The German national consensus on wound documentation and outcomes

The German national consensus on wound documentation and outcomes: Rationale, working program and current status.

Augustin M, Schmitt J, Herberger K, Goepel L, Heyer K, Dissemond J, Mayer A, Aschoff R, Beikert F, Bischoff M, Blome C, Bunse J, Diener H, Eberlein T, Eming S, Fansa H, Flesch F, Gaiser F, Gartner S, Gass S, Gerber V, Glau S, Görge T, Großkopf V, Hampel-Kalthoff C, Hartmann B, Helfrich J, Hirsch T, Hochlenert D, Horn T, Imkamp U, Janetzko C, Jost JO, Jünger M, Kaufmann R, Kamperhoff F, Lange-Asschenfeldt B, Langer S, May M, Münter KC, Nagel R, Nast A, Neubert TR, Niederbichler AD, Peter RU, Petzold T, Protz K, Risse A, Schäfer E, Scharffetter-Kochanek K, Schindzielorz M, Schmidt M, Schuster H, Sindrilaru A, Storck M, Tigges W, Tonn C, Valesky E, van Montfrans C, Vanscheidt W, Waldvogel-Röcker K, Wild T, Zouboulis C, Debus S.

for the German consensus conference on documentation and outcomes measurement in chronic wounds representing the German scientific medical societies, regional wound networks, nursing bodies and further organisations related to health care for chronic wounds:

Ärztegenossenschaft Niedersachsen-Bremen (ägnw eG), AOK Baden-Württemberg, AOK Rheinland/Hamburg, Berufsverband der Deutschen Chirurgen (BDC), Berufsverband der Deutschen Dermatologen (BVDD), Bundesministerium für Gesundheit (BMG), Berufsverband der niedergelassenen Chirurgen (BNC), Deutsche Angestellten-Krankenkasse (DAK), Deutsche Dermatologische Gesellschaft (DDG), Deutsche Diabetes Gesellschaft (DDG), Deutsche Gesellschaft der Plastischen, Rekonstruktiven und Ästhetischen Chirurgen (DGPRÄC), Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV), Deutsche Gesellschaft für Chirurgie (DGCh), Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin (DGG), Deutsche Gesellschaft für Mund-, Kiefer- und Gesichtschirurgie (DGMKG), Deutsche Gesellschaft für Phlebologie (DGP), Deutsche Gesellschaft für Plastische und Wiederherstellungschirurgie (DGPW), Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie, Deutsche Gesellschaft für Thoraxchirurgie (DGT), Deutsche Gesellschaft für Unfallchirurgie (DGU), Deutsche Gesellschaft für Wundheilung und Wundbehandlung e.V. (DGfW), Deutsche Wundakademie (DWA), Deutsches Netzwerk für Qualitätsentwicklung in der Pflege (DNQP), Forum der Wundnetze in Deutschland, Gesellschaft f. Fußchirurgie (GFFC), Gesellschaft für Fußchirurgie (GFFC), Gesundheitsforen Leipzig GmbH, Initiative chronische Wunden e.V. (ICW), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP), Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Leitliniengruppe DDG/ AWMF, Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen e.V. (MDS), Rechtsdepesche, Spitzenverband der Gesetzlichen Krankenversicherung (GKV), WundD•A•CH, Wundforum und AG Wundheilung der DDG, Wundkompetenznetz Mittlerer Oberrhein, Wundnetz Leverkusen-Köln, Wundzentrum Hamburg.

Deutsche Version

Summary

Chronic wounds are challenging medical conditions imposing great burden to the patients, the society and the payers. Accurate and efficient treatment includes the use of outcomes measures both in clinical care and in research. To date, there still is a lack of consensus on standards for the documentation and measurement of chronic wounds, no agreements on the interpretation of wound outcomes and no harmonisation about standardised goal setting in wound treatment.

Key words Chronic wounds, outcomes measurement, documentation, validation, health care, health services research, consensus conference

Objective 1) To establish a national German consensus group for the definition of standards in outcomes measurement and interpretation of chronic wounds, 2) to agree on recommendations for practice and research based on a continuous decision process, including implementation of the standards.

Methods Initiated by the German centers for health services research in dermatology (CVderm) and in vascular diseases (CVvasc), this national consensus group includes delegates from the German scientific medical societies involved in health care for chronic wound, the national boards on nursing, and the chairs of regional wound networks. Moreover, the roof organisations of the German health insurances, the German ministry of health and further single wound experts were invited. The consensus work is based on a structured decision process coordinated by a trained moderator. All processes are regulated in a charter approved by all delegates.

