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Background <p>The Functional Status Scale (FSS) is a validated tool that provides a more comprehensive and multidimensional assessment of functional impairment in neurocritical children compared with the Pediatric Cerebral Performance Category (PCPC) score.</p> Methods <p>This study is a secondary post hoc analysis of a randomized controlled trial, which evaluated the efficacy and safety of early protocolized rehabilitation in neurocritical children. An anchor-based approach was used to calculate the minimal clinically important difference (MCID) for FSS, with PCPC serving as the anchor variable. Participants were dichotomized on the basis of PCPC scores into two groups: those who demonstrated improvement between 12 and 24&#xa0;weeks (defined as a reduction of ≥ 1 point in PCPC score) and those who did not (no change or worsening). Receiver operating characteristic (ROC) curve analysis was performed to identify the optimal FSS change score corresponding to the MCID. Sensitivity, specificity, and Youden’s index were calculated.</p> Results <p>Data from 188 participants were analyzed. On the basis of PCPC, 125 participants improved significantly between 12 and 24&#xa0;weeks. At 24&#xa0;weeks, the reduction in FSS scores was significantly greater in the improved group compared with the stable/not improved group (2.9 ± 0.7 vs. 1.9 ± 0.5, <i>p</i> &lt; 0.001). The optimal MCID cutoff for FSS was 3 points, with an AUC of 0.86 (95% CI: 0.81–0.91), and sensitivity, specificity, accuracy, and a Youden index of 79.2%, 87.3%, 81.9%, and 0.66, respectively. A total of 26 participants (20%) in the “improved” group were misclassified as “stable/not improved”, and 8 participants (12%) in the “stable/not improved” group were misclassified as “improved.”</p> Conclusions <p>The minimal clinically important difference (MCID) for the Functional Status Scale (FSS) in our study was determined to be 3 points. This, however, needs to be externally validated in future studies.</p>

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Minimal Clinically Important Difference of the Functional Status Scale in Pediatric Neurocritical Care Patients: Post Hoc Analysis of a Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2026年5月5日

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  • Indar Kumar Sharawat,
  • Prateek Kumar Panda,
  • Aman Elwadhi,
  • Tanisha Gupta,
  • Sachin Kumar,
  • Vijay Kumar Deo,
  • Lokesh Kumar Tiwari

摘要

Background

The Functional Status Scale (FSS) is a validated tool that provides a more comprehensive and multidimensional assessment of functional impairment in neurocritical children compared with the Pediatric Cerebral Performance Category (PCPC) score.

Methods

This study is a secondary post hoc analysis of a randomized controlled trial, which evaluated the efficacy and safety of early protocolized rehabilitation in neurocritical children. An anchor-based approach was used to calculate the minimal clinically important difference (MCID) for FSS, with PCPC serving as the anchor variable. Participants were dichotomized on the basis of PCPC scores into two groups: those who demonstrated improvement between 12 and 24 weeks (defined as a reduction of ≥ 1 point in PCPC score) and those who did not (no change or worsening). Receiver operating characteristic (ROC) curve analysis was performed to identify the optimal FSS change score corresponding to the MCID. Sensitivity, specificity, and Youden’s index were calculated.

Results

Data from 188 participants were analyzed. On the basis of PCPC, 125 participants improved significantly between 12 and 24 weeks. At 24 weeks, the reduction in FSS scores was significantly greater in the improved group compared with the stable/not improved group (2.9 ± 0.7 vs. 1.9 ± 0.5, p < 0.001). The optimal MCID cutoff for FSS was 3 points, with an AUC of 0.86 (95% CI: 0.81–0.91), and sensitivity, specificity, accuracy, and a Youden index of 79.2%, 87.3%, 81.9%, and 0.66, respectively. A total of 26 participants (20%) in the “improved” group were misclassified as “stable/not improved”, and 8 participants (12%) in the “stable/not improved” group were misclassified as “improved.”

Conclusions

The minimal clinically important difference (MCID) for the Functional Status Scale (FSS) in our study was determined to be 3 points. This, however, needs to be externally validated in future studies.