Reporting guidelines for clinical trial protocols and reports of implantable neurostimulation devices: the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions

Thank you for completing the first round of the Delphi Survey. The second round is now open until the 31st January 2022.

Please note that there is the option to be acknowledged as a study participant upon completion of the survey. f you would like to be acknowledged, please complete the information requested at the end of the survey.

During the second round, for each item you will be shown:

your rating from the first round of the Delphi survey

the distribution of ratings from the other participants who completed the first round of the Delphi survey.

You will then be asked again to rate how relevant you think each of the items are to the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions using the 9-point scale as follows:

1 to 3: Not important

4 to 6: Important but not critical

7 to 9: Important and critical

It is your decision whether to repeat your original rating or whether to change it.

The second round of the Delphi survey includes additional items suggested by participants. Any additional items are marked in the survey by the preface '[SUGGESTED ITEM]'. It is possible that some suggested items:

may already be included in the SPIRIT and CONSORT statements
may not be generalisable to all indications for implantable neurostimulation devices

Inclusion of the suggested items in the SPIRIT-iNeurostim and CONSORT-iNeurostim extensions will be discussed at the consensus meeting and will consider participant ratings during the second round and the above bullet points.

Similar to the first round of the Delphi survey, the order of domains will be displayed in a randomly generated order to reduce the potential effect of order bias and scoring fatigue,

 


The Standard Protocol Items: Recommendations for Interventional Trials (SPIRITstatement was produced to ensure that trial protocols were complete and more likely to produce accurate results, while The Consolidated Standards of Reporting Trials (CONSORTinitiative 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.

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 start rating Round 2 please click here.

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All DelphiManager data is stored on a secure server in the University of Liverpool data centre. For more information please contact delphimg@liverpool.ac.uk