Evaluation of Patient-Relevant Outcomes of Lymphedema and Lipedema Treatment: Development and Validation of a New Benefit Tool
Blome C, Augustin M, Heyer K, Knfel J, Cornelsen H, Purwins S, Herberger K; 2014
Synopsis: This study describes the development of the Patient Benefit Index, a methodology that measures the patient-relevant benefit in the treatment of lymphedema and lipedema. The instrument can be used in both clinical practice and clinical studies to determine patient needs and treatment outcomes.
Abstract: OBJECTIVES: Patient-relevant treatment benefit is traditionally measured with health-related quality of life (HRQoL) instruments. The Patient Benefit Index (PBI) methodology allows for a more direct measurement, with the patients rating both importance and achievement of treatment goals. Here, we developed and validated a PBI version specific for the assessment of benefit in lymphedema and lipedema treatment (PBI-L).
METHODS: The development included five steps: (1) open item collection; (2) consensus of items in a multidisciplinary expert panel; (3) application of the German PBI-L in a cross-sectional study (n = 301); (4) translation into English; (5) application of the English PBI-L in a randomized clinical trial (n = 82). Subscales were developed using factor analysis. Construct validity was analyzed by correlating PBI-L and convergent criteria such as HRQoL and quality of care. To test for responsiveness, the association to change in HRQoL measures was computed.
RESULTS: Floor and ceiling effects were low. There were few missing values. Two well-interpretable subscales were found with Cronbach’s alpha >0.8 each. Global and subscale scores correlated with convergent criteria and with change in disease-specific HRQoL, but not with change in generic HRQoL.
CONCLUSIONS: The PBI-L is an internally consistent, valid, and responsive instrument for the assessment of patient-relevant benefit of edema treatment.
APA Citation: Blome, C., Augustin, M., Heyer, K., Knfel, J., Cornelsen, H., Purwins, S., & Herberger, K. (2014). Evaluation of Patient-relevant Outcomes of Lymphedema and Lipedema Treatment: Development and Validation of a New Benefit Tool. European Journal Of Vascular And Endovascular Surgery, 47(1), 100-107. http://dx.doi.org/10.1016/j.ejvs.2013.10.009
AMA Citation: Blome C, Augustin M, Heyer K et al. Evaluation of Patient-relevant Outcomes of Lymphedema and Lipedema Treatment: Development and Validation of a New Benefit Tool. European Journal of Vascular and Endovascular Surgery. 2014;47(1):100-107. doi:10.1016/j.ejvs.2013.10.009.