Reporting Guidelines for Clinical Trial Protocols and Reports of Implantable Neurostimulation Devices: Protocol for the SPIRIT-iNeurostim and CONSORT-iNeurostim Extensions

Objectives: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) statements have been shown to improve the quality of reporting of trial protocols and randomized controlled trials. Extensions to the SPIRIT and CONSORT statements specific to certain interventions have the potential to address meth-odological considerations that would otherwise be overlooked. The aim of this protocol is to describe the methods to develop reporting guidelines for clinical trial protocols and reports of implantable neurostimulation devices. Materials and Methods: The SPIRIT-iNeurostim and CONSORT-iNeurostim extensions will be developed through a staged consensus process involving literature review and expert consultation. The initial list of candidate items will be informed by findings from previous systematic reviews and published protocols and clinical trials of implantable neurostimulation devices. The candidate items will be included in a two-round Delphi survey. In the first round, participants will be invited to vote on the importance of each item and to suggest additional relevant items. In the second round, participants will be invited to re-score the items considering feedback received and the suggested additional items. A consensus meeting will then take place to discuss the results of the Delphi survey and reach consensus on the items to include in the extensions. Discussion: Development of the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions has the potential to lead to improve-ments and increase in transparency of the reporting of clinical trial protocols and reports of implantable neurostimulation devices.