European Respiratory Journal ( IF 16.6 ) Pub Date : 2024-11-07 Kendzerska, T., Pendharkar, S. R., Talarico, R., Blades, K., Mackenzie, C., Gershon, A. S., Ayas, N., Kaminska, M., Fenton, M., McBrien, K. A., Hawken, S., Ratycz, D., Lishchenko, V., Owens, R. L., Povitz, M.
The real-world consequences of a Philips Respironics recall for positive airway pressure (PAP) devices distributed between 2009 and 2021 are unknown.
We conducted a retrospective population-based study using health administrative databases (Ontario, Canada) on all new adult PAP users identified through the provincial funding system, free of cancer at baseline, who initiated (claimed) PAP treatment between 2012 and 2018. Everyone was followed from the PAP claim date to the earliest of incident cancer diagnosis, death or end of follow-up (March 2022). We used inverse probability of treatment weighting to balance baseline characteristics between individuals on recalled devices and those on devices from other manufacturers. Weighted hazard ratios of incident cancer were compared between groups.
Of 231 692 individuals identified, 58 204 (25.1%) claimed recalled devices and 173 488 (74.9%) claimed devices from other manufacturers. A meaningful baseline difference between groups (standardised difference ≥0.10) was noted only by location-relevant covariates; other variables were mostly equally distributed (standardised differences ≤0.06). Over a median (interquartile range) follow-up of 6.3 (4.9–8.0) years, 11 166 (4.8%) developed cancer: unadjusted rates per 10 000 person-years of 78.8 (95% CI 76.0–81.7) in the recall group versus 74.0 (95% CI 72.4–75.6) in others (p=0.0034). Propensity score weighting achieved excellent balance in baseline characteristics between groups (standardised differences ≤0.07). On a weighted sample, there was no statistical difference in the hazard of incident cancer between groups: cause-specific hazard ratio (recalled versus others) 0.97 (95% CI 0.89–1.06).
In our real-world population study, compared to other manufacturers and adjusting for confounders, recalled Philips Respironics PAP devices do not appear to be independently associated with developing cancer.
中文翻译:
召回的气道正压通气装置与新发癌症之间的关联:一项基于人群的研究
飞利浦伟康召回 2009 年至 2021 年间分发的气道正压通气 (PAP) 设备的实际后果尚不清楚。
我们使用卫生行政数据库(加拿大安大略省)对通过省级资助系统确定的所有新的成人 PAP 使用者进行了一项基于人群的回顾性研究,这些用户基线时没有癌症,他们在 2012 年至 2018 年期间开始(声称)PAP 治疗。从 PAP 索赔日期到最早的癌症诊断、死亡或随访结束(2022 年 3 月),每个人都被跟踪。我们使用治疗加权的逆概率来平衡使用召回设备的个体与其他制造商的设备的个体之间的基线特征。比较各组间新发癌症的加权风险比。
在确定的 231 692 人中,58 204 人 (25.1%) 声称召回了设备,173 488 人 (74.9%) 声称设备来自其他制造商。组间有意义的基线差异(标准化差≥0.10)仅由位置相关的协变量注意到;其他变量大多分布均匀 (标准化差值 ≤0.06)。在 6.3 (4.9-8.0) 年的中位(四分位距)随访中,11 166 人 (4.8%) 患上癌症:回忆组每 10 000 人年的未经校正的发生率为 78.8 (95% CI 76.0-81.7),而其他组为 74.0 (95% CI 72.4-75.6) (p = 0.0034)。倾向评分加权在组间基线特征方面实现了极好的平衡 (标准化差异 ≤0.07)。在加权样本中,组间发生癌症的风险没有统计学差异:特定原因风险比(召回与他人相比)0.97 (95% CI 0.89-1.06)。
在我们的真实世界人群研究中,与其他制造商相比并针对混杂因素进行调整,召回的飞利浦伟康 PAP 设备似乎与癌症的发生无关。