The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies

Angst, Felix; Aeschlimann, André; Angst, Jules

doi:10.1016/j.jclinepi.2016.11.016

Cited by 212 publications

(244 citation statements)

References 28 publications

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“…3,13,14 However, to interpret the magnitude of the results achieved with PR on symptoms relief, it is important to understand the minimal clinically important differences (MCIDs) of patient-reported outcome measures (PROMs), ie, the smallest change in a measure score that is subjectively perceived as relevant to the patient. [15][16][17] Having MCIDs for symptoms-related PROMs will: aid to guide interventions; 18,19 enhance judgement about the clinical relevance and magnitude of the PR effect 15 allow samples size calculations; and contribute for defining expected endpoints in clinical trials. 16,20,21 Thus, establishing MCIDs is of paramount importance for several stakeholders, from health professionals and researchers to guideline developers and policymakers.…”

Section: Introductionmentioning

confidence: 99%

<p>Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Cough and Sputum in Patients with COPD</p>

Rebelo¹,

Oliveira²,

Paixão³

et al. 2020

COPD

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Section: Introductionmentioning

confidence: 99%

<p>Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Cough and Sputum in Patients with COPD</p>

Rebelo¹,

Oliveira²,

Paixão³

et al. 2020

COPD

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“…The patients were grouped according to the anchor, the skin condition change score. The difference in mean change scores for the patients who did not experience any change and those who felt better was used as an estimate for the MIC . A score change in the CADIS total score of 14·37 towards improvement was estimated as the MIC.…”

Section: Resultsmentioning

confidence: 99%

“…For the domain ‘family and social function’ the MIC was not calculated as the correlation with the anchor was not strong enough. The mean change method used, according to Redelmeier and Lorig, is one of the most commonly found in the literature …”

Section: Resultsmentioning

confidence: 99%

“…The difference in mean change scores for the patients who did not experience any change and those who felt better was used as an estimate for the MIC. 20,21 A score change in the CADIS total score of 14Á37 towards improvement was estimated as the MIC. The MIC for the domain 'symptoms' was 5Á11, for the domain 'activity limitations and behaviour' 2Á24, for the domain 'sleep' 1Á13 and for the domain 'emotions' 4Á18.…”

Section: Anchor-based Approachmentioning

confidence: 99%

“…The mean change method used, according to Redelmeier and Lorig, 22 is one of the most commonly found in the literature. 21…”

Section: Anchor-based Approachmentioning

confidence: 99%

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Evaluation of responsiveness and estimation of smallest detectable change and minimal important change scores for the Childhood Atopic Dermatitis Impact Scale

et al. 2019

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Summary Background The Childhood Atopic Dermatitis Impact Scale (CADIS) is an instrument to measure quality of life in young children affected by atopic dermatitis, and their parents. Objectives To evaluate the responsiveness (sensitivity to change), smallest detectable change (SDC) and minimal important change (MIC) of the CADIS. Methods Parents and primary caregivers of 300 young children completed the CADIS and a global rating of their child's skin condition at baseline and a 4‐week follow‐up. Kruskal–Wallis tests, Wilcoxon tests and effect sizes were used to assess responsiveness. The SDC can be seen as a change beyond measurement error. Anchor‐based and distribution‐based methods, and an integration of both methods were used to estimate the MIC. Results In total, 270 families provided data at baseline and 228 at follow‐up. The CADIS total change score and most of the domain scores had moderate‐to‐strong correlations with the skin change score. Patients were grouped according to the skin change score, which served as an anchor. Children whose parents noted an improvement of the skin showed lower CADIS scores at follow‐up (P < 0·001). For the SDC we obtained score changes of 1·34 points on the total score and < 1·0 points on each domain score. All detected MIC values passed the SDC cut‐off. Conclusions The CADIS is sensitive to change towards improvement of quality of life. A change > 12% on the total score or each domain score very likely represents a clinically important change. What's already known about this topic? Atopic dermatitis reduces the quality of life of affected children and their parents. The Childhood Atopic Dermatitis Impact Scale (CADIS) has been evaluated and translated into two further languages. What does this study add? Further validation of the responsiveness of the CADIS, and whether it is sensitive to change in patients whose condition had changed. Calculation of the smallest detectable change. What are the clinical implications of this work? Estimation of the minimal important change in CADIS provides benchmarks for clinical practice.

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The Fragility Index—P Values Reimagined, Flaws and All—Reply

Tignanelli

Napolitano

2019

JAMA Surg

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To the Editor P values are often misused and misinterpreted in the medical literature. Common mistakes include assuming P values measure the probability of a hypothesis being true (ie, indicate uncertainty) and quantify the strength of an observed effect (ie, conflating small P values with true effects). 1 As a solution, Tignanelli et al 2 strongly recommend the use of the Fragility Index (FI) and Fragility Quotient (FQ) in the reporting and appraisal of surgical randomized clinical trials (RCTs).While we agree that it is problematic to use a threshold P value of .05 in evaluating results of RCTs, the FI/FQ is not the solution for several reasons. First, as previously demonstrated, the FI almost perfectly correlates, albeit inversely, with the P value. 3 As a result, comparisons with larger P values (closer to .05) will be categorized as fragile while comparisons with smaller P values (eg, P < .001) will be deemed robust. This language is misleading, as it is widely accepted that P values should not be interpreted as a measure of the strength of an effect. 1 Any effect, no matter how small, can produce a small P value if the sample size is large enough, and large effects may produce unimpressive P values if the sample size is small. Similarly, the FI is a function of the sample size. 3 Randomized clinical trials with larger sample sizes are less likely to have a small FI. To address this issue, Tignanelli et al 2 present the FQ, which is obtained by dividing the FI by the sample size. 4 However, the authors provide no guidance for the interpretation of FQ values, which are less intuitive than the FI. Moreover, the FI is also correlated with the event rate of the outcome of interest. By virtue of this, results for outcomes with low event rates (eg, mortality) will be fragile, even when effects might be clinically meaningful. Lastly, the FI is at odds with the principles of RCT design. To conserve resources and minimize potential harm to patients, superiority RCTs are carefully designed to recruit the fewest patients necessary to detect a minimal clinically important difference. Considering these worthy objectives, it is unsurprising that many RCTs demonstrate fragility. Alternative solutions to improve the appraisal of surgical RCTs include the use of confidence intervals, as these may more directly indicate the size of an effect and its associated uncertainty, 1 and the interpretation of the observed differences in the context of absolute estimates and measures of clinical significance, such as minimal clinically important differences.

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The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies

Cited by 212 publications

References 28 publications

<p>Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Cough and Sputum in Patients with COPD</p>

<p>Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Cough and Sputum in Patients with COPD</p>

Evaluation of responsiveness and estimation of smallest detectable change and minimal important change scores for the Childhood Atopic Dermatitis Impact Scale

The Fragility Index—P Values Reimagined, Flaws and All—Reply

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