首页> 外文期刊>Acta orthopaedica. >Feasibility of 4 patient-reported outcome measures in a registry setting-A cross-sectional study of 6,000 patients from the Danish Hip Arthroplasty Registry
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Feasibility of 4 patient-reported outcome measures in a registry setting-A cross-sectional study of 6,000 patients from the Danish Hip Arthroplasty Registry

机译:在注册表设置中采用4种患者报告的结局指标的可行性-来自丹麦髋关节置换注册表的6,000名患者的横断面研究

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Background and purpose Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting. Methods Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1-2,5-6, or 10-11 years previously were randomly selected from the Danish Hip Arthroplasty Register and sent 2 PRO questionnaires: 1 generic (EuroQoL-5D or SF-12 health survey) and 1 disease-specific (hip dysfunction and osteoarthritis outcome score (HOOS) or Oxford 12-item hip score). We compared response rates, floor and ceiling effects, missing items, and the need for manual validation of forms. Results 4,784 patients (mean age 71 years, 57% females) were included (83%). The response rates ranged from 82-84%. Statistically significantly different floor and ceiling effects ranged from 0% to 0.5% and from 6.1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8-4.3% required manual validation (p < 0.009). A hypothetical repeat study found that group sizes from 51 to 1,566 are needed for subgroup analysis, depending on descriptive factor and choice of PRO. Interpretation All 4 PROs fulfilled a priori set criteria, with the exception of ceiling effects. The high ceiling effects were attributed to postoperative administration and good outcome for THA. We conclude that all 4 PROs are appropriate for administration in a hip registry.
机译:背景和目的在选择要在研究中使用的患者报告结果(PRO)时,可行性是一个重要参数。我们评估了髋关节注册表中PRO的可行性。方法从丹麦髋关节置换术登记册中随机选择1-2,5-6或10-11年前进行手术的原发性全髋关节置换术(THA)患者(n = 5,747),并发送2份PRO问卷:1份(EuroQoL-5D或SF-12健康调查)和1种特定疾病(髋关节功能障碍和骨关节炎结局评分(HOOS)或牛津大学12项髋关节评分)。我们比较了响应率,地板和天花板的影响,缺少的物品以及手动验证表格的需求。结果纳入了4,784例患者(平均年龄71岁,女性占57%)(83%)。回应率为82-84%。从统计上来说,地板和天花板的效果差异显着,分别为0%至0.5%和6.1%至46%。缺失项目的范围从1.2%到3.4%,而0.8-4.3%需要手动验证(p <0.009)。一项假想的重复研究发现,根据描述性因素和PRO的选择,需要进行51至1,566人的小组规模进行亚组分析。解释除上限效应外,所有4个PRO均满足先验设定的条件。最高的天花板效应归因于术后给药和THA的良好预后。我们得出结论,所有4个PRO都适合在髋关节注册表中进行管理。

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