Phlebologie 2017; 46(06): 334-339
DOI: 10.12687/phleb2382-6-2017
Original article
Schattauer GmbH

Quality of life assessment and use of patient-reported outcomes in practice

Erfassung von Lebensqualität und Verwendung patientenberichteter Endpunkte in der Praxis
R. Sommer
1   German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
,
M. Augustin
1   German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
,
C. Blome
1   German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
› Author Affiliations
Further Information

Publication History

Received: 14 June 2017

Accepted: 14 August 2017

Publication Date:
10 January 2018 (online)

Summary

Background: Patient-reported outcomes (PROs) are essential components of wound and vascular diagnostics and management. Aim: To provide an overview of PROs as diagnostic tools in the management of chronic wounds.

Methods: Review of different concepts on inclusion of PROs in wound practice from literature.

Results: PROs are indispensable sources of information for the understanding of the biopsycho- social context of wound diseases. Essential dimensions to be recorded are pain, health-related quality of life and patient benefit. Psychological parameters, adherence, treatment goals and treatment benefits are often needed. Further fields of interest include cumulative life course impairment, coping with disease, stigmatisation specifically applied according to clinical questions.

Conclusion: Patient-reported outcomes are mandatory for the diagnostic work-up of chronic wounds. They also provide essential information in the course of a disease, can be diagnostic clues for non-adherence and treatment failures. Measurement of many PRO parameters in wound disease, such as health-related quality of life and pain, is facilitated by validated instruments, which are recommended for practice.

Zusammenfassung

Hintergrund: Die Erfassung patientenberichteter Endpunkte (PROs) ist essenzieller Bestandteil in der Diagnostik sowie dem Management chronischer Wunden.

Ziel: Es wird eine Übersicht von Messinstrumenten für patientenberichtete Endpunkte für die Diagnostik und Versorgung von Patienten mit chronischen Wunden dargestellt.

Methoden: Literatur zu verschiedenen Konzepten und dem Einschluss von PROs in der Praxis der Praxis der Versorgung chronischer Wunden wurde gesichtet.

Ergebnisse: Patientenberichtete Endpunkte liefern unverzichtbare Informationen für das Verständnis des bio-psycho-sozialen Kontextes von Patienten mit Wunderkrankungen. Wichtige Dimensionen sind Schmerzen, gesundheitsbezogene Lebensqualität (HRQoL) und Patientennutzen. Auch psychologische Parameter, Adhärenz, Behandlungsziele und Behandlungsnutzen werden häufig benötigt. Ein weiterer wichtiger Bereich sind kumulative Beeinträchtigungen im Verlauf des Lebens, Bewältigungsstrategien, Stigmatisierung sowie – je nach Fragestellung – weitere psychosoziale Parameter.

Schlussfolgerung: Die Erfassung von PROs in der Diagnostik chronischer Wunden ist dringend notwendig. PROs liefern darüber hinaus wichtige Informationen im Krankheitsverlauf, können Hinweise auf Behandlungsmisserfolge geben und spiegeln die Patientenorientierung während der Behandlung wieder. Die Erfassung vieler PROs bei Wunderkrankungen, wie HRQoL und Schmerzen, wird durch validierte Instrumente, deren Einsatz empfohlen wird, unterstützt.

