Dataset Information

Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population.

ABSTRACT:

Purpose

Although the pain visual analog scale (VAS-pain) is a ubiquitous patient-reported outcome instrument, it remains unclear how to interpret changes or differences in scores. Therefore, our purpose was to calculate the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population.

Methods

Adult postoperative patients treated by 1 of 5 fellowship-trained orthopedic hand surgeons at a single tertiary academic medical center were identified. Inclusion required VAS-pain scores at baseline (up to 3 months before surgery) and follow-up (up to 4 months after surgery), in addition to a response to a pain-specific anchor question at follow-up. The MCID estimates were calculated with (1) the 1/2 standard deviation method; and (2) an anchor-based approach. The SCB estimates were calculated with (1) an anchor-based approach; and (2) a receiver operator curve method that maximized the sensitivity and specificity for detecting a "much improved" pain status.

Results

There were 667 and 148 total patients included in the MCID and SCB analyses, respectively. The 1/2 standard deviation MCID estimate was 1.6, and the anchor-based estimate was 1.9. The anchor-based SCB estimate was 2.2. The receiver operator curve analysis yielded an SCB estimate of 2.6, with an area under the curve of 0.72, consistent with acceptable discrimination.

Conclusions

We propose MCID values in the range of 1.6 to 1.9 and SCB values in the range of 2.2 to 2.6 for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population.

Clinical relevance

These MCID and SCB estimates may be useful for powering clinical studies and when interpreting VAS-pain score changes or differences reported in the hand surgery literature. These values are to be applied at a population level, and should not be applied to assess the improvement, or lack thereof, for individual patients.

SUBMITTER: Randall DJ

PROVIDER: S-EPMC9271584 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population.

Randall Dustin J DJ Zhang Yue Y Li Haojia H Hubbard James C JC Kazmers Nikolas H NH

The Journal of hand surgery 20220527 7

<h4>Purpose</h4>Although the pain visual analog scale (VAS-pain) is a ubiquitous patient-reported outcome instrument, it remains unclear how to interpret changes or differences in scores. Therefore, our purpose was to calculate the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population.<h4>Methods</h4>Adult postoperative patients treated by 1 of 5 fellowship-trained ortho ...[more]

PMID: 35644742

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Project description:PurposeTo define the minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient-acceptable symptomatic state (PASS) for patient-reported outcome measures (PROMs) after medial patellofemoral ligament reconstruction (MPFLR) and to investigate the role of preoperative, demographic, and intraoperative variables for predicting achievement of these thresholds.MethodsThis retrospective cohort study used a prospectively maintained database of patients undergoing primary MPFLR between August 2015 and December 2019. PROMs included the International Knee Documentation Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS joint replacement (JR), and Kujala. Anchor-based and distribution-based methods were used to calculate the MCID, SCB, and PASS. Regression analyses were performed to identify prognosticators for achievement of clinically significant thresholds.Results139 patients met inclusion criteria (mean age: 21.7± 8.2 years). At 6 months, the MCID values were 8.3 (KOOS-Pain) and 8.5/13.5 (Kujala); SCB values were 1.4 (KOOS-Pain) and 43.7 (KOOS-QOL); and PASS values were 64.9 (IKDC), 83.3 (KOOS-Symptom), 76.8 (KOOS-Pain), 91.2 (KOOS-ADL), 47.5 (KOOS-Sport), 40.6 (KOOS-QOL), and 78.1 (KOOS-JR). At 1 year, the MCID values were 4.2 (KOOS-Pain), 7.2 (KOOS-ADL), 12.4 (KOOS-QOL) and 25.2 (KOOS-JR); SCB were 23.6 (IKDC), 4.2 (KOOS-Symptom), 19.7 (KOOS-Pain), 6.5 (KOOS-ADL), 55.0 (KOOS-Sport), 6.3 (KOOS-QOL), and 19.6/25.2 (KOOS-JR); and PASS were 65.5 (IKDC), 80.4 (KOOS-Symptom), 84.7 (KOOS-Pain), 99.3 (KOOS-ADL), 57.5 (KOOS-Sport), 53.1 (KOOS-QOL), and 76.3 (KOOS-JR). In regression analysis, greater age, body mass index, and preoperative PROMs were negative prognosticators for achieving clinically significant thresholds. Conversely, male gender increased the likelihood of achieving PASS for Kujala at 6 months and KOOS-ADL at 1 year.ConclusionsThis study established thresholds for the MCID, SCB, and PASS at 6 months and 1 year after MPFLR, providing physicians an evidence-based method to advise patients and assess outcomes with this surgery. Older patients and those with higher preoperative outcome scores are less likely to report improvement and satisfaction with MPFLR, while male patients are more likely to report some satisfaction.Level of evidenceLevel III, retrospective cohort study (diagnosis).

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.

Dataset Information

Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population.

Purpose

Methods

Results

Conclusions

Clinical relevance

Publications

Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population.

Similar Datasets

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