Tailoring CONSORT-SPI to Improve the Reporting of Smoking Cessation Intervention Trials: An expert consensus study

Zoe Swithenbank, Alessio Bricca, Nicola Black, Jamie Hartmann-Boyce, Marie Johnston, Neil Scott, Robert West, Ryan J Courtney, Shaun Treweek, Susan Michie, Marijn de Bruin* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

Background and aims
Inadequate reporting of smoking cessation intervention trials is common and leads to significant challenges for researchers. The aim of this study was to tailor CONSORT (Consolidated Standards of Reporting Trials)-SPI (Social and psychological Interventions) guidelines to improve reporting of trials of behavioural interventions to promote smoking cessation.
Method
Informed by missing data from the IC-SMOKE (Intervention and Comparison group support provided in SMOKing cEssation) systematic review project, this study used a multistage Delphi process to examine which items could be added or modified to improve the reporting of smoking cessation trials. The first stage involved an online survey of 16 international experts in smoking cessation and
trial methodology voting on the importance of items for inclusion in the updated guidelines. This was followed by a face-to-face expert consensus meeting attended by 15 of these experts, where the final inclusion and exclusion of new items and modifications were agreed upon. A 9-point Likert scale was used to establish consensus, with suggested modifications requiring agreement of 75% or more. Disagreements in the first stage were presented again at the second stage for discussion and a second round of voting. Only items which reached the threshold for agreement were included.
Results
The experts agreed on the inclusion of 10 new items and the specification of 12 existing items. This included modifications that could apply to trials more widely (e.g., the rationale for the comparator) but also modifications that were very specific to smoking cessation trials (e.g., the reporting of smoking cessation outcomes).
Conclusions
A Delphi study has developed a modified CONSORT-SPI guideline (CONSORT-SPI-SMOKE) to improve the reporting of trials of behavioural interventions to promote smoking cessation.
Original languageEnglish
Pages (from-to)225-235
Number of pages11
JournalAddiction
Volume119
Issue number2
Early online date18 Sept 2023
DOIs
Publication statusPublished - Feb 2024

Bibliographical note

Primary funding:
This work was funded by Cancer Research UK (application number C50862/A25405). The funder has no role in protocol design, decision to publish or preparation of the manuscript.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

Additional supporting information can be found online in the Supporting Information section at the end of this article.

Keywords

  • Smoking cessation
  • trials
  • reporting
  • RCTs
  • expert consensus
  • interventions

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