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Published on: February 19, 2021
A classification of methods used to personalize participative interventions revealed inadequate reporting in trial
Alexandre Malmartel1, Philippe Ravaud2, Lina Ghosn3
1Université de Paris, METHODS Team, CRESS, INSERM, INRA, F-75004 Paris, France; Département de médecine générale, Université de Paris, F-75014 Paris, France.
Objectives:
The objective of the study was to develop a classification of methods used to personalize participative interventions in randomized controlled trials (RCTs).
Study Design And Setting:
We conducted a systematic review including protocols of RCTs assessing participative interventions in PubMed and ClinicalTrials.gov between June 2018 and May 2019. Data extraction was performed by two independent reviewers. We developed a precise classification of methods used to personalize interventions. Then, protocols were reviewed to determine whether personalization was sufficiently described to enable replication.
Results:
We included 109 protocols. The classification used four components and 13 subcomponents accounting for decision points (when interventions were personalized), tailoring variables (on what interventions were personalized), decision rules (how and by whom interventions were personalized), and nature of the subsequent tailoring (what was personalized in the interventions). In 95% of protocols, at least one component or subcomponent of our classification was not adequately reported to enable the replication of the intervention. Components the least well described were tailoring variables (72% of protocols insufficiently described) and the nature of the subsequent tailoring (46% of protocols).
Conclusion:
This study provides the first detailed classification of methods used to personalize interventions. This is required to transparently implement personalization and improve reporting in RCTs.
Insights
This study created a classification for personalizing interventions in randomized controlled trials (RCTs). Reporting of personalization methods in RCT protocols is often inadequate for replication.
Area of Science:
- Clinical trial methodology
- Intervention personalization
- Health services research
Background:
- Personalized interventions enhance participant engagement and treatment efficacy in clinical research.
- Standardized reporting of personalization methods in randomized controlled trials (RCTs) is crucial for reproducibility.
Purpose of the Study:
- To develop a comprehensive classification system for methods used in personalizing participative interventions within RCTs.
- To assess the adequacy of reporting for personalization methods in published RCT protocols.
Main Methods:
- Conducted a systematic review of 109 RCT protocols from PubMed and ClinicalTrials.gov (June 2018-May 2019).
- Developed a four-component, 13-subcomponent classification for intervention personalization: decision points, tailoring variables, decision rules, and tailoring nature.
- Evaluated protocols for sufficient description of personalization methods to enable replication.
Main Results:
- The developed classification encompasses decision points, tailoring variables, decision rules, and the nature of tailoring.
- 95% of reviewed RCT protocols lacked adequate reporting of at least one personalization component, hindering replication.
- Tailoring variables (72%) and the nature of subsequent tailoring (46%) were the least adequately described components.
Conclusions:
- This study introduces the first detailed classification for personalizing interventions in RCTs.
- Improved reporting of personalization methods is essential for transparency and replicability in clinical trials.
- The classification provides a framework to enhance the quality and consistency of intervention personalization reporting.
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