Evaluation of patient-relevant outcomes of lymphedema and lipedema treatment: development and validation of a new benefit tool

TY - JOUR

T1 - Evaluation of patient-relevant outcomes of lymphedema and lipedema treatment: development and validation of a new benefit tool

AU - Blome, C

AU - Augustin, M

AU - Heyer, K

AU - Knöfel, J

AU - Cornelsen, H

AU - Purwins, S

AU - Herberger, K

N1 - Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Cost of Illness

KW - Cross-Sectional Studies

KW - Europe

KW - Factor Analysis, Statistical

KW - Female

KW - Humans

KW - Lymphedema

KW - Male

KW - Middle Aged

KW - Predictive Value of Tests

KW - Quality of Life

KW - Questionnaires

KW - Reproducibility of Results

KW - Severity of Illness Index

KW - Translating

KW - Treatment Outcome

KW - United States

KW - Young Adult

U2 - 10.1016/j.ejvs.2013.10.009

DO - 10.1016/j.ejvs.2013.10.009

M3 - SCORING: Journal article

C2 - 24239143

VL - 47

SP - 100

EP - 107

JO - EUR J VASC ENDOVASC

JF - EUR J VASC ENDOVASC

SN - 1078-5884

IS - 1

ER -