接受与拒绝参与一项探究减肥与膝关节置换术效果以探讨普遍性的随机试验的膝关节骨关节炎合格患者的特征：一项横断面研究。
Characteristics of eligible patients with knee osteoarthritis accepting versus declining participation in a randomised trial investigating the effect of weight loss versus knee arthroplasty to explore generalisability: A cross-sectional study.
作者信息
Aljuboori Saber Muthanna, Christensen Robin, Henriksen Marius, Bliddal Henning, Troelsen Anders, Boesen Mikael, Poulsen Asbjørn Seenithamby, Nielsen Camilla Toft, Bunyoz Kristine Ifigenia, Overgaard Søren
机构信息
Department of Orthopedic Surgery and Traumatology, Copenhagen University Hospital-Bispebjerg & Frederiksberg, Copenhagen, Denmark.
The Parker Institute, Copenhagen University Hospital-Bispebjerg & Frederiksberg, Frederiksberg, Denmark.
出版信息
Knee Surg Sports Traumatol Arthrosc. 2025 Sep;33(9):3070-3079. doi: 10.1002/ksa.12546. Epub 2025 Jan 5.
BACKGROUND
The INtensive diet versus Knee Arthroplasty (INKA) trial is a randomised trial assessing weight loss as an alternative to knee arthroplasty (KA) in obese patients with severe knee osteoarthritis (OA) awaiting KA (NCT05172843). The external validity of the INKA trial may be hampered if the patients who participate differ from those who decline participation.
OBJECTIVE
To compare baseline characteristics between patients who enrol in the INKA trial and those who decline participation (i.e., non-INKA [nINKA] group).
METHODS
We applied a cross-sectional study design, collecting and comparing baseline characteristics among all patients eligible for enrolment in the INKA trial from two clinics in Copenhagen. Imbalance between accepting (INKA) and declining (nINKA) groups was assessed using standardised differences (StdDs). We were prespecified that StdD values < 0.20 would indicate a clinically insignificant imbalance between groups, whereas values > 0.80 indicate incomparability.
RESULTS
Of the 913 patients scheduled for KA, 888 were screened for INKA trial eligibility. Of the 217 eligible patients, 92 (42%) were enroled in the INKA trial, while 37 (17%) participated in the nINKA cross-sectional sample only. Patients enroled in INKA had on average a less severe Oxford knee score (OKS) of 22.0 (standard deviation = 6.7) compared to declining participants in nINKA with 18.6 (7.2), corresponding to an StdD of 0.50, and an absolute difference of 3.45 (95% confidence interval = 0.64-6.26, p = 0.017). A consistent similar pattern was noted across all secondary patient-reported outcomes applied in the INKA trial.
CONCLUSIONS
We observed discrepancies in patient-reported outcomes, with those who declined enrolment reporting more severe symptoms. These differences, however, were below the minimally important difference between groups for OKS, which is set to 4.84 points.
LEVEL OF EVIDENCE
Level II-III cross-sectional study in a randomised control trial.
背景
强化饮食与膝关节置换术（INKA）试验是一项随机试验，旨在评估减肥作为等待膝关节置换术（KA）的重度膝关节骨关节炎（OA）肥胖患者膝关节置换术（KA）的替代方案（NCT05172843）。如果参与试验的患者与拒绝参与的患者不同，INKA试验的外部有效性可能会受到影响。
目的
比较INKA试验入选患者与拒绝参与患者（即非INKA[nINKA]组）的基线特征。
方法
我们采用横断面研究设计，收集并比较哥本哈根两家诊所所有符合INKA试验入选条件的患者的基线特征。使用标准化差异（StdDs）评估接受（INKA）组和拒绝（nINKA）组之间的不平衡。我们预先设定，StdD值<0.20表明两组之间的临床不平衡不显著，而值>0.80表明不可比。
结果
在计划进行KA的913例患者中，888例接受了INKA试验资格筛查。在217例符合条件的患者中，92例（42%）入选INKA试验，而37例（17%）仅参与了nINKA横断面样本。与nINKA中拒绝参与的患者相比，INKA入选患者的牛津膝关节评分（OKS）平均严重程度较低，分别为22.0（标准差=6.7）和18.6（7.2），对应的StdD为0.50，绝对差异为3.45（95%置信区间=0.64-6.26，p=0.017）。在INKA试验应用的所有次要患者报告结局中都观察到了一致的类似模式。
结论
我们观察到患者报告结局存在差异，拒绝入选的患者报告的症状更严重。然而，这些差异低于OKS设定的两组之间最小重要差异，即4.84分。
证据水平
随机对照试验中的II-III级横断面研究。
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