Reporting Guidelines: Clinical Trial Protocols and Reports of Implantable Neurostimulation Devices

Background & Aims

SPIRIT and CONSORT statements have improved the reporting quality of trial protocols and randomised controlled trials.[1] Extensions to the SPIRIT and CONSORT statements specific to certain interventions can address additional methodological considerations. The aim of this study was to develop reporting guidelines for protocols and reports of clinical trials of implantable neurostimulation devices.

Methods

SPIRIT-iNeurostim and CONSORT-iNeurostim extensions were developed through a staged consensus process involving literature review and expert consultation.[2] An initial list of candidate items was generated from previous systematic review findings,[3,4] published protocols and reports of clinical trials of implantable neurostimulation devices. Participants were invited to complete a two-round Delphi survey. In the first round, participants voted on the importance of each item and suggested additional items. In the second round, participants re-scored the items from the first round and the additional items suggested. The Delphi survey results were discussed at a consensus meeting and selected stakeholders voted on items for inclusion in the extensions (>70% consensus vote in favour of inclusion was required for inclusion in the SPIRIT-iNeurostim and/or CONSORT-iNeurostim extensions). The checklists were piloted to assess the clarity of the wording of the new items.

Results

The Delphi survey initially included 42 items relevant to the SPIRIT- and CONSORT-iNeurostim extensions and 7 items relevant to the CONSORT-iNeurostim extension only. There were 132 responses to the first Delphi survey round and participants suggested 34 additional items (14 for SPIRIT- and 20 for CONSORT-iNeurostim). There were 99 responses to the second round.
At the consensus meeting, 57 SPIRIT- and 75 CONSORT-iNeurostim extension items were discussed. Following the consensus meeting, 34 SPIRIT- and 49 CONSORT-iNeurostim extension items were excluded (<70% consensus vote, covered by current SPIRIT/CONSORT statement or beyond scope). The SPIRIT-iNeurostim extension recommends 5 new checklist items (elaborations) as additions to the current SPIRIT statement, including an intervention checklist of 17 items. The CONSORT-iNeurostim extension recommends 7 new checklist items (elaborations) as additions to the current CONSORT statement, including an intervention checklist of 14 items.

Conclusions

SPIRIT-iNeurostim and CONSORT-iNeurostim extensions followed the EQUATOR framework that involved a staged consensus process involving multiple international stakeholder groups. Future steps include dissemination of findings to increase awareness and implementation of the new iNeurostim checklists.

References

1. Ranganathan P. The CONSORT statement and its impact on quality of reporting of trials. Perspect Clin Res 2019; 10:145–147.
2. Duarte RV, Bresnahan R, Copley S, et al. Reporting Guidelines for Clinical Trial Protocols and Reports of Implantable Neurostimulation Devices: Protocol for the SPIRIT-iNeurostim and CONSORT-iNeurostim Extensions. Neuromodulation 2022;25(7):1045-1049.
3. Duarte RV, McNicol E, Colloca L, Taylor RS, North RB, Eldabe S. Randomized Placebo-/Sham-Controlled Trials of Spinal Cord Stimulation: A Systematic Review and Methodological Appraisal. Neuromodulation 2020;23(1):10-18.
4. McNicol E, Ferguson M, Bungay K, et al. Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation for Pain. J Pain 2021;22(2):127-142.