 
  • References

  • 1 Deutsche Gesellschaft für Phlebologie (DGP).. Leitlinie zur Diagnostik und Therapie des Ulcus cruris venosum*. ICD10:I83.0 (ohne Entzündung) und I83.2 (mit Entzündung). Phlebologie 2004; 33: 166-185.
  • 2 European Wound Management Association (EWMA).. tPosition Document: Hard-to-heal wounds: a holistic approach. London: MEP Ltd; 2008. Available at: http://www.woundsinter national.com/media/issues/83/files/content_45. pdf (last accessed 06 June 2017).
  • 3 Stücker M, Pljakic A, Dörler M. Diagnostik des Ulcus cruris venosum. Phlebologie 2016; 45: 85-90.
  • 4 Food and Drug Administration (FDA). Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009 Available at: https://www. fda.gov/downloads/drugs/guidances/ucm193282. pdf (last accessed 06 June 2017).
  • 5 Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S. et al. cPatient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007; 10 (Suppl. 02) S125-137.
  • 6 Augustin M, Rustenbach SJ, Debus S, Grams L, Muenter KC, Tigges W. et al. Quality of care in chronic leg ulcer in the community: introduction of quality indicators and a scoring system. Dermatology 2011; 222: 321-329.
  • 7 Augustin M, Mayer A, Heyer K, Storck M, Debus ES. Stärke durch Standards: Bundeskonferenz zur Ergebnismessung und Nutzenbewertung bei chronischen Wunden. Phlebologie 2016; 45: 81-84.
  • 8 Kimball AB, Gieler U, Linder D, Sampogna F, Warren RB, Augustin M. Psoriasis: is the impairment to a patient’s life cumulative?. J Eur Acad Dermatol Venereol 2010; 24: 989-1004.
  • 9 Linder MD, Kimball AB. Dermatological diseases and cumulative life course impairment. An interdisciplinary and innovative approach to the impact of skin diseases on patients’ lives. Basel: Karger Publisher; 2013
  • 10 Herberger K, Blome C, Sandner A, Altheide F, Heyer K, Münter KC. et al. Quality of care of patients with chronic lymphoedema in Germany. Dermatology 2013; 226: 238-246.
  • 11 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; 01: 2-6.
  • 12 Price P, Harding K. The impact of foot complications on health-related quality of life in patients with diabetes. J Cutan Med Surg 2000; 04: 45-50.
  • 13 Ragnarson GTennvall, Apelqvist J. Health-related quality of life in patients with diabetes mellitus and foot ulcers. J Diabetes Complications 2000; 14: 235-241.
  • 14 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; 07: 493-501.
  • 15 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; 05: 29-38.
  • 16 Augustin M, Langenbruch AK, Gutknecht M, Radtke MA, Blome C. Quality of life measures for dermatology: definition. evaluation, and interpretation. Curr Derm Rep 2012; 01: 148-159.
  • 17 Prinsen CA, de Korte J, Augustin M, Sampogna F, Salek SS, Basra MK. et al. Measurement of healthrelated quality of life in dermatological research and practice: outcome of the EADV Taskforce on quality of life. J Eur Acad Dermatol Venereol 2013; 27: 1195-1203.
  • 18 Lange S, Zschocke I, Seidenglanz K, Schiffler A, Zöllinger A, Amon U. et al. Predictors of the quality of life in patient with atopic dermatitis. Dermatol Psychosom 2000; 01: 66-70.
  • 19 Blome C, Simianer S, Purwins S, Laass A, Rustenbach SJ, Schäfer I. et al. Time needed for treatment is the major predictor of quality of life in chronic wounds. Dermatology 2010; 221: 154-159.
  • 20 Zschocke I, Bross F, Maier K, Vanscheidt W, Augustin M. Quality of life in different stages of chronic venous insufficiency and leg ulcer. Dermatol Psychosom 2002; 03: 126-131.
  • 21 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.
  • 22 Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V. (AWMF).. Leitlinie “Chronischer Schmerz”. Registernummer 053–036. Available at: http://www.awmf.org/ leitlinien/detail/ll/053–036.html (last accessed 06 June 2017).
  • 23 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: 504-514.
  • 24 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; 07: 493-501.
  • 25 Acquadro C, Price P, Wollina U. Linguistic validation of the Cardiff Wound Impact Schedule into French. German and US English. J Wound Care 2005; 14: 14-17.
  • 26 Spech E, Faller H, Franke A, Thiede A, Debus ES. Der Würzburger Wundscore (WWS): Ein neuer Lebensqualitätsfragebogen. Zeitschrift für Wundheilung 2003; 08: 40-42.
  • 27 Bland JM, Dumville JC, Ashby RL, Gabe R, Stubbs N, Adderley U. et al. Validation of the VEINESQOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial. BMC Cardiovasc Disord 2015; 15: 85.
  • 28 Augustin M, Dieterle W, Zschocke I, Brill C, Trefzer D, Peschen M. et al. Development and validation of a disease-specific questionnaire on the quality of life of patients with chronic venous insufficiency. VASA 1997; 26: 291-301.
  • 29 Augustin M, Debus SE, Bruning G, Faubel R, Lohrberg D, Goepel L. et al. Development and validation of a short version of the Freiburg Life Quality Assessment for chronic venous disease (FLQA-vs-10). Wound Medicine 2015; 08: 31-35.
  • 30 Augustin M, Blome C, Zschocke I, Schäfer I, Koenig S, Rustenbach SJ. et al. 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.
  • 31 Engelhardt M, Spech E, Diener H, Faller H, Augustin M, Debus ES. Validation of the disease-specific quality of life Wuerzburg Wound Score in patients with chronic leg ulcer. VASA 2014; 43: 372-379.