid any possibly successful treatment achieved on the previous day, i.e. initial decongestion. When considering local therapy, it is apparent that, irrespective of aetiology, the majority of patients with gravitational ulcer are treated with stage-adapted use of hydroactive wound dressings (14, 18). General practitioners feel more uncertain than specialists in the treatment of chronic wounds (36). Care administered by an interprofessional team with sufficient interface management can also shorten healing time, thus saving costs (11, 13, 22). To date, however, just under 70 % of patients with a gravitational ulcer are treated by general practitioners (14, 27). Particularly against the background of the advanced age of the wound patients and their associated limited mobility, problems with care provision emerge in structurally underdeveloped regions. It is not easy for patients to obtain specialist care and this situation is likely to worsen in the future. Summary and prospects Against the background of demographic change and the increasing number of persons with the respective primary disease, chronic wounds are likely to become increasingly important. According to the routine SHI data, 330,000 people were already being treated for a chronic wound in The estimated prevalence based on the routine SHI data may be even higher, as the analyses only considered those insured persons who were actually treated. Thus, insured persons who did not use the German health care system despite the presence of disease were not identified. Nevertheless, this is the first study based on population-related data that has investigated the prevalence of chronic wounds with the aid of a large statutory health insurance scheme (representing approximately 11 % of the German population). The studies on the current health care situation, taking patients with gravitational ulcer as an example, show deficits in both diagnostics and treatment. In particular, there is room for further improvement in establishing wound origin, which is the basis of causal therapy. In the area of therapy and prevention, considerable deficits in compression care were identified. Prescription of treatment for patients with gravitational ulcer is inadequate in Germany and performance is poor due to a lack of knowledge about compression. These factors lead to an inadequate and prolonged treatment phase. The present overview of current treatment illustrates the need to try and overcome the deficient implementation of guideline-compliant treatment in Germany. Establishing guidelines in routine care has already been rated as difficult in other studies (20, 32), but is nevertheless highly desirable. Realisation of guidelinecompliant treatment requires implementation strategies and structured treatment programmes. Treatment performed in specialist centres is superior to basic care (11, 22) and a care gradient exists with regard to healing rates, avoidance of complications and, not least, patients quality of life (1, 29). Nevertheless, there is a discrepancy between the low number of specialist care providers in Germany and the high number of patients requiring treatment (1), resulting in an appreciable loophole in care provision. Telemedical treatment concepts are an innovative approach to closing this loophole efficiently and effectively (24, 33, 34). Against this background, since October 2014, insured persons with chronic wounds in the metropolitan area of Hamburg have been provided with care as part of the Televisite treatment project. This is an interconnected, cross-sectoral, telemedical care provision for patients with chronic wounds who are treated on the basis of weekly telemedical visits after presenting in the university wound centre and obtaining a condensed diagnostic clarification. This results in a close interconnection between the specialist care providers in the university and the nursing services and physicians in the local situation. Initial experience has shown that the patients with problem wounds can be well treated and complications avoided (16). Care provision in the form of selective contracts offers one option for treating patients with chronic wounds in structured treatment programmes above and beyond routine care and has gained in importance in recent years. A national survey showed that, in 2014, 59 % of health insurance funds in Germany managed selective contracts on chronic wounds, in which a total of 20,068 patients were treated, corresponding to approximately 2 % of all patients with chronic wounds (9). However, only 15 % of the selective contracts were externally evaluated. In addition to scientific support when implementing new treatment concepts, scientific evaluation of new and old care concepts is necessary, in order to achieve the aim of improved, patientoriented treatment quality. There is still an urgent need for action in establishing and evaluating