Hunt Kenneth J, Alexander Ian, Baumhauer Judith, Brodsky James, Chiodo Christopher, Daniels Timothy, Davis W Hodges, Deland Jon, Ellis Scott, Hung Man, Ishikawa Susan N, Latt L Daniel, Phisitkul Phinit, SooHoo Nelson Fong, Yang Arthur, Saltzman Charles L
Stanford University, Redwood City, CA, USA
Cleveland Clinic, Cleveland, OH, USA.
Foot Ankle Int. 2014 Sep;35(9):847-54. doi: 10.1177/1071100714544157.
There is an increasing need for orthopaedic practitioners to measure and collect patient-reported outcomes data. In an effort to better understand outcomes from operative treatment, the American Orthopaedic Foot & Ankle Society (AOFAS) established the Orthopaedic Foot and Ankle Outcomes Research (OFAR) Network, a national consortium of foot and ankle orthopaedic surgeons. We hypothesized that the OFAR Network could successfully collect, aggregate, and report patient-reported outcome (PRO) data using the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS).
Ten sites enrolled consecutive patients undergoing elective surgery for 1 of 6 foot/ankle disorders. Outcome instruments were collected preoperatively and at 6 months postoperatively using the PROMIS online system: Foot and Ankle Ability Measure (FAAM), Foot Function Index (FFI), and PROMIS physical function (PF) and pain computerized adaptive tests (CAT). During the 3-month period, 328 patients were enrolled; 249 (76%) had completed preoperative patient-reported outcomes data and procedure-specific data. Of these, 140 (56%) also completed 6-month postoperative patient- reported outcomes data.
Ankle arthritis and flatfoot demonstrated consistently worse preoperative scores. Five of 6 disorders showed significant improvement at 6 months on PF CAT and FAAM, 4 of 6 showed improvement on pain interference CAT, and no disorders showed improvement on FFI. Ankle arthritis and flatfoot demonstrated the greatest magnitude of change on most patient-reported outcomes scales.
We were able to enroll large numbers of patients in a short enrollment period for this preliminary study. Data were easily aggregated and analyzed. Substantial loss of follow-up data indicates a critical area requiring further effort. The AOFAS OFAR Network is undergoing expansion with goals to ultimately facilitate large, prospective multicenter studies and optimize the quality and interpretation of available outcome instruments for the foot and ankle population.
Level II, prospective comparative study.
骨科从业者对测量和收集患者报告的结局数据的需求日益增加。为了更好地了解手术治疗的结果,美国足踝骨科协会(AOFAS)建立了足踝骨科结局研究(OFAR)网络,这是一个由足踝骨科外科医生组成的全国性联盟。我们假设OFAR网络可以使用美国国立卫生研究院(NIH)患者报告结局测量信息系统(PROMIS)成功收集、汇总和报告患者报告结局(PRO)数据。
10个研究点纳入了因6种足/踝疾病之一接受择期手术的连续患者。术前和术后6个月使用PROMIS在线系统收集结局指标:足踝能力测量量表(FAAM)、足部功能指数(FFI)以及PROMIS身体功能(PF)和疼痛计算机自适应测试(CAT)。在3个月期间,共纳入328例患者;249例(76%)完成了术前患者报告结局数据和特定手术数据。其中,140例(56%)还完成了术后6个月的患者报告结局数据。
踝关节关节炎和平足症术前评分一直较差。6种疾病中有5种在术后6个月时PF CAT和FAAM有显著改善,6种中有4种在疼痛干扰CAT上有改善,而FFI无改善。踝关节关节炎和平足症在大多数患者报告结局量表上的变化幅度最大。
在这项初步研究中,我们能够在短时间内纳入大量患者。数据易于汇总和分析。随访数据大量缺失表明这是一个需要进一步努力的关键领域。AOFAS的OFAR网络正在扩大,目标是最终推动大型前瞻性多中心研究,并优化针对足踝人群的现有结局指标的质量和解读。
二级,前瞻性比较研究。