Benefit evaluation in the therapy of chronic wounds from the patients' perspective--development and validation of a new method

Wound Repair Regen. 2012 Jan-Feb;20(1):8-14. doi: 10.1111/j.1524-475X.2011.00751.x. Epub 2011 Dec 8.


Assessing therapeutic benefit of any drug and medical device is essential in registration and cost reimbursement decisions in Germany and in many nations. In this study, a method for the assessment of patient-relevant benefits in wound therapy was developed and validated. A total of 83 items on treatment benefit from the patients' perspective were collected in an open survey, including n = 50 patients with chronic wounds. The item pool was compiled to a list of 22 items by an interdisciplinary panel of experts including patients. The item list is presented prior to therapy to assess patient-relevant treatment needs and during or after therapy to establish if benefits have been attained. A weighed patient benefit index (PBI) is calculated from the items of both questionnaires. The instrument was examined for practical feasibility, reliability, and validity in a prospective study involving n = 172 patients with acute or chronic wounds treated by vacuum-assisted therapy. Validation criteria were: change in generic and disease-specific quality of life; judgment of efficacy by patients and physicians; treatment satisfaction; patients' willingness to recommend the therapy to others. Construct validity was given for all criteria applied. Cronbach's alpha was 0.88. The instrument was well-accepted by patients and rated relevant for the assessment of benefit in wound treatment.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Chronic Disease / psychology
  • Chronic Disease / therapy
  • Feasibility Studies
  • Female
  • Germany / epidemiology
  • Humans
  • Male
  • Outcome Assessment, Health Care / statistics & numerical data*
  • Patient Satisfaction / statistics & numerical data*
  • Prospective Studies
  • Psychometrics
  • Quality of Life
  • Reproducibility of Results
  • Surveys and Questionnaires*
  • Wounds and Injuries / epidemiology
  • Wounds and Injuries / psychology
  • Wounds and Injuries / therapy*