Case study for medical devices assessment in real-world setting
Normin Health just published a retrospective cohort study assessing powered stapler in video-assisted thoracic surgery (VATS) lobectomy for lung cancer in real-world setting.: Based on the analysis of 433 patients with the utilization of staplers in their VATS lobectomy for lung cancer, using powered stapler was associated with significantly shorter operation time and post-surgery hospital stay length than using the manual stapler in the multivariable generalized linear regression analyses. However, no other significant differences were observed for other clinical outcomes between the two staplers. This study demonstrated the challenges in assessing medical devices in real-world setting due to unmeasurable confounding effects associated with clinical procedures. To balance the unmeasurable confounding effects in the comparisons, this study carefully designed the study by excluding the extreme values and used advanced statistical methods to clarify and demonstrate the clinical benefits associated with the new medical devices.