innovative treatment structures, in order to meet the high need and provide guideline-compliant care to patients with chronic wounds. Simply identifying a potential health care provider often presents a barrier for the patient. Although some wide-reaching, cross-sectoral health care networks do exist, these must be realised in a structured manner and made available to the public. The information platform is operated to facilitate access to specialist care and allow interlinking of health care providers (www. wundnetze.de). This maps the details of wound networks and health care provider groups in Germany, thus making them more easily accessible (8). In conclusion, there is room for improvement in the care of chronic wounds in Germany, particularly with regard to diagnostics and therapy. Various activities and care concepts aiming to close the loopholes in care provision already exist. Nevertheless, the need for innovative, far-reaching care models remains considerable and, in the coming years, the task will be to set the course for guideline-compliant care provision, in order to meet the requirements of patients with chronic wounds Phlebologie 2/2016 Schattauer 2016

5 K. Heyer; K. Protz; M. Augustin; K. Herberger: Epidemiology and health care situation of chronic wounds in Germany 79 against the background of demographic change. Conflict of interest The authors declare that no conflict of interest exists. Ethical guidelines The study was prepared in adherence to national guidelines and the current Declaration of Helsinki. References 1. Augustin M, Debus S. Moderne Wundversorgung: Im Spannungsfeld zwischen Qualitätsanspruch, Zuständigkeit und Sparzwang. Wiesbaden: mhp Augustin M, Brocatti LK, Rustenbach SJ, Schafer I, Herberger K. Cost-of-illness of leg ulcers in the community. Int Wound J 2014; 11 (3): Augustin M, Rustenbach SJ, Debus S, et al. Quality of care in chronic leg ulcer in the community: introduction of quality indicators und a scoring system. Dermatology 2011; 222 (4): Deutsche Gesellschaft für Wundheilung und Wundbehandlung e.v. Lokaltherapie chronischer Wunden bei Patienten mit den Risiken periphere arterielle Verschlusskrankheit, Diabetes mellitus, chronische venöse Insuffizienz awmf.org/uploads/tx_szleitlinien/ l_S3_ Lokaltherapie_chronischer_Wunden_ pdf (abgerufen am 29 Juli 2014) 5. Dissemond J. When is a wound chronic? Haut arzt 2006; 57 (1): Expertenstandard Pflege von Menschen mit chronischen Wunden. Deutsches Netzwerk für Qualitätsentwicklung in der Pflege (Hrsg.). Osnabrück; 1. Aktualisierung (September 2015). 7. Finlayson K, Edwards H, Courtney M. The impact of psychosocial factors on adherence to compression therapy to prevent recurrence of venous leg ulcers. J Clin Nurs 2010; 19(9 10): Goepel L, Herberger K, Debus ES, et al. Wundnetze in Deutschland: Struktur, Funktionen und Ziele 2014 [Wound Networks in Germany: Structure, Functions and Objectives 2014]. Haut arzt 2014; 65 (11): Goepel L, Heyer K, Herberger K, et al. Selektivverträge zu chronischen Wunden aktueller Stand in Deutschland. Gefässchirurgie 2015; 20: Gottrup F, Holstein P, Jorgensen B, Lohmann M, Karlsmark T. New Concept of a Multidisciplinary Wound Healing Center and a National Expert Function of Wound Healing. Arch surg 2001; 136 July. 11. Gottrup F. A specialized wound-healing center concept: importance of a multidisciplinary department structure und surgical treatment facilities in the treatment of chronic wounds. Am J Surg 2004; 187: 38S 43S. 12. Gottrup F, Apelqvist J, Price P. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care 2010; 19(6): Harrison MB, Graham ID, Lorimer K, et al. Legulcer care in the community, before und after implementation of an evidence-based service. CMAJ 2005; 172: Herberger K, Rustenbach SJ, Grams L, et al. Quality-of-care for leg ulcers in the metropolitan area of Hamburg A community-based study. J Eur Acad Dermatol Venerol 2012; 26(4): Herberger K, Rustenbach SJ, Haartje O, et al. Quality of life und satisfaction of patients with leg ulcers results of a community-based study. VASA 2011; 40: Herberger K, Heyer K, Bargel S, Baade K, Helfrich J, Augustin M. Televisite Pilotprojekt zur telemedizinischen Versorgung chronischer Wunden im Großraum Hamburg. JDDG 2015; 13 (Suppl 1): Heyer K, Herberger K, Protz K, et al. Epidemiology of Chronic Wounds in Germany: Analysis of Statutory Health Insurance Data. Wound Repair and Regeneration 2015 Nov 26. doi: /wrr Heyer K, Augustin M. Therapie chronischer Wunden Schwerpunkt Ulcus cruris. In: Sauer K, Rothgang H, Glaeske G. (Eds) BARMER GEK Heil- und Hilfsmittelreport 2014: Schriftenreihe zur Gesundheitsanalyse. Siegburg 2014; Jünger M, Partsch H, Kahle B, et al. Phlebologischer Kompressionsverband (PKV) Leitlinie der Deutschen Gesellschaft für Phlebologie. Phlebologie 2009; 38: Kastner M, Estey E, Bhattacharyya O. 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