Gunn Heather J, Zaniletti Isabella, Breen William G, Leavitt Todd, Bogan Aaron, Mahajan Anita, Brown Paul D, Yan Elizabeth, Vora Sujay A, Merrell Kenneth W, Ashman Jonathan B, Peterson Jennifer L, Leenstra James L, Wilson Zachary C, Laughlin Brady S, Laack Nadia N, DeWees Todd A
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA.
IZ Statistics LLC, Tampa, Florida, USA.
Neurooncol Pract. 2024 Apr 27;11(5):633-639. doi: 10.1093/nop/npae034. eCollection 2024 Oct.
Minimal clinically important differences (MCIDs) quantify the clinical relevance of quality of life results at the individual patient and group level. The aim of this study was to estimate the MCID for the Brief Fatigue Inventory (BFI) and the Worst and Usual Fatigue items in patients with brain or CNS cancer undergoing curative radiotherapy.
Data from a multi-site prospective registry was used. The MCID was calculated using distribution-based and anchor-based approaches. For the anchor-based approach, the fatigue item from the PROMIS-10 served as the anchor to determine if a patient improved, deteriorated, or had no change from baseline to end of treatment (EOT). We compared the unadjusted means on the BFI for the 3 groups to calculate the MCID. For the distribution-based approaches, we calculated the MCID as 0.5 SD of the scores and as 1.96 times the standard error of measurement.
Three-hundred and fifty nine patients with brain or CNS tumors undergoing curative radiotherapy filled out the 9-item BFI at baseline and EOT. The MCID for the BFI was 1.33 (ranging from 0.99 to 1.70 across the approaches), 1.51 (ranging from 1.16 to 2.02) and 1.76 (ranging from 1.38 to 2.14) for the usual and worst fatigue items, respectively.
This study provides the MCID ranges for the BFI and Worst and Usual fatigue items, which will allow clinically meaningful conclusions to be drawn from BFI scores. These results can be used to select optimal treatments for patients with brain or CNS cancer or to interpret BFI scores from clinical trials.
最小临床重要差异（MCID）可在个体患者和群体层面量化生活质量结果的临床相关性。本研究的目的是估计接受根治性放疗的脑癌或中枢神经系统（CNS）癌患者的简明疲劳量表（BFI）以及最严重和通常疲劳项目的MCID。
使用来自多中心前瞻性登记处的数据。MCID采用基于分布和基于锚定的方法计算。对于基于锚定的方法，PROMIS-10中的疲劳项目作为锚定来确定患者从基线到治疗结束（EOT）是改善、恶化还是无变化。我们比较了三组患者在BFI上的未调整均值以计算MCID。对于基于分布的方法，我们将MCID计算为得分的0.5个标准差以及测量标准误的1.96倍。
359例接受根治性放疗的脑或CNS肿瘤患者在基线和EOT时填写了9项BFI。BFI的MCID为1.33（各方法范围为0.99至1.70），最严重和通常疲劳项目的MCID分别为1.51（范围为1.16至2.02）和1.76（范围为1.38至2.14）。
本研究提供了BFI以及最严重和通常疲劳项目的MCID范围，这将有助于从BFI评分中得出具有临床意义的结论。这些结果可用于为脑癌或CNS癌患者选择最佳治疗方案或解释临床试验中的BFI评分。
