Focusing on Patient-outcome performance measures of Active and Passive Implants - A scoping review

MotivationActive implantable electronic medical devices are used in different fields of medicine, in particular cardiology and neurology. Several papers have been published over the years comparing the technical performance of implants between leading manufactures. However, no such comparison has been done with respect to "Patient-Reported Outcomes" (PROs) for most implant types, despite its importance in evaluating the quality of a medical device. With the recent update of the European Unions (EU) regulation on public procurement towards value-based medicine, it has become beneficial for manufacturers to focus more on PROs to differentiate their products in order to create a marketing leverage. Most importantly, investigating PROs can assist shared decision-making, support pharmaceutical labelling claims and influence healthcare policy and practice. Due to this the review aims to showcase the lack of PRO comparisons between implant manufacturers across different medical fields and its impact on patients and surgeons. MethodsA literature search was conducted for active and passive implant performance comparisons in the area of implantable cardioverter-defibrillator (ICDs), deep brain stimulation (DBS), cochlear implants (CIs) and intraocular lenses (IOLs). The search focused on the availability of manufacturer comparisons with regards to PROs. A total of 640 papers from 2000 until 2022 were screened in detail for the search term "patient reported outcomes" for the different implant types. Next, we analyzed the results by tagging papers based on the specific topics they investigated in their study to enable a cross-comparison. We noted whether the implant manufacturers were mentioned as well as whether a manufacturer comparison was done. Studies were also evaluated based on the number of patients included. ResultsA total of 38 papers were identified for ICDs, 31 for DBS, 68 for IOLs and 34 for CIs. 50% of the papers for IOL focused on PROs and 22% and 14% for CIs and DBS, whilst mentioning the manufacturers. No papers dealing with PROs could be identified for ICDs. Manufacturer comparison was not attempted by any of the reviewed papers, despite implants such as CIs and DBS having quite a significant impact on the quality of life. ConclusionsThere is an urgent need for clinical studies which focus on PRO comparisons between implants of different manufacturers, to not only provide physicians and patients with critical information that informs their decision prior to implantation, but also to increase the competition between manufacturers, thus, fostering innovation. The former would allow physicians to recommend the most suitable implant for the patient. In addition, this will drive manufacturers towards PRO focused improvements.