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Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study.

ABSTRACT: BACKGROUND:The Edmonton Symptom Assessment Scale (ESAS) is widely used for symptom assessment in clinical and research settings. A sensitivity-specificity approach was used to identify the minimal clinically important difference (MCID) for improvement and deterioration for each of the 10 ESAS symptoms. METHODS:This multicenter, prospective, longitudinal study enrolled patients with advanced cancer. ESAS was measured at the first clinic visit and at a second visit 3 weeks later. For each symptom, the Patient's Global Impression ("better," "about the same," or "worse") was assessed at the second visit as the external criterion, and the MCID was determined on the basis of the optimal cutoff in the receiver operating characteristic (ROC) curve. A sensitivity analysis was conducted through the estimation of MCIDs with other approaches. RESULTS:For the 796 participants, the median duration between the 2 study visits was 21 days (interquartile range, 18-28 days). The area under the ROC curve varied from 0.70 to 0.87, and this suggested good responsiveness. For all 10 symptoms, the optimal cutoff was ?1 point for improvement and ?-1 point for deterioration, with sensitivities of 59% to 85% and specificities of 69% to 85%. With other approaches, the MCIDs varied from 0.8 to 2.2 for improvement and from -0.8 to -2.3 for deterioration in the within-patient analysis, from 1.2 to 1.6 with the one-half standard deviation approach, and from 1.3 to 1.7 with the standard error of measurement approach. CONCLUSIONS:ESAS was responsive to change. The optimal cutoffs were ?1 point for improvement and ?-1 point for deterioration for each of the 10 symptoms. Our findings have implications for sample size calculations and response determination.

SUBMITTER: Hui D

PROVIDER: S-EPMC4595042 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study.

Hui David D Shamieh Omar O Paiva Carlos Eduardo CE Perez-Cruz Pedro Emilio PE Kwon Jung Hye JH Muckaden Mary Ann MA Park Minjeong M Yennu Sriram S Kang Jung Hun JH Bruera Eduardo E

Cancer 20150608 17

<h4>Background</h4>The Edmonton Symptom Assessment Scale (ESAS) is widely used for symptom assessment in clinical and research settings. A sensitivity-specificity approach was used to identify the minimal clinically important difference (MCID) for improvement and deterioration for each of the 10 ESAS symptoms.<h4>Methods</h4>This multicenter, prospective, longitudinal study enrolled patients with advanced cancer. ESAS was measured at the first clinic visit and at a second visit 3 weeks later. Fo ...[more]

PMID: 26059846

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Project description:BackgroundA minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7).ObjectivesTo estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method.MethodsData were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: "low dose," which includes 40 or 50 mg/day; and "high dose," which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved).ResultsThe least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2).ConclusionsResults from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Project description:Autism Spectrum Disorder (ASD) is associated with persistent impairments in adaptive abilities across multiple domains. These social, personal, and communicative impairments become increasingly pronounced with development, and are present regardless of IQ. The Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) is the most commonly used instrument for quantifying these impairments, but minimal clinically important differences (MCIDs) on Vineland-II scores have not been rigorously established in ASD. We pooled data from several consortia/registries (EU-AIMS LEAP study, ABIDE-I, ABIDE-II, INFOR, Simons Simplex Collection and Autism Treatment Network [ATN]) and clinical investigations and trials (Stanford, Yale, Roche) resulting in a data set of over 9,000 individuals with ASD. Two approaches were used to estimate MCIDs: distribution-based methods and anchor-based methods. Distribution-based MCID [d-MCID] estimates included the standard error of the measurement, as well as one-fifth and one-half of the covariate-adjusted standard deviation (both cross-sectionally and longitudinally). Anchor-based MCID [a-MCID] estimates include the slope of linear regression of clinician ratings of severity on the Vineland-II score, the slope of linear regression of clinician ratings of longitudinal improvement category on Vineland-II change, the Vineland-II change score maximally differentiating clinical impressions of minimal versus no improvement, and equipercentile equating. Across strata, the Vineland-II Adaptive Behavior Composite standardized score MCID estimates range from 2.01 to 3.2 for distribution-based methods, and from 2.42 to 3.75 for sample-size-weighted anchor-based methods. Lower Vineland-II standardized score MCID estimates were observed for younger and more cognitively impaired populations. These MCID estimates enable users of Vineland-II to assess both the statistical and clinical significance of any observed change. Autism Res 2018, 11: 270-283. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.Lay summaryThe Vineland Adaptive Behavior Scales (2nd edition; Vineland-II) is the most widely used scale for assessing day-to-day "adaptive" skills. Yet, it is unknown how much Vineland-II scores must change for those changes to be regarded as clinically significant. We pooled data from over 9,000 individuals with ASD to show that changes of 2-3.75 points on the Vineland-II Composite score represent the "minimal clinically-important difference." These estimates will help evaluate the benefits of potential new treatments for ASD.

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Dataset Information

Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study.

Publications

Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study.

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