ReviewEClinicalMedicine2024
Reporting guidelines for protocols of randomised controlled trials of implantable neurostimulation devices: the SPIRIT-iNeurostim extension.
Review in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in protocols of clinical trials of implantable neurostimulation devices are common. The SPIRIT-iNeurostim extension is a new reporting guideline for randomised controlled trial protocols evaluating implantable neurostimulation devices. Methods: SPIRIT-iNeurostim was developed using the EQUATOR methodological framework including a literature review and expert consultation to generate an initial list of candidate items. The candidate items were included in a two-round Delphi survey, discussed at an international consensus meeting (42 stakeholders including healthcare professionals, methodologists, journal editors and industry representatives from the United States, United Kingdom, Netherlands and other countries), and refined through a checklist pilot (18 stakeholders). Findings: The initial extension item list included 42 candidate items relevant to SPIRIT-iNeurostim. We received 132 responses in the first round of the Delphi survey and 99 responses in the second round. Participants suggested an additional 14 candidate items for SPIRIT-iNeurostim during the first round of the survey, and those achieving initial consensus were discussed at the consensus meeting. The SPIRIT-iNeurostim extension includes 5 new checklist items, including one item for reporting the neurostimulation intervention comprising a separate checklist of 14 items. Interpretation: The SPIRIT-iNeurostim extension will help to promote increased transparency, clarity, and completeness of reporting trial protocols evaluating implantable neurostimulation devices. It will assist journal editors, peer-reviewers, and readers to better interpret the appropriateness and generalisability of the methods used for a planned clinical trial. Funding: Abbott, Boston Scientific Corp., Mainstay Medical, Medtronic Ltd, Nevro Corp., and Saluda Medical.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.