The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement was produced to ensure that trial protocols were complete and more likely to produce accurate results, while The Consolidated Standards of Reporting Trials (CONSORT) initiative was produced to improve the reporting, clarity and transparency of randomised controlled trials (RCTs) after completion.
Extensions of the SPIRIT and CONSORT statements are developed to improve the reporting of trials of specific designs, data or interventions. For example, an extension can include items that are specific to an intervention and that should be routinely reported in addition to the core items listed in the original SPIRIT and CONSORT statements.
SPIRIT and CONSORT extensions have not been developed for clinical trials of implantable neurostimulation devices. Extensions specific to trials of implantable neurostimulation devices will improve the reporting, clarity, and transparency of trials in this area and will improve confidence in the results of clinical trials of implantable neurostimulation devices.
In this project, we aim to develop SPIRIT and CONSORT extensions for clinical trials of implantable neurostimulation devices which we will name SPIRIT-iNeurostim and CONSORT-iNeurostim. We have compiled a list of items that we suggest could be included in the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions.
This survey will ask you to vote on how relevant you think each of the items are to the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions. The survey will also allow you to suggest items of your own for inclusion. Please note that the items are organised into domains, based on which section of a report they are most relevant to. The domains will be shown in a random order to reduce order bias and scoring fatigue.
Any data you enter will be anonymised. Data will initially be stored by the DelphiManager software (the software used to create the survey), which is developed and maintained by the COMET (Core Outcome Measures in Effectiveness Trials) initiative. Once data collection is complete, data will be exported and stored on the University of Liverpool drive of the Liverpool Reviews and Implementation Group (LRiG). Only the research team will be able to access the data collected.
The data will be stored until we have published the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions. We will no longer need the anonymised data after this time point. We intend to publish the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions early 2022. We can therefore confirm that all data will be destroyed by 2023.
To reduce the potential effect of order bias and scoring fatigue, the order of domains will be displayed in a randomly generated order. Each participant will be shown the domains in random order although this order will persist for that participant for the duration of the survey i.e. whatever the order in round 1, it will be the same in round 2.
All DelphiManager data is stored on a secure server in the University of Liverpool data centre. For more information please contact email@example.com