Public Health Institute, Liverpool John Moores University, Liverpool, UK.
Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark, Odense, Denmark.
Addiction. 2024 Feb;119(2):225-235. doi: 10.1111/add.16340. Epub 2023 Sep 18.
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.
Informed by missing data from the IC-SMOKE (Intervention and Comparison group support provided in SMOKing cEssation) systematic review project, this study used a multi-stage Delphi process to examine which items could be added or modified to improve the reporting of smoking cessation trials. The first stage involved an on-line survey of 17 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 nine-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.
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).
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.
戒烟干预试验报告不充分的情况很常见，这给研究人员带来了重大挑战。本研究旨在调整 CONSORT（临床试验报告标准）-SPI（社会和心理干预）指南，以改善促进戒烟的行为干预试验报告。
本研究借鉴了 IC-SMOKE（干预和比较组在戒烟中提供的支持）系统评价项目中的缺失数据，采用多阶段 Delphi 流程，研究可以添加或修改哪些项目来改进戒烟试验报告。第一阶段涉及对 17 名国际戒烟和试验方法学专家进行在线调查，让他们对纳入更新指南的项目的重要性进行投票。随后，15 名专家参加了面对面的专家共识会议，会上商定了新项目的最终纳入和排除以及修改内容。采用九点李克特量表来确定共识，建议修改内容需要得到 75%或以上的同意。第一阶段的分歧在第二阶段再次提出讨论和第二轮投票。只有达到协议门槛的项目才被纳入。
专家们同意纳入 10 个新项目和规定 12 个现有项目。这包括可适用于更广泛试验的修改（例如比较的理由），但也包括非常特定于戒烟试验的修改（例如戒烟结果的报告）。
Delphi 研究制定了改良的 CONSORT-SPI 指南（CONSORT-SPI-SMOKE），以改善促进戒烟的行为干预试验报告。
