Franceschini Marco, Boffa Angelo, Di Martino Alessandro, Pignotti Elettra, Andriolo Luca, Zaffagnini Stefano, Filardo Giuseppe
Università di Bologna Bologna Italy.
Applied and Translational Research (ATR) Center IRCCS Istituto Ortopedico Rizzoli Bologna Italy.
J Exp Orthop. 2025 Feb 10;12(1):e70137. doi: 10.1002/jeo2.70137. eCollection 2025 Jan.
To quantify the influence of baseline values of a specific patient-reported outcome measure (PROM) on the minimal clinically important difference (MCID) calculation in a homogeneous series of knee osteoarthritis patients treated with platelet-rich plasma (PRP) injections.
A data set of 312 patients with knee osteoarthritis treated with intra-articular PRP injections was used. Patients were evaluated through the International Knee Documentation Committee (IKDC) subjective score at 6 months after treatment. According to the baseline IKDC score, the study population was stratified into eight clusters in the first phase (<20, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79 and ≥80) and in three macro clusters in the second phase (<40, 40-69 and ≥70). MCID for the IKDC score was calculated through an anchor-based method in both phases.
The MCID calculation was performed for the eight clusters according to the baseline IKDC values, obtaining values from 16.2 to -3.1. Afterwards, further MCID calculation was performed after unifying patients in three major clusters based on the similarity of the previously obtained MCID values. Ninety-six patients reported a baseline IKDC score <40, 173 patients between 40 and 70, and 43 patients ≥70. MCID values for the three macro clusters were: 14.6 for patients with baseline IKDC score <40, 7.2 for patients with values between 40 and 69, while patients with values ≥70 reported an MCID value of -2.8.
This study demonstrated that the baseline patient clinical status influences the improvement needed to be perceived as clinically relevant. Patients with a worse baseline clinical status presented higher MCID levels, while MCID lost significance in patients with high baseline clinical values. These findings warrant applying general thresholds to a patients' cohort, showing the remarkable impact of the baseline clinical status. Patient stratification ensures a proper quantification of MCID values and the identification of patients benefiting from the studied treatment.
Level 4.
量化特定患者报告结局指标（PROM）的基线值对接受富血小板血浆（PRP）注射治疗的同质膝关节骨关节炎患者系列中最小临床重要差异（MCID）计算的影响。
使用了一组312例接受关节内PRP注射治疗的膝关节骨关节炎患者的数据。在治疗后6个月通过国际膝关节文献委员会（IKDC）主观评分对患者进行评估。根据基线IKDC评分，研究人群在第一阶段被分为八个组（<20、20 - 29、30 - 39、40 - 49、50 - 59、60 - 69、70 - 79和≥80），在第二阶段被分为三个大组（<40、40 - 69和≥70）。在两个阶段均通过基于锚定的方法计算IKDC评分的MCID。
根据基线IKDC值对八个组进行MCID计算，得到的值在16.2至 - 3.1之间。之后，根据先前获得的MCID值的相似性将患者统一分为三个主要组后，进一步进行MCID计算。96例患者报告基线IKDC评分<40，173例患者在40至70之间，43例患者≥70。三个大组的MCID值分别为：基线IKDC评分<40的患者为14.6，值在40至69之间的患者为7.2，而值≥70的患者报告的MCID值为 - 2.8。
本研究表明，患者的基线临床状态会影响被视为具有临床相关性所需的改善程度。基线临床状态较差的患者呈现出较高的MCID水平，而在基线临床值较高的患者中MCID失去意义。这些发现保证了对患者队列应用通用阈值，显示了基线临床状态的显著影响。患者分层确保了MCID值的适当量化以及确定从所研究治疗中受益的患者。
4级。