Results The consensus groups consists of 58 representatives and co-representatives of 26 societies and organisations. Since 2012, in the regular bi-annual meetings a Delphi-based workflow has been followed starting with standards for documentation and outcomes measurement in patients with leg ulcers. Additionally, web-based decision processes are conducted which are then presented for finalisation in the face-to-face meetings. As application areas of particular interest were defined: Clinical routine, health services research, clinical research, analysis of secondary data and health economics. In the meantime, 245 single decision have been approved.

Conclusions Based on a national joint process involving the medical societies, the nursing groups, the German sick funds and health politics, a continuous decision process on standards for outcomes measurement and interpretation could be established. The decision processes based on delphi consensus rounds showed high levels of participations and thus provide a valid and robust set of standards. First results are in the process of approval by the societies. The implementation of the outcomes will then be crucial.

Background

Chronic wounds are challenging medical conditions imposing great burden to the patients, the society and the payers¹. Medical complexity is caused by the large variation in pathogenetic conditions, clinical features and comorbidities². Patients greatly experience marked reductions of quality of life^3,^4,^5,^6,⁷, substantial cumulative life course impairment⁸ and widely unmet needs from treatment⁹. The socio-economic impact of chronic wounds is considerable. Annual average costs per patient are high, reaching 8,500 Euros for venous leg ulcers¹⁰ and about 10,000 Euros for arterial ulcers¹¹ in Germany. Driving factor of the overall costs is the great number of patients with chronic wounds in the society. Based on data from the statutory health insurances, the incidence of chronic wounds in Germany is about 0.1%, the prevalence 0.9%¹². Countrywide, about 900,000 patients with chronic wounds are actively treated. The quality of health care shows large variations. Good quality is predicted by involvement of wound specialists in the treatment process¹³. Finally, achievement of substantial health-related quality of life is a major goal in wound care¹⁴.

Accurate and efficient treatment includes the use of outcomes measures both in clinical care and in research. Health care can further be optimised by using treatment goals over time. Standardised sets of wound documentation and outcomes parameters facilitate wound care in clinical routine. Specific criteria for the interpretation of results and definitions of clinically meaningful outcomes are needed. To date, no such systematic standards have been published and consented in Germany like in most other countries. Instead, there still is a lack of consensus on the documentation and measurement of chronic wounds. Furthermore, no harmonisation on standardised goal setting in wound treatment has occurred.

In order to establish standards for wound outcomes measurement and interpretation, a German national consensus group was started in 2012. This group included representatives from the national medical scientific societies associated with chronic wound care. Moreover, members of regional wound networks, other decision-makers and experts from various professional and institutional fields were invited. The present paper presents the processes and structures of the national consensus group, the quality standards and the prioritised topics of work.

A first comprehensive analysis was conducted by a EWMA task force on wound outcomes¹⁵.

Chronic wound evaluation
Even the trials included in the metaanalysis by Palfreyman et al. ¹⁶ markedly lacked of information and scientific vigour for essentials like blinding, power calculation and comparability of baselines between the comparators. The same findings were reported by Heyer et al. ¹⁷ (Fig. 1). In this more extended metaanalysis, only less than 5% of publications had a satisfying design and reporting of outcomes measures.

Fig. 1: Shortcomings of clinical trials on chronic wounds with regard to parameters of outcomes and baseline included.

Objectives

The project was started 1) in order to establish a national German consensus group for the definition of standards in outcomes measurement and interpretation of chronic wounds, 2) to agree on recommendations for practice and research based on a continuous decision process, including implementation of the standards.

Methods

Initiated by the German centers for health services research in dermatology (CVderm) and in vascular diseases (CVvasc), this national consensus group includes delegates from the German scientific medical societies involved in health care for chronic wounds, the national boards on nursing and the chairs of regional wound networks¹⁸. Moreover, the roof organisations of the German health insurances, the German ministry of health and further single wound experts were invited.

