Bhattacharyya Timothy, Tornetta Paul, Healy William L, Einhorn Thomas A
Boston University Medical Center, Department of Orthopaedic Surgery, Massachusetts 02118, USA.
J Bone Joint Surg Am. 2003 Jul;85(7):1224-8. doi: 10.2106/00004623-200307000-00007.
Orthopaedic surgeons are frequently presented with advertisements for orthopaedic and medical products in which companies make claims of clinical and scientific fact. This study was designed to evaluate the statements made in orthopaedic print advertisements and determine whether they are supported by scientific data.
Fifty statements from fifty advertisements were chosen at random from six peer-reviewed orthopaedic journals. The companies that placed the advertisements were contacted to provide supporting data for the statement of clinical or scientific fact. Three senior orthopaedic surgeons evaluated the data for quality and support. A high-quality study was defined as a study that could be published in the peer-reviewed literature. A well-supported statement was defined as a statement with enough supporting evidence to be used in clinical practice. The evaluating surgeons were blinded to product and company identification.
The supporting data were from a published source for eighteen claims (36%), from a presentation at a public forum or a scientific meeting for twelve claims (24%), or were "data on file" only at the company for twelve claims (24%). Interobserver agreement among the surgeons evaluating the advertisements for quality and support was good (the average intraclass correlation coefficient was 0.72). Of the fifty claims, twenty-two were considered unsupported by scientific data, seventeen were classified as possibly supported, seven were well supported, and four were from companies that did not respond despite three requests. Claims that were supported by published data were significantly more likely to be rated as well supported (p < 0.001). All twelve claims that were supported purely by "data on file" at the company were considered to be poorly supported.
Orthopaedic surgeons should interpret claims made in orthopaedic print advertisements with caution. Approximately half of the claims are not supported by enough data to be used in a clinical decision-making process.
骨科医生经常会看到骨科和医疗产品的广告，其中公司会宣称一些临床和科学事实。本研究旨在评估骨科平面广告中的陈述，并确定它们是否有科学数据支持。
从六种同行评审的骨科期刊中随机选取五十则广告中的五十条陈述。联系刊登广告的公司，要求其提供临床或科学事实陈述的支持数据。三位资深骨科医生对数据的质量和支持情况进行评估。高质量研究被定义为可以在同行评审文献中发表的研究。有充分支持的陈述被定义为有足够支持证据可用于临床实践的陈述。评估医生对产品和公司信息不知情。
支持数据来自已发表来源的有18条声明（36%），来自公共论坛或科学会议报告的有12条声明（24%），仅公司“存档数据”的有12条声明（24%）。评估广告质量和支持情况的医生之间的观察者间一致性良好（组内相关系数平均值为0.72）。在五十条声明中，22条被认为没有科学数据支持，17条被归类为可能有支持，7条有充分支持，4条来自公司，尽管三次请求仍未回应。有已发表数据支持的声明被评为有充分支持的可能性显著更高（p < 0.001）。所有仅由公司“存档数据”支持的12条声明都被认为支持不足。
骨科医生应谨慎解读骨科平面广告中的声明。大约一半的声明没有足够数据支持，无法用于临床决策过程。
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