title: Benefit evaluation in the therapy of chronic wounds from the patients' perspective--development and validation of a new method.
abstract: 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.
authors.affiliation: CVdrem-German Center for Health Services Research in Dermatology, Institute for Health Services Research in Dermatology and Nursing, University Clinics of Hamburg, Hamburg, Germany. m.augustin@derma.de
authors.forename: Matthias
authors.initials: M
authors.lastname: Augustin
authors.forename: Christine
authors.initials: C
authors.lastname: Blome
authors.forename: Ina
authors.initials: I
authors.lastname: Zschocke
authors.forename: Ines
authors.initials: I
authors.lastname: Schäfer
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koenig
authors.forename: Stephan J
authors.initials: SJ
authors.lastname: Rustenbach
authors.forename: Katharina
authors.initials: K
authors.lastname: Herberger
mesh_terms: D002908:Chronic Disease / Q000523:psychology / Q000628:therapy; D005240:Feasibility Studies; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D014947:Wounds and Injuries / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*