Set-up of the national consensus group

The consensus group was initiated by members of different wound healing societies involved in health services research for chronic wounds in Germany. Coordinated by the German centers for health services research and dermatology (CVderm) and in vascular diseases (CVvasc), the major medical societies involved in health care for wounds were identified and invited for collaboration. Moreover, the German sick fund organisations and the major German wound care networks as well as the German conference for nursing standards were approached. Overall, 28 different parties were invited for the first meeting. At this meeting, a charter and procedural standards for the group process were agreed. The delegates elected the chairpersons and the moderator of the meetings. They also decided on the frequency of meetings and the communication between the decision circles.

Formal decision process

The consensus work is based on a structured decision process coordinated by a trained moderator. All processes are regulated in the charter approved by all delegates. The decision process was initiated with a group discussion in the first face-to-face meeting and formally continued by web-based Delphi rounds. The list of topics and the choice of indications was prepared by the steering group and extended to the working group in the next meeting. Voting was obtained independently from the face-to-face meetings. A final decision was achieved and finalised in the next face-to-face meeting.

Standards of the decision process

The decision process was standardised in the following way (Fig. 2): first, a systematic literature search was conducted in order to identify any previous literature relevant to the topics. The state of the art from literature was presented to the group by selected group members and at first recommendation for the decisions was given.

Results

Consensus on standard and minimum data set

The group identified the definition of minimum and standard data sets as a key task of the consensus. After a systematic literature search and work-up of articles published in the international databases (Pubmed, Medline) the publications available on the data sets were reported to the group and discussed. The selection of the variables considered relevant for the minimum standard data set was then agreed in a web-based Delphi process.

Classification of items

Beside of the minimum and standard item set, a consensus was reached on the definition, classification and thresholds of all items selected. This agreement was also based on repeated Delphi rounds.

Selection of topics

The list of topics and indications to be addressed in the standardisation process was consented based on a three steps Delphi consensus process. With respect to indications, leg ulcers had the highest priority, followed by diabetic foot ulcers and pressure ulcers (Fig. 2).

Fig. 2: Choices for the consensus process.

With respect to the methodological scenarios, a set of standards for use in routine care was highly prioritised, followed by standards for health services research, clinical research and health economics.

Clinical research
In this area, items are to be consented which are valid and visible for the use in clinical research, including controlled trials and patient registries. Furthermore, relevant meaningful differences are needed.

Health services research and selective contracts
The set of parameters was consented for the use of specific questions on health care processes and outcomes related to wound care. In particular, a set of quality indicators related to guidelines is defined.

Heads economic parameters
Wound-related standards are consented for health economic analysis related to cost-of-illness as well as cost-effectiveness studies on a wide range of treatments and care.

Analysis of secondary data
The use of German sick fund data and other sources providing secondary data is reflected and consented in this section.

Fig. 3: Results of the Delphi consensus process on the wound indications.

Fig. 4: Results of the prioritisation of items for the standard data set (excerpt; nominated as necessary by ≥60% of participants).

Current status

In the meantime after seven face-to-face meetings and nine web-based Delphi votes, the whole package for leg ulcers has been consented. Currently, the consensus is reported to the boards of the national medical societies for approval. An implementation will start immediately after final approval.

Discussion

The aim of the current project is a systematic development of standards for the documentation and outcomes measurement in chronic wounds. This consensus meets a gap between clinical practice, clinical research, health care research and health economics for wounds on the one hand and evidence-based outcomes research on the other. Standards and harmonisation will support a better comparability and efficiency in routine car for wounds. It will also raise the quality of research by permitting comparing studies and metaanalyses, which so far were challenged by the heterogeneity of outcomes parameters¹⁷. Like in other fields of wound care, the dissemination of such outcomes instruments and the use of specific implementation tools is crucial¹⁹. The national conference has included this in the decision-making process.

Conclusions

Based on a national joint process involving the medical societies, the nursing groups, the German sick funds and health politics, a continuous decision process on standards for outcomes measurement and interpretation could be established. The decision processes based on delphi consensus rounds showed high levels of participations and thus provide a valid and robust set of standards. First results are in the process of approval by the societies. The implementation of the outcomes will then be crucial.

