A protocol for establishing a core outcome set for studies examining treatments for Problematic Internet use

Abstract

Background Randomised controlled trials (RCTs) evaluating Problematic internet use (PIU) have reported many different outcomes, which are themselves often defined and measured in distinct ways. Numerous clinical trials have been conducted on the efficacy and safety of different interventions in the treatment of PIU, resulting in many different outcome measures and different ways of measuring them. In order to facilitate the future research of PIU, it is necessary to produce the core Outcome Set (COS), which can help to translate the results into high-quality evidence. Methods and analysis: This mixed-method project has a three-phase tool: Phase 1, a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions for PIU. Phase 2, a systematic review of PIU literature was conducted to identify potential outcome indicators. Phase 3, final outcome indicators were determined through Modified Delphi Method, Consensus Meetings, Stakeholder Perspectives and Stakeholder Consultations. Conclusions We will develop a COS that should be reported in future clinical trials of PIU. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: www.comet-initiative.org/Studies/Details/2109. Registered in August 2022.