Sprague Sheila, Petrisor Brad A, Jeray Kyle J, McKay Paula, Scott Taryn, Heels-Ansdell Diane, Schemitsch Emil H, Liew Susan, Guyatt Gordon H, Walter Stephen D, Bhandari Mohit
Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
J Orthop Trauma. 2018 Jan;32(1):e5-e11. doi: 10.1097/BOT.0000000000000993.
To analyze FLOW data to identify baseline patient, injury, fracture, and treatment factors associated with lower health-related quality of life (HRQoL) at 12-month postfracture.
Prognostic study using data from a prospective randomized controlled trial.
Thirty-one clinical centers in the United States, Canada, Australia, and India.
PATIENTS/PARTICIPANTS: One thousand four hundred twenty-seven patients with open fracture from the FLOW trial with complete 12-month Short Form-12 (SF-12) follow-up assessment and no missing data for selected baseline factors.
Not applicable.
Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 at 12-month postfracture.
One thousand four hundred twenty-seven patients were included in the SF-12 PCS and MCS linear regression models. Smoking, lower preinjury SF-12 PCS and MCS, and work-related injuries were significantly associated with lower SF-12 PCS and MCS at 12-month postfracture. A lower extremity fracture and a wound that was not closed at initial irrigation and debridement were significantly associated with lower 12-month SF-12 PCS but not MCS. Only the adjusted mean difference for lower extremity fractures approached the minimally important difference for the SF-12 PCS.
We identified a number of statistically significant baseline factors associated with lower HRQoL; however, only the presence of a lower extremity fracture approached clinical significance. More research is needed to quantify the impact of these factors on patients and to determine whether changes to modifiable factors at baseline will lead to clinically significant improvements in HRQoL after open fractures.
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
分析FLOW数据，以确定与骨折后12个月时健康相关生活质量（HRQoL）较低相关的基线患者、损伤、骨折和治疗因素。
使用来自前瞻性随机对照试验的数据进行的预后研究。
美国、加拿大、澳大利亚和印度的31个临床中心。
患者/参与者：来自FLOW试验的1427例开放性骨折患者，有完整的12个月简短健康调查问卷（SF-12）随访评估，且所选基线因素无缺失数据。
不适用。
骨折后12个月时SF-12的身体成分评分（PCS）和心理成分评分（MCS）。
1427例患者纳入了SF-12 PCS和MCS线性回归模型。吸烟、伤前较低的SF-12 PCS和MCS以及与工作相关的损伤与骨折后12个月时较低的SF-12 PCS和MCS显著相关。下肢骨折以及初次冲洗和清创时未闭合的伤口与12个月时较低的SF-12 PCS显著相关，但与MCS无关。只有下肢骨折的校正平均差异接近SF-12 PCS的最小重要差异。
我们确定了一些与较低HRQoL相关的具有统计学意义的基线因素；然而，只有下肢骨折的存在接近临床意义。需要更多研究来量化这些因素对患者的影响，并确定在基线时改变可改变因素是否会导致开放性骨折后HRQoL出现具有临床意义的改善。
预后II级。有关证据水平的完整描述，请参阅作者指南。