References

Augustin M, Debus ES (Hrsg.): Moderne Wundversorgung - im Spannungsfeld zwischen Qualitätsanspruch, Zuständigkeiten und Sparzwang. <Modern wound care in the stress field of quality, responsibilities and economics.> Bd. 2. Bonn: Beta Verlag 2011.
European Wound Management Association (EWMA): Position Document: Hard-to-Heal Wounds: a Holistic Approach. London, MEP, 2008.http://ewma.org/fileadmin/user_upload/EWMA/pdf/Position_Documents/2008/English_EWMA_Hard2Heal_2008.pdf
Phillips T, Stanton B, Provan A, Lew R: A study of the impact of leg ulcers on quality of life: financial, social and psychologic implications. J Am Acad Dermatol 1994; 31: 49–53.
Herberger K, Rustenbach SJ, Haartje O, Blome C, Franzke N, Schäfer I, Radtke M, Augustin M: Quality of life and satisfaction of patients with leg ulcers – results of a community-based study. Vasa 2011; 40: 131–138.
Lindholm C, Bjellerup M, Christensen OB, Zederfeldt B: Quality of life in chronic leg ulcer patients. An assessment according to the Nottingham Health Profile. Acta Derm Venereol 1993; 73: 440–443.
Augustin M, Herberger K, Rustenbach SJ, Schäfer I, Zschocke I, Blome C: Quality of life evaluation in wounds: validation of the Freiburg Life Quality Assessment- wound module, a disease-specific instrument. Int Wound J 2010; 7: 493–501.
Blome C, Baade K, Debus ES, Price P, Augustin M: The "Wound-QoL": A Short Questionnaire Measuring Quality of Life in Patients with Chronic Wounds Based on Three Established Disease-Specific Instruments. Wound Repair Regen 2014; 22(4): 504-5014.
Augustin M, Mayer A, Goepel LM, Baade K, Heyer K, Herberger K: Cumulative Life Course Impairment (CLCI): a new concept to characterize persistent patient burden in chronic wounds. Wound Medicine 2013; 1: 2-6.
Augustin M, Blome C, Zschocke I, Schäfer I, Koenig S, Rustenbach SJ, Herberger K: Benefit evaluation in the therapy of chronic wounds from the patients’ perspective-development and validation of a new method. Wound Repair Regen 2012; 20: 8–14.
Purwins S, Herberger K, Debus ES, Rustenbach SJ, Pelzer P, Rabe E, Schafer E, Stadler R, Augustin M: Cost-of-illness of chronic leg ulcers in Germany. Int Wound J 2010; 7: 7–102.
Augustin M, Brocatti LK, Rustenbach SJ, Schaefer I, Herberger K: Cost-of-Illness of Leg Ulcers in the Community. Int Wound J 2014; 11(3): 283-292.
Heyer K, Augustin M: Therapie chronischer Wunden - Schwerpunkt Ulcus cruris, in: Sauer K, Rothgang H, Glaeske G: Barmer GEK Heil- und Hilfsmittelreport 2014 (Schriftenreihe zur Gesundheitsanalyse, Band 28). Berlin: Asgard Verlagsservice GmbH 2014.
Augustin M, Rustenbach SJ, Debus S, Grams L, Muenter KC, Tigges W, Schaefer E, Herberger K: Quality of Care in Chronic Leg Ulcer in the Community: Introduction of Quality Indicators and a Scoring System. Dermatology 2011; 222(4): 321-329.
Augustin M, Langenbruch AK, Herberger K, Baade K, Goepel L, Blome C: Quality of Life Measurement in Chronic Wounds and Inflammatory Skin Diseases: Definitions, Standards and Instruments. Wound Medicine 2014; 5: 29-38.
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. European Wound Management association Patient Outcome Group. J Wound Care 2010; 19: 237–268.
Palfreyman S, Nelson EA, Michaels JA. Dressings for venous leg ulcers: systematic review and meta-analysis. BMJ 2007; 335(7613):244.
Heyer K, Augustin M, Protz K, Herberger K, Spehr C, Rustenbach SJ: Effectiveness of Advanced versus Conventional Wound Dressings on Healing of Chronic Wounds – Systematic Review and Meta-Analysis. Dermatology 2013; 226(2): 172-184.
Goepel L, Herberger K, Debus ES, Diener H, Tigges W, Dissemond J, Gerber V, Augustin M: Wundnetze in Deutschland: Struktur, Funktionen und Ziele 2014 [Wound Networks in Germany: Structure, Functions and Objectives 2014]. Hautarzt 2014; 65(11): 960-966.
Augustin M, Baade K, Herberger K, Protz K, Goepel L, Wild T, Blome C: Use of the Wound-QoL Instrument in Routine Practice: Feasibility, Validity and Development of an Implementation Tool. Wound Medicine 2014; 5: 4-8.