F A Frans1, P T Nieuwkerk2, R Met3, S Bipat4, D A Legemate3, J A Reekers4, M J W Koelemay3. 1. Department of Vascular Surgery, Academic Medical Center, Amsterdam, The Netherlands; Department of Radiology, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: francelinefrans@gmail.com. 2. Department of Medical Psychology, Academic Medical Center, Amsterdam, The Netherlands. 3. Department of Vascular Surgery, Academic Medical Center, Amsterdam, The Netherlands. 4. Department of Radiology, Academic Medical Center, Amsterdam, The Netherlands.
Abstract
OBJECTIVE: Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI). METHODS: The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method. RESULTS: A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit. CONCLUSIONS: Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance.
OBJECTIVE: Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI). METHODS: The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method. RESULTS: A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit. CONCLUSIONS: Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance.
Authors: Maria A Lopez-Olivo; Aparna Ingleshwar; Robert J Volk; Maria Jibaja-Weiss; Andrea Barbo; Kenneth Saag; Amye Leong; Maria E Suarez-Almazor Journal: Arthritis Care Res (Hoboken) Date: 2017-12-29 Impact factor: 4.794
Authors: Hafizur Rahman; Iraklis I Pipinos; Jason M Johanning; George Casale; Mark A Williams; Jonathan R Thompson; Yohanis O'Neill-Castro; Sara A Myers Journal: J Vasc Surg Date: 2021-05-31 Impact factor: 4.268
Authors: Philip Goodney; Samir Shah; Yiyuan David Hu; Bjoern Suckow; Scott Kinlay; David G Armstrong; Patrick Geraghty; Megan Patterson; Matthew Menard; Manesh R Patel; Michael S Conte Journal: J Vasc Surg Date: 2022-01-24 Impact factor: 4.860
Authors: Ichiro Okano; Courtney Ortiz Miller; Stephan N Salzmann; Yushi Hoshino; Jennifer Shue; Andrew A Sama; Frank P Cammisa; Federico P Girardi; Alexander P Hughes Journal: Clin Orthop Relat Res Date: 2020-10 Impact factor: 4.755