The SPIRIT Checklist-lessons from the experience of SPIRIT protocol editors.

Riaz Qureshi, Alexander Gough, Kirsty Loudon

Abstract readLetter

In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it

0cells of the map it votes in

18citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Riaz QureshiDepartment of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, USA. riaz.qureshi@cuanschutz.edu.ORCID http://orcid.org/0000-0002-6670-4874

Alexander GoughInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.

Kirsty LoudonIndependent researcher, Edinburgh, UK.

Funding

Maximizing Use of High-Quality Evidence in Eye Care: Cochrane Eyes and Vision US ProjectUG1EY020522 · NEI · UNIVERSITY OF COLORADO DENVER · PI Tianjing Li · 2017 to 2026

$10.1M

NEI NIH HHS UG1 EY020522

6 · The paper itself

Abstract

Crystal clear RCT protocols are of paramount importance. The reader needs to easily understand the trial methodology and know what is pre-planned. They need to know there are procedures in place if there are, for instance, protocol breaches and protocol amendments are required, there is loss to follow-up and missing data, and how solicited and spontaneous reported adverse events are dealt with. This plan is important for the trial and for the results that will be published when the data is analysed. After all, individuals have consented to participate in these trials, and their time and their well-being matter. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) provides guidance to structure RCT protocols and ensures all essential information is included. But sadly, not all trialists follow the guidance, and sometimes, the information is misunderstood. Using experience peer-reviewing for Trials over the last 2 years, we have prepared information to assist authors, peer reviewers, editors, and other current and future SPIRIT protocol editors to use the SPIRIT guidance and understand its importance.

Indexed as

ChecklistPublicationsHumansEditorsPeer reviewersProtocolRandomised controlled trialsSPIRITStructured templateTrialists

Identifiers

PMID35477436

DOI10.1186/s13063-022-06316-7

PMCPMC9044711

What OpenQuestion holds

Textmetadata

LicenceCC BY

Read underepoch 390

Registered trials

None linked

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.