Kerger Brent D, Bernal Autumn, Paustenbach Dennis J, Huntley-Fenner Gavin
Exponent, 320 Goddard, Suite 200, Irvine, CA, 92618, USA.
Cardno ChemRisk, 130 Vantis, Suite 170, Aliso Viejo, CA, 92656, USA.
BMC Public Health. 2016 Sep 15;16:979. doi: 10.1186/s12889-016-3595-7.
Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri.
Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events.
We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries.
We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.
关于植入式医疗设备和药品潜在健康危害的负面新闻媒体报道可能会导致“负面光环效应”，即即便科学依据并不充分，对某一产品或产品类型的判断也可能在不知不觉中被改变。为了确定“负面光环效应”如何影响医疗产品的使用和/或取出率，我们分析了这种效应在三种植入式医疗设备和一种药物上的发生情况：1）宫内节育器（IUD）；2）硅胶填充乳房植入物（SGBI）；3）金属对金属髋关节植入物（MoM）；以及4）药物泰萨比（Tysabri）。
1965年至2008年宫内节育器使用数据来自卫生与公众服务部的生命与健康统计数据以及同行评审出版物。1989年至2012年硅胶填充乳房植入物植入及取出率数据来自医学研究所和美国整形外科医师协会。金属对金属髋关节植入物的植入和取出数据从英格兰和威尔士国家联合登记处及同行评审出版物中提取。泰萨比患者数据由伊兰公司或百健艾迪公司报告。将所有产品的数据趋势与历史召回或撤市事件进行比较，并在这些事件之后公众认知的背景下进行讨论。
我们发现，一些共同因素改变了公众的风险认知和持续使用模式。首先，尽管临床结果呈阳性，但持续的患者焦虑可能会引发负面光环效应。其次，关于一种产品的负面报道可能会蔓延，影响同一类中不同产品的使用。第三，无论与安全性相关的科学发现如何，对整个医疗设备类别的负面光环效应都可能持续存在。第四，在美国，一种产品安全声誉的恢复和普遍使用可能需要数十年时间，即便这些产品在其他国家可能广泛使用且安全记录良好。
我们得出结论，与污名相关的“负面光环效应”，而非对医疗产品进行客观的风险效益评估，可能会因产品使用减少或不当而增加患者的负面健康结果。
