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Estimating Change in Tremor Amplitude Using Clinical Ratings: Recommendations for Clinical Trials.

ABSTRACT: Tremor rating scales are the standard method for assessing tremor severity and clinical change due to treatment or disease progression. However, ratings and their changes are difficult to interpret without knowing the relationship between ratings and tremor amplitude (displacement or angular rotation), and the computation of percentage change in ratings relative to baseline is misleading because of the ordinal nature of these scales. For example, a reduction in tremor from rating 2 to rating 1 (0-4 scale) should not be interpreted as a 50% reduction in tremor amplitude, nor should a reduction in rating 4 to rating 3 be interpreted as a 25% reduction in tremor. Studies from several laboratories have found a logarithmic relationship between tremor ratings R and tremor amplitude T, measured with a motion transducer: logT ?=? ?·R + ?, where ? ? 0.5, ? ? -2, and log is base 10. This relationship is consistent with the Weber-Fechner law of psychophysics, and from this equation, the fractional change in tremor amplitude for a given change in clinical ratings is derived: (Tf-Ti)/Ti=10?(Rf-(Ri)-1, where the subscripts i and f refer to the initial and final values. For a 0-4 scale and ? ?=? 0.5, a 1-point reduction in tremor ratings is roughly a 68% reduction in tremor amplitude, regardless of the baseline tremor rating (e.g., 2 or 4). Similarly, a 2-point reduction is roughly a 90% reduction in tremor amplitude. These Weber-Fechner equations should be used in clinical trials for computing and interpreting change in tremor, assessed with clinical ratings.

SUBMITTER: Elble RJ

PROVIDER: S-EPMC6802602 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Estimating Change in Tremor Amplitude Using Clinical Ratings: Recommendations for Clinical Trials.

Elble Rodger J RJ

Tremor and other hyperkinetic movements (New York, N.Y.) 20181011

Tremor rating scales are the standard method for assessing tremor severity and clinical change due to treatment or disease progression. However, ratings and their changes are difficult to interpret without knowing the relationship between ratings and tremor amplitude (displacement or angular rotation), and the computation of percentage change in ratings relative to baseline is misleading because of the ordinal nature of these scales. For example, a reduction in tremor from rating 2 to rating 1 ( ...[more]

PMID: 31637097

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Project description:OBJECTIVE:To demonstrate challenges in the estimation of change in quality of life (QOL). METHODS:Data were taken from a completed clinical trial with negative results. Responses to 13 QOL items were obtained 12 months apart from 258 persons with Alzheimer's disease (AD) participating in a randomized, placebo-controlled clinical trial with two treatment arms. Two analyses to estimate whether "change" in QOL occurred over 12 months are described. A simple difference (later - earlier) was calculated from total scores (standard approach). A Qualified Change algorithm (novel approach) was applied to each item: differences in ratings were classified as either: improved, worsened, stayed poor, or stayed "positive" (fair, good, excellent). The strengths of evidence supporting a claim that "QOL changed", derived from the two analyses, were compared by considering plausible alternative explanations for, and interpretations of, results obtained under each approach. RESULTS:Total score approach: QOL total scores decreased, on average, in the two treatment (both -1.0, p < 0.05), but not the placebo (=-0.59, p > 0.3) groups. Qualified change approach: Roughly 60% of all change in QOL items was worsening in every arm; 17% - 42% of all subjects experienced change in each item. CONCLUSIONS:Totalling the subjective QOL item ratings collapses over items, and suggests a potentially misleading "overall" level of change (or no change, as in the placebo arm). Leaving the items as individual components of "quality" of life they were intended to capture, and qualifying the direction and amount of change in each, suggests that at least 17% of any group experienced change on every item, with 60% of all observed change being worsening. DISCUSSION:Summarizing QOL item ratings as a total "score" collapses over the face-valid, multi-dimensional components of the construct "quality of life". Qualified Change provides robust evidence of changes to QOL or "enhancements of" life quality.

Project description:BackgroundWe have previously reported a simple correction method for estimating pleural pressure (Ppl) using central venous pressure (CVP). However, it remains unclear whether this method is applicable to patients with varying levels of intravascular volumes and/or chest wall compliance. This study aimed to investigate the accuracy of our method under different conditions of intravascular volume and chest wall compliance.ResultsTen anesthetized and paralyzed pigs (43.2 ± 1.8 kg) were mechanically ventilated and subjected to lung injury by saline lung lavage. Each pig was subjected to three different intravascular volumes and two different intraabdominal pressures. For each condition, the changes in the esophageal pressure (ΔPes) and the estimated ΔPpl using ΔCVP (cΔCVP-derived ΔPpl) were compared to the directly measured change in pleural pressure (Δd-Ppl), which was the gold standard estimate in this study. The cΔCVP-derived ΔPpl was calculated as κ × ΔCVP, where "κ" was the ratio of the change in airway pressure to the change in CVP during the occlusion test. The means and standard deviations of the Δd-Ppl, ΔPes, and cΔCVP-derived ΔPpl for all pigs under all conditions were 7.6 ± 4.5, 7.2 ± 3.6, and 8.0 ± 4.8 cmH2O, respectively. The repeated measures correlations showed that both the ΔPes and cΔCVP-derived ΔPpl showed a strong correlation with the Δd-Ppl (ΔPes: r = 0.95, p < 0.0001; cΔCVP-derived ΔPpl: r = 0.97, p < 0.0001, respectively). In the Bland-Altman analysis to test the performance of the cΔCVP-derived ΔPpl to predict the Δd-Ppl, the ΔPes and cΔCVP-derived ΔPpl showed almost the same bias and precision (ΔPes: 0.5 and 1.7 cmH2O; cΔCVP-derived ΔPpl: - 0.3 and 1.9 cmH2O, respectively). No significant difference was found in the bias and precision depending on the intravascular volume and intraabdominal pressure in both comparisons between the ΔPes and Δd-Ppl, and cΔCVP-derived ΔPpl and Δd-Ppl.ConclusionsThe CVP method can estimate the ΔPpl with reasonable accuracy, similar to Pes measurement. The accuracy was not affected by the intravascular volume or chest wall compliance.

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Estimating Change in Tremor Amplitude Using Clinical Ratings: Recommendations for Clinical Trials.

Publications

Estimating Change in Tremor Amplitude Using Clinical Ratings: Recommendations for Clinical Trials.

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