Elkan P, Lagerbäck T, Möller H, Gerdhem Paul
Department of Clinical Sciences, Intervention and Technology (CLINTEC), Karolinska Institutet, 141 86, Stockholm, Sweden.
Department of Clinical Sciences, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Eur Spine J. 2018 Jul;27(7):1538-1546. doi: 10.1007/s00586-018-5541-0. Epub 2018 Mar 9.
Quality registers give unique possibilities to achieve information from large groups of patients, but outcome must be interpreted carefully due to less stringent data collection and lower follow-up rates than in research projects. We tried to quantify any outcome differences between a national spine quality register and a prospective observational study.
Adult patients treated with lumbar discectomy between 2004 and 2010 were retrieved from the Swedish Spine register (Swespine) (n = 7791) and from the single center lumbar disc herniation study (LDHS) in Stockholm (n = 177). The mean follow-up rates at 1 and 2 years were 73 and 62%, compared to 98 and 99%, respectively. Patient-reported outcome measurements included VAS for back and leg pain, ODI, EQ-5D, patient satisfaction, and global assessment.
When comparing the two cohorts at baseline, there were minor differences in the patient-reported outcome measurements, all within reported minimal clinical important differences (MCID). Mean outcome improved significantly in both groups after surgery. All outcomes at 1 and 2 years were similar and within the reported MCID in both groups. Complications and reoperations were similar, except for more surgical site infections in the LDHS group.
Higher response rates than seen in Swespine are not needed to achieve reasonably representative data on patient-reported outcome for large cohorts. Two-year data do not seem to add additional information. These slides can be retrieved under Electronic Supplementary Material.
质量登记册为获取大量患者的信息提供了独特的可能性,但由于数据收集不如研究项目严格且随访率较低,因此对结果的解读必须谨慎。我们试图量化国家脊柱质量登记册与前瞻性观察性研究之间的任何结果差异。
从瑞典脊柱登记册(Swespine)(n = 7791)和斯德哥尔摩的单中心腰椎间盘突出症研究(LDHS)(n = 177)中检索2004年至2010年接受腰椎间盘切除术的成年患者。1年和2年时的平均随访率分别为73%和62%,而研究项目中的随访率分别为98%和99%。患者报告的结局指标包括背部和腿部疼痛的视觉模拟评分(VAS)、腰椎功能障碍指数(ODI)、EQ-5D量表、患者满意度和总体评估。
在基线时比较两组患者,患者报告的结局指标存在微小差异,均在报告的最小临床重要差异(MCID)范围内。两组患者术后平均结局均有显著改善。两组在1年和2年时的所有结局均相似且在报告的MCID范围内。并发症和再次手术情况相似,但LDHS组的手术部位感染更多。
对于大型队列,要获得关于患者报告结局的合理代表性数据,并不需要比Swespine更高的回应率。两年的数据似乎并未增加额外信息。这些幻灯片可在电子补充材料中获取。