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

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.