Background <p>To assess the clinical relevance of trials, facilitate comparisons across studies, and enable a priori power calculations for future trials, concepts coined ‘minimal important difference’ (MID) and ‘patient acceptable symptom state’ (PASS) have been advocated. In this study, we present MID and PASS values for three patient-reported knee outcomes: the Lysholm knee score, the Western Meniscal Evaluation Tool (WOMET), and knee pain after exercise measured on a numerical rating scale (pain-NRS), among patients who underwent arthroscopy for a degenerative meniscus tear of the knee.</p> Methods <p>The outcome scores were prospectively collected from two patient populations: a cohort of 900 consecutive patients undergoing arthroscopic partial meniscectomy (APM) and a trial involving 146 patients with an arthroscopically-verified tear of the medial meniscus who were randomised to either APM or placebo surgery. The anchor question for calculating MID was the Patients’ Global Impression of Change, assessed using a 5-point Likert scale. Data on outcomes were collected at the time of knee arthroscopy (baseline) and at 2, 6, and 12 months postoperatively. PASS was determined at 12 months postoperatively. MID was determined using four methods: predictive, mean difference of change, mean change, and receiver operating characteristic (ROC) methods, by pooling data from all time points in the cohort and trial. PASS values were calculated using the ROC and the 75th percentile methods.</p> Results <p>All instruments demonstrated strong correlation with the anchor question (Spearman’s rho from 0.55 to 0.63). Depending on the method used, MID values varied from 13.8 to 19.2 points for Lysholm, 12.8 to 22.2 points for WOMET, and 1.3 to 2.3 for pain-NRS. The calculated PASS thresholds ranged from 87.5 to 89 points for Lysholm, 89.9 to 91.1 points for WOMET, and 1 to 1.5 for pain-NRS.</p> Conclusions <p>Our study offers credible MID and PASS estimates for Lysholm, WOMET, and pain-NRS scores in patients undergoing arthroscopy for a degenerative meniscus tear. These thresholds can assist in the design and interpretation of future research and in evaluating treatment outcomes in this patient population.</p> Trial registration <p>ClinicalTrials.gov NCT00549172 (first registered October 25, 2007).</p>

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Minimal important difference and patient acceptable symptom state for Lysholm score, WOMET score, and pain in patients with arthroscopy for a degenerative meniscus tear

  • Roope Kalske,
  • Raine Sihvonen,
  • Teemu V Karjalainen,
  • Joona Juurakko,
  • Thomas Ibounig,
  • Lasse Rämö,
  • Kari Kanto,
  • Tuomas Lähdeoja,
  • Jarkko Jokihaara,
  • Mika Paavola,
  • Pirjo Toivonen,
  • Simo Taimela,
  • Teppo LN Järvinen

摘要

Background

To assess the clinical relevance of trials, facilitate comparisons across studies, and enable a priori power calculations for future trials, concepts coined ‘minimal important difference’ (MID) and ‘patient acceptable symptom state’ (PASS) have been advocated. In this study, we present MID and PASS values for three patient-reported knee outcomes: the Lysholm knee score, the Western Meniscal Evaluation Tool (WOMET), and knee pain after exercise measured on a numerical rating scale (pain-NRS), among patients who underwent arthroscopy for a degenerative meniscus tear of the knee.

Methods

The outcome scores were prospectively collected from two patient populations: a cohort of 900 consecutive patients undergoing arthroscopic partial meniscectomy (APM) and a trial involving 146 patients with an arthroscopically-verified tear of the medial meniscus who were randomised to either APM or placebo surgery. The anchor question for calculating MID was the Patients’ Global Impression of Change, assessed using a 5-point Likert scale. Data on outcomes were collected at the time of knee arthroscopy (baseline) and at 2, 6, and 12 months postoperatively. PASS was determined at 12 months postoperatively. MID was determined using four methods: predictive, mean difference of change, mean change, and receiver operating characteristic (ROC) methods, by pooling data from all time points in the cohort and trial. PASS values were calculated using the ROC and the 75th percentile methods.

Results

All instruments demonstrated strong correlation with the anchor question (Spearman’s rho from 0.55 to 0.63). Depending on the method used, MID values varied from 13.8 to 19.2 points for Lysholm, 12.8 to 22.2 points for WOMET, and 1.3 to 2.3 for pain-NRS. The calculated PASS thresholds ranged from 87.5 to 89 points for Lysholm, 89.9 to 91.1 points for WOMET, and 1 to 1.5 for pain-NRS.

Conclusions

Our study offers credible MID and PASS estimates for Lysholm, WOMET, and pain-NRS scores in patients undergoing arthroscopy for a degenerative meniscus tear. These thresholds can assist in the design and interpretation of future research and in evaluating treatment outcomes in this patient population.

Trial registration

ClinicalTrials.gov NCT00549172 (first registered October 25, 2007).