Mell Matthew W, Pettinger Mary, Proulx-Burns Lori, Heckbert Susan R, Allison Matthew A, Criqui Michael H, Hlatky Mark A, Burwen Dale R
Stanford University, Stanford, Calif.
Fred Hutchinson Cancer Research Center, Seattle, Wash.
J Vasc Surg. 2014 Jul;60(1):98-105. doi: 10.1016/j.jvs.2014.01.056. Epub 2014 Mar 11.
Capturing long-term outcomes from large clinical databases by use of claims data is a potential strategy for improving efficiency while reducing study costs. We sought to compare the use of Medicare data with data from the Women's Health Initiative (WHI) to determine peripheral vascular events, as defined by the WHI study design.
We studied participants from the WHI with both adjudicated outcomes and links to Medicare enrollment and utilization data through 2007. Outcomes of interest included hospitalizations for treatment of abdominal aortic aneurysm (AAA), lower extremity peripheral artery disease (LE PAD), and carotid artery stenosis (CAS). Events determined by WHI adjudication were compared with events defined by coding algorithms using diagnosis and procedure codes from Medicare data with a pilot data set and then validated with a test data set. We assessed agreement by a κ statistic and evaluated reasons for disagreement.
In the pilot set, records from 50,511 participants were analyzed. Agreement between the Centers for Medicare and Medicaid Services and WHI for admissions with a diagnosis but no treatment procedures for vascular conditions was poor (κ, 0.02-0.18). On the basis of WHI outcome data collection, vascular treatment procedures occurred in 29 participants for AAA, 204 for LE PAD events, and 281 for CAS. Medicare hospital claims recorded 41 treatments for AAA, 255 for LE PAD, and 317 for CAS. For participants with a Centers for Medicare and Medicaid Services-captured vascular procedure and a record adjudicated by WHI, κ values for treatment procedures were 0.81 for AAA, 0.77 for PAD, and 0.93 for CAS. For vascular procedures identified by WHI but not by Medicare hospital data (n = 82), 55% were captured by Medicare physician claims. Conversely, for treatments identified by Medicare hospital data but not captured by WHI adjudication (n = 57), 74% had physician claims consistent with the procedure. Fifteen participants with AAA or LE PAD procedures in hospital claims had medical records available for review, and nine of these had definitive documentation of procedures that were not captured by the WHI adjudication process. Estimated positive predictive value of Medicare data was 91% to 94% for AAA, 92% to 95% for LE PAD, and 94% to 99% for CAS. Available test set data (n = 50,253) yielded generally similar results with κ of 0.77 for AAA, 0.79 for LE PAD, and 0.94 for CAS.
Medicare data appear useful for identifying vascular treatment procedures for WHI participants. Medicare hospital claims identify more procedures than WHI does, with high positive predictive value, but also may not capture some procedures identified in WHI.
利用索赔数据从大型临床数据库中获取长期结果是一种提高效率同时降低研究成本的潜在策略。我们试图比较医疗保险数据与妇女健康倡议（WHI）数据在确定外周血管事件方面的应用，外周血管事件由WHI研究设计定义。
我们研究了来自WHI的参与者，这些参与者既有经判定的结果，又与2007年之前的医疗保险参保和使用数据相关联。感兴趣的结果包括腹主动脉瘤（AAA）、下肢外周动脉疾病（LE PAD）和颈动脉狭窄（CAS）治疗的住院情况。将WHI判定的事件与使用医疗保险数据中的诊断和程序代码通过编码算法定义的事件进行比较，首先在一个试点数据集中进行，然后用一个测试数据集进行验证。我们通过κ统计量评估一致性，并评估不一致的原因。
在试点数据集中，分析了50511名参与者的记录。医疗保险和医疗补助服务中心与WHI在诊断但无血管疾病治疗程序的入院情况上的一致性较差（κ，0.02 - 0.18）。根据WHI结果数据收集情况，29名参与者因AAA接受了血管治疗程序，204名因LE PAD事件接受了治疗，281名因CAS接受了治疗。医疗保险住院索赔记录了41例AAA治疗、255例LE PAD治疗和317例CAS治疗。对于有医疗保险和医疗补助服务中心记录的血管程序且经WHI判定的参与者，治疗程序的κ值对于AAA为0.81，对于PAD为0.77，对于CAS为0.93。对于WHI确定但医疗保险医院数据未确定的血管程序（n = 82），55%被医疗保险医生索赔记录。相反，对于医疗保险医院数据确定但未被WHI判定捕获的治疗（n = 57），74%有与该程序一致的医生索赔记录。15名在医院索赔中有AAA或LE PAD程序的参与者有可用于审查的病历，其中9名有未被WHI判定过程捕获的程序的确切记录。医疗保险数据对AAA的估计阳性预测值为91%至94%，对LE PAD为92%至95%，对CAS为94%至99%。可用的测试数据集数据（n = 50253）产生了大致相似的结果，AAA的κ值为0.77，LE PAD为0.79，CAS为0.94。
医疗保险数据似乎有助于识别WHI参与者的血管治疗程序。医疗保险住院索赔识别出的程序比WHI多，具有较高的阳性预测值，但也可能未捕获WHI中确定的一些程序。
